WO2025196667A2 - Dispositifs, systèmes et procédés de réparation ou de renforcement d'os - Google Patents

Dispositifs, systèmes et procédés de réparation ou de renforcement d'os

Info

Publication number
WO2025196667A2
WO2025196667A2 PCT/IB2025/052889 IB2025052889W WO2025196667A2 WO 2025196667 A2 WO2025196667 A2 WO 2025196667A2 IB 2025052889 W IB2025052889 W IB 2025052889W WO 2025196667 A2 WO2025196667 A2 WO 2025196667A2
Authority
WO
WIPO (PCT)
Prior art keywords
bone
openings
region
biomaterial
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/052889
Other languages
English (en)
Other versions
WO2025196667A4 (fr
WO2025196667A3 (fr
Inventor
Thomas A. RUSSELL
Gerard Insley
Tanja Limberger
Christophe Geisert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biomimetic Innovations Ltd
Original Assignee
Biomimetic Innovations Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biomimetic Innovations Ltd filed Critical Biomimetic Innovations Ltd
Publication of WO2025196667A2 publication Critical patent/WO2025196667A2/fr
Publication of WO2025196667A3 publication Critical patent/WO2025196667A3/fr
Publication of WO2025196667A4 publication Critical patent/WO2025196667A4/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A61B17/7233—Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone
    • A61B17/7241—Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone the nail having separate elements through which screws pass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/74—Devices for the head or neck or trochanter of the femur
    • A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
    • A61B17/744—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to an intramedullary nail
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/74—Devices for the head or neck or trochanter of the femur
    • A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
    • A61B17/746—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to a plate opposite the femoral head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/8635—Tips of screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/869—Pins or screws or threaded wires; nuts therefor characterised by an open form, e.g. wire helix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00951—Material properties adhesive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0403—Dowels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone

Definitions

  • the devices, systems, and methods of the disclosure provide implants and uses thereof for repairing bone defects (e.g., bone fractures), stabilizing bone, or providing or improving implant fixation.
  • the implants disclosed herein can be used to achieve uniform distribution and delivery of a biomaterial to the bone to be repaired or to a site of implant fixation.
  • the disclosure features a device including a unitary body including from a proximal end to a distal end: a proximal region, a central region, and a distal region, in which one or two of these regions may be absent.
  • the device includes a proximal region, central region, and distal region.
  • the device includes a proximal region and a distal region while the central region is absent.
  • the device includes a central region while the proximal region and distal region are absent.
  • the device includes an internal channel extending longitudinally through the unitary body.
  • the proximal region, central region, and distal region each comprise a plurality of openings or an external thread.
  • the proximal region, central region, and distal region are stiff (i.e., inflexible, incompressible, and/or non-expandible, e.g., having a Young's modulus of greater than about 100 GPa).
  • the device can be configured as a compression screw component, a fastener, and/or a suture anchor.
  • proximal, central, and distal regions are of substantially equal stiffness (e.g., within ⁇ 10% difference or less).
  • the plurality of openings are configured to disperse a biomaterial injected or placed into the internal channel to an area surrounding the unitary body. In some embodiments, the plurality of openings are configured to induce toroidal flow of a biomaterial injected through the internal channel, where such plurality of openings are helical slits.
  • the plurality of openings comprises helical openings.
  • the helical openings are continuous openings spanning the proximal region or central region from a proximal end to a distal end of the region.
  • the helical openings have a pitch of between about 10 mm and 100 mm (e.g., about 50 mm, e.g., 51 .5 mm).
  • the helical openings have a number of turns per unit length of between 0.1 and 5 turns/cm (e.g., about 0.4 turns/cm, e.g., 0.375 turns/cm).
  • the plurality of openings includes 2-10 helical openings; preferably 4-6 helical openings.
  • the helical openings are helical slits.
  • the plurality of openings are slits.
  • the slits are segmented slits, longitudinal slits, or circumferential slits.
  • the plurality of openings includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about 54
  • the plurality of openings include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm,
  • a total surface area of the plurality of openings includes are from about
  • 15% to about 80% e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of the proximal region, central region, and/or distal region.
  • the plurality of openings includes a first plurality of openings and a second plurality of openings, where the first plurality of openings has a different shape than the second plurality of openings.
  • the first plurality of openings are helical openings and the second plurality of openings are non-helical openings.
  • the first plurality of openings are helical slits. In some embodiments, the first plurality of openings are continuous openings spanning or substantially spanning the central region from a proximal end to a distal end. In some embodiments, the helical openings have a pitch of between about 10 mm and 100 mm (e.g., about 50 mm, e.g., 51 .5 mm). In some embodiments, the helical openings have a number of turns per unit length of between 0.1 and 5 turns/cm (e.g., about 0.4 turns/cm, e.g., 0.375 turns/cm).
  • the first plurality of openings includes 2-10 helical openings; preferably 4-6 helical openings. In some embodiments, the first plurality of openings together encompass from between about 20% to 80% (e.g., from about 30% to about 70%, from about 40% to about 60%, or from about 45% to about 55%, e.g., about 40%, about 45%, about 50%, or about 55%) of a total external surface area of the proximal region or the central region.
  • the first plurality of openings includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100 openings, e.g., about 4 helical openings).
  • 1 to 100 openings e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from
  • the first plurality of openings include a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2.4 mm, about 2.3 mm, about 2 mm, or about 1 .8 mm,,) and a length of from about 0.1 mm to about 150 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about
  • the first plurality of openings include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5
  • the second plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes or polygonal holes.
  • the second plurality of openings together encompass from about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of the proximal region, central region, and/or distal region
  • the second plurality of openings includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about
  • the second plurality of openings includes a cross-sectional dimension (e.g., a diameter or a width) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm
  • the unitary body includes an external thread configured to engage with a locking screw (e.g., a lag screw).
  • the proximal region includes the external thread.
  • the unitary body e.g., the proximal, distal, and/or central regions
  • includes a textured surface e.g., having a roughness average (Ra) of between about 1 micron to about 5 microns (e.g., about 3-4 microns, e.g., about 3.5 microns, e.g., about 3.6 microns).
  • the textured surface has a roughness that improves interaction with a biomaterial (e.g., adhesion properties).
  • the internal channel includes an internal thread through at least one of the proximal region, central region, or distal region.
  • the device is 3D printed and/or is made from a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • PEEK polyetheretherketone
  • the disclosure features a system for reinforcing a bone of a subject.
  • the system includes a device of the first aspect, the device may be, for example, a fastener, and one or more implant components which engage with the device.
  • the system further includes an intramedullary nail (e.g., a cephalomedullary nail), in which the device engages with (or, e.g., fastens to) the intramedullary nail to reinforce the bone of the subject.
  • an intramedullary nail e.g., a cephalomedullary nail
  • the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the intramedullary nail includes a first hole having a diameter, wherein the fastener is configured to insert in the hole, and wherein the hole is disposed at a proximal end of the intramedullary nail.
  • the intramedullary nail has a second hole at the distal end and the system further includes a screw configured to be inserted in the second hole.
  • the system for reinforcing a bone of a subject includes a device of the first aspect, the device being, for example, a compression screw component and one or more implants which engage with the device.
  • the system further includes a locking screw (e.g., a lag screw), an intramedullary nail (e.g., a cephalomedullary nail), in which the locking screw and the device (e.g., as a compression screw component) engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
  • a locking screw e.g., a lag screw
  • an intramedullary nail e.g., a cephalomedullary nail
  • the unitary body of the device e.g., a compression screw component
  • the unitary body of the device includes an external thread configured to engage with a locking screw (e.g., a lag screw).
  • the proximal region of the unitary body includes the external thread configured to engage with the locking screw.
  • the locking screw is a lag screw.
  • the compression screw component and lag screw have a complementary pitch, e.g., of between 0.25 and 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about
  • the locking screw has a diameter that is greater than a diameter of the device (e.g., a compression screw component) and/or the nail has a curved trapezoidal cross-section.
  • the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the intramedullary nail includes a first hole having a diameter and a thread and a second hole distal to and adjacent to the first hole; in which the locking screw is configured to engage with the first hole and the device (e.g., a compression screw component) is configured to engage with the second hole; and where the first hole and second hole are disposed at the proximal end of the intramedullary nail.
  • the device e.g., a compression screw component
  • the first and second holes are spaced and angled such that the device (e.g., a compression screw component) and locking screw fixedly engage when both are fully inserted.
  • the intramedullary nail has a third hole at distal end and the system further includes a third screw configured to be inserted in the third hole.
  • the one or more implants includes a bone plate with one or more bone plate holes sized to engage with the device.
  • the bone plate includes two or more bone plate holes.
  • the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the system includes a plurality of the devices of the first aspect.
  • the plurality of devices includes from 2-12 devices (e.g., from 2-10 devices, from 2-8 devices, from 2-6 devices, from 2-4 devices, from 4-12 devices, from 4- 10 devices, from 4-6 devices, from 6-12 devices, from 6-10 devices, from 6-8 devices, from 8-12 devices, from 8-10 devices, or from 10-12 devices).
  • 2-12 devices e.g., from 2-10 devices, from 2-8 devices, from 2-6 devices, from 2-4 devices, from 4-12 devices, from 4- 10 devices, from 4-6 devices, from 6-12 devices, from 6-10 devices, from 6-8 devices, from 8-12 devices, from 8-10 devices, or from 10-12 devices.
  • the disclosure features a system for reinforcing a soft tissue of a subject.
  • the system includes a device of the first aspect, in which the device may be, for example, a suture anchor.
  • the device includes a suture, in which the suture and the device (e.g., as a suture anchor) secure the soft tissue to a bone by way of the suture.
  • the system further includes a plurality of devices (e.g., a plurality of suture anchors, e.g., from 2-6 suture anchors).
  • the disclosure features a kit for reinforcing a bone or soft tissue of a subject (e.g., a human subject).
  • the kit includes a device according to the first aspect and a biomaterial and/or hydrating fluid.
  • the kit further includes a dispenser that is configured to inject a biomaterial and/or a hydrating fluid through the internal channel of the device.
  • the dispenser includes a tube connected to a syringe, a vial, or a reservoir; wherein optionally, the tube further includes the biomaterial or the hydrating fluid.
  • the kit includes an intramedullary nail (e.g., a cephalomedullary nail) and, for example, the device is, or is configured as, a fastener.
  • the fastener is configured to engage with the intramedullary nail to reinforce the bone.
  • the bone is a long bone and the fastener and intramedullary nail are sized to fit the bone.
  • the intramedullary nail includes a hole having a diameter, and wherein the fastener is configured for insertion in the hole.
  • the kit includes a locking screw and an intramedullary nail (e.g., a cephalomedullary nail) and, for example, the device is, or is configured as, a compression screw component.
  • the locking screw and compression screw component are configured to engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
  • the bone is a long bone and the compression screw component, intramedullary nail, and the locking screw are sized to fit the bone.
  • the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the intramedullary nail includes a first hole having a diameter and a thread and a second hole distal to and adjacent to the first hole, and wherein the locking screw is configured to engage with the first hole and the compression screw component is configured to engage with the second hole.
  • the first and second holes are spaced and angled such that the compression screw component and locking screw integrate when both are fully inserted.
  • the one or more implants of the kit includes a bone plate with one or more bone plate holes sized to engage with the device.
  • the bone plate includes two or more bone plate holes.
  • the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the kit includes the device which is configured as a suture anchor.
  • the suture anchor is configured to secure a soft tissue to a bone of a subject.
  • the suture anchor includes a suture.
  • the kit includes a plurality of devices (e.g., a plurality of suture anchors, e.g., from 2-6 suture anchors).
  • the biomaterial includes a polymeric adhesive, a bone void filler material, a cement, a phosphoserine-based bioadhesive, a cohesiveness agent, an osteogenic agent, an osteoconductive agent, a medicinal agent, a solid biomaterial (e.g., a solid dose biomaterial), a pharmaceutical agent, or a combination thereof.
  • the biomaterial includes a calcium phosphate-based bone cement, a non- self-hardening calcium phosphate based bone void filler, a flowable xenograft bone void filler, phosphoserine, phosphocreatine, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a calcium silicate, a calcium phosphate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(a-hydroxy acid), a poly(lactone), a poly(amino acid), a poly(anhydride), a poly(orthoester), a poly(anhydride-co-imide), a poly(orthocarbonate), a poly(a-hydroxy alkanoate), a poly(dioxanone), a poly(phosphoester), poly(L-lactide) (PLLA), poly(
  • the biomaterial is disposed within the biomaterial dispenser.
  • the biomaterial dispenser includes a tube connected to a syringe, a vial, or a reservoir; in which, optionally, the tube further includes the biomaterial.
  • the biomaterial is pre-loaded into the internal channel of a device according to the first aspect (e.g., as a solid biomaterial, such as a solid dose biomaterial (e.g., in the form of pellets)).
  • the plurality of openings are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of pellets of a solid biomaterial (e.g., a solid dose biomaterial) that has been pre-loaded into an internal channel of the device.
  • the pre-loaded solid dose biomaterial includes a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof.
  • the pre-loaded solid dose biomaterial includes from about 65 to about 85% (e.g., about 65-80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71%, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81%, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight.
  • the pre-loaded solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%, about 33%, about 34%, or about 35%) phosphoserine or phosphocreatine by weight.
  • about 15 to about 35% e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%,
  • the pre-loaded solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1 .8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2-1 .0%, about 0.2-0.8%, about 0.2-0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1 .0-2.0%, about 1 .0-1 .5%, about 1 .5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.1 %, about 1 .2%, about 1 .3%, about 1.4%, about 1 .5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight.
  • the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10- 100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, or about 150 MPa).
  • about 10 to about 150 MPa e.g., about 10-140 MPa, about 10-125 MPa, about 10- 100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50
  • the pre-loaded solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1 .20 to about 1 .80 g/cm 3 (e.g., about 1 .20-1 .75 g/cm 3 , about 1 .20-1 .70 g/cm 3 , about 1 .20-1 .60 g/cm 3 , about 1 .20-1 .50 g/cm 3 , about 1 .20-1 .40 g/cm 3 , about 1 .20-1 .30 g/cm 3 , about 1 .20-1 .25 g/cm 3 , about 1 .30-1 .80 g/cm 3 , about 1 .30-1 .50 g/cm 3 , about 1 .5-1 .8 g/cm 3 , e.g., about 1 .20 g/cm 3 , about 1 .25 g/cm 3
  • the disclosure features a method of treating a bone defect in a bone or soft tissue defect in a soft tissue of a subject (e.g., a human).
  • the method includes implanting a device of the first aspect into a bone of the subject and dispersing a biomaterial from the internal channel of the device out of the first plurality of openings and the second plurality of openings into a portion of bone tissue surrounding the device, thereby treating the bone defect.
  • the biomaterial is, e.g., a solid biomaterial, such as a solid dose biomaterial (e.g., in the form of pellets).
  • the solid dose biomaterial includes a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof.
  • the solid dose biomaterial includes from about 65 to about 85% (e.g., about 65-80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71 %, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81 %, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight.
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25- 30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about 19%, about 20%, about 21 %, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31 %, about 32%, about 33%, about 34%, or about 35%) phosphoserine or phosphocreatine by weight.
  • about 15 to about 35% e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25- 30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1 .8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2- 1 .0%, about 0.2-0.8%, about 0.2-0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1 .0-2.0%, about 1 .0-1 .5%, about 1 .5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1 .0%, about 1.1 %, about 1 .2%, about 1 .3%, about 1 .4%, about 1 .5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight.
  • the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10- 20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, or about 150 MPa).
  • a pressure of from about 10 to about 150 MPa e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10- 20 MPa, about 25-50
  • the solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1 .20 to about 1 .80 g/cm 3 (e.g., about 1 .20-1 .75 g/cm 3 , about 1 .20-1 .70 g/cm 3 , about 1 .20-1 .60 g/cm 3 , about 1 .20-1 .50 g/cm 3 , about 1 .20-1 .40 g/cm 3 , about 1 .20-1 .30 g/cm 3 , about 1 .20-1 .25 g/cm 3 , about 1 .30-1 .80 g/cm 3 , about 1 .30-1 .50 g/cm 3 , about 1 .5-1 .8 g/cm 3 , e.g., about 1 .20 g/cm 3 , about 1 .25 g/cm 3 , about
  • the biomaterial can convert to a fluid form (e.g., a paste) following exposure to a hydrating fluid (e.g., blood) that hydrates the biomaterial in the body of a subject after implantation, thereby allowing the biomaterial to disperse from the device and harden.
  • a hydrating fluid e.g., blood
  • the method includes fluidly connecting a source of a biomaterial to the internal channel of the device and injecting the biomaterial into the internal channel so that the biomaterial flows out from the plurality of openings into a portion of bone tissue surrounding the device, thereby treating the bone defect and/or securing the device to the bone.
  • a greater quantity of the biomaterial is delivered to a portion of bone tissue adjacent to the proximal region or the central region than to a portion of bone tissue adjacent to the distal region.
  • the biomaterial flows out from the plurality of openings in a uniformly radially expanding volume.
  • the biomaterial flows out from the plurality of openings with toroidal flow.
  • the plurality of openings that induce toroidal flow of a biomaterial injected through the internal channel are helical slits.
  • method includes inserting a screw through the internal channel of the device, e.g., to distribute the biomaterial.
  • the method further includes securing a bone plate to the bone by inserting the device through the bone plate hole during implantation. In some embodiments, the method further includes fastening the distal end of the device to the distal cortex of the bone. In some embodiments, the bone plate includes two or more bone plate holes and/or the method includes securing the bone plate to the bone using more than one device of the first aspect (e.g., to form a compression assembly). In some embodiments, the bone defect is outside of a fracture zone. In some embodiments, the implanting includes screwing the device into the bone. In some embodiments, the implanting does not include screwing the device into the bone. In some embodiments, the implanting includes inserting the device through a hole drilled into the bone.
  • the inserting includes providing torque perpendicularly to a long axis of the device and/or pushing in a proximal to distal direction along the long axis of the device.
  • the method further includes implanting an intramedullary nail (e.g., a cephalomedullary nail) into a medullary cavity of the bone.
  • an intramedullary nail e.g., a cephalomedullary nail
  • the device may be configured as a fastener that engages with the intramedullary nail to reinforce the bone.
  • the bone is a long bone. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the intramedullary nail includes a hole, wherein during implantation the fastener is inserted through the hole.
  • the method further includes implanting a screw into the bone through a second hole in the intramedullary nail that is distal to the fastener.
  • the method further includes implanting an intramedullary nail (e.g., a cephalomedullary nail) into a medullary cavity of the bone and implanting a locking screw (e.g., a lag screw) into the bone.
  • an intramedullary nail e.g., a cephalomedullary nail
  • a locking screw e.g., a lag screw
  • the device may be configured as a compression screw component and the locking screw and compression screw component engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
  • the bone is a long bone. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
  • the intramedullary nail includes a first hole and a second hole distal to and adjacent to the first hole and, during implantation, the lag screw is inserted through the first hole and the compression screw component is inserted through the second hole.
  • the method further includes implanting a support screw into the bone through a hole in the intramedullary nail that is distal to the compression screw component and the lag screw.
  • the method further includes inserting a second of the device, which may be configured as a suture anchor, into bone to secure the soft tissue to the bone, thereby treating the soft tissue.
  • the second said device e.g., as a suture anchor
  • the method includes implanting a plurality of the devices (e.g., plurality of the devices configured as suture anchors, e.g., from 2-6 suture anchors) into the bone to secure the soft tissue to the bone.
  • the method further includes attaching the suture of at least one of the suture anchors to the soft tissue.
  • the method further includes securing at least one of the suture anchors by way of the suture to a different one of the suture anchors to further secure the soft tissue to the bone.
  • the unitary body includes an internal diameter from about 1 .25 mm to about 25 mm; b) the proximal region includes an inner diameter of from about 3 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; c) the central region includes an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 1 .25 mm to about 25 mm; d) the distal region includes an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; and/or e) the proximal region, the central region, and the distal region include an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 1 .25 mm to about 25 mm.
  • the outer diameter from the proximal end to the distal end is constant.
  • the outer diameter of the proximal region is greater than the outer diameter of the central and distal regions.
  • the device of the first aspect has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, e.g., about 10-150 mm, e.g., about IQ- 20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160- 180 mm, or about 175-180 mm, e.g., about 10 mm, about 20 mm, about 25 mm, e.g., about
  • the proximal region includes a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 mm to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • a length of from about 2 mm to about 100 mm e.g., from about 2 mm to about 5
  • the central region includes a length of from about 5 mm to about 150 mm (e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
  • a length of from about 5 mm to about 150 mm e.g., from about 5 mm to about 10 mm, from about 5 mm to about
  • the central region has a length from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about 10-20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160- 180 mm, about 100-150 mm, about 120-160 mm, about 125-175
  • the distal region includes a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • a length of from about 2 mm to about 100 mm e.g., from about 2 mm to about 5 mm, from
  • the proximal region includes a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .9 mm, about
  • the central region includes a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about
  • the distal region includes a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 mm to about 2.0 mm, about 1 .0 mm to about 2.0 mm, about 0.2 mm to 0.80 mm, about
  • the distal end of the distal region includes a blunt and/or tapered edge. In some embodiments, the distal end of the distal region includes from 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes), in which optionally the distal region includes 3 milling flutes.
  • the proximal region, central region, and/or distal region include an internal thread.
  • the unitary body includes an external thread; in which, optionally, one or more of the proximal region, central region, and/or distal region, if present, include an external thread.
  • the internal and/or external thread has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 0.25 mm to about 15
  • the internal or external thread is formed from protrusions, grooves, waves, or a mesh.
  • the protrusions, grooves, or waves are at from about 1 to about 360 points per 360° (e.g., at 4-20 equidistant points along the circumference of the proximal, central, and/or distal region).
  • the internal and/or external thread includes a continuous thread or non- continuous thread. In some embodiments, the internal and/or external thread is broken by an opening. In some embodiments, the non-continuous thread includes a gap, in which optionally the gap has a length from about 0.5 mm to about 30 mm. In some embodiments, the internal and/or external thread is broken by the plurality of openings.
  • the distal end includes a blunt and/or tapered edge.
  • the distal end includes a milling flute.
  • the distal end includes from 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes); in which, optionally, the distal end includes 3 milling flutes.
  • the distal end includes from 2 to 4 notches (e.g., 2, 3, or 4 notches).
  • the tapered distal end is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting the distal end of the device.
  • the opening at the distal end to the internal channel may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a solid dose of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets).
  • the distal end does not have an opening to the internal channel.
  • the proximal end includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the method includes introducing a volume of the biomaterial of from about 1 ml to about 20 ml (e.g., from about 1 ml to about 2 ml, from about 1 ml to about 3 ml, from about 1 ml to about 4 ml, from about 1 ml to about 5 ml, from about 1 ml to about 10 ml, from about 5 ml to about 10 ml, from about 5 ml to about 15 ml, from about 10 ml to about 15 ml, from about 15 ml to about 20 ml, or from about 15 ml to about 20 ml) to the internal channel at the proximal end of the device.
  • a volume of the biomaterial of from about 1 ml to about 20 ml (e.g., from about 1 ml to about 2 ml, from about 1 ml to about 3 ml, from about 1 ml to about 4 ml, from about 1 ml to about 5
  • the volume of the biomaterial is about 2.5 ml, about 5 ml, or about 10 ml.
  • the method includes injecting a volume of hydrating fluid into the internal channel of the device, in which the device has been pre-loaded with biomaterial (e.g., a solid biomaterial) to yield a combined total volume of hydrating fluid and biomaterial of from 1 ml to about 20 ml, wherein optionally the total volume is about 2.5 ml, about 5 ml, or about 10 ml.
  • the biomaterial is delivered to the bone surrounding both device 100 and a locking screw (e.g., a lag screw) in a compression assembly to secure both device 100 and the locking screw to the bone upon biomaterial hardening.
  • the method further includes inserting a screw including a length through the internal channel at the proximal end of the device (e.g., before or after hardening of the biomaterial).
  • the method further includes aligning the screw with an internal thread.
  • the length of the screw traverses a length of the internal channel of the device, and the method further includes fastening a distal end of the screw to a distal cortex of the bone; in which, optionally, tightening the screw in the distal cortex causes bone compression.
  • tightening the screw in the distal cortex does not cause rotation of the device.
  • the methods of the disclosure can also include extracting the device of the first aspect from a bone, e.g., by inserting a distal region of an extraction tool into the internal channel of the device and twisting the extraction tool to remove the device from the bone.
  • twisting the extraction tool does not cause rotation of the device.
  • twisting of the extraction tool may be clockwise or counterclockwise to remove the device from the bone.
  • the method includes removing a screw from the device.
  • the extraction tool threadedly engages with the internal protrusions (e.g., an internal thread) of the device.
  • the kit further includes a suture anchor.
  • the suture anchor is a soft tissue suture anchor.
  • the kit further includes an intramedullary pin.
  • the kit further includes a nail device.
  • the kit further includes a spinal attachment device.
  • the suture anchor, intramedullary pin, nail device, and/or spinal attachment device can be made from a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • the suture anchor, intramedullary pin, nail device, and/or spinal attachment device can also be 3D printed using these materials or others.
  • the term “about” refers to a value that is within 10% above or below the value being described.
  • any values provided in a range of values include both the upper and lower bounds, and any values contained within the upper and lower bounds.
  • biomaterial refers to any adhesive biocompatible substance, of natural or synthetic origin, suitable for introduction into living tissue for a medical purpose (e.g., therapeutic, diagnostic, or preventative use) and used to fill a void, affix, join, treat, heal or regenerate bone.
  • bone defect refers to any bone deficient region, such as a void, gap, recess, or other discontinuity in a bone.
  • a bone defect can be artificially or naturally established, and can occur, for example, due to disease or trauma.
  • a bone defect can occur as a consequence of pathologic or inflammatory diseases, formation and/or removal of a bone tumor, a surgical intervention, a congenital defect, or a bone fracture, and the like.
  • the bone defect may be artificially established due to removal of the tumor tissue.
  • a bone defect may be an intertrochanteric fracture.
  • bone defect is also intended to include anatomical sites where augmentation to a bony feature is desired by the patient in the absence of disease or trauma, such as in elective cosmetic surgery.
  • the “defect” can be one that is subjectively perceived by the patient, and where augmentation of the bone deficient region is desired.
  • milling flute refers to one or more cutting edges that cut a piece of a material (e.g., bone tissue) as the milling flute rotates.
  • a milling flute may be a cutting projection that is integral to the device of the disclosure.
  • mesh refers to a structure characterized by having one or more openings arranged parallel, diagonally, vertically, spirally, helically, relative to the longitudinal direction of the device.
  • opening refers to any orifice, aperture, void, gap, or hole characterized by the absence of a particular material or structure that defines the region of the device in which the opening is disposed.
  • the “opening” may be round or take any overall shape or geometry outlined by edges that bound the opening (e.g., diamond shaped). Alternatively, an “opening” may be helical.
  • pellet refers to any material having a cylindrical, rounded, square, spherical, tubular, or any other shape.
  • the term “pellet” does not impart any specific shape.
  • the “pellet” may be formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-100 MPa, about 25-50 MPa, or about 125-150 MPa).
  • region refers to any section of the unitary body disposed between the proximal end and distal end of the device and that may include an external thread or a plurality of openings having one type of shape (e.g., helical slits or diamond-shaped holes) or a variety of shapes.
  • the bounds of the “region” are defined by the proximal and distal ends.
  • the “region” may include a proximal region, a central region, and/or a distal region, such that the assigned region is referenced from the proximal end of the device.
  • the device may include one, two, or three of the regions.
  • a device without an external protrusion that includes, from a proximal end to a distal end, a first plurality of openings (e.g., helical openings) and a second plurality of openings (e.g., non-helical openings) has two regions: a proximal region including the first plurality of openings and a distal region including the second plurality of openings.
  • a first plurality of openings e.g., helical openings
  • a second plurality of openings e.g., non-helical openings
  • the term “toroidal flow” refers to rotational flow of a fluid material induced as the fluid material (e.g., a biomaterial, e.g., a biomaterial with non-Newtonian fluid dynamic characteristics) moves through and/or around a device of the disclosure.
  • the “toroidal flow” may be a rotational flow along the longitudinal, central axis of the internal channel whose flow pattern resembles the shape of a torus, a toroid, or a donut. The flow pattern directs the fluid from an edge toward the center axis then back toward the edge.
  • the “toroidal flow” may occur along the internal channel of the device and/or as fluid exits the openings of the device.
  • treating or “treatment” is meant the medical management of a patient with the intent that an amelioration, repair, or prevention of an injury or disease, pathological condition, or disorder will result.
  • This term includes active treatment, that is, treatment directed specifically toward improvement of the injury or disease, pathological condition, or disorder, and also includes causal treatment, that is, treatment directed toward removal of the cause of the injury or disease, pathological condition, or disorder.
  • this term includes palliative treatment, that is, treatment designed for the relief of symptoms rather than the curing of the injury or disease, pathological condition, or disorder; preventive treatment, that is, treatment directed to prevention of the injury or disease, pathological condition, or disorder; and supportive treatment, that is, treatment employed to supplement another specific therapy directed toward the improvement of the injury or disease, pathological condition, or disorder.
  • unitary refers to an undivided body which is of a one-piece construction (e.g., a unitary body that can be manufactured as a single piece, e.g., 3D printed in its entirety).
  • FIGs. 1A-1H are images showing device 100 of the disclosure with unitary body 101 , proximal end 102, distal end 103, proximal region 104 with thread 110 in the exterior of proximal region 104, central region 105, distal region 106, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region 106.
  • Internal channel 109 runs through the center of unitary body 101.
  • FIGs. 1A-1 H show device 100 in various orientations.
  • FIG 1 A is a frontal view.
  • FIG. 1 B is a back view.
  • FIG. 1C is a left view.
  • FIG. 1 D is a right view.
  • FIG. 1 E is a top view.
  • FIG. 1 F is a bottom view.
  • FIG. 1 A is a frontal view.
  • FIG. 1 B is a back view.
  • FIG. 1C is a left view.
  • FIG. 1 D is a right view.
  • FIG. 1 G is a front cross-sectional view taken along line A-A as shown in FIGs. 1 C, 1 D, and 1 E.
  • FIG. 1 H is a diametrical view.
  • Internal channel 109 is shown in FIGs. 1 E-1 G, from top, bottom, and front cross-sectional views, respectively. Internal channel 109 is also visible through first plurality of openings 107 and second plurality of openings 108 of FIGs. 1A-1 D and 1 H.
  • Device 100 can include notches 111.
  • FIG. 2 is an image showing device 100 of the disclosure with thread 110 in the exterior of proximal region 104. Also shown are proximal 102 and distal ends 103, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region 106. Thread 110 in proximal region 104, which is configured to engage with a locking screw (e.g., a lag screw), as shown in FIG. 3.
  • a locking screw e.g., a lag screw
  • FIG. 3 is an image showing an intertrochanteric antegrade nail system, in which device 100 of the disclosure is used as a compression screw component engaged with a locking screw (e.g., lag screw) to form a compression assembly in conjunction with an intramedullary nail (e.g., a cephalomedullary nail).
  • a locking screw e.g., lag screw
  • FIGs. 4A-4M are images showing device 400 of the disclosure with unitary body 401 , proximal end 402, distal end 403, proximal region 404 with thread 410 in the exterior of proximal region 404, distal region 406, and plurality of openings 412 in distal region 406.
  • Internal channel 409 runs through the center of unitary body 401 .
  • FIGs. 4A-4M show device 400 in various orientations.
  • FIG 4A is a frontal view.
  • FIG. 4B is a back view.
  • FIG. 4C is a left view.
  • FIG. 4D is a right view.
  • FIG. 4E is a top view.
  • FIG. 4F is a bottom view.
  • FIG. 4A-4M show device 400 in various orientations.
  • FIG 4A is a frontal view.
  • FIG. 4B is a back view.
  • FIG. 4C is a left view.
  • FIG. 4D is a right view.
  • FIG. 4E
  • FIG. 4G-4K is a front cross-sectional view taken along line A-A as shown in FIGs. 4C, 4D, and 4E.
  • FIG. 4L is a diametrical view.
  • FIG. 4M is an oblique view.
  • Internal channel 409 is shown in FIGs. 4E-4M, from top, bottom, front cross-sectional, front-cross sectional, front-cross sectional, front-cross sectional, diametrical, and oblique views, respectively. Internal channel 409 is also visible through plurality of openings 412 of FIGs. 4A-4D.
  • FIGs. 4H-4K and 4M show device 400 with internal protrusion(s) 413 (e.g., internal thread) that is/are located within internal channel 409.
  • FIG. 4H-4K and 4M show device 400 with internal protrusion(s) 413 (e.g., internal thread) that is/are located within internal channel 409.
  • Device 400 can optionally include notches 411.
  • Device 400 can optionally include pellets of biomaterial 414 pre-loaded into internal channel 409, as shown in FIGs. 4I-4K. Pellets of biomaterial 414 are pictured in FIGs. 4I-4K with a cylindrical shape; however, other shapes can also be used and are envisioned within the scope of the disclosure.
  • FIG. 5 is an image showing device 500 of the disclosure with unitary body 501 , proximal end 502, distal end 503, proximal region 504, distal region 506, first plurality of openings 507 in proximal region 504, second plurality of openings 508 in distal region 506, and without a thread in the exterior of proximal region 504.
  • Device 500 also contains internal channel 509 running through unitary body 501 .
  • FIGs. 6A-6I are images showing device 600 of the disclosure with unitary body 601 , proximal end 602, distal end 603, central region 605, plurality of openings 612 in central region 605, and without a thread in the exterior of the device.
  • Internal channel 609 runs through the center of unitary body 601 .
  • FIGs. 6A-6I show device 600 in various orientations.
  • FIG 6A is a frontal view.
  • FIG. 6B is a back view.
  • FIG. 6C is a left view.
  • FIG. 6D is a right view.
  • FIG. 6E is a top view.
  • FIG. 6F is a bottom view.
  • FIG. 6G is a front cross-sectional view taken along line A-A as shown in FIGs. 6C, 6D, and 6E.
  • FIG. 6H is a diametrical view.
  • FIG. 6I is an oblique view.
  • Internal channel 609 is shown in FIGs. 6E-6I, from top, bottom, front cross-sectional, diametrical, and oblique views, respectively. Internal channel 609 is also visible through plurality of openings 612 of FIGs. 6A-6D.
  • FIGs. 6G and 6I show device 600 with internal protrusion(s) 613 (e.g., an internal thread) that is/are located within internal channel 609.
  • FIG. 6G shows the front cross-sectional view
  • FIG. 6I shows the oblique view.
  • Internal protrusion(s) 613 e.g., internal thread
  • Device 600 can optionally include notches 611 .
  • FIG. 7 is an image showing an X-ray radiograph of a pelvis and femur of a subject with a mockup of a sliding hip screw system for treating proximal femur fractures with a representation of device 100 of the disclosure in place of the compression screw component.
  • the sliding hip screw system includes a bone plate including a barrel, a lag screw, device 100, and four bone screws.
  • FIGs. 8A-8D are images showing device 800 of the disclosure with unitary body 801 , proximal end 802, distal end 803, central region 805, plurality of openings 812 in central region 805, and without a thread in the exterior of the device.
  • Internal channel 809 runs through the center of unitary body 801 .
  • FIGs. 8A-8D show device 800 in various orientations.
  • FIG. 8A is a frontal view.
  • FIG. 8B is a front cross- sectional view taken along line A-A, as shown in FIG. 8A.
  • FIG. 8C is an oblique view.
  • Device 800 can optionally include pellets of biomaterial 814 pre-loaded into internal channel 809, as shown in FIG. 8B.
  • FIG. 8D shows device 800 next to device 400 to demonstrate size differences.
  • FIG. 9 is an image showing an X-ray radiograph of a humerus and glenoid of a subject with a mock-up of a suture anchor system for repair of a rotator cuff with a representation of three of device 800 of the disclosure in place of the suture anchors.
  • the devices, systems, kits, and methods of use thereof for bone repair, bone stabilization, soft tissue repair, soft tissue stabilization, and/or implant fixation are useful for treating a bone defect (e.g., a bone fracture) or a soft tissue defect (e.g., a strained ligament) or for implant fixation by installing at least one of the devices described herein, e.g., using the systems, kits, and/or methods described herein.
  • the devices, systems, kits, and methods can be used to deliver a biomaterial to bone.
  • a biomaterial can be used to repair a bone or soft tissue defect, to stabilize weak or insufficient bone or soft tissue, or to stabilize implanted hardware or prosthesis.
  • the devices and methods herein described can be used to provide uniform biomaterial delivery to produce robust adhesion between an implant (e.g., an implantable screw) and a bone tissue.
  • an implant e.g., an implantable screw
  • the devices and methods overcome challenges associated with the repair of weak or deficient bone or soft tissue and bone augmentation using injected biomaterials (e.g., biomaterials with non-Newtonian fluid dynamic characteristics).
  • Devices of the disclosure are implants that can be used for multiple purposes, including in the repair of bone and soft tissue defects.
  • the devices are configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of a device). Once inserted, the device can be used to uniformly deliver a biomaterial to the bone, secure the bone structure, and promote bone repair and/or healing. Similarly, once inserted, the device can be used to uniformly deliver a biomaterial to the bone, secure the soft tissue to the bone, and promote soft tissue repair and/or healing.
  • the devices can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate, a soft tissue suture anchor, an intramedullary pin, a nail, screw, or other similar hardware, and a spinal attachment device.
  • other hardware such as, e.g., a bone plate, a soft tissue suture anchor, an intramedullary pin, a nail, screw, or other similar hardware, and a spinal attachment device.
  • the device has a unitary cylindrical body.
  • the device includes one or more regions disposed between a proximal end and distal end of the device such that each region includes an external thread and/or a plurality of openings.
  • the device may include a proximal region, a distal region, and/or a central region disposed therebetween, at least one or two of which may be absent.
  • the device includes a proximal region, central region, and distal region.
  • the device includes a proximal region and a distal region while the central region is absent.
  • the device includes a central region while the proximal region and distal region are absent.
  • the device includes an internal channel that extends longitudinally through the unitary body.
  • the device includes a plurality of openings.
  • the device may include a first plurality of openings and a second plurality of openings, where the first plurality of openings has a different shape than the second plurality of openings.
  • the proximal region may include a first plurality of openings (e.g., helical openings) and the distal region may include a second plurality of openings (e.g., non-helical openings).
  • An external thread may be located at the proximal region of the device.
  • the device may not include an external thread.
  • the device may be configured as a compression screw component to configure together with a lag screw to create compression (e.g., as a compression screw assembly).
  • the device may be configured as a fastener.
  • the device may be configured as a suture anchor.
  • the external surface of the unitary body e.g., the proximal, distal, and/or central regions
  • the surface of the device may be textured, or only one or more parts thereof. For example, one or more of the proximal, central, or distal regions may be textured.
  • the rough surface creates a higher surface area which is beneficial for the adhesive properties of the biomaterial. Enhanced interaction with the biomaterial leads to better adhesion with the bone and interdigitation with the implant for better fixation of the implanted device (e.g., improved osseointegration in the area of the implanted device).
  • the internal channel includes an internal surface.
  • the internal surface may be smooth or textured (i.e., rough), e.g., including at least one internal protrusion.
  • the internal channel may be straight, curved, radial, or helical, depending on the implantable device to be used with the present device.
  • the device has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, about 10 to about 50 mm, about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm.
  • the device has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm).
  • 9 mm e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm.
  • the device has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
  • 200 mm e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm
  • the device is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • PEEK polyetheretherketone
  • hydroxyapatite tricalcium phosphate
  • tetracalcium phosphate dicalcium phosphate
  • BIOGLASS® 45S5 polyetheretherketone
  • ceramic composites copper-based materials or composites
  • cobalt chrome xenograft biomaterials, and combinations thereof.
  • the device can also be 3D printed using these materials or others.
  • the device is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets.
  • a biomaterial e.g., a solid biomaterial, such as a solid dose biomaterial
  • the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 1 10 MPa, about 120 MPa, about 130 MPa, about 140 MPa,
  • the solid dose biomaterial includes a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof.
  • the solid dose biomaterial includes from about 65 to about 85% (e.g., about 65-80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71 %, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81 %, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight.
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about 19%, about 20%, about 21 %, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31 %, about 32%, about 33%, about 34%, or about 35%) phosphoserine or phosphocreatine by weight.
  • about 15 to about 35% e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1.8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2-1 .0%, about 0.2-0.8%, about 0.2- 0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1 .0-2.0%, about 1 .0-1 .5%, about 1.5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.1 %, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight.
  • the solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1.20 to about 1 .80 g/cm 3 (e.g., about 1 .20-1 .75 g/cm 3 , about 1 .20-1 .70 g/cm 3 , about 1 .20-1 .60 g/cm 3 , about 1 .20- 1 .50 g/cm 3 , about 1 .20-1 .40 g/cm 3 , about 1 .20-1 .30 g/cm 3 , about 1 .20-1 .25 g/cm 3 , about 1 .30-1 .80 g/cm 3 , about 1 .30-1 .50 g/cm 3 , about 1 .5-1 .8 g/cm 3 , e.g., about 1 .20 g/cm 3 , about 1 .25 g/cm 3 , about 1
  • the device includes a proximal region that has a proximal end, a distal end, and a proximal opening to the internal channel.
  • the proximal region includes an external thread configured to engage with a locking screw (e.g., a lag screw).
  • a locking screw e.g., a lag screw
  • the compression screw component and lag screw have a complementary pitch, e.g., of between 0.25 and 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about
  • the proximal region not including an external thread may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of the proximal region, e.g., the exterior of the proximal region, an interior of the proximal region, and/or interior walls of the openings of the proximal region.
  • the proximal region has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm,
  • the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 1 1 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).
  • the inner diameter of the proximal region is smaller than, larger than
  • the proximal region has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • a length of from about 2 mm to about 100 mm e.g., from about 2 mm to about 5 mm
  • the proximal region has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1.8 mm, about 1 .9 mm, about 2 mm,
  • the proximal region has a plurality of openings (e.g., slits or holes). In some embodiments, the proximal region does not have openings other than the opening to the internal channel. In some embodiments, the plurality of openings in the proximal region are configured to disperse a biomaterial placed into or injected into the internal channel to an area surrounding the unitary body.
  • the proximal region includes a plurality of openings (e.g., slits or holes).
  • the plurality of openings are helical slits.
  • the helical slits are continuous along a length of the proximal region.
  • the plurality of openings includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of the proximal region.
  • the plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • the device includes a central region that has a proximal end and a distal end. In some embodiments, the device only includes the central region. In other embodiments, the central region of the device is disposed between a proximal region and a distal region.
  • the central region has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,
  • the central region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 1 1 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).
  • the central region includes an inner diameter that is smaller than, larger than, larger
  • the central region has a length of from about 5 mm to about 150 mm (e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
  • a length of from about 5 mm to about 150 mm e.g., from about 5 mm to about 10 mm, from about 5 mm to about
  • the central region has a length from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about I Q- 20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160-
  • the central region has a wall thickness of from 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8
  • the central region and the distal region include the same wall thickness.
  • the central region may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of the central region, e.g., the exterior of the central region, an interior of the central region, and/or interior walls of the openings of the central region.
  • the central region has a plurality of openings (e.g., slits or holes).
  • the central region does not have openings other than the opening to the internal channel.
  • the plurality of openings in the central region are configured to disperse a biomaterial placed into or injected into the internal channel to an area surrounding the unitary body.
  • the central region includes a plurality of openings (e.g., slits or holes).
  • the plurality of openings are helical slits.
  • the helical slits are continuous along a length of the central region.
  • the plurality of openings includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of the central region.
  • the device includes a distal region that has a proximal end, a distal end, and a distal opening to the internal channel.
  • distal region has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9
  • distal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).
  • the distal region has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • a length of from about 2 mm to about 100 mm e.g., from about 2 mm to about 5 mm, from
  • the distal region has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1
  • the distal region may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of the distal region, e.g., the exterior of the distal region, an interior of the distal region, and/or interior walls of the openings of the distal region.
  • the distal end of distal region has a blunt edge. In some embodiments, the distal end of distal region has a tapered edge. In some embodiments, the distal end of the distal region has at least one or a plurality of milling flutes, notches, and/or elongated tips.
  • the distal region has a plurality of openings (e.g., slits or holes). In some embodiments, the distal region does not have openings other than the opening to the internal channel. In some embodiments, plurality of openings in the distal region are configured to disperse a biomaterial placed into or injected into the internal channel to an area surrounding the unitary body.
  • the distal region includes a plurality of openings (e.g., slits or holes).
  • the plurality of openings are helical slits.
  • the helical slits are continuous along a length of the distal region.
  • the plurality of openings includes 2- 10 helical slits; preferably 4-6 helical slits.
  • the plurality of openings extends through an entire length of the distal region.
  • the plurality of openings are non-helical slits.
  • the plurality of openings are holes dispersed (e.g., uniformly, with a distribution gradient, randomly, etc.) along a length of the distal region.
  • the second plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • a device may have multiple pluralities of openings, including proximal and distal openings to the internal channel, but also a plurality of openings in the outer surface of the device.
  • the proximal region, central region, and/or distal region may include at least one opening.
  • the openings extend from one region into at least one other, for example an opening in the central region may extend into the proximal region and/or the distal region.
  • an opening may extend from the proximal end of the device to the distal end of the device.
  • the unitary body of the device may be connected by at least one extendable arm.
  • the plurality of openings in a region are of the same shape.
  • the plurality of openings is dispersed along a length of the region from the proximal end of the region to the distal end of the region.
  • the device includes a first plurality of openings in one region and a second plurality of openings in a second region, wherein the first plurality of openings is a different shape than the second plurality of openings.
  • the plurality of openings are slits or holes. In some embodiments, the plurality of openings includes helical slits, segmented slits, longitudinal slits, or circumferential slits. In some embodiments, the openings include circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes.
  • the proximal, central, and distal regions may have different types of openings, e.g., the first plurality of openings in the central regions may be helical openings (e.g., helical slits) that extend the full length of the central region, while the second plurality of openings in the distal region are closed shaped voids that do not extend from a proximal to a distal end of the distal region, e.g., a plurality of holes dispersed along the length of the distal region.
  • a difference in openings in the central and distal regions allows greater volumetric expansion of biomaterial adjacent the central region. Many bone defects being centrally located; such a dispersion profile is advantageous for targeting the defect.
  • the device includes only one region, e.g., the central region, that includes a plurality of openings that extend the full length of the central region.
  • the plurality of openings may be configured to promote toroidal flow in a biomaterial injected into the internal channel, such openings are helical slits.
  • the plurality of openings in a region may additionally induce toroidal flow in the volume of biomaterial as it flows out of the openings and into the adjacent bone tissue.
  • the toroidal flow can reduce flow resistance in the biomaterial during injection.
  • a helical slit may be a slit that extends a full length of a region, e.g., the central region, where a distal end of the helical slit meets the proximal end of the distal region at a point that is not directly opposite the proximal end of the helical slit.
  • the plurality of openings can also contribute to reducing flow resistance in the internal channel.
  • biomaterial in a fluidic state rotates around the center axis of the internal channel, so less friction in the center of the fluid biomaterial mass arises. Friction of biomaterial at an inner wall of the internal channel would restrict intrusion through the internal channel.
  • the plurality of openings allow a decrease in resistance as material exits and creates a rotational force to facilitate flow of the biomaterial along the longitudinal, central axis of the internal channel.
  • the plurality of openings includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53,
  • the device includes a plurality of openings, wherein the plurality of openings comprises a first plurality of openings and a second plurality of openings, and wherein the first plurality of openings has a different shape than the second plurality of openings.
  • the first plurality of openings includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13,
  • the second plurality of openings includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about
  • 1 to 200 openings e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about
  • the openings include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about
  • the openings include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about
  • the openings include slits, in which the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about
  • the plurality of openings are helical slits.
  • the helical slits are continuous along a length of a region.
  • the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30- 60 mm, about 50-100 mm, about 40-80 mm, about 50-70 mm, about 75-100 mm, about 80-100 mm, about 80-90 mm, or about 90-100 mm, e.g., about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about
  • the helical slits have a number of turns per unit length of about 0.1 to 5 turns/cm (e.g., from about 0.1 to 0.2 turns/cm, about 0.1 to 0.3 turns/cm, about 0.1 to 0.4 turns/cm, about 0.1 to 0.5 turns/cm, about 0.25 to 0.5 turns/cm, about 0.3 to 0.6 turns/cm, about 0.4 to 0.5 turns/cm, about 0.4 to 0.6 turns/cm, about 0.5 to 0.6 turns/cm, about 0.5 to 0.9 turns/cm, about 0.6 to 0.8 turns/cm, about 0.7 to 0.9 turns/cm, about 0.75 to 1 turns/cm, about 0.75 to 1 .5 turns/cm, about 0.1 to 1 turns/cm, about 1 .1 to 1 .2 turns/cm, about 1 to 2 turns/cm, about 1 to 1 .5 turns/cm, about 1 .3 to 1 .6 turns/cm,
  • the plurality of openings includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of a region.
  • the openings are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of a solid dose of the biomaterial (e.g., in the form of pellets).
  • the openings have a cross-sectional dimension (i.e., a width, e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6
  • the openings include staggered or straight openings.
  • a total surface area of openings in a region are from about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of the region.
  • the openings are configured for the distribution and delivery of biomaterial to the bone surrounding device.
  • the openings may be configured for the uniform distribution and delivery of biomaterial or configured to distribute and deliver biomaterial at different levels around the outside surface of the device.
  • the porosity of the device, or at regions of the device, determines the distribution and delivery of the biomaterial.
  • the device includes a thread or threads, such as internal and/or external threads.
  • the thread may be present in the proximal region, the central region, and/or distal region.
  • the thread may be configured to engage with a lag screw of a nail system for treating an intertrochanteric fracture.
  • the thread may aid in the placement of implantable devices (e.g., a screw or suture anchor) in the device and/or the use of the device with other components of a delivery system.
  • implantable devices e.g., a screw or suture anchor
  • a component of a delivery system device may thread onto the device.
  • the thread has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about
  • the protrusions, grooves, or waves are at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread.
  • 360 points per 360° points defines a full thread.
  • the thread is a continuous thread or non-continuous thread.
  • the thread is broken by at least one opening, e.g., at least one slit or at least one hole.
  • the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
  • the device includes a thread-like equivalent.
  • a thread-like equivalent is a repeating pattern which allows a second device with threads or thread equivalents to be screwed on and secured. Examples of thread-like equivalents include protrusions that repeat, grooves, mesh, or waves. A thread may be textured.
  • the distal end of the device can be blunt and/or can be tapered. In some embodiments, the tapered distal end is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting the distal end of the device.
  • the opening at the distal end to the internal channel may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a pellet of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, the distal end does not have an opening to the internal channel.
  • the distal end includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, the distal end has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes).
  • the distal end includes at least one notch. In some embodiments, the distal end has from 2 to 4 notches (e.g., 2, 3, or 4 notches).
  • the proximal end includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the outer diameter from the proximal end to the distal end is constant.
  • the device includes from 1 to 70 longitudinal grooves (e.g., from 1 to 2, from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 2 to 6, from 4 to 8, from 5 to 10, from 6 to 12, from 5 to 15, from 10 to 20, from 20 to 40, from 30 to 60, or from 50 to 70 longitudinal grooves).
  • longitudinal grooves e.g., from 1 to 2, from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 2 to 6, from 4 to 8, from 5 to 10, from 6 to 12, from 5 to 15, from 10 to 20, from 20 to 40, from 30 to 60, or from 50 to 70 longitudinal grooves.
  • the longitudinal grooves include a depth of from about 0.15 mm to about 2.5 mm (e.g., from about 0.15 mm to about 0.5 mm, from about 0.15 mm to about 1 mm, from about 0.15 mm to about 1 .5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm, to about 2 mm, from about 1 mm to about 3 mm, from about 2 mm to about 3mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .
  • device 100 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation.
  • a bone defect e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis
  • soft tissue e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle
  • Device 100 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 100) and can be used as a compression screw component, fastener, or suture anchor.
  • Device 100 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (e.g., device 100 in sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., device 100 in nail system of FIG. 3), a screw, a suture, a prosthesis, or other similar hardware, and as a spinal attachment device.
  • a bone plate e.g., device 100 in sliding hip screw system of FIG. 7
  • a soft tissue suture anchor see, e.g., the suture anchor system of FIG. 9
  • an intramedullary pin a nail
  • nail see,
  • device 100 can be used to uniformly deliver a biomaterial to the bone, secure the bone and/or soft tissue structure, and promote bone and/or soft tissue repair and/or healing.
  • device 100 promotes improved (e.g., increased) distribution of a biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of a defect in the bone.
  • Device 100 has unitary body 101 that includes proximal end 102, distal end 103, proximal region 104 with thread 110 in the exterior of proximal region 104, central region 105, distal region 106, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region 106 (see, e.g., FIGs. 1A-1 H and FIG. 2).
  • Device 100 also includes internal channel 109 (see, e.g., FIGs. 1 E- 1 H) that extends longitudinally through unitary body 101 .
  • Device 100 can include notches 11 1.
  • device 100 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from
  • device 100 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm).
  • 9 mm e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm.
  • device 100 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
  • the internal surface of device 100 may be smooth or textured (e.g., rough).
  • Internal channel 109 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 100.
  • device 100 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about 54, about 55
  • device 100 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • Device 100 can also be 3D printed using these materials or others.
  • distal end 103 can be blunt and/or can be tapered. In some embodiments, distal end 103 has a blunt edge. In some embodiments, distal end 103 has a tapered edge. In some embodiments, distal end 103 has at least one or a plurality of milling flutes, notches, and/or elongated tips. In some embodiments, distal end 103 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 103 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 103 includes at least one notch.
  • distal end 103 has from 2 to 4 notches (e.g., 2, 3, or 4 notches).
  • the opening at distal end 103 to internal channel 109 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a pellet of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets).
  • the tapered distal end is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 103 of device 100.
  • distal end 103 does not have an opening to internal channel 109.
  • proximal end 102 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the outer diameter from proximal end 102 to distal end 103 is constant.
  • Proximal region of device 100 includes proximal region 104 that includes internal channel 109 and thread 110 in the exterior of proximal region 104 (see, e.g., FIGs. 1A-1 H). In some embodiments, proximal region 104 does not have openings other than the opening to internal channel 109 at proximal end 102.
  • proximal region 104 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm
  • the outer diameter of proximal region 104 is smaller than, larger than, or equal to the outer diameter of central region 105.
  • the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18
  • proximal region 104 has a length of from about 2 mm to 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • proximal region 104 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .9 mm, about 2
  • Proximal region 104 not including thread 110 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on the exterior of proximal region 104.
  • thread 1 10 located on the exterior of proximal region 104 has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 0.25 mm to about 15 mm, from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1
  • thread 1 10 located on the exterior of proximal region 104 is formed from protrusions, grooves, waves, or a mesh.
  • the protrusions, grooves, or waves of thread 110 is at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread.
  • thread 110 is a continuous thread or non-continuous thread.
  • thread 110 is broken by at least one opening, e.g., at least one slit or at least one hole.
  • the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
  • Central region of device 100 e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm.
  • Device 100 includes central region 105 that includes a first plurality of openings 107 and internal channel 109.
  • central region 105 has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm
  • Central region 105 includes an outer diameter that is smaller than, larger than, or equal to the outer diameter of proximal region 104 and distal region 106.
  • central region 105 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16
  • central region 105 has a length of from about 5 mm to 150 mm (e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
  • 5 mm to 150 mm e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10
  • central region 105 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1
  • Central region 105 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of central region 105, e.g., the exterior of central region 105, an interior of central region 105, and/or interior walls of the openings of central region 105.
  • first plurality of openings 107 in central region 105 includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100, or , e.g., about 4 helical slits).
  • 1 to 100 openings e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40
  • first plurality of openings 107 in central region 105 include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1
  • first plurality of openings 107 in central region 105 include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1
  • First plurality of openings 107 in central region 105 may be slits, helical slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes.
  • First plurality of openings 107 in central region 105 may be configured to promote toroidal flow in a biomaterial injected into internal channel 109, such first plurality of openings 107 are helical slits.
  • First plurality of openings 107 in central region 105 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 107 and into the adjacent bone tissue.
  • the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • a width of from about 0.1 mm to about 5 mm e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1
  • first plurality of openings 107 in central region 105 are helical slits.
  • the helical slits are continuous along a length of the central region.
  • the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-70 mm, about 75-100 mm, about 80-100 mm, about 80-90 mm, or about 90-100 mm, e.g., about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm
  • the helical slits have a number of turns per unit length of between 0.1 and 5 turns/cm (e.g., from about 0.1 to 0.2 turns/cm, about 0.1 to 0.3 turns/cm, about 0.1 to 0.4 turns/cm, about 0.1 to 0.5 turns/cm, about 0.25 to 0.5 turns/cm, about 0.3 to 0.6 turns/cm, about 0.4 to 0.5 turns/cm, about 0.4 to 0.6 turns/cm, about 0.5 to 0.6 turns/cm, about 0.5 to 0.9 turns/cm, about 0.6 to 0.8 turns/cm, about 0.7 to 0.9 turns/cm, about 0.75 to 1 turns/cm, about 0.75 to 1 .5 turns/cm, about 0.1 to 1 turns/cm, about 1 .1 to 1 .2 turns/cm, about 1 to 2 turns/cm, about 1 to 1 .5 turns/cm, about 1 .3 to 1 .6 turns/cm,
  • device 100 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets.
  • a biomaterial e.g., a solid biomaterial, such as a solid dose biomaterial
  • first plurality of openings 107 in central region 105 may be sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets).
  • first plurality of openings 107 in central region 105 together encompass from between about 20% to 80% (e.g., from about 20% to about 30%, from about 20% to about 65%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total external surface area of central region 105.
  • first plurality of openings 107 in central region 105 extend from one region into at least one other, for example an opening in central region 105 may extend into proximal region 104 and/or distal region 106.
  • Central region 105 may have different types of openings than distal region 106, e.g., first plurality of openings 107 in central region 105 may be helical openings (e.g., helical slits) that extend the full length of central region 105, while second plurality of openings 108 in distal region 106 are closed shaped voids that do not extend from proximal to distal end of distal region 106, e.g., plurality of openings 108 that are holes dispersed along the length of distal region 106 (see, e.g., FIGs. 1A-1 D, 1 H, and 2).
  • Such a difference in openings in the central and distal regions allows greater volumetric expansion of biomaterial adjacent the central region. Given that many bone defects are centrally located,
  • Device 100 includes distal region 106 that includes second plurality of openings 108 and internal channel 109. In some embodiments, distal region 106 does not have openings other than the opening to internal channel 109 at distal end 103.
  • distal region 106 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about
  • distal region 106 is smaller than, larger than, or equal to the outer diameter of central region 105.
  • distal region 106 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm,
  • distal region 106 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to
  • distal region 106 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about
  • Distal region 106 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of distal region 106, e.g., the exterior of distal region 106, an interior of distal region 106, and/or interior walls of the openings of distal region 106.
  • Second plurality of openings 108 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • second plurality of openings 108 in distal region 106 include staggered or straight openings.
  • second plurality of openings 108 in distal region 106 includes 2-10 helical slits; preferably 4-6 helical slits.
  • second plurality of openings 108 extend through an entire length of distal region 106.
  • Second plurality of openings 108 in distal region 106 can also contribute to reducing flow resistance in internal channel 109 in combination with first plurality of openings 107 in central region 105.
  • biomaterial in a fluidic state rotates around the center axis of internal channel 109, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation.
  • the perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
  • second plurality of openings 108 in distal region 106 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 ,
  • second plurality of openings 108 in distal region 106 have a cross- sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about
  • second plurality of openings 108 in distal region 106 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets).
  • the opening to internal channel 109 at distal end 103 has a cross-sectional dimension that is narrower than the cross- sectional dimension of the solid dose of the biomaterial.
  • the tapered distal end 103 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 103 of device 100.
  • second plurality of openings 108 in distal region 106 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of distal region 106.
  • a total surface area of an external or an internal surface of distal region 106 e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about
  • a particular device 100 has unitary body 101 that includes proximal end 102, distal end 103, proximal region 104 with thread 1 10 in the exterior of proximal region 104, central region 105, distal region 106, second plurality of openings 108 in distal region 106, and notches 1 11.
  • Device 100 also includes internal channel 109 that extends longitudinally through unitary body 101 (see, e.g., FIGs. 1 E-1 H).
  • Device 100 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 100 can also be 3D printed using these materials or others. Device 100 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, e.g., about 50 mm). Proximal region
  • Central region 105 has a length of from about 5 mm to 150 mm (e.g., from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 100 to about 150 mm).
  • Distal region 106 has a length of from about 2 mm to about 100 mm (e.g., about 2 mm to about 10 mm, from about 10 mm to about 20 mm, from about 50 to about 75 mm, or from about 75 mm to about 100 mm).
  • Proximal region 104 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 25 mm). Proximal region 104 has an inner diameter of from about
  • Central region 105 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 25 mm).
  • Central region 105 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 20 mm).
  • Distal region 106 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 25 mm). Distal region 106 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 20 mm).
  • Proximal region 104 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 4.0 mm to about 5.0 mm, or, e.g., about 2.5 mm, about 3.5 mm, or about 4.5 mm).
  • Central region 105 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 mm to about 2.0 mm, about 1 .0 mm to about 2.0 mm, or about 4.0 mm to 5.0 mm, or, e.g., about 0.7 mm, about 2 mm, or about 4.5 mm).
  • Distal region 106 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 mm to about 2.0 mm, about 1 .0 mm to about 2.0 mm, or about 4.0 mm to 5.0 mm, or, e.g., about 0.7 mm, about 1 .5 mm, or about 4.5 mm).
  • Central region 105 and/or distal region 106 can include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of central region 105 and/or distal region 106, e.g., the exterior of central region 105, an interior of central region 105, and/or interior walls of the openings of central region 105.
  • the internal surface (of the internal channel 109) of device 100 may be smooth or textured (e.g., rough).
  • Internal channel 109 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 100.
  • Thread 110 has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 5 mm to about 10 mm, or, e.g., about 15 mm).
  • Thread 110 is formed from protrusions, grooves, waves, or a mesh. Internal channel 109 can be lined with a mesh so as to form internal threads.
  • the protrusions, grooves, or waves of thread 110 is at from about 1 to about 360 points per 360° (e.g., from about 1 to about 10, from about 10 to about 100, or from about 300 to about 360), in which 360 points per 360° points defines a full thread.
  • Thread 110 is/are a non-continuous thread or can be a continuous thread. Thread 110 is/are broken by at least one opening, e.g., at least one slit or at least one hole.
  • the non-continuous thread(s) include(s) a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, or from about 20 mm to about 30 mm).
  • First plurality of openings 107 in central region 105 includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 50, from about 2 to about 100, or, e.g., about 50, or, e.g., about 4 helical slits), together encompassing from between about 20% to 80% (e.g., from about 20% to about 30%, from about 50% to about 80%, or, e.g., about 80%) of a total external surface area of central region 105.
  • First plurality of openings 107 in central region 105 extend from one region into at least one other, e.g., an opening in central region 105 may extend into proximal region 104 and/or distal region 106.
  • First plurality of openings 107 in central region 105 include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 1 mm to about 1 .5 mm, or, e.g., about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 10 mm to about 20 mm, from about 75 to about 100 mm, or from about 100 mm to 150 mm).
  • a width of from about 0.01 mm to about 5 mm e.g., from about 0.01 mm to about 0.5 mm, from about 1 mm to about 1 .5 mm, or, e.g., about 2.4 mm
  • a length of from about 0.01 mm to about 150 mm e.g., from about 0.01 mm to about 0.5 mm, from about 10 mm to about 20 mm, from about
  • First plurality of openings 107 in central region 105 can be holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 1 .5 mm to about 3 mm, or, e.g., about 2.4 mm).
  • First plurality of openings 107 in central region 105 can be slits, in which the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 1 mm to about 1.5 mm, or, e.g., about 2.4 mm).
  • First plurality of openings 107 in central region 105 may be slits, helical slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes.
  • First plurality of openings107 in central region 105 may be configured to promote toroidal flow in a biomaterial injected into internal channel 109, such first plurality of openings 107 are helical slits.
  • the helical slits are continuous along a length of the central region.
  • the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, about 40- 80 mm, or, e.g., about 100 mm).
  • the helical slits have a number of turns per unit length of between 0.1 and 5 turns/cm (e.g., about 0.1 to 0.5 turns/cm, about 1 to 2 turns/cm, or about 4 to 5 turns/cm).
  • First plurality of openings 107 in central region 105 can include 2-10 helical slits; preferably 4-6 helical slits.
  • Second plurality of openings 108 in distal region 106 includes from 1 to 200 openings (e.g., from about 4 to about 10, from about 50 to about 200, or, e.g., 32 diamond-shaped openings), together encompassing between about 15% to about 80% (e.g., from about 15% to about 30, from about 30% to about 60%, or e.g., about 70%) of a total surface area of an external surface of distal region 106.
  • Second plurality of openings 108 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • Second plurality of openings 108 in distal region 106 include staggered or straight openings.
  • Second plurality of openings 108 in distal region 106 includes 2-10 helical slits; preferably 4-6 helical slits.
  • Second plurality of openings 108 in distal region 106 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 1 mm to about 1 .5 mm, or, e.g., about 2.4 mm).
  • Device 100 can be pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., pellets of biomaterial 414 of FIGs. 4I- 4K). The loading of the pellets of biomaterial in device 400 would be equivalent for device 100.
  • a biomaterial e.g., a solid biomaterial, such as a solid dose biomaterial
  • the solid dose biomaterial can be a compressed powder (e.g., compressed at a pressure of 10 to 150 MPa) and can be a mixture of particles of a calcium phosphate (e.g., 65-85 wt%) and a phosphoserine or phosphocreatine (e.g., 15-35 wt%, such as 20-30 wt% or 22-27 wt%).
  • the biomaterial may further include calcium silicate (e.g., in an amount of 0.2-2 wt%, e.g., 0.5-1 .5 wt%).
  • the biomaterial can also have a density of about 1 .20-1 .80 g/cm 3 .
  • First plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 may be sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of biomaterial (e.g., in the form of pellets).
  • Distal end 103 can be blunt and/or tapered.
  • Distal end 103 has at least one or a plurality of milling flutes, notches, and/or elongated tips.
  • Distal end 103 includes at least one notch or from 2 to 4 notches (e.g., 3 notches), such as notches 111 in distal end 103.
  • Distal end 103 can include at least one milling flute or 2 to 5 milling flutes (e.g., 3 milling flutes) which can have sharpened edges. Distal end 103 can be sized and tapered to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 103 of device 100.
  • Proximal end 102 can include an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. The outer diameter from proximal end 102 to distal end 103 may be constant.
  • device 400 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation.
  • a bone defect e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis
  • soft tissue e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle
  • Device 400 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 400) and can be used as a compression screw component, fastener, or suture anchor.
  • Device 400 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (e.g., sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., nail system of FIG. 3), a screw, a suture, a prosthesis, or other similar hardware, and as a spinal attachment device.
  • a bone plate e.g., sliding hip screw system of FIG. 7
  • a soft tissue suture anchor see, e.g., the suture anchor system of FIG. 9
  • an intramedullary pin a nail (see, e.g., nail system of FIG. 3
  • device 400 can be used to uniformly deliver a biomaterial to the bone, secure the bone structure and/or soft tissue, and promote bone repair and/or soft tissue and/or healing.
  • device 400 promotes improved (e.g., increased) distribution of a biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of a defect in the bone.
  • Device 400 has unitary body 401 that includes proximal end 402, distal end 403, proximal region 404 with thread 410 in the exterior of proximal region 404, distal region 406, and plurality of openings 412 in distal region 406 (see, e.g., FIGs. 4A-4M).
  • Device 400 also include internal channel 409 (see, e.g., FIGs. 4E-4J) that extends longitudinally through unitary body 401 .
  • Device 400 can include internal protrusion(s) (e.g., internal thread) 413 that is/are located within internal channel 409 (see, e.g., FIGs. 4I and 4J).
  • Device 400 can include notches 411 .
  • device 400 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from
  • 110 mm from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 110 mm, from about 90 mm to about 110 mm, from about 95 mm to about 110 mm, from about 100 mm to about 110 mm, from about 105 mm to about 110 mm, about 9 mm, about 10 mm, about
  • device 400 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm).
  • 9 mm e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm.
  • device 400 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
  • 200 mm e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm
  • the internal surface of device 400 may be smooth or textured (e.g., rough), e.g., including at least one internal protrusion 413.
  • Internal channel 409 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 400.
  • device 400 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about 54, about 55
  • device 400 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • Device 400 can also be 3D printed using these materials or others.
  • distal end 403 can be blunt and/or can be tapered. In some embodiments, distal end 403 has a blunt edge. In some embodiments, distal end 403 has a tapered edge. In some embodiments, distal end 403 has at least one or a plurality of milling flutes, notches, and/or elongated tips. In some embodiments, distal end 403 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 403 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 403 includes at least one notch.
  • distal end 403 has from 2 to 4 notches (e.g., 2, 3, or 4 notches).
  • the opening at distal end 403 to internal channel 409 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of pellets of biomaterial 414 (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets).
  • tapered distal end 403 is sized to prevent the pre-loaded pellets of biomaterial 414 from exiting distal end 403 of device 400.
  • proximal end 402 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the outer diameter from proximal end 402 to distal end 403 is constant.
  • Device 400 includes proximal region 404 that includes internal channel 409 and thread 410 in the exterior of proximal region 404 (see, e.g., FIGs. 4A-4M).
  • Proximal region 404 in device 400 can also include internal protrusion(s) 413 (e.g., forming an internal thread) that is/are located in internal channel 409 (see, e.g., FIGs. 4I and 4J).
  • proximal region 404 does not have openings other than the opening to internal channel 409 at proximal end 402.
  • proximal region 404 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm
  • the outer diameter of proximal region 404 is smaller than, larger than, or equal to the outer diameter of distal region 406.
  • the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18
  • proximal region 404 has a length of from about 2 mm to 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • a length of from about 2 mm to 100 mm e.g., from about 2 mm to about 5 mm,
  • proximal region 404 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .9 mm, about 2
  • internal protrusion(s) e.g., internal thread
  • internal thread e.g., internal thread
  • internal protrusion(s) 413 located within internal channel 409 and/or thread 410 located on the exterior of proximal region 404 is/are formed from protrusions, grooves, waves, or a mesh.
  • internal channel 409 is lined with a mesh so as to form internal threads.
  • the protrusions, grooves, or waves of internal protrusion(s) 413 (e.g., internal thread) and/or thread 410 is/are at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread.
  • 360 points per 360° points defines a full thread.
  • internal protrusion(s) 413 e.g., internal thread
  • thread 410 is/are a continuous thread or non-continuous thread.
  • internal protrusion(s) 413 (e.g., internal thread) and/or thread 410 is/are broken by at least one opening, e.g., at least one slit or at least one hole.
  • the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
  • the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
  • Device 400 includes distal region 406 that includes plurality of openings 412 and internal channel 409. In some embodiments, distal region 406 does not have openings other than the opening to internal channel 409 at distal end 403.
  • distal region 406 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about
  • distal region 406 is smaller than, larger than, or equal to the outer diameter of proximal region 404.
  • distal region 406 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14
  • distal region 406 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • mm to about 100 mm e.g., from about 2 mm to about 5 mm, from about 2 mm to about
  • distal region 406 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about
  • Distal region 406 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of distal region 406, e.g., the exterior of distal region 406, an interior of distal region 406, and/or interior walls of the openings of distal region 406.
  • Plurality of openings 412 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • plurality of openings 412 in distal region 406 include staggered or straight openings.
  • plurality of openings 412 in distal region 406 includes 2-10 helical slits; preferably 4-6 helical slits.
  • plurality of openings 412 extend through an entire length of distal region 406. Plurality of openings 412 in distal region 406 can also contribute to reducing flow resistance in internal channel 409.
  • biomaterial in a fluidic state rotates around the center axis of internal channel 409, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation.
  • the perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
  • plurality of openings 412 in distal region 406 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about
  • plurality of openings 412 in distal region 406 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6
  • device 400 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., FIGs. 4I-4K).
  • a biomaterial e.g., a solid biomaterial, such as a solid dose biomaterial
  • plurality of openings 412 in distal region 406 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the pellets of biomaterial 414 (e.g., the solid dose biomaterial, e.g., in the form of pellets) (see, e.g., FIGs. 4I-4K).
  • the opening to internal channel 409 at distal end 403 has a cross-sectional dimension that is narrower than the cross-sectional dimension of the pellets of biomaterial 414.
  • tapered distal end 403 is sized to prevent the pre-loaded pellets of biomaterial 414 from exiting distal end 403 of device 400.
  • plurality of openings 412 in distal region 406 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of distal region 406.
  • device 400 has similar features to device 100 as described previously, including unitary body 401 that includes proximal end 402, distal end 403, proximal region 404, thread 410 in proximal region 404, distal region 406, plurality of openings 412 in distal region 406, and notches 411 .
  • Device 400 also includes internal channel 409 that extends longitudinally through unitary body 401 and can additionally include internal protrusion(s) 413 (e.g., internal thread) (see, e.g., FIGs. 4H-4J and 4M).
  • device 400 does not include a central region and more than one plurality of openings (see, e.g., central region 105, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region of FIGs. 1A-1 H and 2).
  • device 500 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation.
  • a bone defect e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis
  • soft tissue e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle
  • Device 500 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 500) and can be used as a compression screw component, fastener, or suture anchor.
  • Device 500 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (see, e.g., sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., nail system of FIG. 3), screw, a suture, a prosthesis, or other similar hardware, and a spinal attachment device.
  • a bone plate see, e.g., sliding hip screw system of FIG. 7
  • a soft tissue suture anchor see, e.g., the suture anchor system of FIG. 9
  • an intramedullary pin a nail (see, e.g., nail system of FIG
  • device 500 can be used to uniformly deliver a biomaterial to the bone, secure the bone and/or soft tissue structure, and promote bone and/or soft tissue repair and/or healing.
  • device 500 promotes improved (e.g., increased) distribution of biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of the insertion site and/or a defect in the bone.
  • Device 500 has unitary body 501 that includes proximal end 502, distal end 504, proximal region 504, distal region 506, first plurality of openings 507 in proximal region 504, and second plurality of openings 508 in distal region 506 (see, e.g., FIG. 5).
  • Device 500 also includes internal channel 509 that extends longitudinally through unitary body 501 .
  • Device 500 can optionally include notches 511.
  • device 500 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from
  • device 500 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 1 10 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm).
  • 9 mm e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 1 10 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm.
  • device 500 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
  • 200 mm e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm
  • the internal surface of device 500 may be smooth or textured (e.g., rough).
  • Internal channel 509 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 500.
  • device 500 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about 54, about
  • device 500 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • Device 500 can also be 3D printed using these materials or others.
  • distal end 503 can be blunt and/or can be tapered. In some embodiments, distal end 503 has a blunt edge. In some embodiments, distal end 503 has a tapered edge. In some embodiments, distal end 503 has at least one or a plurality of milling flutes, notches, and/or elongated tips. In some embodiments, distal end 503 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 503 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 503 includes at least one notch.
  • distal end 503 has from 2 to 4 notches (e.g., 2, 3, or 4 notches).
  • the opening at distal end 503 to internal channel 509 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a solid dose of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets).
  • tapered distal end 503 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 503 of device 500.
  • proximal end 502 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the outer diameter from proximal end 502 to distal end 503 is constant.
  • proximal region 504 that may not have openings other than the opening to internal channel 509 at proximal end 502.
  • proximal region 504 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about
  • the outer diameter of proximal region 504 is smaller than, larger than, or equal to the outer diameter of distal region 506.
  • the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18
  • proximal region 504 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • proximal region 504 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .9 mm, about 2
  • Proximal region 504 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on the exterior of proximal region 504.
  • first plurality of openings 507 in proximal region 504 includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100, or, e.g., about 4 helical slits).
  • 1 to 100 openings e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to
  • first plurality of openings 507 in proximal region 504 include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm).
  • first plurality of openings 507 in proximal region 504 include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about
  • First plurality of openings 507 in proximal region 504 may be slits, helical slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes.
  • First plurality of openings 507 in proximal region 504 may be configured to promote toroidal flow in a biomaterial injected into internal channel 509, such first plurality of openings 507 are helical slits.
  • First plurality of openings 507 in proximal region 504 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 507 and into the adjacent bone tissue.
  • the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
  • a width of from about 0.1 mm to about 5 mm e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1
  • first plurality of openings 507 in proximal region 504 are helical slits.
  • the helical slits are continuous along a length of proximal region 504.
  • the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-70 mm, about 75-100 mm, about 80-100 mm, about 80-90 mm, or about 90-100 mm, e.g., about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22
  • the helical slits have a number of turns per unit length of between 0.1 and 5 turns/cm (e.g., from about 0.1 to 0.2 turns/cm, about 0.1 to 0.3 turns/cm, about 0.1 to 0.4 turns/cm, about 0.1 to 0.5 turns/cm, about 0.25 to 0.5 turns/cm, about 0.3 to 0.6 turns/cm, about 0.4 to 0.5 turns/cm, about 0.4 to 0.6 turns/cm, about 0.5 to 0.6 turns/cm, about 0.5 to 0.9 turns/cm, about 0.6 to 0.8 turns/cm, about 0.7 to 0.9 turns/cm, about 0.75 to 1 turns/cm, about 0.75 to 1 .5 turns/cm, about 0.1 to 1 turns/cm, about 1 .1 to 1 .2 turns/cm, about 1 to 2 turns/cm, about 1 to 1 .5 turns/cm, about 1 .3 to 1 .6 turns/cm,
  • first plurality of openings 507 in proximal region 504 includes 2-10 helical slits; preferably 4-6 helical slits.
  • device 500 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets.
  • first plurality of openings 507 in proximal region 504 may be sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., the solid dose biomaterial, e.g., in the form of pellets).
  • a cross-sectional dimension e.g., width
  • a cross-sectional dimension e.g., diameter
  • first plurality of openings 507 in proximal region 504 together encompass from between about 20% to 80% (e.g., from about 20% to about 30%, from about 20% to about 65%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total external surface area of proximal region 504.
  • first plurality of openings 507 in proximal region 504 extend through an entire length of proximal region 504. In some embodiments, first plurality of openings 507 in proximal region 504 extend from one region into at least one other, for example an opening in proximal region 504 may extend into distal region 506.
  • Proximal region 504 may have different types of openings than distal region 506, e.g., first plurality of openings 507 in proximal region 504 may be helical openings (e.g., helical slits) that extend the full length of proximal region 504, while second plurality of openings 508 in distal region 506 are closed shaped voids that do not extend from proximal to distal end of distal region 506, e.g., second plurality of openings 508 that are holes dispersed along the length of distal region 506 (see, e.g., FIG. 5).
  • first plurality of openings 507 in proximal region 504 may be helical openings (e.g., helical slits) that extend the full length of proximal region 504, while second plurality of openings 508 in distal region 506 are closed shaped voids that do not extend from proximal to distal end of distal region 506, e
  • proximal region 504 and distal region 506 allows greater volumetric expansion of biomaterial between the proximal and distal region.
  • Many bone defects are centrally located, and, thus, such a dispersion profile is advantageous for targeting the defect.
  • Device 500 includes distal region 506 that includes second plurality of openings 508 and internal channel 509. In some embodiments, distal region 506 does not have openings other than the opening to internal channel 509 at distal end 503.
  • distal region 506 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about
  • distal region 506 is smaller than, larger than, or equal to the outer diameter of proximal region 504.
  • distal region 506 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14
  • distal region 506 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
  • mm to about 100 mm e.g., from about 2 mm to about 5 mm, from about 2 mm to about
  • distal region 506 has a wall thickness of from 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .
  • Distal region 506 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of distal region 506, e.g., the exterior of distal region 506, an interior of distal region 506, and/or interior walls of the openings of distal region 506.
  • Second plurality of openings 508 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • second plurality of openings 508 in distal region 506 include staggered or straight openings.
  • second plurality of openings 508 in distal region 506 includes 2-10 helical slits; preferably 4-6 helical slits.
  • second plurality of openings 508 extend through an entire length of distal region 506.
  • Second plurality of openings 508 in distal region 506 can also contribute to reducing flow resistance in internal channel 509 in combination with first plurality of openings 507 in proximal region 504.
  • biomaterial in a fluidic state rotates around the center axis of internal channel 509, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation.
  • the perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
  • second plurality of openings 508 in distal region 506 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 ,
  • second plurality of openings 508 in distal region 506 have a cross- sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about
  • second plurality of openings 508 in distal region 506 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets).
  • the opening to internal channel 509 at distal end 503 has a cross-sectional dimension that is narrower than the cross- sectional dimension of the solid dose of the biomaterial.
  • tapered distal end 503 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 503 of device 500.
  • second plurality of openings 508 in distal region 506 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of distal region 506.
  • device 500 has similar features to device 100 as described previously, including unitary body 501 that includes proximal end 502, distal end 503, proximal region 504, distal region 506, first plurality of openings 507, second plurality of openings 508 in distal region 506, and notches 511 .
  • Device 500 also includes internal channel 509 that extends longitudinally through unitary body 501 and does not include internal protrusion(s) (e.g., internal thread) as device 400 does (see, e.g., internal protrusion(s) 413 of FIGs. 4H-4J and 4M).
  • internal protrusion(s) e.g., internal thread
  • device 500 does not include an external thread in proximal region 504 and does not include a central region (see, e.g., thread 110 in proximal region 104 and central region 105 of FIGs. 1A-1 H and 2).
  • device 500 includes first plurality of openings 507 that are located in proximal region 504 (see, e.g., FIG. 5) rather than in a central region (see, e.g., first plurality of openings 107 in central region 105 of FIGs. 1A-1 H and 2).
  • device 600 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation.
  • a bone defect e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis
  • soft tissue e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle
  • Device 600 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 600) and can be used as a compression screw component, fastener, or suture anchor.
  • Device 600 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (e.g., sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., nail system of FIG. 3), screw, a suture, a prosthesis, or other similar hardware, and a spinal attachment device.
  • a bone plate e.g., sliding hip screw system of FIG. 7
  • a soft tissue suture anchor see, e.g., the suture anchor system of FIG. 9
  • an intramedullary pin a nail (see, e.g., nail system of FIG. 3), screw,
  • device 600 can be used to uniformly deliver a biomaterial to the bone, secure the bone and/or soft tissue structure, and promote bone and/or soft tissue repair and/or healing.
  • device 600 promotes improved (e.g., increased) distribution of biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of the insertion site and/or a defect in the bone.
  • Device 600 has unitary body 601 that includes proximal end 602, distal end 603, central region 605, and plurality of openings 612 in central region 605 (see, e.g., FIGs. 6A-6I).
  • Device 600 also includes internal channel 609 (see, e.g., FIGs. 6E-6I) that extends longitudinally through unitary body 601 .
  • Device 600 can include internal protrusion(s) 613 (e.g., forming an internal thread) that is/are located within internal channel 609 (see, e.g., FIGs. 6G and 6I).
  • Device 600 can include notches 611.
  • device 600 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from
  • device 600 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 1 10 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm).
  • 9 mm e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 1 10 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm.
  • device 600 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
  • 200 mm e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm
  • the internal surface of device 600 may be smooth or textured (i.e., rough), e.g., including at least one internal protrusion 613.
  • Internal channel 609 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 600.
  • device 600 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about 54, about
  • device 600 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • Device 600 can also be 3D printed using these materials or others.
  • distal end 603 can be blunt and/or can be tapered. In some embodiments, distal end 603 has a blunt edge. In some embodiments, distal end 603 has a tapered edge. In some embodiments, distal end 603 has at least one or a plurality of milling flutes, notches, and/or elongated tips. In some embodiments, distal end 603 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 603 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 603 includes at least one notch.
  • distal end 603 has from 2 to 4 notches (e.g., 2, 3, or 4 notches).
  • the opening at distal end 603 to internal channel 609 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a pellet of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets).
  • tapered distal end 603 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 603 of device 600.
  • proximal end 602 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the outer diameter from proximal end 602 to distal end 603 is constant. Central region of device 600
  • Device 600 includes central region 605 that includes plurality of openings 612 and internal channel 609 (see, e.g., FIGs. 6E-6I). Central region 605 in device 600 can also include internal protrusion(s) 613 (e.g., as an internal thread) that is/are located in internal channel 609 (see, e.g., FIGs. 6G and 6I). In some embodiments, central region 605 does not have openings other than the opening to internal channel 609 at proximal end 602.
  • central region 605 has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm
  • central region 605 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 1 1 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).
  • mm to about 20 mm e.g., from about
  • central region 605 has a length from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about 10-20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50- 150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160-180 mm, about 175-190 mm, about 175-200 mm
  • central region 605 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1
  • Central region 605 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of central region 605, e.g., the exterior of central region 605, an interior of central region 605, and/or interior walls of the openings of central region 605.
  • Plurality of openings 612 in central region 605 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • plurality of openings 612 in central region 605 include staggered or straight openings.
  • plurality of openings 612 in central region 605 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, plurality of openings 612 extend through an entire length of central region 605.
  • Plurality of openings 612 in central region 605 can also contribute to reducing flow resistance in internal channel 609.
  • biomaterial in a fluidic state rotates around the center axis of internal channel 609, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation.
  • the perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
  • plurality of openings 612 in central region 605 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52
  • plurality of openings 612 in central region 605 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6
  • device 600 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., pellets of biomaterial 814 of FIG. 8B).
  • a biomaterial e.g., a solid biomaterial, such as a solid dose biomaterial
  • the loading of the pellets of biomaterial in device 800 would be equivalent for device 100.
  • plurality of openings 612 in central region 605 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets).
  • the opening to internal channel 609 at distal end 603 has a cross-sectional dimension that is narrower than the cross-sectional dimension of the solid dose of the biomaterial.
  • tapered distal end 603 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 603 of device 600.
  • plurality of openings 612 in central region 605 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of central region 605.
  • internal protrusion(s) 613 located within internal channel 609 has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about
  • internal protrusion(s) 613 located within internal channel 609 is formed from protrusions, grooves, waves, or a mesh.
  • internal channel 609 is lined with a mesh so as to form internal threads.
  • the protrusions, grooves, or waves of internal protrusion(s) 613 is at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread.
  • 360 points per 360° points defines a full thread.
  • internal protrusion(s) 613 is a continuous thread or non-continuous thread. In some embodiments, internal protrusion(s) 613 (e.g., internal thread) is broken by at least one opening, e.g., at least one slit or at least one hole.
  • the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
  • the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
  • device 600 has similar features to device 100 as described previously, including unitary body 601 that includes proximal end 602, distal end 603, central region 605, plurality of openings 612, and notches 611.
  • Device 600 also includes internal channel 609 that extends longitudinally through unitary body 601 (see, e.g., FIGs. 6E-6H).
  • device 600 includes internal protrusion(s) 613 (e.g., internal thread) that is/are located within internal channel 609 (see, e.g., FIGs. 6G and 6I).
  • device 600 does not include more than one type of a plurality of openings, nor does it have a proximal region, a distal region, and an external thread (see, e.g., first plurality of openings 107 in central region 105, second plurality of openings 108 in distal region 106, proximal region 104, distal region 106, and thread 110 in proximal region 104 of FIGs. 1A-1 H and 2). Instead, device 600 includes only one type of a plurality of openings 612 and only a central region 605.
  • device 800 of the disclosure is an implant that can be used for multiple purposes, including repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone or providing or improving implant fixation.
  • soft tissue e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.
  • a bone defect e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture
  • Device 800 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 800) and can be used as a screw anchor and/or a fastener.
  • Device 800 can be used in combination with, or to secure, other hardware, such as, e.g., a suture, a prosthesis or other similar hardware.
  • device 800 can be used to uniformly deliver a biomaterial to the bone, secure the soft tissue to the bone, and promote soft tissue repair and/or healing.
  • device 800 promotes improved (e.g., increased) distribution of a biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of an insertion site in the bone.
  • Device 800 has unitary body 801 that includes proximal end 802, distal end 803, central region 805, and plurality of openings 812 in central region 805 (see, e.g., FIGs. 8A-8D).
  • Device 800 also includes internal channel 809 (see, e.g., FIG. 8B) that extends longitudinally through unitary body 801 .
  • device 800 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from
  • device 800 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm).
  • 9 mm e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm.
  • device 800 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
  • 200 mm e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm
  • the internal surface of device 800 may be smooth or textured (e.g., rough), e.g., including at least one internal protrusion.
  • Internal channel 809 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 800.
  • device 800 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52, about 53, about 54, about 55
  • device 800 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
  • Device 800 can also be 3D printed using these materials or others.
  • distal end 803 can be blunt and/or can be tapered. In some embodiments, distal end 803 has a blunt edge. In some embodiments, distal end 803 has a tapered edge. In some embodiments, distal end 803 has at least one or a plurality of milling flutes, notches, and/or elongated tips. In some embodiments, distal end 803 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 803 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 803 includes at least one notch.
  • distal end 803 has from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the distal end does not include an opening to internal channel 809. In some embodiments, the opening at distal end 803 to internal channel 809 may be sized to have a cross- sectional dimension narrower than the cross-sectional dimension of pellets of biomaterial 814 (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, tapered distal end 803 is sized to prevent the pre-loaded pellets of biomaterial 814 from exiting distal end 803 of device 800.
  • the opening at distal end 803 to internal channel 809 may be sized to have a cross- sectional dimension narrower than the cross-sectional dimension of pellets of biomaterial 814 (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets).
  • tapered distal end 803
  • proximal end 802 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the outer diameter from proximal end 802 to distal end 803 is constant.
  • Device 800 includes central region 805 that includes plurality of openings 812 and internal channel 809.
  • central region 805 has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 25 mm, about 1 .5 mm, about 1 .75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm
  • central region 805 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 1 1 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).
  • mm to about 20 mm e.g., from about
  • central region 805 has a length of from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about 10-20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50- 150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160-180 mm, about 175-190 mm, about 175-200
  • central region 805 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1
  • Central region 805 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation.
  • the textured surface may be on any or all surfaces of central region 805, e.g., the exterior of central region 805, an interior of central region 805, and/or interior walls of the openings of central region 805.
  • Plurality of openings 812 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
  • plurality of openings 812 in central region 805 include staggered or straight openings.
  • plurality of openings 812 in central region 805 includes 2-10 helical slits; preferably 4-6 helical slits.
  • plurality of openings 812 extend through an entire length of central region 805.
  • Plurality of openings 812 in central region 805 can also contribute to reducing flow resistance in internal channel 809.
  • biomaterial in a fluidic state rotates around the center axis of internal channel 809, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation.
  • the perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
  • plurality of openings 812 in central region 805 include from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11 , about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21 , about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31 , about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41 , about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51 , about 52
  • plurality of openings 812 in central region 805 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6
  • device 800 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., pellets of biomaterial 814 of FIG. 8B).
  • a biomaterial e.g., a solid biomaterial, such as a solid dose biomaterial
  • the loading of the pellets of biomaterial in device 800 is equivalent to device 400 (see, e.g., pellets of biomaterial 414 of FIGs. 4I-4K).
  • plurality of openings 812 in central region 805 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of pellets of biomaterial 814 (e.g., the solid dose biomaterial, e.g., in the form of pellets).
  • the opening to internal channel 809 at distal end 803 has a cross- sectional dimension that is narrower than the cross-sectional dimension of pellets of biomaterial 814.
  • tapered distal end 803 is sized to prevent the pre-loaded pellets of biomaterial 814 from exiting distal end 803 of device 800.
  • plurality of openings 812 in central region 805 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of central region 805.
  • device 800 has similar features to device 100 as described previously, including unitary body 801 that includes proximal end 802, distal end 803, central region 805, and plurality of openings 812.
  • Device 800 also includes internal channel 809 that extends longitudinally through unitary body 801 (see, e.g., FIG. 8B).
  • Device 800 does not include internal protrusion(s) (e.g., internal thread) that is/are located within internal channel 809 as device 400 does (see, e.g., internal protrusion(s) 413 of FIGs. 4H-4J and 4M).
  • device 800 does not include more than one plurality of openings, a proximal region, a distal region, an external thread, and notches at the distal end (see, e.g., first plurality of openings 107 in central region 105, second plurality of openings in distal region 106, proximal region 104, distal region 106, thread 110 in proximal region 104, and notches 111 of FIGs. 1 A-1 H and 2).
  • device 800 includes a tapered distal end that may include an opening to internal channel 809 that has a cross-sectional dimension narrower than the cross- sectional dimension of pellets of biomaterials 814.
  • device 800 has a shorter length than device 400 (see, e.g., FIG. 8D).
  • Systems of the disclosure include a device of the disclosure (e.g., device 100, device 400, device 500, device 600, and/or device 800) and one or more additional implants with which the device engages to reinforce the bone (e.g., at a defect site, e.g., a fracture, osteoporosis, etc.).
  • implants include nails (e.g., intramedullary nails, e.g., a cephalomedullary nails) and bone plates (e.g., extramedullary plate).
  • Systems may include multiple devices of the disclosure.
  • the disclosure features a system that is particularly advantageous for reinforcing a long bone (e.g., a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus) of a subject (e.g., a subject with a defect in the bone, e.g., in the proximal femur, e.g., an intertrochanteric fracture, osteoporosis, etc.).
  • the system includes a device as described herein (e.g., device 100, device 400, device 500, or device 600), which can be configured as a compression screw component, a lag screw, and a nail, e.g., as shown in FIG.
  • the three components together integrate as a compression assembly to reinforce the bone (e.g., the femur).
  • the nail is an intramedullary nail (e.g., a cephalomedullary nail), configured to be inserted into the medullary cavity of the femur.
  • a proximal portion of the nail includes two adjacent holes into which the device of the disclosure and the lag screw can be inserted, such that, when inserted, the screws align substantially along a centerline of, e.g., the femoral head and neck.
  • the device acts as a compression screw component in concert with the lag screw to stabilize the nail and the proximal femur.
  • the lag screw and compression screw component engage with each other to form a compression assembly in conjunction with the nail to reinforce the proximal femur of the subject.
  • device 100 is discussed, but device 400, device 500, and device 600 may also be similarly used.
  • Device 400, device 500, and device 600 include structurally and operationally similar components in comparison to device 100, as previously discussed (see the Detailed Description).
  • Device 100 for use as a compression screw component is shown in FIGs. 1A-1 H and 2.
  • Device 400 for use as a compression screw component is shown in FIGs. 4A-4M.
  • Device 500 for use as a compression screw component is shown in FIG. 5.
  • Device 600 for use as a compression screw component is shown in FIGs. 6A-6I.
  • first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 allow biomaterial to be delivered to bone tissue around the implant, providing additional reinforcement, and the possibility for other therapeutic remediation (e.g., promoting growth of new bone tissue).
  • First plurality of openings 107 e.g., helical slits
  • Rotation of the biomaterial in the center of internal channel 109 also results in less friction at the wall of internal channel 109, preventing restriction of the flow of the biomaterial.
  • the combination of openings for biomaterial delivery and stiffness affords synergistic improvement over existing systems. For example, increased stability and resistance to collapse and deformity.
  • the lack of expansion or compression affords a cleaner extraction.
  • a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe, or from the pressure of expansion of solid dose biomaterial) or due to the stress of the compression screw component engaging the bone.
  • An expanded proximal region 104, central region 105, or distal region 106 could make extraction of device 100 (e.g., during a revision surgery) more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • Device 100 may include thread 110 located in the exterior of proximal region 104 (see FIGs. 1A- 1 D, 1G, 1 H, and 2) configured to engage with the lag screw.
  • parts of unitary body 101 e.g., central region 105 and/or distal region 106) have a textured surface, e.g., having a roughness between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns).
  • the textured surface improves interaction between a biomaterial and device 100.
  • the lag screw has a diameter that is greater than a diameter of device 100 and the nail has a curved trapezoidal cross-section (e.g., tapering to a narrower cross-section distally to allow easier insertion into the medullary cavity).
  • the system can also include a device as described herein (e.g., device 100, device 400, device 500, device 600, or device 800), which can be configured as a fastener and a nail.
  • the two components together integrate to reinforce the bone (e.g., the femur).
  • the nail is an intramedullary nail (e.g., a cephalomedullary nail), configured to be inserted into the medullary cavity of the femur.
  • a proximal portion of the nail includes a hole into which the device of the disclosure can be inserted, such that, when inserted, the device aligns substantially along a centerline of, e.g., the femoral head and neck. The hole is drilled into the bone in alignment with the hole of the nail.
  • the device acts as a fastener to stabilize the nail and the proximal femur.
  • device 500 is discussed, but device 100, device 400, device 600, or device 800 may also be similarly used.
  • Devices 100, 400, 600, and 800 include structurally and operationally similar components in comparison to device 500, as previously discussed (see the Detailed Description).
  • Device 100 for use as a fastener is shown in FIGs. 1A-1 H and 2.
  • Device 400 for use as a fastener is shown in FIGs. 4A-4M.
  • Device 500 for use as a fastener is shown in FIG. 5.
  • Device 600 for use as a fastener is shown in FIGs. 6A-6I.
  • proximal end 502 has a larger diameter than the diameter of the bone hole.
  • device 500 is completely inserted into the bone hole until the screw head of proximal end 502 reaches the edge of the nail, securing device 500 to the nail.
  • First plurality of openings 507 in proximal region 504 and second plurality of openings 508 in distal region 506 allow biomaterial to be delivered to bone tissue around the implant, providing additional reinforcement, and the possibility for other therapeutic remediation (e.g., promoting growth of new bone tissue).
  • First plurality of openings 507 create a rotational force that facilitates flow of the biomaterial along the center, longitudinal axis of internal channel 509, while, together with second plurality of openings 508 (e.g., diamond shaped openings), also decreasing resistance in the biomaterial as it exits. Rotation of the biomaterial in the center of internal channel 509 also results in less friction at the wall of internal channel 509, preventing restriction of the flow of the biomaterial.
  • the combination of openings for biomaterial delivery and stiffness affords synergistic improvement over existing systems. For example, increased stability and resistance to collapse and deformity.
  • a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe, or from the pressure of expansion of solid dose biomaterial) or due to the stress of the compression screw component or the fastener engaging the bone.
  • fluid e.g., a biomaterial
  • An expanded proximal region 504 or distal region 506 could make extraction of device 500 (e.g., during a revision surgery) more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • parts of unitary body 501 e.g., proximal region 504 and/or distal region 506 have a textured surface, e.g., having a roughness between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns).
  • the textured surface improves interaction between a biomaterial and device 500. Enhanced interaction with the biomaterial leads to better adhesion properties with the bone and interdigitation with the implant for better fixation of implanted device 500 (e.g., improved osseointegration in the area of device 500).
  • the system may be provided in a kit including a device of the disclosure (e.g., device 100, device 400, device 500, device 600, or device 800), and may be supplied with a source of biomaterial, e.g., a pre-filled biomaterial dispenser, e.g., a syringe with a tube fitting configured to fluidly connect the syringe with internal channel 509 of the device.
  • a source of biomaterial e.g., a pre-filled biomaterial dispenser, e.g., a syringe with a tube fitting configured to fluidly connect the syringe with internal channel 509 of the device.
  • the biomaterial dispenser includes a tube connected to a syringe, a vial, or a reservoir; in which, optionally, the tube further includes the biomaterial.
  • the dispenser and biomaterial may be provided separately. Biomaterial may be included in the kit, or the kit may be provided separately to the biomaterial.
  • Biomaterial may also be provided by being pre-loaded into the device (e.g., device 100, device 400, device 500, device 600, or device 800) or included for insertion by the user before or after implantation.
  • the device may pre-loaded with a solid dose biomaterial (e.g., in the form of pellets) within internal channel 509 (see, e.g., device 400 including pellets of biomaterial 414 in internal channel 409 of FIGs. 4I-4K).
  • the loading of the pellets of biomaterial in device 400 would be equivalent for device 500.
  • the kit includes the intramedullary nail (e.g., a cephalomedullary nail). In some embodiments, the kit further includes the intramedullary nail and the lag screw.
  • Another system particularly advantageous for reinforcing a long bone (e.g., a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus) of a subject includes a device as described herein (e.g., device 100, device 400, device 500, or device 600), which can be configured as a compression screw component, a bone plate with a barrel, a lag screw, and bone screws (see, e.g., the sliding hip screw system of FIG.
  • the bone plate is an extramedullary plate configured to be secured to the femur by way of four bone screws fastened through holes of the extramedullary plate designed to engage the bone screws and into the shaft of the femur, as shown in FIG. 7.
  • device 100 is discussed, but device 400, device 500, and/or device 600 may also be similarly used.
  • Device 400, device 500, and device 600 include structurally and operationally similar components in comparison to device 100, as previously discussed (see the Detailed Description).
  • Device 100 for use as a compression screw component is shown in FIGs. 1A-1 H and 2.
  • Device 400 for use as a compression screw component is shown in FIGs. 4A-4M.
  • Device 500 for use as a compression screw component is shown in FIG. 5.
  • Device 600 for use as a compression screw component is shown in FIGs. 6A-6I.
  • Upper and lower holes are drilled into the bone in alignment with the lag screw portion of the sliding hip screw system and the device 100 portion of the sliding hip screw, respectively.
  • Device 100 configures to the sliding hip screw system by way of a hole in the barrel of the bone plate.
  • the lag screw is inserted into the upper hole of the barrel of the bone plate.
  • the three components together integrate as a compression assembly to reinforce the bone (e.g., the femur) while the four bone screws further secure the implant.
  • Device 100 has proximal region 104, distal region 106 with second plurality of openings 108, and central region 105 with first plurality of openings 107 disposed therebetween.
  • Proximal region 104 of device 100 has thread 110 (see, e.g., FIGs. 1 A-1 D, 1G, 1 H, and 2) that engages with a screw thread of the lag screw.
  • Device 100 is completely inserted into the lower bone hole such that the compression screw component and lag screw engage via their complementary screw threads.
  • the bone plate includes two or more bone plate holes sized to engage device 100.
  • the sliding hip screw system includes a plurality of device 100 (e.g., from 2-12 of device 100, e.g., from 2-10 of device 100, from 2-8 of device 100, from 2-6 of device 100, from 2-4 of device 100, from 4-12 of device 100, from 4-10 of device 100, from 4-6 of device 100, from 6-12 of device 100, from 6-10 of device 100, from 6-8 of device 100, from 8-12 of device 100, from 8-10 of device 100, or from 10- 12 of device 100).
  • device 100 e.g., from 2-12 of device 100, e.g., from 2-10 of device 100, from 2-8 of device 100, from 2-6 of device 100, from 2-4 of device 100, from 4-12 of device 100, from 4-10 of device 100, from 4-6 of device 100, from 6-12 of device 100, from 6-10 of device 100, from 6-8 of device 100, from 8-12 of device 100, from 8-10 of device 100, or from 10- 12 of device 100.
  • a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe, or from the pressure of expansion of solid dose biomaterial) or due to the stress of the compression screw component engaging the bone.
  • fluid e.g., a biomaterial
  • An expanded proximal region 104, central region 105, or distal region 106 could make extraction of device 100 (e.g., during a revision surgery) more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • parts of unitary body 101 have a textured surface, e.g., having a roughness between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns).
  • the textured surface increases the surface area and improves interaction between a biomaterial and device 100. Enhanced interaction with the biomaterial leads to better adhesion properties with the bone and interdigitation with the implant for better fixation of implanted device 100 (e.g., improved osseointegration in the area of device 100).
  • the lag screw has a diameter that is greater than a diameter of device 100.
  • the system particularly advantageous for reinforcing a long bone (e.g., a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus) of a subject includes a device as described herein (e.g., device 100, device 400, device 500, device 600, or device 800), which can be configured as a fastener, a bone plate with a barrel, and bone screws (see, e.g., the sliding hip screw system of FIG.
  • the bone plate is an extramedullary plate configured to be secured to the femur by way of four bone screws fastened through holes of the extramedullary plate designed to engage the bone screws and into the shaft of the femur, as shown in FIG. 7.
  • device 500 is discussed, but device 100, device 400, device 600, or device 800 may also be similarly used.
  • Device 100, device 400, device 600, and device 800 include structurally and operationally similar components in comparison to device 500, as previously discussed (see the Detailed Description).
  • Device 100 for use as a fastener is shown in FIGs. 1A-1 H and 2.
  • Device 400 for use as a fastener is shown in FIGs. 4A-4M.
  • Device 500 for use as a fastener is shown in FIG. 5.
  • Device 600 for use as a fastener is shown in FIGs. 6A-6I.
  • Device 800 for use as a fastener is shown in FIGs. 8A-8D.
  • One or more upper holes are drilled into the bone upper portion of the sliding hip screw system. Upper holes are drilled into the bone in alignment with the upper holes of the plate.
  • Each of device 500 configures to the sliding hip screw system by way of an upper hole in the barrel of the bone plate.
  • Device 500 is fastened to the bone plate to reinforce the bone (e.g., the femur) while the four bone screws further secure the implant.
  • proximal end 502 has a larger diameter than the diameter of the bone hole.
  • device 500 is fastened to upper hole of the bone plate and the aligned upper bone hole until the tapered screw head of proximal end 602 reaches the edge of the bone plate, securing device 600 to the bone plate.
  • Device 500 has distal region 506 with second plurality of openings 508 and proximal region 504 with first plurality of openings 507.
  • the bone plate includes two or more bone plate holes sized to engage device 500.
  • the sliding hip screw system includes a plurality of device 500 (e.g., from 2-12 of device 500, e.g., from 2-10 of device 500, from 2-8 of device 500, from 2-6 of device 500, from 2-4 of device 500, from 4-12 of device 500, from 4-10 of device 500, from 4-6 of device 500, from 6-12 of device 500, from 6-10 of device 500, from 6-8 of device 500, from 8-12 of device 500, from 8-10 of device 500, or from 10-12 of device 500).
  • device 500 e.g., from 2-12 of device 500, e.g., from 2-10 of device 500, from 2-8 of device 500, from 2-6 of device 500, from 2-4 of device 500, from 4-12 of device 500, from 4-10 of device 500, from 4-6 of device 500, from 6-12 of device 500, from 6-10 of device 500, from 6-8 of device 500, from 8-12 of device 500, from 8-10 of device 500, or from 10-12 of device 500).
  • a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe, or from the pressure of expansion of solid dose biomaterial) or due to the stress of the compression screw component engaging the bone.
  • fluid e.g., a biomaterial
  • An expanded proximal region 504 or distal region 506 could make extraction of device 500 (e.g., during a revision surgery) more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • parts of unitary body 501 e.g., proximal region 504 and/or distal region 506 have a textured surface, e.g., having a roughness between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns).
  • the textured surface increases the surface area and improves interaction between a biomaterial and device 500. Enhanced interaction with the biomaterial leads to better adhesion properties with the bone and interdigitation with the implant for better fixation of implanted device 500 (e.g., improved osseointegration in the area of device 500).
  • the system may be provided in a kit including the device (e.g., device 100, device 400, device 500, device 600, and/or device 800), a bone plate with a barrel, and the kit may also be supplied with a source of biomaterial, e.g., a pre-filled biomaterial dispenser, e.g., a syringe with a tube fitting configured to fluidly connect the syringe with internal channel 109 of device 100.
  • a source of biomaterial e.g., a pre-filled biomaterial dispenser, e.g., a syringe with a tube fitting configured to fluidly connect the syringe with internal channel 109 of device 100.
  • the system provided in the kit may include a plurality ofthe device (e.g., from 2-12 of device 100, e.g., from 2-10 of device 100, from 2-8 of device 100, from 2-6 of device 100, from 2-4 of device 100, from 4-12 of device 100, from 4-10 of device 100, from 4-6 of device 100, from 6-12 of device 100, from 6-10 of device 100, from 6-8 of device 100, from 8-12 of device 100, from 8-10 of device 100, or from 10-12 of device 100).
  • the biomaterial dispenser includes a tube connected to a syringe, a vial, or a reservoir; in which, optionally, the tube further includes the biomaterial. Alternatively, the dispenser and biomaterial may be provided separately.
  • Biomaterial may be included in the kit, or the kit may be provided separately to the biomaterial. Biomaterial may also be pre-loaded into the device or included for insertion by the user before or after implantation.
  • the device e.g., device 100, device 400, device 500, device 600, or device 800
  • a solid dose biomaterial e.g., in the form of pellets
  • the loading of the pellets of biomaterial in device 400 would be equivalent for devices 100, 500, 600, and 800.
  • the kit further includes bone screws.
  • the kit further includes a lag screw and bone screws.
  • the bone plate includes one or more bone plate holes sized to engage with the device. In some embodiments, the bone plate includes two or more bone plate holes.
  • Systems of the disclosure include a device of the disclosure (e.g., device 100, device 400, device 500, device 600, and/or device 800) and one or more additional implants with which the device engages to attach and reinforce the soft tissue (e.g., an injured tendon or ligament) to the bone.
  • implants include prosthesis (e.g., prosthetic ligament) and sutures.
  • Systems may include multiple devices of the disclosure.
  • the disclosure features a system that is particularly advantageous for reinforcing a soft tissue (e.g., a ligament, a tendon, a meniscus, a muscle, a rotator cuff, a joint capsule, etc.) of a subject (e.g., a subject with a defect in the soft tissue, e.g., in the shoulder, e.g., a rotator cuff tear, etc.).
  • the system includes a device as described herein (e.g., device 100, device 400, device 500, device 600, and/or device 800), which can be configured as a suture anchor as shown in FIG. 9.
  • One or more of device 100, device 400, device 500, device 600, and device 800 work together with a suture to attach the damaged soft tissue or prosthesis (e.g, a prosthetic ligament) to the bone.
  • the components together integrate to reinforce the soft tissue (e.g., the ligament) to the bone, enabling reconstruction of the soft tissue.
  • One or more of the devices acts as a suture anchor in concert with each suture to stabilize the soft tissue to the bone.
  • device 800 is discussed, but device 100, device 400, device 500, or device 600 may also be similarly used.
  • Device 800 includes structurally and operationally similar components in comparison to device 100, device 400, device 500, and device 600, as previously discussed (see the Detailed Description).
  • Device 800 for use as a suture anchor is shown in FIGs. 8A-8D and FIG. 9.
  • Device 100 for use as a suture anchor is shown in FIGs. 1A-1 H and 2.
  • Device 400 for use as a suture anchor is shown in FIGs. 4A-4M.
  • Device 500 for use as a suture anchor is shown in FIG. 5.
  • Device 600 for use as a suture anchor is shown in FIGs. 6A- 6I.
  • Plurality of openings 812 allow biomaterial to be delivered to bone tissue around the implant, providing additional reinforcement, and the possibility for other therapeutic remediation (e.g., promoting growth of new bone tissue).
  • the combination of openings for biomaterial delivery and stiffness affords synergistic improvement over existing systems. For example, increased stability and resistance to collapse and deformity.
  • a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe, or from the pressure of expansion of solid dose biomaterial) or due to the stress of the suture anchor component engaging the bone.
  • An expanded central region 805 could make extraction of device 800 (e.g., during a revision surgery) more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • parts of unitary body 801 (e.g., central region) has a textured surface, e.g., having a roughness between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns).
  • the textured surface improves interaction between a biomaterial and device 800. Enhanced interaction with the biomaterial leads to better adhesion properties with the bone and interdigitation with the implant for better fixation of implanted device 800 (e.g., improved osseointegration in the area of device 800).
  • the system may be provided in a kit including the suture and a device of the disclosure (e.g., device 100, device 400, device 500, device 600, and/or device 800), and may be supplied with a source of biomaterial, e.g., a pre-filled biomaterial dispenser, e.g., a syringe with a tube fitting configured to fluidly connect the syringe with internal channel 809 of the device.
  • a source of biomaterial e.g., a pre-filled biomaterial dispenser, e.g., a syringe with a tube fitting configured to fluidly connect the syringe with internal channel 809 of the device.
  • the biomaterial dispenser includes a tube connected to a syringe, a vial, or a reservoir; in which, optionally, the tube further includes the biomaterial.
  • the dispenser and biomaterial may be provided separately. Biomaterial may be included in the kit, or the kit may be provided separately to the biomaterial.
  • Biomaterial may also be provided by being pre-loaded into the device (e.g., device 100, device 400, device 500, device 600, and/or device 800) or included for insertion by the user before or after implantation.
  • the device may pre-loaded with a solid dose biomaterial (e.g., in the form of pellets) within internal channel 809 (see, e.g., pellets of biomaterial 814 in internal channel 809 of FIG. 8B).
  • the kit further includes a plurality of devices (e.g., plurality of suture anchors, e.g., from 2-6 suture anchors).
  • Device 100 is discussed, but devices 400, 500, 600, and/or 800 may also be similarly used.
  • Device 400, device 500, device 600, and device 800 include structurally and operationally similar components in comparison to device 100.
  • Device 100 is shown in FIGs. 1A-1 H and 2.
  • Device 400 is shown in FIGs. 4A-4M.
  • Device 500 is shown in FIG. 5.
  • Device 600 is shown in FIGs. 6A-6I.
  • Device 800 is shown in FIGs. 8A-8D.
  • the devices, systems, and methods herein described are configured to deliver biomaterial to bone using, e.g., a biomaterial dispenser.
  • the biomaterial may be a solid dose biomaterial, e.g., already pre- loaded in internal channel 109 of device 100 or added in conjunction with device 100.
  • the solid dose biomaterial may be in the form of pellets that are pre-loaded into device 100 within internal channel 109 (see, e.g., device 400 including pellets of biomaterial 414 in internal channel 409 of FIGs. 4I-4K).
  • the biomaterial dispenser includes a tube connected to a syringe, a vial, a reservoir, or any suitable fluid container configured to hold and dispense a biomaterial.
  • the tube may include a male Luer-lock plug disposed at one end of the tube configured to connect to the female Luer-lock threads of proximal region of a connector configured to engage with a proximal end 102 of device 100.
  • a biomaterial can be a polymeric adhesive, a bone void filler material, a cement, a phosphoserine-based bioadhesive, a cohesiveness agent, an osteogenic agent, an osteoconductive agent, a medicinal agent, a solid dose biomaterial, a pharmaceutical agent, or a combination thereof.
  • the biomaterial is selected from a calcium phosphate-based bone cement, a non- self-hardening calcium phosphate based bone void filler, a flowable xenograft bone void filler, phosphoserine, phosphocreatine, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a calcium silicate, a calcium phosphate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(a-hydroxy acid), a poly(lactone), a poly(amino acid), a poly(anhydride), a poly(orthoester), a poly(anhydride-co-imide), a poly(orthocarbonate), a poly(a-hydroxy alkanoate), a poly(dioxanone), a poly(phosphoester), poly(L-lactide) (PLLA),
  • PMMA
  • the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, or about 150 MPa).
  • about 10 to about 150 MPa e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50
  • the solid dose biomaterial may include a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof.
  • the solid dose biomaterial e.g., in the form of pellets
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 65 to about 85% (e.g., about 65- 80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71 %, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81 %, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight.
  • about 65- 80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85% e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71 %, about 72%, about 73%, about 74%, about
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about 19%, about 20%, about 21 %, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31 %, about 32%, about 33%, about 34%, or about 35%) phosphoserine or phosphocreatine by weight.
  • about 15 to about 35% e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., about 15%, about 16%, about 17, about 18%, about
  • the solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1 .8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2- 1 .0%, about 0.2-0.8%, about 0.2-0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1.0-2.0%, about 1.0-1 .5%, about 1.5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1 .0%, about 1.1 %, about 1 .2%, about 1 .3%, about 1 .4%, about 1 .5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight.
  • the solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1 .20 to about 1 .80 g/cm 3 (e.g., about 1 .20-1 .75 g/cm 3 , about 1 .20-1 .70 g/cm 3 , about 1 .20-1 .60 g/cm 3 , about 1 .20-1 .50 g/cm 3 , about 1 .20-1 .40 g/cm 3 , about 1 .20-1 .30 g/cm 3 , about 1 .20-1 .25 g/cm 3 , about 1 .30-1 .80 g/cm 3 , about 1 .30-1 .50 g/cm 3 , about 1 .5-1 .8 g/cm 3 , e.g., about 1 .20 g/cm 3 , about 1 .25 g/cm 3 , about
  • a device of the disclosure may be implanted with one or more additional orthopedic screws other than those described herein.
  • device 100 is discussed, but device 400, device 500, device 600, and/or device 800 may also be similarly used.
  • the devices, systems, and methods herein described may be used to treat a bone or soft tissue defect in combination with a standard screw (e.g., a bone screw).
  • a standard screw e.g., a bone screw
  • an additional screw may engage with a distal portion of a nail in a system of device 100 for intertrochanteric fracture stabilization, e.g., to stabilize the distal portion of the nail (see, e.g., FIG. 3).
  • the additional screw may be inserted into interior channel 109 of device 100, e.g., after biomaterial injection, e.g., to provide additional stability.
  • the additional screw may be inserted into interior channel 409 to be in threaded communication with internal protrusion(s) 413 (e.g., an internal thread) of device 400, e.g., after biomaterial injection, e.g., to provide additional stability.
  • the additional screw may further distribute biomaterial through internal channel 409 and out of plurality of openings 412.
  • the additional screw may engage with a distal portion of a bone plate (e.g., extramedullary plate) in a system of device 100 for proximal femur reinforcement, e.g., to stabilize the bone plate to the femur (see, e.g., FIG. 7).
  • a bone plate e.g., extramedullary plate
  • suitable bone screws include those that are compliant with American Society for Testing and Materials (ASTM) standard F543-17, Standard
  • the additional screw has a diameter from about 1 mm to about 20 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 1 1 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm).
  • the additional screw has a length of from about 5 mm to about 300 mm (about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 1 1 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm,
  • the additional screw has a length suitable for traversing the length of internal channel of a device of the disclosure and fastening to bone distally disposed relative to the distal end of device.
  • the additional screw has threadless body.
  • the additional screw has threads having a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 7.5 mm, from about
  • a screw head of the additional screw is shaped and sized to mate with an internal channel of a washer. In some embodiments, the screw head of the additional screw is shaped and sized to mate with hole of bone plate. In some embodiments, the screw is made of a material suitable for implantation into the body (e.g., a bone) of a subject.
  • a screw material of the additional screw is selected from the group consisting of stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, and combinations thereof.
  • PEEK polyetheretherketone
  • a bone defect e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis
  • soft tissue e.g., a ligament, a meniscus, a muscle, a tendon, etc.
  • hardware e.g., an implant.
  • the methods, devices, and systems ensure the biomaterial is uniformly distributed to the bone.
  • devices of the disclosure promote improved (e.g., increased) distribution of biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of a defect in the bone.
  • the devices, systems, and methods herein described are useful for implant fixation by installing at least one of the devices described herein, e.g., using the systems, kits, and/or methods described herein, which can be used to anchor or stabilize the implant (e.g., hardware) to bone.
  • the treatment of a bone defect or condition with any device described herein includes inserting the device into the bone alone or in conjunction with other hardware, for example, as a part of a component screw assembly, and securing the device to bone with a biomaterial.
  • device 100 can be used in combination with bone plate to repair the bone defect and/or condition.
  • Device 100 may be used for repair of bone trauma or a bone defect that may have resulted from surgery or disease.
  • the damaged or fragmented bone tissue may be reconstructed using device 100 by delivering a biomaterial (e.g., a bone cement or a solid dose biomaterial, which may also include a therapeutic agent, such as an osteogenic agent) to the damaged bone tissue, for example, for immediate repair of, or restoration of anatomical shape of, the bone.
  • a biomaterial e.g., a bone cement or a solid dose biomaterial, which may also include a therapeutic agent, such as an osteogenic agent
  • Device 100 can also be used for bone augmentation (e.g., improving bone quality surrounding a bone defect).
  • Device 100 may further provide mechanical support for bone fragments at the site of damage and simultaneously allow blood and bone forming cells from adjacent tissues to penetrate device 100 for improved healing.
  • device 100 can be used in orthopedic and spine surgery, as well as in fixation of fragmented pieces of bone and cosmetic surgeries, including the repair of bone defects and in reconstructions of bony tissues, including jaw bones.
  • device 100 can be used to reinforce the long bones and cover openings where cortical bone is lost.
  • Device 100 may also be used with bones of reduced quality (e.g., osteoporotic bone) or in revision surgeries (e.g., they can be used to replace previously inserted implants).
  • Device 100 can be used, for example, in osteosynthesis to internally stabilize and/or join bones, e.g., fractured (broken) bones.
  • Device 100 may also be used to treat a bone defect in a patient with a fracture requiring compression. Device 100 may also be used to provide fixation of a bone plate or an implant to bone.
  • the devices, systems, and kits described herein can be used in a method of treating a patient having a bone defect (e.g., subarticular fracture, a defect of the spine or vertebra, or a defect of the radius, ulna, fibula, clavicle, humerus, pelvis, femur, patella, tibia, talus, calcaneus, navicular, cuneiforms, metatarsals, metacarpals, phalanges, scapula, ankle, maxilla, or mandible) by positioning device 100 in proximity to the bone defect (e.g., positioning the device so that it contacts the intraosseous space of a bone).
  • a bone defect e.g., subarticular fracture, a defect of the spine or vertebra, or a defect of the radius, ulna, fibula, clavicle, humerus, pelvis, femur, patella, tibia, talus, calc
  • the method of treatment includes use of device 100 to deliver uniformly distributed biomaterial into and/or around the site of damaged bone tissue.
  • Particular bone defects that may be treated using devices described herein include, e.g., any bone deficient region, such as a void, gap, recess, or other discontinuity in a bone.
  • the bone defect may be due to, for example, disease or trauma.
  • Device 100 can be applied, for example, in the repair of periodontal defects, in craniofacial or maxillofacial surgery or reconstruction, in hand surgery, in joint reconstruction, in fracture repair, in orthopedic surgical procedures, and in spinal fusion.
  • Non-limiting examples of bone fractures include, e.g., stable fractures, transverse fractures, oblique fractures, spiral fractures, comminuted fractures and open and displaced fractures.
  • Exemplary large bones that may require fracture fixation include, e.g., the femur, tibia, fibula, humerus, ulna, radius, 7 th and 8 th ribs, innominate bone (hip bone), sacrum, sacroiliac joint, and sternum.
  • the method of treating a patient having a bone defect includes the following: a) positioning device 100 in proximity to the bone defect (e.g., positioning device so that it contacts the intraosseous space of a bone, and/or, in the treatment of a fracture, spans the fracture line); b) introducing biomaterial (e.g., a bone void filler material, a cement, a solid dose biomaterial, or a pharmaceutical agent); c) allowing the flowable medium to be extruded through first plurality of openings 107 and second plurality of openings
  • a screw can be inserted to threadedly engage with internal protrusion(s) 413 (e.g., internal thread) of internal channel 409 of device 400 (e.g., internal protrusion(s) 413 (e.g., internal thread) of device 400 of FIGs. 4I and 4J).
  • the method of treating a bone defect previously detailed may include the use of device 100 that is pre-loaded in internal channel 109 with a solid biomaterial (e.g., a solid dose material, such as in the form of pellets) which becomes flowable on contact with a hydrating fluid (e.g., water or sterile saline or blood) (see, e.g., device 400 including pellets of biomaterial 414 in internal channel 409 of FIGs. 4I-4K). Fluids can be introduced from the surrounding tissue or exogenously added, e.g., by syringe. The biomaterial expands through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 to the surrounding tissue.
  • a solid biomaterial e.g., a solid dose material, such as in the form of pellets
  • a hydrating fluid e.g., water or sterile saline or blood
  • Fluids can be introduced from the surrounding tissue or exogenously added,
  • the method further includes d) inserting a screw (e.g., a threadless screw) or other device into interior channel 109 of device 100 (see, e.g., interior channel 109 of device 100 of FIGs. 1A-1 H and 2) or, e.g., to further distribute biomaterial out of interior channel 109 and into surrounding bone and/or to provide additional support, and e) allowing the biomaterial to harden, thereby fixing device 100 (and bone screw, if present) in place.
  • a screw e.g., a threadless screw
  • a screw can be inserted to threadedly engage with internal protrusion(s) 413 (e.g., internal thread) of internal channel 409 of device 400 (e.g., internal protrusion(s) 413 (e.g., internal thread) of device 400 of FIGs. 4I and 4J).
  • device 100 may be placed within a pedicle, used to anchor an interbody device, used to anchor spinal fusion plates and spacer replacement, used in an osteoporotic vertebra, or positioned in proximity to the spinous processes of adjacent vertebrae.
  • the method may include drilling a hole into the bone to provide access to the interior of the bone.
  • the hole may be drilled using any suitable tool known in the art.
  • a bone hole is typically drilled according to the size of device 100 to be inserted into the hole.
  • the size of device 100 to be inserted into the bone may, in some embodiments, be determined by the volume of biomaterial needed to treat the bone defect.
  • the size and/or degree of damage to a bone is used to determine the size of device 100 to be inserted.
  • a subject age, body weight, bone defect location, the type of bone affected by the bone defect, and/or other medical conditions can be used to determine the size of device 100 to insert.
  • the length of the hole is at most about one third the diameter of the bone in which device 100 is to be inserted.
  • two or more (e.g., 2, 3, 4, 5, 6, 7, 8, 9, or 10) of device 100 may be inserted into the bone near and/or around the defect area.
  • the bone defect and/or condition requires two or more of device 100 to be inserted to ensure adequate stabilization and/or bone healing.
  • a screw may be inserted into interior channel 409 of device 400 that may include internal protrusion(s) 413 (e.g., internal thread), as shown in FIGs. 4I and 4J, and, optionally, fastened to the bone tissue beyond distal end 403 of device 400.
  • the screw may be fastened until the screw head presses against bone plate to ensure adequate stabilization.
  • the proximal end includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the standard surgical instrument with which the interface of the proximal end is designed to engage with is used (e.g., a hex driver used for a hex interface of the proximal end).
  • the treatment of a soft tissue defect or condition with any device described herein includes inserting the device into the bone.
  • Device 800 may be used for repair of soft tissue trauma or a soft tissue defect that may have resulted from surgery, trauma, disease, or overuse.
  • the damaged or torn soft tissue may be reconstructed inserting one or more of device 800 into the bone to attach and secure the soft tissue to the bone.
  • a biomaterial may be delivered (e.g., a bone cement or a solid dose biomaterial, which may also include a therapeutic agent, such as an osteogenic agent) to the bone tissue, for example, for immediate repair of, or restoration of anatomical shape of, the bone and/or fixation to the bone.
  • a biomaterial e.g., a bone cement or a solid dose biomaterial, which may also include a therapeutic agent, such as an osteogenic agent
  • Device 800 may also be used with soft tissues of reduced quality (e.g., loss of soft tissue volume) or in revision surgeries (e.g., they can be used to replace previously inserted implants).
  • soft tissues of reduced quality e.g., loss of soft tissue volume
  • revision surgeries e.g., they can be used to replace previously inserted implants.
  • the devices, systems, and kits described herein can be used in a method of treating a patient having a soft tissue defect (e.g., a tear or rupture of a rotator cuff, acromioclavicular joint, bicep tendon, or other defects or injuries to a ligament, a meniscus, a tendon, a muscle, etc.) by positioning device 800 in proximity to or at the attachment site of the soft tissue to the bone (e.g., positioning the device so that it contacts bone at the site of attachment or positioning the device so it contacts the bone nearby the site of attachment of the soft tissue to the bone) to attach the soft tissue to the bone.
  • the method of treatment includes use of device 800 to deliver uniformly distributed biomaterial into and/or around the site of damaged soft tissue.
  • Soft tissue defects that may be treated using devices described herein include, e.g., any soft tissue deficient region, such as a void, gap, recess, loss of volume, or other discontinuity in a soft tissue.
  • the bone defect may be due to, for example, disease, overuse, or trauma.
  • Device 800 can be applied, for example, in the repair of a tear or rupture of a rotator cuff, in joint reconstruction, in ligament repair, in orthopedic surgical procedures, and in other repairs of torn or ruptured soft tissue.
  • Soft tissue damage include, e.g., contusions, tendonitis, sprains, strains, abrasions, and bursitis.
  • Exemplary soft tissues that may require soft tissue fixation to the bone include, e.g., ligaments, tendons, muscles, menisci, e.g., the rotator cuff, Achilles tendon, anterior cruciate ligament, etc.
  • Device 800 may also be used to provide fixation of an implant (e.g., a prosthesis, a tissue flap) to bone.
  • an implant e.g., a prosthesis, a tissue flap
  • the method of treating a patient having a soft tissue defect includes the following: a) positioning device 800 in proximity to the site of attachment of the soft tissue to the bone (e.g., positioning the device so that it is near or at the site of attachment of the soft tissue to the bone and contacts the bone); b) introducing biomaterial (e.g., a bone void filler material, a cement, a solid dose biomaterial, or a pharmaceutical agent); c) allowing the flowable medium to be extruded through plurality of openings 812 (e.g., through substantially all of the openings); d) optionally inserting a screw (e.g., a threadless screw) or other device into interior channel 809 of device 800 (see, e.g., interior channel
  • a screw e.g., a threadless screw
  • a screw can be inserted to threadedly engage with internal protrusion(s) 613 (e.g., internal thread) of internal channel 609 of device 600 (e.g., internal protrusion(s) 613 (e.g., internal thread) of device 600 of FIG. 6G).
  • the method includes insertion of a plurality of device 800 (e.g., from 2-6 of device 800) using steps a) - f).
  • the method includes an additional step g) of attaching the suture of one device 800 to one or more of another device 800 such that they are in attached (e.g., by way of a suture) with at least one other device 800 to further secure the soft tissue to the bone.
  • the method of treating a soft tissue defect previously detailed may include the use of device 800 that is pre-loaded in internal channel 809 with a solid biomaterial (e.g., a solid dose material, such as in the form of pellets) which becomes flowable on contact with a hydrating fluid (e.g., water or sterile saline or blood) (see, e.g., pellets of biomaterial 814 in internal channel 809 of device 800 in FIG. 8B).
  • a hydrating fluid e.g., water or sterile saline or blood
  • Fluids can be introduced from the surrounding tissue or exogenously added, e.g., by syringe.
  • the biomaterial expands through plurality of openings 812 in central region 805 to the surrounding tissue.
  • the method further includes d) inserting a screw (e.g., a threadless screw) or other device into interior channel 809 of device 800 (see, e.g., interior channel 809 of device 800 of FIG. 8B) or, e.g., to further distribute biomaterial out of interior channel 809 and into surrounding bone and/or to provide additional support; e) allowing the biomaterial to harden, thereby fixing device 800 (and bone screw, if present) in place; and f) optionally attaching the suture anchor to the soft tissue by way of a suture included with the suture anchor.
  • a screw e.g., a threadless screw
  • a screw in step d) and in using, e.g., device 600 rather than device 800, a screw can be inserted to threadedly engage with internal protrusion(s) 613 (e.g., internal thread) of internal channel 609 of device 600 (e.g., internal protrusion(s) 613 (e.g., internal thread) of device 600 of FIG. 6G).
  • the method includes insertion of a plurality of device 800 (e.g., from 2-6 of device 800) using steps a) - f).
  • the method includes an additional step g) of attaching the suture of one device 800 to one or more of another device 800 such that they are attached (e.g., by way of a suture) with at least one other device 800 to further secure the soft tissue to the bone.
  • a device of the disclosure can also be provided in the context of a kit.
  • the description below references device 100 although device 400, device 500, device 600, and/or device 800 may also be similarly packaged as part of a kit.
  • a kit of the disclosure may include device 100 alone (or any one or more of devices 100, 400, 500, 600, and/or 800) or the kit may include a device of the disclosure and one or more other components described herein (e.g., one or more of the components of the system described herein).
  • the kit may include device 100 and one or more of an insertion tool, an extraction tool, a pusher, a connector, a washer, a bone plate, a screw, a suture, and one or more biomaterial(s), e.g., as known in the art or as herein described.
  • the kit may also include a biomaterial dispenser (e.g., as a single unit or one or more components thereof, such as tubing and/or connection materials (e.g., pumps, reservoirs, syringes, vials, etc.).
  • the kit may also include a biomaterial, either in ready to use form or in a container ready to be prepared for use.
  • the biomaterial may be provided as a prefilled container as part of a biomaterial dispenser.
  • the biomaterial e.g., a solid biomaterial, for example a solid dose material, such as in the form of pellets
  • the kit may include a funnel.
  • the kit may include device 100 pre- loaded into the funnel.
  • the kit may also include any of the components described above, each in a quantity of 1 to 100 (e.g., 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 , 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 , 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 , 52, 53, 54, 55, 56, 57,
  • 1 to 100 e.g., 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 , 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 , 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 , 52, 53, 54, 55, 56, 57,
  • kits may be supplied in sterile condition.
  • the kit may also include a package insert that instructs a user of the kit, such as a physician, to perform the methods disclosed herein.
  • Device 100 can also be sterilized prior to use in a method of bone repair, as needed.
  • a device of the disclosure may be packaged in a kit with a biomaterial that is to be used in an orthopedic procedure.
  • device 100 is discussed in this section, device 400, device 500, device 600, and/or device 800 may also be similarly used.
  • Delivery of biomaterial may include directly flowing biomaterial, e.g., via a syringe, into internal channel 109 of device 100 (e.g., device 100 of FIGs. 1A-1 H, 2, 3, and 7), e.g., after uncoupling any tool used for insertion of device 100 into bone. Delivery of biomaterial may include keeping a connector fastened to internal channel 109 of device 100 at proximal region 104 after uncoupling the pusher and insertion tool from device 100. Alternatively, connector can be engaged with device 100 independent of the use of other system components.
  • a biomaterial dispenser can be coupled to proximal region 104 of device 100, e.g., via a connector configured to connect at a proximal end to the dispenser and at distal end 103 to proximal end 102 of device 100.
  • a male Luer-lock plug of biomaterial dispenser may be fastened to female Luer-lock threads of a proximal end of the connector.
  • biomaterial is uniformly delivered to the bone surrounding device 100 by flowing biomaterial from the biomaterial dispenser along, e.g., a tube (which can be part of, for example, a syringe, a vial, a container, or a reservoir), through internal channel 109 of device 100 until biomaterial exits device 100 and flows into the bone via first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106.
  • second plurality of openings 108 in distal region 106 of device 100 contribute to the delivery of biomaterial to the bone.
  • first plurality of openings 107 in central region 105 of device 100 contribute to the delivery of biomaterial to the bone.
  • first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 of device 100 contribute to the delivery of biomaterial to the bone.
  • the biomaterial is introduced at a flow rate of from about 0.5 ml/min to about 10 ml/min (e.g., about 0.5 ml/min, about 0.6 ml/min, about 0.7 ml/min, about 0.8 ml/min, about 0.9 ml/min, about 1 ml/min, about 1 .1 ml/min, about 1 .2 ml/min, about 1.3 ml/min, about 1.4 ml/min, about 1.5 ml/min, about 1.6 ml/min, about 1.7 ml/min, about
  • 1 ml to about 20 ml (e.g., from about 1 ml to about 2 ml, from about 1 ml to about 3 ml, from about 1 ml to about 4ml, from about 1 ml to about 5 ml, from about 1 ml to about 10 ml, from about 5 ml to about 10 ml, from about 5 ml to about 15 ml, from about 10 ml to about 15 ml, from about 15 ml to about 20 ml, from about 15 ml to about 20 ml, about 1 ml, about 1.1 ml, about 1 .2 ml, about 1 .3 ml, about 1 .4 ml, about 1 .5 ml, about 1 .6 ml, about 1 .7 ml, about 1 .8 ml, about 1 .9 ml, about 2 ml, about 2.1 ml, about 2.2 ml, about 2.3
  • the biomaterial hardens or solidifies after from about 30 seconds (s) to about 600 s (e.g., about 30 s, about 40 s, about 50 s, about 60 s, about 70 s, about 80 s, about 90 s, about 100 s, about 110 s, about 120 s, about 130 s, about 140 s, about 150 s, about 160 s, about 170 s, about 180 s, about 190 s, about 200 s, about 210 s, about 220 s, about 230 s, about 240 s, about 250 s, about 260 s, about 270 s, about 280 s, about 290 s, about 300 s, about 310 s, about 320 s, about 330 s, about 340 s, about 350 s, about 360 s, about 370 s, about 380 s, about 390 s, about 400 s, about 410 s, about 420 s, about 430
  • the hardening of biomaterial secures device 100 to the bone.
  • the biomaterial is delivered to the bone surrounding both device 100 and a locking screw (e.g., a lag screw) in a compression assembly to secure both device 100 and the locking screw to the bone upon biomaterial hardening.
  • a locking screw e.g., a lag screw
  • device 100 is pre-loaded in internal channel 109 with a solid biomaterial (e.g., a solid dose biomaterial, such as in the form of pellets), which becomes flowable on contact with a fluid (e.g., a hydrating fluid, a biological fluid, such as blood, or by the addition of a fluid, such as water or sterile saline) (see, e.g., pellets of biomaterial 414 in internal channel 409 of FIGs. 4I-4K).
  • a fluid that converts the biomaterial to a flowable paste can be from the surrounding tissue or exogenously added, e.g., by syringe, e.g., a syringe as part of a kit described herein.
  • the biomaterial may expand through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 to the surrounding tissue.
  • the fluid is provided by the surrounding tissue.
  • the fluid is provided externally, e.g., by syringe.
  • internal channel 109 of device 100 is injected with biomaterial from a biomaterial dispenser in addition to the pre- loaded solid biomaterial (e.g., a solid dose biomaterial, such as in the form of pellets) becoming a flowable paste after contact with a fluid (e.g., a hydrating fluid, e.g., provided from the surrounding tissue, e.g., exogenously added by syringe), in order to, e.g., to fill any gaps or voids surrounding device 100 with biomaterial.
  • a fluid e.g., a hydrating fluid, e.g., provided from the surrounding tissue, e.g., exogenously added by syringe
  • a fluid (e.g., a hydrating fluid) dispenser can be coupled to proximal region 104 of device 100 that is pre-loaded in internal channel 109 with a solid biomaterial (e.g., a solid dose biomaterial, such as in the form of pellets), e.g., via a connector configured to connect at a proximal end to the dispenser and at distal end 103 to proximal end 102 of device 100.
  • a male Luer-lock plug of the fluid dispenser may be fastened to female Luer-lock threads of a proximal end of the connector.
  • biomaterial is uniformly delivered to the bone surrounding device 100 by flowing fluid (e.g., a hydrating fluid) from the fluid dispenser along, e.g., a tube (which can be part of, for example, a syringe, a vial, a container, or a reservoir), through internal channel 109 of device 100.
  • fluid e.g., a hydrating fluid
  • the biomaterial e.g., the pre-loaded pellets of solid dose biomaterial
  • second plurality of openings 108 in distal region 106 of device 100 contribute to the delivery of biomaterial to the bone.
  • first plurality of openings 107 in central region 105 of device 100 contribute to the delivery of biomaterial to the bone.
  • first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 of device 100 contribute to the delivery of biomaterial to the bone.
  • the fluid is introduced at a flow rate of from about 0.5 ml/min to about 10 ml/min (e.g., about 0.5 ml/min, about 0.6 ml/min, about 0.7 ml/min, about 0.8 ml/min, about 0.9 ml/min, about 1 ml/min, about 1 .1 ml/min, about 1 .2 ml/min, about 1 .3 ml/min, about 1 .4 ml/min, about 1 .5 ml/min, about 1 .6 ml/min, about 1 .7 ml/min, about 1 .8 ml/min, about 1 .9 ml/min, about 2 ml/min, about 2.1 ml/min, about 2.2 ml/min, about 2.3 ml/min, about 2.4 ml/min, about 2.5 ml/min, about 2.6 ml/min, about 2.7
  • the volume of biomaterial and fluid together is from about 1 ml to about 20 ml (e.g., from about 1 ml to about 2 ml, from about 1 ml to about 3 ml, from about 1 ml to about 4ml, from about 1 ml to about 5 ml, from about 1 ml to about 10 ml, from about 5 ml to about 10 ml, from about 5 ml to about 15 ml, from about 10 ml to about 15 ml, from about 15 ml to about 20 ml, from about 15 ml to about 20 ml, about 1 ml, about
  • the biomaterial hardens or solidifies after from about 30 seconds (s) to about 600 s (e.g., about 30 s, about 40 s, about 50 s, about 60 s, about 70 s, about 80 s, about 90 s, about 100 s, about 110 s, about 120 s, about 130 s, about 140 s, about 150 s, about 160 s, about 170 s, about 180 s, about 190 s, about 200 s, about 210 s, about 220 s, about 230 s, about 240 s, about 250 s, about 260 s, about 270 s, about 280 s, about 290 s, about 300 s, about 310 s, about 320 s, about 330 s, about 340 s, about 350 s, about 360 s, about 370 s, about 370
  • the hardening of biomaterial secures device 100 to the bone.
  • the biomaterial is delivered to the bone surrounding both device 100 and a locking screw (e.g., a lag screw) in a compression assembly to secure both device 100 and the locking screw to the bone upon biomaterial hardening.
  • a locking screw e.g., a lag screw
  • the biomaterial is expelled through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 by inserting a non-engaging or engaging screw or probe extending the length of internal channel 109 of device 100.
  • the engaging screw threadedly engages with internal protrusion(s) (e.g., internal thread) (internal protrusion(s) 413) within internal channel 409.
  • inserting an additional screw into internal channel 109 promotes the uniform distribution of biomaterial throughout device 100 and into the bone surrounding device 100.
  • the methods of bone repair may, in some cases, require removal of a device of the disclosure (e.g., device 100, device 400, device 500, device 600, and/or device 800) after insertion. Described below is an extraction procedure for a device of the disclosure.
  • device 100 can be removed using an extraction tool (e.g., a hex-driver or an extraction tool, for example, as described in WO 2023/052844, incorporated herein by reference).
  • the extraction tool can be used to remove device 100 from bone by inserting the distal region of the extraction tool into internal channel 109 of device 100, followed by engaging a pair of nubs of the extraction tool, e.g., with second plurality of openings 108 of distal region 106 of device 100.
  • the method may include first removing a non-engaging screw from device 100 prior to inserting the extraction tool into device 100.
  • Extracting the device may include a step of twisting the extraction tool (e.g., clockwise) to remove device 100 (e.g., to unthread or release device 100) from the bone.
  • the extraction tool may also be used to remove device 100 from bone by twisting in a counterclockwise direction.
  • the direction of twisting may depend upon whether device 100 includes exterior thread 110 (e.g., in proximal region 104) and, if so, the twisting may depend upon the orientation of thread 110 of device 100.
  • the extraction tool may threadedly engage with internal protrusions 413 (e.g., internal thread).
  • the proximal end includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation).
  • the standard surgical instruments may include, e.g., a standard Torx or hex driver.
  • the standard surgical instrument with which the interface of the proximal end is designed to engage with is used (e.g., a hex driver used for a hex interface of the proximal end).
  • a threadless version of device 100 may also be twisted for removal.
  • proximal region 104, central region 105, and distal region 106 confers an advantage in the removal of device 100. Lack of expansion or compression due to the stiffness of proximal region 104, central region 105, and distal region 106 affords a cleaner extraction.
  • a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe, or from the pressure of expansion of solid dose biomaterial) or due to the stress of the compression screw component engaging the bone.
  • An expanded proximal region, central region, or distal region could make extraction of the device (e.g., during a revision surgery) more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • a device of the disclosure may be fabricated as a unitary body or as separate parts subsequently combined to form the device. Described below are examples of fabrication methods focusing on device 100. Similar fabrication methods can be applied to manufacture device 400, device 500, device 600, and/or device 800.
  • device 100 may be fabricated as a unitary body or as separate parts subsequently combined to form device 100 (e.g., proximal region 104, central region 105, and distal region 106 of device 100 may be manufactured separately and later combined to form unitary body 101).
  • Device 100 may be fabricated with pellets of a solid dose biomaterial packaged within internal channel 109 (see, e.g., device 400 including pellets of biomaterial 414 in internal channel 409 of FIGs. 4I-4K).
  • Device 100 can be fabricated using, for example, additive manufacturing techniques. Device 100 may also be fabricated using laser cutting and wire electrical discharge machining (EDM). When device 100 is composed of a metal or metal alloy material, a four axis CNC lathe or a Swiss lathe system may be used to fabricate device 100 from solid or tubular stock material. When device 100 is composed of a non- metallic material, molding or additive manufacturing may be used. For example, device 100 may be manufactured using 3D printing techniques and materials (see, e.g., Dhandapani et al., Bioact. Mater. 5:458-467, 2020 (incorporated herein by reference), e.g., 3D printing using coral-cultured powder (calcium carbonate).
  • 3D printing techniques and materials see, e.g., Dhandapani et al., Bioact. Mater. 5:458-467, 2020 (incorporated herein by reference), e.g., 3D printing using coral-cultured powder (calcium carbonate).
  • An insertion tool, pusher, or extraction tool may all be fabricated using standard CNC lathe milling, gun drilling, and/or molded handle type technologies known in the art. Extraction tools may be milled or EDM machined as separate components (e.g., each member separately fabricated) and subsequently joined.
  • Example 1 Treatment of an intertrochanteric fracture with a nail system including device 100
  • the devices, systems, and methods herein described may be used for treating an intertrochanteric fracture.
  • Device 100 of FIGs. 1A-1 H and 2 may be implanted as a compression screw component in a system such as the one shown in FIG. 3, in which device 100 acts as a stabilization screw replacement in, e.g., an intertrochanteric antegrade nail system or an integrated proximal fixation antegrade nail system.
  • a stabilization screw replacement in, e.g., an intertrochanteric antegrade nail system or an integrated proximal fixation antegrade nail system.
  • a surgeon can treat a patient in need of proximal femur reinforcement using device 100 and system as herein described.
  • the nail of the system (e.g., an intramedullary nail, e.g., a cephalomedullary nail) is first inserted into the medullary canal and a proximal portion of the nail including an upper hole and a lower hole is positioned such that the holes are aligned with a centerline of the femoral head and neck. Upper and lower holes are drilled into the bone in alignment with the upper and lower holes of the nail. The lag screw is inserted into the upper hole.
  • Device 100 as a compression screw component is designed to be inserted into the lower bone hole of the nail.
  • Device 100 has stiff proximal region 104, stiff distal region 106 with second plurality of openings 108, and stiff central region 105 with first plurality of openings 107 disposed therebetween.
  • Proximal region 104 has screw thread 110 that engages with a screw thread of the lag screw.
  • Device 100 is then completely inserted into the lower bone hole such that device 100 and lag screw engage via their complementary screw threads, as shown in FIG. 3.
  • the lag screw and device 100 (e.g., as a compression screw component) engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
  • the biomaterial dispenser which may include, e.g., a syringe filled with a fluid biomaterial (e.g., an osteoconductive composition), is brought into fluid communication with proximal end 102 of device 100 and fixedly attached (e.g., by pressure fit or by a locking mechanism, such as a Luer-lock).
  • a 5-15 ml volume of the biomaterial e.g., a fluid biomaterial, e.g., an osteoconductive composition
  • a 5-15 ml volume of the biomaterial is injected into interior channel 109 of device 100 and flows into the surrounding bone tissue through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106.
  • a pellet injector for, e.g., pellets of solid dose biomaterial
  • a fluid injector in a similar fashion to hydrate and create a fluid form of the biomaterial.
  • Sufficient biomaterial may be injected to contact not only central region 105 and distal 106 region of device 100, but also portions of the lag screw and nail in the vicinity thereof. Thereafter, the biomaterial dispenser is disconnected from device 100.
  • First plurality of openings 107 in central region 105 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 107 and second plurality of openings 108 and into the adjacent bone tissue.
  • first plurality of openings 107 e.g., helical slits
  • Rotation of the biomaterial in the center of internal channel 109 also results in less friction at the wall of internal channel 109, preventing restriction of the flow of the biomaterial.
  • the fluid biomaterial delivered using, e.g., one or more of device 100 herein described, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the fluid biomaterial in the bone tissue, thereby further reinforcing the proximal femur and reducing the risk of failure of the implant.
  • device 100 can be pre-loaded with a solid dose biomaterial in interior channel 109 (see, e.g., pellets of biomaterial 414 of FIGs. 4I - 4K) before implantation.
  • the loading of the pellets of biomaterial in device 400 would be equivalent to device 100.
  • the pre-loaded solid dose biomaterial is exposed to an aqueous fluid (e.g., water, sterile saline, or a biological fluid, such as blood, etc.), e.g., from surrounding tissue or added (e.g., by syringe).
  • an aqueous fluid e.g., water, sterile saline, or a biological fluid, such as blood, etc.
  • the solid dose material becomes hydrated by the aqueous fluid, forming a paste that flows into the surrounding bone tissue through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106.
  • a central probe is inserted into internal channel 109 to enhance extrusion of the biomaterial.
  • the hardened paste, or cement provides effective bone tissue growth and tissue restoration due to the uniform distribution of the solid dose biomaterial in the bone tissue.
  • the pre-loaded solid dose biomaterial may include a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof.
  • proximal region 104, central region 105, and distal region 106 of device 100 affords a cleaner extraction, in the event revision surgery is required.
  • prior known compression bone screws with a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe) or due to the stress of engagement of the compression screw component with the bone.
  • proximal region 104, central region 105, or distal region 106 would make extraction of the compression screw component more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • the devices described herein avoid those that outcome by having a stiff stiffness proximal region, central region, and distal region.
  • Device 100 may be extracted with an extraction tool (e.g., a standard surgical instrument, e.g., a standard Torx or hex driver) that engages with the interface of proximal end 102.
  • an extraction tool e.g., a standard surgical instrument, e.g., a standard Torx or hex driver
  • Example 2 Treatment of an intertrochanteric fracture with a nail system including device 400
  • the devices, systems, and methods herein described may be used for treating an intertrochanteric fracture.
  • Device 400 of FIGs. 4A-4M may be implanted as a compression screw component in a system such as the one shown in FIG. 3, in which device 400 acts as a stabilization screw replacement in, e.g., an intertrochanteric antegrade nail system or an integrated proximal fixation antegrade nail system.
  • a surgeon can treat a patient in need of proximal femur reinforcement using device 400 and system as herein described.
  • the nail of the system (e.g., an intramedullary nail, e.g., a cephalomedullary nail) is first inserted into the medullary canal and a proximal portion of the nail including an upper hole and a lower hole is positioned such that the holes are aligned with a centerline of the femoral head and neck. Upper and lower holes are drilled into the bone in alignment with the upper and lower holes of the nail. The lag screw is inserted into the upper hole.
  • Device 400 as a compression screw component is designed to be inserted into the lower bone hole of the nail.
  • Device 400 has stiff proximal region 404 and stiff distal region 106 with plurality of openings 412.
  • Proximal region 404 has screw thread 410 that engages with a screw thread of the lag screw.
  • Device 400 is then completely inserted into the lower bone hole such that device 400 and lag screw engage via their complementary screw threads, as shown in FIG. 3.
  • the lag screw and device 400 (e.g., as a compression screw component) engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
  • the biomaterial dispenser which may include, e.g., a syringe filled with a fluid biomaterial (e.g., an osteoconductive composition), is brought into fluid communication with proximal end 402 of device 400 and fixedly attached (e.g., by pressure fit or by a locking mechanism, such as a Luer-lock).
  • a 5-15 ml volume of the biomaterial e.g., a fluid biomaterial
  • a pellet injector for, e.g., pellets of solid dose biomaterial
  • a fluid injector in a similar fashion to hydrate and create a fluid form of the biomaterial.
  • Sufficient biomaterial may be injected to contact not only proximal region 404 and distal region 406 of device 400, but also portions of the lag screw and nail in the vicinity thereof. Thereafter, the biomaterial dispenser is disconnected from device 400.
  • the fluid biomaterial delivered using, e.g., one or more of device 400 herein described, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the fluid biomaterial in the bone tissue, thereby further reinforcing the proximal femur and reducing the risk of failure of the implant.
  • device 400 can be pre-loaded with a solid dose biomaterial in interior channel 409 (e.g., pellets of biomaterial 414 of FIGs. 4I - 4K) before implantation.
  • the solid dose biomaterial is a compressed powder (e.g., compressed at a pressure of 10 to 150 MPa) and is a mixture of particles of a calcium phosphate (e.g., 65-85 wt%), a phosphoserine or phosphocreatine (e.g., 15-35 wt%, such as 20-30 wt% or 22-27 wt%).
  • the biomaterial may further include calcium silicate (e.g., in an amount of 0.2-2 wt%, e.g., 0.5-1.5 wt%).
  • the biomaterial also has a density of about 1 .20-1 .80 g/cm 3 .
  • pellets of biomaterial 414 are exposed to an aqueous fluid (e.g., water, sterile saline, or a biological fluid, such as blood, etc.), e.g., from surrounding tissue or added (e.g., by syringe).
  • aqueous fluid e.g., water, sterile saline, or a biological fluid, such as blood, etc.
  • Pellets of biomaterial 414 become hydrated by the aqueous fluid, forming a paste that flows into the surrounding bone tissue through plurality of openings 412 in distal region 406.
  • a central probe is inserted into internal channel 409 to enhance extrusion of the biomaterial.
  • the hardened paste, or cement provides effective bone tissue growth and tissue restoration due to the uniform distribution of the biomaterial in the bone tissue.
  • proximal region 404 and distal region 406 of device 400 affords a cleaner extraction, in the event revision surgery is required.
  • prior known compression bone screws with a flexible proximal, central, or distal region may expand when fluid (e.g., a biomaterial) is pushed through the internal channel of the device (e.g., with pressure from the syringe) or due to the stress of engagement of the compression screw component with the bone.
  • An expanded proximal region 404 or distal region 406 would make extraction of the compression screw component more difficult, as the hardened biomaterial might prevent compression back to the original shape, necessitating a larger hole to be drilled or causing damage to the bone on removal.
  • the devices described herein avoid those that outcome by having a stiff stiffness proximal region and distal region.
  • Device 400 may be extracted with an extraction tool that threadedly engages with internal protrusion(s) 413 (e.g., internal thread).
  • Device 400 may be extracted with an extraction tool (e.g., a standard surgical instrument, e.g., a standard Torx or hex driver) that engages with the interface of proximal end 402.
  • an extraction tool e.g., a standard surgical instrument, e.g., a standard Torx or hex driver
  • Example 3 Treatment of an intertrochanteric fracture with a nail system including device 500
  • the devices, systems, and methods herein described may be used for treating an intertrochanteric fracture.
  • device 500 of FIG. 5 may be implanted as a fastener in a system such as the one shown in FIG. 3, in which device 500 acts as a stabilization screw replacement in an intertrochanteric antegrade nail system or an integrated proximal fixation antegrade nail system.
  • a surgeon can treat a patient in need of proximal femur reinforcement using device 500 and system as herein described.
  • the nail of the system e.g., an intramedullary nail, e.g., a cephalomedullary nail
  • the nail of the system is first inserted into the medullary canal and a proximal portion of the nail including and hole positioned such that the hole is aligned with a centerline of the femoral head and neck.
  • the hole is drilled into the bone in alignment with the hole of the nail.
  • Device 500 as a fastener is designed to be inserted into the bone hole of the nail.
  • Device 500 has stiff proximal region 504 with first plurality of openings 507 and stiff distal region 506 with second plurality of openings 508.
  • Proximal end 502 has a screw head that has a diameter that is larger than the bone hole.
  • Device 500 is completely inserted into the bone hole until the screw head of proximal end 502 reaches the edge of the nail, securing device 500 to the nail.
  • the biomaterial dispenser which may include, e.g., a syringe filled with a fluid biomaterial (e.g., an osteoconductive composition), is brought into fluid communication with proximal end 502 of device 500 and fixedly attached (e.g., by pressure fit or by a locking mechanism, such as a Luer-lock).
  • a 5-15 ml volume of the biomaterial e.g., a fluid biomaterial, e.g., an osteoconductive composition
  • a 5-15 ml volume of the biomaterial is injected into interior channel 509 of device 500 and flows into the surrounding bone tissue through first plurality of openings 507 in proximal region 504 and second plurality of openings 508 in distal region 506.
  • a pellet injector for, e.g., pellets of solid dose biomaterial
  • a fluid injector in a similar fashion to hydrate and create a fluid form of the biomaterial.
  • Sufficient biomaterial may be injected to contact not only proximal region 504 and distal 506 region of device 500. Thereafter, the biomaterial dispenser is disconnected from device 500.
  • First plurality of openings 507 in proximal region 504 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 507 and second plurality of openings 508 and into the adjacent bone tissue.
  • first plurality of openings 507 e.g., helical slits
  • second plurality of openings 508 e.g., diamond shaped openings
  • Rotation of the biomaterial in the center of internal channel 509 also results in less friction at the wall of internal channel 509, preventing restriction of the flow of the biomaterial.
  • the fluid biomaterial delivered using one or more of device 500 herein described, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the fluid biomaterial in the bone tissue, thereby further reinforcing the proximal femur and reducing the risk of failure of the implant.
  • device 500 is pre-loaded with a solid dose biomaterial in interior channel 509 (see, e.g., pellets of biomaterial 414 of FIGs. 4I - 4K) before implantation.
  • a solid dose biomaterial in interior channel 509 (see, e.g., pellets of biomaterial 414 of FIGs. 4I - 4K) before implantation.
  • the pre-loaded solid dose biomaterial is exposed to an aqueous fluid (e.g., water, sterile saline, or a biological fluid, such as blood, etc.), e.g., from surrounding tissue or added (e.g., by syringe).
  • the solid dose material becomes hydrated by the aqueous fluid, forming a paste that flows into the surrounding bone tissue through first plurality of openings 507 in proximal region 504 and second plurality of openings 508 in distal region 506.
  • a central probe is inserted into internal channel 509 to enhance extrusion of the biomaterial.
  • the hardened paste, or cement provides effective bone tissue growth and tissue restoration due to the uniform distribution of the solid dose biomaterial in the bone tissue.
  • the pre- loaded solid dose biomaterial e.g., in the form of pellets
  • device 500 can be readily extracted due to a lack of expansion or compression due to the stiffness of proximal region 504 and distal region 506, which affords a cleaner extraction.
  • Device 500 may be extracted with an extraction tool (e.g., a standard surgical instrument, e.g., a standard Torx or hex driver) that engages with the interface of proximal end 502.
  • an extraction tool e.g., a standard surgical instrument, e.g., a standard Torx or hex driver
  • Example 4 Treatment of a tibial plateau periarticular fracture with a bone plate system including device 600
  • the devices, systems, and methods herein described may be used to treat a tibial plateau periarticular fracture.
  • a surgeon treats a patient with a tibial plateau periarticular fracture, diagnosed using X-ray radiography, using device 600 of FIGs. 6A-6I, e.g., using a kit as herein described.
  • the fracture site is first prepared for implantation of a pre-contoured bone plate (e.g., extramedullary plate) having from one to ten bone plate holes.
  • the desired number of holes is to be drilled into the two main fracture fragments of the tibia (such as, e.g., five holes on each fragment if ten holes are used).
  • One device 600, as herein described, is prepared to be implanted into each upper bone hole.
  • the plate of the system is first fastened to exterior of the tibia, where a proximal portion of the plate includes one or more upper holes that is positioned such that the holes are aligned with a centerline of the femoral head and neck.
  • Upper holes are drilled into the bone in alignment with the upper holes of the plate.
  • Lower holes are drilled below the upper holes of the bone plate for insertion of additional bone screws to stabilize the bone plate to the tibia.
  • the lower holes are drilled into the bone in alignment with the lower holes of the plate.
  • Each of device 600 has stiff central region 605 with plurality of openings 612.
  • Proximal end 602 has a screw head that has a diameter that is larger than the bone hole.
  • Device 600 can be provided as part of a kit, which can include additional tools, such as an insertion tool, e.g., with a standard hex driver.
  • an insertion tool e.g., a hex driver
  • a hex driver can be connected to a first of device 600 to be implanted.
  • Each of device 600 is completely inserted into an upper bone hole that has been prepared at the surgical site until the tapered screw head of proximal end 602 reaches the edge of the nail, securing device 600 to the bone plate.
  • Each bone screw is inserted through a lower hole that has been prepared at the surgical site and is then fastened through the bone plate to the bone.
  • the components together reinforce the bone (e.g., the tibia) while the bone screws further secure the implant at the distal end of the bone plate.
  • the biomaterial dispenser including a syringe filled with a fluid biomaterial can then be connected to a proximal region of the connector, e.g., via Luer lock threads therein.
  • a 5-15 ml volume of the biomaterial e.g., a fluid biomaterial, e.g., an osteoconductive composition
  • a pellet injector for, e.g., pellets of solid dose biomaterial
  • the fluid biomaterial delivered using one or more of device 600 herein described, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the fluid biomaterial in the bone tissue, thereby further reinforcing the tibia and reducing the risk of failure of the implant.
  • device 600 can be pre-loaded with a solid dose biomaterial in internal channel 609 (see, e.g., pellets of biomaterial 414 of FIGs. 4I - 4K) before implantation.
  • the loading of the pellets of biomaterial in device 400 would be equivalent for device 600.
  • the pre-loaded solid dose biomaterial is exposed to an aqueous fluid (e.g., water, blood, etc.), e.g., from surrounding tissue or added (e.g., by syringe).
  • the solid dose material becomes hydrated by the aqueous fluid, forming a paste that flows into the surrounding bone tissue through plurality of openings 612 in central region 605, as previously described.
  • a central probe is inserted into internal channel 609 to enhance extrusion of the biomaterial.
  • the hardened paste, or cement provides effective bone tissue growth and tissue restoration due to the uniform distribution of the solid dose biomaterial in the bone tissue.
  • the pre-loaded solid dose biomaterial e.g., in the form of pellets
  • a screw may then be inserted into interior channel 609 of device 600 that includes internal protrusion(s) 613 (e.g., internal thread), as shown in FIGs. 6G and 6I, and, optionally, fastened to the bone tissue beyond distal end 603 of device 600.
  • the screw may be fastened until the screw head presses against bone plate. The process is repeated for each device 600 that is to be inserted into bone and the surgery proceeds to completion.
  • device 600 can be readily extracted due to a lack of expansion or compression due to the stiffness central region 605, which affords a cleaner extraction.
  • Device 600 may be extracted with an extraction tool that threadedly engages with internal protrusion(s) 613 (e.g., internal thread).
  • Device 600 may be extracted with an extraction tool (e.g., a standard surgical instrument, e.g., a standard Torx or hex driver) that engages with the interface of proximal end 602.
  • a standard surgical instrument e.g., a standard Torx or hex driver
  • Example 5 Treatment of an intertrochanteric fracture with a sliding hip screw system including device 100
  • the devices, systems, and methods herein described may be used for treating an intertrochanteric fracture.
  • Device 100 of FIGs. 1A-1 H may be implanted as a compression screw component in a system such as the one shown in FIG. 7, in which device 100 acts as a stabilization screw replacement in a sliding hip screw system.
  • a surgeon can treat a patient in need of proximal femur reinforcement using device 100 and system as herein described.
  • the sliding hip screw system includes device 100, which can be configured as a compression screw component, a bone plate with a barrel, a lag screw, and bone screws, e.g., as shown in FIG. 7.
  • the plate is an extramedullary plate configured to be secured to the femur by way of four bone screws fastened through four holes of the extramedullary plate and into the shaft of the femur.
  • Upper and lower holes are drilled into the bone in alignment with the lag screw portion of the sliding hip screw system and device 100 portion of the sliding hip screw, respectively.
  • Device 100 has stiff proximal region 104, stiff distal region 106 with second plurality of openings 108, and stiff central region 105 with first plurality of openings 107 disposed therebetween.
  • Proximal region 104 has screw thread 110 that engages with a screw thread of the lag screw.
  • the lag screw is inserted into the upper hole of the bone through a hole in the upper barrel portion of the sliding hip screw.
  • Device 100 as a compression screw component is designed to be inserted into the lower bone hole through a hole in the lower barrel portion of the sliding hip screw system.
  • Device 100 is completely inserted into the lower bone hole such that device 100 and lag screw engage via their complementary screw threads, as shown in FIG. 7.
  • the three components together integrate as a compression assembly to reinforce the bone (e.g., the femur) while the four bone screws further secure the implant at the distal end of the bone plate.
  • the biomaterial dispenser which may include, e.g., a syringe filled with a fluid biomaterial (e.g., an osteoconductive composition), is brought into fluid communication with proximal end 102 of device 100 and fixedly attached (e.g., by pressure fit or by a locking mechanism, such as a Luer-lock).
  • a 5-15 ml volume of the biomaterial e.g., a fluid biomaterial, e.g., an osteoconductive composition
  • a 5-15 ml volume of the biomaterial is injected into interior channel 109 of device 100 and flows into the surrounding bone tissue through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106.
  • a pellet injector for, e.g., pellets of solid dose biomaterial
  • a fluid injector in a similar fashion to hydrate and create a fluid form of the biomaterial.
  • Sufficient biomaterial may be injected to contact not only proximal region 105 and distal 106 region of device 100, but also portions of the lag screw and nail in the vicinity thereof. Thereafter, the biomaterial dispenser is disconnected from device 100.
  • First plurality of openings 107 in central region 105 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 107 and second plurality of openings 108 and into the adjacent bone tissue.
  • first plurality of openings 107 e.g., helical slits
  • Rotation of the biomaterial in the center of internal channel 109 also results in less friction at the wall of internal channel 109, preventing restriction of the flow of the biomaterial.
  • the fluid biomaterial delivered using device(s) 100 herein described, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the fluid biomaterial in the bone tissue, thereby further reinforcing the proximal femur and reducing the risk of failure of the implant.
  • device 100 can be pre-loaded with a solid dose biomaterial in internal channel 109 (see, e.g., pellets of biomaterial 414 of FIGs. 4I - 4K) before implantation.
  • the loading of the pellets of biomaterial in device 400 would be equivalent for device 100.
  • the pre-loaded solid dose biomaterial is exposed to an aqueous fluid (e.g., water, blood, etc.), e.g., from surrounding tissue or added (e.g., by syringe).
  • the solid dose material becomes hydrated by the aqueous fluid, forming a paste that flows into the surrounding bone tissue through first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106.
  • a central probe is inserted into internal channel 109 to enhance extrusion of the biomaterial.
  • the hardened paste or e.g., cement, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the solid dose biomaterial in the bone tissue.
  • the pre-loaded solid dose biomaterial (e.g., in the form of pellets) may include a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof.
  • device 100 can be readily extracted due to a lack of expansion or compression due to the stiffness of proximal region 104, central region 105, and distal region 106, which affords a cleaner extraction.
  • Device 100 may be extracted with an extraction tool (e.g., a standard surgical instrument, e.g., a standard Torx or hex driver) that engages with the interface of proximal end 102.
  • an extraction tool e.g., a standard surgical instrument, e.g., a standard Torx or hex driver
  • Example 6 Treatment of a torn or ruptured rotator cuff with a soft tissue suture anchor system including device 800
  • the devices, systems, and methods herein described may be used for treating a tear or rupture of a rotator cuff.
  • Device 800 of FIGs. 8A-8D may be implanted as a suture anchor in a system such as the one shown in FIG. 9, in which device 800 acts as a suture anchor in a soft tissue suture anchor system.
  • a surgeon can treat a patient in need of rotator cuff repair using device 800 and the system as herein described.
  • One or more of device 800 acts as a suture anchor in concert with sutures and each other to attach and stabilize the damaged rotator cuff to the humerus.
  • the components together integrate to reinforce the rotator cuff to the humerus, enabling repair of the rotator cuff.
  • the suture anchor system includes three of device 800, which are configured as suture anchors, e.g., as shown in FIG. 9.
  • Device 800 can be provided as part of a kit, which can include additional tools, such as an insertion tool, e.g., with a standard hex driver. Each device 800 is implanted into its respective bone hole. First, an insertion tool (e.g., a hex driver), if used, can be connected to a first of device 800 to be implanted. Each of device 800 are configured to be secured to the head of the humerus near the site of attachment of the rotator cuff by way of fastening each device 800 through a hole into the head of the humerus. Each of device 800 can include a suture.
  • an insertion tool e.g., a hex driver
  • the suture of one of device 800 is attached to one or more of another device 800 to further secure the rotator cuff to the head of the humerus.
  • the suture of one or more of device 800 is attached to the rotator cuff to stabilize it to the head of the humerus.
  • Device 800 has stiff central region 805 with plurality of openings 812.
  • the biomaterial dispenser including a syringe filled with a fluid biomaterial (e.g., an osteoconductive composition) can be connected to a proximal region of the connector, e.g., via Luer lock threads therein.
  • a 5-15 ml volume of the biomaterial e.g., a fluid biomaterial, e.g., an osteoconductive composition
  • a pellet injector for, e.g., pellets of solid dose biomaterial
  • the fluid biomaterial delivered using one or more of device 800 herein described, provides effective bone tissue growth and tissue restoration due to the uniform distribution of the fluid biomaterial in the bone tissue, thereby further reinforcing the head of the humerus and rotator cuff and reducing the risk of failure of the implant.
  • device 800 can be pre-loaded with a solid dose biomaterial in internal channel 809 (see, e.g., pellets of biomaterial 814 of FIG. 8B) before implantation.
  • the solid dose biomaterial is a compressed powder (e.g., compressed at a pressure of 10 to 150 MPa) and is a mixture of particles of a calcium phosphate (e.g., 65-85 wt%), a phosphoserine or phosphocreatine (e.g., 15-35 wt%, such as 20-30 wt% or 22-27 wt%).
  • the biomaterial may further include calcium silicate (e.g., in an amount of 0.2-2 wt%, e.g., 0.5-1 .5 wt%).
  • the biomaterial also has a density of about 1 .20-1 .80 g/cm 3 .
  • an aqueous fluid e.g., water, blood, etc.
  • Pellets of biomaterial 814 become hydrated by the aqueous fluid, forming a paste that flows into the surrounding bone tissue through plurality of openings 812 in central region 805, as previously described.
  • a central probe is inserted into internal channel 809 to enhance extrusion of the biomaterial.
  • the hardened paste, or cement provides effective bone tissue growth and tissue restoration due to the uniform distribution of the solid dose biomaterial in the bone tissue.
  • device 800 can be readily extracted due to a lack of expansion or compression due to the stiffness central region 805, which affords a cleaner extraction.
  • Device 800 may be extracted with an extraction tool (e.g., a standard surgical instrument, e.g., a standard Torx or hex driver) that engages with the interface of proximal end 802.
  • an extraction tool e.g., a standard surgical instrument, e.g., a standard Torx or hex driver

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  • Health & Medical Sciences (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

Les dispositifs, les systèmes et les procédés décrits permettent une distribution de biomatériau améliorée pour produire une adhérence robuste entre un implant (par exemple, une vis implantable) et un tissu osseux. En outre, les dispositifs, les systèmes et les procédés de l'invention résolvent les défis associés à la réparation d'un os faible ou déficient et à l'augmentation osseuse à l'aide de biomatériaux injectés.
PCT/IB2025/052889 2024-03-21 2025-03-19 Dispositifs, systèmes et procédés de réparation ou de renforcement d'os Pending WO2025196667A2 (fr)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023052844A2 (fr) 2021-09-28 2023-04-06 Biomimetic Innovations Limited Dispositifs, systèmes et procédés de réparation osseuse ou de fixation d'implant

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Publication number Priority date Publication date Assignee Title
EP2967694B1 (fr) * 2013-03-15 2022-04-20 INNOVISION, Inc. Vis à os
EP2856958A1 (fr) * 2013-10-07 2015-04-08 Arthrex Inc Vis à os canulée
EP3593745B1 (fr) * 2018-02-02 2024-10-09 Stryker European Operations Holdings LLC Vis orthopédique et ses structures poreuses
US11832860B2 (en) * 2018-06-22 2023-12-05 University Of Virginia Patent Foundation Bone fixation system for promoting the union of a bone fracture and fusion of bones across a joint space and related methods thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023052844A2 (fr) 2021-09-28 2023-04-06 Biomimetic Innovations Limited Dispositifs, systèmes et procédés de réparation osseuse ou de fixation d'implant

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DHANDAPANI ET AL., BIOACT. MATER., vol. 5, 2020, pages 458 - 467

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