WO2025029749A2 - Dispositifs de fermeture par compression et leurs procédés d'utilisation - Google Patents

Dispositifs de fermeture par compression et leurs procédés d'utilisation Download PDF

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Publication number
WO2025029749A2
WO2025029749A2 PCT/US2024/040072 US2024040072W WO2025029749A2 WO 2025029749 A2 WO2025029749 A2 WO 2025029749A2 US 2024040072 W US2024040072 W US 2024040072W WO 2025029749 A2 WO2025029749 A2 WO 2025029749A2
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WIPO (PCT)
Prior art keywords
component
leg
deformable
sternal device
lateral
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PCT/US2024/040072
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WO2025029749A3 (fr
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Joseph Paul RITZ
Eric Alberto Marcano
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Individual
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Individual
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Priority to AU2024315210A priority Critical patent/AU2024315210A1/en
Publication of WO2025029749A2 publication Critical patent/WO2025029749A2/fr
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Anticipated expiration legal-status Critical
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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
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8076—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the ribs or the sternum
    • 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
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/823—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the sternum also called the “breastbone,” is a long, generally flat bone located centrally in a person’s chest.
  • the sternum generally protects the heart and lungs.
  • a sternotomy is a surgical procedure in which a patient’s sternum or a portion of the sternum is divided laterally, for example, using a sternal saw.
  • a sternotomy may be performed to provide access to the heart, thymus, or lungs, such as for a heart transplant, a lung transplant, a biopsy of removal of certain thoracic tumors, a corrective procedure for congenital heart defects, or a coronary artery bypass procedure.
  • sternotomies exist, for example, a median sternotomy (e.g., in which the sternum is divided laterally along a medial line thereof), an inverse “T” — type sternotomy (e.g., in which an upper portion of the sternum is divided from a lower portion of the sternum, and the upper portion is divided laterally), a partial upper “L” — type sternotomy (e.g., in which a “L”-shaped is used to divide an upper corner from the remainder of the sternum), and a manubriotomy (e.g., in which the manubrium portion of the sternum is divided laterally).
  • a median sternotomy e.g., in which the sternum is divided laterally along a medial line thereof
  • T type sternotomy
  • L partial upper “L” — type sternotomy
  • manubriotomy e.g., in which the manubrium portion
  • a sternal device comprising at least one anchor component configured to engage a sternum or a portion thereof, and at least one deformable component configured to transition between an axially-extended conformation and an axially-retracted conformation.
  • a sternal device may comprise at least one anchor component configured to engage a sternum or a portion thereof.
  • the sternal device may further comprise at least one deformable component configured to transition between an axially-extended conformation and an axially-retracted conformation.
  • a method for repair or reconstruction of bones may comprise providing a sternal device comprising one or more anchor components and one or more deformable components.
  • the method may also comprise engaging the sternal device with the sternum of a patient.
  • the method may also comprise allowing the deformable component to transition from the axially-extended conformation into the axially-retracted conformation so as to apply a compressive force to the sternum.
  • Embodiments described herein comprise a combination of features and characteristics intended to address various shortcomings associated with certain prior devices, systems, and methods for fracture repair or reconstruction.
  • the foregoing outlines, broadly, the features and technical characteristics of the various disclosed embodiments.
  • the various characteristics and features described above, as well as others, will be readily understood to those skilled in the art upon reading the following detailed description, and by referring to the accompanying drawings. It should be appreciated that the conception and the specific embodiments disclosed herein are not limiting and may be modified or used to design other structures for carrying out the various embodiments. It should also be realized that such equivalent constructions do not depart from the spirit and scope of the principles disclosed herein.
  • the embodiments disclosed here may be described in connection with sternal devices, the devices disclosed and claimed herein may be used to repair and reconstruct other bones.
  • Figure 1 is a top view of a first embodiment of sternal device according to the disclosure herein;
  • Figure 2 is a bottom view of the first embodiment of sternal device according to the disclosure herein;
  • Figure 3 is a side view of the first embodiment of sternal device according to the disclosure herein;
  • Figure 4 is an end view of the first embodiment of sternal device according to the disclosure herein;
  • Figure 5 is a perspective view of the first embodiment of sternal device according to the disclosure herein;
  • Figure 6 is a perspective view of the first embodiment of sternal device according to the disclosure herein;
  • Figure 7 is a perspective view of the first embodiment of sternal device according to the disclosure herein;
  • Figure 8 is a perspective view of a second embodiment of sternal device according to the disclosure herein;
  • Figure 9 is a perspective view of the second embodiment of sternal device according to the disclosure herein;
  • Figure 10 is a perspective view of the second embodiment of sternal device according to the disclosure herein;
  • Figure 11 is a perspective view of a third embodiment of sternal device according to the disclosure herein;
  • Figure 12 is a perspective view of the third embodiment of sternal device according to the disclosure herein;
  • Figure 13 is a perspective view of the third embodiment of sternal device according to the disclosure herein;
  • Figure 14 is a perspective view of the third embodiment of sternal device according to the disclosure herein;
  • Figure 15 is a top view of the third embodiment of sternal device according to the disclosure herein;
  • Figure 16 is a top view of the third embodiment of sternal device according to the disclosure herein;
  • Figure 17 is a top view of a fourth embodiment of sternal device according to the disclosure herein;
  • Figure 18 is a perspective view of the fourth embodiment of sternal device according to the disclosure herein;
  • Figure 19 is a top view of the fourth embodiment of sternal device according to the disclosure herein;
  • Figure 20 is a perspective view of a fifth embodiment of sternal device according to the disclosure herein;
  • Figure 21 is a top view of the fifth embodiment of sternal device according to the disclosure herein;
  • Figure 22 is a side view of the fifth embodiment of sternal device according to the disclosure herein;
  • Figure 23 is a perspective view of a sixth embodiment of sternal device according to the disclosure herein;
  • Figure 24 is a top view of the sixth embodiment of sternal device according to the disclosure herein;
  • Figure 25 is a side view of the sixth embodiment of sternal device according to the disclosure herein;
  • Figure 26 is a perspective view of a seventh embodiment of sternal device according to the disclosure herein;
  • Figure 27 is a top view of the seventh embodiment of sternal device according to the disclosure herein;
  • Figure 28 is a side view of the seventh embodiment of sternal device according to the disclosure herein;
  • Figure 29 is a perspective view of an eighth embodiment of sternal device according to the disclosure herein;
  • Figure 30 is a side view of the eighth embodiment of sternal device according to the disclosure herein;
  • Figure 31 is a top view of the eighth embodiment of sternal device according to the disclosure herein;
  • Figure 32 is a perspective view of a ninth embodiment of sternal device according to the disclosure herein;
  • Figure 33 is a top view of the ninth embodiment of sternal device according to the disclosure herein;
  • Figure 34 is a side view of the ninth embodiment of sternal device according to the disclosure herein;
  • Figure 35 is a top view of a tenth embodiment of sternal device according to the disclosure herein;
  • Figure 36 is a second top view of the tenth embodiment of sternal device according to the disclosure herein;
  • Figure 37 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 38 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 39 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 40 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 41 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 42 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 43 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 44 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 45 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 46 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 47 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 48 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 49 is a front view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 50 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein;
  • Figure 51 is a perspective view of a sternal device in a deployed state according to one or more embodiments herein.
  • the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to... .”
  • the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first component couples to a second component, that connection may be through a direct connection of the two components, or through an indirect connection that is established via another component.
  • the terms “axial” and “axially” generally mean along or parallel to a given axis (e.g. , central axis of a body or a port), while the terms “radial” and “radially” generally mean perpendicular to the given axis.
  • an axial distance refers to a distance measured along or parallel to the axis
  • a radial distance means a distance measured perpendicular to the axis.
  • the terms “approximately,” “about,” “substantially,” and the like mean within 20% (i.e., plus or minus 20%) of the recited value, and alternatively, within 10% (i.e., plus or minus 10%) of the recited value.
  • a recited angle of “about 80 degrees” refers to an angle ranging from 64 degrees to 96 degrees, and alternatively ranging from 72 degrees to 88 degrees.
  • a closure device configured to provide dynamic, long-term compression and stability for the repair and reconstruction of bone segments.
  • the sternal devices generally include at least one deformable component and at least one anchor component.
  • the disclosed sternal devices provide a low-profile means of dynamic, long-term compression and stability.
  • the at least one deformable component is configured to provide tension to the at least one anchor component such that the at least anchor component applies a compressive force to a patient’s sternum.
  • the deformable component may be generally configured to be deformable between an axially-retracted conformation, relative to a longitudinal axis, and an axially-extended conformation, relative to the longitudinal axis.
  • the deformable component may also exhibit a tendency, when in the axially-extended conformation, to return to the axially-retracted conformation.
  • the one or more anchor components may be generally configured to be engaged with respect to the sternum such that the forces applied by the deformable component are applied to the one or more portions of the sternum.
  • each of the one or more anchor components may be configured to be wrapped around the sternum, to be hooked to a portion of the sternum, or to be fixed to a portion of the sternum, such as via an acceptable fastener, for example, a surgical screw.
  • the deformable component may be made from a suitable shape memory material, for example, a shape memory material suitable for surgical applications, for example, a medical grade shape memory allow.
  • a suitable shape memory material for example, a shape memory material suitable for surgical applications, for example, a medical grade shape memory allow.
  • the shape memory material may be medical grade Nitinol.
  • Nitinol is a metal alloy made of approximately half nickel and half titanium, for example, from about 40% to about 60% nickel, by weight, and about 40% to about 60% titanium, by weight.
  • Nitinol may be characterized as exhibiting a phase transformation, for example, such that the molecular arrangement of Nitinol varies according to its temperature. At lower temperatures, the crystalline architecture of Nitinol resembles an accordion making it relatively unstable, malleable, and weak. This is referred to as the martensitic phase of Nitinol (e.g., martensite). At higher temperatures, the crystalline structure of Nitinol is rearranged into a cubic form making it contracted, rigid, and strong.
  • Nitinol e.g., austenite
  • the temperature range at which Nitinol transforms from the martensitic phase into austenitic phase can be adjusted and manipulated through manufacturing processes. For example, during manufacturing, a Nitinol device may undergo heat treatments that “program” the temperature ranges that yield the transition between the martensitic and austenitic phases. For example, when a Nitinol device is heated, the treatments dictate the temperatures associated with the phase transformation from martensite to austenite (Austenite Start temperature or A s ) and the end of the transformation (Austenite Finish temperature or Af). In addition, when a Nitinol device is cooled, the treatments dictate the beginning of the phase transformation from austenite to martensite (Martensite Start temperature or M s ) and the end of the transformation (Martensite Finish temperature or M f ).
  • Nitinol exhibits shape memory and superelastic/pseudoelastic characteristics.
  • shape memory a Nitinol device can be designed to transform from one shape to another when exposed to heat. For example, prior to heat treating, the Nitinol device may be cooled, and thus become malleable in the martensite material phase and shaped into a particular form that imparts internal residual stresses. Heat treatment can then be applied, which sets or “bakes” this established shape into the memory of the implant. Then, when the Nitinol device is heated through its transformation temperature range, the device will revert to its predetermined final shape as it undergoes the phase transformation to Austenite.
  • Nitinol can withstand a large amount of strain, for example up to 8%, and still recover its original shape.
  • the superelastic characteristic is exhibited when a deformable component made of Nitinol is warmed through its transformation temperature range but is constrained and prevented from returning to its original shape. While constrained in a deformed shape, as is the case when a deformable component made of Nitinol is implanted, continuous exposure to sufficient heat allows the implant to behave like an elastic spring. This superelastic effect thus may be used to maintaining tension applied to the one or more anchor components and, thereby, compression of the sternum, a long-term compressive force between portions of the sternal over a large displacement range.
  • a deformable component made from Nitinol may be characterized as thermally-activated or Superelastic.
  • the transition temperature ranges of these types of implants vary and can be classified as either heat-activated or body temperature-activated.
  • Heat-activated Nitinol bone staples have an austenite start temperature (A s ) and austenite finish temperature (Af) above body temperature. These implants are implanted, for example, in the sternum in the malleable martensitic phase and are exposed to an external heat via electrocautery or bi-polar electrical resistance to convert the implant from martensite to austenite, and thus, promote shape change that creates compression between portions of the sternum being joined.
  • a deformable component made from Nitinol that is temperature-activated may have a transition temperature range that is slightly lower than body temperature. Since the A s may be at or below room temperature, these implants may utilize freezer storage to prevent premature transition. These implants may be placed with respect to the sternum while still in a frozen state, and then compress the portions of the sternum through the shape memory effect as they warm to body temperature. Compression is again maintained through the superelastic effect as the implant is constrained in an axially- extended conformation by the sternum.
  • a deformable component that is superelastic may have an austenite finish temperature (Af) for these implants is significantly below room temperature, for example 10 to -20 degrees C, thus freezer storage to maintain an initial shape in the martensite material phase may not be sufficient, as implants may begin to deflect before placement with respect to the sternum.
  • external constraint devices may be used to mechanically extend the deformable component prior to or during placement with respect to the sternum. Upon release of the constraining tool, the superelastic effect is transferred from the tool to the bone to achieve compression of the portions of the sternum.
  • one or more of the at least one anchor components may also be made from a shape memory material, for example, a shape memory material suitable for surgical applications, for example, a medical grade shape memory allow.
  • the shape memory material may be medical grade Nitinol.
  • one or more of the at least one anchor components may comprise (e.g., be made from) surgical grade stainless steel, ceramic materials, tungsten carbide, titanium, polyetheretherketone (PEEK), and combinations thereof.
  • Figures 1 , 2, 3, 4, 5, 6, and 7, a first embodiment of a sternal device 100 is shown.
  • Figures 1 , 2, 3, 4, and 5 illustrate a top view, a bottom view, an end view, a side view, and a perspective view, respectively, of the sternal device 100 in an undeployed, axially-retracted conformation.
  • Figure 6 illustrates the sternal device 100 in an axially-extended conformation, as deployed.
  • Figure 7 illustrates the sternal device 100 in an axially-retracted conformation, as deployed.
  • the sternal device 100 includes a plurality of, for example, four (4), anchor components 110 integrated with a deformable component 120.
  • the embodiment of Figures 1 , 2, 3, 4, 5, 6, and 7 includes four anchor components 110, in some embodiments a sternal device may similarly in 2, 6, 8, or 10 anchor components.
  • each of the four (4) anchor components 110 comprises a leg and the deformable component 120 comprises a bridge that extends between a first group of legs (first leg 111a and third leg 111c) and a second group of legs (second leg 111 b and fourth leg 111 d).
  • Each of the first leg 111a and the third leg 111c extends from the deformable component 120 at a first end 120a and, likewise, each of the second leg 111 b and the fourth leg 111 d extends from the deformable component 120 at a second end 120b.
  • the sternal device 100 may be defined with respect to a central axis 102 passing through the geometric center of the deformable component 120 and centered between the legs.
  • the sternal device 100 may be defined with respect to each of a first latitudinal axis 104a and a second latitudinal axis 104b.
  • the first latitudinal axis 104a generally extends between the deformable component 120 and a connection point for each of the first leg 111 a and the third leg 111 c.
  • the second latitudinal axis 104b generally extends between the deformable component 120 and a connection point for each of the second leg 111 b and the fourth leg 11 1 d.
  • the central axis 102, the first latitudinal axis 104a, and the second latitudinal axis 104b lie in a common place, which may also be referred to herein as the “reference plane.”
  • Each of the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 111 d has a central axis 112a, 112b, 112c, 112d, respectively, laterally spaced apart from central axis 105, a first or fixed end fixably attached to and integral with the corresponding end 110a, 1 10b of the sternal device 100, and a second or free or distal end.
  • each axis 112a, 112b, 112c, 112d may also simply be referred to as axis 112.
  • the central axis 112 of each of the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 111 d is a linear, longitudinal that intersects the first latitudinal axis 104a or the second latitudinal axis 104b.
  • each anchor component 110 (for example, the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 111d) is oriented substantially parallel to the reference place.
  • each anchor component 110 (for example, the first leg 111 a, the second leg 111 b, the third leg 111 c, and the fourth leg 11 1 d) is oriented at a leg angle a measured between the corresponding axis 112 and the reference plane.
  • leg angle a of each leg ranges from about 90 degrees to about 60 degrees, additionally or alternatively, from about 90 degrees to about 75 degrees, additionally or alternatively, from about 90 degrees to about 80 degrees. In embodiments where the leg angles a are less than 90 degrees, the distal ends of the legs of opposing legs are disposed relatively closer together and, thus the legs may be referred to herein as “inwardly biased.” In various, the leg angles a of any two or more legs may be the same or different. In the embodiment illustrated in Figure 6 and 7, each leg angle a is an acute angle between 90 degrees and 80 degrees, such that the legs are inwardly biased, and each leg angle a is approximately the same.
  • each leg may be characterized with respect to a crosssection taken in a plane oriented perpendicular to the corresponding axis 135.
  • an outer surface of each of the legs may be characterized as defining a non-rectangular outer shape or profile.
  • the outer surface of each leg comprises a cylindrical surface extending axially (relative to corresponding axis 112) and, thus, the profile at cross-section is circular.
  • the cylindrical radial outer surface of the legs may be advantageous as the cylindrical geometry can more fully fill the drilled hole, as compared to a rectangular prismatic geometry, and thus, offers the potential for enhanced bending strength and fixation within the bone segments.
  • rectangular cross-sectional dimensions of legs having a rectangular prismatic shape are limited as the sharp corners of the cross-section contact the cylindrical inner surface of the bone defined by the drilled hole, and any increases in one of the cross-sectional dimensions of the rectangular cross-section may result in sufficient interference between the legs and bone segments to restrict insertion of the legs into the bone segments.
  • the legs illustrated in the embodiment of Figures 1 , 2, 3, 4, 5, 6, and 7 have cylindrical outer surfaces defining circular profiles in cross-sections taken perpendicular to axes 112
  • the legs may have outer surfaces with other geometries that define other non-rectangular profiles in cross-sections taken perpendicular to the central axes of the legs, such as polygons, semi-circular, or elliptical cross-sections.
  • each leg also comprises a leg taper 1 15 disposed at the distal end of each leg.
  • the leg taper 115 may have an angle 0 measured from central axis 1 12 of each leg.
  • the outer surface of each leg or a portion thereof may be characterized as frustoconical and characterized by a non-zero leg taper angle 0.
  • the leg taper angle 0 may range from 0 degrees to about 2.5 degrees, additionally or alternatively, from about 0.075 degrees to about 1.5 degrees, or, additionally or alternatively, from about 0.125 degrees to about 1 .25 degrees.
  • a non-zero taper angle 0 may advantageously facilitate a wedging fit between the legs and a cylindrically shaped drilled hole, which may enhance the retention of the implant with the bone segments.
  • non-zero taper angles 0 may allow a narrower tip, which may aid in insertion of the leg into holes, while allowing an increased diameter at the fixed ends of the legs to increase the bending strength at the joints between the legs and the deformable component.
  • one or more bevels may be provided along the outer surface on each leg, for example, along the sides of legs that face away from each other
  • each of the legs may comprise one or more serrations 118 axially spaced (relative to corresponding axis 112) along outer surface on the inside of each leg, for example, along the sides of legs that face toward each other.
  • each serration 118 is defined by a sloped surface 118a that slopes radially inward toward the corresponding axis 112 moving axially toward the distal end of each corresponding leg, and an upward facing shoulder 118b extending radially inward from the sloped surface toward axis 1 12 of the corresponding leg.
  • the sloped surface 118a on the inside of each leg at the distal end thereof and the bevel on the outside of each leg collectively define the tapered tips at the distal end of each leg.
  • the deformable component 120 is configured such that a portion of the deformable component 120 may be deformed, for example, such that the sternal device 100 may have both a first, contracted state and a second, expanded state.
  • the deformable component 120 is configured to deform such that the sternal device 100 expands or contracts in a direction parallel to the central axis 105.
  • the deformable component 120 is shown in a deformed state such that the sternal device 100 moves into the axially-extended conformation.
  • the deformable component 120 may exhibit a tendency or bias toward the undeformed state such that the sternal device 100 exhibits a tendency to return to the axially contracted conformation.
  • the deformable component 120 may comprise a first deformable bridge 122 and a second deformable bridge 124.
  • the deformable component particularly, both the first deformable bridge 122 and the second deformable bridge 124 are shown in the undeformed state.
  • both the first deformable bridge 122 and the second deformable bridge 124 exhibit a curvature in a second reference plane parallel to the central axis 105 and perpendicular to the previously-referenced reference plane.
  • a central axis associated with the first deformable bridge 122 and/or the second deformable bridge 124 may have a constant or variable radius of curvature measured in the second reference plane from a point.
  • the radius of curvature of the central axis associated with the first deformable bridge 122 and/or the second deformable bridge 124 about 0 mm (i.e., linear) to about 200 mm, alternatively range from about 25 mm to about 150 mm, and more alternatively range from about 50 mm to about 100 mm.
  • the radius of curvature of the central axis associated with the first deformable bridge 122 and/or the second deformable bridge 124 can vary along its length between ends 120a, 120b or, alternatively, can be constant along its length between ends 120a, 120b.
  • the first deformable bridge 122 and/or the second deformable bridge 124 may deform via a decrease in the curvature associated with the first deformable bridge 122 and/or the second deformable bridge 124.
  • the first deformable bridge 122 and/or the second deformable bridge 124 may be flattened, such that the distance between the ends 120a, 120b increases.
  • the first deformable bridge 122 and the second deformable bridge 124 may together form a “diamond”-shape.
  • the first deformable bridge 122 and second deformable bridge may be bowed or splayed away from each other at a midpoint between the first end 120a and the second end 120b.
  • the bow splay may provide working-room to sever the first deformable bridge 122 and the second deformable bridge 124 in the event of an emergency surgical procedure in which access to the chest cavity is required.
  • each of the first deformable bridge 122 and the second deformable bridge 124 may be characterized as having a radially outer surface extending axially along the length thereof, respectively, generally substantially from first end 120a to the second end 120b.
  • each of the first deformable bridge 122 and the second deformable bridge 124 may be characterized with respect to a cross-section taken in a plane oriented perpendicular to its length. In cross-section, the outer surface of each of the first deformable bridge 122 and the second deformable bridge 124 defines a non-rectangular outer shape or profile. In this embodiment, the profile at the crosssection is generally elliptically-shaped.
  • each of the first deformable bridge 122 and the second deformable bridge 124 includes a flat upper surface, a flat lower surface, and a pair of rounded edges extending from flat upper surface to the flat lower surface.
  • the flat upper surface and flat lower surface 114 are generally oriented parallel to each other and to the reference plane.
  • the first deformable bridge 122 and/or the second deformable bridge 124 exhibit a curvature in the second reference plane and, thus, the flat upper surface of each of the first deformable bridge 122 and the second deformable bridge 124 comprises a convex surface, whereas the lower flat surface comprises a concave surface.
  • the cross-sectional area of the of each of the first deformable bridge 122 and the second deformable bridge 124 in any plane oriented perpendicular to its length is equal to or greater than the cross-sectional area of each leg taken in any plane oriented perpendicular to axis 112.
  • the ratio of (i) the cross-sectional area of each of the first deformable bridge 122 and the second deformable bridge 124 in any plane oriented perpendicular to its length to (ii) the cross-sectional area of each leg in any plane oriented perpendicular to the axis of the leg is 10.0 to 1.0, additionally or alternatively, about 2.5 to 1.0 or, additionally or alternatively, about 1.5 to 1.0.
  • the sternal device 100 comprises a first lateral component 132 disposed toward the first end 120a of the deformable component and a second lateral component 134 disposed toward the second end 120b of the deformable component 120b.
  • each of the first lateral component 132 and the second lateral component 134 may extend perpendicular to the central axis, for example, parallel to the first latitudinal axis 104a and the second latitudinal axis 104b, respectively.
  • the first deformable bridge 122 and the second deformable bridge 124 each extend between the first lateral component 132 and the second lateral component 134, for example, such that a first end of each of the first deformable bridge 122 and the second deformable bridge 124 is fixed to and integrated with the first lateral component 132 and, likewise, such that a second end of each of the first deformable bridge 122 and the second deformable bridge 124 is fixed to and integrated with the second lateral component 134.
  • the first lateral component 132 and the second lateral component 134 may be characterized as having a radially outer surface extending axially along the length thereof, respectively (e.g., generally in the direction of the lateral axes 104a, 104b).
  • each of the first lateral component 132 and the second lateral component 134 has a cross-section taken in a plane oriented perpendicular to its length, for example, perpendicular to the lateral axes 104a, 104b, respectively.
  • the outer surface of each of the first lateral component 132 and the second lateral component 134 defines a non-rectangular outer shape or profile.
  • the profile at cross-section is generally oval or elliptical in shape.
  • legs, first deformable bridge 122, second deformable bridge 124, first lateral component 132, and second lateral component 134 may have different cross-sectional geometries.
  • the sternal device 100 may include smoothly curved concave transitional surfaces at the intersection of various components.
  • the transitional surfaces may be effective to reduce bending stress concentrations and may be used to grip sternal device 100 with a surgical insertion or retaining tool.
  • sternal device 100 is made of a Nitinol material, and thus, can be heat treated and programed, as discussed above, to have shape memory and superelastic/pseudoelastic characteristics such that sternal device 100 may be classified as a superelastic shape memory implant, and may transform from one shape to another when exposed to heat.
  • Figures 8, 9, and 10 another embodiment of a sternal device 800 is shown.
  • Figure 8 illustrate the sternal device 800 in an axially-extended conformation
  • Figure 9 illustrates an axially-retracted conformation.
  • the sternal device 800 includes two anchor components 810 and a deformable component 820.
  • a first anchor component 810 is incorporated with the deformable component 820 and a second anchor component 810 is configured to be engaged with the deformable component 120.
  • Figure 10 illustrates the second anchor component 810 separate, for example, from the deformable component 820 which, as noted above, is integral with the first anchor component 10.
  • the first and second anchor components 810 are configured to engage a sternum by via a hook or grapple structure.
  • the hook structure of the anchor components 810 are generally configured to hook or wrap partially around the edges of the sternum, or into drilled or punched holes of the sternum such that the sternum can be pulled together (e.g., toward each other).
  • the deformable component 820 is configured such that a portion of the deformable component 820 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 820 to expand or contract.
  • the deformation of the deformable component 820 allows the deformable component to move into the axially-extended conformation.
  • the deformable component 820 may exhibit a tendency for a portion of the deformable component 820 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 820 exhibits a tendency to return to the axially contracted conformation.
  • one or more of the at least one anchor components 810 may be configured to be selectively engaged to the deformable component 820.
  • the deformable component 820 and one or more of the at least one anchor components 810 may comprise any suitable combination of mating or interlocking structures.
  • the deformable component 820 and one or more of the at least one anchor components 810 comprise a “zip-tie” engagement structure.
  • the one or more of the at least one anchor components 810 comprise a linear ratchet gear rack and the deformable component 820 comprises a pawl, cleat, or other structure configured to engage the ratchet gear rack.
  • the deformable component 820 and one or more of the at least one anchor components 810 may comprise separate structure, enabling the deformable component 820 and the one or more of the at least one anchor components 810 to be joined together during placement of the sternal device 800 with respect to the sternum.
  • Figure 11 illustrates the sternal device 1100 in an axially- extended conformation
  • Figures 14 and 16 illustrate an axially-retracted conformation
  • figures 12, 13, and 15 illustrate intermediate conformations.
  • the sternal device 1100 includes two anchor components 1 110 and a deformable component 1120.
  • the deformable component 1120 is an independent structure from the anchor components 1 110, and a first and second anchor component 11 10 are each configured to be engaged with the deformable component 1120.
  • first and second anchor components 11 10 are configured to engage a sternum by via a hook or grapple structure.
  • the deformable component 1120 is configured such that a portion of the deformable component 1120 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 1120 to expand or contract.
  • the deformation of the deformable component 1120 allows the deformable component to move into the axially-extended conformation and the deformable component 1120 may exhibit a tendency for a portion of the deformable component 1120 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 1120 exhibits a tendency to return to the axially contracted conformation.
  • the deformable component 1120 and the anchor components 1110 comprise a “zip-tie” engagement structure.
  • Figure 17 illustrates the sternal device 300 in an intermediate conformation, for example, between the axially-extended and axially-retracted conformations and Figures 18 and 19 illustrate the anchor components 1710 of the sternal device of Figure 17.
  • the sternal device 300 includes two anchor components 1710 and a deformable component 1720.
  • the deformable component 1720 is an independent structure from the anchor components 1710, and a first and second anchor component 1710 are each configured to be engaged with the deformable component 1720.
  • the first and second anchor components 1710 are configured to engage a sternum by via a suitable fastener.
  • the first and second anchor components each include a plurality of holes suitable to receive a surgical screw, for example, such that the first and second anchor components may be secured with respect to the sternum.
  • any suitable fastener may be employed, for example, a surgical staple.
  • An example of a suitable surgical staple is disclosed in International Application No. PCT/US2021040544 published as WO/2022/010920 and entitled “ORTHOPEDIC COMPRESSION IMPLANTS AND DEVICES FOR INSTALLING AND RETAINING SAME,” which is incorporated herein by reference in its entirety.
  • the deformable component 1720 is configured such that a portion of the deformable component 1720 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 1720 to expand or contract.
  • the deformation of the deformable component 1720 allows the deformable component to move into the axially-extended conformation and the deformable component 1720 may exhibit a tendency for a portion of the deformable component 1720 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 1720 exhibits a tendency to return to the axially contracted conformation.
  • the deformable component 1720 and the anchor components 1710 comprise a “zip-tie” engagement structure.
  • FIG. 20 Another embodiment of a sternal device 2000 is shown.
  • Figures 13-15 illustrate the sternal device 2000 in an axially-retracted conformations.
  • the sternal device 2000 includes a single anchor component 2010 and a deformable component 2020.
  • the deformable component 2020 is integrated with the anchor components 2010 and the anchor component 2010 is configured to be engaged with the deformable component 2020.
  • the anchor component 2010 is configured to engage a sternum by being wrapped around the sternum.
  • the sternal device may be wrapped around the sternum and the anchor component 2010 engaged with the deformable component 2020.
  • the deformable component 2020 is configured such that a portion of the deformable component 2020 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 2020 to expand or contract.
  • the deformation of the deformable component 2020 allows the deformable component to move into the axially-extended conformation and the deformable component 2020 may exhibit a tendency for a portion of the deformable component 2020 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 2020 exhibits a tendency to return to the axially contracted conformation.
  • the deformable component 2020 and the anchor components 2010 comprise a “zip-tie” engagement structure.
  • Figures 23-25 illustrate the sternal device 2300 in an axially-retracted conformations.
  • the embodiment of Figures 23-25 illustrates an embodiment similar to the embodiment of Figures 20-22.
  • the sternal device 2300 includes a single anchor component 2310 and a deformable component 2320.
  • the deformable component 2320 is integrated with the anchor components 2310 and the anchor component 2310 is configured to be engaged with the deformable component 2320.
  • Figures 23-25 illustrates an alternative embodiment of a deformable component, for example, as shown in Figures 23-25.
  • the deformable component 2320 of is configured such that a portion of the deformable component 2320 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 2320 to expand or contract.
  • the deformation of the deformable component 2320 allows the deformable component to move into the axially-extended conformation and the deformable component 2320 may exhibit a tendency for a portion of the deformable component 2320 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 2320 exhibits a tendency to return to the axially contracted conformation.
  • FIG. 26-28 illustrate the sternal device 2600 in an axially-retracted conformations.
  • the sternal device 2600 includes a single anchor component 2610 and a deformable component 2620.
  • the deformable component 2620 is integrated with the anchor components 2610 and the anchor component 2610 is configured to be engaged with the deformable component 2620.
  • the anchor component 2610 is configured to engage a sternum by being wrapped around the sternum.
  • the sternal device may be wrapped around the sternum and the anchor component 2610 engaged with the deformable component 2620.
  • the deformable component 2620 is configured such that a portion of the deformable component 2620 may be deformed laterally, for example, in a direction perpendicular to the direction of expansion or contraction, thereby allowing the deformable component 2620 to expand or contract.
  • the deformation of the deformable component 2620 allows the deformable component to move into the axially-extended conformation and the deformable component 2620 may exhibit a tendency for a portion of the deformable component 2620 to take on a serpentine or undulating pattern in a direction perpendicular to the direction of expansion or contraction, for example, such that the deformable component 2620 exhibits a tendency to return to the axially contracted conformation.
  • the anchor component 2610 may be configured to be selectively engaged to the deformable component 2620.
  • the deformable component 2620 and the anchor component 2610 comprise combination of mating or interlocking structures.
  • the anchor component 2610 comprises a plurality of linearly-arranged holes and the deformable component 2620 comprises a peg or other structure configured to engage one of the holes in the anchor component 2610.
  • FIG. 29-31 illustrate the sternal device 2900 in an axially-extended conformations.
  • the sternal device 2900 includes a single anchor component 2910 and a deformable component 2920.
  • the deformable component 2920 is independent from the anchor component 2910 and the anchor component 2910 is configured to be engaged with the deformable component 2920.
  • the anchor component 2910 is configured to engage a sternum by being wrapped around the sternum.
  • the sternal device may be wrapped around the sternum and the anchor component 2910 engaged with the deformable component 2920.
  • the deformable component 2920 is configured as a deformable, surgical staple 2920.
  • the deformable, surgical staple 2920 may be deformable over the length thereof, for example, such that distance between the terminal ends of the staple vary between the axially-retracted and axially-extended conformations.
  • the anchor component 2910 may be configured to be engaged with the deformable component 2920.
  • the anchor component 2910 comprises one or more holes in each end thereof, such that the deformable staple may be received into a hole within each end of the anchor component 2910, for example, so as to hold the respective ends of the anchor component with respect to each other.
  • the anchor component 2910 is configured such that the deformable surgical staple 2920 may also be received into the sternum; for example, the deformable surgical staple may extend through the holes in the anchor component 2910 and be secured within holes in the sternum.
  • FIG. 32 Another embodiment of a sternal device 3200 is shown.
  • Figures 32-34 illustrate the sternal device 3200 in an axially-extended conformations.
  • the sternal device 3200 includes a single anchor component 3210 and a deformable component 3220.
  • the deformable component 3220 is independent from the anchor component 3210 and the anchor component 3210 is configured to be engaged with the deformable component 3220.
  • the anchor component 3210 is configured to engage a sternum by being wrapped around the sternum.
  • the sternal device may be wrapped around the sternum and the anchor component 3210 engaged with the deformable component 3220.
  • the deformable component 3220 is configured as a deformable, surgical staple 3220.
  • the deformable, surgical staple 3220 may be deformable over the length thereof, for example, such that distance between the terminal ends of the staple vary between the axially-retracted and axially-extended conformations.
  • the anchor component 3210 may be configured to be engaged with the deformable component 3220.
  • the anchor component 3210 comprises one or more holes in each end thereof, such that the deformable staple may be received into a hole within each end of the anchor component 3210, for example, so as to hold the respective ends of the anchor component with respect to each other.
  • the anchor component 3210 is configured such that the deformable surgical staple 3220 is not received into the sternum; for example, the deformable surgical staple may extend through the holes in the anchor component 3210 and extend generally parallel to the surface of the sternum.
  • Figure 35 illustrates the sternal device 3500 in an axially-extended conformation
  • Figure 36 illustrates the sternal device 3500 in an axially-retracted conformation.
  • the sternal device 3500 includes two anchor components 3510 and three deformable components 3520.
  • the deformable components 3520 are independent structures from the two anchor components 3510, and a first and second anchor component 3510 are each configured to be engaged with the plurality of deformable components 3520.
  • the first and second anchor components 3510 are configured to engage a sternum by via a suitable fastener.
  • the first and second anchor components 3510 each include a plurality of holes suitable to receive a surgical screw, for example, such that the first and second anchor components may be secured with respect to the sternum.
  • any suitable fastener may be employed, for example, a surgical staple.
  • the deformable components 3520 are configured as deformable, surgical staples 3520.
  • the deformable, surgical staple 3520 may be deformable over the length thereof, for example, such that distance between the terminal ends of the staple vary between the axially-retracted and axially-extended conformations.
  • the plurality of anchor components 3510 may be configured to be engaged with the deformable component 3520.
  • the anchor component 3510 comprises a plurality of holes along one edge thereof, such that the deformable staple may be received into a hole within each the two anchor components 3510, for example, so as to hold the two anchor components with respect to each other.
  • each of the anchor components 3510 is configured such that the deformable surgical staple 3220 is not received into the sternum; for example, the deformable surgical staple may extend through the holes in the anchor component 3510 and extend generally parallel to the surface of the sternum.
  • a sternal device for example, as disclosed with respect to one or more of the embodiments and/or figures herein, may be employed in the performance of a medical procedure (e.g., a surgical procedure).
  • a sternal device may be employed in the performance of a sternotomy to provide closure of a surgically divided sternum.
  • a method of using a sternal device in the performance of a surgical procedure may include the step of providing a sternal device, for example, including at least one anchor component and at least one deformable component.
  • the deformable component may be provided in an axially-extended conformation.
  • the one or more anchor components may also be provided in an extended conformation.
  • a method of using a sternal device in the performance of a surgical procedure may also include the step of positioning the one or more anchor components with respect to the sternum of the patient.
  • the anchor components may be hooked onto the sternum, wrapped around or partially around the sternum, fastening the anchor component in place with respect to the sternum or a portion thereof (e.g., via surgical screws or staples), or combinations thereof.
  • a method of using a sternal device in the performance of a surgical procedure may also include the step of engaging the one or more deformable components with the one or more anchor components, for example, as disclosed with respect to the various embodiments herein.
  • a method of using a sternal device in the performance of a surgical procedure may also include the step of allowing the deformable component to transition from the axially-extended conformation into the axially-retracted conformation and, as such, thereby applying a compressive force to the sternum.
  • Figures 37-51 illustrate various embodiments of a sternal device as employed in the context of a surgical procedure.
  • sternal device 100 may utilize the shape memory characteristics of Nitinol to impart compressive loads across a sternotomy site, for examples, to apply compression across a break or fracture, to aid and enable fusion.
  • sternal device 100 can be made of Nitinol and programed though deformation and heat treatment, such that the shape memory of the Nitinol material causes opposing legs to be biased toward each other, for example, by decreasing leg angle a (e.g.
  • distal ends move inward toward each other and/or causes the first deformable bridge 122 and the second deformable bridge 124 to return to an initial state (e.g., where the first deformable bridge 122 and the second deformable bridge 124 spread laterally) so as to draw the first end 120a and the second end 120b together (e.g., toward each other), in response to heating of sternal device 100.
  • Such heating of sternal device 100 may be accomplished with an external source (e.g. , heat- activated), or as sternal device 100 is brought to room temperature or body temperature (e.g., body temperature-activated).
  • the shape transformation may have already occurred and an external tool may be used to restrain the deformation of sternal device 100.
  • the external tool may apply forces to the first deformable bridge 122 and the second deformable bridge 124 to elastically flex the deformable component such that the first end 120a and second end 120 are forced apart.
  • the legs may be constrained with axes 1 12 oriented parallel and perpendicular to the reference plane so as to be inserted into holes in bone segments. The legs may be advanced into the holes until a lower surface deformable component 120 is pressed into contact (or approximate contact) with the sternum. The external tool may be removed, thereby releasing the strain energy of the elastically deformed sternal device 100 and allowing the legs to apply compression across the sternum to draw a break or fracture together.

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Abstract

Un dispositif sternal peut comprendre au moins un composant d'ancrage qui vient en prise avec un sternum ou une partie de celui-ci. Le dispositif sternal peut en outre comprendre au moins un composant déformable conçu pour effectuer une transition entre une conformation axialement étendue et une conformation axialement rétractée.
PCT/US2024/040072 2023-07-28 2024-07-29 Dispositifs de fermeture par compression et leurs procédés d'utilisation Pending WO2025029749A2 (fr)

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US11278277B2 (en) * 2019-01-17 2022-03-22 Acumed Llc Bone clip with resilient arm for proximal compression
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