WO2016197328A1 - 固定骨板 - Google Patents

固定骨板 Download PDF

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Publication number
WO2016197328A1
WO2016197328A1 PCT/CN2015/081085 CN2015081085W WO2016197328A1 WO 2016197328 A1 WO2016197328 A1 WO 2016197328A1 CN 2015081085 W CN2015081085 W CN 2015081085W WO 2016197328 A1 WO2016197328 A1 WO 2016197328A1
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WO
WIPO (PCT)
Prior art keywords
plate
bone
plate body
bone plate
fixed bone
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Ceased
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PCT/CN2015/081085
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English (en)
French (fr)
Inventor
佘承鑫
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Individual
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Individual
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Priority to PCT/CN2015/081085 priority Critical patent/WO2016197328A1/zh
Priority to US15/580,714 priority patent/US11707306B2/en
Priority to EP15894598.0A priority patent/EP3308736B1/en
Publication of WO2016197328A1 publication Critical patent/WO2016197328A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61B17/8071—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 jaw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • 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
    • A61B17/8028—Cushions, i.e. elements forming interface between bone plate and bone
    • 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
    • A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C7/00—Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • B22F10/20—Direct sintering or melting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P10/00—Technologies related to metal processing
    • Y02P10/25—Process efficiency

Definitions

  • the present invention relates to a fixed bone plate, and more particularly to a fixed bone plate device for dental, orthodontic and facial shaping surgery.
  • Orthognathic surgery is known to correct the structural and developmental problems of the ankle and face, or to improve sleep apnea, TMJ disorders, and skeletal problems.
  • the resulting malocclusion, or other surgery that is not easily performed with the orthodontic correction.
  • This procedure is often used to treat patients with congenital cleft lip and palate.
  • the doctor performs a corrective operation on the patient, the original bone needs to be cut and adjusted, and then the bone plate and the bone nail are used to join the bone to shape.
  • doctors often need to use medical metal plates, screws, bone nails, stainless steel wire and other materials during surgery to fix and shape the patient's ankle and face.
  • the known metal plate structure does not have a standard product that can completely conform to the bone.
  • the bone plate When the doctor performs the operation, the bone plate is often required to be processed by hand to adjust the angle of the locking plate, resulting in an excessively long operation time. Difficulty in surgery. Because the bone plate can not lock the bone, it may cause the patient to be unable to properly bite, excessively bite, and misalignment in the future.
  • a known Taiwan patent 201313207 "A hinged fixation device for combining upper jaw corrections" comprising: a first foot plate comprising a plurality of frames configured to be attached to a first bone portion a foot plate body; a second foot plate comprising a plurality of second foot plate bodies configured to be attached to a second bone portion; and a joint assembly coupled to the first and second portions Between the body portions of the foot plate, the engagement assembly includes a hinge defining a pivot axis, the first foot plate body being responsive to a force applied to the second foot plate body about the pivot axis Passing passively on the body of the second footboard.
  • the former patent is a rotating hinge to adjust the joint angle between the plate and the bone, but it still cannot solve the problem of accurate alignment and stable combination between the existing bone plate and the bone topography.
  • the guiding device includes a two-nail nail and an orthopedic plate, each of the bone nails having a bare segment and an implanting segment, the exposed portion of the nail is provided with a first twisting portion, a fastening portion and a a second twisting portion, the first twisting portion is adjacent to the implanting portion of the bone nail, the circumferential surface of the first twisting portion is non-circular, and the engaging portion is located at the first twisting portion and the second portion
  • the correcting plate has a connecting portion, a positioning portion and a rotating buckle portion, the bridge portion is located between the positioning portion and the buckle portion, and the bridge portion is provided with at least one hook portion The positioning segment and the buckle segment are respectively fastened to the fastening portion of the two nails.
  • the gingival correction anchoring module can lock the two nails to the proper position of the tibia through the surgical guiding device, so as to make correction
  • the plate is lapped with two bone nails.
  • the existing patented orthotic plate and bone nail cannot adjust the angle of the bone plate to accurately engage the bone, and the patient may still be unable to properly bite, excessively bite, or misalign the bite in the future.
  • Taiwanese patent I398241 "dental upper tibia micro-implant", which consists of a plate body and a corrective fitting, which is placed in the keratinized epithelial tissue of the orthodontic oral cavity, and then The first locking component and the second locking component respectively pass through the first locking hole and the second locking hole provided at the two ends of the board body to lock the board body to the upper jaw, and then to a third The locking component passes through the fourth locking hole provided on the correcting accessory, and the third locking hole provided on the plate body, so that the correcting accessory is locked on the upper jaw.
  • the plate of the previous patent still cannot solve the problems of accurate alignment and stable combination of the existing bone plate and bone topography.
  • a fixed bone plate which can be used for dental, orthodontic and facial shaping surgery, and the fixed bone plate can be accurately positioned and firmly combined with the human bone topography to solve the aforementioned known fixed bone plate.
  • Techniques require manual processing of bone plates or doctors to adjust the locking angle by hand.
  • One of the objects of the present invention is to provide a fixed bone plate which can be used for dental, orthodontic and facial shaping surgery, by which the fixed bone plate can further conform to the human bone morphology feature. Precise positioning and a solid combination of effects.
  • One of the objects of the present invention is to provide a fixed bone plate, wherein the fixing portion of the fixed bone plate has a bone fitting surface, and the bone fitting surface can be calculated by a computer program to make the fixed bone plate and the human bone Precise positioning and solid combination.
  • the present invention provides a fixed bone plate, comprising: a plate body having a plate body and a locking portion penetrating the plate body, wherein the plate body is connected to the plate body corresponding to two In the locking portion of the end, the plate body further has a fitting portion, and the fitting portion is disposed on the other side of the locking portion.
  • the plate body is a flat plate body or a curvature plate body.
  • the locking portion is an opening or a screw hole.
  • the abutting portion is a guide post or a spacer.
  • the bone abutting surface is a plane or a curved surface.
  • the plate body is made of a titanium alloy material or a human body absorbable biological material.
  • the bonding portion is made of a titanium alloy material or a human body absorbable biological material.
  • the fixed bone plate further comprises a bonding device that fixes the fixed bone plate to the bone.
  • the bonding device is a bone nail or a rivet or a screw.
  • the plate body and the bonding portion are respectively manufactured by a metal laser lamination process or respectively by a 3D metal printing process.
  • FIG. 1 is a top plan view of a fixed bone plate of the present invention.
  • Figure 2 is a side elevational view of the fixed bone plate of the present invention.
  • FIG. 3 is a diagram showing input parameter of simulation calculation graphical software of the fixed bone plate of the present invention.
  • FIG. 4 is a perspective view of a fixed bone plate of the present invention.
  • Fig. 5 is a schematic view showing the combination of the fixed bone plate and the bonding device of the present invention.
  • Fig. 6 is a schematic view showing the combination of the fixed bone plate and the human bone of the present invention.
  • the present invention provides a fixed bone plate 10, which is a top plan view of the fixed bone plate 10 as shown in FIG. According to the above embodiment, as shown in FIG. 2, it is a side view of the fixed bone plate 10.
  • the fixed bone plate 10 includes a plate body 11 having a plate. The body 111 and a locking portion 12 penetrating the plate body 11. The locking portion 12 is disposed at two ends of the plate body 11 for connecting the locking portions 12 at opposite ends of the plate body 11.
  • the fixed bone plate 10 further has a affixing portion 20 having a skeletal abutting surface 21 , wherein the affixing portion 20 is disposed on the other side of the locking portion 12 .
  • the plate body 111 is a curvature plate body, and the curvature and slope change angle of the plate body 111 can be calculated by a computer graphics interface operation software.
  • the computer graphics interface software can use the commercially available GRASSHOPPER graphics software to calculate the X, Y, Z triaxial position and angle range of the board body 111.
  • the manufacturing parameters of the board body 111 are calculated by the simulation calculation GRASSHOPPER graphics software, and the board body 111 is manufactured by a metal laser lamination process, thereby forming the appearance of the bridge support frame of the board body 111.
  • the locking portion 12 at the opposite ends of the plate body 11 can be implemented as a screw hole that can lock the fixed bone plate 10.
  • the bonding portion 20 can be implemented as a guide post, and the bone bonding surface 21 of the bonding portion 20 can be implemented as a curved surface.
  • the height of the bonding portion 20 and the area of the bone bonding surface 21 are calculated by computer graphics interface software (such as GRASSHOPPER graphics software), and the bonding portion 20 and the bone bonding are formed by a metal laser lamination process. Face 21.
  • FIG. 4 is a perspective view of the fixed bone plate 10 of the present invention.
  • the fixed bone plate 10 includes a plate body 11 having a plate body 111 and a locking portion 12 extending through the plate body 11.
  • the locking portion 12 is disposed at two ends of the plate body 11 , wherein the plate body 111 is used for connecting the locking portions 12 of the corresponding ends of the plate body 11 .
  • the fixed bone plate 10 further has a bonding portion 20, wherein the plate body 11 is made of a medical grade titanium alloy material (Ti-6AI-4V), and the bonding portion 20 is made of a medical grade titanium alloy material (Ti-6AI- 4V).
  • the body 111 can be replaced by a flat plate.
  • the locking portion 12 can be replaced by an opening.
  • the fitting portion 20 can be replaced by a gasket.
  • the bone fitting surface 21 can be replaced by a flat surface.
  • the plate body 11 can be replaced with a human body absorbable biological material.
  • the material of the bonding portion 20 can be replaced with a human body absorbable biological material.
  • the plate body 11 and the bonding portion 20 can be manufactured by a 3D metal printing process.
  • FIG. 5 it is a schematic diagram of a combination of a fixed bone plate 10 and a bonding device 30 of the present invention.
  • the fixed bone plate 10 includes a plate body 11 having a plate body 111 and a locking portion 12 extending through the plate body 11.
  • the locking portion 12 is disposed at two ends of the plate body 11 for connecting the locking portions 12 at opposite ends of the plate body 11.
  • the fixed bone plate 10 further has a bonding portion 20 having a bone abutting surface 21, and the bonding portion 20 is disposed on the The other side of the locking portion 12.
  • the fixed bone plate 10 further includes a coupling device 30 by which the fixed bone plate 10 and the bone are fixed.
  • the plate body 111 is a curvature plate body, and the plate body 111 can be calculated by computer graphic interface calculation software, and the X, Y, and Z axial positions of the plate body 111 are calculated. And the angle range, and then the plate body 111 is fabricated by a metal laser lamination process to form the appearance of the bridge support frame.
  • the locking portion 12 at the opposite ends of the plate body 11 can be implemented as a screw hole for locking the fixed bone plate 10.
  • the bonding portion 20 can be implemented as a guide post, and the bonding portion 20 has the bone bonding surface 21, and the bone bonding surface 21 can be implemented as a curved surface.
  • the height of the bonding portion 20 and the area of the bone bonding surface 21 are calculated by a computer graphics interface operation software (such as GRASSHOPPER graphics software), and the bonding portion 20 and the bone sticker are formed by a metal laser lamination process. Face 21.
  • the fixed bone plate 10 further includes a coupling device 30 by which the bone and the fixed bone plate 10 are fixed. It is worth mentioning that the bonding device 30 can be implemented as a bone nail, the plate body 11 is made of medical grade titanium alloy material (Ti-6AI-4V), and the bonding part 20 is made of medical grade titanium alloy material (Ti -6AI-4V).
  • the body 111 can be replaced by a flat plate body, and the locking portion 12 can be replaced by an opening.
  • the fitting portion 20 can be replaced by a gasket, and the bone fitting surface 21 can be replaced with a
  • the plate body 11 can be replaced with a human body absorbable biological material, and the material of the bonding portion 20 can be replaced with a human body absorbable biological material.
  • the bonding device 30 can be replaced with a rivet or a screw, and the plate body 11 and the sticker
  • the joint 20 can be fabricated using a 3D metal printing process.
  • FIG. 6 a schematic diagram of a combination of a fixed bone plate 10 and a human skeleton of the present invention is shown.
  • the original bone is cut and adjusted, and the bone and the face are shaped by the bone plate and the bone nail.
  • the fixed bone plate 10 can be further fixed to the head bone 40 by the bone nail according to the upper and lower jaws of the bone 40 and the cheekbones on both sides, and the fixed bone plate 10 is The skeletal features are precisely aligned and firmly combined.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Surgical Instruments (AREA)
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  • Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)

Abstract

一种固定骨板，其包括板体，板体具有板身和贯穿板体的锁固部，板身连接板体相对应两端的锁固部。固定骨板还包括贴合部，贴合部具有一骨骼贴合面，贴合部设置于锁固部的另一侧。板体可采用金属激光积层工艺制造或采用3D金属打印工艺制造。固定骨板可根据骨骼形貌特征与人体骨骼精准定位且稳固结合。

Description

固定骨板 技术领域
本发明涉及一种固定骨板，尤其涉及一种用于牙科、正颚及颜面整型手术的固定骨板装置。
背景技术
正颚手术(Orthognathic surgery)是一种已知的，为了修正颚部及脸部的构造及发育问题，或为了改善睡眠中止症(sleep apnea)、颞颚关节功能障碍(TMJ disorders)、骨骼问题导致的咬合不正，或其他不易以牙齿矫正器完成的齿列矫正问题而施行的手术。通常这项手术常被用于治疗先天唇颚裂的患者。当医生为患者施行正颚手术时，原骨骼需要被切开并调整，再以骨板及骨钉接合骨骼而塑形。通常医生在手术时，时常需要使用医疗用的金属骨板、螺丝、骨钉、不锈钢线等材料，以固定及塑形患者颚部及脸部。已知的金属骨板结构并没有可完全贴合骨骼的标准产品，医生在施行手术时，锁固骨板常常需要凭借经验徒手加工以调整锁固骨板角度，造成手术时间过长，增大手术难度。由于骨板无法锁固骨骼，可能造成患者日后无法正确咬合、过度咬合、咬合失准等问题。
一种已知的台湾专利201313207，“用于组合上颚矫正之具铰炼的固定装置”，其包括：一第一足板，其包括一组构为被附接至一第一骨部分之第一足板体部；一第二足板，其包括一组构为被附接至一第二骨部分之第二足板体部；及一接合组件，其被耦合于该第一及第二足板体部之间，该接合组件包括一界定一枢转轴线之铰炼，该第一足板体部可回应于施加至该第二足板体部的一力而绕该枢转轴线相对于第二足板体部被动地旋转。前案专利是旋转铰链进而调整板体与骨骼的接合角度，但仍然无法解决现有骨板与骨骼形貌特征之间精准对位且稳固结合等问题。
一种已知的台湾专利201404364，“齿颚矫正锚定模组及其矫正板与手术导 引装置”，包括二骨钉及一矫正板，各该骨钉具有相连接之一裸露段及一植入段，该骨钉之裸露段设有一第一旋锁部、一扣合部及一第二旋锁部，该第一旋锁部与该骨钉之植入段相邻，该第一旋锁部之环周面呈非圆形，该扣合部位于该第一旋锁部及第二旋锁部之间；该矫正板具有相连接之一桥接段、一定位段及一旋扣段，该桥接段位于该定位段及旋扣段之间，该桥接段设有至少一勾套部，该定位段及旋扣段分别卡扣于该二骨钉之扣合部。该齿颚矫正锚定模组可通过手术导引装置将二骨钉锁固于颚骨的适当位置，使得矫正板搭接二骨钉。但现有专利的矫正板与骨钉无法调整骨板角度从而精准地与骨骼接合，仍有可能造成患者日后无法正确咬合、过度咬合、咬合失准等问题。
一种已知的台湾专利I398241，“牙科上颚颚骨微植体”，其由一板体及一矫正配件组成，将该板体置入矫正者口腔上颚之角化上皮组织内，再由一第一锁固组件和一第二锁固组件分别穿通过该板体两端所设之第一锁固孔及第二锁固孔，以将该板体锁固在上颚，再由一第三锁固组件穿通过该矫正配件上所设之第四锁固孔，及该板体上所设之第三锁固孔，使该矫正配件锁固在上颚。但前案专利的板体仍无法解决现有骨板与骨骼形貌特征精准对位且稳固结合等问题。
因此，有必要提出一种固定骨板，可用于牙科、正颚及颜面整型手术，且使该固定骨板可与人体骨骼形貌特征精准定位且稳固结合，以解决前述已知固定骨板技术需通过人工加工骨板或医生徒手调整锁固角度等问题。
发明内容
本发明的目的之一在于提供一种固定骨板，其可用于牙科、正颚及颜面整型手术，通过该固定骨板，可使固定骨板更进一步地贴合人体骨骼形貌特征，达到精准定位且稳固结合的效果。
本发明的目的之一在于提供一种固定骨板，其中该固定骨板的贴合部，具有一骨骼贴合面，可由计算机程序计算该骨骼贴合面，以使得该固定骨板与人体骨骼精准定位且稳固结合。
为达到上述目的，本发明提供一种固定骨板，其包括：一板体，该板体具有一板身及贯穿该板体的一锁固部，其中该板身连接该板体相对应两端的该锁固部，该板体还具有一贴合部，该贴合部设置于该锁固部的另一侧。
根据本发明的一个实施例，其中该板身为一平面板身或一曲率板身。
根据本发明的一个实施例，其中该锁固部为一开口或一螺丝孔。
根据本发明的一个实施例，其中该贴合部为一导柱或一垫片。
根据本发明的一个实施例，其中该骨骼贴合面为一平面或一曲面。
根据本发明的一个实施例，其中该板体为钛合金材质或人体可吸收生物材质。
根据本发明的一个实施例，其中该贴合部为钛合金材质或人体可吸收生物材质。
根据本发明的一个实施例，其中该固定骨板进一步包括一结合装置，该结合装置将该固定骨板固定于骨骼。
根据本发明的一个实施例，其中该结合装置为一骨钉或一铆钉或一螺丝。
根据本发明的一个实施例，其中该板体和该贴合部分别采用金属激光积层工艺制造或分别采用3D金属打印工艺制造。
附图说明
图1是本发明的固定骨板的俯视示意图。
图2是本发明的固定骨板的侧视示意图。
图3是本发明的固定骨板的仿真计算图形化软件输入参数图。
图4是本发明的固定骨板的立体示意图。
图5是本发明的固定骨板与结合装置的组合示意图。
图6是本发明的固定骨板与人体骨骼的结合示意图。
具体实施方式
以下描述用于揭露本发明以使本领域技术人员能够实现本发明。以下描述中的优选实施例只作为举例，本领域技术人员可以想到其他显而易见的变型。在以下描述中界定的本发明的基本原理可以应用于其他实施方案、变形方案、改进方案、等同方案以及没有背离本发明的精神和范围的其他技术方案。
根据本发明的一个优选实施例，本发明提供一种固定骨板10，如图1所示是该固定骨板10的俯视示意图。根据上述实施例，如图2所示，是该固定骨板10的侧视示意图。其中该固定骨板10包括一板体11，该固定骨板10具有一板 身111及贯穿该板体11的一锁固部12。该锁固部12设置于该板体11的两端，该板身111用于连接该板体11相对应两端的该锁固部12。该固定骨板10还具有一贴合部20，该贴合部20具有一骨骼贴合面21，其中该贴合部20设置于该锁固部12的另一侧。
根据上述实施例，如图2所示，该板身111为一曲率板身，可由一计算机图形化接口运算软件计算该板身111的曲度及斜率变化角度。计算机图形化接口运算软件可采用市售GRASSHOPPER图形化软件，可计算该板身111的X、Y、Z三轴向位置及角度范围。如图3所示，通过仿真计算GRASSHOPPER图形化软件计算该板身111的制造参数，采用金属激光积层工艺制造该板身111，从而形成该板身111的桥形支撑架外观。该板体11相对应两端的该锁固部12可实施为一螺丝孔，其可锁固该固定骨板10。该贴合部20可实施为一导柱，该贴合部20的该骨骼贴合面21可实施为曲面。通过计算机图形化接口运算软件(如GRASSHOPPER图形化软件)，计算该贴合部20的高度及该骨骼贴合面21的面积，再采用金属激光积层工艺形成该贴合部20及骨骼贴合面21。
根据上述实施例，如图4是本发明的固定骨板10的立体示意图。该固定骨板10包括一板体11，该固定骨板10具有一板身111及贯穿该板体11的一锁固部12。其中该锁固部12设置于该板体11两端，其中该板身111用于连接该板体11相对应两端的锁固部12。该固定骨板10还具有一贴合部20，其中该板体11材质为医疗级钛合金材质(Ti-6AI-4V)，该贴合部20材质为医疗级钛合金材质(Ti-6AI-4V)。
根据上述实施例，该板身111可替换为一平面板身，该锁固部12可替换为一开口，该贴合部20可替换为一垫片，该骨骼贴合面21可替换为一平面，该板体11可替换为人体可吸收生物材质，该贴合部20材质可替换为人体可吸收生物材质，该板体11及该贴合部20可采用3D金属打印工艺制造。
根据本发明的一个变形实施例，如图5所示，是本发明的一固定骨板10与一结合装置30的组合示意图。该固定骨板10包括一板体11，该固定骨板10具有一板身111及贯穿该板体11的一锁固部12。该锁固部12设置于该板体11的两端，该板身111用于连接该板体11相对应两端的该锁固部12。该固定骨板10还具有一贴合部20，该贴合部20具有一骨骼贴合面21，该贴合部20设置于该 锁固部12的另一侧。值得一提的是，该固定骨板10进一步包括一结合装置30，通过该结合装置30固定该固定骨板10与骨骼。
根据上述变形实施例，如图5所示，该板身111为一曲率板身，该板身111可由计算机图形化接口运算软件计算，计算该板身111的X、Y、Z三轴向位置及角度范围，再采用金属激光积层工艺制造该板身111，以形成桥形支撑架外观。该板体11相对应两端的该锁固部12可实施为一螺丝孔，可锁固该固定骨板10。该贴合部20可实施为一导柱，该贴合部20具有该骨骼贴合面21，该骨骼贴合面21可实施为曲面。通过计算机图形化接口运算软件(如GRASSHOPPER图形化软件)，计算该贴合部20的高度及该骨骼贴合面21的面积，再采用金属激光积层工艺形成该贴合部20及该骨骼贴合面21。该固定骨板10进一步包括一结合装置30，通过该结合装置30固定骨骼和该固定骨板10。值得一提的是，该结合装置30可实施为一骨钉，该板体11材质为医疗级钛合金材质(Ti-6AI-4V)，该贴合部20材质为医疗级钛合金材质(Ti-6AI-4V)。
根据上述变形实施例，该板身111可替换为一平面板身，该锁固部12可替换为一开口，该贴合部20可替换为一垫片，该骨骼贴合面21可替换为一平面，该板体11可替换为人体可吸收生物材质，该贴合部20材质可替换为人体可吸收生物材质，该结合装置30可替换为一铆钉或一螺丝，该板体11及该贴合部20可采用3D金属打印工艺制造。
根据本发明的另一个变形实施例，如图6所示，是本发明的一固定骨板10与人体骨骼的结合示意图。当医生为患者施行正颚手术时，切开并调整原骨骼，利用骨板及骨钉接合骨骼和脸部塑形。如图6所示，该固定骨板10可根据一头骨骼40的上下颚及两侧颊骨，将该固定骨板10进一步通过骨钉固定在该头骨骼40，并由该固定骨板10与骨骼形貌特征精准对位且稳固结合。
本领域的技术人员应理解，上述描述及附图中所示的本发明的实施例只作为举例而并不限制本发明。本发明的目的已经完整并有效地实现。本发明的功能及结构原理已在实施例中展示和说明，在没有背离所述原理下，本发明的实施方式可以有任何变形或修改。

Claims (10)

  1. 一种固定骨板，其特征在于，包括：
    一板体，该板体具有一板身及贯穿该板体的一锁固部，其中该板身连接该板体相对应两端的该锁固部，该板体还具有一贴合部，该贴合部设置于该锁固部的另一侧。
  2. 如权利要求1所述的一种固定骨板，其中该板身为一平面板身或一曲率板身。
  3. 如权利要求1所述的一种固定骨板，其中该锁固部为一开口或一螺丝孔。
  4. 如权利要求1所述的一种固定骨板，其中该贴合部为一导柱或一垫片。
  5. 如权利要求1所述的一种固定骨板，其中该骨骼贴合面为一平面或一曲面。
  6. 如权利要求1所述的一种固定骨板，其中该板体为钛合金材质或人体可吸收生物材质。
  7. 如权利要求1所述的一种固定骨板，其中该贴合部为钛合金材质或人体可吸收生物材质。
  8. 如权利要求1所述的一种固定骨板，其中该固定骨板进一步包括一结合装置，该结合装置将该固定骨板固定于骨骼。
  9. 如权利要求8所述的一种固定骨板，其中该结合装置为一骨钉或一铆钉或一螺丝。
  10. 如权利要求1所述的一种固定骨板，其中该板体和该贴合部分别采用金属激光积层工艺制造或分别采用3D金属打印工艺制造。
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US11707306B2 (en) 2023-07-25

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