WO2018113579A1 - 一种高强度可吸收骨折内固定骨螺钉 - Google Patents

一种高强度可吸收骨折内固定骨螺钉 Download PDF

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Publication number
WO2018113579A1
WO2018113579A1 PCT/CN2017/116143 CN2017116143W WO2018113579A1 WO 2018113579 A1 WO2018113579 A1 WO 2018113579A1 CN 2017116143 W CN2017116143 W CN 2017116143W WO 2018113579 A1 WO2018113579 A1 WO 2018113579A1
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Prior art keywords
bone screw
polylactic acid
internal fixation
nut
fracture internal
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PCT/CN2017/116143
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English (en)
French (fr)
Inventor
曾晨光
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兰州西脉记忆合金股份有限公司
苏州西脉新诚生物科技有限公司
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Application filed by 兰州西脉记忆合金股份有限公司, 苏州西脉新诚生物科技有限公司 filed Critical 兰州西脉记忆合金股份有限公司
Priority to US16/462,486 priority Critical patent/US11607257B2/en
Priority to CA3046716A priority patent/CA3046716C/en
Priority to EP17883541.9A priority patent/EP3530297B1/en
Publication of WO2018113579A1 publication Critical patent/WO2018113579A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A61B17/8665—Nuts
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • 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
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C71/00—After-treatment of articles without altering their shape; Apparatus therefor
    • B29C71/02—Thermal after-treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C71/00—After-treatment of articles without altering their shape; Apparatus therefor
    • B29C71/02—Thermal after-treatment
    • B29C2071/025—Quenching, i.e. rapid cooling of an object
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B29K2067/04—Polyesters derived from hydroxycarboxylic acids
    • B29K2067/046—PLA, i.e. polylactic acid or polylactide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor

Definitions

  • the invention belongs to the field of medical surgical instruments, and particularly relates to a high-strength absorbable fracture internal fixation bone screw.
  • Polylactic acid is a completely biodegradable fully degradable absorbent material, which can be degraded into lactic acid in the body and enters the tricarboxylic acid cycle.
  • the final product is CO2 and H2O. It is non-toxic and harmless to human body. It is the current medicine.
  • One of the most widely used synthetic degradable polymers It is widely used in medical fields as drug delivery materials, implant materials in vivo, surgical sutures, orthopedic internal fixation materials, and tissue engineering materials.
  • Screw internal fixation technology has been used to treat fractures for hundreds of years, from ordinary screws to screws with different pitches and screws, to hollow screws, hip screws, expansion screws, doubles. Head thread screws, locking screws, micro-screws, even some screws for specific parts (such as pedicle screws), or screws made of special materials (such as absorbable nails), can be described in a variety of ways, each change different. It can be used alone or as an essential part of any other fixed system (such as nail board system or intramedullary nail system). With the improvement of the concept and technology of fracture trauma diagnosis and treatment, the requirements for the manufacture and processing technology of internal fixation equipment are constantly updated, and the shape and function of the screws have also undergone great changes.
  • the existing bone screw is mainly made of a polylactic acid material composed of D-lactic acid and trimethylene carbonate, however, a bone screw made of a polylactic acid material composed of D-lactic acid or trimethylene carbonate is used. Due to the racemic type D, the racemic D synthesized by D-polylactic acid and D-polylactic acid (PDLA) have an amorphous structure, which has poor mechanical properties and a short degradation time, and cannot maintain sufficient time and sufficient strength in the human body. The patient's bone injury healing time is not sufficient, leaving hidden dangers.
  • PDLA D-polylactic acid and D-polylactic acid
  • the object of the present invention is to overcome the above-mentioned deficiencies of the prior art and to provide a high-strength absorbable fracture internal fixation bone screw.
  • a high-strength absorbable fracture internal fixation bone screw the bone screw is made of an oriented polylactic acid profile, and the raw material of the oriented polylactic acid profile is left-handed poly
  • the specific optical rotation of lactic acid and L-polylactic acid is -155° to -160°; the crystallinity of the profile is 45% to 85%, and the bending strength of the bone screw is 200 MPa to 450 MPa.
  • the oriented polylactic acid profile is prepared by sequentially preparing, expanding, and quenching L-polylactic acid, wherein the method of making the embryo is injection molding, and the method of orientation strengthening is forging or extrusion.
  • the temperature of the embryo is 180 ° C - 220 ° C
  • the extrusion strengthening temperature in the orientation strengthening method is 130 ° C - 180 ° C
  • the forging strengthening temperature is 160 ° C - 190 ° C
  • the quenching cooling rate The temperature is from 60 ° C / min to 140 ° C / min
  • the quenching time is from 1 min to 2 min.
  • the bone screw is made of the oriented polylactic acid profile by a turning method, a engraving method or a direct molding method.
  • the turning method uses a two-way interlocking jig to clamp both ends of the oriented polylactic acid profile and perform turning processing on the intermediate portion of the oriented polylactic acid profile.
  • the engraving method is processed using a grading clamping jig, and the oriented polylactic acid profiles are hierarchically clamped and processed.
  • the direct molding method forms the threaded bar in the mold cavity by the extrusion strengthening process by the extrusion strengthening process, and then performs turning processing or engraving processing on other parts of the bar.
  • the bone screw is composed of a nut and a screw segment, the top end of the nut is spherical, the middle portion of the nut is cylindrical, the end of the nut is chamfered, and the top end of the nut is provided with a groove.
  • the groove is one of a cross type, a flat type, and an inner hexagon type.
  • the thread of the screw segment is one of a rectangular thread, a triangular thread, a trapezoidal thread or a zigzag thread.
  • the invention provides a high-intensity absorbable fracture internal fixation bone screw, which is prepared by using oriented polylactic acid, and the oriented polylactic acid is prepared by sequentially producing L-lactic acid by making embryo, orientation strengthening and quenching;
  • the state of the polylactic acid profile is high in the strength of the bone screw made by stamping and machining. After 18-36 weeks of implantation, the implant will gradually lose its strength, ensuring that the bone does not deform during the healing process, but in 2-4 years. Bioresorption occurs in the body, and the biocompatibility is good, so that the damaged bone has sufficient healing time.
  • the high-intensity absorbable fracture internal fixation bone screw has a small attenuation rate of mechanical strength, which can ensure sufficient mechanical support during the healing period. With the degradation of the bone screw, the stress gradually shifts to the healing fracture surface, and the increase in bone density can reduce osteoporosis and have a significant effect on the fixation of cancellous bone fracture. In special cases, the size of the bone screw can be adjusted according to the osteotomy of the ankle, the degree of ankle fracture, and the growth plate characteristics of the ulna.
  • FIG. 1 is a schematic structural view of a preferred embodiment of a bone screw in a high-strength absorbable internal fixation assembly of the present invention
  • FIG. 2 is a schematic view showing a preferred embodiment of a bone screw nut tip groove in the high-strength absorbable internal fixation assembly of the present invention
  • FIG 3 is a partial schematic view of a preferred embodiment of a bone screw thread in a high strength absorbable internal fixation assembly of the present invention.
  • the invention discloses a high-intensity absorbable fracture internal fixation bone screw, wherein the bone screw is made of an oriented polylactic acid profile, and the oriented polylactic acid profile material is L-polylactic acid, and the specific rotation of the L-polylactic acid is -155. ° ⁇ -160°; the oriented polylactic acid profile is prepared from the L-polylactic acid by seeding, orientation strengthening and quenching.
  • the method of making the embryo is injection molding, the method of orientation strengthening is forging or extrusion; the crystallization of the profile The degree is 45% to 85%.
  • the temperature of the embryo in the preparation process of the oriented polylactic acid profile of the present invention is 180 ° C - 220 ° C
  • the temperature of extrusion strengthening is 130 ° C - 180 ° C
  • the temperature of forging strengthening is 160 ° C - 190 ° C
  • the quenching cooling rate is 60 ° C / min - 140 ° C / min
  • quenching time is 1 min - 2 min.
  • the present invention provides the following three processing techniques:
  • Engraving method using the graded clamping fixture, the profile is clamped, and the clip shortens the processing length and increases its stability;
  • Direct molding method the embryo material after the embryo is extruded through an extrusion strengthening process, and directly extruded into a threaded bar to form a threaded bar, and then the other parts of the bar are turned or processed.
  • the oriented state polylactic acid profile used in the invention has high strength of the bone screw produced by extrusion strengthening and machining, and the maximum bending strength in the embodiment can reach 420 MPa.
  • the mechanical strength has a small attenuation rate. After 18-36 weeks of implantation, the implant will gradually lose its strength, which can ensure sufficient mechanical support during the healing period, and bioresorption occurs in 2-4 years to ensure damage.
  • the bones have enough healing time.
  • the bone screw of the present invention is composed of a nut and a screw segment, and the length of the bone screw is 37 to 43 mm.
  • the height of the nut is 1.8-2.2mm, the diameter is 4.0-4.6mm, the radius of the spherical surface of the nut is 4.6-5.0mm, the height of the middle part of the nut is 0.6-1.0mm, and the radius of the chamfer at the end of the nut is 2.5. ⁇ 2.9mm;
  • the top surface of the nut is provided with a groove, and the groove is one of a cross type, a word type, and an inner hexagon type, the groove width is 0.2 to 0.6 mm, and the depth is 0.7 to 1.1 mm.
  • the thread of the screw segment is one of a rectangular thread, a triangular thread, a trapezoidal thread and a zigzag thread; the outer diameter of the thread is 2.6-3.0 mm, the pitch is 0.5-0.9 mm, and the vertical distance from the root of the thread to the crest is 0.1- 0.3mm, the opening angle of the adjacent two threads is 50° ⁇ 60°, and the radius of the bottom of the tooth is 0.2mm.
  • the height of the connecting portion between the upper end of the threaded portion of the screw segment and the nut is 0.6 to 1.0 mm, the diameter of the end surface of the screw end is 1.3 to 1.5 mm, and the angle of the chamfering end is 120 to 130.
  • the diameter of the screw hole on the fixed bone plate used together is smaller than the diameter of the nut, which is larger than the outer diameter of the screw thread.
  • FIG. 1 A preferred embodiment of the invention is seen in Figures 1 to 3.
  • the bone screw is composed of a nut 1 and a screw segment 2, and the length of the bone screw is preferably 40 mm.
  • the height of the nut 1 is 2 mm
  • the diameter of the nut 1 is 4.2 mm
  • the radius of the chamfer of the top surface 13 of the nut 1 is 4.8 mm
  • the height of the middle portion 11 of the nut is 0.8 mm
  • the radius of the chamfer of the end end 14 of the nut 1 is 2.7.
  • the spherical surface 13 of the nut 1 is provided with a groove 12, and the groove 12 is preferably of a cross type, and the groove 12 has a width of 0.4 mm and a depth of 0.9 mm.
  • the thread 21 of the screw segment 2 is preferably a trapezoidal thread having an outer diameter of 2.8 mm, a pitch of 0.7 mm, and a vertical distance of the thread 21 from the root 211 to the crest 212 of 0.2 mm.
  • the opening angle of the thread is 54°, and the radius of the corner of the root 211 is 0.2 mm.
  • the height of the connecting portion 3 of the upper end of the thread 21 of the screw section 2 and the nut 1 is 0.8 mm, the end surface 22 of the screw section 2 has a diameter of 1.4 mm, and the angle of the trailing end chamfer 23 is 125°.

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Abstract

一种高强度可吸收骨折内固定骨螺钉，骨螺钉采用可降解的取向态聚乳酸型材制成；取向态聚乳酸型材的原料为左旋聚乳酸，左旋聚乳酸的比旋光度为－155°～－160°；型材由左旋聚乳酸依次经过制胚、取向强化、淬火制备而成；制胚的方法为注塑，取向强化的方法为锻压或挤出；型材经车削法、精雕法或直接成型法制成骨螺钉。骨螺钉强度高，机械强度衰减率小，确保骨愈合期内的力学支持，保证损伤的骨骼有足够的愈合时间，生物相容性好，可降解吸收。

Description

一种高强度可吸收骨折内固定骨螺钉 技术领域
本发明属于医疗手术器械领域，具体涉及一种高强度可吸收骨折内固定骨螺钉。
背景技术
聚乳酸是一种具有良好生物相容性的完全可降解吸收性材料，在体内可降解成乳酸，进入三羧酸循环，最终产物是为CO2和H2O，对人体无毒无害，是当前医学上应用最多的合成可降解聚合物之一。它在医用领域中广泛应用为药物缓释材料、体内植入材料、手术缝合线、骨科内固定材料以及组织工程材料等。
人体或动物体的断骨可以通过内部固定的装置进行结合，螺钉内固定技术治疗骨折已有百年历史，从普通螺钉到不同螺距、螺杆的螺钉，再到空心螺钉、髋螺钉、膨胀钉、双头螺纹螺钉、锁定螺钉、微动螺钉，甚至到某些用于特定部位的螺钉(如椎弓根螺钉等)，或特殊材料制成的螺钉(如可吸收钉等)，可谓千姿百态，变化各异。它既可以单独使用，也可以作为配合其他各种固定系统(如钉板系统或髓内钉系统等)的必不可少装备。随着骨折创伤诊疗理念、技术的提高，对内固定器械制造、加工技术的要求也在不断更新，螺钉的形态和功能也发生了很大的变化。现有的骨螺钉主要采用由D-乳酸、三亚甲基碳酸盐组成的聚乳酸材料制成，然而，采用由D-乳酸或三亚甲基碳酸盐组成的聚乳酸材料制成的骨螺钉由于消旋型D,右旋聚乳酸合成的消旋体D,D-聚乳酸(PDLA)为无定型结构,其机械性能较差,降解时间较短，无法在人体内保持足够时间和足够强度，使患者的骨伤愈合时间不充分，留下隐患。
发明内容
本发明目的在于克服上述现有技术的不足，提供一种高强度可吸收骨折内固定骨螺钉。
为达到上述目的，本发明采用的技术方案如下：一种高强度可吸收骨折内固定骨螺钉，所述骨螺钉采用取向态聚乳酸型材制成，所述取向态聚乳酸型材的原料为左旋聚乳酸，左旋聚乳酸的比旋光度为-155°～-160°；所述型材结晶度为45％～85％，所述骨螺钉的弯曲强度为200MPa～450MPa。
优选的，所述取向态聚乳酸型材由左旋聚乳酸依次经过制胚、取向强化、淬火制备而成，其中制胚的方法为注塑，取向强化的方法为锻压或挤出。
优选的，所述制胚的温度为180℃-220℃，所述取向强化方法中的挤出强化温度为130℃-180℃，锻压强化的温度为160℃-190℃，所述淬火冷却速率为60℃/min-140℃/min，所述淬火时间为1min-2min。
优选的，所述骨螺钉由所述取向态聚乳酸型材通过车削法、精雕法或直接成型法制成。
优选的，所述车削法使用双向联动夹具，夹持所述取向态聚乳酸型材两端，对取向态聚乳酸型材中间部分进行车削加工。
优选的，所述精雕法使用分级夹持夹具加工，对所述取向态聚乳酸型材分级夹持并加工。
优选的，所述直接成型法将所述制胚后的胚材通过挤出强化工艺在模具型腔形成带螺纹的棒材，然后对棒材其他部分进行车削处理或精雕处理。
优选的，所述骨螺钉由螺帽和螺杆段组成，所述螺帽的顶端呈球面，螺帽中间部分为圆柱形，螺帽尾端有倒角；所述螺帽顶端球面设有凹槽，所述凹槽 为十字型、一字型、内六角型中的一种。
优选的，所述螺杆段的螺纹为矩形螺纹、三角形螺纹、梯形螺纹或锯齿形螺纹中的一种。
优选的，所述螺杆段的螺纹上端与所述螺帽尾端之间有连接部分，螺杆段尾端端面有倒角。
本发明的有益效果：
1、本发明提供的一种高强度可吸收骨折内固定骨螺钉，其采用取向态聚乳酸制成，取向态聚乳酸由左旋聚乳酸依次经过制胚、取向强化、淬火制备而成；采用取向态聚乳酸型材经冲压和机加工制成的骨螺钉强度高，在植入18-36周后，植入物才会逐渐失去强度，确保骨骼愈合过程中不发生变形，而在2-4年中发生生物再吸收，生物相容性好，保证损伤的骨骼有足够的愈合时间。
2、该高强度可吸收骨折内固定骨螺钉机械强度的衰减率小，可以保证愈合期内足够的力学支持。随着骨螺钉的降解，应力逐渐转移到愈合的骨折面，利用骨密度的增加，可以降低骨质疏松，对松质骨骨折的固定有显著的效果。在特殊情况下，可以根据踝的截骨术、踝关节骨折程度、尺骨的生长板特性来调整骨螺钉尺寸。
附图说明
图1是本发明高强度可吸收内固定组件中骨螺钉的优选实施例结构示意图；
图2是本发明高强度可吸收内固定组件中骨螺钉螺帽顶端凹槽优选实施例示意图；
图3是本发明高强度可吸收内固定组件中骨螺钉螺纹优选实施例局部示意图。
具体实施方式
下面结合附图对本发明的具体实施方式作进一步说明：
本发明的一种高强度可吸收骨折内固定骨螺钉，骨螺钉采用取向态聚乳酸型材制成，所述取向态聚乳酸型材的原料为左旋聚乳酸，左旋聚乳酸的比旋光度为-155°～-160°；取向态聚乳酸型材由左旋聚乳酸依次经过制胚、取向强化、淬火制备而成，其中，制胚的方法为注塑，取向强化的方法为锻压或挤出；型材的结晶度为45％～85％。
本发明的取向态聚乳酸型材制备工程中的制胚的温度为180℃-220℃，挤出强化的温度为130℃-180℃，锻压强化的温度为160℃-190℃，淬火冷却速率为60℃/min-140℃/min，淬火时间为1min-2min。
本发明的骨螺钉加工过程中由于强化得到的型材韧性高，加工难度大，效率低,为了提高加工效率及稳定性，所以本发明提供了以下三种加工工艺：
车削法：使用双向联动夹具，夹持所述型材两端，对型材中间部分进行车削加工，防止加工过程中抖动；
精雕法：使用分级夹持夹具，对型材分级夹持，夹缩短加工长度，增加其稳定性；
直接成型法：将制胚后的胚材通过挤出强化工艺，在模具型腔直接挤出形成带螺纹的棒材，然后对棒材其他部分进行车削加工处理或精雕处理。
本发明采用的取向态聚乳酸型材经挤出强化和机加工制成的骨螺钉强度高，在本实施例中弯曲强度最大值可达到420MPa。其机械强度的衰减率小，在植入18-36周后，植入物才会逐渐失去强度，可以保证愈合期内足够的力学支持，而在2-4年中发生生物再吸收，保证损伤的骨骼有足够的愈合时间。
本发明的骨螺钉由螺帽和螺杆段组成，骨螺钉长度为37～43mm。螺帽高度 为1.8～2.2mm，直径为4.0～4.6mm，螺帽的顶端球面倒角半径为4.6～5.0mm，螺帽中间部分高度为0.6～1.0mm，螺帽尾端的倒角半径为2.5～2.9mm；螺帽顶端球面设有凹槽，凹槽为十字型、一字型、内六角型中的一种，凹槽宽度为0.2～0.6mm，深度为0.7～1.1mm。螺杆段的螺纹为矩形螺纹、三角形螺纹、梯形螺纹和锯齿形螺纹中的一种；螺纹外径为2.6～3.0mm，螺距为0.5～0.9mm，螺纹牙底到牙顶的垂直距离为0.1～0.3mm，相邻两螺纹牙的开口角度为50°～60°，牙底圆角半径为0.2mm。螺杆段的螺纹上端与所述螺帽的连接部分高度为0.6～1.0mm，螺杆段尾端端面直径为1.3～1.5mm，尾端倒角角度为120°～130°。配合使用的固定骨板上的螺钉孔直径小于螺帽的直径，大于螺杆螺纹外径。
本发明的一个优选方案参见图1至图3。
参见图1，本实施例中骨螺钉由螺帽1和螺杆段2组成，骨螺钉长度优选为40mm。螺帽1高度为2mm，螺帽1直径为4.2mm，螺帽1顶端球面13的倒角半径为4.8mm，螺帽中间部分11高度为0.8mm，螺帽1尾端14的倒角半径2.7mm；参见图1和图2，螺帽1顶端球面13设有凹槽12，凹槽12优选为十字型，凹槽12宽度为0.4mm，深度为0.9mm。参见图1和图3，螺杆段2的螺纹21优选为梯形螺纹，螺纹21外径为2.8mm，螺距为0.7mm，螺纹21牙底211到牙顶212的垂直距离为0.2mm，相邻两螺牙的开口角度为54°，牙底211的圆角半径为0.2mm。螺杆段2的螺纹21上端与螺帽1的连接部分3高度为0.8mm，螺杆段2尾端端面22直径为1.4mm，尾端倒角23角度为125°。
根据上述说明书的揭示和教导，本发明所属领域的技术人员还可以对上述实施方式进行变更和修改。因此，本发明并不局限于上面揭示和描述的具体实施方式，对发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。此 外，尽管本说明书中使用了一些特定的术语，但这些术语只是为了方便说明，并不对本发明构成任何限制。

Claims (10)

  1. 一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述骨螺钉采用取向态聚乳酸型材制成，所述取向态聚乳酸型材的原料为左旋聚乳酸，左旋聚乳酸的比旋光度为-155°～-160°；所述型材结晶度为45％～85％，所述骨螺钉的弯曲强度为200MPa～450MPa。
  2. 根据权利要求1所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述取向态聚乳酸型材由左旋聚乳酸依次经过制胚、取向强化、淬火制备而成，其中制胚的方法为注塑，取向强化的方法为锻压或挤出。
  3. 根据权利要求2所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述制胚的温度为180℃-220℃，所述取向强化方法中的挤出强化温度为130℃-180℃，锻压强化的温度为160℃-190℃，所述淬火冷却速率为60℃/min-140℃/min，所述淬火时间为1min-2min。
  4. 根据权利要求1所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述骨螺钉通过车削法、精雕法或直接成型法制成。
  5. 根据权利要求4所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述车削法使用双向联动夹具，夹持所述取向态聚乳酸型材两端，对取向态聚乳酸型材中间部分进行车削加工。
  6. 根据权利要求4所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述精雕法使用分级夹持夹具加工，对所述取向态聚乳酸型材分级夹持并加工。
  7. 根据权利要求2或4所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述直接成型法将所述制胚后的胚材通过挤出强化工艺在模具型腔直接形成带螺纹的棒材，然后对棒材其他部分进行车削处理或精雕处理。
  8. 根据权利要求1所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于， 所述骨螺钉由螺帽和螺杆段组成，所述螺帽的顶端呈球面，螺帽中间部分为圆柱形，螺帽尾端有倒角；所述螺帽顶端球面设有凹槽，所述凹槽为十字型、一字型、内六角型中的一种。
  9. 根据权利要求8所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述螺杆段的螺纹为矩形螺纹、三角形螺纹、梯形螺纹或锯齿形螺纹中的一种。
  10. 据权利要求8或9所述的一种高强度可吸收骨折内固定骨螺钉，其特征在于，所述螺杆段的螺纹上端与所述螺帽尾端之间有连接部分，螺杆段尾端端面有倒角。
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