CN108618836A - A kind of inner fixing device for tubular bone fracture - Google Patents
A kind of inner fixing device for tubular bone fracture Download PDFInfo
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- 208000010392 Bone Fractures Diseases 0.000 title claims abstract description 46
- 229910000861 Mg alloy Inorganic materials 0.000 claims abstract description 48
- 239000011248 coating agent Substances 0.000 claims abstract description 24
- 238000000576 coating method Methods 0.000 claims abstract description 24
- 229910001069 Ti alloy Inorganic materials 0.000 claims abstract description 22
- ZQBZAOZWBKABNC-UHFFFAOYSA-N [P].[Ca] Chemical compound [P].[Ca] ZQBZAOZWBKABNC-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000000758 substrate Substances 0.000 claims abstract description 11
- 210000000988 bone and bone Anatomy 0.000 claims description 19
- MWKXCSMICWVRGW-UHFFFAOYSA-N calcium;phosphane Chemical compound P.[Ca] MWKXCSMICWVRGW-UHFFFAOYSA-N 0.000 claims description 11
- 239000011777 magnesium Substances 0.000 claims description 9
- 239000011575 calcium Substances 0.000 claims description 7
- 229910052779 Neodymium Inorganic materials 0.000 claims description 4
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 3
- 229910001093 Zr alloy Inorganic materials 0.000 claims description 3
- 229910052791 calcium Inorganic materials 0.000 claims description 3
- 239000001506 calcium phosphate Substances 0.000 claims description 3
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 3
- 229910052751 metal Inorganic materials 0.000 claims description 3
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 3
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 3
- 229940078499 tricalcium phosphate Drugs 0.000 claims description 3
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 3
- 229910052726 zirconium Inorganic materials 0.000 claims description 3
- 229910052725 zinc Inorganic materials 0.000 claims description 2
- 229910019142 PO4 Inorganic materials 0.000 claims 2
- ZNKMCMOJCDFGFT-UHFFFAOYSA-N gold titanium Chemical compound [Ti].[Au] ZNKMCMOJCDFGFT-UHFFFAOYSA-N 0.000 claims 1
- 238000010422 painting Methods 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 229910001258 titanium gold Inorganic materials 0.000 claims 1
- 239000011159 matrix material Substances 0.000 abstract description 21
- 239000007943 implant Substances 0.000 abstract description 15
- 239000000463 material Substances 0.000 abstract description 11
- 229910000831 Steel Inorganic materials 0.000 abstract description 4
- 239000010959 steel Substances 0.000 abstract description 4
- 230000007797 corrosion Effects 0.000 abstract description 3
- 238000005260 corrosion Methods 0.000 abstract description 3
- 230000002980 postoperative effect Effects 0.000 abstract 2
- 206010017076 Fracture Diseases 0.000 description 30
- 230000035876 healing Effects 0.000 description 16
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 5
- 230000008439 repair process Effects 0.000 description 5
- 241000282414 Homo sapiens Species 0.000 description 4
- 208000014674 injury Diseases 0.000 description 4
- 229910052749 magnesium Inorganic materials 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- 230000001737 promoting effect Effects 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 230000008733 trauma Effects 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 206010065687 Bone loss Diseases 0.000 description 2
- 241000283707 Capra Species 0.000 description 2
- 206010016454 Femur fracture Diseases 0.000 description 2
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 2
- 230000008827 biological function Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000002324 minimally invasive surgery Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- QEFYFXOXNSNQGX-UHFFFAOYSA-N neodymium atom Chemical compound [Nd] QEFYFXOXNSNQGX-UHFFFAOYSA-N 0.000 description 2
- 229910000392 octacalcium phosphate Inorganic materials 0.000 description 2
- 229910052698 phosphorus Inorganic materials 0.000 description 2
- 239000011574 phosphorus Substances 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- YIGWVOWKHUSYER-UHFFFAOYSA-F tetracalcium;hydrogen phosphate;diphosphate Chemical compound [Ca+2].[Ca+2].[Ca+2].[Ca+2].OP([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O YIGWVOWKHUSYER-UHFFFAOYSA-F 0.000 description 2
- 208000012260 Accidental injury Diseases 0.000 description 1
- 208000007356 Fracture Dislocation Diseases 0.000 description 1
- 206010020649 Hyperkeratosis Diseases 0.000 description 1
- 208000001132 Osteoporosis Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- QCWXUUIWCKQGHC-UHFFFAOYSA-N Zirconium Chemical compound [Zr] QCWXUUIWCKQGHC-UHFFFAOYSA-N 0.000 description 1
- 230000001464 adherent effect Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 239000008367 deionised water Substances 0.000 description 1
- 229910021641 deionized water Inorganic materials 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 210000003414 extremity Anatomy 0.000 description 1
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- 238000002513 implantation Methods 0.000 description 1
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- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 229910052761 rare earth metal Inorganic materials 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
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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
-
- 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
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- 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
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
- A61L31/086—Phosphorus-containing materials, e.g. apatite
-
- 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
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
Description
技术领域technical field
本发明属于医疗器械领域，涉及一种医疗器械装置，具体涉及一种用于管状骨骨折的内固定装置。The invention belongs to the field of medical instruments and relates to a medical instrument device, in particular to an internal fixation device for tubular bone fractures.
背景技术Background technique
随着社会文明进步和经济发展，人民生活水平日益提高，人类对自生的医疗康复事业越来越重视。交通工具大量涌现，生活节奏加快，疾病、自然灾害、事故工伤的频繁发生和局部战争等，也导致人类意外伤害剧增。目前，全世界每年约有 2500万例骨折发生，平均每人一生中会遭受两次骨折。在我国，每年发生创伤的人数约三百万，其中相当一部分骨创伤者需要进行不同程度的早期救治或晚期修复，骨组织修复材料对此有重要意义。With the advancement of social civilization and economic development, people's living standards are improving day by day, and human beings are paying more and more attention to self-generated medical rehabilitation. The emergence of a large number of means of transportation, the accelerated pace of life, the frequent occurrence of diseases, natural disasters, accidents and industrial injuries, and local wars have also led to a sharp increase in human accidental injuries. At present, about 25 million fractures occur every year in the world, and the average person suffers two fractures in their lifetime. In my country, about three million people suffer from trauma every year, and a considerable number of bone trauma patients need early treatment or late repair to varying degrees. Bone tissue repair materials are of great significance for this.
目前临床上用于管状骨骨折外科手术重建的内固定装置主要存在以下问题：1）内植物与骨骼弹性模量不匹配，植入后容易产生应力遮挡现象，加速骨量丢失的同时二次骨折的风险增加；2）内植物不具备促进骨折愈合的生物学功能，仅提供骨折愈合所需的稳定环境；3）骨折愈合后需要再次手术取出所有内植物，增加患者负担。At present, the internal fixation devices used clinically for surgical reconstruction of tubular bone fractures mainly have the following problems: 1) The elastic modulus of the implant does not match that of the bone, and stress shielding is likely to occur after implantation, which accelerates bone loss and secondary fractures 2) Implants do not have the biological function of promoting fracture healing, and only provide a stable environment for fracture healing; 3) Reoperation is required to remove all implants after fracture healing, which increases the burden on patients.
因此，需要研发一种内固定装置，其不仅能固定骨骼，还能促进骨骼愈合，提高骨折愈合后的强度，且术后不需取出。Therefore, it is necessary to develop an internal fixation device, which can not only fix the bone, but also promote bone healing, improve the strength of the fracture after healing, and does not need to be removed after the operation.
发明内容Contents of the invention
本发明的目的是解决目前用于骨折固定的内植物可能加速骨量流失，增加二次骨折，不能提供骨折愈合的稳定环境，且需再次手术取出整个内植物的不足，采用镁合金支撑基体作为内植物支撑基体，该支撑基体上设置钙磷涂层，实现骨折复位固定的同时，缩短骨折愈合时间，提升骨折愈合质量。The purpose of the present invention is to solve the disadvantages that the implants currently used for fracture fixation may accelerate bone loss, increase secondary fractures, fail to provide a stable environment for fracture healing, and require another operation to remove the entire implant. Magnesium alloy support matrix is used as The support base of the implant is provided with a calcium-phosphorus coating to achieve fracture reduction and fixation while shortening the fracture healing time and improving the quality of fracture healing.
为了达到上述目的，本发明公开了一种用于管状骨骨折的内固定装置，该内固定装置包含可降解镁合金支撑基体及固定组件，所述的固定组件包含若干钛合金螺钉，所述的支撑基体设置有若干通孔，该通孔与钛合金螺钉适配，所述的支撑基体表面负载有镁合金钙磷涂层。支撑基体固定的目的是希望患者可以进行早期的肢体功能锻炼，如果支撑基体不能够提供良好的力学支撑的话，在早期的功能锻炼过程中会出现断板，进而会导致已经复位的骨折出现错位，故而，本发明的内固定装置采用了若干力学性能良好的钛合金螺钉辅助固定。In order to achieve the above object, the present invention discloses an internal fixation device for tubular bone fractures, the internal fixation device includes a degradable magnesium alloy support matrix and a fixation component, the fixation component includes a number of titanium alloy screws, the The support base is provided with several through holes, which are adapted to titanium alloy screws, and the surface of the support base is loaded with a magnesium alloy calcium phosphorus coating. The purpose of fixing the support matrix is to hope that patients can perform early limb functional exercises. If the support matrix cannot provide good mechanical support, the plate will break during the early functional exercise, which will lead to dislocation of the fracture that has been reduced. Therefore, the internal fixation device of the present invention uses several titanium alloy screws with good mechanical properties to assist fixation.
本发明所述的镁合金钙磷涂层是指适用于镁合金基体的钙磷涂层。The magnesium alloy calcium-phosphorus coating in the present invention refers to a calcium-phosphorus coating suitable for a magnesium alloy substrate.
较佳地，所述的固定组件还包含若干与所述通孔适配的可降解镁合金螺钉，该镁合金螺钉表面负载有镁合金钙磷涂层。钙磷涂层的作用有两个：1.单纯的镁金属具有降解过快的缺点，在其表面负载了钙磷涂层以后可以明显延缓内植物的降解速度，保证其在骨折愈合之前都可以提供有效的力学支撑。2.钙磷涂层在体内释放后可以提供对骨折有益的富含钙磷的环境，更有效的促进骨折愈合。Preferably, the fixing component further includes several degradable magnesium alloy screws adapted to the through holes, and the surface of the magnesium alloy screws is loaded with magnesium alloy calcium phosphorus coating. Calcium-phosphorus coating has two functions: 1. Pure magnesium metal has the disadvantage of degrading too quickly. After the calcium-phosphorus coating is loaded on its surface, it can significantly delay the degradation rate of the implant, ensuring that it can be restored before the fracture heals. Provide effective mechanical support. 2. Calcium and phosphorus coating can provide a calcium and phosphorus-rich environment beneficial to fractures after being released in the body, and more effectively promote fracture healing.
较佳地，所述的镁合金钙磷涂层选择Ca(H2PO4)2·H2O、羟基磷灰石、磷酸三钙、磷酸八钙中的任意一种或几种的混合物。Preferably, the magnesium alloy calcium phosphorus coating is selected from any one or a mixture of Ca(H 2 PO 4 ) 2 ·H 2 O, hydroxyapatite, tricalcium phosphate, and octacalcium phosphate.
较佳地，钙磷涂层的厚度为7-9微米。该厚度对于本发明的装置是有实质性的影响的。既要保证支撑基体降解速度既不能太快，因为这样会出现在骨折愈合之前支撑基体就失去力学支撑的作用；也不能太慢因为在骨折愈合后我们期望钢板会完全降解这样就可以免除患者二次手术取出钢板的负担。Preferably, the calcium phosphorus coating has a thickness of 7-9 microns. This thickness has a substantial effect on the device of the present invention. It is necessary to ensure that the degradation rate of the support matrix cannot be too fast, because it will cause the support matrix to lose its mechanical support before the fracture heals; it should not be too slow, because we expect the steel plate to degrade completely after the fracture heals, so that patients can be exempted. The burden of taking out the steel plate in one operation.
较佳地，镁合金螺钉与钛合金螺钉交替设置。Preferably, magnesium alloy screws and titanium alloy screws are arranged alternately.
较佳地，所述的通孔包含普通螺钉孔及锁定螺钉孔。Preferably, the through holes include ordinary screw holes and locking screw holes.
较佳地，所述的镁合金螺钉通过锁定螺钉孔固定，所述的钛合金螺钉通过普通螺钉孔固定。Preferably, the magnesium alloy screws are fixed through locking screw holes, and the titanium alloy screws are fixed through ordinary screw holes.
较佳地，所述的支撑基体选择具有与管状骨贴合的弧度的骨板。Preferably, the supporting base is a bone plate with a curvature that fits the tubular bone.
较佳地，镁合金是指Mg–Nd–Zn–Zr合金。镁（Mg）为主要成分，具有可降解，促进骨修复和抗感染的生物学功能。其他元素主要是起到加强本发明的固定装置的力学强度的作用。其中，Nd(钕)是一种稀土元素，添加钕可以提高镁合金的力学强度和抗腐蚀能力。Zr(锆)可以有效地改善材料内部的晶格结构，提升材料的强度。Preferably, magnesium alloy refers to Mg—Nd—Zn—Zr alloy. Magnesium (Mg) is the main component, which has the biological functions of degradable, promoting bone repair and anti-infection. The other elements mainly serve to enhance the mechanical strength of the fixing device of the present invention. Among them, Nd (neodymium) is a rare earth element, and the addition of neodymium can improve the mechanical strength and corrosion resistance of magnesium alloys. Zr (zirconium) can effectively improve the lattice structure inside the material and increase the strength of the material.
较佳地，所述的镁合金由以下金属元素构成： 3.13%的Nd，0.164%的Zn， 0.413%的Zr，余量为Mg，以上均以重量百分数计。Preferably, the magnesium alloy is composed of the following metal elements: 3.13% of Nd, 0.164% of Zn, 0.413% of Zr, and the balance of Mg, all of which are in weight percentage.
本发明提供的一种用于管状骨骨折的内固定装置，其包含可降解内植物基体，与非可降解内植物基体两部分。该内植物基体可降解部分上设置有钙磷涂层。内植物基体支撑基体为直线型略带弧度，支撑基体上设置有若干通孔。如果支撑基体和骨体不贴服，会导致内固定不可靠，在应力过程中极易出现上述支撑基体折断，骨折错位的现象。为了契合骨折的骨体在多个方向存在的生理曲度，将支撑基体设计成具有贴合骨体的弧度设计，同时，该结构也可以更牢固的固定骨折部位。The invention provides an internal fixation device for tubular bone fractures, which comprises two parts: a degradable implant matrix and a non-degradable implant matrix. The degradable part of the implant matrix is provided with a calcium phosphorus coating. The support base of the inner plant base is straight and slightly curved, and a number of through holes are arranged on the support base. If the support matrix and the bone body are not adherent, it will lead to unreliable internal fixation, and the above-mentioned support matrix is prone to breakage and fracture dislocation during the stress process. In order to conform to the physiological curvature of the fractured bone in multiple directions, the support matrix is designed to have a curvature that fits the bone, and at the same time, this structure can also fix the fracture more firmly.
相较采用传统材料（不锈钢、钛合金）制备的内植物修复管状骨骨折，本发明设计的可降解镁合金内固定装置具有以下优势：1）镁基材料（镁合金）的弹性模量与骨质疏松症患者的骨骼完美匹配，镁材料的弹性模量为~45GPa，相较传统的内植物制作材料不锈钢（~186GPa）及钛合金（~110GPa）更加接近人体骨骼（3~20GPa），具有良好生物相容性，可以有效地降低二次骨折的风险。2）镁基材料植入体内后的降解产物Mg2+具有促进骨折愈合的作用。3）内植物可降解支撑基体表面负载的钙磷涂层在释放后可形成骨折愈合所需的富含钙磷的环境，具有促进骨折愈合的作用。4）由于单纯的镁合金力学强度不如钛合金高，因此，本发明采用钛合金螺钉、镁合金螺钉交替使用的方法，使得内固定装置拥有良好的可降解性能，同时兼顾骨折愈合过程所需要的坚强内固定强度。5）由于此内固定装置中镁合金支撑基体及镁合金螺钉均具有可降解特性，因此，术后仅需将不可降解的钛合金螺钉取出即可，所以手术创伤较全部使用传统材料要小很多，病人恢复也更快。Compared with implants made of traditional materials (stainless steel, titanium alloy) to repair tubular bone fractures, the degradable magnesium alloy internal fixation device designed by the present invention has the following advantages: 1) The elastic modulus of magnesium-based materials (magnesium alloy) is similar to that of bone The bones of patients with osteoporosis are perfectly matched. The elastic modulus of magnesium materials is ~45GPa, which is closer to human bones (3~20GPa) than traditional implant materials such as stainless steel (~186GPa) and titanium alloys (~110GPa). Good biocompatibility can effectively reduce the risk of secondary fractures. 2) Mg 2+ , the degradation product of magnesium-based materials implanted in the body, can promote fracture healing. 3) The calcium-phosphorus coating loaded on the surface of the degradable support matrix of the implant can form a calcium-phosphorus-rich environment required for fracture healing after release, and has the effect of promoting fracture healing. 4) Since the mechanical strength of pure magnesium alloy is not as high as that of titanium alloy, the present invention adopts the method of alternately using titanium alloy screws and magnesium alloy screws, so that the internal fixation device has good degradable performance, and at the same time takes into account the needs of the fracture healing process. Strong internal fixation strength. 5) Since the magnesium alloy support matrix and magnesium alloy screws in this internal fixation device have degradable properties, only the non-degradable titanium alloy screws need to be removed after surgery, so the surgical trauma is much smaller than that of all traditional materials , and the patient recovers faster.
附图说明Description of drawings
图1为本发明的一种用于管状骨骨折的内固定装置的结构示意图。FIG. 1 is a schematic structural view of an internal fixation device for tubular bone fractures according to the present invention.
图2为本发明的一种用于管状骨骨折的内固定装置用于山羊股骨骨折修复中骨折愈合X线对照（术后2周及术后1月）示意图。Fig. 2 is a schematic diagram of an internal fixation device for tubular bone fractures of the present invention used in the fracture healing of goats in the repair of femur fractures (2 weeks and 1 month after operation) in contrast to X-rays.
具体实施方式Detailed ways
以下结合附图和实施例对本发明的技术方案做进一步的说明。The technical solutions of the present invention will be further described below in conjunction with the drawings and embodiments.
如图1所示，为本发明的一种用于管状骨骨折的内固定装置，该内固定装置包含可降解镁合金支撑基体11及固定组件，所述的固定组件包含若干钛合金螺钉12及若干可降解镁合金螺钉13，所述的支撑基体设置有若干通孔（图中未示），该通孔与钛合金螺钉12、镁合金螺钉13适配，所述的支撑基体表面负载有镁合金钙磷涂层（图中未示）。As shown in Figure 1, it is an internal fixation device for tubular bone fractures according to the present invention. The internal fixation device includes a degradable magnesium alloy support base 11 and a fixation component, and the fixation component includes several titanium alloy screws 12 and A number of degradable magnesium alloy screws 13, the support base is provided with a number of through holes (not shown in the figure), the through holes are adapted to titanium alloy screws 12 and magnesium alloy screws 13, the surface of the support base is loaded with magnesium Alloy calcium phosphorus coating (not shown).
所述的通孔包含普通螺钉孔及锁定螺钉孔。所述的镁合金螺钉通过锁定螺钉孔固定，所述的钛合金螺钉通过普通螺钉孔固定。The through holes include ordinary screw holes and locking screw holes. The magnesium alloy screws are fixed through locking screw holes, and the titanium alloy screws are fixed through ordinary screw holes.
所述的支撑基体11具有与管状骨体1贴合的弧度，以契合骨折的管状骨体1。The support base 11 has a curvature that fits the tubular bone body 1 so as to fit the fractured tubular bone body 1 .
所述的镁合金钙磷涂层选择Ca(H2PO4)2·H2O、羟基磷灰石、磷酸三钙、磷酸八钙中的任意一种或几种的混合物。The magnesium alloy calcium phosphorus coating is selected from any one or a mixture of Ca(H 2 PO 4 ) 2 ·H 2 O, hydroxyapatite, tricalcium phosphate, and octacalcium phosphate.
镁合金支撑基体、镁合金螺钉表面钙磷涂层制备过程：将基体材料加工成具有特定外形的支撑基体和螺钉后，支撑基体和螺钉预先使用紫外照射3~5分钟，然后室温环境下将其浸泡在过饱和的Ca(H2PO4)2·H2O溶液中12小时。然后，采用去离子水冲洗支撑基体和螺钉表面，并在氮气环境中干燥，钙磷涂层即制备完成。较优的实施例中，钙磷涂层的厚度为7-9微米。The preparation process of magnesium alloy support matrix and calcium phosphorus coating on the surface of magnesium alloy screws: After the matrix material is processed into a support matrix and screws with a specific shape, the support matrix and screws are irradiated with ultraviolet rays for 3 to 5 minutes in advance, and then they are irradiated at room temperature. Soak in supersaturated Ca(H 2 PO 4 ) 2 ·H 2 O solution for 12 hours. Then, the surface of the supporting substrate and the screw was rinsed with deionized water, and dried in a nitrogen environment, and the calcium-phosphorus coating was prepared. In a preferred embodiment, the thickness of the calcium phosphorus coating is 7-9 microns.
所述的镁合金是指Mg–Nd–Zn–Zr合金。更优的实施例中，所述的镁合金由以下金属元素构成： 3.13%的Nd，0.164%的Zn， 0.413%的Zr，余量为Mg，以上均以重量百分数计。The magnesium alloy refers to Mg-Nd-Zn-Zr alloy. In a more preferred embodiment, the magnesium alloy is composed of the following metal elements: 3.13% Nd, 0.164% Zn, 0.413% Zr, and the balance is Mg, all of which are in weight percentage.
上述的用于管状骨骨折的内固定装置用于山羊股骨骨折修复中骨折愈合X线对照示意图如图2所示，其中，a代表术后2周的X线，b代表术后1月的X线。从X线中可以看出术后2周时骨折线仍然明显，在术后1月的时候已经形成连续的骨痂，骨折愈合速度较传统材料相比明显加快。通过微创手术取出其中的钛合金螺钉即可。The above-mentioned internal fixation device for tubular bone fractures used in goat femur fracture repair X-ray control schematic diagram of fracture healing is shown in Figure 2, wherein, a represents the X-ray at 2 weeks after operation, and b represents the X-ray at 1 month after operation. Wire. It can be seen from the X-ray that the fracture line is still obvious at 2 weeks after operation, and a continuous callus has been formed at 1 month after operation, and the fracture healing speed is significantly faster than that of traditional materials. The titanium alloy screws can be removed through minimally invasive surgery.
一些实施例中，所述的内固定装置由可降解镁合金支撑基体与若干钛合金螺钉构成，其中，支撑基体设置有钙磷涂层。术后，经X线影像评估，骨折明显愈合后，通过微创手术取出钛合金螺钉。In some embodiments, the internal fixation device is composed of a degradable magnesium alloy support base and several titanium alloy screws, wherein the support base is provided with calcium phosphorus coating. After the operation, X-ray image evaluation showed that the fracture healed obviously, and the titanium alloy screws were removed through minimally invasive surgery.
综上所述，本发明提供的用于管状骨骨折的内固定装置采用弹性模量与人体骨骼完美匹配的镁合金作为内植物支撑基体，该支撑基体还设有螺钉孔（通孔）：可降解锁定螺钉（镁合金螺钉）与医用钛合金螺钉交替位于螺钉孔中。可降解支撑基体及螺钉表面完全覆盖钙磷涂层，可以有效地降低镁合金基体材料的腐蚀速率，且本装置可降解部件术后不需取出，减小患者术后钢板取出的痛苦，应用前景良好。In summary, the internal fixation device for tubular bone fractures provided by the present invention uses a magnesium alloy whose elastic modulus perfectly matches that of human bones as the implant support base, and the support base is also provided with screw holes (through holes): Degradable locking screws (magnesium alloy screws) alternate with medical titanium alloy screws in the screw holes. The degradable support matrix and the surface of the screw are completely covered with calcium-phosphorus coating, which can effectively reduce the corrosion rate of the magnesium alloy matrix material, and the degradable parts of the device do not need to be taken out after surgery, reducing the pain of patients taking out the steel plate after surgery. Application prospects good.
尽管本发明的内容已经通过上述优选实施例作了详细介绍，但应当认识到上述的描述不应被认为是对本发明的限制。在本领域技术人员阅读了上述内容后，对于本发明的多种修改和替代都将是显而易见的。因此，本发明的保护范围应由所附的权利要求来限定。Although the content of the present invention has been described in detail through the above preferred embodiments, it should be understood that the above description should not be considered as limiting the present invention. Various modifications and alterations to the present invention will become apparent to those skilled in the art upon reading the above disclosure. Therefore, the protection scope of the present invention should be defined by the appended claims.
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