CN114732947A - 一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法 - Google Patents

一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法 Download PDF

Info

Publication number
CN114732947A
CN114732947A CN202210532239.8A CN202210532239A CN114732947A CN 114732947 A CN114732947 A CN 114732947A CN 202210532239 A CN202210532239 A CN 202210532239A CN 114732947 A CN114732947 A CN 114732947A
Authority
CN
China
Prior art keywords
support
layer
powder
skeleton
diameter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202210532239.8A
Other languages
English (en)
Other versions
CN114732947B (zh
Inventor
徐淑波
张森
胡馨支
韩娟娟
郑伟
任国成
潘悦飞
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shandong Jianzhu University
Original Assignee
Shandong Jianzhu University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shandong Jianzhu University filed Critical Shandong Jianzhu University
Priority to CN202210532239.8A priority Critical patent/CN114732947B/zh
Publication of CN114732947A publication Critical patent/CN114732947A/zh
Application granted granted Critical
Publication of CN114732947B publication Critical patent/CN114732947B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3859—Femoral components
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/12—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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/222—Gelatin
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D 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 [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B33Y70/10—Composites of different types of material, e.g. mixtures of ceramics and polymers or mixtures of metals and biomaterials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30943—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using mathematical models
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Ceramic Engineering (AREA)
  • Civil Engineering (AREA)
  • Composite Materials (AREA)
  • Structural Engineering (AREA)
  • Geometry (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种多孔功能梯度结构支架，尤其涉及一种可定制、可降解的3D打印骨骼植入物的制备方法，本发明是根据CT扫描得到股骨中端图像数据来设计尺寸，以金属混合材料作为多孔骨骼支架材料，配套的护板采用骨骼本身所含有的羟基磷灰石混合贝壳粉等为主要原料打印，本发明打印出的多孔支架采用环状多功能梯度结构，孔隙率由外向内逐渐减小，多孔植入物的大小可根据骨骼受损情况灵活安排，适用于中、重度骨骼破损修复，同时对于骨骼破损处有良好的缓冲及保护作用，更兼有可降解、生物活性高能够很好地促进骨细胞形成的优点。

Description

一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法
技术领域
本发明涉及医疗器械技术领域，具体涉及一种可定制、多功能梯度，可降解，多孔骨骼支架植入物。
背景技术
骨骼受损在日常生活中时有发生，骨骼破损的原因有很多，例如创伤或骨骼疾病，骨骼疾病导致的骨折称为病理性骨折，日常生活中此类疾病可通过药物治疗起到一定的防治效果，生活中骨骼破损主要的原因一般有直接暴力、间接暴力引起，但当骨骼面临中大面积缺损时，使用自体骨粉或者羟基磷灰石等材料填充治疗往往效果较差，并且治疗难度大，周期长，给病人带来的痛苦巨大。
目前针对骨折临床所用的方法主要有钢板固定、外固定架固定等，但都需要后期二次手术取出，钢板固定虽然较为牢固，但在人体内容易与体液发生反应，且灵活性较低，所用钢钉对骨骼损伤较大，最重要的是钢板需要通过二次手术取出，对于患者容易造成二次伤害，外固定架固定易于微调且微创，但也会有发生伤口感染及固定松动情况发生从而损害伤周围神经组织，在治疗过程中，也存在畸形愈合和不愈合率较高的情况，治疗不当常遗留前臂旋转功能障碍。
本发明与传统骨骼愈合治疗方案不同，所用的材料均具有较高的生物活性，能够在体内自行降解的同时也能很好地适应骨骼的生物力学性能，同时支架结构采用的是功能梯度结构，通过不同的孔隙率设置可更好的为骨细胞的生长提供再生条件，与支架配套的护板可实现护板、支架、骨骼的定位与连接，同时对破损处起到很好地保护缓冲作用，防止在骨骼愈合过程中支架的转动和位移，提升愈合效果。
发明内容
本发明专利的目的是针对在股骨中端发生中、大面积骨骼缺损后无法进行自体骨治疗或治疗难度大等情况下，提供了一种具有高性能仿生结构的支架，本发明提供的支架采用梯度结构，空隙率由外往内逐渐较小，并且在制备支架材料方面采用具有较高生物相容性的原料，在保证支架力学性能的前提下拥有较高的生物活性，从而促进骨骼重生。
本发明是通过如下技术方案来实现的：用CT扫描得到股骨缺损处数据，根据CT图像建立符合股骨尺寸（直径）的支架模型，利用3D打印机将金属混合材料为原料打印多孔状骨骼植入物，将羟基磷灰石-贝壳粉-聚乳酸作为骨骼环状护板原料进行打印。其具体方案如下：
1：多功能梯度支架建模
采用CT扫描设备对双腿股骨进行扫描，获取骨骼图像数据，根据骨骼缺损处的直径、体积尺寸建立相符合的支架及环状护板模型，用UG三维制图软件设计出多功能梯度模型，将模型与健康骨骼进行比对，校验模型尺寸是否合适，有无偏差，支架采用环状多层结构设计，模型的第一层孔隙率为80%，孔径为600μm，第二层孔隙率为60%，孔径为400μm，第三层孔隙率为30%，孔径为200μm，整体支架大小的直径尺寸根据CT扫描获得的数据设定，支架第一层结构占整体结构40%的体积，第二层占整体结构的40%体积，第三层占整体结构的20%体积；环状护板模型根据受损情况可分为1-2片，每片厚度为2.00mm，每片的圆心角为120°，环状护板长度比整个骨骼破损处长30%-40%。
2.金属混合粉末的制备
采用氩气雾化法得到TC4钛合金、镁（纯度为99.9％）、锌、锶粉末，粉末直径在30-50μm之间，按质量分数为钛-60.0%, ,镁-35.0%，锌-4.0%，锶-1.0%，混合均匀后得到金属混合粉末。
3. 羟基磷灰石-贝壳粉-聚乳酸浆料制备
将直径30-50μm的羟基磷灰石粉末、天然贝壳粉和聚乳酸按质量分数比为10:9:1进行取量混合均匀后命名为材料A，将明胶、光固化树脂、液体聚丙烯酸钠盐按1:1:2混合均匀后命名为材料B，然后将材料A、B进行磁力搅拌混合至两种材料完全分散均匀。
液体聚丙烯酸钠盐，对温度变化稳定，具有固定金属离子的作用，能阻止金属离子对产品的消极作用，是一种具有多种特殊性能的表面活性剂。
4.3D技术打印多孔功能梯度支架
将预先设计好的体心立方结构支架模型导入SLM打印机中，将金属混合粉末放入供粉仓中，支架内部单元体采用体心立方形式打印，打印时激光直径为50μm，扫描速度为700mm/s，扫描间距为0.1mm，激光功率为100W，其中打印的支架第一层孔隙率为80%，孔径为600μm，支架第二层孔隙率为60%，孔径为400μm，第三层支架孔隙率为30%，孔径为200μm，最终成形具有三层的环状结构支架，取出后采用无水乙醇清洗去除部分易清除的未熔融粉末。
将打印好的环状结构支架置于由2.2%HF和20%HNO3组成的溶液中，静置5min后取出，用酒精冲洗后烘干。
接下来是环抱式片状结构打印，将模型导入光固化3D打印机中，调整位置，光固化打印机参数设置为：功率为60W，曝光时间8s，光强10000μW/cm2，层厚0.1mm，温度控制在50-55℃，打印机刮刀将浆料平铺于成型模上，紫外线投影透过料槽底部成型模，将一层截面光固化成型，如此往复逐层制。
5.支架活性培养
将胎牛血清及双抗溶液（青霉素/链霉素）按10:1混合后加入 500ml 的 α-MEM培养基中，充分混匀后得到细胞培养液，将支架和护板经环氧乙烷灭菌后，按照ISO 10993-12标准，以 0.1g/ml 的比例浸泡在上述混合均匀的α-MEM 培养基中，于细胞培养箱中浸润72小时后取出。
附图说明
图1为股骨大面积破损支架植入的正面剖视图，图中1为股骨，2为多孔功能梯度支架，3为环状护板。
图2为修复大面积骨骼缺损的多孔功能梯度支架俯视图，其中4为孔隙率为80%的第一层环状结构，5为孔隙率为60%的第二层环状结构，6为孔隙率为30%的第三层环状结构。
图3为股骨部分缺损支架植入的正面剖视图，图中7为股骨，8为多孔功能梯度支架，9为环状护板。
图4为修复部分缺损的多孔功能梯度支架俯视图，其中10为第一层环状结构，11为第二层环状结构，12为第三层环状结构。
图5为环状护板示意图，其中13为骨骼，14为环状护板，15为环状护板上的长条状螺钉槽，16为配套螺钉。
图6为体心立方结构单元体示意图，其中17为体心立方支撑杆，18为节点中心处的节点球，19为支撑杆顶端处节点球，节点球与杆连接处均有过度圆角。
具体实施方式：
第一步：骨骼支架建模，下面结合具体实例对支架尺寸进行说明：
实例1：例如患者缺损处为股骨中端重度骨折，如图1所示，股骨中端破损处直径为5cm，破损长度为5cm，破损总体积为19.625cm3。
采用CT扫描设备对双腿股骨进行扫描，获取骨骼图像数据，根据骨骼缺损出的直径、体积尺寸建立相符合的支架及环状护板模型，用UG三维制图软件设计出多功能梯度模型，将模型与健康骨骼进行比对，校验模型尺寸是否合适，有无偏差。
支架采用环状多层结构设计，多孔功能梯度支架的具体大小设计参数为：第一层多孔支架在设计时总体积为7.85 cm3，孔隙率为80%，孔径为600μm，第二层多孔支架在设计时总体积为7.85cm3，孔隙率为60%，孔径为400μm，第三层多孔支架在设计时总体积为3.925cm3，孔隙率为30%，孔径为200μm；环状护板模型分为2片，每片厚度为2.00mm，每片的圆心角为120°，护板直径为5cm，长度为 6.5-7cm。
实例2：例如患者缺损处为骨骼中端部分骨骼受损，如图3所示，股骨中端破损处直径为2cm，破损长度为5cm，破损总体积为15.7cm3。
采用CT扫描设备对双腿股骨进行扫描，获取骨骼图像数据，根据骨骼缺损出的直径、体积尺寸建立相符合的支架及环状护板模型，用UG三维制图软件设计出多功能梯度模型，将模型与健康骨骼进行比对，校验模型尺寸是否合适，有无偏差。
支架采用环状多层结构设计，多孔功能梯度支架的具体大小设计参数为：第一层多孔支架在设计时总体积为6.28cm3，孔隙率为80%，孔径为600μm，第二层多孔支架在设计时总体积为6.28cm3，孔隙率为60%，孔径为400μm，第三层多孔支架在设计时总体积为3.14cm3，孔隙率为30%，孔径为200μm；环状护板模型分为1片，每片厚度为2.00mm，每片的圆心角为120°，护板直径为5cm，长度为 6.5-7cm。
第二步：采用氩气雾化法得到钛合金、镁（纯度为99.9％）、锌、锶粉末，粉末直径在30-50μm之间，按质量分数为钛-50.0%, ,镁-45.0%，锌-4.0%，锶-1.0%，混合均匀后得到金属混合粉末。
第三步：将直径30-50μm的羟基磷灰石粉末、天然贝壳粉和聚乳酸按质量分数比为：10:9:1进行取量均匀混合，命名为材料A，将明胶、光固化树脂、液体聚丙烯酸钠盐按1:1:2均匀混合后命名为材料B，将材料A、B进行磁力搅拌混合至两种材料完全分散均匀。
第四步：将预先设计好的体心立方结构支架模型导入SLM打印机中，将金属混合粉末放入供粉仓中，支架内部单元体采用体心立方形式打印，打印时激光直径为50μm，扫描速度为700mm/s，扫描间距为0.1mm，激光功率为100W，最终成形具有三层的环状结构支架，取出后采用无水乙醇清洗去除未熔融粉末。
第五步：将打印好的环状结构支架置于由2.2%HF和20%HNO3组成的溶液中，静置5min后取出，用酒精冲洗后烘干。
第六步：将胎牛血清及双抗溶液（青霉素/链霉素）按10:1混合后加入 500ml 的α-MEM培养基中，充分混匀后得到细胞培养液，将支架和护板经环氧乙烷灭菌后，按照ISO10993-12标准，以 0.1g/ml 的比例浸泡在上述混合均匀的α-MEM 培养基中，于细胞培养箱中浸润72小时后取出。

Claims (3)

1.一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法，其特征在于用CT扫描得到股骨缺损处数据，根据CT图像建立符合股骨尺寸（直径）的支架模型，利用3D打印机将金属混合材料为原料SLM成形多孔状骨骼植入物，将羟基磷灰石-贝壳粉-聚乳酸作为骨骼环状护板原料进行光固化打印，通过该方法制得的骨骼植入物具有良好的功能梯度，不同孔隙率的设置有利于细胞在支架的流动与增殖，所述支架的具体工艺步骤为；
（a）采用CT扫描设备对双腿股骨进行扫描，获取骨骼图像数据，根据骨骼缺损出的直径、体积尺寸建立相符合的支架及环状护板模型，用UG三维制图软件设计出多功能梯度模型，将模型与健康骨骼进行比对，校验模型尺寸是否合适，有无偏差，支架采用环状多层结构设计，模型的第一层孔隙率为80%，孔径为600μm，第二层孔隙率为60%，孔径为400μm，第三层孔隙率为30%，孔径为200μm，整体支架大小的尺寸根据CT扫描获得的数据设定，支架第一层结构占整体结构40%的体积，第二层占整体结构的40%体积，第三层占整体结构的20%体积；环状护板模型分为1-2片，每片厚度为2.00mm，每片的圆心角为120°，环状护板长度比整个骨骼破损处长30%-40%；
（b）采用氩气雾化法得到TC4钛合金、镁（纯度为99.9％）、锌、锶粉末，粉末直径在30-50μm之间，按质量分数为钛-50.0%，镁-45.0%，锌-4.0%，锶-1.0%，混合均匀后得到金属混合粉末；
（c）将直径30-50μm的羟基磷灰石粉末、天然贝壳粉和聚乳酸按质量分数比为10:9:1进行取量混合均匀后命名为材料A，将明胶、光固化树脂、液体聚丙烯酸钠盐按1:1:2混合均匀后命名为材料B，然后将材料A、B进行磁力搅拌混合至两种材料完全分散均匀；
（d）将预先设计好的体心立方结构支架模型导入SLM打印机中，将金属混合粉末放入供粉仓中，支架内部单元体采用体心立方形式打印，打印时激光直径为50μm，扫描速度为700mm/s，扫描间距为0.1mm，激光功率为100W，最终成形具有三层的环状结构支架，取出后采用无水乙醇清洗去除未熔融粉末；
（e）将打印好的环状结构支架置于由2.2%HF和20%HNO3组成的溶液中，静置5min后取出，用酒精冲洗后烘干；
（f）将胎牛血清及双抗溶液（青霉素/链霉素）按10:1混合后加入 500ml 的 α-MEM培养基中，充分混匀后得到细胞培养液，将支架和护板经环氧乙烷灭菌后，按照ISO 10993-12标准，以 0.1g/ml 的比例浸泡在上述混合均匀的α-MEM 培养基中，于细胞培养箱中浸润72小时后取出。
2.根据权利要求1所述一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法，其特征在于：第一、二层骨骼支架的单元体形状为体心立方结构，在体心立方单元体的中心连接处、支撑杆顶端处均加入了节点球及过度圆角，各个单元体在连接时依靠节点球和过度圆角进行过度连接，中心处过度角半径为0.3-0.4mm，支撑杆顶部节点球与杆的连接过度角半径为0.15-0.25mm，同时第三层骨骼支架采用块状结构打印，内部设有上下联通的孔洞，孔洞直径大小为200μm，分布方式为均匀分布，第三层孔隙率为30%。
3.根据权利要求1所述一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法，其特征在于：在环状护板上距离上下两边缘5mm处均设有宽度为3-4mm宽的长条状螺钉槽，用于给钉提供装钉位置来固定护板与骨骼。
CN202210532239.8A 2022-05-17 2022-05-17 一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法 Active CN114732947B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210532239.8A CN114732947B (zh) 2022-05-17 2022-05-17 一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210532239.8A CN114732947B (zh) 2022-05-17 2022-05-17 一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法

Publications (2)

Publication Number Publication Date
CN114732947A true CN114732947A (zh) 2022-07-12
CN114732947B CN114732947B (zh) 2022-11-15

Family

ID=82285861

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210532239.8A Active CN114732947B (zh) 2022-05-17 2022-05-17 一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法

Country Status (1)

Country Link
CN (1) CN114732947B (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115517828A (zh) * 2022-09-06 2022-12-27 深圳先进技术研究院 组织工程支架的打印方法、打印系统、终端及存储介质

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190201584A1 (en) * 2018-01-02 2019-07-04 Shandong Branden Medical Device Co.,Ltd Porous bionic skull repairing material, preparation method and implement method thereof
WO2019149890A1 (en) * 2018-02-02 2019-08-08 Evonik Degussa Gmbh Functionally graded polymer knee implant for enhanced fixation, wear resistance, and mechanical properties and the fabrication thereof
CN112704555A (zh) * 2021-01-26 2021-04-27 山东建筑大学 一种可降解多孔尺骨中端骨折接骨器的制备方法
US20210316367A1 (en) * 2018-08-07 2021-10-14 Ohio State Innovation Foundation Fabrication of porous scaffolds using additive manufacturing with potential applications in bone tissue engineering

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190201584A1 (en) * 2018-01-02 2019-07-04 Shandong Branden Medical Device Co.,Ltd Porous bionic skull repairing material, preparation method and implement method thereof
WO2019149890A1 (en) * 2018-02-02 2019-08-08 Evonik Degussa Gmbh Functionally graded polymer knee implant for enhanced fixation, wear resistance, and mechanical properties and the fabrication thereof
US20210316367A1 (en) * 2018-08-07 2021-10-14 Ohio State Innovation Foundation Fabrication of porous scaffolds using additive manufacturing with potential applications in bone tissue engineering
CN112704555A (zh) * 2021-01-26 2021-04-27 山东建筑大学 一种可降解多孔尺骨中端骨折接骨器的制备方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MICHAELA FOUSOVÁ等: "Promising characteristics of gradient porosity Ti-6Al-4V alloy prepared by SLM process", 《JOURNAL OF THE MECHANICAL BEHAVIOR OF BIOMEDICAL MATERIALS》 *
夏晓光等: "功能梯度材料增材制造技术的研究进展及展望", 《材料导报》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115517828A (zh) * 2022-09-06 2022-12-27 深圳先进技术研究院 组织工程支架的打印方法、打印系统、终端及存储介质

Also Published As

Publication number Publication date
CN114732947B (zh) 2022-11-15

Similar Documents

Publication Publication Date Title
Wang et al. Black bioceramics: combining regeneration with therapy
JP6412601B2 (ja) 生体活性代用骨移植片
EP3415174B1 (en) Moldable formulations containing an oxysterol in an acellular tissue matrix
CN107185039B (zh) 一种多孔金属骨植入材料及其制备方法和应用
WO2021120353A1 (zh) 复合多孔生物陶瓷的金属假体及其制备方法
CN103961751B (zh) 多功能生物陶瓷义眼台、制备工艺及其应用
CN114732947B (zh) 一种股骨中端多孔功能梯度结构再生骨骼支架的制备方法
Uysal et al. Comparison of the biological activities of high-density porous polyethylene implants and oxidized regenerated cellulose-wrapped diced cartilage grafts
CN113749825B (zh) 一种框架式骨关节假体及其制备方法和应用
CN110916853A (zh) 一种胫骨中段重建装置及制备方法、装置模型构建方法、计算机可读存储介质、设备
CN108553691B (zh) 可注射自固化人工骨修复材料及其制备方法
RU2218895C1 (ru) Способ контурной пластики, восстановления, коррекции, устранения или замещения дефектов, повреждений или деформаций костной или хрящевой ткани и имплантат для его реализации
RU28608U1 (ru) Эндопротез из керамического материала
CN109432493A (zh) 纳米羟基磷灰石涂层多孔钛支架及其制备方法和应用
CN211561236U (zh) 一种骨缺损修复支架
RU25996U1 (ru) Имплантат для контурной пластики, восстановления, коррекции, устранения или замещения дефектов, повреждений или деформаций костной или хрящевой ткани
CN111921014B (zh) 一种地黄多糖/异种煅烧骨复合骨修复材料
CN213525691U (zh) 一种基于3d打印多孔钛合金的仿真颌骨植入物
CN210644251U (zh) 一种用于四肢大段骨缺损的3d打印管状多孔钛合金假体
TWI708621B (zh) 骨植入物材料
CN111921011A (zh) 一种包覆涂层的人工骨及制备方法
TWI708620B (zh) 骨植入物的製造方法、骨植入物
CN114848921B (zh) 一种用3d打印可再生功能梯度骨骼支架的制备方法
CN213993857U (zh) 一种基于金属橡胶的骨缺损植入体
CN211187658U (zh) 一种胫骨中段重建装置

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant