CN105534619A - 一种软骨修复补偿假体 - Google Patents

一种软骨修复补偿假体 Download PDF

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CN105534619A
CN105534619A CN201610058993.7A CN201610058993A CN105534619A CN 105534619 A CN105534619 A CN 105534619A CN 201610058993 A CN201610058993 A CN 201610058993A CN 105534619 A CN105534619 A CN 105534619A
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cartilage
compensates
repair
body part
prosthesis
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朱健
徐龙伟
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Suzhou Zhongke Biomedical Material Co., Ltd.
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Jiangsu Okani Medical Technology Co Ltd
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    • 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
    • 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
    • A61F2/28—Bones
    • 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
    • A61F2/30756—Cartilage endoprostheses
    • 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
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical

Abstract

本发明涉及一种软骨修复补偿假体，其包括软骨补偿假体部分和软骨固定假体部分，其中软骨补偿假体部分由聚醚醚酮制成，其顶部层为可与软骨关节面良好吻合的曲面，底部层为能够与软骨面相连的平面状。通过将本发明的软骨修复补偿假体植入受损软骨部位能够将干细胞吸附于其上，并在软骨形成因子作用下诱导干细胞分化为关节软骨细胞。从而为干细胞顺利分化为关节软骨细胞创造了理想的环境，加速了软骨的修复。

Description

一种软骨修复补偿假体
技术领域
本发明涉及一种软骨损伤康复器械，特别涉及一种软骨修复补偿假体。
背景技术
软骨是在人体关节内起到缓冲垫或避震器作用的“装置”，其弹性极强，覆盖和保护骨头末端，用来应付生活中跳跃、摩擦等动作。软骨在人年轻时是正常的，但随着年龄的增长，会逐渐发生退变，甚至消失。失去了软骨的保护，关节就会发生骨头与骨头之间直接的摩擦和碰撞，病人会出现关节疼痛、肿胀。同时，在骨与骨的直接摩擦刺激下，会向旁边增生形成骨刺，关节活动受到影响。
因此，针对关节软骨再生和修复方面的研究目前已经成为骨关节炎相关领域的前沿和热点，人们在修复软骨方面也做了很多尝试，目前主要有微骨折法、马赛克成形术、自体软骨细胞移植等。
微骨折手术是一种利用关节镜做的微创手术。通过关节镜，医生首先清除关节中已经钙化的软骨，然后在软骨有缺损的位置，在软骨下方的骨头上钻出小孔，令一部分骨髓和血液从孔中渗出，形成血液凝块。这种血液凝块中含有干细胞，可以从中分化形成类软骨的细胞。人体自身会将微骨折的部位当作机体损伤来应对，为患者提供新的替代性软骨。但是，这种方法形成的并非真正的关节透明软骨，而是一种类似关节软骨的性能较差的纤维组织，且术后恢复期相当长，可能需要半年到一年的时间。
自体骨软骨移植术又叫马赛克成形术，就是如镶嵌马赛克一样将不同直径的正常骨软骨复合体置于软骨缺损区。一般选择膝关节非负重区域的正常软骨及其下方骨质作为供体，取直径5～12mm、长10～20mm的柱状骨软骨复合体，清理受损的软骨面及其下方骨质，将供体置于缺损区。由于供区有限，所以采用该方法能修复的软骨缺损面积比较有限。另外，该手术操作繁琐，对人体创伤也较大。
自体软骨细胞移植(ACI)是最近才开始尝试的新方法。它是通过取患者自身的关节软骨细胞在体外进行培养和增殖，然后再植入软骨缺损区。该方法需要经过两次手术来完成：第一次手术评估软骨缺损，并取软骨细胞组织；经过大约两周的培养后，在第二次手术时再植入缺损区域。
尽管理论上该方法的前景很好，但目前其治疗效果尚有争议，该方法需要两次手术才能完成手术过程负载，对医护人员提出了较高的水平要求，因此费用也比较高昂。故而，尽管该方法在已经应用于临床，但尚未得到广泛推广。
发明内容
发明所要解决的课题
本发明的发明人针对上述技术问题提出了利用具有生物亲和性的聚醚醚酮(PEEK)材料制备软骨修复补偿假体以加速软骨细胞生长，恢复软骨组织功能。具体地，本发明通过如下技术手段解决了该问题：
根据本发明的一个具体实施方式，提供了一种软骨修复补偿假体，其包括软骨补偿假体部分和软骨固定假体部分，其中所述软骨补偿假体部分由聚醚醚酮制成，其顶部层为能够与软骨关节面良好吻合的曲面，底部层为能够与软骨面相连的平面状。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述软骨补偿假体部分侧面呈能够与软骨边缘紧密结合的圆锥台形，所述软骨固定假体部分为圆柱形或圆锥台形。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述软骨补偿假体部分与所述软骨固定假体部分形成为一体或是可装配的。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述软骨固定假体部分的侧面设置有螺纹。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述软骨补偿假体部分的锥度为6°-18°。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述软骨补偿假体部分侧面呈能够与软骨边缘紧密结合的圆锥台形，其锥度为6°-18°，所述软骨固定假体部分为锥度为3°-6°的圆锥台形。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述软骨固定假体部分由聚醚醚酮制成。以往所使用的骨钉材料多为金属制品，经常含有Mo等对人体有害的金属离子，采用聚醚醚酮有效避免了Mo等重金属离子渗入人骨骼中难以排除造成的危害。
根据本发明的一个实施例，提供了一种软骨修复补偿假体，其中，所述可装配的软骨补偿假体部分顶面由聚醚醚酮或PU材料制成。与聚醚醚酮类似，聚氨酯(PU)的各种力学性能例如刚度、弹性模量等也比较接近人体骨骼，因此与人体骨骼能够实现良好的生物相容，从而有利于关节软骨细胞的附聚生长。
发明效果
通过将本发明的软骨修复补偿假体植入受损软骨部位能够将干细胞吸附于其上，并在软骨形成因子作用下诱导干细胞分化为关节软骨细胞。从而为干细胞顺利分化为关节软骨细胞创造了理想的环境，加速了软骨的修复。
附图说明
图1为本发明的软骨修复补偿假体的一个实施方式的示意图；
图2为本发明的软骨修复补偿假体的另一个实施方式的示意图。
附图标记说明
1、软骨补偿假体部分；
2、软骨固定假体部分。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳的实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
首先参考图1，本发明的软骨修复补偿假体包括软骨补偿假体部分1和软骨固定假体部分2，该两者可成形为一体。在两者形成为一体的情况下，软骨补偿假体部分1和软骨固定假体部分2均由聚醚醚酮制成。软骨补偿假体部分1的顶部呈可与软骨关节面良好吻合的曲面，底部呈能够与软骨面相连的平面状。软骨补偿假体部分1侧面呈能够与软骨边缘紧密结合的圆锥台形，锥度为6°-18°；软骨固定假体部分2为圆柱形或圆锥台形，当该软骨固定假体部分2为圆锥台形时其锥度为3°-6°。
继续参考图1并参考图2，在本发明的软骨修复补偿假体的进一步的实施例中，软骨补偿假体部分1与软骨固定假体部分2是分别成形并可装配以进行使用的。此时，软骨补偿假体部分1与软骨固定假体部分2仍可均由聚醚醚酮制成，在该软骨固定假体部分2侧面可进一步设置有螺纹以加强固定效果。
继续参考图1和2，在本发明的软骨修复补偿假体的进一步的实施例中，当软骨补偿假体部分1与软骨固定假体部分2是分别成形的部件时，软骨补偿假体部分1的顶面还可由PU(聚氨酯)材料制成，其余部分仍均由聚醚醚酮材料制成。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。
产业上的实用性
本发明的软骨修复补偿假体植入在植入受损软骨部位之后能够将干细胞吸附于其上，并在软骨形成因子作用下诱导干细胞分化为关节软骨细胞，从而为干细胞顺利分化为关节软骨细胞创造了理想的环境，加速了软骨的修复。与其他软骨修复技术相比，本发明价格低廉，无生物毒性，使用方便等诸多优点，因此具有广阔的应用前景。

Claims (8)

1.一种软骨修复补偿假体，其特征在于，其包括软骨补偿假体部分和软骨固定假体部分，其中所述软骨补偿假体部分由聚醚醚酮制成，其顶部层为能够与软骨关节面良好吻合的曲面，底部层为能够与软骨面相连的平面状。
2.根据权利要求1所述的软骨修复补偿假体，其特征在于，所述软骨补偿假体部分侧面呈能够与软骨边缘紧密结合的圆锥台形，所述软骨固定假体部分为圆柱形或圆锥台形。
3.根据权利要求1或2所述的软骨固定假体部分，其特征在于，所述软骨补偿假体部分与所述软骨固定假体部分形成为一体或是可装配的。
4.根据权利要求1或2所述的软骨修复补偿假体，其特征在于，所述软骨固定假体部分的侧面设置有螺纹。
5.根据权利要求2所述的软骨固定假体部分，其特征在于，所述软骨补偿假体部分的锥度为6°-18°。
6.根据权利要求1所述的软骨修复补偿假体，其特征在于，所述软骨补偿假体部分侧面呈能够与软骨边缘紧密结合的圆锥台形，其锥度为6°-18°，所述软骨固定假体部分为锥度为3°-6°的圆锥台形。
7.根据权利要求2所述的软骨固定假体部分，其特征在于，所述软骨固定假体部分由聚醚醚酮制成。
8.根据权利要求3所述的软骨固定假体部分，其特征在于，所述可装配的软骨补偿假体部分顶面由聚醚醚酮或聚氨酯PU材料制成。
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CN109730812A (zh) * 2019-01-31 2019-05-10 重庆凝骄生物科技有限公司 一种局灶性软骨缺损修复体
CN111281608A (zh) * 2020-02-28 2020-06-16 北京大学第一医院 软骨缺损处修复用模块及其形成方法
CN112245069A (zh) * 2020-11-20 2021-01-22 北京爱康宜诚医疗器材有限公司 软骨假体
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CN112245069A (zh) * 2020-11-20 2021-01-22 北京爱康宜诚医疗器材有限公司 软骨假体
CN112245069B (zh) * 2020-11-20 2022-06-14 北京爱康宜诚医疗器材有限公司 软骨假体
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