CN1642497A - 外科植入物 - Google Patents

外科植入物 Download PDF

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CN1642497A
CN1642497A CNA038074761A CN03807476A CN1642497A CN 1642497 A CN1642497 A CN 1642497A CN A038074761 A CNA038074761 A CN A038074761A CN 03807476 A CN03807476 A CN 03807476A CN 1642497 A CN1642497 A CN 1642497A
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implant
cavity
entity
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bone
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CN100428920C (zh
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蒂埃里·施托尔
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Synthes USA LLC
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MARS MEDICAL TECHNOLOGY AG
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    • 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
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    • 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
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Abstract

本发明涉及一种椎间植入物形式的外科植入物(1)，具有多个用来容纳骨替代材料的空腔(2)。骨替代材料是完全人工合成的物质。因此可实现这样的优点，即，不再存在在选择天然物质的骨替代材料时传染的危险，此外，通过选用合成骨替代材料使其物理性能不再波动(孔隙度、孔隙直径、机械抗压强度)。

Description

外科植入物
本发明涉及一种按权利要求1前序部分的外科植入物，特别是椎间植入物、髓内钉或内置关节假体。
椎间植入物或其他外科植入物具有与骨构成的空腔，其在大多数情况下通过手术用骨或类似于骨的材料填充，以便能够最佳地生长(对椎间植入物，就是所谓的两个椎骨体的长合)。
以下技术是现有技术：
a)填充从患者骨盆腔上提取下来的自身固有的(autologe)骨屑；这种方式对于患者常常带来附加的发病率。
b)植入物用自身固有的骨填充，对于椎间植入物的情况，这种骨通过身体腹面的(anteriore)开口从相邻椎骨体上提取。
c)用类似于骨的材料填充植入物。这可以是天然的或完全合成的物质。在天然物质的情况下，不管是对于同种异基因(allogene)材料、还是对于异种(xenogene)材料都存在传染疾病的危险。此外，由于不同的物质特殊性及其在身体上的提取部位，骨替代材料的物理性能具有很大的波动。
现有技术的上述讨论仅仅用来说明本发明的背景，并不意味着所提到的现有技术在本申请或其优先权提出的时刻也实际发表或公知。
在这里本发明提供一种改进方法。本发明的目的是，制造一种植入物，它在其供给的形式中，以完全人工合成为基础的骨替代材料已经包含在一种复合产品形式的植入物本身内。
本发明用具有权利要求1特征的植入物实现所提出的目的。
本发明可以借助于采用完全人工合成的骨替代材料防止上面所提到的所有缺点。由此可以达到这样的优点，即，与天然物质的骨替代产品相比，由于不存在可能引起疾病的朊、病菌、病毒或细菌，故不存在传染疾病的危险。
完全人工合成的骨替代材料最好由磷酸钙，典型地由β-磷酸三钙组成。它有这样的优点，即，采用一种陶瓷，其化学计量学的成分基本上相当于人骨的成分。再者，β-磷酸三钙的降解时间既不太快也不太慢，从而不会在降解过程中形成空腔或植入物残渣。
本发明对于患者带来其他的优点。这归功于手术的简化，特别是表现在：达到
a)显著缩短手术时间；
b)缩短的麻醉时间；
c)减少患者的失血，
此外通过选择合成骨替代材料，使其物理性能(孔隙率、孔隙大小、机械抗压强度)不会出现波动。
骨替代材料既可以相应于空腔几何特征的刚性实体形式、也可以可塑性变形的可填入空腔的物质的形式存在。
在一种特别的实施形式中，植入物的空腔朝植入物的顶面或底面锥形或楔形扩大。因此填入空腔的完全人工合成的骨替代材料实体在空腔内得到牢固的压配合。
但是实体也可以用合适的固定装置，尤其是螺钉或销钉或锁紧装置固定在空腔内。
植入物可以具有一单独的空腔或许多个、通常是2至8个相互隔开的空腔。
植入物最好做成椎间植入物，但是也可以做成髓内钉或其他人造骨植入体或内置关节假体的形式。
在做成椎间植入物的一种结构中，它最好做成筐笼形，它具有一顶面和一底面，这二个面适合于用来贴合在两个相邻椎骨体的端板上。在这种情况下空腔将筐笼的顶面与底面连接。筐笼的顶面和/或底面适宜于具有一种三维构造，例如条纹、凹槽、粒结或其他突起或凹陷的形状。
植入物最好由一种透X光的材料特别是聚合物例如PEEK组成。其优点在于，可以进行长合的临床判定。
一种优选的改进结构在于，骨替代材料由一种可吸收材料，尤其是由羟基磷灰石(Hydroxylapatit)或磷酸三钙组成。这有这样的优点，即，可以通过材料的吸收长出新的骨组织，而不必强制穿过永久材料的孔隙。
由骨替代材料组成的实体最好具有至少25％、通常至少35％的孔隙率，其中至少50％的孔隙应该具有200至500微米范围内的直径。在另一种实施形式中，骨替代材料在各个孔隙之间具有连接通道，它们具有在10至500微米、尤其是200至400微米范围内的直径。
植入物的制造例如可以通过这样的方法进行，即，由完全人工合成的骨替代材料组成的相应于空腔几何形状的刚性实体压入植入物的空腔中，或者用固定装置固定于其中。按照另一种方法，将可成形的尤其是可塑造的完全人工合成的物质，尤其是以颗粒状存在的骨替代材料，装入空腔内，并以未硬化或硬化的状态保留在那里。后一种方法也适合于通过手术用骨替代材料填充空腔。
下面借助于一个实施例的局部示意图较详细地说明本发明和按本发明的改进结构。
附图表示：
图1未填充状态的植入物的透视图；
图2填充状态的植入物的透视图；
图3按图2的植入物沿III-III线的纵剖视。
图1至3中所示的植入物是一带有四个相互分开的空腔2的筐笼形椎间植入物，空腔连接着筐笼的顶面4和底面5。顶面4和底面5确定用来贴合在两个相邻椎骨体的端板上，并且局部具有粒结形状的三维构造。
如图3可见，空腔2朝植入物1的顶面4楔形或金字塔形或锥形扩大，并如图2所示，包含有几何特征相应地成形的、由完全人工合成的骨替代材料组成的实体3。实体3借助于牢固的压配合支承在空腔2内。
筐笼由PEEK组成，而实体3由多孔的羟基磷灰石组成。

Claims (19)

1.具有至少一个用来容纳骨替代材料的空腔(2)的外科植入物(1)，其特征为：骨替代材料是完全人工合成的物质。
2.按权利要求1的植入物(1)，其特征为：骨替代材料以相应于空腔(2)几何特征的刚性实体(3)的形式存在。
3.按权利要求1的植入物(1)，其特征为：骨替代材料以可塑性变形的、可填充到空腔(3)内的物质的形式存在。
4.按权利要求1至3之任一项的植入物(1)，其特征为：空腔(2)朝向植入物(1)的顶面(4)或底面(5)锥形或楔形扩大。
5.按权利要求2或4之任一项的植入物(1)，其特征为：实体(3)借助于牢固的压配合支承在空腔(2)内。
6.按权利要求2或4的植入物(1)，其特征为：实体(3)用一固定装置尤其是螺钉或销钉固定在空腔(2)内。
7.按权利要求1至6之任一项的植入物(1)，其特征为：它具有2至8个相互分开的空腔(3)。
8.按权利要求1至7之任一项的植入物(1)，其特征为：它做成椎间植入物。
9.按权利要求8的植入物(1)，其特征为：它做成筐笼形的，具有一顶面(4)和一底面(5)，这二个面适合于贴合在两相邻椎骨体的端板上。
10.按权利要求9的植入物(1)，其特征为：空腔(3)将顶面(4)与底面(5)相连。
11.按权利要求9或10的植入物(1)，其特征为：顶面(4)和/或底面(5)具有一种三维构造(6)。
12.按权利要求1至11之任一项的植入物(1)，其特征为：它由一种透X光的材料组成，尤其是由一种聚合物组成。
13.按权利要求12的植入物(1)，其特征为：聚合物是PEEK。
14.按权利要求1至13之任一项的植入物(1)，其特征为：实体(3)由一种骨替代材料组成，它至少部分由可生物吸收的材料、尤其是由羟基磷灰石或磷酸三钙组成。
15.按权利要求1至14之任一项的植入物(1)，其特征为：实体(3)由一种具有至少25％、尤其是至少35％孔隙率的骨替代材料组成。
16.按权利要求1至15之任一项的植入物(1)，其特征为：实体(3)由一种多孔的骨替代材料组成，其中至少50％的孔隙具有在200至500微米范围内的直径。
17.按权利要求1至16之任一项的植入物(1)，其特征为：实体(3)由一种在各个孔隙之间具有连接通道的骨替代材料组成，这些孔隙具有从10至500微米、尤其是从200至400微米范围内的直径。
18.用于制造按权利要求1至17之任一项的植入物的方法，其特征为：将一种相应于空腔(2)几何特征的、由完全人工合成的骨替代材料组成的刚性实体(3)压入植入物的空腔(2)中或用固定装置固定于其中。
19.用于制造按权利要求1至17之任一项的植入物的方法，其特征为：将一种可成形的尤其是可塑造的完全人工合成的物质，尤其是以颗粒状存在的骨替代材料，装入空腔(2)中。
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