CN1236736C - 经皮肤的假体 - Google Patents

经皮肤的假体 Download PDF

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Publication number
CN1236736C
CN1236736C CNB018115195A CN01811519A CN1236736C CN 1236736 C CN1236736 C CN 1236736C CN B018115195 A CNB018115195 A CN B018115195A CN 01811519 A CN01811519 A CN 01811519A CN 1236736 C CN1236736 C CN 1236736C
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CN
China
Prior art keywords
ingredient
prosthese
kind according
skin
described prosthese
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.)
Expired - Lifetime
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CNB018115195A
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English (en)
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CN1437457A (zh
Inventor
G·布伦
J·科布
A·古德施普
P·昂温
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University College London
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University College London
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Abstract

本发明涉及一种经皮肤的假体，该假体包括一个其形状能植入骨头的第一组成部分、一个用来安置在骨头和皮肤之间的第二组成部分和一个第三组成部分，该第二组成部分进行了表面处理，以促使纤维细胞增殖并附着上皮细胞，该第三组成部分用来安置在皮肤表面外部，和在使用时延伸通过皮肤或从皮肤伸出，并且有不同于第一和第二组成部分的低表面能量的外表面，该低表面能量的外表面的位于皮肤表面外部的部分可以阻止细菌粘附。

Description

经皮肤的假体
技术领域
本发明涉及一种经皮肤的假体并包括一种将一个具有经皮肤的组成部分的假体安装在病人身上的方法。
背景技术
肢体或趾的切断可能由于创伤或外科切除而发生。创伤的例子包括在机械故障中丧失手指、在交通事故中丧失肢体或由于采掘区矿山爆炸。外科切除也可能是由于心血管疾病、糖尿病和骨头或软组织上的癌性肿瘤。
在截肢后，通常安装一个外部的假体内装置，该装置通过一个皮肤界面附接在身体上。这通常涉及制造一个定做的残肢窝，用橡皮膏或夹具固定在残肢上。使用此类假体内装置产生许多缺点。例如：
(1)皮肤不是一种令人满意的能承受高载荷的结构，而在载荷下常常破裂，变成发炎和不舒服，在严重情况下生成难以治痊的褥疮。
(2)残肢形状的变化可能意味着需要新的定做的残肢窝。
(3)使用残肢窝来装入残肢通常会出汗和不舒服。
(4)在涉及关节的场合，该外部假体通常通过离附接的假体一段距离的肌肉群而活动，因此活动效率低而不自然。
发明内容
本发明的主要目的是提供一种能克服上述缺点的一部分或全部的假体。
根据本发明，提供了一种经皮肤的假体，该假体包括一个其形状能植入骨头的第一组成部分、一个用来安置在骨头和皮肤之间的第二组成部分和一个第三组成部分，该第二组成部分进行了表面处理，以促使纤维细胞增殖并附着上皮细胞，该第三组成部分用来安置在皮肤表面外部，和在使用时延伸通过皮肤或从皮肤伸出，并且有不同于第一和第二组成部分的低表面能量的外表面，该低表面能量的外表面的位于皮肤表面外部的部分可以阻止细菌粘附。
因此，本发明提供的假体是一种骨内的经皮肤的假体(ITAP)，并具有许多优点。例如，该第一组成部分直接附着在骨骼的承受载荷部分上，使得载荷通过骨头传递。这意味着病人能够对假体施加更大的力量。而且，由于骨头的附着，活动和活动的感受更为自然。此外，因为皮肤不参加从骨头到假体外面部分的载荷传递，所以皮肤表面上没有会引起发炎或不舒服的压力。
第一组成部分形成一些合适的机构，以防止该组成部分在骨头中转动，这些机构可以包括凹槽或沟或功能相似的异型表面。这些表面的形状可以做成符合该处存在的髓内腔的轮廓。而且，该第一组成部分最好进行促进骨结合的表面处理。合适的表面处理包括羟基磷灰石，这是一种水合的磷酸钙。该表面也可以形成小孔或微坑，以促进骨头和该第一组成部分之间的整体结合。在表面中形成微坑时，这些微坑的孔径可以为20至500微米，最好20至100微米。
第二组成部分延伸在骨头和上皮表面之间。该组成部分进行表面处理，以促进纤维组织向内生长。再次，该组成部分可以用羟基磷灰石或氧化铝涂层处理，而该涂层用促使上皮细胞粘附在第二组成部分上的物质处理。该组成部分也可以有一个多孔的涂层，以促使软组织向内生长。促进这种生长的物质包括促进粘连的蛋白质，如纤维结合素或层粘素。为了有助于纤维组织对第二组成部分的粘连，最好在安装假体的手续期间用手术切除皮下组织。目的是将皮肤附着在植入物上，以防止皮肤移动和在界面及其下面的真皮处分离上皮细胞的剪切力，从而防止感染进入皮肤和假体之间。
第三组成部分包括假体的外面部分，该部分具有阻止细菌粘附的低表面能量。低的表面能量可以通过用一种不粘的物质如一种金刚石状的碳、一种氟化聚合物或一种硅酮聚合物来涂敷假体的该部分而获得。
该假体可以用连接在一起的独立组成部分制成，或者两个或更多个组成部分可以整体形成并受到合适的表面处理。
该外面的组成部分最好包括一个由连接件组成的安全装置，该连接件在一个异常的载荷下如病人跌倒产生的载荷下会破裂。这将使该外面的组成部分从骨骼组成部分和经皮肤的组成部分上分离而不会损伤骨头或皮肤。一个保护髓内柱固定配置的附加特点是一个限制传递到该可以调整的固定配置上的转矩的外部装置。传递的转矩可以调整，因此，随着时间的推移，当外部组成部分与骨头结合成整体时，该传递的转矩可以增大。
在本发明的另一优选实施例中，该第二组成部分可以设置成从第一和第三组成部分向外伸出，从而增大该第二组成部分的外部表面积。该第二组成部分还可以设置通孔，这些通孔进一步增大外部表面积，并允许组织通过第二组成部分生长。这已经发现有利地便于该组成部分与纤维组织生长的整体结合。
附图说明
本发明通过附图例示，附图中：
图1和2是通过鹿角和头颅骨的一部分的示意图；
图3是表示安装在病人身上的一种按照本发明所述的经皮肤的假体的部分截面示意图；
图4是一种按照本发明所述的假体的优选实施例的与图3相比以更大尺寸比例绘制的透视图。
具体具施方式
参照附图，本发明部分地受到红鹿鹿角周围的皮肤-骨头界面的研究的激励。这是一种独特的结构，可以认为是一种经皮肤的植入物的生物模型。在动情期期间在这一年的几个时期内，鹿角大量地增加重量。组织学检查表明，当上皮层接近鹿角时，皮肤的上皮细胞层变得更薄，使得在鹿角一皮肤界面处一个上皮皮肤层只有约一个细胞的厚度。真皮紧密地附着在骨头(蒂)界面上。这种附着是通过一系列“骨纤维”(“sharpey’s fibers”)而获得的，这一系列“骨纤维”附着在真皮和骨头上，并防止不同的皮肤运动。鹿角正常情况下不会受到感染，而带有直径18至40微米的小孔的骨头结构被折入。这有助于真皮和骨头之间的界面抵抗剪切应力。这些特点示于附图的图1和2中。
本发明的假体示于图3中，并可以看作鹿角的一种人工类似物。该假体包括一个插入骨头(2)的髓内腔中的第一组成部分(1)。组成部分(1)带有纵向延伸的切削凹槽，当假体插入髓内腔时，这些凹槽接合在骨头中并防止转动。组成部分(1)的表面可以涂一层促进骨结合的物质如羟基磷灰石物质，并/或带有微坑。第二组成部分(4)从骨头端部延伸到皮肤表面。该组成部分可以是如图示的圆柱形，或者可以做成扁平的蘑茹形，从而增大使软组织可以附着在其上面的表面积。组成部分(4)受到表面处理，以促进上皮组织对植入物的附着。此类表面处理包括使表面有一个微坑结构和/或用层粘素(laminin)或纤维结合素之类的粘连蛋白质涂敷表面，这些粘连蛋白质促使纤维长入假体组成部分(4)的表面中。
在安装假体之前，最好用外科手术切除皮下组织。其次，在第二组成部分上设置一个多孔的表面，该表面促使纤维组织向内生长。涂敷该表面的合适材料包括氧化铝氧化物陶瓷和羟基磷灰石。该表面最好在受到多孔表面处理后涂敷一种促进粘连的蛋白质，例如通过用促进粘连的蛋白质的溶液喷涂该假体，通过将该假体浸入该蛋白质的浓溶液而后冷冻干燥，或者通过在植入前浸入该促进粘连的蛋白质的无菌溶液中。
在截肢和安装手续期间用外科手术切除皮下组织有助于促使皮肤附着在植入物上，从而防止皮肤上在界面处分离上皮细胞的剪切力。
假体的第三组成部分(5)通过皮肤伸出，并在其外面部分上有一个不粘的表面。合适的物质包括氟化聚合物如聚四氟乙烯、硅化聚合物和金刚石如碳。存在不粘的表面能阻止细菌附着假体并有助于防止感染。该不粘的表面可以利用化学气相沉积(CVD)技术外加在第三组成部分(5)的外面部分上。CVD的使用在用于外加一个金刚石状的碳表面的技术中是熟知的。当外加一个金刚石表面层时，如E-P-B-0545542中公开的，该方法通常涉及提供一种氢气或氧气和合适的气态碳化合物如碳氢化合物的混合物，对该气体外加能量，以便将氢离解为原子氢或将氧离解为原子氧并将碳离解为活性的碳离子、碳原子或CH基，并使这些活性的物质沉积在衬底上以形成金刚石。产生离解的能量可以以多种该技术费用的方法提供，例如通过热丝或通过微波源。一个氟化聚合物或硅酮聚合物的不粘表面可以通过使一种与该组成部分接触的单体或预聚合物产生聚合作用而外加到该第三组成部分上。
将低能表面处理外加到第三组成部分上而掩蔽假体的其余组成部分可能是方便的。而且，可以在对第三组成部分外加低能表面之后用促进粘连的蛋白质处理假体的第二组成部分，最好在外加促进粘连的蛋白质时掩蔽第三组成部分。
第三组成部分可以连接在一个人工肢体或人工趾上。例如，在取代手指或部分手指的情况下，第一组成部分可以与建立经皮肤部分的第二组成部分一起植入残留的骨头中，而第三组成部分越过切断的残肢伸出。一个人工手指或部分手指然后可以固定在该第三组成部分上。
假体可以在一步手续或两步手续中植入，在两步手续中，在附接经皮肤部分之前，将第一组成部分植入骨头中并使其能够整体结合。
图4中示出本发明的另一个优选实施例，其中，第二组成部分(4)以盘状形式沿垂直于第一和第三组成部分的向外方向伸出。该特点使第二组成部分(4)有一个大的表面积，这有利地便于第二组成部分(4)与纤维组织生长整合(integration)。也如图4中所示，可以在第二组成部分(4)的板状延伸部中设置通孔(6)，这些通孔进一步增大外部表面积，并且也允许组织通过第二组成部分生长而进一步有利于整合。虽然上面的描述参考一系列组成部分，但可以理解，每个组成部分可以是一个用单独一件材料制成的整体部分的一部分。但是，最好在第三和第二组成部分之间或第二和第一组成部分之间设置一个易碎的连接件，使得在一个高的载荷外加在该第三组成部分上或外加在附接于其上的部件上的场合，该连接件将断裂，从而保护植入的骨头不受损伤。
虽然本发明的描述特别参考提供一种假体用于取代失去的趾或肢体，但本发明也适用于通过皮肤伸出的其它假体，如牙齿植入物。

Claims (15)

1.一种经皮肤的假体，该假体包括一个其形状能植入骨头的第一组成部分、一个用来安置在骨头和皮肤之间的第二组成部分和一个第三组成部分，该第二组成部分进行了表面处理，以促使纤维细胞增殖并附着上皮细胞，该第三组成部分用来安置在皮肤表面外部，和在使用时延伸通过皮肤或从皮肤伸出，并且有不同于第一和第二组成部分的低表面能量的外表面，该低表面能量的外表面的位于皮肤表面外部的部分可以阻止细菌粘附。
2.一种按照权利要求1所述的假体，其特征在于，这些组成部分是整体形成的，并进行了不同的表面处理。
3.一种按照权利要求1所述的假体，其特征在于，该第一组成部分进行了一种促进骨生长和骨整合的表面处理。
4.一种按照权利要求1所述的假体，其特征在于，该第二组成部分有一个具有微坑的表面。
5.一种按照权利要求1所述的假体，其特征在于，该第二组成部分的表面带有蛋白质的涂层。
6.一种按照权利要求1所述的假体，其特征在于，该第二组成部分从第一和第三组成部分向外伸出。
7.一种按照权利要求6所述的假体，其特征在于，该第二组成部分具有一些通孔。
8.一种按照权利要求1所述的假体，其特征在于，该第三组成部分带有一个包含氟化聚合物或硅酮聚合物的涂层。
9.一种按照权利要求1所述的假体，其特征在于，该第三组成部分带有一个包含金刚石状碳的涂层。
10.一种按照权利要求1所述的假体，其特征在于，该第三组成部分包括一个易碎的或可以分开的连接件，该连接件使得在一个异常高的载荷施加到该假体上时一个外面的组成部分可以分开。
11.一种按照权利要求1所述的假体，其特征在于，该第三组成部分连接在一个人造肢体或趾上。
12.一种按照权利要求5所述的假体，其特征在于，所述蛋白质涂层是纤维结合素或层粘素。
13.一种按照权利要求1所述的假体，其特征在于，所述第二组成部分的表面带有水合磷酸钙涂层。
14.一种按照权利要求13所述的假体，其特征在于，所述水合磷酸钙涂层是羟基磷灰石。
15.一种按照上述权利要求中任何一项所述的假体，其特征在于，所述第三组成部分的表面能量水平是一种不粘物质即氟化聚合物或硅酮聚合物或金刚石状的碳的表面能量水平。
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