CN107072772A - 原位人造膀胱内假体 - Google Patents

原位人造膀胱内假体 Download PDF

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CN107072772A
CN107072772A CN201580053194.4A CN201580053194A CN107072772A CN 107072772 A CN107072772 A CN 107072772A CN 201580053194 A CN201580053194 A CN 201580053194A CN 107072772 A CN107072772 A CN 107072772A
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inflatable element
prosthese
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安东尼奥·桑布瑟蒂
詹尼·坎卡里尼
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Abstract

原位人造膀胱内假体，其包含：由PGA纤维织物制成的外壳(2)；所述外壳(2)具有用于与患者的输尿管连接的两个第一连接器(3)和用于与患者的尿道连接的另一连接器(4)；***所述外壳(2)中的可膨胀元件(5)；所述可膨胀元件(5)可在膨胀构型与收缩构型之间切换，在所述膨胀构型中，可膨胀元件对外壳(2)进行支撑并且使外壳(2)保持就位。

Description

原位人造膀胱内假体
技术领域
本发明涉及原位人造膀胱内假体。
本发明的应用在于：如果患者膀胱罹患严重到危害其正常功能的不可治愈的疾病，就替换患者膀胱。
背景技术
已知的膀胱内假体包含由不可渗透的层状硅酮膜制成的球囊外壳，其被由生物可相容和生物可降解材料制成的层覆盖。据了解，该生物可相容和生物可降解的覆盖材料是由PGA纤维制成的织物。
该外壳足够刚硬以稳定地保持其形状并且足够柔韧以使得能够被手动压缩来确保其排空。
该外壳具有位于外壳下部部分处的连接元件，以与患者的尿道连接。类似地，两个连接体定位在顶部处以实现与输尿管的连接。
连接体也被生物可降解材料覆盖。
在将内假体植入患者后，在外壳的覆盖物周围形成肌肉-纤维组织层或纤维囊(不可渗透)，同时生物可降解材料分解。以这种方式，在内假体周围产生新膀胱。
在再吸收期间，形成过渡上皮层，过渡上皮层也称为尿路上皮，其有利地是不可渗透的。这对于确保假体和正在形成的新膀胱的正确发挥功能至关重要。
获得这种内假体是复杂和昂贵的。
确实，必须获得由生物可相容和生物可降解材料制成的覆盖物，以便安装在硅酮外壳上。
实际上，外壳和覆盖物的正确相对定型必须极为精确。已知覆盖物还覆盖连接器。
这使得内假体的获得复杂、耗时且成本高昂。
发明内容
在本文中，本发明的技术任务是提出一种克服现有技术上述缺点的原位人造膀胱内假体。
特别地，本发明的目的是提供一种制造更为简单且更快速的原位人造膀胱内假体。
该特定技术任务和特定目的通过包含所附权利要求中一项或更多项权利要求所阐述的技术特征的原位人造膀胱内假体而基本实现。
附图说明
本发明的其他特征和优势将通过对如附图所示的原位人造膀胱内假体的优选但非排他的实施方案之示例性因而非限制性的描述而更清楚，在附图中：
-图1是根据本发明的原位人造膀胱内假体处于第一构型时的示意图；
并且
-图2是图1的内假体处于第二构型时的示意图。
具体实施方式
参照附图，附图标记1总体上指示根据本发明的原位人造膀胱内假体。
内假体1包含由PGA纤维织物制成的外壳2。
在用以获得外壳2的织物中使用的PGA(polyglycolide或polyglycolic acid，聚乙交酯或聚乙醇酸)优选为均聚物。PGA是一种高度生物可相容和可再吸收的聚合物，对尿液具有抗性。详细地说，PGA的吸收时间约为一个月。
外壳2的织物可以通过以各种方式对PGA线进行编织来获得，从而产生针织织物、织造织物或非织造织物。
优选地，外壳2的织物为针织织物，还更优选地为经编针织织物(warp knittedfabric)。
在这种情况下，外壳2的织物具有能够呈现网格足够小的网构型的较粗糙表面。
详细地，外壳2之织物的纬线使得织物的间隙小于200μm、优选地大约为160μm，从而对应于孔的大约等于0.02mm2的平均面积。这保证了尿液不渗透，从而防止泄漏。
此外，一旦***内假体1，则覆盖物被血液浸渍，特别是被血浆浸渍，这允许抗生素药物起效。
此外，外壳2的织物优选地为带纹理的，从而赋予其更大的表面粗糙度和更大的刚度和抗渗性(impermeability)。织物的较大粗糙度限制了纤维囊的粘附风险。
仅作为示例，外壳2之织物的厚度大致为0.3mm至0.6mm，更优选为0.4mm至0.53mm，还更优选大致为0.45mm。
此外，用于获得外壳织物之线的密度为50旦尼尔(denier)至200旦尼尔。
外壳2大致上呈球形并且具有第一连接器3，所述第一连接器3旨在通过可再吸收的缝合线与患者的输尿管连接。
外壳2还具有第二连接器4，所述第二连接器4旨在通过可再吸收的缝合线与患者的尿道连接。
可以通过连接两个半球形盖获得外壳2。或者，可以以单件的方式获得外壳2。
仅作为示例，外壳2的体积为300cm3至400cm3，优选地基本上等于350cm3。
内假体1还包含位于外壳2内的可膨胀元件5。
可膨胀元件5可在膨胀构型(图2)与收缩构型(图1)之间切换。
在膨胀构型中，可膨胀元件5以扩大、拉紧和可操作的构型支撑外壳2。
在与PGA外壳2之逐渐溶解同时发生的新膀胱形成所需的整个时间内保持膨胀构型。
通常，如上所述，PGA纤维溶解所需的时间约为1个月。
因此，膨胀构型中的可膨胀元件5具有外壳2的结构功能。
仅作为示例，在膨胀构型中，可膨胀元件5的体积为300cm3至400cm3，优选大致上等于350cm3。
在将内假体1植入患者体内之前存储内假体1的步骤期间，替代地选择收缩构型。此外，当外壳2溶解之后，在形成新膀胱并且必须通过例如通过膀胱造口术移除可膨胀元件5时，恢复收缩构型。
可膨胀元件5由硅酮膜构成。优选地，可膨胀元件5由多层硅酮膜构成。
仅作为示例，膜包含大致20层，每层约30μm厚。
用以获得可膨胀元件5之膜的厚度为500μm至700μm，优选地膜的厚度大致上为600μm。
可膨胀元件5具有指向密闭空间(enclosure)6的内表面5a，用于容纳填充流体。
此外，可膨胀元件5具有从内部指向外壳2的外表面5b。
有利地，可膨胀元件5的外表面5b被热解涡轮层碳(turbostratic pyrolyticcarbon)层覆盖。
热解涡轮层碳层的厚度为0.2μm至0.3μm。
在可膨胀元件5的外表面5b上涂敷碳层可以避免形成中的纤维囊可能会粘附在外壳2本身上的风险。此外，热解涡轮层碳层阻止形成尿液引起的结壳。
在外表面5b上涂敷碳层还允许保护可膨胀元件5免受由尿液引起的腐蚀。
在膨胀构型中，可膨胀元件5基本呈球形。
可膨胀元件5还具有阀7，其允许在密闭空间6的内部引入和提取填充流体。
仅作为示例，填充流体是生理溶液。
可以看出，可膨胀元件5独立于外壳2。换句话说，可膨胀元件5与外壳2完全分离。再换句话说，在外壳2与可膨胀元件5之间没有设置任何类型的连接装置。
更具体地，阀7独立于第一连接器3和/或第二连接器4。换句话说，阀7不以任何方式与第一连接器3和/或第二连接器4连接。
还可以看出，在内假体1的制造期间，将可膨胀元件5***外壳2中。
在使用期间，一旦移除患者之被例如严重疾病所危害的自然膀胱，即植入根据本发明的内假体1。
一旦已经如所述的通过可再吸收的缝合线获得与输尿管的连接，就使可膨胀元件5进入膨胀构型。为了做到这一点，外科医生例如通过适当的诊断仪器识别阀7，并且通过第二连接器4到达阀7，所述第二连接器4具有用于通过患者尿道转移生理溶液的导管。然后，外科医生接近密闭空间6并用生理溶液填充密闭空间6，直到密闭空间6以正确的方式填满为止。
一旦打开阀7并且证实可膨胀元件5的正确膨胀及其定位，就通过可再吸收的缝合线将第二连接器4固定至尿道，并将手术部位重新闭合。
就此而言，有必要等待预定的时间段以允许重建新膀胱。
在所述时间段过去之后，外科医生重新打开手术部位，并且使可膨胀元件5重新回到收缩构型。现在可膨胀元件的功能已经终止，因为已经成功形成新膀胱。
一旦可膨胀元件5收缩，外科医生切割新膀胱以进入其内部，找到现在已收缩的可膨胀元件5以便将其取出。
随后重新闭合新膀胱和手术部位，使得内假体1的植入手术结束。
此外，可以设置***患者尿道中的排尿管(未示出)。
排尿管越过患者的***，到达第二连接器4并固定在其上。排尿管的端部包含网格，以实现连接。
排尿管由硅酮制成，并且(内部和/或外部)被热解涡轮层碳层覆盖，以防止结壳。
排尿管的最小长度为15cm。
排尿管具有基本呈环形的部分。内径约为6mm，而外径约为9mm。
如此描述的本发明实现了预设目的。
实际上，在内假体的制造期间使用可膨胀元件及其在PGA外壳中的引入使得内假体本身的获得大为简化。
实际上，由可再吸收织物制成的外壳和可膨胀元件彼此独立地获得，并且不需要特定的手段和精度。

Claims (7)

1.原位人造膀胱内假体，其包含：
-外壳(2)，所述外壳(2)由PGA纤维织物制成；所述外壳(2)具有用于与患者的输尿管连接的两个第一连接器(3)和用于与患者的尿道连接的第二连接器(4)；其特征在于，所述原位人造膀胱内假体还包含
-可膨胀元件(5)，所述可膨胀元件(5)***所述外壳(2)中；所述可膨胀元件(5)可在膨胀构型与收缩构型之间切换，在所述膨胀构型中，所述可膨胀元件(5)对所述外壳(2)进行支撑并且使所述外壳(2)保持就位。
2.根据权利要求1所述的内假体，其特征在于，所述可膨胀元件(5)具有被热解涡轮层碳覆盖的外表面(5b)。
3.根据权利要求1或2所述的内假体，其特征在于，所述可膨胀元件(5)在所述膨胀构型中基本呈球形。
4.根据前述权利要求中任一项所述的内假体，其特征在于，所述可膨胀元件(5)独立于所述外壳(2)。
5.根据前述权利要求中任一项所述的内假体，其特征在于，所述可膨胀元件(5)具有用于引入和提取填充流体的阀(7)。
6.根据权利要求5所述的内假体，其特征在于，所述阀(7)独立于所述第一连接器(3)和/或所述第二连接器(4)。
7.根据前述权利要求中任一项所述的内假体，其特征在于，所述可膨胀元件(5)由多层硅酮膜构成。
CN201580053194.4A 2014-09-30 2015-09-28 原位人造膀胱内假体 Pending CN107072772A (zh)

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