CN106163450A - 原位人造膀胱内假体 - Google Patents
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Abstract
一种原位人造膀胱内假体,包括:外壳(2),该外壳限定了用于容纳患者的尿液的封罩;所述外壳(2)由PGA纤维织物制成;两个第一连接器(3),所述两个第一连接器连接至外壳(2)并且能够连接至患者的输尿管以允许尿液进入封罩;第二连接器(4),该第二连接器连接至外壳(2)并且能够连接至患者的尿道以允许尿液从封罩流出;导液管(7),该导液管通过所述第二连接器(4)插入封罩并且该导液管包括导管(8)和与所述导管(8)流体连通的可膨胀元件(9)。
Description
技术领域
本发明涉及一种原位人造膀胱内假体。
本发明的应用在于:在患者的膀胱经受严重的、不可治愈的疾病以致危害膀胱的正确功能的情况下替换患者的膀胱。
背景技术
已知的膀胱内假体包括由不可渗透的层状硅酮膜制成的球囊外壳。
这种外壳足够刚硬以稳定地保持其形状并且是足够柔韧的以能够被手动压缩来确保将该外壳排空。
该外壳具有位于外壳的下部部分处的连接元件,以与患者的尿道连接。类似地,在顶部处定位有两个连接体以确保与输尿管连接。
这些连接是通过缝合或通过简单的互锁来实现的。
在给患者植入内假体之后,在壳体周围形成肌肉纤维组织层(非不可渗透)。以这种方式,在内假体周围形成新膀胱。
由于已知类型的内假体是永久性的,所以甚至在患者完全康复之后仍可能出现并发症。
实际上,可能发生以下情况:新膀胱会以偶发的方式或者在导液管的使用之后受到感染。
在这种情况下,合适的抗生素治疗是必要的。这样的药物在消除生物组织中滋生的细菌载量时是有效的,但是对消除人造材料——如构成外壳的人造材料——等上滋生的细菌载量具有很小的或者甚至为零的效果。
因此,不利的是,已知类型的内假体可能对抗生素治疗的有效性构成障碍。
发明内容
在本文中,本发明的技术任务是提出一种克服上述现有技术的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限制与细菌感染相关联的风险的原位人造膀胱内假体。
具体技术任务和具体目的大致通过包含所附权利要求中的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来实现。
附图说明
本发明的其他特征和优势将从下文中的关于附图所示的原位人造膀胱内假体的优选的但非排他的实施方式的非限制性的描述中变得更清楚,在附图中:
-图1是根据本发明的处于第一构型的原位人造膀胱内假体的示意图;
-图2是处于第二构型的图1中的原位人造膀胱内假体的示意图。
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。
根据示出的,内假体1包括外壳2,外壳2在其内部限定了用于容纳尿液的封罩。
两个第一连接器3连接至外壳2以能够将患者的输尿管连接至外壳2并且允许来自肾脏的尿液流动进入封罩。
类似地,第二连接器4连接至外壳2以能够将患者的尿道连接至外壳2并且允许尿液从封罩排出。
外壳2具有大致球形的形状。
更详细地,外壳2包括两个半球形帽罩件5、6,所述两个半球形帽罩件5、6在各自的边缘处例如通过缝合彼此连接。
优选地,外壳2是通过使用超轻质的线或优选地源自均聚物PGA(polyglycolideor polyglycolic acid(聚乙交酯或聚乙醇酸))纤维的单丝而获得的。PGA是一种高度生物可相容的和可再吸收的聚合物并且对尿液具有抵抗性。具体地,PGA的再吸收时间是大约一个月。
有利地,用PGA纤维来获得外壳2的织物的过程中允许在内假体1的再吸收阶段期间形成肌肉纤维组织。
此外,在再吸收期间,总是形成有也称为尿路上皮的过渡上皮层。有利地,尿路上皮层是不可渗透的,这是确保假体和正在形成的新膀胱发挥正确的功能的必要事实。
另外,一旦内假体1被插入时,外壳2的织物浸渍有血液并且特别是浸渍有血浆,这允许抗生素药物对内假体起作用。
外壳2的织物可以通过以各种方式编织PGA线来获得,从而产生针织织物、机织织物或非织造织物。
优选地,织物为针织织物,还更优选地为经编针织织物。
在这种情况下,织物具有较粗糙的表面,所述较粗糙的表面能够呈现具有足够小的网眼的网构型。
详细地,织物的纬线是这样的:织物的纬线的孔隙间隔小于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,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透性。织物的较大的粗糙度限制了纤维囊的粘附的风险。
仅通过示例,织物具有大致上介于0.3mm与0.6mm之间的厚度,该厚度更优选介于0.4mm与0.53mm之间,还更优选为大致上0.45mm。
通过示例,外壳2具有介于250cm3与625cm3之间的容积。应当考虑到,通常,在使用期间,一旦外壳2被植入时,其容积平均减小20%。
内假体1还包括插入外壳2的封罩中的导液管7。
导液管7优选为弗利类型(Foley type)。
导液管7包括导管8和连接在导管8的自由端附近的可膨胀元件9(或球囊)。
导管8与可膨胀元件9流体连通。以这种方式,通过将流体引入可膨胀元件9,可膨胀元件9膨胀(图2)。并行地,通过抽吸流体,可膨胀元件9缩瘪(图1)。
可膨胀元件9在完全展开的构型中具有介于200cm3与500cm3之间的容积。
观察到,已知的弗利类型的导液管具有最大容量不超过120cm3的可膨胀元件。
在使用(在下文将更加清楚)期间,当导液管7被插入外壳2的封罩中时,流体(例如,生理溶液)通过导管8被引入可膨胀元件9中,可膨胀元件9被扩展,可膨胀元件9扩展并支撑外壳。
详细地,可膨胀元件9在使用期间能够稳定地呈现高达最大容积的任何容积。以这种方式,可膨胀元件9可以支承任何尺寸的外壳2。实际上,外壳2的尺寸取决于待被替换的膀胱的尺寸,待被替换的膀胱的尺寸会基于患者的年龄和性别而不同。
导液管7可以由硅酮、乳胶、覆盖有乳胶或者甚至是聚氨酯的硅酮制成。
优选地,在描述的实施方式中,导液管7由聚氨酯构成。
在每种情况下,导液管7至少在外部覆盖有高度生物可相容的保护材料层。通过示例,这样的材料是具有介于0.2μm与0.3μm之间的厚度的热解乱层碳。
热解乱层碳层允许促进在尿道与PGA外壳2之间的连结点处的组织的再生。应当指定热解乱层碳层覆盖导液管7的导管8和可膨胀元件9这两者。
优选地,导液管7的导管8的自由端以倾斜的方式定形状。
导液管7优选地为双路导液管。以这种方式,允许流体从可膨胀元件9进入和流出。
导液管7也可以是三路导液管。在这种情况下,第三通路允许通过该导液管的导管8的自由端将药用物质直接地引入外壳2的封罩内,这样的药用物质包括例如抗生素。
内假体1可以设置成呈套件的形式,其中,导液管7与外壳2分开并且能够插入内假体1中。
在替代性实施方式中,内假体1包括单个外壳2和两个导液管7。
从操作的观点来看,当必须植入内假体1时,内假体1在自然膀胱被移除之后定位在患者的骨盆中。
内假体1嵌入有从外壳2引出的导液管7和松弛的外壳2。
外壳2连接至患者的输尿管,通过例如薇乔类型(Vicryl type)的可再吸收的线将患者的输尿管缝合至第一连接器3。
随后,导液管7被插入患者的尿道,其中,可展开元件9自然地缩瘪。
一旦导液管7在操作区域中从尿道退出时,导液管7通过第二连接器4插入到外壳2中。
只有在该步骤之后,患者的尿道才被连接至外壳2的第二连接器4,通过例如薇乔类型的可再吸收的线将患者的尿道缝合。
一旦完成该连接步骤,生理溶液被注入导液管7中。具体地,生理溶液被引入导管8并且被引入可展开元件9中,以使可展开元件9充胀。
详细地,可展开元件9一直充胀到最大展开构型。
使导液管7展开的该步骤通过开放的手术区域执行以允许直接地观察该操作。
实际上,外科医生检验附着在外壳2的内部的可展开元件9以使可展开元件9是圆形的或变成圆形的。
在这时,能够再次封闭手术区域。
如上所述,明显的是,外壳2内部的充胀的可展开元件9具有在再吸收步骤期间的肌肉纤维组织形成阶段期间支承外壳2本身的功能。
一旦这种肌肉纤维组织已经稳定地生长,则可以通过如下方式将导液管7移除:从可展开元件9抽出生理溶液,接着使可展开元件9缩瘪,并且将可展开元件9从尿道中移除。
如果套件包括两个导液管7,则有利地是可以在外壳2的再吸收阶段期间在中间步骤中以一个导液管7代替另一导液管。
通过示例,可以从植入内假体1起的二十天至二十五天的时间段内以第二导液管来代替第一导液管。可以从植入内假体1起的介于四十天与五十天之间的时间段内来将第二导液管7确定地移除。
在使用期间,在再生后续阶段期间,可膨胀元件9保持完全充胀约十天。接着,为期大约三天,可膨胀元件9部分地充胀以允许在可膨胀元件9与正形成的新膀胱之间形成空间。因此便于尿液的排泄,允许肾脏本身被排空。可膨胀元件9被部分地缩瘪的短暂时间不会危及可膨胀元件9的结构功能也不会使新膀胱塌陷。
可膨胀元件9的这样暂时的、局部缩瘪的操作在大约五个月的时期内每十五天重复进行一次。
考虑到外壳2的再吸收阶段是约一个月,观察到可膨胀元件的暂时的、局部缩瘪操作进一步延长四个月。这是为了避免即使是完全形成的新膀胱自身塌陷或者自身闭合的风险。
在该随后的步骤期间,需要至少每15天将弗利导液管7更换成新的无菌弗利导液管。这样描述的发明达到了预先设定的目的。
实际上,以上描述的内假体并不需要合适的永久支承结构。
因此,减少或消除了细菌载量可能向内迁移从而导致手术后的感染和并发症的机会。
由于在将导液管移除之后使得抗生素直接地作用在生物组织上,所以也增强了抗生素的有效性。
Claims (11)
1.一种原位人造膀胱内假体,包括:
-外壳(2),所述外壳(2)限定了用于容纳患者的尿液的封罩;所述外壳(2)由PGA纤维织物制成;
-两个第一连接器(3),所述两个第一连接器(3)连接至所述外壳(2)并且能够连接至患者的输尿管以允许尿液进入所述封罩;
-第二连接器(4),所述第二连接器(4)连接至所述外壳(2)并且能够连接至所述患者的尿道以允许尿液从所述封罩流出;
-导液管(7),所述导液管(7)通过所述第二连接器(4)插入所述封罩并且所述导液管(7)包括导管(8)和与所述导管(8)流体连通的可膨胀元件(9);
所述可膨胀元件(9)在完全展开的构型中具有介于200cm3与500cm3之间的容积。
2.根据权利要求1所述的内假体,其特征在于,所述导液管(7)是弗利类型的导液管。
3.根据权利要求1或2所述的内假体,其特征在于,所述导液管(7)的所述可膨胀元件(9)由聚氨酯制成。
4.根据前述权利要求中的任一项所述的内假体,其特征在于,所述导液管(7)在外部覆盖有热解乱层碳层。
5.根据前述权利要求中的任一项所述的内假体,其特征在于,所述导液管(7)包括以倾斜的方式定形状的自由端。
6.根据前述权利要求中的任一项所述的内假体,其特征在于,所述可膨胀元件(9)能够构造成稳定地呈现高达最大容积的任何预定容积。
7.根据前述权利要求中的任一项所述的内假体,其特征在于,所述外壳(2)具有大致球形的形状。
8.根据前述权利要求中的任一项所述的内假体,其特征在于,所述导液管(7)是三路导液管以填充和排空所述可膨胀元件(9)并且将液体引入所述封罩内。
9.根据前述权利要求中的任一项所述的内假体,其特征在于,所述外壳(2)包括在所述外壳(2)的边缘处连接在一起的两个半球形帽罩件。
10.根据前述权利要求中的任一项所述的内假体,其特征在于,所述外壳(2)的所述织物为经编针织型的和/或优选地为带纹理的织物。
11.一种原位人造膀胱内假体套件,包括:
-外壳(2),所述外壳(2)限定了用于容纳患者的尿液的封罩;所述外壳(2)由PGA纤维织物制成;
-两个第一连接器(3),所述两个第一连接器(3)连接至所述外壳(2)并且能够连接至患者的输尿管以允许尿液进入所述封罩;
-第二连接器(4),所述第二连接器(4)连接至所述外壳(2)并且能够连接至患者的尿道以允许尿液从所述封罩流出;
-至少一个导液管(7),所述至少一个导液管(7)能够通过所述第二连接器(4)插入所述封罩中并且包括导管(8)和与所述导管(8)流体连通的可膨胀元件(9)。
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ITMI20140694 | 2014-04-14 | ||
ITMI2014A000694 | 2014-04-14 | ||
PCT/IB2015/052535 WO2015159185A1 (en) | 2014-04-14 | 2015-04-08 | Orthotopic artificial bladder endoprosthesis |
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US (1) | US10092389B2 (zh) |
EP (1) | EP3131499A1 (zh) |
JP (1) | JP6672164B2 (zh) |
KR (1) | KR20160145015A (zh) |
CN (1) | CN106163450A (zh) |
AU (1) | AU2015248579B2 (zh) |
BR (1) | BR112016023550A2 (zh) |
CA (1) | CA2942633A1 (zh) |
EA (1) | EA031708B1 (zh) |
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IT201800006814A1 (it) * | 2018-06-29 | 2019-12-29 | Espansore per endoprotesi ortotopica di vescica artificiale | |
KR102271744B1 (ko) | 2018-07-25 | 2021-07-01 | 가톨릭대학교 산학협력단 | 생체 모사형 인공방광 및 이의 제어방법 |
KR20200062491A (ko) | 2018-11-27 | 2020-06-04 | 주식회사 에이치엘메디텍 | 인체 모사 방광 |
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IL247708B (en) | 2021-02-28 |
JP2017511183A (ja) | 2017-04-20 |
JP6672164B2 (ja) | 2020-03-25 |
EA201692022A1 (ru) | 2017-02-28 |
EA031708B1 (ru) | 2019-02-28 |
WO2015159185A1 (en) | 2015-10-22 |
MX2016012875A (es) | 2017-05-12 |
CA2942633A1 (en) | 2015-10-22 |
IL247708A0 (en) | 2016-11-30 |
AU2015248579A1 (en) | 2016-10-27 |
KR20160145015A (ko) | 2016-12-19 |
US10092389B2 (en) | 2018-10-09 |
AU2015248579B2 (en) | 2018-09-27 |
EP3131499A1 (en) | 2017-02-22 |
US20170165047A1 (en) | 2017-06-15 |
BR112016023550A2 (pt) | 2017-08-15 |
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