CN106456306B - 人造括约肌 - Google Patents

人造括约肌 Download PDF

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CN106456306B
CN106456306B CN201580033873.5A CN201580033873A CN106456306B CN 106456306 B CN106456306 B CN 106456306B CN 201580033873 A CN201580033873 A CN 201580033873A CN 106456306 B CN106456306 B CN 106456306B
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安东尼奥·桑布瑟蒂
詹尼·坎卡里尼
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Abstract

人造括约肌包含彼此相关联的并且是中空的以用于容纳加压流体的至少两个元件(2)；所述元件(2)适于布置在患者尿道的侧面并且呈大致半锥形；每个元件(2)均具有大致半筒形的与尿道的接触表面(3)。

Description

人造括约肌
技术领域
本发明的目的是人造括约肌。
特别地，本发明可以应用于调节患者泌尿器官中的尿流。
背景技术
根据现有技术，人造括约肌包含布置在患者的紧靠膀胱下游的尿道周围的两个中空球部。
球部充注有生理溶液，以便在尿道上以确保尿道密封的方式施加压力，从而防止尿液流出，直到达到特定的尿压。当由尿液施加在尿道上的压力超过由括约肌施加在尿道上的压力时，尿液流出。
球部内生理溶液的压力可以经由增加或减少通过可从患者体外触及的两个输入导管引入的液体量来调节。
US 4,587,955、US 2010/312052和US 2012/123195中可以看到还能够用于治疗括约肌病症的装置的实例。
US 4,587,955公开了用于将人造括约肌装置紧固在身体内的机械闩锁，并且更具体地，公开了将带围绕人造括约肌的可膨胀封套部紧固的机械闩锁；不利的是，该技术方案没有产生最佳结果。事实上，两个球部不能长时间保持在指定位置中。当被以这种方式移动时，两个球部确定了与患者尿道的非理想接触，并且不确保期望的密封。
替代性地，US 2010/312052中公开了解剖增强装置，所述解剖增强装置构造成增强人体的管状构件；根据所述技术方案，使用可缠绕在尿道周围的环，该环也能够充注有生理溶液。在这种情况下，环内的压力同样可以通过从外部调节引入环本身的液体量来调节。
然而，这种技术方案一点也不令人满意。事实上，环逐渐趋于硬化，从而丧失必要的密封，并且由此丧失环的功能。
US 2012/123195公开了胃带，所述胃带还适合用于治疗大便失禁或尿失禁。
发明内容
在本文中，本发明潜在的技术任务是提出克服上述现有技术的缺点的人造括约肌。
特别地，本发明的目的是提供随着时间有效且可靠的人造括约肌。
通过包含所附权利要求中的一项或更多项中阐述的技术特征的人造括约肌基本上实现了所指定的技术任务和所指定的目的。
附图说明
本发明的其它特征和优点将通过对附图中所示的人造括约肌的优选但非排他的实施方案的示例性且因此非限制性的描述而更加清楚，在附图中：
-图1是根据本发明的人造括约肌的立体图；
-图2是图1的人造括约肌沿截面II-II的侧视截面图；
-图3是图1的人造括约肌的平面图；以及
-图4是图1的人造括约肌根据不同角度的立体图。
具体实施方式
参照附图，附图标记1总体上表示根据本发明的人造括约肌。
括约肌1包含相互面对并彼此连接的等效的两个元件2。元件2沿着延伸轴线“A”呈细长形式。
元件2内部中空，以允许容纳加压流体。例如，流体是生理溶液。
元件2沿着尿道布置，并且更确切地布置在尿道的相对侧面。
更详细地，彼此连接的元件2在使用期间布置成使得相应的第一端2a的位置靠近膀胱并且相应的第二端2b在远端位置。
每个元件2均具有大致半筒形的相应接触表面3以用于与尿道的相对侧面接触。
有利地，以这种方式，元件2与尿道之间的接触在宽的表面上进行。因此，元件2的作用得到改善，并且与尿道的联接明显变得稳定。
详细地，元件2通过接触表面3在患者的尿道上施加从第一端2a向第二端2b降低的压力。
换句话说，元件2在靠近膀胱处，此处由尿液施加的压力较大，施加较大压力，并且在远离膀胱处施加较小压力，与来自尿液的压力沿着尿道递减相一致。
这允许沿着与元件2接触的尿道长度施加最佳压力。
根据上述内容，每个元件2均呈大致半锥形。
详细地，每个元件2均具有平整表面4和面向平整表面4的半锥形表面5。沿着每个沿着轴线“A”的平整表面4的整个长度获得接触表面3。事实上，每个平整表面5均由接触表面3分成两部分。
同样平整的基部表面6使元件2完整。
以这种方式，每个元件2均在纵向延伸轴线“A”处具有面积从第一端2a向第二端2b减小的截面。
人造括约肌1还包含与相应元件2相关联的两个导管7。
如上所述，元件2是中空的，并且在元件2的内部限定了用于容纳加压流体的腔8，所述加压流体优选地是生理溶液。
导管7与相应的腔8流体连通，以便能够将生理溶液引入腔8中以及抽出腔8中的生理溶液，并且以这种方式调节流体施加的压力。
在使用期间，当将人造括约肌1安装在患者体内时，导管7的未连接至元件2的端部在患者自身体外，使得还可以随后对生理溶液的压力进行调节。
元件2由生物相容性材料制成。优选地，元件2由硅酮制成。替代性地，元件2可以由聚砜、聚酯或聚氨酯制成。这样的材料允许元件2粘附至相邻的生物组织，以允许有效地锚定人造括约肌1。
此外，每个接触表面3均覆盖有热解涡轮层碳(pyrolytic turbostratic carbon)层。这允许防止这种接触表面3附接至患者的尿道，从而防止变形或狭窄。
这种热解涡轮层碳层的厚度为0.1mm至0.3mm，并且优选地基本上等于0.2mm。
人造括约肌1还包含布置在元件2之间以连接元件2的连接构件9。
这允许防止元件2之间过度地相对运动。
在优选实施方案中，连接构件9包含固定在元件2的半锥形表面5上的生物相容性织物条10。
优选地，织物条10与半锥形表面5之间借助于胶合进行固定。
换句话说，条10具有固定至元件2之一的第一端和固定至另一元件2的第二端。
有利地，连接构件9仅在元件2的第一相向边缘11处起作用。
第一边缘11为限定在彼此面对的半锥形表面5与平整表面4之间并且布置在人造括约肌1一侧的边缘。自然地，还限定了第二相向边缘11，并且第二相向边缘11为限定在彼此面对的半锥形表面5与平整表面4之间并且布置在人造括约肌1的相对侧的边缘。
条10仅经过第一边缘11附近。以这种方式，元件2之间限定了大致铰链状的连接。这样的元件2的平移受条10的未固定至半锥形表面5的长度限制，并且这样的元件2可以相对于彼此旋转。
以这样的方式，基本上确保了元件2之间的相对位置，同时还防止了可能对患者组织造成损伤或导致括约肌1故障的刚性。
替代性地，连接构件9包含固定至元件2并且全都布置在人造括约肌1的同一侧上的两个或更多个生物相容性织物条。
这样描述的发明实现了所提出的目的。事实上，根据本发明的人造括约肌允许相对于尿道的正确位置及人造括约肌的功能保持较长时间。
事实上，尿道的逆成型(counter-shaped)的接触表面的存在允许元件随着时间的推移呈现出稳定的位置。
另外，形成括约肌的元件的大致半锥形允许容易且稳定地锚定在患者的骨盆中。

Claims (9)

1.人造括约肌，其包含彼此相连的并且是中空的以用于容纳加压流体的至少两个元件(2)；所述元件(2)适于布置在患者尿道的侧面；
每个元件(2)各自具有大致半筒形的与所述尿道的接触表面(3)，其特征在于，每个元件(2)均具有与所述接触表面(3)相对的半锥形表面(5)。
2.根据权利要求1所述的括约肌，其特征在于，所述元件(2)在所述尿道上施加从第一端(2a)向第二端(2b)降低的压力，所述第一端(2a)在使用期间布置在靠近所述患者之膀胱的位置，所述第二端(2b)在使用期间布置在远离所述患者之膀胱的位置。
3.根据权利要求1或2所述的括约肌，其特征在于，每个元件(2)均具有面积从第一端(2a)向第二端(2b)减小的截面，所述第一端(2a)在使用期间布置在靠近所述患者之膀胱的位置，所述第二端(2b)在使用期间布置在远离所述患者之膀胱的位置。
4.根据权利要求1或2所述的括约肌，其特征在于，所述括约肌包含布置在所述元件(2)之间的操作性连接构件(9)。
5.根据权利要求4所述的括约肌，其特征在于，所述连接构件(9)包含固定在所述元件(2)的所述半锥形表面(5)上的生物相容性织物条(10)。
6.根据权利要求4所述的括约肌，其特征在于，所述连接构件(9)仅在所述元件(2)的第一相向边缘(11)处起作用，其中，所述连接构件(9)在所述元件(2)之间于所述第一相向边缘(11)处限定了铰链状连接。
7.根据权利要求1、2或5所述的括约肌，其特征在于，所述元件(2)由硅酮制成。
8.根据权利要求1、2或5所述的括约肌，其特征在于，每个接触表面(3)均覆盖有热解涡轮层碳层。
9.根据权利要求1、2或5所述的括约肌，其特征在于，所述括约肌包含与每个元件(2)连接的导管(7)以用于向所述元件本身引入流体和/或从所述元件本身移除流体。
CN201580033873.5A 2014-06-27 2015-06-08 人造括约肌 Expired - Fee Related CN106456306B (zh)

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