CN100548227C - 用于治疗女性小便失禁的外科手术器械 - Google Patents

用于治疗女性小便失禁的外科手术器械 Download PDF

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CN100548227C
CN100548227C CNB008113491A CN00811349A CN100548227C CN 100548227 C CN100548227 C CN 100548227C CN B008113491 A CNB008113491 A CN B008113491A CN 00811349 A CN00811349 A CN 00811349A CN 100548227 C CN100548227 C CN 100548227C
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J·莱赫
C·-C·陈
B·H·卢斯科姆贝
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Abstract

一种用于治疗女性小便压力失禁的外科手术器械和方法。该器械包括一弯曲的针状件(10)，部分地限定了具有一个远端(17)和一个近端(19)的弯曲轴(18)。针(10)的直径从近端到远端呈减少地变化，且针终止于钝状顶端(16)。带(12)与针相连，用于植入女性下腹部给尿道(54)提供支撑。带(12)可由合成和天然材料制成。针(10)和带(12)还可改进成允许外科医生在外科手术期间能连上和取下该带。

Description

用于治疗女性小便失禁的外科手术器械
相关申请的相互引用
本发明要求了1999年6月9日所申请的序号为60/138231的美国早期申请的临时专利申请的权益，在这里整体引入作为参考。
发明背景
本发明通常涉及一种用于治疗女性小便失禁的外科手术器械和方法，具体而言，涉及一种便于穿过不同的组织层的锥形针，每个组织层具有不同的抗穿力。
多于一千一百万的女性有失禁的情况。而且，大多数失禁的女性患的是压力小便失禁(SUI)。患有SUI的女性在正常的日常活动和运动期间，例如大笑、大哭、打喷嚏和常规锻炼中，会不由自主地遗尿。
阴道壁与骨盆肌肉和耻骨相连的组织或韧带的功能性缺陷可能引起SUI。通常由包括骨盆肌肉的反复性拉伸、生小孩、骨盆肌肉缺少韧性和缺少雌激素引起。这种缺陷使得尿道功能不正常。SUI不象其它类型的失禁，它不是膀胱引起的问题。
通常，当尿道由有力的骨盆底部肌肉和健康的连接组织正确支撑时，尿道能保持紧固密闭，以阻止不由自主地遗尿。然而，当女性患有SUI的最普通形式时，变弱的肌肉和骨盆组织不能在它的正确位置充分支撑尿道。因此，在正常运动期间，从横隔膜对膀胱施加压力时，尿道不能保持其密闭，从而让尿漏出。因为SUI既令人难堪又不可预期，很多患有SUI的女性避免活跃的生活方式，并且羞于参加社会工作。
美国专利5112344描述了一种用于治疗女性小便失禁的方法和器械。应用长纤维件进入人体内的该外科手术器械，其一端包含一个有把手的管状轴，而其另一端包含一个柔性针，该柔性针可滑动地接纳在轴内，用于接纳长纤维件。这种治疗女性小便失禁的方法包括，使长纤维件在阴道壁和腹部前壁内的直肌腹鞘之间结成环，从而使它通到尿道的每一侧，拉紧环可使阴道壁和尿道相对于耻骨形成正确的空间关系，使阴道壁和腹部耻骨的前壁之间的疤痕组织生长愈合，然后取出长纤维件。
美国专利5899909公开了一种外科器械，其一端包含一个有把手的轴，而另一端包含连接装置，连接装置用来接纳两个弯曲的针状件，每次一件，该针状件的一端与准备用来植入人体内的带的一端相连。实际上，带的一端首先穿过阴道进入人体，然后带的另一端分别在尿道的一侧和另一侧形成一个围绕尿道的环，并固定在尿道和阴道壁之间。该带越过耻骨延伸，并穿过腹部壁拉紧。该带的两端在腹部壁被切断，而留下该带植入人体内。
目前的用于植入带的针有一个短的锥形顶端和一个有恒定直径的弯曲体部。当锥形针顶端穿过一层有高抗穿力(如筋膜或肌肉)的人体组织时，所要求的力比穿过人体软组织(如脂肪)所要求的力要高。为了降低外科医生穿过筋膜或肌肉所要求的最大力，针的顶端具有尖角。但是，在锥形顶端穿过有高抗穿力的组织层后，针再穿过组织所要求的力突然降低到接近零。于是，作为一个所不希望的结果，所述针穿过组织可比外科医生所希望的要快，可能使外科医生对针失去控制，并冒有可能用尖的针顶端穿过不希望的其它身体结构如骨头、器官或血管的风险。
对于设置一个用于把一个网状带植入女性身体内以防止失禁的针来说，具有这种设计是有益的，即，具有更均匀的阻力穿过不同类型的组织。
简化以便于在手术操作中把带装入针中的外科手术器械的设计还是有好处的。在这种方式中，该器械应该能接纳不同类型的带，例如合成尸体组织和工程组织。
发明内容
本发明克服了现有技术的不足，并提供了一种改进的针，用于供治疗女性小便失禁的外科手术器械和方法中使用。本发明提供的外科手术器械，其一端包括一个把手，而另一端包括连接装置，连接装置用来接纳两个针状件，每次一件，每个针具有一个钝状顶端和变化的直径。每个针的一端与准备用来植入人体内的带的不同端相连。实际上，带的第一端通过一个弯曲的针经尿道一侧的阴道进入人体。针和带的第一端越过耻骨，并穿过腹部壁。第二个针件与该把手以及带的第二端相连，并从与带的第一端处于尿道相反位置的阴道穿入人体，从而用带形成围绕尿道的一个环或吊环。该带的第二端越过耻骨延伸，并穿过腹部壁。该带的两端在腹部壁被切断，并且留下该带植入人体内。
本发明还提供一个有钝状顶端和变化的直径的单个弯曲的针件，而且还提供了一个简易的连附装置，该连附装置能让外科医生把带的第一端和第二端都与单个针相连，以进行上述手术操作。
本发明还设有一个带，其包含一个合并有天然材料的合成网状物，从而该天然材料将留在尿道下以消除潜在的腐蚀问题。
本发明的一个方面设有一个有远端和近端的针状件。该针的直径从远端到近端呈增加地变化。远端还限定一个有钝状端头的顶端。近端设有与把手的连接装置。
本发明的目的是要提供一种外科手术器械，能满足使带穿过组织的最大力减少的要求。
本发明的另一个目的是要提供一种针，能满足使其穿过组织的力更恒定的要求。
本发明的一个优点是能减少穿过其它身体结构的风险。
本发明的另一个优点是能提供一个使带连接到针上的快速连接装置，从而允许使用非合成组织作为支撑件。
结合以示例方式说明本发明原理的附图，从以下更详细的描述中本发明的这些和其它特征和优点将变得更加清楚。
附图简述
图1为其中一实施例中的针的侧视图；
图2a为两个针和把两个针连接起来的一根带的侧视图；
图2b-2d为带以及在带和针之间的连接装置的其它实施例；
图3a为针的其它实施例的侧视图；
图3b-3c是图3a中所示的针的远端以及把带可拆卸地连接到针上的一种装置的放大视图；
图3d-3e是图3a中所示的针的远端以及把带可拆卸地连接到针上的另一种装置的放大视图；
图3f-3g是图3a中所示的针的远端以及把带可拆卸地连接到针上的另一种装置的放大视图；
图4a-4g示出根据本发明使用两个针治疗SUI的方法的几个示意性的外科手术步骤；
图4h示出了带在带的两端被切断之前在人体内的最后位置；
图5a-5g示出根据本发明使用一个针治疗SUI的方法的几个示意性的外科手术步骤；
图5h示出了带的另一个实施例在带的两端被切断之前在人体内的最后位置。
发明内容
在详细说明本发明前，应该指出的是，由于本发明示例性的实施例可以补充或引入其它实施例、变型和改进，还可以不同的方式实行或进行，本发明不限于在附图和说明中所示部件的结构和安装的应用或使用。此外，除非另外指出，这里所采用的术语和表达语是为了描述本发明的示例性的实施例而选用的。
本发明公开了用于治疗SUI的一种器械和方法。一根带穿过骨盆组织，并位于尿道下，形成了一根起支撑作用的吊环。该带提供了一种用于组织生长的结构装置，从而提供了一个新形成的身体组织支撑尿道装置。当对下腹部施加压力，例如大笑或打喷嚏，该带给尿道提供支撑，并使它保持密闭以阻止不希望的排尿。
参照图1和2，该外科手术器械包括一个针状件10，该针状件10与网状带12相连。该针状件10确定了某一半径R来进行在这里论述的外科手术操作。针状件10的远端终止于圆锥形部分14，该圆锥形部分14有一个顶端16。在另外的结构中，也有可能有例如刀状、箭头或针球状的顶端。顶端16优选为钝状，其中顶端16的半径大约是0.6毫米。优选钝状顶端，是因为它不太可能刺入骨头，或穿透膀胱壁组织或血管壁组织，在如下所述的植入带的方法中将会理解这一点。
针10的近端终止于连接部分20，该连接部分20适用于紧密配合和锁住在把手21中，如前面在美国专利No.5899909中所述，在这里引入作为参考。
弯曲轴部分18设置在顶端14和部分20之间，其有一个远端17和一个近端19。轴18的形状大致延伸成圆的四分之一，使其大致跟随阴道和腹部壁之间的耻骨的轮廓。对这个将在下面更详细论述的方法来说，轴18优选的半径R大约是106毫米。此外，部分18的直径可以在远端17的较小直径到近端19的较大直径逐渐变化。由于在远端的应力最小，所以远端17的最小直径可以小如0.5mm。近端19的最小直径可约为4mm。近端19的最小直径最好约为6mm，且以连续减少的方式在远端17的最小直径最好约为3mm。在植入带12的方法中要考虑这种设计，即在远端17的弯曲应力最小，而在近端19的弯曲应力最大。另一种说法是在该手术操作中，在远端17的内弯曲运动可以忽略不计，而在近端19的内弯曲运动是相当大的。针具有最小直径，当针穿过对抗针的不同的组织层时，由于所述针给外科医生提供触觉反馈，该设计还是有好处的。
针10有一个钝状顶端16和一个直径变化的轴18，该针引起的一个不可预料的结果是穿过例如筋膜层、肌肉层、脂肪层和皮肤的组织层所需要的减少的最大力。而且，针的顶端16已经通过一个组织层之后，外科医生继续使针10穿过该组织层或下面的具有较小抗穿力的组织层所需要的力不会如现有技术一样急剧下降。这是轴18引起的结果，由于轴18从远端17到近端19的直径增加，因此必须要求外科医生用一个更恒定的力来继续穿过组织。
表1比较了现有技术的针和本发明的针穿过猪的筋膜(腹部白线旁)所需要的力。现有技术的针的特征在于，针的直径恒定为5mm，针的顶端半径为0.2mm。本发明的针的特征在于，针从弯曲轴18的远端到近端有一个3mm到6mm的变化直径，针的顶端半径为0.6mm。该筋膜放入试验装置内，并且每个针以90度的角度、每分钟50mm的速度穿过该筋膜。表1列出穿过该试验组织所需要的最大力。
表1
  试验编号   现有技术的针最大力(N)   本发明的针最大力(N)
  1   7.10   6.41
  2   7.32   7.85
  3   8.16   5.75
  4   9.20   6.60
  5   13.14   5.30
  平均力(N)   8.98   6.38
  s   2.47   0.97
该试验结果指出，本发明的针的穿过力比现有技术的针减少了约29％。
针10优选为管状并具有圆截面，它由与人体相容的材料制成。针10还优选为由能高压灭菌的材料制成，使针10能够进行多个外科手术。针10还优选为由AI S I 303不锈钢制成。轴18的表面可以是光滑的，最好是打磨过的，以便于穿过软组织。另外，针10的表面可以是稍微有点粗糙的表面。较粗糙的表面可能导致轻微的、附加的组织损伤，这样又刺激了带12周围的纤维原细胞的活性。
针10可作为单一的、连续的装置制造，或者可选择的是，弯曲部18可与线性部20分开制造。在这种方式中，两个部件将用任何一种传统的连接装置来连接，例如螺纹，或是本技术领域中的技术人员所熟知的其它传统的装置。
参照图2a-2d，带12包含任何一种与组织相容的合成材料，或是任何一种天然材料，包括但不限于自体同源、同种移植物、异种移植物、组织工程基体或是它们组合而成的组织。合成材料的例子是由美国新泽西Somerville的Ethicon公司(Ethicon，Inc.，Somerville，NewJersey，U.S.A)制造的
Figure C0081134900081
聚丙烯网，该网厚0.7mm，开口大约1mm。该材料由美国食品和药品管理部门批准可用于植入人体内。还有带12的另一个实施例，其包括合成材料11和天然材料13的合并物，天然材料13在图2b-2c所示的合成材料11之间的中央。还有带12的另一个实施例，其包括合成材料11和天然材料13的合并物，而天然材料13放置或混合在合成材料11的大概中央部分内。带结构的一个优点是，天然材料13处于沿带的中央区域，使得带12安装后，天然材料13位于尿道下面，并且能消除在尿道和带的接口处可能发生的腐蚀问题。天然材料13可通过缝制、生物相容的胶、细胞培植技术或其它的已知方法与合成材料11相连。
带12可以具有适合本发明的目的的任意一种方便的形状。一个实例的宽为1cm，而其长度将依赖于女性进行该手术所需的尺寸。带12可以是单层或双层，通常是平面结构，或是管状(图2d)，以提供一个附加的支撑力和更多的表面区域，组织纤维可连接于表面区域上。而且，带12可以包含不同类型的材料，例如一种生物可吸收和非生物可吸收的材料。带12还可以涂有一层抗菌添加剂和一层光滑涂层，抗菌添加剂用来防止感染或使感染最小化，而光滑涂层，例如生物可吸收的水凝胶，以便于带穿过如下所述的组织。带12最好覆盖有一层可去掉的塑料套，如美国专利No.5899909中所述。该带还可以制成辐射透不过的和/或具有与身体组织相对照的颜色，用于将来的诊断观察。
在一个实施例中，带12可通过打结、胶合或其它适合的连附装置与针的部分20相连。优选的是一种生物相容的热缩管把带12固定到针的部分20上。在另一个实施例中，如图2b-2d和图3a-3g，针10和带12还具有这种结构，使得在手术操作中外科医生很容易把带12连接到针10上，以及把带2从针10上取下。这个实施例中允许使用至少部分是由天然材料构成的带，而由于这些天然材料不能经受住库存延长期限的考验，所以它们不能适用于预固定的实施例。
如图3a-3c中所示，在一个实施例中，轴18设置了一个凹口和狭槽40，用于可滑动地接纳用于连接的接头32和32a，接头32和32a可连在带12的任意一端。狭槽40优选贯穿弯曲轴18，并且还位于针10的远端17处，以使针10穿过腹壁之后，带12可马上从针10上取下，可见下面所述。
接头32可由例如塑料或金属的生物相容的材料制成。只要接头32能牢固插入凹口和狭槽40中，接头32可以是任意形状，例如方形或箭头形。图3b-3c示出了接头32，其具有两个弹性臂33和33a，当插入到狭槽40中时，弹性臂33和33a展开，并且把接头32牢固地固定在狭槽40内。接头32可以任意多的方便的方式与带12相连，这些方式如前所述，并且是该技术领域中的技术人员所熟知的。
图3d-3e示出了一个两层的狭槽40，其中接头32滑入下层，该下层把接头32固定就位。还可得到带有狭槽40的接纳接头32的另外的装置，这在本技术领域中是众所周知的。
图3f-3g示出了把带12固定到针10的远端17的另一个实施例。可拆卸的钝状顶端16a有一个连接柱15，钝状顶端通过安装孔15a与远端17a相连以接纳柱15。柱15可通过压接、螺纹配合或其它方便的连接方式牢固地连接在孔15a上。远端17a还确定了有不同深度的沟槽23，使与柱15相连的带12的端头从孔15a中移动到针10的外部。本实施例和图3a-3e的实施例一起，允许外科医生只在外科手术操作之前才把带12固定到针10上。一个优点是能够使用一个至少部分由天然材料构成的带12。
在本技术领域的一个技术人员将能理解，即存在多种装置可把带可拆卸地连接到针上。另一个实施例包括把带12的端部打结以形成一个结，并把该结牢固地插入轴18的V形槽中。另外，轴18上的一个斜缝能够接纳带12或从带12展开的一个缝合线。
使用两个针植入带12的外科手术的操作如图4a-4g中所示。在图中示出了女性下腹部相关的部分，如阴道50、子宫52、尿道54、耻骨56、泌尿膀胱58和腹部壁60。第一个针10a穿入阴道壁，最初已在该壁上开了个切口以制造一个组织片状物。针与把手21相连，而外科医生引导针10a穿过阴道壁和穿过尿道54一侧的软组织，然后按照图4b所示，针穿到靠近耻骨56的背面，穿过另外的脂肪层、肌肉层和筋膜层，接着又穿过耻骨56上的腹部壁60。通过腹部壁可以开一个切口作为针经过的通道。从针10a取下把手21，见图4c，并且将连有带12的针10a用镊子从腹部壁抽出，见图4d。
参照图4e，此时针10b与把手21相连，外科医生引导针10b穿过阴道壁的切口，然后穿过不同于带12前一次终端的尿道相反侧的软组织。针10b靠近耻骨背面穿过另外的脂肪层、肌肉层和筋膜层，见图4f，接着又穿过在耻骨上方的腹部壁并拉出见图4g。
图5a-5g示出使用单个针10植入带12的另一种方法。带12通过接头32(未示出)与针10相连。针10穿入阴道壁，阴道壁中首先已做好一个切口用于制造一个组织片状物。外科医生引导针10穿过阴道壁和穿过在尿道54一侧的软组织，然后按照图5b，针靠近耻骨56的背面穿过另外的脂肪层、肌肉层和筋膜层，接着又穿过在耻骨56上方的腹部壁60。穿过阴道壁可以做一个切口，用作远端17经过的通道。针10继续穿过腹部壁，一直到接头32可以从轴18分离为止，见图5c。为了这么做，外科医生可简单用一个狭窄的工具插入狭槽40，以迫使接头32从接头32插入的相反侧出来。然后接头32被断开，带12可被拉出腹部壁，以使外科医生有额外的长度进行手术操作。接着针10沿着它进入的同一路径，只不过从相反方向从病人体中取出，见图5d。另外，如在用两个针的手术操作中所述，针10可从把手21上分离，并用镊子从腹部壁60拉出。
参照图5e，现在针10用连接器32a与带12的相反端连接。外科医生让针10穿过阴道壁的切口，然后穿过不同于带12前一次终端的尿道相反侧的软组织。针10靠近耻骨的背面穿过另外的脂肪层、肌肉层和筋膜层，见图5f，接着又穿过在耻骨上方的腹部壁。针10继续穿过腹部壁，一直到接头32a可以从轴18分离为止，见图5g。带12可被拉出腹部壁，以使外科医生有额外的长度进行手术操作。接着针10沿着它进入的同一路径，只不过从相反方向从病人体中取出。另外，针10可从把手21上分离，并用镊子从腹部壁60拉出。
由于所有手术操作可以使用局部麻醉进行，病人能够在带12放入就位后给外科医生提供反馈。典型的是使用导尿管让泌尿膀胱58充满例如水的流体和要求病人咳嗽。外科医生能确定尿道的手术操作，如果必要，可通过调整位于腹部60的外侧的带12的端头来调整带12，见图4h和5h。在调整之后，剩余的带在腹部被切断，带的两端固定在腹部内，并缝合腹部。同样，缝合阴道壁的切口，从而组织片状物把带密封在尿道54和阴道50的壁之间。
带12留在身体里，并形成一个与腹部壁相连的人工韧带，能如所要求那样给尿道提供支撑，从而恢复病人的小便节制。
从已示出和描述的本发明的特定形式的上述内容将明显看出，在不背离本发明的精神和范围的情况下可做出不同的变型。因此，除了附加的权利要求书，它不会用来限定本发明。

Claims (9)

1.一种用于治疗女性小便压力失禁的外科手术器械，其包括：
a.一个用于植入女性下腹部给尿道提供支撑的带，它具有连接装置；和
b.一个部分限定一个弯曲轴的针，所述弯曲轴具有一个远端和一个近端以及用于可拆卸地接纳所述连接装置的连附装置，其中，该连接装置是一个接头部件，而该连附装置是一个狭槽。
2.如权利要求1所述的外科手术器械，其特征在于，弯曲轴限定有从近端到远端呈减少地变化的直径。
3.如权利要求2所述的外科手术器械，其特征在于，该带限定了一种合成材料制成的第一端和第二端，而且该带还包含一种天然材料。
4.如权利要求3所述的外科手术器械，其特征在于，天然材料可从包括自体同源、同种移植物、异种移植物、组织工程基体的组合中选择。
5.如权利要求1-3中任意一项所述的外科手术器械，其特征在于，该连附装置位于远端。
6.如权利要求1-3中任意一项所述的外科手术器械，其特征在于，该远端限定为钝状顶端。
7.如权利要求1-3中任意一项所述的外科手术器械，其特征在于，针的钝状顶端的半径约为0.6mm。
8.如权利要求1-3中任意一项所述的外科手术器械，其特征在于，所述针的远端的直径约在3mm到5mm。
9.如权利要求1-3中任意一项所述的外科手术器械，其特征在于，所述针的近端的直径约在5mm到6mm。
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