CN1083708C - 用于治疗妇女尿失禁的外科器械 - Google Patents

用于治疗妇女尿失禁的外科器械 Download PDF

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CN1083708C
CN1083708C CN 95195812 CN95195812A CN1083708C CN 1083708 C CN1083708 C CN 1083708C CN 95195812 CN95195812 CN 95195812 CN 95195812 A CN95195812 A CN 95195812A CN 1083708 C CN1083708 C CN 1083708C
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J·克拉伦
U·乌姆斯坦
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Johnson and Johnson Medical SAS
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Abstract

本发明涉及一种用于治疗妇女尿失禁的外科器械。该器械包括一个杆部(10),杆部(10)在其一端具有一个把手(11)和两个针状元件(21A,21B),两个元件(21A,21B)的每一个都以其一端与一根要被植入人体的带子(26)的一端连接。这两个元件在所述杆部的另一端一次一个地与该杆部连接,以便形成该杆部的一个弯曲的端部,并且使这些元件经阴道进入人体内,每个元件的尺寸使其从阴道壁的内部延伸过耻骨的背面而到达腹壁的外面。

Description

用于治疗妇女尿失禁的外科器械
本发明涉及一种用于治疗妇女尿失禁的外科器械,即一种用于治疗妇女失去控制排尿量的外科器械。
将阴道壁与骨盆肌肉和耻骨连接起来的组织或韧带的功能缺陷会引起尿失禁。
美国专利US-A-5 112 344说明了一种无需开腹而治疗妇女尿失禁的方法,此方法需要住院,可能需要四天。在这种方法中,使一根带子在尿道的每一侧进入人体,并植入阴道壁和延伸过耻骨的腹壁之间。拉紧这根带子,以便使阴道壁和尿道相对于耻骨达到正确位置,并把这根带子留在人体内,以便使纤维组织围绕这根带子发育,所述纤维组织在软组织中起到支撑韧带的作用。当这样的纤维组织已发育完成时,从人体中去除这根带子,这大约需要两个月。
还提出了用于这种方法的一种特殊结构的外科器械,这种外科器械包括一个杆部,这个杆部在其一端有一个把手而在其另一端有一个弯曲部分,可使所述弯曲部分经阴道进入人体内。
这种外科手术所得到的结果并非总是令人满意的,这是由于下述事实,即:由于阴道壁和腹壁之间的软组织状况不好,纤维组织将不会充分发育。
本发明的目的就治愈尿失禁而言,提供了显著改善预后状况的、改进并简化的外科手术。
而且为此目的,本发明提供了一种用于治疗妇女尿失禁的外科器械,该器械包括一个杆部,杆部在其一端具有一个把手,而在其另一端具有一个弯曲部分,使所述弯曲部分经阴道进入人体内,其特征在于,两个弯曲的针状元件中的每一个的一端分别连接到要被永久植入人体内的一根带子的一端和另一端以形成一个围绕尿道的回线,把两个元件一次一个地与杆部连接以便形成所述弯曲部分,每个元件的尺寸使其从阴道壁的内表面延伸过耻骨的背面而到达腹壁的外面。
本发明还提供了一种用于治疗妇女尿失禁的方法。在这种方法中,一根带子进入位于阴道壁和腹壁之间的组织中,但这根带子永久性地留在人体内,以便使其本身作为一根人工韧带,提供治愈尿失禁所需要的所述组织的增强,或者通过纤维组织的发育来提供所述增强。
将参照附图更详细地说明本发明,这些附图公开了本发明的外科器械、以及当采用所述外科器械实施本发明的方法时的几个外科手术步骤。
在这些附图中:
图1是本发明的一个实施例中的外科器械的侧视图,
图2是外科器械的平面图,
图3是用于连接上述器械的可替换部件的该器械的一种连接件的局部轴向剖面放大图,
图4至10示意性地说明了本发明的方法的几个外科手术步骤,而
图11以同样的方式说明了本发明的方法的最后步骤。
外科器械包括一个圆柱形管状杆部10,杆部10在其一端有一个把手11,把手11在一个共同平面内沿两个相对的方向形成两个凸翼12和一个开口13。在所述杆部的另一端有一个套管14,套管14部分地套在该杆部上并被软焊或硬焊在该杆部上,该套管的一部分从所述杆部的所述另一端伸出。一个圆柱形轴15可旋转地装在所述杆部中,并可借助于在其外表面上沿轴上滚花的一个旋钮16而手动地旋转,旋钮16装在所述轴的一端并容纳在开口13中。所述轴的另一端形成一个具有比该轴更小外径的圆柱形部分17,圆柱形部分17连接到一个具有外螺纹的部分18,一个直径进一步减小了的光滑端部19连接到螺纹部分18上,端部19在所述轴的所述另一端形成一个导销。部分18和19容纳在从上述杆部伸出的套管14的那部分中,而且还有一个从上述杆部伸出的台肩20容纳在套管14的所述那部分中。
意图使至此所述的外科器械使用几次,因此,该外科器械应该由一种可通过高压灭菌来消毒的材料制成,例如由不锈钢制成。
外科器械还包括一个被称为针的、可替换的一次性部件21。在所述针的一端,该针的一个直的部分连接到所述杆部,而且该针到其另一自由端基本上延伸了四分之一个圆,以便于基本上符合位于阴道和腹壁之间的耻骨外形。所述针有一个圆形剖面,并且具有光滑的、优选地是经过抛光的外表面。所述针朝向它的自由端逐渐稍微变细,在该自由端可通过在所述针上刻面使该针形成一个尖端22,但还可以使该针是钝头端部的并有一个沿横向切开的末端。外科器械的实际使用会表明哪个实施例是优选的。一次性的针将由一种与组织相容的塑料例如由聚碳酸酯制成,或者由钢或一种类似的材料制成。
为了把针21连接到杆部10上,该针在所述一端形成一个被容纳在套管14内的所述部分中的直的部分,该针21在其所述一端有一个从端面延伸的轴向盲孔,所述盲孔有一个螺纹部分23和一个由此向内的较窄的圆柱形部分24。导销19的尺寸使得当通过人工转动旋钮16而转动轴15来把用于将针21连接到外科器械的其余部分上的螺纹部分18旋入所述盲孔的螺纹部分23中时,导销19由较窄的圆柱部分24导向容纳,所述杆部的端面和所述针彼此相对挤压。所述针应相对于所述杆部定位在预定的旋转位置;它应该以与把手16的平面成直角而伸出,而且通过所述杆部的台肩20来固定这个旋转位置,台肩20容纳在位于所述针的外表面上的一个相配合的凹槽25中。
针21的部分23不采用车上螺纹的方式,而是使该部分23的尺寸:使得当把轴15的螺纹部分18拧入其中时,轴15的螺纹部分18在所述针的塑料中钻出一个螺纹。
当把外科器械的两部分以所述方式拧在一起时,它们形成一个刚性的整体,当应用本发明的方法而将其用于外科手术时,可以用把手11以高精度控制这个整体。
当实施本发明的方法时,所述实施例的两根针21A和21B将各自连接在带子26的每一端上,见图4。在优选的实施例中,带子的端部粘接到所述针上,但还可以通过下述这些方式进行所述连接:使所述带子穿过该针的与连接到所述杆部的端部相邻接的孔27,见图3,或者通过超声焊接使带子的端部连接到所述针上,或者当对针进行注射模型时将带子的这个端部烤熔而凝结到所述针的塑料材料中。
带子应该是在纬线和经线之间具有约为0.1mm的孔的编织带,从而使纤维细胞能够生长进该带子中,以用于将该带子固定在周围的组织中。用于所述带子的合适的材料是聚丙烯,还可以用一种纤维细胞刺激物质、例如一种搪瓷基质的衍生物来涂覆聚丙烯。所述带子的宽度优选为8至10mm,而厚度优选为约1mm。
当要开始进行植入带子的外科手术时,一根针21A连接到杆部10,而另一根针21B松驰地悬挂在带子26上,就如图4所示的那样。
在图4至图11中,示意性示出了妇女下腹部的一些相关部位,阴道标号为28,膀胱标号为29,尿道标号为30,耻骨标号为31,而腹壁标号为32。
图4中示出了植入带子26的外科手术的第一步,这第一步包括用针21A刺穿阴道壁,在所述壁上首先刺一个开口,还包括在尿道30的一侧刺穿软组织,然后按照图5使所述针靠近耻骨31的背面穿过,之后穿过位于耻骨上面的腹壁。可穿过腹壁形成一个开口以作为使所述针穿过该腹壁的通路,但如果把所述针弄尖,就足以使该针从腹壁的内部刺进腹壁,并在腹壁的外面在腹壁上产生一个对齐的开口。
现在,通过在旋钮16处转动轴15使所述器械的杆部与针21A脱开,见图6,这使得所述轴的螺纹部分18从针21A中的螺纹部分23拧出,然后借助于钳子把所述针从腹壁抽出,而带子26被拉进并穿过组织,如图7所示。
现在参照图8,将另一根针连接到所述杆部上并穿过阴道壁中的一个开口,以便在尿道30的另一侧穿过软组织。图9示出,针21B穿过腹壁,然后在将针21B与所述杆部脱开后,将该针从腹壁抽出,见图10,所有这些都与先前的针21A采用的步骤中的方式相同。
如图10所示,现在带子26位于尿道30的每一侧,并且由位于阴道壁内表面上的带子所形成的回线拉紧,见图11。位于腹壁外边的剩余带子被切掉。然后,所述带子作为一种植入物留在体内,以便形成治愈尿失禁所需要的连接到腹壁并为尿道提供所需支承的一根人工韧带。
可用于本发明的方法中的另一种带子可比上述带子编织得更紧密,并且可以是这样的材料:使得在一段更短或更长的时间后所述带子被完全重新吸收。通过由所述带子所刺激的纤维细胞增生的发育,就会获得为了治愈尿失禁所需的组织的增强。

Claims (16)

1.一种用于治疗妇女尿失禁的外科器械,该器械包括一个杆部(10),杆部(10)在其一端具有一个把手(11),而在其另一端具有一个弯曲部分(21),使所述弯曲部分经阴道进入人体内,其特征在于,两个弯曲的针状元件(21A,21B)中的每一个的一端分别连接到要被永久植入人体内的一根带子(26)的一端和另一端以形成一个围绕尿道的回线,把两个元件(21A,21B)一次一个地与杆部(10)连接以便形成所述弯曲部分,每个元件的尺寸使其从阴道壁的内表面延伸过耻骨的背面而到达腹壁的外面。
2.如权利要求1所述的器械,其特征在于,杆部(10)具有一组螺纹连接件(18,23),用于把元件(21A,21B)连接到杆部(10)上。
3.如权利要求2所述的器械,其特征在于,所述螺纹连接件包括一根轴(15),该轴(15)可旋转地安装在杆部(10)中且在该轴的一端有一个操纵旋钮(16),所述旋钮适用于安装在所述杆部的把手端,而位于所述轴另一端的螺纹部分(18)与元件(21A,21B)进行螺纹连接。
4.如权利要求1至3中的任何一项所述的器械,其特征在于,杆部(10)在其所述的另一端有一个套管部分(14),以便在针状元件(21A,21B)的一端将该元件的所述端部容纳在该套管部分中。
5.如权利要求1至3中的任何一项所述的器械,其特征在于,把手(11)包括两个从杆部(10)沿相反方向伸出的翼(12)。
6.如权利要求5所述的器械,其特征在于,杆部(10)和针状元件(21A,21B)具有相互协同操作的装置(20,25),用于把所述各个元件以与翼(12)的平面成直角地安装在杆部(10)上。
7.如权利要求1至3中的任何一项所述的器械,其特征在于,意图使杆部(10)使用几次,杆部(10)由一种可高压灭菌的材料构成,而使针状元件(21A,21B)只使用一次,元件(21A,21B)由塑料材料、不锈钢或类似的材料构成。
8.如权利要求7所述的器械,其特征在于,通过把带子(26)的端部粘接或焊到相联的元件(21A,21B)上或者将带子的端部烤熔而凝结到所述元件的塑料材料中而把该带子(26)连接到相联的元件(21A,21B)上。
9.如权利要求7所述的器械,其特征在于,所述带子的端部穿过相联的元件(21A,21B)中的一个孔(27)。
10.如权利要求1至3中的任何一项所述的器械,其特征在于,所述针状元件基本上弯曲成四个之一个圆。
11.如权利要求1至3中的任何一项所述的器械,其特征在于,元件(21A,21B)朝向其另一个自由端逐渐变细。
12.如权利要求11所述的器械,其特征在于,所述另一端是尖的。
13.如权利要求11所述的器械,其特征在于,所述另一端是钝的。
14.如权利要求1至3中的任何一项所述的器械,其特征在于,带子(26)被穿孔以便于纤维细胞生长进其中。
15.如权利要求14所述的器械,其特征在于,带子(26)包括编织的带子。
16.如权利要求14所述的器械,其特征在于,用一种纤维细胞刺激材料涂覆所述带子。
CN 95195812 1994-08-30 1995-08-28 用于治疗妇女尿失禁的外科器械 Expired - Lifetime CN1083708C (zh)

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SE9402872-7 1994-08-30
SE9402872A SE503271C2 (sv) 1994-08-30 1994-08-30 Instrumentarium för behandling av urininkontinens hos kvinnor samt sätt för sådan behandling
SE94028727 1994-08-30

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JP (1) JP3333519B2 (zh)
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AU (1) AU697010B2 (zh)
CA (1) CA2198778C (zh)
DE (2) DE69519737D1 (zh)
DK (1) DK0778749T5 (zh)
ES (1) ES2152423T3 (zh)
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CA2198778A1 (en) 1996-03-07
CN1161640A (zh) 1997-10-08
JP3333519B2 (ja) 2002-10-15
DE69519737D1 (de) 2001-02-01
EP0778749A1 (en) 1997-06-18
ES2152423T3 (es) 2001-02-01
DE69519737T4 (de) 2003-12-24
DK0778749T5 (da) 2003-06-23
WO1996006567A1 (en) 1996-03-07
AU697010B2 (en) 1998-09-24
DK0778749T3 (da) 2001-02-05
SE9402872D0 (sv) 1994-08-30
JPH10506803A (ja) 1998-07-07
DE69519737T2 (de) 2001-04-19
SE9402872L (sv) 1996-03-01
EP0778749B1 (en) 2000-12-27
AU3402495A (en) 1996-03-22
CA2198778C (en) 2003-05-06
SE503271C2 (sv) 1996-04-29

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