CN1277512C - 治疗女性尿失禁的医用器械及方法 - Google Patents
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Abstract
本发明涉及一治疗女性尿失禁的医用器械和方法。该器械包括一手柄机构和一个或两个连接在一植入体内的带子的相对两端的弯曲针状元件。这些元件可以与手柄相连并通过阴道进入体内,每个针状元件的尺寸适合于从阴道壁内部延伸出,经过耻骨下方并穿出腹壁。当实际操作该方法时将带子从阴道穿入体内,首先将一端从尿道旁的一侧穿过,然后将另一端从尿道旁的另一侧穿过,从而形成一环绕尿道的回路,该回路位于尿道与阴道壁之间。带子从耻骨下方延伸并穿过腹壁并被调整。在腹壁处将带子末端剪断,带子的其余部分则留置在体内。
Description
相关申请的交叉参考
本申请是1998年7月27日申请的申请号为09/051,311的共同未决的美国申请的继续申请,该未决申请是PCT/SE96/01269的371款申请。在此参考引用了申请号为09/051,311的专利申请的全部内容。
技术领域
本申请涉及一治疗女性尿失禁即失去排尿控制能力的医用器械和方法。
背景技术
尿失禁可能是由于连接阴道壁与骨盆肌和耻骨的组织或韧带的功能产生缺陷而引起的。
美国申请No.5,112,344公开了一种不用打开腹部而治疗女性尿失禁的方法,该方法需要长期的医院护理。该方法是将一根带子环绕腹部中尿道任一侧的肌肉组织,并将其植入阴道壁和覆盖在耻骨上的腹壁之间的软组织中,而带子的末端延伸进入阴道。该带子留置在体内促使纤维组织在其周围生长,所述疤痕组织起到支持软组织中韧带的作用。当上述疤痕组织已经长成后,再将该带子从体内取出,这需要经过大约两个月的时间。
由于阴道壁和腹壁之间的组织处于不良状态,纤维组织不能充分生长,因而上述手术结果不一定总令人满意。
发明内容
本发明的目的是提供一改进的且简化的外科手术,该手术目的在于恢复排尿控制能力并具有相当良好的预后效果。
为了实现上述目的本发明提供了一治疗上面提及的女性尿失禁的医用器械,该器械包括一个套杆,一位于所述套杆一端的手柄,一永久植入体内并环绕在尿道周围的带子,两个各自连接在带子相对两端的弯曲针状元件,和位于所述套杆和每个所述元件上用于可变化地将元件连接在另一端的套杆的装置,从而在所述另一端形成一尺寸适合于从阴道壁内表面延伸经过耻骨前方到达腹壁外的弯曲末端部分。
本发明还提供了一种治疗女性尿失禁的方法,该方法包括以下步骤:将一根带子的一端和另一端先后通过阴道穿入体内,并分别将带子的一端从尿道一侧穿入,然后将另一端从尿道旁另一侧穿入从而形成一环绕尿道的环,该环位于尿道和阴道壁之间,将所述带子从耻骨前方延伸穿过下腹壁,带子的末端穿出腹壁之外,调整带子,并将带子留置植入体内。优选的,该带子作为人工韧带永久留在体内,起到增强组织恢复排尿控制能力的作用,和/或通过纤维组织的生长而达到所述增强效果。
附图说明
本发明将结合附图做更详细的描述,附图公开了根据本发明的医用器械的具体实施例及应用该医用器械实现本发明的方法的若干手术步骤。
附图中:
图1是该医用器械的一个实施例的正视图。
图2是图1所示的医用器械的俯视图。
图3是该器械用于附加一可拆卸部件的连接部分的放大局部轴杆向截面的剖视图。
图4至图11描述的是应用图1的医用器械实现本发明的方法的若干手术步骤。
图12是该医用器械的一个第二优选实施例的正视图。
图13是图12所示的医用器械的俯视图。
图14是其中一针和带子及连接所述针的收缩软管的分解侧视图。
图15是带子连接图14中所示的针的侧视图。
图16是该器械的连接图14和15所示的可拆卸针头的部分的改进的放大局部轴杆向截面剖视图。
图17是两根针和一连接两针的带子的侧视图。
具体实施方式
在详细描述本发明之前,应当注意的是本发明并不仅限于本申请中附图和说明书所描述的具体结构和结构组合,因为本发明的这些例证性的实施例可以实施为其它实施例或与其它实施例相结合,或对其进行变化和修改,因而可以有多种实现方式。此外,除非另外说明,这里采用的术语和措辞是用来描述本发明例证性的实施例。
本发明公开了一种治疗SUI的器械和方法。一根带子穿过骨盆组织并留置在尿道下面,从而形成一支持系带。该带子的具有一利于组织生长的结构从而促使新生出用以支持尿道的人体组织。当腹部受到压力时,例如在咳嗽和打喷嚏的过程中,该带子为尿道提供支持,使之保持闭合而防止尿液失控流出。
图1至3的医用器械包括一个圆柱管状套杆10,它的一端具有一手柄11,该手柄11上形成在两个水平方向相对伸出的翼12和一开口13。在该套杆的另一端具有一套管14,该套管部分套住该套杆并与该套杆焊接或铜焊,该套管的一部分从该套杆的所述另一端伸出。一圆柱状的轴杆15可旋转的安装在套杆内并可通过一具有轴向纹路的旋钮16手工旋转该轴杆,该旋钮安装在轴杆的一端并容纳在开口13中。该轴杆的另一端为一外径小于该轴杆的圆柱状部件17,它与一具有外螺纹的部件18相结合,一具有更小直径的光滑的末端部件19与螺纹部件18相结合,末端部件19在所述的轴杆的另一端形成一导向针。部件18和19容纳于伸出套杆外的套管14中,并且一凸缘20也伸出套杆外并容纳于所述部件内。
上述的医用器械可多次使用,因而应当由可以经受高压灭菌法的材料如不锈钢等制成。
该医用器械还包括一可互换和可置换的元件21,称为针。该针的一端上的一直形部件21’与套杆连结,另一端充分延伸形成一半圆,其自由端可以由阴道内的开口从耻骨下方穿过。该针具有圆形横截面和光滑的、最好为抛光的外表面。它在朝向自由端方向逐渐变细形成一针尖22,如图所示为圆锥形,或小平面形,但其也可以是一钝端并具有一横断切头。上述医用器械的实际应用表明最好的是圆锥形的针尖。该可置换针应当由与组织相容的各种塑料,如聚碳酸酯,或钢铁或类似材料制成。
为了将针21与套杆10连接,该针在所述形成的容纳在套管14的直形部件21’的一末端具有一从该末端表面延伸的轴向盲孔,所述孔具有螺纹部分23并在孔内含有一更细的圆柱部分24。当通过手工旋转旋钮16带动轴杆15旋转,将用于将针21安装在医用器械其余部分上的螺纹部分18旋入盲孔的螺纹部分23,使得套杆的末端表面和针紧密地压在一起时,导向针19的尺寸适合于可以导向的容纳于所述圆柱部分24中。该针被导入一个相对该套杆的预定旋转位置;它相对于手柄11的平面成直角并且,通过将套杆上的凸缘20容纳在针外表面内的一配合凹口25而确保该旋转位置。
针21的部分23上可以不形成螺纹而是做成这样的尺寸,即当针旋入轴杆15时轴杆15的螺纹部分18可在针上切出相应的螺纹。
当将该医用器械的两个部分按照上述方式拧在一起时即形成一刚性单元,当按照本发明的方法应用该刚性单元时,可以通过手柄11进行非常精确的控制。
在根据本发明的方法实际操作时,如图4所示,可将所述实施例中的两根针21A和21B连接在一根带子的两端。该带子的末端可以粘在针上但也可以通过将带子穿过图3所示的一个孔27与针连接,该孔位于针上临近与套杆相连的末端的位置,或将该带子的末端通过超声波焊接在针上或通过喷射模塑法烘烤使之融入塑料材料制成的针上来实现连接。
如图4所示,当植入该带子的手术开始时,一根针21A安装在套杆10上,另一根针21B松弛的垂在带子26上。在另一个实施例中,如申请日为2000年3月9日的共同未决的美国申请No.09/521,801中所述,该申请的全部内容结合在此作为参考,针21可以包括快速连接和拆卸装置从而可以只使用一根针。
图4至11概略的表示出女性下腹部的相关部分,阴道标记为28,膀胱标记为29,尿道为30,耻骨为31,腹壁为32。
图4描述了带子26植入手术的第一步,包括使用针21A穿过阴道壁,其中在所述壁上第一次形成一道切口,然后继续穿透尿道30一侧上的软组织,随后该针如图5所示在靠近耻骨31的下侧的地方穿过下腹壁32。可以在腹壁上预先形成用于该针穿过腹壁的一切口,但是如果该针足够锐利即可从腹壁内侧充分穿透腹壁并在腹壁的外表面形成一寄存切口。
如图6所示,此时通过旋钮16旋转轴杆15使得轴杆螺纹部分18从针21A中的螺纹部分23中旋开,将该器械的套杆从针21A上取下。随后如图7所示,使用夹钳装置将针21A从腹壁抽出从而使得带子26穿入并穿过组织。
如图8所示,此时将另一根针21B安装在套杆上,然后通过阴道壁中的切口穿过尿道30旁的另一侧软组织。如图9所示,针21B在耻骨31下面通过并穿过腹壁,随后,如图10所示,将针21B从套杆上拆下,并从腹壁中抽出,其操作过程与针21A相同。
此时如图10所示,带子26就位于尿道30的两侧,并如图11所示形成一个环绕尿道且位于尿道和阴道壁之间的回路。随后剪去带子露在腹壁外的剩余部分。带子26就作为一植入物留置在体内从而形成一人工韧带并为尿道提供所需的支持以防止尿失禁。
在图12至17所示的具体实施例中,套管14的末端部分14’从相对两侧拉平使得所述末端部分的横截面呈非圆形,位于针21与套杆10连结的末端的直形部分21’是圆柱状的但所述部分21’的外端部分被铣成平面21”,该平面21”从针的邻近的末端延伸出来并容纳于套管部分14’中。非圆形状的套管部件14’和具有平面21”且可配装入套管14’内的针的末端部分可以确保该针的预定旋转位置相对于套杆与手柄11的平面成直角。具有平面21”的针的末端部分通过一圆锥部分33连接到针体上,该圆锥部分朝凸缘33’方向逐渐变细。
在优选的实施例中,带子包括一个形成1mm大小的孔的筛或网。这些孔使得纤维原细胞可以长入带子并将带子固定在周围组织上。一种适合于带子的材料是FROLENE,一种厚度为0.7mm的聚丙烯编织网,由美国新泽西的Ethiconcr公司生产。这种材料经美国FDA核准可用于植入人体。
另一种可用于本发明的方法的带子可以比上述的带子编织的更为紧密而且可以是那种经过较短或较长时期即可被完全吸收的材料制成。通过带子的刺激引起纤维原细胞增殖从而恢复组织控制排尿的能力。
带子的材料可以具有一刺激纤维原细胞的物质的涂层,例如一种釉质基体的派生物。
编织网(带子)的宽度最好大约为10mm并被装入一薄的聚乙烯护套34中,该护套是扁平的并与具有与带子基本相同的宽度,但在图14中为了表示清楚而夸大了的它们之间宽度的差异。编织网的长度大约为400mm。编织网和护套可通过所示的两行35针缝合线相互连接,但这并不是必需的。护套的末端通过一收缩橡胶软管36与针的圆锥部分33连接,该软管36从凸缘331延伸并覆盖针的圆锥部分33并且部分的覆盖针的圆柱部分221。该收缩软管在凸缘处基本与针的表面嵌平。通过这种方式改编织网就可以安全的附着在针上,如果需要,还可以再将护套粘在部分33上。
护套34的最首要的目的是使编织网在上述方法中,也就是当编织网的末端从阴道壁被拉向腹壁皮肤时,可以顺利的插入,并且避免编织网的粗糙边缘刺激或破坏人体组织。
当带子作为环绕尿道的系带已经处于正确的位置时,可以除去聚乙烯护套。为了方便护套的去除,可以在护套的纵向中心如图17中所示的点划线位置打孔。对露出体外的护套末端分别施加拉力,在拉力的作用下护套在打孔位置分为两半并被抽出体外。可选的情况是,护套可以制成两部分,其在编织网的纵向中心互相重叠而不是相互连接。
聚乙烯护套的目的还是为了在将编织网安装在针上的过程中、之前的操作中和插入人体的过程中保护编织网。
带子和护套的纵向中心应当由一明显的彩色标记38作为指示如图17所示,使得医生在手术过程中可以容易的知道编织网何时处于关于尿道对称的位置。
从前面所述的可以明显看出,虽然已对本发明的特定形式进行了图示和描述,但在不背离本发明的精神和范围的情况下可以对其进行多种变形。因此,上述内容并不是对本发明的限制,在随后的权利要求中将对本发明进行限定。
Claims (15)
1.一用于治疗女性尿失禁的医用器械,包括:
(a)一植入女性下腹部为尿道提供支持的带子;和
(b)一具有一近端和一远端并可和该带子相连接的弯曲针状元件,该针状元件的尺寸适合于将带子从阴道壁中一开口穿过,经过耻骨下方并穿出腹壁。
2.如权利要求1的医用器械,其中所述针状元件被基本上弯曲成半圆形。
3.如权利要求1的医用器械,其中所述针状元件朝向末端方向逐渐变细。
4.如权利要求1的医用器械,其中带子是多孔的,适于纤维原细胞在其中生长。
5.如权利要求1的医用器械,其中带子涂有对纤维原细胞有刺激作用的原料。
6.如权利要求1的医用器械,还包括一包裹带子的薄塑料护套。
7.如权利要求6的医用器械,其中所述护套由聚乙烯制成。
8.如权利要求6的医用器械,其中护套在其纵向中心处有一穿孔线。
9.如权利要求6的医用器械,其中护套包括两个在相邻末端相互重叠的对半部分。
10.如权利要求6的医用器械,其中护套在其纵向中心有一明显标记。
11.如权利要求1的医用器械,其中针状元件的尺寸还适合于将带子从耻骨前面穿过。
12.如权利要求1的医用器械,其中通过剪断带子可使针状元件与带子分开。
13.如权利要求1的医用器械,还包括一可拆卸的将针状元件与带子附着在一起的附着机构。
14.如权利要求13的医用器械,其中附着机构包括一附着于带子一端的连接器和一位于针状元件远端的容纳槽,该容纳槽的尺寸和形状适合于安全并可拆卸的容纳该连接器。
15.如权利要求14的医用器械,其中附着机构包括一附着于带子近端的连接套杆和一位于针状元件远端的安装孔,该安装孔的尺寸和形状适合于安全并可拆卸的容纳该安装套杆。
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EP (1) | EP1343418B1 (zh) |
JP (1) | JP4156364B2 (zh) |
KR (1) | KR20030068153A (zh) |
CN (1) | CN1277512C (zh) |
AT (1) | ATE424769T1 (zh) |
AU (2) | AU2002230695B2 (zh) |
CA (1) | CA2429350C (zh) |
DE (1) | DE60137964D1 (zh) |
ES (1) | ES2322551T3 (zh) |
WO (1) | WO2002039890A2 (zh) |
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US6475139B1 (en) * | 1999-06-09 | 2002-11-05 | Ethicon, Inc. | Visually-directed surgical instrument and method for treating female urinary incontinence |
-
2001
- 2001-11-08 CN CNB01819074XA patent/CN1277512C/zh not_active Expired - Lifetime
- 2001-11-08 CA CA002429350A patent/CA2429350C/en not_active Expired - Lifetime
- 2001-11-08 EP EP01990938A patent/EP1343418B1/en not_active Expired - Lifetime
- 2001-11-08 WO PCT/US2001/047416 patent/WO2002039890A2/en active Application Filing
- 2001-11-08 DE DE60137964T patent/DE60137964D1/de not_active Expired - Lifetime
- 2001-11-08 AT AT01990938T patent/ATE424769T1/de not_active IP Right Cessation
- 2001-11-08 AU AU2002230695A patent/AU2002230695B2/en not_active Ceased
- 2001-11-08 ES ES01990938T patent/ES2322551T3/es not_active Expired - Lifetime
- 2001-11-08 KR KR10-2003-7006742A patent/KR20030068153A/ko not_active Application Discontinuation
- 2001-11-08 AU AU3069502A patent/AU3069502A/xx active Pending
- 2001-11-08 JP JP2002542268A patent/JP4156364B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
WO2002039890A2 (en) | 2002-05-23 |
ATE424769T1 (de) | 2009-03-15 |
AU3069502A (en) | 2002-05-27 |
EP1343418A2 (en) | 2003-09-17 |
CA2429350A1 (en) | 2002-05-23 |
EP1343418B1 (en) | 2009-03-11 |
AU2002230695B2 (en) | 2006-07-20 |
JP2004535835A (ja) | 2004-12-02 |
CA2429350C (en) | 2009-08-11 |
DE60137964D1 (de) | 2009-04-23 |
ES2322551T3 (es) | 2009-06-23 |
JP4156364B2 (ja) | 2008-09-24 |
KR20030068153A (ko) | 2003-08-19 |
CN1536976A (zh) | 2004-10-13 |
WO2002039890A3 (en) | 2003-05-01 |
EP1343418A4 (en) | 2006-05-24 |
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