CN1798533A - 用于泌尿生殖器脱垂和女性小便失禁的治疗中的修补物 - Google Patents

用于泌尿生殖器脱垂和女性小便失禁的治疗中的修补物 Download PDF

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CN1798533A
CN1798533A CNA2004800151504A CN200480015150A CN1798533A CN 1798533 A CN1798533 A CN 1798533A CN A2004800151504 A CNA2004800151504 A CN A2004800151504A CN 200480015150 A CN200480015150 A CN 200480015150A CN 1798533 A CN1798533 A CN 1798533A
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M·切尔维尼
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Abstract

本发明涉及一种修补物(1)，其由不可吸收的或部分可吸收的或生物材料构成的网形成。中心体具有置于膀胱颈(B)和中尿道下面的第一部件(3)，以及用于膀胱体(D)和位于膀胱(A)下部下方的膀胱基部(E)的第二部件(4)。所述部件是按照修补物(1)的插入方向的顺序被定义为第一和第二部件的。第一对臂状物(5)和(6)从中心体(2)的第一部件(3)的两侧延伸出来，所述臂状物(5)和(6)被双侧向地置于闭孔(F)内并且第二对臂状物(7)和(8)从中心体(2)的第二部件(4)的两侧延伸出来，所述的臂状物(7)和(8)被用于阴唇主体侧的会阴并且穿透球形海绵体肌肉。

Description

用于泌尿生殖器脱垂和女性小便失禁的治疗中的修补物
相关申请的交叉参考
本申请要求2003年4月30日申请的发明人为Mauro Cervigni的意大利专利申请No.RM2003A000210的名称为“Protesi daimpiegarsi nella terapia chiurgica del prolasso urogenitale edell’incontinenza urinaria femminile”的权益(其全部内容结合在此作为参考)。
背景技术
本发明涉及一种由不可吸收的或部分可吸收的或生物材料构成的网形成的修补物1。中心体2具有一个被置于膀胱颈B和中尿道C下面的第一部件3，以及一个用于膀胱体D和位于膀胱下部下方的膀胱基部E的第二部件4；所称的第一和第二部件是根据修补物插入方向的顺序确定的；第一对臂状物5和6从中心体2的第一部件3的两侧延伸出来，所述臂状物5和6被双侧向地置于闭孔F内并且第二对臂状物7和8从中心体2的第二部件4的两侧延伸出来，所述的臂状物7和8被用于球形海绵体肌肉侧面阴唇主体的侧会阴。
发明内容
本发明涉及一种用于泌尿生殖器脱垂和女性小便失禁的外科治疗中的修补物。
本发明尤其涉及一种在泌尿生殖器脱垂和女性小便失禁的外科治疗中伴随使用的修补物，可一次手术解决上述两个问题。
术语泌尿生殖器脱垂，对照女性骨盆的生理结构，一般指的是子宫，膀胱和直肠的内错位引起的阴道壁错位。
在生物进化过程中，从解剖学的角度，由所谓盆腔内脏的位置的颠倒判定人类采取一种直立的姿势。
特别地，女性骨盆必须支撑腹内器官的重量，却没有来自骨盆结构的充分相对支撑。
因此，上述泌尿生殖器脱垂可由很多原因造成，其中包括任何可增加女性骨盆腹内压力的情况，如损伤性的体育活动，长时间的站立，久咳，以及肥胖。
此外，脱垂不但在多次分娩中是常见的，而且在支撑子宫的结构虚弱并且健康状况不良的女性中，甚至未生育过的女性中更为普遍。
脱垂不太严重或较严重都会导致生活质量降低，并且引起局部循环紊乱、外生殖器肿胀、背痛、下腹坠重，严重的可导致溃疡和伤流溢泌，小便和大便困难。
此外，脱垂的一个重要后果就是应激性尿失禁，这是由于阴道前壁，尿道和膀胱颈的下移引起的。
泌尿生殖器脱垂的各种类型迥异，取决于其涉及的区域，在该区域的精确位置以及下移的程度，即：阶段I为子宫颈的下限或前阴道壁到达阴道腔中部但还未到达阴门孔；阶段II为子宫颈或前阴道壁到达阴门孔；阶段III为子宫颈的下端或前阴道壁从阴门伸出。
术语子宫突出指的是子宫脱垂；尿道突出是指尿道脱垂；膀胱突出症是指膀胱下移；脱肛是指直肠下移。当不止一种症状出现时合并术语，如尿道-膀胱脱垂或肛门-膀胱下移。
脱肛可由于侧或横向内盆筋膜或两者(中-侧)脱落而产生。
这些不同的表症可用特定的外科方法处理，这些方法有时也在变化。
有人已提出治疗筋膜侧脱落的手术，包括腹部(近阴道修复)和阴道(阴道近阴道修复)手术；前阴道壁的四个点用外科方法由四对不可吸收的缝合线连接至后阴区域，就是所谓的“四来者”技术。在中心分离中，该方法包括平均(medializing)相邻的阴道结构，也就是说，提肌和筋膜，以抬高阴道，膀胱和偶尔抬高子宫。
关于脱肛的外科手术方法包括所称的后阴道缝合术，即所涉及组织固定于提肌ani的中部(提肌缝合术)，或穿肛治疗。
虽然甚至在早期治疗泌尿生殖器脱垂的外科疗法多种多样，当比较不同方法时，结果不尽人意，因为术后6个月至1年内复发率高达30％。
近期对于国际文献的分析数据表明，前阴道壁脱垂的外科修复在术后6-48个月内复发率为20～78％。
病人在一个区域治疗的脱垂随着时间推移发展到其它未治疗区域的几率也与此相似。
复发的原因可能主要在于任何修复手术在疤形成期都需要相应连接结构的稳定和加固。事实上，许多情形下，新形成的胶原质是构成外科处理结构的下移的诱因。
事实上，连接组织被弱化，尤其是因为在脱垂发生(近绝经或绝经后妇女)的典型年龄期，雌激素降低促进了弱型胶原质组织的形成。
从1995年起，本发明人已经提出了在生殖器脱垂修复中人造网的使用，其灵感来自于在普通外科手术中提出和使用的过程，即在腹股沟囊修复中使用的人造网。腹股沟囊的复发率最终从20-30％降至1-2％。
同样，人造网在修复生殖器脱垂的应用将复发率从过去的30-50％急剧降至现在的3-6％。
使用的材料多种多样并且“理想”的材料还未被确定，但是聚丙烯纺织纤维(prolene)(交织人工单丝：聚丙烯)是最接近生物相容的材料的理想必需品。这些材料，为将并发症和长期后遗症减少到最低，必须“无张力”使用，即它们不能对阴道壁或膀胱或直肠造成拖拉或压力，否则不可避免地会造成这些器官功能的改变。
经常性的泌尿生殖器脱垂也和小便失禁有关。
应激性尿失禁(SUI)主要影响女性并且其特征在于，身体活动时或如举重物压迫时尿失控。原因很多，其中有：胎儿通过阴道腔时阵痛和分挽造成的外伤；更年期；反复的骨盆外科手术，如子宫切除术。从病理生理的角度看，本已脆弱的女性尿道括约肌由于支撑和拉伸会阴肌(肛门提肌)的韧带的伸缩而更加脆弱。
过去，矫正SUI的各种技术都采用病人自己的组织来加强括约肌的活动。然而，仔细分析文献表明，复发率可达到15-20％。由于瑞典学校(Ulmsten)的工作，提出了一种新的使用聚丙烯纺织纤维网的微入侵外科方法，在尿道的中三分之二处采用“无张力”技术。带子的两个末端用两个弯针移至耻骨区域。更新的变化是使用闭孔来稳定尿道下的网。这样尿道括约肌的支撑就尽可能“生理化”地完成。
因此目前已有治疗SUI的修补物和治疗生殖器脱垂的修补物，但是解决上述问题需要单个的手术从而给病人带来不便。很明显，需要一种新的在一次手术中可同时解决生殖器脱垂和SUI问题的修补物。
本发明人制备了一种由不可吸收的或部分可吸收的材料构成的网形成的修补物以运用“无张力”技术，也就是说，没有对周围组织的拉伸力，可解决上述两个问题。
因此本发明为一种用于泌尿生殖器脱垂和妇女小便失禁外科治疗的修补物，由不可吸收的或部分可吸收的或生物材料构成的网形成。中心体具有一个被置于膀胱颈和中尿道下面的膀胱附近的第一部件；被放置于膀胱下部下方与膀胱体和膀胱基部连接的第二部件。第一和第二部件是根据修补物插入方向的顺序确定的；第一对臂状物从中心体的第一部件两侧延伸出来，所述臂状物被双侧向地置于闭孔内并且第二对臂状物从中心体的第二区的每一侧延伸出来，所述的臂状物被置于阴唇主体的侧面的会阴上并且穿过球形海绵体肌肉。
上述命名的臂状物被指定为第一和第二对，在其各个未与中心体连接的末端，作为连接一次性使用的弯针的装置，即所谓的连接装置实际上是不可重复使用的。
特别地，所述的第一对臂状物在与实际修补物的所述插入方向相反的方向上与修补物的中心体成一个角度。
继续描述本发明，所述第二对臂状物在与修补物的前述插入方向上与修补物的中心体成一个角度。优选，第一和第二臂状物都涂敷尼龙外皮以助于其在组织上滑动。
本发明所述的修补物由不可吸收的或部分可吸收的人造物构成。本发明涉及一种用于泌尿生殖器脱垂和女性小便失禁的外科治疗中的修补物。
网为消毒和惰性的，具有双向弹性延伸性，并且可耐受超过10kg/cm2的拉力，厚度为0.5mm-0.9mm，优选约为0.7mm。
网线之间的交叉是互相连接的，这样网就可以在任意方向上剪开而不分散。
约为菱形的孔的横向尺寸为1mm-3mm之间。
每根线都为聚乙烯(C3H6)不可吸收的单丝，更特定地为聚乙烯全同立体异构体(isotactic stereoisomer)。
一种类型的网，尤其适于本申请的类型，是由Ethicon公司出品的聚丙烯纺织纤维单丝构成的，以商品名聚乙烯聚丙烯纺织纤维网进行销售。
作为上述不可吸收的网的替代物，可用相同功效的一种部分可吸收的网或一种生物材料如真皮，围心膜，或肠黏膜下层。优选网的中心部分由生物组织构成并且第一和第二对臂状物由人造材料构成。
外科技术如下所述。
在外尿道下方至前阴道穹窿纵切1cm的口子。下面的阴部子宫颈筋膜于是脱落，到达坐骨阴部向上分枝和侧穹窿的侧面。在腹股沟褶里的阴蒂上方1cm处切两个切口(2)，并且一个弯针穿过闭孔从膀胱颈两侧引出。修补物的一个臂状物的顶点缠绕在针上(或用Luer锁连接)并且从前面的通道拉出。在阴唇主体侧面阴道前庭的水平处再做两个1-2cm的切口并且使用穿透球形海绵体肌肉的相同弯针，针末端从侧穹窿后面露出2cm。网的一个自由皮片位于膀胱基部下面，阴道开口紧密缝合。用一种综合方法，对已被置于前阴道壁上且位于其外部的臂状物实施拉力，放置网时越轻巧越好，接着将多余的组织切除并且封闭4个(4)皮肤开口。
关于骨盆下移病因学的新发现表明，膀胱突出症被认为是真正的“膀胱突出”。内盆筋膜的改变和松弛(“骨盆底的解剖学”，J.O.DeLancey，Curr.Opin.Obstet.Gynecol.1994年8月；6(4)：313-6)以及肌肉和韧带的下垂(“生殖器脱垂的解剖学和生物力学”，J.O.DeLancey，Clin.Obstet.Gynecol.1993年12月；36(4)：897-909)的原因是“膀胱脱出”的最初过程。因此治疗方案类似对脱肠的治疗。“无张力”网的放置有助于重建已改变的内盆筋膜的支撑。“无张力”技术这个概念还有助于考虑作用于骨盆出口的作用力线从而避免了解剖变形，这在骨盆外科手术的修复技术中频频发生。由于这些原因，穿会阴放置使用“无张力”网被认为是校正膀胱突出症和应激性尿失禁(SUI)的新技术。
发明人将本发明的修补物以上述技术用于大量病人，约400人，并跟踪研究超过3年，治愈率超过90％，并发症频率很低，其中包括：溃烂(6％)，性交困难(5％)，骨盆疼痛(7％)。
本发明修补物的另一个优点在于增加外科移植网孔间连接组织的产生，建立一种自然不可吸收的并具有弹性的支撑，从而提供了有效的支撑并且避免了由于脱垂和失禁引起的骨盆下移。
此外，可在脱垂和失禁的早晚期外科施用前述的修补物，能够校正所有的现有缺陷，主要和/或次要和SUI避免了进一步缺陷的潜在表现，所以在外科治疗前对修补物的位置差异诊断是多余的。
附图说明
现在对参照最佳实施方式和特定附图对本发明进行描述，该描述为说明性的而非限制性的，其中：
图1为根据本发明的修补物的外形；
图2为图1所示的修补物施用于女性泌尿生殖器的后观图；
图3为图1所示的修补物施用于女性泌尿生殖器的前视图；
图4为施用图1所示的修补物的外科技术的最后步骤，其中示出供修补物的臂状物插入的切口。
具体实施方式
观察附图，演示了本发明的修补物实现的形态，一般用编码1表示。
修补物1由不可吸收的或部分可吸收的或生物材料构成的网构成并且包括一个具有一个被置于膀胱颈B和中尿道C下面的第一部件3的中心体2，以及一个用于膀胱体D和位于膀胱下部下方的膀胱基部E的第二部件4；第一和第二部件是根据修补物的优选插入方向的顺序得名的；第一对臂状物5和6从中心体2的第一部件3两侧延伸出来，所述臂状物5和6被双侧向地置于闭孔F内并且第二对臂状物7和8从中心体2的第二部件4的两侧延伸出来，所述的臂状物7和8被用于阴唇主体侧的会阴并且穿透球形海绵体肌肉(参见图4，显示臂状物7和8穿过的切口H)。为利于4个臂状物的导入和固定，所述臂状物覆盖一个尼龙外皮，一旦就位即被取掉。
如上所述，本发明的修补物施用的外科技术主要包括暴露前阴道壁并且在外尿道下方至前阴道穹窿纵切1cm的口子。下面的阴部子宫颈筋膜(fascia)于是脱落，到达坐骨阴部向上分枝的侧面和穹窿的侧面。接着在腹股沟褶里的阴蒂上方1cm处切两个(2)侧切口(G)，并且一个弯针穿过闭孔(F)从膀胱颈沿两侧向引出。修补物的一个臂状物的顶点缠绕在针上并且从前面的通道拉出，这样就将中心体(2)的第一部件(3)置于膀胱颈(B)下的膀胱(A)和中尿道(C)以及闭孔(F)内的臂状物(5和6)旁边(参见图4，示出臂状物5和6穿过的切口G)。在阴唇主体侧面阴道前庭的水平处再做两个(2)1-2cm的切口(H)并且使用相同弯针从球形海绵体肌肉的侧面穿透通道，针末端从侧穹窿后面露出2cm，以将修补物(1)中心体(2)的第二部件(4)置于膀胱体(D)和膀胱基部(E)旁以及膀胱下部和会阴内位于阴唇主体侧面并且侧面穿过会阴至球形海绵体肌肉的臂状物(7和8)的下部(参见图4，示出臂状物7和8穿过的切口H)。网的一个自由皮片位于膀胱内部下面，在用Metzenbaum剪刀确定膀胱颈下面的两个前臂状物没有张力后，阴道开口被紧密缝合。用一种综合方法，对已被置于前阴道壁上且位于其外部的臂状物实施拉力(用放于阴道内的两个手指)，放置网时越轻巧越好，接着将多余的组织切除并且封闭4个(4)皮肤开口(G，H)。
根据最佳实施方式对本发明的描述为说明性的而非限定性的，但是必须了解，可能对本发明做出改变和/或改进，但都不超出所附权利要求的保护范围。

Claims (14)

1.一种用于泌尿生殖器脱垂和女性小便失禁外科治疗的修补物，其由不可吸收的或部分可吸收的或生物材料构成的网形成，所述修补物包括一个具有一个被置于膀胱颈和中尿道下面的膀胱下方的第一部件的中心体；被放置于膀胱下部下方与膀胱连接的第二部件；从中心体的第一部件两侧延伸出来的第一对臂状物，所述臂状物被双侧向地置于闭孔内；以及从中心体的第二部件的两侧延伸出来的第二对臂状物，所述的第二对臂状物被置于阴唇主体侧面的会阴上并且穿过提肌。
2.如权利要求1所述的修补物，其特征在于，所述第一和第二对臂状物的各个末端不与所述中心体连接，而是作为外科弯针，优选一次使用的外科弯针的连接装置。
3.如权利要求2所述的修补物，其特征在于，所述连接装置是不可重复使用的。
4.如权利要求2所述的修补物，其特征在于，所述第一和第二对臂状物具有尼龙外皮。
5.如权利要求1所述的修补物，其特征在于，所述第一对臂状物在与该修补物优选的插入方向相反的方向上与修补物的中心体成一个角度。
6.如权利要求1所述的修补物，其特征在于，所述第二对臂状物在该修补物优选的插入方向上与修补物的中心体成一个角度。
7.如权利要求1所述的修补物，其特征在于，不可吸收的或部分可吸收的的人造网具有双向弹性膨胀性并且可耐受大于10KG/cm2的拉力。
8.如权利要求7所述的修补物，其特征在于，网的厚度在0.5mm至0.9mm之间。
9.如权利要求7所述的修补物，其特征在于，网的厚度约为0.7mm。
10.如权利要求1所述的修补物，其特征在于，网是由聚丙烯制成的。
11.如权利要求1所述的修补物，其特征在于，网中心由生物材料制成且第一和第二对臂状物由人造材料制成。
12.如权利要求2所述的修补物，其特征在于，所述第一对臂状物在与修补物优选的插入方向相反的方向上与修补物的中心体成一个角度。
13.如权利要求3所述的修补物，其特征在于，所述第一对臂状物在与修补物优选的插入方向相反的方向上与修补物的中心体成一个角度。
14.如权利要求4所述的修补物，其特征在于，所述第一对臂状物在与修补物优选的插入方向相反的方向上与修补物的中心体成一个角度。
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ITRM20030210A1 (it) 2004-11-01
WO2004098461A3 (en) 2005-06-30
BRPI0409826A (pt) 2006-05-09
US20050004427A1 (en) 2005-01-06
ITRM20030210A0 (it) 2003-04-30
CA2524149A1 (en) 2004-11-18
WO2004098461A2 (en) 2004-11-18
EP1617786A2 (en) 2006-01-25

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