CN102740797A - 用于治疗骨盆病状的细长植入系统和方法 - Google Patents
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Abstract
植入系统可以包括一根或多根针,诸如用于骨盆底修复程序中的针;和一个或多个细长植入物。可以利用注射器或类似样式的中空针,将细长网状物或其它植入装置通过一个或多个小刺创切口递送到靠近阴道的骨盆内的靶组织部位中。通过切口插入后,可以将植入装置设放成接合和拉紧或收紧支撑组织(例如盆内筋膜、耻骨宫颈筋膜、直肠阴道筋膜、提肌,或患者骨盆内的其它支撑性肌肉或组织)。
Description
优先权
本申请要求2009年12月30日提交的美国临时申请第61/291,031号的优先权和权益,所述申请的全部内容据此以引用方式并入本文。
技术领域
本发明总体上涉及手术方法和设备,更具体地涉及经由针的微创脱垂修复,以及形成和使用所述针的方法。
背景技术
男性和女性的骨盆健康是重要性日益增加的医学领域,这至少部分是由于人口的老龄化。常见骨盆疾病的实例包括失禁(例如,大便失禁和尿失禁)、骨盆组织脱垂(例如,女性阴道脱垂)和骨盆底的诸多病状。
尿失禁可以进一步分类为包括不同的类型,例如压力性尿失禁(SUI)、急迫性尿失禁、混合型尿失禁,等等。其它骨盆底病症包括膀胱膨出、直肠膨出、肠膨出,以及脱垂,例如肛门脱垂、子宫脱垂和阴道穹窿脱垂。膀胱膨出是一种膀胱疝气,通常会进入阴道和阴道口中。诸如这些的骨盆病症可由正常骨盆支撑系统的弱化或损伤引起。
尿失禁的特征可以是在膀胱充满尿液时保持尿道括约肌闭合的能力丧失或衰退。男性或女性压力性尿失禁(SUI)一般在患者身体受压迫时发生。
阴道穹窿脱垂的最严重形式可以导致阴道尖扩张到阴道外。肠膨出是一种阴道疝气,其中含有小肠的一部分的腹膜囊延伸到直肠阴道空间中。阴道穹窿脱垂和肠膨出对于外科医生而言是具有挑战性的骨盆病症。这些程序涉及的手术时间往往很长。
与尿失禁一样,已证明大便失禁在治疗方面有挑战性。由肛门外括约肌损伤引起的大便失禁的患者需要通过手术治疗,如用括约肌成形术。其它患者被认为具有神经性或特发性大便失禁,成功治疗这些患者的可能性较小。各种程序,例如肛门后修补、总骨盆底修复、肌肉移位技术、动力性股薄肌成形术(dynamic graciloplasty)、人工括约肌程序,和骶神经刺激。成效有限,并且各种治疗形式都可导致发病。
期望获得可用于治疗失禁(尿失禁或大便失禁)和/或器官脱垂以及其它骨盆病状的微创而高效的修复装置和方法。
发明内容
本发明描述了用于治疗骨盆病状的系统、针和方法,所述骨盆病状例如失禁、阴道脱垂(包括各种形式,诸如肠膨出、膀胱膨出、直肠膨出、顶部或穹窿脱垂、子宫下垂等),以及由肌肉和韧带弱化引起的其它骨盆病状。
所述系统的实施方案可以包括一根或多根针,诸如用于骨盆底修复程序中的针。可以利用注射器或类似样式的中空针,将细长网状物(mesh)或其它植入装置通过一个或多个小刺创切口递送到骨盆内的靶组织部位中。通过切口插入后,可以将植入装置设放成接合和拉紧或收紧支撑组织,例如盆内筋膜、耻骨宫颈筋膜、直肠阴道筋膜、提肌,或患者骨盆内的其它支撑性肌肉或组织。所述装置可以包括一个或多个适合于支撑各种靶组织或器官的网状物构件、杆或编织构件。
所述植入装置可以接合、拉紧或以其它方式张紧组织,从而导致组织收紧并减少松弛以便加强支撑。这样,利用所述植入物的实施方案,可以省去失禁悬带情况下通常需要的置于尿道下的网状物或其它支撑性结构。
本发明可以包括用于泌尿学应用,特别是用于治疗压力性和/或急迫性尿失禁、大便失禁,以及脱垂和会阴部修复的手术器械、可植入制品以及方法。如所述的,失禁的常见治疗包括设放悬带来压制尿道括约肌或者提升或支撑膀胱缺陷的颈部。
附图说明
图1示出根据本发明植入法的女性解剖学的各种相关结构的横截面示意图。
图2示出根据本发明实施方案的递送工具。
图3-6示出根据本发明实施方案的示例性细长植入物。
图7示出女性患者和相关的解剖学结构。
图8示出为根据本发明实施方案的植入做准备的阴道扩张的女性患者。
图9-11示出根据本发明实施方案的细长植入物在刺创切口内的植入。
图12示出根据本发明实施方案的各种相关解剖学结构和经过部署的细长植入物的横截面示意图。
具体实施方式
总体上参考图1-图12,公开了骨盆修复系统10的各种实施方案。本发明一个方面是治疗男性或女性尿失禁的设备和方法。在各种实施方案中,将一个或多个植入物或植入构件设放在策略性定位的(strategically located)位置以便拉起或以其它方式收紧尿道外侧或者阴道前方或后方的组织和/或肌肉,从而大体上重建患者的原始解剖学结构。
本文详述的各种实施方案的结构或部分可以用诸如聚丙烯、聚乙醇酸交酯、聚L-丙交酯,或其它已知的可生物解降(可再吸收)或不可生物降解的聚合物的材料构建。进一步来说,可以将生长因子或干细胞接种或者以其它方式提供在所述装置的一个或多个组件上,从而促进愈合或组织向内生长。除了利用针导入器装置导入和部署所述装置或组件之外,还可以利用套管或导管系统。
图1示出女性解剖学的一般解剖学结构,包括尿道U、阴道V和肛门A。
系统10可以包括一个或多个注射器或针装置12,如图2所示。针装置12可以包括中空针部分14和手柄部分16。针部分14可以包括适合于容纳、部署和释放一个或多个植入物18的内腔。中空针部分14可以包括远侧尖端20,其适合于靠近阴道V(例如前方或后方)制造一个或多个小刺创切口并穿过所述刺创切口。针部分14可以是笔直的、弯曲的或螺旋状。进一步来说,装置12可以包括一个或多个适合于选择性地保留或部署来自装置12的一个或多个植入物18的致动或触发机构(例如,针腔)。
远侧尖端20和针部分14的至少一部分适合于插入从而制造刺创切口并穿过所述刺创切口进入患者骨盆内的靶组织部位。可预想本文详述的各种系统10、植入物、工具、特征部件和方法是与已知植入物和修复系统(例如,供男性和女性用的植入物和修复系统)、特征部件和方法的全部或部分一起使用,或者可以利用已知植入物和修复系统(例如,供男性和女性用的植入物和修复系统)、特征部件和方法的全部或部分,包括美国专利第7,267,645号、第7,500,945号、第7,229,453号、第7,407,480号、第7,393,320号、第7,351,197号、第7,347,812号、第7,303,525号、第7,291,104号、第7,025,063号、第6,691,711号、第6,648,921号、第6,612,977号、第6,592,515号,和国际专利公布WO 2010/027796、WO 2008/057261和WO 2007/097994,以及美国专利公布2002/151762和2002/147382中公开的那些植入物和修复系统、特征部件和方法。因此,上面列举的公开和公布的全部内容以引用方式并入本文。
图3-6示出植入物18的各种示例性实施方案。一般而言,所述植入物是构建成细长或杆形构造。植入物18可以定形、构建或形成为细长网状条(图6)、细长杆(图5),或编织杆(图3)。进一步来说,植入物18的各种实施方案可以包括一个或多个端部锚固件22从而促进部署和定位期间的组织接合和保持。另外,植入物18的诸多部分可以包括延伸构件、隆起部、倒钩、尖部、表面糙度、表面边缘或类似特征部件,从而促进部署后的植入物18对组织的固定。
如图7-12所示,描绘了骨盆修复系统10的各种可用步骤或程序。首先,如图7所示,将患者置于仰卧位。然后如图8所示,扩张阴道V。可以利用各种已知工具、牵开器、充气球或类似装置和程序实现这种阴道扩张。
提供的一个或多个针装置12用于从外部穿入或者靠近阴道V或沿着阴道V外围刺创切口。或者,刺创切口可以首先由医生用手术工具制造,然后针装置12可以通过一个或多个刺创切口导入以便部署针14和植入物18。
接着,可以通过一个或多个切口插入针装置12,从而将植入物18(例如,网状物、杆、编织材料或类似植入物)部署到针14的内腔中并从所述内腔部署所述植入物。然后,当将植入物18固定在适当的位置时,拔出中空管针14,从而将植入物18留在适当的位置以支撑骨盆底。许多这些步骤可以重复进行,直至部署所需数量的针或植入物,或者实现所需的支撑。本发明的配置提供了适合于控制植入物深度从而提供一致性和最佳设放的系统。进一步来说,远侧尖端20或针14,以及植入物18适合于穿入阴道V周围的骨盆内的靶组织或解剖学结构,从而提供用于解决失禁或脱垂弱化的所需接合和组织支撑。
在某些实施方案中,针14适合于通过刺创切口插入,使得植入物18可以插入到阴道、尿道等周围的内部支撑组织中,或者以其它方式与所述内部支撑组织接合,所述内部支撑组织例如耻骨宫颈筋膜、直肠阴道筋膜、盆内筋膜、提肌,仅以这些为例。如图9-11所示,用于部署植入物18的间距、方位和模式可以有很大的变化。各种前方模式布置(相对于阴道)和定位的植入物18在图9和11中示出。图10示出植入物18的示例性后方模式和定位。图中所示的植入物18的数量、定位和切入点仅用于说明目的,并且可预想本发明的无数其它模式和植入构件。图12示出部署并接合在患者体内以便提供所需的支撑和张紧力的本发明的各种示例性植入物18。植入物18可以延伸进入骨盆区或靶接合组织,即延伸相关器官或腔(例如,尿道U或阴道V)的全程,或者沿着短于整个器官或腔长度的距离延伸。
本发明实施方案提供了优于常规方法和系统的关键优势,包括:控制植入深度从而减少植入物变化,降低挤压或糜烂的风险,缩短恢复时间,因为没有大切口、钝性解剖、缝合等。系统10的各个部分可以用已知或相容性聚合物或金属材料(例如,镍钛诺(Nitinol))构建。
本发明替代实施方案可以用于恢复肛提肌结构从而提供进一步支撑。还可预想使用所述系统来恢复或支撑其它解剖学结构。进一步来说,导引导管工具或系统、磁导传感器和工具,以及其它已知装置和递送系统也可以与本发明一起使用。
本文引用的所有专利、专利申请和公布的全部内容据此以引用方式并入,如同单独并入一样,并包括所列专利、专利申请和公布中并入的那些参考文献。
显然,根据本文的教导,本发明的许多修改和变化是可能的。因此,应理解在附属权利要求书的范围内,本发明可以按不同于本文具体描述的方式来实践。
权利要求书(按照条约第19条的修改)
1.一种骨盆底修复系统,其包括:
针递送工具,其具有手柄部分和针部分,其中所述针部分包括内腔;
一个或多个细长植入物,其适合于至少部分地插入到所述针部分的内腔内并从所述内腔予以部署;和
其中所述针部分的远侧部适合于通过靠近患者阴道和围绕患者阴道外围的一个或多个外部刺创切口插入,使得所述一个或多个细长植入物通过所述一个或多个外部刺创切口插入,并在所述患者骨盆区内接合到靠近所述阴道的组织上,以便大体上将所述组织维持在其正确解剖学位置,从而治疗骨盆底病症。
2.根据权利要求1所述的系统,其中所述一个或多个细长植入物包括一个或多个细长网状物植入物。
3.根据权利要求1所述的系统,其中所述一个或多个细长植入物包括一个或多个细长杆状植入物。
4.根据权利要求1所述的系统,其中所述一个或多个细长植入物包括一个或多个细长编织植入物。
5.根据权利要求1所述的系统,其中所述一个或多个刺创切口是设在所述患者的所述阴道前方。
6.根据权利要求1所述的系统,其中所述一个或多个刺创切口是设在所述患者的所述阴道后方。
7.根据权利要求1所述的系统,其中所述一个或多个植入物包括至少一个端部组织锚固件。
8.根据权利要求1所述的系统,其中所述一个或多个植入物适合于与选自由耻骨宫颈筋膜、直肠阴道筋膜和提肌组成的组的组织接合。
9.根据权利要求1所述的系统,其中所述一个或多个植入物包括至少三个植入物。
10.一种用于治疗骨盆病症的植入系统,其包括:
至少一个针递送工具,其具有手柄部分和针部分,其中所述针部分包括内腔;
多个细长植入物,其适合于至少部分地插入到所述针部分的内腔内并从所述内腔予以部署;和
其中所述针部分的远侧部适合于通过靠近患者阴道的多个外部刺创切口插入,使得所述多个植入物通过各个外部刺创切口部署以固定靠近所述阴道的内部组织,以便大体上将所述组织维持在其正确解剖学位置。
11.根据权利要求10所述的系统,其中所述多个细长植入物包括多个细长网状物植入物。
12.根据权利要求10所述的系统,其中所述多个细长植入物包括多个细长杆状植入物。
13.根据权利要求10所述的系统,其中所述多个细长植入物包括多个细长编织植入物。
14.根据权利要求10所述的系统,其中所述多个刺创切口是设在所述患者的所述阴道前方。
15.根据权利要求10所述的系统,其中所述多个刺创切口是设在所述患者的所述阴道后方。
16.根据权利要求10所述的系统,其中所述多个植入物包括至少一个端部组织锚固件。
17.根据权利要求10所述的系统,其中所述多个植入物中的至少一个适合于与选自由耻骨宫颈筋膜、直肠阴道筋膜和提肌组成的组的组织接合。
18.一种治疗患者的骨盆病症的方法,其包括:
提供具有手柄部分和针部分的递送工具,其中所述针部分包括内腔;
提供多个细长植入物;
靠近所述患者的阴道制造多个外部刺创切口;
将所述多个细长植入物中的至少一个提供到所述递送工具的所述针部分的所述内腔内;
通过所述多个外部刺创切口的至少一个插入所述针部分的至少一部分;
将所述多个细长植入物中的至少一个部署在所述多个外部刺创切口的至少一个内,以固定靠近所述阴道的内部组织;和
将所述针部分的插入部分从所述多个外部刺创切口的至少一个中移去。
19.根据权利要求18所述的方法,其中制造多个刺创切口包括制造多个位于所述阴道前方的刺创切口。
20.根据权利要求18所述的方法,其中制造多个刺创切口包括制造多个位于所述阴道后方的刺创切口。
21.根据权利要求18所述的方法,其中提供多个细长植入物包括提供多个细长网状物植入物。
22.根据权利要求18所述的方法,其中提供多个细长植入物包括提供多个细长杆状植入物。
23.根据权利要求18所述的方法,其中提供多个细长植入物包括提供多个具有一个或多个端部组织锚固件的细长植入物。
Claims (23)
1.一种骨盆底修复系统,其包括:
针递送工具,其具有手柄部分和针部分,其中所述针部分包括内腔;
一个或多个细长植入物,其适合于至少部分地插入到所述针部分的内腔内并从所述内腔予以部署;和
其中所述针部分的远侧部适合于通过靠近患者阴道的一个或多个刺创切口插入,使得所述一个或多个细长植入物在患者骨盆区内接合到靠近所述阴道的组织上,以便大体上将所述组织维持在其正确解剖学位置,从而治疗骨盆底病症。
2.根据权利要求1所述的系统,其中所述一个或多个细长植入物包括一个或多个细长网状物植入物。
3.根据权利要求1所述的系统,其中所述一个或多个细长植入物包括一个或多个细长杆状植入物。
4.根据权利要求1所述的系统,其中所述一个或多个细长植入物包括一个或多个细长编织植入物。
5.根据权利要求1所述的系统,其中所述一个或多个刺创切口是设在所述患者的所述阴道前方。
6.根据权利要求1所述的系统,其中所述一个或多个刺创切口是设在所述患者的所述阴道后方。
7.根据权利要求1所述的系统,其中所述一个或多个植入物包括至少一个端部组织锚固件。
8.根据权利要求1所述的系统,其中所述一个或多个植入物适合于与选自由耻骨宫颈筋膜、直肠阴道筋膜和提肌组成的组的组织接合。
9.根据权利要求1所述的系统,其中所述一个或多个植入物包括至少三个植入物。
10.一种用于治疗骨盆病症的植入系统,其包括:
至少一个针递送工具,其具有手柄部分和针部分,其中所述针部分包括内腔;
多个细长植入物,其适合于至少部分地插入到所述针部分的内腔内并从所述内腔予以部署;和
其中所述针部分的远侧部适合于通过靠近患者阴道的多个刺创切口插入,使得所述多个植入物部署在各个刺创切口内以固定靠近所述阴道的内部组织,以便大体上将所述组织维持在其正确解剖学位置。
11.根据权利要求10所述的系统,其中所述多个细长植入物包括多个细长网状物植入物。
12.根据权利要求10所述的系统,其中所述多个细长植入物包括多个细长杆状植入物。
13.根据权利要求10所述的系统,其中所述多个细长植入物包括多个细长编织植入物。
14.根据权利要求10所述的系统,其中所述多个刺创切口是设在所述患者的所述阴道前方。
15.根据权利要求10所述的系统,其中所述多个刺创切口是设在所述患者的所述阴道后方。
16.根据权利要求10所述的系统,其中所述多个植入物包括至少一个端部组织锚固件。
17.根据权利要求10所述的系统,其中所述多个植入物中的至少一个适合于与选自由耻骨宫颈筋膜、直肠阴道筋膜和提肌组成的组的组织接合。
18.一种治疗患者的骨盆病症的方法,其包括:
提供具有手柄部分和针部分的递送工具,其中所述针部分包括内腔;
提供多个细长植入物;
靠近所述患者的阴道制造多个刺创切口;
将所述多个细长植入物中的至少一个提供到所述递送工具的所述针部分的所述内腔内;
将所述针部分的至少一部分插入到所述多个刺创切口的至少一个内;
将所述多个细长植入物中的至少一个部署在所述多个刺创切口的至少一个内,以固定靠近所述阴道的内部组织;和
将所述针部分的插入部分从所述多个刺创切口的至少一个中移去。
19.根据权利要求18所述的方法,其中制造多个刺创切口包括制造多个位于所述阴道前方的刺创切口。
20.根据权利要求18所述的方法,其中制造多个刺创切口包括制造多个位于所述阴道后方的刺创切口。
21.根据权利要求18所述的方法,其中提供多个细长植入物包括提供多个细长网状物植入物。
22.根据权利要求18所述的方法,其中提供多个细长植入物包括提供多个细长杆状植入物。
23.根据权利要求18所述的方法,其中提供多个细长植入物包括提供多个具有一个或多个端部组织锚固件的细长植入物。
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- 2010-12-29 JP JP2012547263A patent/JP2013516236A/ja active Pending
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BR112012015838A2 (pt) | 2017-12-12 |
JP2016120323A (ja) | 2016-07-07 |
AU2010339575A1 (en) | 2012-06-21 |
AU2010339575B2 (en) | 2013-04-18 |
WO2011082220A1 (en) | 2011-07-07 |
CA2785560A1 (en) | 2011-07-07 |
JP2013516236A (ja) | 2013-05-13 |
US10470861B2 (en) | 2019-11-12 |
KR20120098806A (ko) | 2012-09-05 |
EP2519185A4 (en) | 2018-01-24 |
US20120283511A1 (en) | 2012-11-08 |
EP2519185A1 (en) | 2012-11-07 |
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