CN102137633B - 微创植入物 - Google Patents

微创植入物 Download PDF

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CN102137633B
CN102137633B CN200980132897.0A CN200980132897A CN102137633B CN 102137633 B CN102137633 B CN 102137633B CN 200980132897 A CN200980132897 A CN 200980132897A CN 102137633 B CN102137633 B CN 102137633B
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anchor pole
tissue
implanting device
patient
extension
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CN102137633A (zh
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J·L·罗尔
M·N·达达
J·F·奥特
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AMS Research LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/042—Urinary bladders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072—Delivery tools therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

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Abstract

提供一种用于使用一个或多个横向植入物来增强尿道的支撑性组织来治疗男性和女性的尿失禁、大便失禁以及其它骨盆缺陷或功能障碍的设备和方法。植入物构造成接合和拉动(例如，上拉)骨盆组织，以致使诸如盆内筋膜的横向尿道下组织张紧和减少松弛，从而实现改进的支撑。这样，植入物的某些实施例可以用于排除对尿道下方的网状物或其它支撑性结构的需要，这种需要对于其它失禁吊带而言是普遍的。

Description

微创植入物
相关申请 
本申请要求享有2008年8月25日提交的美国临时申请No.61/091,586的优先权，所述申请的全部内容通过参考包含于此。 
技术领域
本发明涉及用于通过提供和使用一个或多个骨盆植入物以支撑骨盆组织来治疗骨盆病况的设备、工具以及方法。 
背景技术
已经报道，超过13,000,000的美国各年龄阶段的男性和女性忍受尿失禁和大便失禁。对于失禁患者的社会意义包括丧失自尊、尴尬、限制社会活动和性活动、隔离、抑郁，并且在某些情况下，依赖于护理者。失禁是把老年人送交专门机构治疗的最普遍的原因。 
泌尿***包括肾、输尿管、膀胱和尿道。膀胱是中空的、肌肉的、球囊状的囊，膀胱用作尿的储存容器。膀胱位于耻骨后方并且被骨盆保护。韧带将膀胱保持在适当的位置中并且将膀胱连接到骨盆和其它组织。图1示意性地示出了有关的女性解剖结构。尿道16是尿从膀胱14流出身体的管道。尿道16在膀胱14内的较窄的内部开口是膀胱颈18。在这个区域中，膀胱的束肌(bundled muscular)纤维转变为称为内***的***横纹肌中。图2示意性地示出了有关的男性解剖结构。尿道16从膀胱颈18延伸到***22的端部。男性尿道16由三个部分构成：***部分、球根状部分和悬垂部分。***部分是管道的最宽部分，所述***部分穿过***24。图3是***和直肠的解剖结构的示意图。直肠1是胃肠道的最远端部分。直肠的外部开口是***2。排便节制涉及的是***的外***3和内***4的控制。 
当泌尿***的肌肉受伤、机能失常或弱化时，会出现尿失禁。诸如尿道区的外伤、神经损伤、激素失衡或药物副作用的其它因素也会导致或辅助产生失禁。失禁有五种基本类型：压力性尿失禁、急迫性尿失禁、混合型尿失禁、充溢性尿失禁和功能性失禁。压力性尿失禁(SUI)是由于腹腔压力的突然增加而导致的尿的无意损失，其中所述腹腔压力的突然增加是由诸如咳嗽、打喷嚏、上升、应变、锻炼以及在严重的情况下甚至简单的改变身***置的活动所产生的。急迫性尿失禁，也称为“机能亢进膀胱”“频繁/紧迫性综合征”或“刺激性膀胱”，在人急需排尿并且在到达厕所之前失去对膀胱的控制时发生。混合型尿失禁是最普通的尿失禁形式。不适当的膀胱收缩和虚弱的***通常导致这种类型的失禁。混合型尿失禁是压力性尿失禁和急迫性尿失禁两种失禁的病症的结合。充溢性尿失禁是由过度充满的膀胱所导致的恒定的尿液滴漏或泄漏。当人难以从一个位置运动到另一个位置时，导致功能性失禁。通常功能性失禁通过下尿路外侧的因素而导致，例如身体机能和/或认知功能中的缺损。 
SUI通常被认为与膀胱颈的过度活动或固有的尿道***缺陷有关。当前多种治疗选择可以用于治疗失禁。这些治疗选择中的某些包括外部装置，行为疗法(例如生物反馈、电剌激、或凯格尔(Kegal)练习)、可注射性材料、假肢器官装置和/或外科手术。根据年龄、医疗条件和个人喜好，外科手术可以用于完全的修复节制。 
SUI的保守治疗包括生活方式的改变，例如减轻体重、戒烟、以及改变诸如咖啡和酒精的利尿流体的摄入。关于外科手术治疗，号称的“金标准”是***尿道悬吊术(Burch Colposuspension)，在所述***尿道悬吊术中，膀胱颈被悬吊。尿道中段吊带已经是同样有效的。被认为是对于男人和女人的SUI尤其成功的治疗选择的一种处理是吊带和支撑处理。 
吊带处理是一种包括放置吊带以稳定或支撑膀胱颈或尿道的外科手术方法。有多种不同的吊带处理。用于耻骨***(pubovaginal)处理的吊带在材料类型和锚固方法上不同。在某些情况下，吊带放置在 膀胱颈下方，并且经由悬吊结构或缝线通过腹部切口和/或***切口固定到附着点(例如，组织或骨)。在美国专利No.5,112,344；5,611,515；5,842,478；5,860,425；5,899,909；6,039,686，6,042,534，6,110,101，6,911,003，6,652,450以及国际PCT公布No.2008/057261中公开了吊带处理的示例，这些文献中的全部的整个内容通过参考包含于此。 
虽然与吊带处理相关联的严重的并发症是罕见的，但是它们可能会发生。某些吊带处理的并发症可以包括尿道阻塞、急迫性尿失禁重新发展、出血、延长的尿潴留、感染、对周围组织的破坏以及糜烂。 
大便失禁如同尿失禁一样已经证明对治疗具有挑战性。与***成形术一样，采用外科手术来治疗由于外******损伤而导致大便失禁的患者。虽然认为其他患者具有神经性的或突发性的大便失禁，但是治疗这些患者的努力是很少成功的。有多种处理，例如，肛后修复、全骨盆底修复、肌肉移位技术、动态股薄肌成形术(Dynamicgraciloplasty)、人工***处理、以及骶神经刺激。成功是有限的，并且多种治疗方式可能会导致发病。 
期望一种微创且高效的治疗方式，所述治疗方式可以在最小化副作用至没有副作用的情况下使用，以用于治疗尿失禁和大便失禁二者。这种方式应当减少治疗处理的复杂性，是生物相容的，应当减轻疼痛、降低手术风险、感染和术后呆在医院的时间，并且具有较好的活动持续时间。另外，治疗方法也应当提高患者的生活质量。 
发明内容
本发明可以包括用于泌尿科学应用的、尤其用于治疗压力性尿失禁和/或急迫性尿失禁、大便失禁以及脱垂和***底修复的手术器械、可植入制品和方法。应注意到，SUI的普通治疗包括放置吊带以便压缩尿道***或以便提升或支撑膀胱缺陷的颈部。 
本发明的实施例可以包括用于使用一个或多个横向植入物以增强尿道的支撑性组织来治疗男性和女性的尿失禁、大便失禁、以及其它骨盆缺陷或功能障碍的设备和方法。植入物构造成接合和拉动(例如， 上拉)横向尿道支撑(例如，盆内筋膜)组织，以致使尿道下组织张紧和减轻松弛，从而改进支撑。这样，植入物可以用于排除对尿道下方的网状物或其它支撑性结构的需要，这种需要对其它失禁吊带而言是普遍的。植入物的形状可以设定成帮助这种支撑，例如，植入物设有锚固端部部分或可构造成“U状”、“V状”或类似形状。另外，可以采用一个或多个锚杆或组织接合部分来将植入物附装到组织并使植入物在组织处稳定。 
本发明的其它实施例可以包括支撑性吊带植入物，所述支撑性吊带植入物具有一个或多个臂部分和张紧杆。如本文中所描述的那样，这些实施例可以设置在尿道下方的传统支撑性结构中，或相对于尿道横向地定位。 
本发明的实施例可以提供更小的植入物，更少的植入物部件，从而减小了切口的尺寸和数量，改进了植入操纵和调节，并且减轻了***步骤和展开步骤的复杂性。 
附图说明
图1示出了女性泌尿***的示意图； 
图2示出了男性泌尿***的示意图； 
图3示出了***和直肠的解剖结构的示意图； 
图4示出了根据本发明的实施例的骨盆植入装置； 
图5示出了能够与本发明的实施例一起使用的导引器或***装置； 
图6示出了根据本发明的实施例的大致U状的骨盆植入装置； 
图7示出了根据本发明的实施例的骨盆植入装置的锚杆； 
图8示出了图7的骨盆植入装置的锚杆的侧视图； 
图9示出了根据本发明的实施例的具有沿着延伸部分的一部分的锚固构件的骨盆植入装置； 
图10示出了根据本发明的实施例的锚固骨盆植入装置； 
图11示出了根据本发明的实施例的、具有带多倒钩的锚杆的骨盆 植入装置； 
图12至15示出了根据本发明的实施例的、具有前端锚杆和尾端基部或大块锚杆的多种骨盆植入装置； 
图16示出了根据本发明的实施例的植入到横向尿道支撑组织中的骨盆植入装置； 
图17示意性地示出了根据本发明的实施例的植入到横向尿道支撑组织中的U状骨盆植入装置； 
图18示意性地示出了根据本发明的实施例的植入到横向尿道支撑组织中的U状骨盆植入装置； 
图19示意性地示出了根据本发明的实施例的具有前端锚杆和尾端大块锚杆的植入装置的植入，用于提供用于横向尿道支撑组织的张紧支撑； 
图20至21示意性地示出了根据本发明的实施例的具有前端锚杆和尾端大块锚杆的植入装置的植入，用于提供用于横向尿道支撑组织的张紧支撑； 
图22至23示意性地示出了根据本发明的实施例的、通过闭孔到横向尿道支撑组织中的植入装置的植入； 
图24至25示意性地示出了根据本发明的实施例的、提供用于横向尿道支撑组织的张紧支撑的植入装置的耻骨后植入； 
图26示出了根据本发明的实施例的具有与导引器装置选择地接合的带套环螺栓(toggle bolt)锚杆的植入装置； 
图27示出了根据本发明的实施例的、具有带套环螺栓锚杆和管状基部锚杆的植入装置； 
图28示意性地示出了根据本发明的实施例的图27的植入装置的植入，用于为横向尿道支撑组织提供支撑； 
图29示出了根据本发明的实施例的具有带套环螺栓锚杆、管状基部锚杆和中间尿道卷起(cradling)部分的植入装置； 
图30示出了根据本发明的实施例的装置部分的管状植入装置； 
图31示出了根据本发明的实施例的、具有管状部分和大致平坦的 部分的植入装置； 
图32示意性地示出了根据本发明的实施例的管状和/或平坦的植入装置的植入，用于提供用于横向尿道支撑组织的张紧支撑； 
图33示出了根据本发明的实施例的具有第一臂、第二臂和调节构件的植入装置； 
图34示意性地示出了根据本发明的实施例的沿着耻骨后路径得到的图33的植入装置的植入； 
图35示意性地示出了根据本发明的实施例的沿着经闭孔路径得到的图33的植入装置的植入。 
具体实施方式
总体上参照图1至35，其中在所有的附图中，相同的附图标记可以指示相同的、类似的或相对应的部件。对于本说明书，下面的描述仅仅是例示性的，其并不限制对于本领域的技术人员来说显而易见的本发明的其它实施例。 
本发明的一个方面在于治疗男性或女性的尿失禁的设备和方法。在多种实施例中，一个或多个植入物或植入构件放置在策略上定位的位置上，以向上拉或以其它方式拉紧横向于尿道的组织和/或肌肉，以便总体上重新建立起患者的原始的解剖结构。美国专利No.6,911,003，6,612,977，6,802,807，2002/0161382，2004/0039453和2008/0045782以及国际PCT公开No.2008/057261中所公开的单独的或组合的多种***、装置、结构、技术和方法可以与本发明一起使用，其中上述公开的全部内容通过引用包含于此。本文中所述的装置或结构可以经***地、经皮地或以本领域的技术人员已知的任何其它方式使用或引入到患者的骨盆区域中。 
如图4所示，本发明的多种实施例可以包括张紧或支撑植入装置30，所述张紧或支撑植入装置30具有延伸部分32和一个或多个接合部分34。一个或多个接合部分可以包括位于张紧装置30的第一端部或前端端部处的第一锚杆34a以及设置在张紧装置30的相对的尾端端 部处的第二锚杆34b。延伸部分32可以由已知能够使用的并且与尿道吊带、其它骨盆支撑装置和类似物相容的相容性的网状物或类似的多孔材料构造。网状物材料可以帮助组织和细胞穿过延伸部分32的内部，以促进组织向肉内生长，并且继而将装置30固定到周围的解剖结构。延伸部分32还可以包括突起、锯齿状的边缘、延伸的纤维、或类似的特征部件，以促进组织固定和向肉内生长。在其它的实施例中，延伸部分32可以由柔性的或半刚性的一段能够相容的大致无孔的材料构造。装置30和相对应的延伸部分32的长度和柔性可以依据特定的过程和解剖学支撑应用而显著地改变。延伸部分32可以在引入处大致是平面的，预成形或预形成或以其它方式构造成允许用于在植入过程期间进行调整、操纵和成形。延伸部分32的多种实施例可以是能够形成为大致V状的或U状的装置(图6)，或者以其它方式进行调整以通过、围绕和/或沿着骨盆区域的多种组织和肌肉灵活或选择地进行操纵和横移(traversal)。在某些实施例中，装置30的长度可以在.5cm至6cm的范围。装置30也可以具有大于或小于5cm至6cm的范围的长度。 
在某些实施例中，植入物可以构造成可折叠的合成网状物补片(patch)的形式，并且可以包括粘附覆盖物(例如，fibron胶(fibronglue))。另外，伞状特征部件可以包括有从补片延伸的金属线花键(wire spline)或构件。伞状特征部件可以经由诸如环、紧固件等的连接结构而连接有补片。植入物导引器(例如，柱塞和/或金属线)的一部分可以构造成推进补片并且使伞状特征部件展开和/或膨胀，以提供用于补片的组织接合。 
一个或多个接合部分34可以构造为固定或自固定尖端或锚杆34，所述固定或自固定尖端或锚杆34适于穿透骨盆区域的目标组织或肌肉(T)并固定在骨盆区域的目标组织或肌肉(T)内。如图4、6和7至11所示，锚杆34可以在形状、尺寸和沿着装置30放置方面改变。例如，如图4和6所示，锚杆34可以与延伸部分32的端部成一体、附装到延伸部分32的端部或以其它方式设置在延伸部分32的端部附 近。延伸部分32可以经由锚杆34的端部部分36连接到锚杆34。可以使用许多附装结构或技术来将延伸部分32的端部连接到锚杆34的端部部分36。另外，锚杆34可以包括相对的尖齿或倒钩38，以帮助穿透目标组织并固定在目标组织内。例如图9至11中绘制的其它实施例可以包括沿着延伸部分32的多个部分设置的一个或多个尖齿38(图9)，或沿着锚杆34布置的多个倒钩38(图11)。此外，一个或多个接合部分34可以构造为带套环螺栓锚杆(toggle bolt anchor)(图26)、管状构件、平面构件、球根状构件和类似物，带套环螺栓锚杆(图26)、管状构件、平面构件、球根状构件和类似物中的任一种都可以由相容性聚合物、金属、网状物或无孔的材料、或生物可吸收的或不可吸收的材料构造。如本文中所绘制和描述的那样，接合部分34可以适于接合包括骨盆内筋膜、直肌筋膜/肌肉、闭孔肌和骨盆的其它解剖结构在内的多种目标组织区域。 
另外，如图10中所绘制的那样，可以沿着一段延伸部分32选择地设置有护套或轴套40，以帮助将装置30导引和***到患者的骨盆区域内。可以采用一个或多个***或导引装置42来帮助装置30在骨盆区域内横移，并且帮助装置30(例如，锚杆34)展开到目标组织位置中。可以利用多种已知的***装置42，包括在先前加入的专利文献中所公开的那些装置。装置42的针体实施例可以包括把柄、管状构件43(直线构件或弯曲构件)和适于与本文公开的植入物的一个或多个部件选择性接合的尖端45。如图10所示，延伸部分32可以包括适于进一步促进组织向肉内生长和固定的多个纤维材料或铰合线44。 
如本文中所详细描述的那样，本发明的多种实施例构造成通过为尿道附近或周围的组织或解剖结构提供支撑来治疗尿失禁，而不是通过在尿道下方提供更加传统的吊床状支撑件来治疗尿失禁。如本文中所详细描述的那样，装置30和用于这些实施例的本发明的接合方面可以显著地改变。 
如图12至15所示，装置30可以包括位于延伸部分32的前端端部处的带倒钩的锚杆34和位于相对的尾端端部处的大块基部构件50。 延伸部分32可以由网状物材料(图12)或其它的多孔或无孔的材料(图14至15)构造。另外，基部构件50可以是网状物、或其它的多孔或无孔的材料，并且可以采取包括平面、球根状、管状等在内的任何种类的形状。基部构件50可以与延伸部分32成一体，或使用紧固件52(例如，铆钉)附装、结合、或者以其它方式利用已知的结构和技术附装。在其它实施例中，延伸部分32可以由任意的纤维或织造的、编织的、扭绞的、或针织的聚合物材料制成。 
如图16中所绘制的那样，装置30可以沿着大致朝向闭孔的路径***，以用于穿透尿道16的任一侧上或两侧上的盆内筋膜(EF)。因而，锚杆34定位成用于与筋膜附近的组织或肌肉固定，以便使基部构件50布置在筋膜的进入侧上。每个装置30的基部构件50的尺寸和形状可以设定成使得基部构件50保留在筋膜的进入侧上并且可以包括一个或多个锚杆、突起或类似的结构以抵抗筋膜提供额外的接合和保持。推进并且定位锚杆34，以穿透选择的目标组织或以其它方式与所述选择的目标组织接合，以便向上拉动诸如盆内筋膜的横向延伸的尿道下组织，从而消除松弛并且将筋膜和/或尿道重新定位到更加优化和正确的解剖学位置。也可以使用其它的调节机构和技术来提升筋膜，以在横向延伸的尿道支撑组织中提供期望的拉紧或减轻松弛。除了延伸部分32和基部构件50可以采取不同的设计构造并且可以由不同的材料构造之外，图14至15的装置30以相同的方式起作用，其中所述不同的材料例如是相对坚硬的或柔性的聚合物、网状物、无孔的网状物和其它已知的相容性材料。 
本文中详细描述的多种实施例的多种结构或部分可以由诸如聚丙烯、聚乙醇酸交酯、聚-l-交酯(poly-l-lactides)、或其它已知的生物可降解的(可再吸收的)或非生物可降解的聚合物。另外，可以种植生长因子或干细胞，或者以其它方式设有装置30的一个或多个部件，以帮助康复或组织向肉内生长。除了用针体导引器装置导引和展开装置30以外，也可以利用套管或导管***。 
图16至17的实施例包括植入装置30，所述植入装置30具有延 伸部分32和设置在延伸部分32的一个端部区域处的一个或多个接合或锚杆部分34。装置30可以设计成具有一定程度的柔性，从而允许使用者容易地指引和推进装置30并且允许在展开和锚固期间操作装置30从而使装置30成为大致U状或类似的构造。在一个实施例中，装置30适于总体上扩张患者的支撑性骨盆底的横向组织。例如，锚杆中的第一锚杆34a可以***通过盆内筋膜以用于固定在组织内。同样地，可以被调节或拉动另一个锚杆34b以张紧和提升支撑性尿道组织。锚杆34a、34b中的一个或多个可以固定到闭孔内肌或闭孔膜处或附近的组织。在将支撑组织向上拉动以大致获得正确的解剖学尿道支撑时，第二锚杆固定在最近的组织内，其中延伸部分32的弯曲部延伸通过筋膜。可以对尿道的另一侧上的支撑性组织重复这个处理，以提供双侧扩张和支撑。 
图18示出了具有第一锚杆34a和第二锚杆34b的装置30的实施例，其中在所述第一锚杆34a和第二锚杆34b之间延伸有部分32。锚杆34a、34b可以根据本文中公开的多种设计进行构造。例如，第一锚杆34a可以是穿透尖端，第二锚杆34b的形状设定成管状或大块(bulk)锚杆。锚杆中的一个可以固定在筋膜上方的组织中，并且另一个锚杆固定在筋膜处或筋膜附近或穿过筋膜固定以向上拉动支撑性尿道组织，从而消除组织中的松弛。可以在尿道的另一侧上重复这个处理，以提供双侧扩张和支撑。延伸部分32的实施例可以由网状物、带角钉的(braded)、扭绞的、针织的、管状的或胶原质基体材料构造，以帮助固定和组织向肉内生长。另外，可以在尿道的任一侧或两侧上植入多个这样的装置30，以促进组织扩张和支撑。 
图20至21示出了本发明的某些实施例以及与图16中所绘制的装置类似的装置30。大块锚杆34b(例如，管状、套环(图26)、平坦的等)可以***通过诸如盆内筋膜的支撑性组织，或者它可以留在支撑性组织下方，其中锚杆34a向上延伸通过组织。同样地，锚杆34a、34b中的任一个可以定位在支撑性组织的相对侧上。另外，锚杆中的至少一个可以用于在沿着组织的一个或多个位置处穿透支撑性组织。 例如，装置30的某些实施例可以用于沿着组织在组织内外编织或穿线，以便为延伸部分32提供支撑性波状布局。这能够帮助附装，更好地分配组织上的或沿着组织的拉力，并且提供类似的支撑优点。 
如图22至23所示，从外向内的植入方法可以用于装置30。即，可以在长收肌***到耻骨支中的位置下方切出皮肤切口。然后，装置30的第一锚杆34a可以在坐耻骨支附近穿过并且通过闭孔和内肌而***到与尿道成横向的组织中，例如支撑膀胱颈和尿道的盆内筋膜。一旦固定，可以拉动装置30，以提供沿着延伸部分32的张力来扩张尿道支撑组织并使尿道支撑组织返回到正确的解剖学位置。在这个方面，可以锚固或以其它方式定位延伸部分32和装置30的相对近端端部，以维持装置30上的张力。可以使用本文中描述的针体和/或套管导引器装置中的任一个将装置30***到患者体内并在患者体内展开。装置30的这个实施例可以提供更容易的接近和患者定位，可以使得不再需要在尿道下方切开，并且可以在患者醒着的时候植入，以便可以基于患者的指示和运动选择地调节装置30。延伸部分32在组织的入口侧上的基部或端部的实施例也可以胶合、缝合或使用多种已知的结构和技术以其它方式固定在组织中或组织处。此外，装置30可以植入在尿道的任一侧上，以提供双侧支撑。图23公开了这个实施例的变型方案，其中延伸部分32由诸如缝线、聚合物材料、绳索等无孔的材料构造。 
图24至25绘制出植入装置30的另一个实施例，该植入装置30沿着耻骨后路径而不是沿着经闭孔路径引入。通常切出一个或多个皮肤切口，使得装置30可以在尿道的任一侧或两侧上向下延伸，其中至少一个锚杆34延伸到盆内筋膜中达到前部***壁。如本文中公开的其它实施例一样，将植入装置30固定到尿道的横向支撑组织容许调节以将支撑性组织返回到其正确的解剖学位置。此外，本文中描述的锚杆34、延伸部分32和导引器装置中的任一个都可以用在图24至25的实施例中。 
图27至29示出了植入装置30的多种实施例，所述植入装置30包括位于延伸部分32的各端部处的接合或锚固部分34a、34b，以为 尿道提供横向支撑。锚杆可以包括本文中描述的结构或特征部件中的任一个。例如，一个实施例包括带套环锚杆34a和管状(例如，网状物)基部锚杆34b。管状基部34b可以包括设置在其端部处的帽或其它结构35。如同装置30的其它实施例一样，诸如管状基部34b的锚杆中的至少一个可以与尿道的横向支撑组织接合，以便使组织可以张紧或提升，以去除松弛。可以包括有诸如杆、缝线或类似特征部件的调节构件60，以对装置30进行选择地调节，从而进一步帮助张紧控制。对于包括管状接合特征部件34b的那些实施例，特征部件34b可以是网状物构造，以促进组织固定和向肉内生长。如图29所示，装置30的这个实施例还可以包括适于定位在尿道下方以提供额外的支撑的中间支撑件62。支撑件62可以是多孔的或无孔的，并且任一种结构(例如，锚杆34、支撑件62)都可以由可再吸收的或不可吸收的材料构造。 
图30至32绘制出了植入物70，所述植入物70能够沿着诸如盆内筋膜的横向尿道支撑组织的一部分固定。这些植入物70可以包括一个或多个管状的和/或平坦的网状物结构72，所述网状物结构72适于与支撑组织接合，以对组织和/或组织上的张力进行调节。结构70、72也可以适于与导引器装置42选择性地接合，以帮助***和展开。植入物可以不设有锚杆34，其中植入物的构造和特征部件(例如，突起、网状物、磨损、粘合剂、纤维等)可以提供接合支撑组织以及在支撑组织上提供可调节张力所必需的附装结构。其它实施例可以包括锚杆34，以刺穿或接合横向组织。另外，植入物70可以由可再吸收的或不可吸收的材料构造。 
图33至35的实施例可以包括植入装置80，所述植入装置80具有第一延伸臂82、第二延伸臂84和调节构件86。延伸臂82、84可以包括位于它们的相应端部处的一个或多个锚杆88。臂82、84可以由多孔的网状物或本文中描述的用于装置30的延伸部分32的其它材料构造。类似地，锚杆88可以采取本文中描述的锚杆34的任一个的构造。包括这些臂和调节构件在内的装置80的部件可以由相容性材料构 造，所述相容性材料例如是聚丙烯、PGA、PLLA、网状物、编织物、绳索、细丝和类似物。 
在使用中，臂82、84(例如，不同的或分离的构件)中的每个都沿着耻骨后路径穿过一个或多个***切口，直到锚杆88固定在诸如直肌筋膜/肌肉的组织中。另外，任一个臂的一部分可以在尿道下方延伸，以提供卷起的支撑。为了张紧装置80，臂82、84之一的构件86(例如，杆或聚合物延伸部)可以***另一个臂的附装或锁定机构90(例如，紧固件、装置、孔口等)或与其接合。然后，构件86可以沿着锁定机构90滑动以接合部件，直到获得适当的张紧为止。可以切掉并丢弃在臂下方延伸的构件86的其余部分。在其它实施例中，每个臂82、84都可以包括构件86或类似的调节机构，以帮助在尿道的任一侧上实现平衡或等同的张紧。如图35所示，可以展开装置80，并且该方法也可以沿着经闭孔路径预执行，其中锚杆88固定在骨盆的任一侧上的闭孔肌中。 
多种材料可以用于形成植入物和装置30的多个部分或部件，这些材料包括镍钛诺、聚合物、弹性体、多孔的网状物、热塑性弹性体、金属、陶瓷、弹簧、金属线、塑料管和类似物。在阅读本文中提供的公开之后，***、部件和方法可以具有对于本领域的技术人员来说已知的多个适当的构造。 
本文中引用的所有专利、专利申请和公布的全部内容通过参考包含于此，好像单独地包含在此一样，并且包括并入在上述专利、专利申请和公布内的那些参考文献。 
明显地，在本文中的教导的基础上，能够得到本发明的多个修改和变型方案。因此，应当理解，在所附权利要求书的范围内，可以以不同于本文中具体地所述的方式实施本发明。 

Claims (9)

1.一种用于张紧患者的横向尿道支撑组织的骨盆植入***，所述骨盆植入***包括：
至少一个植入装置，所述至少一个植入装置具有：
前端端部部分、尾端端部部分、和在所述前端端部部分与所述尾端端部部分之间延伸的延伸部分；
第一锚杆部分，所述第一锚杆部分设置在所述至少一个植入装置的前端端部部分处，并且能够在患者的一侧穿透患者的横向尿道支撑组织的至少一部分；
第二锚杆部分，所述第二锚杆部分设置在所述至少一个植入装置的尾端端部部分处，并且能够在患者的所述一侧穿透患者的盆内筋膜的一部分，以便能够张紧所述组织，从而将所述组织大致放置在正确的解剖学位置中，并且所述至少一个植入装置不直接接触患者的尿道；以及
导引器装置，所述导引器装置能够将所述至少一个植入装置***到所述患者体内并在所述患者体内展开。
2.根据权利要求1所述的***，其中，所述至少一个植入装置包括适于在患者的第一侧支撑组织的第一植入装置和适于在患者的第二侧支撑组织的第二植入装置，以提供双侧尿道支撑。
3.根据权利要求1所述的***，其中，所述第一锚杆部分是具有一个或多个延伸倒钩的固定锚杆。
4.根据权利要求1所述的***，其中，所述第二锚杆部分是大块锚杆，所述大块锚杆能够抵靠所述盆内筋膜的一侧，以限制所述尾端端部部分的运动并且帮助组织张紧。
5.根据权利要求1所述的***，其中，所述延伸部分能够***纵，以形成用于所述至少一个植入装置的大致U状的构造。
6.根据权利要求1所述的***，其中，所述延伸部分由多孔的网状物材料构造。
7.根据权利要求1所述的***，其中，所述延伸部分由无孔的材料构造。
8.根据权利要求1所述的***，其中，所述第一锚杆部分还能够与从由闭孔肌和直肌筋膜组成的群组中所选出的组织接合。
9.根据权利要求1所述的***，其中，所述第二锚杆部分包括管状或大块锚杆，所述管状或大块锚杆能够穿透所述盆内筋膜的一部分。
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EP2323586A1 (en) 2011-05-25
US20110201876A1 (en) 2011-08-18
JP5860102B2 (ja) 2016-02-16
US8968181B2 (en) 2015-03-03
HK1159460A1 (zh) 2012-08-03
CA2734165A1 (en) 2010-03-11
KR20160102327A (ko) 2016-08-29
WO2010027796A4 (en) 2010-04-22
AU2009288353A1 (en) 2010-03-11
JP2012500712A (ja) 2012-01-12
KR20110059706A (ko) 2011-06-03
AU2009288353B2 (en) 2015-03-05
KR101739304B1 (ko) 2017-05-24
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CA2734165C (en) 2015-05-26
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WO2010027796A1 (en) 2010-03-11
BRPI0917694A2 (pt) 2017-07-11
US20150164626A1 (en) 2015-06-18
US9918816B2 (en) 2018-03-20
JP2016073690A (ja) 2016-05-12
KR101651634B1 (ko) 2016-08-26

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