CN101854883B - 可调节组织支撑构件 - Google Patents

可调节组织支撑构件 Download PDF

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CN101854883B
CN101854883B CN200880115957.3A CN200880115957A CN101854883B CN 101854883 B CN101854883 B CN 101854883B CN 200880115957 A CN200880115957 A CN 200880115957A CN 101854883 B CN101854883 B CN 101854883B
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anchor
support system
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D·埃文斯
H·霍尔斯坦
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CR Bard Inc
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B2017/0437—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
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    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
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Abstract

本发明涉及植入体，所述植入体具有两个臂以及被配置来支撑例如尿道的本体组织的支撑部分。所述植入体被具有多个倒钩的组织锚定器锚定于软组织。所述组织锚定器包括孔，穿过所述孔，臂的部分被维持。锁定构件被设置在所述臂中的至少一个中，以便利所述臂到所述锚定器中的至少一个的固定。

Description

可调节组织支撑构件
本申请要求下述申请的优先权，本文通过引用将下述公开的全部内容并入本申请：2008年11月12日提交的题目为“可调节组织支撑构件(Adjustable Tissue SupportMember)”的美国专利申请第12/269,749号，以及2007年11月13日提交的题目为“具有可调性特征的植入体(Implant with Adjustability Feature)”的美国临时专利申请第60/987,469号；2007年12月21日提交的题目为“组织锚定器插入设备(Tissue AnchorInsertion Device)”的美国临时专利申请第61/015,741号；2008年1月10日提交的题目为“连续编织管形网状植入体(Continuous Knit Tubular Mesh Implant)”的美国临时专利申请第61/020,231号；2008年2月1日提交的题目为“可调节组织支撑构件(AdjustableTissue Support Member)”的美国临时专利申请第61/025,461号；以及2008年10月2日提交的题目为“可调节组织支撑构件(Adjustable Tissue Support Member)”的美国临时专利申请第61/102,147号。
女性尿失禁通常通过悬吊手术(sling suspension procedure)进行治疗。一般地，悬吊手术包括在患者尿道下放置悬带构件(sling member)。利用导引针将所述悬带构件恰当地植入到患者的组织，所述导引针有助于将所述悬带拖入合适的位置。
悬带已由多种材料(合成的和天然的)来制成，并且一般是网状物的形式。传统的吊带手术包括在尿道下放置植入体材料(天然组织、合成网状物或这二者的组合)带，并且将所述植入体材料带固定到直肌筋膜(rectus fascia)或患者解剖结构的其他部分，在医治过程中利用缝合来使所述植入体保持合适的位置。
改进的方法已有所发展，通过减少切出切口的数目和改变所述植入体被导引进入本体(body)所通过的路径，来加快所述植入过程的速度。这些采用专门仪器的改进有助于减少手术时间并且已降低所述手术的创伤。所述改进的方法一般地需要植入体被连接(join)到导引针。然后，所述植入体被插入并被拉动通过所述本体。随后，所述植入体从所述导引针分离。
这样的手术(如进行耻骨后或耻骨弓上手术的情况下)会需要长针的穿刺进针和大量组织的分割(dissection)。长针的穿刺进针增加本体结构(例如膀胱)意外穿孔的可能性。此外，所述手术典型地需要不仅至少一个阴道切口，而且需要两个外部切口，在采用经闭孔(transobturator)方式的情况下，是两个在闭孔(obturator foramina)处的外部切口，而在采用耻骨后和耻骨弓上的方式下，是两个在耻骨上面的外部切口。
这样的手术通常使用缺乏可调性特征的仪器。网状悬带必需在尿道施加适量的张力。张力过量可以导致尿道扭曲和/或非正常的组织糜烂(erosion)，然而张力不足可以导致无效的悬带。，在所述悬带的两端已被锚定于组织之后，但在所述张力被固定和外科手术结束之前，期望能够对所述悬带的所述张力进行调节。此外，期望提供双向调节而非仅单一方向的调节。促进达到前述目标中的至少一个的特征是可以期望的。
鉴于上述，具有适用于治疗各种病况(如失禁，例如大便和尿失禁，如女性尿失禁)的微创(minimally invasive)悬带将会是有益的。根据各种实施方案，植入的微创悬带的每一端均终止于组织锚定器(anchor)。所述悬带的长度(以及由所述悬带施在尿道上的张力)被配置为一旦所述组织锚定器中的至少一个已被植入时可调节。
发明内容
根据一个实施方案，本文公开了一种组织支撑系统，所述组织支撑系统包括：可植入组织支撑构件，其中，所述可植入组织支撑构件包括：具有长度和宽度的组织支撑部分；设置在所述组织支撑部分的一端的第一臂和设置在所述组织支撑部分的相对端的第二臂；连接到所述第一臂的第一组织锚定器；以及连接到所述第二臂的第二组织锚定器，其中所述第二软组织锚定器沿所述第二臂的长度是可滑动的。
根据另一实施方案，本文公开了一种组织支撑系统，所述组织支撑系统包括：可植入组织支撑构件，其中，所述可植入组织支撑构件包括：具有第一端和第二端的组织支撑部分；具有第一端头和第二端头的第一臂，其中所述第一臂的所述第一端头连接到所述组织支撑部分的所述第一端；具有第一端头和第二端头的第二臂，其中所述第二臂的所述第一端头连接到所述组织支撑部分的所述第二端；固定到所述第一臂的所述第二端头的第一组织锚定器；以及第二组织锚定器，在所述第二组织锚定器中具有孔，其中所述孔被配置来至少部分包围所述第二臂的部分。
根据又另一实施方案，本文公开了一种用于向本体组织提供支撑的方法，包括：在阴道壁切出切口；在闭孔膜的方向，将所述导引针插入所述切口，在所述导引针远端具有第一组织锚定器，其中所述第一导引针连接到植入体；从所述导引针放出所述第一组织锚定器；从所述切口收回所述导引针，并且在所述导引针的所述远端插入第二组织锚定器，其中所述第二组织锚定器连接到植入体；在对侧闭孔膜的方向，再次将所述导引针插入所述切口；从所述导引针放出所述第二组织锚定器；以及向所述植入体施加牵引，直到获得期望量的组织支撑。
根据另一实施方案，本文公开了一种被配置用于在组织中植入的医疗设备，包括：由柔韧材料形成的内腔；至少一个组织锚定器，所述至少一个组织锚定器中具有至少一个孔，所述至少一个孔被配置来接纳所述由柔韧材料形成的内腔；以及设置在所述内腔中的锚定器止动件，其中所述锚定器止动件被配置为，当在所述内腔中的一个方向被推进时，所述锚定器止动件抵制运动。
附图说明
参考所附附图，所述公开的实施方案可以被更好地理解。在所述附图中的组件不一定是按比例绘制的。
图1图示说明根据本公开的组织支撑系统的一个方面。
图2图示说明可植入的组织支撑构件与导引针的一个方面。
图3图示说明从导引针被释放的组织锚定器。
图4图示说明被推进入内腔的通管针。
图5图示说明组织支撑构件的视图。
图6图示说明组织支撑构件的分解视图。
图7图示说明组织支撑构件的一个方面的视图。
图8图示说明导引针的分解视图。
图9A-9B图示说明示例性组织锚定器的剖面图。
图10图示说明组织支撑系统的一个实施方案。
图11图示说明示例性组织锚定器的剖面图。
图12A-12B图示说明示例性组织锚定器的底视和侧视图。
具体实施方式
应参考所述附图阅读如下说明。不一定按比例绘制的所述附图，描绘选出的实施方案而不是意图要限制本发明的范围。
图1图示说明根据本公开不同方面的组织支撑系统10。所述系统包括可植入组织支撑构件100，通管针(stylet)185以及导引针200。所述组织支撑构件包括组织支撑部分130，所述组织支撑部分130具有连接到臂120和160的端132和134，以及定向标记(orientingindicia)140。所述臂129具有端头121和122，并且臂160具有端头162和164。
所述定向指示器(indicator)140可以包括，通过举非限制性例子的方式，染色的中心线或织入所述植入体的中心部分的有色细丝。根据一个实施方案，所述指示器是以通过组织支撑部分130中间编织的蓝色聚丙烯细丝的形式的有色中线指示器。
所述可植入支撑构件100还包括第一组织锚定器(tissue anchor)110以及第二组织锚定器150。组织锚定器150被配置为连接到臂160，但沿臂160的长度是可移动的(即，可滑动地附着)。根据一个实施方案，组织锚定器150沿臂160的长度滑动。根据各种实施方案，组织锚定器150中具有孔，通过所述孔接纳臂160。根据某些实施方案，锚定器110被固定到臂120的端头121。根据另一实施方案，锚定器110被配置为连接到臂120，但沿臂120的长度是可移动的。
根据一个实施方案，组织支撑部分130为平坦的单层网状物(mesh)，并且臂120和160为管形网状结构。一旦所述组织锚定器110和150被放置在适合的位置，所述管形编织形式允许所述植入体的双向可调性。所述臂被通过任一适合的方式(包括缝合、粘合、声波焊接以及热熔(heat-staking))连接到支撑件(feature)。根据一个实施方案，所述臂中的每一个采用相同类型和尺寸的聚丙烯纤维被缝到所述组织支撑部分130，由所述聚丙烯纤维构成所述组织支撑部分130以及臂120和160。
根据另一实施方案，组织支撑部分130以及臂120和160是由具有纵向延伸经过的单一内腔的一体管形构件构成的。在这样的实施方案中，所述臂在162和122处的直径过渡形成所述组织支撑部分130。根据这一实施方案，在162或122处无接合点(joint)。根据各种实施方案，所述管形网状物是光滑的，在调节中提供轻微的“棘轮”效应，来向使用者给出触觉反馈。
可以通过若干公知的方法来制备管形网状物植入体。例如，所述管形网状物可以通过圆形编织加工，单端或双端的，以获得增加的强度，从而提供稳定的编织、一致的横截面以及光滑的轮廓。所述网状物可以由纬编织(weft knitting)通过“手套”类编织机加工来形成光滑的链连(chain link)缝合，这可以允许在给定长度上的直径变化。根据另一实施方案，所述管形网状物为双经编织物(warp knit)，使用两个平的网状经编织物提供了高的强度、多端编织，所述两个平的网状经编织在侧边处被连接来形成管(tube)网状物。根据另一实施方案，所述管形网状物由平型编织机(flat knitting machine)制成，例如由日本和歌山县的株式会社岛精机制作所(Shima Seiki Mfg..Ltd.of Wakayama.JP.)出售的平型编织机。
植入体100的所述网状物部分可以具有单线式或双线式结构。根据某些实施方案，所述组织支撑部分130为平坦的网状物，所述网状物包括编织的、开孔孔隙度、单丝、聚丙烯网状物的带。所述网状物设计的所述开孔孔隙度和大孔径允许巨噬细胞的穿透(penetration)以及用于组织向内生长(ingrowth)的惰性支架(inert scaffold)的生成，以生成用于尿道的永久性支撑。所述孔尺寸(pore size)可以为允许组织向内生长的任一适合的直径。植入体100的所述组织支撑部分130可以具有直径范围从0.4mm至1.1mm的较小的孔，例如0.5mm至1.0mm，如0.6至0.9mm。所述网状物可以附加地具有直径范围从0.8mm至1.3mm的较大孔，例如1.0mm至1.2mm。
根据一个实施方案，所述网状物为由小直径的纤维制成的聚丙烯编织物，从而生成软而韧的材料。根据各种实施方案，所述网状物被这样构造，以致避免或至少最小化在纵长方向施加张力时所述植入体的卷曲。根据一个实施方案，所述网状植入体为单面编织、双线结构。所述纤维可以为任一适合的直径。例如，所述纤维可以具有范围从0.0015″至0.100″的直径，例如0.002″、0.0025″、0.003″或0.004″。
本文公开的所述植入体可以由不同类型的网状物构成。一个适合的非限制性实施例为编织的聚丙烯单丝网状织物，如来自C·R·巴德股份有限公司(C.R.Bard.Inc.)的巴德网状物(BARD MESH)。其他材料，包括软组织补丁(SOFT TISSUE PATCH)(多微孔的ePTFE-可从W.L L.戈尔公司(W.L.Gore & Associates.Inc.)获得)；SURGIPRO(可从美国外科公司(US Surgical.Inc.)获得)；TRELEX(可以从密道克斯医药(MeadoxMedical)公司获得)；PROLENE和MEESILENE(可以从爱惜康公司(Ethicon.Inc.)获得)；以及其他网状物材料(例如可以向心房医药公司(Atrium Medical Corporation)获得)。也预期所述网状织物可以由多纤维纱(yarn)形成，并且预期任一适合的方法(例如编织、纺织、编结、模制以及类似的方法)可以被采用来形成假体(prosthetic)的网状物材料。所述网状物还可以由可吸收的材料(例如聚乳酸)构成。根据各种实施方案，本文公开的所述网状植入体是通过编织机加工的，例如计算机化的提花平型编织机。
本文公开的所述植入体可以包括或全部由天然材料构成。例如，所述天然材料可以被设置在本文共开的所述组织支撑构件的至少一个表面上。所述天然材料可以为任一适合的材料，包括但不限于，生物衍生(biologically derived)材料，如尸体(人类)或异种移植物(xenograft)组织(特别是猪或牛源的)-例如被处理来制成无细胞(acellular)胶原支架的真皮或肠黏膜下层或其他生物材料和/或通过生物工程制成的(bioengineered)材料。胶原材料可以从不同的源头获得，如从酷客生物医药公司(Cook Biomedical，Inc.)可获得名为COOK SURGSIS的软组织移植物(graft)。在一个实施方案中，所述天然材料包括交联的猪真皮胶原材料，如从Davol(R.I.)得到的COLLAMEND外科植入体。由于本公开在此方面不受限，可以采用其他适合的通过生物工程制成的材料。
所述臂120和160可以具有任何足以实现所述植入体的意图目的的宽度。例如，所述臂可以具有范围从0.5至5.0mm的宽度，包括1mm至5mm，例如2.0mm至4mm，或2.5mm至3.5mm。所述臂可以具有范围从10mm至100mm的长度，例如20mm至60mm，包括30mm至50mm。根据各种实施方案，组织支撑部分130具有范围从约30mm至约100mm的长度，例如约40mm至约80mm，包括65mm。所述支撑部分130可以具有任何足以向本体组织提供支撑的宽度。根据各种实施方案，所述宽度可以在5mm至20mm的范围内，例如7mm至15mm，包括10mm至14mm。根据一个实施方案，组织支撑部分130的宽度可以在5mm至15mm的范围内，例如10mm至12mm。根据各种实施方案，臂120和160具有相同的长度或基本相同的长度。根据另一实施方案，臂120和160具有不同的长度。例如，臂120为5mm至20mm长，例如80mm至15mm长，而臂160为80至200mm，例如长度为100mm至150mm。
根据各种实施方案，组织锚定器可以被固定，要么直接地要么间接地(即，通过连接器)固定到臂120和160中的一个或两个。任何适于锚定植入体到组织(如软组织，例如肌肉组织、韧带、腱或膜，如所述经闭孔膜)的锚定器将满足要求。所述锚定器可以通过任何适合的方式被固定到所述臂，包括机械地通过粘合、摩擦配合、超声波焊接、溶剂粘合以及热熔方式。
根据各种实施方案，第一组织锚定器110被配置为沿臂120的长度自由移动，并且第二锚定器150也被配置为沿臂160的长度自由移动。一旦所述锚定器被植入并且获得期望的张力(tension)，两个锚定器可以被固定到臂120和160的合适的位置。根据另一实施方案，第一组织锚定器110是永久性地固定到所述臂120的所述终端端头121，并且第二锚定器150被配置为沿臂160的长度自由移动。这便利所述植入体的调节特征，以至于一旦所述第一锚定器和然后所述第二锚定器被植入，由所述悬带施在尿道上的所述张力通过在相应于所述锚定器150的任何方向操纵臂160而被调节。所述操纵是通过设置在臂160的端头164处的抓持件(gripping feature)180来进行的。一旦达到了所述期望的张力，所述臂160在合适的位置被固定到所述锚定器。
根据一个实施方案，所述组织锚定器中的少一个，例如组织锚定器150，包括垂直于所述锚定器的纵轴的孔。这在图9A-9B以及图11中被图示说明。图9A图示说明具有倒钩(barb)151a的锚定器150a，以及被配置来接纳网状臂160的孔152a。所述孔151a和网状臂160分别被选择尺寸，从而臂160从中穿过的运动被限制。限制的程度将取决于所述臂和所述孔的边缘间的配合(fit)。根据一个实施方案，所述臂160和孔152a相对地选择尺寸，从而拉动所述臂通过所述锚定器孔1cm要求范围从4盎司至6磅(例如2至6磅，或1至2磅)的量的力的滑动阻力。图9B图示说明具有三角形孔152b的组织锚定器150b。臂160被接纳于孔152b中，并且示例性特征153b(孔152b的所述远端)帮助抵制所述臂的运动。附加的示例性组织锚定器在图11中被图示说明。
图12A图示说明根据本公开的示例性组织锚定器150的底视图。根据一个实施方案，所述组织锚定器具有由一内腔(lumen)限定的纵轴。根据一个实施方案，所述内腔被配置来接纳可以刺穿(pierce)臂160的销(pin)，并且由此锚定在合适位置。图12B图示说明组织锚定器150的侧视图。
图10图示说明根据本公开的另一实施方案。组织支撑部分130被设置在尿道310下，来帮助完成来自膀胱300的尿液的流动。分别具有倒钩111a和151a的锚定器110a和150a，分别被锚定在两个闭孔膜(obturator membrane)330a和330b中。第一调节缝合线410被附着到臂160的位置412处。第一调节缝合线410的所述远端被附着到小片(tab)414。第二调节缝合线416被附着到组织支撑部分130的位置418处。调节缝合线416的所述远端被附着到小片420。两个调节缝合线416和410被配置为设置在阴道切口320外。根据各种实施方案，并类似于所述组织锚定器和所述组织支撑系统，所述调节缝合线可以是生物可吸收的(bioabsorbable)。
一旦锚定器110a和151a被牢固地锚定在所述两闭孔膜中，外科医生可以调节由组织支撑部分130施在尿道310上的张力的量。根据一个实施方案，所述张力可以由通过小片420拉动缝合线416而被减少。可替换地，张力可以由通过小片414拉动缝合线410而被增加。根据各种实施方案，所述调节缝合线410和416可以是不同地着色的，以协助识别。根据一个实施方案，小片414和420是有不同形状的、有不同颜色的、和/或被标记来协助从两个缝合线中分辨其中的一个。根据另一实施方案，缝合线410和416每一个均为环(loop)的形式(图未示)，所述环分别自由通过点412和418。那样，当所述环在所述植入体的最终张力下被切断时，缝合线的全部长度被从所述本体去除。
根据各种实施方案，在所述植入体被张紧后，缝合的线410和416立即被切断并去除，并且切口320被缝合关闭。根据另一实施方案，所述植入体是初步被张紧的，并且所述切口是临时被缝合和/或被包扎的。12至72小时后，患者回到外科医生处，并且复查所述患者的失禁或闭尿(retention)程度。通过小片414和/或420对所述植入体进行最终调节，所述缝合线410和416被切断并去除，并且切口320被缝合关闭。
本文公开的所述组织锚定器可以由任一具有生物相容的(biocompatible)材料构成，包括不锈钢、聚丙烯以及可吸收的材料，包括但不限于聚乳酸、羟乙酸乳酸聚酯(polyglactin)以及聚乙醇酸或其他在可吸收外科材料中被普遍使用的材料。根据各种实施方案，本文公开的所述锚定器可以为适合抵抗(withstand)特定拉动力的任一尺寸(dimension)。所述锚定器的长度范围可以为从，例如，5mm至20mm，例如10mm至15mm，如10.1、10.2、10.3、10.4或10.5mm。所述锚定器具有范围从1mm至5mm的厚度，例如2mm至3mm厚。所述锚定器具有大约2.5mm的基底(base)，例如2.2mm至2.3mm。
参考图1，所述组织支撑系统10还可以包括通管针185。通管针185被配置来插入抓持件180，并且然后插入臂160的所述内腔166。通管针185包括具有近端194和远端192的杆(shaft)190、抓持件196，以及远端198。通管针185的长度范围可以为从，例如12cm至25cm，包括18cm至22cm，如21cm。
所述组织支撑系统还可以包括具有柄210、杆220、夹头240的导引针200，所述夹头240被配置来可释放地固定(secure)组织锚定器，以及人工可操作的致动器(actuator)230。所述致动器230被配置为当在位置231时(图2)固定组织锚定器至所述夹头240，并且当移动到位置232时(图3)，释放所述组织锚定器。所述图示说明的导引针200具有弯曲的杆220，其中所述弯曲与所述柄基本上是在相同的平面。参考图2，杆220可以具有范围从3cm至7cm的长度213，如4cm至6cm，例如5cm。杆220可以具有范围从3.5cm至5.5cm的长度214，例如4cm至5cm，以及4.5cm。根据各种实施方案，杆220被这样选择尺寸和形状，从而在锚定器被插入所述闭孔区域内时，可以贴合地(snugly)绕坐骨耻骨的支(ischiopubic ramus)旋转。根据另一实施方案，所述杆具有螺旋的形状。根据这一实施方案，所述系统可以提供给临床医生两个螺旋形状的针，患者解剖结构的每一侧一个针。
图1-6图示说明根据本公开的被设置于内腔166中的锁定构件170。根据各种实施方案，所述锁定构件170是由聚丙烯构成的。所述锁定构件170可以具有适合用于其意图目的的任一尺寸。通过非限制性实施例的方式，所述锁定构件具有范围从1mm至2mm的直径，例如1.2mm至1.8mm，范围从1.5mm至2.5mm的宽度，以及范围从2.5mm至5.5mm的长度，例如4.5mm。
参考图4，所述锁定构件170被配置为初始被设置在臂160的所述内腔166中临近抓持件180的位置。在锚定器150被设置在期望的组织位置后，在所述锁定构件170邻接锚定器150之前，臂160被固定于相对于所述锁定件(locking feature)的位置。所述滑动可以借助插入柔韧的通管针185通过抓持件185中的内腔182来实现，所述内腔与臂160中的内腔166流畅地连通。通管针185的所述远端198接触锁定构件170，并且在锚定器150的方向推进所述锁定构件。所述锁定构件在反向的运动(即朝向臂160的端头164)被叉状物(prong)172阻止。当锚定器止动件(anchor stop)被朝向所述端头164推进，所述叉状物170将趋于锚定进入所述网状物，因而阻止进一步运动。
图5图示说明所述可植入组织支撑构件100的另一视图。图6图示说明所述组织支撑构件的部分分解图。图7图示说明锚定器110固定到臂120的一个实施方案。臂120的端头121被插入锚定器110的孔112。然后插头(plug)111被插入内腔166和孔112，由此提供所述插头112、所述臂120以及锚定器110间的摩擦配合。
根据本公开的所述组织支撑系统可以被用于对不同类型的组织恢复(restore)正确的支撑。例如，所述系统可以被用于治疗女性和男性尿失禁，例如压力性失禁(stressincontinence)。所述系统可以被用于治疗大便失禁。此外，所述系统可以被用来进行骨盆底(pelvic floor)修复，如盆腔器官脱垂，通过固定组织支撑部分到韧带和/或肌肉用于前面的、后面的以及顶上的阴道穹窿(vault)的修复。
根据一个实施方案，本文公开的所述组织支撑系统包括尿道的悬带。根据一个实施方案，用于植入尿道的悬带的手术一般包括进行尿道中段的切口以及在所述闭孔的上内侧面(superior-medial aspect)的方向横向地分割出阴道组织。然后所述悬带的端使用导引设备(introducer device)穿过所述闭孔内肌/闭孔膜。根据一个实施方案，在腹股沟处切出两个出切口(exit incision)以允许所述导引针和悬带端的外置(exteriorization)。这些出切口允许使用所述网状物的所述自由臂在所述出切口处对在尿道下的所述悬带张力的调节。根据本公开的另一实施方案，尿道的悬带不需要任何出切口，因为网状物的调节可以在阴道的切口处完成。
以下图示说明根据本公开的组织支撑系统可以被用来治疗女性尿失禁的一种方式。患者以肾背位式安置，其中髋部(hips)屈曲大约90度并且臀部(buttocks)恰好贴近桌面的边缘。外科部位标准的手术准备完成，并且膀胱以弗利导管(Foley catheter)导空。首先通过确定外部尿道口(meatus)的位置，以及然后通过识别所述费利导管球(bulb)确定膀胱颈的位置来识别尿道中段(mid-urethra)。
水分离(hydro-dissection)通过在阴道壁和尿道间的中线处注射溶液(solution)(例如，1％的利多卡因和肾上腺素)来进行，由此生成尿道阴道间隔(space)。附加的水分离可以通过横向地朝向所述坐骨耻骨支的向头侧的面(cephalad aspect)注射溶液来进行以更好地识别侧沟(lateral sulci)。组织钳被放置在所述前面的阴道壁上的所述尿道中段的水平处。
小的(大约1.5cm)切口在所述前面的阴道壁中被切出，所述切口起始在尿道口下大约1cm处。所述切口的深度可以延伸进入阴道肌层(muscularis)。尿道被小心地从所述前面的阴道壁分开。接下来，横向地在45度角使用剪刀(例如，梅曾堡剪(Metzenbaumscissor))直到所述剪刀头(tip)与所述坐骨耻骨支(大约1-2cm)的中间向头侧面接触完成分割。然后这一过程在对侧边重复进行。
所述导引针200被装上锚定器110，如图2中所示。然后所述导引针(introducer)被插入横向地通过朝向所述坐骨耻骨支的所述向头侧的面的分割的面中的一个的阴道切口(dissection)。所述导引针200成角度地朝向所述闭孔的所述上内侧面。一旦所述固定的锚定器在所述坐骨耻骨支的后面，锚定器110被推入所述组织直到所述锚定器稍稍超过所述分支。
所述柄210枢转地在所述闭孔的所述上内侧面内插入所述锚定器110通过所述闭孔内肌肌肉/膜，以至于所述定向标记140处于或在插入方向稍稍越过所述尿道中段(约0.5cm)。可以听到表示所述肌肉/膜的穿破(perforation)的特殊的砰的一声(pop)。通过在所述导引柄210内将所述致动器230从位置231向前推至位置232释放所述锚定器110。然后，通过反向通过所述插入通道(path)，所述导引针被小心地缩回。
在锚定器110从夹头240被释放后，柔和的牵引被施加到尿道下的(sub-urethral)悬带上，以确认在所述组织中的牢固固定。
接下来，可调节的锚定器150被装入导引器并且通过将所述人工致动器230从所述柄210上的位置232缩回到位置231被固定。确认牢固装载的轻微的“咔哒声(click)”可以被感觉到或被听到。手术中的这一时刻，要加以细心来确保所述植入体不是扭曲的(twisted)。
接下来，在插入前，期望确认在所述组织支撑部分130和所述锚定器150间至少有4cm的可调节的网状物。
所述锚定器150被插入所述对侧的分割平面，并且所述导引针200被定向朝向所述闭孔的所述上内侧面。锚定器150被推入所述组织稍稍超过所述坐骨耻骨支，并且所述柄210枢转地在所述闭孔的所述上内侧面内插入所述锚定器150通过所述闭孔内肌肌肉/膜。
锚定器150通过在所述导引柄210中将所述致动器230从位置231推至位置232而从夹头240被释放。导引针200通过反向通过所述插入通道而被缩回。在锚定器150被释放后，柔和的牵引被施加到所述组织支撑系统100上来确认在所述组织中的牢固的固定。
抓持件180被小心地拉动来调节由所述组织支撑部分130施在尿道上的所述张力。为协助调节，手指被插入阴道来在所述闭孔内肌肌肉处稳固锚定器150。所述悬带也可以通过在所述组织支撑部分130最靠近锚定器150的侧边上使用柔和的反向牵引而被松开。在尿道和尿道下的悬带间的纤细的、钝(blunt)的器械(如止血钳)可以被用来作为隔离器(spacer)，以协助设置适当的张力。也可以采用咳嗽测试或克雷德(créde)测试来达到所述适当的张力。所述定向标记140应当是在中线处可见的，在任何方向远离尿道不多于1cm。
一旦达到合适的张力，通管针185被插入所述抓持件180的内腔182。所述通管针185被插入内腔166来在锚定器150处推进锁定构件170进入合适的位置。当锁定构件170适当地就位时，所述通管针185会弯曲，这表示所述锁定构件170是在合适的位置并且所述组织支撑构件已经被固定。一旦锚定器150被锁定进入合适的位置，使用所述抓持件180可以达到附加的绷紧。
在所述组织支撑构件100被最终固定后，通管针185被去除。根据一个实施方案，臂160在锚定器150和端头164间被切断。然后使用缝合线缝合阴道切口。根据各种实施方案，所述切口被临时缝合并且绕臂160包扎。这将允许临床医生在手术后改变由所述植入体施在尿道上的张力的量。一旦获得并确认期望程度的张力，所述锚定器150可以可选地被固定到臂160，并且剩余材料可以被切断，并在其中所述植入体是由非生物可吸收的材料构成的情况下，可以从所述本体移除。
根据各种实施方案，护套(sheath)可以包围本文公开的所述组织支撑构件的至少部分以便利他们进入组织的通道。在这样的实施方案中，所述组织支撑构件，或其至少所述支撑部分，被夹(sandwich)在两个护套间。所述护套侧边是由具有低摩擦系数的材料(如聚四氟乙烯(PTFE))为原料恰当地制成的。根据另一实施方案，植入的所述组织支撑构件不带护套。
除非另行定义，本文使用的所有技术及科学术语具有如本发明所属领域的普通技术人员所普遍理解的含义相同的含义。本文的发明的说明书中使用的所述术语仅是用来描述具体实施方案而并不是意图对本发明造成限制。如在本发明的说明书以及所附权利要求书中使用的单数形式的“一(a或an)”以及“所述”也意图包括复数形式，除非本文内容明确地另行指定。所有本文提到的公开文件、专利申请文件、专利以及其他参考文献均通过引用被清楚地并入其全部内容。
同时，除非另行指定，在本说明书和权利要求书中使用的表示物理参数数量的所有数字等，被理解为在所有情况下由术语“约”来修饰。因此，除非指定是相反的，在如所述的说明书及所附的权利要求书中说明的数字参数是大约的数，可以根据本发明所力求获得的期望性能而改变。丝毫没有，并且不试图去限制等同性条款对所述权利要求书的范围的应用，每一个数字参数应根据有效数字的个数以及普通圆整方法来解释。
尽管说明本发明的宽广范围的数值范围及参数是大约的数，在具体实施例中说明的数值被尽可能精确地记载。然而，任一数值固有地包括由在它们各自的测试度量中均存在的标准偏差所必然造成的某些误差。在本说明书的全文中给出的数值范围将包括落入此较宽的数值范围内的所有较窄的数值范围，如同此较窄的范围都已在本文中被清楚地写出一样。

Claims (12)

1.一种包括可植入组织支撑构件的组织支撑系统，所述可植入组织支撑构件包括：
组织支撑部分；
具有第一端头的第一臂，所述第一臂的所述第一端头连接到所述组织支撑部分的第一端；
由网状物构成的第二臂，所述第二臂包括由所述网状物的管形编织结构形成的内腔，所述第二臂具有第一端头，所述第二臂的所述第一端头连接到所述组织支撑部分的第二端；
固定到所述第一臂的第二端头的第一组织锚定器；
第二组织锚定器，在所述第二组织锚定器中具有孔，所述孔至少部分包围所述第二臂的部分；以及
锁定构件，所述锁定构件在所述第二组织锚定器与所述第二臂的第二端头间设置于所述第二臂的所述内腔中。
2.如权利要求1所述的组织支撑系统，其中所述孔被配置来抵制所述第二臂通过所述孔的无约束运动。
3.如权利要求1所述的组织支撑系统，其中所述锁定构件被配置来朝所述第二组织锚定器的方向被推进，并且被配置来抵制朝所述第二臂的所述第二端头的方向的运动。
4.如权利要求1所述的组织支撑系统，还包括通管针，所述通管针被配置用于从所述第二臂的所述第二端头导引进入所述内腔并且被配置用于朝所述第二组织锚定器的方向推进所述锁定构件。
5.如权利要求1所述的组织支撑系统，还包括被配置来可释放地固定所述组织锚定器的导引针。
6.如权利要求5所述的组织支撑系统，其中所述导引针包括杆和柄。
7.如权利要求6所述的组织支撑系统，其中所述杆具有弯曲部分。
8.如权利要求7所述的组织支撑系统，其中所述杆具有基本上为螺旋的形状。
9.如权利要求6所述的组织支撑系统，其中所述导引针包括在所述杆的远端的夹头。
10.如权利要求6所述的组织支撑系统，其中所述柄包括用于从所述杆的远端释放所述组织锚定器的人工可操作的机构。
11.如权利要求1所述的组织支撑系统，其中所述组织支撑部分包括定向标记。
12.如权利要求11所述的组织支撑系统，其中所述定向标记包括在所述组织支撑部分的中心的有色特征。
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US20090137862A1 (en) 2009-05-28
EP2211764A4 (en) 2013-04-10
CN101854883A (zh) 2010-10-06
US8574149B2 (en) 2013-11-05
AU2008320999A1 (en) 2009-05-22
MX2010005271A (es) 2010-06-01
EP2211764A1 (en) 2010-08-04
US20140058193A1 (en) 2014-02-27
US20120253110A1 (en) 2012-10-04
KR20100084543A (ko) 2010-07-26
US8206280B2 (en) 2012-06-26
WO2009064866A1 (en) 2009-05-22
JP2011502712A (ja) 2011-01-27

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