CN107106176B - 用于组织修复的改进的抓持器 - Google Patents

用于组织修复的改进的抓持器 Download PDF

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CN107106176B
CN107106176B CN201580069505.6A CN201580069505A CN107106176B CN 107106176 B CN107106176 B CN 107106176B CN 201580069505 A CN201580069505 A CN 201580069505A CN 107106176 B CN107106176 B CN 107106176B
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迈克尔·F·韦
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Abstract

本发明提供用于在治疗部位处接近及修复组织的改进的装置、系统和方法。本发明提供通过改进组织到装置中的捕获而可以更顺利地接近及修复组织的装置、系统和方法。本发明可以是允许组织进入机构但不允许其容易地离开的单向机构，比如片簧、突出部、枢转臂以及一个或更多个摩擦元件。

Description

用于组织修复的改进的抓持器
相关申请的交叉引用
本申请要求于2014年12月19日提交的美国申请No.14/577,852的优先权和权益，该申请通过参引全部并入本文中。
背景技术
本发明总体上涉及的医疗方法、医疗设备和医疗系统。具体地，本发明涉及用于身体组织腔内的、经皮的或微创治疗——比如组织接近或瓣修复——的方法、设备和系统。更具体地，本发明涉及修复心脏瓣膜或静脉瓣膜以及将通过微创手术将二尖瓣瓣膜修复部件移除或禁用的设备和方法。
身体组织的外科修复通常涉及组织接近以及这些组织在接近的装置中的紧固。在修复瓣膜时，组织接近包括将瓣膜的瓣叶对合在治疗装置中，该治疗装置随后可以通过紧固或固定瓣叶而被保持。这种对合可以用于治疗最常发生在二尖瓣中的返流。
二尖瓣反流的特征在于逆向血流从心脏的左心室通过关闭不全的二尖瓣流动到左心房。在心肌收缩(心脏收缩)的正常循环期间，二尖瓣用作用以防止含氧血液向回流动到左心房的止逆阀。以这种方式，含氧血液通过主动脉瓣被泵送到主动脉中。二尖瓣的反流会显著地降低心脏的泵送效率，从而使病人处于严重且渐进的心力衰竭的风险。
二尖瓣反流可能会因二尖瓣或左心室壁的多种不同的机械缺陷引起。瓣叶、将瓣叶连接至乳头肌的瓣索或者乳头肌自身或者左心室壁可能会被损坏或以其他方式机能失调。通常，瓣环可能会被损坏、膨胀或变弱，从而限制二尖瓣抵抗左心室的较大压力充分关闭的能力。
对二尖瓣反流的最常规的治疗依赖于瓣的置换或者瓣的修复包括瓣叶和瓣环重构，瓣叶和瓣环重构通常被称为瓣膜成形术。依赖于将相对两个瓣叶的相邻部段缝合在一起的一种二尖瓣修复的技术被称为“蝴蝶结”或“缘对缘”技术。尽管所有这些技术可能都非常有效，但其通常依赖于开心手术，在开心手术中，通常经由胸骨切开术将患者的胸腔剖开并且对患者进行心肺转流术。需要剖开胸腔并对患者进行心肺转流术是创伤性的并且具有相关联的发病率。
在一些患者中，固定装置可以利用微创技术安装到心脏中。该固定装置将相对的瓣叶的相邻的部段保持在一起并且可以使二尖瓣反流减小。用于将二尖瓣的前后瓣叶夹持在一起的一种设备是由美国加州Santa Clara的Abbott Vascular(雅培血管公司)出售的
Figure GDA0002220581740000021
固定装置。
背景技术描述
存在用于接近组织或器官以及在治疗部位处修复组织或器官的许多技术。例如，在PCT公布的NOs.WO 98/35638；WO 99/00059；WO 99/01377；以及WO 00/03759；WO 2000/060995；WO 2004/103162中描述了用于对合及修改二尖瓣瓣叶以治疗二尖瓣反流的微创技术和经皮穿刺技术。Maisano等人在(1998)Eur.J.Cardiothorac.Surg.(欧洲胸心外科杂志)13:240-246；Fucci等人在(1995)Eur.J.Cardiothorac.Surg.(欧洲胸心外科杂志)9:621-627；以及Umana等人在(1998)Ann.Thorac.Surg.(胸外科年鉴)66:1640-1646中描述了用于进行“缘对缘”或“蝴蝶结”二尖瓣修复的开放式外科手术，在该开放式外科手术中，相对的瓣叶的边缘被缝合在一起以使反流减小。Dec和Fuster在(1994)N.Engl.J.Med.(新英格兰医学杂志)331:1564-1575以及Alvarez等人在(1996)J.Thorac.Cardiovasc.Surg.(胸心血管外科杂志)112:238-247中的评论文章中论述了扩张型心肌病的本质以及治疗。
在下述出版物中描述了二尖瓣瓣膜成形术Bach和Bollin(1996)Am.J.Cardiol.(美国心脏病学杂志)78:966-969；Kameda等(1996)Ann.Thorac.Surg.(胸外科年鉴)61:1829-1832；Bach和Bolling(1995)Am.Heart J.(美国心脏学杂志)129:1165-1170；以及Bolling等(1995)109:676-683。在Ricchi等人在(1997)Ann.Thorac.Surg.(胸外科年鉴)63:1805-1806中描述了用于二尖瓣修复的线性区段瓣膜成形术。在McCarthy和Cosgrove(1997)Ann.Thorac.Surg.(胸外科年鉴)64:267-268；Tager等(1998)Am.J.Cardiol.(美国心脏病学杂志)81:1013-1016；以及Abe等(1989)Ann.Thorac.Surg.(胸外科年鉴)48:670-676中描述了三尖瓣瓣膜成形术。
在Park等(1978)Circulation 58:600-608；Uchida等(1991)Am.Heart J.121:1221-1224；以及Ali Khan等(1991)Cathet.Cardiovasc.Diagn.23:257-262中描述了经皮腔内的心脏修复手术。在美国专利Nos.5,840,081；5,411,552；5,554,185；5,332,402；4,994,077；以及4,056,854中描述了腔内心脏瓣膜置换术。专利No.3,671,979描述了用于人造心脏瓣膜的临时放置的导管。
在美国专利Nos.4,917,089；4,484,579；以及3,874,338和PCT公布No.WO 91/01689中描述了经皮和腔内心脏修复手术。
在美国专利Nos.5,855,614；5,829,447；5,823,956；5,797,960；5,769,812；以及5,718,725中描述了胸腔镜和其他微创心脏瓣膜修复及置换手术。
发明内容
本公开描述了意图用于血管内的输送并且用于治疗病人的二尖瓣缺陷的装置。人体心脏的二尖瓣具有心房侧、心室侧、前瓣叶、后瓣叶以及瓣叶之间的开口。
在一个实施方式中，该装置可以包括本体、一对近端元件和一对远端元件。各近端元件在第一端部处、分别于所述本体的相反两侧联接至所述本体，并且每个近端元件均具有第二自由端部。每个近端元件均具有位于其第一端部与第二端部之间的近端接合表面。每个近端接合表面构造成接近并接合瓣叶的与心房侧上的二尖瓣相邻的部分。每个近端接合表面还具有近端保持元件，所述近端保持元件构造成允许组织朝向近端元件的第一端部移动并且阻碍组织远离近端元件的第一端部移动。
各远端元件在第一端部处、分别于所述本体的相反两侧枢转地联接至所述本体，每个远端元件均具有第二自由端部。每个远端元件均具有位于其第一端部与第二端部之间的远端接合表面。每个远端接合表面构造成接近并接合瓣叶的与心室侧上的二尖瓣相邻的部分。
近端元件中的第一近端元件与远端元件中的第一远端元件进行配合，以在第一近端元件与第一远端元件之间形成用于接纳前瓣叶的一部分的空间。近端元件中的第二近端元件与远端元件中的第二远端元件进行配合，以在第二近端元件与第二远端元件之间形成用于接纳后瓣叶的一部分的空间。每个这种空间具有敞开的端部和闭合的端部，并且闭合的端部形成顶。
该装置包括致动器，所述致动器用于使远端元件在第一位置、第二位置与第三位置之间选择性地移动，其中，在第一位置中，远端元件处于收缩的小体积构型以便于该装置的输送，在第二位置中，远端元件处于扩张构型以将该装置相对于二尖瓣定位，在第三位置中，远端元件抵靠瓣叶的与心室侧上的二尖瓣相邻的部分而固定就位。
该装置还包括致动器，该致动器用于使近端元件在第一位置与第二位置之间选择性地移动，其中，在第一位置中，近端元件处于收缩的小体积构型以便于该装置的输送，在第二位置中，近端元件处于扩张构型以接合瓣叶的与心房侧上的二尖瓣相邻的部分。
每个远端元件还可以包括沿着远端接合表面定位的远端保持元件。每个远端保持元件构造成与对应的近端保持元件进行配合，以在该装置被相对于二尖瓣定位时捕获二尖瓣的瓣叶的自由边缘。每个保持元件可以构造成与摩擦元件进行配合，以允许瓣叶的前部自由边缘在几乎没有阻力或限制的情况下沿第一方向朝向本体移动以及阻碍或阻止瓣叶的自由边缘沿相反方向远离本体移动。
通过以下描述和所附权利要求，本公开的这些及其他目的和特征将变得充分明显，或者可以通过实施下文中阐述的本发明的实施方式而获得。
附图说明
为了进一步阐明本公开的以上以其他优点和特征，参照附图中示出的具体实施方式对本发明进行更具体的描述。应当理解的是，这些附图仅描绘本发明的示出的实施方式并且因此不被视为限制其范围。将通过使用附图以附加的特征和细节对本发明进行描述和说明：
图1示出了在正常对合时的二尖瓣的瓣叶的自由边缘，并且图2示出了处于反流对合时的自由边缘。
图3A至图3C分别示出了瓣叶的具有固定装置、固定装置的远端元件倒置以及将固定装置去除时的瓣叶的抓持。
图4示出了相对于瓣叶处于期望取向的固定装置。
图5示出了联接至轴的示例性固定装置。
图6A至图6B、图7A至7B和图8示出了在将该装置导入并布置在体内以进行治疗操作期间的处于各种可能的位置中的固定装置。
图9A至图9B示出了具有片簧的固定装置的实施方式。
图10示出了另一实施方式的固定装置的一部分的放大图。
图11A示出了另一实施方式的固定装置的一部分的放大图。
图11B和图11C分别示出了另一实施方式的固定装置的一部分的放大截面侧视图。
图11D和11E分别示出了另一实施方式的固定装置的一部分的放大截面横向视图。
图12示出了另一实施方式的固定装置的一部分的放大图。
具体实施方式
I.概述
A.心脏生理学
如图1中所示，二尖瓣(MV)包括具有自由边缘(FE)的一对瓣叶(LF)，所述自由边缘在具有正常心脏结构和功能的患者中均匀地接合以沿着对合线(C)闭合。瓣叶(LF)沿着被称为环(AN)的环形区域附接至周围的心脏结构。瓣叶(LF)的自由边缘(FE)通过腱索(或者“腱”)固定至左心室(LV)的下部。
作为心脏收缩(被称为“心脏收缩”)的左心室，从左心室通过二尖瓣至左心房的血液流动(被称为“二尖瓣反流”)通常被二尖瓣阻止。
反流在瓣叶闭合不全并且允许从左心室泄露到左心房中时发生。许多心脏结构缺陷会导致二尖瓣反流。图2示出了具有缺陷从而造成通过间隙(G)的反流的二尖瓣。
II.二尖瓣固定技术的总体概述
存在用于修复或置换有缺陷的二尖瓣的若干种方法。二尖瓣的一些缺陷可以通过血管内手术来处理，在血管内手术中，介入工具和设备通过血管被导入心脏并从心脏移除。修复某些二尖瓣缺陷的一种方法包括在血管内输送固定装置以将二尖瓣组织的一部分保持处于特定位置中。可以使用一个或更多个介入导管将固定装置输送至二尖瓣并将其作为治疗二尖瓣反流的植入物安装在二尖瓣处。
图3A示出了具有输送轴12和固定装置14的介入工具10的示意图。工具10已经从心房侧接近二尖瓣MV并抓持瓣叶LF。
固定装置14在轴12的远端端部处以可释放的方式附接至介入工具10的轴12，在本申请中，当描述装置时，“近端”指的是朝向该装置的待被位于患者体外的使用者操纵的端部的方向，“远端”指的是朝向该装置的定位在治疗部位处且远离使用者的工作端部的方向。当描述二尖瓣时，近端指的是瓣叶的心房侧，而远端指的是瓣叶的心室侧。
固定装置14包括近端元件16和远端元件18，近端元件16和远端元件18沿径向向外突出并且能够定位在瓣叶LF的相反两侧以将瓣叶捕获或保持在近端元件16与远端元件18之间。固定装置14能够通过联接机构17联接至轴12。
图3B示出了远端元件18可以沿箭头40的方向移动至反转位置。近端元件16可以如图3C中示出的那样被升高。在反转位置中，装置14可以被重新定位并且随后反转至如图3A中的抵靠瓣叶的抓持位置。或者，固定装置14可以如图3C中示出的那样从瓣叶收回(由箭头42指示)。这种反转可以减小对瓣叶的损伤并且可以使装置与周围组织的任何缠结最小化。
图4示出了相对于瓣叶LF处于期望的取向的固定装置14。由于从心房侧观察二尖瓣MV，所以近端元件16以实线示出而远端元件18以虚线示出。近端元件16和远端的元件18被定位成大致垂直于对合线C。在心脏舒张(当血液从左心房流动至左心室)期间，固定装置14将瓣叶LF在被由舒张压力梯度造成的开口或孔口围绕的元件16、18之间保持就位，如图4中所示。
一旦将瓣叶以期望的布置对合，则固定装置14从轴12脱离并且作为植入物留下。
A.示例性固定装置
图5示出了示例性固定装置14。固定装置14被示出为联接至轴12以形成介入工具10。固定装置14包括联接构件19、一对相对的近端元件16以及一对相对的远端元件18。
远端元件18包括长形臂53，每个臂均具有自由端部54以及以可旋转的方式连接至连接联接构件19的近端端部52。优选地，每个自由端部54限定绕下述两个轴线的曲率：垂直于臂53的纵向轴线的轴线66以及垂直于轴线66或臂53的纵向轴线的轴线67。
臂53具有接合表面50。臂53和接合表面50被构造成接合约4-10mm的组织，并且优选地沿者臂53的纵向轴线接合约6-8mm的组织。臂53还包括多个开口。
近端元件16优选地被朝向远端元件18弹性地偏置。当固定装置14处于打开位置时，每个近端元件16在臂53的近端端部52附近与接合表面50分离并且在自由端部54附件朝向接合表面50倾斜，使得近端元件16的自由端部接触接合表面50，如图5中所示。
近端元件16包括多个开口63和扇形侧边缘61以增强其对组织的抓持。近端元件16可选地包括摩擦元件或多个摩擦元件，以辅助抓持瓣叶。该摩擦附件可包括倒钩60，倒钩60具有朝向接合表面50延伸的逐渐变细的尖端。可以使用任何适合的摩擦元件，比如叉状物、翼状物、带状物、倒钩、凹槽、通道、突起、表面粗糙化、烧结、高摩擦垫、覆盖物、涂层或这些的组合。
近端元件16可以覆盖有织物或其他柔性材料。优选地，当织物或覆盖物与倒钩或其他摩擦特征组合使用时，这些特征将伸出穿过这些织物或其他覆盖物以接触被近端元件16接合的任何组织。
固定装置14还包括致动器或致动机构58。致动机构58包括两个连结构件或支腿68，每个支腿68均具有第一端部70和第二端部72，其中，第一端部70在铆接接合部76处以可旋转的方式与远端元件18中的一个远端元件接合，并且第二端部72可以以可旋转的方式与双头螺栓74接合。致动机构58包括各自以可移动的方式联接至基部69的两个支腿68。或者，每个支腿68可以通过单独的铆钉或销分别附接至双头螺栓74。双头螺栓74可以与下述致动器杆接合：该致动器杆延伸穿过轴12并且能够轴向延伸及缩回以使双头螺栓74移动并且因此使支腿68移动从而使远端元件18在闭合位置、打开位置和/或反转位置之间旋转。双头螺栓74的制动可以将支腿68保持就位并且因此将远端元件18保持在期望位置中。双头螺栓74还可以通过锁定特征被锁定就位。该致动器杆和双头螺栓组件可以被视为用于使远端元件在第一位置、第二位置与第三位置之间选择性地移动的第一器件，其中，在第一位置中，远端元件处于收缩的小体积构型以便于该装置的输送，在第二位置中，远端元件处于扩张构型以将该装置相对于二尖瓣定位，在第三位置中，远端元件抵靠瓣叶的与心室侧上的二尖瓣相邻的部分而固定就位。
图6A至图6B、图7A至图7B和图8示出了图5的固定装置14的各种可能的位置。图6A示出了通过导管86输送的介入工具10。导管86可以采用引导导管或护套的形式。介入工具10包括联接至轴12的固定装置14并且固定装置14被示出处于闭合位置。
图6B以较大的示图示出了与图6A的装置的类似的装置。在闭合位置中，该对相对的远端元件18定位成使得接合表面50面向彼此。每个远端元件18均包括长形臂53，长形臂53具有杯状形状或凹形形状，使得臂53一起围绕轴12。这为固定装置14提供了小体积。
图7A至图7B示出了处于打开位置的固定装置14。在打开位置中，远端元件18被旋转成使得接合表面50面向第一方向。致动器杆相对于轴12的向远端的前进运动并且因此双头螺栓74相对于联接构件19的向远端的前进运动向远端元件18施加力，远端元件18开始绕接合部76旋转。远端元件18的这种沿径向向外的旋转和移动使支腿68绕接合部80旋转，使得支腿68被略微向外引导。双头螺栓74可以前进与远端元件18的期望分离相关联的任意期望的距离。在打开位置中，接合表面50设置成相对于轴12成锐角，并且设置成优选地相对于彼此成90度与180度之间的角度。在打开位置中，臂53的自由端部54在其之间具有大约10mm-20mm、通常为大约12mm-18mm并且优选地为大约14mm-16mm的跨距。
近端元件16典型地朝向臂53向外偏置。近端元件16可以借助于呈缝合线、金属丝、镍-钛合金线材、杆、线缆、聚合物线材或其他适合的结构形式的近端元件线90而朝向轴12向内移动并且被保持抵靠轴12。近端元件线90延伸穿过输送导管300的轴302并与近端元件16连接。近端元件16通过近端元件线90的操纵而被升高或降低。一旦该装置被正确定位且部署，近端元件线就可以通过将其通过导管收回并离开装置10的近端端部而被移除。近端元件线90可以被视为用于使近端元件在第一位置与第二位置之间选择性地移动的第二器件，其中，在第一位置中，近端元件处于收缩的小体积构型以便于该装置的输送，在第二位置中，近端元件处于扩张构型以接合瓣叶的与心房侧上的二尖瓣相邻的部分。
在打开位置中，固定装置14可以接合待被接近或治疗的组织。介入工具10从左心房穿过二尖瓣前进至左心室。远端元件18随后通过下述方式部署：使致动器杆相对轴12前进从而将远端元件18重新定向成垂直于对合线。整个组件随后在近端收回并且定位成使得接合表面50接触瓣叶的心室表面、从而接合瓣叶的左心室侧表面。近端元件16保持处于瓣叶的左心房侧，使得瓣叶位于近端元件与远端元件之间。介入工具10可以被反复操纵以对固定装置14进行再定位，使得瓣叶在期望的位置处被适当地接触或者抓持。再定位可以通过处于打开位置的固定装置实现。在一些情况下，还可以在装置14处于打开位置时检查反流。如果反流未被令人满意地减少，则该装置可以被再定位并且反流被再次检查直到获得期望的结果为止。
还可以期望使固定装置14的远端元件18反转以辅助固定装置14的再定位或移除。图8示出了处于反转位置中的可固定装置14。通过致动器杆相对于轴12进一步前进，并且因此双头螺栓74相对于联接构件19的进一步前进，远端元件18进一步旋转，使得接合表面50面向外并且使得自由端部54在远端对准，使得每个臂53均相对于轴12形成钝角。
在该装置反转时，臂53之间的角度优选地在大约270度到360度的范围内。双头螺栓74的进一步前进还使远端元件18绕接合部76旋转。远端元件18的径向向外的旋转和移动使支腿68绕接合部80旋转，使得支腿68朝向其大致平行于彼此的初始位置返回。双头螺栓74可以前进至与远端元件18的期望反转相关联的任一期望距离。优选地，在完全反转的位置中，自由端部54之间的跨距不超过大约20mm，通常小于大约16mm，并且优选地是大约12mm-14mm。倒钩60在远端方向上(远离近端元件16的自由端部)略微成角度，从而降低了倒钩在固定装置收回时钩住或者撕裂组织的风险。
一旦固定装置14的远端元件18已经被定位在抵靠瓣叶的左心室侧表面的期望位置中，瓣叶就可以被捕获在近端元件16与远端元件18之间。近端元件16通过从近端元件线90释放张力从而释放近端元件16而使其朝向接合表面50降低，使得近端元件16响应于形成在近端元件16中的内部的弹簧偏置力从被约束的收缩位置自由移动至扩张的部署位置，并且使得瓣叶可以被保持在近端元件16与远端元件18之间。如果反流未能被令人满意地减少，则可以升高近端元件16并且调整或者反转远端元件18以对固定装置14进行再定位。
在瓣叶已经以期望的设置被捕获在近端元件16与远端元件18之间之后，远端元件18可以被锁定成将瓣叶LF保持在该位置或者固定装置14可以返回至闭合位置或者朝向闭合位置返回。这可以通过下述方式实现：双头螺栓74相对于联接构件19向近端缩回使得致动机构58的支腿68向远端元件18施加向上的力，这又使得远端元件18旋转，从而使得接合表面50再次面向彼此。朝向远端元件18向外偏置的被释放的近端元件16通过远端元件18被同时向内推动。固定装置14随后可以被锁定以将瓣叶保持在闭合位置。固定装置14随后可以被从轴12释放。
固定装置14可选地包括用于将装置14锁定在特定位置比如打开位置、闭合位置或反转位置或在打开位置、关闭位置与反转位置之间的任何位置的锁定机构。
锁定机构可以包括释放带。对释放带施加的张力可以解锁锁定机构。
锁线92接合锁定机构106的释放带108以锁定及解锁锁定机构106。锁线92延伸穿过输送导管300的轴302。使用附接至该轴的近端端部的把手来操纵固定装置14以及使固定装置14断开联接。
关于这种固定装置14的另外的公开内容可以在PCT公布No.WO2004/103162和美国专利申请No.14/216,787中找到，这两个申请的公开内容通过参引全部并入本文中。
B.改进的抓持机构
有时，可能难以将组织捕获或保持在固定装置内14内从而难以使固定装置14根据需要接近或者修复组织。尽管可以贯穿安装固定装置14的整个过程来评估瓣叶插入，但是可能难以区分良好和不佳的瓣叶插入和保持。例如，当在血管内的手术或微创手术中使用固定装置14时，组织的捕获或保持的可视化可能是困难的。
有时，在安装固定装置14的过程期间，在期望被捕获或者保持在近端元件16与远端部件18之间的组织实际上仅被部分地捕获或未牢固地捕获时，其可能看上去被牢固地捕获或保留。因此，瓣叶组织LF的自由边缘FE可能随后就与固定装置14分离，并且固定装置14随后可能不能正确地接合、接近或修复组织。即使成像方法使得在组织被捕获在固定装置中时可以可视化，但是也可能不允许观察者辨别被牢固捕获的组织和未被牢固捕获的组织。例如，尽管彩色多普勒超声可以示出反流已减小，但是其不能提供下述精确细节：固定装置14沿着瓣叶LF的哪个位置捕获了组织以及该捕获是否是牢固的。
如果瓣叶被不佳地抓持在近端元件16与远端元件18之间，则最终瓣叶LF会与固定装置14分开。这可导致固定装置14仅附接至瓣叶LF中的一个瓣叶，或者导致与两个瓣叶LF都分开，并且不再像所期望的那样起作用。
除了装置14在其被安装时的成像或可视化引起的困难之外，将组织捕获或者保持在固定装置14内的困难也由期望被捕获或保持的组织的性质造成。例如，在使用固定装置14将二尖瓣瓣叶LF固定至彼此以阻止或减小二尖瓣反流的情况下，瓣叶LF在心脏跳动时不断地移动。
图9至图12示出了意在在固定装置14’的布置期间辅助固定装置14’的捕获以及保持瓣叶LF的自由边缘FE的各种实施方式。为此，这些实施方式包括添加定位在每个远端元件18’的近端侧上的保持元件400。保持元件400与摩擦元件——比如倒钩410——在近端元件16’的下端部处结合，以在固定装置14’最初插入时捕获瓣叶的自由边缘FE并辅助将其保持在自由边缘处，直到近端元件和远端元件被完全部署。近端元件16’的下端部是最靠近双头螺栓74’的端部。
保持元件400和倒钩410构造成进行配合以允许瓣叶LF的自由边缘FE沿第一方向朝向形成于每个近端元件16’与对应的远端元件18’之间的顶430容易地或自由地移动，但同时阻碍或阻止瓣叶组织LF的自由边缘FE沿相反的方向远离顶430移动。以此方式，保持元件400与倒钩410配合来帮助在装置14’相对于瓣叶LF定位并且在近端元件16’和远端元件18’被完全部署之前将瓣叶LF保持在装置14’中。
保持元件400可以用作在无需被致动的情况下保持瓣叶组织LF的被动捕获机构。例如，保持元件400可以在长约4-10mm、优选地为大约6-8mm的组织沿着远端元件18’的纵向轴线定位时将瓣叶组织LF保持在装置14’中。如示出的实施方式中所示，保持元件400可以定位在远端元件18’上，或者保持元件400可以定位在近端元件16’上，或者保持元件400定位在远端元件18’和近端元件16’两者上。保持元件400可以在不使固定元件18’和抓持元件16’闭合的情况下将瓣叶LF保持就位。
如9A至图9B中所示，在一个实施方式中，保持元件400可以是保持插入到固定装置14’中的瓣叶LF的弹簧元件402。弹簧元件402可以帮助捕获或保持沿着远端元件18’插入穿过被确定是足够的插入深度的给定点的任何瓣叶LF。
再次参照图9A至图9B，弹簧元件402位于远端元件18’上。每个远端元件18’具有结合到远端元件18’中或者附接至远端元件18’的弹簧元件402。弹簧元件402可以在远端元件18’的附接至双头螺栓74’的第一端部404与远端元件18’的自由端部406之间的中点414处结合到远端元件18’中或者附接至远端元件18’。弹簧元件402也可以靠近每个远端元件18’的自由端部406或者靠近每个远端元件18’的第一端部404结合到远端元件18’中或者附接至远端元件18’。如图9A至图9B中所示，弹簧元件402的固定端部412位于远端元件18’的中点414与自由端部406之间。另外，保持元件400的弹簧元件402是长形的并且可以沿着远端元件18’和相关联的远端接合表面的整个长度以长形方式延伸。替代性地，保持元件400可以从第一端部404附近或者与第一端部404相邻的位置以长形方式延伸至远端元件18’的远端接合表面的位于中点远侧的位置或者从第二端部406附近或者与第二端部406相邻的位置延伸至远端元件18’的远端接合表面的位于中点远侧的位置。
弹簧元件402可以包括较小力的片簧408，片簧408偏置成将弹簧元件402朝向瓣叶LF推动并迫使摩擦元件或倒钩410深入地插入到瓣叶LF中，因此瓣叶LF保持处于完全就座状态直到远端元件18’被进一步闭合为止。如示出的，倒钩410以一角度指向顶430定向。在倒钩410沿该方向定向的情况下，瓣叶组织LF的前部边缘LE可以在几乎没有限制或阻力的情况下沿第一方向朝向顶430移动。当瓣叶组织的前部边缘朝向顶430移动时，弹簧元件420将瓣叶组织LF朝向倒钩410引导或者推动并使其与倒钩410接触。一旦瓣叶组织LF与倒钩410接触并接合，倒钩410的成角度的定向就使倒钩410穿入到瓣叶组织LF中并且随后限制或阻止瓣叶组织LF沿相反的方向远离顶430移动。因此，保持元件400与倒钩的组合有效地起到下述方向捕获器的作用：该方向捕获器允许瓣叶组织LF在几乎没有阻力的情况下沿第一方向朝向顶430移动且同时限制或者阻止瓣叶组织LF沿第二方向或相反的方向远离顶430移动。
片簧408可具有一个或更多个凸角或部分凸角。片簧408可以偏置成在瓣叶插入时对瓣叶几乎没有阻力。片簧408可以具有形成阻力使得瓣叶LF难以收回的表面特征、尖锐的边缘或其他元件。这些表面特征可以包括例如凹坑、凸块、脊部或凹进部。
例如，如图9A至图9B中所示，弹簧元件402的自由端部416可以构造成在瓣叶组织LF被捕获时朝向远端元件18’弯曲(如图9A中所示)并且在组织LF被释放时远离远端元件18’弯曲(如图9B中所示)。当瓣叶陷入远端元件18’与近端元件16’之间时，弹簧元件402的自由端部416可以构造成平伏抵靠远端元件18’。
在近端元件16’升高并且远端元件18’仍部分打开的情况下，保持元件400有助于固定装置14捕获组织。保持元件400可以构造成推动瓣叶组织抵靠近端元件16上的倒钩410。保持元件400可以是允许组织进入但不允许组织离开的单向机构，比如棘轮或者与棘轮类似的东西。
由于有时需要对固定装置14’进行再定位和再抓持，所以单向机构应当具有允许瓣叶组织LF脱离方法。保持元件可以设计成允许组织在某些情况下——比如当远端元件18’如图9B中示出的那样打开约180°，或者如图8中示出的那样进一步打开到反转位置时——离开。或者，当近端元件16’升高时，瓣叶组织LF可以被释放以允许再抓持。
为了确保瓣叶LF被正确地抓持在固定装置14’中，使用具有靠近每个成组的远端元件18’和近端元件16’定位的保持元件400——比如弹簧元件402——的装置的一个方法是首先将一个或两个瓣叶LF捕获在弹簧元件402中。该弹簧元件推动瓣叶LF在近端元件16’的下端部处抵靠倒钩410以在其初始插入时就捕获瓣叶LF的自由边缘FE并帮助将自由边缘FE保持在该位置处，直到近端元件16和远端元件18被完全部署为止。
基于比如彩色多普勒超声之类的成像方法可以确定一个或更多个瓣叶LF被捕获。当瓣叶LF被捕获在弹簧元件402与倒钩410之间时，随后近端元件16’可以朝向远端元件18’的表面50’降低，使得瓣叶LF被保持在近端元件16’与远端元件18’之间并且远端元件18’可以被锁定成将瓣叶LF保持在该位置或者固定装置14’可以返回至闭合位置或者朝向闭合位置返回。
在另一实施方式中，如图10中所示，保持元件400包括臂部417。每个远端元件18’具有结合到远端元件18’中或者附接至远端元件18’的臂部417。臂部417可以以固定端部415在远端元件18’的附接至双头螺栓74’的第一端部404与远端元件18’的自由端部406之间的中点414处结合到远端元件18’中或者附接至远端元件18’。臂部417还可以靠近每个远端元件18’的自由端部406或者靠近每个远端元件18’的第一端部404结合到远端元件18’中或者附接至远端元件18’。如图10中所示，臂部417的固定端部415位于远端元件18’的自由端部406与中点414之间。
臂部417具有适合形状和尺寸的、用以辅助将瓣叶LF保持就位的突出部或多个突出部418。这些突出部418可以具有与臂部417相对地定位的尖端，或者在其梢端与臂部417之间具有锐边。这些突出部可以包括具有渐缩的尖端的倒钩、扇形边缘、叉状物、翼状物、带状物、凹槽、通道、突起、表面粗糙化、烧结、高摩擦垫、覆盖物、涂层或这些的组合。如图10中所示，这些突出部可以远离表面50’定向并且远离远端元件18’的自由边缘406成角度地定向。这些突出部也可以朝向自由边缘406定向或者垂直于表面50’。这些突出部可以在固定装置14’闭合时朝向远端元件18’挠曲或收缩并且在固定装置14’打开时向外挠曲成固定角度。例如，突出部418可以从接合表面50’向固定角度偏置，但在远端元件18’绕轴12闭合时被推动成平伏抵靠远端元件18’。
该固定装置应该在近端元件16’与远端元件18’之间构造有足够的空间以使瓣叶LF在远端元件18’上容易地插入经过突出部418。腱索束缚(chordal tethered)的瓣叶LF可以在固定装置14’使远端元件18’和近端元件16’即将闭合之前略微地张紧。瓣叶LF也可以在远端元件18’与近端元件16’闭合之前牢固地附连至装置14’。
在一个实施方式中，臂部417可以是在固定端部415处进行枢转并且定位在近端元件16’与远端元件18’之间的柔性片簧。臂部还可以包括成角度的以允许组织进入远端元件18’与近端元件16’之间、但是阻止组织LF收回的突出部418系统。如示出的，突出部418和片簧417可以以相同的结构组合。另外，保持元件400的臂部417是长形的并且可以大致沿着远端元件18’和相关联的远端接合表面的整个长度以长形方式延伸。替代性地，保持元件400可以从第一端部404附近或者与第一端部404相邻的位置以长形方式延伸至远端元件18’的远端接合表面的位于中点远侧的位置或者从第二端部406附近或者与第二端部406相邻的位置延伸至远端元件18’的远端接合表面的位于中点远侧的位置。
如图11中所示，在另一实施方式中，保持元件400可以包括一个或更多个突出部420。一个或更多个突出部420可以定位成靠近远端元件18’在接合表面50’上的铰接点。当瓣叶LF插入经过突出部420时，突出部420可以在部署固定装置14’时通过引导或者推动瓣叶LF与位于对面的近端元件16’上的抓持表面或倒钩410接触而减少瓣叶脱离。突出特征420可以定位在远端元件18’的附接至双头螺栓74’的第一端部404与远端元件18’的自由端部406之间的中点414附近。突出特征420还可以靠近每个远端元件18’的自由端部406或者靠近每个远端元件18’的第一端部404结合到远端元件18’中或者附接至远端元件18’。突出特征420可以是附连至远端元件18’的接合表面50’的刚性材料件，并且突出特征420可以是能防损伤的以辅助引导或推动瓣叶LF且同时使对瓣叶LF的损害最小化，比如不穿刺或不穿透瓣叶LF。突出特征可以由任何一种或多种材料——比如聚合物、镍钛诺或其它合金或生物可吸收材料——制成。
远端元件18’的突出特征420可以在瓣叶组织LF被充分插入到装置14’中时被动地接合瓣叶组织LF。或者，突出特征420可以构造成在近端元件16’降低并且还被固定至瓣叶组织LF时帮助接合瓣叶组织并将其固定就位。突出特征420可以帮助使组织陷入突出特征420与近端元件16’的抓持表面之间。特征420可以推动组织LF抵靠倒钩410。
尽管突出特征420被示出为包括大体弯曲或半球形的外表面，但是将理解的是，只要保持防损伤性以及辅助引导或推动瓣叶LF的能力，各种其他表面取向示也是适合的。例如，如图11B至图11E中所示，突出特征420可以具在下述方向上对称的或不对称的弯曲表面：(i)从第一端部404朝向第二端部406的第一方向，(ii)与从第一端部404朝向第二端部406的方向相交的、横向于该方向或者相对于该方向倾斜的方向，或者(iii)上述第一方向以及与第一方向相交的、横向于该第一方向或者相对于该第一方向倾斜的方向两者。因此突出特征420可以在至少一条轴线、至少两条轴线上或者在所有三条轴线上是对称的。替代性地，突出特征420可以在至少一条轴线、至少两条轴线或者在所有轴线上是不对称的。
在图12中示出的另一实施方式中，保持元件400可以包括附接至远端元件18’的表面50’的铰接件422。铰接件422连接至可以朝向远端元件18’摆动或者远离远端元件18’摆动的臂部424。如图12中所示，臂部424可以朝向每个远端元件18’的第一端部404偏置。臂部424能够在朝向远端元件18’的第一端部404定向时平行于表面50’或者平伏抵靠表面50’。臂部424还能够在朝向远端元件18’的自由端部406定向时平行于表面50’或者平伏抵靠表面50’，并且因此能够旋转180°。铰接件422可以限制臂部424的运动，使得臂部424在朝向远端元件18’的第一端部404定向时例如仅平行于表面50’，并能够被旋转大约90°，从而使得在臂部424与远端元件18’的位于铰接件422下面的部分之间形成的角度不大于90°。铰接件422还可以是枢转元件。
还可以在远端元件18’上设置多个臂部424。例如，可以设置两个臂部，每个臂部定位成与端部404和端部406之间的距离相同并且在接合表面50’上彼此相邻地定位。如果设置有多个保持元件400，比如多个臂部424或多个弹簧元件402，则其可以构造成定位在近端元件上的倒钩410的两侧。如果在近端元件16’上设置有多个倒钩410，则一个或多个保持元件400还可以定位成位于近端元件16’上的倒钩410之间。另外，保持元件400的臂部424是长形的并且可以大致沿着远端元件18’和相关联的远端接合表面的整个长度以长形方式延伸。替代性地，保持元件400和相关联的臂部424可以从第一端部404附近或者与第一端部404相邻的位置以长形方式延伸至远端元件18’的远端接合表面的位于中点远侧的位置或者从第二端部406附近或者与第二端部406相邻的位置延伸至远端元件18’的远端接合表面的位于中点远侧的位置。
远端元件18可以覆盖有织物或其他柔性材料。优选地，当织物或覆盖物与突出部418组合使用时，这些特征将伸出穿过所述织物或其他覆盖物以接触瓣叶组织LF。
类似于机械爪，保持元件400的偏置、角度和方向可以允许瓣叶在没有太多阻力但可以限制瓣叶LF往回移出的能力的情况下下落或滑动地更深。通过允许瓣叶LF容易地进入但不允许其容易地从固定装置14’移除，可以有助于使瓣叶LF陷入完全插入状态。
在上述实施方式中，保持元件400是被动元件。然而，保持元件400也可以包括主动元件，使得当瓣叶组织LF件行进超出保持元件400的一部分或者与保持元件400的一部分相邻时，保持元件400可以自动地弹开或部署成使得将组织LF保持就位。
在另一实施方式中，固定装置14或14’可以包括指示在远端元件18’闭合以及固定装置14或14’部署之前瓣叶何时正确地插入到该装置中的机械或物理传感器或一些视觉指示器。例如，触觉传感器可以嵌置在每个远端元件的第一端部404附近。每个触觉传感器可以提供瓣叶何时触及传感器的信号或指示，并且传感器可以定位成使得瓣叶LF将不能够或不太可能触及传感器，除非瓣叶被充分地捕获。
使瓣叶组织LF在固定装置14或14’中的布置和保持增强的又一机理是便于每个近端元件16或16’和每个远端元件18和18’独立于彼此的致动。当用于两个叶瓣LF的近端元件16或16’被同时启用并且用于每个瓣叶LF的远端元件18或18’也被同时启用时，可能难以捕获两个瓣叶，这是因为需要同时捕获两个瓣叶。换言之，当两个近端元件16或16’的启用是对称的并且两个远端元件18或18’的启用也是对称的时，固定装置14或14’不能够先抓持一个瓣叶并且随后抓持另一瓣叶。如果导管或固定装置14或14’没有正确地定位，或者如果任一瓣叶LF具有冗余长度或松弛长度，则固定装置14或14’不能使瓣叶完全坐置在每个远端固定元件18或18’与近端抓持元件16或16’之间。
在一个实施方式中，每个近端元件16或16’和/或每个远端元件18或18’可以独立于彼此被启用。例如，为每个近端元件16或16’设置有单独的近端元件线。类似地，可以设置延伸穿过轴12的两个致动器杆64，其中每个致动器杆可以构造成启用一个远端元件18或18’。
除了用于修复二尖瓣之外，这些装置还可以用在多种治疗手术中，包括腔内手术、微创手术和开放式外科手术，并且还可以用在多种解剖学区域中，包括腹部系统、胸部系统、心脏血管系统、肠系统、消化系统、呼吸系统、泌尿系统以及其他系统和组织。本发明提供了通过改进组织到装置中的捕获而可以更顺利地接近及修复组织的装置、系统和方法。
可以在不背离本发明的精神或基本特征的条件下以其他具体形式实施本发明。所描述的实施方式在所有方面都仅为说明性的而非限制性的考虑。因此，本发明的范围由所附权利要求而不是由前面的描述指定。落入权利要求的等效含义和范围内的所有变化都包括在权利要求的范围内。

Claims (6)

1.一种用于接合组织的固定装置，包括：
一对远端元件，每个所述远端元件均具有第一端部、与所述第一端部相反的自由端部以及位于所述第一端部与所述自由端部之间的接合表面，一对所述远端元件具有打开位置和闭合位置；
一对近端元件，每个所述近端元件均具有第一端部、与该第一端部相反的自由端部以及位于该第一端部与该自由端部之间的接合表面，一对所述近端元件构造成能够朝向所述远端元件被升高和降低；以及
轴，所述近端元件的第一端部和所述远端元件的第一端部以可操作的方式联接至所述轴；
其中，所述远端元件中的每个远端元件均包括接合至所述远端元件的自由端并且从临近所述远端元件的自由端的位置延伸的保持元件，所述保持元件构造成允许组织朝向所述远端元件的第一端部移动并且阻碍组织远离所述远端元件的第一端部移动，在所述闭合位置，所述保持元件大致沿着所述远端元件的整个长度从临近所述远端元件的自由端部朝向所述远端元件的第一端部延伸。
2.根据权利要求1所述的固定装置，其中，每个所述近端元件还包括位于所述接合表面上的一个或更多个摩擦元件。
3.根据权利要求2所述的固定装置，其中，定位在每个所述近端元件上的所述摩擦元件包括一个或更多个倒钩。
4.根据权利要求1所述的固定装置，其中，每个所述保持元件还包括一个或更多个摩擦元件。
5.根据权利要求4所述固定装置，其中，定位在所述保持元件中的每个保持元件上的摩擦元件包括至少一个片簧，所述至少一个片簧构造成朝向定位在所述近端元件中的一个近端元件上的一个或更多个倒钩引导或推动组织以使组织与定位在所述近端元件中的一个近端元件上的所述一个或更多个倒钩接合。
6.根据权利要求4所述的固定装置，其中，定位在所述保持元件中的每个保持元件上的摩擦元件包括至少一个突出部，所述至少一个突出部构造成朝向定位在所述近端元件中的一个近端元件上的一个或更多个倒钩引导或推动组织以使组织与定位在所述近端元件中的一个近端元件上的所述一个或更多个倒钩接合。
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