CN107666868A - 改进的组织固定装置 - Google Patents

改进的组织固定装置 Download PDF

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CN107666868A
CN107666868A CN201680031471.6A CN201680031471A CN107666868A CN 107666868 A CN107666868 A CN 107666868A CN 201680031471 A CN201680031471 A CN 201680031471A CN 107666868 A CN107666868 A CN 107666868A
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迈克尔·F·韦
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Abstract

本公开描述了用于在二尖瓣的治疗期间以及在将组织固定装置植入二尖瓣时抓持二尖瓣组织的组织抓持装置、系统和方法。该组织抓持装置包括挠性构件和与挠性构件的一个或更多个臂联接的一个或更多个组织抓持构件。挠性构件由形状记忆材料比如镍钛诺形成，并且组织抓持构件由比形状记忆材料硬的材料形成。组织抓持构件通过将缝合线围绕和/或穿过组织抓持构件和挠性构件穿线或打环以及/或者通过向组织抓持装置施加覆盖材料以保持组织抓持构件抵靠挠性构件而附接至挠性构件。

Description

改进的组织固定装置
背景技术
本申请要求于2015年4月2日提交的申请号为14/677,294的美国专利申请的权益和优先权，该美国专利申请的全部内容通过参引并入本文中。
本发明总体上涉及医疗方法、医疗装置和医疗系统。具体地，本发明涉及用于身体组织的比如组织闭合或瓣膜修复的腔内的、经皮的或微创外科治疗的方法、装置和系统。更具体地，本发明涉及心脏瓣膜或静脉瓣膜的修复以及用于通过微创手术将二尖瓣修复部件移除或禁用的装置和方法。
身体组织的外科修复通常涉及组织闭合以及这些组织在闭合装置中的紧固。在修复瓣膜时，组织闭合通常包括使瓣膜的瓣叶在治疗装置中对合，该治疗装置随后可以通过紧固或固定瓣叶来保持。瓣叶的这种固定可以用于治疗二尖瓣中最常发生的反流。
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中。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中的止逆阀。以这种方式，含氧血液通过主动脉瓣被泵送到主动脉中。瓣膜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力学缺陷而引起。瓣叶、将瓣叶连接至乳头肌的瓣索、乳头肌自身或者左心室壁可能会受损或以其他方式机能失调。通常，瓣环可能会受损、膨胀或变弱，从而限制二尖瓣在心脏收缩期间抵抗左心室的较大压力而充分关闭的能力。
对二尖瓣反流的最常规治疗依赖于瓣膜置换或者依赖于包括瓣叶和瓣环重构的瓣膜修复，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技术被称为“蝴蝶结”或“缘对缘”技术。尽管所有这些技术都可能有效，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较高的死亡率和发病率。
在一些患者中，固定装置可以利用微创技术安装到心脏中。该固定装置可以将相对两个瓣叶的相邻部段保持在一起以减小二尖瓣反流。用于将二尖瓣的前后瓣叶夹持在一起的一种装置是由美国加州SantaClara的AbbottVascular(雅培血管公司)出售的固定装置。
这些固定装置通常包括夹具，所述夹具设计成在夹具臂移动并定位成抵靠治疗部位处的组织时抓持并保持抵靠组织并且接着抵靠组织闭合。这些夹具设计成在固定装置闭合处于最终位置时继续抓持组织。为了实现此效果，这些夹具有时配备有倒钩或挂钩，以在夹具抵靠组织挠曲就位时抓持组织。
然而，一些组织固定治疗需要固定装置移动经过较大范围的抓紧角度，以相对于目标组织适当地定位并且接着抓紧组织并使其处于闭合位置。固定装置的这种在该装置的定位和闭合期间移动并塑性变形的部件会导致固定装置的弱化和过早退化。另外，一些组织固定治疗需要固定装置保持一定程度的挠性和移动性以允许一定范围的生理移动，甚至在装置已经适当地放置并且目标组织已经被适当地固定到期望位置中之后也允许一定范围的生理移动。由于挠曲部件的持续塑性变形(例如，由于瓣叶的连续打开和闭合)导致装置的不利的退化，这会增大装置过早失效的风险。
由于这些原因，存在对提供替代性的且额外的用于组织固定的方法、装置和系统的持续需求，这些方法、装置和系统在不过度增大挠曲部件的相关制造成本的情况下提供挠曲部件的有益的弹性和耐久性。还存在对以不限制组织固定装置的组织抓持能力的方式提供这些方法、装置和系统的需要。下面公开的实施方式中的至少一些实施方式是针对这些目的的。
背景技术描述
在PCT公布的NOs.WO98/35638；WO99/00059；WO99/01377；以及WO00/03759；WO2000/060995；WO2004/103162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等人(1996)Ann.Thorac.Surg.(胸外科年鉴)61:1829-1832；Bach和Bolling(1995)Am.HeartJ.(美国心脏学杂志)129:1165-1170；以及Bolling等人(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等人(1998)Am.J.Cardiol.(美国心脏病学杂志)81:1013-1016；以及Abe等人(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等人(1978)Circulation58:600-608；Uchida等人(1991)Am.HeartJ.121:1221-1224；以及AliKhan等人(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.WO91/01689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
本公开描述了用于在组织修复和/或固定手术中比如在二尖瓣修复手术中抓持组织的方法和装置。组织抓持装置的某些实施方式包括：由形状记忆材料形成的挠性构件，该挠性构件包括基部部段和臂，臂具有连接至基部部段的第一端部、延伸远离基部部段的自由端部以及设置在接合端部与自由端部之间的附接表面；以及由第二材料形成的至少一个组织抓持构件，第二材料比形状记忆材料硬，该组织抓持构件包括与臂的附接表面联接以将组织抓持构件与挠性构件接合的配合表面以及与配合表面相反地设置的组织抓持表面，该组织抓持表面包括构造成在组织已经接触组织抓持表面之后阻碍组织移动离开组织抓持表面的摩擦元件。
构造成用于血管内输送以及用于在二尖瓣的治疗中接合二尖瓣组织的组织固定系统，该组织固定系统包括：本体；近端元件，近端元件包括由形状记忆材料形成的挠性构件和由第二材料形成的至少一个组织抓持构件，其中，挠性构件包括基部部段和臂，该臂具有连接至基部部段的第一端部、延伸远离基部部段的自由端部以及设置在接合端部与自由端部之间的附接表面，第二材料比形状记忆材料硬，组织抓持构件包括与臂的附接表面联接以将组织抓持构件与挠性构件接合的配合表面以及与该配合表面相反地设置的组织抓持表面，该组织抓持表面包括构造成在组织已经接触组织抓持表面之后阻碍组织移动离开组织抓持表面的摩擦元件；以及远端元件，该远端元件具有枢转地联接至所述本体的第一端部并且第一端部延伸至自由的第二端部，并且该远端元件具有位于第一端部与第二端部之间的组织接合表面，该组织接合表面构造成接近并接合二尖瓣的瓣叶的一部分，其中，近端元件构造成与远端元件配合以形成用于将二尖瓣组织的一部分接纳在近端元件与远端元件之间的空间。
制造本公开的组织抓持装置的方法的某些实施方式包括：由形状记忆合金以下述方式形成挠性构件：切割图案形状并热定形至少一个弯折特征，该挠性构件包括基部部段和臂，该臂具有连接至基部部段的第一端部、延伸远离基部部段的自由端部以及设置在接合端部与自由端部之间的附接表面，所述至少一个弯折特征设置在臂的第一端部与自由端部之间；由第二材料以下述方式形成组织抓持构件：模压第二材料以沿着组织抓持构件的侧边缘形成多个凸起倒钩和多个槽式凹部，第二材料比形状记忆材料硬，组织抓持构件包括配合表面以及与该配合表面相反地设置的组织抓持表面；以及通过将组织抓持构件的配合表面联接至臂的附接表面而将组织抓持构件附接至挠性构件。
某些实施方式与现有技术的组织抓持装置、系统和方法相比提供了优点和益处。例如，提供由形状记忆材料形成的挠性构件可以在将组织抓持装置定位在治疗部位期间——比如，在二尖瓣修复手术期间的二尖瓣瓣叶抓持尝试期间——在所覆盖的较宽范围的抓持角度上提供超弹性。另外，在定位期间和/或在植入后移动期间避免挠性构件的塑性变形可以增加该装置的功能和/或寿命。此外，与使用形状记忆材料形成组织抓持摩擦元件和组织抓持构件的其他特征——比如，通过使其直接形成在挠性构件上——相比，提供由第二材料形成的一个或更多个组织抓持构件的实施方式可以使得更容易且更具成本效益地制造组织抓持摩擦元件和组织抓持构件的其他特征。因此，某些实施方式可以在需要超弹性特性时提供这种特性的益处，同时在需要更大的刚性和/或更容易的可制造性时提供这些特性。
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及其他优点和特征，将参照附图中图示的本发明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图示的实施方式并且因此不被视为限制本发明的范围。将通过使用附图利用附加的特征和细节对本发明的实施方式进行描述和说明，在附图中：
图1图示了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分别图示了具有固定组件、固定组件的远端元件反转以及固定组件移除时的瓣叶的抓持；
图4图示了相对于瓣叶处于期望取向的固定组件；
图5图示了联接至轴的示例性固定组件；
图6A至图6B、图7A至图7C和图8图示了在将该组件导入并布置在体内以进行治疗手术期间处于各种可能的位置中的固定组件；
图9A至图9C图示了组织固定装置的近端元件的详细视图，近端元件包括挠性构件和多个组织抓持构件；
图10A至图10C图示了组织固定装置的近端元件的详细视图，其中，多个组织抓持构件经由缝合线接合至挠性构件；以及
图11A至图11C图示了组织固定装置的近端元件的详细视图，其中，近端元件具有覆盖件，并且多个组织抓持构件通过所述覆盖件保持抵靠挠性构件。
具体实施方式
I.心脏生理学
如图1中所示，二尖瓣(MV)包括具有自由边缘(EF)的一对瓣叶(LF)，所述自由边缘在具有正常的心脏结构和功能的患者中均匀地相接以沿着对合线(C)闭合。瓣叶(LF)沿着被称为瓣环(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。当心脏的左心室收缩(这被称为“心脏收缩”)时，从左心室通过二尖瓣(MV)至左心房的血液流(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.二尖瓣固定系统的概述
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，介入工具和介入装置通过血管被导入心脏及从心脏移除。修复某些二尖瓣缺陷的一种方法包括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固定装置作为治疗二尖瓣反流的植入物安装在二尖瓣处。
图3A图示了具有输送轴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使用者在患者体外操纵的端部的方向，“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如所示出的那样定位在瓣叶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图示了远端元件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图示了相对于瓣叶LF处于期望取向的固定装置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。在心脏舒张期间(当血液从左心房流动至左心室时)，固定装置14将瓣叶LF保持就位于由因舒张压力梯度而产生的开口或孔口O围绕的元件16、18之间，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。
图5图示了示例性固定装置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和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4mm-10mm的组织，并且优选地沿着臂53的纵向轴线接合约6mm-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附近朝向接合表面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。摩擦元件可以包括倒钩60，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、表面皱折、烧结物、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，这些特征将穿过这些织物或其他覆盖物伸出以接触被近端元件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能够与下述致动器杆接合：该致动器杆延伸穿过轴12并且能够沿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还可以由锁定特征锁定就位。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的二尖瓣相邻的部分而固定就位。
图6A至图6B、图7A至图7C和图8示出了图5的固定装置14的各种可能位置。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被示出为处于闭合位置。
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，所述一对相对的远端元件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共同围绕轴12。这为固定装置14提供了较小体积。
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向远端的前进运动以及因此双头螺栓74相对于联接构件19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。例如，图7C图示了由于使近端元件线90变松弛而处于降低位置的近端元件16。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可以接合待被闭合或治疗的组织。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。再定位通过处于打开位置的固定装置来实现。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的固定装置14。通过致动器杆相对于轴12的进一步前进以及因此双头螺栓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指向远端，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的这种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将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而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可以被锁定以将瓣叶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向近端缩回以使得致动机构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，这两份申请的公开内容全部并入本文中。
III.改进的组织固定装置
本公开的组织固定装置的某些实施方式包括形成为如下面详细描述的组织抓持装置的近端元件16。在一些实施方式中，组织抓持装置可以形成组织固定装置(比如，上面参照图3至图8和相关论述描述的组织固定装置14中的任何组织固定装置)的近端元件16，并且组织抓持装置可以被用作组织固定装置的近端元件16。因此，本文中定义的术语“组织抓持装置”和“近端元件”是可互换的。
图9A至图9C图示了组织抓持装置100的实施方式，组织抓持装置100包括挠性构件102和联接至挠性构件102的至少一个组织抓持构件122(例如，如所图示的一对组织抓持构件122)。挠性构件102可以由第一材料形成，并且组织抓持构件122可以由不同的第二材料形成。在优选实施方式中，第二材料的刚性比第一材料的刚性大，从而使得组织抓持构件122比挠性构件102硬。因此，在这样的实施方式中，挠性构件102与组织抓持构件122相比是较易弯曲的。挠性构件102优选地由形状记忆材料比如镍钛诺制成。在此构型中，挠性构件102在挠曲、弯折和/或以其他方式对组织抓持装置100进行定位期间(例如，在将该装置定位并部署在治疗部位处期间以及/或者在部署之后的继续移动期间)呈现超弹性。
例如，在二尖瓣修复手术期间，在进行多次组织抓持尝试以及/或者在组织抓持装置100移动到抵靠二尖瓣的瓣叶的可接受位置中时，组织抓持装置的一部分可能需要反复经过较大角度。此外，甚至在部署成抵靠二尖瓣组织之后，由于经修复的二尖瓣组织在心动周期期间继续移动，因而组织抓持装置100可能需要提供一定量的挠性和移动。由形状记忆材料比如镍钛诺形成挠性构件102避免了挠性构件102在这些运动期间塑性变形，从而在部署期间促进更容易的组织抓持并且减小了由于反复的塑性变形和/或较高的塑性变形水平而造成的组织抓持装置100的机械退化。
组织抓持构件122可以由不锈钢或钴-铬合金——比如，钴-铬-镍合金或钴-铬-镍-铁-钼-锰合金——形成。在优选实施方式中，组织抓持构件122由形成，然而，可以使用任何合适的材料或材料的组合。例如，组织抓持构件122可以由组织抓持构件的摩擦元件128(例如，凸起倒钩)或其他特征容易被机加工或者以其他方式形成(例如，相对于使用形状记忆材料来机加工这些特征——比如，将摩擦元件128直接机加工到挠性构件102的臂106上——而言较容易被机加工)的材料形成。
挠性构件102包括近端侧面114、远端侧面116、基部部段104和一对臂106，其中，每个臂106从基部部段104延伸至自由端部108。在其他实施方式中，可以具有从基部部段延伸的一个臂，或者可以具有从基部部段延伸的多于两个的臂。例如，一些实施方式可以具有绕基部部段(例如，以径向方式)排列的多个臂，以及/或者可以包括多个第一臂和与所述多个第一臂相对设置的多个第二臂。
图示的实施方式中的每个臂均包括设置在邻近基部部段104的区域处的第一弯折特征110以及设置成与第一弯折特征110相比距自由端部106较远距离的第二弯折特征112。第一弯折特征110形成相对于近端侧面114测量的大约90度或略低于90度(例如，大约60度至120度、大约70度至110度、或大约80度至100度)的角度，并且第二弯折特征112形成相对于远端侧面116测量的大约90度或略低于90度(例如，大于约60度至120度、大约70度至110度、或大约80度至100度)的角度。
第一弯折特征110和第二弯折特征112构造成在挠性构件102处于松弛状态时给予挠性构件102弯折构型，使得当挠性构件102被迫进入受力状态(例如，通过使挠性构件102在第一弯折特征110和/或第二弯折特征112中的一者或更多者处弯折)时，挠性构件102朝松弛状态弹性偏置。
例如，臂106可以在第二弯折特征112处以下述方式变形：使臂106沿近端方向和向内方向挠曲，从而使臂106向较直构型挠曲(例如，增大相对于远端侧面116测量的第二弯折特征112的角度)。在这样的位置中，挠性构件102处于受力状态，使得挠性构件102的臂106朝向远端方向和向外方向弹性地偏置。其他实施方式可以省去弯折特征中的一个或更多个弯折特征，并且其他实施方式可以包括额外的弯折特征。这些及其他实施方式可以包括在处于松弛状态时具有不同弯折角度的弯折特征。例如，一些实施方式可以包括在处于松弛状态时测量为大于约90度或小于约90度的弯折特征。
图示的实施方式的挠性构件102包括沿每个臂106的长度分布的多个孔118。孔118构造成为一条或更多条缝合线、金属丝、镍钛诺线材、杆、线缆、聚合物线材或其他这样的结构提供通道或连结点。如上面所论述的，这些材料可以联接至一个或更多个臂106，以作为近端元件线(例如，图7A至图7C中图示的元件线90)操作成用于升高、降低以及以其他方式操纵、定位和/或部署挠性构件102。另外或替代性地，孔118可以构造成提供挠性构件102与一个或更多个组织抓持构件的联接(如下面详细论述的)。
其他实施方式可以包括具有更多个或更少个孔以及/或者具有位于挠性构件的其他位置中的孔的挠性构件。例如，一些实施方式可以完全省去孔，并且一些实施方式可以仅包括一个孔和/或每个臂仅包括一个孔。其他实施方式可以包括不同形状和/或不同尺寸的孔，例如形成为槽状、狭缝状或其他形状的孔。在包括多于一个的孔的实施方式中，这些孔可以在尺寸、形状和分布方面是一致的，或者可以在尺寸、形状和分布中的一者或更多者方面是非一致的。
所图示的实施方式的各个臂106均包括分叉部段120。分叉部段120可以从基部部段104沿着臂106朝向臂106的自由端部108延伸至较远位置，如所图示的。在其他实施方式中，分叉部段可以沿着臂和/或基部部段定位在其他位置处。其他实施方式可以包括完全延伸至臂的自由端部、从而形成分叉臂或叉形臂的一个或更多个分叉部段。其他实施方式省去了任何分叉部段。所图示的实施方式的分叉部段120与第二弯折特征112一致。分叉部段120可以(例如，在尺寸、形状、间隔、位置等方面)构造成在一致的第二弯折特征112处提供期望的弹性和/或挠性。
所图示的实施方式包括一对组织抓持构件122，每个组织抓持构件122均具有配合表面124和组织抓持表面126。每个组织抓持构件122均包括多个摩擦元件128，所述多个摩擦元件128构造成与治疗部位处的组织接合并且在摩擦元件128已经与组织接合之后阻碍组织移动离开组织抓持构件。如在所图示的实施方式中示出的，摩擦元件128形成为向远端且向内延伸的成角度的倒钩。以此方式，与组织抓持构件122的摩擦元件128接合的组织被阻止相对于组织抓持构件122向近端且向外移动。
所图示的组织抓持构件122的摩擦元件128从组织抓持构件122的侧边缘130突出，从而形成沿着各个组织抓持构件122的每个侧边缘130设置在与摩擦元件128相邻的部段处的多个槽式凹部132。其他实施方式可以仅包括一个组织抓持构件或者可以包括多于两个的组织抓持构件。例如，一些实施方式可以包括构造成联接至每个臂的多个单独形成的组织抓持构件。在其他实施方式中，并非每个臂都包括对应的组织抓持构件。其他实施方式可以包括不同尺寸、数量和/或形状的摩擦元件。例如，在一些实施方式中，摩擦元件可以形成为柱状物、齿状物、叉状物、带状物、凹槽、通道、突起、垫或这些特征的组合或者适于增大被接触的组织的摩擦力和/或抓持力的任何其他特征。
所图示的实施方式的组织抓持构件122包括沿着每个组织抓持构件122的长度分布的多个孔138。与挠性构件102的孔118一样，组织抓持构件122的孔138构造成向用以作为近端元件线(例如，图7A至图7C中所图示的元件线90)进行操作的一条或更多条缝合线、金属丝、镍钛诺线材、杆、线缆、聚合物线材或其他这样的结构提供通道或连结点以及/或者提供组织抓持构件122中的一个或更多个组织抓持构件与挠性构件102的联接。
所图示的实施方式的组织抓持构件122的孔138形成为与挠性构件102的孔118一致。以此方式，组织抓持构件122可以相对于挠性构件102定位成使得组织抓持构件122的孔138中的每个孔与挠性构件102的对应的孔118对准。
其他实施方式可以包括具有更多个或更少个孔和/或位于组织抓持构件的其他位置中的孔的组织抓持构件。例如，一些组织抓持构件可以省去孔，或者可以仅包括一个孔。其他实施方式可以包括不同形状——比如，槽状、狭缝状或其他形状——和/或不同尺寸的孔。在包括多于一个孔的实施方式中，这些孔可以在尺寸、形状和分布方面是一致的，或者可以在尺寸、形状和分布中的一者或更多者方面是非一致的。在其他实施方式中，并非组织抓持构件的每个孔都构造成与挠性构件的对应的孔对准，并且并非挠性构件的每个孔都构造成与组织抓持构件的对应的孔对准。在一些实施方式中，在组织抓持构件相对于挠性构件适当地定位时没有孔对准。
在图示的实施方式中，挠性构件102的每个臂106的远端侧面包括附接表面134。组织抓持构件122定位在挠性构件102的臂106的远端侧面上，其中，组织抓持构件122的配合表面124面向附接表面134。组织抓持构件122通过将配合表面124联接至附接表面134而接合至挠性构件102。在其他实施方式中，配合表面和附接表面可以形成为具有对应的压配合部分或其他锁定/接合部分，所述对应的压配合部分或其他锁定/接合部分构造成通过使所述对应的压配合部分和/或其他对应的锁定部分接合而允许组织抓持构件接合至挠性构件。在一些实施方式中，组织抓持构件可以通过使用粘合剂或者通过熔接、钎焊、螺栓连接、夹持、铆接、卷边压接而紧固至挠性构件或者以其他方式将组织抓持构件固定至挠性构件。
在一些实施方式中，挠性构件的臂构造成在从松弛构型朝受力构型移动时向近端弯折并且在被定位成处于受力构型时朝松弛构型向远端弹性地挠曲，从而迫使臂的附接表面在臂朝松弛构型向远端挠曲时抵靠组织抓持构件。例如，当组织抓持装置被适当地定位并部署在二尖瓣处时，挠性构件的臂将操作成将组织抓持构件“夹置”在臂与被抓持的二尖瓣组织之间。
图10A至图10C图示了组织抓持装置200的实施方式，其中，组织抓持构件222已联接至挠性构件202。在图示的实施方式中，各个组织抓持构件222已通过将各个组织抓持构件222的每个配合表面(未示出)接合至挠性构件202的对应的附接表面(未示出)中的一个附接表面而被定位成与挠性构件202相邻。在图示的实施方式中，组织抓持构件222通过形成穿过挠性构件202和组织抓持构件222各自的对准的孔218和238的缝合环240而固定至挠性构件202。在此构型中，缝合环240可以通过在被打结、拉紧或者以其他方式被固定以将组织抓持构件222抵靠挠性构件202保持就位之前环绕组织抓持构件的至少一部分和挠性构件202的臂206的至少一部分而将组织抓持构件222紧固至挠性构件202。
在其他实施方式中，可以使用一条或更多条缝合线以其他构型将一个或更多个组织抓持构件系至或紧固至挠性构件。例如，一条或更多条缝合线可以在被打结、拉紧或者以其他方式固定就位之前穿线或系带穿过组织抓持构件和挠性构件两者上的多个孔，以将组织抓持构件固定至挠性构件。在其他实施方式中，一条或更多条缝合线不穿过任何孔。在这样的实施方式中，缝合线可以绕挠性构件的臂和组织抓持构件打环或卷绕以将组织抓持构件固定至臂。
形成缝合环240或其他缝合紧固结构的缝合线可以在被打结、拉紧或者以其他方式设定就位之前卷绕和/或穿线一次或多次。例如，一些缝合线可以被反复卷绕以及/或者可以自身对折以加强或进一步固定组织抓持构件至臂的联接。在一些实施方式中，用于形成缝合环240或其他缝合紧固结构的缝合线中的一条或更多条缝合线也可以从组织抓持装置200延伸以用作上述元件线(例如，图7A至图7C中图示的元件线90)。
图示的实施方式的组织抓持构件222还包括多个槽式凹部232。在诸如此类的实施方式中，一个或更多个缝合环240可以形成为使得缝合线穿过并容纳于相反地设置的槽式凹部232，从而进一步辅助将组织抓持构件222固定至臂206以及促进缝合环240的适当放置并且防止内部缝合环240从其适当位置滑动、变松或解开。
在其他实施方式中，缝合环或其他缝合紧固结构不穿过且不容纳于任何槽式凹部。一些实施方式可以包括穿过并且/或者容纳于一个或更多个(不一定相对地设置的)槽式凹部以辅助将组织抓持构件紧固至挠性构件的臂的缝合环和/或缝合紧固结构。又一些实施方式可以包括形成穿过并且/或者容纳于一个或更多个槽式凹部但不穿过任何孔的缝合环和其他缝合紧固结构的缝合线。相反地，一些实施方式可以包括形成穿过一个或更多个孔但不穿过并且/或者不容纳于任何槽式凹部的缝合环或其他缝合紧固结构的缝合线。
图示的实施方式在每个组织抓持构件222处包括两个缝合环240。在其他实施方式中，可以使用更多个或更少个缝合环或缝合紧固结构，但是在优选实施方式中，(例如，通过使用两个或更多个缝合环或者通过将缝合线穿线或系带穿过多个点)形成有至少两个紧固点以防止组织抓持构件由于力矩而从挠性构件旋转滑动。
图11A至图11C图示了组织抓持装置300的实施方式，其中，组织抓持构件322已通过使用至少一个覆盖件350而联接至挠性构件302。覆盖件350定位在挠性构件302的臂306的至少一部分上并且定位在组织抓持构件322的至少一部分上，以保持组织抓持构件322抵靠臂306。
在优选实施方式中，覆盖件350形成为聚合物覆盖件，聚合物覆盖件可以通过浸渍、喷涂、涂布或者以其他方式将聚合物覆盖件粘附至组织抓持装置300的表面或组织抓持装置300的一部分而形成在组织抓持装置300上。在一些实施方式中，聚合物涂层可以在组织抓持构件322抵靠挠性构件306保持就位时被施加至组织抓持构件322和臂306(或其一部分)。该聚合物涂层接着可以固化、硬化和/或凝固以形成覆盖件350并保持组织抓持构件322抵靠挠性构件302。在其他实施方式中，聚合物涂层可以用作粘合剂，并且聚合物涂层可以被施加至配合表面(未示出)和/或附接表面(未示出)，以在配合表面抵靠附接表面定位并且聚合物涂层固化时将组织抓持构件322粘附至臂306。
覆盖件350可以完全地或部分地由聚对苯二甲酸乙二酯、聚酯、棉制品、聚氨酯、膨体聚四氟乙烯(ePTFE)、硅或各种生物相容性聚合物或纤维形成，并且覆盖件350具有任何合适的形式，比如织物、网状物、带纹理的编织物、毛毡、环状结构或多孔结构。覆盖件350还可以构造成使摩擦元件328(在包括摩擦元件328的实施方式中)露出。覆盖件350还可以包括药物、抗生素、抗血栓剂或抗血小板剂比如肝素或华法林钠。这些药剂可以被浸渍在覆盖件350中和/或涂布在覆盖件350上，使得这些药剂在组织抓持装置300被植入到患者体内时被输送至周围组织和/或血流。
图11A至图11C中所图示的实施方式包括定位在每个组织抓持构件322的整体上和臂306的与每个组织抓持构件322相邻的部分上的一些覆盖件350。在包括覆盖件的其他实施方式中，覆盖件可以定位成覆盖组织抓持装置的大部分或者甚至覆盖整个组织抓持装置(例如，整个装置可以被喷涂、浸渍或以其他方式涂布有形成覆盖件的聚合物涂层)。替代性地，一些实施方式可以包括定位在组织抓持装置的较少部分上以使得组织抓持构件和/或臂的其他部分(例如，内部部分和/或外部部分)露出的覆盖件(比如图11A至图11C中图示的覆盖件350中的一些覆盖件)。
在一些实施方式中，一个或更多个组织抓持构件除了使用如关于图11A至图11C所论述的覆盖件保持就位之外，还可以使用如关于图10A至图10C所论述的缝合线来联接至挠性构件的臂。例如，可以使用一个或更多个缝合环和/或缝合紧固结构来将一个或更多个组织抓持构件紧固至挠性构件。之后(或者替代性地之前或同时)，可以施加聚合物涂层以形成环绕组织抓持构件的至少一部分和一致的臂的至少一部分的覆盖件。
IV.制造方法
本公开的组织抓持装置的实施方式可以通过由形状记忆材料(比如，镍钛诺)形成挠性构件来制造。形成挠性构件可以通过从形状记忆材料片状坯料(或者替代性地，条状或带状坯料或其他形式的坯料)切割图案形状来实现。各个特征(例如，分叉部段、孔等)可选地可以在挠性元件由坯料材料初始形成期间或者在挠性元件由坯料材料初始形成之后形成在挠性元件中。这可以使用任何合适的减材制造工艺——比如，钻凿、车削、模压、切割等——来完成。在一些实施方式中，可以使用增材制造工艺来添加其他特征。在其他实施方式中，没有通过任何减材或增材制造工艺形成额外的特征或元件。
在一些实施方式中，挠性构件可以通过定形工艺被进一步加工。例如，可以通过使挠性构件经受热定形工艺以在挠性构件的形状记忆材料中设定弯折形状而在挠性构件中形成一个或更多个弯折特征。
在一些实施方式中，一个或更多个组织抓持构件与挠性构件单独形成。形成组织抓持构件可以通过具有用于这种制造过程的合适的机加工性能的材料的切割和/或级进模压工艺来完成。例如，形成所述一个或更多个组织抓持构件的材料可以通过从片状坯料(或者替代性地，条状或带状坯料或其他形式的坯料)切割和/或模压出形状来获得。例如，坯料材料可以是不锈钢或钴-铬合金，比如，钴-铬-镍合金或钴-铬-镍-铁-钼-锰合金。在优选实施方式中，组织抓持构件由形成。由于组织抓持构件由所述坯料材料形成，所以可以在组织抓持构件上形成各个特征(例如，孔、摩擦元件、槽式凹部等)。
在一些实施方式中，组织抓持构件可以通过单个模压工艺或级进模压工艺被进一步制造。例如，组织抓持构件可以经受级进模压工艺，以在组织抓持构件上形成和/或进一步限定各种特征，比如，多个凸起倒钩和槽式凹部。
在一些实施方式中，在形成挠性构件和组织抓持构件之后，组织抓持构件通过将组织抓持构件的配合表面(例如，图9A至图9C的实施方式的配合表面124)联接至挠性构件的附接表面(例如，图9A至图9C的实施方式的附接表面134)而附接至挠性构件。组织抓持构件接着可以被进一步固定至挠性构件。
例如，如在图10A至图10C的示例性实施方式中所图示的，一条或更多条缝合线可以绕组织抓持构件的一部分和挠性构件的一部分(例如，臂部分，比如图10A至图10C的实施方式的臂206)卷绕或穿线。缝合线可以形成为环或者可以在被拉紧和/或打结之前绕组织抓持构件和臂(或挠性构件的其他部分)穿线或卷绕以将组织抓持构件固定至挠性构件。
在一些实施方式中，组织抓持构件和/或挠性构件可以包括孔，并且所述一条或更多条缝合线可以穿过孔中的一个或更多个孔以将组织抓持构件紧固或进一步固定至挠性构件。例如，如由图10A至10C中所图示的实施方式所示的，组织抓持构件可以具有多个孔，其中，各个孔构造成在组织抓持构件被适当地定位成靠近或抵靠挠性构件的臂时与挠性构件的臂上的孔对应。一条或更多条缝合线可以在其绕组织抓持构件和臂被系带、卷绕、打环或穿线时穿过一对或更多对对应的孔。
在一些实施方式中，一条或更多条缝合线也可以在其绕组织抓持构件和臂被系带、卷绕、打环或穿线时穿过组织抓持构件的槽式凹部或容纳在组织抓持构件的槽式凹部内。在这样的实施方式中，槽式凹部可以进一步辅助将缝合线固定就位以及/或者防止缝合线的变松、滑动或其他不必要的移动。
另外或替代性地，组织抓持构件可以通过向组织抓持装置添加覆盖件而固定至或进一步固定至挠性构件，其中，覆盖件插在挠性构件的臂和组织抓持构件(或组织抓持构件的一部分)上以保持组织抓持构件抵靠挠性构件就位。
例如，在一些实施方式中(比如在图11A至图11C中所图示的实施方式中)，覆盖件可以是被涂布或者以其他方式施加到组织抓持装置(或组织抓持装置的一部分)上的聚合物材料。接着可以允许聚合物涂层设定、固化或者以其他方式形成保持组织抓持构件抵靠挠性构件的臂就位的覆盖件。另外或替代性地，聚合物涂层可以用作粘合剂并且可以被施加至配合表面和/或附接表面以将所述表面粘附在一起。
本发明可以在不背离本发明的精神或基本特征的情况下以其他具体形式实施。所描述的实施方式在所有方面都被视为仅是说明性的而非限制性的。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 (20)

1.一种组织抓持装置，包括：
由形状记忆材料形成的挠性构件，所述挠性构件包括基部部段和臂，所述臂具有连接至所述基部部段的第一端部、延伸远离所述基部部段的自由端部以及设置在接合端部与所述自由端部之间的附接表面；以及
由第二材料形成的至少一个组织抓持构件，所述第二材料比所述形状记忆材料硬，所述组织抓持构件包括与所述臂的所述附接表面联接以将所述组织抓持构件与所述挠性构件接合的配合表面以及与所述配合表面相反地设置的组织抓持表面，所述组织抓持表面包括构造成在组织已经接触所述组织抓持表面之后阻碍所述组织移动离开所述组织抓持表面的摩擦元件。
2.根据权利要求1所述的组织抓持装置，其中，所述形状记忆材料为镍钛诺。
3.根据权利要求1所述的抓持固定装置，其中，所述第二材料选自包括下述各者的组：钴-铬合金、钴-铬-镍合金、钴-铬-镍-铁-钼-锰合金和不锈钢。
4.根据权利要求1所述的组织抓持装置，其中，所述摩擦元件形成为沿着所述组织抓持构件的侧边缘设置的多个凸起倒钩，并且其中，所述组织抓持构件包括沿着所述侧边缘设置在与所述凸起倒钩相邻的部段处的多个槽式凹部。
5.根据权利要求4所述的组织抓持装置，还包括环绕所述组织抓持构件的至少一部分和所述臂的至少一部分的至少一条缝合线，所述缝合线构造成将所述组织抓持构件紧固至所述臂，所述缝合线在其环绕所述组织抓持构件和所述臂时穿过并容纳于所述槽式凹部中的一个或更多个槽式凹部。
6.根据权利要求1所述的组织抓持装置，其中，所述臂还包括至少一个孔，并且其中，所述组织抓持构件还包括构造成在所述组织抓持构件的所述配合表面联接至所述臂的所述附接表面时与所述臂的孔对应的至少一个孔。
7.根据权利要求6所述的组织抓持装置，还包括构造成将所述组织抓持构件紧固至所述臂的缝合线，所述缝合线穿过所述臂的孔和所述组织抓持构件的孔。
8.根据权利要求1所述的组织固定装置，还包括覆盖件，所述覆盖件环绕所述臂和所述组织抓持构件以将所述组织抓持构件保持至所述挠性构件。
9.根据权利要求1所述的组织固定装置，其中，
所述摩擦元件形成为沿着所述组织抓持构件的侧边缘设置的多个凸起倒钩，并且
其中，所述组织抓持构件包括沿着所述侧边缘设置在与所述凸起倒钩相邻的部段处的多个槽式凹部，并且
其中，所述臂还包括至少一个孔，并且所述组织抓持构件还包括构造成在所述配合表面联接至所述附接表面时与所述臂的孔对应的至少一个孔，并且
其中，所述组织固定装置还包括环绕所述组织抓持构件的至少一部分和所述臂的至少一部分的至少一条缝合线，所述缝合线穿过第一臂或第二臂的孔和所述组织抓持构件的孔并且穿过并容纳于所述槽式凹部中的一个或更多个槽式凹部，并且
其中，所述组织固定装置还包括聚合物覆盖件，所述聚合物覆盖件环绕所述臂和所述组织抓持构件以将所述组织抓持构件保持至所述挠性构件。
10.根据权利要求1所述的组织固定装置，其中，所述组织抓持构件通过将所述组织抓持构件的所述配合表面熔接或钎焊至所述臂的所述附接表面而接合至所述挠性构件。
11.根据权利要求1所述的组织固定装置，其中，所述组织抓持构件的所述配合表面包括压配合部分，并且所述臂的所述附接表面包括对应的压配合部分，从而允许所述组织抓持构件通过接合对应的压配合部分而接合至所述挠性构件。
12.根据权利要求1所述的组织固定装置，其中，所述臂还包括近端侧面和远端侧面，并且其中，所述附接表面设置在所述远端侧面上。
13.根据权利要求12所述的组织固定装置，其中，所述臂构造成在从松弛构型朝受力构型移动时向近端弯折以及在被定位成处于受力构型时朝松弛构型向远端弹性地挠曲，从而在所述臂朝松弛构型向远端挠曲时迫使所述臂的所述附接表面抵靠所述组织抓持构件。
14.一种构造成用于血管内输送以及用于在二尖瓣的治疗期间接合二尖瓣组织的组织固定系统，所述系统包括：
本体；
近端元件，所述近端元件包括：
由形状记忆材料形成的挠性构件，所述挠性构件包括基部部段和臂，所述臂具有连接至所述基部部段的第一端部、延伸远离所述基部部段的自由端部以及设置在接合端部与所述自由端部之间的附接表面；以及
由第二材料形成的至少一个组织抓持构件，所述第二材料比所述形状记忆材料硬，所述组织抓持构件包括与所述臂的所述附接表面联接以将所述组织抓持构件与所述挠性构件接合的配合表面以及与所述配合表面相反地设置的组织抓持表面，所述组织抓持表面包括构造成在组织已经接触所述组织抓持表面之后阻碍所述组织移动离开所述组织抓持表面的摩擦元件；以及
远端元件，所述远端元件具有枢转地联接至所述本体的第一端部并且所述第一端部延伸至自由的第二端部，并且所述远端元件具有位于所述第一端部与所述第二端部之间的组织接合表面，所述组织接合表面构造成接近并接合二尖瓣的瓣叶的一部分，其中，所述近端元件构造成与所述远端元件配合以形成用于将二尖瓣组织的一部分接纳在所述近端元件与所述远端元件之间的空间。
15.根据权利要求14所述的系统，其中，所述摩擦元件形成为沿着所述组织抓持构件的侧边缘设置的多个凸起倒钩，并且
其中，所述组织抓持构件包括沿着所述侧边缘设置在与所述凸起倒钩相邻的部段处的多个槽式凹部，并且
其中，所述臂还包括至少一个孔，并且所述组织抓持构件还包括构造成在所述组织抓持构件的所述配合表面联接至所述臂的所述附接表面时与所述臂的孔对应的至少一个孔，并且
所述近端元件还包括环绕所述组织抓持构件和所述臂的至少一条缝合线，所述缝合线穿过所述臂的孔和所述组织抓持构件的孔并且穿过并容纳于所述槽式凹部中的一个或更多个槽式凹部。
16.根据权利要求14所述的系统，其中，所述形状记忆材料为镍钛诺，并且所述第二材料为钴-铬-镍-铁-钼-锰合金。
17.一种制造组织抓持装置的方法，所述方法包括：
由形状记忆合金通过下述方式形成挠性构件：切割图案形状并热定形至少一个弯折特征，所述挠性构件包括基部部段和臂，所述臂具有连接至所述基部部段的第一端部、延伸远离所述基部部段的自由端部以及设置在接合端部与所述自由端部之间的附接表面，所述至少一个弯折特征设置在所述臂的所述第一端部与所述自由端部之间；
由第二材料通过下述方式形成组织抓持构件：模压所述第二材料以沿着所述组织抓持构件的侧边缘形成多个凸起倒钩和多个槽式凹部，所述第二材料比所述形状记忆材料硬，所述组织抓持构件包括配合表面以及与所述配合表面相反地设置的组织抓持表面；以及
通过将所述组织抓持构件的所述配合表面联接至所述臂的所述附接表面来将所述组织抓持构件附接至所述挠性构件。
18.根据权利要求17所述的方法，还包括：在所述臂中形成至少一个孔，并且在所述组织抓持构件中形成至少一个孔，所述组织抓持构件的孔在所述组织抓持构件的所述配合表面联接至所述臂的所述附接表面时与所述臂的孔对应。
19.根据权利要求18所述的方法，其中，所述配合表面使用至少一条缝合线来联接至所述附接表面，所述缝合线定位成穿过所述臂的孔和所述组织抓持构件的对应的孔，并且所述缝合线环绕所述组织抓持构件和所述臂的至少一部分以将所述组织抓持构件紧固至所述挠性构件。
20.根据权利要求17所述的方法，其中，通过向包括所述臂和所述组织抓持构件的区域添加覆盖件以将所述组织抓持构件保持至所述挠性构件而将所述组织抓持构件的所述配合表面联接至所述臂的所述附接表面。
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