CN109996581B - 用于快速收回经导管心脏瓣膜递送系统的方法和系统 - Google Patents

用于快速收回经导管心脏瓣膜递送系统的方法和系统 Download PDF

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CN109996581B
CN109996581B CN201780072040.9A CN201780072040A CN109996581B CN 109996581 B CN109996581 B CN 109996581B CN 201780072040 A CN201780072040 A CN 201780072040A CN 109996581 B CN109996581 B CN 109996581B
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catheter
delivery device
delivery
prosthesis
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CN109996581A (zh
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伊恩·弗雷泽·克尔
凯伦·太祖吉·王
科林·亚历山大·纽利
兰迪·马修·莱恩
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Neovasc Tiara Inc
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0064—Sets comprising a plurality of prosthetic parts of different sizes

Abstract

提供了用于快速收回经导管心脏瓣膜递送系统的方法。快速收回经导管心脏瓣膜递送系统包括基于导管的递送系统。该递送系统具有允许心脏瓣膜假体受控展开的内部机构，以及一旦心脏瓣膜假体被植入就允许快速地关闭导管的机构。这种快速收回能力允许缩短手术持续时间，从而降低患者的风险。

Description

用于快速收回经导管心脏瓣膜递送系统的方法和系统
交叉引用
本申请要求2016年11月21日提交的序列号为62/424,910(代理人案号53235-712.101)的美国临时专利申请的优先权，该临时专利申请通过引用以其整体并入本文。
本申请涉及：2011年4月28日提交的美国专利第8,579,964号(代理人案号53235-703.201)；并且还涉及2012年11月16日提交的美国公布第2013/0211508号(代理人案号53235-704.201)；2013年2月8日提交的2014/0052237(代理人案号53235-705.201)；2013年5月29日提交的2014/0155990(代理人案号53235-706.201)；2014年3月3日提交的2014/0257467(代理人案号53235-707.201)；和2014年4月1日提交的2014/0343669(代理人案号53235-708.201)；这些专利申请中的每一个的全部内容通过引入并入本文。
发明背景
1.发明领域
二尖瓣反流(Mitral regurgitation)，也称为二尖瓣闭锁不全或二尖瓣关闭不全，是一种心脏疾病，在这种心脏疾病中，二尖瓣不能正确关闭，从而导致血液从左心室通过二尖瓣向上游逆流回左心房的异常泄漏。持续的二尖瓣反流会导致充血性心脏衰竭，这是一种代价高昂且往往致命的疾病。传统的瓣膜外科修复通常会产生良好的临床效果，但是需要开放性心脏手术和长时间且昂贵的住院时间以及延长的恢复期。最近，已经开发了微创手术，以通过导管将人工心脏瓣膜通过患者的脉管经皮递送到心脏，或者通过使用经心尖手术(transapical procedure)将假体通过胸壁并通过心尖引入治疗部位。示例性假体包括美国专利第8,579,964号中描述的实施方案中的任一种，其全部内容通过引用并入本文。这些假体和递送手术看起来是有希望的，但是仍然有机会通过最小化从操作者与递送系统的第一次接触到递送系统的最终退出和患者的伤口闭合的手术持续时间来改善手术结果。因此，需要提供减少从患者体内移除递送系统所需的时间、提高易用性、加快手术过程并降低风险的改进的装置、系统和方法。这些目标中的至少一些将通过本文描述的示例性实施方案来实现。
2.背景技术 美国专利第8,579,964号公开了一种示例性人工心脏瓣膜和经导管递送系统(trans-catheter delivery system)，其全部内容通过引用并入本文。
发明内容
本公开总体上涉及医疗系统、装置和方法，并且更具体地涉及假体和递送系统，例如可以用于植入假体的心脏瓣膜递送系统，假体是例如瓣膜，包括人工二尖瓣、心脏瓣膜或任何其他瓣膜。本公开强调了人工二尖瓣和递送系统的示例性实施方案，但是本领域技术人员将理解，其并不旨在进行限制。
在许多实施方案中，提供了展开人工心脏瓣膜和快速收回递送系统的经导管方法和系统。在某些实施方案中，递送系统包括经心尖递送系统(trans-apical deliverysystem)，其可用于通过心尖中的切口将人工心脏瓣膜植入解剖位置。经心尖递送系统可以包括导管系统，该导管系统可以同心地彼此嵌套，并且当组合时，可以保持压缩的心脏瓣膜假体。然后，移除由某些导管提供的约束可以有助于将心脏瓣膜假体展开到心脏中。可用于本文公开的任何递送系统中的经心尖递送系统的进一步实施方案可允许以提高的速度关闭递送导管，例如通过导管部件在彼此内沿与展开操作所需的方向相反的方向的平移。这种递送系统的操作可以通过使用致动器机构来促进，所述致动器机构例如是可以与连杆系统相连的按钮机构，或者致动器机构例如是可以与柔性构件相连的按钮机构，或者甚至是简化使用的销联接部件。
本文的其他实施方案可以包括递送系统，该递送系统允许替代的植入路径，例如通过下腔静脉或上腔静脉、主动脉或心房。
在本公开的一个方面，一种快速收回递送系统的方法包括：提供递送系统，该递送系统具有用于递送心脏瓣膜假体的多个导管；提供可控展开机构，该可控展开机构具有优先从导管释放假体的能力；以及致动可控展开机构，从而从导管释放假体。该方法还可以包括提供快速收回机构，该快速收回机构具有快速地关闭导管的能力，致动快速收回机构从而快速地关闭导管。
该方法可以包括经心尖地将递送系统引入心尖，或者经中隔地将递送系统递送至心脏，经由锁骨下静脉将递送系统递送至心脏，经由主动脉将递送系统递送至心脏，或者经由左心房或右心房将递送系统递送至心脏。
致动快速收回机构可以包括致动按钮和连杆。快速收回机构可以包括螺纹区域和干涉构件，并且该方法还可以包括用螺纹区域和干涉构件约束快速收回机构的运动。快速收回机构可以包括柔性干涉构件，并且该方法还可以包括偏转柔性干涉构件。快速收回机构可以包括销和销-孔杆组件(pin-hole link assembly)，并且该方法可以包括从销-孔杆组件移除销。
在本公开的另一个方面，用于递送假体的递送装置包括用于控制递送导管的运动的第一致动机构，其中递送导管可以被配置成在其中携带假体，并且其中第一致动机构的致动可以将递送导管从假体移开，从而至少部分地移除来自递送导管的约束；以及用于控制假体从锚定导管的释放的展开机构，锚定导管至少部分地设置在递送导管中，并且其中展开机构的致动可以将锚定导管从假体移开，从而释放来自锚定导管的约束。递送系统还可以包括具有锥形远侧尖端的内导丝导管(inner guidewire catheter)，内导丝导管设置在锚定导管中；以及用于控制递送导管相对于锥形远侧尖端的运动的快速收回机构，其中快速收回机构的致动关闭递送装置，使得远侧尖端的近侧端部抵靠递送导管的远侧端部，从而形成递送装置的平滑连续的外表面。
致动机构可以包括拇指轮。展开机构可以包括可致动按钮，可致动按钮带有联接到其上的连杆。快速收回机构可以包括螺纹区域和干涉构件、柔性干涉构件或者销和销-孔连杆组件(pin-hole linkage assembly)。
在本公开的另一个方面，用于递送假体的系统包括上述递送装置和假体，例如人工二尖瓣。
在以下关于附图的描述中对这些和其他实施方案进行了更详细的描述。
通过引用的并入
本说明书中所提及的所有出版物、专利和专利申请均通过引用而并入于此，程度犹如具体地和个别地指出要通过引用而并入每一单个出版物、专利或专利申请。
附图说明
本公开的新颖特征在所附的权利要求中具体地陈述。通过参考以下详细描述和附图将获得对本公开的特征和优点的更好理解，该详细描述阐述了利用本公开的原理的说明性实施方案，在附图中：
图1示出了被配置成允许快速收回的经心尖递送系统的透视图。
图2A-图2E图示了被配置成允许快速收回的经心尖递送系统的操作顺序的示意性侧视图。
图3A-图3D图示了被配置成允许快速收回的经心尖递送系统的操作顺序的局部横截面剖视图。
图4A-图4B图示了被配置成允许快速收回的经心尖递送系统内的内部机构的一系列动作的等距局部横截面剖视图。
图5图示了被配置成允许快速收回的经心尖递送系统的分解图和内部部件。
图6A-图6E图示了被配置成允许快速收回的经心尖递送系统的替代实施方案的操作顺序的示意性侧视图。
图7A-图7D图示了被配置成允许快速收回的经心尖递送系统的另一替代实施方案的操作顺序的示意性侧视图。
图8图示了示例性假体的示意图。
图9A-图9B图示了图8中的假体的示例性横截面。
图10A-图10B图示了联接到递送导管的假体。
图11图示了基本的人类心脏解剖。
图12A-图12C图示了示例性递送方法。
图13A-图13C图示了在心脏中展开假体的示例性方法。
具体实施方式
在以下详细描述中，参考形成本文一部分的附图。在附图中，相似的符号通常标识相似的部件，除非上下文另有规定。在详细描述、附图和权利要求中所述的说明性实施方案并非意在进行限制。在不脱离本文所述主题的范围的情况下，可采用其他实施方案，并且可作出其他改变。应容易理解，在本文中大致描述和在附图中图示的本公开的方面可以在各种不同的配置中被布置、代替、组合、分开和设计，所有这些配置在本文被明确地设想。
尽管下面公开了某些实施方案和示例，但是本发明的主题超出了具体公开的实施方案，延伸到其他替代实施方案和/或用途，以及其修改和等同物。因此，所附权利要求的范围不受下面描述的任何特定实施方案的限制。例如，在本文公开的任何方法或过程中，该方法或过程的动作或操作可以以任何合适的顺序执行，并且不必限于任何特定的公开顺序。以可以有助于理解某些实施方案的方式，各种操作可以依次被描述为多个离散操作，然而，描述的顺序不应被解释为暗示这些操作依赖于该顺序。此外，本文所述的结构、系统和/或装置可以体现为集成部件或独立部件。
为了比较各种实施方案，描述了这些实施方案的某些方面和优点。所有这些方面或优点不一定都是通过任何特定实施方案实现的。因此，例如，如本文教导的各种实施方案可以以实现或优化一个优点或一组优点的一种方式实施，而不必实现本文也可能教导或建议的其他方面或优点。
图1示出了经心尖递送系统1的透视图，该经心尖递送系统1可以被配置成允许递送假体，例如人工心脏瓣膜，并且允许在递送假体之后递送系统快速收回，由此本文的快速收回可以包括从患者的心尖(未示出)或患者的其他治疗区域方便移除递送导管8和扩张尖端9。经心尖递送系统1可包括直接递送到患者心尖(未示出)的扩张锥形尖端9、递送导管8(有时称为护套导管)、手柄组件，该手柄组件包括远侧手柄3、近侧外部手柄2和致动器机构(例如在远侧手柄3和近侧外部手柄2之间的拇指轮4)，该致动器机构可配置成致动所述递送导管8，以使其远离扩张尖端9可滑动地平移进入打开构型或打开位置。当经心尖递送系统处于打开位置时，可在扩张尖端9和递送导管8的远侧边缘之间界定用于人工心脏瓣膜或任何其他假体的空间11(在图2A中最佳可见)。最内部的内腔可以在导丝内腔入口13(位于扩张尖端9的最远端处)和导丝内腔出口14之间界定，导丝内腔出口14可以位于在近侧外部手柄2的最近侧部分处的连接器内，例如针接口(needle hub)12内，针接口12在其近侧端部处具有鲁尔连接器(Luer connector)。导丝内腔可以延伸穿过导丝导管(有时也称为扩张器导管)，导丝导管可以轴向地且同心地设置在包括钟形导管10的其他导管下。导丝导管可以被称为导丝导管。描述递送导管8的任何特征可以应用于本文公开的任何递送导管实施方案。类似地，为人工心脏瓣膜描述的任何人工心脏瓣膜特征都可以应用于本文公开的假体。
图1中还示出了致动机构5的实施方案，该致动机构5可以允许使用者控制假体(例如人工心脏瓣膜)从递送系统的最终释放，并且可以使下面将描述的进一步的机械动作成为可能。致动机构5可以包括任何致动器，例如按钮6，并且设置在壳体7中，壳体7描绘了按钮6可以平移的空间。平移背后的机械细节将在下面进一步描述。
现在转向图2A-图2E，呈现了被配置成允许快速收回的经心尖递送系统1的操作顺序。图2A示出了处于关闭构型的递送系统1，其中所有导管可以同心地彼此重叠设置，并且递送导管8的远侧前缘22可以抵靠扩张尖端9的近侧端部设置，以形成平滑连续的外表面。诸如人工心脏瓣膜的假体可以被装载和设置在空间11中，并由导管约束。关闭构型可被配置成用于将假体经心尖递送至心脏中的治疗区域。图2B示出了指示递送导管的远侧前缘22在近侧方向上的平移20的箭头。指示拇指轮4的旋转15的箭头也被示出，并且当拇指轮4旋转时，递送导管8的远侧前缘的向近侧平移可以通过内部部件的机械关系发生，例如在美国专利第8,579,964号(本文也称为专利‘964)中描述的那样，该专利通过引用并入本文。例如，专利‘964的图11-图15C描述了递送系统的一个示例性实施方案，该递送系统具有可应用于本示例性实施方案的特征，并且专利‘964的图16-图20描述了另一示例性实施方案，该另一示例性实施方案具有可应用于本示例性实施方案的特征。拇指轮沿相反方向的旋转可以使递送导管8沿相反方向向远侧移动。
图2C示出了指示致动器径向向内平移16的箭头，这里的致动器是按钮6。指示递送导管8的远侧前缘22的向近侧平移21的箭头也被示出，并且同样当按钮6被径向地向内按压时，钟形导管10的前缘可以从锚定导管(有时称为中心导管(hub catheter))的锚定尖端23向近侧平移，远离并脱离锚定导管的锚定尖端23，例如，如在专利‘964中的图16-图20中进一步描述的。通过从锚定导管的锚定尖端23释放钟形导管10(类似地称为钟形导管)的前缘，可以优先释放假体，例如人工心脏瓣膜(未示出)。下面将进一步详细描述这种部件关系的内部机制。
图2D描绘了本文公开的经心尖递送系统1的快速收回功能的操作。通过保持按钮6上的压力，近侧外部手柄2可以如指示旋转17的箭头所描绘的那样旋转。通过在第一方向上(相对于操作者顺时针)将近侧外部手柄2旋转一个360度的旋转，手柄可以从内部手柄24的中间部分脱离，并因此可以在内部手柄24上自由地向近侧平移，如指示平移18的箭头所描绘的(图2E)。扩张器尖端9通过连接器(如针接口12(图5))并且锚定导管50(图5)通过锚定导管的外螺纹部分51(图5)可以与近侧外部手柄2配合。钟形导管的近侧端部68(图5)可以紧固到导管支架30(图5)，导管支架30可以与近侧外部手柄2一起平移，并且由指示平移19的箭头(图2E)描绘。这种移动可以允许当递送系统处于关闭构型时，扩张器尖端的近侧端部抵靠递送导管8的远侧端部，以形成平滑连续的表面。
图3A-图3D更清楚地图示了一些致动机构。现在转到图3A，图示了被配置为允许递送系统1的快速收回的经心尖递送系统的操作顺序的一系列视图的第一视图，通过截面剖开的方式来描绘。示出了内部手柄24的中间部分，其用作近侧外部手柄2在其上滑动的支撑结构。具体而言，内部圆形肋25可以横向于近侧外部手柄2的内径的最远侧部分，并且与内部手柄24的中间部分的外螺纹27以及外部圆形凸缘42结合可以为内部手柄24的中间部分提供支撑和定位，以在近侧外部手柄2(如图5所示)内平移。近侧外部手柄2的内螺纹28可以与内部手柄24的中间部分的外螺纹27可操作地相连，这可以允许两个手柄之间的相对旋转和受控的平移，而不会在脱离之前发生束缚或翘起。特别地，关于内部手柄24的中间部分的外螺纹27，可以用在本文公开的递送系统的任何实施方案中的该装置的实施方案的附加特征是内部狭槽40(图4A)，其细节将在下面进一步描述。
如前所述，可以设置按钮6，当如指示按钮6的平移16的箭头所示推动按钮6时，按钮6可以沿着按钮6的轴并通过连杆臂31传递力和运动，从而将其施加到导管支架30并使其向近侧平移，如指示导管支架30的平移43的箭头所示。按钮6平移的方向控制可以由按钮壳体7提供，按钮壳体7可以是圆柱形的，并且用作活塞室来引导类似圆柱形的活塞状按钮6。在功能上，按钮6、连杆臂31和导管支架30的组合可以表现为机械连杆。这些部件之间的力和运动的传递可以通过每个连续部件与下一个部件的销-孔连接来实现；而按钮6一端的多个按钮销46(图5)可以与连杆臂31的远侧销孔32同心地配合，并且导管支架30一端的多个导管支架销47(图5)可以与连杆臂31的近侧销孔33同心地配合。导管支架30具有几个特性，这些特性可以有助于其在近侧外部手柄2内在没有束缚或翘起的情况下平稳地平移的能力。例如，导管支架30可以具有多个支撑凸台36(在图4A中可以最佳看到)，其可以通过接触所述近侧外部手柄2的内表面而允许支架在近侧外部手柄2内滑动。导管支架30还可以具有多个支撑翅片35，支撑翅片35也可以通过接触所述近侧外部手柄2的内表面来帮助支架在近侧外部手柄2内滑动。另外，多个支撑翅片35也可以为多个导管支架销47(图5)提供位置。
为了通过钟形导管10的远侧端部为适当的瓣膜捕获能力提供必要的复位力，圆柱形保持螺母38可以与导管支架30和压缩弹簧39两者接触。当按钮被释放时，该压缩弹簧39可用于将导管支架30和钟形导管10的近侧端部68和远侧端部推向扩张尖端9，这是由于压缩弹簧39提供的偏压导致钟形导管的远侧端部10在锚定导管的锚定尖端23的顶部上滑动。
通过转向图3B，通过被配置为允许递送系统1快速收回的经心尖递送系统的操作顺序的一系列视图来继续，图3B示出了近侧外部手柄2的进一步旋转(如指示旋转17的箭头所描绘的)可以允许内部手柄24的中间部分的外螺纹27和近侧外部手柄2的内螺纹28进一步脱离。如果这种旋转继续(如图3C中指示近侧外部手柄2的持续旋转41的箭头)，上述螺纹可能最终完全脱离，如图3D所图示的。一旦上述螺纹完全脱离，当被操作者向近侧拉动时，近侧外部手柄2可以自由平移远离远侧手柄3，如指示近侧外部手柄2的平移18的箭头所描绘的。扩张器尖端的近侧端部现在可以抵靠递送导管8的远侧端部对接，形成平滑连续的外表面，并且所有导管可以彼此嵌套。这可以完成快速收回过程，由此该装置可以安全地从患者的心尖(未示出)或另一治疗部位移除。应当注意，位于近侧外部手柄2的远侧端部的内部圆形肋25可以在与位于内部手柄的中间部分24的近侧端部处的外部圆形凸缘42接触时充当刚性的物理止动件。这限制了近侧外部手柄2和相关部件相对于内部手柄的平移，从而确保手柄不会完全彼此分离。
如前所述，在内部手柄24的中间部分的最近侧端部处定位有内部狭槽40(图4A)。该内部狭槽40的目的是提供空间，在该空间中可以放置连杆臂31的矩形突出部34，以防止近侧外部手柄2相对于内部手柄24或远侧手柄3的不希望的旋转，并且当看到如图4A所描绘的，这些部件之间的关系更容易理解。当按钮保持未按下时，矩形突出部可以被偏置以搁置在狭槽中。必须理解的是，由按钮6、连杆臂31和导管支架30限定的机械连杆的另一个特征可以通过按压按钮6来实现，于是连杆臂31的矩形突出部34变得从内部狭槽40中完全移除，从而使得近侧外部手柄2能够相对于内部手柄24完全旋转。
现在转到图5，其图示了被配置为允许递送系统1的快速收回的经心尖递送系统的内部部件的分解图。虽然图5的许多元件已经在本文中在前面进行了描述，但是现在将重点给出用于将部件锚定在手柄内的某些元件的附加细节。近侧外部手柄2可以包括两个手柄半部，具体地说，上部部分44和下部部分45，它们可以通过常用的医疗装置粘合剂紧固(例如氰基丙烯酸酯紫外线固化粘合剂)在一起，该粘合剂可以施加到用于配合所述近侧外部手柄部分44、45的多个栓58。用于将两个手柄半部联接在一起的其他方式包括但不限于压入配合、螺钉、超声波焊接等。栓58被图示为位于近侧外部手柄2的下部部分45内，并且每个栓可以具有互补的凸台，该互补的凸台具有在上部部分44中的孔，栓58配合在孔中，尽管未示出。栓和凸台的相对位置可以互换。在近侧外部手柄2的每个部分(上部部分44和下部部分45)的最近侧端部处，图示了多个矩形狭槽60，其可用于牢固地定位和保持连接器(例如针接口12)的主体59。另外，用于保持针接口凸缘57的多个凹穴56可以设置在多个矩形狭槽60的附近，以便保持和定位针接口12的特定紧固特征，主要是针接口凸缘57。在近侧外部手柄2的上部部分44和下部部分45中还可以发现多个矩形凹穴55，其用于定位和保持锚定螺母48，并且还提供用于粘合剂结合(其将锚定螺母固定到手柄部分中)的位置。应当记住，锚定螺母48可以通过锚定导管50上的外螺纹部分51和锚定螺母48内的内螺纹部分52来提供锚定导管50的机械紧固和定位。
图6A-图6E提供了被配置为允许快速收回的经心尖递送系统1的替代实施方案的操作顺序的图示。图6A描绘了操作顺序的第一视图，示出了近侧外部手柄65的另一个实施方案。在近侧外部手柄65的这个实施方案中，可以通过如本文中前述的类似方式提供快速收回，但是具有用于近侧外部手柄65从远侧手柄部分66的另一个实施方案脱离的替代装置。具体而言，该实施方案中的致动器机构可包括闩锁按钮49(图6A-图6C)，闩锁按钮49可用于保持远侧手柄部分66的该实施方案与近侧外部手柄65的该实施方案联接。闩锁按钮49可以与远侧手柄部分66的该实施方案连续且柔性地连接，但是通常可以位于近侧外部手柄实施方案65的凹部内。因此，在接合之前，闩锁按钮的干涉边缘63可以抵靠在近侧外部手柄实施方案65内的另一干涉边缘62对齐。如图6D所描绘的，一旦按压两个闩锁按钮49(由箭头61图示，箭头61指示悬臂式闩锁按钮49的平移/弯曲)，按钮的干涉边缘63可以通过弯曲式挠曲实现与近侧外部手柄65的干涉边缘62间隔开(图6E)。部件之间间隔开可以允许近侧外部手柄65的该实施方案平移远离远侧手柄66的该实施方案，如指示近侧外部手柄实施方案65平移的方向箭头67所描绘的(图6E)。经心尖递送系统1的该实施方案(图6A-图6E)的其余内部元件和外部元件可以被配置为允许快速收回，如专利‘964中描述的递送系统那样。
图7A-图7D提供了被配置为允许快速收回的经心尖递送系统1的又一替代实施方案的操作顺序的图示。图7A描绘了操作顺序的第一视图，示出了近侧外部手柄72的又一实施方案。在近侧外部手柄72的这个实施方案中，可以通过如本文中前述的类似方式提供快速收回，但是具有用于近侧外部手柄72从远侧手柄部分73的又一个实施方案脱离的替代装置。在图7A所图示的实施方案中，可以提供类似于在现代手榴弹中可以看到的手柄保持的保持销/闩锁类型。具体而言，可由具有抓握部分76和轴75(图7C)的优选形状的线形构成的保持销71可以用于通过将轴75设置在接收销孔77(位于远侧手柄实施方案73的近侧端部)和销孔78(位于近侧手柄实施方案72)中将近侧外部手柄部分实施方案72销接到远侧手柄实施方案73。手柄中用于保持销71的凹部74(图7B)可以为销提供与近侧手柄实施方案72的外表面齐平的位置，防止钩住临床使用者(未示出)可能佩戴的无菌手套。这里，具有保持销71的致动机构的操作可以如下所述：在通过拇指轮4(图7B)的持续旋转最终展开人工心脏瓣膜(未示出)之后，然后使用者可以抓住保持销71，并将其拉出凹部74，如指示保持销71的平移的方向箭头69所描绘的。一旦保持销轴75完全从销孔77、78移除，近侧外部手柄实施方案72可以变得自由平移远离远侧手柄实施方案73，如指示近侧外部手柄实施方案72的平移的方向箭头70所描绘的。经心尖递送系统1的该实施方案(图7A-图7D)的其余内部元件和外部元件可以被配置为允许快速收回，如专利‘964中描述的递送系统那样。
假体
图8图示了示例性假体802的示意图，该假体可与本文公开的任何递送导管一起使用。假体802优选为人工瓣膜，例如人工二尖瓣，尽管它也可以是用于身体中任何其他区域的人工瓣膜，例如人工三尖瓣、人工主动脉瓣或人工肺动脉瓣。或者，它可以是人工静脉瓣膜，或者任何其他人工瓣膜，或者人工装置。假体802优选包括具有人工瓣膜机构806的可膨胀框架804，并且优选包括锚定机构808。可膨胀框架可以是气囊可膨胀的或自膨胀的，并且框架膨胀成与天然瓣膜接合。人工瓣膜机构806可以包括一个、两个、三个或更多个人工瓣膜小叶，其具有允许顺行流体流过的打开位置，以及人工瓣膜小叶彼此接合以防止或最小化逆向流体流过的关闭构型。流体可以是血液或其他体液。人工小叶可以是心包组织或其他组织，或者它们可以由合成材料(如聚合物或金属)形成。锚定机构可以是构造成有助于与组织接合并且将假体与天然瓣膜锚定的任何结构。
图9A-图9B图示了沿着图8中的线A-A所截取的横截面，并且示出了框架804的可能横截面。图9A示出了假体可以具有圆形横截面，并且在优选实施方案中，优选地对于二尖瓣，假体可以具有D形横截面，使得假体符合天然解剖结构。关于假体的示例性实施方案的附加细节公开在专利‘964中，该专利先前通过引用并入本文。
图10A-图10B图示了联接到递送导管1002的假体1008，例如图8中描述的假体。在图10A中，假体处于折叠构型，并由递送导管1002承载和约束。递送导管1002可以是本文所述的任何递送导管。外护套1004约束假体1008，并使其保持折叠构型，并设置在内轴1006上，内轴1006可滑动地设置在外护套1004中。内轴1006可以是本文公开的任何内轴，包括先前公开的钟形导管。为了方便起见，未图示递送导管中的其他可选轴。随着外护套1004向近侧收回，或者钟形导管向远侧推进，假体变得不受外护套约束，并开始自膨胀，如图10B所见。一旦假体完全不受约束，就会自动膨胀到位，优选地与天然瓣膜接合。
递送
图11图示了基本的人类心脏解剖结构。心脏包括四个腔室，右心房RA、右心室RV、左心房LA和左心室LV。若干瓣膜防止血液倒流。三尖瓣TV控制从右心房到右心室的流动，以及肺动脉瓣PV控制流出右心室RV。二尖瓣MV控制左心房LA和左心室LV之间的流动，以及主动脉瓣AOV控制流出主动脉AO。联接到心脏的主要血管包括腔静脉VC，其将静脉血带回右心房RA，以及肺动脉将血液从右心室RV带到肺(未图示)。来自肺的富氧血(Oxygenatedblood)经由肺静脉PVE返回左心房LA，以及血液通过主动脉AO从左心室LV流出，递送到身体。
图12A图示了一种用于治疗二尖瓣MV的示例性递送方法。在该实施方案中，递送导管C可以是本文公开的任何递送装置，并且可以具有本文公开的任何假体，递送导管C通常从腹股沟中的股静脉向上前进进入腔静脉VC，进入右心房RA，然后经中隔地穿过心房隔膜壁进入左心房LA，然后向下进入跨过或邻近天然二尖瓣MV的位置，在该位置，假体可以如本文所述进行展开。
图12B图示了用于治疗二尖瓣MV的另一种示例性递送方法。在该实施方案中，递送导管C可以是本文公开的任何递送装置，并且可以具有本文公开的任何假体，递送导管C典型地从股动脉或其他动脉(例如桡动脉)向上前进进入主动脉AO，进入左心室LV，然后穿过二尖瓣MV或其附近，用于展开本文所述的假体。
图12C图示了用于治疗二尖瓣MV的另一种示例性递送方法。在该实施方案中，递送导管C可以是本文所述的任何递送装置，并且可以具有本文所公开的任何假体，递送导管C通常经心尖地从体外穿过胸壁前进进入心尖，进入左心室LV，然后邻近或穿过二尖瓣MV，然后假体如本文所公开的在二尖瓣MV处展开。
图13A-图13C图示了使用递送导管C在心脏中展开假体P的示例性方法，递送导管C可以是本文公开的任何递送装置。假体优选为二尖瓣假体，但也可以是本文公开的任何假体。在图13A中，递送导管优选经心尖地递送到二尖瓣MV。在图13B中，一旦假体P已经相对于天然二尖瓣MV合适地定位，外护套向近侧收回(或者内部钟形轴向远侧前进)，使得假体不受约束并被允许自膨胀成与天然二尖瓣接合并锚定就位。在人工瓣膜已经展开并合适地定位并且锚定之后，然后递送导管向近侧收回并从心脏移除，如图13C所见。人工瓣膜现在接管了天然二尖瓣的功能，允许从左心房到左心室的顺行流动，并防止或最小化血液从左心室到左心房的逆流。
虽然本文已经示出和描述了本发明的优选实施方案，但对于本领域技术人员明显的是，这样的实施方案仅以示例的方式提供。在不偏离本发明的情况下，本领域技术人员现将会想到许多更改、改变和替代。应当理解，在实践本发明的过程中可以采用对本文所描述的本发明实施方案的各种替代方案。意图是，所附权利要求限定本发明的范围，并因此覆盖这些权利要求范围内的方法和构造及其等同物。

Claims (16)

1.一种用于递送假体的递送装置，所述递送装置包括：
递送导管，所述递送导管被配置成在所述递送导管中携带假体；
扩张器导管，所述扩张器导管设置在所述递送导管中，所述扩张器导管具有与所述扩张器导管联接的锥形远侧尖端；
快速收回机构，所述快速收回机构用于控制所述递送导管相对于所述锥形远侧尖端的运动，
其中，所述快速收回机构包括内部手柄、外部手柄和快速收回按钮，其中，所述内部手柄螺纹连接到所述外部手柄，并且
其中，所述快速收回按钮的致动允许所述内部手柄与所述外部手柄螺纹分离，以允许所述外部手柄相对于所述内部手柄向近侧收回，从而关闭所述递送装置，使得所述锥形远侧尖端的近侧端部抵靠所述递送导管的远侧端部，从而在所述递送装置上形成平滑连续的外表面。
2.根据权利要求1所述的递送装置，还包括用于控制所述递送导管的运动的第一致动机构，其中，所述第一致动机构的致动将所述递送导管从所述假体移开，从而至少部分地移除来自所述递送导管的约束。
3.根据权利要求2所述的递送装置，还包括用于控制所述假体从锚定导管的释放的展开机构，所述锚定导管至少部分地设置在所述递送导管中，并且其中，所述展开机构的致动将所述锚定导管从所述假体移开，由此释放来自所述锚定导管的约束。
4.根据权利要求2或3所述的递送装置，其中，所述第一致动机构包括拇指轮。
5.根据权利要求3所述的递送装置，其中，所述展开机构包括联接到所述快速收回按钮的连杆，其中，所述连杆的一部分被偏置成与所述内部手柄接合，并且其中，所述快速收回按钮的致动使所述连杆的所述一部分从所述内部手柄脱离。
6.根据权利要求1-3和5中任一项所述的递送装置，其中，所述快速收回机构还包括干涉构件，所述干涉构件与所述内部手柄和所述外部手柄接合，以防止所述内部手柄和所述外部手柄相对于彼此旋转，并且其中，所述干涉构件从所述内部手柄和所述外部手柄的脱离允许所述内部手柄和所述外部手柄之间的相对运动。
7.根据权利要求4所述的递送装置，其中，所述快速收回机构还包括干涉构件，所述干涉构件与所述内部手柄和所述外部手柄接合，以防止所述内部手柄和所述外部手柄相对于彼此旋转，并且其中，所述干涉构件从所述内部手柄和所述外部手柄的脱离允许所述内部手柄和所述外部手柄之间的相对运动。
8.根据权利要求1-3、5和7中任一项所述的递送装置，其中，所述快速收回机构包括柔性干涉构件。
9.根据权利要求4所述的递送装置，其中，所述快速收回机构包括柔性干涉构件。
10.根据权利要求6所述的递送装置，其中，所述快速收回机构包括柔性干涉构件。
11.根据权利要求1-3、5、7和9-10中任一项所述的递送装置，其中，所述快速收回机构包括销和销-孔连杆组件。
12.根据权利要求4所述的递送装置，其中，所述快速收回机构包括销和销-孔连杆组件。
13.根据权利要求6所述的递送装置，其中，所述快速收回机构包括销和销-孔连杆组件。
14.根据权利要求8所述的递送装置，其中，所述快速收回机构包括销和销-孔连杆组件。
15.一种用于递送假体的系统，所述系统包括：
根据权利要求1至14中任一项所述的递送装置；和
所述假体。
16.根据权利要求15所述的系统，其中，所述假体包括人工二尖瓣。
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