CN112955080A - 支架加载装置 - Google Patents

支架加载装置 Download PDF

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CN112955080A
CN112955080A CN201980072997.2A CN201980072997A CN112955080A CN 112955080 A CN112955080 A CN 112955080A CN 201980072997 A CN201980072997 A CN 201980072997A CN 112955080 A CN112955080 A CN 112955080A
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diameter section
sheath
stent
lumen
loading device
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詹森·S·迪德林
萨拉瓦纳·B·库玛尔
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4C Medical Technologies 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices 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
    • 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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A61F2/9525—Means for mounting a stent or stent-graft onto or into a placement instrument using a funnel
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • 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
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0071—Three-dimensional shapes spherical

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Abstract

一种用于可预测且控制可塌缩且可扩张的支架的塌缩的装置和方法，以随后通过递送鞘管管腔平移到解剖目标(例如心脏瓣膜或血管内位置)以进行扩张和植入。加载装置限定内部管腔，该内部管腔包括从近侧方向到远侧方向连续减小的内径，减小到其中支架处于塌缩构造的恒定内径的区域。所述装置和方法可以提供支架的至少部分塌缩构造，该构造作为植入过程的一部分可以进一步塌缩，并且可包括被预加载以供将来使用的支架。

Description

支架加载装置
相关申请的交叉引用
本申请要求于2019年9月3日提交的、标题为“支架加载装置”的美国非临时专利申请第16/559055号的优先权，并进一步要求于2018年9月4日提交的、标题为“用于支架的漏斗加载装置”的美国临时申请第62/726,602号的权益，两个申请的全部内容通过引用并入本文。
关于联邦资助的研究或开发的声明
不可适用的
背景技术
技术领域
本发明涉及用于将设备植入心脏腔室内的装置和方法。更具体地，本发明涉及构造为将例如假体心脏瓣膜框架的支架加载到递送鞘管或导管的管腔中以通过所述管腔平移到递送鞘管或导管的远端的装置。
相关技术的描述
一般而言，支架且尤其是假体心脏瓣膜和左心耳闭塞装置在本领域中是众所周知的。天然心脏瓣膜，例如主动脉瓣膜、肺动脉瓣膜、三尖瓣瓣膜和二尖瓣瓣膜，在确保通过心血管系统的充足血液供应的仅向前流动方面是至关重要的。这些心脏瓣膜可能尤其由于先天性、炎性、传染性疾病或状况而丧失功能。早期干预是在开放性心脏手术中修复或更换功能异常的一个或多个瓣膜。最近，除了上述开放性心脏手术方案外，还可以经由至少下列已知穿刺途径之一经由皮肤地实现对所感兴趣的瓣膜的穿刺：经心尖递送技术；经股递送技术；经心房递送技术；和经隔膜递送技术，统称为经导管技术。
通常，在经导管技术中，假体瓣膜安装在能够实现塌缩和扩张状态的带支架框架内。使该装置塌缩并前进通过定位在患者的血管中的鞘管或递送导管，直到到达植入部位。带支架框架通常从导管或鞘管释放，并通过各种方式在心脏内与瓣膜一起扩张到扩张功能大小和定向。关键问题之一是假体瓣膜(包括支架框架和瓣膜)的易递送性。更具体地，导管内的塌缩装置的外径是令人感兴趣的。本发明解决了这个问题。
相关技术的描述
人心脏包括四个腔室和四个心脏瓣膜，该四个腔室和四个心脏瓣膜辅助血液向前(顺行)流动通过心脏的。所述腔室包括左心房、左心室、右心房和右心室。四个心脏瓣膜包括二尖瓣瓣膜、三尖瓣瓣膜、主动脉瓣膜和肺动脉瓣膜。大致参见图1。
二尖瓣瓣膜位于左心房和左心室之间，并且通过充当单向阀以防止回流到左心房中来帮助控制血液从左心房到左心室的流动。类似地，三尖瓣瓣膜位于右心房和右心室之间，而主动脉瓣膜和肺动脉瓣膜则是位于使血液流离心脏的动脉中的半月瓣膜。所述瓣膜均为单向瓣膜，其中叶打开以允许向前(顺行)血流。正常运行瓣膜叶在倒置血液施加的压力下关闭，以防止血液回流(逆行)到其刚流出的腔室中。例如，二尖瓣瓣膜在正常工作时在左心房和左心室之间提供单向阀，打开以允许从左心房顺行流动到左心室，以及关闭以防止从左心室逆行流动到左心房。这种逆行流动(当存在时)称为二尖瓣返流或二尖瓣瓣膜返流。
天然心脏瓣膜可能由于多种原因和/或状况(包括但不限于疾病、创伤、先天性畸形和衰老)而功能失调或变得功能失调。在二尖瓣瓣膜失效的情况下，这些类型的状况可导致瓣膜结构无法正确关闭，从而导致血液从左心室向左心房的返流逆行流动。
二尖瓣返流是由功能失调的二尖瓣瓣膜导致的特定问题，该功能失调的二尖瓣瓣膜允许至少一些逆行血液从右心房流回到左心房中。在一些情况下，功能失调的原因是由于一个或多个二尖瓣瓣膜叶向上垂入左心房腔室中，即环的上表面上方，而不是连接或配合以阻止逆行流动。这种血液的回流会给左心室增加容积负荷的负担，该容积负荷可能导致一系列左心室代偿性适应和调整，包括心室腔室大小和形状的重塑，其在二尖瓣返流的长期临床过程中会发生很大变化。
通常，对于天然心脏瓣膜(包括三尖瓣瓣膜、主动脉瓣膜和肺动脉瓣膜以及二尖瓣瓣膜)，返流可能是个问题。
因此，天然心脏瓣膜(例如二尖瓣瓣膜)通常可能需要功能性修复和/或协助，包括部分或完全更换。这样的干预可以采取几种形式，包括更换心脏瓣膜的开放性心脏植入和开放性心脏手术。参见例如美国专利第4,106,129(Carpentier)号，其中的过程具有高度侵入性，充满患者风险，并且不仅需要延长住院时间，而且还需要非常痛苦的康复期。
用于更换功能失调心脏瓣膜的较小侵入性的方法和装置也是已知的，并且涉及经由皮肤穿刺和更换瓣膜的导管辅助递送。这些解决方案中的大多数涉及一种更换心脏瓣膜，该更换心脏瓣膜被附接到本领域中熟知的结构性支撑件(例如，支架)，或被附接到设计成在从递送导管释放时扩张的其他形式的线网络。参见例如美国专利第3,657,744(Ersek)号；美国专利第5,411,552(Andersen)号。支撑支架的自扩张变体有助于在受体心脏腔室或血管内定位瓣膜，并将扩张装置保持在适当位置。当装置在第一次定位尝试中未被正确定位且因此必须被重新捕获并调整位置时(这是通常情况)，这种自扩张形式也会带来问题。在完全或甚至部分扩张的装置的情况下，这种重新捕获过程需要将装置重新塌缩到允许操作者进行如下操作的点：将塌缩的装置退回到递送鞘管或导管中，调整装置的入站位置(inbound position)，且然后通过将位置调整后的装置向远侧重新部署到递送鞘管或导管之外而重新扩张到正确位置。因为扩张后的支架或线网络通常被设计成实现也抵抗收缩或塌缩力的扩张状态，因此使已扩张装置塌缩是困难的。
除了以上讨论的开放性心脏外科手术方案外，经由至少以下已知穿刺途径之一经由皮肤地实现对感兴趣的瓣膜的穿刺：经心尖递送技术；经股递送技术；经心房递送技术；和经隔膜递送技术。
通常，本领域关注的系统和方法使用上述已知穿刺途径之一而允许对塌缩瓣膜装置的部分递送，其中装置的一端从递送鞘管或导管释放并扩张以进行初始定位，然后在实现正确定位时完全释放并扩张。参见例如美国专利第8,852,271(Murray，III)号；第8,747,459(Nguyen)号；第8,814,931(Wang)号；第9,402,720(Richter)号；第8,986,372(Murray，III)号；和第9,277,991(Salahieh)号；和美国专利公开第2015/0272731(Racchini)号；和第2016/0235531(Ciobanu)号。
另外，已知的“更换”假体心脏瓣膜旨在完全更换天然心脏瓣膜。因此，这些更换心脏瓣膜物理地接合环形喉道内的组织，即在环形平面和上环形表面下方，和/或瓣膜叶，从而消除了天然瓣膜的所有剩余功能性，并使患者完全依赖于更换瓣膜。一般而言，维持和/或保留心脏瓣膜的固有功能是优选解决方案，因此优选补充瓣膜而不是完全更换。显然，将存在情况：天然瓣膜在干预植入过程之前已经失去几乎完全功能性，或者天然瓣膜在植入过程之后继续失去功能性。优选解决方案是递送和植入一种瓣膜装置，该瓣膜装置将既用作附属和/或辅助功能瓣膜，又完全能够更换已经失去或将要失去其大部分或全部功能性的瓣膜的天然功能。但是，除非另有说明，否则下文所述的本发明解决方案通常将适用于所有类型和形式的心脏瓣膜装置。如技术人员将认识到的，本公开通常还适用于支架。
此外，用于例如二尖瓣瓣膜更换系统、装置和方法的已知解决方案需要2-腔室解决方案，即，植入的更换瓣膜装置包含并接合在左心房和左心室中。通常，这些解决方案包括在左心房中的径向扩张支架，以及从支架装置向下穿过环形喉部、通过下环表面(sub-annular surface)锚固或系链连接(设置为向下穿过天然环或环形喉部)在左心室、左心室腱索内和甚至连接到一个或多个左心室壁表面中。参见例如雅培集团(Abbott Group)销售且目前是美国唯一认可的修复装置的
Figure BDA0003051639280000041
在使用
Figure BDA0003051639280000042
时，包含
Figure BDA0003051639280000043
的导管被插入股静脉中。该装置进入心脏、穿过下腔静脉、到右心房并经隔膜地递送。
Figure BDA0003051639280000044
穿过环、进入左心室中，并置于叶下方，从而夹住叶以减少返流。
这样的2-腔室和天然环解决方案不必要是笨重的，因此从严格结构性角度来看，更难以递送和定位/重新捕获/重新定位。此外，该2-腔室解决方案在进行保持就位所需的心室锚固和/或系链连接方面存在困难。而且，这些解决方案如上所述地干扰了天然瓣膜功能性，因为设置在左心室内的装置部分必须被规划路径为穿过天然环和/或环形喉和天然二尖瓣瓣膜，从而破坏了天然叶的任何剩余接合能力。另外，该2-腔室解决方案通常需要对天然组织中的一些进行侵入性锚固，导致不必要创伤和潜在并发症。
还将认识到，因此该装置的心房部分不能将其自身充分锚固到心房腔室和/或环的上部，所以该2-腔室二尖瓣瓣膜解决方案需要下环和/或心室与锚固件、系链等精确地接合。同样，除非另有说明，否则本文描述的一些实施例或其部分可易于应用到单腔室或2-腔室解决方案。
最后，已知假体心脏瓣膜由两个或三个叶组成，这些叶被布置成用作单向阀，从而允许流体在顺行方向上流过它们，同时防止逆行流动。天然二尖瓣瓣膜在胸骨后位于第四软骨处，由前和后叶、腱索、乳头肌、心室壁和与心房相连的环组成。每个天然叶都由腱索支撑，该腱索附着到乳头肌，该乳头肌随着每次心室收缩而变得绷紧，从而保持瓣膜能力。天然瓣膜的前和后叶都通过初级、次级和第三级腱附接到前外侧乳头肌和后内侧乳头肌。在心肌损伤的设置中，任一乳头肌的破坏都可能导致二尖瓣瓣膜的前或后叶的功能失调。其他机制可能会导致天然二尖瓣叶中一个或两者的失效。在单个二尖瓣瓣膜叶失效的情况下，则返流可能采取回到左心房的非居中偏心血液射流的形式。其他叶失效可能包括更集中的返流射流。已知假体瓣膜更换物通常包括布置成模仿天然瓣膜结构的叶，这些叶随着时间流逝可能会受到类似返流结果的影响。
可塌缩和可扩张支架的应用不限于假体心脏瓣膜植入物。血管支架是常用的并且通常是可塌缩的，以利于通过递送导管的管腔递送到工作部位，在该部位处，支架平移出导管的管腔，并被自扩张装置或通过扩张机构(例如尤其是可扩张气球)扩张。
如上所述，已知递送方法和装置包括可扩张假体瓣膜支架和血管支架，其在通过递送导管的递送过程中塌缩。这种塌缩和扩张结构的问题包括在结构(例如支架)的、必须弯曲以适应塌缩和扩张状态的区域上设置应变。此外，已知装置中的塌缩几何结构可能不是受控的或可预测的，这增加了塌缩和扩张结构元件上的应变。因此，用于在递送导管或鞘管管腔内实现塌缩状态的结构和方法必须允许可预测且可重复塌缩，以维持并保留塌缩结构的完整性。此外，支架(例如假体心脏瓣膜或血管支架)可以包括不可允许变得干燥的生物和/或生物相容性材料。因此，保留可将受体支架驻留在其内的流体贮器是至关重要的。
本发明的各种实施例尤其解决了这些问题。
发明内容
一种用于可预测且控制可塌缩且可扩张支架的塌缩以便随后通过递送鞘管管腔平移到解剖目标(例如心脏瓣膜或血管内位置)以进行扩张和植入的装置和方法。加载装置限定内部管腔，该内部管腔包括从近侧方向向远侧方向连续减小的内径，减小到其中支架处于塌缩构造的恒定内径的区域。该装置和方法可以提供支架的至少部分塌缩构造，该构造可以作为植入过程的一部分可以进一步塌缩，并且可以包括被预加载以供将来使用的支架。
附图说明
图1以横截面示出了心脏的某些特征。
图2示出了示例性支架的立体图。
图3A示出了图2的示例性支架的过渡段的一个实施例的仰视图。
图3B示出了图2的示例性支架的过渡段的一个实施例的仰视图。
图3C示出了图2的示例性支架的过渡段的一个实施例的仰视图。
图4A示出了图2的示例性支架的塌缩的过渡段的一个实施例的仰视图。
图4B示出了图2的示例性支架的塌缩的过渡段的一个实施例的仰视图。
图5示出了本发明的一个实施例的侧面剖视图。
图6示出了本发明的一个实施例的立体图。
具体实施方式
总体上，本发明的各个实施例涉及如下的装置和方法：所述装置和方法用于实现用于可塌缩且可扩张支撑结构或支架的可预测塌缩构造或状态，以及用于提供一种在塌缩步骤期间可以与所述可塌缩且可扩张支撑结构附接或以其它方式与所述可塌缩且可扩张支撑结构集成的用于确保湿气保持在生物材料中的机构。
支撑结构或支架具有多种功能，以辅助治疗心脏瓣膜返流(二尖瓣或三尖瓣)。这些功能包括其作为用于功能性4C瓣膜的架的功能，并附于心房解剖结构，优化的径向力以符合心房扩张，从微创递送系统加载和展开的能力以及支撑减轻瓣周漏(PVL)的几何形状。支架的设计特征适于满足以上标识的功能中的一种或多种功能。下面详细讨论用于示例性支架的特定设计特征和属性，以帮助理解漏斗式加载装置和相关方法的实用性。如上所述，本发明不限于包括支架支撑结构的假体心脏瓣膜，而是还可以应用于例如通常用于血管内过程的可塌缩和可扩张支架。
某些示例性实施例支架设计构思旨在支持用于对二尖瓣、三尖瓣和/或其他方式的瓣膜返流的治疗的微创手术。所述支架可以是自扩张的(例如镍钛诺或类似材料)或可球囊扩张的(例如钴铬或类似材料)。所述支架通常由单元制成，所述单元可以是开放单元的菱形结构或具有工作单元元件的连续结构。所述支架也可以使用管、线、编织物或类似结构来构建。下文详细描述了有助于支架功能的特定设计特征。
支架“虹膜”过渡单元
现在参考图2-3B，本发明的支架100的一个实施例包括：外部段102，其在完全和/或部分扩张时可以大致是圆形，但不必是浑圆的圆形结构；和内部瓣膜支撑段104，其可以是圆柱形的但不必是恒定直径的圆柱体，并且适于将假体瓣膜叶(图2中未示出)支撑和保持在内部瓣膜支撑段104内，最优选地在位于天然环(例如，二尖瓣瓣膜环)上方的点处，尽管用于假体叶的其他附接点也在本发明范围内。此外，如上所述，支架100可以构造为补充和/或更换三尖瓣瓣膜的功能。一种优选构建物包括设置在天然叶上方的假体叶，其中该假体叶被附接到天然叶并与天然叶(在上方)充分隔开，从而不会物理上干扰天然叶或与之相互作用。但是，某些实施例考虑了与天然叶的一些相互作用。
形成支架100的外部段102的各个单元CO在图2中可见为由用于形成可扩张支架100的材料所限定的开放单元区域。
形成内部瓣膜支撑段104的各个单元CI也被示为形成在由外部段102限定的内部区域R内的开放单元区域，其中内部瓣膜支撑段径向向上延伸到内部区域R中。如所示的，各个单元CI的大小与各个单元CO的大小不同，并且可以包括与各个单元CO的形状不同的形状。
有助于支架100从支架100的外部段102到内部段104径向向内过渡的支架100的区域是过渡单元区域106。过渡单元区域106可以包括单元CT，单元CT可以包括与外部段单元CO和/或内部段单元CI不同的大小和/或形状。支架100的外部和/或内部区域102、104和/或过渡单元区域106可以由一个连续结构构建，或者可以组合两个或更多个结构以实现预期设计目标。过渡单元区域106通常包括径向向上弯转，以允许内部瓣膜支撑段104驻留在内部区域102内，如图2中所示。在一些实施例中，内部瓣膜支撑段104的下部部分，即与过渡单元区域106的单元CT关联的、内部瓣膜支撑段104的部分还可包括弯曲形状，以方便和/或完成到内部区域102中的径向向上弯转。
过渡单元CT的几何构造和/或形状如下图3A中所示在扩张时可以是基本笔直段，或者如图3B中所示，在扩张时可以在支架单元模式中包含偏移或扭转以允许支架的受控压缩。从支架100的底部看的过渡单元区域106的示例性横截面几何结构在图3A和3B中示意性地表示。
支架100的该过渡单元区域106可以是支柱、完整单元段或部分单元段。过渡单元区域106可具有通常满足设计需求所需的任何数量的支柱(最少3个)或单元段。如图3A中所示，过渡单元CT或支柱可以均匀间隔开，并且由基本笔直且相等间隔开的支柱108形成，所述支柱108在支柱108的两侧上以相等角度α远离内部瓣膜支撑部104延伸，并且相对于其与外部支撑段102的相交或集成处在支柱108的两侧上以相等角度β远离内部瓣膜支撑部104延伸。
在优选实施例中，过渡段106的支柱108可以如图3A中所示是笔直的，但是相对于内部瓣膜支撑段104和外部支撑段102具有不相等角度，如图3C中所示。在那里，笔直支柱108是倾斜的，从而相对于内部瓣膜支撑段104提供较小角度α和较大角度α‘。类似地，相对于外部支撑段102提供较小角度β’和较大角度β。这允许过渡段106的倾斜支柱108的压缩嵌套。
在另一优选实施例中，过渡单元区域106可以包括过渡单元支柱108’，该过渡单元支柱108’包括过渡单元CT，该过渡单元CT由具有偏移(即，不笔直)的支柱108’形成，是扭转和/或曲线的。支柱108’的偏移和/或扭转和/或曲率的程度，且因此所得到的扩张单元CT的大小和/或形状可以根据过渡单元区域106中的单元/支柱的数量、支架塌缩时的堆积密度以及过渡单元区域106的应力/应变分布限制而变化。
由于一些原因，图3B和3C的结构优于图3A的笔直过渡单元区域106的结构。图4A示出了使用图3A的基本笔直支柱108呈塌缩形式的过渡单元区域106，并且在所选的支柱108之间具有不希望的间隙G。尽管这种得到的间隙塌缩过渡单元区域106是可行的，但这不是最佳的。
因此，使用例如图3B的偏移和/或扭转和/或弯曲的多个支柱108’或图3C的倾斜笔直支柱108的图4B的过渡段106允许在支柱108’之间没有间隙的情况下、支架的受控且可预见的塌缩形式。这进而使塌缩期间在支架100的下部区域处的应力/应变集中的量最小化，这是将可扩张支架100递送到感兴趣的心脏区域所需的。另外，单元的塌缩也是对称且均匀的，这可以帮助减轻当瓣膜组织或织物附接到支架单元时对瓣膜组织或织物的损害。减少过渡支柱段的总应力/应变可有益于支架和瓣膜组织的耐久性。
如图3B、3C和4B中所示，过渡单元区域106的某些实施例的特征，即具有偏移、扭转和/或弯曲的支柱108’或倾斜的笔直的支柱108，如图3B中最佳地示出，在于支柱108’各自包括相同的偏移、扭转和/或曲率。当支架100向下塌缩以用于递送和随后扩张时，这又使得相邻支柱108’能够紧密嵌套。
因此，当使支架塌缩以装载到递送系统中时，过渡段设计允许对支架的受控压缩，并降低支架单元上的应力集中。过渡支柱段可有利于支架和瓣膜组织的耐用性。
如本领域技术人员现在将从以上认识到的，示例性支架的支柱的几何结构使得能够从扩张过渡到塌缩。使用以下本发明实施例可塌缩的支架当然不限于上述示例性情况。需要从扩张构造塌缩以实现适配在递送鞘管的管腔中的构造的任何支架都可以利用本发明方案而塌缩。
因此，图5示出了示例性加载装置200，其可以启动示例性支架从扩张到塌缩的过渡，其中准备塌缩状态或构造，并且该塌缩状态或构造足以平移到递送导管或鞘管中并沿着递送导管或鞘管平移到目标解剖位置。
因此，图5示出了在图像的近侧上的加载漏斗200以及鞘管300，其可以包括如本文所述的已知递送导管的修改。加载漏斗200和鞘管300被示为可以使用已知技术可移除地连接的两个单独元件。然而，如本领域技术人员将认识到的，在某些实施例中，加载漏斗200和鞘管300可以被预组装和/或制造为集成单位。加载漏斗200包括近侧减小直径(从近侧向远侧)段202，近侧减小直径段202示出为圆锥形的，但是在其他实施例中可以包括曲线的和/或凹的轮廓。在每种情况下，尺寸要求是：近侧减小直径段202的内径D1’包括管腔，该管腔包括从近侧内径D1’向远侧内径D2移动的平滑减小的内径。因此，近侧减小直径段202在其近端包括最大内径(示出为D1’)，且在其远端包括最小内径(示出为D2)。并且，如所示，近侧段202的近侧外径D1大于近侧内径D1’。
加载漏斗200的减小直径近侧段202向远侧过渡到恒定直径段204，该恒定直径段204包括内径D3，内径D3与减小直径近侧段202在其远端的最小内径D2基本相同，它们之间的过渡优选地是平滑的以有利于塌缩的示例性支架沿着它的无应力平移。
过渡鞘管300包括近端部分P和远端D，外径D4并限定包括内径D5的管腔，其中D4和D5均基本恒定。图5中以虚线示出了对于装置200和300中每个装置的管腔。
鞘管300的外径D4可以与加载漏斗200的恒定直径段204的内径D3相同或小于该内径D3。因此，如所示，鞘管300的近端部分P适于或被构造为适配在加载漏斗200的恒定直径段204的管腔的至少远侧部分中，以形成从加载鞘管200的近端流体连通到鞘管300的远端D的管腔。通常，但非局限性地，使用上面和图5中提供的术语，各种相关直径关系如下：
D1＞D1'＞D2＝D3≥D4
鞘管300可以以各种方式可移除地与恒定直径段204连接，包括但当然不限于：摩擦适配和/或所示的棘爪公构件206，其设置在加载漏斗200的恒定直径段204上，直到被鞘管300的近端部分P接合并径向向外推动。最终，当公构件206与狭槽或孔口302对准时，如技术人员将认识到的，公构件206可以掉落或卡入到如示例性地限定在鞘管300的恒定直径段204的外壁中的容纳孔口302和/或狭槽内。在一些情况下，狭槽302可允许鞘管300和加载漏斗200在狭槽302内的相对转动，从而实现加载漏斗200和过渡鞘管300之间、在狭槽302的长度的限制内的相对转动。如技术人员将认识到的，以上公构件/狭槽或孔口布置可以有效倒置：其中公构件206可以设置在鞘管300上，并且狭槽或孔口可以设置在加载漏斗200的恒定直径段204上。在限制内，在加载漏斗200和鞘管300之间的其他可能的连接替代方案可以包括螺纹连接和摩擦适配。另外更可替代地，部件200、300可以提供为单个单位，其中减小直径段的单个单位远侧的内径是恒定的。在所有情况下都需要将加载漏斗200和鞘管300在功能性上连接，以提供上述尺寸特征。
在一些实施例中，鞘管300的近端部分P当接合在加载漏斗的恒定直径段204内时可以向近侧地延伸到加载漏斗202的远端，有效地滑动通过恒定直径段204的管腔的整个长度。在其他实施例中，近端部分P仅与恒定直径段204的管腔的长度的一部分接合。
示例性可塌缩支架从扩张构造的塌缩可以通过使扩张的支架向远侧沿着减小直径段202且穿过减小直径段202渐进地平移到加载漏斗200的管腔中来实现，其中加载漏斗的管腔的壁对支架施加恒定且相等的压力，导致渐进、可预测且相对地无应力的塌缩以及进入到包括内径D5的管腔的鞘管300中的向远侧平移。在这个阶段，使示例性支架塌缩，并且准备向远侧平移到解剖目标。示例性支架从鞘管300的远端的释放允许支架(如果是自扩张的)扩张到其工作扩张构造。在其他情况下，如本领域中已知的，支架可能需要额外辅助来扩张，例如通过推/拉线和/或扩张球囊来扩张。
图6提供了过渡鞘管300’的可替代的蛤壳型构建物，其中过渡鞘管300’由平面片材304形成，该平面片材可具有如图所示的预弯曲形状。加载漏斗200如以上结合图5所述的。
当平面片材304的直径减小以滑动地适配在加载漏斗200的恒定直径段204内并形成鞘管300’时，位于加载漏斗200上的上述公构件206可以与过渡鞘管300’的孔口或狭槽302’对准并适配在其内，以提供过渡鞘管300’和加载漏斗200之间的可移除锁定适配，如上所述。如以上在图5的实施例中所指出的，公构件206和孔口或狭槽302’在图6的实施例中可以倒置位置。在302’的情况下，当公构件206在狭槽302’内转动时，加载漏斗200可以相对于鞘管300转动。在某些情况下，图6的蛤壳型鞘管300’在直径减小以适配在过渡鞘管300’的恒定直径段204内时可能没有沿其长度达到完全闭合，从而留有沿过渡鞘管300’的纵向狭槽。恒定直径段204的公构件206可以沿着该纵向狭槽被引导到图6中所示的径向狭槽302’，在此处，其可以转动以将两个元件可移除地锁定在一起，或者公构件206和狭槽302’可以如上所述地在适当位置倒置。
现在说明加载装置的结构，技术人员将认识到在影响实现支架从扩张大小到具有预定直径的预定塌缩大小的转变中的实用性。因此，上面示出的示例性支架可以沿着减小直径段缓慢平移。当支架前进时，加载漏斗200的减小直径段202的内壁围绕支架施加沿周向相等的力，从而使支架能够沿着具有最小阻力和最小应力的点塌缩。如上所述，圆形和/或螺旋形支柱将实现预定的、可预测且可重复的塌缩运动，导致预定的、可预测且可重复的塌缩形状。当支架已经在加载漏斗200的恒定直径段204内和/或鞘管300、300’的恒定直径管腔内塌缩时，塌缩的支架可沿其平移到感兴趣的解剖位置。当塌缩的支架从300、300’的管腔的远端释放时，它将被允许偏置地扩张，从而有效地使塌缩运动倒置以达到扩张状态或构造。
在一些情况下，如所讨论的，鞘管300、300’可包括过渡鞘管，该过渡鞘管提供过渡以与包括相同或相似内径的递送鞘管或导管连接。在其他情况下，鞘管300、300’可以形成递送鞘管或导管。
上面讨论的加载装置，例如加载漏斗200和过渡鞘管300、300’，还使得能够预加载支架以供使用。因此，支架可以塌缩并与流体一起加载到加载漏斗202的管腔中，以将生物和/或生物相容性的一种或多种材料保持为适当润湿以准备平移、递送和植入。
在一些实施例中，恒定直径段204的远端(或鞘管300、300’的远端)可以被盖住或塞住，以将流体保持在减小直径段202和/或恒定直径段204的管腔中(和/或鞘管300、300’的管腔中)，并且在其他实施例中，可以在减小直径段202的近端上方放置盖子，以进一步帮助将流体保持在其中。这种布置可以为包括对湿气敏感的生物材料的塌缩或部分塌缩支架提供更长存储机制。
可替代地，可以如上所述使支架塌缩并平移到鞘管300、300’的管腔中，填充流体并在两端盖住或塞住以保持流体，以帮助保护与支架关联的湿气敏感的生物材料。
一旦被加载并浸入流体中，则支架可以以塌缩构造被保持一段时间和/或被运输到需要的位置。
本文提出的对本发明及其应用的描述是说明性的，并不旨在限制本发明的范围。在本发明的构思范围内，各种实施例的特征可以与其他实施例组合。本文公开的实施例的变型和修改是可能的，并且在研究该专利文件之后，本领域普通技术人员将理解实施例的各种元件的实际替代方案和等同方案。在不脱离本发明范围和精神的情况下，可以对本文公开的实施例进行这些和其他变型和修改。

Claims (24)

1.一种加载装置，所述加载装置用于使可塌缩支架塌缩以准备递送和植入到身体中，所述加载装置包括：
近侧减小直径段，所述近侧减小直径段限定管腔，所述近侧减小直径段限定的管腔的内径从所述减小直径段的近端处的最大值到所述减小直径段的远端处的最小值平滑过渡，并且范围为从所述最大值到所述最小值；和
恒定直径段，所述恒定直径段在所述减小直径段的所述远端处连接到所述近侧减小直径段或与所述近侧减小直径段集成，并且所述恒定直径段限定管腔，所述恒定直径段限定的管腔的内径基本恒定并且基本等于所述近侧减小直径段的最小直径；和
鞘管，所述鞘管包括穿过所述鞘管的管腔并且操作地连接到恒定直径段并在所述恒定直径段的管腔内延伸，所述鞘管的外径与所述近侧减小段的最小内径相同或小于所述近侧减小段的最小内径。
2.根据权利要求1所述的加载装置，其中，所述鞘管适于在所述恒定直径段内平移。
3.根据权利要求1所述的加载装置，其中，所述鞘管与所述恒定直径段可移除地连接。
4.根据权利要求1所述的加载装置，其中，所述鞘管整体地延伸穿过由所述恒定直径段限定的管腔。
5.根据权利要求1所述的加载装置，其中，所述鞘管部分地延伸穿过由所述恒定直径段限定的管腔。
6.根据权利要求1所述的加载装置，还包括流体，所述流体设置在所述近侧减小直径段的管腔、所述恒定直径段的管腔和/或所述鞘管的管腔内。
7.根据权利要求1所述的加载装置，还包括限定在所述鞘管的外壁中的孔口和沿着所述恒定直径段设置的公构件，其中，所述鞘管适于在所述恒定直径段管腔内滑动，使得所述公构件与所述孔口对准并与所述孔口可移除地连接。
8.根据权利要求7所述的加载装置，其中，当所述公构件与所述孔口可移除地连接时，防止所述鞘管和恒定直径段相对于彼此转动或纵向平移。
9.根据权利要求6所述的加载装置，其中，所述孔口包括径向狭槽。
10.根据权利要求7所述的加载装置，其中，所述径向狭槽尺寸设计为允许所述公构件沿着所述狭槽滑动，并且从而防止所述鞘管和恒定直径段相对于彼此纵向平移。
11.根据权利要求1所述的加载装置，其中，所述鞘管包括平面片材，所述平面片材可适于限定管状形式，所述管状形式的外径使得能够在恒定直径段的所述管腔内平移和/或转动。
12.根据权利要求11所述的加载装置，其中，所述鞘管在呈所述管状形式时还包括纵向狭槽，并且所述恒定直径段包括公构件，所述公构件适于当所述鞘管在恒定直径段的所述管腔内平移时与所述纵向狭槽接合并且在所述纵向狭槽内滑动。
13.根据权利要求12所述的加载装置，其中，通过所述公构件与所述纵向狭槽的所述接合防止所述鞘管和所述恒定直径段之间的相对转动。
14.根据权利要求12所述的加载装置，其中，鞘管还包括与所述纵向狭槽连通的径向狭槽，其中，所述公构件还适于在所述径向狭槽内滑动，以防止所述恒定直径段和所述过渡鞘管之间的纵向平移。
15.根据权利要求1所述的加载装置，其中，所述支架包括假体心脏瓣膜框架。
16.根据权利要求15所述的加载装置，其中，所述支架包括假体二尖瓣瓣膜框架。
17.根据权利要求15所述的加载装置，其中，包括所述假体心脏瓣膜框架的所述支架经心尖递送到患者的心脏内的位置。
18.根据权利要求1所述的加载装置，其中，所述支架通过以下递送方法之一进行递送：股穿刺递送技术、静脉穿刺递送技术、经心尖递送技术、经主动脉递送技术、经隔膜递送技术、经心房递送技术、从主动脉逆行递送技术。
19.根据权利要求1所述的加载装置，其中，所述支架包括弯曲或螺旋形的支柱，当塌缩到所述加载装置中时，所述弯曲或螺旋形的支柱一起适配成可预测且可重复的形状。
20.根据权利要求1所述的加载装置，其中，所述鞘管包括递送鞘管，所述递送鞘管适于允许所述支架以塌缩构造平移到解剖部位。
21.根据权利要求1所述的加载装置，其中，鞘管包括过渡鞘管，其中，所述鞘管的远端与递送鞘管操作地连接。
22.一种加载和/或预加载支架以使所述支架在加载装置管腔内受控且可预测地塌缩的方法，所述方法包括：
提供可塌缩支架；
提供加载装置，所述加载装置包括：
近侧减小直径段，所述近侧减小直径段限定管腔，所述近侧减小直径段限定的管腔的内径从所述减小直径段的近端处的最大值到所述减小直径段的远端处的最小值平滑过渡，并且范围为从所述最大值到所述最小值；和
恒定直径段，所述恒定直径段在所述减小直径段的所述远端处连接到所述近侧减小直径段或与所述近侧减小直径段集成，并且所述恒定直径段限定管腔，所述恒定直径段限定的管腔的内径基本恒定并且基本等于所述近侧减小直径段的最小直径；和
鞘管，所述鞘管包括穿过所述鞘管的管腔并且操作地连接到恒定直径段并在所述恒定直径段的管腔内延伸，所述鞘管的外径与所述近侧减小段的最小内径相同或小于所述近侧减小段的最小内径；
使所述支架在所述减小直径段内向远侧平移，以开始所述支架的受控、可预测的塌缩；并且
对所述支架施加压力，以使所述支架向远侧平移通过减小直径段的所述管腔，并部分地平移到所述恒定直径段的管腔中，以使所述支架部分地塌缩在所述恒定直径段的管腔中。
23.根据权利要求20所述的方法，还包括：继续施加压力，以使所述支架整体向远侧平移到恒定直径段的所述管腔中，以使所述支架完全塌缩在所述恒定直径段的管腔中。
24.根据权利要求21所述的方法，还包括：继续施加压力，以使完全塌缩的支架向远侧至少部分地平移到所述鞘管的管腔中。
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