CN105208973A - 低轮廓人工瓣膜结构 - Google Patents

低轮廓人工瓣膜结构 Download PDF

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CN105208973A
CN105208973A CN201480028213.3A CN201480028213A CN105208973A CN 105208973 A CN105208973 A CN 105208973A CN 201480028213 A CN201480028213 A CN 201480028213A CN 105208973 A CN105208973 A CN 105208973A
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assembly
implanting device
supporting construction
bindiny mechanism
valving members
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CN105208973B (zh
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约翰·P·盖诺
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Edwards Lifesciences Corp
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HLT 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
    • A61F2/2412—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
    • A61F2/02—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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

一种人工瓣膜部件，包括一移植片固定模、一组织瓣膜和一固定机构。通过将人工瓣膜部件的三个组件以串联的形式载入一传送导管，使得其中一组件不位于另一组件之内，缩小了传送导管的尺寸。

Description

低轮廓人工瓣膜结构
相关申请
本申请要求申请日为2013年3月15日、专利号为61/800，153、主题名称为低轮廓人工瓣膜结构的专利申请的美国临时专利申请的优先权，并以引用的方式将这一专利申请的整体并入本申请。
技术领域
本发明涉及人工瓣膜结构，尤其涉及一种经由皮肤传送的低轮廓人工瓣膜结构。
背景技术
迄今为止，用人工瓣膜替换心脏瓣膜是一种复杂的手术，手术过程中涉及到剖开胸腔、通过血液泵建立血液流动、使心脏停止跳动等。即便当该手术完美地进行时，由于进入植入位置产生的侵入和伤害，手术需要很长的恢复时间。另外，感染或者其他并发症的风险非常高。
开发人工瓣膜已经取得了许多进步，采用一导管使人工瓣膜通过脉管系统迂回到达植入位置使得人工瓣膜可以经由皮肤植入体内。如果人工瓣膜植入成功，那么相对于传统的心内直视手术能够极大地减少了恢复时间。
然而，经由皮肤传送的人工瓣膜的设计者面临许多挑战。首要的挑战是设计一种可被充分压缩以插入一导管的人工瓣膜，该导管足够小以能够通过脉管系统穿入瓣膜位置。其他的挑战包括在瓣膜位置固定瓣膜使得瓣膜释放后不会移动；包括一具有足够强度以推动原瓣膜的瓣膜支撑结构，该瓣膜支撑结构通常是使瓣膜钙化并将其移走，并防止其妨碍新瓣膜的功能；确保新的瓣膜在所需方向上能够有适当的流动，以及能够有效地阻止在所需方向的反方向的流动；确保在植入装置的周围没有血液流动(即瓣周漏)；设计不会在无数次的小叶功能循环后因疲劳而失效的人工瓣膜装置；设计既能满足所有标准又经济的瓣膜等。
设计人工瓣膜和其各自的传送导管替换特定的原瓣膜，例如主动脉瓣。经由皮肤传送至瓣膜是最简单的，且当使用较小的导管时，对病人创伤最小。然而，更小的导管，对设计可充分压缩以与较小的导管，例如16Fr或者14Fr(导管周长参数)的导管的内壁配合且能在内壁中滑动的有效的人工瓣膜提出了挑战。近些年在设计人工瓣膜方面取得了显著的进步，在已装载导管的构造中，缩小了人工瓣膜的轮廓尺寸。例如在授予Thill等人的、公开号为2006/0271166的美国专利中描述的装置，在导管内传送时，该装置可呈细长、展开的构造，而当在目标位置将该装置从导管释放时，该装置又恢复为折叠的构造，其中，该美国专利中的内容通过引用并入本申请。本发明旨在采纳这一创新构思，并提供另外的方法使得承载结构的轮廓更小。
发明内容
本发明的一个方面，旨在提供一种在已装载导管的构造中呈低轮廓的人工瓣膜装置。
本发明的另一方面旨在提供一种大小能够替换主动脉瓣且能够采用小尺寸的弹性导管传送的人工瓣膜装置。
本发明的另一方面旨在提供一种人工瓣膜装置，所述人工瓣膜装置包括两个相连接的组件，但该两个组件串联放置(即轴向间隔设置)于传送导管中，以减小所需的传送导管尺寸。
本发明的一个方面提供一种替换原瓣膜的装置，所述替换原瓣膜的装置包括一移植片固定模(stent)、一组织套筒(tissuesleeve)和一固定机构，所述固定机构用于将所述组织套筒固定在所述移植片固定模内。其中，在传送导管内部的结构中，所述固定机构不位于所述移植片固定模内，而在备用的结构中，所述组织套筒位于所述移植片固定模内。
本发明的另一方面提供了一种人工瓣膜装置，所述人工瓣膜装置包括一连接于瓣膜框架(wireform)近端的编织固定机构(braidedanchoringmechanism)。
本发明的另一方面提供了一种植入装置，所述植入装置包括具有伸展构造和折叠构造的支撑结构，所述支撑结构包括一第一端、一第二端和一位于所述第一端和第二端之间的预成形折痕，其中，当所述支撑结构从一传送装置中被释放时，所述预成形折痕至少辅助将第一部分翻转至第二部分内。所述植入装置还包括一人工瓣膜结构，所述人工瓣膜结构包括一铰接端，所述人工瓣膜结构铰接于所述支撑结构的第一端，由此，不用翻转所述人工瓣膜结构便使得所述第一部分得以翻转至所述第二部分内。
本发明的另一方面提供了一种含有支撑结构的可植入人工瓣膜结构，所述可植入人工瓣膜结构具有一折叠构造，所述人工瓣膜结构在所述折叠构造中至少部分地伸展至所述支撑结构内。
本发明的另一方面提供了一种人工瓣膜装置，所述人工瓣膜装置包括一支撑结构，当所述支撑结构处于折叠构造时，所述支撑结构具有向内弯曲的侧壁。
附图说明
这些及其他方面、特征以及本发明的实施例所能够带来的好处是明显的，并且通过参考附图，可由对本发明的实施例的以下说明阐明。附图中
图1为本发明的一实施例的植入装置的侧视图。
图2A-2D示出图1的实施例的传送过程。
图3A-F示出本发明一实施例的传送过程。
图4为本发明一实施例的侧视图。
图5为本发明一实施例的侧视图。
图6为本发明一实施例的侧视图.
图7A-D示出本发明一实施例的传送过程。
图8A-D示出本发明一实施例的传送过程。
具体实施方式
下面通过具体实施例的方式，结合附图进一步说明本发明。然而本发明的实施方式有多种，并不因此将本发明限制在所述的实施例范围之中；提供这些实施例是为了使本发明公开充分，并向本领域技术人员充分传达本发明的范围。附图中所示的用于详细描述实施例的术语并不旨在对本发明进行限制。在附图中，相同的数字代表相同的元件。
首先参考图1，图1示出本发明的装置10。装置10大体包括一支撑结构20，一瓣膜部件40和一连接部60，支撑结构20和瓣膜部件40之间的连接部60。如图1所示，在被压缩以安装于一传送导管的内腔之前，该装置10处于细长构造。从图1可以看出，支撑结构20、瓣膜部件40和连接结构60线性地沿着纵轴排列为一串联构造，而没有部件的重叠。
对于支撑结构20，虚线22表示在支撑结构20内设置的预成形折痕，预成形折痕至少部分地致使当装置10从所述传送导管释放时，装置10沿预成形折痕22向内折叠。支撑结构20可描述为具有一第一端24，位于第一端24和预成形折痕22之间的一第一部分26，一第二端30和位于预成形折痕22和第二端30之间的一第二部分32。
瓣膜部件40包括连接于一瓣膜框架(wireform)44的组织瓣膜42。瓣膜框架44使得组织瓣膜42的结构统一。
接下来，详细阐述瓣膜部件40和支撑结构20之间的连接部60。
图2示出处于完全扩展、已传送构造的图1中的装置10。装置10向内折叠，预成形折痕22为支撑结构20的近端。当装置10折叠，包括组织瓣膜42的瓣膜框架44被拖入支撑结构20。由于第一部分26现在被翻转了，换言之，第一部分相比于图1中折叠前的构造里外翻转，为了保持瓣膜部件40的朝向，连接部60必须铰接或枢接。由于连接部60铰接，当第一部分26翻转至第二部分32，瓣膜部件40只需线性(轴向)地移动至支撑结构20，如图2中的箭头100所示。因此，在支撑结构20上只需设有一预成形折痕22，就能使得瓣膜部件40在轴向移动时保持其朝向。
图3示出了一实施例的连接机构60。连接机构60可以是一连接环62，连接环62具有由一分隔部(spacer)66隔开的两环连接器64。在植入装置10处于细长构造时，第一分隔部66的大小确保连接机构60充分隔开支撑结构20和瓣膜部件40。连接机构60可由生物相容材料，如合金，包括但不限于不锈钢和镍钛合金，或者由聚合物或者其他适合的非金属制成。
图4示出另一实施例的连接机构60。连接机构60可以是一系链(tether)70，系链70具有端部72，端部72系于瓣膜部件40的瓣膜框架44和支撑结构20。系链70可由任意缝合材料或具有适当弹性使得其能够打结的金属丝制成。系链70中，位于端部72之间的长度构成了一第二分隔部74，第二分隔部74的大小确保在图1所示的细长构造下充分隔开支撑结构20和瓣膜部件40。
图5示出了一实施例的连接机构60，其为一单个的环80。环80围绕瓣膜框架44和支撑结构20的一股伸展。环80的大小确保装置10处于细长构造时充分隔开支撑结构20和瓣膜部件40。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这仅是举例说明，本发明的保护范围是由所附权利要求书限定的。本领域的技术人员在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改，但这些变更和修改均落入本发明的保护范围。

Claims (20)

1.一种植入装置，包括：
一支撑结构，所述支撑结构具有一伸展构造和一折叠构造，所述支撑结构包括:
一第一端；
一第二端；
所述第一端和所述第二端之间的预成形折痕；
位于所述第一端和所述预成形折痕之间的一第一部分；
位于所述第二端和所述预成形折痕之间的一第二部分；
其中，当所述支撑结构从一传送装置中被释放时，所述预成形折痕至少帮助使得所述第一部分翻转至所述第二部分；
一瓣膜部件，铰接于所述支撑结构的第一端，进而使得所述支撑结构的第一部分在不翻转所述人工瓣膜结构的情况下得以翻转至所述支撑结构的第二部分。
2.如权利要求1所述的植入装置，其中，所述铰接端通过一连接机构铰接于所述支撑结构的第一端。
3.如权利要求2所述的植入装置，其中，所述连接机构包括一铰链。
4.如权利要求2所述的植入装置，其中，所述连接机构包括一连接环。
5.如权利要求4所述的植入装置，其中，所述连接环包括由一分隔部隔开的两个环连接器。
6.如权利要求1所述的植入装置，其中，处于细长构造时，所述连接机构将所述支撑机构和所述瓣膜部件隔开。
7.如权利要求1所述的植入装置，其中，所述连接机构包括一系链。
8.一种植入装置，包括：
一支撑结构，具有一第一部分和一第二部分，所述第一部分和所述第二部分被一预成形折痕隔开；
一瓣膜部件；
一连接机构，将所述瓣膜部件连接至所述支撑机构的第一部分；
其中，所述植入装置具有一第一构造和一第二构造；所述第一构造中，所述支撑结构是展开的，所述支撑结构、所述瓣膜部件和所述连接机构轴向排列；所述第二构造中，所述第一部分翻转至所述第二部分，所述瓣膜部件由所述连接机构至少部分地拖入所述第一部分。
9.如权利要求8所述的植入装置，其中，所述连接机构在枢轴上转动以使得，当所述第一部分翻转时，所述瓣膜部件不翻转。
10.如权利要求8所述的植入装置，其中，所述连接机构包括一铰链。
11.如权利要求8所述的植入装置，其中，所述连接机构包括一连接环。
12.如权利要求11所述的植入装置，其中，所述连杆机构包括由一分隔部隔开的两个环连接器。
13.如权利要求8所述的植入装置，其中，处于细长构造时，所述连接机构将所述支撑机构和所述瓣膜部件隔开。
14.如权利要求8所述的植入装置，其中，所述连接机构包括一系链。
15.如权利要求14所述的植入装置，其中，所述系链包括系于所述支撑结构的一第一端和系于所述瓣膜部件的一第二端。
16.如权利要求8所述的植入装置，其中，所述连接机构包括一环。
17.一种传送植入装置的方法，包括以下步骤：
在一传送导管内轴向设置一第一组件，一连接器和一第二组件，所述连接器连接所述第一组件和所述第二组件，以使得所述第一组件和所述第二组件不重叠；
在目标位置处从所述传送导管内释放所述第一组件、所述连接器和所述第二组件；
使所述第一组件在所述连接器绕枢轴转动时得以折叠与自身重叠，进而将所述第二组件沿轴向拖向所述第一组件。
18.如权利要求17所述的方法，其中，使所述第一组件得以折叠与自身重叠包括，在设置所述第一组件、所述连接器和所述第二组件之前，在所述第一组件上制造一预成形折痕，在所述设置步骤期间展开所述预成形折痕，从而所述预成形折痕致使所述第一组件在被释放时折叠与自身重叠。
19.如权利要求17所述的传送植入装置的方法，其中，在所述传送导管内轴向设置所述第一组件，所述连接器和所述第二组件包括在所述传送导管内设置一支撑结构、一连接器和一瓣膜部件。
20.如权利要求17所述的传送植入装置的方法，其中，在所述传送导管内轴向设置所述第一组件，所述连接器和所述第二组件，所述连接器连接所述第一组件和所述第二组件，以使得所述第一组件和所述第二组件不重叠包括，在所述传送导管内轴向设置所述第一组件、所述连接器和所述第二组件，以使得所述第一组件和所述第二组件相互间隔开。
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