CN116172753A - 具有带系绳的锚定件的假体心脏瓣膜设备以及相关联的系统和方法 - Google Patents

具有带系绳的锚定件的假体心脏瓣膜设备以及相关联的系统和方法 Download PDF

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CN116172753A
CN116172753A CN202310355685.0A CN202310355685A CN116172753A CN 116172753 A CN116172753 A CN 116172753A CN 202310355685 A CN202310355685 A CN 202310355685A CN 116172753 A CN116172753 A CN 116172753A
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heart
valve
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M·克里沃鲁奇科
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Medtronic Vascular 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
    • 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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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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
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    • 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
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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
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

本文中公开了具有带系绳的锚定件的假体心脏瓣膜(104)和相关联的系统以及方法。根据本技术的实施例构造的心脏瓣膜(104)设备可包括，例如，用于承载假体瓣膜(104)的瓣膜支承件(102)。瓣膜支承件(102)可构造为植入在天然二尖瓣(104)的瓣环处。设备还可包括沿心室方向从瓣膜支承件(102)延伸的至少一个细长柔性构件(106)和经由细长柔性构件(106)联接至瓣膜支承件(102)的锚定件(108)。锚定件(108)可定形为围绕心脏的心尖部(101)的外部区域缠绕。此外，锚定件(108)可抑制瓣膜支承件(102)的逆行迁移。

Description

具有带系绳的锚定件的假体心脏瓣膜设备以及相关联的系统 和方法
本发明专利申请是是国际申请号为PCT/US2017/028093，国际申请日为2017年4月18日，进入中国国家阶段的申请号为201780026591.1，名称为“具有带系绳的锚定件的假体心脏瓣膜设备以及相关联的系统和方法”的发明专利申请的分案申请。
相关申请的交叉引用
本申请要求于2016年04月29日提交的美国临时专利申请第62/329,400号的权益，其全部内容以参见的方式纳入本文。
技术领域
本技术总地涉及假体心脏瓣膜设备。具体地，本技术的各种实施例涉及具有带系绳的锚定件的假体二尖瓣设备以及相关联的方法和系统。
背景技术
二尖瓣用作为止回阀，用于在心脏收缩期间，即，在左心室收缩时，防止氧合血流回到左心房中。这允许将氧合血泵送通过主动脉瓣而进入主动脉中。二尖瓣反流会显著地降低心脏的泵送效率，并且由此增加了严重的、发展中的心力衰竭的概率。二尖瓣反流的特征可在于从心脏的左心室通过机能不全的二尖瓣进入左心房中的逆行流动。二尖瓣反流可由多种机械性缺陷导致。例如，小叶、联接到小叶的腱索和/或二尖瓣的乳头肌可能是受损的或以其它方式功能有障碍的。在至少一些情形中，二尖瓣瓣环本身可能是损坏的、扩张的或弱化的，使得二尖瓣在心脏收缩期间无法充分地闭合。
一种用于治疗二尖瓣反流的途径是二尖瓣置换。经皮二尖瓣置换比主动脉瓣置换明显地更有挑战性，因为天然的二尖瓣和周围的结构提出了独特的解剖学上的障碍。与相对对称和均匀的天然主动脉瓣不同，二尖瓣瓣环具有非圆形的、D形的或肾形的形状，具有非平面的鞍状的几何形状。这样的复杂性使得难以设计出充分顺应二尖瓣瓣环以避免泄漏和回流的二尖瓣假体。例如，在假体与天然组织之间的间隙会允许血液的通过该间隙从左心室回流到左心房。因此，圆柱形假体瓣膜会在天然瓣膜的连合区中留下间隙，其潜在地导致在这些区域中的瓣周泄漏。
除了其不规则的、不可预测的形状(其在每次心跳的过程中改变尺寸)之外，二尖瓣瓣环也缺乏来自周围组织的显著的径向支承量。主动脉瓣例如完全由纤维弹性组织所围绕，该纤维弹性组织提供天然的结构支承，用于锚定假体瓣膜。然而，天然二尖瓣的内壁由将二尖瓣瓣环与主动脉流出道的下部隔离开的薄血管壁连结。因此，在二尖瓣瓣环上显著的径向力、诸如由使支架假体扩张所施加的那些径向力会导致主动脉道的下部塌缩。此外，因为腱索从乳头肌延伸到小叶的下侧，所以在天然二尖瓣瓣环的心室侧上展开瓣膜假体是具有挑战性的。因此，假体二尖瓣必须适应二尖瓣和环绕结构的困难的解剖结构。
附图说明
参照附图可以更好地理解本技术的许多方面。附图中的各部件不一定按比例绘制。而是重点在于清楚地说明本技术的原理。为了便于参考，在整个申请中，相同的附图标记可以用以表示相同的或至少基本相似或类似的部件或特征。
图1A是根据本技术的一个实施例定位在心脏中的心脏瓣膜设备的局部剖切侧视图。
图1B是图1A示出的心脏瓣膜设备的一部分的放大剖视图。
图2A-图2C是示出根据本技术的一个实施例的心脏瓣膜设备的经心尖植入手术程序的各阶段的局部剖切侧视图。
图3A-图3C是示出根据本技术的一个实施例的心脏瓣膜设备的经中隔植入手术程序的各阶段的局部剖切侧视图。
详细描述
本技术总体涉及具有带系绳的锚定件的假体心脏瓣膜设备以及相关联的系统和方法。参照图1A-图3C，本文中描述了本技术的若干实施例的具体细节。虽然是关于用于置换天然二尖瓣的的假体心脏瓣膜设备的设备、系统和方法描述了许多实施例，但是除了本文所述的这些之外的其它应用和其它实施例也在本技术的范围内。例如，本技术的至少一些实施例可用于置换其它瓣膜，诸如三尖瓣或主动脉瓣。应当注意的是，除本文公开的实施例之外的其它实施例在本技术的范围内。另外，本技术的实施例可以具有与本文所示或所述不同的构造、部件和/或程序。另外，本领域的普通技术人员将会理解的是，本技术的实施例可以具有除本文所示或所述的之外的构造、部件和/或程序，并且其它实施例可以在不偏离本技术的情况下，没有本文所示或所述的若干构造、部件和/或程序。
关于在本说明书中的术语“远侧”和“近侧”，除非另有说明，术语可以参照操作者和/或脉管或心脏中的位置来引用假体心脏瓣膜和/或相关联的递送装置的各部分中的相对的(有关系的)部分。例如，参照适于对本文所描述的假体心脏瓣膜进行递送和定位的递送导管，“近侧”可以是指更靠近装置的操作者或是进入脉管中的切口的位置，而“远侧”可以是指更远离装置的操作者或是沿着脉管离切口更远的位置(例如，导管的端部)。对于假体心脏瓣膜设备，术语“近侧”和“远侧”可以是指设备的各部分相对于血液流动的方向的位置。例如，近侧可以是指血液流入的位置或上游位置，而远侧可以是指血液流出的位置或下游位置。
图1A是根据本技术的一个实施例的、定位在心脏H中的心脏瓣膜设备100(“设备100”)的部分剖切侧视图，而图1B是设备100的一部分的放大剖视图。如图1A所示，设备100包括用于承载假体瓣膜104的瓣膜支承件102和多个细长柔性构件(单独地分别标示为第一至第四细长柔性构件106a-106d；总地称为细长柔性构件106)。细长柔性构件106从瓣膜支承件102沿远侧或心室方向延伸。设备100还包括经由细长柔性构件106联接至瓣膜支承件102的锚定件108。锚定件108可被形状和尺寸设计为围绕心脏H的心尖部101的外部区域缠绕或以其它方式至少基本上顺应于该外部区域。瓣膜支承件102可植入在心脏H的天然二尖瓣MV的瓣环A处或在其近侧，而细长柔性构件106可从瓣膜支承件102沿心室方向经在心脏壁105的心尖部101中的开口103延伸到锚定件108。细长柔性构件106可将瓣膜支承件102拴系到锚定件108，使得锚定件108沿心房或近侧方向抵抗瓣膜支承件102的运动。由此，被系住的锚定件108抑制瓣膜支承件102的逆行迁移。
设备100可从扩张状态或展开状态(图1A中示出)被压缩到低轮廓的递送状态，使得设备100可被递送到目标部位(例如，二尖瓣MV)。如在下文中更详细地讨论的，当处于低轮廓的递送状态中时，设备100可被约束在递送导管(未示出)之内，该递送导管可例如经心尖、经股或经中隔将设备100而递送到目标部位。在目标部位处，瓣膜支承件102可从递送导管中展开，并且转换到更大的扩张状态，使得瓣膜支承件102接合目标部位处的天然组织，诸如二尖瓣MV的天然瓣环A、小叶L和/或二尖瓣MV处的其它组织。在各种实施例中，瓣膜支承件102可自扩张到扩张状态。在其它实施例中，瓣膜支承件102可使用囊体导管或其它支架扩张装置来进行扩张。在其它实施例中，瓣膜支承件102可为可机械自扩张的。
瓣膜支承件102可由支架或能承载假体瓣膜104的其它类型的框架制成。例如，瓣膜支承件102可由弹性的、可生物相容的材料和/或其它适于承载假体瓣膜的框架材料制成，该材料从低轮廓递送状态运动到扩张状态，该弹性的可生物相容材料诸如为不锈钢、铂、镍钴或钴铬合金(例如，MP35N)、镍钛合金(例如，镍钛诺)。当瓣膜支承件102由超弹性形状记忆材料、如镍钛诺制成时，瓣膜支承件102能够塌缩进入超低轮廓递送构造，该递送构造适于经由导管(未示出)被递送通过脉管，并且当被从导管释放时，该瓣膜支承件自扩张到展开构造，其尺寸被适当地设定为用于替换目标瓣膜。瓣膜支承件可以是编织的或纺织的框架、由金属管制成的激光切割框架和/或其它合适的支架结构。
假体瓣膜104可包括两个、三个或更多个小叶110，其被布置成二尖瓣、三尖瓣或其它合适的瓣膜构造，并且使用缝线、胶水和/或其它适于将假体瓣膜104连结到瓣膜支承件102的附连机构来附连到瓣膜支承件102。小叶110可由各种可生物相容的、柔性的并且至少基本是不可渗透的材料形成。例如，小叶110可由聚四氟乙烯(PTFE)、聚对苯二甲酸乙二醇酯、热解碳、生物组织(例如，心包组织或异种移植瓣膜组织，诸如猪心脏组织或牛心包)和/或其它可生物相容材料制成。在二尖瓣应用场合中的瓣膜操作中，小叶110从闭合位置移动至打开位置，在闭合位置中，阻挡血液流从左心室通过瓣膜支承件102到右心房，而在打开位置中，血液从左心房沿下游方向通过瓣膜支承件102流到右心室。瓣膜支承件102可用作为支撑架，其具有径向刚度以维持假体瓣膜104的圆形的或其它所期望的横截面形状，从而确保当设备100经受外部径向压力(例如，在心脏收缩期间)时，小叶100合紧或以其它方式密封。例如在2012年10月31日提交的Duffy等人的美国专利申请第13/664,652号、2009年4月23日提交的Hill等人的美国专利第8,323,336号、2012年6月21日提交的Gifford等人的PCT专利申请第PCT/US2012/043636号、2012年10月19日提交的Morriss等人的PCT专利申请第PCT/US2012/061215号、2012年10月19日提交的Morriss等人的PCT专利申请第PCT/US2012/061219号以及2014年3月14日提交的Morriss等人的PCT专利申请第PCT/US2014/29549号中描述了合适的瓣膜支承件102和假体瓣膜104。所有上述申请和专利全文以参见的方式纳入本文。
细长柔性构件106可以是线、系绳、弦和/或适于将瓣膜支承件102连接至锚定件108的其它结构。在图1A所示的实施例中，设备100包括四个柔性构件106。在其它实施例中，设备100可包括一个、两个、三个或超过四个柔性构件106。图1A-图1B中示出的每个柔性构件106包括附连到瓣膜支承件102的第一端部部分112和附连到锚定件108的第二端部部分114。在其它实施例中(未示出)，瓣膜支承件102可附连到线束，该线束具有从瓣膜支承件102向下延伸到左心室中的一根或多根弦(例如，三根或四根弦)和将线束附连支锚定件108的单根线。所示实施例中的各第一端部部分112在瓣膜支承件102的不同的、间隔开的部分处附连至瓣膜支承件102。例如，第一端部部分112围绕瓣膜支承件102的周缘或周界间隔开。第一端部部分112可附连至瓣膜支承件102的近侧区域(例如，靠近左心房LA)、瓣膜支承件102的中心区域、瓣膜支承件102的远侧区域(例如，靠近左心室LV)、瓣膜支承件102的外侧和/或瓣膜支承件102的内侧。第一端部部分112可附连至瓣膜支承件102的单独的支柱、瓣膜支承件102的支柱的相交部、与瓣膜支承件102相关联的移植物材料和/或在瓣膜支承件102上的系绳附连环或点。可使用各种附连机构以将第一端部部分112附连至瓣膜支承件102，比如：将第一端部部分112系结到瓣膜支承件102的各部分；使用夹子、图片、夹紧件或其它紧固件将第一端部部分112紧固至瓣膜支承件102；和/或将第一端部部分胶粘到瓣膜支承件的各部分。在其它实施例中，细长柔性构件106的第一端部部分112可附连至小叶110。例如，第一端部部分112可被抽拉过小叶，并且经由缝线、凸片和/或其它适合的紧固机构来紧固。
如图1A和1B所示，细长柔性构件106可从瓣膜支承件102延伸通过左心室并且通过心脏壁105中的开口103，到达第二端部部分114附连至锚定件108的地方。细长柔性构件106的第二端部部分114可在锚定件108上的单个附连点处附连至锚定件108。如图1B所示，在其它实施例中，细长柔性构件106的各个第二端部部分114可附连在锚定件108上彼此间隔开的相分离的附连区域处(分别标示为第一至第四附连区域116a-116d；总地称为附连区域116)。这些分离的附连区域116可有助于由每个细长柔性构件106所施加的力在锚定件108上的分布。第二端部部分114可使用紧固件(例如，夹子、凸片、缝线和/或胶水)附连至锚定件108，或者，第二端部部分114本身可在系结附连区域116处。
细长柔性构件106可由合成的或收集的可生物相容的材料制成。这些材料可选择为使得，即便在大量循环之后，它们仍抵抗疲劳失效，在该大量循环的作用下，柔性构件106经历了相对高水平的在心脏收缩期间所经受的应力。适于细长柔性构件106的材料可以是弹性或非弹性的，并且可包括可生物相容的聚合材料，诸如PTFE(聚四氟乙烯)、聚丙烯、超高分子量聚乙烯、尼龙、丝、聚酯、PVDF(聚偏二氟乙烯)和/或其它合适的可生物相容的材料。
在各种实施例中，细长柔性构件106可在长度方面是可调节的，使得可对瓣膜支承件102与锚定件108之间的张力进行调节。例如，细长柔性构件106的第二端部部分114可延伸通过在锚定件108处的紧固件，其仅允许沿一个方向(例如，近侧或远侧方向)的运动。操作者可拉或推细长柔性构件106的第二端部部分114(延伸通过一个或多个紧固件)，直至沿着每个细长柔性构件106的张力已达到所期望的程度，并且随后，单向紧固件可抑制细长柔性构件106朝向瓣膜支承件102的收回。在其它实施例中，单向紧固件也可以是或替代地附连在瓣膜支承件102处。在其它实施例中，每个细长柔性构件106的一个端部部分可保持未附连至瓣膜支承件102或锚定件108，并且一旦实现了所期望的长度，就可对该端部部分进行打结或以其它方式附连至瓣膜支承件102或锚定件108。在还有其它实施例中，细长柔性构件106可以是不可调节的并且具有预先确定的长度。例如，细长柔性构件106的预先确定的长度可在设备植入手术程序之前基于患者的解剖结构来确定。在某些实施例中，细长柔性构件106可各自具有2-8cm的长度。在其它实施例中，根据患者的解剖结构和/或根据细长柔性构件106是否为可调节的，细长柔性构件106可短于2cm或长于8cm。
如图1B所示，锚定件108可由框架118和框架118上的不可渗透材料120制成。在所示实施例中，不可渗透材料120在框架118的内部部分上。然而，在另外的实施例中，不可渗透材料120可附连至框架118的外部或与框架118成一体。在其它实施例中，框架118本身可以是不可渗透的，和/或不可渗透材料120可省去。框架118可以是半刚性又弹性或柔性的结构，诸如篮子、笼子、垫或由编织的材料、纺织的材料、连结件制成的其它结构，和/或其它半刚性结构，其可维持大致凸出或杯状的形状，同时也是足够柔性的，以在动态心脏循环期间顺应心脏H的心尖部101。例如，框架118可由可自扩张的材料(例如，镍钛诺)、碳和钛合金(例如，Ti-6AL-4V)、不锈钢、碳纤维和/或其它合适的刚性的、可生物相容的塑料或金属材料制成。不可渗透材料120可由柔性的、基本上无孔的材料制成，诸如聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、聚丙烯、聚酯、其它移植材料、组织(例如，合成的或动物心包组织)和/或聚酯。
当扩张时，锚定件108具有凹入的内表面区域，该区域绕心脏H的心尖部101弯曲并且大致顺应于该心脏H的心尖部101。在各种实施例中，锚定件108可通过围绕心尖部101的外表面缠绕来将其自身固定至心脏H，从而经由自扩张而附连至心脏H的心尖部101。在其它实施例中，锚定件108可经由缝线和/或将锚定件108连结至心脏H的其它合适的紧固件而附连至心脏H的心尖部101。
当固定就位时，锚定件108和到瓣膜支承件102的带系绳的连接部抵抗在心室收缩期间施加到瓣膜支承件102的逆行力。这避免了瓣膜支承件102的逆行运动，以维持瓣膜支承件102在二尖瓣MV内的期望位置。因为锚定件108使瓣膜支承件102稳定，并且抵抗在心脏收缩期间施加到支承件102的力，瓣膜支承件102本身不必包括将本身作为假体心脏瓣膜设备而固定至天然瓣环A会需要的相同水平的固定结构和机构，该假体心脏瓣膜设备不包括细长柔性构件106和锚定件108。例如，瓣膜支承件102可具有相对小的固定面积，其接触天然组织(例如，在瓣环A处)，并且因此有助于使用更小的递送导管。在某些实施例中，例如，瓣膜支承件102的近侧部分或上部部分不在天然瓣环之上延伸。
在心脏收缩期间施加在瓣膜支承件102上并且由细长柔性构件106传递至锚定件108的力可在锚定件108的表面区域上扩散。这被期望比起细长柔性构件106附连至靠近心脏壁105中的开口103的在心脏H的心尖部101中单独的点处的更小的紧固件所施加到锚定件108和心脏壁105的相对区域的反作用力更小。在某些实施例中，例如，锚定件108的内表面积(即，面向心脏壁105的心尖部101的表面积)可比细长柔性构件106延伸通过的心脏壁106的开口103的面积大若干倍。例如，心脏壁105中的开口103可以是18弗伦奇(Fr，French)(直径为6mm)，而锚定件108可具有与患者的心脏的尖端的直径对应的直径(例如，内直径或其它横截面尺寸)，而患者的心脏的尖端直径可以范围是从约10mm至100mm。由此，锚定件108的内表面积可以是比开口103大两倍、三倍、十倍、二十倍、三十倍或更多倍。锚定件108尺寸和形状被设计为顺应心脏H的尖端的三维曲率，使得锚定件108提供足够的表面积，以分布由细长柔性构件106施加于锚定件108的应力。因此，锚定件108可限制施加于心尖区域101和心室的应力的程度，并且避免对心脏壁105的相对的组织的损坏。
锚定件108还可用作为密封机构，其密封在心脏壁105之间的、为细长柔性构件106所延伸通过的开口103。当设备100经心尖植入时，开口103必须在心尖区域101中形成，以将设备100递送到二尖瓣MV。由此，锚定件108可以是通常用于闭合在经心尖的植入手术程序期间形成的开口的荷包线缝线或其它闭合机构的替代方式。在其它实施例中，心尖区域101中的开口103可以缝合或以其它方式闭合，并且锚定件108可覆盖闭合的开口103。
此外，锚定件108的大型篮状结构支承心脏的心尖区域101，并且因此抑制左心室LV的扩张。经历二尖瓣置换的患者经常具有进行性心脏疾病，其通常使心脏的左心室LV扩张(例如，变大和/或边长)，并且使二尖瓣MV扩张，使得天然小叶不再合紧。通过围绕心脏H的心尖部101缠绕并且为半刚性的，锚定件108也将心尖部101支承于其当前的状态中，以减小进一步扩张的可能性并且维持心室结构。在其它实施例中，锚定件108被构造为围绕心尖部101收缩，以限制扩张并且潜在地减小左心室LV的尺寸。
图2A-图2C是示出根据本技术的一个实施例的、图1A和图1B示出的设备100经心尖植入手术程序的各阶段的侧视图。设备100可使用递送导管230而展开，该递送导管可由操作者使用在患者体外的、在递送导管230的远侧部分(未示出)处的控制设备(例如，手柄；未示出)来进行控制。在经心尖递送期间，设备100在递送导管230的远侧部分232内被压缩到低轮廓递送状态，并且递送导管230的远侧部分232被插入通过开口103而进入左心室LV中。如图2A所示，一旦递送导管230的远端处于靠近二尖瓣MV的瓣环A的目标部位处，瓣膜支承件102就被从递送导管230的远侧部分232释放并且扩张到扩展状态，使得瓣膜支承件102接触天然瓣环A和/或周围组织。瓣膜支承件102可自扩张到扩展状态或可使用囊体导管和/或其它类型的扩张装置来进行扩张。
在瓣膜支承件102于二尖瓣MV处固定就位之后，递送导管230沿近侧方向缩回(即，朝向操作者，沿离开二尖瓣MV的心室方向)。如图2B所示，在递送导管230被取回时，细长柔性构件106从递送导管230的远侧部分232展开并且穿过在心脏壁105中的开口103。
在离开开口103时，锚定件108被从递送导管释放，并且围绕心脏的心尖部101扩张。在各种实施例中，锚定件108可围绕外心脏壁105自扩张，以附连至心脏的心尖部101。在其它实施例中，锚定件108可缝合或以其它方式附连至外心脏壁105。在锚定件108是不可渗透的实施例中，锚定件108也可密封心脏壁105中的开口103(图2A和图2B)，设备100通过该开口103被递送至二尖瓣MV。在其它实施例中，在锚定件108的展开之前或之后，开口103可缝合或以其它方式闭合。在细长柔性构件106在长度方面是可调节的实施例中，如果需要，在锚定件108展开时和/或锚定件108已展开之后，对柔性构件106的长度进行调节，使得柔性构件106具有在瓣膜支承件102与锚定件108之间所期望的绷紧。在展开之后，锚定件108通过对抗在心脏收缩期间施加于瓣膜支承件102的力来抑制瓣膜支承件102的逆行运动或其它迁移。期望有大型的杯状锚定件108，以相较于单点系绳连接在相对较大的表面积上分散由细长支承构件106施加到锚定件108的力，由此减小施加到心脏壁105的单位面积的力。此外，适形的杯状锚定件108也可支持心脏的心尖部101，以如上所述地稳定和抑制心室扩张。
图3A-图3C是示出根据本技术的一个实施例的、图1A和图1B示出的设备100的经中隔植入手术程序的各阶段的侧视图。类似于上文中参照图2A-图2C所讨论的经心尖递送手术程序，设备100可经心尖从递送导管330的远侧部分332展开，这使用在递送导管330的近侧部分(未示出)(患者体外)的控制设备(例如，手柄；未示出)来进行控制。然而，与经心尖递送手术程序不同，经中隔递送可在血管中执行，并且设备100的展开通常以与在经心尖手术程序期间的展开顺序大体相反的顺序发生。在该实施例中，递送导管330在血管中被递送至心脏的右心室(例如，经由主动脉或上静脉腔)。然后，在右心房与左心房之间的中隔壁309中形成中隔开口307，使得递送导管330的远侧部分可定位在左心房中。
如图3A所示，递送导管330的远侧部分332穿过二尖瓣MV，进入左心室LV中，并且通过形成于心脏壁105的心尖部101中的开口303。心脏壁105的心尖部101中的开口303和中隔开口307可使用各种孔形成装置(例如取心针)来形成，各种孔形成装置联接至递送导管330和/或是在递送导管330的远侧部分332之前前进的单独的装置。一旦递送导管330的远侧部分332定位在心脏壁105的外部处，锚定件108就可自扩张或以其它方式从远侧部分332围绕心脏的心尖部101的外壁展开。在该实施例中，开口303可小于用于经心尖展开的开口103(图2A-图2C)，因为仅锚定件108需要穿过开口303而展开，而不是瓣膜支承件102和瓣膜104，瓣膜支承件102和瓣膜104会具有比锚定件108更大的横截面尺寸。展开的锚定件108可密封形成用于展开锚定件108的开口303，或者在通过开口303缩回递送导管330时，开口330可被缝合或以其它方式闭合。
在递送装置330通过开口303缩回而进入左心室LV中时，细长柔性构件106可从导管330释放(图3B)。在靠近二尖瓣MV的目标部位处，瓣膜支承件102从递送导管330的远侧部分332展开，并且扩张到扩张状态或展开状态，使得瓣膜支承件102被放置成与天然瓣环A和/或二尖瓣MV的周围组织并置(图3C)。在某些实施例中，可调节细长柔性构件106，以提供锚定件108与瓣膜支承件102之间期望的张紧程度，使得锚定件108在心脏收缩期间可抑制瓣膜支承件102的逆行运动。在设备100完全展开之后，递送导管330可缩回而进入左心房LA中并且通过开口307返回，在将递送装置330从人体中取回之前，该开口303可被缝合或以其它方式闭合。
附加示例
1.一种用于植入在心脏的天然二尖瓣中的心脏瓣膜设备，所述心脏瓣膜设备包括：
用于承载假体瓣膜的瓣膜支承件，其中，所述瓣膜支承件构造为植入在天然二尖瓣的瓣环处；
至少一个细长柔性构件，所述至少一个细长柔性构件沿心室方向从所述瓣膜支承件延伸；以及
经由所述细长柔性构件联接至所述瓣膜支承件的锚定件，其中，所述锚定件成形为围绕所述心脏的心尖部的外部区域缠绕，并且其中所述锚定件构造为抑制所述瓣膜支承件的逆行迁移。
2.如示例1所述的心脏瓣膜设备，其中：
所述细长柔性构件构造为延伸通过心脏的心尖部中的开口，以连接至所述锚定件；以及
所述锚定件包括构造为覆盖和密封在心脏的所述心尖部中的开口。
3.如示例1或2所述的心脏瓣膜设备，其中，所述细长柔性构件包括第一细长柔性构件和第二细长柔性构件，并且其中所述第一细长柔性构件连接至所述锚定件的第一区域，而所述第二细长柔性构件连接至所述锚定件间隔开的第二区域，所述第一区域与所述第二区域间隔开。
4.如示例1-3中任一项所述的心脏瓣膜设备，其中，所述细长柔性构件是系绳，该系绳限制在所述瓣膜支承件与所述锚定件之间的运动。
5.如示例1-4中任一项所述的心脏瓣膜设备，其中，所述锚定件包括半刚性框架和在所述框架上的不可渗透的材料。
6.如示例1-5中任一项所述的心脏瓣膜设备，其中，所述锚定件包括具有适形的凹入形状的可自扩张框架，所述锚定件构造为自扩张，以附连至心脏的心尖部。
7.如示例1-6中任一项所述的心脏瓣膜设备，其中，所述锚定件尺寸和形状被设计为围绕心脏的心尖部收缩，以使左心室扩张减轻。
8.如示例1-7中任一项所述的心脏瓣膜设备，其中，所述锚定件包括构造为顺应于心脏的心尖部的网篮。
9.如示例1-8中任一项所述的心脏瓣膜设备，其中：
所述瓣膜支承件包括框架部分，所述框架部分支承假体瓣膜；以及
所述细长柔性构件连接至所述框架部分。
10.如示例1-8中任一项所述的心脏瓣膜设备，其中：
所述瓣膜支承件包括框架部分，所述框架部分支承假体瓣膜；
所述假体瓣膜包括多个小叶；以及
所述细长柔性构件连接至所述假体瓣膜的所述小叶中的一个。
11.如示例1-10中任一项所述的心脏瓣膜设备，其中，所述细长柔性构件在长度方面是能调节的。
12.如示例1所述的心脏瓣膜设备，其中：
所述瓣膜支承件包括框架部分；
所述细长柔性构件是多个细长柔性构件中的一个，所述多个细长柔性构件在围绕所述框架部分的周缘间隔开的多个连接部位处连接到所述框架部分；
所述多个细长柔性构件尺寸被设计为从所述框架部分延伸通过心脏的心尖部中的开口，以连接至所述锚定件；以及
所述锚定件包括可自扩张的材料，所述可自扩张的材料具有对应于心脏的心尖部的凹入形状，并且构造为覆盖和密封在心脏的所述心尖部中的开口。
13.一种用于植入在心脏的天然瓣膜中的心脏瓣膜设备，所述心脏瓣膜设备包括：
构造为支承假体瓣膜的瓣膜支承件；
锚定件，所述锚定件具有构造为附连至且顺应于所述天然瓣膜下游的心脏的外部部分的表面区域；以及
将所述瓣膜支承件连接至所述锚定件的多个细长柔性构件。
14.如示例13所述的心脏瓣膜设备，其中：
所述瓣膜支承件尺寸和形状被设计为植入在天然二尖瓣的天然瓣环中；以及
所述锚定件被构造为附连至靠近心脏的左心室的心脏的心尖部。
15.如示例13或14所述的心脏瓣膜设备，其中，所述锚定件包括可自扩张的材料，并且其中所述锚定件自扩张到凸出的形状。
16.如示例13-15中任一项所述的心脏瓣膜设备，其中，所述细长柔性构件是柔性的线，其连接在所述瓣膜支承件与所述锚定件之间。
17.如示例13-16中任一项所述的心脏瓣膜设备，其中，所述锚定件包括构造为抓握心脏的心尖部的、具有杯状形状的编织篮。
18.一种用于植入在心脏的天然瓣膜中的心脏瓣膜设备，所述心脏瓣膜设备包括：
用于承载假体瓣膜的瓣膜支承件，其中，瓣环构造为植入在天然瓣膜的瓣环处；
锚定件，所述锚定件包括在扩张时具有凹入形状的网结构，其中，所述网结构构造为顺应于心脏的心尖区域的外部部分；以及
将所述瓣膜支承件连接至所述锚定件的至少一个细长柔性构件。
19.如示例18所述的心脏瓣膜设备，其中，所述网结构由镍钛诺制成。
20.一种用于植入在心脏的天然瓣膜中心脏瓣膜设备的方法，所述方法包括：
经由递送导管将所述心脏瓣膜设备递送至靠近天然瓣膜的天然瓣环的心脏的腔室处；
将瓣膜支承件从递送导管展开至抵靠所述天然瓣环而固定；
从所述递送导管展开至少一个细长柔性构件，其中，所述细长柔性构件连接至所述瓣膜支承件；
将所述细长柔性构件延伸通过心脏的在所述天然瓣膜下游的部分中的开口；以及
展开锚定件以围绕心脏在所述天然瓣膜下游的外部部分而顺应，其中，所述锚定件构造为密封在心脏中的所述开口，并且抑制所述瓣膜支承件的逆行迁移。
21.如示例20所述的方法，其中，展开瓣膜支承件包括将所述瓣膜支承件固定至所述天然瓣环，使得所述瓣膜支承件的上部不在所述天然瓣环之上延伸。
22.如示例20或21所述的方法，其中，展开锚定件包括允许所述锚定件自扩张到顺应于心脏的外心尖部的凹入形状。
23.如示例20-22中任一项所述的方法，其中：
将所述心脏瓣膜设备递送至心脏的腔室包括将递送导管经心尖递送至心脏的左心室；
展开瓣膜支承件包括将所述瓣膜支承件抵靠心脏的二尖瓣的天然瓣环而固定；以及
将细长柔性构件延伸通过心脏中的开口包括将所述细长柔性构件延伸穿过在心脏的左心室中用于递送所述递送导管到左心室的同一开口。
24.如示例20-22中任一项所述的方法，其中：
将所述心脏瓣膜设备递送至心脏的腔室包括将递送导管经中隔递送至心脏的左心室；以及
展开锚定件在展开瓣膜支承件之前发生，从而沿上游方向取回所述递送导管，以使所述细长柔性构件露出并且展开所述瓣膜支承件。
25.如示例20-24中任一项所述的方法，还包括调节细长柔性构件的长度，使得细长柔性构件在所述瓣膜支承件与所述锚定件之间绷紧。
26.如示例20-25中任一项所述的方法，还包括用锚定件支承心脏的外部部分，以抑制外部部分在锚定件内的扩张。
27.一种用于在心脏的天然二尖瓣中植入心脏瓣膜设备的方法，所述方法包括：
将递送导管穿过心脏的中隔壁递送到心脏的腔室，其中，所述递送导管包含心脏瓣膜设备；
在心脏的心尖部中靠近心脏的左心室形成开口；
在所述天然二尖瓣的所述心尖部的外部部分处，从所述递送导管展开锚定件；
从所述递送导管展开至少一个细长柔性构件，其中，所述细长柔性构件从所述锚定件延伸通过心脏中的开口；以及
从所述递送导管展开瓣膜支承件进入到抵靠所述天然二尖瓣的天然瓣环而固定，其中，所述细长柔性构件在所述瓣膜支承件与所述锚定件之间延伸，并且所述锚定件构造为抑制所述瓣膜支承件的逆行迁移。
结论
本申请并不意在穷尽或限制本技术于本文所公开的确切形式。尽管本文中所公开的具体实施例是用于示意性的目的，但是各种等同的改型在不偏离本技术的情况下是可能的，如在相关领域中的普通技术人员将会认识到的。在一些情况下，未详细地示出和/或描述众所周知的结构和功能，以避免不必要地模糊对本技术的实施例的描述。尽管方法的各步骤可能在本文中以特定的顺序呈现，但是在替代的实施例中各步骤可具有另一合适的顺序。类似地，在具体实施例的内容中所公开的本技术的某些方面可组合在其它实施例中或被排除。此外，尽管在这些实施例的内容中描述了与某些实施例相关联的优点，但是其它实施例也可呈现这些优点，且不是所有的实施例都必需呈现这些优点或本文中所公开的其它优点才落入本技术的范围内。由此，本申请和所关联的技术可包含未在本文中明确示出和/或描述的其它实施例。
在本说明书中所使用的单数形式“一”“一个”和“该”包括复数形式，除非文中清楚地另有说明。类似的，除非单词“或者”明确地限定成仅仅意味单个术语，而非与一列两个或多个术语相关的其它术语，则在此种列表中使用“或者”应解释成包括(a)该列表中的任何单个术语，(b)该列表中的所有术语，或者(c)该列表中术语的任何组合。此外，术语“包括”等在整个本申请用于意味着至少包括所记载的(一个或多个)特征，而并不排除任何更多数量的相同的(一个或多个)特征和/或附加类型的一个或多个特征。方向术语，诸如“上”、“下”、“前”、“后”、“垂直”和“水平”可在本文中用于表示和阐明各种元件之间的关系。应理解的是这些术语不指示绝对的定向。在本文中对于“一个实施例”、“一实施例”或类似表述的参照意味着：结合实施例描述的具体特征、结构、操作或者特性可被包括在本技术的至少一个实施例中。因此，这些词组或表述在本文中的出现并不一定都参照同一实施例。另外，各种特定的特征、结构、操作或特性可以任何合适的方式组合在一个或多个实例中。

Claims (18)

1.一种用于植入在心脏的天然二尖瓣中的心脏瓣膜设备，所述心脏瓣膜设备包括：
用于承载假体瓣膜的瓣膜支承件，所述假体瓣膜具有多个小叶，其中，所述瓣膜支承件包括框架部分，所述框架部分支承所述假体瓣膜，以及其中，所述瓣膜支承件构造为植入在天然二尖瓣的瓣环处；
至少一个细长柔性构件，所述至少一个细长柔性构件沿心室方向从所述瓣膜支承件延伸，其中，所述细长柔性构件连接至所述假体瓣膜的所述小叶中的一个，且所述细长柔性构件的一端被抽拉过所述小叶；以及
经由所述细长柔性构件联接至所述瓣膜支承件的锚定件，其中，所述锚定件成形为围绕心脏的心尖部的外部区域而缠绕，并且其中所述锚定件构造为抑制所述瓣膜支承件的逆行迁移。
2.如权利要求1所述的心脏瓣膜设备，其特征在于，
所述细长柔性构件构造为延伸通过所述心脏的所述心尖部中的开口，以连接至所述锚定件；以及
所述锚定件包括构造为覆盖和密封在所述心脏的所述心尖部中的开口。
3.如权利要求1或2所述的心脏瓣膜设备，其特征在于，所述细长柔性构件包括第一细长柔性构件和第二细长柔性构件，并且其中所述第一细长柔性构件连接至所述锚定件的第一区域，而所述第二细长柔性构件连接至所述锚定件的间隔开的第二区域，所述第一区域与所述第二区域间隔开。
4.如权利要求1-3中任一项所述的心脏瓣膜设备，其特征在于，所述细长柔性构件是系绳，所述细长柔性构件限制所述瓣膜支承件与所述锚定件之间的运动。
5.如权利要求1-4中任一项所述的心脏瓣膜设备，其特征在于，所述锚定件包括半刚性框架和在所述框架上的不可渗透的材料。
6.如权利要求1-5中任一项所述的心脏瓣膜设备，其特征在于，所述锚定件包括具有适形的凹入形状的可自扩张框架，所述锚定件构造为自扩张以附连至所述心脏的所述心尖部。
7.如权利要求1-6中任一项所述的心脏瓣膜设备，其特征在于，所述锚定件尺寸和形状被设计为围绕所述心脏的所述心尖部收缩，以使左心室的扩张减轻。
8.如权利要求1-7中任一项所述的心脏瓣膜设备，其特征在于，所述锚定件包括构造为顺应于所述心脏的所述心尖部的网篮。
9.如权利要求1-8中任一项所述的心脏瓣膜设备，其特征在于，
所述瓣膜支承件包括框架部分，所述框架部分支承所述假体瓣膜；以及
所述细长柔性构件连接至所述框架部分。
10.如权利要求1-9中任一项所述的心脏瓣膜设备，其特征在于，所述细长柔性构件在长度方面是能调节的。
11.如权利要求1所述的心脏瓣膜设备，其特征在于，
所述瓣膜支承件包括框架部分；
所述细长柔性构件是多个细长柔性构件中的一个，所述多个细长柔性构件在围绕所述框架部分的周缘间隔开的多个连接部位处连接到所述框架部分；
所述多个细长柔性构件尺寸被设计为从所述框架部分延伸通过心脏的心尖部中的开口，以连接至所述锚定件；以及
所述锚定件包括可自扩张的材料，所述可自扩张的材料具有对应于所述心脏的所述心尖部的凹入形状并且构造为覆盖和密封在所述心脏的所述心尖部中的开口。
12.一种用于植入在心脏的天然瓣膜中的心脏瓣膜设备，所述心脏瓣膜设备包括：
构造为支承假体瓣膜的瓣膜支承件，所述瓣膜支承件包括框架部分，所述假体瓣膜具有多个小叶；
锚定件，所述锚定件具有构造为附连至且顺应于所述天然瓣膜下游的所述心脏的外部部分的表面区域；以及
将所述瓣膜支承件连接至所述锚定件的多个细长柔性构件，其中所述细长柔性构件连接于所述假体瓣膜的所述小叶，且所述细长柔性构件的一端被抽拉过所述小叶。
13.如权利要求12所述的心脏瓣膜设备，其特征在于，
所述瓣膜支承件尺寸和形状被设计为供植入在天然二尖瓣的天然瓣环中；以及
所述锚定件构造为附连至靠近所述心脏的左心室的所述心脏的所述心尖部。
14.如权利要求12或13所述的心脏瓣膜设备，其特征在于，所述锚定件包括可自扩张的材料，并且其中所述锚定件自扩张到凸出的形状。
15.如权利要求12-14中任一项所述的心脏瓣膜设备，其特征在于，所述细长柔性构件是连接在所述瓣膜支承件与所述锚定件之间的柔性线。
16.如权利要求12-15中任一项所述的心脏瓣膜设备，其特征在于，所述锚定件包括构造为抓握心脏的心尖部的、具有杯状形状的编织篮。
17.一种用于植入在心脏的天然瓣膜中的心脏瓣膜设备，所述心脏瓣膜设备包括：
用于承载假体瓣膜的瓣膜支承件，所述瓣膜支承件包括框架部分，所述假体瓣膜具有多个小叶，其中，所述瓣环构造为植入在天然瓣膜的瓣环处；
锚定件，所述锚定件包括在扩张时具有凹入形状的网结构，其中，所述网结构构造为顺应于所述心脏的心尖区域的外部部分；以及
将所述瓣膜支承件连接至所述锚定件的至少一个细长柔性构件，其中所述细长柔性构件连接到所述假体瓣膜的至少一个所述小叶，且所述细长柔性构件的一端被抽拉过所述小叶。
18.如权利要求17所述的心脏瓣膜设备，其特征在于，所述网结构由镍钛诺制成。
CN202310355685.0A 2016-04-29 2017-04-18 具有带系绳的锚定件的假体心脏瓣膜设备以及相关联的系统和方法 Pending CN116172753A (zh)

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US20210267760A1 (en) 2021-09-02
US11033390B2 (en) 2021-06-15

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