CN110891525A - 人工心脏瓣膜装置 - Google Patents

人工心脏瓣膜装置 Download PDF

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CN110891525A
CN110891525A CN201880045252.2A CN201880045252A CN110891525A CN 110891525 A CN110891525 A CN 110891525A CN 201880045252 A CN201880045252 A CN 201880045252A CN 110891525 A CN110891525 A CN 110891525A
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valve
inner core
extension member
prosthetic heart
recesses
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CN110891525B (zh
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R·弗朗西斯
S·罗伯特森
M·拉利
K·米亚西洛
J·凯欧
A·希尔
P·弗里斯比
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Twelve 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
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    • 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
    • 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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    • 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
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
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    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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Abstract

本发明技术是一种用于治疗具有天然环和天然小叶的人心脏的天然瓣膜的人工心脏瓣膜装置以及相关系统和方法。一个实施例包括瓣膜支撑件、所述瓣膜支撑件内的人工瓣膜组合件以及具有上游部分和下游部分的锚固构件。所述装置进一步包含联接到固定框架并从所述固定框架径向向外延伸的延伸构件。所述延伸构件包含多条金属丝，所述多条金属丝的至少一部分包含由外部材料包围的内芯。所述金属丝包含多个延伸穿过所述外部材料的厚度的至少一部分的凹部以及所述凹部中用于在所述人工心脏瓣膜装置定位在天然环处时递送到解剖结构的治疗剂。

Description

人工心脏瓣膜装置
相关申请的交叉引用
本申请要求于2017年7月6日提交的美国临时申请第15/642,834号的优先权，所述美国临时申请通过引用并入本文。
本申请结合了以下文献的主题：(1)于2014年3月14日提交的国际专利申请第PCT/US2014/029549号；(2)于2012年10月19日提交的国际专利申请第PCT/US2012/061219号；(3)于2012年10月19日提交的国际专利申请第PCT/US2012/061215号；以及(4)于2012年6月21日提交的国际专利申请第PCT/US2012/043636号。本申请还结合了于2017年4月18日提交的美国申请第15/490,047号和与本申请同时提交的美国申请第15/643,011号(代理人案卷号：C00013493.USU2)的主题。
技术领域
本发明的技术总体上涉及人工心脏瓣膜装置。具体地，多个实施例涉及用于天然二尖瓣的经皮修复和/或置换的人工二尖瓣和装置以及相关系统和方法。
背景技术
心脏瓣膜可能受多种条件的影响。例如，二尖瓣可能受二尖瓣返流、二尖瓣脱垂和二尖瓣狭窄的影响。二尖瓣返流是由二尖瓣的小叶未能在峰值收缩压力下并置接合的心脏病状引起的血液从左心室异常泄漏到左心房中。二尖瓣小叶可能由于心脏疾病通常引起心肌扩张而无法充分接合，这进而扩大天然二尖瓣环，达到小叶在心缩期期间不会接合的程度。当乳突肌由于缺血或其它病症而功能受损时，也可能发生异常回流。更具体地说，因为左心室在心缩期期间收缩，所以受影响的乳突肌不会充分收缩以实现小叶的适当闭合。
二尖瓣脱垂是二尖瓣小叶异常向上凸出到左心房中时的病症。这可能引起二尖瓣的不规则行为并且导致二尖瓣反流。小叶可能脱垂并且无法接合，因为将乳突肌连接到二尖瓣小叶的下侧的肌腱(腱索)可能撕裂或拉伸。二尖瓣狭窄是阻止在心舒期填充左心室的二尖瓣口狭窄。
二尖瓣返流通常使用利尿剂和/或血管舒张剂减少回流到左心房中的血液量来进行治疗。还已经使用用于修复或置换瓣膜的手术入路(开腹和血管内)治疗二尖瓣返流。例如，典型的修复技术涉及缩小或切除经扩张环的部分。缩小例如包含植入通常固定到环或周围组织的环形或接近环形的环。其它修复手术将瓣膜小叶缝合或夹紧为彼此并置。
可替代地，更多有创手术通过将机械瓣膜或生物组织植入到心脏中以代替天然二尖瓣从而置换整个瓣膜本身。这些有创手术通常需要很大程度的开胸手术，并且因此非常痛苦、发病率高且需要很长的恢复期。此外，在许多修复和置换手术中，装置的耐用性或瓣环成形术环或置换瓣膜的不当尺寸可能给患者带来另外的问题。修复手术还需要技艺精湛的心脏外科医生，因为缝线的不当或不准确放置可能影响手术的成功。
近年来，已经实施了创伤性较小的主动脉瓣置换方法。经预组装的经皮人工瓣膜的实例包含例如来自美敦力公司(Medtronic/Corevalve Inc.)(美国加利福尼亚州尔湾市)的CoreValve
Figure BDA0002356734720000021
系统和来自爱德华生命科学公司(Edwards Lifesciences)(美国加利福尼亚州尔湾市)的Edwards-
Figure BDA0002356734720000022
瓣膜。两种瓣膜系统均包含可膨胀框架和附接到可膨胀框架的三小叶生物人工瓣膜。主动脉瓣是基本上对称的、圆形的并且具有肌肉环。主动脉应用中的可膨胀框架在主动脉瓣环处具有对称的圆形形状以便与天然解剖结构相匹配，而且因为三小叶人工瓣膜需要圆对称以实现人工小叶的适当接合。因此，主动脉瓣解剖结构适合于容纳置换瓣膜的可膨胀框架，因为主动脉瓣解剖结构基本上均匀、对称且相当强健。然而，其它心脏瓣膜解剖结构不均匀、不对称或不够强健，并且因此，经血管主动脉瓣置换装置可能不太适用于其它类型的心脏瓣膜。
尽管心脏右侧的三尖瓣通常具有三个小叶，但其对创伤性较小的治疗也提出了与二尖瓣类似的挑战。因此，也需要一种更好的假体来治疗三尖瓣疾病。
鉴于与当前手术相关的困难，仍然需要简单、有效且创伤性较小的装置和方法来治疗功能失调的心脏瓣膜。
附图说明
参考以下附图可以更好地理解本公开的许多方面。附图中的组件不一定按比例绘制，而是着重于清楚地展示本公开的原理。此外，可以在某些视图中仅出于说明目的将组件示出为透明的，而不指示所展示的组件必须是透明的。为了便于参考，在整个本公开中，使用相同的附图标记和/或字母来标识相似或类似的组件或特征，但使用相同的附图标记并不意味着所述部件应被解释为相同。实际上，在本文所描述的许多实例中，附图标记相同的组件是指在结构和/或功能上有差异的不同实施例。本文所提供的标题仅仅是为了方便起见。
图1是心脏的示意性横截面图，其示出了根据本发明技术的各个实施例的从静脉脉管系统到天然二尖瓣的顺行入路。
图2是心脏的示意性横截面图，其示出了根据本发明技术的各个实施例的通过在导丝之上放置导引导管来维持的穿过房间隔(IAS)的通路。
图3和4是心脏的示意性横截面图，其示出了根据本发明技术的各个实施例的穿过主动脉瓣和动脉脉管系统到天然二尖瓣的逆行入路。
图5是心脏的示意性横截面图，其示出了根据本发明技术的各个实施例的使用经心尖扎孔到天然二尖瓣的入路。
图6A是示意性地展示了根据本发明技术的实施例的人工心脏瓣膜装置的横截面侧视图，并且图6B是示意性地展示了所述人工心脏瓣膜装置的俯视图。
图7A是根据本发明技术的实施例的人工心脏瓣膜装置的俯视等距视图。
图7B是图7A所示出的人工心脏瓣膜装置的支撑构件的线的放大视图。
图7C是沿线7C-7C截取的图7A所示出的线的横截面视图。
图8A是根据本发明技术的实施例配置的处于展开配置的人工心脏瓣膜装置的示意性俯视图。
图8B是根据本发明技术的实施例配置的定位在递送导管内的处于递送配置的图8A的人工心脏瓣膜装置的示意性端视图。
图8C-8E是根据本发明技术的实施例的图8A和8B所示出的处于展开期间的人工心脏瓣膜装置的一部分的横截面侧视图。
图9A和9B是分别被示出为处于重叠配置和延伸配置的图8A的人工心脏瓣膜装置的延伸构件的三个分离片段的端视图。
图9C和9D是分别被示出为处于重叠配置和延伸配置的人工心脏瓣膜装置的延伸构件的三个分离片段的端视图。
图9E和9F是分别被示出为处于重叠配置和延伸配置的人工心脏瓣膜装置的延伸构件的三个分离片段的端视图。
图10是根据本发明技术的另一实施例的人工心脏瓣膜装置的示意性等距视图。
具体实施方式
下文参照图1-10描述了本发明技术的多个实施例的具体细节。尽管下文关于用于天然二尖瓣的经皮置换的人工瓣膜装置、系统和方法描述了所述实施例中的许多实施例，但是除了本文所描述的应用和实施例之外的其它应用和其它实施例也处于本发明技术的范围内。此外，本发明技术的多个其它实施例的配置、组件和程序可以不同于本文描述的配置、组件或程序。因此，本领域的普通技术人员因而应理解，本发明技术可以包括具有另外元件的其它实施例，或者本发明技术可以包括不具有下文参照图1-10示出和描述的特征中的多个特征的其它实施例。
关于本说明书内的术语“远侧”和“近侧”，除非另有说明，否则所述术语可以指人工瓣膜装置和/或相关递送装置的部分关于操作者和/或脉管系统或心脏中的位置的相对位置。例如，在提到适于递送和定位本文所描述的各种人工瓣膜装置的递送导管时，“近侧”可以指较靠近装置的操作者或脉管系统中的切口的位置，而“远侧”可以指离装置的操作者更远或沿脉管系统离切口更远的位置(例如，导管的端部)。关于人工心脏瓣膜装置，术语“近侧”和“远侧”可以指装置的部分相对于血流方向的位置。例如，近侧可以指上游位置或血液流到装置中的位置(例如，流入区域)，而远侧可以指下游位置或血液从装置中流出的位置(例如，流出区域)。
概述
本发明技术的多个实施例涉及解决了经皮置换天然二尖瓣的独特挑战并且非常适用于向解剖结构递送治疗剂的二尖瓣置换装置。与置换主动脉瓣相比，经皮二尖瓣置换面临独特的解剖学障碍，所述解剖学障碍使经皮二尖瓣置换明显比主动脉瓣置换更具挑战性。首先，与相对对称且均匀的主动脉瓣不同，二尖瓣环具有非圆形的D形形状或肾脏样形状，具有通常缺乏对称性的非平面鞍状几何结构。二尖瓣的复杂且高度可变的解剖结构使得难以设计非常适形于特定患者的天然二尖瓣环的二尖瓣假体。因此，假体可能不太适合天然小叶和/或环，这可能留下使血液回流发生的间隙。例如，在天然二尖瓣中放置圆柱形瓣膜假体可能在天然瓣膜的连合区域中留下间隙，可能通过所述间隙发生瓣周漏。
目前开发的用于经皮主动脉瓣置换的人工瓣膜不适合在二尖瓣中使用。首先，这些装置中的许多装置需要在与环和/或小叶接触的支架状结构与人工瓣膜之间建立直接结构连接。在多个装置中，支撑人工瓣膜的支架柱也与环或其它周围组织接触。这些类型的装置将组织和血液在心脏收缩时施加的力直接传递到瓣膜支撑件和人工小叶，所述力进而使瓣膜支撑件从其期望的圆柱形状扭曲。这是一个值得关注的问题，因为大多数心脏置换装置使用三小叶瓣膜，所述三小叶瓣膜需要在人工瓣膜周围存在基本上对称的圆柱形支撑件，以使所述三个小叶在数年寿命内正常开启和闭合。因此，当这些装置经历移动或来自环和其它周围组织的力时，假体可能压缩和/或扭曲，从而使假体小叶发生故障。此外，病变的二尖瓣环比任何可获得的人工主动脉瓣大得多。随着瓣膜尺寸增加，瓣膜小叶上的力显著增加，因此简单地将主动脉假体的大小增加到经扩张的二尖瓣环的大小将需要显著更厚、更高的小叶，并且可能不可行。
除了具有在每次心跳的过程中改变大小的不规则的复杂形状之外，二尖瓣环还缺乏来自周围组织的显著量的径向支撑。与被提供充分支撑以锚固假体瓣膜的纤维弹性组织完全包围的主动脉瓣相比，二尖瓣仅仅受外壁上的肌肉组织约束。二尖瓣解剖结构的内壁受将二尖瓣环与主动脉瓣流出道的下部部分离的薄血管壁约束。因此，二尖瓣环上的显著径向力(如通过支架假体膨胀赋予的径向力)可能导致主动脉道的下部部分塌陷。此外，较大的假体会施加较大的力并膨胀到较大的尺寸，这加剧了二尖瓣置换应用的这种问题。
在展开二尖瓣假体时，左心室的腱索也可能产生障碍。与主动脉瓣不同，二尖瓣在左心室中的小叶下具有绳索迷宫(maze of cordage)，所述绳索迷宫在植入期间限制展开导管和置换装置的移动和位置。因此，在天然二尖瓣环的心室侧展开、定位和锚固瓣膜置换装置很复杂。
本发明技术的实施例提供了用于治疗身体的心脏瓣膜(如二尖瓣)的系统、方法和设备，所述系统、方法和设备解决了与二尖瓣的解剖结构相关的挑战并提供向局部解剖结构递送治疗剂。所述设备和方法使用血管内递送穿过静脉或动脉进入心脏的导管或通过插入穿过心脏壁的插管实现经皮入路。例如，所述设备和方法特别适合于经隔膜入路，而且可以是人工置换瓣膜到心脏中的目标位置的经心尖、经心房且直接的主动脉递送方式。此外，本文所描述的装置和方法的实施例可以与许多已知的外科手术和手术(如通过顺行入路或逆行入路和其组合接近心脏的瓣膜(例如，二尖瓣或三尖瓣)的已知方法)组合。
到二尖瓣的通路
为了更好地理解根据本发明技术的瓣膜置换装置的结构和操作，首先理解用于植入所述装置的入路是有帮助的。可以以经皮方式通过患者的脉管系统接近二尖瓣或其它类型的房室瓣。经皮意味着通过皮肤，通常使用外科切割手术或微创手术(如使用通过例如塞尔丁格技术(Seldinger technique)的针接近)接近脉管系统的远离心脏的位置。经皮接近远端脉管系统的能力是众所周知的并且在专利和医学文献中进行了描述。根据血管接近点，到二尖瓣的通路可以是顺行的并且可以依赖于通过穿过房间隔(例如，经隔膜入路)进入左心房。可替代地，到二尖瓣的通路可以是逆行的，其中通过主动脉瓣进入左心室。还可以使用插管通过经心尖入路实现到二尖瓣的通路。根据入路，介入工具和一个或多个支撑导管可以在血管内前进到心脏并以各种方式定位在目标心脏瓣膜附近，如本文所描述的。
图1示出了用于植入瓣膜置换装置的经隔膜入路的一个阶段。在经隔膜入路中，通路为经由下腔静脉IVC或上腔静脉SVC，穿过右心房RA，跨房间隔IAS并进入二尖瓣MV上方的左心房LA。如图1所示出，具有针2的导管1从下腔静脉IVC移动到右心房RA中。一旦导管1到达房间隔IAS的前侧，针2就前进，使得其例如在卵圆窝FO或卵圆孔处穿透隔膜并进入左心房LA。此时，导丝替代针2，并且抽出导管1。
图2展示了经隔膜入路的随后阶段，在所述阶段中，导丝6和导引导管4穿过房间隔IAS。导引导管4提供到二尖瓣的通路以植入根据本发明技术的瓣膜置换装置。
在可替代的顺行入路(未示出)中，可以通过肋间切口(优选地不移除肋骨)获得外科手术通路，并且可以在左心房壁中形成小扎孔或切口。导引导管穿过此扎孔或切口直接进入通过荷包缝合(purse string-suture)密封的左心房。
如上所述，到二尖瓣的顺行入路或经隔膜入路在许多方面是有利的。例如，顺行入路通常将实现导引导管和/或人工瓣膜装置的更精确且有效的置中和稳定。顺行入路还可以降低导管或其它介入工具损坏腱索或其它瓣膜下结构的风险。此外，顺行入路可以降低与逆行入路中穿过主动脉瓣相关的风险。这可能与具有人工主动脉瓣的患者特别相关，根本无法或在不产生实质性损坏风险的情况下无法穿过人工主动脉瓣。
图3和4示出了接近二尖瓣的逆行入路的实例。可以从主动脉弓AA，跨主动脉瓣AV并进入二尖瓣MV下方的左心室LV实现到二尖瓣MV的通路。可以通过传统的股动脉接近路径或通过经由肱动脉、腋动脉、桡动脉或颈动脉的更直接的入路进入主动脉弓AA。可以通过使用导丝6实现此类通路。一旦就位，就可以在导丝6之上跟踪导引导管4。可替代地，可以通过胸部中的切口(优选地在不移除肋骨的情况下在肋骨间)并通过主动脉本身中的扎孔放置导引导管来得到外科手术入路。导引导管4提供随后通路以允许放置人工瓣膜装置，如本文更详细地描述的。有利地，逆行入路不需要经隔膜扎孔。心脏病专家也更普遍地使用逆行入路，并且因此逆行入路更为人熟知。
图5示出了经由经心尖扎孔的经心尖入路。在此入路中，到心脏的通路通过胸部切口(其可以是常规的开胸术或胸骨切开术)或较小的肋间或剑状下切口或扎孔实现。然后，通过左心室壁中的扎孔将接近插管放置在心脏的顶点处或附近。然后，可以通过此接近插管将本发明的导管和假体装置引入到左心室中。经心尖入路提供了更短、更直且更直接的到二尖瓣或主动脉瓣的路径。此外，由于经心尖入路不涉及血管内通路，所以其不需要介入心脏病学训练就可以执行其它经皮入路中所需的导管插入。
人工心脏瓣膜装置和方法的所选实施例
本发明技术的实施例可以治疗心脏的瓣膜中的一个或多个瓣膜，并且具体地，多个实施例有利地治疗二尖瓣。本发明技术的人工瓣膜装置还可以适于患者的心脏中的其它瓣膜(例如，双尖瓣或三尖瓣)的置换。这部分中参照图6A-10描述了根据本发明技术的实施例的人工心脏瓣膜装置的实例。参照图6A-10描述的实施例的具体元件、子结构、优点、用途和/或其它特征可以适当地交换、替换或以其它方式配置成彼此包含。此外，参照图6A-10描述的实施例的适当元件可以用作独立装置和/或自含式装置。
图6A是根据本发明技术的实施例的人工心脏瓣膜装置(“装置”)100的侧视横截面视图，并且图6B是所述人工心脏瓣膜装置的俯视平面视图。装置100包含瓣膜支撑件110、附接到瓣膜支撑件110的锚固构件120以及位于瓣膜支撑件110内的人工瓣膜组合件150。参照图6A，瓣膜支撑件110具有流入区域112和流出区域114。人工瓣膜组合件150布置在瓣膜支撑件110内，以允许血液从流入区域112流到流出区域114(箭头BF)，但阻止血液在流出区域114到流入区域112的方向上流动。
在图6A所示出的实施例中，锚固构件120包含附接到瓣膜支撑件110的流出区域114的基部122和从基部122侧向向外凸出的多个臂124。锚固构件120还包含从臂124延伸的固定结构130。固定结构130可以包含第一部分132和第二部分134。固定结构130的第一部分132例如可以是固定结构130的上游区域，在如图6A所示出的展开配置中，所述上游区域与瓣膜支撑件110的流入区域112侧向向外间隔开间隙G。固定结构130的第二部分134可以是固定结构130的最下游部分。固定结构130可以是圆柱形环(例如，直圆柱体或圆锥)，并且固定结构130的外表面可以限定被配置成向外按压抵靠天然环的环形接合表面。固定结构130可以进一步包含多个径向向外凸出并且朝上游方向倾斜的固定元件136。固定元件136例如可以是仅在上游方向(例如，延伸远离装置100的下游部分的方向)上倾斜的倒钩、钩或其它元件。
仍然参照图6A，锚固构件120在臂124与固定结构130之间具有光滑弯曲部140。例如，固定结构130的第二部分134在光滑弯曲部140处从臂124延伸。臂124和固定结构130可以由连续支柱或支撑元件整体形成，使得光滑弯曲部140为连续支柱的弯曲部分。在其它实施例中，光滑弯曲部140相对于臂124或固定结构130可以是单独组件。例如，可以使用焊接、粘合剂或形成光滑连接的其它技术将光滑弯管140附接到臂124和/或固定结构130。光滑弯曲部140被配置成使得在装置100已经至少部分的展开之后，可以将装置100重新捕获在胶囊或其它容器中。
装置100可以进一步可以包含瓣膜支撑件110上的第一密封构件162和锚固构件120上的第二密封构件164。第一密封构件162和第二密封构件164可以由柔性材料制成，如
Figure BDA0002356734720000101
或另一类型的聚合物材料。第一密封构件162可以覆盖瓣膜支撑件110的内表面和/或外表面。在图6A所展示的实施例中，第一密封构件162附接到瓣膜支撑件110的内表面，并且人工瓣膜组合件150附接到第一密封构件162和瓣膜支撑件110的连合部分。第二密封构件164附接到锚固构件120的内表面。因此，固定结构130的外部环形接合表面未被第二密封构件164覆盖，使得固定结构130的外部环形接合表面直接接触天然环的组织。
装置100可以进一步包含延伸构件170。延伸构件170可以是第二密封构件164的延伸部，或者其可以是附接到第二密封构件164和/或固定结构130的第一部分132的单独组件。延伸构件170可以是柔性构件，在如图6A所示出的展开状态下，所述柔性构件相对于固定结构130的第一部分132挠曲。在操作中，延伸构件170在植入期间引导装置100，使得装置定位在期望高度处并相对于天然环置中。如下所述，延伸构件170可以包含可以在植入期间可视化和/或被配置成递送治疗剂的支撑构件(如金属丝或其它结构)。
图7A是装置100的实例的俯视等距视图。在此实施例中，瓣膜支撑件110限定第一框架(例如，内框架)，并且锚固构件120的固定结构130限定第二框架(例如，外框架)，所述第一框架和第二框架各自包含多个结构元件。更具体地说，固定结构130包含被布置成菱形单元138的结构元件137，当所述结构元件如图7A所示那样自由且完全膨胀时，所述结构元件一起形成至少一个基本上圆柱形的环。结构元件137可以是支柱或由金属、聚合物或可以自膨胀或通过球囊或其它类型的机械膨胀器膨胀的其它适合的材料形成的其它结构特征。
固定结构130的多个实施例可以是具有面朝外的接合表面的总体上圆柱形的固定环。例如，在图7A所示出的实施例中，结构元件137的外表面限定被配置成在展开状态下向外按压抵靠天然环的环形接合表面。在不受任何限制的完全膨胀状态下，固定结构130与瓣膜支撑件110至少基本上平行。然而，在展开状态下，当固定结构130向外径向按压抵靠心脏瓣膜的天然环的内表面时，所述固定结构可以向内挠曲(箭头I)。
图7A所示出的装置100的实施例包含形成瓣膜支撑件110的内部表面的内衬的第一密封构件162和沿固定结构130的内表面的第二密封构件164。延伸构件170具有柔性网172(例如，织物)和包括附接到柔性网172的多条线180(例如，金属丝、支柱、电缆、条带、纤维等)的支撑构件174。柔性网172可以从第二密封构件164延伸，而无需在固定结构130与支撑构件174之间形成金属-金属连接。例如，延伸构件170可以是第二密封构件164的材料的延续。因此，延伸构件170的多个实施例是可以相对于固定结构130容易地挠曲的松软结构。
图7B是图7A所示出的支撑构件174的线180之一的一部分的放大视图，并且图7C是沿线7C-7C截取的图7B所示出的线180的横截面视图。一起参考图7B和7C，线180的至少一部分可以包含由具有厚度t的外部材料184包围的内芯186。外部材料184可以是第一材料，并且内芯186可以是不同于第一材料的第二材料。例如，在一些实施例中，线180的至少一部分是由至少两种不同材料形成的拉伸填充管(“DFT”)，使得线180包含不同材料中的每种材料的期望物理和机械属性。在图7A-7C所示出的实施例中，外部材料184是向线180提供结构支撑的超弹性合金(例如，镍钛诺、钴铬、
Figure BDA0002356734720000111
等)，并且内芯186是改进了支撑构件174的可视化和/或向线180提供另外的结构支撑的不透射线材料(例如，铂、钽、钨、钯、金、银等)。
在某些实施例中，线180进一步包含定位在外部材料184与内芯186之间的任选的中间材料185(图7C，以虚线示出)。在此类实施例中，内芯材料和外部材料184可以相同，并且中间材料185可以是不同的材料。例如，外部材料184和内芯材料可以是第一材料，并且中间材料185可以是不同于第一材料的第二材料。例如，外部材料184和内芯材料186可以是超弹性合金(例如，镍钛诺、钴铬等)，并且中间材料185可以是不透射线材料(例如，铂、钽、钯、金等)。在其它实施例中，外部材料184、内芯材料和中间材料185是不同的材料。在又其它实施例中，线180可以包含多于三个材料层。
如图7B和7C所示出的，线180的至少一部分包含延伸穿过外部材料184的厚度t的至少一部分的多个凹部182以及凹部182中的一种或多种治疗剂188。在一些实施例中，凹部182中的一个或多个凹部可以具有延伸穿过外部材料184的整个厚度t的深度，使得内芯186的顶表面通过凹部182暴露。在某些实施例中，凹部182中的一个或多个凹部可以延伸穿过外部材料184的整个厚度和内芯186的厚度的一部分，使得凹部182在内芯186内的某一深度处终止。在前述实施例的任一实施例中，治疗剂188可以定位在内芯186上，或者内芯186可以用治疗剂188浸渍。在其它实施例中，凹部182仅延伸穿过外部材料184的厚度t的一部分，使得内芯186不暴露，并且凹部182在外部材料184内的中间深度处终止。在此类实施例中，治疗剂188可以定位在外部材料184的暴露的内表面上。此外，线180可以包含延伸到外部材料184和/或内芯186内的不同深度的凹部。另外，在包含中间材料185的那些实施例中，线180可以包含一个或多个延伸穿过外层并且暴露中间材料185的第一凹部，以及一个或多个延伸穿过外部材料184和中间材料185并且暴露内芯186的第二凹部。在一些实施例中，凹部182是穿过线180的整个横截面尺寸(例如，直径)的通孔。在前述实施例中的任何实施例中，治疗剂188可以占据整个凹部182或其一部分。
尽管图7A-7C中所示出的凹部182具有圆形横截面形状，但是在其它实施例中，所述凹部中的一个或多个凹部可以具有其它合适的横截面形状(例如，正方形、椭圆形、矩形等)。同样，凹部182中的一个或多个凹部可以在凹部的不同深度处具有相同的横截面面积或不同的横截面面积。例如，凹部182中的一个或多个凹部可以具有朝着凹部的底表面逐渐减小的横截面面积。此外，凹部182中的至少一些凹部可以沿线定位在同一圆周位置处和/或凹部182中的至少一些凹部可以具有不同的圆周位置。另外，在一些实施例中，多个凹部可以沿线180定位在同一轴向位置处。在其它实施例中，所有凹部182沿线定位在不同的轴向位置处。
合适的治疗剂188可以包含一种或多种药物和/或生物活性剂，所述药物和/或生物活性剂可以减少环处的炎症并且促进延伸构件170与小叶中的一个或多个小叶和/或心房底之间的向内生长。如此，一种或多种治疗剂188的结合可以增加人工心脏瓣膜装置的耐受性和结合和/或可以减少瓣周漏。合适的抗炎药物的实例包含紫杉醇、西罗莫司等。生物活性剂的实例包含一种或多种生长因子，如血小板衍生生长因子(“PDGF”)、成纤维细胞生长因子(“FGF”)、转化生长因子(“TGF”)和刺激内皮细胞、平滑肌细胞和成纤维细胞的生长的其它合适的丝裂原。
在一些实施例中，治疗剂188可以被配置成经期望时间段具有受控递送速率。例如，治疗剂188可以与如生物可吸收的聚合物共混物等递送载剂相关(例如，由所述递送载剂包囊或与其结合等)以实现治疗剂188的定时释放。在某些实施例中，可以用生物活性剂或生物活性剂和递送载剂浸渍网以控制生物活性剂的释放速率。
虽然图7A所展示的实施例展示了形成交错的蛇形图案(例如，锯齿图案、菱形图案)的线180的总体上同心布置，但是也可以形成所述一条或多条线180的其它布置和图案(例如，蛇形、波浪形、径向臂、正方形等)以向延伸构件170提供期望刚性。此外，尽管图7A所示出的支撑构件174与固定结构130分离，但在其它实施例中，支撑构件174与固定结构130成一体。此外，支撑构件174、瓣膜支撑件110和/或锚固构件120可以包含如上所述的材料、合金、支柱、金属丝、线类型和/或线尺寸的混合。例如，在一些实施例中，结构、支柱或线的一部分可以是DFT，并且结构、支柱或线的另一部分可以由聚合物纤维和/或金属丝制成。在特定实施例中，延伸构件包括位于织物的摺边中或作为垂直于环形网的周界的条带的环形织物网和编织超弹性材料(例如，镍钛诺)。在本文所公开的实施例中的任何实施例中，延伸构件包含铂浸渍织物和/或可以包含沉积到织物上的薄膜超弹性材料(例如，镍钛诺)。此外，本文中所公开的结构构件中的任何结构构件可以包含一个或多个激光切割的镍钛诺条带(例如，直条带、弯曲条带等)。在一些实施例中，结构构件、支撑构件174、瓣膜支撑件110和/或锚固构件120的一个或多个部分可以具有一个或多个与不透射线标记铆接的孔。
图8A是处于展开配置的人工心脏瓣膜装置200(“装置200”)的另一实施例的示意性俯视图，并且图8B是定位在递送导管C腔内的处于递送配置的装置200的示意性端视图。图8C-8E是在装置200展开时沿线8C-8E(图8B)截取的装置200的横截面视图(为了便于说明，在图8C-8E中未示出递送导管C)。装置200可以包含在结构和功能上与图6A-7C中的装置100的组件总体上类似的多个组件。例如，装置200可以包含瓣膜支撑件110(图8A)、锚固构件120(图8A)、人工瓣膜组合件150(图8A)和第二密封构件164(在图8A-8E中不可见)，所有所述组件总体上与上文参照图6A-7C所讨论的组件类似。如此，共同的动作和结构和/或子结构通过相同的附图标记标识，并且下文仅描述了操作和结构方面的显著区别。
参照图8A，装置200包含延伸构件270，所述延伸构件具有围绕其周界的多个离散织物片段290(为了便于说明，在图8中仅标记了一个片段290)，所述织物片段各自具有位于锚固构件120处的第一端部部分295、与锚固构件120间隔开的第二端部部分297以及在相对边缘291之间延伸的宽度。在一些实施例中，相邻片段290可以通过柔性部分292(见图9A和9B)沿其相应的边缘291联接，使得边缘291可以相对于彼此自由滑动。
图9A和9B是分别示出为处于重叠配置和延伸配置的三个相邻的分离片段(分别被称为“第一片段290a、第二片段290b和第三片段290c”)的端视图。在重叠配置(图9A)中，第一片段290a的边缘291a和第三片段290c的边缘291c与第二片段290b的相邻边缘291b重叠。响应于一个或多个由周围解剖结构施加在延伸构件270上的力，第一片段290a、第二片段290b和第三片段290c的至少一部分可以在周向相反的方向上背离彼此移动(图9A中的箭头A1所指示)，使得边缘291a和291c在圆周方向C上相对于边缘291b滑动。根据所施加的力，边缘291a和291c可以滑动经过对应的相邻边缘291b，使得第一片段290a、第二片段290b和第三片段290c处于延伸配置(图9B)，在所述延伸配置中，边缘291a和291c与对应的相邻边缘291b沿延伸构件270的周界C间隔开。在一些实施例中，边缘291a和291c中的每个边缘可以以不超过柔性部分292的长度与对应的相邻边缘291b间隔开。当第一片段290a、第二片段290b和第三片段290c处于延伸配置，并且周围解剖结构在延伸构件270上施加一个或多个力时，第一片段290a、第二片段290b和第三片段290c的至少一部分可以在周向相反的方向上背离彼此移动(图9B中的箭头A2所指示)。
在一些实施例中，延伸构件270和/或片段290可以具有其它配置。例如，图9C和9D是根据本发明技术的另一个实施例配置的分别被示出为处于重叠配置和延伸配置的延伸构件270'的三个分离片段290a-290C(统称为“片段290”)的端视图。同样，图9E和9F是根据本发明技术配置的分别被示出为处于重叠配置和延伸配置的另一延伸构件270"的三个分离片段290a-290C(统称为“片段290”)的端视图。在如图9C-9F所示出的实施例等一些实施例中，片段290不沿其相应的边缘291通过柔性部分292联接。当装置200定位在环内时，所述多个片段290可以相对于彼此移动以适应环的天然几何结构和/或在必要时在延伸构件270用局部心脏解剖结构密封的同时调整其相对位置。
在一些实施例中，单独的片段290包含沿其单独边缘的至少一部分延伸和/或限定所述至少一部分的支撑构件274(例如，金属或聚合物线)，并且柔性网272(例如，织物)可以在每个片段290的支撑构件274之间延伸。在此类实施例中，柔性部分292可以包括在相邻片段290的边缘291之间延伸的单独的柔性网。在其它实施例中，延伸构件270和/或单独片段290可以具有其它合适的配置。例如，在一些实施例中，单独片段290包含从固定结构130径向向外延伸的支撑构件274(例如，金属或聚合物线)，其中每个单独片段290具有由从每个支撑构件274延伸的柔性网272(例如，织物)覆盖的至少一个支撑构件。在一些实施例中，每个单独片段290的柔性网272的至少一部分与相邻的单独片段构件290的柔性网272的至少一部分重叠。在一些实施例中，柔性网272在每个片段290的支撑构件274之间延伸。在一些实施例中，延伸构件270包括在固定结构130周围连续的柔性网272。例如，在一个实施例中，柔性网272可以包括一个或多个凹座，其中单独支撑构件290可以在所述一个或多个凹座内自由移动或滑动。在一个实施例中，柔性网凹座的数量等于单独支撑构件的数量。在替代性实施例中，凹座的数量小于单独支撑构件的数量。例如，在一个实施例中，所有单独支撑构件都存在于单个凹座内。
图10是根据本发明技术的另一实施例的人工心脏瓣膜装置300的示意性等距视图。装置300可以包含在结构和功能上与图6A-7C中的装置100的组件总体上类似的多个组件。例如，装置300可以包含瓣膜支撑件110、锚固构件120、人工瓣膜组合件150和第二密封构件164，所有所述组件总体上与上文参照图6A-7C所讨论的组件类似。如此，共同的动作和结构和/或子结构通过相同的附图标记标识，并且下文仅描述了操作和结构方面的显著区别。
在图10所示出的实施例中，延伸构件370包含从锚固构件120径向向外延伸的第一环形部分370a和从第一环形部分370a径向向外延伸的第二环形部分370b。第一环形部分370a可以具有与图8-9B所示出的延伸构件270的片段290和柔性部分292类似的多个离散片段390a和柔性部分392(每种组件仅标记一个)。第二环形部分370b也可以具有与图8-9B所示出的延伸构件270的片段290和柔性部分292类似的多个离散片段390b和柔性部分392b(每种组件仅标记一个)。如图10所示出的，在一些实施例中，第二环形部分370b的片段390b与第一环形部分370a的片段390b周向对齐，并且第二环形部分370b的柔性部分392b与第一环形部分370a的柔性部分392a周向对齐。
实例
以下实例说明本发明技术的多个实施例：
1.一种人工心脏瓣膜装置，其包括：
锚固构件，所述锚固构件具有环形固定框架，所述环形固定框架具有上游部分和下游部分；
管状瓣膜支撑件，所述管状瓣膜支撑件具有联接到所述固定框架的所述下游部分的第一部分和与所述固定框架的所述上游部分径向向内间隔开的第二部分；
瓣膜组合件，所述瓣膜组合件联接到所述瓣膜支撑件并且具有至少一个能够从闭合位置和开启位置移动的小叶，在所述闭合位置中，血流被阻止穿过所述瓣膜支撑件，在所述开启位置中，血流被允许在下游方向上穿过所述瓣膜支撑件；以及
延伸构件，所述延伸构件联接到所述固定框架并从所述固定框架径向向外延伸，其中所述延伸构件包含多条金属丝，其中所述金属丝的至少一部分包含由外部材料包围的内芯，并且其中(a)所述内芯为第一材料，(b)所述外部材料是与所述第一材料不同的第二材料并且具有厚度，(c)所述金属丝包含多个延伸穿过所述外部材料的所述厚度的至少一部分的凹部以及(d)所述凹部中用于在所述人工心脏瓣膜装置定位在天然环处时递送到解剖结构的治疗剂。
2.根据实例1所述的装置，其中所述固定框架的所述上游部分能够径向变形，而基本上不使所述管状瓣膜支撑件的所述第二部分变形。
3.根据实例1或实例2所述的装置，其中所述延伸构件进一步包含密封构件，所述密封构件沿所述延伸构件的长度的至少一部分延伸，并且其中所述金属丝联接到所述密封构件。
4.根据实例1到3中任一项所述的装置，其中所述金属丝与所述固定框架的所述上游部分成一体。
5.根据实例1到3中任一项所述的装置，其中所述金属丝与所述固定框架机械隔离。
6.根据实例1到5中任一项所述的装置，其中所述第一材料不透射线，并且所述第二材料是超弹性合金。
7.根据实例1到6中任一项所述的装置，其中所述治疗剂包含抗炎药物和生物活性剂中的至少一种。
8.根据实例1到7中任一项所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述内芯的至少一部分。
9.根据实例1到8中任一项所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述内芯的所述厚度的至少一部分，使得所述多个凹部中的至少一些凹部在所述内芯内的中间深度处终止。
10.根据实例1到9中任一项所述的装置，其中所述延伸构件进一步包括定位在所述内芯与所述外部材料之间的中间材料。
11.根据实例10所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述中间材料的至少一部分。
12.根据实例10所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述中间材料的整个厚度，由此暴露所述内芯的至少一部分。
13.一种人工心脏瓣膜装置，其包括：
锚固构件，所述锚固构件具有环形固定框架，所述环形固定框架具有上游部分和下游部分；
管状瓣膜支撑件，所述管状瓣膜支撑件具有联接到所述锚固构件的所述下游部分的第一部分和与所述锚固构件的所述上游部分径向向内间隔开的第二部分；
瓣膜组合件，所述瓣膜组合件联接到所述瓣膜支撑件并且具有至少一个能够从闭合位置和开启位置移动的小叶，在所述闭合位置中，血流被阻止穿过所述瓣膜支撑件，在所述开启位置中，血流被允许在下游方向上穿过所述瓣膜支撑件；以及
延伸构件，所述延伸构件联接到所述固定框架并从所述固定框架径向向外延伸，其中所述延伸构件包含多条金属丝，其中所述金属丝的至少一部分包含由外部材料包围的内芯，并且其中(a)所述内芯为第一材料，(b)所述外部材料是与所述第一材料不同的第二材料并且具有厚度，(c)所述金属丝包含多个延伸穿过所述外部材料的所述厚度的至少一部分的凹部以及(d)所述凹部中的不透射线材料。
14.根据实例13所述的装置，其中所述固定框架的所述上游部分能够径向变形，而基本上不使所述管状瓣膜支撑件的所述第二部分变形。
15.根据实例13或实例14所述的装置，其中所述延伸构件进一步包含密封构件，所述密封构件沿所述延伸构件的长度的至少一部分延伸，并且其中所述金属丝联接到所述密封构件。
16.根据实例13到15中任一项所述的装置，其中所述金属丝与所述固定框架的所述上游部分成一体。
17.根据实例13到15中任一项所述的装置，其中所述金属丝与所述固定框架机械隔离。
18.根据实例13到17中任一项所述的装置，其中所述第一材料不透射线，并且所述第二材料是超弹性合金。
19.根据实例13到18中任一项所述的装置，其中所述治疗剂包含抗炎药物和生物活性剂中的至少一种。
20.根据实例13到19中任一项所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述内芯的至少一部分。
21.根据实例13到20中任一项所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述内芯的厚度的至少一部分，使得所述多个凹部中的至少一些凹部在所述内芯内的中间深度处终止。
22.根据实例13到21中任一项所述的装置，其中所述延伸构件进一步包括定位在所述内芯与所述外部材料之间的中间材料。
23.根据实例22所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述中间材料的至少一部分。
24.根据实例22所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述中间材料的整个厚度，由此暴露所述内芯的至少一部分。
27.一种人工心脏瓣膜装置，其包括：
锚固构件，所述锚固构件具有可径向膨胀的框架，所述可径向膨胀的框架具有内部并且具有上游部分和下游部分，其中所述上游部分包含组织固定部分，所述组织固定部分被配置成向外按压抵靠定位在受试者的心脏瓣膜的天然环处和/或下游的组织并且被配置成能够至少部分地变形以适形于所述组织的形状；
瓣膜，所述瓣膜相对于所述锚固构件定位并且具有至少一个能够从闭合位置和开启位置移动的小叶，在所述闭合位置中，血流被阻止穿过所述内部，在所述开启位置中，血流被允许在所述上游部分到所述下游部分的流动方向上穿过所述内部，其中所述瓣膜与所述锚固构件的所述组织固定部分向内间隔开，使得当所述组织固定部分变形以适形于所述组织的所述形状时，所述瓣膜保持能力；以及
延伸组合件，所述延伸组合件在展开配置下侧向延伸远离所述锚固构件的所述上游部分，其中所述延伸构件包括多个离散的织物片段，所述多个离散的织物片段具有位于所述锚固构件处的第一端和与所述锚固构件间隔开的第二端，其中所述织物片段在所述延伸构件周围并排布置，并且相邻的织物片段通过柔性联接装置松散地联接在一起，使得相邻的织物片段的所述第二端在展开状态下能够彼此独立地配置。
28.根据实例27所述的人工心脏瓣膜装置，其中所述片段不包含结构构件。
29.根据实例27或实例28所述的人工心脏瓣膜装置，其中所述延伸构件被配置成在所述展开配置下相对于所述可膨胀框架变形。
30.根据实例27到29中任一项所述的人工心脏瓣膜装置，其中所述联接装置是弹性的。
31.根据实例27到29中任一项所述的人工心脏瓣膜装置，其中所述联接装置为缝线。
32.根据实例27到31中任一项所述的人工心脏瓣膜装置，其中所述片段的远端与所述延伸构件的所述第二端重合。
33.根据实例27到32中任一项所述的人工心脏瓣膜装置，其中所述片段与所述可膨胀框架间隔开，使得所述片段仅间接联接到所述锚固构件。
34.根据实例27到32中任一项所述的人工心脏瓣膜装置，其中所述片段直接连接到所述可膨胀框架。
根据上文，应理解，在本文中已经出于说明的目的描述了本发明的具体实施例，但可以在不偏离本发明的范围的情况下进行各种修改。例如，在不同实施例中，多个单独组件可以彼此互换。因此，除受所附权利要求限制之外，本发明不受限制。

Claims (34)

1.一种人工心脏瓣膜装置，其包括：
锚固构件，所述锚固构件具有环形固定框架，所述环形固定框架具有上游部分和下游部分；
管状瓣膜支撑件，所述管状瓣膜支撑件具有联接到所述固定框架的所述下游部分的第一部分和与所述固定框架的所述上游部分径向向内间隔开的第二部分；
瓣膜组合件，所述瓣膜组合件联接到所述瓣膜支撑件并且具有至少一个能够从闭合位置和开启位置移动的小叶，在所述闭合位置中，血流被阻止穿过所述瓣膜支撑件，在所述开启位置中，血流被允许在下游方向上穿过所述瓣膜支撑件；以及
延伸构件，所述延伸构件联接到所述固定框架并从所述固定框架径向向外延伸，其中所述延伸构件包含多条金属丝，其中所述金属丝的至少一部分包含由外部材料包围的内芯，并且其中(a)所述内芯为第一材料，(b)所述外部材料是与所述第一材料不同的第二材料并且具有厚度，(c)所述金属丝包含多个延伸穿过所述外部材料的所述厚度的至少一部分的凹部以及(d)所述凹部中用于在所述人工心脏瓣膜装置定位在天然环处时递送到解剖结构的治疗剂。
2.根据权利要求1所述的装置，其中所述固定框架的所述上游部分能够径向变形，而基本上不使所述管状瓣膜支撑件的所述第二部分变形。
3.根据权利要求1所述的装置，其中所述延伸构件进一步包含密封构件，所述密封构件沿所述延伸构件的长度的至少一部分延伸，并且其中所述金属丝联接到所述密封构件。
4.根据权利要求1所述的装置，其中所述金属丝与所述固定框架的所述上游部分成一体。
5.根据权利要求1所述的装置，其中所述金属丝与所述固定框架机械隔离。
6.根据权利要求1所述的装置，其中所述第一材料不透射线，并且所述第二材料是超弹性合金。
7.根据权利要求1所述的装置，其中所述治疗剂包含抗炎药物和生物活性剂中的至少一种。
8.根据权利要求1所述的装置，其中：
所述第一材料不透射线，
所述第二材料是超弹性合金，并且
所述治疗剂包含抗炎药物和生物活性剂中的至少一种。
9.根据权利要求1所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述内芯的至少一部分。
10.根据权利要求1所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述内芯的厚度的至少一部分，使得所述多个凹部中的至少一些凹部在所述内芯内的中间深度处终止。
11.根据权利要求1所述的装置，其中所述延伸构件进一步包括定位在所述内芯与所述外部材料之间的中间材料。
12.根据权利要求11所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述中间材料的至少一部分。
13.根据权利要求11所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述中间材料的整个厚度，由此暴露所述内芯的至少一部分。
14.一种人工心脏瓣膜装置，其包括：
锚固构件，所述锚固构件具有环形固定框架，所述环形固定框架具有上游部分和下游部分；
管状瓣膜支撑件，所述管状瓣膜支撑件具有联接到所述锚固构件的所述下游部分的第一部分和与所述锚固构件的所述上游部分径向向内间隔开的第二部分；
瓣膜组合件，所述瓣膜组合件联接到所述瓣膜支撑件并且具有至少一个能够从闭合位置和开启位置移动的小叶，在所述闭合位置中，血流被阻止穿过所述瓣膜支撑件，在所述开启位置中，血流被允许在下游方向上穿过所述瓣膜支撑件；以及
延伸构件，所述延伸构件联接到所述固定框架并从所述固定框架径向向外延伸，其中所述延伸构件包含多条金属丝，其中所述金属丝的至少一部分包含由外部材料包围的内芯，并且其中(a)所述内芯为第一材料，(b)所述外部材料是与所述第一材料不同的第二材料并且具有厚度，(c)所述金属丝包含多个延伸穿过所述外部材料的所述厚度的至少一部分的凹部以及(d)所述凹部中的不透射线材料。
15.根据权利要求14所述的装置，其中所述固定框架的所述上游部分能够径向变形，而基本上不使所述管状瓣膜支撑件的所述第二部分变形。
16.根据权利要求14所述的装置，其中所述延伸构件进一步包含密封构件，所述密封构件沿所述延伸构件的长度的至少一部分延伸，并且其中所述金属丝联接到所述密封构件。
17.根据权利要求14所述的装置，其中所述金属丝与所述固定框架的所述上游部分成一体。
18.根据权利要求14所述的装置，其中所述金属丝与所述固定框架机械隔离。
19.根据权利要求14所述的装置，其中所述第一材料不透射线，并且所述第二材料是超弹性合金。
20.根据权利要求14所述的装置，其中所述治疗剂包含抗炎药物和生物活性剂中的至少一种。
21.根据权利要求14所述的装置，其中：
所述第一材料不透射线，
所述第二材料是超弹性合金，并且
所述治疗剂包含抗炎药物和生物活性剂中的至少一种。
22.根据权利要求14所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述内芯的至少一部分。
23.根据权利要求14所述的装置，其中所述多个凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述内芯的厚度的至少一部分，使得所述多个凹部中的至少一些凹部在所述内芯内的中间深度处终止。
24.根据权利要求14所述的装置，其中所述延伸构件进一步包括定位在所述内芯与所述外部材料之间的中间材料。
25.根据权利要求24所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度，由此暴露所述中间材料的至少一部分。
26.根据权利要求24所述的装置，其中所述凹部中的至少一些凹部延伸穿过所述外部材料的整个厚度和所述中间材料的整个厚度，由此暴露所述内芯的至少一部分。
27.一种人工心脏瓣膜装置，其包括：
锚固构件，所述锚固构件具有可径向膨胀的框架，所述可径向膨胀的框架具有内部并且具有上游部分和下游部分，其中所述上游部分包含组织固定部分，所述组织固定部分被配置成向外按压抵靠定位在受试者的心脏瓣膜的天然环处和/或下游的组织并且被配置成能够至少部分地变形以适形于所述组织的形状；
瓣膜，所述瓣膜相对于所述锚固构件定位并且具有至少一个能够从闭合位置和开启位置移动的小叶，在所述闭合位置中，血流被阻止穿过所述内部，在所述开启位置中，血流被允许在所述上游部分到所述下游部分的流动方向上穿过所述内部，其中所述瓣膜与所述锚固构件的所述组织固定部分向内间隔开，使得当所述组织固定部分变形以适形于所述组织的所述形状时，所述瓣膜保持能力；以及
延伸组合件，所述延伸组合件在展开配置下侧向延伸远离所述锚固构件的所述上游部分，其中所述延伸构件包括多个离散的织物片段，所述多个离散的织物片段具有位于所述锚固构件处的第一端和与所述锚固构件间隔开的第二端，其中所述织物片段在所述延伸构件周围并排布置，并且相邻的织物片段通过柔性联接装置松散地联接在一起，使得相邻的织物片段的所述第二端在展开状态下能够彼此独立地配置。
28.根据权利要求27所述的人工心脏瓣膜装置，其中所述片段不包含结构构件。
29.根据权利要求27所述的人工心脏瓣膜装置，其中所述延伸构件被配置成在所述展开配置下相对于所述可膨胀框架变形。
30.根据权利要求27所述的人工心脏瓣膜装置，其中所述联接装置是弹性的。
31.根据权利要求27所述的人工心脏瓣膜装置，其中所述联接装置是缝线。
32.根据权利要求27所述的人工心脏瓣膜装置，其中所述片段的远端与所述延伸构件的所述第二端重合。
33.根据权利要求27所述的人工心脏瓣膜装置，其中所述片段与所述可膨胀框架间隔开，使得所述片段仅间接联接到所述锚固构件。
34.根据权利要求27所述的人工心脏瓣膜装置，其中所述片段直接连接到所述可膨胀框架。
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