CN1993090A - 用于心脏瓣膜递送的方法和系统 - Google Patents

用于心脏瓣膜递送的方法和系统 Download PDF

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CN1993090A
CN1993090A CNA2005800208668A CN200580020866A CN1993090A CN 1993090 A CN1993090 A CN 1993090A CN A2005800208668 A CNA2005800208668 A CN A2005800208668A CN 200580020866 A CN200580020866 A CN 200580020866A CN 1993090 A CN1993090 A CN 1993090A
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valve
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CN1993090B (zh
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比亚内·贝里海姆
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Medtronic 3F Therapeutics Inc
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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
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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
    • 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
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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
    • 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
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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
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Abstract

本发明提供了用于将递送装置引入到心脏或心尖附近的方法和系统，其中所述递送装置包括假体，将假体推进到目标部位，以及使所述假体在目标部位与递送装置脱离以便植入。具体地，本发明提供了用于将置换心脏瓣膜递送至目标部位或心脏附近的瓣膜置换系统。该瓣膜置换系统包括套管针或其他合适的穿透心脏或心尖附近的装置，递送部件被可移动地设置在套管针内，而置换心脏瓣膜被设置在递送部件上。所述递送部件可以进一步包括机械的或可充气的扩展构件，以促进在目标部位人工瓣膜的植入。

Description

用于心脏瓣膜递送的方法和系统
技术领域
本发明总体上涉及用于心血管外科手术的方法和系统。更具体地，本发明涉及用于心脏瓣膜的修补、切除、和/或置换的方法和系统，以及还用于在心血管外科手术期间提供临时瓣膜和/或远端栓塞保护(embolic protection)的方法和系统。
背景技术
各种外科技术可以用于修补患病的或受损的心脏瓣膜，如瓣环成形术(收缩瓣膜环)、四角形的切除术(quadrangular resection)(窄化瓣叶)、连合部切开术(将瓣膜连合切成单独的瓣叶)、或瓣膜和瓣膜环组织的脱钙。可替换地，可以通过人工瓣膜置换患病的心脏瓣膜。在表明心脏瓣膜的置换的地方，患病的瓣膜通常被去除并用机械瓣膜或组织瓣膜置换。组织瓣膜通常优于机械瓣膜，由于它们一般并不需要用抗凝血剂长期处理。
已经采用了各种不同策略，以修补或置换有缺陷的心脏瓣膜。开放的心脏瓣膜修补或置换手术是冗长的手术并涉及总的胸廓切开术，通常为正中胸骨切开术的形式。在这种手术中，锯或其他切割工具用于纵向的切开胸骨，并分开胸腔前面或腹部的两个相对的部分。由此形成进入胸腔内的大的开口，通过该开口外科医生可以直接看到心脏和其他胸部内容物并对其手术。在外科手术期间必须对患者实施心肺分流术。
开放性胸腔瓣膜置换手术具有允许直接在其希望部位植入置换瓣膜的好处。然而，这种方法是高度侵入性的并且经常导致患者严重的外伤、并发症的危险，以及延长住院治疗时间和疼痛痊愈期。
出现了作为开放性胸腔手术的可替换方式的最低程度侵入性经皮瓣膜置换术。与开放性心脏手术不同，这种手术间接并涉及从股动脉到心脏的血管内导管插入术。由于该最低程度侵入方法仅要求小的切口，使得疼痛和身体外伤较少的患者较快痊愈。这又降低了医疗成本并减少对患者的生活的完全扰乱。
然而，使用最低程度侵入方法，将新的复杂性引入外科手术。在最低程度侵入经皮方法中固有的困难是在脉管系统内可用的有限空间。与开放性心脏手术不同，最低程度侵入心脏手术提供仅血管直径大小的外科手术区域。因此，工具和修复装置的引入变得更极为复杂。该装置必须被尺寸化并构造为使得其能被引入到脉管系统、通过那里进行操作以及定位在需要的位置上。这可能涉及在从引入初始点的某一距离上通过显著的盘旋的通道。
因此，当心脏瓣膜手术对于许多患者产生有益效果时，许多可能从这样的外科手术中获益的其他患者不愿意或不希望经受当前技术的外伤和危险。因此，需要那些在心脏和心脏的大血管内进行心脏瓣膜修补和置换以及其他手术的方法和装置，其提供比目前最低程度侵入技术更容易到达心脏瓣膜的入口，同时减少了伴随更加侵入技术的外伤、危险、恢复时间以及疼痛。
发明内容
本发明提供了用于进行心血管外科手术的方法和系统，其中提供了通过心脏的心尖区进入心脏或大血管的入口。心脏的心尖区通常是由左心室和右心室形成的钝圆的心脏下端。在正常健康的人体内，它通常位于中央胸骨线的第五左肋间隙后面。
心尖区的独特解剖结构允许将各种手术装置和工具引入到心脏内，而无自然机械和电心脏功能的显著破坏。由于本发明的方法和系统允许通过心尖直接进入心脏和大血管，它并不受通过经皮手术方法呈现的尺寸限制的局限。尽管在经皮方法中通过股血管进入心脏要被限制为血管的直径(大约8mm)，通过心尖区进入心脏是非常大的(大于25mm)。因此，相对于心脏和大血管内可以实施的装置和手术方法的类型，心尖进入心脏允许较大的灵活性。
因此，本发明的一个目的是提供通过进入心脏的心尖区用于心脏瓣膜的修补、切除、和/或置换的方法和装置。
在本发明的一个优选的实施方式中，提供了用于将假体递送到心脏内或心脏附近的目标部位的方法。该方法包括：在心尖(心脏的心尖)或心尖附近引入递送装置到心脏中，其中递送装置包括假体；将假体推进到目标部位；以及使假体与递送装置在目标部位脱离以便进行植入。
本发明还提供了用于将置换心脏瓣膜递送到心脏内或心脏附近的目标部位的瓣膜置换系统。在一个具体实施方式中，该瓣膜置换系统包括：套管针或其他合适装置以在心尖处或心尖附近穿透心脏；递送部件，被移动地设置在套管针内；置换心脏瓣膜，设置在递送部件上。
该瓣膜置换系统可以用于递送各种人工的心脏瓣膜，包括带支架的和无支架的组织瓣膜。在本发明的另一具体实施方式中，该递送部件进一步包括机械或可充气扩展构件，以促进在目标部位进行人工瓣膜的植入。
在本发明的另一具体实施方式中，可以提供成像系统(imagingsystem)以观察手术区域。在任何时间或整个手术期间都可以使用成像系统。成像系统对于本领域的技术人员是众所周知的，其包括经食道回声、经胸回声、血管内超声成像(IVUS)、或辐射透不过的可注射染料。还可以利用荧光屏电影摄影检查术(cinefluoroscopy)。
在一个具体实施方式中，该成像系统是通过导管或插管到达手术区域递送的。在本发明的另一具体实施方式中，超声换能器可以位于递送部件的可膨胀气囊的一侧或两侧。在本发明的又一具体实施方式中，超声换能器可以位于递送部件的气囊上。
在本发明的又一具体实施方式中，该方法和系统可以进一步包括通过设置在递送部件上的切割工具切除至少患者的心脏的一部分的装置。该切割工具可以由导电金属制成，其中导电金属提供射频能量给用于提高瓣膜去除的切割工具。高频能量切除(术)在本领域是众所周知的。
在本发明的另一具体实施方式中，本发明的方法和装置可以适合提供瓣膜脱钙系统，其中递送部件能通过进入心脏的心尖区提供溶解溶液至治疗部位。该递送部件可以是导管，其用以引入并移除治疗地点的溶解溶液装置构成。该递送部件还可以提供用于隔离治疗部位的装置，以防止溶解溶液进入患者的循环系统。这种用于隔离治疗部位的装置可以包括阻挡件，例如在导管上的双气囊系统，其在治疗部位的两侧膨胀。
本发明还提供了用于提供远端栓塞保护的装置和系统。更具体地，本发明提供了用于俘获栓塞物质的过滤器，同时在相同装置中提供临时瓣膜。在过滤器组件中存在的瓣膜防止栓塞物质和碎片的回流，同时还使得在手术期间流体流入过滤器。瓣膜-过滤器结合可以被压缩和膨胀，以允许进入小的血管或其他体腔。在本发明的一个具体实施方式中，瓣膜过滤器组件被植入到位于手术部位的下游的心脏或心脏的大血管内。
通过以下优选的具体实施方式以及附图的描述，对于本领域的技术人员来说，本发明的以上方面和其他目的、特征和优点将变得显而易见。
附图说明
图1为示出了置换瓣膜递送装置通过第五肋骨间隙引入到心尖的患者胸腔的部分正视图。
图2示出了穿透心尖并进入左心室的置换瓣膜递送装置的套管针。
图3示出了通过位于心尖的套管针引入到左心室的气囊膨胀递送部件。
图4示出了向主动脉瓣推进的气囊膨胀构件。
图5示出了在狭窄的主动脉瓣内的气囊膨胀构件的设置。
图6示出了在狭窄的主动脉瓣内的扩张的气囊膨胀构件。
图7示出了具有设置气囊膨胀构件周围的人工置换瓣膜的置换瓣膜递送部件通过心尖的插入。
图8是位于在主动脉内的置换瓣膜递送部件的截面视图。
图9示出了通过置换瓣膜递送部件的气囊的人工置换瓣膜的膨胀。
图10示出了完全膨胀并展开的人工置换瓣膜和分离的置换瓣膜递送部件。
图11为示出了放置在主动脉的人工置换瓣膜的心脏的部分截面图。
图12示出了用于瓣膜置换系统的递送部件的一个具体实施方式。
图13示出了放置于主动脉，在主动脉瓣下游的瓣膜过滤器组件的一个具体实施方式。
具体实施方式
图1至图13示出了用于心脏瓣膜的修补、切除、和/或置换的方法和系统的具体实施方式，以及用于在心血管外科手术期间提供远端栓塞保护和临时瓣膜的方法和系统的具体实施方式。
瓣膜置换方法和系统
图1为患者10的胸腔11的部分正视图，并示出了相对于其他的解剖标志(如胸骨13、剑突14、肋骨15以及心脏12)的瓣膜置换系统29的位置。瓣膜置换系统29图示为通过第五肋骨间隙16并通过心脏12的心尖进入体腔。瓣膜置换系统29可以通过胸腔11中各种其他位置(17A、17B和17C)进入体腔。
在本发明的一个优选的具体实施方式中，该瓣膜置换系统包括套管针或其他适于穿透心脏的心尖区的装置、和递送部件以及被设置在递送部件上的置换人工瓣膜。
本发明的方法和系统可用于植入本领域已知的各种人工心脏瓣膜组件，包括有支架的和无支架的组织瓣膜。有支架瓣膜可以通过机械或气囊膨胀装置扩展，或它们可以自扩展。自扩展支架可以通过金属合金如镍钛合金构造，披露于美国专利第6,451,025号中，其结合于此作为参考。
可替换地，本发明的方法和装置还可以用于植入无支架的人工心脏瓣膜。在本发明的一个具体实施方式中，该递送部件适合定位目标部位上的组织瓣膜，并且该递送部件进一步包括将组织瓣膜缝合或钉到瓣膜环上的装置。
合适的人工瓣膜的实例披露于以下通常自身拥有的(commonlyowned)专利：美国专利第6,682,559、5,480,424、5,713,950、5,824,063、6,092,529、6,270,526、6,673,109、6,719,787、6,719,788、以及6,719,789号中，其结合于此作为参考。适用于与本发明结合使用的其他瓣膜组件的实例披露于美国专利第5,411,552、6,458,153、6,461,382、以及6,582,462号中，其结合于此作为参考。
适用于与本发明结合使用的套管针通常包括空心腔(hollowlumen)以及第一和第二末端。该第一末端包括用于穿透心脏组织的装置，而第二末端包括端口(port)，通过该端口该递送部件可以被引入到该套管针的空心腔并引入到心脏内。图2示出了穿过心脏12的心尖18的套管针。套管针31的移动方向通过箭头19指出。套管针31可以进入右心室20或左心室21。为了进入主动脉瓣或二尖瓣，套管针31优选穿过左心室21。这产生进入主动脉瓣或二尖瓣的直接入口。为了进入肺动脉瓣或三尖瓣，套管针31可以优选穿过右心室20。
在本发明的另一具体实施方式中，该套管针进一步包括设置于该腔内的瓣膜。该瓣膜被设计为在该套管针被插入跳动的心脏后显著降低血液回流出心脏外，同时允许通过套管针引入递送部件和其他手术装置。其他合适的套管针和装置在本领域是众所周知的，并且披露于美国专利第5,972,030、6,269,819、6,461,366、6,478,806、和6,613,063号中，其结合于此作为参考。
该瓣膜置换系统的递送部件适合将人工瓣膜递送至通过心脏的心尖区植入的部位。在本发明的一个具体实施方式中，该递送部件是包括机械膨胀和收缩装置的棒状物(rod)。在本发明的一个具体实施方式中，该机械膨胀和收缩装置可以包括多个管状线(呈环形排列)、抓柄、圆筒(包括沿着其圆周向外的斜钻孔)。人工瓣膜被设置在处于收缩状态的机械膨胀部件周围并且被递送至用于植入的目标部位。一旦适当的定位，该机械膨胀部件通过使该线穿过该斜钻孔来扩展，并该人工瓣膜被展开用于植入。
在本发明的另一具体实施方式中，用于植入该人工瓣膜组件的该机械膨胀和收缩装置可以包括由多个壁板(wall panel)围绕的空心管，其中多个壁板被连接至多个从管的外部延伸到管内部的中心板的弹簧负载销。该中心板具有螺旋形边缘，以便该中心板的旋转放射状地向外推进这些销。其他机械膨胀和收缩装置更完全地描述于同系列待审(co-pending)美国专利申请序列第10/680,719号中。
在本发明的又一具体实施方式中，该递送部件可以是具有可膨胀的部件例如气囊的空心管。图3示出了具有气囊41的递送部件40，其通过心尖18被插入并进入左心室21并向前推进到心脏12的天然主动脉瓣23。一旦气囊41被放置在主动脉瓣23内，它可以被充气，以加宽僵硬的或狭窄的心脏瓣膜(窄化的(心脏瓣膜)，并提高通过心脏并到达身体的其它部分的血流。这使心脏更高效地抽吸(pump)并降低心脏和肺内的压力。用于进行瓣膜成形术的先前方法需要在股动脉插入导管，然后被引导穿过心脏并被定位穿过患病的心脏瓣膜。然而，本发明的方法和装置提供了更直接的到达要治疗的瓣膜的途径。
图4示出了向主动脉瓣23推进的递送部件40和气囊41的近图特写镜头，其中主动脉狭窄是明显的。如这里所示出的，主动脉瓣具有多个瓣叶24。在一个具体实施方式中，递送装置40包括顶端或远端附件42，其适合接收参与瓣膜置换手术的各种辅助装置。这种辅助装置可以包括远端栓塞保护组件、临时瓣膜、成像系统、瓣膜去除系统、瓣膜脱钙系统。
图5示出了定位于主动脉22内和主动脉瓣23以及主动脉瓣膜环25内的气囊41。该气囊41图示为箭头58所示的径向充气，以压缩瓣叶24抵靠在主动脉22的壁上。在图6中，气囊41被完全充气以通过压缩瓣叶24抵靠主动脉壁来加宽狭窄的主动脉瓣23。内部元件59也可以用于插入用于控制顶端偏转的引导线(a guidewire)或者用于气囊膨胀的流体注入导管。
图7示出了具有气囊膨胀构件41的递送部件40的插入。折叠的(collapsed)置换人工瓣膜51被设置在气囊膨胀构件41上，并被引入到套管针31的端口32。递送部件40图示为穿过心脏12的心尖18。
图8～9示出了放置在天然主动脉瓣23内的气囊41的膨胀。图8是置换瓣膜递送部件40的截面图，置换瓣膜递送部件40包括气囊41和被设置于未扩展气囊41上的置换瓣膜51。置换瓣膜51此处被图示为位于主动脉瓣23内。图9示出了气囊41的径向膨胀52引起置换瓣膜51向着瓣膜环25压缩主动脉瓣23的主动脉瓣叶24。
图10示出了在其完全膨胀的状态下展开的瓣膜。如这里所示出的，置换人工瓣膜51包括基座环57和带有突出物56的支承结构或支架54，以支承组织瓣膜55。一旦人工瓣膜51被植入，气囊41随后被放气，并且递送部件40通过箭头53所指的方向离开身体。图11示出了位于主动脉瓣位置的植入的置换瓣膜51。
成像系统
观察手术区域的成像系统可以在任何时间或整个手术期间使用。对于本领域的技术人员来说，成像系统是众所周知的，包括经食道回声、经胸回声、血管内超声成像(IVUS)、或辐射透不过的可注射染料。还可以利用荧光屏电影摄影检查术。在一个具体实施方式中，该成像系统可通过导管或插管递送到手术区域。
血管内超声(IVUS)利用称为换能器(transducer)的装置发送的高频声波。该换能器可以连接到本发明的递送部件。在这种设置中，声波从血管或心脏壁反射，并返回换能器作为回声。
在本发明的一个具体实施方式中，递送部件可以包括至少一个超声换能器，以便在瓣膜植入前、植入期间和植入后提供目标部位的图像。图12示出了本发明递送部件的另一具体实施方式。在这个具体实施方式中，递送部件包括可缩回到外部构件49B的腔内的内部构件49A。一旦展开递送部件40，内部构件49A的远端44被暴露超过外部构件49B的末端45。
该内部构件的远端44包括与流体注入机械装置48和递送部件的手柄43流体连通的可膨胀气囊41，通过其气囊41可以被充气或放气。递送部件40的内部构件49A进一步包括邻近膨胀气囊41的超声换能器47和适于接收参与瓣膜置换手术的各种辅助装置的顶端或远端附件42。这样的辅助装置可以包括远端栓塞保护组件、临时瓣膜、成像系统、瓣膜去除系统、瓣膜脱钙系统。
当这里披露的超声换能器位于邻近气囊时，应当理解，超声换能器可以被放置在递送部件上、气囊上、和/或顶端或远端附件上的任何位置。
瓣膜去除系统
本发明还提供通过进入心脏的心尖区用瓣膜去除装置去除瓣膜的方法或系统。作为实例，按在同系列待审的美国专利申请序列第10/375,718和10/680,562号教导的可以完成瓣膜去除，其全部内容结合于此作为参考。
在本发明的一个具体实施方式中，该方法可以进一步包括通过被设置在递送部件上的切割工具切除患者心脏瓣膜的至少一部分的步骤。在本发明的另一方面，该切割工具可以由导电金属制成，其为切割工具提供用于提高瓣膜去除的射频能量。高频能量切除(术)在本领域是众所周知的。
在本发明的另一具体实施方式中，该递送部件包括切割装置，该切割装置包括多个卡爪元件，每一卡爪元件具有锋利的末端使得卡爪元件能刺穿至少天然瓣膜的一部分。在另一个方面，该切割装置包括多个电极元件，其中射频能量被传递到每一个电极元件上，能使该电极元件刺穿至少天然瓣膜的一部分。在本发明的进一步方面中，切割装置包括多个超声换能器元件，其中超声能量被递送到每一个换能器元件，能使换能器元件刺穿至少天然瓣膜的一部分。
瓣膜脱钙系统
在心血管组织例如血管和心脏瓣膜上，动脉粥样硬化斑和病变的形成是心血管病的一个主要部分。已经开发了各种不同的方法以治疗与钙化的动脉粥样硬化斑和病变相关的心血管病。这样的方法包括机械切除或缩小病变，例如旁路手术(bypass surgery)、气囊血管成形术、机械清创术、动脉粥样硬化斑切除术、以及瓣膜置换。
钙化的动脉粥样硬化斑和病变还可以通过化学装置治疗，其可以通过各种导管装置被递送到已感染的区域。例如，授予Constantz等人的美国专利第6,562,020号公开了通过利用酸性溶解溶液和能定位冲洗脉管部位的导管流体递送系统治疗脉管钙化病变。合适的导管装置包括描述于美国专利第6,562,020号中的那些导管装置，其全部内容结合于此作为参考。
因此，在本发明的另一具体实施方式中，本发明的方法和装置可以适合提供瓣膜脱钙系统，其中该递送部件通过进入心脏的心尖区能提供溶解溶液至治疗部位。合适的溶解溶液在本领域是已知的，并且通常具有以下特征，能增加治疗部位的质子浓度达到足以至少部分溶解钙化的动脉粥样硬化病变的矿物成分的所需水平。
该递送部件可以是导管，其用引入并去除治疗部位的溶解溶液的装置构成。该递送部件还可以提供用于隔离治疗部位以防止溶解溶液进入患者的循环系统的装置。这种用于隔离治疗部位的装置可以包括阻挡件，例如在治疗部位两侧充气的导管上的双气囊系统。
临时瓣膜
在瓣膜置换手术期间，被置换的天然瓣膜的功能停止，因此在心脏内的天然流体流动血液被扰乱(中断)。这又可以导致心脏和血管内的显著的回流血压。因此，需要预防或降低在置换瓣膜手术期间当天然瓣膜功能停止时产生的回流血压。
本发明提供了在置换心脏瓣膜递送之前或递送同时提供临时瓣膜的装置。
在本发明的一个具体实施方式中，该递送部件包括临时瓣膜，其能以收缩(collapsed)状态设置在需要的位置，扩展并固定在心脏或血管壁，并随后在完成瓣膜置换手术后再收缩并从身体移出。该临时瓣膜可以作为顶端附件提供给包括置换瓣膜的递送部件。可替换地，该临时瓣膜能以与置换心脏瓣膜类似的方式被设置在单独的递送部件上。
在本发明的优选具体实施方式中，该临时瓣膜被设置在足以靠近无功能瓣膜的位置上。该临时瓣膜的位置可以放置在无功能瓣膜的上游或下游。
远端栓塞保护组件
在瓣膜修补或置换手术中，对严重钙化瓣膜的操作能导致钙和瓣膜或其他周围组织的移动，并伴随栓塞(现象)和阻塞。虽然，动脉粥样化碎片在大脑中栓塞最频繁，但其他受影响的身体部位包括脾、肾、胰脏以及胃肠道。这些周围器官的栓塞(现象)和阻塞可以导致组织局部缺血或死亡。因此，存在在心血管外科手术期间安全地容纳栓塞物质的需要。
在本发明的一个具体实施方式中，提供了瓣膜过滤器组件。这种瓣膜过滤器组件可以在手术进行前植入到该部位的下游。该瓣膜过滤器组件的一个优选的具体实施方式示于图13中，其示出了位于主动脉22中并在主动脉瓣膜23下游的瓣膜过滤器组件61。临时瓣膜过滤器组件61包括临时瓣膜62和从那里延伸的过滤器63。该瓣膜过滤器组件提供远端栓塞保护，并可以通过导管或插管或任何传统方法被递送到天然主动脉瓣23下游侧。在临时瓣膜过滤器组件被安装在需要的位置64后，其被展开以提供临时止回瓣膜和过滤器的双功能，以捕获手术期间任何掉落的栓子或碎片。
瓣膜被包含于远端栓塞保护组件中，以提供在瓣膜置换手术期间充当临时瓣膜和防止栓塞物质脱离过滤器的双功能。在过滤器的流入(处)加入单向瓣膜防止栓塞物质脱离(escaping)，由此降低栓塞和阻塞的发生率。瓣膜同时提供在瓣膜手术期间使用的临时瓣膜。过滤器和瓣膜以相同排列结合也产生使得进行其他操作的更多空间的更紧凑的装置。在主动脉修补和置换手术中，例如，在主动脉瓣和无名支之间存在有限的空间。过滤器和瓣膜结合成紧凑的装置，为用于瓣膜修补或置换手术的装置提供更多空间。
如上所述，在瓣膜过滤器装置的经皮植入中固有的困难是在脉管系统内可用的空间有限。该装置必须被尺寸化并被构造为使得它能被引入到脉管系统、通过那里进行操作(maneuvered)以及定位在处理部位的位置下游。这涉及在从引入的初始点的某一距离上通过显著的盘旋的通道。一旦在(适当的)位置，该装置必须可展开足够大的截面，以有效拉紧(strain)基本所有的由此通过的血液，而不会不能接受的降低其流速。此外，这种装置的使用或存在必须不干扰脉管系统部位的治疗，治疗装置也不干扰栓塞俘获装置的功能。
另外，由上述过滤器俘获物质被容纳并且不允许其脱离过滤器附近是至关重要的。在瓣膜修补手术中，例如，在手术期间脱落并由放置在主动脉瓣和无名支之间的过滤器截留的物质在回流和由此进入冠状动脉期间不允许离开过滤器是重要的。当存在不容易附着在过滤材料上的较大颗粒时，防止碎片离开过滤器是特别重要的。
瓣膜过滤器组件的过滤器可以是要求捕获所有栓塞物质同时还提供用于在使用期间提供足够的血流的充足表面积的任何尺寸和形状的网。该过滤器可以是不同网格尺寸(mesh size)的片或袋。在一个优选的具体实施方式中，考虑到诸如流动条件、应用场所、过滤袋尺寸、和凝固速率这些因素，该网格尺寸被最佳化。
尽管参照优选的具体实施方式和特定实施例描述了本发明，但是，本领域的普通技术人员很容易理解可在不背离如所附权利要求书中所声明本发明的精神和保护范围的情况下可以作出许多其它的变化和修改。

Claims (26)

1.一种用于将假体递送到在心脏内或心脏附近的目标部位的方法，所述方法包括：
在心尖或在心尖附近将递送装置引入到心脏内，其中所述递送装置包括所述假体；
将所述假体推进到目标部位；以及
使所述假体与递送装置在目标部位的脱离。
2.根据权利要求1所述的方法，进一步包括在手术期间使心脏成像的步骤。
3.根据权利要求2所述的方法，其中，所述使心脏成像的步骤通过成像系统进行，所述成像系统选自由超声观察仪器、血管内超声系统、经食道回声系统、经胸回声系统、荧光透视法、荧光屏电影摄影检查术、以及可注射的辐射透不过染料组成的组。
4.根据权利要求1所述的方法，其中，所述假体是临时瓣膜。
5.根据权利要求1所述的方法，其中，所述假体是远端栓塞保护组件。
6.根据权利要求1所述的方法，其中，所述假体是置换心脏瓣膜。
7.根据权利要求6所述的方法，其中，所述目标部位是选自由主动脉瓣和二尖瓣组成的组。
8.根据权利要求7所述的方法，其中，所述递送装置被引入到心脏的左心室内。
9.根据权利要求6所述的方法，其中，所述目标部位是选自由肺动脉瓣和三尖瓣组成的组。
10.根据权利要求9所述的方法，其中，所述递送装置被引入到心脏的右心室内。
11.根据权利要求6所述的方法，其中，所述置换心脏瓣膜包括固定到支架结构的组织瓣膜。
12.根据权利要求11所述的方法，其中，所述支架结构是径向的折叠和可扩展的圆筒形支架。
13.根据权利要求12所述的方法，其中，所述圆筒形支架由镍钛合金制成。
14.根据权利要求6所述的方法，进一步包括在将所述假体与所述递送装置脱离之前移除异常或病变的天然瓣膜的步骤。
15.根据权利要求14所述的方法，进一步包括在移除所述天然瓣膜的所述步骤之前在目标部位附近植入远端栓塞保护组件的步骤。
16.根据权利要求6所述的方法，进一步包括清洁天然瓣膜区域的步骤。
17.一种用于将置换瓣膜递送到心脏内或心脏附近的目标部位的瓣膜置换系统，所述系统包括：
套管针，用于在心尖处或心尖附近穿透心脏；
递送部件，可移动地设置于所述套管针内，所述递送部件具有远端和近端以及膨胀和收缩构件；以及
置换心脏瓣膜，设置于所述递送部件的膨胀和收缩构件上。
18.根据权利要求17所述的系统，其中，所述套管针包括内腔和设置在所述内腔中的止回瓣膜。
19.根据权利要求17所述的系统，其中，所述递送部件是空心管。
20.根据权利要求17所述的系统，其中，所述递送部件进一步包括超声换能器。
21.根据权利要求20所述的系统，其中，所述递送部件进一步包括在所述气囊两端的第一和第二超声换能器。
22.根据权利要求17所述的系统，其中，所述导管进一步包括顶端附件。
23.根据权利要求22所述的系统，其中，所述顶端附件选自由远端栓塞保护系统、临时瓣膜、成像系统、瓣膜去除系统、以及瓣膜清洁系统组成的组。
24.根据权利要求17所述的系统，其中，所述递送部件进一步包括内部元件。
25.根据权利要求24所述的系统，其中，所述内部元件用于插入用于控制顶端偏转的引导线或牵引线。
26.根据权利要求25所述的系统，其中，所述内部元件是用于膨胀和收缩构件的流体注入导管。
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