CN102548486A - 用于人工心脏瓣膜的导引器 - Google Patents
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
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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
- A61F2/2427—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
- A61B2017/3425—Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports
Abstract
本公开涉及适于促进人工装置如人工心脏瓣膜插入患者血管系统的导引器的实施方式。在一个实施方式中,导引器包括细长体,所述细长体限定在所述体的远端和近端之间延伸的中央腔。导引器体还可具有纵向延伸的间隙,其沿所述体的长度在远端与近端之间延伸。导引器中的间隙允许使用者通过使缝线穿过间隙和进入中央腔而将导引器置于植入缝线周围。类似地,所述间隙容易通过使缝线和/或递送装置向外通过间隙而将导引器从缝线和/或递送装置移除。
Description
相关申请资料
本申请按照35U.S.C.§119(e)要求享有2009年7月23日提交的美国临时申请号61/228,072的优先权。
发明领域
本发明涉及可用于促进人工心脏瓣膜(prosthetic heart vavle)植入的导引器(introducer)。
发明背景
人工心脏瓣膜已被用于治疗心脏瓣膜疾病多年。固有的心脏瓣膜(如主动脉瓣、肺动脉瓣和二尖瓣)在确保充足血液供应通过心血管系统正向流动中起重要作用。先天性、炎性或感染性病症可使这些心脏瓣膜的有效性降低。这些病症最终可导致严重的心血管损伤或死亡。
当置换固有瓣膜时,人工瓣膜的外科植入一般需要开胸手术,在该过程中,心脏停止,并且患者被置于心肺转流(cardiopulmonary bypass)(所谓“心肺机”)上。在一个普通的外科手术中,切口形成在主动脉中,并且患病的固有瓣叶被切离。一系列植入缝线被固定在固有瓣膜的外周,并且缝线的相对端通过切口被拉出,然后穿过人工瓣膜的缝合环。然后将人工瓣膜“投放(parachuted)”到这一系列缝线下面,直至其靠在固有瓣环(annulus)上。然后,缝线可被打结并切断以将人工瓣膜固定于所述瓣环。
用于引导人工瓣膜进入主动脉的一个具体技术被称为“鞋拔(shoehorn)”技术。在鞋拔技术中,横向切口形成于主动脉根部中,其一般小于人工瓣膜的横截面轮廓。为使瓣膜通过切口,将瓣膜以与切口所限平面相对的角度插入主动脉根部,就像使纽扣穿过纽扣孔一样。可见,该技术增加了手术的复杂性,可引起组织撕裂,并可引起人工瓣膜的损坏。
用于植入人工瓣膜的另一技术包括在主动脉中形成倾斜或“曲棍球棒”状切口。这种切口产生更大的开口用于瓣膜通过,但更难以封闭,因此与直的横向切口相比更容易泄露。
因此,对新型和改进的用于引导人工瓣膜进入患者血管系统的设备和方法存在需要。
发明概述
本公开涉及适于促进人工装置如人工心脏瓣膜插入患者血管系统的导引器的实施方式。在具体的实施方式中,导引器包括细长体(elongated body),其限定出在所述体的远端和近端之间延伸的中央腔。所述体适于通过切口如横向主动脉切开术插入患者血管系统。人工瓣膜可通过导引器推进瓣膜而被引导进入患者血管系统。
导引器体可具有纵向延伸的间隙(gap),该间隙沿远端和近端之间的体长度延伸,其在瓣膜被推进通过切口时使导引器放射状扩展并扩张切口。导引器的间隙还允许使用者通过使缝线穿过间隙并进入中央腔而将导引器置于植入缝线周围。类似地,间隙使导引器易于从缝线和/或递送装置移除——通过使它们向外穿过间隙进行。导引器体可具有锥形远端部分,以促进导引器插入通过切口。
在一个代表性实施方式中,植入人工心脏瓣膜的方法包括在患者身体的血管系统中形成切口;将一根或多根缝线穿过心脏的固有瓣环,并将所述一根或多根缝线向外延伸通过该切口和通过部分人工瓣膜;将导引器置于所述一根或多根缝线周围,并将导引器插入并通过切口,使得导引器的远端和近端在切口的相对侧上;将人工瓣膜沿所述一根或多根缝线滑动并通过导引器,直至人工瓣膜接合(engage)瓣环;从切口移除导引器;以及用所述一根或多根缝线将瓣膜固定于瓣环。
在另一个代表性实施方式中,植入人工心脏瓣膜的方法包括在患者身体的血管系统中形成切口;将导引器插入通过切口并进入患者血管系统;以及提供人工瓣膜,该人工瓣膜被安置在包含细长手柄的递送装置上。本方法进一步包括将人工瓣膜和部分手柄推进通过导引器直至人工瓣膜接合心脏的固有瓣环;和通过使手柄穿过导引器侧形成的间隙将导引器从切口移除并远离手柄周围的位置。
在另一个代表性实施方式中,引导人工装置进入患者血管系统的导引器包括细长体,该细长体具有远端和近端以及从远端至近端延伸穿过该体的中央通道。该体包括两个相对的纵向边缘,其限定出其间的间隙,该间隙从近端延伸至远端。
本发明前述和其他特征和优势从下文的详细描述看将变得更加明显,该详细描述参考附图进行。
附图简述
图1是根据一个实施方式所述的可用于引导人工心脏瓣膜进入患者血管系统的导引器的透视图。
图2是图1所示导引器的底部平面图。
图3是导引器的另一实施方式的透视图。
图4-10示例利用图1所示导引器将人工主动脉瓣膜植入心脏的一个具体程序。
图11示例利用图1所示导引器将人工主动脉瓣膜植入心脏的另一程序。
图12显示根据另一实施方式所述的可用于引导人工心脏瓣膜进入患者血管系统的导引器组件。
图13-17示例利用图12所示导引器组件将人工主动脉瓣膜植入心脏的一个具体程序。
图18是可用于引导人工心脏瓣膜进入患者血管系统的导引器的另一实施方式的透视图。
发明详述
本公开涉及适于促进将人工装置如人工心脏瓣膜插入患者血管系统的导引器的实施方式。下文所述的实例包括在心脏的主动脉瓣环中植入人工瓣膜。但是,导引器也可用于促进人工瓣膜植入心脏的其他固有瓣环。进一步,导引器也可用于引导多种其他人工装置进入其他体腔。
首先参考图1和2,根据一个实施方式,导引器10包括细长体12,该体具有近端14和远端16。体12具有从近端14延伸至远端16的长度L。体12具有近端口18、远端口20、从近端口至远端口纵向延伸通过该体的中央腔或通道22。体12期望地具有在近端口周围环向延伸并从此向外放射状延伸的近端凸缘24。近端凸缘24可具有增大部分(enlarged portion)26,其在使用中充当掌握和操纵导引器的手柄。
在示例的实施方式中,体12具有沿其大部分长度的大体圆柱形和延伸约三分之一体长度的锥形远端部分28。因此,如在图1和2中可见,近端口18的直径大于远端口20的直径。锥形远端部分28促进导引器插入外科切口,如下文所述。体12期望地具有多个成角度间隔的、纵向延伸的间隙30,该间隙30限定多个纵向延伸的、环向排列的指32。指32可相互由非扩张或收缩状态(图1)放射状向外弯曲至扩张状态(图8),从而在人工瓣膜被推动通过导引器远端部分时扩张远端口来容纳人工瓣膜。各间隙30的近端可终止于促进指在其近端弯曲或挠曲的增大圆孔34,其中各指结合(join)体12的其余部分。
体12期望地具有纵向间隙36,其从近端14至远端16延伸该体的全长并限定纵向边缘38。在示例的实施方式中,间隙36从远端16至近端附近的位置具有恒定的宽度,然后从该位置向近端14张大或变宽,在近端形成间隙的增大的口40。间隙36使导引器10容易被安置在缝线和/或递送装置周围和从缝线和/或递送装置移除,如下文进一步所描述。间隙36还使导引器体12放射状扩张,从而在推进瓣膜通过导引器时容纳直径大于导引器的人工瓣膜。在示例的实施方式中,间隙36可被称为永久性(permanent)间隙,因为在导引器处于图1所示其非扩张或收缩状态时纵向边缘36之间存在间隙或开口。
在可选的实施方式中,间隙36的全长或其部分可用在纵向边缘38之间纵向延伸的狭缝(slit)代替。当体处于非扩张状态时,边缘38可彼此接触以封闭狭缝。由于导引器体由弹性材料制成,边缘38可分开以在其间产生开口或间隙,如用于在缝线或递送装置周围安置导引器,如下文所述。类似地,远端部分28可由限定指32的多个狭缝,而非示例性实施方式所示相邻指之间的永久性间隙30组成。
导引器10可由多种适当的材料中的任意一种制成,包括金属(例如,不锈钢或镍钛诺(Nitinol))、合金、聚合物(例如,尼龙或PTFE)、复合材料或其组合。在某些实施方式中,导引器可调整尺寸以用于多种瓣膜尺寸(例如,17-35mm瓣膜)。可选地,导引器可以以不同尺寸的范围提供,而各尺寸适用于一种瓣膜尺寸或一定范围的瓣膜尺寸。
图3显示根据另一实施方式所述的导引器50。导引器50在大多数方面类似于图1和2所示的导引器10。与导引器10不同,导引器50具有凸缘部分52,所述凸缘部分52形成有开口54。开口54可适于接收细长手柄56的远端,该细长手柄56可在使用过程中用于协助定位和操纵导引器。
图4-11示例导引器10在人工心脏瓣膜60植入主动脉瓣环的一个具体程序中的应用。示例性实施方式中的人工瓣膜60包括基本上刚性的、不可折叠的环形框架(annular framne)62、由该框架支撑的多个瓣叶(leaflets)64、缝合环66和从缝合环向下延伸的塑性可扩张支架或支撑框架68。人工瓣膜60可被称为混合瓣膜,因为其组合了不可折叠的外科瓣膜和可扩张支架,该可扩张支架一般被并入微创手术中递送的可扩张人工瓣膜中。人工瓣膜60可被安装于递送装置72的细长轴或手柄的远端。人工瓣膜60和递送装置72的示例性实施方式被进一步描述于共同在审的2009年3月31日提交的美国申请号61/165,455和2009年6月26日提交的美国申请号61/220,968中,在此将其引入作为参考。
如图4所示,切口可形成在主动脉中,以接近主动脉瓣环。一般,虽然并不要求,但固有瓣叶在植入人工瓣膜前被切除,如图所示。多条植入缝线70可以常规方式穿过主动脉瓣环外周,在体的外侧延伸通过切口,然后穿过人工瓣膜60的缝合环66。已经发现,当瓣膜至瓣环的固定由支架68协助时,三条植入缝线足以充分将人工瓣膜固定在植入部位的适当位置。在其他应用中可使用更多或更少数量的植入缝线。
为利用导引器协助人工瓣膜60穿过主动脉的切口,首先将导引器10置于缝线70周围,并插入通过切口。由于导引器具有沿导引器长度延伸的间隙36,其可容易地通过使缝线穿过间隙36而置于切口与瓣膜之间位置处的缝线周围,如图4和5所示。间隙的增大的口部分40促进该过程,因为其允许操作者更容易地引导植入缝线70进入并穿过间隙36。
如图6所示,然后导引器10可通过切口被插入主动脉。锥形远端部分28促进导引器通过切口插入。导引器期望地被定位,使得远端16位于固有瓣环或紧邻固有瓣环的Valsalva窦中。以此方式,人工瓣膜在从导引器远端推进时可被直接引导至期望的植入位置。在导引器被插入主动脉后,外科医师可推动人工瓣膜穿过导引器并且进入主动脉。如果人工瓣膜60的外径大于导引器直径,导引器在人工瓣膜穿过导引器时由于间隙36的存在可放射状扩张,如图6-8所示。此外,指32可彼此放射状向外扩张以容许瓣膜通过导引器的锥形远端部分28。
在示例性实例中,可形成小于在缝合环66处获取的人工瓣膜横截面轮廓(横截面轮廓是在延伸通过缝合环并垂直于瓣膜中心轴的平面上获取的)的切口。因此,在本实例中瓣膜通过切口时,瓣膜对导引器的径向力造成切口扩大,使瓣膜在切口位置滑动通过导引器,同时最小化或防止组织撕裂。此外,可推动人工瓣膜穿过切口,同时将瓣膜保持在瓣膜横截面轮廓大致垂直于穿过导引器和切口移动的线路的位置;换句话说,瓣膜不需倾斜或偏斜,以便使瓣膜穿过切口,如进行常规“鞋拔”技术所需要的。
如图9所示,瓣膜可被推出导引器10远端,并安置于主动脉瓣环上。此时,导引器10可从切口以及从其在缝线70和递送装置72周围延伸的位置被移除。通过将导引器简单地侧向撤离缝线和递送装置同时引导它们通过导引器间隙36,可将导引器从其在缝线70和递送装置72周围延伸的位置移除。由于间隙的存在,导引器可相对于递送装置侧路移除,而无需撤出递送装置近端,该递送装置把持于外科医师的一只手中。有利地,这使外科医师容易和快速地移除导引器,而不必把手移开递送装置近端。
如图9进一步所示,移除导引器10后,可通过如下来部署可扩张支架68:相对于瓣膜向近端推进递送装置的球囊导管74,以移动前端锥体(nose cone)76脱离与支架68的接合和定位气囊导管的球囊78延伸通过支架68。然后球囊78可被膨胀,导致支架68放射状扩张和接合周围组织。然后,收缩球囊,将缝线70打结从而将缝合环66固定至主动脉瓣环,并且将递送装置与瓣膜60分离,从身体移除。可知,在示例性实例中,人工瓣膜通过缝线70和可扩张支架68径向向外的力的组合被固定在固有瓣环的适当位置上。
可知,导引器可用于协助其他类型人工瓣膜的植入。例如,导引器可用于引导常规外科瓣膜(即,不具有可扩张支架如瓣膜60的支架68的外科瓣膜)进入患者血管系统。当植入常规外科瓣膜时,更多数量的植入缝线70——一般约15-21根缝线——被用于将瓣膜固定至固有瓣环。导引器也可用于引导经导管心脏瓣膜进入患者血管系统,该经导管心脏瓣膜可放射状收缩至减小的直径以插入患者血管系统以及在体内部署部位放射状可扩张至其功能尺寸。
此外,导引器10可用于通过任意类型的主动脉切开术(主动脉中的切口)引导瓣膜进入患者血管系统。例如,图11示例了人工瓣膜60通过横向主动脉切开术的植入,其中横向切口通过主动脉根部形成。多根植入缝线可穿过固有瓣环和瓣膜的缝合环66,如上所述。如示,导引器10可通过如下被置于缝线周围:使缝线穿过间隙36,然后将导引器的远端部分28插入主动脉根部直到远端刚好在固有瓣环上。然后人工瓣膜60可推动通过导引器,进入主动脉并进入固有瓣环。通过部署支架68和打结植入缝线70,瓣膜可被固定在适当的位置,如上所述。如果人工瓣膜的直径大于瓣膜经过的主动脉部分的直径,则导引器10在瓣膜通过导引器向瓣环递送时使主动脉沿瓣膜周围扩大,从而允许瓣膜无创伤通过和保护瓣膜本身免受损伤。此外,瓣膜可被引导,同时保持垂直于移动进入和通过主动脉的线路;也就是说,瓣膜无需相对于移动线路偏斜或倾斜以使相对较大的瓣膜经过进入主动脉。
图12示例了根据另一实施方式所述的可用于引导人工装置如人工瓣膜60进入患者血管系统的导引器组件100。该示例性实施方式中的组件100包括导引器101(也被称为套筒)和施用器框架(applicator frame)或安装框架102,该施用框架或安装框架102被配置以将导引器101安置在人工瓣膜周围。导引器101可包括由可拉伸的弹性和/或弹力材料如织物制成的管状套筒。施用器102被配置以保持导引器101在具有大致圆柱形构型的扩张状态,从而允许人工瓣膜在应用时被置于导引器内。施用器102可分别包括近端环和远端环104、106,它们通过多个纵向元件108相互连接,该纵向元件在环之间延伸并使环相互连接。施用器102期望地由与导引器相比相对刚性的材料如金属或塑料制成。
图13-17示例了瓣膜通过在主动脉根部进行的横向主动脉切开术植入主动脉瓣环中。但是,应当理解的是,多种其他主动脉切开术可被进行以接近固有瓣环,利用导引器组件100植入人工瓣膜。在任何情况下,如图13所示,植入缝线70可穿过固有瓣环和瓣膜的缝合环66。通过将缝线70和递送装置的近端(近端在图13中未显示)插入施用器102的远端口和向下滑动组件至图13所示的位置,导引器101首先被置于施用器102周围,以及组件100被置于缝线70周围,如图13所示。施用器102的内径(由近端环和远端环104、106限定)被设置足够大,从而允许瓣膜容易通过施用器。
参考图14,然后瓣膜60可被置于扩张的导引器101中。如通过保持导引器和瓣膜静止并以箭头110的方向向上撤回施用器102,导引器连同导引器101中的瓣膜被从施用器移除。通过将施用器向上撤出缝线和递送装置的近端,施用器102可被移出其在缝线和递送装置72周围的位置。当施用器被移除时,导引器101在整个瓣膜周围萎缩并期望地在整个瓣膜上延伸,覆盖整个瓣膜,使得导引器的远端部分112延伸超出瓣膜的下端,如图15所示。
参考图16,然后导引器101的远端部分被插入主动脉根部。然后通过在导引器101上(以箭头114的方向)保持略微向上的拉力同时在瓣膜60上通过递送装置(以箭头116的方向)向下推动,瓣膜60可被插入主动脉根部。在瓣膜被推动通过导引器并进入主动脉根部时,血管(vessel)扩大,并允许瓣膜被推进通过血管到达主动脉瓣环处的植入部位。当瓣膜位于期望位置时,瓣膜通过递送装置被稳固地维持在适当的位置,并且导引器101被拉出主动脉根部,然后通过将导引器向上移出缝线和递送装置的近端和缝线而从递送装置移除(图17)。然后,瓣膜可通过部署支架68并打结植入缝线70被固定在适当的位置,如上所述。
图18显示根据另一实施方式所述的可用于引导人工装置如人工瓣膜60进入患者血管系统的导引器150。导引器150包括薄壁的、大致管状的体152,该体限定中央腔或通道154。导引器体152由如下构成:由弹性材料如弹性聚合物制成的薄膜,该弹性材料形成管状外膜156和管状内膜158。外膜和内膜在体的相对端彼此结合,从而形成密封的内腔,该内腔可容纳流体,如无菌液体。导引器体呈现足够的弹性以允许内部和外部元件的位置翻转;也就是说,在所述体的一端外膜156可向内翻转并推动进入内腔154,从而成为部分内膜(如箭头160所示),同时在所述体的相对端的内膜158由此向外翻转并移动(如箭头162所示),从而成为部分外膜。
在应用中,可被安置于本文所述递送装置远端的人工瓣膜60(或其他人工装置)可插入导引器150的内腔154中。这可通过推动或促使瓣膜进入导引器一端的开口实现。所述膜的滚动或翻转动作导致导引器“滚动”到瓣膜上或在瓣膜上“滚动”。随着导引器150覆盖瓣膜,导引器的一端被插入主动脉(或患者血管系统的另一部分)中形成的切口。然后瓣膜可被推动通过导引器并进入主动脉。在瓣膜被推进通过导引器时,膜156、158可相对于瓣膜滚动,从而促进其通过腔154。
鉴于本公开发明的原理可应用的多种可能的实施方式,应当理解的是,示例性实施方式仅为本发明的优选实例,不应被用作限制本发明的范围。相反,本发明的范围由所附权利要求限定。因此我们要求保护出现在这些权利要求的范围和宗旨内的全部内容作为我们的发明。
Claims (18)
1.用于引导人工心脏瓣膜进入患者血管系统的导引器,包括
细长体,其具有远端和近端;和
中央通道,其从所述远端至所述近端延伸通过所述细长体;
所述细长体包括两个相对的纵向边缘,所述纵向边缘限定其之间的间隙,所述间隙开口于所述近端。
2.权利要求1所述的导引器,其中所述间隙从所述近端延伸至所述远端。
3.权利要求1所述的导引器,其中所述间隙在与所述近端间隔一定距离的位置具有第一宽度,并在所述近端增加至第二宽度,所述第二宽度大于所述第一宽度。
4.权利要求1所述的导引器,其中所述细长体包括锥形远端部分,所述远端部分包括多个环向排列、可放射状扩张的指,所述指具有限定所述细长体的远端口的远端,所述指可从非扩张状态放射状扩张至扩张状态,从而扩张所述远端口。
5.权利要求4所述的导引器,其中所述远端部分包括在所述指之间纵向延伸的间隙。
6.权利要求5所述的导引器,其中在所述指之间纵向延伸的各间隙的近端终止于增大的圆孔,所述圆孔促进所述指的弯曲或挠曲。
7.权利要求1所述的导引器,其中所述近端包括在近端口周围环向延伸并由此放射状向外延伸的近端凸缘。
8.权利要求7所述的导引器,其中所述近端凸缘具有增大的手柄部分,所述手柄部分从所述凸缘一侧向外延伸。
9.权利要求1所述的导引器,其中所述细长体具有沿其大部分长度的大致管形和延伸所述细长体约三分之一长度的锥形远端部分。
10.权利要求1所述的导引器,其中所述中央通道具有可通过心脏瓣膜的直径,所述心脏瓣膜具有基本刚性的、不可折叠的环形框架。
11.用于引导人工装置进入患者血管系统的导引器,包括:
管状细长体,其具有近端和远端,所述远端在锥形远端部分逐渐变细,并终止于多个纵向延伸的、环向排列的指;
中央通道,其从所述远端至所述近端延伸通过所述细长体,具有可通过心脏瓣膜的直径,所述心脏瓣膜具有基本刚性的、不可折叠的环形框架;
12.权利要求11所述的导引器,其中所述远端部分包括在所述指之间纵向延伸的间隙。
13.权利要求12所述的导引器,其中在所述指之间纵向延伸的各间隙的近端终止于增大的圆孔,所述圆孔促进所述指的弯曲或挠曲。
14.权利要求11所述的导引器,其中所述细长体包括两个相对的纵向边缘,所述纵向边缘限定其之间的间隙,所述间隙从所述近端延伸至所述远端。
15.权利要求14所述的导引器,其中所述间隙在与所述近端间隔一定距离的位置具有第一宽度,并在所述近端增加至第二宽度,所述第二宽度大于所述第一宽度。
16.权利要求11所述的导引器,其中所述近端包括在近端口周围环向延伸并由此放射状向外延伸的近端凸缘。
17.权利要求16所述的导引器,其中所述近端凸缘具有增大的手柄部分,所述手柄部分从所述凸缘一侧向外延伸。
18.权利要求11所述的导引器,其中所述锥形远端部分延伸所述细长体约三分之一长度。
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PCT/US2010/042697 WO2011011481A2 (en) | 2009-07-23 | 2010-07-21 | Introducer for prosthetic heart valve |
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WO2011011481A3 (en) | 2011-05-05 |
EP2456363B1 (en) | 2018-01-24 |
EP2456363A2 (en) | 2012-05-30 |
US8858621B2 (en) | 2014-10-14 |
EP2456363A4 (en) | 2014-01-29 |
US20130282112A1 (en) | 2013-10-24 |
CA2768496C (en) | 2017-06-13 |
US20110022165A1 (en) | 2011-01-27 |
WO2011011481A2 (en) | 2011-01-27 |
CA2768496A1 (en) | 2011-01-27 |
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