CN102858276A - 经导管瓣膜结构和用于瓣膜输送的方法 - Google Patents
经导管瓣膜结构和用于瓣膜输送的方法 Download PDFInfo
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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
- 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
- A61F2/2436—Deployment by retracting a sheath
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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
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
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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
- A61F2220/0025—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
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/008—Quadric-shaped paraboloidal
Abstract
一种带瓣膜支架,该带瓣膜支架包括:支架结构,该支架结构具有带有内部区域的大体管状本体部分、第一端、第二端以及纵向轴线;瓣膜结构,该瓣膜结构包括多个小叶并且定位在支架结构的内部区域内;以及可翻转结构,该可翻转结构从支架结构的第一端和第二端中的一个端部延伸出。可翻转结构可相对于支架结构的延伸出该可翻转结构的端部转动。
Description
技术领域
本发明涉及经导管瓣膜的植入。更具体地,本发明涉及经皮植入假体心脏瓣膜的经导管瓣膜结构、输送系统以及方法。
背景技术
病变的或者以其它方式有缺陷的心脏瓣膜可使用各种不同类型的心脏瓣膜手术来修复或置换。一种常见类型的心脏瓣膜手术是在普通麻醉下进行的开放式心脏手术过程,在此过程中心脏停止且血流由心肺旁路机来控制。这种类型的瓣膜手术是高度侵入性的,并且会将病人暴露于多种潜在的风险中,诸如感染、中风、肾衰竭以及例如与心肺旁路机的使用相关的不利作用。
由于开放式手术步骤的缺点,越来越感兴趣的是心脏瓣膜的最小侵入性经皮置换。此种外科手术技术包含在患者皮肤内产生相对较小的开口,由此通达脉管系统。然后,经由类似于导管的输送装置将瓣膜组件插入患者体内并输送至心脏。这种技术经常对于诸如上述开放式心脏手术过程的侵入性较大的手术形式是较佳的。
各种类型和构造的假体心脏瓣膜被用于经皮瓣膜手术中以置换病变的天然人体心脏瓣膜。任何特定的假体心脏瓣膜的实际形状和构造在一定程度上取决于被置换的瓣膜(即,二尖瓣、三尖瓣、主动脉瓣或肺动脉瓣)。一般来说,假体心脏瓣膜的设计试图复制被置换瓣膜的功能,并因此将包括瓣膜小叶状结构。这些小叶状结构可用于心脏瓣膜假体,这包括使用天然瓣膜材料(例如,猪瓣膜)来制造心脏瓣膜。更确切地说,这些生物假体置换瓣膜包括带瓣膜段,该带瓣膜段以某种方式安装于可扩张支架或框架结构内以制成带瓣膜的支架。为了制备这种用于经皮植入的瓣膜,一种类型的带瓣膜的支架起初可设置在已扩张或未褶缩状况下,然后褶缩或压缩在导管的气囊部周围,直至带瓣膜的支架尽可能接近导管的直径。在希望使支架扩张时,例如在支架处于其所期望的植入位置时,气囊膨胀,以提供特定的向外径向力以实现特定的支架扩张。在其它经皮植入系统中,带瓣膜支架的支架可由自扩张材料制成。借助于这些系统,带瓣膜的支架褶缩到期望的尺寸,并例如用套管保持在该压缩状态。使套管从该带瓣膜的支架缩回允许支架在例如处于病人内期望位置时扩张到较大的直径。借助于这些类型的经皮支架输送系统,通常不必以传统方式将假体心脏瓣膜缝合至病人天然组织。
尽管经皮瓣膜置换技术和装置已有进步,但一直希望提供不同的支架或框架结构以及输送系统,来用于以侵入性最小和经皮的方式将心瓣膜输送到植入位点。还持续地期望能够在植入过程中控制瓣膜的入流侧,以控制身体内的布置精确度。
发明内容
在本发明的一个方面中,提供一种输送系统,该输送系统能用在患者解剖结构的多个区域中,其中一个特定的示例构造包括将新的或置换主动脉经股动脉输送至患者的天然主动脉瓣区域。采用本发明,医师能更清楚地确定瓣膜在完全展开之前在患者体内的最终位置。这样,可调节瓣膜的位置以使瓣膜在患者体内的布置优化。
应注意到,在使用其它可获得的系统来植入装置时,一旦可植入的装置附连于输送导管,则在不留下对于植入装置的功能不必要的任何部件的情形下,该装置有时会难于与导管脱开,与此相反,本发明的可植入装置通过使用附连于置换瓣膜的入流周缘的可翻转结构而克服了该问题。提供该可翻转结构以固定地附连于输送系统,易于通过对输送系统和支架的特定操纵而与输送系统脱开,并且一旦植入的瓣膜或装置已展开则还为该植入瓣膜或装置提供额外的结构完整性。此外,本发明的装置包括边缘(例如,装置的入流边缘),能够通过将该边缘直接附连于输送导管而对该边缘进行控制。
在本发明的一个方面中,当将可植入的装置或瓣膜加载到导管或输送系统上时,该装置的可翻转结构定位成最接近输送系统的远侧梢端,且瓣膜及其架子、框架或支架位于可翻转结构近侧。于是,可翻转结构可被认为处于翻转状态。当该装置展开时,可翻转结构运动至不再翻转的状态,而是位于或定位于瓣膜架子的内部。于是,能够为展开的瓣膜提供附加的径向力和更佳的裙部并置。
在本发明的一个方面中,可翻转结构附连于管腔内输送的心脏瓣膜的入流端,然而应理解的是,可翻转结构也可用于使用管腔内和/或经导管输送方法输送的其它装置。可翻转结构的至少一部分可被认为相对于瓣膜翻转,然后例如利用链轮或心轴机构附连于导管梢端或其它的输送系统结构。瓣膜的入流端在导管的梢端区域中保持向下,由此使得该装置能精确地定位在心脏内。可翻转结构然后能缓慢地展开,这使得心脏瓣膜结构在释放之前能完全并置。在释放时,可翻转结构会回复至非翻转位置,在该非翻转位置,可翻转结构会抵靠于瓣膜结构或处于瓣膜结构内。此种附加结构的一个优点是使支架的一部分具有附加层,该附加层能使得整个结构为植入支架的周围器官提供附加的径向力。
在本发明的另一方面中,可翻转结构附连于带支架经导管心脏瓣膜的一个端部,使得在输送和展开过程中,该可翻转结构能为带支架瓣膜提供附加的长度,而在带支架瓣膜展开之后,该瓣膜的总长度不会增大。这是由于可翻转结构转动或翻转,以在支架结构展开之后邻近于支架结构,从而这不会增大支架机构的总长度。
附图说明
借助于附图将进一步阐释本发明,其中在几个视图中,类似的结构用类似的附图标记表示,且其中:
图1是根据本发明的附连有支架或框架结构的输送系统的远侧部分的正视图,其中输送系统的套管相对于支架缩回;
图2是图1所示输送系统的支架和远侧部分的正视图,其中套管进一步缩回;
图3是图1和2所示输送系统的支架和远侧部分的立体图,示出在支架开始释放时该输送系统的捕获机构或可翻转结构;
图4是图1-3所示输送系统的支架和远侧部分的立体图,示出在可翻转结构处于从输送系统进一步释放的位置中时的可翻转结构;
图5是图1-4所示输送系统和支架的远侧部分的正视图,示出刚好在从输送系统完全释放之前的可翻转结构,其中可翻转结构相对于输送系统的纵向轴线处于大约90度;
图6是图1-5所示输送系统和支架的立体图,示出相对于支架处于其释放位置的可翻转结构,该可翻转结构附连于该支架;
图7是输送系统的支架和远侧部分的示意正视图,该支架处于其压缩状态;
图8是图7所示输送系统和支架的示意正视图,该支架处于局部展开状态;
图9是图7和8所示输送系统和支架的示意正视图,该支架处于进一步展开状态;
图10是图7-9所示输送系统和支架的示意正视图,该支架处于其完全展开状态;
图11是根据本发明的支架和所附连的可翻转结构的一部分的示意正视图;以及
图12是图11所示支架和可翻转结构的示意正视图,且可翻转结构相对于支架结构处于非翻转位置。
具体实施方式
如在此所提及地,用在各种装置和方法中的假体心脏瓣膜可包括各种不同的构造,诸如具有组织小叶的假体心脏瓣膜或具有聚合物、金属或组织设计的小叶的合成心脏瓣膜,并可为置换任何心脏瓣膜而专门构造。此外,虽然本文的大部分描述涉及主动脉瓣的置换,但本发明的假体心脏瓣膜一般也可用于置换天然二尖瓣、肺动脉瓣或三尖瓣,用作为静脉瓣,或者用于置换诸如在主动脉瓣或二尖瓣之类区域内的失效生物假体。然而,本发明并不局限于用于心脏瓣膜置换装置和系统,而是可用于各种脉管装置和系统,例如可用于支架移置件、支架、腔静脉过滤器、封堵器等等。
通常,本文所述支架或支架框的一个实施例包括支承结构,这些支承结构包括相对于彼此设置的多个支撑件或线材部,以向心脏瓣膜提供期望的可压缩性和强度。下文还描述了根据本发明的支架或支架框的特定结构的其它细节;然而,一般而言,本文所描述的支架或支架框通常是管状支承结构,该支承结构具有固定有小叶的内部区域。小叶可由多种材料制成,诸如自体同源组织、异种移植组织或本领域已知的合成物。小叶可设置成均质的生物瓣膜结构,诸如猪、牛、马瓣膜。替代地,小叶可彼此设置成独立结构(例如牛或马心包膜小叶)并随后组装至支架框的支承结构,以提供瓣膜结构。在另一替代方式中,支架框和小叶可同时制造,诸如可使用例如在德克萨斯州圣安东尼奥的先进生物假体表面有限公司(Advanced Bio Prosthetic Surfaces Ltd.(ABPS))生产的高强度纳米制造的NiTi膜来完成。支架框支承结构一般构造成容纳三个小叶,然而可设想到,在此所述类型的置换假体心脏瓣膜可包含多于或少于三个小叶。
本发明支架框相对于输送系统的定向和定位可通过支架框的自定向(例如通过支架框的结构和事先植入支架框或瓣膜结构之间的干涉)或者通过支架框的人工定向来实现,以使支架框的结构与解剖结构或事先植入生物假体结构对准,这例如能通过使用荧光镜显像技术来实现。例如,当使本发明的支架框与天然解剖结构对准时,它们对准使得不会堵塞冠动脉,并且天然二尖瓣或三尖瓣应相对于前小叶和/或三角/接缝对准。
本文所描述的支架框的一些实施例可以是一系列线材或线材段,它们设置成能够从塌缩状态过渡到扩张状态。在一些实施例中,包括支承结构的许多单独的线材可由金属或其它材料制成。这些线材设置成使得支承结构允许折叠或压缩到紧缩构造,在此构造中内径小于处于扩张状态下的内径。在塌缩构造下,这种具有附连的瓣膜的支承结构可安装到输送系统上。支承结构构造成使得它们能在期望时诸如通过一个或多个套管相对于支架框长度的相对运动变化到它们的扩张构造。用于此种支架框的输送系统应具有一定程度的旋转和轴向的定向能力,以将新的支架框适当地定位在其期望位置处。
本发明各实施例中的支架框支承结构的线材可由诸如镍钛合金(例如,镍钛诺TM)的形状记忆材料制成。借助于此材料,支承结构可诸如通过施加热量、能量等或者通过去除外力(例如,压缩力)从紧缩状态自扩张到扩张状态。这种支承结构还可多次压缩和再膨胀,而不会破坏支架框的结构。此外,这种实施例的支承结构可由单件材料激光切割出或者由许多不同的部件组装而成。对于这些类型的支架框结构,可使用的输送系统的一个示例包括具有可缩回套管的导管,该套管覆盖支架框直至支架框被部署为止,在此位置,套管可缩回以允许支架框扩张。然而,可设想的是,制造支架的材料构成可随着施加外力而扩张的结构,例如气囊可扩张支架结构。
现参见附图,其中各部件在几个附图中标有相似的附图标记,且首先参见图1和2,示出支架输送系统10的一个实施例的远端。输送系统10包括远侧梢端12、捕获颈环14以及套管16,中心纵向轴20从该远侧梢端延伸出。如图1所示,带瓣膜支架18压缩并加载到输送系统10上,并且相对于远侧梢端12沿近侧方向(即朝向附图左侧)部分地抽回套管16。应注意到,当一开始引入该输送系统10以将带瓣膜支架18输送至所期望的植入位置时,套管16能定位成足够靠近远侧梢端12,以覆盖带瓣膜支架18的所有部分或大部分。例如通过将套管16的远端定位成邻近于远侧梢端12的近端,套管16能可选地定位成还会覆盖或部分地覆盖捕获颈环14,从而在插入过程中,该套管能保护输送系统的更多部分。在将支架输送至患者体内一定位置的过程中,套管16能以此方式定位,直到带瓣膜支架18合适地定位在患者解剖结构内为止。因此,输送系统10的各部件相对于图1所示支架18的构造代表就在带瓣膜支架18处于其所期望的位置之后并且刚好开始通过缩回套管16而释放支架的过程时的状态的一个实施例,而图2示出在套管16从支架进一步缩回时支架18所处状态的一个实施例。
带瓣膜支架18大体包括支架框22,瓣膜附连在该支架框的内部区域内,其中这些附图示出代表性的组织或瓣膜材料24,其示出可用于瓣膜和密封裙部的示例性材料容积。例如通过使用上文所述的材料和/或构造,瓣膜能由多种材料中的任何材料制成并且能以多种不同的方式构造,或者使用其它技术和材料进行制造。在该实施例中示出,支架框22的定位有瓣膜的部分包括线材结构,该线材结构设置成相对正弦或z字形的排,这些排定位成彼此相邻。具体地说,一排线材结构的“峰顶”设置成与相邻排线材结构的“谷底”相遇。瓣膜能够位于沿着支架长度的任何期望位置处,这会与瓣膜在患者解剖结构内的期望位置重合。
一旦带瓣膜支架18在患者体内处于其合适的期望位置,如图2所示,将套管16拉离(即,沿近侧方向)远侧梢端12,以使支架18的远端脱开套管。用于支架18的材料在该实施例中是形状记忆材料,从而将由套管16所提供的压缩力移除会使得支架18能相对于在其远端附近的轴20直径扩张。然而,在支架框的输送过程中,支架框的近端在该位点处在套管16内仍会限制在其压缩状态中。此外,支架框22的远端被可翻转结构28局部地限制以防止径向扩张,该可翻转结构如下文所述附连于输送系统的一部分。在该实施例中,可翻转结构28在一端处永久地或者半永久地通过缝合件附连于密封裙部,而在另一端处临时地附连于输送系统的结构。可翻转结构28通常包括材料环,该材料环围绕该可翻转结构的周缘设置成正弦或z字形形状。可翻转结构28围绕其周缘的峰顶和谷底可具有与该可翻转结构的其它峰顶和谷底相同或不同的尺寸、形状等等。可翻转结构28的第一端局部地限制在捕获颈环14的内直径内,而可翻转结构28的第二端经由缝合件附连于带瓣膜支架18。应注意到,术语“可翻转结构”在本文用于描述支架的如下部分,该部分大体构造成从支架的一个端部延伸出的延伸部,该延伸部可绕支架的端部转动、回转或翻转,以大体沿着支架的一部分延伸。或者,该结构可称为“可外翻的”或者能够相对于支架的结构从内部向外翻。
现在参见图3-6,示出相对于带瓣膜支架18和输送系统10释放可翻转结构28的一个示例过程。为了开始该过程,颈环14保持静止,而链轮型部件30(参见图6)缩回。该部件30附连于管件,该管件骑跨在另一管件,而另一管件再附连于远侧梢端12和颈环14。这样,该部件30能相对于颈环14独立地运动。在图3中,可翻转结构28刚好开始从捕获颈环14中释放,并且该可翻转结构相对于支架18处于其翻转状态。图4示出在可翻转结构28从捕获颈环14进一步释放时的可翻转结构28。图5示出相对于支架框22的远端以大约90度定向的可翻转结构28,该可翻转结构28处于就在从输送系统中释放之前所处的位置。最后,图6示出在可翻转结构28从输送系统10释放之后的可翻转结构,但这在输送系统从支架的区域中移除之前。在此种释放之后,可翻转结构28定位在其相反的或者非翻转位置,其中该可翻转结构定位在支架框22的远端内。由于该结构在该区域的“双层”类型,该结构28为支架框22的远端提供附加的结构完整性。
还应注意到,输送系统10包括如上所述的链轮型部件30,该链轮型部件在图6中可见。该部件30用于在支架18的输送过程中加载和保持可翻转结构28,并且还用于从输送系统10中可控制地释放支架18。在该实施例中,支架的V形结构能放置在部件30的延伸部分上,从而当支架压缩时,支架能限制在部件30和颈环14之间。然而,应理解的是,可使用其它方法和装置来将可翻转结构保持在其所期望的预释放状态中,直到期望从输送系统中释放支架为止。
虽然本文的大部分描述指代用在经导管瓣膜输送操作中的可压缩和可扩张的心脏瓣膜,但本发明的心脏瓣膜结构也可用于更具侵入性的手术形式,例如开放式心脏手术。在这些情形中,支架结构无需是可压缩和可扩张的,但仍可在一个或两个端部处包括可翻转结构,该可翻转结构在支架框附近提供第二支架层。该层例如能为支架提供额外的结构完整性。
还应注意到,可翻转结构可由一种或多种材料制成,这些材料与制造支架的一种或多种材料相同或不同。此外,为了提供具有特定期望性能特征(例如,柔性、强度等等)的最终结构,可翻转结构可由与所附连的支架相同的材料制成,但厚度、形状或其它材料特性在可翻转结构和支架之间是不同的。
图7-12示出类似于上文参照图1-6所描述的实施例类似的本发明实施例。具体地说,这些附图示出输送系统50的远端,该远端包括远侧梢端52、心轴60(例如,链轮型部件)以及套管54。如图7所示,带支架经导管瓣膜56(该瓣膜包括支架框,该支架框在其内部区域内附连有瓣膜)压缩并加载到输送系统50上,并且使用套管54来压缩和覆盖瓣膜56。可翻转结构58从瓣膜56的远端延伸出并且朝向输送系统的远端52延伸,且该可翻转结构58也保持在套管54内。心轴或其它保持机构60相对于远侧梢端52保持可翻转结构58,且心轴60在输送过程中在捕获颈环62内定位在该位点处。
一旦瓣膜56处于其合适的期望位置,如图8所示,将套管54拉离(即,沿近侧方向)远侧梢端52,以使瓣膜56的远端脱开套管。在用于瓣膜56的支架的材料在该实施例中是形状记忆材料时,将由套管54所提供的压缩力移除会使得瓣膜56能直径扩张。然而,在瓣膜的输送过程中,瓣膜56的近端在该位点处在套管54内仍能限制在其压缩状态中。此外,瓣膜的远端由可翻转结构58至少局部地限制以防止径向扩张,该可翻转结构(可选地)利用缝合件或任何其它构造附连于密封裙部,而这不会限制可翻转结构58相对于支架翻转或转动的能力。可翻转结构58可包括材料环,该材料环围绕该可翻转结构的周缘设置成正弦或z字形形状。可翻转结构58围绕其周缘的峰顶和谷底可具有与该可翻转结构的其它峰顶和谷底相同或不同的尺寸、形状等等。可翻转结构58的第一端经由心轴或保持机构60局部地限制在捕获颈环62的内直径内,而可翻转结构58的第二端附连于瓣膜56。
现在参见图9和10,示出相对于瓣膜56和输送系统50释放可翻转结构58。具体地说,图9示出在可翻转结构58从捕获颈环62释放时的可翻转结构58。可翻转结构58相对于瓣膜56处于其翻转状态。图10示出在可翻转结构58从输送系统50释放时的可翻转结构58。在此种释放之后,可翻转结构58会重新定向至其非翻转位置,其中该可翻转结构定位在瓣膜56的远端内。该可翻转结构58会为瓣膜56的远端提供附加的结构完整性。图11和12示出相对于瓣膜56的远端分别处于其翻转和非翻转位置的可翻转结构58的附加视图。
现已经参照本发明的几个实施例对本发明进行了描述。给出前述详细说明和实施例的目的仅是为了清楚地理解本发明。不应从中理解为不必要的限制。对本领域的技术人员显然可对所述实施例进行多种改变而不偏离本发明的范围。因此,本发明的范围不应限于在此所述的结构,而是只由通过权利要求书的语言所描述的结构和那些结构的等同物限定。
Claims (18)
1.一种带瓣膜支架,包括:
支架结构,所述支架结构包括大体管状本体部分、内部区域、第一端以及第二端;
瓣膜结构,所述瓣膜结构包括多个小叶并且定位在所述支架结构的内部区域内;以及
可翻转结构,所述可翻转结构可枢转地附连于所述支架结构的第一和第二端中的一个端部。
2.如权利要求1所述的带瓣膜支架,其特征在于,所述可翻转结构从所述支架结构的第一端延伸出,并且可相对于所述支架结构的第一端枢转。
3.如权利要求2所述的带瓣膜支架,其特征在于,还包括中间材料,所述中间材料位于所述支架结构的第一端和所述可翻转结构之间。
4.如权利要求3所述的带瓣膜支架,其特征在于,所述中间材料包括组织材料。
5.如权利要求2所述的带瓣膜支架,其特征在于,所述可翻转结构能相对于所述支架结构的第一端从第一位置枢转至第二位置,在所述第一位置,所述可翻转结构延伸超出所述支架结构的第一端,而在所述第二位置,所述可翻转结构定位在所述支架结构的内部区域内。
6.如权利要求5所述的带瓣膜支架,其特征在于,在所述可翻转结构处于所述第二位置时,所述可翻转结构在所述支架结构的内部区域内邻近于所述管状本体部分。
7.如权利要求5所述的带瓣膜支架,其特征在于,所述可翻转结构还包括第三位置,所述第三位置位于所述第一和第二位置之间,其中所述可翻转结构在处于其第三位置时大体垂直于所述支架结构。
8.如权利要求1所述的带瓣膜支架,其特征在于,还包括至少一个中间可翻转结构,所述至少一个中间可翻转结构在所述内部区域内可枢转地附连于所述支架结构并且附连在所述第一端和所述第二端之间。
9.如权利要求1所述的带瓣膜支架,其特征在于,还包括密封裙部,所述密封裙部在所述支架结构的第一和第二端的一个端部处围绕所述管状本体的周缘的至少一部分延伸。
10.如权利要求1所述的带瓣膜支架,其特征在于,所述可翻转结构的长度小于所述支架结构的长度。
11.如权利要求1所述的带瓣膜支架,其特征在于,所述可翻转结构包括至少一个线材,所述至少一个线材具有多个峰顶和谷底,所述多个峰顶和谷底定位在所述支架结构的第一和第二端的一个端部的周缘周围。
12.如权利要求5所述的带瓣膜支架,其特征在于,在所述可翻转结构处于所述第二位置时,所述可翻转结构对于所述支架结构的内部区域提供向外径向力。
13.如权利要求1所述的带瓣膜支架,其特征在于,所述支架结构和所述可翻转结构中的至少一个包括形状记忆材料。
14.一种用于将可植入带支架装置输送至患者内腔的输送系统,所述输送系统包括:
纵向轴,所述纵向轴具有近端和远端;
捕获颈环,所述捕获颈环邻近于所述轴的远端;
支架捕获机构,所述支架捕获机构邻近于所述轴的远端并且能相对于所述颈环轴向滑动,其中所述支架捕获机构包括第一位置和第二位置,在所述第一位置,所述支架捕获机构可定位在所述颈环内,而在所述第二位置,所述支架捕获机构与所述颈环隔开;以及
套管,所述套管能相对于所述纵向轴轴向滑动。
15.如权利要求14所述的输送系统,其特征在于,所述支架捕获机构包括从中心芯部延伸出的多个链轮。
16.一种利用输送系统来输送和部署支架的方法,所述输送系统包括纵向轴、捕获颈环、支架捕获机构以及套管,所述纵向轴具有近端和远端,所述捕获颈环邻近于所述轴的远端,所述支架捕获机构邻近于所述轴的远端并且能相对于所述颈环轴向滑动,而所述套管能相对于所述纵向轴轴向滑动,所述方法包括以下步骤:
将支架安装在所述输送系统上,所述支架包括大体管状本体部分、内部区域、第一端、第二端以及可翻转结构,所述可翻转结构具有第一端和第二端,所述第一端可枢转地附连于所述支架的第一端,而所述第二端包括至少一个支架配合结构,其中所述支架捕获机构与至少一个所述支架配合结构配合,并且所述支架至少部分地由所述套管覆盖,所述可翻转结构处于翻转位置;
将所述支架定位在植入位置处;
沿近侧方向轴向地缩回所述套管,以露出所述支架的至少一部分;以及
相对于所述捕获颈环轴向地缩回所述支架捕获机构,以使得所述可翻转结构能绕其第一端枢转,直到所述可翻转结构定位在所述支架的内部区域内为止。
17.如权利要求16所述的方法,其特征在于,所述支架还包括瓣膜结构,所述瓣膜结构包括多个小叶并且定位在所述支架结构的内部区域内。
18.如权利要求16所述的方法,其特征在于,在所述可翻转结构处于所述翻转位置时,所述可翻转结构延伸超出所述管状本体部分的端部。
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US12/711,289 US9226826B2 (en) | 2010-02-24 | 2010-02-24 | Transcatheter valve structure and methods for valve delivery |
PCT/US2011/025854 WO2011106371A1 (en) | 2010-02-24 | 2011-02-23 | Transcatheter valve structure and methods for valve delivery |
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Also Published As
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BR112012021249A2 (pt) | 2018-04-03 |
WO2011106371A1 (en) | 2011-09-01 |
US9226826B2 (en) | 2016-01-05 |
EP2538880A1 (en) | 2013-01-02 |
AU2011220860B2 (en) | 2014-08-14 |
AU2011220860A1 (en) | 2012-09-06 |
EP2538880B1 (en) | 2017-05-10 |
US20110208283A1 (en) | 2011-08-25 |
BR112012021249A8 (pt) | 2018-06-26 |
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