CN101198296B - 心脏瓣膜传送系统 - Google Patents
心脏瓣膜传送系统 Download PDFInfo
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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
- 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
-
- 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
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
Abstract
传送系统,用于将人工心瓣膜传送至人体脉管系统内原来的瓣膜位置上。该人工瓣膜被置于气囊导管末端处的气囊上。该气囊导管穿过传送套管组件和手柄。拉线从手柄通过直到该传送套管组件的远端。开启手柄拉拉线,其使得该传送套管组件的有槽管里的开口关闭,从而使得该传送套管组件弯曲。可伸展的盖子被置于有槽管之上,以使可操纵导管偏离直的位置。一旦前进到原来的瓣膜位置,该人工瓣膜通过给气囊充气被展开。
Description
技术领域
本发明涉及用于将人工瓣膜(prosthetic valve)传送至心脏的系统。更具体地,本发明涉及改良的用于将人工瓣膜传送至人心脏的可操纵的传送系统。
背景技术
导管是本领域公知的,并且通常被用于到达身体内的各个部位,而这些部位是通过外科手术不容易到达的,或者希望不通过手术到达的。导管的有用性很大程度上受到导管能成功地操纵通过小血管和周围的急弯的能力的限制,例如在主动脉弓的周围。
多年来,已经推出各种有利于穿过复杂血管的可操纵导管。举例来说,一些公知的装置使用了一系列相连的片段,每一片段具有这样的形状,这样的形状允许导管形成弯的部分以有利于满足特定的需要。然而,使用许多相连的片段是复杂且昂贵的。
以下这种装置也是本领域公知的,其中从中空的通管丝中已经取出某些部分,因此允许该中空丝在已经取出某些部分的区域弯曲。然而,这种类型的已知器件被用作通管针,而且已经不适合用在可操纵导管上。
这种装置是本领域公知的,其中弹带被应用到可操纵导管里,其中一个弹带具有与该器件弯曲方向相反的自然弯曲,因此使得该器件具有稳定性。然而,这些带给该器件增加了不必要的复杂性,并且因此对于许多应用是不期望的。
尽管多年来已经推出各种可弯曲并且可操纵的器件,但是现统,其有利于移植和/或治疗装置穿过病人的血管前进至治疗部位。期望这样的系统克服与现有装置相关的缺点。也期望这样的系统是通用的、可靠的并且易于使用。本发明正是用于解决这种需求。
发明内容
本发明优选的实施方式提供了一种心脏瓣膜传送系统,其将人工(即替换)心脏瓣膜传送至人体脉管系统内原来的瓣膜位置。该传送系统包括传送套管组件,其具有可操纵部件以有利于穿过这些弯曲。该系统非常适合于通过主动脉(即以逆行方法)推进人工瓣膜,以替换狭窄的主动脉瓣膜。
在一个优选的实施方式中,该心脏传送系统包括管状套管、与该套管远端连接的选择性地可操纵的部分、延伸穿过该套管和可操纵部件的伸长球状导管和沿着该伸长气囊导管的远端部分置于可膨胀球上方的人工瓣膜。该套管、可操纵部件、气囊导管和人工瓣膜被装配成单个组件,所述组件前进穿过病人的脉管系统。在前进期间,该人工瓣膜被置于该可操纵部件远端部分的附近,并且如果需要可从那里被推进。
在一种变例中,该心脏瓣膜传送系统的套管包括沿该套管的一边延伸的第一和第二外腔。拉线穿过第一外腔,途经该可操纵部件直到该操纵部分的远端部分,并且通过可操纵部件和通过第二外腔返回。该拉线优选地通过旋转手柄组件启动,其中该旋转手柄组件位于该套管附近。
在另一变例中,该可操纵部件包括具有第一直的位置和第二弯曲的位置的有槽管。该可操纵部件可以形成为不锈钢假管的至少一部分。在一个优选的实施方式中,该套管由聚醚嵌段酰胺(polyetherblock amide)形成,被称为Pebax,并且包括靠近其远端的软的硬度计(soft durometer)Pebax。
该人工瓣膜可位于可操纵部件的远端,以致使可操纵部件的远端部分毗连于人工瓣膜的近端。可选地,罩可以与可操纵部件的远端连接。在进入病人的脉管系统期间,该罩环绕在人工瓣膜的至少一部分上。
在另一实施方式中,心脏瓣膜传送系统包括具有主腔的传送套管组件、形成传送套管组件的可操纵部件的有槽管,该可操纵部件具有第一构件,其中的可操纵部件是直的,和第二构件,其中的可操纵部件是弯曲的。该可操纵部件用盖子封套,其中该盖子是可伸长的,如此以致该盖子使该可操纵部件从第二构件偏斜至第一构件。伸长气囊导管延伸穿过该传送套管组件的主腔,并且人工瓣膜被安装到位于气囊导管的远端的气囊上。该可操纵部件优选地通过拉线起作用,其是通过安装于该传送套管组件的近端的旋转手柄启动。该盖子优选地用软的刚性体聚醚嵌段酰胺制成,所述聚醚嵌段酰胺被称为Pebax。该套管优选地用聚醚嵌段酰胺制成,并且包括靠近其远端的软硬度计Pebax。
在另一实施方式中,将人工瓣膜传送至病人原来的瓣膜位置的方法涉及将人工瓣膜置于气囊导管的气囊上,以及将该气囊导管置于具有可操纵部件的传送套管组件的内部,所述可操纵部件通过沿该传送套管组件的长度的拉线来启动并且被连接到手柄的移动构件上。该人工瓣膜这样被推至原来的瓣膜位置的:通过推该瓣膜,穿过病人的髂和股动脉,到达主动脉弓之上,并且直到原来的瓣膜位置,由此当手柄以第一方向旋转时,该移动构件拉此拉线使得该可操纵部件弯曲,并且当手柄以第二方向旋转时,该移动构件松开拉线,允许该传送套管组件变得刚直,以使该可操纵部件伸直。到达原来的瓣膜位置时,该气囊被充气使人工瓣膜展开。
在一种变例中,当可操纵部件被弯曲时人工瓣膜被推穿过主动脉瓣膜位置的狭窄小叶。在另一变例中,该气囊导管相对于该传送套管组件被远端地推进,直到该人工瓣膜位于原来的瓣膜位置内。该人工瓣膜优选地包括支撑瓣膜结构的展幅部分。因为该传送套管组件提供可操纵性,在前进到主动脉弓上方的期间该展开部分的外表面可以基本上被暴露,而没有损伤主动脉。为了增强的推力,当将人工瓣膜推进至原来的瓣膜位置时,该可操纵部件的远端毗连展开部分的近端。
在另一实施方式中,将人工瓣膜传送至原来的瓣膜位置的方法包括将可膨胀的人工瓣膜置于沿着气囊导管的远端部分的气囊上,以及将该气囊导管置于具有可操纵部件的传送套管组件的内部,所述可操纵部件通过拉线来启动,并且当选择性地调整可操纵部件的弯曲以利于前进时,将人工瓣膜和传动套管组件基本上作为单个的单元推向原来的瓣膜位置。当人工瓣膜采用逆行的方法(即在主动脉弓上方)被推进时,在定位到主动脉弓之后,该人工瓣膜可以被推到传送套管组件的外面。更特别地,该人工瓣膜可能从该传送套管组件被推到原来的瓣膜位置里。该气囊被充气以使可膨胀人工瓣膜展开。
附图说明
参考说明书、权利要求书和本文的附图,本发明的特征和优点将逐渐被意识到同时逐渐被更好地理解;
图1是根据本发明的一个优选实施方式所述的将心脏瓣膜传送至原来的瓣膜位置的心脏瓣膜传送系统的侧视图;
图2是用在传送系统上的手柄的横截面图;
图3A和3B分别是形成手柄部分的第一中心构件(coremember)的透视图和横截面图;
图4A和4B分别是置于该中心构件周围的部分带螺纹的构件的透视图和横截面图;
图5A和5B分别是旋转手柄的侧视图和横截面图;
图6A和6B分别是形成手柄另一部分的第二中心构件的透视图和横截面图;
图7A和7B分别是置于该第二中心构件周围的毂的透视图和横截面图;
图8是引导管的侧视图,所述引导管具有通道以滑动地容纳拉线;
图9是套管的透视图,所述套管被制备有中心腔;
图10是传送套管组件远端部分的横截面图;
图11是提供有可操纵部件的弯曲管的侧视图,其中为了说明,该弯曲管已经被平放;
图12是根据可选的实施方式所述的传送套管组件部分的横截面图;
图13是该传送套管组件的罩部分的横截面图;
图14A和14B分别是用于形成图13的罩部分的罩的透视图和横截面图;
图15A、15B和15C分别是用于形成图13的罩部分的环的透视图、横截面图和仰视图;
图16是该心脏瓣膜传送系统所用的设计的气囊导管的横截面图;
图17A和17B分别是形成图16的气囊导管部分的气囊的透视图和横截面图;
图18A和18B是该传送系统远端的横截面图,其中图18A阐述的是置于该罩远端的人工心脏瓣膜的第一实施方式,以及图18B显示的是置于该罩之内的人工心脏瓣膜的第二实施方式;
图19是引导鞘组件的侧视图;
图20是装载组件的分解透视图,所述装载组件用于将气囊导管和人工瓣膜装载入引导鞘组件;
图21A和21B是阐述将该传送系统插入该装载组件的侧视图;
图22是阐述该传送系统、引导鞘组件和装载组件之间关系的侧视图;和
图23是使用期间的传送系统的侧视图,阐述了该人工心脏瓣膜在原来的瓣膜位置展开,以替换有缺陷的原瓣膜的功能。
具体实施方式
现在参考图1,为了说明的目的,显示的是心脏瓣膜传送系统10的一个优选的实施方式,其用于将人工瓣膜11传送至人心脏的患病的主动脉瓣膜12。该传送系统非常适合将人工瓣膜11穿过病人的脉管系统和主动脉弓13上方,直至传送到患病的瓣膜12附近的位置上。
该传送系统10一般包括引导线14和气囊导管15,该气囊导管被设计在引导线14上方以利于推进。沿着球形导管的远端部分提供有该人工瓣膜11。该气囊导管15包括管部分16和在管部分16的近端的手柄/支撑17。该气囊导管15的管部分16被容纳在传送套管组件18之内。该传送套管组件一般包括套管19、可操纵部件20和罩部分21。该传送套管组件18的近端被安装到手柄22上。该传送系统10穿过引导鞘组件400和载体组件500,它们两个都将在下面被更详细地描述,以到达身体血管并且传送该瓣膜11。
参考图2,在该传送套管组件18的近端的手柄22一般包括端帽23、可调节部分24和止血部分25。该可调节部分24包括第一中心构件26、环绕第一中心构件26的部分带螺纹构件27和环绕部分带螺纹构件27的旋转手柄28。该止血部分25包括第二中心构件29和环绕第二中心构件29的毂30。止血管31伸出毂30之外。引导管32被放在手柄22之内,这将在下面被更详细地描述。
参考图3A和3B,第一中心构件26一般是管状的,其具有纵向延伸的通道33。环状凸缘34形成该第一中心构件26的近端36。第一槽形开口38允许从第一中心构件26的外表面进入该通道33并且沿着第一中心构件26的长度方向的连通。第二狭槽40沿着第一中心构件26的外表面长度方向,穿过远端42直至凸缘34。该凸缘34包括第一紧固件开口44,其从第一中心构件26的外表面径向地伸出。位于狭槽40近端的纵向延伸入口46,从狭槽40的近端壁47延伸入第一紧固件开口44。
参考图4A和图4B,该部分带螺纹的构件27具有近端48和远端50。部分带螺纹构件27一般是管状的,其具有纵向延伸的通道52。关于近端48,该部分带螺纹的构件27的外表面具有外部的螺纹54。该螺纹54包括径向延伸的销钉开口56,其延伸到该部分带螺纹的构件27的通道里。关于远端50,该部分带螺纹的构件27的外表面形成环形的凹槽58。该部分带螺纹的构件27的外表面也形成锥形表面60,其位于该环形凹槽58的远端附近,朝向远端50。环状尖端61形成该部分带螺纹的构件27的远端50。
参考图5A和5B,旋转手柄28优选地包括含有近端62和远端63的细长圆筒,并且包括纵向延长的通道64。在其外表面,旋转手柄28包括沿其长度延伸的槽纹部分66。在其内表面,旋转手柄28包括从远端63向内延伸的带螺纹部分68、与带螺纹部分68最接近的第一环状凹槽70、从内表面向内延伸的与第一环状凹槽70毗连的环状凸缘72、以及与旋转手柄28的近端62毗连的第二环状凸缘74。紧固件开口75穿过旋转手柄28的外表面直到旋转手柄28的通道64的区域内的内表面,近端毗连于第二环形凸缘74而远端毗连于旋转手柄28的近端62。检修孔或检查口(access opening)76穿过旋转手柄28的外表面直到旋转手柄28的通道64的区域内的内表面,其远端毗连于第二环形凸缘74而近端毗连于环状凸缘72。第二检修孔77也是从旋转手柄28的外表面延伸至螺纹部分68的近端处的内表面。
参考图6A和6B,第二中心构件29一般是管状的,并且包括从中延伸的通道78。第二中心构件29平的部分80进一步限定了其外表面。第二中心构件29的外表面包括沿其长度方向纵向延长的狭槽82。第二中心构件29也包括纵向延伸的狭槽84,所述狭槽穿过外表面的平的部分80并进入第二中心构件29的通道78。
参考图7A和7B,彀30是由通过锥形部分87所连接的第一和第二圆筒部分85、86形成的。通道88延伸穿过彀30。通道88在大小上增加了锥形部分87同时将第一圆筒部分85过渡到第二圆筒部分86。止血阀开口90倾斜地从第二圆筒部分86的外表面延伸至其内表面。在彀30的近端92,内表面包括环状主凹槽94,其形成了通道88的近端的轴肩。另外的半圆筒状的凹槽96被定位于环状主凹槽94的周围。第二环状凹槽98环绕彀30的内表面延伸,在其区域内半圆筒状的凹槽96被定位其中,留下单个凸缘100,所述凸缘沿着彀30的近端92处的内表面径向地向内延伸。
显示在图8中的引导管32是管状的并且具有纵向延伸的通道。近端110和远端112都是直的并且相互构成了角度关系。过渡部分113是弯曲的,并且连接着近端和远端部分110、112。
手柄22的各个构件部分优选地如图2所示被组装。第一推力垫圈114被置于第一中心构件26的外表面上,其远端毗连于第一中心构件26的凸缘34(参见图3A),并且第一中心构件26通过旋转手柄28的近端62(参见图5A)被插入旋转手柄28里。第二推力垫圈116靠近第一中心构件26的近端36放置。第一推力垫圈114被夹在旋转手柄28的环状凸缘72与第一中心构件26的凸缘34之间。凸缘34在位于旋转手柄28的环状凸缘72与第二环状凹槽74之间的区域上。扣环118被置于第二环状凹槽74内(参见图5B)并且接触第二推力垫圈116,因此保留了第一中心构件26的位置。
第一中心构件紧固件(未示出)啮合第一中心构件26的第一紧固件开口44(参见图3B)。球轴承122被置于第一紧固件开口44内。旋转手柄28的检修孔76(参见图5B)允许第一中心元件紧固件进入。
部分带螺纹构件27从旋转手柄28的远端63被旋进手柄28里。部分带螺纹构件27的外部螺纹54与旋转手柄28的内表面螺纹部分68相啮合。第一中心构件26位于部分带螺纹构件27的通道52内部。如图2所示,当部分带螺纹构件27被完全啮合在旋转手柄28内时,部分带螺纹构件27的近端48毗连于旋转手柄28的环状凸缘72。
销钉124与部分带螺纹构件27的销钉开口啮合(参见图4B),并且从部分带螺纹构件27的外表面延伸入第一中心构件26的第一狭槽开口38。当部分带螺纹构件27被完全啮合在旋转手柄28内时,销钉124位于与第一环状凹槽70相对应的旋转手柄28的通道64的区域内(参见图5B)。当部分带螺纹构件27被旋进旋转手柄28内并且销钉开口56、第二检修孔77和第一中心构件26的第一狭槽开口38被对准时,销钉124通过旋转手柄的第二检修孔77被置于部分带螺纹构件27的销钉开口56内。
端帽23被固定到旋转手柄28的近端62上。端帽23包括圆筒状的第一接触表面126,其与旋转手柄28的内表面相接触,以及第二接触表面128,其与旋转手柄28的近端62相接触。通道130延伸到端帽23并且与旋转手柄28的通道64相连通设置。端帽23的第一接触面126与旋转手柄28的紧固件开口75对准。使螺钉(未示出)啮合紧固件开口75以将端帽23固定到旋转手柄28上。
第二中心构件29被置于彀30的通道88里。第二中心构件29的狭槽开口84(参见图6B)与彀30的止血阀开口90(参见图7B)对准。板层134被置于毗连于第二中心构件29近侧的彀30的环状主凹槽94内。板层134优选地用聚异戊二烯制成,并且包括中央开口136,其与第二中心构件29的通道88相连通设置,以及引导管开口138,其与第二中心构件29的狭槽82相连通设置。板层126可被连接于彀30的内表面上。
引导管32的近端部分110(参见图8)被插入到第一中心构件26的狭槽40里。引导管32穿过板层134。引导管32的远端部分112被插入到第二中心构件29的狭槽82内。
部分带螺纹构件27的环型尖端61(参见图4B)被压入板层134,并且彀30近端92处的单个凸缘100(参见图7A)与部分带螺纹构件27的环状凹槽58啮合,以将彀30连接到部分带螺纹构件27上。在与部分带螺纹构件27的环状凹槽58啮合前,凸缘100沿着部分带螺纹构件27的锥形表面60依附。在部分带螺纹元件27与彀30装配之后并且当部分带螺纹构件27被完全啮合到旋转手柄28里时,彀30的近端92毗连旋转手柄28。另外,如图2所示,引导管32的中心部分113穿过板层134。
参考图9,套管19优选是具有中心内腔139以及第一和第二外腔140、141的伸长管状结构。套管包括近端142和远端143、外表面144、和内表面145。套管20可以用任何合适的材料制成,但优选地用从聚醚嵌段酰胺形成的热塑性弹性体制成,所述聚醚嵌段酰胺商业上可得到为Pebax。关于远端143,套管19包括能弯曲的软硬度计部分。套管19的软硬度计部分(soft duromether section)优选地用55DPebax制成,并且如下所述能够弯曲。套管19的其余部分优选地用72D Pebax制成,所述72D Pebax比55D Pebax更硬。72D Pebax的硬度防止套管过量地弯曲,因此使得操作者能将传送系统10推过潜在收缩的身体血管,并且允许传送系统10更有效地跟踪至原来的瓣膜位置,如下所述。套管19也能用沿其长度方向的任何位置的金属丝编织物制成。金属丝编织物也能对传送系统10的硬度和推力起作用。
参考图10,传送套管组件的可操纵部件20以横截面形式显示。可操纵部件一般包括弯曲管146和盖子148。弯曲管146优选是管状的,其具有内表面150、外表面152和沿其延伸的通道154。弯曲管146进一步通过近端156、中心部分158和远端160限定。参考图11,在与近端156毗连的弯曲管146上提供有多个V-形凹口162,例如通过激光切割。凹口162被定形以提供尖的倒钩164。沿着弯曲管146的中心部分158,提供有周围延伸的伸长开口166。每个伸长开口166优选地包括用弯曲部分170连接的两个伸长部分168。在伸长开口的末端提供有圆形部分172。管部分174保持基本上完整,并且在下面被更详细地描述。凹口176在弯曲管146的远端160处形成。在一个优选的实施方式中,弯曲管146用不锈钢亚管(hypo-tube)制成。
再次参考图10,盖子148优选地是管状的,其具有近端和远端178、180,并且包括外表面182和内表面184,带有从中纵向延伸的通道186。在一个优选的实施方式中,盖子148用软硬度计材料例如55D Pebax制成。如下所述,盖子148的软硬度计的55D Pebax允许它伸长和弯曲。
可操纵部件20是通过将弯曲管146放到盖子148内而组装。如下面所概述,在组装使得可操纵部件20具有期望的特征之前,盖子148可以被拉伸。弯曲管146的外表面与盖子148的内表面接触。盖子148的近端178从弯曲管146的近端156向近侧延伸,并且盖子148的远端180从弯曲管的远端160向远侧延伸。
参考图12,可操纵部件20可选的实施方式包括具有近端190和远端192的连接器188。连接器188是管状的,具有从中纵向延伸的通道194。环状凸缘196从连接器188的内表面198突出出来。
为了装配包括连接器188在内的可操纵部件20的可选实施方式,弯曲管146的近端156被插入到连接器188的通道194内,直到它毗连环状凸缘196。弯曲管146的外表面152接触连接器188的内表面198,并且可利用粘合粘附上去。盖子148被置于弯曲管146和连接器188的上方。连接器188的近端190从盖子148的近端178向近侧延伸,并且盖子148的远端180从弯曲管146的远端160向远侧延伸(参见图10)。
参考图13,罩部分21被显示在截面中。该罩部分21包括罩200和环202。参考图14A和14B,罩200优选地是圆筒状的,并且包括三个连续的圆筒状部分:靠近近端206的边缘204、靠近远端210的主体208和位于两者之间的颈212。通道213延伸穿过罩200,其包括内表面216和外表面218。狭槽214从罩200的近端210直到颈212内。该颈212具有比边缘204和主体208更小的圆周,使得套管220沿着罩200的外表面218。
现在参考图15A至图15C,环202具有近端222、远端224和沿其纵向延伸的通道225。环202包括近端外表面226、远端外表面228和内表面230。外表面232与环202的近端和远端外表面226、228垂直,并且连接着近端和远端外表面226、228,其一般是相互平行的。内表面230包括向远端224倾斜的表面234,使得环的通道225靠近环202的远端224处直径增加。
狭槽236延伸到环202的远端内,并且穿过远端外表面228到达内表面230并且与环的中心轴202平行,使得狭槽表面238与外表面232相对。第一内腔240和第二内腔242从狭槽表面238延伸至环202的外表面232。近端外表面226也包括第一半圆筒状凹槽244和第二半圆筒状246,其与环202的中心轴平行并且穿过近端222直到环202的外表面232。第一圆筒状凹槽244与第一内腔240对准,并且第二圆筒状凹槽246与第二内腔242对准。
依照根据图13,罩部分21通过将罩200的近端插入环202种而形成的。边缘204弯曲以允许这一点。环202密和地装配在套管220内(参见图14B),使得环202的内表面230以及近端和远端222、224(参见图15A)接触罩200的外表面218。环202被定位使得罩200的狭槽214中的任一个(参见图14A)与环202的狭槽236对准。
参考图16,气囊导管15包括管部分16和支架17。管部分16包括导向线(guidewire)轴248、气囊轴250,它们两个都被连接到支架17上,以及气囊252。具有近端256和远端258的导向线轴248包括内表面260、外表面262和从中纵向延伸的通道264。根据所需要的刚性和弹性,导向线轴248沿其长度方向的不同部分处可用尼龙、编织的不锈钢丝或Pebax制成。Teflon可被用于制成导向线轴248的内表面260。具有近端266和远端268的气囊轴250包括内表面270、外表面272和从中纵向延伸的通道274。根据所需要的刚性和弹性,气囊轴250沿其长度方向的不同部分处可用尼龙、Pebax或编织的不锈钢丝的任意组合制成。
现在参考图17A和17B,气囊252具有近端276和远端278,包括内表面280、外表面282和从中纵向延伸的通道284。当从近端276向远端278观看时,气囊252包括五部分:第一细长部分286、第一椎形部分288、主圆筒状部分290、第二锥形部分292和第二细长部分294。气囊252可用尼龙制成,并且额定爆破压力为6-8atm。在优选的实施方式中,气囊的膨胀直径在大约20至28mm的区域内,并且更优选地在大约23mm。
再次参考图16,支架17包括丝线入口开口296、流体入口开口298和主轴开口300。丝线入口开口296包括内表面302,并且主轴开口300同样地包括内表面304。开口296、298、300被布置成使得相互连通。
气囊导管15如图16所示被装配。导向线轴248被插入到主轴开口300内。导向线轴248的近端被置于丝线开口296内,并且导向线轴248的外表面262被固定到丝线入口开口296的内表面302上,例如通过粘附。导向线轴248具有比主轴开口300小的直径,并且因为这样,不会接触到主轴开口300的内表面。
气囊轴250被置于导向线轴248的上方。气囊250的近端266被置于支架17的主轴开口300里,并且气囊轴250的外表面272被固定到主轴开口300的内表面304上。如图1 6所示,导向线轴248具有比气囊轴250小的直径,并且导向线轴248的外表面262不会接触到气囊轴的内表面270,以允许空气流动。
导向线轴248的近端256从气囊轴250的近端266向近侧延伸,并且导向线轴的远端258从气囊轴250的远端268向远侧延伸。
气囊252的近端276被置于气囊轴250的远端268上方。第一细长部分286区域内的气囊252的内表面280被固定到气囊轴250的外表面272上。气囊252的远端278被置于导向线轴248的远端258之上。第二细长部分294区域内的气囊252的内表面280被固定到导向线轴248的外表面262上。气囊252可被固定到气囊轴250和导向线轴248上,通过涉及用紫外光或激光焊接进行的粘合剂的固化方法。
沿着导向线轴248将第一和第二标记带306、308置于气囊252的通道284内。标记带306、308可通过粘合剂或模锻被固定到导向线轴248的外表面262上。第一标记带306的定位大致对应着第一椎形部分288与气囊252的主圆筒部分290之间的过渡部分(参见图17B)。第二标记带308的位置大致对应于主圆筒部分290与气囊252的第二锥形部分292之间的过渡部分(参见图17B)。为了用荧光检查,本领域公知的方法,标记病人体内气囊导管19的位置,标记带306、308可用百分比90的铂和百分比10的铱制成。位于气囊252远端处的软尖端310被置于导向线轴248的远端258的上方。
传送套管组件18通过将套管19和可操纵部件20连接制成。套管19的远端143被插入盖子148的通道186和弯曲管146的通道154内,如图10所示。套管19相对于可操纵部件16被定位,使得第一和第二外腔140、141与弯曲管146的伸长开口166的弯曲部分170对准。套管19的外表面144被固定到弯曲管146的内表面上,例如通过热和粘合剂连接。另外,倒钩164可以与套管19的远端143啮合,以使其连接。通过粘合剂或通过热连接,盖子148的内表面184也被固定到盖子148近端178处的套管19的外表面上。
在涉及连接器188的可选实施方式(参见图12)中,套管19的外表面144在其远端被固定到朝向连接器188近端190的连接器188的内表面198上。套管19的远端143毗连于连接器188的环状凸缘196。
罩部分21也被连接到可操纵部件20上,以构成传送套管组件18(参见图10)。罩200的近端206在盖子148的远端180处被插入到盖子148的通道186内。罩200的近端206在弯曲管146的远端160处进一步被插入到弯曲管146的通道154内。罩200的狭槽214与弯曲管146的凹口176对准(也参见图11和14A)。
边缘204区域内的罩200的外表面218被固定到弯曲管146的内表面150上。该环202的近端外表面226在靠近弯曲管146的远端160处被固定到弯曲管146的内表面150上。弯曲管146的远端160与环202的外表面232毗连。罩部分21可用机械结合物和粘合剂被固定到弯曲管146上。
盖子148的内表面184被固定到环202的远端外表面228上。盖子148的内表面184也被固定到主体208区域内的罩200的外表面218上。这些连接可通过粘合剂或热连接或两者来实现。罩200的主体208从盖子148的远端180向远侧延伸。
当套管19的近端142被插入到彀30的通道88内并且套管19的外表面144被固定到彀30的内表面上,例如通过粘合剂时,传送套管组件18被连接到手柄22上。
图2中所示的拉线312被插入到传送系统10里。拉线312的第一端被置于第一中心构件26的第一紧固件开口44里。第一中心构件紧固件(未示出)将压力施加在球轴承122上,其将拉线312稳固在第一紧固件开口44里。拉线312穿过第一中心构件26纵向延伸的检修孔46(参见图3B)。拉线312穿过位于第一中心构件26的狭槽40里的引导管32的通道、板层134的引导管开口138、和第二中心构件29的狭槽82,并且然后穿过彀30的通道88。然后,拉线312穿过套管19的第一内腔140(参见图9)。拉线312离开套管19并且穿过弯曲管146的通道154(参见图10)。拉线312穿过第一半圆筒凹槽244和环202的第一内腔240。拉线312靠着环202的狭槽面238被拉紧。然后拉线312被返回穿过第二内腔242和环202的第二半圆筒凹槽246。拉线312再次穿过弯曲管146的通道154。拉线312穿过传送套管19的第二外腔141、彀30的通道88(再次)、引导管32的通道(再次)和第一中心构件26的狭槽40的检修孔46。借助球轴承122上第一中心构件紧固件(未示出)所施加的压力,其稳固拉线312,拉线312的第二末端被固定到第一中心构件26上。
现在参考图1和16,现在将更详细地描述心脏瓣膜传送系统10优选的使用方法。本文所公开的装置和方法特别适合代替狭窄的主动脉瓣膜。本领域技术人员将认识到:在将人工瓣膜在主动脉瓣膜内展开之前使狭窄的主动脉瓣膜预膨胀(pre-dilate)可能是必须的。预膨胀增加了通过主动脉瓣膜的流通面积并且产生足够大小的小叶开口以容纳人工瓣膜。预膨胀优选地使用可膨胀构件来实现,例如膨胀气囊导管。与预膨胀和瓣膜代替有关的另外的详情可在申请人2002年5月2日提交的共同未决申请序列号10/139,741中找到。
现在将描述心脏瓣膜传送系统10的装配和操作。在装配期间,气囊导管15被插入到手柄22的组件和传送套管组件18所产生的开口内。气囊导管15的支架17位于手柄22的近侧。气囊轴250和导向线轴248穿过端帽23的通道130(参见图2)、第一中心构件26的通道33、板层134的中央开口136、第二中心构件29的通道78、彀30的通道88、套管19的中心腔139和弯曲管146的通道154。依照图18A,气囊轴250穿入罩200的通道213内,而导向线轴248穿过罩200的通道213。气囊252的近端276位于罩200的通道213里,并且气囊252从罩200的远端210向远侧延伸。
如图18A所示,从罩200的远端210的远侧,人工瓣膜11被安装到气囊252的主圆筒部分290。如图1所示,瓣膜11在本领域是公知的并且可收缩到气囊252的第一位置。可选地,瓣膜11可被安装到气囊252上并且被置于罩200内,如图18B所示。
瓣膜11可采取各种不同的形式。在优选的实施方式中,该瓣膜一般包括可膨胀展幅部分,其支撑瓣膜结构。该展伸部分具有足够的半径强度以支持治疗位点处的瓣膜并且抵抗狭窄的瓣膜小叶的反作用力。与优选的气囊可膨胀瓣膜实施方式相关的另外详情可在申请人的美国专利号6,730,118和6,893,460中找到,每篇专利的名称都为“可植入的人工瓣膜(IMPLANTABLRE PROSTHETIC VALVE)”,其以引用的方式并入本文。也应被理解的是,自膨胀人工瓣膜可以与传送系统一起使用。举例来说,当使用自膨胀瓣膜时,推进器可用气囊导管代替,以将自膨胀瓣膜从传送套管组件中推出。
继续参考示例性的实施方式,导向线(guide wire)14被置于导向线轴248的通道264里,如此以致它从导向线轴248的远端258向远侧延伸并且从气囊导管15的支架17的线入口开口296向近侧延伸。为了跟踪而将导管插入人身体的方法在本领域是公知的,例如可通过名称为“脉管内传送系统(ENDOVASCULAR DELIVERYSYSTEM)”的美国专利号5,968,068了解该方法,其以引用方式被并入本文。
导向线14通过扩张器(未示出)被置于身体内,所述扩张器使身体脉管的内径膨胀,以将导入器鞘组件400引入到导向线14上方,如图19所示。优选的扩张器直径在12与22弗伦奇(French)之间的范围内。该导入器鞘组件400包括导入器套管402和连接于导入器套管402近端的导入器室404。优选的是22或24弗伦奇的导入器鞘组件直径。
一系列瓣膜位于导入器室404的内部。在导入器室404的近端,端件406被粘附,端件406具有延伸到一系列瓣膜区域内的导入器室404内的开口,和面向导入器室404远端的脊408。导入器套管402延伸入身体脉管内,导入器室404位于身体脉管近端外部导入器套管402的近端。在优选的实施方式中,导入器套管402涂有亲水涂料并且延伸到身体脉管内大约9英寸,正好经过髂骨的杈并且进入病人的腹部主动脉。导入鞘组件400以安全有效的方式提供将人工瓣膜推进主动脉的机构。
参考图20,装载组件500包括装载器502、装载帽502和装载密封506。装载器502是管状的,其近端处具有外部螺纹508,以与装载帽504连接。装载器502包括挠性凸缘510,其与装载器502平行延伸并且具有面向装载器502近端的铆钉纹512。装载帽504包括其近端处的装载帽开口514和与装载器502的外部螺纹508啮合的螺纹内表面516。装载密封506被固定到装载帽504上,并且将装载密封开口518与装载帽开口514对准。
参考图21A,当套管19与装载帽开口514和装载密封开口518啮合时,装载帽504和装载密封506被传到传送系统10上。如图21B所示,传送系统10的远端,其传到导向线14之上,被插入到装载器502的近端内。装载帽504旋到装载器502的近端上。
参考图22,装载器502的挠性凸缘510吸到导入器室404的端件406里。在这个位置,端件406的脊408将压力施加在挠性凸缘510的扣脊512上,并且装载器502穿过位于导入器室404内部的系列瓣膜,因此放置传送系统10与导入器鞘的内通道连通并且因此与身体脉管连通。装载器组件500有利地允许传送系统10引入导入器鞘组件400内,而病人基本上没有血液损失。
人工瓣膜11、气囊导管15和传送套管组件18(优选地作为单个单元)被推进到导向线14之上通过导入器鞘,同时跟踪穿过身体脉管直到原来的瓣膜位置(参见图1)。在一个有优势特征中,传送系统10提供优良的推力,使得有利于人工瓣膜11前进穿过导入器鞘。在一个实施方式中,传送系统10提供足够的推力使其推过导入器鞘,所述导入器鞘具有比瓣膜11或罩200的外周长小2弗伦奇大小的内周长。
当人工瓣膜11到达如图1所示的主动脉弓13时,下面所述的传送系统10的可操纵功能被开启,以利于瓣膜11前进到所述弓的周围。更具体地,可操纵部件20的弯曲有助于控制瓣膜11和/或罩200的远端210(参见图14A)远离主动脉弓13的内表面。因此,可以实现在主动脉弓13周围瓣膜11倒退的推进,而不损伤主动脉13和瓣膜11。在一个优选的传送方法中,该瓣膜被推进到主动脉弓上方,瓣膜与主动脉之间存在很少或没有接触。
在该示例性的实施方式中,当操作者旋转旋转手柄28(参见图2)时,传送系统10的可操纵功能被完成。当旋转手柄28被旋转时,螺纹部分68与部分带螺纹构件27的外螺纹54(参见图4A)相连接,所述部分带螺纹构件没有旋转。因此旋转手柄28相对于部分带螺纹构件27直线运动。第一中心构件26相对于部分带螺纹构件27也直线运动(参见图2)。销钉124防止第一中心构件26与部分带螺纹构件27之间的相对旋转。
当第一中心构件26从部分带螺纹构件27向远侧移动时,拉线312,其通过球轴承122被连接到第一中心构件26上,在环202的狭槽面238上施加一个力(参见图15A)。拉线312将环202拉向手柄22。当弯曲管146的伸长开口166会聚(参见图11)时,传送系统10的边沿着可操纵部件20弯曲,拉线312沿着所述边穿过。可操纵部件20弯曲直到拉线312上的压力被解除。因此旋转手柄28另外的旋转导致另外的弯曲。旋转手柄28的螺纹部分68与部分带螺纹构件27的外部螺纹54(参见图4A和5B)之间的摩擦足以使拉线312绷紧,因此当操作者松开旋转手柄28时保留可操纵部件20的弯曲形状。
盖子148(参见图10)固有的刚性以及气囊导管15(参见图16)固有的刚性,对可操纵部件20的弯曲起相反的作用。拉线312上的力使可操纵部件20弯曲,而上述盖子148和气囊导管15的刚性抵抗此弯曲,因此根据旋转手柄28的旋转,将传送系统10“锁”在从直到完全弯曲的位置区域的位置。盖子148也将保护身体脉管免受弯曲管146的作用(参见图10),当不存在盖子148时所述弯曲管可能会擦伤或另外割裂身体脉管。
当气囊导管15被推进原来的瓣膜位置时,根据本领域众所周知的荧光检查方法操作者使用标记带306、308(参见图16)来鉴别瓣膜20的位置。通过开启旋转手柄28同时保持彀30不变(参见图2),操作者可调整瓣膜11的位置。通过转动彀30可实现对瓣膜位置的进一步控制。套管19被连接于彀30上,并且传送系统10的刚性足够使其旋转移动至远端。当弯曲管146的管部分174(参见图11)相互接触时,旋转运动通过可操纵部件20被转移。当弯曲管完全被弯曲时这样的接触可能会发生,或者在旋转期间这样的接触可能发生,因为伸长开口的弯曲部分170靠拢致使管部分174相互接触。
当弯曲管148所有剩余的管部分174(参见图11)相互接触并且可操纵部件20被完全弯曲时,传送套管组件18(参见图1)处于其最刚硬状态。在这个位置,为了容易跟踪,可操纵部件20的形状优选地与主动脉弓13的形状(如图1所示)最对应。当推过狭窄瓣叶12时,可操纵部件20位于病人向上的主动脉内,并且套管19的软硬度计部分弯曲并且正对着主动脉弓伸展(参见图1),因此防止主动脉的内壁受到损害。
在该传送系统10已经被推进使得瓣膜11位于原来的瓣膜附近之后,气囊导管15可以相对于该传送套管组件18向远侧推进至原来的瓣叶内瓣膜11更好的位置上。为了完成这一点,气囊导管15滑动穿过套管19和可操纵部件20。在另一优点中,传送套管组件18有利于使医师调整可操纵部件20的弯曲,为了将人工瓣膜11相对于原来的瓣膜正确地对准。因此,当气囊导管15向远侧被推进时,人工瓣膜前进到原来的瓣膜中心里。此外,传送系统10提供足够的推力以将气囊瓣膜15和瓣膜11推着穿过狭窄瓣叶12,或可替换地推着气囊瓣膜15穿过狭窄瓣叶12。在这个过程中,该罩200(参见图14A)也可横过狭窄瓣叶12。
一旦狭窄瓣叶12已经被推离,该传送系统10使瓣膜11在原来的瓣膜位置展开,如图23所示。套管19的软硬度计部分正对着主动脉弓伸展,而可操纵部件20穿过上升的主动脉并且被调整以定位瓣膜11。瓣膜11是可膨胀的气囊,并且一旦定位,该气囊252被充气以将瓣膜11的位置稳固在原来的瓣膜位置。然后该气囊252被放气,并且当其拉回到导向线14上方并且通过导入器鞘离开身体脉管系统时,整个传送系统10被收回。然后导向线14被收回,接着是导入器鞘。
在本发明可选的实施方式中,其中瓣膜11被放置在罩200内部,一旦瓣膜11已经到达原来的瓣膜位置,该传送套管组件18(参见图1)被收回。当操作者将支架17稳定并且拉回(向近侧)到手柄22上,这使得该传送套管组件18向近侧收回,该传送套管组件18被收回,将瓣膜11暴露于原来的瓣膜位置并且允许气囊252如图23所示充气并且因此将瓣膜11如上所述展开。
应当理解的是,该心脏瓣膜传送系统10的实施方式提供了将人工瓣膜推着穿过病人脉管系统的改进装置和方法。在一个优选的实施方式中,本文所述部件的协作使得未覆盖的人工瓣膜以安全的方式被推着穿过病人的脉管系统以及主动脉弓周围。因此,该传送系统使得人工瓣膜前进到主动脉弓周围,而不需要向主动脉弓引入外鞘。这是一个优点,因为鞘的使用将增加传送系统的直径,因此使得瓣膜的传送复杂。除了提供通过主动脉的改进控制机构,而没有损伤主动脉的内壁,本领域普通技术人员将要理解的是:该转送系统提供了极好的推力,使得医师可以对人工瓣膜在前进到原来的瓣膜内期间的移动和位置进行极好的控制。当穿过狭窄瓣膜叶时这个特征特别地有利。因此,本发明所述的实施方式提供了改进的传送系统,其采用可操纵组件将人工瓣膜推进到原来的主动脉瓣膜位置上,所述可操纵组件消除了主动脉内外鞘的需要,同时提供的推力足以穿过窄的脉管系统和/或狭窄瓣膜叶。因此,本发明所述的实施方式提供改进的装置和方法,其采用逆行法将可膨胀气囊状的人工瓣膜经皮推到狭窄的主动脉瓣膜。
尽管本发明以其优选的实施方式已经被描述,要理解的是已经被使用的词是描述性的词并且不是限制性的。因此,在所附权利要求的范围内可进行变化,而没有背离本发明真实的范围和精神。
Claims (7)
1.一种传送系统,其用于穿过病人的脉管系统和主动脉弓上方将人工瓣膜传送至所述病人的心脏,所述传送系统包括:
管状套管,其被装配成前进穿过所述病人的脉管系统,所述管状套管具有中心腔;
与所述套管的远端连接的选择性地可操纵部件,所述可操纵部件具有通道;
延伸穿过所述套管的所述中心腔和所述可操纵部件的所述通道的伸长气囊导管,所述气囊导管具有导向线轴用以可滑动地容纳导向线;和
人工瓣膜,其适合于通过沿着所述伸长气囊导管的末端部分的可膨胀气囊膨胀,其中所述人工瓣膜位于所述可操纵部件的远侧,使得所述可操纵部件的所述远端部分毗连所述人工瓣膜的近端,以增强所述人工瓣膜穿过所述病人的脉管系统的推力;
手柄组件,其位于所述管状套管的近侧;和
拉线,其通过所述手柄组件来启动,以选择性地调整所述可操纵部件的弯曲以利于所述人工瓣膜前进到所述主动脉弓上方;
其中所述套管、可操纵部件、气囊导管和人工瓣膜被装配,以作为单个组件在所述导向线上方前进穿过所述病人的脉管系统,并且其中所述气囊导管被装配成在将所述人工瓣膜定位到所述主动脉弓上方之后,相对于所述管状套管和可操纵部件前进,以将所述人工瓣膜定位在所述病人的心脏内。
2.根据权利要求1所述的传送系统,其中所述套管进一步包括沿所述套管的一边延伸的第一和第二外腔。
3.根据权利要求2所述的传送系统,其中所述拉线穿过所述第一外腔,途经所述可操纵部件直到所述可操纵部件的所述远端部分,并且穿过所述可操纵部件以及穿过所述第二外腔返回。
4.根据权利要求1所述的传送系统,其中所述可操纵部件包括有槽管,所述有槽管具有第一直的位置和第二弯曲的位置。
5.根据权利要求1所述的传送系统,其中所述套管是用聚醚嵌段酰胺制成,并且其中所述套管包括靠近其远端的软硬度聚醚嵌段酰胺。
6.根据权利要求3所述的传送系统,其中所述手柄组件是旋转手柄组件。
7.根据权利要求1所述的传送系统,其进一步包括与所述可操纵部件的所述远端部分连接的罩,并且其中在前进穿过病人的脉管系统期间所述罩包围着所述人工瓣膜的至少一部分。
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US11/152,288 US7780723B2 (en) | 2005-06-13 | 2005-06-13 | Heart valve delivery system |
US11/152,288 | 2005-06-13 | ||
PCT/US2006/022540 WO2006138173A2 (en) | 2005-06-13 | 2006-06-09 | Heart valve delivery system |
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CN201110161728.9A Division CN102247224B (zh) | 2005-06-13 | 2006-06-09 | 心脏瓣膜传送系统 |
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CN2006800211769A Active CN101198296B (zh) | 2005-06-13 | 2006-06-09 | 心脏瓣膜传送系统 |
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US (12) | US7780723B2 (zh) |
EP (2) | EP2319459B1 (zh) |
JP (1) | JP2008546431A (zh) |
CN (2) | CN102247224B (zh) |
AT (1) | ATE505154T1 (zh) |
CA (2) | CA2609201C (zh) |
DE (1) | DE602006021309D1 (zh) |
DK (2) | DK2319459T3 (zh) |
ES (2) | ES2432648T3 (zh) |
HK (2) | HK1110765A1 (zh) |
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Patent Citations (1)
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US5702368A (en) * | 1991-07-16 | 1997-12-30 | Heartport, Inc. | System for cardiac procedures |
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