CN101553190A - 一体的心脏瓣膜运送系统 - Google Patents
一体的心脏瓣膜运送系统 Download PDFInfo
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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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- 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
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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- 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
- A61M25/0136—Handles therefor
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- 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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
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- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
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- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
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- 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
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- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0613—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof with means for adjusting the seal opening or pressure
Abstract
本公开内容的实施方式提供了一种用于经由人体的脉管系统将人工心脏瓣膜运送到本体瓣膜部位的运送设备。所述运送设备特别适合于通过主动脉(即以倒退的方法)使人工瓣膜前进从而替换狭窄的主动脉瓣膜。
Description
技术领域
【0001】本申请涉及用于经由患者的脉管系统将人工瓣膜运送到心脏的系统的实施方式。
背景技术
【0002】血管内运送导管被用于在通过外科手术不易到达或不期望以外科手术的方式到达的体内位置植入人工装置,例如人工瓣膜。导管能够成功地通过小血管并围绕例如主动脉弓等脉管系统中的绷紧的弯曲从而极大地限制了运送导管的有效性。
【0003】公知的运送设备包括球囊导管,该球囊导管具有可膨胀球囊和可伸缩的壳体,该球囊安装处于卷曲状态的人工瓣膜,该壳体延伸于瓣膜上以在瓣膜向着植入部位前进时保护脉管系统的内壁。多种技术可被用来调节运送设备的一部分的曲率以帮助“操纵”瓣膜通过脉管系统中的弯曲。球囊导管还可以包括安装到球囊远端的锥形尖端部以促进通过脉管系统。然而,尖端部增加了设备的相对坚硬、不可操纵的部件的长度。不幸的是,由于相对长的坚硬部分,已证实通过曲折的脉管系统成功运送人工瓣膜是困难的,例如对于人工大动脉心脏瓣膜的倒退运送。
【0004】一种用于调节运送设备的曲率的公知技术使用牵引线,该牵引线具有固定地安装到可操纵段的远端以及可操作地连接到位于身体外部的可转动调节旋钮的近端。调节旋钮的转动在牵引线上提供了牵引力,这依次使得可操纵段弯曲。调节旋钮的转动产生了牵引线的小于1∶1的运动;也就是,旋钮的转动不使可操纵段产生相等的运动。为了促进操纵,需要的是提供可以使可操纵段产生基本为1∶1运动的调节机构。
【0005】同样公知的是使用将运送设备安全地导入患者的脉管系统(例如股动脉)内的导引鞘。导引鞘具有被插入到脉管系统内的细长套筒和密封壳体,所述密封壳体包括一个或多个密封瓣膜从而允许运送设备被放置成以最小的血液损失与脉管系统流体连通。常规的导引鞘通常要求通过鞘壳体中的密封件插入一个管状加载器从而为安装在球囊导管上的瓣膜提供通过密封壳体的无阻碍的路径。常规的加载器从导引鞘的近端延伸出并且因此降低了能够被插入通过鞘并进入到体内的运送设备的可用工作长度。
【0006】因此,本领域仍然需要改进的用于植入瓣膜和其他假肢器官的血管内系统。
发明内容
【0007】本公开内容中的某些实施方式提供了用于经由人的脉管系统将人工心脏瓣膜运送到自体瓣膜部位的心脏瓣膜运送设备。所述运送设备特别适用于通过主动脉使人工瓣膜前进(即以倒退法)从而替代狭窄的自体主动脉瓣膜。
【0008】在具体实施方式中的运送设备包括球囊导管,该球囊导管具有膨胀的球囊,该球囊安装了卷曲的瓣膜以便运送通过患者的脉管系统。所述运送设备可以包括导向或伸缩导管,该导向或伸缩导管具有在球囊导管轴上延伸的轴。该导向导管轴具有可操纵段,该可操纵段的曲率可以被操作者调节以促进围绕脉管系统中的弯曲导航运送设备。所述运送设备还可以包括前端导管,该前端导管具有通过球囊导管轴延伸的轴以及位于瓣膜的远端的前端片。这个前端片理想地具有锥形外表面并且由柔性材料构造以提供通过动脉和狭窄的自体瓣膜的损伤跟踪。前端片理想地具有内部孔,该内部孔被成尺寸为在运送瓣膜期间至少接收缩小的球囊的远端部。
【0009】通过将球囊的一部分插入到前端片中,运送设备的不可操纵段的长度可以被减小(例如,在一些示例中减小1.5-2.0cm),这极大地增强了运送设备追踪通过主动脉弓且在运送设备端部和主动脉的内壁之间的很少接触或不接触的能力。一旦运送设备前进到植入部位,则前端导管可以相对于球囊导管向远端移动以从前端片将球囊缩回从而不妨碍膨胀球囊。
【0010】导向导管的轴可以在其远端具有壳体以覆盖球囊的一部分和/或覆盖未被前端片覆盖的瓣膜。在具体实施方式中,所述壳体在球囊的其余部分和不被前端片覆盖的瓣膜上延伸。在此方式中,瓣膜的整个外表面和球囊被前端片和壳体保护。因此,导引鞘不需要被用于将运送设备导入患者的脉管系统内。与导引鞘不同的是,壳体仅需要接触股动脉和髂骨动脉一段很短的时间,并且由此最小化了这些血管的损伤可能性。此外,通过除去导引鞘,系统的最大直径可以被减小,并且因此更少地阻塞股动脉。
【0011】在所述运送设备的一个变型中,所述前端片具有内部孔,该内孔被成尺寸为在瓣膜的运送期间接收整个瓣膜以及大致整个球囊。由此,在本实施方式中,不需要提供连接到导向导管的端部的壳体。在另一个变型中,导向导管的壳体在瓣膜和球囊上充分延伸,并且不提供前端导管。所述壳体可以是可扩大的网篮,该网篮可以围绕瓣膜和球囊收缩以提供平滑的跟踪剖面。网篮可以被操作者扩大,例如通过拉动一条或多条牵引线,这样扩大了在网篮中的远端开口从而允许球囊和瓣膜从网篮前进以展开。
【0012】如上所述,导向导管理想地具有可操纵段,该可操纵段可以由操作者偏转或弯曲以协助围绕脉管系统中的弯曲而跟踪运送设备。在某些实施方式中,导向导管可以具有由人工操作的调节机构,该调节机构产生基本为1∶1的可操纵段的运动。为此目的,所述调节机构可以包括可转动杆,该可转动杆经由通过导向导管轴中的腔延伸的牵引线而可操作地连接到可操纵段。转动所述杆可操作滑轮,该滑轮收回牵引线,从而产生基本为1∶1的可操纵段的运动。在相反方向上转动所述杆释放了牵引线中的张力,并且可操纵段的弹性使得可操纵段返回到其正常的、未偏转的形状。
【0013】在导引鞘被用于协助将运送设备插入患者的脉管系统中的情况下,导引鞘可以具有一体的装载器管,该装载器管伸入鞘的密封外罩中。装载器管连接到端片,该端片连接到密封外罩的远端。端片可沿密封外罩的长度在第一延伸位置和第二收回位置之间运动,在所述第一延伸位置,加载器管与密封外罩中的密封瓣膜相分离,在所述第二收回位置,加载器管通过密封瓣膜延伸以便为安装在球囊导管上的瓣膜提供畅通无阻的路径。因为加载器管不延伸到端片后面,所以加载器管不会降低运送设备可通过鞘插入到脉管系统中的有效工作长度。
【0014】在一个代表性的实施方式中,用于通过患者的脉管系统运送人工瓣膜的设备包括球囊导管、导向导管和前端导管,其被配置为相对于彼此纵向运动。所述球囊导管包括细长轴和球囊,该球囊连接到所述轴的远端部,所述球囊适于承载处于卷曲状态的瓣膜并且膨胀以在患者体内的植入部位上展开该瓣膜。导向导管包括细长轴,该细长轴在球囊导管轴上延伸,导向导管的轴包括可操纵段。导向导管还包括可操作地连接到可操纵段的调节机构。该调节机构被配置为调节可操纵段的曲率并且调节通过可操纵段延伸的球囊导管轴的部分。前端导管包括细长轴和前端片,该细长轴延伸通过球囊导管轴,前端片连接到前端导管轴的远端。所述前端片具有内孔,该内孔适于在运送瓣膜期间至少接收处于缩小状态的球囊的远端部。
【0015】在另一个代表性的实施方式中,一种在患者体内的植入部位上植入人工瓣膜的方法包括将瓣膜放置在运送设备的球囊导管的可膨胀球囊上并且将至少球囊的远端部插入到运送设备的前端导管的前端片中。之后所述球囊导管和前端导管被插入到体内并且前进通过患者的脉管系统。在到达或接近植入部位时,前端导管被相对于球囊导管向远端运动以便不覆盖球囊在前端片内部的部分,并且此后可以通过膨胀球囊而在植入部位展开瓣膜。
【0016】在另一个代表性的实施方式中,一种在患者体内的植入部位上植入人工瓣膜的方法包括将处于卷曲状态的瓣膜放置在细长运送设备的远端部上并且使运送设备前进通过患者的脉管系统。在使运送设备前进的动作之后,卷曲的瓣膜被移动到运送设备的远端部上的可膨胀球囊上并且之后在植入部位通过膨胀球囊而被展开。
【0017】在另一个代表性的实施方式中,用于通过患者的脉管系统运送人工瓣膜的设备包括球囊导管和前端导管。球囊导管包括细长轴、连接到该轴的远端部的球囊以及连接到邻近球囊的远端部的锥形楔。前端导管包括细长轴,该细长轴延伸通过球囊导管的轴、球囊和楔。前端导管还包括连接到前端导管轴的远端的前端片。所述瓣膜可以以卷曲的状态被安装到前端片和楔之间。所述前端片可以向近端收回以将瓣膜推到楔上并且使瓣膜位于球囊上,同时所述楔在瓣膜被放置到球囊上之前局部扩张该瓣膜。
【0018】在另一个代表性的实施例中,用于血管内运送设备的导向导管包括具有可操纵段的细长轴、包括可转动杆(pivotable lever)的手柄以及牵引线。牵引线具有被连接到杆上的近端部和远端部,该远端部被牢固地固定到可操纵段以便杆的转动运动将牵引力施加到牵引线上从而使可操纵段弯曲。
【0019】在另一个代表性的实施例中,血管内运送设备包括球囊导管,所述球囊导管包括细长轴和球囊,所述球囊连接到轴的远端部。导向导管包括细长轴,该细长轴包括具有腔的内部聚合物管状衬垫,所述腔被成尺寸为允许通过其中插入球囊以及球囊导管轴。所述轴还包括围绕管状衬垫的编织金属层,以及围绕编织金属层的外部聚合物层。
【0020】在另一个代表性的实施例中,用于制作导管的方法包括:由聚合物材料形成内部管状层,该内部管状层具有腔,该腔被成尺寸为允许球囊导管的球囊从其中穿过;由聚合物材料形成管状牵引线管道;以相互平行的关系并排放置管道和内部管状层;形成围绕所述管道和内部管状层的编织金属层;以及形成围绕编织金属层的外部聚合物层。
【0021】在另一个代表性的实施例中,导引鞘包括细长管状套筒、密封外罩和端片,所述细长管状套筒具有腔并且适于插入患者的脉管系统内,所述密封的外罩包括与所述套筒的腔连通的内孔以及被容纳在所述孔中的一个或多个密封瓣膜,所述端片连接到与套筒相对的密封外罩。所述端片包括加载器管,该加载器管伸入所述孔并且可沿密封外罩的长度运动从而使加载器管从第一位置运动到第二位置,所述第一位置与一个或多个密封瓣膜相分离,在所述第二位置中加载器管延伸通过密封瓣膜。
【0022】从以下参考附图进行的详细描述中,本发明之前和其他特征和优点将变得更加清楚。
附图说明
【0023】图1是根据一个实施方式的用于植入人工瓣膜的血管内系统运送设备的侧视图;
【0024】图2A是部分以截面显示的图1的运送设备的球囊导管的侧视图;
【0025】图2B是沿图2A中所示的导管长度的球囊导管的放大截面图;
【0026】图3A是沿导向导管的长度延伸的平面截取的图1的运送设备的导向导管的截面图;
【0027】图3B是沿垂直于限定了图3A所示的横截面图的平面的平面截取的导向导管的截面图;
【0028】图4A是沿前端导管的长度截取的图1中所示的运送设备的前端导管的截面图;
【0029】图4B是前端导管的放大截面图;
【0030】图5A和5B分别为用在导向导管的手柄部分中的滑动螺母的截面图和透视图;
【0031】图6A和6B分别为用在导向导管的手柄部分中的内套筒的透视图和侧视图;
【0032】图7A是沿其长度截取的根据一个实施方式的导向导管的截面图;
【0033】图7B是图7A所示的导向导管的横向的截面图;
【0034】图7C是图7A所示的导向导管的远端部的放大纵向截面图;
【0035】图8A-8C是图1的运送设备的远端部的截面图,该截面图示出了用于植入人工瓣膜的相同操作;
【0036】图9是根据另一个实施方式的用于植入人工瓣膜的血管内运送设备的侧视图;
【0037】图10A是图9所示的运送设备的导引鞘的侧视图;
【0038】图10B是部分以截面显示的图10A的导引鞘的侧视图;
【0039】图10C是图10A的导引鞘的端视图;
【0040】图11是导向导管的可选实施方式的透视图;
【0041】图12是图11的导向导管的顶部平面图;
【0042】图13是图11的导向导管的侧面正视图;
【0043】图14是图11的导向导管的透视分解图;
【0044】图15是图11的导向导管的局部截面图;
【0045】图16A和16B是用在图11的导向导管中的滑轮的透视图;
【0046】图17是用在图11的导向导管中的杆部分的透视图;
【0047】图18A和18B是图11的导向导管的局部截面图,该局部截面图示出了用于调节导向导管的曲率的可调节杆的操作;
【0048】图19A是前端导管的可选实施方式的远端部的透视图;
【0049】图19B和19C是示出了图19A所示的前端导管的操作的截面图;
【0050】图20A是根据另一实施方式的运送设备的远端部的侧面正视图;
【0051】图20B是图20A中的运送设备的导向导管的横向截面图;
【0052】图21A-21C是运送设备的可选实施方式的截面图,该截面图示出了用于植入人工瓣膜的相同操作;
【0053】图22A和22B是运送设备的另一实施方式的远端部的截面图;
【0054】图23A示出了导引鞘和能够经由所述鞘导入患者的脉管系统内的示例性运送设备的另一实施方式的截面图;
【0055】图23B是将运送设备插入到鞘之后的图23A的导引鞘的截面图;
【0056】图24A-24B是运送设备的另一实施方式的截面图;
【0057】图25A-25E示意性地示出了运送设备的另一实施方式;
【0058】图26A-26E示意性地示出了导引鞘的另一实施方式。
具体实施方式
【0059】图1示出了根据一个实施方式的运送设备10,该运送设备10适于将人工心脏瓣膜12(例如,人工动脉瓣膜)运送到心脏。所述设备10一般包括可操纵的导向导管14(还被称为弯曲导管)、延伸通过导向导管14的球囊导管16以及延伸通过球囊导管16的前端导管18。如以下的详细描述,在所示的实施方式中的导向导管14、球囊导管16和前端导管18适于相对于彼此纵向滑动以促进瓣膜12的运送和在患者体内的植入部位处的定位。
【0060】导向导管14包括手柄部分20和从手柄部分20延伸的细长导向管或轴22。球囊导管16包括邻近手柄部分20的近部分24以及从近部分24延伸并且通过手柄部分20和导向管22的细长轴26。可膨胀球囊28被安装在球囊导管的远端。瓣膜12被显示为以具有减小的直径的卷曲状态安装在球囊28上以便经由患者的脉管系统而运送到心脏。
【0061】前端导管18包括细长轴30,该轴30延伸通过球囊导管的近部分24、轴26和球囊28。前端导管18还包括安装在轴30的远端处的前端片32并且在设备10被用于使瓣膜前进通过患者的脉管系统到植入部位时,该前端片32适于接收球囊的远端部。
【0062】如可从图2A和2B看到的,在所示的配置中的球囊导管16还包括内轴34(图2B),该内轴34从近部分24延伸并且共轴地通过外轴26和球囊28。球囊28可被支撑在内轴34的远端部上,该内轴34的远端部自外轴26向外延伸,且所述球囊的近端部36被固定到外轴26的远端(例如通过适当的粘接)。内轴34的外直径被成尺寸为沿外轴的整个长度在内轴和外轴之间限定有环形空间。球囊导管的近部分24可以具有流体通路38,该流体通路38可流动地连接到用于膨胀球囊的流体源(例如水源)。流体通路38与内轴34和外轴26之间的环形空间流体连通从而使来自流体源的流体能够流经流体通路38、流经所述轴之间的空间并且流入球囊28从而膨胀该球囊28并展开瓣膜12。
【0063】近部分24还限定了内腔40,该内腔40与内轴34的腔42连通。在所示的实施方式中的腔40、42被成尺寸为接收前端导管的轴30。球囊导管16还可以包括连接到近部分24的连接器44以及自该连接器延伸的管46。管46限定了流动地连通到腔40的内部通道。球囊导管16还可以包括连接到连接器44的近端的滑动支撑物48。如以下将更为详细描述的,该滑动支撑物48支撑并配合前端导管18的调节环50(图1和图4A-4B)以允许前端导管被维持在相对于球囊导管16的选定的纵向位置上。
【0064】如图2A所示,外轴26的外表面可以包括沿轴26的近端部彼此分离开的一个或多个环形凹槽或凹口52a、52b、52c。如以下将更详细描述的,凹槽配合导向导管14的锁紧机构84(图3A-3B)以允许导向导管14被维持在相对于球囊导管16的选定的纵向位置上。
【0065】球囊导管的内轴34和外轴26可以由例如尼龙、编织的不锈钢线或聚醚嵌段酰胺(商购获得为)等多种适合的材料中的任意一种材料形成。轴26、34可以具有由不同材料形成的纵向段以便改变沿轴长度的轴的挠性。内轴34可以具有由(特富)形成的内衬垫或内层以最小化与前端导管轴30的滑动摩擦。
【0066】图3A和3B中更详细地显示了导向导管14。如上所述,导向导管14包括手柄部分20和从手柄部分20远端延伸的细长导向管或轴22。导向管22限定了腔54,该腔54被成尺寸为接收球囊导管的外轴26并允许球囊导管相对于导向导管纵向滑动。导向管22的远端部包括可操纵段56,该可操纵段56的曲率可以由操作者调节以协助指引设备通过患者的脉管系统,并且具体地,通过患者的动脉弓。
【0067】导向导管理想地包括被固定到导向管22的远端的壳体或覆盖物23。在具体实施方式中的壳体23被成尺寸并被成形为接收围绕球囊卷曲的瓣膜12并且邻接前端片32的近端表面,该前端片32适于覆盖球囊28的远端部(如图8A中所示)。因此,当所述设备前进到展开部位时,瓣膜12和球囊28可以被完全装入到壳体23和前端片32内。
【0068】进一步如图3A和3B所示,手柄部分20包括主体或外罩58,该主体或外罩58形成有中心腔60,该中心腔60接收导向管22的近端部。手柄部分20可以包括侧臂62,该侧臂62限定了与腔60流动地连通的内部通道。活栓63可以被安装到侧臂62的上端。
【0069】手柄部分20可操作地被连接到可操纵段56并且用作调节器从而允许操作者通过手动调节手柄部分而调节可操纵段56的曲率。在所示的实施方式中,例如,手柄部分20包括内套筒64,该内套筒64围绕手柄体58内的导向管22的一部分。螺纹的滑动螺母68被置于套筒64上并可相对于套筒64滑动。滑动螺母68形成有外螺纹,该外螺纹与调节旋钮70的内螺纹相匹配。
【0070】如在图5A和5B中的最佳显示,滑动螺母68形成有两个槽76,所述槽76形成在螺母的内表面上并且沿螺母的长度延伸。如在图6A和6B中的最佳显示,套筒64还形成有纵向延伸的槽78,当滑动螺母被放置在套筒上时所述纵向延伸的槽78与滑动螺母68的槽76对齐。置于每个槽78中的是相应的细长的螺母导向件66a、66b(图3B),所述螺母导向件66a、66b可以是细长棒或销的形式。螺母导向件66a、66b径向地伸入滑动螺母68中的相应的槽76内以防止滑动螺母68相对于套筒64的转动。由于该配置,调节旋钮70的转动(顺时针或逆时针)使得滑动螺母68在由双箭头72所示的方向上相对于套筒64纵向运动。
【0071】一条或多条牵引线74将调节旋钮70连接到可操纵段56以基于调节旋钮的转动而产生可操纵段的运动。在某些实施方式中,牵引线74的近端部可以伸入止动销80内并被固定到止动销80(图3A),例如通过使牵引线卷曲到销80。销80被置于滑动螺母68的槽82中(如在图5A中的最佳显示)。牵引线74从销80延伸出,经过滑动螺母中的槽98、套筒64中的槽100,并且进入并通过轴22中的牵引线腔(图3A)。牵引线74的远端部被固定到可操纵段56的远端部。
【0072】保持牵引线74的近端的销80被捕获在滑动螺母68中的槽82中。因此,当调节旋钮70被转动以在近端方向上移动滑动螺母68(向着球囊导管的近部分24)时,牵引线74也在近端方向上运动。牵引线将可操纵段56的远端向着手柄部分拉回,从而弯曲可操纵段并且减小其曲率半径。调节旋钮70和滑动螺母68之间的摩擦足以支持牵引线拉紧,由此在操作者释放调节旋钮70时保持可操纵段中的弯曲形状。当调节旋钮70在相反方向上转动以在远端方向上移动滑动螺母68时,牵引线中的张力被释放。当牵引线上的张力减小时,可操纵段56的弹性使得该可操纵段56回复其正常的、未偏转的形状。因为牵引线74未被固定到滑动螺母68,因此滑动螺母在远端方向上的运动未推动牵引线的端部使得其弯曲。作为替代地,当旋钮70被调节以减小牵引线中的张力以防止牵引线弯曲时,销80被允许悬置在滑动螺母68的槽82内。
【0073】在具体实施方式中,处于未偏转的形状下的可操纵段56被略微弯曲并且在其完全弯曲的位置内可操纵段大致符合动脉弓的形状。在另一些实施方式中,可操纵段可以在其未偏转位置上基本笔直。
【0074】手柄部分20还可以包括锁紧机构84,该锁紧机构84被配置为将球囊导管16保持在相对于导向导管14的选定的纵向位置上。在所示的配置中的锁紧机构84包括按钮86,该按钮86具有孔眼88,球囊导管的外轴26延伸通过所述孔眼88。如在图3A中的最佳显示,按钮86具有远端部90,该远端部90被部分地接收在内部槽92中。被置于槽92中的螺旋弹簧94被挤向轴26并且将远端部90弹性地推向轴26。远端部90可以形成有小凸出物96,该小凸出物96可以嵌在轴26上的凹槽52a、52b、52c中的任意一者中(图2A)。当所述凹槽中的任意一个凹槽与凸出物96对齐时,弹簧94将凸出物推入凹槽中从而将轴26保持在相对于导向导管的纵向位置上(如图3A所示)。由于在所示的实施方式中的凹槽完全沿圆周地围绕轴26延伸,所以当球囊导管的纵向位置通过按钮86被锁紧在适当位置上时,所述球囊导管可以相对于导向导管转动。可以通过抵向弹簧94的偏压向内按压按钮86以便从轴26上的相应凹槽内移除凸出物96,从而释放球囊导管的位置。
【0075】手柄部分20可以具有适于调节可操纵段56的曲率的其他配置。一个这样的可选手柄配置在共同未决的美国专利申请No.11/152,288(以公开号US2007/0005131公布)中示出,该专利申请作为参考结合于此。手柄部分的另一个实施方式将在以下描述并且在图11-15中示出。
【0076】图7A和7B示出了根据一个具体实施方式构造的导向导管轴22。在所示的实施方式中的轴22包括管状内衬垫104,该管状内衬垫104由例如聚四氟乙烯(PTFE)等低摩擦的聚合物材料构成。衬垫104被尺寸为允许偏转的球囊28和球囊导管轴26被插入其中。沿内衬垫104的外侧延伸的更小的管道或衬垫106限定了牵引线74延伸通过的腔。外层108围绕衬垫104、106并且向轴22施加期望的挠性和硬度。
【0077】在所示的实施方式中的外层108包括编织层,该编织层由编织的金属线110和聚合物材料112形成,该金属线110缠绕在衬垫104和管道106周围,所述聚合物材料112围绕并且封装编织的金属线层。在具体实施方式中,可以通过如下过程形成轴:形成衬垫104、106;以相互平行的关系并排放置衬垫;围绕衬垫缠绕金属线以形成编织层;在编织层之上放置聚合物套筒;以及流回(reflowing)所述套筒以形成围绕衬垫的均匀的碾压层108。在某些实施方式中,聚合物材料112包括任意适合的材料,但理想地包括热塑性弹性体,例如编织的金属层可以由不锈钢线构造。
【0078】如图7A中的最佳显示,轴22理想地包括从轴的近端116延伸到可操纵段56的近端118的相对坚硬段114。在具体实施方式中,可操纵段56的长度包括轴22的总长度的约四分之一。虽然轴的总长度和/或可操纵段的长度可以依据具体应用而变化,但是在工作的实施方式中,轴22的总长度约为45英寸(包括可操纵段)并且该可操纵段的长度约为11.7英寸。
【0079】如上所述,轴的可操纵段56由相对柔软的硬度计材料(softdurometer material)112形成以允许可操纵段基于调节旋钮70的调节而弯曲。坚硬段114理想地由相对坚硬的聚合物材料112形成,从而在牵引线被调节旋钮70张紧时抵抗弯曲。坚硬段114理想地显示出足够的刚性以允许操作者推动设备10通过潜在收缩的身体脉管。在具体实施方式中,可操纵段的聚合物材料112包括55D并且轴的剩余段114的聚合物材料112包括比55D更坚硬的72D
【0080】在可选实施方式中,在可操纵段56中的金属编织层可以由金属线圈(例如不锈钢线圈)替代,该金属线圈被置于内衬垫104上以增强可操纵段的挠性。因此,在该可选实施方式中,编织的金属层沿坚硬段114延伸并且金属线圈沿可操纵段56延伸。在另一个实施方式中,可操纵段56中的编织的金属层可以由具有圆周延伸的开口的不锈钢波纹管替代,该不锈钢波纹管通过激光切割而成,例如在共同未决的美国专利申请No.11/152,288中公开的。
【0081】如图7C所示,轴22的远端可以包括向外展开的或扩大的端部116。端部116的外直径D等于或约等于支撑在球囊28上的卷曲的瓣膜12的外直径。因此,当瓣膜12前进通过导引鞘时,端部116推动卷曲的瓣膜12而不是推动球囊28。这最小化了球囊导管和瓣膜之间不经意的运动,该不经意的运动可以引起球囊上的瓣膜的位置的运动。在具体实施方式中,轴22具有约16F-18F的外直径并且端部116具有约22F的外直径D。扩大的端部116可以由多种适合材料中的任意一种材料构成。例如,端部116可以由(例如55D)注塑而成并且回流到可操纵段56的端部上。
【0082】如上所述,牵引线74的远端被固定到可操纵段56的远端。如图7C中的最佳显示,这可以通过将牵引线74的远端部固定到嵌入到轴的外层108中的金属环118上而获得,该固定可通过例如将牵引线焊接到金属环而实现。
【0083】虽然在图7A-7C中未显示,但导向导管轴22可以包括壳体23,该壳体23用于在瓣膜的运送期间覆盖瓣膜12和球囊28(或球囊28的一部分)。如下所述,如果当插入到患者的脉管系统时瓣膜是被覆盖的,则导引鞘的使用是可选的。
【0084】参考图4A和4B,并且如以上的简要描述,前端导管18包括位于其近端的调节环50和位于远端的前端片32以及延伸在其间的细长轴30。轴30理想地形成有腔120,该腔120延伸了轴的长度以便接收导向线140(图8A),从而在设备10被插入体内的运送路径后设备10可以在导向线上前进。如图4A和4B所示,前端片32理想地形成有开口或孔洞122,该开口或孔洞122被成尺寸且成形为至少接收球囊28的远端部。
【0085】如图4A中的最佳显示,调节环50被放置在球囊导管的滑动支撑物48上并且可相对于球囊导管的滑动支撑物48滑动,从而作为锁紧或止动机构以将前端导管保持在相对于球囊导管的选择的纵向位置处。进一步解释,轴30延伸通过轴支撑物124并且被牢固地固定到该轴支撑物124,该轴支撑物124被置于侧支撑物48内。调节环50通过螺丝钉126被固定到轴支撑物124上,所述螺丝钉126延伸通过滑动支撑物48中的细长槽128a、128b。槽128a、128b沿滑动支撑物48的长度纵向延伸。因此,当调节环50沿滑动支撑物48的长度纵向滑动(在由双箭头130表示的方向上)时,使得轴支撑物124和轴30在相同方向上运动从而调节前端导管相对于球囊导管的纵向位置。
【0086】槽128a形成有沿圆周延伸的凹口132a-132d,并且槽128b形成与凹口132a-132d相对的有类似的沿圆周延伸的凹口134a-134d。因此,对每个凹口132a-132d,均有从槽128b延伸的相应的沿直径相对的凹口134a-134d。为了保持前端导管相对于球囊导管的纵向位置,调节环50被移动以将螺丝钉126对准一对沿直径相对的凹口并且之后略微转动以将螺丝钉126定位在凹口中。例如,图4A示出了置于凹口132b和134b中的螺丝钉126。凹口限制了螺丝钉126在远端方向和近端方向上的运动并且由此限制了轴支撑物124和轴30在远端方向和近端方向上的运动。
【0087】在所示的实施方式中,每个槽128a、128b均形成有四个凹口。当螺丝钉126被置于凹口132c、134c中或凹口132d、134d中时,前端片32被保持在覆盖了球囊28的远端部并且邻接导向导管14的壳体23的位置上从而使球囊28和瓣膜12被壳体23和前端片32完全封入(图8A)。当螺丝钉126被置于凹口132b、134b中时,前端片32被保持在距球囊28向远端第一距离的位置上从而能够通过在不受前端片干扰的情况下膨胀球囊来展开瓣膜(图8C)。当螺丝钉被置于凹口132a、134a中时,前端片32被保持在距球囊28向第二距离的位置上,该第二距离大于第一距离。在此位置上,球囊28可以在不受前端片干扰的情况下在壳体23内侧再打摺(在瓣膜展开后)。
【0088】瓣膜12可以采用多种不同的形式。在具体实施方式中,瓣膜通常包括支撑瓣膜结构的可扩大的支架部分。支架部分理想地具有足够的径向强度从而将瓣膜支撑在治疗部位上并且抵抗狭窄的自体瓣膜叶的弹回。关于球囊可扩大的瓣膜的实施方式的额外的细节可以在名称均为IMPLANTABLE PROSTHETIC VALVE的美国专利No.6,730,118和No.6,893,460中找到,所述专利作为参考结合于此。同样可以理解的是,运送系统可以使用自扩大的人工瓣膜。例如,当使用自扩大的瓣膜时,可以使用推动器以协助从运送套筒弹出该自扩大的瓣膜,其中所述运送套筒将瓣膜维持在该瓣膜的压缩状态。
【0089】当瓣膜12被用于替代自体动脉瓣膜(或之前植入的失败的人工动脉瓣膜)时,瓣膜12可以倒退的方式植入,其中以卷曲的状态被安装到球囊上的瓣膜经由股动脉被导入体内并前进通过动脉弓到达心脏。在使用中,导向线140(图8A)可以被用于协助运送装置10前进通过患者的脉管系统。导向线140可以通过扩张器(未示出)被置于体内脉管中,该扩张器可扩大体内脉管的内直径以导入运送装置。扩张器的直径范围在例如12弗伦奇(French)至22弗伦奇之间。
【0090】如上所述并且如图8A所示,瓣膜12可以被置于壳体23的内侧,同时前端片32覆盖球囊28的远端部并且邻接壳体23的远端。前端导管的调节环50可以被锁紧在适当位置以在运送期间保持前端片32抵靠壳体23。在此位置中,前端导管理想地被放置为与前端片32略有张力,该前端片32紧紧抵靠壳体32以防止在通过脉管系统跟踪装置时以及在从体内移除运送设备期间所述前端片与壳体的分离。
【0091】有益地,因为在所示的实施方式中的瓣膜12可以被壳体23完全覆盖,因此导引鞘不需要将瓣膜导入到体内脉管中。具有约22-24弗伦奇直径的导引鞘通常被用在倒退过程中。相反地,壳体23理想地具有小于导引鞘外直径的外直径,并且在具体实施方式中,壳体23的外直径在约0.260英寸至约0.360英寸的范围内,同时具体示例是约0.330英寸。通过减小所述装置的整体直径,该装置将更不容易堵塞骨动脉并且患者的腿在过程中仍可以被很好灌注(well perfused)。此外,因为代表运送装置的最大直径的壳体23仅需要接触股动脉和髂骨动脉非常短的时间周期,因此对这些脉管的损伤可以被最小化。
【0092】虽然不是最理想的,但是在其他的实施方式中,壳体23可以在长度上更短以便在运送期间壳体23覆盖了更少的瓣膜和球囊的外表面。例如,壳体23的尺寸可以被设计为仅在球囊的近端部或瓣膜的近端部上延伸。
【0093】当运送设备10在导向线140上前进并通过动脉弓时,导向导管14被用于“操纵”设备离开大动脉的内表面。前端片32的锥形远端部协助沿股动脉和髂骨动脉跟踪,同时提供沿动脉弓的无损伤跟踪以及自体大动脉瓣膜的平滑穿越。在现有的运送系统中,公知的是在球囊导管的远端固定前端片,这增加了所述装置不能通过导向导管的操作而被弯曲的部分的长度。相反地,在所示实施方式中的前端片32安装在独立的前端导管18上,该前端导管18可以相对于瓣膜12运动。因此前端片32可以在运送期间被安装到球囊的远端部上以最小化在运送装置的远端处的不可操纵段的长度。这允许更简单的沿动脉弓的跟踪,而在运送装置的端部和大动脉的内壁之间具有很少的接触或没有接触。在具体实施方式中,在运送装置的端部处的不可操纵段的长度L(图8A)约为6cm或更小。
【0094】使用常规的荧光透视法,操作者可以跟踪导向线轴34上的标记带142(图2A和2B)的位置以便将瓣膜定位在植入部位上。在瓣膜12前进到大动脉环面后,前端导管可以相对于球囊导管向远端运动以使前端片32向远端前进从而远端离开球囊28(图8B),并且导向导管可以相对于球囊导管向近端运动以从壳体23中暴露出瓣膜12(图8C)。如上所述,在操作者调节瓣膜12的位置并且之后展开该瓣膜12时,前端导管和导向导管的纵向位置相对于球囊导管被固定。球囊28的膨胀有效地扩张了瓣膜12从而接合自体瓣膜叶。球囊28之后可以被缩小并且缩入壳体23并且前端片32可以被拉回到球囊的远端部上。整个运送设备之后可以被拉回到导向线140上并且从体内移除,在这之后,导向线可以从体内移除。
【0095】图9示出了运送设备10的可选实施方式。在此实施方式中,导向导管14不具有壳体23(如前面的图3A和3B所示),而代替地,导引鞘150可被用于将运送设备导入体内。如图10A和10B中的最佳显示,在所述的实施方式中的导引鞘150包括导引外罩152和从该外罩152延伸的导引套筒154。外罩152容纳密封阀(sealing valve)166。在使用中,当外罩152仍在体外时,套筒154被插入体内脉管中(例如股动脉)。运送设备10被插入通过外罩中的近端开口168、密封阀166、套筒154并且进入到体内脉管中。密封阀166密封地接合导向导管轴22的外表面以最小化血液损耗。在某些实施方式中,套筒154可以被涂覆有亲水性涂层并且伸入体内脉管中约9英寸,恰好超过回肠分叉并且进入患者的腹部大动脉。
【0096】套筒154可以具有锥形段156,该锥形段156自近端158处的第一直径减缩到远端160处的更小的第二直径。减小的直径远端部162自锥形部分156延伸到套筒154的远端。锥形部分156提供了套筒154的外表面和导向导管14的导向轴22的外表面之间的更平滑的过渡。锥形部分156还允许套筒154在患者的脉管系统中的可变放置以帮助最小化股动脉的完全闭塞。
【0097】图11-15示出了由200表示的手柄部分的一个可选实施方式,该手柄部分可以用于取代在导向导管14内的手柄部分20(图1和3A)。在所示的实施方式中的手柄部分200包括主外罩202和调节杆204,该调节杆204转动连接到外罩202。如下进一步的描述,杆204可以向远端和向近端转动(如由图13中的双箭头206所示)以调节轴22的曲率。
【0098】如图14中的最佳显示,外罩202可以由第一和第二外罩部分208、210形成,所述第一和第二外罩部分208、210可以使用适当的粘合剂、机械紧固件、卡扣连接或其他适当的技术而被彼此固定。置于外罩202内的是密封外罩212,该密封外罩212具有延伸通过该密封外罩212的中心孔226。孔226的远端部可以形成扩大的部分,该扩大的部分接收轴22的近端部214。轴22从密封外罩212延伸通过主外罩202并且离开连接到主体202的远端上的前端片228。端片216可以连接到密封外罩212的近端,且在这两个部件之间捕获一个密封件218。如图15中的最佳显示,端片216可以形成有阶梯孔,该阶梯孔被成形为接收密封件218和密封外罩212的端部。密封件218可以由适当的弹性体构成,例如硅。球囊导管16的轴26延伸通过端片216、密封件218内的中心开口、密封外罩212和导向导管轴22。密封外罩212可以形成有与中心孔226流体连通的冲洗端口220。冲洗端口220接收柔性管222的一端。管222的另一端可以连接到活栓224(图11)。
【0099】如图14所示,在所示的配置中的杆204包括分别安装到主外罩202的相对侧上的第一杆部分230和第二杆部分232。每个杆部分的内表面均可以形成有环形凹槽274,该环形凹槽274适于接收相应的O形环234。杆部分230可以连接到安装在外罩中的滑轮236以基于杆部分的转动运动而产生滑轮的旋转。例如,杆部分230可以形成有凸出物238,该凸出物238延伸通过外罩部分208并且进入滑轮236中的互补形凹进240内(图16A)。凸出物236可以在其外表面上形成有平面,所述平面接合凹进240内的相应平面以便在杆被制动时产生滑轮的旋转。滑轮236还可以形成有非圆形的凹进或开口242,该凹进或开口242被成形为接收轴244的一个端部(图14)。轴244的相对端延伸通过第二外罩部分210并且进入杆部分232的互补形凹进或开口246(图17)。虽然可以使用其它多种非圆形的形状,不过在所示的配置中,轴244的端部和相应的开口242和246为六边形以防止轴244、滑轮236和杆部分232之间的相对旋转。可替换地,如果轴相对于滑轮和杆部分以其它方式固定以不转动,则轴的端部和开口242、246可以为圆形。
【0100】上横棒和下横棒248、250分别连接到第一和第二杆部分230、232的上耳状物和下耳状物并在其间延伸。延伸通过杆部分230、232的耳状物并且紧固到横棒248、250内的螺丝钉252可以被用于将杆204的部件固定到主体202。螺丝钉254可以延伸通过杆部分230、外罩部分208并且进入轴244的螺纹开口。调节旋钮266可以被牢固地固定到螺丝钉268,该螺丝钉268可以延伸通过杆部分232、外罩部分210并且进入轴244的相对端中的螺纹开口中。螺丝钉268可以被牢固地固定到调节旋钮,例如,通过将螺丝钉的头部粘合地固定在调节旋钮的内表面上的凹进中(未示出)。因此,调节旋钮266可以手动地旋转以放松或紧固螺丝钉到轴244中以调节滑轮236的旋转摩擦。
【0101】再次参考图15,牵引线74延伸通过轴22中的牵引线腔并且从主外罩202内侧的轴延伸出。例如一条绳子的柔性受拉构件256在其一端被打结或以其它方式连接到牵引线74的一端。受拉构件256延伸绕过横构件258、部分绕过滑轮236的外圆周、通过滑轮中的径向延伸开口260并且被打结或以其它方式连接到邻近滑轮236中心处的轴244上。如图16A和16B所示,滑轮236可以形成有环形凹槽或凹进262,该环形凹槽或凹进262用于接收受拉构件256。
【0102】说明了手柄部分200的操作,图18A示出了最前向位置上的调节杆204。在此位置上,轴22的可操纵段56处于其正常的、未偏转状态(例如图1所示笔直,或略微弯曲)。当杆204向后转动时,在箭头264的方向上,在所述实施方式中的滑轮236沿顺时针旋转,使得受拉构件缠绕在滑轮上并且向后拉动牵引线74。以如前所述的方式,牵引线74接着拉动轴的远端从而调节可操纵段56的曲率。图18B示出了相应于轴22的可操纵段的完全弯曲位置、在最后向位置上的杆204。
【0103】滑轮236的旋转摩擦足以支持牵引线拉紧,由此如果操作者释放调节杆204,则可保持可操纵段中的弯曲形状。当杆204被向着最前向位置转动时(图18A),牵引线中的张力被释放。当牵引线上的张力被释放时,可操纵段56的弹性使得可操纵段回到其正常的未偏转形状。因为在所示实施方式中的受拉构件256不向牵引线提供推力,因此杆204朝向最前向位置的运动不引起牵引线的弯曲。此外,如上所述,调节旋钮266能够由操作者调节以改变滑轮236的旋转摩擦。旋转摩擦理想地被调节成如果导向导管在患者的脉管系统中时无意中被拉回,则滑轮可以在牵引线的前向拉力下向着最前向位置旋转(如图18B中的箭头270所示),从而允许可操纵段在拉过脉管系统时被拉直而最小化对脉管系统壁的损伤。
【0104】有益地,在所示实施方式中的调节杆204响应于杆的运动提供基本为1∶1的可操纵段的偏转;也就是,杆204的旋转引起基本为1∶1的牵引线的运动并且由此引起可操纵段56的运动。在此方式中,调节杆204提供给操作者可操纵段的曲率的触觉反馈以促进脉管系统的跟踪。此外,杆被符合人体工程学地放置以在使用中维持导向导管的恰当定向。所示的手柄部分200的另一个益处是球囊导管16的近部分24(图2B)或其一部分可以位于端片216内以最小化球囊导管的工作长度。
【0105】图19A和19B示出了根据一个实施方式的可选前端导管300,该可选前端导管300可替代前端导管18与运送设备10(图1)一同使用。在所示配置中的前端导管300包括连接到前端导管轴304的前端片或瓣膜壳体302。瓣膜壳体302适于覆盖球囊28和安装在球囊上的瓣膜12。因此,在此实施方式中,导向导管14不需要具有壳体23(图8A)来在运送中覆盖瓣膜。轴304在其远端被牢固地固定到壳体302的远端并且延伸通过球囊28和球囊导管轴26。轴304可以具有腔以接收导向线140。轴304可以相对于球囊导管和导向导管纵向运动,与前面所述的前端导管18非常类似。
【0106】如图19A中的最佳显示,壳体302具有形成有多个裂缝的近端部306,所述裂缝限定了三角形的副翼308。副翼308可以相对于彼此径向向外弯曲以形成足够大的开口,从而在希望展开瓣膜时允许球囊28和瓣膜12的通过。近端部306可以如所示为锥形以促进壳体302收缩回导引鞘中。端部306的锥形还提供了无损伤表面以在运送设备被从体内取回时最小化对脉管系统壁的损伤。壳体还可以具有锥形远端部310以协助通过股动脉和髂骨动脉的跟踪,同时提供通过动脉弓的无损伤跟踪并且本体动脉瓣膜的平滑穿过。
【0107】壳体302理想地由柔性材料构成,例如尼龙、或PET并且可以具有厚度在约0.0015英寸至约0.015英寸的范围内的壁。通过将壳体302做得足够有柔性,沿运送设备的前进通过患者的脉管系统的部分的唯一的相对坚硬、非柔性段是由瓣膜覆盖的球囊的段。这极大地增强了运送设备被前进经过曲折的体内脉管时该运送设备跟随导向线140的路径的能力。
【0108】在使用中,运送设备在导向线140上前进直至瓣膜被置于展开位置或接近展开位置。之后前端导管300相对于球囊导管16向远端前进从而不覆盖球囊和瓣膜12,如图19C所示。当壳体302向着远端前进时,球囊和瓣膜可以穿过由副翼308形成的近端开口。一旦瓣膜12被暴露,则球囊28可被膨胀以展开所述瓣膜。
【0109】图20A示出了导向导管14的改型,其中瓣膜壳体23被替换为连接到导向导管轴22的远端的可扩大的网篮或壳体400。壳体400被成尺寸且成形为覆盖瓣膜12和球囊28。因此,在本实施方式中,不需要使用前端导管(例如,前端导管18)。壳体400可以具有由金属线形成的编织的网状结构(例如镍钛诺或不锈钢线)。
【0110】一条或多条带状线402被连接到壳体400的远端404并且沿导向导管轴22的长度延伸通过该导向导管轴22中的相应的腔(图20B)。线402可以为例如0.003英寸×0.020英寸的镍钛诺带状线。线402在其近端被连接到导向导管的手柄部分,从而允许操作者将推力或拉力施加到所述线。在箭头406的方向内向前推动线402使得壳体折叠在球囊28和瓣膜12上以提供平滑的跟踪剖面。在箭头408的方向内向后拉动线402使得壳体扩大并允许球囊和瓣膜向外前进通过位于壳体400的远端404处的开口。
【0111】在使用中,壳体400被置于覆盖瓣膜和球囊的折叠状态以通过患者的脉管系统运送到展开部位。之后,线402在近端方向上(如箭头408所示)被拉动以扩大壳体400。之后,导向导管可以在近端方向上被拉动以使球囊和瓣膜从壳体的远端前进。可替换地,球囊导管16可以相对于导向导管14向远端前进以使球囊和瓣膜从壳体400前进。
【0112】图21A-21C示出了500指代的运送设备的可选实施方式。运送设备500允许瓣膜12被安装到体内脉管内部的球囊导管的球囊28上。该球囊导管可以具有类似于图2A和2B所示的球囊导管的结构,除了图21A-21B的实施方式中,球囊导管轴26具有远端部504,该远端部504从球囊28向远端延伸并且环状锥形楔502置于邻近球囊的远端部504上。如下更详细的描述,锥形楔502用于扩大瓣膜以有助于将瓣膜定位在身体内部的球囊上。楔502理想地由例如尼龙的低摩擦材料构成以允许瓣膜在楔上容易地滑动并且容易地滑动到球囊上。
【0113】所述运送设备包括前端导管,该前端导管包括轴506和连接到轴506的远端上的前端片508。前端导管轴506可以具有导向线腔以接收导向线140,从而使所述设备能够在导向线上前进且导向线穿过腔。运送设备500还可以包括导向导管,该导向导管包括导向导管轴22和细长壳体510,该细长壳体510从轴22的远端延伸。前端导管、球囊导管和导向导管可相对于彼此纵向运动并且能够在所述设备的近端具有锁紧机构以将导管相对于彼此保持在选定的纵向位置,如以下的详细描述。
【0114】如图21A所示,瓣膜12最初在将运送设备插入到身体中之前以卷曲状态安装在前端片508和锥形楔502之间的前端导管轴506上,而不是将该瓣膜12安装到球囊上。瓣膜被卷曲在前端导管轴上从而当需要将瓣膜放置在球囊28上时所述瓣膜仍可以沿轴运动。前端片508可以形成有阶梯孔,该阶梯孔包括第一孔部分512和在前端片的近端处的第二扩大的孔部分514。阶梯孔可以形成有环状肩部516,该环状肩部516延伸在第一和第二孔部分之间并且适于在瓣膜被插入到第二部分514中时接合瓣膜12的远端。前端片508可以具有外表面,该外表面在向着前端片508的远端的方向上渐缩以提供通过曲折的脉管系统的无损伤跟踪。当瓣膜被置于前端导管轴上以便运送时,可选择的壳体510适于延伸过并且覆盖球囊28、楔502和瓣膜12的至少近端部。在所示的实施方式中,壳体510的远端可以被放置成邻接前端片508的近端从而在运送期间完全封装瓣膜。在可选实施方式中,壳体510的长度可以更短从而在运送期间覆盖更少的瓣膜或球囊的外表面。
【0115】当前端片508相对于球囊导管向近端运动时(在箭头518表示的方向上),前端片508将瓣膜12推动越过楔502并到达球囊28上。当瓣膜越过楔时,瓣膜略微扩大以促进该瓣膜在球囊上的定位。球囊导管轴26可以具有不透射线的标记520(图21A)以协助操作者将瓣膜对准球囊上的恰当位置。前端片可以具有由相对更软和更有柔性的材料形成的外层522和由相对更坚硬的材料形成的内层524。在所示的实施例中的内层524形成肩部516和第一孔部分512的内表面。以此方式,前端片展示出足够的刚性以推动瓣膜12越过楔并且到达球囊上并提供柔软的外层以最小化对体内脉管的损伤。例如,外层522可以由55D构成并且内层可以由72D构成,72D比55D坚硬。
【0116】运送设备安装瓣膜的段通常限定了插入体内的设备的最大外直径。通过在插入体内前将瓣膜12安装到前端导管轴上而不是安装到球囊上,瓣膜12能够被卷曲为比将瓣膜安装到球囊上时的直径更小的直径。因此,运送设备的最大外直径可以被减小以便插入并通过脉管系统。如上所述,通过减小运送设备的最大直径,该运送设备将减少对股动脉的阻塞并且因此使患者的腿可以在过程期间仍被很好地灌注。在一些实施方式中,壳体510和前端片508(在其近端)的最大外直径约为0.223英寸,这是运送设备插入体内的那部分的最大直径。楔502在其近端可以具有约0.120英寸的直径并且导向导管轴22可以具有约0.184英寸的外直径。
【0117】现在根据一个实施方式解释运送设备500的操作,瓣膜12最初被安装在前端导管轴上并且插入前端片508和壳体510中。在导向线140插入体内后,从体内延伸出的所述线的近端可以被插入到导向线腔的远端中并且运送设备500可以被插入体内脉管中(例如股动脉)并且前进通过体内(如图21A中所示)。可替换地,例如,如果未提供壳体510来覆盖瓣膜12,则导引鞘可以首先被插入到体内脉管中。在插入导引鞘后,运送设备可以通过导引鞘被插入并且进入体内脉管。
【0118】当运送设备的远端前进到便于使瓣膜12滑动到球囊上的位置时,导向导管相对于球囊导管被向近端收回以使所述瓣膜和球囊从壳体510前进。例如,如果将人工瓣膜植入到本体动脉瓣膜内,则瓣膜和球囊可以前进到升大动脉中或前进到左心室,之后瓣膜在此处可以被移动到球囊上。在任何情况下,如图21B所示,前端导管均可以被向近端收回以使瓣膜前进越过楔502并到达球囊28上。标记520(图21A)可以被用于将瓣膜中心定位在球囊上。在将瓣膜安装到球囊上之后,前端导管可以向远端前进以便不阻碍球囊的膨胀,如图21C所示。之后瓣膜可以被定位在植入部位(例如在本体动脉瓣膜内)并且通过球囊的膨胀而展开瓣膜。
【0119】图22A和22B示出了运送设备10(图1-8)的改型。在图22A和22B的实施方式中,壳体23具有大体管状形状但以卷起的状态提供在导向导管轴22的远端部上。在瓣膜12被安装到球囊28上后,壳体可以展开在瓣膜12上以插入并通过患者的脉管系统。图22A和22B中所示的运送设备的操作与以上参考图8A-8C描述的运送设备10的操作相同。
【0120】图23A和23B示出了以600表示的改进的导引鞘的实施方式,该导引鞘可以用于促进运送设备插入体内脉管中。导引鞘600特别适合与用于植入人工瓣膜的运送设备一同使用,例如此处所述的运送设备的实施方式。导引鞘600还可以用于引导其他类型的运送设备以将各种类型的腔内装置(例如支架、支架移植件等)放置到多种类型的脉管的或非脉管的体腔中(例如静脉、动脉、食道、胆道系统的输送管、肠、尿道、输卵管管道、其他内分泌或外分泌的管道等)。图23A中所示的示例示出了用于植入人工瓣膜12的运送设备的远端部。所述运送设备包括球囊导管和导向导管。球囊导管包括轴26和安装到该轴的远端部上的球囊28。导向导管包括轴22,该轴22在球囊导管轴26上延伸。球囊导管和导向导管的其余部分可以根据图1-8中所示的实施方式而构造。
【0121】常规的导引鞘通常需要管状加载器以被插入通过所述鞘外罩中的密封件从而为安装到球囊导管上的瓣膜提供不被阻塞的路径。加载器从导引鞘的近端延伸,由此增加了其工作长度并且减小了运送设备可以插入体内的可用工作长度。导引鞘600包括被容纳在所述鞘外罩中的一体的加载器管,从而减小鞘的工作长度并且由此增加运送设备可插入体内的可用工作长度。
【0122】例如,所示的鞘600包括密封外罩602和从外罩向远端延伸的管状套筒604。密封外罩602容纳一个或多个密封阀,例如所述的实施方式中所示的横切阀(cross-slit valve)606、碟型阀608和止血阀610。所述阀理想地由弹性生物相容材料制成,例如聚异戊二烯,不过类似的生物相容材料也可以被使用。阀606、608、610还显示并描述在美国专利No.6,379,372中,该专利作为参考结合于此。隔离物612可以被插入碟型阀608和横切阀606之间。
【0123】连接到密封外罩的近端的是端片614,该端片614适于沿密封外罩的长度纵向运动。在所述的实施方式中,端片具有形成有内螺纹616的管状体,内螺纹616与形成在密封外罩602的外表面上的外螺纹618相接合。因此,端片614的旋转使该端片相对于密封外罩向内和向外运动。端片614具有中心开口620和细长的加载器管622,该加载器管622牢固地固定到端片的近端部并且从端片的近端部向远端延伸。开口620和加载器管622被成尺寸为允许安装到运送设备上的瓣膜12(或其他假体)的通过。端片614还容纳密封件624,该密封件624具有与开口620对准的中心开口。当运送设备插入导引鞘600时,密封件624密封地接合运送设备的外表面。
【0124】如上所述,端片614可以相对于密封外罩602向内和向外调节。将端片614从图23A中所示的延伸位置调节到图23B所示的收回位置使得加载器管622移动通过密封件606、608、610从而为瓣膜12提供了通过导引鞘的不被阻塞的路径。因为与常规的导引鞘中的加载器管不同,所述加载器管不延伸到端片的后面,因此加载器管不减小运送设备可插入到脉管系统中的可用工作长度。
【0125】在使用中,在图23A所示的延伸位置中的导引鞘600可以被放置在事先插入的导向线140上并且在其上延伸直至套筒604伸入体内脉管一个期望的距离。运送设备之后可以被插入通过开口620以将瓣膜12放置到加载器管622内且密封件624形成了在导向导管轴22周围的流体不泄漏密封。之后,端片614被旋转以使加载器管622滑动通过阀606、608、610(图23B),由此将运送设备放置为与套筒604的腔以及该套筒所插入的体内脉管连通。有益地,这种方法简化了加载过程并且减少了将瓣膜加载到所述鞘中步骤和部件的数量。
【0126】在导引鞘600的可选实施方式中,密封外罩602可以具有内螺纹,所述内螺纹接合端片614上的外螺纹。所述端片可以被旋转以如前所述地调节加载器管622的位置。此外,密封外罩和端片上的螺纹的斜度可以被改变以改变将加载器延伸通过密封阀所需要的旋转移动量。在另一个实施方式中,通过在不旋转端片的情况下推和拉该端片,端片614可以沿密封外罩的长度被滑动地定位。
【0127】图24A和24B示出了由700表示的可以用在运送设备10(图1)中的前端导管的另一个实施方式。前端导管700包括前端片702和前端导管轴704。前端片702具有连接到前端导管轴704的远端706和连接到球囊导管轴26的远端上的近端。前端片702包括球囊或由例如尼龙或PET(聚对苯二甲酸乙二醇酯)的柔性薄材料形成的类似结构,该前端片702能够呈现倒置的形状,当前端片702被向着球囊28推进时,该倒置的形状覆盖瓣膜12和球囊28或其中的部分。例如,前端片702可以具有类似于球囊28的结构。
【0128】虽然前端片702的近端被连接到球囊导管轴,但是前端导管轴704可相对于球囊导管轴26滑动。因此,当前端导管轴704相对于球囊导管轴26从第一延伸位置(图24B)向着第二收回位置(图24A)向近端运动(在箭头710的方向上)时,前端片702被推向球囊导管轴26的远端,从而使得前端片702呈现倒置的位置、覆盖了球囊28的外表面的一部分和瓣膜12。类似地,可以看出,相对于前端导管轴从图24B中所示的延伸位置向远端移动球囊导管轴还有效地使得前端片在球囊和瓣膜上呈现倒置的位置。
【0129】在使用中,前端片702最初放置在图24A中所示的倒置的位置以在瓣膜通过患者的脉管系统的运送期间提供平滑的跟踪剖面。在植入部位处或植入部位附近,前端导管轴704相对于球囊导管轴20向远端运动(在箭头712的方向上)从而为了之后瓣膜的展开而不覆盖瓣膜12和球囊28。虽然不必要,但仍期望前端片702可以被部分地膨胀从而使该前端片702可以更易于呈现图24A中所示的倒置的位置。为此,前端导管轴704的腔可以流动地连接到流体源以便部分地膨胀前端片702,这与球囊导管轴被用于运送流体到球囊28的方式类似。
【0130】图25A示出了运送设备10的一个改型的远端部。本实施方式中的运送设备包括阶梯球囊800,该球囊800安装在球囊导管轴26的远端部和内轴34上。如图25B所示,所述的球囊800包括第一细小部分802、第一圆锥部分804、主圆柱部分806、第二圆锥部分808、第二圆柱部分810、第三圆锥部分812和第二细小部分814。瓣膜12(图25A)可以卷曲状态安装在主圆柱部分806上。阶梯球囊800还在共同未决的美国申请No.11/252,657(‘657申请)(以美国专利申请公开号No.2007/0088431公开)中进行了更详细的描述,该申请作为参考结合于此。
【0131】如图25A所示,运送设备包括导向导管,该导向导管包括导向导管轴22,该导向导管轴22具有邻接瓣膜12的近端的扩大的端部816。所述导向导管还包括可收回的壳体818,该可收回的壳体818在瓣膜12之上延伸并覆盖瓣膜12。壳体818可操作地相对于瓣膜和导向导管轴22的远端纵向地滑动从而不覆盖瓣膜以便在体内脉管中展开。球囊800的部分802、804从壳体818的远端延伸并且可以部分地膨胀以提供球囊导管的远端和壳体818之间的过渡构件,由此有助于通过患者脉管系统的跟踪,类似前端片32(图1)。从壳体818延伸的球囊的端部还可以被用作扩张器以在期望的植入部位处展开瓣膜之前扩张本体心脏瓣膜的狭窄的叶或患者脉管系统的其他部分,如在‘657申请中的进一步的描述。
【0132】如图25A中进一步的显示,在所述实施方式中的壳体818具有在瓣膜12之上延伸的圆柱状的远端部820以及从圆柱状的远端部820的近端向近端延伸的多个沿圆周分隔的指822。每个指822的近端部均连接到牵引线826,该牵引线826延伸通过导向导管轴22中的相应的腔。如图25C所示,每条牵引线826从相应的腔828向远端延伸通过相应的指822的近端部824中的开口830并返回到腔828中。导向导管还可以包括柔性外部壳体838,该柔性外部壳体838在牵引线826自轴22延伸出的部分上延伸以防止线接触脉管系统的内壁。壳体838可以牢固地固定到轴22的外表面,例如通过适当的粘合剂。可替换地,壳体838可以适于相对于轴22纵向地滑动。
【0133】在所述的示例中的壳体818具有四个指822,每个指连接到延伸通过相应的腔828的牵引线826。如图25D所示,腔828可以围绕轴22的中心腔54等距地隔开。如上所述,轴22还可以包括另一个腔以便接收牵引线74从而调节导向导管的曲率。牵引线826在导向导管轴22的长度上延伸并且可操作地连接到位于轴的近端处的调节机构以允许手动调节牵引线826且由此手动调节壳体818。
【0134】图25E是连接到导向导管轴的近端的手柄部分832的示意性的图示。除了手柄部分832可以包括连接到牵引线826的附加调节机构834外,手柄部分832可以具有类似于手柄部分20(如上所述并如图3A-3B所示)的构造。调节机构834可以通过操作者移动牵引线826而前后移动(在双箭头836的方向上)。牵引线826理想地显示出足够的刚性以在远端方向上无变形地将推力施加到壳体818。牵引线可以为例如0.006英寸×0.012英寸的镍钛诺带状线。以此方式,壳体818可在相对于瓣膜的近端方向上被收回,并且如果必要,则在远端方向上运动,例如以通过调节机构834的操作而将瓣膜收回到壳体818中。可以用于产生牵引线在远端和近端方向上的运动的调节机构的进一步的细节在‘657申请中详细描述。
【0135】当瓣膜前进到体内的植入部位时,壳体818通过调节机构的操作而被收回以便不覆盖瓣膜。当壳体818被收回(相对于轴22和外部壳体838)时,轴端部816的远端邻接瓣膜以防止瓣膜在球囊800上的位置的不当运动。此后,球囊导管可以相对于导向导管向远端前进以使球囊800从壳体838和轴端部816前进一个足够的距离以允许球囊的充分膨胀,从而展开瓣膜12。瓣膜12可以是由球囊展开的可扩大的球囊瓣膜,或者可替换地,瓣膜12可以是当前进离开壳体818时径向扩大的自扩大的瓣膜。在后一种情况下,球囊800可以用于进一步扩大瓣膜以确保该瓣膜与本体瓣膜的口紧密地接合。
【0136】在可替换的实施方式中,轴远端部816可以被配置为将可释放的附件提供到瓣膜12,如在‘657申请中的详细描述。以此方式,导向导管可以被前后移动以在瓣膜被展开时调节该瓣膜在体内脉管中的位置。在展开之前(或者在瓣膜被部分展开或被扩大之后),瓣膜位置的控制可以通过操作者对导向导管的推、拉或扭动而获得。一旦操作者满意瓣膜的位置,则瓣膜可以完全展开并且该瓣膜脱离导向导管轴的远端。
【0137】图25A-25E示出了由900所示的导引鞘的另一个实施方式,该导引鞘900可以用于促进运送设备被导入血管。导引鞘900具有可扩大的细长套筒902,该套筒902可以从第一直径(图25A)径向地扩大到更大的第二直径(图25B),从而促进运送设备的最大部分(安装了瓣膜或其他假体装置的部分)的插入。鞘900还包括手柄部分904,该手柄部分904连接到套筒902的近端。套筒902包括内层906和外层908。内层906可以为编织的聚合物层,该聚合物层由例如聚醚醚酮(peek)、尼龙或聚丙烯等适当的材料构成。外层908可以由氨基甲酸酯(urethane)或其他适当的材料形成。外层908的外表面可以具有亲水性涂层。手柄部分904可以容纳一个或多个密封阀,如前所述,所述密封阀被构造为密封地接合被插入通过所述鞘的运送设备的外表面。
【0138】如图25C所示,套筒902可以形成有主腔910和一个或多个内部管道912,所述主腔910被成尺寸为允许运送设备通过,所述内部管道912限定了围绕主腔910相分隔的侧腔。延伸通过每个侧腔的是相应的牵引线914。每条牵引线914的近端被连接到手柄部分904上的调节机构916。每条牵引线914的远端被牢固地固定到套筒902的远端部。例如,如图25D所示,每条牵引线914均可以从相应腔的远端向外延伸并且可以被焊接到与套筒的远端相邻的内层906上。
【0139】调节机构916被配置为允许套筒902的直径在第一直径(图25A)和更大的第二直径(图25B)之间被手动调节。在所示的实施方式中,例如,调节机构可以在由双箭头918指示的方向上相对于手柄部分904纵向运动。在近端方向上(远离套筒902)使调节机构运动有效地在相同方向上拉动了牵引线914,这使得套筒902径向地扩大并且在长度上缩短。在远端方向上(向着套筒)使调节机构914运动释放了牵引线914上的张力以允许套筒902在其本身的弹性下径向地收缩并伸长。在具体实施方式中,套筒902在其收缩状态下具有约18F的外直径并且可以扩大到约28F的外直径。
【0140】在使用中,套筒902可以被如前所述地插入到血管中。当运送设备(例如运送设备10)被插入通过套筒902时,套筒902可以径向地扩大以允许安装在运送设备上的人工瓣膜(例如瓣膜12)或其他人工装置容易地通过套筒902。一旦人工瓣膜被插入到血管中,套筒902的直径可以被减小以最小化血管的阻塞。
【0141】在可选实施方式中,如图25E所示,内层906可以是激光切割管而不是编织层。所述管可以由多个纵向延伸的切口或裂缝920形成,所述切口或裂缝920允许所述管径向地扩大和收缩。
【0142】此处公开的运送设备的多种实施方式可以被用于将除人工心脏瓣膜以外的人工装置植入到身体。例如,运送设备可以用于将多种类型的腔内装置(例如支架、支架移植等)运送和展开到多个类型的脉管和非脉管的体腔(例如静脉、动脉、食道、胆道系统的输送管、肠、尿道、输卵管管道、其他内分泌或外分泌的管道等)。在一个具体示例中,运送设备可以用于将可扩大的球囊植入冠状动脉(或其他血管)以维持血管腔的开放。
【0143】鉴于可以应用公开的本发明的原理的许多可行的实施方式,应该意识到,所述的实施方式仅是本发明的优选示例并且不应被作为本发明范围的限制。此外,本发明的范围由所附权利要求限定。因此我们将落入这些权利要求的范围和精神内的全部内容作为我们的发明。
Claims (22)
1.一种用于运送人工瓣膜通过患者的脉管系统的设备,该设备包括:
球囊导管,该球囊导管包括细长轴和球囊,该球囊连接到所述轴的远端部,所述球囊适于承载处于卷曲状态下的所述瓣膜并且可在患者体内的植入部位处膨胀以展开所述瓣膜;
导向导管,该导向导管包括在所述球囊导管轴之上延伸的细长轴,该导向导管的所述轴包括可操纵段,所述导向导管还包括调节机构,该调节机构可操作地连接到所述可操纵段,所述调节机构被配置为调节所述可操纵段的曲率以及延伸通过该可操纵段的所述球囊导管轴的部分;以及
前端导管,该前端导管包括延伸通过所述球囊导管轴的细长轴以及连接到前端导管轴的远端的前端片,所述前端片具有内孔,该内孔适于在所述瓣膜的运送期间至少接收处于缩小状态的所述球囊的远端部;
其中所述球囊导管、所述导向导管和所述前端导管被配置为相对于彼此纵向运动。
2.根据权利要求1所述的设备,其中所述导向导管包括壳体,该壳体连接到所述导向导管轴的远端,所述壳体适于在运送期间在所述瓣膜之上延伸。
3.根据权利要求1所述的设备,其中所述前端片和所述壳体可以被定位成在运送期间完全包围所述瓣膜和处于缩小状态下的所述球囊。
4.根据权利要求1所述的设备,该设备还包括锁紧机构,该缩紧机构被配置为将所述球囊导管保持在相对于所述导向导管的选定的纵向位置上。
5.根据权利要求1所述的设备,该设备还包括锁紧机构,该缩紧机构被配置为将所述前端导管保持在相对于所述球囊导管的选定的纵向位置上。
6.根据权利要求1所述的设备,其中所述前端导管轴具有腔,该腔适于接收导向线,从而使所述前端导管、所述球囊导管和所述导向导管可以在所述导向线上一起前进。
7.根据权利要求1所述的设备,其中所述前端片适于在运送期间完全覆盖所述瓣膜。
8.根据权利要求7所述的设备,其中所述前端片适于在运送期间基本覆盖所述球囊。
9.根据权利要求1所述的设备,其中所述调节机构包括可转动杆和牵引线,该牵引线具有连接到所述杆上的近端部和被固定到所述可操纵段的远端部上的远端部,从而所述杆的转动有效地将牵引力施加在所述牵引线上,依次导致了所述可操纵段的弯曲。
10.根据权利要求4所述的设备,其中所述球囊导管轴具有形成有多个纵向隔开的凹槽的近端部,并且所述锁紧机构包括连接到所述导向导管的闭锁构件,所述闭锁构件与所述凹槽可接合并且在该闭锁构件对准并接合选定的凹槽时适于保持所述球囊导管使其不相对于所述导向导管纵向运动。
11.根据权利要求10所述的设备,其中在所述闭锁构件接合所述凹槽中的一个凹槽时所述闭锁构件和所述凹槽允许所述球囊导管相对于所述导向导管的旋转运动。
12.一种在患者体内的植入部位处植入人工瓣膜的方法,该方法包括:
将所述瓣膜放置在运送设备的球囊导管的可膨胀球囊上;
将至少所述球囊的远端部插入到所述运送设备的前端导管的前端片中;
将所述球囊导管和所述前端导管插入到体内并且使其通过患者的脉管系统前进;
相对于所述球囊导管向远端移动所述前端导管以便不覆盖所述球囊在所述前端片内部的部分;以及
通过膨胀所述球囊而在所述植入部位处展开所述瓣膜。
13.根据权利要求12所述的方法,其中在将所述球囊导管和所述前端导管插入体内之前,将至少所述球囊的近端部插入所述运送设备的导向导管的壳体中,并且插入所述球囊导管和所述前端导管的动作包括将所述球囊导管、所述前端导管和所述导向导管插入体内并且使其前进通过患者的脉管系统,并且在展开所述瓣膜前,相对于所述球囊导管向近端移动所述导向导管以便不覆盖所述球囊在所述壳体内部的部分。
14.根据权利要求13所述的方法,其中前进动作包括:调节所述运送设备的一部分的曲率以操纵所述瓣膜通过所述患者的脉管系统。
15.根据权利要求12所述的方法,其中将所述球囊导管和所述前端导管插入体内的动作是在不使用导引鞘的情况下完成的。
16.根据权利要求12所述的方法,其中将至少所述球囊的远端部插入所述前端片的动作包括:将所述球囊插入所述前端片从而使所述瓣膜被所述前端片完全覆盖。
17.一种在患者体内的植入部位处植入人工瓣膜的方法,该方法包括:
将处于卷曲状态的所述瓣膜放置在细长的运送设备的远端部上;
使所述运送设备前进通过患者的脉管系统;
在使所述运送设备前进的动作之后,将卷曲的瓣膜移动到所述运送设备的所述远端部上的可膨胀球囊上;以及
通过膨胀所述球囊而在所述植入部位处展开所述瓣膜。
18.根据权利要求17所述的方法,其中所述运送设备包括具有前端片的前端导管,该前端片位于邻近并在所述卷曲的瓣膜的远端,并且将所述卷曲的瓣膜移动到所述球囊上的动作包括:收回所述前端导管以使得所述前端片将所述卷曲的瓣膜推动到所述球囊上。
19.根据权利要求17所述的方法,其中将所述瓣膜移动到所述球囊上的动作包括:在锥形楔上移动所述瓣膜并且之后将该瓣膜移动到所述球囊上,在所述瓣膜被放置到所述球囊上之前所述楔部分地扩大所述瓣膜。
20.一种导引鞘,包括:
细长的管状套筒,该管状套筒具有腔并且适于被插入到患者的脉管系统内;
密封外罩,该密封外罩包括与所述套筒的所述腔连通的内孔以及被容纳在所述孔中的一个或多个密封阀;以及
端片,该端片被连接到与所述套筒相对的所述密封外罩处并且包括延伸进入所述孔中的加载器管,所述端片可沿所述密封外罩的长度移动以将所述加载器管从第一位置移动到第二位置,所述第一位置与所述一个或多个密封阀相分离,在所述第二位置中所述加载器管延伸通过所述密封阀。
21.根据权利要求47所述的导引鞘,其中所述端片可相对于所述密封外罩旋转以沿所述密封外罩的所述长度移动所述端片。
22.根据权利要求47所述的导引鞘,其中所述端片具有开口并且容纳邻近所述开口的密封件,从而密封地接合通过所述开口和所述密封件的血管内运送设备。
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