CN103637861B - 用于部署假体装置的可扩展元件 - 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
- A61F2/243—Deployment by mechanical expansion
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
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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
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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
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
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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
-
- 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
- A61F2230/0076—Quadric-shaped ellipsoidal or ovoid
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0008—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a position by translation along an axis or two perpendicular axes
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
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- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
Abstract
通过患者的脉管***递送假体装置的器械包括与细长轴的远端连接的可放射状扩展元件。可扩展元件具有开放框架配置和用于将收缩状态下的假体装置安装在其上的外部安装表面。可扩展元件从第一配置放射状地向外扩展到第二配置来扩展安装在其上的假体装置。
Description
本申请为分案申请,原申请的申请日为2009年03月02日,申请号为200980106695.9(PCT/US2009/035756),发明名称为“用于部署假体装置的可扩展元件”。
技术领域
本发明一般涉及医疗装置和方法。更具体而言,本发明提供用于将可扩展假体心脏瓣膜经皮经导管植入心脏有瓣解剖位点内或其附近的微创方法和装置。
发明背景
当治疗某些医学病症时,有时期望在患者体内的孔口或管道中扩展框架或其它可放射状扩展元件。例如,称作支架的可扩展管通常被***到患者身体天然管道中并在所述管道内被扩展,以将所述管道保持在开放位置。这些可扩展支架可以用于扩展、加宽人体的各种管道,包括,例如动脉、静脉、胆管、食道和结肠或另外对其提供结构支撑。在其它治疗程序中,包括框架元件在内的假体心脏瓣膜在治疗位点(例如,心脏瓣膜环)处被植入到身体。这些假体心脏瓣膜可以通过将框架元件扩展到大致瓣膜环的大小而定位在心脏瓣膜环中。
这些框架或支架可以是自动扩展的或用扩展球囊扩展的。一种常规的方法包括将框架定位在球囊导管的球囊上,操纵球囊和框架至治疗位点,并用液体使球囊膨胀以将框架或支架扩展到期望的大小。然而,这样的方法可具有缺陷。例如,在球囊扩展过程中,孔口或管道通常至少部分被阻塞——如果不是完全被阻塞,这可以引起某些不期望的结果。因此,期望提供消除或减少这些或其它潜在缺陷的方法和递送***。
发明概述
在假体装置在主动脉弓或在颅内动脉的部署中,球囊在植入过程中堵塞管腔,即使短时间,也可以将并发症引入到医疗程序中。本文各种实施方式中描述的器械和方法可以减少和/或基本上消除其中假体装置扩展过程中管腔(例如,动脉或其它通道)的阻塞。
在本文各种实施方式中描述的器械和方法可以延长假体装置部署时间、消除起搏及其相关风险,以及允许在部署过程中假体装置的重新定位。
在一个实施方式中,通过患者的脉管***递送假体装置的器械包括具有远端的细长轴和连接到细长轴远端的可放射状扩展元件。可扩展元件可以包括在第一方位(orientation)和第二方位之间相对于彼此可移动的远端部分和近端部分。许多个支杆可以与可扩展元件的远端部分和近端部分中的至少一个连接,并且可以具有假体装置接收区域。在第一方位中,远端部分和近端部分相距第一距离,以及在第二配置中,远端部分和近端部分相距第二距离。第二距离可以比第一距离小。远端部分和近端部分从第一方位到第二方位的移动可以引起连接元件从第一配置放射状地向外扩展到第二配置来扩展假体装置。
在具体的实施中,可扩展元件可以包括在远端部分和近端部分之间延伸的螺旋元件,并且螺旋元件的旋转可以引起远端部分和近端部分从第一方位移动到第二方位。在其它具体的实施中,可扩展元件可以包括在远端部分和近端部分之间延伸的丝(wire),并且所述丝的移动可以引起远端部分和近端部分从第一方位移动到第二方位。
在其它具体的实施中,许多个支杆中的一个或更多个可以从远端部分延伸到近端部分。在其它具体的实施中,可扩展元件可以包括至少部分包围许多个支杆的罩。在其它具体的实施中,罩可以被配置成打开以允许液体穿过可扩展元件从远端部分流到近端部分,以及可以配置成关闭以基本上防止液体穿过可扩展元件从近端部分流到远端部分。在其它具体的实施中,罩可以在近端部分附近具有至少一个缝以允许罩打开。
在具体的实施中,许多个支杆中的一个或更多个可以被配置成以预先确定的方式扩展。在其它具体的实施中,许多个支杆中的一个或更多个可以在期望的弯曲点的内面具有凹口(notch),以促进可扩展元件以预先确定的方式扩展。
在其它具体的实施中,许多个支杆中的一些可以从远端部分延伸,以及许多个支杆中的一些可以从近端部分延伸。假体装置可以在第一末端与从远端部分延伸的支杆可移动地连接并且在第二末端与从近端部分延伸的支杆可移动地连接。
在另一个实施方式中,通过患者的脉管***递送假体装置的器械包括具有远端的细长轴和与细长轴的远端连接的可放射状扩展元件。可扩展元件可以具有开放框架配置(openframeconfiguration)和用于将收缩状态下的假体装置安装到可扩展元件上的外部安装表面。可扩展元件可以被配置成从第一配置放射状地向外扩展到第二配置来扩展假体装置。
在具体的实施中,可扩展元件可以包括在远端部分和近端部分之间延伸的螺旋元件,并且螺旋元件的旋转可以引起远端部分和近端部分一起靠近移动和引起许多个支杆放射状地扩展。
在其它具体的实施中,可扩展元件可以包括许多个在远端部分和近端部分之间延伸的纵向延伸支杆。在其它具体的实施中,许多个支杆中的一个或更多个被配置成以预先确定的方式扩展。
在其它具体的实施中,可扩展元件可以包括至少部分包围许多个支杆的罩。罩可以被配置成打开以允许液体穿过可扩展元件从远端部分流到近端部分以及被配置成关闭以基本上防止液体穿过可扩展元件从近端部分流到远端部分。在其它具体的实施中,罩可以在近端部分附近具有至少一个缝以允许罩打开。
在另一个实施方式中,提供了通过患者的脉管***递送假体装置的方法。该方法可以包括在细长轴的远端提供可扩展元件,将假体装置与许多个支杆连接,以及将扩展装置从第一配置扩展到第二配置以扩展假体装置。可扩展元件可以具有许多个形成开放框架配置的支杆。
在其它具体的实施中,可扩展元件可以包括许多个从可扩展元件的远端部分延伸到可扩展元件的近端部分的支杆,并且所述方法可以进一步包括减少远端部分和近端部分之间的距离的动作以引起许多个支杆放射状地扩展。
在其它具体的实施中,许多个支杆中的至少一些可以从可扩展元件的远端部分延伸以及许多个支杆中的至少一些可以从可扩展元件的近端部分延伸,并且假体装置可以在第一末端与从远端部分延伸的支杆可释放地连接以及在第二末端与从近端部分延伸的支杆可释放地连接。所述方法可以进一步包括从许多个支杆释放假体装置。在其它具体的实施中,在扩展假体装置后,可扩展元件可以收缩回到第一配置并从身体中移走。
从下面参考附图进行的详细描述来看,本文公开的各种实施方式的上述和其它优点将变得更加明显。
附图简述
图1是用于将假体装置植入体内的可扩展元件的透视图。
图2是图1可扩展元件的侧视图。
图3是图1可扩展元件的端视图。
图4是部分可扩展元件的侧视图。
图5是收缩配置中显示的可扩展元件的视图,以及为了清楚其部分被去除。
图6是部分收缩的配置中显示的可扩展元件的视图,以及为了清楚其部分被去除。
图7是扩展配置中显示的可扩展元件的视图,以及为了清楚其部分被去除。
图8是具有可扩展元件的递送***的横截面图。
图9是具有可扩展元件和安装在其上的假体装置的递送***的部分横截面图。
图10是具有可扩展元件和安装在其上的假体装置的递送***的视图,其显示有罩和在扩展配置中的可扩展元件。
图11是具有罩的可扩展元件的部分横截面图,所述罩至少部分包围可扩展元件。
图12是具有罩的可扩展元件的视图,所述罩至少部分包围可扩展元件,并且所述罩显示在打开配置中。
图13是通过可扩展元件在身体内扩展的假体装置的部分横截面图。
图14是具有可扩展元件的递送***的视图,显示有假体装置被固定在可扩展元件上。
图15是具有可扩展元件和安装在其上的假体装置的递送***的视图,显示其在扩展配置中。
图16是递送***的视图,其中可扩展元件在体内治疗位点处,并且显示假体装置在扩展配置中。
图17A是具有可扩展元件和安装在其上的收缩假体装置的递送***。
图17B是在图17A的线17B-17B处获取的横截面图。
图18是可扩展元件的支杆和用于将支杆连接到假体装置的连接工具的视图。
图19显示锚定装置的视图。
图20显示图19的锚定装置的视图,所述锚定装置被定位在体内以相对于锚定装置将假体装置保持在适当的位置。
图21A显示具有图19显示的锚定装置的递送***的横截面图,其中显示所述锚定装置在非部署状态下。
图21B显示具有图19显示的锚定装置的递送***的横截面图,其中显示所述锚定装置在部署状态下。
图22显示具有可扩展元件的递送***的图解,所述可扩展元件可通过棘轮机构部署。
图23显示适于与图22的递送***使用的轴的图解。
图24显示与图22所示类型的递送***使用的机构的图解。
图25显示具有可扩展元件的递送***的图解,所述可扩展元件可应用位于所述可扩展元件附近的致动装置操作。
发明详述
下面的描述在本质上是示例性的并且不意图以任何方式限制本发明的范围、应用性或配置。在本文描述的元件的功能和排列上,可以对描述的实施方式进行各种改变,而不背离本发明的范围。
如本申请和权利要求中所用,除非上下文另外清楚地指明,单数形式“一个(a)”、“一个(an)”和“所述(the)”包括复数形式。另外,术语“包括(includes)”指“包括(comprises)”。进一步,术语“连接(coupled)”和“结合(associated)”一般指电、电磁和/或物理(例如,机械或化学)连接或联接,并不排除连接或结合项目之间中间元件的存在。
尽管为了方便地呈现,公开的方法的示例性实施方式的操作可以以特定的、连续的顺序被描述,但是应理解为公开的实施方式可以包括除公开的特定的、连续的顺序外的操作顺序。例如,连续描述的操作在一些情况下可以被重新排列或同时完成。进一步,结合一个特定的实施方式提供的描述和公开并不限于那个实施方式,可以应用到公开的任何实施方式。
而且,为了简单起见,所附的图可以不显示公开的***、方法和器械可以与其它***、方法和器械组合使用的各种方式(其为本领域普通技术人员基于本公开可容易地识别的)。此外,说明书有时使用术语如“产生(produce)”和“提供(provide)”来描述公开的方法。这些术语是可以进行的实际操作的高度抽象概念。与这些术语对应的实际操作可以根据特定的实施而变化,并且本领域普通技术人员基于本公开可容易地识别。
在某些实施方式中,本文公开的递送***和方法可以用于部署没有扩展球囊的框架元件(frameelement)或支架。因此,应用这些扩展球囊递送管腔内装置,特别是血管内装置有关的许多困难可以被避免或基本上消除。本文公开的递送***和方法可以基本上与常规方法中使用的那些递送***和方法相同,除了假体装置的扩展是通过实施机械元件之间的相对移动,而不是通过球囊元件的扩展和收缩来实现之外。
图1-3公开了具有开放框架配置的可扩展元件(可扩展笼形体)100的例证性实施方式。可扩展元件100可以包括许多个纵向延伸的、沿圆周间隔的支杆102,其在可扩展元件的对端终止并连接在一起。如图1所示,例如,支杆102可以在可扩展元件100的远端104和近端106之间延伸。支杆102可以由多种材料形成并可以是多种形状,只要形状和结构足够坚固以引起假体装置的扩展,如下面更详细的描述。例如,每个支杆102可以由弹性材料诸如硬塑料或金属的管状结构形成。此外,如本文所描述,可扩展元件100可由若干数目的支杆102形成,只要支杆具有足够的数目、强度和/或形状,以便给假体装置的表面和/或接触点提供足够的力量来扩展该装置。
许多个支杆102可以为待被递送的可扩展管腔内装置限定出环形支撑表面。环形排列中的每个支杆102可以侧向变形,以放射状地扩展或放射状地收缩支杆102的环形排列和由它们限定的环形支撑表面。
可扩展元件100可在第一配置或非扩展配置(图5)至第二配置或扩展配置(图1)之间扩展。可扩展元件100被可期望地配置,以便在其扩展配置(图1)中的可扩展元件的环形支撑表面所限定的形状被基本上预先确定和已知。因此,当可扩展元件100被扩展时,可扩展元件100的环形支撑表面将推动安装在其上的假体装置,以将假体装置扩展成预先确定的形状(即与其扩展配置中的可扩展元件100的形状互补的形状)。
可扩展元件100可被配置,以便其以各种方式扩展到预先确定的扩展配置。例如,支杆102在部署前可被预先形成或“热定形(heat-set)”到期望的扩展配置。通过以这种方式预先形成支杆102,在可扩展元件100扩展后,支杆102将符合它们已被预先形成的预先确定的形状。
可选地,或除了预先形成支杆102外,支杆102均可以包括至少一个凹口108,其形成于支杆102上期望的弯曲点110的内面。如图4所示给适当的弯曲点100开凹口促进支杆102的弯曲并且在部署过程中可以对可扩展元件100的形状提供更大的控制。还有,凹口108可以允许使用较少的致动(例如,压缩)力部署支杆102。凹口108的大小和深度可根据对每个支杆102所期望的强度与可成形性的比率而变化。
许多种不同的机构可被用于扩展和/或收缩可扩展元件100。在一个实施方式中,如图5-7所示,扩展和/或收缩可扩展元件100的机构可包括螺旋机构120,其被配置成施加纵向力来扩展或收缩可扩展元件100。为了清楚,图5-7图解的是除了一个支杆102之外其余支杆都被去除的可扩展元件100。参考图5,当在收缩配置中时,假体装置(未显示)可以被安装到可扩展元件100上。然后,可扩展元件100可以从收缩配置扩展到图7显示的扩展配置。图6图解的是可扩展元件100扩展过程中可扩展元件100可以经过的部分收缩的配置。可选地,部分收缩的配置(图6)可以是可扩展元件100的最初配置。换言之,可扩展元件100可以从任何第一配置(例如,图5的完全收缩的配置、图6的部分收缩的配置或另一个部分收缩的配置)扩展到第二、扩展的配置(例如,图7)。
当在最小的外形配置(即,最初收缩配置或部分收缩的配置)中时,可扩展元件100的近端106和可扩展元件的远端104相距最远,并且螺旋机构120处于延伸位置。为了扩展可扩展元件100并部署安装在其上的假体装置,可扩展元件100可以通过致动外部机构进行扩展。外部机构的致动(例如,图8所示的外部手柄上的致动元件130的旋转)引起螺旋机构120绕可扩展元件100的纵轴旋转,如图7中的箭头122所示。如图8所示,螺旋机构120可具有外螺纹部分136,其被接收在远端104的内螺纹部分134中。螺旋机构120的旋转引起螺旋机构120的外螺纹部分136进一步延伸到远端104的内螺纹部分134中,从而引起远端104向近端106移动。随着可扩展元件100的两端之间的距离变短,支杆102被轴向地压缩(如箭头121、124所示)并被迫使得放射状地扩展(图7)。
在假体装置被扩展之后,可扩展元件100可以收缩回到较小的外形配置,以通过患者的脉管***从治疗位点移除。为了将可扩展元件100恢复到收缩配置(图5)或部分收缩的配置(图6),螺旋机构120的旋转可以是反向的,从而引起可扩展元件100的近端106和远端104之间的距离增大以及引起支杆放射状地收缩。
图8图解的是递送***的实施方式,该***在远端包括可扩展元件100。可旋转的致动元件130可以与螺旋机构120连接。螺旋机构120可以穿过一个或更多个轴132纵向地延伸并附着到可扩展元件100的远端。如上面所论述,可扩展元件100的远端104优选与内螺纹元件134连接,内螺纹元件134与螺旋机构120的外螺纹部分136螺纹啮合。致动元件130的旋转引起螺旋机构120旋转,如上面讨论的那样,缩短了可扩展元件100的近端106和远端104之间的距离。
图9图解的是使用可扩展元件100部署假体装置152的递送***150的示例性实施方式。假体装置152可以是任何可扩展管腔内装置,诸如可扩展假体心脏瓣膜。在该示例性实施方式中,递送***150可包括外部元件(轴)154和内部元件(轴)156,其中外部元件154同轴向地布置在内部元件156周围。外部元件154和内部元件156可以由许多合适的材料制成,诸如聚合材料或金属材料。
内部元件156可包括附着在内部元件156远端附近的可扩展元件100。内部元件156还可具有导向丝管腔,以便递送***150随着导向丝158被推进,其中导向丝穿过管腔。依照与球囊型导管使用的常规方法,导向丝158可以被引入到身体管腔中并被引导到适当的位置。可扩展元件100和假体装置152可以跟踪导向丝158至靶位置,以部署假体装置152。
图9显示在基本上未扩展的配置中的可扩展元件100的支杆102。图9图解的是在部分收缩的配置中的可扩展元件100(如图6所示);然而,如上面讨论的那样,可扩展元件100可以被进一步收缩(如图5所示)以实现较小的外形配置。假体装置152被显示安装在支杆102的外表面,支杆102共同限定用于接收收缩状态下假体装置152的环形表面。如图9所示,可扩展元件100可以收缩到外部元件154的远端中并受其约束,这形成在瓣膜之上延伸的外壳(sheath)。因此,假体装置152可以在收缩的情况下被约束和/或定位在外部元件154和由支杆102限定的环形表面之间。当被安装在可扩展元件100上时,假体装置152可以通过患者的脉管******纵到治疗位点,如图9所示。
可选地,如美国专利申请公开号2008/0065011和美国专利申请序列号12/247,846中所描述,假体装置152可以在收缩(卷缩)状态下被最初安装在可扩展元件100远端或近端的位置。美国专利申请公开号2008/0065011和美国专利申请序列号12/247,846的全部公开内容被并入本文作为参考。在假体装置被推进穿过患者脉管***的狭窄部分(例如,髂动脉,其通常是相关脉管***的最狭窄部分)后,假体装置可以被定位在可扩展元件100上(或之上)。如果当可扩展元件被重新定位到假体装置之下时,假体装置还没被推进到部署位点,那么假体装置和可扩展元件可以一起被推进到治疗位点,并且可扩展元件可以被扩展以将假体装置部署在治疗位点。以这种方式,假体装置可以卷缩到甚至更小的直径,并且递送***的外形可以被进一步减小。
一旦假体装置152和可扩展元件100到达期望的部署位置,外部元件154可以向近端收缩,暴露假体装置152进行部署。图10图解的是外部元件154相对于可扩展元件100已被收缩之后在扩展配置中的可扩展元件100。可扩展元件的扩展可以通过致动螺旋机构120以纵向地压缩可扩展元件100并迫使支杆102放射状地扩展而被引起(如上面讨论的那样)。如图10所示,递送***可具有位于外部手柄元件128上或周围的致动元件130。外部手柄元件128具有指示可扩展元件的扩展量的可视标识131。致动元件130的旋转(如上面例如针对图8所讨论的那样)迫使可扩展元件100上的支杆102纵向地收缩并放射状地扩展,从而引起假体装置152扩展并锚定在靶位置。
图9和10显示的递送***150还可期望包括至少部分包围可扩展元件100的罩160。如图11和12所示,罩160可以布置在可扩展元件100的整个工作长度(假体装置安装区域)162上,其中罩160延伸假体装置152的长度并在可扩展元件100的近端部分164之上。为了清楚,图11显示了被部分切去的罩160,其显示了在工作长度162和近端部分164处罩160下面的支杆102的位置。可期望地,如图11所示,远端部分166保持不被罩住。罩160可期望地沿着工作长度162附着在支杆102的外表面。罩160可期望地包括一个或更多个缝170并在近端部分164处至少部分与支杆102的外表面分离。
缝170可以在近端部分164处按大约120度安排在罩160的圆周周围。缝170允许罩160的近端部分164充当临时小叶(leaflets)168,当液体如箭头172所指从远端104至近端106流过可扩展元件100时,所述小叶可打开(第二配置)(图10和12),而当液体如箭头174所指试图从近端106至远端104流过可扩展元件100时,所述小叶可关闭(第一配置)(图11)。
通过提供允许液体在一个方向上流动而在其它的方向上限制液体流动的罩160,当假体装置152被部署时递送***可以模拟天然瓣膜。在常规的***中,例如,球囊元件可以阻塞孔口(诸如主动脉瓣),从而引起麻烦。当瓣膜关闭时跨主动脉瓣压力下降,以及跨瓣膜流量(~5L/min)如此大以致瓣环的阻塞可导致心室将阻塞的元件(例如可扩展球囊)喷射入主动脉。通过允许穿过可扩展元件的流动,在假体装置部署过程中造成的压力可被避免。
还有,通过允许液体在假体装置部署过程中流经孔口,对起搏心脏的需要可以被减小或完全消除。尽管目前的起搏程序是有效的,但是它们仍然需要假体装置的快速部署。例如,在某些程序中,假体装置应在约3至5秒内被部署。因为本文描述的部署***允许在假体装置部署过程中跨孔口流动,假体装置可以被更缓慢地部署,并在部署过程中可以由操作者进行重新定位和/或移动。相比之下,起搏程序一般不允许部署过程中假体装置的任何重新定位或移动。此外,通过去除起搏,程序可以被大大简化,而且为起搏而进行的患者解剖结构和***(例如,心室压力和流量)的改变不需要被考虑。
图13图解的是具体实施方式,其中假体装置152是将置换天然主动脉瓣的假体心脏瓣膜。本文公开的实施方式允许血液从左心室182流经可扩展元件100并进入主动脉184。当假体装置152移动到主动脉环180的位置时,血液可以从左心室流经主动脉环180进入主动脉184(如箭头185所示)。然而,当血流反向时,罩160关闭(如图11所示)并至少基本上阻止血液从主动脉184流回到左心室182。因此,当假体装置152被部署时,罩160(及其小叶168)打开(如图10、13和13所示),以允许血液流进主动脉。然而,当心室完成收缩并开始舒张时,罩160(及其小叶168)向近端部分164处的支杆102移动(图11)并基本上防止血液流回到左心室。
罩160也可以在将假体装置递送和部署在治疗位点的过程中通过在支杆102和假体装置之间形成屏障而给待递送的可扩展假体装置的挠性膜或其它组件提供保护。罩160可以由任何合适的材料形成,包括,例如聚氨酯等。而且,除在示例性实施方式中显示的缝170和小叶168外,罩160可以包括任何合适的形状和配置,只要该形状和配置在假体装置的放置和部署过程中适于在一个方向上限制流动而在其它方向上允许流动。
各种假体装置适于用本文公开的递送***部署,包括例如心脏瓣膜,其包括可扩展框架元件和附着在可扩展框架元件上的一个或更多个小叶元件。在假体装置部署后,可扩展元件可以如上所述放射状地收缩并且可扩展元件可以从身体中移除。
在其它的实施方式中,假体装置本身可以至少包括部分可扩展元件。图14是递送***200的图解,其中开放框架可扩展元件包括假体装置。在例证性实施方式中,递送***200包括可植入假体装置202(下文中为“瓣膜202”),其适于经皮部署并且其与扩展支杆216可释放地连接,以形成可扩展元件。瓣膜202优选适合放射状地卷缩和放射状地扩展,这简化了在瓣膜202的递送和定位过程中穿过患者脉管***的狭窄通道的航行。瓣膜202还优选包括挠性膜204和可收缩支撑结构(框架)206。
在部署在治疗位置之后,挠性膜204可以被定位在穿过瓣膜202的流动路径中,以允许在第一方向上流动并基本上抵抗在第二方向上流动。在一个实施方式中,挠性膜204可包括形成为挠性小叶208的可收缩柔韧材料,其可以被安排成以例如单尖、双尖或三尖瓣的排列方式收缩。
在例证性实施方式中,可收缩支撑结构206可以从第一直径扩展到第二直径,并可以具有沿其结构轴穿过可收缩支撑结构206的流动路径。可收缩支撑结构206可包括可扩展框架元件210的大致圆柱状可扩展构架,其主要是将瓣膜202固定在缺损瓣膜环处或其附近。可收缩支撑结构206可以给瓣膜202提供稳定性并有助于防止瓣膜202在它已经植入后迁移。
这种类型的假体瓣膜通常植入在一个人体通道中,以置换天然瓣膜。在例证性实施方式中,结合心脏瓣膜假体对假体瓣膜进行说明,所述心脏瓣膜假体被配置成植入在主动脉环处;然而,应被理解为本文公开的递送***可以与其它可扩展元件和假体装置一起使用。
可收缩支撑结构206可以是支撑支架,所述支撑支架被配置成平滑地卷缩以便呈现相对小的外形或狭窄配置。可收缩支撑结构206还可以由小的外形配置放射状地部署,以便延伸占据身体管道中进行植入的靶位置处的通道。在一个实施方式中,可收缩支撑结构206可包括一系列框架元件(支杆)210,它们被安排和连接以限定几何结构,所述几何结构当被轴向地压缩时引起可收缩支撑结构206放射状地扩展。例如,框架元件210可以限定出大致菱形的小室212,当轴向地被压缩时,这些小室迫使可收缩支撑结构206放射状地扩展。瓣膜202可以在位于瓣膜202近端和远端的附着区域214与连接支杆(连杆)216可释放地连接。
在操作中,递送导管将瓣膜202——当其与扩展支杆216连接时——通过导向丝之上的外壳推进到身体管道中的靶位置,例如,主动脉瓣。如图4所示,当在收缩位置时,连接支杆216可以相对于部署***基本上轴向地被布置。为了扩展瓣膜202,远端104和近端106之间的距离可以通过旋转螺旋机构120而缩短。如上面所论述,螺旋机构的旋转引起远端104靠近近端106移动,这迫使连接支杆216放射状地扩展。为了促进连接支杆216的放射状扩展,连接支杆可具有铰链或弯曲区域217,连接支杆在其周围进行弯曲。这些弯曲区域可以是预先形成的或带有凹口,或另外被配置以便当连接支杆216被轴向地压缩时它们会在弯曲区域217放射状地伸展。
因为连接支杆216在附着区域与框架元件210相连,所以连接支杆216的放射状扩展将方向呈放射状的力(radiallydirectedpower)经由框架元件210施加到瓣膜202。连接支杆216的放射状地移动引起瓣膜202放射状地扩展(部署)。如图16所示,一旦瓣膜202开始扩展,小叶204可被立即启用并开始调节通过瓣环的流量。一旦瓣膜202被完全部署,连接支杆216可从附着区域214脱离并从靶位置移去。
在图17A、17B和18中显示的具体实施中,连接支杆216可以在枢轴连接区域(pivotconnectingareas)(弯曲区域)234与环形元件230、232的一部分可转动地连接。例如,在一个实施方式中,位于近端的连接支杆可以在近端与第一环形元件230连接,并且位于远端的连接支杆可以在远端与第二环形元件232连接。环形元件230和232可包括许多个邻近的、沿圆周间隔的延伸元件236,间隔位于邻近的延伸元件236之间,用于接收连接支杆216。连接支杆216可以被定位并捕获在延伸元件236之间,并且被配置成围绕枢轴连接区域234转动或弯曲。环元件219可以经过每一个连接支杆216,以将每一个连接支杆216保持在环形元件230和232之一的合适位置。
在这个和其它实施方式中,连接支杆216的数目可以变化。例如,图17B显示4个沿圆周间隔的连接支杆216;然而,可以使用更多或更少的连接支杆216,只要连接支杆216当经受压缩时产生的方向向外的力足以将瓣膜202从具有较小直径的未扩展配置扩展到具有较大直径的扩展配置。在例证性实施方式中,图17B显示了延伸元件236之间八个不同位置,连接支杆216可以位于这些位置中。
通过螺旋机构或其它轴向施加的力,可以引起环形元件230和232的相对移动(如上面所更详细地描述),从而引起连接支杆216放射状地扩展。为了均一地扩展瓣膜202,可以期望绕环形元件230和232环形地间隔连接支杆216。此外,可以期望将支杆216与瓣膜在瓣膜具有结构支撑或支柱的区域连接,以便瓣膜在支杆216接触瓣膜202的区域具有足够的刚性。
可以使用将连接支杆216附着到瓣膜202的各种手段。例如,连接支杆216可具有第一末端和第二末端,所述第一末端与环形元件230和232可转动地连接,所述第二末端包括用于将瓣膜202固定到连接支杆的固定机构,如图18所示。例如丝元件238可以穿过连接支杆216,以及部分瓣膜202可以捕获在丝238和连接支杆216的保持区域240之间(例如,丝元件238可以穿过形成于支杆210之一中并位于区域240中的圈或开口)。通过将丝238向近端(在箭头242的方向上)拉一段距离可以使瓣膜202从连接支杆216释放,所述距离大得足以从保持区域240释放瓣膜202。
图19-21显示了可扩展锚定装置300的实施方式,该装置可以用于在瓣膜302部署过程中将瓣膜302保持在期望的位置。如图19所示,锚定装置300可包括许多个挠性元件或指状物304。这些挠性元件304可以用于在瓣膜302部署过程中将递送***锚定在合适的位置。如图20所示,例如,在将假体装置(瓣膜302)部署在主动脉环的过程中,挠性元件304可以在左心室中被扩展,其中挠性元件304可以被配置成接触天然主动脉瓣310周围部分组织。一旦被部署,锚定装置300可以固定瓣膜302相对于天然瓣膜310的位置。因此,然后瓣膜302可以在天然瓣膜310中扩展,而不用担心由例如跳动的心脏的运动或穿过天然瓣膜310的血压所引起的定位误差。
此外,锚定装置300可以通过防止递送***在部署过程中向近端移动而有助于将瓣膜保持在合适的位置。例如,锚定装置300在左心室内扩展后,递送***可以向近端移动,直至锚定装置300接触主动脉环附近的心室壁,从而有效地防止递送***任何进一步的向近端移动。锚定装置300固定假体装置(瓣膜)的相对位置后,假体装置可以在主动脉环处扩展。
参考图21A和21B,可以将锚定装置300递送到限制在外部元件(罩)314中的治疗位点(或锚定位置)。为了部署锚定装置300,外部元件314可以被收缩,从而暴露挠性元件304。挠性元件304可以向外偏并在罩元件314收缩后,挠性元件304放射状地扩展并且可以与天然瓣环310附近的组织接触放置。锚定装置的可扩展部分可以以许多种形状形成。例如,如果期望,挠性元件304可以用可扩展编织杯(explandablebraidedcup)代替。在被适当定位后,瓣膜302可以使用元件315进行扩展,所述元件315可以是例如本文所描述的可扩展元件或球囊元件。
为了将锚定装置300从治疗位置移除,收缩套环308可以被用来“再捕获”挠性元件304。在一个实施方式中,牵引丝312可以附着到套环308,所述套环308位于锚定装置300的挠性元件304远端附近。通过将牵引丝向近端拉,套环308可以相对于挠性元件312向近端移动,从而引起它们沿着递送***的轴放射状地收缩。一旦被收缩,锚定装置300可以通过递送***的导管从体内收缩而从治疗位点去除。
螺旋机构120是特别可期望用于扩展可扩展元件的机构,原因是它可以在局部区域(例如,可扩展元件)提供显著的压缩力,从而迫使可扩展元件放射状地扩展,而不用在递送***的所有其它位置给予显著的力。然而,如上所论述,可以使用用于扩展可扩展元件的其它机构。例如,图22图解的是部署***的另一个实施方式,其中可扩展元件100的远端104和近端106之间的距离可以被调节以扩展瓣膜或其它假体装置。
在这个实施方式中,可扩展元件两端之间的距离可以通过向部署***400的长度施加纵向(非旋转)力来进行调节。与本文描述的其它部署***一样,部署***400可以用于递送假体装置,诸如心脏瓣膜,但并不限于这些,并且也可适合支架递送***。在一个实施方式中,部署***400可包括轴402,其可以穿过脉管***并还具有足够的“纵向”压缩强度,以允许用足够的力将丝或钢索404拉过被限定穿过轴402的中心管腔,部署例如可扩展元件100(为了清楚,显示时去除了一些支杆102)。
在一个实施方式中,丝404的一端延伸穿过可扩展元件100并与可扩展元件100的远端104连接。丝404的近端与手柄406可操作地连接,以与棘轮机构420接合(图24所示)。
棘轮机构420可以这样启用:例如,通过握紧和挤压手柄408和410(图22)以引起丝404被拉向近端穿过轴402的中心管腔并通过使锁定轮422、424相对(图24)以本领域普通技术人员熟知的方式锁定到适当位置。其它锁定组件可以被提供以至少暂时固定丝404相对于轴402的位置。释放旋钮412也可包括在手柄406上并且如所期望的那样用于释放锁定轮422、424和丝404上的张力。
图23是挠性轴402沿纵向长度的横截面图。在一个实施方式中,挠性轴402由圆形的横截面闭合的缠绕线圈(circularcrosssectionclosedwoundcoil)430组成,其***有三角形的横截面闭合的缠绕线圈(triangularcrosssectionclosedwoundcoil)432。每个线圈430和432均限制在管状罩434内,所述罩可由乙烯基或相似的材料制成。线圈430和432限定出沿挠性轴402的长度延伸的管腔,其中丝404布置在所述管腔中。
在操作中,一旦可扩展元件100如期望的那样被定位在脉管***中,手柄406的棘轮机构420可以被启用。棘轮机构420向近端(在箭头438的方向上)拉丝404,这进而将可扩展元件100的远端104拉向近端106,以引起可扩展元件100以先前描述的方式“部署”。所形成的用于拉丝404的力(箭头440所示)被传递到轴402,该轴被配置成吸收压缩负荷并抵抗压缩(箭头442所示),而轴402没有明显扭曲或变形。
由于轴402提供稳定的安装平台,在可选的实施方式中,除通过拉丝404来部署可扩展元件100外,还可以使用旋转致动器450。有利地,由于旋转致动器450被安装到“刚性”平台,扭曲致动是可接受的。
本文描述的机构还可以通过许多动力源来致动。例如,上面描述的螺旋机构可以使用动力源诸如发动机或电池来致动。在图25显示的例证性实施方式中,旋转致动器450如DC发动机或相等物与轴402的远端452连接。在这个实施方式中,旋转致动器450可与驱动轴454如螺杆连接。驱动轴454可以与位于可扩展元件100的远端104的螺纹插孔456可操作地啮合(一些支杆102被去除)。通过操作,旋转致动器450使驱动轴454旋转,引起螺纹插孔456在驱动轴454上线性移动。螺纹插孔456向近端106的线性移动引起远端104向近端106移动以部署可扩展元件100。
在一个实施方式中,齿轮减速机构460可以添加到旋转致动器450,以产生较高的输出转矩并且还允许放置程序的微调。应当理解为发动机电压(仅DC)、齿轮箱减速比(gearboxratio)和螺纹螺距的变化可用于获得部署可扩展元件100所必需要求或期望的转矩。
本文描述的器械和方法可以通过允许医师更准确地定位并部署假体装置——而不扰乱患者的血流动力学——来改善目前部署程序中最关键的阶段之一。
尽管上面论述的具体实施方式描述了用于扩展各种假体装置的方法和器械,但是应当理解为,本文公开的装置和方法可以用于其它目的。例如,本文公开的可扩展元件可以用于代替许多种医学程序中的可扩展球囊元件。因此,本文描述的可扩展元件可以用于例如血管成形术(例如,打开梗塞的冠状动脉)、瓣膜成形术(例如,扩张狭窄的心脏瓣膜)以及常规采用扩展球囊元件的其它程序。
本发明已被以例证性的方式公开。因此,全文使用的术语应以示例性而不是限制性方式进行理解。尽管本领域普通技术人员会想到本发明较小的修改,但是应当理解为,此处意图限制在授权的专利范围内的是合理地落入所贡献的领域的进展范围内的所有这些实施方式,而且除根据所附的权利要求和其相等物外,那个范围将不被限制。
Claims (6)
1.通过患者脉管***递送假体心脏瓣膜(152)的***,其包括:
具有远端的细长轴(132);
可放射状扩展元件(100),其与所述细长轴(132)的所述远端连接,所述可放射状扩展元件(100)具有开放框架配置,包括许多个支杆(102),所述许多个支杆(102)在所述可放射状扩展元件(100)上限定环形支撑表面,所述可放射状扩展元件(100)被配置成从收缩配置放射状地扩展到扩展配置;以及
假体心脏瓣膜(152),其具有支架和组织瓣膜,当所述可放射状扩展元件(100)处于所述收缩配置时所述假体心脏瓣膜(152)可收缩以放置在所述可放射状扩展元件(100)上,以及其中所述可放射状扩展元件(100)可扩展到所述扩展配置以部署所述假体心脏瓣膜(152),同时允许血液经过所述可放射状扩展元件(100);
其中所述许多个支杆(102)被预先形成,以便在所述可放射状扩展元件(100)的所述扩展配置中,所述环形支撑表面的形状和所述假体心脏瓣膜(152)的扩展形状互补。
2.权利要求1所述的***,其中所述可放射状扩展元件(100)包括远端部分(104)和近端部分(106),它们可相对于彼此在第一方位和第二方位之间移动。
3.权利要求2所述的***,其中所述许多个支杆(102)与所述远端部分(104)和近端部分(106)连接以及其中所述远端部分(104)和近端部分(106)从所述第一方位到所述第二方位的移动引起所述许多个支杆(102)从第一配置放射状地向外扩展到第二配置来扩展所述假体心脏瓣膜(152)。
4.权利要求3所述的***,其中所述可放射状扩展元件(100)包括螺旋元件(120),所述螺旋元件(120)在所述远端部分(104)和所述近端部分(106)之间延伸,以及其中所述螺旋元件(120)的旋转引起所述远端部分(104)和近端部分(106)从所述第一方位移动到所述第二方位。
5.前述权利要求任一项所述的***,进一步包括罩(160),所述罩(160)至少部分包围所述可放射状扩展元件(100)。
6.权利要求5所述的***,其中所述罩(160)包括至少一个缝(170),其限定至少一个小叶(168),所述至少一个小叶(168)具有在所述假体心脏瓣膜(152)部署期间基本上防止在第一方向上的液体流动的关闭配置和允许在与所述第一方向相反的第二方向上的液体流动的打开配置。
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CN101959478B (zh) | 2013-12-18 |
CN101959478A (zh) | 2011-01-26 |
WO2009108942A1 (en) | 2009-09-03 |
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