CN202740158U - 用于经导管心脏瓣膜的小外形传送系统 - Google Patents
用于经导管心脏瓣膜的小外形传送系统 Download PDFInfo
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- 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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- 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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- 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
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- 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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- 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
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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Abstract
提供了一种用于传送人工瓣膜通过病人的脉管系统的传送系统。传送系统包括具有细长轴的导向导管(14)。传送系统还包括球囊导管(16),球囊导管具有细长轴、延长部分(74)和连接于所述轴远端部分的球囊(28)。球囊导管能够在导向导管的轴内纵向移动。人工心脏瓣膜包括可扩张框架部分和具有小叶的内部部分。球囊导管的延长部分适于接纳卷曲状态的人工心脏瓣膜,以在推进穿过病人的脉管系统期间将所述人工心脏瓣膜保持在球囊导管上。导向导管的细长轴具有将人工心脏瓣膜推到球囊上的远端。球囊能够膨胀以在自体动脉瓣内扩张该人工瓣膜。
Description
本申请是分案申请,原申请的申请日为2009年5月1日、申请号为200990100366.9(PCT/US2009/042566)、发明名称为“用于经导管心脏瓣膜的小外形传送系统”。
技术领域
本发明涉及可植入的装置,更具体地说,本发明涉及用于人工心脏瓣膜植入的装置和方法。
背景技术
经导管心脏瓣膜(THV)是一种构造成通过插管术被植入的人工心脏瓣膜。一种类型的THV已经由加利福尼亚州Irvine的Edward Lifesciences研制出并且公开在美国专利6,730,118中,该专利的整个内容并入本文作为参考。在美国专利6,730,118中描述的THV主要构造成代替人心脏中狭窄的主动脉瓣的功能。该THV的重要特征是被植入自体主动脉瓣狭窄区的性能。植入之后,THV保持打开自体主动脉瓣开口的小叶并且利用自体瓣膜环作为THV的连接装置。
THV的重要设计参数是折叠或卷曲外形的直径。该卷曲外形的直径是重要的,因为它直接影响医生将THV推进通过股动脉或静脉的能力。更具体地说,较小的外形考虑到治疗更多的病人,同时安全性提高。
发明内容
传统上,THV直接卷曲在球囊导管的球囊上并且卷曲的THV和球囊被导引通过病人的脉管系统到植入部位。由于球囊材料的厚度,瓣膜不能被卷曲成其可能更小的外形。在下面公开的某些实施方式中,球囊安置在卷曲的THV或远侧或近侧。这使THV能够卷曲成更小的直径。在THV被推进通过病人脉管系统的狭窄部分(例如,髂动脉,其通常是相关脉管系统最狭窄的部分)之后,该THV被放置在球囊上。如果当球囊部件重新安置在THV下面时THV还没有被推进到治疗部位,那么该THV然后可以进一步推进到治疗部位并且球囊能够被膨胀以在自体心脏瓣膜内径向扩张该THV。
有利的是,某些实施方式使THV能够被卷曲成非常小的直径,因此克服了与THV部署(deployment)相关的主要缺点。
在一个实施方式中,公开了一种用于传送人工瓣膜通过病人脉管系统的设备。该设备包括主导管、球囊导管以及瓣膜携带部件。该主导管包括细长的轴。该球囊导管包括细长的轴和连接于该轴远端部分的球囊。球囊导管的轴能够在主导管的轴内纵向地移动。该瓣膜携带部件具有用于接纳卷曲的瓣膜的安装表面,该卷曲的瓣膜用于插入病人的脉管系统中。球囊安置在该安装表面的远侧或近侧,并且球囊构造成相对于该安装表面可以移动,或反之亦然,以在该瓣膜插入病人的脉管系统中之后将球囊安置在延伸通过该卷曲的瓣膜的位置。
在具体的实施中,该设备还包括前端件(nose piece)并且瓣膜携带部件在该前端件的近端和主导管的轴的远端之间延伸。
在具体的实施中,瓣膜携带部件包括两个或更多个条部件(strip member),并且该条部件连接于前端件的近端和主导管的轴的远端。在其它具体的实施中,条部件由聚合物材料形成。在其它具体的实施中,条部件连接于前端件的内表面和主导管的轴的远端的内表面。在其它具体的实施中,条部件包括四个聚合物条。
在具体的实施中,前端件的近端包括一个或多个狭槽(slit),并且主导管的轴的远端包括一个或多个狭槽。在其它具体的实施中,主导管的轴的远端还包括设置在该狭槽位置处的弯曲适配器(flex adapter),其中该弯曲适配器具有两个或更多个指形物(finger),所述指形物构造成在没有向内指向的力的情况下将狭槽保持在径向扩张的位置。
在具体的实施中,前端件还包括围绕该前端件狭槽至少一部分的聚合物套(polymer jacket)。在其它具体的实施中,一个或多个条部件设置在前端件的近端上的狭槽和主导管的轴的远端上的狭槽之间。
在具体的实施中,瓣膜携带部件包括相对于主导管的轴同轴地延伸的细长轴。在其它具体的实施中,瓣膜携带部件的轴具有远端部分,其延伸超过主导管的轴的远端。瓣膜携带部件的轴的远端部分可以包括瓣膜携带部件的安装表面。
在具体的实施中,利用临时连接装置将人工瓣膜连接于主导管的轴的远端。在其它具体的实施中,该临时连接装置可以包括连接于瓣膜的缝线(sutrue)以及连接于主导管的轴和该缝线的金属丝。在其它具体的实施中,瓣膜携带部件的轴包括Nitinol编织物(braid)或聚合物编织物。
在具体的实施中,该设备还包括前端件,并且瓣膜携带部件的轴在该前端件的近端和主导管的轴的远端之间延伸。在其它具体的实施中,瓣膜携带部件的轴的远端连接于前端件的内表面,并且瓣膜携带部件的轴的一部分设置在主导管的轴内。
在另一个实施方式中,公开了一种用于传送人工瓣膜通过病人脉管系统的设备。该设备包括主导管和球囊导管。该主导管包括细长的轴。该球囊导管包括细长的轴、连接于该轴远端部分的球囊以及延长部分。球囊导管能够在主导管的轴内纵向地移动。该球囊导管的延长部分位于球囊和细长轴之间,并且构造成将卷曲状态的人工瓣膜接纳在该延长部分的外表面上。
在具体的实施中,球囊导管的延长部分由与球囊相同的材料形成。在其它具体的实施中,该设备还包括前端件,其中球囊的远端部分连接于该前端件。球囊的远端部分可以连接在前端件的大致中点处。此外,前端件可以构造成相对于卷曲的人工瓣膜移动,以便当卷曲的人工瓣膜在病人的脉管系统中时前端件能够移动靠近卷曲的人工瓣膜。前端件可以具有有近端凹入部分的大致沙漏形状,其中前端件的近端凹入部分构造成当前端件移动靠近该卷曲的人工瓣膜时接纳球囊的至少一部分。
在其它具体的实施中,该设备还包括设置在球囊导管的延长部分下面的扩张部件(expansion member)。球囊和该扩张部件两者都构造成扩张到各自的最大扩张直径,其中球囊的最大扩张直径大于扩张部件的最大扩张直径。在其它具体的实施中,扩张器设置在延长部分的远端,该扩张器构造成当该扩张器相对于卷曲的瓣膜移动时部分地扩张该卷曲的瓣膜。在其它具体的实施中,止动器设置在延长部分的近端,该止动器构造成阻止卷曲的瓣膜在延长部分上移动。
在另一个实施方式中,公开了一种在病人身体中的植入部位植入人工瓣膜的方法。该方法包括提供一种传送设备,该传送设备包括具有细长轴的主导管、具有细长轴和连接于该轴的远端部分的球囊的球囊导管,以及瓣膜携带部件。该瓣膜在瓣膜携带部件的安装表面上卷曲成较小的外形。该瓣膜和传送设备经由插管器鞘(introducer sheath)插入病人身体的脉管系统中。在瓣膜通过插管器鞘之后瓣膜被安装在球囊上。通过扩张球囊将瓣膜部署在植入部位。
在具体的实施中,该方法还包括将瓣膜推进到植入部位,其中将瓣膜安装在球囊上的动作发生在瓣膜通过插管器鞘之后但是在将瓣膜推进到植入部位之前。
在具体的实施方式中,在卷曲瓣膜的动作期间,球囊安置在安装表面的近侧,并且将瓣膜安装在球囊上的动作包括向远侧移动球囊,使得球囊安置在卷曲的瓣膜下面。在其它具体的实施中,在卷曲瓣膜的动作期间,球囊安置在安装表面的远侧,并且将瓣膜安装在球囊上的动作包括向近侧移动该球囊,使得球囊安置在卷曲的瓣膜下面。
在具体的实施中,该传送设备还包括前端件和在该前端件的近端和主导管的轴的远端之间延伸的瓣膜携带部件。在其它具体的实施中,该方法还包括利用临时连接装置将人工瓣膜固定在主导管的轴的远端。在其它具体的实施中,该方法还包括在将瓣膜安装在球囊上之后从主导管释放该瓣膜。
在另一个实施方式中,公开了一种在病人身体中的植入部位植入人工瓣膜的方法。该方法包:(a)提供一种传送设备,该传送设备包括主导管和球囊导管,所述主导管具有细长轴,所述球囊导管具有细长轴、瓣膜携带部件、以及连接于该轴的远端部分的球囊,所述球囊导管的瓣膜携带部件位于球囊和细长轴之间;(b)将瓣膜在瓣膜携带部件的安装表面上卷曲成较小的外形;(c)操纵该卷曲的瓣膜通过插管器鞘进入病人身体的脉管系统中;(d)相对于该卷曲的瓣膜调节球囊的位置,使得该球囊位于该卷曲的瓣膜下面;以及(e)通过扩张该球囊将瓣膜部署在植入部位。
在具体的实施中,该方法还包括在相对于该瓣膜调节该球囊的位置之前通过将扩张部件扩张来部分地扩张该瓣膜。
在另一个实施方式中,公开了一种在病人身体中的植入部位植入人工瓣膜的方法。该方法包括:将成卷曲状态的瓣膜放置在细长的传送设备的远端部分上;将该卷曲的瓣膜插入病人的身体中;在将该卷曲的瓣膜插入病人身体中的动作之后,将该卷曲的瓣膜移动到传送设备远端部分上的可膨胀球囊上;以及通过使该球囊膨胀将该瓣膜部署在植入部位。
在另一个实施方式中,公开了一种用于推进导管通过插管器鞘的设备。该设备包括保持部件和驱动部件。该保持部件构造成相对于该设备将插管器鞘保持在适当位置。该驱动部件是可操作的以啮合并驱动该导管通过该插管器鞘。
在具体的实施中,该驱动部件包括可旋转部件和第一齿轮部件。该第一齿轮部件包括构造成摩擦地啮合该导管的外表面的啮合表面。旋转该可旋转部件使第一齿轮部件旋转并且相对于该插管器鞘纵向驱动该导管。
在其它具体的实施中,该设备还包括第二齿轮部件。该第二出论部件也具有构造成摩擦地啮合该导管的外表面的啮合表面。在其它具体的实施中,该第一齿轮部件和第二齿轮部件都具有齿,并且当第一齿轮部件旋转时,第一齿轮部件的齿啮合第二齿轮部件的齿,使得第二齿轮部件也旋转并且相对于该插管器鞘纵向驱动该导管。
在其它具体的实施中,该第一齿轮部件的啮合表面的至少一部分涂覆有弹性体材料。在其它具体的实施中,该第一齿轮部件包括两个平行的O形环部件。
在另一个实施方式中,公开了一种推进导管通过插管器鞘的方法。该方法包括提供一种具有驱动部件和保持部件的推进设备。该保持部件构造成相对于该推进设备将插管器鞘保持在适当位置。该方法还包括将该保持部件固定于该插管器鞘;和手动地驱动该驱动部件以便该驱动部件啮合并驱动该导管通过该插管器鞘。
在具体的实施中,该驱动部件包括可旋转部件和第一齿轮部件,该第一齿轮部件包括构造成摩擦地啮合该导管的外表面的啮合表面,并且手动驱动该驱动部件的动作包括旋转该可旋转的部件,以使第一齿轮部件旋转并且相对于该插管器鞘纵向驱动该导管。
在另一个实施方式中,公开了一种用于指示导管远端弯曲的设备。该设备包括细长轴;至少一个连接于该细长轴的远端部分的金属丝;包括弯曲激发部件(flexactivating member)的手柄部分,该弯曲激发部件连接于该至少一个金属丝,以便弯曲激发部件的调节使轴的远端部分弯曲;以及弯曲指示部件。弯曲激发部件的调节使弯曲指示部件相对于手柄移动,以指示该轴远端部分弯曲的量。
在具体的实施中,该弯曲激发部件包括可旋转部件。在其它具体的实施中,手柄部分包括用于接纳至少一部分弯曲指示部件的狭槽(slot)。在其它具体的实施中,可旋转部件包括内螺纹表面部分和外螺纹表面部分。该内螺纹表面部分构造成接纳连接于该至少一个金属丝的滑动部件,并且外螺纹表面部分构造成接纳该弯曲指示部件的延伸部分。在其它具体的实施中,旋转可旋转部件使该滑动部件沿着内螺纹表面部分移动,并且该滑动部件沿着内螺纹表面部分的移动改变了该轴远端部分弯曲的量。可旋转部件的旋转使弯曲指示部件纵向地移动并且改变其在手柄部分的狭槽内的位置,并且弯曲指示部件在狭槽内的位置指示该轴远端部分弯曲的量。
在另一个实施方式中,公开了一种操纵传送设备通过病人脉管系统的方法。该方法包括提供一种传送设备,该设备具有细长轴、弯曲指示部件和手柄部分,该手柄部分包括弯曲激发部件。该方法还包括操纵该弯曲激发部件,使该轴的远端部分弯曲并且使弯曲指示部件相对于手柄部分移动。该方法还包括通过观察弯曲指示部件相对于手柄部分的位置,确定该轴远端部分弯曲的量。
在另一个实施方式中,用于传送人工瓣膜通过病人脉管系统的设备可以包括主导管、球囊导管以及前端件。该主导管可以包括细长的轴。该球囊导管可以包括细长的轴和连接于该轴的远端部分的球囊。球囊导管的轴能够在主导管的轴内纵向地移动。该前端件可以设置在主导管的远端并且可以包括球囊。
在另一个实施方式中,一种设备可以包括主导管、球囊导管和调节装置,该主导管包括细长轴,该球囊导管包括细长轴和连接于该轴的远端部分的球囊。该球囊导管的轴可以在主导管的轴内纵向地移动。该调节装置可以具有第一部分和第二部分,该第一部分和第二部分连接在一起并且构造成相对于彼此旋转,以从第一配置(configuration)向第二配置移动。第一和第二部分在第一配置中的相对纵向位置可以不同于第一和第二部分在第二配置中的相对纵向位置。该第一部分可以连接于主导管的细长轴,以限制该主导管的细长轴相对于该第一部分的运动,而该第二部分可以连接于该球囊导管的细长轴,以限制该球囊导管的细长轴相对于该第二部分的运动,使得该第一部分和第二部分在该第一和第二配置之间的运动有效地相对于彼此移动主导管的细长轴和球囊导管的细长轴。
在具体的实施中,该第一和第二部分在第二配置中比在第一种配置中彼此更加分开。在其它的实施中,该第二部分还包括固定机构,该固定机构构造成将该球囊导管的细长轴可释放地固定于该第二部分。
在其它的实施中,球囊导管的细长轴至少具有一个开槽的部分,该固定机构被偏置来啮合该开槽的部分,以限制球囊导管的细长轴相对于第二部分的运动。在其它具体的实施中,该固定机构包括开口和限定该开口的部分,并且固定机构设置在第二部分中,以便该球囊导管的细长轴通过该开口,并且限定该开口的部分构造成与开槽的部分啮合。
在其它具体的实施中,第一和第二部分中每一个均具有螺纹部分,该螺纹部分构造成将该第一部分和第二部分连接在一起。在其它具体的实施中,该调节装置还包括可旋转部件,该可旋转部件是可旋转的,以将该第一部分和第二部分从第一配置移动到第二配置。在其它的实施中,该设备还包括止动部件,该止动部件构造成防止第一和第二部分相互分开。
在另一个实施方式中,公开了一种用于调节传送设备中细长轴的相对位置的方法。该方法包括提供一种传送设备,该传送设备具有主导管的细长轴和球囊导管的细长轴,该球囊导管的细长轴至少部分地设置在主导管的细长轴内。提供一种调节设备,该调节设备具有连接于第二部分的第一部分,该第一部分和第二部分相对于彼此是可旋转的。该主导管的细长轴固定于该第一部分。该球囊导管的细长轴固定于该第二部分。该第一部分和第二部分相对于彼此旋转,该旋转有效地改变第二部分相对于第一部分的位置,使得球囊导管的细长轴和主导管的细长轴的相对位置被调节。
在具体的实施中,该球囊导管包括设置在该球囊导管的细长轴的远端的球囊,并且该传送设备还包括设置在该传送设备的远端的瓣膜,并且其中相对于彼此旋转该第一和第二部分的动作有效地将该瓣膜安装在该球囊上。
在具体的实施中,该第一和第二部分包括将该第一部分和第二部分连接在一起的螺纹部分,并且对于彼此旋转该第一和第二部分的动作包括绕螺纹部分旋转该第一和第二部分其中之一或两者。
从下面参考附图进行的详细描述来看,本发明的前述和其它目的、特征和优点将变得更加明显。
附图说明
图1是用于植入人工瓣膜的血管内传送设备的侧视图。
图2A是图1传送设备的球囊导管的侧视图,部分地以剖视的方式示出。
图2B是图2A所示球囊导管的放大的横截面图。
图3是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图4是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图5是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图6是与植入人工瓣膜的血管内传送设备一起使用的前端件的透视图。
图7是与植入人工瓣膜的血管内传送设备一起使用的前端件的透视图。
图8是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图9是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图10是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图11是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图12是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图13是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图14是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图15是用于植入人工瓣膜的血管内传送设备的侧横截面图。
图16是用于植入人工瓣膜的血管内传送设备的侧横截面图。
图17是用于植入人工瓣膜的血管内传送设备的侧横截面图。
图18是用于植入人工瓣膜的血管内传送设备的侧横截面图。
图19是用于植入人工瓣膜的血管内传送设备的侧横截面图。
图20是用于植入人工瓣膜的血管内传送设备的侧横截面图。
图21A是与植入人工瓣膜的血管内传送设备一起使用的扩张器的透视图。
图21B是与植入人工瓣膜的血管内传送设备一起使用的扩张器的底视图。
图21C是沿着线21C-21C截取的、与植入人工瓣膜的血管内传送设备一起使用的扩张器的剖视图。
图22A是与植入人工瓣膜的血管内传送设备一起使用的弯曲顶端的透视图。
图22B是与植入人工瓣膜的血管内传送设备一起使用的弯曲顶端的侧视图。
图22C是与植入人工瓣膜的血管内传送设备一起使用的弯曲顶端的俯视图。
图22D是与植入人工瓣膜的血管内传送设备一起使用的弯曲顶端的另一侧视图。
图23A是连接于与植入人工瓣膜的血管内传送设备一起使用的导管远端的弯曲顶端的透视图。
图23B是连接于与植入人工瓣膜的血管内传送设备一起使用的导管远端的弯曲顶端的横截面图。
图24是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图25是导管推进装置的实施方式的侧视图,以部分打开的状态示出。
图26是图25的导管推进装置的侧视图。
图27是图25的导管推进装置的分解透视图。
图28是与导管推进装置一起使用的齿轮部件的透视图。
图29是与导管推进装置一起使用的另一个齿轮部件的端视图。
图30是推进装置的实施方式的部分透视图,其中为了清楚起见一些部件被去掉。
图31是在将导管部署在病人的脉管系统中所用的弯曲指示装置的实施方式的侧视图。
图32是与图31所示弯曲指示装置一起使用的弯曲激发部件的透视图。
图33是图31显示的弯曲指示装置的部分透视图。
图34是与图31显示的弯曲指示装置一起使用的指示销(indicator pin)的透视图。
图35A是弯曲指示装置的部分透视图。
图35B是弯曲指示装置的部分透视图。
图36是具有细长轴的弯曲指示装置的手柄部分的部分横截面图,该细长轴在远端具有可操作的部分。
图37是弯曲指示装置的部分透视横截面图。
图38A是与图31所示的弯曲指示装置一起使用的指示销的俯视透视图。
图38B是与图31所示的弯曲指示装置一起使用的指示销的底视透视图。
图39A是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图39B是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图39C是用于植入人工瓣膜的血管内传送设备的侧视图,部分地以剖视的方式示出。
图40是用于调节细长导管轴的相对位置的调节装置的透视图。
图41是与图40的调节装置一起使用的固定机构。
图42是图40的调节机构的横截面图。
图43A是图40的调节机构的部分横截面图,示出了处于未固定状态的固定机构。
图43B是图40的调节机构的部分横截面图,示出了处于固定状态的固定机构。
图43C是图40的调节机构的部分横截面图,示出了锁定在未固定状态的固定机构。
具体实施方式
正如在本申请和权利要求中所用的,单数形式的“一个(a,an)”以及“该(the)”包括复数形式,除非上下文另外清楚地指出。此外,术语“包括”意味着“包含”。还有,术语“连接(coupled)”通常是指电、电磁和/或物理(例如机械或化学)连接或连结(linked),并且不排除被连接物件之间存在中间部件。
图1示出了根据一个实施方式的适于将人工瓣膜12(例如人工主动脉瓣)传送到心脏的传送设备10。该设备10通常包括可操纵导向导管14和延伸通过该主导管14的球囊导管16。该导向导管14也可以称为弯曲导管或主导管。但是,术语主导管的应用应当理解为包括弯曲或导向导管,以及不具有弯曲或引导通过病人脉管系统的其它导管。
正如在下面详细描述的,在所示实施方式中的导向导管14和球囊导管16适于相对于彼此纵向地滑动,以促进瓣膜12的传送并将其放置在病人身体中的植入部位。
导向导管14包括手柄部分20和从手柄部分20延伸的细长的导向管或轴22。球囊导管16包括邻近手柄20的近端部分24和从近端部分24延伸并且通过手柄部分20和导向管22的细长轴26。该手柄部分20可以包括具有内部通道的侧臂27,该内部通道与手柄部分20限定的腔以流体连通。可膨胀的球囊28安装在球囊导管16的远端。在图1中,瓣膜12设置成远离球囊28(图1中未示出)并且以卷曲的状态示出,以提供具有减小的直径的瓣膜12,用于通过病人的脉管系统传送到心脏。由于瓣膜12在与球囊28的位置不同的位置处被卷曲(例如,在这个实施方式中瓣膜12卷曲在离球囊远的位置),所以瓣膜12能够卷曲成比如果瓣膜12卷曲在球囊28的顶部所可能的外形更小的外形。这种更小的外形使外科医生能够更加容易地导引该传送设备(包括卷曲的瓣膜12)通过病人的脉管系统到治疗位置。当导引通过病人脉管系统特别狭窄的部分如髂动脉的时,较小外形的卷曲的瓣膜是特别有用的。
前端件32安装在传送设备10的远端,以便于推进传送设备10通过病人的脉管系统到植入部位。在一些情况下,具有连接于单独的细长轴的前端件32可以是有用的,使得前端件32能够独立于传送设备10的其它部件而移动。
前端件32可以由各种材料形成,包括各种塑料。可选地,前端件32可以包括可膨胀的球囊部件。膨胀时,前端件32通常能够形成诸如图1所示的锥形形状。当前端件32包括球囊部件时,前端件32的膨胀能够通过具有从传送设备的近端延伸到前端件32的腔得以实现。流体加压装置可以与该腔流体接触,并且前端件32可以通过流体加压装置膨胀或紧缩。前端件32可以被膨胀以帮助前端件32穿过病人的脉管系统和/或提供瓣膜12可以邻接的表面,这可以帮助将瓣膜12的位置保持在传送设备上直到部署在治疗部位。例如,参考图24(在下面更详细地讨论),球囊前端件可以设置成远离瓣膜12并且球囊前端件可以用于将传送系统穿过病人的脉管系统。在瓣膜12部署在治疗部位之后,前端件32可以被紧缩,从而减小传送设备的外形,以从病人的脉管系统撤出。
正如在图2A和2B中能够看到的,在所示配置中的球囊导管16还包括从近端部分24延伸并且同轴地通过外轴26和球囊28的内轴34(图2B)。球囊28可以支撑在从外轴26向外延伸的内轴34的远端部分上,并且球囊的近端部分36固定于外轴26的远端(例如,用合适的粘结剂)。内轴34的外径被定径,以便环形空间沿着外轴的整个长度限定在内轴和外轴之间。球囊导管的近端部分24可以由流体通道38形成,该流体通道38可以与流体源(例如,水源)流体连接,以使该球囊膨胀。流体通道38与内轴34和外轴26之间的环形空间流体连通,这样流体源的流体能够流过流体通道38,穿过两轴之间的空间,并进入球囊28,以使该球囊膨胀并部署瓣膜12。
近端部分24也限定出与内轴34的腔42连通的内腔40。如果期望的话,在所示实施方式中的腔40、42可以定径成接纳前端导管的轴。球囊导管16也可以包括连接于近端部分24的连接器44和从该连接器延伸的管子46。管子46限定出与腔40流体连通的内部通道。球囊导管16还可以包括连接于连接器44的近端的滑动支撑件件(slide support)48。该滑动支撑件48可以支撑导管(例如前端导管)的调节环50并与其合作以使该导管相对于球囊导管16保持在选定的纵向位置。
球囊导管的内轴34和外轴26可以由任何各种合适的材料形成,例如尼龙、编织的不锈钢丝,或聚醚嵌段酰胺(可以购得)。轴26、34可以具有由不同材料形成的纵向部分,以便沿着所述轴的长度改变它们的挠性。内轴34可以具有由形成的内衬或内层,以最小化与前端导管轴30的滑动摩擦。
图3-5示出了一个实施方式,其中球囊导管16的球囊28最初设置成靠近瓣膜12。图3示出具有支撑部件58的传送设备,该支撑部件58连接于前端件32和导向导管14的远端。正如在下面更详细地讨论的,在这个实施方式中,支撑部件58(或瓣膜携带部件)可以采用聚合物条的形式。为了清楚起见,图3示出了没有瓣膜12的传送设备。图4显示了瓣膜12卷曲在支撑部件58上的传送设备。图5显示了瓣膜12被球囊28扩张的传送设备。在图4和图5中,瓣膜12以剖视图的形式示出,以便能够更容易地了解瓣膜12下面的元件。
期望地,在这个实施方式中的前端件32是分裂前端件(split nose piece),具有一个或多个狭槽54,以容纳球囊28的扩张。类似地,期望导向导管14的远端形成有一个或多个狭槽56,以容纳球囊28的扩张。在传送设备10上的狭槽54、56的数目可以变化。期望前端件32和导向导管14的远端每个具有大约1-8个狭槽。在本实例中,前端件32和导向导管14的远端两者都具有4个狭槽。
支撑部件58连接于前端件32的近端和导向导管14的远端。像狭槽的数目一样,支撑部件58的数目也可以变化。在本实例中,有四个支撑部件58,每个支撑部件(或条)在邻近的狭槽54、56之间连接于前端件32和导向导管14的远端。由于支撑部件的数目与前端件和导向导管中狭槽的数目相同,支撑部件58能够设置在狭槽54、56位置的中间。
此外,如果狭槽和支撑部件的数目相同,则狭槽和条可以在单个切割步骤中形成。例如,未切割的圆柱部件可以最初连接于未切割的前端件32和未切割的导向导管14。在将该圆柱部件连接于前端件32和导向导管14之后,可以在前端件32、导向导管14以及圆柱部件(形成支撑部件或聚合物条58)的每一个中进行切割。以这种方式,圆柱部件可以切割成条,同时形成前端件和导向导管中的狭槽。此外,通过在相同动作中切割条和狭槽,支撑部件58将自然对齐在狭槽54、56之间。
可选地,在将条固定于前端件和导向导管之前,狭槽54、56可以形成在前端件32和导向导管14中。还有,在另一个实施方式中,支撑部件可以激光刻痕(laserscored)而不用形成条。当应用径向压力(例如,球囊扩张压力)时,被激光刻痕的支撑部件将破裂开,从而允许支撑部件的扩张。
不需要一个对一个地将支撑部件58与狭槽54、56对应。相反,如果期望的话,支撑部件58可以多于狭槽54、56,可选地,狭槽54、56可以多于支撑部件58。根据所选的用于支撑部件(或条)的材料类型,可期望改变支撑部件的形式和形状。例如,可以期望具有较多的支撑部件、较少的支撑部件、支撑部件之间较小的空间(或间隔)、或支撑部件之间较宽的空间(或间隔)。
支撑部件58可以由各种材料形成。例如,支撑部件58可以由聚合物如尼龙、PET、PEEK、PE、Pebax、聚氨酯(Urethane)和PVC形成。支撑部件58可以由非柔性的(non-compliant)材料形成。可选地,支撑部件58可以柔性的和/或可拉伸的材料形成,以便当球囊20膨胀时,支撑部件可以随着球囊28的扩张而弯曲和/或拉伸。
支撑部件58可以连接于前端件32和导向导管14的远端的里面部分或外面部分。但是,期望支撑部件58连接在前端件32和导向导管14的里面。以这种方式,当瓣膜12卷曲在支撑部件58上时,前端件32的近端边缘和导向导管14的远端边缘能够邻接瓣膜的对端(opposite ends),并且形成天然的屏障,从而减少瓣膜12纵向滑动或移动到前端件32和导向导管14之间的位置以外的可能性。如果支撑部件58连接在前端件32和导向导管14的外面部分,前端件和导向导管的端部不会将瓣膜12保持在适当的位置。因此,如果支撑部件58连接到这些部件的外面部分,可以期望在恰好在瓣膜要安放在支撑部件上的位置的外面区域,进一步包括止动机构(例如,升高的部分或凸缘),以减少瓣膜12滑动到前端件32和导向导管14的邻近边缘的位置之外的危险性。
图4示出卷曲在支撑部件58上的瓣膜12,其中球囊28设置成靠近瓣膜12。如上所述,由于球囊28没有设置在瓣膜12里面,瓣膜12能够卷曲成更小的外形。因此,传送设备可以更加容易地导引通过病人脉管系统的最狭窄部分。在瓣膜12推进通过病人脉管系统的最狭窄部分(例如髂动脉)之后,如图4中箭头59所示,通过将球囊导管16推向前端件32,能够向远侧推进球囊28,以将该球囊设置在瓣膜12里面,进行瓣膜部署。然后可以将瓣膜12在病人的脉管系统中进一步推进到治疗部位。正如在图5中所能够看到的,球囊28通常比瓣膜长,以便当球囊设置在瓣膜中时球囊的远端部分延伸到前端部件32中,而球囊的近端部分保持在导向导管的远端部分中。
可选地,在远离(如这个实施方式描述的)或靠近(如下面的其它实施方式所描述的)球囊28的位置,可以将瓣膜12完全推进通过脉管系统到达治疗部位。一旦瓣膜12到达治疗部位,球囊可以移动到瓣膜下面的位置,以进行部署。应当理解,对于本文公开的每个实施方式,在通过病人脉管系统的狭窄部分之后的任何时间,包括在刚刚通过插管器鞘之后,在治疗部位或在这之间的一些位置,可以将球囊重新安置在瓣膜的里面。
图5示出扩张状态的球囊28,其中球囊28扩张瓣膜12。狭槽54、56使前端件32和导向导管14可以至少部分地与球囊28一起扩张。使球囊膨胀的方法和方式是已知的,并且球囊28可以用任何已知的方式膨胀。一旦瓣膜12被扩张到期望的大小之后,球囊28可以紧缩,并且球囊导管14和传送设备的其它部件可以从病人的脉管系统撤回。
可选地,可以使用由弹性材料形成的单个圆柱形部件,而不使用形成为条的一个或多个支撑部件。如果该圆柱形部件由足够弹性的材料形成,以扩张来容纳被扩张球囊的直径,该圆柱形部件可以以单个或单一材料件形成,而不被如上所述切割成多个条。
图6示出了形成有狭槽54的前端件32,以容纳球囊28的远端部分的扩张。狭槽54限定出片状物(flap)60,所述片状物60能够彼此向外径向弯曲,以形成更大的开口。因此,在球囊扩张期间,如果球囊28的远端的一部分位于前端件32的近端部分的下面,由于前端件32的近端部分能够扩张以容纳被扩张球囊,该球囊仍然能够充分地膨胀。
图7示出前端件32的另一个实施方式。可以期望将套(jacket)62放置于片状物60的至少一部分上。可期望套62由弹性的、柔性的聚合物形成,当球囊膨胀迫使片状物60径向向外时该聚合物能够扩张。但是,一旦球囊被紧缩之后,套62的弹性性能使片状物60返回到其正常(闭合)位置。套62可以由各种弹性材料形成,包括例如聚氨酯、聚硅氧烷(silicone)和乳胶(latex)。可选地,前端件32或前端件32的至少一部分可以浸渍到弹性材料(例如上面所讨论的那些材料)中以形成套62,而不用将聚合物包裹在片状物60的至少一部分周围。以这种方式,套62可以通过在前端件32上涂覆弹性材料而形成,这样该涂层以与上面所述聚合物包裹基本相同的方式起作用。
图8-12示出了利用瓣膜携带部件将瓣膜12传送到治疗部位的传送设备的另一个实施方式。正如在下面更加详细地讨论的,在这个实施方式中瓣膜携带部件可以采取外套管(outer sleeve)的形式。外套管64在导向导管14的近端附近从远端(图8中所示)向近端延伸在导向导管14上方,并且能够由手柄部分(未示出)独立地操纵。该外套管64可以用与如上所述能够操纵导向导管的方式相同或相似的方式操纵。
外套管64连接于前端件32。外套管64可以连接于前端件32的里面或外面部分;但是期望连接于里面部分,以便前端件32的近端边缘能够邻接卷曲的瓣膜12并且限制卷曲的瓣膜12向远侧的运动。期望外套管64由Nitinol、不锈钢或诸如尼龙、PET、PEET、PE、Pebax、聚氨酯和PVC的聚合物形成。
瓣膜12最初卷曲在外套管64的远端部分上,如图9所示。期望的是,外套管64作为编织物或用激光切割而形成,以便在治疗部位植入瓣膜12的过程中外套管64能够径向地扩张。如果期望的话,外套管64可以这样形成:其仅仅一部分是编织的或激光切割的。该编织的或切割的部分应当至少包括上面卷曲有瓣膜12的那部分外套管64,以便延伸通过瓣膜12的那部分外套管64能够与瓣膜12一起扩张。
在瓣膜12处在用于部署的位置后(或如果期望,有时在瓣膜通过病人脉管系统的最狭窄部分之后),球囊28可以相对于导向导管14向远侧移动并安置成延伸通过瓣膜12,如图10所示。图11示出扩张状态的球囊28。一旦瓣膜12扩张到期望的直径后,球囊28可以紧缩(如图12所示)并且传送设备可以从病人的脉管系统撤回。
图13-15示出了瓣膜12卷曲在内套管66上的实施方式。参考图13,内套管66类似于外套管64,所不同的是内套管66位于导向导管14的里面,而不是位于导向导管14的外面。期望内套管66延伸导向导管14的长度,并且能够在其近端被独立地操纵,以相对于导向导管14纵向地移动内套管66。由于内套管66位于导向导管14的里面,导向导管14的远端边缘能够邻接卷曲的瓣膜12的近端并且防止瓣膜12移动或滑动到不适当的位置。此外,如图15所示,导向导管14的远端可以形成有凸缘68,以便导向导管14能够更好地安置在瓣膜12的近端上。
还期望,将内套管66的远端连接于前端件32近端的里面部分。由于将内套管66连接于前端件32的里面部分,瓣膜12能够更加牢固地保持在前端件32和导向导管14之间的位置中。
图14示出了在球囊28已经推进到延伸通过安装有瓣膜的那部分内套管66的位置之后呈扩张状态的球囊28。膨胀球囊使那部分内套管66和瓣膜12扩张。正如在其它实施方式中所讨论的,一旦瓣膜12扩张到合适的直径,球囊28可以紧缩并且撤回。图15是传送设备的横截面图。瓣膜12包括外框架部分(outer frameportion)70和包括小叶72的内部部分。瓣膜12位于前端件32和导管14的远端之间,该导管14可以包括凸缘68,以更好地与瓣膜12的框架部分70配合。
由诸如Nitinol的金属形成的、编织的或激光切割的外套管或内套管的应用也允许瓣膜12在其已经被部分扩张之后进行重新安置。在传统的传送设备中,瓣膜卷曲在球囊上。如果球囊被部分膨胀并且外科医生观察到瓣膜被不恰当地安置,那么重新安置瓣膜是非常困难的。首先,球囊必须紧缩以便孔口(orifice)不被堵塞太长的时间。由于球囊的扩张堵塞了孔口(例如主动脉瓣),球囊可以在治疗部位扩张的时间相对短。但是,一旦球囊被紧缩,没有物体将瓣膜相对于球囊保持在适当位置。但是,当应用上面所讨论的内套管或外套管时,该内套管或外套管与瓣膜一起扩张。因此,瓣膜在内套管或外套管上保持在适当位置。如果外科医生观察到瓣膜被不恰当地安置,外科医生能够使球囊紧缩并且通过操纵内套管或外套管的位置来操控该瓣膜。通过任何已知的方法,金属套管能够从部分扩张的状态塌陷。例如,拉伸力可以施加于金属套管以拉伸或拉长该金属套管,使得金属套管的直径减小。这可以通过使用例如刚性金属丝在金属套管的近端或在金属套管的远端施加力来实现。
图16示出了瓣膜靠近球囊导管16的球囊28卷曲在传送设备上的实施方式。球囊导管16包括从球囊28的近端延伸的延长部分74。该延长部分74可以由与球囊28相同的材料形成并且可以是球囊28的整体件(integral piece)。可选地,延长部分74可以是这样的单独材料:其由相同或不同的材料形成并且在接合区域76处被粘接、焊接、胶接或者另外连接在球囊28和球囊导管16之间。期望延长部分74具有比球囊28小的横截面或外形,以便瓣膜12在延长部分74上能够卷曲成比在球囊28上能够卷曲的外形更小的外形。延长部分74可以由任何合适的材料形成,例如上面讨论的聚合物,包括尼龙、PET、PEEK、PE、Pebax、聚氨酯和PVC。
球囊28可以连接于前端件32。期望的是,球囊28的远端部分连接在前端件32的大致中间位置。前端件32可以用来提供使传送设备的远端更有效地穿过病人脉管系统的外形。例如,前端件32的锥形形状及其较刚性的结构(与球囊28相比)能够起到使瓣膜更有效地传送通过脉管系统的作用。具体说,前端件32可以呈大致沙漏形状,如图16所示。通过使前端件32形成有如图16所示的近端凹入(锥形)部分,当前端件32向近侧移动以邻接或邻近卷曲的瓣膜(如图17所示)时,该凹入部分可以接纳至少一部分球囊。因此,通过移动前端件32使得它邻接卷曲的瓣膜,一部分球囊能够被接纳在该凹入部分中,并且能够实现平滑的、无损伤的(atraumatic)外形,以促进瓣膜穿过主动脉弓并同时越过狭窄的瓣膜。
还期望包括连接于前端件32的细长轴。该细长轴18在引导球囊导管16通过病人脉管系统中能够提供附加的结构和支撑。
在瓣膜12通过病人脉管系统的最狭窄部分(或者,如果期望,在一些较后的位置,包括例如部署位点)之后,通过撤回其手柄(未示出)处的球囊导管轴16可以将球囊28拉回(向近侧移动),以将球囊安置在瓣膜12内,如图17所示。图17示出了未扩张状态的球囊28。正如在其它实施方式中更加详细地描述的,当瓣膜12处在治疗部位时,通过使球囊28膨胀,瓣膜12可以扩张到期望的直径,球囊28能够紧缩并且通过摩擦力而将瓣膜12固定在治疗部位,以及传送设备可以从病人的脉管系统撤回。
如果期望的话,图18的配置可以在将瓣膜12插入病人的脉管系统之前实现。也就是说,前端件32的沙漏形状可以提供有益的穿过外形(beneficial trackingprofile),而与图18所示的配置是否在病人脉管系统之内或之外实现无关。但是,正如上面详细讨论的,当病人的脉管系统中允许较小的插入外形时,将该设备移动到图18所示的配置,该较小的插入外形期望促进将瓣膜插入病人的脉管系统中。
此外,通过提供球囊在瓣膜远端的设备,在将球囊移动到适当位置以扩张瓣膜之前,可能膨胀球囊来进行瓣膜成形术,以打开狭窄的心脏瓣膜。在这种手术中,将球囊移动到适当位置进行扩张瓣膜的过程与本文所讨论的相同,所不同的是其发生在下列之后:(1)扩张该球囊以对狭窄的心脏瓣膜施加扩张力和(2)使球囊紧缩以便它能够返回到图16所示的状态。
图18示出了另一个实施方式,其中扩张部件(第二较小的球囊84)位于球囊28里面并且瓣膜12卷曲在该扩张部件(第二球囊84)的顶部上。由于第二球囊84的直径比球囊28小,瓣膜12当卷曲在第二球囊84上时比卷曲在球囊28上时能够卷曲成更小的直径。
当装置被操控通过病人的脉管系统时,第二球囊84可以用来将瓣膜12保持在适当位置。此外,第二球囊84可以单独扩张,因此第二球囊84能够部分扩张瓣膜12,这样比较容易将球囊28移动到瓣膜12内的适当位置,将瓣膜12部署在治疗部位。第二球囊84可以连接于轴86的端部。轴86具有能够与流体源和第二球囊84以流体连接的腔。流体能够输送通过轴86的腔并且进入第二球囊中,以使第二球囊84膨胀并且至少部分扩张瓣膜12。参考图19,示出了膨胀状态的第二球囊84,其中瓣膜12被部分扩张。在部分地扩张瓣膜12之后,第二球囊84可以紧缩并且球囊28可以拉回(向近侧移动)到该部分扩张的瓣膜12下面的位置。在球囊28回到延伸通过该部分扩张的瓣膜12的位置之后,瓣膜12然后可以通过膨胀球囊28而扩张到期望的直径,球囊28可以紧缩并且瓣膜12被扩张在治疗部位处的期望位置,以及传送设备可以从病人的脉管系统撤回。
图20是传送设备的另一个实施方式。类似于图16和17所示的实施方式,球囊导管16具有延长部分74,该延长部分具有小于球囊28的直径,因此瓣膜12在延长部分74上比在球囊28上能够卷曲成更小的外形。延长部分74可以由与球囊28相同的材料形成并且是球囊28的整体件。可选地,延长部分74可以是这样的单独材料:其由相同或不同的材料形成并且在接合区域76处被粘接、焊接、胶接或者另外连接在球囊28和球囊导管16之间。图20所示的设备还包括扩张器88和止动器90。扩张器88和止动器90可以连接于延长部分74的内表面或前端导管18(如果包括前端导管的话)的轴的外表面。扩张器88和止动器90都可以用来将卷曲的瓣膜12保持在延长伸部分74上的适当位置。
止动器90的形状可以是大致圆柱形,并且一个或多个开口通过其中心以容纳前端导管的细长轴并且使流体流进球囊中。当延长部分74相对于导向导管14被向前推或向后拉时,该薄的延长部分容易弯曲或隆起。止动器90通过对延长部分74增加结构强度能够减少薄层材料的弯曲。
当准备通过球囊28扩张瓣膜时,随着球囊28和扩张器88相对于瓣膜向近侧移动,扩张器88可以用来部分地扩张瓣膜12,这样容易将球囊28安置在瓣膜12内。图21A-21C示出了扩张器88更多的细节。随着扩张器88向近侧移动通过瓣膜时,扩张器88的锥形形状使瓣膜12平滑地扩张,这样球囊能够更容易滑进瓣膜内。扩张器88或止动器90还可以包括标记,如不透射线的标记,以在植入手术期间为医生提供参考点。
应当理解,这里公开的实施方式中,球囊28或者能够被推(或拉)到瓣膜12内,或者瓣膜12能够被推(或拉)到球囊28上。例如,在上述实施方式中,期望将瓣膜12推过扩张器88并且推到球囊28上。导向导管14的远端邻接瓣膜12的金属丝框架,并且通过向远侧(相对于球囊导管16)推动或移动导向导管14,瓣膜12能够移动到适当位置,部署在球囊18的顶部上。
参考图21A,扩张器88具有前端导管18能够通过的开口92。此外,如图21B所示,扩张器88可以具有两个狭槽部分94。狭槽部分94沿着扩张器88的长度纵向延伸。狭槽部分94允许流体在扩张器88的前后区域之间流动。
图22A-22D示出了弯曲适配器96而图23A和23B示出了安置在导向导管14远端上的弯曲适配器96。弯曲适配器96具有多个(在所示实施方式中为三个)间隔开的指形物98。弯曲适配器96可以安置在导向导管14的远端,并且端部件100可以过压成型(overmold)和/或激光焊接到导向导管14的远端。端部件100可以过压成型到三个间隔开的指形物98上,使得它具有对应于三个间隔开的指形物的三个部分。
弯曲适配器96可以由诸如Nitiol的弹性材料形成,其自然地向外推端部件100的三个部分,但同时允许这三个部分在压力下被迫向内,以形成较小的外形(lowerprofile)。因此,当插入到插管器鞘中时端部件100的三个部分能够压缩成较小的外形。因此,当经受插管器鞘朝向内的径向压力时,导向导管14的远端能够配合到插管器鞘中。但是,在离开插管器鞘后,导向导管的三个部分100再次扩张成图23A所示的外形。这三个部分100的径向向外扩张使导向导管14的远端边缘对接在卷曲的瓣膜12的框架上,这有助于在操控传送设备期间保持瓣膜12相对于导向导管14的位置。
还有,这三个部分100的扩张(图23A中所示)能够使球囊部件以上面讨论的方式容易地拉动或推动到卷曲的瓣膜下面。此外,切开的弯曲适配器96和导向导管14切开的远端允许导向导管14的远端扩张,以便在球囊至少部分地被导向导管14的远端容纳时球囊能够扩张。
图24示出传送设备的另一个实施方式,其中瓣膜12在球囊28的远侧定位并卷曲在内套管106上。导向丝109的远端延伸超过瓣膜12的远端。海波管(hypotube)111可以至少部分延伸到瓣膜12内,以促进瓣膜12向传送设备的转移。
期望内套管106由一种或多种上面讨论的材料形成,包括Nitinol、不锈钢、或诸如尼龙、PET、PEET、PE、Pebax、聚氨酯和PVC的聚合物。瓣膜12可以临时固定到金属丝圈102和单独的金属丝部件107的远端。期望使用缝线104或其它类型的临时捆绑连接件将瓣膜12系固于金属丝部件107和金属丝圈102上。期望瓣膜12以这样的方式系固于金属丝圈102和金属丝部件107上:缝线104连接可以通过拉动能够延伸导向导管14整个长度的金属丝部件107的近端而被释放。在操作中,通过向近侧拉动或移动金属丝部件107,瓣膜12被释放并且缝线104仍然固定于金属丝圈102。金属丝圈102能够延伸导向导管14的整个长度,并且可以通过拉动金属丝圈102穿过导向导管14的轴而从导向导管移除。
通过系固瓣膜12使其相对于导向导管14的远端向远侧的移动被限制,球囊28能够更加容易推动到瓣膜12下面。如上所述,将瓣膜12系固到导向导管14的远端能够与本文的每个实施方式相结合,以相对于导向导管进一步固定瓣膜12。
上述某些实施方式讨论了利用第二球囊元件部分地扩张瓣膜12,使更加容易将主球囊28移动到瓣膜12下面的位置。图24示出了利用第二球囊108促进主球囊28安置的另一个例子。第二球囊108可以在球囊28的远端安置在球囊28的里面。球囊导管16的远端可以部分移动到卷曲的瓣膜12下面。然后第二球囊108可以经由第二球囊膨胀腔110而被膨胀,使得在卷曲的瓣膜12内的那部分第二球囊108部分地扩张瓣膜12。如果期望,第二球囊108然后可以被紧缩并且向远侧移动以便将第二球囊108进一步布置在瓣膜12内。然后第二球囊108可以再次膨胀以便现在在第二球囊108顶部上的瓣膜12的区域能够被扩张。通过使第二球囊108紧缩并且将其进一步向远侧移动到瓣膜12内直至整个瓣膜12被扩张(或直至瓣膜12被扩张得足以将球囊28接纳在其内),瓣膜12可以均匀地、部分地扩张这样球囊28能够容易地安置在瓣膜12内,以部署瓣膜12。也就是说,如果期望的话,第二球囊108可以被反复膨胀、紧缩和重新安置,以便瓣膜12扩张得足以以允许较大的主球囊28操控到瓣膜12的下面。
当在上面讨论的实施方式中将瓣膜卷曲在球囊近侧时,期望这样卷曲瓣膜12:使小叶朝着瓣膜的外流端并且沿着传送设备的近侧方向向外折叠。以这种方式,当向后(向近侧)拉动球囊通过瓣膜使球囊安置在瓣膜12的下面时,沿着折叠小叶的方向向后拉动该球囊。因此,球囊移动到瓣膜下面的位置是更加有效的,并且小叶干扰球囊移动的可能性被最小化。因为球囊的移动方向与瓣膜的小叶方向相同,所以球囊的移动对小叶的损坏也很少可能发生。
图25-27示出了用于机械操控导管或其它管子通过病人脉管系统的设备的实施方式。在下面的实施方式中,公开了方法和设备,其中当推进设备被插入通过股动脉进入插管器鞘(femoral access introducer sheath)和密封壳体(sealed housing)时,推进设备被夹紧在导向导管上。该设备通过减少外科医生为使导向导管通过插管器鞘而必须施加的力的量来促进导向导管推进通过插管器鞘,同时为外科医生提供足够的对导向导管推进的控制。虽然下面在推进导管以部署人工瓣膜的背景下讨论了该设备,但是该设备可以用在需要或使用机械辅助来相对于另一个导管或平台轴向地推动或拉动一个管子或导管的其它操作或手术中。
推进设备110包括顶部件112和底部件114。图25示出了彼此分开的顶部件112和底部件114,而图26示出了处在闭合位置并且锁定到插管器鞘119(图27所示)和导向导管116上的顶部件12和底部件114。顶部件112和底部件114沿着图25中所示的箭头A的方向闭合到导向导管116上并且覆盖导向导管116。此外,顶部件112和底部件114闭合到锁定部件118的近端上并且覆盖锁定部件118的近端,这防止插管器鞘119相对于设备110移动。
插管器鞘锁定部件118(保持部件)锁定到插管器鞘119的近端。锁定到鞘壳(sheath housing)上的机构可以是任何机械锁定机构,包括例如将鞘壳牢固地保持在鞘锁定部件118上的卡扣配合(snap-fit)或压入配合(press-fit)连接。可选的或附加的机械装置可以用于确保该锁定部件118不相对于鞘壳移动。
导向导管116设置在顶部齿轮部件120和底部齿轮部件122之间。该顶部齿轮部件120和底部齿轮部件122(分别)具有顶部轴部件124和底部轴部件126。该顶部轴部件124和底部轴部件126(分别)配合在顶部件112的开口130和底部件114的开口132中。顶部齿轮部件120和底部齿轮部件122可以具有齿128,其摩擦地啮合导向导管116的外表面。该推进设备包括驱动部件134,该驱动部件在图27中是旋转旋钮。驱动部件134驱动底部齿轮部件122,该底部齿轮部件122的齿啮合顶部齿轮部件120的齿。通过旋转驱动部件134,底部齿轮部件122的齿沿着旋转力的方向驱动导向导管116。此外,由于底部齿轮部件122的齿还驱动顶部齿轮部件120的齿,顶部齿轮部件120也沿着旋转力的方向驱动导向导管116。
因为推进设备110的锁定部件118锁定在鞘壳上,所以该合力被抵消并且推进导向导管通过插管器鞘能够更加容易控制。此外,由于净力为零,在外科医生推进导向导管期间插管器鞘不太可能被无意地拉出病人的体外。
齿128包括跨夹紧部件(spanning grip member)129,其跨越齿轮部件两侧上相对的齿128之间。跨夹紧部件129在相对的齿之间形成凹形圆弧,并且该圆弧遵循导向导管116的轴的大致形状。期望夹紧部件129包含弹性体材料,该弹性体材料被选择以提供足够的夹紧力夹紧导向导管。将跨夹紧部件压紧在导向导管116上所引起的摩擦力使跨夹紧部件129夹紧导向导管116的轴,以确保对驱动部件134稳定地施加力得到导向导管116的稳定移动。
齿轮部件可以设置有单向轴承以便驱动部件134可以用作棘轮手柄。也就是说,驱动部件134可以这样构造:其可以仅仅沿着一个方向推进。当驱动部件134形成有单向棘轮机构时,旋钮(或其它手动调节机构)在操作期间可以被释放,而不被阻止导向导管推进的、插管器鞘内的力迫使导向导管向后。这也减少当导向导管在插管器鞘内时导向导管116被外科医生向后拉的危险——其将会损害瓣膜或使瓣膜从传送设备上的相关卷曲位置移位。当瓣膜已经通过插管器鞘的远端时,推进设备110可以从导向导管移除,以使不用推进设备110而能够继续穿过和部署。
图27示出了具有两个齿轮的推进设备,该两个齿轮在驱动轮(底部齿轮部件122)上和惰轮(idler wheel)(顶部齿轮部件120)上均具有齿。以这种方式,导向导管16同时被两个轮驱动。但是,该驱动机构可以变化并且导向导管116可以被一个齿轮部件或多于两个齿轮部件驱动。此外,驱动机构的传动(gearing)或齿数比可以变化。齿轮部件也可以在尺寸和支持力(holding power)(破坏扭矩)上变化,并且可以构造成在某个转矩下提供过载(override)。此外,各种手柄选择功能可以连接于推进设备110。
齿轮部件和导向导管之间的摩擦对提供导向导管116通过推进设备110的可控传送是非常重要的。因此,齿轮部件的尺寸、形状、刚度和表面可以变化,以提供驱动导向导管所需的适当量的摩擦(或夹紧)。
图28-30示出了可选的齿轮部件,其能够用来结合推进设备110驱动导向导管116。图28示出了具有中央凹形形状的齿轮部件136,该中心凹形形状具有用于夹紧导向导管的凹进部分138。该凹进部分的数量和深度可以根据应用所需的摩擦或夹紧的量而变化。齿轮部件136可以是单个驱动齿轮部件,而没有齿轮齿将其连接于第二齿轮部件。可选地,齿轮部件136上可以具有齿轮齿,以便两个齿轮部件能够驱动导向导管。
图29示出了具有附加夹紧材料(additional gripping material)140的齿轮部件136,所述附加夹紧材料140设置在至少一些凹进部分138中。夹紧材料140可以以任何连接方式连接于凹进部分138,并且可以连接于一些或全部凹进部分138。夹紧材料140提供齿轮部件136和导向导管116之间增加的摩擦接触。夹紧材料140可以是弹性体材料,如聚硅氧烷、橡胶或其它弹性聚合物。这些材料能够增加齿轮部件136和导向导管116之间的摩擦,但是具有在推进期间不引起导向导管136的表面损坏的接触表面。
图30示出了具有顶部齿轮部件142和底部齿轮部件144的推进设备的另一个实施方式。顶部齿轮部件142和底部齿轮部件144中每一个包括两个O形环部件146。当驱动部件134旋转时每个齿轮部件上的两个O形环部件146啮合并驱动导向导管116。虽然图30示出了底部齿轮部件114作为唯一的驱动部件,但是图30的推进设备可以修改有适当的传动装置(gearing),以便顶部齿轮部件和底部齿轮部件都驱动导向导管116。O形环可以由各种材料形成,包括上面关于夹紧材料所讨论的材料。期望O形环的材料被选择以便在导向导管推进通过插管器鞘期间当与该导向导管摩擦啮合时O形环不引起导向导管表面的损坏。
在另一个实施方式中,弯曲指示装置可以结合在其远端能够弯曲的导向导管使用。导管如导向导管可以设置有弯曲能力,以便能够操纵导管通过病人的脉管系统。但是,当操纵导管通过病人的脉管系统时,确定导管在任何给定的时间已经弯曲到什么程度可能非常困难。
参考图31,弯曲指示装置为医生提供一种用于测量导管远端的相对弯曲量的装置。此外,该指示器在该装置的近侧手柄端提供可视和触觉响应,这为外科医生提供了确定导管远端的弯曲量的即时的和直接的方式。
弯曲指示装置150包括弯曲激发部件154、指示销156和手柄部分158。弯曲指示装置构造成通过持续拉动连接于轴152的远顶端并且延伸该轴长度的金属丝来弯曲导管(例如导向导管)的细长轴152的远端。金属丝的拉动通过旋转弯曲激发部件154(例如,旋钮)来实现,所述弯曲激发部件154具有贯穿其长度的阴螺纹。
参考图32,弯曲激发部件154包括调节旋钮155和从该旋钮延伸的轴157。轴157具有内螺纹表面部分160,其与具有阳螺纹的滑动螺母配合。金属丝的近端经由卷曲销(crimp pin)和柱孔(counter bored hole)或狭槽连接于滑动螺母。随着弯曲激发部件的旋转,滑动螺母沿着内螺纹表面部分160朝着弯曲指示装置150的近端移动,从而使导管152的远端弯曲。随着弯曲激发部件154旋转量的增加,滑动螺母朝着弯曲指示装置150的近端进一步移动,并且导管152远端的弯曲量增加。
轴157还包括外螺纹表面部分162。如图37所示,指示销156的延伸部分166与弯曲激发部件154的外螺纹表面部分162配合。轴157延伸到手柄部分158中,并且指示销156被限制在该外螺纹表面部分162和手柄部分158之间,以及一部分指示销156向上延伸到手柄的纵向狭槽164中。当旋转旋钮155以增加导管152的轴的远端的弯曲时,指示销156遵循弯曲激发部件的外螺纹部分162,并且在狭槽164内向近侧移动。弯曲激发部件154的旋转量越大,指示销156朝着手柄158的近端移动得越远。相反,沿着相反方向旋转旋钮155减少导管的轴的远端弯曲,并且引起指示销156朝着手柄158远端的相应移动。
参考图35A和35B,期望弯曲指示装置150包括指示导管152的远端弯曲量的标记(indicia)168。标记168能够以各种方式中的任何一种识别弯曲的量。例如,图35示出了用三角形标记系统表示弯曲量的标记168,而图36示出了利用数字表示弯曲量的标记168
图36中更详细地示出了手柄部分168。正如上面所讨论的,弯曲指示装置150(例如导向导管)包括手柄部分158和从其向远侧延伸的细长导向管或轴152。该导向管152限定出腔157,所述腔157被定径以接纳球囊导管的轴,并且使球囊导管能够相对于导向导管纵向地滑动。导向管152的远端部分包括可操纵部分188,其曲率能够由操作者调节,以帮助引导该装置通过病人的脉管系统,以及具体而言通过动脉弓。
手柄部分158包括形成有中心腔161的主体或壳体159,该中心腔161接纳导向管152的近端部分。手柄部分158可以包括侧臂62(如图1所示),所述侧臂62限定出与腔161流体连通的内部通道。管塞(stopcock)可以安装在侧臂62的上端上。
手柄部分158可以可操作地连接于可操纵部分并且起调节作用,以允许操作者通过手动调节手柄来调节可操纵部分的曲率。在所示的实施方式中,例如,手柄部分158包括内套管190,该内套管190包绕一部分在手柄主体159内的导向管152。带螺纹的滑动螺母192设置在套管190上并且相对于套管190是可滑动的。滑动螺母192形成有与调节旋钮155的内螺纹配合的外螺纹。套管190还具有外螺纹部分,其与弯曲指示部件156的延长部件配合。图37更详细地示出了弯曲指示部件156。
滑动螺母192可以形成有形成在螺母内表面上并且延伸其长度的两个狭槽。套管190可以形成有纵向延伸的狭槽,当滑动螺母放置在套管上时该纵向延伸的狭槽与滑动螺母192的狭槽对齐。各自的细长螺母导向件设置在每个狭槽中,螺母导向件可以是细长杆或销的形式。该螺母导向件径向延伸到滑动螺母192中的各自的狭槽中,以防止滑动螺母192相对于套管190旋转。借助于这种安排,调节旋钮155的旋转(或者顺时针,或者逆时针)使滑动螺母192沿着双头箭头172所示的方向相对于套管190纵向移动。
一个或多个牵引丝174将调节旋钮155连接于可操纵部分188,以便当调节旋钮旋转时产生可操纵部分的移动。在某些实施方式中,牵引丝174的近端部分可以延伸到止动销180中并且可以例如通过将销180夹压到牵引丝上而固定于止动销180。牵引丝174从销180延伸通过滑动螺母中的狭槽、套管190中的狭槽200、并且进入并通过轴152中的牵引丝腔。牵引丝174的远端部分固定于可操纵部分188的远端部分。
保持牵引丝174的近端部分的销180,被限制在滑动螺母192的狭槽中。因此,当调节旋钮155旋转来向近侧移动滑动螺母192时,该牵引丝174也向近侧移动。牵引丝朝着手柄部分向后拉动可操纵部分188的远端,从而弯曲该可操纵部分并且减小其曲率半径。调节旋钮155和滑动螺母192之间的摩擦足以保持牵引丝拉紧,因此如果操作者释放该调节旋钮155,保持可操纵部分中的弯曲的形状。当调节旋钮155沿着相反方向旋转来向远侧移动滑动螺母192时,牵引丝的张力被释放。随着牵引丝上的张力被释放时,可操纵部分188的弹性使该可操纵部分返回到其正常的、非偏转的形状。由于牵引丝174没有固定于滑动螺母192,滑动螺母向远侧的移动不推动牵引丝的端部使其弯曲。相反,当旋钮155被调节来减小牵引丝的张力时,销180能够在滑动螺母192的狭槽内浮动,防止牵引丝的弯曲。
在具体实施方式中,呈非偏转形状的可操纵部分188被稍微弯曲,并且在其充分弯曲的位置中,该可操纵部分大致与主动脉弓的形状一致。在其它实施方式中,在其非偏转位置中,该可操纵部分可以是基本上直的。
手柄部分158可以具有适合于调节可操纵部分188的曲率的其它配置。一种这样的可选手柄配置公开在共同未决的美国专利申请号11/152,288(以公开号US2007/0005131公开)中,其整个内容通过引用而并入本文。与上面所讨论的可操纵部分和手柄配置相关的其它细节可以在美国专利申请号11/852977(以美国专利公开号US2008/0065011公开)中找到,其整个内容通过引用而并入本文。
指示销可以以各种形状形成。例如,如图38A和38B所示,指示销可以具有一个或多个延伸部分166。附加的延伸部分可以用来使指示销稳定在狭槽中,以及提供弯曲的更精确的读数或测量。
图39A-39C示出了以500表示的传送设备的可选实施方式。该传送设备500使瓣膜12能够安装在主体(bodyvessel)内球囊导管的球囊28上。除了图39A-39C的实施方式中,球囊导管轴526具有从球囊28向远侧延伸的远端部分504并且环形的锥形楔502临近该球囊布置在远端部分504上之外,该球囊导管可以具有类似于图2A和2B所示球囊导管的构造。正如在下面进一步描述的,该锥形楔502起扩张瓣膜以促进将瓣膜安置在主体内的球囊上的作用。期望楔502由诸如尼龙的低摩擦材料制成,以使瓣膜能够容易地滑过该楔并且滑到球囊上。
该传送设备包括前端导管,该前端导管包括轴506和连接于该轴506远端的前端件508。该前端导管轴506可以具有接纳导向丝540的导向丝腔,以便该设备能够随着导向丝通过导向丝腔而在导向丝之上推进。传送设备500还可以包括导向导管,该导向导管包括导向导管轴22和从该轴22的远端延伸的细长罩510。该前端导管、球囊导管和导向导管相对于彼此是可以纵向移动的,并且在该设备的近端可以具有锁定机构,用于将导管相对于彼此保持在选定的纵向位置,如在上面所详细描述的。
如图39A所示,瓣膜12初始以卷曲状态安装在前端件508和锥形楔502之间的前端导管轴506上,而不是在传送设备插入到身体中之前安装在球囊上。瓣膜卷曲在前端导管轴上,这样当期望将瓣膜放置在球囊28上时,瓣膜仍然能够沿着该轴移动。前端件508可以形成有阶梯孔(stepped bore),该阶梯孔包括第一孔部分512和在前端件近端的第二、加大的孔部分514。该阶梯孔可以形成有环形凸肩(annular shoulder)516,该环形凸肩516在第一和第二孔部分之间延伸并且当瓣膜12插入第二孔部分514中时适于啮合瓣膜12的远端。前端件508可以具有外表面,该外表面沿着朝向该前端件508远端的方向逐渐变细,以无损伤地穿过曲折的脉管系统。可以是任选的罩510适于在球囊28、楔502以及瓣膜12的至少近端部分上方延伸并且覆盖它们——当瓣膜12安置在前端导管轴上进行传送时。在所示的实施方式中,罩510的远端可以安置成邻接前端件508的近端,以便在传送期间完全封闭瓣膜。在可选的实施方式中,罩510的长度可以比较短,这样在传送期间瓣膜或球囊的外表面被覆盖得较少。
前端件508,当相对于球囊导管(沿着箭头518所示的方向)向近侧移动时,将瓣膜12推过楔502并且推到球囊28上。当瓣膜通过该楔时,瓣膜稍微扩张以便于将瓣膜安置在球囊上。球囊导管轴26可以具有不透射线的标记520(图39A)以帮助操作者将瓣膜对齐在球囊上的适当位置处。前端件可以具有由相对软的并且可弯曲的材料形成的外层522和由相对硬的材料形成的内层524。所示实施方式中的内层524形成凸肩516和第一孔部分512的内表面。以这种方式,前端件展示足够的刚度,以将瓣膜12推过楔并推到球囊上,并且提供柔软的外表面,以最小化对体内管腔的损伤。例如,外层552可以由55D制成,以及内层可以由比55D硬的72D制成。
传送设备安装瓣膜的部分通常限定出该设备插入体内的最大外径。通过在插入身体内之前将瓣膜12安装在前端导管轴上而不是球囊上,瓣膜12能够比如果瓣膜卷曲在球囊上卷曲成更小的直径。因此,为了插入并通过脉管系统,传送设备的最大外径可以减小。正如在上面所指出的,通过减小传送设备的最大直径,传送设备很少闭塞股动脉,因此在手术期间病人的腿能够保持很好的灌注。在某些实施方式中,罩510和前端件508(在其近端)的外径大约是0.223英寸,这是插入身体中的那部分传送设备的最大直径。楔502近端的直径可以是大约0.120英寸,而导向导管轴22可以具有大约0.184英寸的外径。
现在根据一个实施方式说明传送设备500的操作,最初将瓣膜12安装在前端导管轴上并且插入前端件502和罩510中。在导向丝540被插入主体中之后,从主体延伸的金属丝的近端可以插入该导向丝腔的远端中,并且传送设备500可以插入体内腔管(例如股动脉)中并推进通过该主体(如图39A所示)。可选地,插管器鞘可以首先插入体内管腔中,例如,如果罩510不配置成覆盖瓣膜12。在插入插管器鞘之后,可以将传送设备插入通过该插管器鞘并进入体内管腔中。
当传送设备的远端被推进到方便将瓣膜12滑动到球囊上的位置时,导向导管相对于球囊导管向近侧从罩510撤回,以推进瓣膜和球囊。例如,如果将人工瓣膜植入自体动脉瓣内,该瓣膜和球囊可以推进到升动脉和左心室中,然后在那里可以将瓣膜移动到球囊上。在任何情况下,如图39B所示,前端导管可以向近侧撤回,以将瓣膜推过楔502并且推进到球囊28上。标记520(图39A)可以用来使瓣膜处在球囊中心。在将瓣膜安装在球囊上之后,前端导管可以向远侧推进,以便不干扰球囊的膨胀,如图39C所示。然后可以将瓣膜安置在植入部位(例如自体动脉瓣内),并且通过膨胀球囊来部署。
在另一个实施方式中,提供调节装置,用于调节球囊相对于卷曲的瓣膜的位置。正如在上面各种实施方式中所述,球囊导管可以与导向(或弯曲)导管共轴地延伸,并且球囊导管远端的球囊部件可以安置在卷曲的瓣膜近侧或远侧。正如上面详细地讨论的,球囊部件和卷曲的瓣膜能够通过插管器鞘进入病人的脉管系统中,以及一旦球囊部件和卷曲的瓣膜到达体内的合适位置,瓣膜和球囊部件的相对位置可以调节,以便将球囊部件安置在瓣膜的框架内,这样能够在治疗部位扩张瓣膜。下面的实施方式提供用于调节球囊部件相对于瓣膜的位置的设备和方法,以在瓣膜部署在治疗部位之前实现球囊部件在瓣膜内的精确对齐。
图40示出调节装置600。调节装置600可以包括第一部分(例如,弯曲指示部分602)和位于第一部分近端的第二部分(例如,调节部分604)。该第一部分可以是诸如参考图31示出并描述的弯曲指示装置。可选地,第一部分可以是不包括弯曲指示特征的结构。
如图40所示,导管(例如导向或弯曲导管)的细长轴606延伸到调节装置600的远端中。导向导管的细长轴606具有终止于调节装置600的第一部分(弯曲指示部分602)内的近端620(图42所示)。正如在上面各实施方式中详细描述的,球囊导管的细长轴608可以同轴地延伸通过导向导管的细长轴606。球囊导管在远端可以具有球囊部件。球囊导管还可以具有限定出内腔的近端部分612,该内腔与球囊导管的细长轴608的腔连通并且在球囊部件膨胀期间与流体加压装置(未示出)连通。近端部分612可以位于调节装置600近端。
如在前面各种实施方式中更详细地描述的,当传送设备导入到病人的脉管系统中时,球囊部件可以布置在卷曲的瓣膜部件的近侧或远侧。例如,图16示出了在球囊导管16的球囊28近侧卷曲在传送设备上的瓣膜12。在球囊28扩张并且瓣膜12部署在治疗部位之前,球囊28相对于瓣膜12移动使得球囊28适当地被安置以在瓣膜12的框架内膨胀。正如下面所述,调节装置600可以用来将球囊向近侧移动到瓣膜12的框架内的位置中。
如图40所示,固定机构610可以设置在调节部分604中。固定机构610还可以包括锁定按钮622,该锁定按钮622能够将固定机构610锁定在打开位置以允许细长轴608相对于调整装置600自由移动。正如在下面更加详细地描述的,锁定按钮622可以与固定机构610可滑动地连接,如图42所示。
参考图41,固定机构610可以包括上部614、开口616和下部618。如图42所示,细长轴608通过固定机构610的开口616。固定机构610被弹簧626向下偏置(也就是,参照图42向下)。弹簧626通过接触下部618并且提供方向朝着固定机构610、远离弹簧626的偏置力来偏置固定机构610。细长轴608形成有一个或多个槽部分624。如图42所示,当槽部分624被一部分在弹簧626一侧上围绕开口616的固定机构610啮合时,该固定机构固定细长轴608并且限制细长轴608相对于调节部分604在纵向方向上的进一步移动。
如图42所示,导向导管的细长轴606的近端620终止于调节装置600的弯曲指示部分602内。导向导管的细长轴606的近端620可以固定于调节装置600的弯曲指示部分602,以防止细长轴606相对于弯曲指示部分602移动。细长轴606可以通过利用例如粘结剂或任何其它类型的机械紧固件而固定于弯曲指示部分602。因此,当固定机构610啮合细长轴608的槽部分624时,两个轴606、608均相对于调节装置600的相应部分在纵向方向上被固定。也就是,轴608相对于调节部分604(即,调节装置600的第二部分)被固定,而轴606相对于弯曲指示部分602(即,调节装置600的第一部分)被固定。
调节部分604具有起夹紧旋钮或手柄作用的外部夹紧表面628,该夹紧旋钮或手柄能够沿着图40中箭头630所示的方向旋转。调节部分604可以具有内螺纹部分632,并且弯曲指示装置部分602可以具有外螺纹部分634。这些螺纹部分可以配合(或拧)在一起,并且夹紧表面628顺时针或逆时针方向的旋转(如箭头630所示)使调节部分604更接近或进一步远离弯曲指示部分602移动,这进而使轴608相对于轴606轴向地移动。因此,当传送设备的球囊部件和卷曲的瓣膜已经被推进到病人脉管系统内、可期望将瓣膜部件安装在球囊上的位置时,调节装置600可以用于精确地改变球囊部件相对于导向导管的位置。
因此,在操作中,球囊部导管的细长轴608可以在调节装置600的调节部分604内被操纵,直到细长轴608的槽部分624啮合固定机构610。图43A示出了处在固定机构610不啮合槽部分的位置的细长轴608,而图43B示出了处在固定机构610啮合槽部分624的位置的细长轴608。由于固定机构被朝着细长轴608偏置,当槽部分624通过固定机构610的开口616时,固定机构610自动夹紧槽部分624,限制细长轴608相对于调节部分604的纵向移动。一旦固定机构610啮合槽部分624,球囊部件的纵向位置可以通过旋转外部夹紧表面628以向瓣膜的近端或远端移动细长轴608(乃至细长轴远端的球囊部件)来进行调节。在调节球囊部件相对于瓣膜部件的位置期间,诸如荧光检查的成像技术可以用于观察球囊部件和瓣膜的相对位置。
当外部夹紧表面628旋转时,调节部分604可以向近侧(或向远侧)平移,将细长轴608和球囊部件相对于弯曲指示部分602向近侧(或向远侧)拉动。因此,细长轴608的位置可以以相对慢的且可控的方式进行调节。在细长轴608的球囊部件被重新安置使得瓣膜适当地安装在球囊部件上之后,通过朝着弹簧626(即,相对于图43A-43C向下)按压固定机构610,固定机构610可以从其与槽部分的啮合中释放。
有时期望防止固定机构610锁定到细长轴608上。因此,锁定按钮622可以构造成将固定机构610锁定在阻止弹簧626偏置的“打开”位置,使得固定机构不能啮合轴608中的槽部分之一。锁定旋钮622可以与固定机构610连接。可选地,锁定旋钮622可以设置成邻近固定机构610。用于接纳锁定旋钮622的支腿部分的开口或狭槽640可以配置在调节部分604的相邻壁(adjacent wall)中。当固定机构610被对着弹簧626压紧到未固定的位置时,锁定旋钮622可以纵向移动,使得锁定旋钮622的支腿部分滑动到开口640中。通过将锁定旋钮622滑动到开口640中,固定机构610能够被锁定在“打开”位置,其中细长轴608能够相对于调节部分604自由移动。为了从“打开”位置释放锁定按钮622,通过向后滑动锁定旋钮622并且从开口640中移出支腿部分,该锁定按钮622可以向后移动到“未锁定”位置。这使固定机构610再次啮合细长轴608的槽部分624。
调节的量可以根据调节装置600螺纹的应用和螺纹的长度而改变。球囊部件的期望可用调节长度,例如可以在约2-10mm之间,并且更期望在4-6mm之间。调节装置600可以构造有螺纹,该螺纹允许第一部分和第二部分相互移动预定的距离,然后两部分彼此分开。但是期望,移动的长度受机械止动器636限制。机械止动器636可以形成有(或连接于)第一或第二部分其中之一(例如弯曲指示部分602)并且构造成使机械止动器邻接相对部分(例如,调节部分604)的壁部分。机械止动器636操作来防止第一和第二部分(例如,弯曲指示部分602和调节部分604)分开超过预定的量。
期望地,固定机构610中的开口616被定径并构造成使球囊导管的细长轴608不与调节部分604的旋转一起旋转。调节装置600的固定机构和其它部件可以由各种材料形成,包括各种塑料或金属如不锈钢。
仅仅需要一个能够与固定机构610啮合的槽部分624。可选地,细长轴608可以形成有多个槽部分。附加的槽部分可以被安置,以便在手术的其它时间,包括在传送瓣膜到治疗部位期间或在从病人的脉管系统撤回球囊部件期间,能够调节球囊部件与导向导管的相对位置。期望槽部分624安置在细长轴608上的多个位置,以便当槽部分624与固定机构610啮合时,球囊部件相对地靠近卷曲的瓣膜内的期望位置。以这种方式,在调节部分604和弯曲指示部分602之间可用的移动距离的量足以将瓣膜安装在球囊部件上。
应当指出,调节装置600的螺纹部分的位置可以颠倒。也就是说,调节部分604可以具有外螺纹部分,而弯曲指示装置部分602可以具有内螺纹部分。此外,对于球囊部件最初安置在瓣膜部件近侧的实施方式,调节装置600可以构造成使球囊部件能够被操纵来向远侧移动,以便安置在瓣膜部件的框架内。
鉴于本发明的原理可以用于许多可能的实施方式,应当认识到,所示的实施方式仅仅是本发明的优选实例,并且不应当当作限制本发明的范围。而是,本发明的范围由权利要求限定。因此我们请求保护在这些权利要求的范围和精神内的全部发明。
Claims (7)
1.一种传送系统,所述传送系统用于传送人工瓣膜通过病人的脉管系统,所述传送系统包括:
导向导管(14),其具有细长轴;和
球囊导管(16),其具有细长轴、延长部分(74)和连接于所述轴的远端部分的球囊(28),所述球囊导管能够在所述导向导管的所述轴内纵向地移动;和
人工心脏瓣膜(12),其包括可扩张框架部分和具有小叶的内部部分;
其中所述球囊导管的所述延长部分适于接纳卷曲状态的所述人工心脏瓣膜,以在推进穿过所述病人的所述脉管系统期间将所述人工心脏瓣膜保持在球囊导管上,并且其中所述导向导管的所述细长轴具有将所述人工心脏瓣膜推到所述球囊上的远端。
2.根据权利要求1所述的传送系统,其中所述球囊导管的所述延长部分由与所述球囊相同的材料形成。
3.根据权利要求1所述的传送系统,所述传送系统还包括前端件,其中所述球囊的远端部分连接于所述前端件。
4.根据权利要求3所述的传送系统,其中所述球囊的所述远端部分连接在所述前端件的大致中点。
5.根据权利要求1所述的传送系统,其中所述导向导管还包括用于调节所述导向导管的曲率的牵引丝。
6.根据权利要求5所述的传送系统,其还包括调节旋钮(155),用于操纵所述导向导管。
7.根据权利要求1所述的传送系统,其中所述人工心脏瓣膜是可扩张的以在自体动脉瓣中展开。
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CN110621262B (zh) * | 2017-04-27 | 2022-11-29 | 美敦力公司 | 经导管的带支架的假体张紧和锁定系统以及装置 |
US11571302B2 (en) | 2017-04-27 | 2023-02-07 | Medtronic, Inc. | Tension member routing elements in transcatheter stented prosthesis tensioning system |
CN110013356A (zh) * | 2018-01-07 | 2019-07-16 | 苏州杰成医疗科技有限公司 | 心脏瓣膜假体递送系统 |
CN110013356B (zh) * | 2018-01-07 | 2023-08-01 | 苏州杰成医疗科技有限公司 | 心脏瓣膜假体递送系统 |
WO2024021961A1 (zh) * | 2022-07-28 | 2024-02-01 | 上海纽脉医疗科技股份有限公司 | 一种定位件、瓣膜输送系统及球囊扩张式介入器械 |
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