CN109475410B - 医疗装置手柄 - Google Patents

医疗装置手柄 Download PDF

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CN109475410B
CN109475410B CN201780043040.6A CN201780043040A CN109475410B CN 109475410 B CN109475410 B CN 109475410B CN 201780043040 A CN201780043040 A CN 201780043040A CN 109475410 B CN109475410 B CN 109475410B
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迈克尔·P·卡洛梅尼
塔卡什·H·伊诺
欧文·雷博尔德
兰迪·S·加马拉
德怀特·J·柯那比
安德鲁·J·H·巴克斯
弗罗里扎·Q·埃斯帕诺拉
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
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    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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    • A61F2/00Filters 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
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    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

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Abstract

医疗装置手柄可具有手柄壳体,该手柄壳体包括设置在手柄壳体内部的空腔。该医疗装置手柄可包括设置在空腔内部并且可操作地连接到管状构件和医用植入物的运载组件,通过控制旋钮相对于手柄壳体的旋转,运载组件可在远侧位置与近侧位置之间纵向地移动,控制旋钮被设置为围在手柄壳体的近端。运载组件可包括运载构件、第一滑动构件、第二滑动构件、及构造成相对于运载构件可分离地固定第一滑动构件和第二滑动构件的锁定元件。该锁定元件可相对于手柄壳体而旋转。

Description

医疗装置手柄
相关的申请
本申请要求于2016年5月13日提交的美国临时专利申请第62/335,999号和于2017年4月27日提交的美国发明申请第15/499,009号的优先权。
技术领域
本公开是关于医疗装置及制造和/或使用医疗装置的方法。更具体地,本公开是关于置换心脏瓣膜的构造。
背景技术
已开发出了用于医疗用途(例如血管内用途)的种类广泛的体内医疗装置。这些装置有些包括导丝、导管、医疗装置输送系统(例如,用于运载、移植物、置换瓣膜等),等。这些装置是通过多种不同制造方法中的任一种方法而制造,并且可按照多种方法中的任一种方法而使用。就已知的医疗装置和方法而言,各自具有某些优点和缺点。对于提供替代的医疗装置以及用于制造和使用医疗装置的替代方法存在着持续的需求。
发明内容
在第一方面,用于医用植入物经由管状构件(该管状构件从医疗装置手柄向远侧延伸)的经皮输送的医疗装置手柄可包括具有从手柄壳体近端延伸至手柄壳体远端的纵向轴线的手柄壳体;该手柄壳体包括设置在手柄壳体内部的空腔、及设置在空腔内部且可操作地连接到管状构件和医用植入物的运载组件;通过控制旋钮相对于手柄壳体的旋转该运载组件可在远侧位置与近侧位置之间纵向地移动;控制旋钮被设置在手柄壳体的近端周围。运载组件可包括运载构件、第一滑动构件、第二滑动构件、及构造成相对于运载构件可分离地固定第一滑动构件和第二滑动构件的锁定元件。该锁定元件可相对于手柄壳体旋转。
此外或可替代地,并且在第二方面,医疗装置手柄还可包括设置在手柄壳体近端部周围的管状套圈构件,该管状套圈构件可围绕手柄壳体而旋转。
此外或可替代地,并且在第三方面,锁定元件与运载构件物理地接合。
此外或可替代地,并且在第四方面,管状套圈构件围绕纵向轴线的旋转使锁定元件从与运载构件的接合中旋转出。
此外或可替代地,并且在第五方面,在使锁定元件从与运载构件的接合中旋转出之后,第一滑动构件可相对于第二滑动构件纵向地移动。
此外或可替代地,并且在第六方面,第一滑动构件可相对于第二滑动构件从第一位置向近侧移动到第二位置。
此外或可替代地,并且在第七方面,在第二位置,第一滑动构件紧靠一部分的第二滑动构件。
此外或可替代地,并且在第九方面,在使锁定元件从与运载构件的接合中旋转出之后,管状套圈构件的进一步旋转使第一滑动构件相对于第二滑动构件向近侧移动。
此外或可替代地,并且在第九方面,在第一滑动构件处在第二位置之后,管状套圈构件的进一步旋转使第二滑动构件相对于运载构件向近侧移动。
此外或可替代地,并且在第十方面,在第一滑动构件处于第二位置之后,管状套圈构件的进一步旋转使第一滑动构件和第二滑动构件两者相对于运载构件向近侧移动。
此外或可替代地,并且在第十一方面,第二滑动构件包括从其中向远侧延伸至医用植入物的至少一个致动构件,其中运载组件从远侧位置朝向近侧位置的移动将至少一个致动构件置于张紧状态。
此外或可替代地,并且在第十二方面,在从运载构件中释放出第一滑动构件和第二滑动构件之后,释放在至少一个致动构件上的张紧力直到第一滑动构件与在形成于第二滑动构件中的槽的近端的第二滑动构件重新接合。
此外或可替代地,并且在第十三方面,用于医用植入物经由管状构件(该管状构建从医疗装置手柄中向远侧延伸)的经皮输送的医疗装置手柄可包括具有从手柄壳体近端延伸至手柄壳体远端的纵向轴线的手柄壳体;该手柄壳体包括设置在手柄壳体内部的空腔、设置在空腔内部并且可操作地连接到管状构件和医用植入物的运载组件;通过控制旋钮相对于手柄壳体的旋转,该运载组件可在远侧位置与近侧位置之间纵向地移动,该控制旋钮被设置在手柄壳体的近端周围,其中运载组件包括运载构件、第一滑动构件、第二滑动构件、及构造成相对于运载构件可分离地固定第一滑动构件和第二滑动构件的锁定元件(该锁定元件可相对于手柄壳体而旋转)、和设置在手柄壳体的近端部周围的管状套圈构件,该管状套圈构件可围绕手柄壳体而旋转。手柄壳体可包括构造成当第一滑动构件和第二滑动构件被锁定元件固定到运载构件时与处在管状套圈构件相对于手柄壳体的第一方位的管状套圈构件相接合的按钮机构,该按钮机构构造成与当第一滑动构件和第二滑动构件被锁定元件固定到运载构件时处在管状套圈构件相对于手柄壳体的第二方位的管状套圈构件相接合。
此外或可替代地,并且在第十四方面,至少一部分的按钮机构从手柄壳体径向地向外延伸。
此外或可替代地,并且在第十五方面,当按钮机构与处在管状套圈构件的第一方位的管状套圈构件相结合时,防止管状套圈构件围绕手柄壳体而旋转。
此外或可替代地,并且在第十六方面,当按钮机构与处在管状套圈构件的第二方位的管状套圈构件相接合时,防止管状套圈构件围绕手柄壳体而旋转。
此外或可替代地,并且在第十七方面,医疗装置系统可具有包括设置在其中的可纵向移动的运载组件的手柄壳体;该运载组件包括:运载构件、第一滑动构件、第二滑动构件、及相对于运载构件可分离地固定第一滑动构件和第二滑动构件的锁定元件(该锁定元件可相对于手柄壳体而旋转)、和从手柄壳体向远侧延伸的管状套圈构件、可从管状构件的远端进行布置的置换心脏瓣膜、从架组件经过管状构件向远侧延伸至置换心脏瓣膜的至少一个致动构件、可分离地附接到置换心脏瓣膜的至少一个致动构件、和设置在手柄壳体周围并且可相对于手柄壳体而旋转的管状套圈构件,该管状套圈构件构造成当围绕手柄壳体旋转时从运载构件中释放第一滑动构件和第二滑动构件。
此外或可替代地,并且在第十八方面,管状套圈构件围绕手柄壳体的部分旋转使第一滑动构件相对于第二滑动构件向近侧平移直到第一滑动构件紧靠一部分的第二滑动构件,由此不可逆地使至少一个致动构件与置换心脏瓣膜分开。
此外或可替代地,并且在第十九方面,在第一滑动构件紧靠一部分的第二滑动构件之后管状套圈构件围绕手柄壳体的部分旋转使第二滑动构件相对于运载构件向近侧平移。
此外或可替代地,并且在第二十方面,第二滑动构件相对于运载构件向近侧的平移将至少一个致动构件从置换心脏瓣膜中收回。
上面对一些实施方式、方面和/或例子的概述并非意图描述各公开的实施方式或本公开的每个实施例。接下来的附图和详细说明更具体地举例说明了这些实施方式。
附图说明
基于以下对各种实施方式的详细说明并结合附图可更完全地理解本公开,在附图中:
图1示出了示范性的医疗装置系统;
图2示出了与该医疗装置系统相关的示范性医用植入物的所选择部件;
图3示出了与该医疗装置系统相关的示范性医用植入物的所选择部件;
图4示出了示范性的医疗装置手柄;
图5示出了示范性医疗装置手柄的所选择部件;
图6示出了示范性医疗装置手柄的所选择部件;
图7-图8示出了与示范性医疗装置手柄相关的示范性套圈;
图9是示出了与示范性医疗装置手柄相关的所选择部件的局部剖视图;
图10-图12示出了在示范性医疗装置手柄内部的所选择部件的协调运动的实例;
图13-图14示出了与示范性医用植入物的释放过程相关的示范性医疗装置手柄的所选择部件;
图15-图17示出了在示范性医疗装置手柄内部的所选择部件的协调运动的实例。
虽然本公开的各方面适合于各种修改和替代形式,但已通过在附图中的举例揭示了其细节并且将详细地描述。然而,应当理解的是意图并非是将本公开的各方面局限于所描述的具体实施方式。相反,意图是涵盖落在本公开的精神和范围内的所有修改、等同物和替代物。
具体实施方式
以下的描述应当参考未必按比例绘制的附图而进行阅读,其中在所有的若干个视图中类似的附图标记表示类似的元件。详细说明和附图是用来说明但不限制请求保护的本发明。本领域技术人员将认识到,在不背离本公开的范围的前提下,所描述的和/或图示的各种元件可在各种组合和构造中而布置。详细说明和附图说明了请求保护的本发明的示范性实施方式。
就以下所定义的术语而言,应当采用这些定义,除非在权利要求中或者在本说明书中的别处给出不同的定义。
本文中的所有数值假定被术语“大约”所修饰,无论是否明确地指出。在数值的语境中,术语“大约”通常指代本领域技术人员将会认为等同于所列举值(例如,具有相同的功能或结果)的一系列数字。在许多情况下,术语“大约”可包括被四舍五入到最近的有效数字的数字。术语“大约”(例如,在除数值外的语境中)的其他使用可假定具有它们的普通和通常的定义,如从并基于本说明书的上下文所理解的,除非另有说明。
利用端点对数值范围的叙述包括在该范围内的所有数字,包括端点(例如,1至5包括1、1.5、2、2.75、3、3.80、4、和5)。
尽管公开了与各种部件、特征和/或规格有关的一些合适的尺寸、范围、和/或值,但本领域技术人员在受到本公开的启发下,将会理解理想的尺寸、范围、和/或值可偏离明确公开的尺寸、范围、和/或值。
在本说明书和所附权利要求中所使用的单数形式“一”、“一种”、和“该”包括复数的所指对象,除非上下文明确地指出。在本说明书和所附权利要求中所使用的术语“或者”通常是以包括“和/或”的其含义而使用,除非上下文明确地指出。
相对的术语如“近侧”、“远侧”、“行进”、“收回”、它们的变体等通常可针对各种元件相对于装置的使用者/操作者/操纵者的定位、方向、和/或操作而考虑,其中“近侧”和“收回”表示或指代更靠近或朝向使用者,并且“远侧”和“行进”表示或指代更远离或离开使用者。其他相对的术语,如“上游”、“下游”、“流入”、和“流出”是指流体在管腔(如体腔、血管)内部或在装置内部的流动方向。
应注意的是,在本说明书中对“一个实施方式”、“一些实施方式”、“其他实施方式”等的引述表示所描述的实施方式可包括特定的特征、结构、或特性,但每个实施方式会未必包括该特定的特征、结构、或特性。而且,这种短语未必涉及到相同的实施方式。此外,当结合一个实施方式来描述特定的特征、结构、或特性时,无论是否明确地描述本领域技术人员将能够结合其他实施方式而实现这种特征、结构、或特性,除非清楚地指出相反的情况。也就是说,可以想到的是,下述的各种单独元件,即使未在特定的组合中明确地示出,也可相互组合或排列而构成其他另外的实施方式或者补充和/或充实所描述的实施方式,如本领域技术人员将会理解的。
为了清楚起见,在整个描述和/或权利要求中可使用某些识别性的数字命名(例如,第一、第二、第三、第四等)来命名,并且/或者在各种所描述和/或请求保护的特征之间进行区分。应当理解的是,数字命名并非意图是限制性的而只是示例性的。在一些实施方式中,为了简洁和清楚,可作出对前面所使用数字命名的变更和偏离。也就是说,被鉴定为“第一”元件的特征可在随后被称为“第二”元件、“第三”元件等或者可完全地省略,并且/或者不同的特征可被称为“第一”元件。在各情况下,其含义和/或指定对于本领域技术人员而言将是显而易见的。
影响心血管系统的疾病和/或病况在全世界是普遍的流行。传统地,对心血管系统的治疗常常是通过直接地进入心血管系统的受影响部分而实施。例如,对一个或多个冠状动脉中的堵塞的治疗,传统地是利用冠状动脉旁路手术而进行治疗。正如可以容易地理解的,这种治疗对于患者而言是相当有创伤性的并且需要大量的恢复时间和/或治疗。最近,已开发出创伤性较低的治疗方法,例如,其中可以经由经皮导管而进入堵塞的冠状动脉并进行治疗(例如,血管成形术)。这种治疗方法已在患者和临床医生中获得广泛的接受。
一些相对较常见的病况可包括或者是在心脏内部的一个或多个瓣膜的低效、无效、或完全失效的结果。例如,主动脉瓣或二尖瓣的失效会对人体具有严重影响,并且如果未适当地处理则可能导致严重的健康问题和/或死亡。有缺陷心脏瓣膜的治疗带来其他问题,亦即治疗常常需要有缺陷瓣膜的修复或完全置换。这种治疗方法对于患者而言会是高度创伤性的。本文中所公开的是可用于将医疗装置输送至一部分的心血管系统从而对心血管系统进行诊断、治疗、和/或修复的医疗装置。至少部分的本文中所公开的医疗装置可用于输送和植入置换心脏瓣膜(例如,置换主动脉瓣、置换二尖瓣等)。此外,本文中所公开的装置可经皮地输送置换心脏瓣膜,因此对于患者而言创伤性会低得多。本文中所公开的装置也可提供一些其他可取的特征和益处,如下面更详细地描述。
各附图图示说明了例如在图1中示意性示出的医疗装置系统10的所选择部件和/或布置。应当指出的是,为简单起见,在任何给定的附图中可以不示出或者可示意性地示出医疗装置系统10的一些特征。有关医疗装置系统10的部分部件的其他细节可在其他附图中更详细地示出。医疗装置系统10可用于将多种医疗装置输送和/或布置到在解剖结构内部的一些部位。至少在一些实施方式中,医疗装置系统10可包括可以用于医用植入物16(如置换心脏瓣膜)的经皮输送的置换心脏瓣膜输送系统(例如,置换主动脉瓣输送系统)。然而,这并非意图是限制性的,因为医疗装置系统10也可使用于其他介入手术,包括瓣膜修复、瓣膜成形术等,或者其他类似的介入手术。
医疗装置系统10通常可被描述为导管系统,该导管系统包括外护套12、至少部分地延伸经过外护套12的管腔的内导管14(在图1中在假想线中示出了其一部分)、和在医用植入物16的输送期间可联接到内导管14并设置在外护套12的管腔内部的医用植入物16(例如,置换心脏瓣膜植入物,例如在本文中该术语可与术语“医用植入物”互换地使用)。在一些实施方式中,医疗装置手柄18可设置在外护套12和/或内导管14的近端,并且可包括与之相联的一个或多个致动装置。换句话说,管状构件(例如,外护套12、内导管14等)可从医疗装置手柄18向远侧延伸。通常,医疗装置手柄18可构造成操纵外护套12相对于内导管14的位置并且/或者帮助医用植入物16的布置。在一些实施方式中,医疗装置系统10可包括设置在导丝延伸管远端的鼻锥,其中导丝延伸管可从内导管14和/或外护套12向远侧延伸。至少在一些实施方式中,鼻锥可被设计具有非创伤性的形状,并且/或者可包括构造成在医用植入物16的输送期间紧靠外护套12远端的脊部或突出部。
在使用中,可经皮地使医疗装置系统10经过脉管系统行进至与感兴趣区域和/或治疗部位相邻的位置。例如,在一些实施方式中,可使医疗装置系统10经过脉管系统行进至与有缺陷自体瓣膜(例如,主动脉瓣、二尖瓣等)相邻的位置。利用医疗装置系统10治疗有缺陷主动脉瓣和/或其他心脏瓣膜的替代方法也是可以想到的。在输送期间,例如,通常可将医用植入物16设置在位于管腔内部和/或外护套12远端的细长且低剖面(low profile,小轮廓)的“输送”构型中,如图1中示意性地示出。一旦被定位,可相对于医用植入物16和/或内导管14将外护套12收回以使医用植入物16暴露。在一些实施方式中,当设置在管腔的内部和/或外护套12的远端时并且/或者当在收回外护套12之后刚刚暴露时,医用植入物16以“外翻”构型而设置。在一些实施方式中,“输送”构型与“外翻”构型可大体上相似并且/或者可互换地使用。例如,可利用医疗装置手柄18来致动医用植入物16,从而将医用植入物16平移进入适合于植入在解剖结构内部的通常是缩短且更大剖面的“布置”构型,如在图2中所见。当把医用植入物16适当地布置在解剖结构内部时,可将医疗装置系统10从医用植入物16中分离、分开、和/或释放,并且可以将医疗装置系统10从脉管系统中取出,从而使医用植入物16以“释放”构型停留在适当位置,如图3中所见,从而起到例如自体瓣膜的合适置换的作用。至少在一些介入手术中,可将医用植入物16布置在自体瓣膜的内部(例如,使自体瓣膜停留在原处并且不被切除)。可替代地,可将自体瓣膜取出,并且可将医用植入物16布置在其位置作为置换物。
在一些实施方式中,外护套12和/或内导管14可采用挤出聚合物管的形式。其他形式也是可以想到的,包括其他的聚合物管、金属管、加强管等,包括如本文中所公开的其他合适材料。在一些实施方式中,外护套12和/或内导管14可以是单数的整体或单一构件。在其他实施方式中,外护套12和/或内导管14可包括联接到一起的多个部分或段。在一些实施方式中,外护套12和/或内导管14也可以是弯曲的,例如与其远端相邻。在一些实施方式中,外护套12和/或内导管14可包括具有不同硬度/刚度(例如,不同的邵氏硬度)的一个或多个部分。
在一些实施方式中,内导管14可包括纵向地延伸经过内导管14的一个或多个管腔。例如,内导管14可包括第一管腔、第二管腔、第三管腔、和第四管腔。通常,各管腔可沿内导管14的全长而延伸。然而,其他实施方式也是可以想到的,其中一个或多个管腔仅沿内导管14的一部分长度而延伸。
在一些实施方式中,设置在第一管腔内部的可以是至少一个致动构件84,该致动构件可用于在“输送”构型与“布置”构型之间可逆地致动(例如,轴向地平移或者纵向地和/或径向地扩张)医用植入物16,如在本文中更详细地说明。为了本公开和任何相关诉讼的目的,在本文中术语“致动构件”与“推拉杆”(包括其单数形式和复数形式两者)可互换地使用。在一些实施方式中,医疗装置系统10可包括从医疗装置手柄18延伸至医用植入物16的至少一个致动构件84。在一些实施方式中,至少一个致动构件84可包括多个致动构件84、两个致动构件84、三个致动构件84、四个致动构件84、或其他合适或期望数量的致动构件84。仅仅为了说明的目的,医疗装置系统10和/或医用植入物16被图示具有三个致动构件84。
在一些实施方式中,设置在第二腔内部的可以是销释放心轴92和/或至少一个释放销88,尽管专用的释放销88不是严格地必需的。在一些实施方式中,第三腔可以是构造成在其中可滑动地接纳导丝的导丝腔。在一些实施方式中,第四管腔可用于容纳非拉伸金属丝或其他增强构件。非拉伸金属丝或其他增强构件的确切形态可变化。在一些实施方式中,可将非拉伸金属丝或其他增强构件埋入第四管腔和/或内导管14的内部。此外,非拉伸金属丝或其他增强构件可延伸至与远端相邻的位置,但并不完全地延伸至内导管14的远端。例如,在一些实施方式中,可用与内导管14的远端相邻的聚合物材料将第四管腔的短的远侧段加以填充。
图2和图3示出了处于“布置”构型(如图2中所见)和“释放”构型(如图3中所见)的医疗装置系统10和/或医用植入物16的所选择部件。例如,这里可以看到医用植入物16包括多个瓣叶68(例如,牛心包、聚合物等)这些瓣叶可被固定到管状锚固构件70,也就是说可逆地在“输送”构型(如图1中所示)与“布置”构型之间运动。在一些实施方式中,管状锚固构件70可包括近端和远端。在一些实施方式中,管状锚固构件70可大体上具有圆柱形的形状或构造。在一些实施方式中,管状锚固构件70可限定从管状锚固构件70近端延伸至管状锚固构件70远端的中心纵向轴线、和/或沿着、平行于中心纵向轴线、与中心纵向轴线同轴和/或重合而延伸经过管状锚固构件70的管腔。在一些实施方式中,管状锚固构件70可以是并且/或者包括由一根或多根细丝或金属丝(例如,单个细丝或金属丝,两根细丝、或金属丝等)所组成的编织物。其他形状和/或构造也是可以想到的。下面会对用于管状锚固构件70的一些合适的但非限制性的材料,例如金属材料或聚合物材料进行描述。
在一些实施方式中,管状锚固构件70可包括和/或构成分布在管状锚固构件70的圆周附近的多个锚固构件交叉点。在一些实施方式中,多个的锚固构件交叉点可包括管状锚固构件70和/或其编织物、细丝、金属丝等的两个或更多的重叠段(例如,第一段、第二段、第三段等)。在一些实施方式中,可将两个或更多的重叠段以交替的上与下图案或排列而布置。例如,在第一锚固构件交叉点处,可将第一段径向地设置在第二段的外部。在包括第一段的相邻的第二锚固构件交叉点处,可将第一段径向地设置在重叠段(例如,第三段)的内部。如果第一段(或任何的单个段)跟随在管状锚固构件70的圆周附近,上与下图案将会继续在管状锚固构件70的整个圆周附近交替。
在一些实施方式中,医用植入物16可包括附接到管状锚固构件70的多个锁定机构,多个锁定机构构造成将管状锚固构件70固定在“布置”构型和/或“释放”构型中。在一些实施方式中,至少一个致动构件84可构造成在“输送”构型、“布置”构型、和/或“释放”构型之间与多个锁定机构和致动管状锚固构件70和/或医用植入物16接合。在一些实施方式中,一个致动构件84可对应于、与接合、和/或致动一个锁定机构。在一些实施方式中,一个致动构件84可对应于、与接合、和/或致动多于一个的锁定机构。其他构造也是可以想到的。
在一些实施方式中,多个锁定机构可各自包括可轴向移动的柱构件72,例如在瓣叶68的接合部(柱构件72有时可被称为“接合柱”,该接合柱可用来紧固多个瓣叶68)、及固定地附接到管状锚固构件70(例如,沿管状锚固构件70的内表面)的搭扣构件76。在一些实施方式中,可在一个柱构件72处,将多个瓣叶68的每个瓣叶固定到管状锚固构件70。在一些实施方式中,可在瓣叶68的相反侧,将多个瓣叶68的每个瓣叶固定到两个相邻的柱构件72。换句话说,至少在一些实施方式中,医用植入物16可包括多个柱构件72及相应的多个搭扣构件76。其他的构造和对应关系也是可以想到的。在图示的实例中,医用植入物16包括被固定到具有三个柱构件72的管状锚固构件70的三个瓣叶68。多个瓣叶68也可固定到管状锚固构件70的基部或“远端”。相应地,可利用缝合线或其他合适的方式将多个柱构件72固定到管状锚固构件70(例如,沿管状锚固构件70的内表面)。
在一些实施方式中,至少一个致动构件84可构造成与多个锁定机构接合,并且在“输送”构型、“布置”构型、和/或“释放”构型之间致动管状锚固构件70和/或医用植入物16。在一些实施方式中,一个致动构件84可对应于、与接合、并且/或者致动一个锁定机构。在一些实施方式中,致动构件84通常可具有圆形、椭圆形、卵圆形、矩形、多边形(例如,两边形、三边形、四边形、五边形、六边形等)的形状。其他形状(规则和不规则)也是可以想到的。在一些实施方式中,致动构件84可由单件的金属丝、圆料、或其他合适的材料构成,如本文中所述。在一些实施方式中,致动构件84可通过单件的金属丝、圆料、或者其他合适材料的进一步加工而形成,例如通过机械加工、冲压、激光切割、或者其他合适的技术。下面对一些合适的但非限制性的用于致动构件84的材料,例如金属材料或聚合物材料进行描述。
应当指出的是,为了便于理解,本公开的某些特征可以以单数形式进行描述,即使这些特征可以是复数的或者在所公开的实施方式内重现。这些特征的每个实例可包括并且/或者由单数的公开所包含,除非明确地指出相反的情况。例如,对“致动构件”、“锁定元件”、“管腔”、或其他特征的引述可同样地涉及到超过一个的所述特征的所有情况和数量。为了简单和清楚的目的,并非所公开的本发明的所有元件必须在各附图中示出或者在下面详细地论述。在一些说明性的实例中,仅示出并描述了多个致动构件84中的一个、多个柱构件72中的一个、多个搭扣构件76中的一个,等(并且/或者可以不示出整个医用植入物16和/或管状锚固构件70以便于对某些元件的理解)。然而,应当理解的是,以下的论述可同样地适用于在医用植入物16(例如,至少一个致动构件84、多个锁定元件等)和/或医疗装置系统10内部所存在的多于一个的部件中的任何和/或全部部件,除非明确地指出相反的情况。此外,为清楚起见在各附图中可以不示出一些元件或特征的所有情况。
在一些实施方式中,柱构件72可在“布置”构型中因而在“释放”构型中与搭扣构件76接合。在一些实施方式中,柱构件72可在“输送”构型和/或“外翻”构型中轴向地和/或纵向地与搭扣构件76间隔。下面会对用于柱构件72和/或搭扣构件76的一些合适的但非限制性的材料,例如金属材料或聚合物材料进行描述。
在一些实施方式中,柱构件72的远端可紧固和/或附接(例如,固定地附接、可移动地附接、可移除地附接,等)到管状锚固构件70的远侧部,如通过缝合线、系绳、胶粘剂、或其他合适的元件。在一些实施方式中,柱构件72可相对于管状锚固构件70和/或搭扣构件76而移动。在一些实施方式中,柱构件72可相对于管状锚固构件70和/或搭扣构件76轴向地或纵向地移动。在一些实施方式中,搭扣构件76可固定地附接到管状锚固构件70。其他实施方式是可以想到的,其中可将搭扣构件76可移动地或可移除地附接到管状锚固构件70。在一些实施方式中,柱构件72可紧固或附接(例如,固定地附接、可移动附接、可移除地附接,等)到管状锚固构件70的远端。在一些实施方式中,搭扣构件76可固定或附接到管状锚固构件70的近端部。在一些实施方式中,搭扣构件76可固定或附接在或到管状锚固构件70的近端。
在一些实施方式中,医用植入物16可包括在多个柱构件72处、与多个柱构件72相邻地、和/或利用(至少部分地)多个柱构件72被固定到管状锚固构件70的多个瓣叶68中的一个或多个。在一些实施方式中,也可将多个瓣叶68固定到管状锚固构件70的基部、或远端。因此,当柱构件72向近侧被拉动到与搭扣构件76接合时(如将在本文中所描述),也可将管状锚固构件70的远端相对于搭扣构件76向近侧拉动,由此将管状锚固构件70和/或医用植入物16从“输送”构型和/或“外翻”构型朝向“布置”构型转变。
至少在一些实施方式中,管状锚固构件70的远端可互换地被描述为管状锚固构件70和/或医用植入物16的“流入”端或“上游”端。至少在一些实施方式中,管状锚固构件70的近端可互换地被描述为管状锚固构件70和/或医用植入物16的“流出”端或“下游”端。在一些实施方式中,可利用一个或多个缝合线、螺纹、金属丝、细丝、或其他合适的元件,将多个瓣叶68联接和/或紧固(例如,到柱构件72、到管状锚固构件70、和/或反向到它们自身)。在一些实施方式中,可利用胶粘剂、粘结剂、或其他合适的固定方式将多个瓣叶68可联接和/或紧固(例如,到柱构件72、到状锚固构件70、和/或反向地到它们自身)。在一些实施方式中,可利用织物、纺织物、或其他薄的柔性材料将多个瓣叶68联接和/或紧固(例如,到柱构件72、管状锚固构件70、和/或反向地到它们自身)。
在一些实施方式中,管状锚固构件70可具有总共三个搭扣构件76及附接和/或紧固到其上的三个柱构件72。类似地,就在图示的实例中总共三个致动构件84而言,可将一个致动构件84可操作地与各柱构件72和搭扣构件76相联。其中可使用更少或更多的搭扣构件76、柱构件72、致动构件84等其他实施方式也是可以想到的。
在一些实施方式中,可将密封构件74周向地设置在管状锚固构件70的远侧部和/或流入部上和/或附近,例如在图2和3中所见,并且如术语所提示,可有助于在布置时(例如,在“布置”构型和/或“释放”构型中)将医用植入物16的外部密封并且/或者将管状锚固构件70密封在靶部位或感兴趣区域的内部和/或抵接靶部位或感兴趣区域的内部,由此防止在医用植入物16和/或管状锚固构件70附近的泄漏。在一些实施方式中,可将密封构件74设置在管状锚固构件70的外表面附近并且/或者径向地设置在管状锚固构件70的外部。在一些实施方式中,可将密封构件74设置在管状锚固构件70的圆周附近并且/或者抵接管状锚固构件70的外部或外表面。在一些实施方式中,密封构件74可联接和/或紧固在管状锚固构件70的远端和/或流入端。
在一些实施方式中,密封构件74可包含多层的聚合物材料。一些合适的聚合物材料可包括但未必局限于:聚碳酸酯、聚氨酯、聚酰胺、聚醚嵌段酰胺、聚乙烯、聚对苯二甲酸乙二醇酯、聚丙烯、聚氯乙烯、聚四氟乙烯、聚砜、及其共聚物、共混物、混合物或组合。其他构造和/或其他合适的材料也是可以想到的。
在一些实施方式中,密封构件74的远端可包括加强带,并且在管状锚固构件70的远端和/或流入端和/或与之相邻的位置固定地附接到密封构件74。在一些实施方式中,加强带可与密封构件74形成为整体,并入、粘附到密封构件74,并且/或者至少部分地埋入密封构件74内部。在一些实施方式中,加强带可由机织或非机织织物带、纺织物、或其他薄的柔性材料所构成。加强带可提供在与医用植入物16的各部件或方面相关的缝合线、细丝、或者其他附接元件附近的抗撕裂性能。在一些实施方式中,密封构件74和/或加强带可纵向地延伸超过管状锚固构件70的远端和/或流入端。
在一些实施方式中,在医用植入物16与内导管14(和/或外护套12)之间的附接可通过联接件78的使用而实现。联接件78通常可包括可设置在内导管14(和/或外护套12)的远端附近、附接到该远端、和/或从该远端延伸出的圆柱形基部(未图示)。从基部向远侧突出的是多个指状物(例如,两个指状物、三个指状物、四个指状物等),这些指状物各自构造成在多个搭扣构件76中的一个处(例如,在搭扣构件76的近端)与医用植入物16接合,与从其中延伸经过且与柱构件72接合的多个致动构件84相接合。可将套圈80设置在联接件78的各自指状物附近从而进一步有助于将指状物与搭扣构件76保持在一起。可将导杆82设置于在套圈80近侧的每个指状物上方并且可用于保持与延伸至与联接件78的指状物相邻位置(并且可相对于联接件78的指状物轴向地滑动)的致动构件84相联的联接件78的指状物。最后,在一些实施方式中,如图2中所示,销释放组件86可以是例如保持柱构件72、搭扣构件76、和致动构件84相互联接的联接结构。销释放组件86可包括多个释放销88,可将这些释放销连接到一起(例如具有线圈连接90)并保持到销释放心轴92(例如,利用卡套94)。如上所述,销释放组件86可不存在于医用植入物16的所有实施方式中,并且至少在一些实施方式中,可采用一个或多个的各种“无销”释放和/或锁定机构。其他合适的构造也是可以想到的。下面会对用于联接件78、指状物、套圈80、导杆82、和/或销释放组件86的一些合适的但限制性的材料(例如金属材料或聚合物材料)进行描述。
在输送期间,借助于与搭扣构件76的突出的近端联接(并且利用设置在连接上方的套圈80被固定就位)的联接件78的指状物的结合并且借助于可操作地紧固到一起的致动构件84和柱构件72,可将医用植入物16紧固在内导管14的远端。当使医用植入物16在解剖结构内部行进到理想位置时,可将外护套12移出(例如,相对于内导管14和/或医用植入物16向近侧移动)以使医用植入物16暴露。然后,可利用致动构件84通过向近侧收回致动构件84从而拉动柱构件72到与搭扣构件76接合,而将管状锚固构件70和/或医用植入物16平移并且“锁定”在“布置”构型。最后,在一些实施方式中,可以将释放销88取出,由此将致动构件84与柱构件72分开,这允许将管状锚固构件70和/或医用植入物16从医疗装置系统10中释放出并且在“释放”构型中停留在解剖结构中。在一些实施方式中,释放销88和/或销释放组件86可以不存在,并且可采用释放医用植入物16的其他和/或替代方式,如释放医用植入物16的基于位移或基于距离的方式。
图4-图6示出了示范性的医疗装置手柄18。这里可以看到医疗装置手柄18可包括细长的手柄壳体120。该手柄壳体120可限定从手柄壳体120的近端延伸至手柄壳体120的远端的纵向轴线。在一些实施方式中,手柄壳体120可包括设置在手柄壳体120内部的空腔。可旋转控制旋钮122可设置在手柄壳体120(例如,在手柄壳体120的近端)的周围,并且可用于致动和/或移动医疗装置系统10的一个或多个部件(例如,外护套12、致动构件84,等)。在一些实施方式中,可旋转控制旋钮122可围绕和/或相对于手柄壳体120而旋转。
在一些实施方式中,手柄壳体120可包括设置在其中并且可操作地连接到可旋转控制旋钮122的轴向平移机构。在一些实施方式中,轴向平移机构可包括设置在空腔和/或手柄壳体120内部的运载组件(如下面进一步的描述)。在一些实施方式中,可将设置在空腔和/或手柄壳体120内部的运载组件可操作地连接到从医疗装置手柄18向远侧延伸并且/或者连接到医用植入物16的管状构件(例如,外护套12、内导管14等)。在一些实施方式中,通过可旋转控制旋钮122相对于手柄壳体120的旋转,运载组件145可在空腔和/或手柄壳体120内部在远侧位置与近侧位置之间纵向地移动。在一些实施方式中,轴向平移机构可将可旋转控制旋钮122的旋转运动转变成设置在空腔和/或手柄壳体120内部的运载组件的轴向平移,正如基于下面的描述将变得显而易见。
在一些实施方式中,可将管状套圈构件156设置在手柄壳体120的近端部的周围。在一些实施方式中,管状套圈构件156可围绕和/或相对于手柄壳体120而旋转。在一些实施方式中,如图5中所示,可将可旋转控制旋钮122围绕管状套圈构件156的近侧部180设置。在一些实施方式中,可旋转控制旋钮122可围绕和/或相对于管状套圈构件156而旋转。在一些实施方式中,医疗装置手柄18也可包括经过细长手柄壳体120一个或多个孔口和/或可进入的冲洗端口,可以用于冲洗医疗装置系统10的某些元件(例如,部件、管腔等),如本文中所描述。
在一些实施方式中,医疗装置手柄18和/或手柄壳体120可包括按钮机构124,该按钮机构124构造成接合并且/或者延伸进入延伸经过管状套圈构件156的壁的第一孔口126,管状套圈构件156处在相对于手柄壳体120的第一方位。在一些实施方式中,按钮机构124可构造成接合并且/或者延伸进入延伸经过管状套圈构件156的壁的第二孔口128,管状套圈构件156处在相对于手柄壳体120的第二方位的。在一些实施方式中,第二方位可不同于第一方位。在一些实施方式中,至少一部分的按钮机构124相对于手柄壳体120的纵向轴线从手柄壳体120中径向地向外延伸。
在一些实施方式中,按钮机构124可相对于管状套圈构件156、手柄壳体120、和/或手柄壳体120的纵向轴线在第一位置与第二位置之间移动,从而释放联锁结构而允许管状套圈构件156围绕和/或相对于细长的手柄壳体120而旋转,以便将医疗装置系统10置于使医用植入物16从“布置”构型平移和/或致动到“释放”构型的状态中。在一些实施方式中,第二位置在第一位置径向向内的位置。换句话说,为了启动和/或致动按钮机构124,必须使按钮机构124朝向手柄壳体120的纵向轴线径向地向内从第一位置移动、平移、和/或推动到第二位置。在一些实施方式中,在将按钮机构124启动和/或致动到第二位置之后,管状套圈构件156围绕和/或相可对于细长手柄壳体120旋转从而使医疗装置系统10的一个或多个部件(例如,销释放心轴92等)移动。
在一些实施方式中,当按钮机构124与处在管状套圈构件156的第一方位的管状套圈构件156相接合(例如,按钮机构124被设置在第一位置)时,可锁定和/或防止管状套圈构件156围绕和/或相对于手柄壳体120旋转。在一些实施方式中,当按钮机构124与处在管状套圈构件156的第二方位的管状套圈构件156相接合(例如,按钮机构124被设置在第一位置)时,可锁定和/或防止管状套圈构件156围绕和/或相对于手柄壳体120旋转。在一些实施方式中,当按钮机构124被设置在第二位置时,可释放管状套圈构件156并且/或者允许其围绕和/或相对于手柄壳体120而旋转。相对于手柄壳体120锁定和/或释放管状套圈构件156的其它方式也是可以想到的。
图7和图8示出了示范性管状套圈构件156的某些方面。在一些实施方式中,管状套圈构件156可包括近侧部180和远侧部182。在一些实施方式中,近侧部180可包括在管状套圈构件156近端的多个凹口,这些多个凹口构造成与下面会说明的可旋转环相接合。在一些实施方式中,可旋转控制旋钮122可设置在管状套圈构件156的近侧部180的周围和/或上方。在一些实施方式中,远侧部182可为波状外形并且/或者包括凹槽,以便于被使用者抓紧以使管状套圈构件156围绕和/或相对于手柄壳体120旋转。
在一些实施方式中,管状套圈构件156的远侧部182可包括第一孔口126和/或第二孔口128,这两个孔口被设置在和/或延伸穿过管状套圈构件156的壁。在一些实施式中,第一孔口126和/或第二孔口128可构造成在其中接纳至少一部分的按钮机构124。在一些实施方式中,管状套圈构件156可包括设置在近侧部180与远侧部182之间的中部。在一些实施方式中,该中部可与近侧部180和/或远侧部182相比径向地向外延伸更远,并且/或者可构成沿管状套圈构件156的外表面而径向延伸的脊部。
在一些实施方式中,管状套圈构件156可包括沿管状套圈构件156的内表面而设置的一个或多个槽、脊部、和/或凹凸结构。在一些实施方式中,管状套圈构件156可包括第一内部延伸的纵向脊部186,该纵向脊部从管状套圈构件156的内表面径向地向内延伸,其长度短于管状套圈构件156的全长。在一些实施方式中,运载组件145可包括运载构件152,该运载构件152构造成与第二滑动构件150接合从而相对于手柄壳体120致动和/或平移致动构件84。至少在一些实施方式中,运载构件152可包括侧向延伸的突起或标志构件(旗形构件)164(例如在图9中所见),其构造成与第一向内延伸的纵向脊部接合并且/或者沿第一向内延伸的纵向脊部186行进直到它到达周向向内延伸的脊部185。当到达周向向内延伸的脊部185时,利用周向朝内部延伸的脊部185与标志构件164之间的相互作用,可停止和/或防止运载构件152的近侧平移。通常,可将侧向延伸的突起或标志构件164设计为可以防止管状套圈构件156比期望的更早地旋转的凹凸结构。例如,可将侧向延伸突起或标志构件164定位成沿着管状套圈构件156内表面跟随第一内部延伸纵向脊部186。至少在一些实施方式中,利用第一内部延伸纵向脊部186与标志构件164之间的相互作用,可防止管状套圈构件156围绕手柄壳体120旋转。
在一些实施方式中,当使运载组件145和/或锁定元件148在手柄壳体120内部向近侧平移时,第一面向内部的纵向槽187可引导锁定元件148的一部分。至少在一些实施方式中,利用第一面向内部的纵向槽187与锁定元件148延伸入第一面向内部的纵向槽187中的部分之间的相互作用,可防止锁定元件148围绕引导螺杆162旋转。
图9示出了其中将手柄壳体120一部分去除从而使设置在空腔内部的至少一些部件暴露的医疗装置手柄18。这里可以看到,外护套12的近端可固定地附接到护套接头130。护套接头130可固定地附接到护套运载件132,该护套运载件132可螺纹连接到引导螺杆134上。可将远侧冲洗端口设置在护套接头130上。通常,远侧冲洗端口可提供到外护套12的内部或管腔的通路(例如,到内导管14与外护套12之间的空间的通路)使得临床医生可以将流体冲洗经过外护套12的管腔以便在医疗装置系统10的使用前去除在其中的任何不需要的材料(例如,空气、流体、污染物等)。至少在一些实施方式中,远侧冲洗端口可具有鲁尔型连接器(例如,单向鲁尔连接器),该连接器允许具有相应连接器的装置(如注射器)附接到其上以便冲洗。
在一些实施方式中,内导管14可延伸经过护套接头130并且从护套接头130向近侧延伸。内导管14的近端可附接(例如,固定地附接)到转向器136。转向器136可附接到支撑体140。通常,转向器136和/或支撑体140可具有形成于其中的一个或多个通道或管腔。在一些实施方式中,致动构件84和/或销释放心轴92可延伸经过形成于转向器136和/或支撑体140中的各自(例如,不同的)通道或管腔。可替代地,致动构件84和/或销释放心轴92的近端可各自固定地附接到轴(例如,截面中为实心、管状等),并且每个轴可延伸经过一个或多个通道或管腔。例如,第一轴142和第二轴144可延伸经过在转向器136中的通道,在一些实施方式中,第一轴142延伸经过第一通道并且第二轴144延伸经过第二通道,也就是说与第一通道分离或分开。至少在一些实施方式中,第一轴142可固定地附接到销释放心轴92。至少在一些实施方式中,第二轴144可固定地附接到致动构件84。应当指出的是,在医疗装置系统10的至少一些实施方式中,采用三个致动构件84。在这些实施方式中,三个致动构件84可在与内导管14的远端相邻的位置会合(例如,相互接触或者相互较紧密地靠近)。在沿它们的长度的一个或多个位置,致动构件84可以固定地相互连接(例如,焊接等)。
在一些实施方式中,海波管可延伸经过在其中的通道内部的转向器136然后在一部分的转向器136和支撑体140附近“转向”,最终延伸到在医疗装置手柄18近端的位置,从而给使用者提供进入内导管14的导丝管腔的路径。可将近侧冲洗端口设置在支撑体140上,该支撑体140可以用于冲洗内导管14的管腔,并且例如可起到类似于远侧冲洗端口的作用。
在一些实施方式中,医疗装置手柄18可包括可移除地设置在空腔内部的运载组件145。在一些实施方式中,通过可旋转控制旋钮122相对于手柄壳体120的旋转,运载组件145可在空腔内部在远侧位置与近侧位置之间纵向地移动。在一些实施方式中,运载组件145可包括运载构件152、第一滑动构件146、第二滑动构件150、及构造成可分离地将第一滑动构件146和/或第二滑动构件150固定到运载构件152的锁定元件148。在一些实施方式中,可将运载组件145和/或运载构件152用螺纹连接到设置在手柄壳体120内部的导螺杆134上并且/或者可沿设置在手柄壳体120内部的导螺杆134而轴向地平移。
在它们的各自的近端,可将第一轴142和/或销释放心轴92固定到第一滑动构件146,并且可将第二轴144和/或致动构件84固定到第二滑动构件150。换句话说,第二滑动构件150可包括从其向远侧延伸至医用植入物16的至少一个致动构件84(和/或第二轴144)。在各种部件之间的连接可包括一些不同类型的连接,包括机械结合(例如,销连接、螺纹、过盈配合等)、胶粘剂结合、热粘合等。在一些实施方式中,可将第一滑动构件146可分离地固定到第二滑动构件150和/或运载构件152并且/或者可选择性地相对于第二滑动构件150和/或运载构件152而滑动。在一些实施方式中,可利用锁定元件148将第一滑动构件146可分离地固定和/或选择性地锁定到第二滑动构件150和/或运载构件152,由此防止第一滑动构件146与第二滑动构件150之间的相对移动。可利用锁定元件148将第二滑动构件150可分离地固定和/或选择性地锁定到运载构件152。因此,导螺杆134的旋转可以导致运载组件145、运载构件152、第一滑动构件146、和第二滑动构件150沿着导螺杆134和/或与手柄壳体120一同和/或相对于手柄壳体120而轴向地移动和/或平移。因此,运载组件145从远侧位置朝向近侧位置的移动可将至少一个致动构件84置于张紧状态,并且/或者通过导螺杆134的旋转,致动构件84也可相对于手柄壳体120(利用第二轴144)轴向地平移。在本文中可以发现有关此运动的一些其他细节。
通常,医疗装置手柄18可包括并且/或者限定止动特征(例如,挡块、干涉构件,等凹凸结构),该止动特征防止运载组件145和/或运载构件152在近侧方向上进一步平移,并且/或者可给使用者提供触觉反馈(例如,对可旋转控制旋钮122的进一步旋转的阻力)从而表明已将多个致动构件84向近侧收回达足够的距离以便用搭扣构件76锁定柱构件72(例如,将医用植入物16和/或管状锚固构件70致动进入“布置”构型)。为了验证医用植入物16的正确锁定和/或定位,临床医生可采用适当的可视化技术(例如,以使多个锁定机构可视化等)。
可将锁定元件148定位在与第一滑动构件146靠近的位置以便选择性地将第一滑动构件146锁定到第二滑动构件150。为了允许销释放心轴92向近侧被收回以便拉动释放销88,可以使锁定元件148旋转或者其它方式移动到第二位置或构型。当处在此构型时,锁定元件148不再构成对例如第一滑动构件146和销释放心轴92进一步移动的障碍。因此,由于锁定元件148不再充当阻碍,因而可以将第一滑动构件146和销释放心轴92向近侧收回以便于通过允许释放销88被拉动而布置医用植入物16。
如在图15中最容易地看到,例如,医疗装置手柄18可包括具有内齿的可旋转环155,该内齿构造成与在联接到导螺杆134的齿轮(不可见)上的齿相啮合。可将可旋转环155可操作地联接到可旋转控制旋钮122,使得可旋转控制旋钮122的旋转导致可旋转环155和因此导螺杆134的相似运动。医疗装置手柄18可包括具有内齿的可旋转环154,该内齿构造成与在联接到导螺杆162的齿轮160上的齿相啮合。可将可旋转环154可操作地联接到管状套圈构件156,使得管状套圈构件156的旋转导致可旋转环154和因此导螺杆162的相似运动。在一些实施方式中,导螺杆162可延伸经过第一滑动构件146并且/或者与第一滑动构件146接合,其中导螺杆162的旋转导致第一滑动构件146相对于第二滑动构件150和/或运载构件152近侧轴向平移。
再次返回到图10-图12,医疗装置手柄18通常可用于医疗装置系统10的多个结构的协调运动。例如,医疗装置手柄18可构造成允许使用者使外护套12(例如,相对于内导管14)移动,从而使多个致动构件84移动并且/或者使销释放心轴92移动。此外,医疗装置手柄18构造成使得可以在介入手术期间的恰当时间使恰当的结构移动以便可以以高效的方式输送医用植入物16。
为了有助于促成协调运动,医疗装置手柄18可包括空程圆筒158。该空程圆筒158可构造成在介入手术期间的不同时间与护套运载件132和/或运载构件152和/或与护套运载件132和/或运载构件152相关的螺杆相接合以使运动停止(例如,导致恰当运载件的“空程”)。图10-图12示出了由医疗装置手柄18所实现的部分的协调运动。应当指出的是,为清楚起见,医疗装置系统10的一些元件在图10-图12中未示出。例如,图10示出了医疗装置手柄18的第一状态,其中外护套12相对于内导管14、医用植入物16、和/或手柄壳体120向远侧延伸从而完全地将医用植入物16包覆(例如,容纳)在外护套12的管腔内部。当处于此状态中时,护套运载件132位于靠近医疗装置手柄18远端的位置。此外,与运载构件152相联的螺杆(rod screw)153从运载构件152向远侧延伸并且位于空程圆筒158的内部。当可旋转控制旋钮122(例如,在顺时针方向上)旋转时,导螺杆134开始旋转。导螺杆134的旋转导致护套运载件132在近侧方向上沿导螺杆134移动,从而导致外护套12相对于内导管14、医用植入物16、和/或手柄壳体120的近侧移动(例如,“拔出”医用植入物16)。导螺杆134的此初始旋转也会导致螺杆153旋转。这会是因为例如在螺杆153上的旋钮或突出部(未图示)可与沿空程圆筒158内表面而设置的螺旋状螺纹相接合。然而,因为螺杆153与运载构件152间隔,所以螺杆153不施加力到运载构件152上。因此,可旋转控制旋钮122的初始运动并不导致运载构件152的轴向平移和,而是仅导致护套运载件132的轴向平移和螺杆153的旋转(和/或平移)。
最终,螺杆153(例如,形成于其中的旋钮)到达形成于空程圆筒158近端的大体上线性的螺纹或通路。该线性螺纹允许螺杆153沿导螺杆134向近侧轴向地平移到其中螺杆153接触(例如,在内部螺纹连接并且紧靠)运载构件152的位置。在这种情况下,螺杆153可以接触运载构件152并且使运载构件152向近侧轴向地平移。因此,导螺杆134的进一步旋转不仅导致护套运载件132向近侧移动而且导致运载构件152向近侧移动,例如如图11中所示。
当护套运载件132到达空程圆筒158时,护套运载件132的护套运载螺杆133进入空程圆筒158,例如如图12中所示。这可以类似于螺杆153如何拧入和拧出沿空程圆筒158所形成的螺旋状螺纹的方式而发生。例如,当护套运载件132正在轴向地平移时,护套运载螺杆133可跟随沿空程圆筒158和/或与空程圆筒158相邻地形成的大体上线性的螺纹或通路。在达到空程圆筒158时,护套运载螺杆133(例如,在其上形成的旋钮或突出部)可转成与在空程圆筒158内部的螺旋状螺纹相接合并且旋转。此旋转将护套运载螺杆133从护套运载件132中“拧出”。因此,导螺杆134的进一步旋转导致运载构件152向近侧继续轴向平移同时护套运载件132的运动停止。
至少在一些实施方式中,导螺杆134具有多个部分,例如第一部135和第二部137,各自具有相对于彼此的螺纹螺距。这可允许护套运载件132和/或运载构件152以不同的速率沿导螺杆134行进。例如,护套运载件132沿其平移的导螺杆134的螺距与在与运载构件152相邻的位置相比通常会是更加间隔开或更倾斜。因此,护套运载件132和/或运载构件152的协调运动也可用于使得护套运载件132以与运载构件152相比更大的速率沿导螺杆134平移。其他构造也是可以想到的(其中上述构造被反转)以及其中导螺杆134的螺距是大体上恒定或者包括一些不同的螺距区的其他构造。
运载构件152的充分的近侧收回,例如在图12中所示,可导致多个致动构件84被充分地收回以便柱构件72可以与搭扣构件76接合并且用搭扣构件76锁定。当临床医生确信锁定完成时(例如,在利用适当的可视化技术核实之后),临床医生可向近侧收回销释放心轴92从而拉动释放销88以使多个致动构件84与柱构件72分离和/或分开(并且随后将联接件78与搭扣构件76分开),由此使医用植入物16停留在“释放”构型中。
图13-图17示出了与释放过程有关的医用植入物16和/或医疗装置系统10的所选择部件的释放过程的所选择方面。为了在致动和/或平移医用植入物16和/或管状锚固构件70到“布置”构型之后起动医用植入物16的释放,在管状套圈构件156处在第一方位时,可相对于手柄壳体120的纵向轴线将按钮机构124从第一位置径向地向内按下、致动、和/或平移到第二位置,由此使按钮机构124与第一孔口126分离。将按钮机构124从第一位置按下、致动、和/或平移到第二位置可将管状套圈构件156解锁,由此允许管状套圈构件156相对于手柄壳体120做相对移动(例如,旋转运动等)。
然后,管状套圈构件156可围绕和/或相对于手柄壳体120从第一方位(例如在图13中所见)旋转到第二方位(例如在图14中所见)。在一些实施方式中,当管状套圈构件156处在第一方位时,锁定元件148可与第二滑动构件150和/或运载构件152物理地接合,由此当锁定元件148处在锁定方位时锁定第一滑动构件146、第二滑动构件150、和运载构件152之间的纵向和/或轴向移动,例如如图15中所见。当锁定元件148处在锁定方位时,可位于在第二滑动构件150内部的槽或凹槽中的第一滑动构件146可以第一位置被紧固和/或被设置在第二滑动构件150与锁定元件148之间并且/或者与在第二滑动构件150内部的槽或凹槽的远端相邻,由此防止第一滑动构件146相对于第二滑动构件150、运载构件152、和/或手柄壳体120的轴向移动和/或滑动。
管状套圈构件156围绕纵向轴线和/或远离第一方位的初始旋转可导致从管状套圈构件156的内表面径向地向内延伸的突起部188(参见图7)与锁定元件148的与第一面向内部纵向槽187接合的部分相接触,并且使锁定元件148相对于导螺杆162、第一滑动构件146、第二滑动构件150、和/或手柄壳体120等从与第二滑动构件150和/或运载构件152相接合的状态旋转到未锁定方位,例如在图16中所见。在使锁定元件148从与第二滑动构件150和/或运载构件152的接合中旋转出并且/或者旋转到未锁定方位之后,第一滑动构件146可相对于第二滑动构件150和/或运载构件152向近侧从第一位置朝向在位于第二滑动构件150中的槽或凹槽的近端和/或靠近该近端的第二位置纵向地和/或轴向地移动。在一些实施方式中,在将第一滑动构件146和第二滑动构件150从运载构件152中释放出之后,可释放在至少一个致动构件84上的张紧力,直到第一滑动构件146在形成于第二滑动构件150中的槽的近端处与第二滑动构件150重新接合,如下所述。
管状套圈构件156围绕和/或相对于手柄壳体120的进一步旋转可导致导螺杆162转动,由此使第一滑动构件146在位于第二滑动构件150中的槽或凹槽内部向近侧(和/或相对于第二滑动构件150)从第一位置平移和/或轴向地移动到第二位置。至少在一些实施方式中,当第一滑动构件146处在第二位置时,第一滑动构件146紧靠第二滑动构件150的一部分。在一些实施方式中,当第一滑动构件146处在第二位置时,第一滑动构件146紧靠在第二滑动构件150的槽或凹槽内部的面向远侧表面。第一滑动构件146从第一位置到第二位置的近侧平移和/或移动可收回和/或拉动销释放心轴92和/或释放销88,从而使释放销88与医用植入物16、锁定机构、和/或柱构件72分离和/或分开。由此不可逆地将至少一个致动构件84与医用植入物16分来。
在一些实施方式中,在第一滑动构件146处在位于第二滑动构件150中的槽或凹槽内部的第二位置之后,管状套圈构件156围绕和/或相对于手柄壳体120的进一步和/或部分旋转可使第二滑动构件150相对于运载构件152和/或手柄壳体120向近侧移动和/或轴向地平移,如在图17中所见。在一些实施方式中,在第一滑动构件146处在位于第二滑动构件150中的槽或凹槽内部的第二位置之后,管状套圈构件156围绕和/或相对于手柄壳体120的进一步和/或部分旋转可使第一滑动构件146和第二滑动构件150一同和/或同时地相对于运载构件152和/或手柄壳体120向近侧移动和/或轴向地平移。第二滑动构件150相对于运载构件152向近侧的轴向平移可将至少一个致动构件84从医用植入物16、锁定机构、和/或柱构件72向近侧收回。
当达到管状套圈构件156的第二方位时,按钮机构124可在第二孔口128内部从第二位置向地向外延伸、致动、和/或平移到第一位置,并且可将管状套圈构件156相对于手柄壳体120重新接合和/或锁定,例如如图14中所见。按钮机构124与处于第二方位的管状套圈构件156的重新接合可向使用者指示释放过程已完成并且/或者医用植入物16已从医疗装置系统10中被释放出。
可以用于本文中所公开医疗装置系统10(和/或本文中所公开的其他系统)的各种部件及其各种元件的材料可包括通常与医疗装置相关的材料。为简单起见,以下的论述参考了输送系统和/或医用植入物16。然而,这并非意图限制本文中所描述的装置和方法,因为该论述也可适用于本文中所公开的其他元件、构件、部件、或装置,例如但不限于管状锚固构件70、致动构件84、锁定机构、柱构件72、搭扣构件76、和/或它们的元件或部件。
在一些实施方式中,输送系统和/或医用植入物16、和/或其部件(例如但不限于管状锚固构件70、锁定机构、致动构件84等)可由金属、金属合金、聚合物(下面公开了其一些例子)、金属-聚合物复合材料、陶瓷、其组合等,或者其他合适的材料制成。合适的金属和金属合金的一些例子包括不锈钢,如444V、444L、和314LV不锈钢;低碳钢;镍-钛合金(如线性弹性和/或超弹性镍钛合金);其他镍合金,如镍-铬-钼合金(例如,UNS:N06625如
Figure BDA0001941749890000211
625,UNS:N06022如
Figure BDA0001941749890000212
UNS:N10276如
Figure BDA0001941749890000213
Figure BDA0001941749890000214
其他
Figure BDA0001941749890000215
合金等)、镍-铜合金(例如,UNS:N04400如
Figure BDA0001941749890000216
400、镍
Figure BDA0001941749890000217
400、
Figure BDA0001941749890000218
400等)、镍-钴-铬-钼合金(例如,UNS:R44035如
Figure BDA0001941749890000219
等)、镍-钼合金(例如UNS:N10665如
Figure BDA00019417498900002110
合金
Figure BDA00019417498900002111
)、其他镍-铬合金、其他镍-钼合金、其他镍-钴合金、其他镍-铁合金、其他镍-铜合金、其他镍-钨或钨合金等;钴-铬合金;钴-铬-钼合金(例如,UNS:R44003如
Figure BDA00019417498900002112
等);富含铂的不锈钢;钛;它们的组合等;或者任何的其他合适材料。
如本文中所提到的,在市售镍-钛或镍钛合金的一类合金中是被命名为“线性弹性”或“非超弹性”的类型,该类型尽管在化学性质上可类似于常规的形状记忆和超弹性变体,但可表现出独特和有用的机械性能。线性弹性和/或非超弹性镍钛合金与超弹性镍钛合金的不同制成在于:线性弹性和/或非超弹性镍钛合金在其应力/应变曲线中不显示如超弹性镍钛合金那样明显的“超弹性稳定状态”或“标志区”。相反,在线性弹性和/或非超弹性镍钛合金中,随着可恢复应变增加,应力继续以大体上线性或者某种程度但未必是完全线性关系而增大,直到塑性形变开始或者至少以与在超弹性镍钛合金中可看见的超弹性稳定状态和/或标志区相比更加线性的关系。因此,为了本公开的目的,线性弹性和/或非超弹性镍钛合金也可被称为“大体上”线性弹性和/或非超弹性的镍钛合金。
在一些情况下,线性弹性和/或非超弹性镍钛合金也可与超弹性镍钛合金加以区分,亦即线性弹性和/或非超弹性镍钛合金可接受高大约2-5%的应变同时剩余的是大体上弹性的(例如,在发生塑性形变之前)而超弹性镍钛合金在发生塑性形变之前可接受高达大约8%的应变。可将这两种材料与在发生塑性形变之前仅可接受大约0.2至0.44%应变的其他线性弹性材料如不锈钢加以区分(也可以基于其组成而区分)。
在一些实施方式中,线性弹性和/或非超弹性镍-钛合金是不显示可利用在大温度范围内的差示扫描量热法(DSC)和动态金属热分析(DMTA)分析而检测的任何马氏体/奥氏体相变的合金。例如,在一些实施方式中,在线性弹性和/或非超弹性镍-钛合金中,可不存在可利用在大约-60摄氏度(℃)至大约120℃范围内的DSC和DMTA分析而检测到的马氏体/奥氏体相变。因此,这种材料的机械弯曲性能在此非常宽的温度范围内对温度的影响通常是惰性的。
在一些实施方式中,在环境温度或室温下的线性弹性和/或非超弹性镍-钛合金的机械弯曲性能与在体温下的机械性能是大体上相同的,例如它们不显示超弹性稳定状态和/或标志区。换句话说,在宽的温度范围内,线性弹性和/或非超弹性镍-钛合金维持其线性弹性和/或非超弹性特性和/或性能。
在一些实施方式中,线性弹性和/或非超弹性镍-钛合金可含有在大约50至大约60重量%范围内的镍,并且剩余的大体上是钛。在一些实施方式中,组成是在大约54至大约57重量%范围内的镍。合适的镍-钛合金的一个例子是从日本神奈川县古河技术材料公司购得的FHP-NT合金。其他合适的材料可包括ULTANIUMTM(从Neo-Metrics购得)和GUM METALTM(从丰田公司购得)。在一些其他实施方式中,超弹性合金(例如超弹性镍钛合金)可以用于获得所期望的性能。
至少在一些实施方式中,部分的或全部的输送系统和/或医用植入物16和/或其部件,也可用不透射线材料进行掺杂、制成、或包含。不透射线材料应被理解成是在医疗过程期间能够在荧光屏上或另一种成像技术而产生相对较明亮图像的材料。此相对较明亮的图像有助于使用者判定输送系统和/或医用植入物16的位置。不透射线材料的一些例子可以包括但不限于:金、铂、钯、钽、钨合金、用不透射线填料加载的聚合物材料,等。此外,也可将其他不透射线的标记带和/或线圈结合入输送系统和/或医用植入物16的设计中以实现相同的结果。
在一些实施方式中,将一定程度的磁共振成像(MRI)相容性给予医用植入物16。例如,输送系统和/或医用植入物16和/或其各部件或各部分可由不显著地使图像失真并产生明显的伪像(例如,图像中的间隙)的材料所制成。例如,某些铁磁材料会是不合适的,因为它们可产生在MRI图像中的伪像。输送系统和/或医用植入物16或其各部分也可由MRI机器可以成像的材料所制成。表现出这些特性的一些材料包括例如:钨、钴-铬-钼合金(例如,UNS:R44003如
Figure BDA0001941749890000231
等)、镍-钴-铬-钼合金(例如,UNS:R44035如
Figure BDA0001941749890000232
等)、镍钛合金等、及其他。
在一些实施方式中,可将护套或覆盖物(未图示)设置在部分或全部的输送系统和/或医用植入物16的上方。护套可由聚合物或其他合适的材料制成。合适聚合物的一些例子可包括:聚四氟乙烯(PTFE)、乙烯四氟乙烯共聚物(ETFE)、氟化乙烯丙烯共聚物(FEP)、聚甲醛(POM,例如从DuPont公司购得的
Figure BDA0001941749890000233
)、聚醚嵌段酯、聚氨酯(例如,聚氨酯85A)、聚丙烯(PP)、聚氯乙烯(PVC)、聚醚酯(例如,从DSM工程塑料公司购得的
Figure BDA0001941749890000234
)、基于醚或酯的共聚物(例如,丁烯/聚邻苯二甲酸(亚烷基醚)共聚物和/或其他聚酯弹性体如从DuPont公司购得的
Figure BDA0001941749890000235
)、聚酰胺(例如,从Bayer公司购得的
Figure BDA0001941749890000236
或从Elf Atochem公司购得的
Figure BDA0001941749890000237
)、弹性聚酰胺类、嵌段聚酰胺/聚醚类、聚醚嵌段酰胺(PEBA,例如以商品名
Figure BDA0001941749890000238
购得)、乙烯-醋酸乙烯共聚物(EVA)、有机硅、聚乙烯(PE)、Marlex高密度聚乙烯、Marlex低密度聚乙烯、线性低密度聚乙烯(例如
Figure BDA0001941749890000239
)、聚酯、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丙二醇酯、聚萘二甲酸乙二醇酯(PEN)、聚醚醚酮(PEEK)、聚酰亚胺(PI)、聚醚酰亚胺(PEI)、聚苯硫醚(PPS)、聚苯醚(PPO)、聚对苯二甲酸对苯酯(例如,
Figure BDA00019417498900002310
)、聚砜、尼龙、尼龙-12(如从EMS American Grilon公司购得的
Figure BDA00019417498900002311
)、全氟丙基乙烯基醚(PFA)、乙烯-乙烯醇共聚物、聚烯烃、聚苯乙烯、环氧树脂、聚偏氯乙烯(PVdC)、(苯乙烯-b-异丁烯-b-苯乙烯)三嵌段共聚物(例如,SIBS和/或SIBS 50A)、聚碳酸酯类、离子交联聚合物、生物相容性聚合物、其他合适的材料、或它们的混合物、组合、共聚物、聚合物/金属复合材料,等。在一些实施方式中,可将护套与液晶聚合物(LCP)混合。例如,该混合物可以含有多大约6%的LCP。
应当理解的是,本公开在许多方面只是说明性的。在不超出本发明范围的前提下可在细节中作出变更,尤其是在形状、尺寸、和步骤的安排中。在适当的程度上,这可包括,将一个示范性实施方式的任何特征使用于其他实施方式中。当然,本发明的范围被限定于其中表达所附权利要求的用语中。

Claims (20)

1.一种医疗装置手柄,用于经由从所述医疗装置手柄向远侧延伸的管状构件经皮输送医用植入物,包括:
手柄壳体,具有从所述手柄壳体的近端延伸至所述手柄壳体的远端的纵向轴线,且包括设置在所述手柄壳体内部的空腔;和
运载组件,设置在所述空腔内部并且可操作地连接到所述管状构件和所述医用植入物,通过控制旋钮相对于所述手柄壳体的旋转,所述运载组件可在远侧位置与近侧位置之间纵向地移动,所述控制旋钮被设置成围绕所述手柄壳体的近端;
其中所述运载组件包括运载构件、第一滑动构件、第二滑动构件、和构造成相对于所述运载构件可分离地固定所述第一滑动构件和所述第二滑动构件的锁定元件;
其中所述锁定元件可相对于所述手柄壳体旋转。
2.根据权利要求1所述的医疗装置手柄,还包括围绕所述手柄壳体的近端部设置的管状套圈构件,所述管状套圈构件可围绕所述手柄壳体而旋转。
3.根据权利要求2所述的医疗装置手柄,其中所述锁定元件与所述运载构件物理地接合。
4.根据权利要求3所述的医疗装置手柄,其中使所述管状套圈构件围绕所述纵向轴线旋转使得所述锁定元件从与所述运载构件的接合中旋转出。
5.根据权利要求4所述的医疗装置手柄,其中在使所述锁定元件从与所述运载构件的接合中旋转出之后,所述第一滑动构件可相对于所述第二滑动构件纵向地移动。
6.根据权利要求5所述的医疗装置手柄,其中所述第一滑动构件可相对于所述第二滑动构件从第一位置向近侧移动至第二位置。
7.根据权利要求6所述的医疗装置手柄,其中在所述第二位置,所述第一滑动构件紧靠所述第二滑动构件的一部分。
8.根据权利要求6所述的医疗装置手柄,其中在使所述锁定元件从与所述运载构件的接合中旋转出之后,所述管状套圈构件的进一步旋转使所述第一滑动构件相对于所述第二滑动构件向近侧移动。
9.根据权利要求8所述的医疗装置手柄,其中在所述第一滑动构件处在所述第二位置之后,所述管状套圈构件的进一步旋转使所述第二滑动构件相对于所述运载构件向近侧移动。
10.根据权利要求9所述的医疗装置手柄,其中在所述第一滑动构件在所述第二位置之后,所述管状套圈构件的进一步旋转使所述第一滑动构件和所述第二滑动构件两者相对于所述运载构件向近侧移动。
11.根据权利要求1所述的医疗装置手柄,其中所述第二滑动构件包括从其向远侧延伸至所述医用植入物的至少一个致动构件,其中所述运载组件从所述远侧位置朝向所述近侧位置的移动将所述至少一个致动构件置于张紧状态。
12.根据权利要求11所述的医疗装置手柄,其中在从所述运载构件中释放出所述第一滑动构件和所述第二滑动构件之后,释放所述至少一个致动构件上的张紧状态,直到所述第一滑动构件与所述第二滑动构件在形成于所述第二滑动构件中的槽的近端处重新接合。
13.一种医疗装置手柄,用于经由从所述医疗装置手柄向远侧延伸的管状构件经皮输送医用植入物,包括:
具有从所述手柄壳体的近端延伸至所述手柄壳体的远端的纵向轴线的手柄壳体,所述手柄壳体包括设置在所述手柄壳体内部的空腔;
设置在所述空腔的内部且可操作地连接到所述管状构件和所述医用植入物的运载组件,通过控制旋钮相对于所述手柄壳体的旋转,所述运载组件可在远侧位置与近侧位置之间纵向地移动,所述控制旋钮围绕着所述手柄壳体的近端设置;
其中所述运载组件包括运载构件、第一滑动构件、第二滑动构件、及构造成相对于所述运载构件可分离地固定所述第一滑动构件和所述第二滑动构件的锁定元件,所述锁定元件可相对于所述手柄壳体而旋转;和
设置成围绕所述手柄壳体的近端部的管状套圈构件,所述管状套圈构件可围绕所述手柄壳体而旋转;
其中所述手柄壳体包括按钮机构,该按钮机构构造成当所述第一滑动构件和所述第二滑动构件被所述锁定元件固定到所述运载构件时,与处在所述管状套圈构件相对于所述手柄壳体的第一方位的所述管状套圈构件相接合,并且所述按钮机构构造成当所述第一滑动构件和所述第二滑动构件不被所述锁定元件固定到所述运载构件时,与处在所述管状套圈构件相对于所述手柄壳体的第二方位的所述管状套圈构件相接合。
14.根据权利要求13所述的医疗装置手柄,其中所述按钮机构的至少一部分从所述手柄壳体径向地向外延伸。
15.根据权利要求13所述的医疗装置手柄,其中当所述按钮机构与处在所述管状套圈构件的第一方位的所述管状套圈构件相接合时,防止所述管状套圈构件围绕所述手柄壳体旋转。
16.根据权利要求13所述的医疗装置手柄,其中当所述按钮机构与处在所述管状套圈构件的第二方位的所述管状套圈构件相接合时,防止所述管状套圈构件围绕所述手柄壳体旋转。
17.一种医疗装置系统,包括:
包括设置在其中的可纵向移动的运载组件的手柄壳体,所述运载组件包括运载构件、第一滑动构件、第二滑动构件、及相对于所述运载构件可分离地固定所述第一滑动构件和所述第二滑动构件的锁定元件,所述锁定元件可相对于所述手柄壳体而旋转;
从所述手柄壳体向远侧延伸的管状构件;
可从所述管状构件的远端进行布置的置换心脏瓣膜;
从所述运载组件经过所述管状构件向远侧延伸至所述置换心脏瓣膜的至少一个致动构件,所述至少一个致动构件可分离地附接到所述置换心脏瓣膜;和
设置成围绕所述手柄壳体并且可相对于所述手柄壳体而旋转的管状套圈构件,所述管状套圈构件构造成当围绕所述手柄壳体旋转时从所述运载构件中释放所述第一滑动构件和所述第二滑动构件。
18.根据权利要求17所述的医疗装置系统,其中所述管状套圈构件围绕所述手柄壳体的部分旋转使所述第一滑动构件相对于所述第二滑动构件向近侧平移,直到所述第一滑动构件紧靠所述第二滑动构件的一部分,由此将所述至少一个致动构件与所述置换心脏瓣膜不可逆地分开。
19.根据权利要求18所述的医疗装置系统,其中在所述第一滑动构件紧靠所述第二滑动构件的一部分之后,所述管状套圈构件围绕所述手柄壳体的部分旋转使所述第二滑动构件相对于所述运载构件向近侧平移。
20.根据权利要求19所述的医疗装置系统,其中所述第二滑动构件相对于所述运载构件向近侧的平移将所述至少一个致动构件从所述置换心脏瓣膜向近侧收回。
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