CN112399836A - 置换心脏瓣膜连合组件 - Google Patents
置换心脏瓣膜连合组件 Download PDFInfo
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- CN112399836A CN112399836A CN201980047309.7A CN201980047309A CN112399836A CN 112399836 A CN112399836 A CN 112399836A CN 201980047309 A CN201980047309 A CN 201980047309A CN 112399836 A CN112399836 A CN 112399836A
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- Prior art keywords
- heart valve
- locking portion
- replacement heart
- fabric
- locking
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Abstract
置换心脏瓣膜连合组件可包括:锁定机构,其包括第一锁定部,其在输送构型中与第二锁定部隔开,且构造成在展开构型中与第二锁定部接合,该第一锁定部纵向地可相对于第二锁定部在输送构型与展开构型之间切换;并且第一瓣叶和第二瓣叶紧固到第一锁定部。第一瓣叶的第一衬套部可固定地附接到包绕在第一锁定部的第一腿周围的第一织物衬套。第二瓣叶的第二衬套部可固定地附接到包绕在第一锁定部的第二腿周围的第二织物衬套。第一织物衬套可包括第一端部和第二端部,并且弹性中心部构造成与第一腿接合。
Description
相关申请的交叉引用
本申请要求于2018年5月15日提交的美国临时专利申请序列号62/671,520的优先权,该临时专利申请的全部内容以参考的方式并入本文中。
技术领域
本公开是关于医疗器械以及用于制造和/或使用医疗器械的方法。更具体地,本公开是关于用于置换心脏瓣膜植入物的连合组件。
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器械。部分的这些器械包括导丝、导管、医疗器械输送系统(例如,用于支架、移植物、置换瓣膜等),等。这些器械是通过多种不同制造方法中的任一种方法而制造并且可根据多种方法中的任一种方法而使用。就已知的医疗器械及方法而言,各自具有某些优点和缺点。对于提供替代的医疗器械以及用于制造和使用医疗器械的替代方法存在着持续的需求。
发明内容
在第一方面,置换心脏瓣膜连合组件可包括:锁定机构,该锁定机构包括处于输送构型中时与第二锁定部间隔开的第一锁定部,其中该第一锁定部构造成处于展开构型中时与第二锁定部相结合,并且第一锁定部可纵向地相对于第二锁定部在输送构型与展开构型之间进行切换;紧固到第一锁定部的第一瓣叶;和紧固到第一锁定部的第二瓣叶。第一瓣叶的第一衬套部可固定地附接到包围在第一锁定部的第一腿周围的第一织物衬套,并且第二瓣叶的第二衬套部可固定地附接到包围在第一锁定部的第二腿周围的第二织物衬套。第一织物衬套可包括第一端部、第二端部及弹性中心部,构造成与第一腿接合,第一端部、第二部和弹性中心部的每个部具有长度和厚度。
另外或者可替代地,并且在第二方面,第一织物衬套构造成在松弛状态与当第一织物衬套处于拉紧状态时的拉长状态之间转换。
另外或者可替代地,并且在第三方面,第一织物衬套的弹性中心部构造成当拉力被释放时施加压缩力于第一腿上。
另外或者可替代地,并且在第四方面,第一织物衬套的的弹性中心部的长度在拉长状态中比在松弛状态中至少大50%。
另外或者可替代地,并且在第五方面,第一织物衬套的的弹性中心部的厚度在拉长状态中比在松弛状态中至少小50%。
另外或者可替代地,并且在第六方面,第一织物衬套的第一端部的长度在松弛状态与拉长状态之间变化小于10%。
另外或者可替代地,并且在第七方面,第一织物衬套的第二端部的长度在松弛状态与拉长状态之间变化小于10%。
另外或者可替代地,并且在第八方面,第一锁定部的第一腿和第一锁定部的第二腿限定延伸经过第一锁定部的纵向取向组织槽。第一瓣叶的第一衬套部和第二瓣叶的第二衬套部两者可穿过第一锁定部的纵向取向组织槽。
另外或者可替代地,并且在第九方面,纵向取向组织槽的宽度大于第一瓣叶的第一衬套部、第二瓣叶的第二衬套部、处于拉长状态的第一织物衬套的弹性中心部、和处于拉长状态的第二织物衬套的的弹性中心部的总厚度。
另外或者可替代地,并且在第十方面,第一瓣叶的第一衬套部利用大致地平行于第一锁定部的第一腿而取向的第一长丝的一次或多次缝合(一个或多个针脚)而固定地附接到第一织物衬套。
另外或者可替代地,并且在第十一方面,第二瓣叶的第二衬套部利用大致地平行于第一锁定部的第二腿而取向的第二长丝的一次或多次缝合而固定地附接到第二织物衬套。
另外或者可替代地,并且在第十二方面,置换心脏瓣膜植入物可包括:可在输送构型与展开构型之间切换的可扩张锚固构件;及置换心脏瓣膜连合组件,该组件包括:包括与处于输送构型中的第二锁定部间隔开的第一锁定部的锁定机构,其中第一锁定部构造成处于展开构型时与第二锁定部相结合,并且第一锁定部可纵向地相对于第二锁定部在输送构型与展开构型之间进行切换;紧固到第一锁定部的第一瓣叶;和紧固到第一锁定部的第二瓣叶。第一瓣叶的第一衬套部可固定地附接到包围在第一锁定部的第一腿周围的第一织物衬套,并且第二瓣叶的第二衬套部可固定地附接到包围在第一锁定部的第二腿周围的第二织物衬套。第一织物衬套可包括第一端部、第二端部、和弹性中心部,构造成与第一腿接合,第一端部、第二端部、和弹性中心部的每个部具有长度和厚度。该锁定机构可构造成将可扩张锚固构件锁定于展开构型。
另外或者可替代地,并且在第十三方面,置换心脏瓣膜植入物可进一步包括聚合物密封构件,该密封构件设置在可扩张锚固构件的外表面上并且附接到可扩张锚固构件的远端。
另外或者可替代地,并且在第十四方面,第一织物衬套和第二织物衬套各自是由编织材料构成。
另外或者可替代地,并且在第十五方面,将第一织物衬套和第二织物衬套的每个织物衬套的至少弹性中心部用聚氨酯进行浸渍。
另外或者可替代地,并且在第十六方面,对使用于置换心脏瓣膜植入物的置换心脏瓣膜连合组件进行组装的方法可包括:将第一瓣叶的第一衬套部和第二瓣叶的第二衬套部经过锁定机构的第一锁定部的纵向取向组织槽而插入;将第一织物衬套在拉力作用下在拉长状态中在第一瓣叶的第一衬套部与第一锁定部的第一腿之间插入经过纵向取向组织槽,以及将第二织物衬套在拉力作用下在拉长状态中在第二瓣叶的第二衬套部与第一锁定部的第二腿之间插入经过纵向取向组织槽;其中在处于拉长状态的第一织物衬套的弹性中心部的厚度与处于松弛状态的第一织物衬套的的弹性中心部的厚度相比较小,并且处于拉长状态的第二织物衬套的弹性中心部的厚度与处于松弛状态的第二织物衬套的弹性中心部的厚度相比减小;并且释放作用于第一织物衬套和第二织物衬套的拉力使得第一织物衬套和第二织物衬套的每个织物衬套的弹性中心部朝向松弛状态转换并且厚度的增加将第一瓣叶的第一衬套部和第二瓣叶的第二衬套部以压缩状态置于第一锁定部的第一腿与第一锁定部的第二腿之间。
另外或者可替代地,并且在第十七方面,所述方法可进一步包括:将第一织物衬套包裹在第一锁定部的第一腿周围使得第一织物衬套在与第一瓣叶的第一衬套部相邻的位置自身重叠以形成第一重叠部,并将第二织物衬套包裹在第一锁定部的第二腿周围使得第二织物衬套在与第二瓣叶的第二衬套部相邻的位置自身重叠以形成第二重叠部;以及将第一织物衬套的第一重叠部固定地附接到第一瓣叶的第一衬套部,并将第二织物衬套的第二重叠部固定地附接到第二瓣叶的第二衬套部。
另外或者可替代地,并且在第十八方面,所述方法还可包括在地附接之前:将第一织物衬套的第一重叠部夹紧到第一瓣叶的第一衬套部,并将第二织物衬套的第二重叠部夹紧到第二瓣叶的第二衬套部。
另外或者可替代地,并且在第十九方面,第一织物衬套包括设置在弹性中心部的相反侧上的第一端部和第二端部,当处于拉紧状态中时第一端部和第二端部的各端部的厚度变化小于10%。
另外或者可替代地,并且在第二十方面,第一织物衬套包括设置在弹性中心部的相反侧上的第一端部和第二端部,当处于拉紧状态中时第一端部和第二端部的各端部的长度变化小于10%。
以上对一些实施方案、方面和/或实例的概述并非意图描述本公开的各实施方案或每个实施例。接下来的附图和详细描述更具体地举例说明了这些实施方案。
附图说明
基于以下对各种实施方案的详细描述并结合附图可更全面地理解本公开,在附图中:
图1示出了一个示范性医疗器械系统;
图2是处于展开构型中的示范性置换心脏瓣膜植入物的透视图;
图3示出了一个示范性柱构件;
图4示出了一个示范性锁扣构件;
图5示出了与处于输送构型中的示范性医疗器械系统相联的示范性置换心脏瓣膜植入物的所选部件;
图6示出了与处于释放构型中的示范性医疗器械系统相联的示范性置换心脏瓣膜植入物的所选部件;
图7示出了一个示范性瓣叶;
图8是图示说明置换心脏瓣膜连合组件的所选部件的前透视图;
图8A是沿直线8A-8A所截取的图8的所选部件的剖视图。
图9是图示说明图8的置换心脏瓣膜连合组件的所选部件的后透视图;
图10是处于松弛状态的一个示范性织物衬套的俯视图;
图11是处于拉长状态的图10中的示范性织物衬套的俯视图;
图12至图17示出了对图8的置换心脏瓣膜连合组件的所选部件进行组装的方法的各方面;
图18是图2的示范性置换心脏瓣膜植入物的所选部件的俯视图。
虽然本公开的各方面可具有各种修改及替代形式,但已通过附图中的举例揭示了其细节并且将详细地进行描述。然而,应当理解的是意图并非将本公开的各方面局限于所描述的具体实施方案。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
以下的描述应当参照未必按比例绘制的附图进行阅读,其中在全部若干视图中附图中类似的附图标记表示类似的元件。详细描述和附图是用来说明但不限制申请专利保护的本发明。本领域技术人员将认识到,在不脱离本公开的范围的前提下,所描述和/或示出的各种元件可以以各种组合和构型而布置。详细描述和附图说明了申请专利保护的本发明的示范性实施方案。
就以下所定义的术语而言,应采用这些定义,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。
本文中所有数值假设被术语“约”所修饰,无论是否明确地指出。术语“约”在数值的语境中通常是指本领域技术人员将会认为等同于所陈述值(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“约”可包括被四舍五入为最近有效数字的数字。除非另有说明,术语“约”(例如,在除数值以外的语境中)的其他使用可假设具有它们的普通且通常的定义,正如基于本说明书的上下文并与之一致所理解的。
利用端点对数值范围的陈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)。
尽管公开了从属于各种部件、特征和/或规格的一些合适的尺寸、范围和/或值,但本领域技术人员在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。
如本说明书和所附权利要求中所使用的单数形式“一个”、“一种”和“该”包括复数所指对象,除非上下文明确地指出。如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”的其含义而应用,除非上下文明确地指出。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公开的实施方案中反复出现。各情况下的这些特征可包括单数的公开内容并且/或者被单数的公内容开所包括,除非明确地陈述相反的情况。为了简单和清楚的目的,所公开发明的所有元件未必在各附图中示出或者在下面详细地进行论述。然而,应当理解的是,以下的论述可同样地适用于多于一个的部件中的任何和/或全部部件,除非明确地陈述相反的情况。此外,为了清楚起见,在各附图中可不示出一些元件或特征的所有情况。
相对性术语诸如“近侧的”、“远侧的”、“行进”、“收回”、它们的变体等通常可关于各种元件相对于该器械的使用者/操作者/操纵者的定位、方向和/或操作而考虑,其中“近侧的”和“收回”表示或是指更靠近或朝向使用者并且“远侧的”和“行进”表示或是指更远离或背离使用者。在一些情况下,为了便于对本公开的理解,术语“近侧的”和“远侧的”可任意地指定,并且本领域技术人员将容易地理解这种情况。其他相对性术语,诸如“上游”、“下游”、“流入”和“流出”是指在管腔(诸如体腔、血管)内部或者在器械内部的流体流动方向。进一步的其他相对性术语,诸如“轴向的”、“周向的”、“纵向的”、“侧向的”、“径向的”等和/或它们的变体通常是指相对于所公开结构或装置的中心纵向轴线的方向和/或方位。
术语“范围”和/或“最大范围”可被理解为表示所陈述或所标示尺寸的最大测量,而术语“最小范围”可被理解为表示所陈述或所标示尺寸的最小测量。例如,“外范围”可被理解为表示最大外尺寸,“径向范围”可被理解为表示最大径向尺寸,“纵向范围”可被理解为表示最大纵向尺寸等。“范围”的各情况可以是不同的(例如,轴向的、纵向的、侧向的、径向的、周向的等)并且基于单独使用的上下文对于本领域技术人员而言将是显而易见的。通常,“范围”或“最大范围”可被认为是根据预期用途所测量的最大可能尺寸。可替代地,“最小范围”可被认为是根据预期用途进行测量的最小可能尺寸。在某些情况下,“范围”通常可在一个平面和/或截面内直角地进行测量,但正如基于具体上下文显而易见的可以以不同方式进行测量,例如但不限于:有角度地、径向地、周向地(例如,沿弧形)等。
应注意的是,在本说明书中对“一个实施方案”、“一些实施方案”、“其他实施方案”等的引述表示所描述的实施方案可包括特定的特征、结构或特性,但每个实施方案未必包括该特定的特征、结构或特性。此外,这种短语未必指代相同的实施方案。另外,当结合一个实施方案对一个特定的特征、结构、或特性进行描述时,结合其他实施方案来实现该特定的特征、结构或特性将会是在本领域技术人员的知识范围内,无论是否明确地描述,除非明确地陈述相反的情况。也就是说,下面描述的各种单独元件,即使未以特定的组合明确地中示出,但被设想为可彼此组合或排列,以形成其他另外的实施方案或者补充和/或充实所描述的实施方案,正如本领域技术人员将会理解的。
为了清楚的目的,某些识别的数字命名(例如,第一、第二、第三、第四等)可在整个描述和/或权利要求中用于命名各种所描述和/或申请专利保护的特征和/或在各种所描述和/或申请专利保护的特征之间进行区别。应当理解的是,该数字命名并非意图是限制性的而只是示例性的。在一些实施方案中,为了简洁明了,可作出前面所使用数字命名的变更和偏差。也就是说,被标示为“第一”元件的特征可随后被称为“第二”元件、“第三”元件等或者可完全地省略,并且/或者可将不同的特征称为“第一”元件。在各情况下的含义和/或命名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/或病况在全世界是流行的。传统地,心血管系统的治疗常常是通过直接地接近该系统的受影响部分而进行。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搭桥术进行治疗。正如可以容易地理解的,这种疗法是对于患者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,已开发出创伤性较小的疗法,例如,其中堵塞的冠状动脉可以经由经皮导管而接近并治疗(例如,血管成形术)。这种疗法已在患者和临床医生中得到广泛的接受。
一些相对常见的病况可包括或者是心脏内部的一个或多个瓣膜内部的低效率、无效、或完全衰竭的结果。例如,主动脉瓣或二尖瓣的衰竭会对人产生严重影响并且如果不适当地处理则可能导致严重的健康状况和/或死亡。对有缺陷心脏瓣膜的治疗造成其他问题,因为该治疗常常需要对有缺陷瓣膜进行修复或完全置换。这种疗法对于患者而言会是高度创伤性的。本文中所公开的是医疗器械可用于将医疗器械输送至一部分的心血管系统从而对该系统进行诊断、治疗和/或修复。至少部分的本文中所公开的医疗器械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)。另外,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小得多。本文中所公开的器械也可提供如下面所描述的其他可取的特征和/或益处。
附图中图示说明了例如图1中示意性示出的医疗器械系统10的所选择部件和/或布置。应当指出的是在任何给定的附图中,为了简单起见,医疗器械系统10的一些特征可以不示出,或者可示意性地示出。其他附图中可更详细地示出关于医疗器械系统10的部分部件的其他细节。医疗器械系统10可用于将多种医疗器械和/或植入物输送和/或布置到解剖结构内的一个或多个位置。至少在一些实施方案中,医疗器械系统10可包括可以用于将置换心脏瓣膜植入物16(例如,置换二尖瓣、置换主动脉瓣等)经皮输送至解剖结构中的感兴趣区域(如天然心脏瓣膜)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,因为医疗器械系统10也可用于其他介入治疗,包括瓣膜修复、瓣膜成形术等,或者其他类似的介入治疗。
图1图示说明了医疗器械系统10包括置换心脏瓣膜植入物16,该植入物构造成设置在感兴趣区域诸如天然心脏瓣膜(例如,二尖瓣、主动脉瓣等)内部,其中可将置换心脏瓣膜植入物16在输送构型中设置在医疗器械系统10的管腔内部以便输送至感兴趣区域,在其中可使置换心脏瓣膜植入物16转换至展开构型。在一些实施方案中,医疗器械系统10可包括外套管12,该外套管具有从外套管12的近侧部和/或近端延伸至外套管12的远端的管腔。可在输送构型中将置换心脏瓣膜植入物16设置在外套管12的管腔内部最接近外套管12的远端的位置。在一些实施方案中,医疗器械系统10可包括手柄18,该手柄设置在最接近和/或在外套管12的近端的位置。
医疗器械系统10可包括内套管或导管14,该内套管或导管设置在外套管12的管腔内部并且/或者可在外套管12的管腔内部相对于外套管12而滑动。在一些实施方案中,可将手柄18设置在最接近内套管或导管14的近端和/或设置在内套管或导管14的近端。在一些实施方案中,内套管或导管14可以是管状结构,该管状结构具有延伸经过其中的一个或多个管腔,内套管或导管14可以是实心轴,或者内套管或导管14可以是它们的组合。在一些实施方案中,医疗器械系统10可包括致动器元件15,该致动器元件将置换心脏瓣膜植入物16可分离地连接到手柄18。例如,致动器元件15可从手柄18延伸至置换心脏瓣膜植入物16,该置换心脏瓣膜植入物16设置在外套管12的管腔的远端。致动器元件15可从内套管或导管14向远侧延伸至置换心脏瓣膜植入物16。在一些实施方案中,致动器元件15可可滑动地设置在内套管或导管14内部并且/或者可可滑动地延伸经过内套管或导管14。
手柄18和/或致动器元件15可构造成操纵外套管12相对于内套管或导管14的位置并且/或者帮助置换心脏瓣膜植入物16的布置。例如,内套管或导管14和/或致动器元件15可用于使置换心脏瓣膜植入物16相对于医疗器械系统10的外套管12而移动。在一些实施方案中,可使内套管或导管14和/或致动器元件15在外套管12的管腔内部向远侧行进从而将置换心脏瓣膜植入物16从外套管12和/或医疗器械系统10的远端推出,以便将置换心脏瓣膜植入物16布置在感兴趣区域(例如,天然心脏瓣膜等)内部。可替代地,可将内套管或导管14和/或致动器元件15保持在相对于置换心脏瓣膜植入物16的固定位置,并且可将外套管12相对于内套管或导管14、致动器元件15、和/或置换心脏瓣膜植入物16向近侧收回,从而将置换心脏瓣膜植入物16布置在感兴趣区域(例如,天然心脏瓣膜等)的内部。下面对用于医疗器械系统10、外套管12、内套管或导管14、致动器元件15、手柄18、和/或它们的部件或元件的合适的但非限制性材料的一些实例进行描述。
在一些实施方案中,医疗器械系统10可包括设置在导丝伸长管远端的鼻锥,其中导丝伸长管可从内套管或导管14和/或外套管12向远侧延伸。在至少一些实施方案中,该鼻锥可被设计成具有无创伤性的形状并且/或者可包括脊部或突出部,该脊部或突出部构造成在置换心脏瓣膜植入物16的输送期间抵接外套管12的远端。
在使用中,可使医疗器械系统10经皮地经过脉管系统行进至感兴趣区域。例如,可使医疗器械系统10经过脉管系统和穿过主动脉弓而行进至有缺陷的心脏瓣膜(例如,主动脉瓣、二尖瓣等)。用医疗器械系统10对有缺陷心脏瓣膜进行治疗的替代方法也是可想到的。在输送期间,可将置换心脏瓣膜植入物16大致地以拉长和低剖面“输送”构型设置在外套管12的管腔内部。一旦被定位,可将外套管12相对于置换心脏瓣膜植入物16而收回以使置换心脏瓣膜植入物16暴露。至少在一些实施方案中,设置在外套管12的管腔内部时并且/或者在收回外套管12之后刚刚暴露时,将置换心脏瓣膜植入物16设置于“外翻”构型或部分外翻构型。在一些实施方案中,置换心脏瓣膜植入物16可在“输送”构型中被外翻。“外翻”构型涉及在输送期间置换心脏瓣膜植入物16的至少一部分瓣叶(下面有论述)在置换心脏瓣膜植入物16的可扩张锚固构件(下面论述)外侧,由此允许置换心脏瓣膜植入物16的较小径向轮廓及外套管12和/或医疗器械系统10的较小总体轮廓的使用。在一些实施方案中,“输送”构型与“外翻”构型可基本上相似并且/或者在本文中可互换地使用。
可利用驱动手柄18和/或致动器元件15置换心脏瓣膜植入物16,从而将置换心脏瓣膜植入物16转换至适于在感兴趣区域或靶位置植入解剖结构内部的径向扩张和较大轮廓“展开”构型。当适当地将置换心脏瓣膜植入物16布置在解剖结构内部时,可以将外套管12和/或医疗器械系统10从脉管系统中取出,从而使置换心脏瓣膜植入物16在“释放”构型中留在原地以便起到例如用于天然心脏瓣膜的合适置换的作用。至少在一些介入治疗中,可将置换心脏瓣膜植入物16布置在天然心脏瓣膜内部(例如,使天然心脏瓣膜留在原处并且不被切除)。可替代地,可将天然心脏瓣膜取出并且可是置换心脏瓣膜植入物16在其原位展开作为置换。
设置在内套管或导管14的第一管腔内部的可以是致动器元件15,该致动器元件可用于在“输送”构型与“展开”构型之间驱动和/或转换(例如,扩张和/或拉长)置换心脏瓣膜植入物16。在一些实施方案中,致动器元件15可包含或包括多个致动器元件15,例如两个致动器元件15、三个致动器元件15、四个致动器元件15、或者其他合适或理想数量的致动器元件15。在一些实施方案中,可将各致动器元件15设置在内套管或导管14的独立管腔内部。仅为了说明的目的,医疗器械系统10和置换心脏瓣膜植入物16被图示具有三个致动器元件15。在这一实例中,可将三个致动器元件15设置在内套管或导管14三个独立管腔(例如,第一管腔、第二管腔和第三管腔)内部,尽管这种构型不是必须的。
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,即使这特征可以是复数的或者在所公开的实施方案中反复出现。各情况的特征可包含并且/或由单数的公开内容所包括,除非明确地指出相反的情况。例如,对“致动器元件”的引述同样地可关系到“至少一个致动器元件”或“多个致动器元件”中超过一个的所有情况和数量。
图2图示说明了被图示处于“展开”构型中的医疗器械系统10和/或置换心脏瓣膜植入物16的一些所选择部件。置换心脏瓣膜植入物16可包括可扩张锚固构件17,该构件可在拉长“输送”构型与径向扩张和/或轴向缩短的“展开”构型之间可逆地切换。在一些实施方案中,可扩张锚固构件17可呈管状并且限定管腔,该管腔从可扩张锚固构件17和/或置换心脏瓣膜植入物16的远端或流入端沿中心纵向轴线同轴地延伸至可扩张锚固构件17和/或置换心脏瓣膜植入物16的近端或流出端。
在一些实施方案中,可扩张锚固构件17可包括可扩张支架结构和/或框架。在一些实施方案中,可扩张锚固构件17可包括由周向地设置并且/或者交织在可扩张锚固构件17和/或置换心脏瓣膜植入物16的管腔周围的一根或多根长丝所组成的自扩张编织和/或机织网结构。非自我扩张、可机械扩张、和/或辅助自扩张的可扩张锚固构件也是可想到的。至少在一些实施方案中,可扩张锚固构件17可形成为整体结构(例如,由单根长丝或股线构成,从单个管状构件中切出等)。在一些实施方案中,可扩张锚固构件17在展开构型中可限定大致地呈圆柱形的外表面。其他构型也是可行的,例如限定大致地椭圆形外表面的剖面。下面对用于置换心脏瓣膜植入物16、可扩张锚固构件17、和/或它们的部件或元件的合适但非限制性材料的一些实例进行了描述。
也如图2中所示,但为了清楚从若干其他附图中省略,置换心脏瓣膜植入物16可包括设置在置换心脏瓣膜植入物16和/或可扩张锚固构件17的管腔内部的多个瓣叶22。在一些实施方案中,多个瓣叶22可在置换心脏瓣膜植入物16和/或可扩张锚固构件17的管腔内部的多个位置附接并且/或者紧固到可扩张锚固构件17。在一些实施方案中,多个瓣叶22可利用缝合线、胶粘剂、或其他合适的手段附接并且/或者到可扩张锚固构件17。
在一些实施方案中,根据需要,多个瓣叶22可包含或包括两个瓣叶、三个瓣叶、四个瓣叶等。例如,多个瓣叶22可包括第一瓣叶24、第二瓣叶30、第三瓣叶36等(例如,图7和图18),并且可统称为多个瓣叶22(例如,图2)。置换心脏瓣膜植入物16的多个瓣叶22可构造成在允许经过置换心脏瓣膜植入物16和/或置换心脏瓣膜植入物16和/或可扩张锚固构件17的管腔的顺行流体流动的开放构型,与防止经过置换心脏瓣膜植入物16和/或置换心脏瓣膜植入物16和/或可扩张锚固构件17的管腔的逆行流体流动的闭合构型之间移动。多个瓣叶22可各自具有自由边,其中多个瓣叶22的自由边在闭合构型中在置换心脏瓣膜植入物16、可扩张锚固构件17、和/或延伸经过置换心脏瓣膜植入物16和/或可扩张锚固构件17管腔的内部接合。下面提供了关于多个瓣叶22的其他细节。
置换心脏瓣膜植入物16可包括设置在置换心脏瓣膜植入物16和/或可扩张锚固构件17的管腔内部的置换心脏瓣膜连合组件。在一些实施方案中,置换心脏瓣膜植入物16可包括多于一个的置换心脏瓣膜连合组件。例如,各相邻的一对瓣叶22可形成并且/或者限定一个置换心脏瓣膜连合组件。因此,置换心脏瓣膜连合组装的数目可与瓣叶22的数目直接相关(例如,三个瓣叶形成并且/或者限定三个置换心脏瓣膜连合组件,两个瓣叶形成并且/或者限定两个置换心脏瓣膜连合组件等)。
在一些实施方案中,置换心脏瓣膜植入物16和/或置换心脏瓣膜连合组件可包括锁定机构48,该锁定机构构造成将可扩张锚固构件17锁定于“展开”构型。在一些实施方案中,置换心脏瓣膜植入物16可包含或包括多个锁定机构48,例如两个锁定机构48、三个锁定机构48等。在一些实施方案中,各置换心脏瓣膜连合组件可对应于并且/或者包括一个相应的锁定机构48。各锁定机构48可包括第一锁定部或柱构件60,其固定到可扩张锚固构件17并且构造成与到可扩张锚固构件17的第二锁定部或锁扣构件50相结合,如下面将更详细地描述。
在一些实施方案中,致动器元件15可构造成与锁定机构48可分离地接合,并且/或者在致动器元件15与锁定机构48接合时在“输送”构型与“展开”构型和/或“释放”构型之间可逆地驱动可扩张锚固构件17和/或置换心脏瓣膜植入物16。在一些实施方案中,一个致动器元件15对应于一个锁定机构48,与一个锁定机构48结合,并且/或者驱动一个锁定机构48。在一些实施方案中,一个致动器元件15可相对于多于一个的锁定机构48、与多于一个的锁定机构48结合,并且/或者驱动多于一个的锁定机构48。其他构型也是可想到的。
在一些实施方案中,致动器元件15可包括近端和远端。在使用中,近端可操作式地连接到手柄18,并且/或者由使用者利用手柄18进行操纵或驱动,从而使置换心脏瓣膜植入物16在“输送”构型与“展开”构型之间可逆地转换。在一些实施方案中,致动器元件15可相对于置换心脏瓣膜植入物16的第一锁定部或柱构件60和/或第二锁定部或锁扣构件50轴向地平移。
在一些实施方案中,致动器元件15(例如,各致动器元件15等)包括细长杆,该细长杆具有平坦远侧部和从致动器元件15纵向地和/或径向地向外延伸的斜面,使得该斜面具有比细长杆更大的外范围。该斜面可位于最接近致动器元件15的平坦远侧部的近端位置并且/或者位于致动器元件15的平坦远侧部的近端。
在一些实施方案中,致动器元件15的平坦远侧部可与第一锁定部或柱构件60对准并且/或者可分离地联接到第一锁定部或柱构件60。在一些实施方案中,平坦远侧部可以可滑动地被接纳于第一锁定部或柱构件60的纵向取向通道内部,如下所述。手柄18可构造成在“输送”和/或“展开”构型中相对于外套管12、置换心脏瓣膜植入物16、相应的锁定机构48(例如,多个锁定机构48等)、和/或第一锁定部或柱构件60驱动和/或转换致动器元件15(例如,各致动器元件15等)。
在一些实施方案中,致动器元件15(各致动器元件15等)的近端可操作式地连接到从手柄18在内套管或导管14内部向远侧延伸的中心轴。该中心轴可利用手柄18和/或设置在手柄18内部的机构进行驱动和/或转换。在一些实施方案中,致动器元件15(各致动器元件15,等)可从手柄18内套管或导管14的内部向远侧延伸。
在一些实施方案中,致动器元件15和/或细长杆的形状可大致地呈圆形、椭圆形、卵圆形、矩形、多边形(即,具有两个边、三个边、四个边、五个边、六个边)和/或它们的组合。其他形状(规则和不规则的)也是可想到的。在一些实施方案中,致动器元件15可由单件的金属丝、圆料、或其他合适材料构成,如本文中所论述。在一些实施方案中,致动器元件15可通过对单件的金属丝、圆料、或其他合适材料进行进一步加工而形成,如通过机械加工、冲压、激光切割等。下面对用于致动器元件15、细长杆、平坦远侧部和/或的斜面一些合适但非限制性的材料(例如金属材料或聚合材料)进行描述。
在一些实施方案中,置换心脏瓣膜植入物16可包括设置在可扩张锚固构件17的外表面的至少一部分上和/或周围的密封构件20(部分地在剖视图中示出)。在一些实施方案中,密封构件20可附接并且/或者固定到可扩张锚固构件17和/或置换心脏瓣膜植入物16的远端或流入端,并且/或者密封构件20可在靠近可扩张锚固构件17和/或置换心脏瓣膜植入物16的远端或流入端的位置附接和/或固定到多个瓣叶22。密封构件20可以是充分地柔软和/或柔韧,以便在展开构型中与天然瓣叶和/或天然心脏瓣膜一致并且/或者围绕天然瓣叶和/或天然心脏瓣膜,由此将置换心脏瓣膜植入物16和/或可扩张锚固构件17的外部密封,并且/或者抵接天然心脏瓣膜和/或天然瓣叶并且防止在置换心脏瓣膜植入物16和/或可扩张锚固构件17周围的泄露。
在一些实施方案中,密封构件20可包括多层的聚合材料。一些合适的聚合材料可包括但不必限于: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、及它们的共聚物、共混物、混合物或组合。其他合适的聚合材料也是可想到的,下面对部分的这些材料进行论述。
销释放组件86可以是将第一锁定部或柱构件60与致动器元件15可分离地联接的连接结构。销释放组件86可包括多个释放销88,这些释放销可通过螺旋连接连接到一起并且保持到销释放芯棒87(例如利用卡套、焊接、或其他附接方法)。
在输送期间,可利用联接件78的多个指状件79并利用多个释放销88将置换心脏瓣膜植入物16和/或可扩张锚固构件17固定在内套管或导管14的远端,该联接件78在第二锁定部或锁扣构件50的近端与突出部联接(并且利用设置在该连接上方的可滑动接箍80而固定就位),各释放销88将致动器元件15与第一锁定部或柱构件60紧固到一起。致动器元件15的平坦远侧部可包括可以与第一锁定部或柱构件60的横向远侧部的孔口68对准的开口或孔口(下面更详细地描述)。当如此地对准时,多个释放销88可以经过延伸经过靠近细长近侧部62和致动器元件15的开口或孔口的第一锁定部或柱构件60的耦合孔而成环。由此将致动器元件15可分离地紧固到第一锁定部或柱构件60,从而限制致动器元件15与第一锁定部或柱构件60之间的相对轴向运动并且形成在置换心脏瓣膜植入物16的输送期间可以采用的这些结构的构型。导向装置82可设置于在可滑动接箍80近侧的多个指状件79的每个指状件上方并且可用来保持联接件78的多个指状件79与它们的各自致动器元件15相联,这些致动器元件延伸至与联接件78的多个指状件79相邻(并且可相对于这些指状件轴向地滑动)。
在使置换心脏瓣膜植入物16和/或可扩张锚固构件17在解剖结构内部移动至感兴趣区域之后,致动器元件15可以用于通过相对于第二锁定部或锁扣构件50和/或可扩张锚固构件17向近侧收回致动器元件15而将置换心脏瓣膜植入物16和/或可扩张锚固构件17驱动至“展开”构型,由此将第一锁定部或柱构件60拉动至与第二锁定部或锁扣构件50接合,如下所述。最后,通过利用手柄18收回销释放芯棒87和/或销释放组件86可以除去多个释放销88,由此使致动器元件15与第一锁定部或柱构件60分开,这允许置换心脏瓣膜植入物16在“释放”构型中从医疗器械系统10中被释放。
在一些实施方案中,第一锁定部或柱构件60和第二锁定部或锁扣构件50可在“输送”构型和/或“展开”构型中沿可扩张锚固构件17的内表面相对于彼此纵向地移动。在一些实施方案中,第一锁定部或柱构件60可沿可扩张锚固构件17的内表面不可分离地紧固到可扩张锚固构件17的远侧部和/或靠近可扩张锚固构件17的远端或上游端。在一些实施方案中,第二锁定部或锁扣构件50可固定紧固到可扩张锚固构件17的近侧部和/或靠近可扩张锚固构件17的近端或下游端并抵接可扩张锚固构件17的内表面。第二锁定部或锁扣构件50可构造成在其中可滑动地接纳至少一部分的第一锁定部或柱构件60。下面提供了关于这些元件的相对运动的其他论述。
图3图示说明了一个示范性第一锁定部或柱构件60。至少在一些实施方案中,第一锁定部或柱构件60可包括细长近侧部62、固定地附接到细长近侧部62并从细长近侧部62向远侧延伸的第一腿64、和固定地附接到细长近侧部62并从细长近侧部62向远侧延伸的第二腿66。第一锁定部或柱构件60可包括横向远侧部,该横向远侧部固定地附接到第一腿64的远端和第二腿66的远端,并且在第一腿64的远端与第二腿66的远端之间侧向地和/或周向地延伸。在一些实施方案中,第一锁定部或柱构件60可形成为单个整体结构,其中细长近侧部62、第一腿64、第二腿66、和横向远侧部彼此整体地成型并且/或者由单件的材料制成。在一些实施方案中,第一锁定部或柱构件60的横向远侧部可包括孔口68,该孔口在径向方向上相对于置换心脏瓣膜植入物16和/或可扩张锚固构件17的中心纵向轴线而延伸经过第一锁定部或柱构件60的横向远侧部。
在一些实施方案中,第一锁定部或柱构件60的细长近侧部62可包括至少部分地延伸通过细长近侧部62的第一锁定部或柱构件60的纵向取向通道61,其中致动器元件15的平坦远侧部构造成可滑动地与第一锁定部或柱构件60的细长近侧部62的纵向取向通道61相接合。在一些实施方案中,纵向取向通道61可完全地延伸通过第一锁定部或柱构件60的细长近侧部62。在一些实施方案中,第一锁定部或柱构件60的纵向取向通道61和/或细长近侧部62的纵向轴线可布置为大致地平行于可扩张锚固构件17和/或置换心脏瓣膜植入物16的中心纵向轴线。
纵向取向通道61可构造成可滑动地接纳致动器元件15的平坦远侧部。纵向取向通道61可包括与致动器元件15的平坦远侧部的外剖面形状或轮廓相对应的内剖面形状或轮廓。在一些实施方案中,致动器元件15的平坦远侧部可以可滑动地设置在纵向取向通道61内部并且/或者可以例如利用释放销88可分离地联接到第一锁定部或柱构件60。在一些实施方案中,当致动器元件15的平坦远侧部与第一锁定部或柱构件60的细长近侧部62的纵向取向通道61接合时,例如在拉长“输送”构型和/或“外翻”构型中,致动器元件15的平坦远侧部的至少一部分可延伸进入纵向取向通道61。
在一些实施方案中,当可扩张锚固构件17处于拉长“输送”构型和/或“外翻”构型时,可将第一锁定部或柱构件60设置在置换心脏瓣膜植入物16和/或可扩张锚固构件17的管腔内部最接近置换心脏瓣膜植入物16和/或可扩张锚固构件17的远端或流入端的位置。在一些实施方案中,当可扩张锚固构件17处于拉长“输送”构型和/或“外翻”构型中时,可将至少一部分的第一锁定部或柱构件60设置在可扩张锚固构件17的远侧。
在一些实施方案中,第一锁定部或柱构件60的第一腿64与第一锁定部或柱构件60的第二腿66可侧向地和/或周向地彼此隔开,以限定在径向方向上相对于置换心脏瓣膜植入物16和/或可扩张锚固构件17的中心纵向轴线而延伸经过第一锁定部或柱构件60的纵向取向组织槽67。在一些实施方案中,一定长度的纵向取向组织槽67可大致地与可扩张锚固构件17和/或置换心脏瓣膜植入物16的中心纵向轴线平行地延伸并且/或者取向。第一锁定部或柱构件60的第一腿64可包括在第一腿64内部靠近纵向取向组织槽67的近端而形成的第一侧向凹槽63。第一侧向凹槽63可形成并且/或者侧向地和/或周向地延伸进入第一腿64的外表面朝向纵向取向的组织槽67。第一锁定部或柱构件60的第二腿66可包括在第二腿66内部最接近纵向取向组织槽67的近端而形成的第二侧向凹槽65。第二侧向凹槽65可形成并且/或者朝向纵向取向组织槽67侧向地和/或周向地延伸进入第二腿66的外表面。至少在一些实施方案中,第一侧向凹槽63和第二侧向凹槽65可面向相反的侧向或周向方向。
在一些实施方案中,第一锁定部或柱构件60的细长近侧部62可包括最接近细长近侧部62近端的横向取向的凹部和/或脊部。如下面将进一步地说明,细长近侧部62的横向取向凹部和/或脊部可构造成与第二锁定部或锁扣构件50的横向取向脊部接合,从而将置换心脏瓣膜植入物16和/或可扩张锚固构件17锁定在“展开”构型中。
在一些实施方案中,第一锁定部或柱构件60的细长近侧部62可包括形成于第一锁定部或柱构件60的细长近侧部62的长度和/或外表面中并且/或者沿第一锁定部或柱构件60的细长近侧部62的长度和/或外表面纵向地延伸的有键的或定向形状。在一些实施方案中,该有键的或定向形状可沿第一锁定部或柱构件60的细长近侧部62的全长而延伸。正如将变得显而易见的,该有键的或定向形状可起相对于第二锁定部或锁扣构件50的对准和/或防旋转特征的作用。例如,该有键的或定向形状可防止当第一锁定部或柱构件60的细长近侧部62与第二锁定部或锁扣构件50接合时第一锁定部或柱构件60与第二锁定部或锁扣构件50之间的相对转动。下面对用于第一锁定部或柱构件60的一些合适但非限制性的材料,例如金属材料或聚合材料进行了描述。
图4图示说明了示范性的第二锁定部或锁扣构件50。该第二锁定部或锁扣构件50可包括基部51,该基部具有在第二锁定部或锁扣构件50的近端与远端之间延伸的纵向轴线。第二锁定部或锁扣构件50可包括附接到基部51并且/或者与基部51整体地形成的主体部52,该主体部52限定延伸经过第二锁定部或锁扣构件50的主体部52的纵向通道56。至少在一些实施方案中,纵向通道56可与基部51的纵向轴线大致地平行地取向。在一些实施方案中,主体部52的至少一部分可在远离基部51顶面的远侧部的方向上延伸。例如,主体部52可从基部51相对于置换心脏瓣膜植入物16和/或可扩张锚固构件17的中心纵向轴线而径向地向内延伸。
在一些实施方案中,第二锁定部或锁扣构件50的主体部52可包括从主体部52向近侧和/或朝向近侧基部51延伸的盖部53。在一些实施方案中,盖部53可包括横向取向脊部54,该脊部朝向基部51延伸并横跨基部51,使得当沿基部51的纵向轴线观看第二锁定部或锁扣构件50时,横向取向脊部54阻塞了至少一部分的纵向通道56。在一些实施方案中,第二锁定部或锁扣构件50的主体部52和/或盖部53可包括在其中形成的至少一个孔或孔口,用于将不透射线标记物附接到第二锁定部或锁扣构件50从而有助于第二锁定部或锁扣构件50的可视化。
盖部53可构造成相对于可扩张锚固构件17和/或置换心脏瓣膜植入物16的中心纵向轴线而径向地偏转。正如基于下面的论述中将变得显而易见的,致动器元件15的斜面可构造成当斜面(并且第一锁定部或柱构件60与其接合)经过第二锁定部或锁扣构件50的主体部52的纵向通道56而纵向地转换时,使第二锁定部或锁扣构件50的盖部53径向地向内偏转。在一些实施方案中,盖部53可朝向与主体部52对准的中间位偏移或自偏移置并且/或者可偏移或自偏移进入纵向通道56和/或朝向第二锁定部或锁扣构件50的基部51偏移或自偏移。
在一些实施方案中,第二锁定部或锁扣构件50可包括在第二锁定部或锁扣构件50的基部51近端的突出部55,该突出部55构造成将置换心脏瓣膜植入物16可分离地附接到医疗器械系统10和/或内套管或导管14。至少在一些实施方案中,纵向通道56可具有构造成可滑动地接纳第一锁定部或柱构件60的有键的、定向的、或非圆形的剖面轮廓或形状。第一锁定部或柱构件60可具有与有键的、定向的、或非圆形的内剖面轮廓或形状的纵向通道56相对应的外剖面轮廓或形状。例如,纵向通道56和/或突出部55可包括与第一锁定部或柱构件60的直边相对应的平坦表面。其他相应的表面和/或轮廓也是可想到的。因此,当第一锁定部或柱构件60的细长近侧部62与第二锁定部或锁扣构件50的纵向通道56接合并且/或者至少部分地设置在第二锁定部或锁扣构件50的纵向通道56内部时并且/或者当第一锁定部或柱构件60的直边与第二锁定部或锁扣构件50的平坦表面对准和/或处于面对接合中时,第一锁定部或柱构件60不相对于第二锁定部或锁扣构件50而旋转。下面对用于第二锁定部或锁扣构件50的一些合适但非限制性的材料(例如金属材料或聚合材料)进行描述。
简略地返回至图2,在一些实施方案中,置换心脏瓣膜植入物16与内套管或导管14之间的附接可通过联接件78的使用而实现。联接件78可大致地包括可附接到内套管或导管14的远端的基部(未图示)。从底部向远侧突出的是多个指状件79(例如,两个指状件、三个指状件、四个指状件等),这些指状物各自构造成在锁定机构48的第二锁定部或锁扣构件50的突出部55处与置换心脏瓣膜植入物16结合。在一些实施方案中,多个指状件79的每个指状件可从所述基部和/或内套管或导管14的远端延伸至置换心脏瓣膜植入物16。在一些实施方案中,各指状件79可包括接箍80,该接箍可滑动地设置在其各自的指状件79和其各自的第二锁定部或锁扣构件50的突出部55的周围。
在输送期间,置换心脏瓣膜植入物16可利用联接件78的指状件79的两个细长齿被固定在联接件78和/或内套管或导管14的远端,该联接件78利用接箍80与第二锁定部或锁扣构件50的突出部55配对地联接,并且利用致动器元件15联接到其相应的第一锁定部或柱构件60,例如利用释放销88。当使置换心脏瓣膜植入物16在解剖结构内部行进至感兴趣区域时,可将外套管12向近侧转换和/或驱动,以使置换心脏瓣膜植入物16暴露。然后,通过将致动器元件15向近侧收回和/或平移从而例如利用手柄18将第一锁定部或柱构件60拉动至与第二锁定部或锁扣构件50接合,可以驱动致动器元件15(例如,向近侧收回)以便轴向地缩短并且/或者从“输送”构型朝向“展开”构型径向地扩张置换心脏瓣膜植入物16和/或可扩张锚固构件17。在证实置换心脏瓣膜植入物16的满意的置入(例如利用适当的成像技术)之后,致动器元件15可各自相对于第一锁定部或柱构件60旋转并且与第一锁定部或柱构件60分离,这允许致动器元件15的远侧部从第二锁定部或锁扣构件50向近侧拉动,其中斜面随后与接箍80接合并由此从两个细长齿中和突出部55中将接箍80收回。一旦接箍80已被收回,则两个细长齿与突出部55分离,并且可将联接件78的指状件79从置换心脏瓣膜植入物16中收回,由此使置换心脏瓣膜植入物16(和/或可扩张锚固构件17)在“释放”构型中留在解剖结构中的感兴趣区域。
图5-图6图示说明了锁定机构48的所选部件,这些所选部件构造成将置换心脏瓣膜植入物16(和/或可扩张锚固构件17)可逆地锁定在“展开”构型和/或“释放”构型、及这些部件的一般操作。为了简单和清楚的目的,仅示出并描述了各致动器元件15、第一锁定部或柱构件60、第二锁定部或锁扣构件50等中的一个(全部置换心脏瓣膜植入物16未被图示以便于对锁定机构48的理解)。然而,应当理解的是,以下的论述同样可适用于在置换心脏瓣膜植入物16内部存在多于一个的任何和/或全部的部件(即,致动器元件15、第二锁定部或锁扣构件50,第一锁定部或柱构件60等)和/或医疗器械系统10,除非明确地陈述相反的情况。
如图5中所见,各致动器元件15经过导向装置82延伸至与联接件78的指状件79相邻并包围该指状件79,经过接箍80、经过第二锁定部或锁扣构件50,而延伸至与第一锁定部或柱构件60接合。例如,与各锁定机构48(例如,多个锁定机构48等)相对应的致动器元件15(例如,多个致动器元件15等)在“输送”构型中纵向地延伸经过其各自的锁定机构48的第二锁定部或锁扣构件50。
致动器元件15可经过并且/或者相对于导向装置82、接箍80和/或第二锁定部或锁扣构件50而轴向地和/或可滑动地平移。致动器元件15可在第一锁定部或柱构件60的纵向取向通道61内部滑动。如上所述,致动器元件15的平坦远侧部可构造成可以可滑动地与第一锁定部或柱构件60的纵向取向通道61接合并且/或者延伸进入第一锁定部或柱构件60的纵向取向通道61中。
释放销88可延伸经过延伸经过第一锁定部或柱构件60最接近细长近侧部62的耦合孔,以及延伸经过致动器元件15的平坦远侧部的开口或孔口从而在“输送”构型中将致动器元件15的平坦远侧部可分离地联接到第一锁定部或柱构件60。正如可以理解的,在“输送”构型中,第一锁定部或柱构件60的近端与第二锁定部或锁扣构件50的远端可纵向地分开和/或隔开(例如,如图5中所见)。至少在一些实施方案中,第一锁定部或柱构件60可在“输送”构型中并且/或者在“输送”构型与“展开”构型之间相对于第二锁定部或锁扣构件5纵向地切换和/或平移。
当置换心脏瓣膜植入物16到达在解剖结构内部的感兴趣区域时,临床医生可以驱动(例如,向近侧收回)致动器元件15,例如利用手柄18,由此使第一锁定部或柱构件60的近端朝向第二锁定部或锁扣构件50的远端移动和/或平移并且进入第二锁定部或锁扣构件50的纵向通道56,从而轴向地缩短并且/或者朝向“展开”构型径向地扩张可扩张锚固构件17和/或置换心脏瓣膜植入物16。最后,可以充分地将致动器元件15达足够远的距离以便当斜面穿过第二锁定部或锁扣构件50的纵向通道56时使致动器元件15平移经过第二锁定部或锁扣构件50的盖部53,由此当使2斜面(及与其接合的第一锁定部或柱构件60)纵向地平移经过第二锁定部或锁扣构件50的主体部52的纵向通道56时允许致动器元件15的斜面使盖部53的第二锁定部或锁扣构件50径向地向内偏转。至少在一些实施方案中,第一锁定部或柱构件60可以相对于第二锁定部或锁扣构件50在“输送”构型与“展开”构型之间纵向地切换和/或平移。
当将第一锁定部或柱构件60的近侧经过和/或相对于第二锁定部或锁扣构件50驱动和/或平移时,最接近细长近侧部62的近端的横向取向凹部和/或脊部与第二锁定部或锁扣构件50的横向取向脊部54接合从而将可扩张锚固构件17和/或置换心脏瓣膜植入物16锁定至“展开”构型。最接近细长近侧部62的近端和第二锁定部或锁扣构件50的横向取向脊部54的横向取向凹部和/或脊部的接合限制或防止在致动器元件15已与锁定机构48和/或第一锁定部或柱构件60分离之后和/或轴向位移的第一锁定部或柱构件60在“展开”构型中相对于第二锁定部或锁扣构件50的远端运动。在将可扩张锚固构件17和/或置换心脏瓣膜植入物16锁定在“展开”构型之后,可利用合适的成像技术来确认置换心脏瓣膜植入物16的定位。
在一些实施方案和/或一些手术中,期望将置换心脏瓣膜植入物16和/或可扩张锚固构件17取出和/或重新定位。这样,临床医生可在第二(例如,远侧)方向上推动和/或平移致动器元件15从而使可扩张锚固构件17向后地朝向“输送”构型而延伸和/或拉长。致动器元件15在第二(例如,远侧)方向上相对于锁定机构48(例如,第一锁定部或柱构件60和/或第二锁定部或锁扣构件50)的轴向位移可以与致动器元件15的斜面与第二锁定部或锁扣构件50的盖部53和/或横向取向脊部54接合可滑动地,由此使第二锁定部或锁扣构件50的盖部53在远离第二锁定部或锁扣构件50和/或致动器元件15的纵向通道56的方向上偏转并且/或者相对于可扩张锚固构件17的中心纵向轴线的径向地向内偏转,并且允许第一锁定部或柱构件60向后穿过第二锁定部或锁扣构件50纵向通道56并且/或者从第二锁定部或锁扣构件50纵向通道56中穿出。
在确认在感兴趣区域的适当定位时,可将释放销88从延伸经过最接近细长近侧部62的第一锁定部或柱构件60的耦合孔中及经过致动器元件15的平坦远侧部的开口或孔口收回。一旦致动器元件15已与第一锁定部或柱构件60分离和/或分开,并且已使斜面在远离锁定机构48及处于“展开”构型中的置换心脏瓣膜植入物16和/或可扩张锚固构件17(例如,第一锁定部或柱构件60和/或第二锁定部或锁扣构件50)的方向上轴向地平移,则致动器元件15的进一步的驱动和/或收回会导致致动器元件15的斜面与接箍80接合并且将接箍80沿指状件79向近侧拉动/滑动同时从第一锁定部或柱构件60中进一步收回致动器元件15。这样,可使指状件79的两个细长齿暴露并且与第二锁定部或锁扣构件50的突出部55分离,如图6中所见。完全地将致动器元件15从第一锁定部或柱构件60的纵向取向通道61中收回释放可扩张锚固构件17和/或置换心脏瓣膜植入物16并在“释放”构型中离开设置在置换心脏瓣膜植入物16的感兴趣区域。
图7图示说明了多个瓣叶22的一个示范性瓣叶的(例如,第一瓣叶24、第二瓣叶30、第三瓣叶36)。在一些实施方案中,第一瓣叶24、第二瓣叶30、和/或第三瓣叶36可各自包括主体部29/35/41(分别地)、第一衬套部(第一袖部)25/31/37(分别地)、相对于主体部29/35/41(分别地)与第一衬套部25/31/37(分别地)相反的第二衬套部26/32/38(分别地),及在第一衬套部25/31/37(分别地)与第二衬套部(第二袖部)26/32/38之间延伸(分别地)的自由边27/33/39(分别地)。自由边27/33/29可在闭合构型中彼此吻合,以防止经过置换心脏瓣膜植入物16的逆向流体流动,并且可在开放构型中相对于中心纵向轴线和/或可扩张锚固构件17径向地向外移动从而允许经过置换心脏瓣膜植入物16顺向流体流动。
第一瓣叶24、第二瓣叶30、和/或第三瓣叶36可各自进一步包括前表面、后表面、和侧边28/34/40(分别地)。在一些实施方案中,前表面可具有不同于后表面的纹理。至少在一些实施方案中,第一瓣叶24的前表面、第二瓣叶30的前表面、和第三瓣叶36的前表面可各自径向地向内面向纵向中心轴线。在一些实施方案中,第一瓣叶24、第二瓣叶30、和/或第三瓣叶36可各自限定沿与第一衬套部25/31/37(分别地)和第二衬套部26/32/38(分别地)相邻的侧边28/34/40(分别地)的凹口。用于多个瓣叶22(例如,第一瓣叶24、第二瓣叶30、第三瓣叶36等)的合适但非限制性材料的一些实例包括牛心包、聚合材料、或其他适当地柔性的生物相容性材料。
图8、图8A和图9图示说明了本公开的置换心脏瓣膜连合组件所选择元件的不同视图。在一些实施方案中,置换心脏瓣膜连合组件包括紧固到第一锁定部或柱构件60的第一瓣叶24、和紧固到第一锁定部或柱构件60的第二瓣叶30。如上,本文中的描述是利用这些示例性特征而撰写,但对于该特征或类似特征的其他/另外情况而言,必要时可改变数字标记(例如,第一、第二等),正如对于本领域技术人员而言将是显而易见的。
在一些实施方案中,第一瓣叶24的第一衬套部25和第二瓣叶30的第二衬套部32两者穿过纵向取向组织槽67,该槽在第一锁定部或柱构件60的第一腿64与第一锁定部或柱构件60的第二腿66之间延伸通过第一锁定部或柱构件60。为了更加清楚,未示出第一瓣叶24和第二瓣叶30的一些部分(例如,主体部29/35/41、侧边28/34/40等)。第一瓣叶24的第一衬套部25可固定地附接到第一织物衬套70,该第一织物衬套利用第一长丝90包围第一锁定部或柱构件60的第一腿64。第二瓣叶30的第二衬套部32可固定地附接到第二织物衬套72,该第二织物衬套利用第二长丝94包围第一锁定部或柱构件60的第二腿66。
为了清楚而仅在图8A中示出,第一织物衬套70可包括第一端部701、第二端部703、和弹性中心部702。第一织物衬套70的第一端部701和第一织物衬套70的第二端部703可设置在第一织物衬套70的弹性中心部702的相反侧上。类似地,第二织物衬套72可包括第一端部721、第二端部723、和弹性中心部722。第二织物衬套72的第一端部721和第二织物衬套72的第二端部723可设置在第二织物衬套72的弹性中心部722的相反侧上。下面根据图10和图11论述了与它们相关的其他细节。
第一织物衬套70可包围第一锁定部或柱构件60的第一腿64,使得第一织物衬套70自身重叠于与第一瓣叶24的第一衬套部25相邻位置以形成第一织物衬套70的第一重叠部71。第二织物衬套72可包围第一锁定部或柱构件60的第二腿66,使得第二织物衬套72自身于与第二瓣叶30的第二衬套部32相邻的位置重叠以形成第二织物衬套72的第二重叠部73。
在一些实施方案中,第一瓣叶24的第一衬套部25可利用以大致地平行于第一锁定部或柱构件60的第一腿64的方式而取向的第一长丝90的一次或多次缝合(一个或多个针脚)而固定地附接到第一织物衬套70。在一些实施方案中,第二瓣叶30的第二衬套部32可利用以大致地平行于第一锁定部或柱构件60的第二腿66的方式而取向的第二长丝94的一次或多次缝合而固定地附接到第二织物衬套72。其他构型(包括长丝的数目和/或长丝的方位)也是可想到的。此外,用于将第一衬套部25固定地附接到第一织物衬套70和/或将第二衬套部32固定地附接到第二织物衬套72的其他连接方法(例如,钉合、铆接、胶粘剂等)以及它们的变化数目也是可想到的。
在一些实施方案中,第一长丝90包括穿过延伸经过第一锁定部或柱构件60的横向远侧部的孔口68的第一远侧部91,并且第二长丝94包括穿过延伸经过第一锁定部或柱构件60的横向远侧部的孔口68的第二远侧部95。在一些实施方案中,第一长丝90包括围绕第一织物衬套70的近侧的第一锁定部或柱构件60的第一腿64的第一近侧部92,并且第二长丝94包括围绕第二织物衬套72的近侧的第一锁定部或柱构件60的第二腿66的第二近侧部96。在一些实施方案中,第一长丝90的第一近侧部92的至少一部分定位于形成于位于第一织物衬套70近侧的第一腿64内部的第一侧向凹槽63的内部。在一些实施方案中,第二长丝94的第二近侧部96的至少一部分定位于形成于位于第二织物衬套72近侧的第二腿66的第二侧向凹槽65的内部。至少在一些实施方案中,第一长丝90不穿过第一锁定部或柱构件60的第一腿64。至少在一些实施方案中,第二长丝94不穿过第一锁定部或柱构件60的第二腿66。例如,第一锁定部或柱构件60的第一腿64和/或第二腿66可没有经过其中而延伸的孔或孔口,因此减少第一锁定部或柱构件60的加工和/或制造时间及成本。
在一些实施方案中,第一织物衬套70和/或第二织物衬套72可各自是由编织材料构成。在一些实施方案中,第一织物衬套70和/或第二织物衬套72可各自由聚合材料构成。在一些实施方案中,第一织物衬套70和/或第二织物衬套72可各自由金属材料构成。在一些实施方案中,第一织物衬套70和/或第二织物衬套72可各自由提供充分的柔性、强度、和抗扯性的其他材料和/或各材料的组合而构成。在一些实施方案中,至少第一织物衬套70的弹性中心部702和/或第二织物衬套72的弹性中心部722可用弹性聚合材料(如聚氨酯)或其他合适的材料进行浸渍。在一些实施方案中,第一织物衬套70的至少弹性中心部702和/或第二织物衬套72的弹性中心部722可由胶原织物构成并且/或者包含胶原织物,该胶原织物构造成在与液体接触时发生溶胀。在一些实施方案中,至少第一织物衬套70的弹性中心部702和/或弹性中心部722的第二织物衬套72可由编织材料构成并且/或者包含编织材料,将该编织材料用构造成在与液体接触时发生溶胀的水凝胶进行涂覆和/或浸渍。下面对用于第一织物衬套70、第二织物衬套72、第一长丝90、第二长丝94等的合适但非限制性材料的一些实例(例如金属材料、聚合材料和/或编织材料)进行描述。
第一织物衬套70和/或第二织物衬套72可构造成当第一织物衬套70和/或第二织物衬套72在松弛状态与处于张紧状态时的拉长状态之间进行转换。图10和图11图示说明了分别处于松弛状态和拉长状态中的第一织物衬套70和/或第二织物衬套72。可在没有拉力被施加到第一织物衬套70和/或第二织物衬套72的情况下获得和/或达到松弛状态。例如,当施加到第一织物衬套70和/或第二织物衬套72的拉力被释放时,第一织物衬套70和/或第二织物衬套72会偏移和/或自偏移从而恢复到松弛状态并且/或者可朝向松弛状态移动或转换。第一织物衬套70的第一端部701、第一织物衬套70的第二端部703、和第一织物衬套70的弹性中心部702可各自具有长度和厚度。第二织物衬套72的第一端部721、第二织物衬套72的第二端部723、和第二织物衬套72的弹性中心部722各自可具有长度和厚度。
向和/或在衬套70的第一端部701和第一织物衬套70的第二端部703施加拉力可导致第一织物衬套70的弹性中心部702拉伸和/或拉长,以及厚度变薄和/或减小。向和/或在第二织物衬套72的第一端部721和第二织物衬套72的第二端部723施加压力会导致第二织物衬套72的弹性中心部722拉伸和/或拉长,以及厚度变薄和/或减小。例如,在一些实施方案中,第一织物衬套70的弹性中心部702的长度和/或第二织物衬套72的弹性中心部722的长度,在拉长状态中与在松弛状态中相比,可至少大50%。在一些实施方案中,第一织物衬套70的弹性中心部702的厚度和/或第二织物衬套72的弹性中心部722的厚度,在拉长状态中与在松弛状态中相比,可至少小50%。例如,处于拉长状态的第一织物衬套70的弹性中心部702的的厚度与处于松弛状态的第一织物衬套70的弹性中心部702的厚度相比可减小,并且/或者第二织物衬套72的弹性中心部722的厚度与处于松弛状态的第二织物衬套72的弹性中心部722的厚度相比可减小。
在一些实施方案中,第一织物衬套70的第一端部701和/或第一织物衬套70的第二端部703可构造成限制在拉力作用下的尺寸变化。在一些实施方案中,第一织物衬套70的第一端部701的长度和/或第一织物衬套70的第二端部703的长度在松弛状态与拉长状态之间可变化小于10%。例如,当第一织物衬套70处于拉紧状态时,第一织物衬套70的第一端部701和第一织物衬套70的第二端部703的各自长度可变化小于10%。类似地,当第二织物衬套72处于拉紧状态时,第二织物衬套72的第一端部721和第二织物衬套72的第二端部723的每个端部的长度可变化小于10%。在一些实施方案中,当第一织物衬套70处于拉紧状态时,第一织物衬套70的第一端部701和第一织物衬套70的第二端部703的厚度各自可变化小于10%。类似地,当第二织物衬套72处于拉紧状态时,第二织物衬套72的第一端部721和第二织物衬套72的第二端部723的各端部的厚度可变化小于10%。
图12-图17图示说明了对用于置换心脏瓣膜植入物16的置换心脏瓣膜连合组件进行组装的示范性方法中的所选元件。如图12中所示,该方法可包括将第一瓣叶24的第一衬套部25和第二瓣叶30的第二衬套部32通过锁定机构48的第一锁定部或柱构件60的纵向取向组织槽67而插入,锁定机构48包括第一锁定部或柱构件60及第二锁定部或锁扣构件50。
如图13中所见,该方法可包括在拉力作用下在拉长状态中将第一织物衬套70经过纵向取向组织槽67在第一瓣叶24的第一衬套部25与第一锁定部或柱构件60的第一腿64之间插入,并且将第二织物衬套72在拉力作用下在拉长状态中经过纵向取向组织槽67在第二瓣叶30的第二衬套部32与第一锁定部或柱构件60的第二腿66之间插入。如上所述,处于拉长状态的第一织物衬套70的弹性中心部702的厚度与处于松弛状态的第一织物衬套70的弹性中心部702的厚度相比减小,并且处于拉长状态的第二织物衬套72的弹性中心部722的厚度与处于松弛状态的第二织物衬套72的弹性中心部722的厚度相比减小。
处于拉长状态的第一织物衬套70的弹性中心部702和/或第二织物衬套72的弹性中心部722的厚度减小可便于第一织物衬套70和/或第二织物衬套72在纵向取向组织槽67内部的定位,因为纵向取向组织槽67(例如,在第一锁定部或柱构件60的第一腿64与第一锁定部或柱构件60的第二腿66之间)的宽度可大于第一瓣叶24的第一衬套部25、第二瓣叶30的第二衬套部32、处于拉长状态的第一织物衬套70的弹性中心部702、及处于拉长状态的第二织物衬套72的弹性中心部722的总厚度。另外或者可替代地,在一些实施方案中,纵向取向组织槽67(例如,在第一锁定部或柱构件60的第一腿64与第一锁定部或柱构件60的第二腿66之间)的宽度可大于第一衬套部25的第一瓣叶24、第二衬套部32的第二瓣叶30、第一织物衬套70的第一端部701或第二端部703、及第二织物衬套72的第一端部721或第二端部723的总厚度。
至少在一些实施方案中,由于正常的制造偏差、公差等,第一瓣叶24和/或第二瓣叶30的厚度可以是不一致的并且/或者可略微地变化。例如,用于构成第一瓣叶24和/或第二瓣叶30的材料的厚度可变化达5%、10%、15%或以上。此变化会对可具有大致固定的宽度尺寸的纵向取向组织槽67内部的装配带来问题。在一些实施方案中,在置换心脏瓣膜连合组件组装后的“松动”配合可允许瓣叶在纵向取向组织槽67内部移动,这会导致作用于瓣叶材料的应力、摩擦、和/或磨损增加。
因此,第一织物衬套70和/或第二织物衬套72可构造成使得处于松弛状态的第一织物衬套70的弹性中心部702的厚度与处于拉长状态的第一织物衬套70的弹性中心部702的厚度相比增加,并且处于松弛状态的第二织物衬套72的弹性中心部722的厚度与处于拉长状态的第二织物衬套72的弹性中心部722的厚度相比增加。例如,第一织物衬套70的弹性中心部702和/或第二织物衬套72的弹性中心部722可构造成,当拉力被释放时(例如,当第一织物衬套70的弹性中心部702和/或弹性中心部722的第二织物衬套72朝向松弛状态转换时),向和/或针对第一锁定部或柱构件60的第一腿64和第一锁定部或柱构件60的第二腿66施加压缩力。
在一些实施方案中,所述方法还可包括使第一瓣叶24的第一衬套部25的轮廓(例如,外周边、外边缘等)与第一织物衬套70的轮廓和/或的第一织物衬套70的第一重叠部71的轮廓对齐,以及使第二瓣叶30的第二衬套部32的轮廓与第二织物衬套72的轮廓和/或第二织物衬套72的第二重叠部73的轮廓对齐。
图14图示说明了所述方法中的步骤:释放作用于第一织物衬套70和第二织物衬套72的拉力使得第一织物衬套70的弹性中心部702和第二织物衬套72的弹性中心部722朝向松弛状态转换并且增加厚度从而将第一瓣叶24的第一衬套部25和第二瓣叶30的第二衬套部32置于在第一锁定部或柱构件60的第一腿64与第一锁定部或柱构件60的第二腿66之间的压缩状态。第一织物衬套70的弹性中心部702和/或第二织物衬套72的弹性中心部722的扩张通过占据在第一锁定部或柱构件60的第一腿64与第一锁定部或柱构件60的第二腿66之间的任何空余空间而允许和/或控制瓣叶的可变厚度,从而在各瓣叶和第一锁定部或柱构件60的腿之间形成压缩过盈配合。至少在一些实例中,当拉力被释放时第一织物衬套70的弹性中心部702和/或第二织物衬套72的弹性中心部722不完全地恢复到松弛状态而是仍然朝向松弛状态偏置。
如图15中所示,所述方法可包括将第一织物衬套70包裹在第一锁定部或柱构件60的第一腿64使得第一织物衬套70在与第一瓣叶24的第一衬套部25相邻的位置自身重叠以形成第一织物衬套70的第一重叠部71,以及第二织物衬套72包裹在第一锁定部或柱构件60第二腿66使得第二织物衬套72自身在与第二衬套部32的第二瓣叶30相邻的位置重叠以形成第二织物衬套72的第二重叠部73。
如图16中所见,所述方法可包括用第一夹紧元件98将第一织物衬套70的第一重叠部71夹紧到第一衬套部25的第一瓣叶24,及利用第二夹紧元件99将第二织物衬套72的第二重叠部73夹紧到第二瓣叶30的第二衬套部32。在一些实施方案中,第一夹紧元件98和第二夹紧元件99可以是独立和/或单独的结构。在一些实施方案中,第一夹紧元件98和第二夹紧元件99可连接到一起,可连接到共同的夹持机构,并且/或者可以是单个结构。其他构型也是可想到的。
如图17中所示,所述方法可包括如上所述利用第一长丝90将第一织物衬套70的第一重叠部71固定地附接到第一瓣叶24的第一衬套部25,以及如上所述利用第二长丝94将第二织物衬套72的第二重叠部73固定地附接到第二瓣叶30的第二衬套部32。在一些实施方案中,利用第一长丝90的线性连图案和/或线性对齐缝合(针脚)将第一织物衬套70的第一重叠部71固定地附接到第一瓣叶24的第一衬套部25,并且利用第二长丝94的线性连接图案和/或线性对齐缝合将第二织物衬套72的第二重叠部73固定地附接到第二瓣叶30的第二衬套部32。
如上所述,可有存在于所公开装置和/或器件中的某些特别描述特征的多种情况。仅仅作为便于对某些特征的理解的一个实例,图18示出了置换心脏瓣膜植入物16的所选择元件的俯视图。如在图18中可见,置换心脏瓣膜植入物16可包括:可扩张锚固构件17、包括第一锁定部或柱构件60的第一锁定机构、包括第一锁定部或柱构件60的第二锁定机构、和包括第一锁定部或柱构件60的第三锁定机构。各锁定机构和/或第一锁定部或柱构件60可以是相同的,或者根据置换心脏瓣膜植入物16的需要在它们之间可存在差异。置换心脏瓣膜植入物16可包括:具有第一衬套部25和相反的第二衬套部26的第一瓣叶24、具有第一衬套部31和相反的第二衬套部32的第二瓣叶30、及具有第一衬套部37和相反的第二衬套部38的第三瓣叶36。
如上所述,第一瓣叶24的第一衬套部25和第二瓣叶30的第二衬套部32可穿过第一锁定机构的第一锁定部或柱构件60的纵向取向组织槽。第二瓣叶30的第一衬套部31和第三瓣叶36的第二衬套部38可穿过第二锁定机构的第一锁定部或柱构件60的纵向取向组织槽。第三瓣叶36的第一衬套部37和第一瓣叶24的第二衬套部26可穿过第三锁定机构的第一锁定部或柱构件60的纵向取向组织槽。
可以用于本文中所公开医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等(和/或本文中所公开的其他系统)的各种部件及它们的各种元件的材料可包括通常与的医疗器械相关联的材料。为了简单的目的,以下的论述提到了医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等。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,例如但不限于致动器元件15、密封构件20、多个瓣叶22、可扩张锚固构件17、第二锁定部或锁扣构件50、第一锁定部或柱构件60、第一织物衬套70、第二织物衬套72、接箍80、导向装置82、第一长丝90、第二长丝94等、和或它们的元件或部件。
在一些实施方案中,医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等、和/或它们的部件(例如但不限于:致动器元件5、密封构件20、多个瓣叶22、可扩张锚固构件17、第二锁定部或锁扣构件50、第一锁定部或柱构件60、第一织物衬套70、第二织物衬套72、接箍80、导向装置82、第一长丝90,第二长丝94等)可由金属、金属合金、聚合物(下面公开了其一些实例)、金属-聚合物复合材料、陶瓷、它们的组合等,或者其他合适的材料所制成。合适的金属和金属合金的一些实例包括:不锈钢,如444V、444L和314LV不锈钢;软钢;镍-钛合金,如线弹性和/或超弹性镍钛合金;其他镍合金,如镍-铬-钼合金(例如,UNS:N06625如625、UNS:N06022如UNS:N10276如其他合金等)、镍-铜合金(例如,UNS:N04400如400、镍400、400等)、镍-钴-铬-钼合金(例如,UNS:R44035,如等)、镍-钼合金(例如,UNS:N10665,如合金)、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,如等);富含铂的不锈钢;钛;铂;钯;金;它们的组合;等;或者任何其他合适材料。
如本文中所提到的,在市售镍-钛合金或镍钛合金合金的家族内的是被命名为“线弹性”或“非超弹性”的类别,尽管可在化学性质上类似于常规的形状记忆和超弹性品种,但可表现出独特且有用的机械性能。线弹性和/或非超弹性镍钛合金可与超弹性镍钛合金区别之处在于线弹性和/或非超弹性镍钛合金在其应力/应变曲线中不显示如同超弹性镍钛合金那样的明显的“超弹性平台区”或“标志区”。相反,在线弹性和/或非超弹性镍钛合金中,当可恢复应变增大时,应力继续以大致地线性或稍微线性的关系但未必完全线性关系而增大,直到塑性变形开始或者至少以与使用超弹性镍钛合可看见的超弹性平台区和/或标志区相比更加线性的关系发生塑性变形。因此,为了本公开的目的,线弹性和/或非超弹性镍钛合金也可被称为“大致地”线弹性和/或非超弹性镍钛合金。
在某些情况下,线弹性和/或非超弹性镍钛合金也可与超弹性镍钛合金的区别之处在于线弹性和/或非超弹性镍钛合金可接受高达约2-5%的应变同时仍然大致地具有弹性(例如,在发生塑性变形之前)而超弹性镍钛合金在发生塑性变形之前可接受高达约8%的应变。这两种材料均可以与其他线弹性材料(如不锈钢,其也可以基于其组成而加以区别)区别,不锈钢在发生塑性变形之前可仅接受约0.2至0.44%的应变。
在一些实施方案中,线弹性和/或非超弹性镍-钛合金是不显示可在较大温度范围内利用差示扫描量热法(DSC)和动态金属热分析(DMTA)检测到的任何马氏体/奥氏体相变的合金。例如,在一些实施方案中,在线弹性和/或非超弹性镍-钛合金中可不存在通过DSC和DMTA分析在约60摄氏度(℃)至约120℃的范围内可检测到的马氏体/奥氏体相变。因此,这种材料的机械弯曲性质可对在此非常宽温度范围内的温度的影响基本上为惰性。在一些实施方案中,在环境温度或室温下线弹性和/或非超弹性镍-钛合金的机械弯曲性质与在体温下的机械性质大致相同,例如亦即它们不显示超弹性平台区和/或标志区。换句话说,在较宽的温度范围内,线弹性和/或非超弹性镍-钛合金维持其线弹性和/或非超弹性特性和/或性质。
在一些实施方案中,线弹性和/或非超弹性镍-钛合金可包含在约50至约60质量%范围内的镍,剩余的基本上是钛。在一些实施方案中,其组成是在约54至约57重量%范围内的镍。合适的镍-钛合金的一个实例是购自日本神奈川县的古河技术材料公司的FHP-NT合金。其他合适的材料可包括ULTANIUMTM(购自Neo-Metrics公司)和GUM METALTM(从丰田公司获得)。在一些其他实施方案中,超弹性合金(例如超弹性镍钛合金)可以用于获得理想的性质。
至少在一些实施方案中,部分或全部的医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等,和/或它们的部件,也可用不透射线材料进行掺杂,由不透射线材料制成,或者包含不透射线材料。不透射线材料被理解成是能够在医疗程序期间在荧光屏上或者利用另一种成像技术产生相对较明亮的图像的材料。此相对较明亮的图像有助于使用者确定医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等的位置。不透射线材料一些实例可以包括但不限于:金、铂、钯、钽、钨合金、用不透射线填充物加载的聚合物材料等。此外,其他的不透射线标记带和/或线圈也可并入医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等的设计中,以得到相同的结果。
在一些实施方案中,可将一定程度的磁共振成像(MRI)相容性赋予医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等。例如,医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等,和/或它们的部件或部分可由不明显地使图像失真并产生明显的伪像(例如,图像中的间隙)的材料制成。某些铁磁材料,例如会是不合适的,因为它们会产生MRI图像中的伪像。医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等,或它们的部分也可由核磁共振仪可以成像的材料制成。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,如等)、镍-钴-铬-钼合金(例如,UNS:R44035,如等)、镍钛合金等、及其他。
在一些实施方案中,医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等、和/或它们的部分可由聚合物或其他合适的材料制成或者包含聚合物或其他合适的材料。合适的聚合物的一些实例可包括:聚四氟乙烯(PTFE)、聚四氟乙烯(ETFE)、氟化乙丙烯(FEP)、聚甲醛(POM,例如购自Dupont公司的)、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,购自DSMEngineering Plastics公司的)、基于醚和酯的共聚物(例如,聚对苯二甲酸亚烷基丁二醇酯和/或其他聚酯弹性体,如从Dupont公司获得的)、聚酰胺(例如,购自Bayer公司的或者从Elf Atochem公司获得的)、弹性聚酰胺类、聚酰胺/醚共聚物、聚醚嵌段酰胺(PEBA,例如以商品名称购得)、乙烯-乙酸乙烯酯共聚物(EVA)、聚硅酮、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)、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)、聚对苯二甲酰对苯二胺(例如,)、聚砜、尼龙、尼龙-12(如购自EMS American Grilon的)、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)、聚(苯乙烯-b-异丁烯-b-苯乙烯)三嵌段共聚物(例如,SIBS和/或SIBS50A)、聚碳酸酯类、离子交联聚合物、聚氨酯-聚硅氧烷共聚物(例如,来自Aortech生物材料公司的或者来自AdvanSource生物材料公司的)、生物相容性聚合物、其他合适的材料、或者它们的混合物、组合、共聚物、聚合物/金属复合材料,等。在一些实施方案中,套管可以与液晶聚合物(LCP)共混。例如,该混合物可以含有高达约6%的LCP。
在一些实施方案中,医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18、第一织物衬套70、第二织物衬套72等和/或本文中所公开的其他元件可包含设置在该结构的上方或内部的织物材料。织物材料可由生物相容性材料构成,这种聚合材料或生物材料适合于促进组织长入。在一些实施方案中,织物材料可包括生物可吸收材料。合适的织物材料的一些实例包括但不限于:聚乙二醇(PEG)、尼龙、聚四氟乙烯(PTFE、ePTFE)、聚烯烃材料如聚乙烯、聚丙烯、聚酯、聚氨酯、和/或它们的共混物或组合。
在一些实施方案中,医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18、第一织物衬套70、第二织物衬套72、第一长丝90、第二长丝94等可包含纺织材料并且/或者由纺织材料构成。合适的纺织材料的一些实例可包括可以是平直的、成形的、扭转的、有纹理的、防缩的或未缩水的合成纱线。适于在本发明中使用的合成生物相容性纱线包括但不限于:聚酯类,包括聚对苯二甲酸乙二醇酯(PET)聚酯类、聚丙烯类、聚乙烯类、聚氨酯类、聚烯烃类、乙烯类聚合物、聚乙酸甲酯类、聚酰胺类、萘二羧酸酯衍生物、蚕丝、和聚四氟乙烯类。此外,合成纱线中的至少一种可以是金属纱线或者玻璃或陶瓷纱线或纤维。有用的金属纱线包括由不锈钢、铂、金、钛、钽或基于Ni-Co-Cr的合金制成或者含有它们的纱线。该纱线可进一步包含碳纤维、玻璃纤维或陶瓷纤维。理想地,该纱线是由热塑性材料制成,包括但不限于:聚酯类、聚丙烯类、聚乙烯类、聚氨酯类、聚萘类、聚四氟乙烯类等。纱线可以是复丝、单丝、或纺丝型。所选择纱线的类型和旦尼尔可以以形成生物相容性的可植入假体(更具体地具有可取性质的血管结构)的方式进行选择。
在一些实施方案中,医疗器械系统10、外套管12、内套管或导管14、置换心脏瓣膜植入物16、手柄18等可包含合适的治疗剂并且/或者用合适的治疗剂进行处理。合适的治疗剂的一些实例可包括:抗凝血剂(如肝素、肝素衍生物、尿激酶、和PPack(右旋苯丙氨酸-脯氨酸-精氨酸-氯甲基酮));抗增生药(如依诺肝素、血管肽、能够阻止平滑肌细胞增殖的单克隆抗体、水蛭素、和乙酰水杨酸);抗炎剂(如地塞米松、泼尼松龙、皮质酮、布地奈德、雌激素、柳氮磺胺吡啶、和美沙拉嗪);抗肿瘤、抗增殖/抗有丝分裂药(如紫杉醇、5-氟尿嘧啶、顺铂、长春花碱、长春新碱、埃博霉素类、内皮抑素、血管抑素、和胸苷激酶抑制剂);麻醉剂(如利多卡因、布比卡因、和罗哌卡因);抗凝血剂(如D-Phe-Pro-Arg氯甲基酮、含RGD肽的化合物、肝素、抗凝血酶化合物、血小板受体拮抗剂、抗凝血酶抗体、抗血小板受体抗体、阿司匹林、前列腺素抑制剂、血小板抑制剂、和蜱抗血小板肽类);血管细胞生长促进剂(如生长因子抑制剂、生长因子受体拮抗剂、转录激活剂、和转录促进剂);血管细胞生长抑制剂(如生长因子抑制剂、生长因子受体拮抗剂、转录抑制因子、翻译抑制因子、复制抑制剂、抑制性抗体、针对生长因子的抗体、由生长因子和细胞毒素组成的双功能分子、由抗体和细胞毒素组成的双功能分子);降胆固醇药;血管扩张剂;及干预内源性血管活性机制的药物。
应当理解的是本公开在许多方面只是说明性的。可在不超出本发明范围的情况下,对细节作出变更,具体地在形状、尺寸、和步骤的安排方面。这可包括,在适当的程度上,将一个示范性实施方案的任何特征用于其他实施方案。当然本发明的范围是由其中表述所附权利要求的用语所限定。
Claims (15)
1.一种置换心脏瓣膜连合组件,包括:
锁定机构,其包括第一锁定部,在输送构型中所述第一锁定部与第二锁定部分开,其中所述第一锁定部构造成在展开构型中与所述第二锁定部接合,并且所述第一锁定部能相对于所述第二锁定部在所述输送构型与所述展开构型之间被纵向地致动;
紧固到所述第一锁定部的第一瓣叶;和
紧固到所述第一锁定部的第二瓣叶;
其中所述第一瓣叶的第一衬套部固定地附接到包围第一锁定部的第一腿的第一织物衬套,并且第二瓣叶的第二衬套部固定地附接到包围所述第一锁定部的第二腿的第二织物衬套;
其中所述第一织物衬套包括构造成与所述第一腿接合的第一端部、第二端部及弹性中心部,所述第一端部、第二部、和所述弹性中心部各自具有长度和厚度。
2.根据利要求1所述的置换心脏瓣膜连合组件,其中所述第一织物衬套构造成在松弛状态与当所述第一织物衬套受到拉力时的拉长状态之间转换。
3.根据权利要求2所述的置换心脏瓣膜连合组件,其中第一织物衬套的所述的弹性中心部构造成当所述拉力被释放时施加压缩力于第一腿上。
4.根据权利要求2至3中任一项所述的置换心脏瓣膜连合组件,其中在所述拉长状态中与在所述松弛状态中相比,所述第一织物衬套的所述的弹性中心部长度至少大50%。
5.根据权利要求2至4中任一项所述的置换心脏瓣膜连合组件,其中在所述拉长状态中与在所述松弛状态中相比,所述第一织物衬套的所述的弹性中心部厚度至少小50%。
6.根据权利要求2至5中任一项所述的置换心脏瓣膜连合组件,其中在所述松弛状态与所述拉长状态之间所述第一织物衬套的第一端部的长度变化小于10%。
7.根据权利要求2至6中任一项所述的置换心脏瓣膜连合组件,其中在所述松弛状态与所述拉长状态之间,所述第一织物衬套的第二端部的长度变化小于10%。
8.根据权利要求2至7中任一项所述的置换心脏瓣膜连合组件,其中所述第一锁定部的所述第一腿和所述第二腿限定延伸穿过第一锁定部的纵向取向组织槽;
其中所述第一瓣叶的所述第一衬套部和所述第二瓣叶的所述第二衬套部两者穿过所述第一锁定部的所述纵向取向组织槽。
9.根据权利要求8所述的置换心脏瓣膜连合组件,其中所述纵向取向组织槽的宽度大于所述第一瓣叶的所述第一衬套部、所述第二瓣叶的所述第二衬套部、处于拉长状态中的所述第一织物衬套的弹性中心部、和处于拉长状态中的所述第二织物衬套的所述弹性中心部的总厚度。
10.根据权利要求1至9中任一项所述的置换心脏瓣膜连合组件,其中所述第一瓣叶的所述第一衬套部利用大致地平行于所述第一锁定部的所述第一腿而取向的第一长丝的一次或多次缝合而固定附接到所述第一织物衬套。
11.根据权利要求1至10中任一项所的置换心脏瓣膜连合组件,其中所述第二瓣叶的所述第二衬套部利用大致地平行于所述第一锁定部的所述第二腿而取向的第二长丝的一次或多次缝合而固定地附接到所述第二织物衬套。
12.一种置换心脏瓣膜植入物,包括:
能在输送构型与展开构型之间被致动的可扩张锚固构件;和
根据权利要求1所述的置换心脏瓣膜连合组件;
其中所述锁定机构构造成将所述可扩张锚固构件锁定在所述展开构型。
13.根据权利要求12所述的置换心脏瓣膜植入物,还包括聚合物密封构件,所述聚合物密封构件被设置在所述可扩张锚固构件的外表面上并且附接到所述可扩张锚固构件的远端。
14.根据权利要求12至13中任一项所述的置换心脏瓣膜植入物,其中所述第一织物衬套和所述第二织物衬套各自由编织材料构成。
15.根据权利要求12至14中任一项所述的置换心脏瓣膜植入物,其中所述第一织物衬套和所述第二织物衬套各自的至少所述弹性中心部用聚氨酯进行浸渍。
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Also Published As
Publication number | Publication date |
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US20190350701A1 (en) | 2019-11-21 |
US11229517B2 (en) | 2022-01-25 |
EP3793478A1 (en) | 2021-03-24 |
WO2019222367A1 (en) | 2019-11-21 |
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