CN107645941A - 小外形瓣膜锁定机构与接合组件 - Google Patents

小外形瓣膜锁定机构与接合组件 Download PDF

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CN107645941A
CN107645941A CN201680026063.1A CN201680026063A CN107645941A CN 107645941 A CN107645941 A CN 107645941A CN 201680026063 A CN201680026063 A CN 201680026063A CN 107645941 A CN107645941 A CN 107645941A
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fastener
component
locking mechanism
heart valve
replacement heart
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安德鲁·J·H·巴克斯
塔卡什·H·伊诺
克里斯莉·V·克里索斯托莫
迈克尔·P·卡洛梅尼
安·休·法姆
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Boston Scientific Scimed Inc
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Boston Scientific Scimed Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)

Abstract

一种置换心脏瓣膜锁定机构，可包括：扣件(58)，其固定地附接到界定了纵向中心轴线的管状的锚固构件；柱构件(86)，其可相对于扣件沿轴向平移；以及致动构件(50)，其在附接点可释放地连接于柱构件。柱构件可包括插销部(80)，配置成与形成在扣件的锁扣接合来阻止柱构件相对于扣件向远侧移动。附接点被设置在插销部的近侧。插销部的相对于纵向中心轴线的周向平移可使插销部脱离锁扣。

Description

小外形瓣膜锁定机构与接合组件
相关申请的交叉引用
本申请要求于2015年3月6日提交的美国临时申请第62/129，177号以及于2016年3月2日提交的美国发明申请第15/058，841号的优先权。
技术领域
本公开涉及医疗设备，以及用于制造和/或使用医疗设备的方法。更具体地，本公开涉及用于置换心脏瓣膜的锁定机构。
背景技术
现已开发出种类广泛的用于医疗用途的体内医疗设备，例如血管内用途。这些设备中的部分包括导丝、导管、医疗设备输送系统(例如，用于支架、移植物、置换瓣膜等)等。这些设备通过多种不同的制造方法中的任一种而制造，并且可根据多种方法中的任一种而使用。已知的医疗设备和方法各自具有某些优点和缺点。对提供替代的医疗设备以及用于制造和使用医疗设备的替代方法持续存在需求。
发明内容
在第一方案中，置换心脏瓣膜锁定机构可包括：扣件，其固定地附接到管状的锚固构件；柱构件，其可相对于所述扣件沿轴向平移；以及致动构件，其在附接点可释放地连接于所述柱构件。所述柱构件可包括插销部，配置成与形成在所述扣件的锁扣接合来阻止所述柱构件相对于所述扣件向远侧移动。所述附接点可被设置在所述插销部的近侧。
另外或可替代地，在第二方案中，所述置换心脏瓣膜锁定机构可包括销构件，所述销构件在所述附接点可释放地与所述致动构件和所述柱构件接合，并且延伸穿过所述致动构件和所述柱构件。
另外或可替代地，在第三方案中，所述销构件包括伸直的远侧区段，以及位于所述远侧区段的末端的弯曲的远侧顶端部分。
另外或可替代地，在第四方案中，所述销构件从所述远侧区段沿单一方向弯曲至所述远侧顶端部分。
另外或可替代地，在第五方案中，所述柱构件的向近侧的轴向平移使所述附接点从远离所述扣件的第一位置移动至接近所述扣件的远端的第二位置。
另外或可替代地，在第六方案中，所述柱构件包括从所述柱构件的远端向近侧延伸的悬臂式支腿。
另外或可替代地，在第七方案中，所述扣件是大致刚性的。
另外或可替代地，在第八方案中，所述柱构件的至少一部分是挠性的。
另外或可替代地，在第九方案中，所述插销部能够相对于所述柱构件的主体部移动。
另外或可替代地，在第十方案中，置换心脏瓣膜锁定机构可包括：扣件，其固定地附接到管状的锚固构件，所述锚固构件界定了纵向中心轴线；柱构件，其可相对于所述扣件在所述扣件内沿轴向平移；以及致动构件，其在附接点可释放地连接于所述柱构件。所述柱构件可包括主体部与插销部，所述插销部能够相对于所述主体部移动，且配置成与形成在所述扣件的锁扣接合来阻止所述柱构件相对于所述扣件向远侧移动。所述插销部的相对于所述纵向中心轴线的周向平移可使所述插销部脱离所述锁扣。
另外或可替代地，在第十一方案中，所述扣件包括：轴向延伸的两个侧壁，往远离所述锚固构件的方向延伸；后壁，延伸于所述两个侧壁之间，并且界定出沿轴向延伸穿过所述扣件的通道；以及一个或多个孔，开设于所述后壁上且位在所述两个侧壁之间。紧固件可穿过所述一个或多个孔并将所述扣件固定到所述锚固构件。
另外或可替代地，在第十二方案中，所述扣件包括沿着所述两个侧壁中的其中一个，从中沿轴向穿过的槽。
另外或可替代地，在第十三方案中，所述槽至少部分地与所述通道重合。
另外或可替代地，在第十四方案中，所述后壁被设置成相对于所述两个侧壁径向远离所述纵向中心轴线，所述后壁包括与所述一个或多个孔和所述扣件的远端相通的凹入部。
另外或可替代地，在第十五方案中，当所述柱构件被设置在所述通道内时，所述紧固件经由所述凹入部往远离所述扣件的方向延伸。
另外或可替代地，在第十六方案中，所述锁扣形成在所述两个侧壁中的至少一个上。
另外或可替代地，在第十七方案中，所述柱构件包括从所述柱构件的远端向近侧延伸的悬臂式支腿。
另外或可替代地，在第十八方案中，所述致动构件包括固定地附接到D形的细长杆的扁平的附接部。
另外或可替代地，在第十九方案中，所述细长杆的至少一部分延伸向所述附接部的远侧。
另外或可替代地，在第二十方案中，所述细长杆的延伸向所述附接部的远侧的所述部分，是配置成在所述致动构件向远侧前进时使所述插销部相对于所述纵向中心轴线向周向平移，以使所述插销部脱离所述锁扣。
上面对一些实施方式、方案、和/或实施例的概述，并非意图对本公开的每个公开实施方式或每个具体实现方案进行描述。接下来的附图和详细描述将更加具体地例示说明这些实施方式。
附图说明
通过下面结合附图对各种实施方式进行的详细描述，将更充分理解本公开的内容，其中：
图1是处于布置构型的一示范性植入物的一部分的立体图。
图2是一示范性扣件的立体图。
图3是图2所示的示范性扣件的端视图。
图4是一示范性柱构件的立体图。
图5是图4所示的示范性柱构件的正视图。
图6是图4所示的示范性柱构件的侧视图。
图7是图4所示的示范性柱构件的端视图。
图8是一示范性致动构件的立体图。
图9是图8所示的示范性致动构件的端视图。
图10是一示范性锁定机构的用于接合插销部与锁扣的选定部件的立体图，该锁定机构与一示范性植入物相联。
图11是图10所示的示范性锁定机构的选定部件的正视图。
图12是图10所示的示范性锁定机构的选定部件的侧视图。
图13是一示范性锁定机构的用于接合插销部与锁扣的选定部件的立体图。
图14是图13所示的示范性锁定机构的选定部件的正视图。
图15是一示范性锁定机构的用于接合插销部与锁扣的选定部件的立体图。
图16是图15所示的示范性锁定机构的选定部件的正视图。
图17是一示范性锁定机构的用于分开插销部与锁扣的选定部件的正视图。
图18是图17所示的示范性锁定机构的选定部件的侧视图。
图19是一示范性锁定机构的用于分开插销部与锁扣的选定部件的正视图。
图20是一示范性锁定机构的用于分开插销部与锁扣的选定部件的正视图。
图21至24是一示范性锁定机构的选定部件的操作的立体图，该示范性锁定机构的选定部件与一示范性释放系统的选定部件相联。
虽然本公开的各方案可修改为多种改型和替代形式，但是已经在附图中以例示的方式示出其特定细节，并将进行详细描述。然而，应当理解的是，这并非意图使本公开的各方案局限于所描述的特定实施方式。相反地，其意图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
以下的描述应参照附图进行阅读，这些附图未必是按比例绘制，其中在所有若干视图中以类似的附图标记标示类似的元件。详细描述和附图是用来说明而不是限制本发明请求保护的范围。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，所描述和/或图示的各种元件可在各种组合和构型中进行布置。详细描述和附图说明了本发明请求保护的范围的示范性实施方式。
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了不同的定义。
在本文中的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指代本领域技术人员将会认为等同于所列举值(即，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”可包括被四舍五入到最接近的有效数字的数字。术语“约”的其它使用(即，在除数值外的语境中)可假设具有它们的普通的和通常的定义，正如基于并且符合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描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，但受到本公开启发的本领域技术人员，将会理解期望的尺寸、范围和/或值可偏离所明确公开的尺寸、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“一个”、“一种”、和“该”包括复数所指对象，除非在该内容中另外明确地指出。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”的含义来使用，除非在该内容中另外明确地指出。
相对的术语例如“近侧”、“远侧”、“前进”、“回撤”、及其变体等通常可被认为是关于各种元件相对于设备的使用者/操作者/操纵者的定位、方向、和/或操作，其中“近侧”和“回撤”表示或者是指更靠近或朝向使用者，“远侧”和“前进”表示或者是指更加远离或离开使用者。
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，但每个实施方式可未必包括该特定的特征、结构、或特性。此外，这种短语未必是针对相同的实施方式。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，将会是在本领域技术人员的知识范围内结合其他实施方式来实现这种特征、结构、或特性，无论是否明确地描述，除非清楚地陈述了相反的情况。也就是说，下面描述的各种单独元件，尽管未明确地在特定的组合中被示出，但可想到可彼此组合或排列而形成其他附加的实施方式或者补充和/或充实所描述的实施方式，正如本领域技术人员将会理解的。
为了清楚起见，某些标识数字命名法(例如，第一、第二、第三、第四等)将被用于本说明书和/或权利要求中来命名和/或区别所描述和/或请求保护的多种特征。应当理解的是，该数字命名法仅是示例性的，而不是意图作为限制。在一些实施方式中，可能会为了简洁和清楚起见而变更或偏离先前使用的数字命名法。也就是说，被指定为“第一”元件的特征以后可能会被指定为“第二”元件、“第三”元件等，或可能会被完全地省略，并且/或者不同的特征可能会被指定为“第一”元件。在各情况下的含义和/或指定的目标对本领域从业者来说将是显而易见的。
影响心血管系统的疾病和/或病况在美国和全世界是普遍存在的。传统上，心血管系统的治疗常常是通过直接地进入该系统的受影响部位而实施。例如，对在一个或多个冠状动脉中的堵塞的治疗传统上是利用冠状动脉搭桥术进行治疗。正如可容易地理解的，这种治疗对于患者而言是相当具有创伤性的并且需要大量的恢复时间和/或治疗。近来，已开发出创伤性较低的疗法，例如，可利用经皮导管(例如血管成形术)进入堵塞的冠状动脉并进行治疗。这种疗法在患者和临床医生中已获得广泛的认可。
—些相对常见的病况可包括在心脏内部的一个或多个瓣膜的低效率、无效或完全失效，或者是其结果。例如，主动脉瓣膜的失效会对人造成严重的影响，如果不进行处理将会导致严重的健康状况和/或死亡。有缺陷心脏瓣膜的治疗引起其他挑战，由于该治疗经常需要针对有缺陷瓣膜的修复或完全置换。这种疗法对于患者而言会是高度创伤性的。在本文中所公开的是可用于将医疗设备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/或修复的医疗设备。至少部分的在本文中所公开的医疗设备可用于输送和植入置换心脏瓣膜(例如置换主动脉瓣膜)。另外，在本文中所公开的设备可经皮地输送置换心脏瓣膜，因此对患者而言创伤性较低。本文中所公开的设备也可提供如下面更详细描述的若干其它的可取特征和益处。
图1是一示范性医疗植入系统10的一部分的立体图。应注意的是，为了简单起见，医疗植入系统10的一些特征在图1中未示出或者仅示意性地示出。在其他附图中，将更详细地提供关于医疗植入系统10的部分部件的其它细节。医疗植入系统10可用于将多种医疗设备输送和/或布置到解剖结构内部的一些位置。至少在一些实施方式中，医疗植入系统10可以是可用于置换心脏瓣膜的经皮输送的置换心脏瓣膜系统(例如置换主动脉瓣膜系统)。然而，这并非意图是限制性的，因为医疗植入系统10也可用于其他介入治疗，包括二尖瓣瓣膜置换、瓣膜修复、瓣膜成形术等，或其他类似的介入治疗。
医疗植入系统10通常可被描述为包括输送系统12和医用植入物14(即，例如瓣膜置换植入物)的导管系统，在医用植入物14的输送期间，医用植入物14可联结到输送系统12并且被设置在输送系统12的管腔内部。在一些实施方式中，可将手柄或致动器设置在输送系统12的近端。一般来说，手柄可操纵输送系统12的位置、以及帮助布置医用植入物14。
在使用中，可使医疗植入系统10经皮地前进经过脉管系统而到达与感兴趣区域相邻的位置。例如，可使医疗植入系统10前进经过脉管系统并且经过主动脉弓而到达与有缺陷的主动脉瓣膜(或其他心脏瓣膜)相邻的位置。在输送期间，通常可将医用植入物14以被拉长且小外形(low profile)的“输送”构型设置在输送系统12内部。一旦被定位，可将输送系统12回撤以使医用植入物14露出。可驱动医用植入物14从而使医用植入物14径向地扩张到适合植入解剖结构内部的通常被缩短且较大外形的“布置”构型(例如图1中所示)。当把医用植入物14适当地布置在解剖结构内部时，可将输送系统12从脉管系统中取出，从而使医用植入物14以“释放”构型留在原地从而起到例如作为天然主动脉瓣膜的合适替代物的作用。至少在一些介入治疗中，可将医用植入物14布置在天然瓣膜的内部(例如，使天然瓣膜留在原位并且不被切除)。或者，可将天然瓣膜取出，并且可将医用植入物14布置在其位置作为置换。
在一些实施方式中，输送系统12可包括延伸穿过其中的一个或多个管腔。例如，在一些实施方式中，输送系统12可包括第一管腔、第二管腔、第三管腔、和第四管腔。一般来说，一个或多个管腔沿着输送系统12的全长延伸。然而，可考虑其他实施方式，即一个或多个管腔中的一个或多个仅沿着输送系统12的一部分长度延伸。例如，在一些实施方式中，第四管腔可停止在离输送系统12的远端短一点的位置并且/或者在其远端被填充，从而有效地将第四管腔终止在输送系统12的远端的近侧。
设置在输送系统12的第一管腔内部的可以是至少一个致动构件(例如致动构件50)，其例如可用于在输送构型和布置构型之间驱动(即，扩张和/或拉长)医用植入物14。在一些情况下，在本文中致动构件50可被称为术语“致动元件”，或者与术语“致动元件”互换使用。换句话说，医疗植入系统10可包括至少一个致动构件50。在一些实施方式中，至少一个致动构件50可包括两个致动构件50、三个致动构件50、四个致动构件50、或其他合适或期望数量的致动构件50。仅为了说明的目的，医疗植入系统10和/或医用植入物14被图示为具有三个致动构件50。
至少在一些实施方式中，第一管腔可用低摩擦衬里材料(例如FEP衬里材料)作衬里。设置在第二管腔内部的可以是会在本文中作更详细解释的销释放芯棒20。至少在一些实施方式中，第二管腔可用海波管衬里材料作衬里。第三管腔可以是导丝管腔而且在一些实施方式中，第三管腔也可用海波管衬里材料作衬里。在一些实施方式中，第四管腔可用于容纳非伸缩性丝或其他加固构件。非伸缩性丝或其他加固构件的形式可变化。在一些实施方式中，非伸缩性丝可采用不锈钢编织物的形式。非伸缩性丝可任选地包括设置在编织物的相反侧的一对纵向地延伸的芳纶和/或对位芳纶绞线(例如)。一般来说，除了被“设置在”第四管腔的“内部”，也可将非伸缩性丝埋入第四管腔的内部。另外，非伸缩性丝可延伸至与输送系统12的远端区域相邻的位置，但不完全地延伸至输送系统12的远端。例如，第四管腔的短的远侧区段可用与输送系统12的远端相邻的聚合物材料加以填充。
输送系统12也可包括从远端区域向远侧延伸的导丝管延伸部。在一些实施方式中，鼻锥体可被附接到导丝管延伸部。在一些实施方式中，鼻锥体通常被设计成具有无创伤性形状。在一些实施方式中，鼻锥体也可包括在医用植入物14的输送期间用于紧靠输送系统12的远侧顶端的脊部或突出部。
图1示出了医疗植入系统10和/或医用植入物14的一些选定部件。例如，在这里可看到医用植入物14可包括可被固定到管状的锚固构件或编织物40的多个瓣膜小叶16(例如牛心包)，该编织物40可在“输送”构型和“布置”构型之间可逆地驱动。在一些实施方式中，锚固构件或编织物40可以是大体上圆筒形的形状或构型。一些合适但非限制性的用于锚固构件或编织物40的材料，例如金属材料或聚合物材料，将在下面进行描述。在一些实施方式中，医用植入物14可包括用于将锚固构件或编织物40固定在“布置”构型的多个锁定机构。在一些实施方式中，至少一个致动构件50可用于与多个锁定机构接合并且在“输送”构型和“布置”构型之间驱动锚固构件或编织物40。在一些实施方式中，一个致动构件50可对应于、接合、和/或驱动一个锁定机构。在一些实施方式中，一个致动构件50可对应于、接合、和/或驱动多于一个的锁定机构。也可考虑其他构型。
虽然多个致动构件50和/或相应的锁定机构可被包括在医用植入物14中，但为了清楚和简洁起见，以下讨论很多将限制在这些元件的单个情况。本领域技术人员将容易地认识到，下面所讨论的实施例的特征和操作同样地可适用于包括多个锁定机构和/或多个致动构件50的所有情况。一些合适但非限制性的用于多个锁定机构和/或多个致动构件50的材料，例如金属材料或聚合物材料，将在下面进行描述。
在一些实施方式中，多个锁定机构可各自包括可沿轴向移动的柱构件76(例如在瓣膜小叶16的接合部(柱构件76有时可被称为“接合柱”))、以及被固定地附接到锚固构件或编织物40的扣件58。换句话说，至少在一些实施方式中，医用植入物14可包括多个柱构件76和相应的多个扣件58。也可考虑其他构型和对应性。在一些实施方式中，在“布置”构型，柱构件76可与扣件58接合。在一些实施方式中，在“输送”构型，柱构件76可轴向地或纵向地与扣件58相互间隔。一些合适但非限制性的用于柱构件76和/或扣件58的材料，例如金属材料或聚合物材料，将在下面进行描述。
在一些实施方式中，可沿轴向移动的柱构件76的远端86可被固定和/或附接(即，固定地附接、可移动地附接、可移除地附接等)到锚固构件或编织物40的远侧部，例如，利用缝合线、系绳、胶粘剂、或其他合适的元件。在一些实施方式中，柱构件76可相对于锚固构件或编织物40轴向地或纵向地移动并且/或者扣件58可固定地附接到锚固构件或编织物40。可考虑其他实施方式，即扣件58可以可移动地或可移除地附接到锚固构件或编织物40。在一些实施方式中，柱构件76可固定地附接到锚固构件或编织物40，并且扣件58可固定地附接到锚固构件或编织物40。在一些实施方式中，柱构件76和扣件58中的一个可固定地附接到锚固构件或编织物40，而另一个可以可移动地或可移除地附接到锚固构件或编织物40。在一些实施方式中，柱构件76可以可移动地或可移除地附接到锚固构件或编织物40，并且扣件58也可以可移动地或可移除地附接到锚固构件或编织物40。在一些实施方式中，柱构件76可被固定或附接(即，固定地附接、可移动地附接、可移除地附接等)到锚固构件或编织物40的远端。在一些实施方式中，扣件58可被固定或附接到锚固构件或编织物40的近侧部。在一些实施方式中，扣件58可被固定或附接在或附接到锚固构件或编织物40的近端。
在一些实施方式中，医用植入物14可包括多个瓣膜小叶16中的一个或多个，它们在各个相应的柱构件76处、在邻近各个相应的柱构件76处、和/或利用(至少部分地)各个相应的柱构件76而固定到锚固构件或编织物40。瓣膜小叶16也可被固定到锚固构件或编织物40的基部或远端。位于与多个柱构件76相邻(例如与其对准)位置的是相应的多个扣件58。在图示的实施例中，一个扣件58被附接到锚固构件或编织物40与三个柱构件76的每一个相邻。因此，锚固构件或编织物40具有总共三个扣件58和附接到三个扣件58的三个柱构件76。类似地，就在图示的实施例中总共三个的致动构件50而言，一个致动构件50可以可操作地与各个柱构件76和扣件58相联。可考虑其他实施方式，即可采用更少或更多的扣件58、柱构件76、和致动构件50。在一些实施方式中，可绕锚固构件或编织物40设置密封件44，并且如该术语所提示，密封件44可有助于在布置时将医用植入物14密封在靶标部位或感兴趣区域的内部并且/或者使医用植入物14抵接在靶标部位或感兴趣区域。
在一些实施方式中，医用植入物14与输送系统12之间的附接可通过联结器32的使用而实现。在一些实施方式中，联结器32可通常包括可被设置在输送系统12周围并且/或者附接到输送系统12的圆筒形基部(未图示)。从基部向远侧突出的是各自用于在其中一个扣件58的近端与医用植入物14相接合的多个指状件34(例如，两个、三个、四个等)。可围着联结器32的指状件34设置套管36，以进一步帮助将指状件34与扣件58保持在一起，如将在下面更详细地描述的。导向装置38可被设置在每个指状件34上方的靠近套管36的位置，并且可用于保持联结器32的指状件34与多个致动构件50相联，致动构件50延伸至邻近联结器32的指状件34(且相对于联结器32的指状件34可轴向地滑动)。最后，销释放构件18可以是保持柱构件76、扣件58、和致动构件50彼此相联的连接结构。在一些实施方式中，销释放构件18可以包括可经由盘旋状连接件24而连接到一起并且利用金属环22被保持到销释放芯棒20的多个单独的销构件26。一些合适但非限制性的用于联结器32、多个指状件34、套管36、导向装置38、销释放构件18、多个单独的销构件26、销释放芯棒20、和/或金属环22的材料，例如金属材料或聚合物材料，将在下面进行描述。
在输送期间，可借助于与扣件58的突出近端相连接的联结器32的指状件34的结合(并且利用设置在该连接处上的套管36保持就位)并且借助于将多个致动构件50和柱构件76固定到一起的销构件26，将医用植入物14固定在输送系统12的远端，如将在下面描述的。当使医用植入物14前进到靶标部位或感兴趣区域时，可将输送系统12拔出或回撤以使医用植入物14露出(或者，医用植入物14可相对于输送系统12向远侧前进)。然后，多个致动构件50可用于通过向近侧回撤多个致动构件50以拉动柱构件76使其与扣件58接合，而使医用植入物14和/或锚固构件或编织物40轴向地缩短和/或径向地扩张并且将其从“输送”构型“锁定”到扩张或“布置”构型(例如图1中所示)。最后，可将销构件26取出，由此使多个致动构件50与柱构件76分开，进而允许将多个致动构件50和联结器32的指状件34从医用植入物14中拔出，由此将医用植入物14(和/或锚固构件或编织物40)以“释放”构型布置在靶标部位或感兴趣区域。换句话说，“布置”构型与“释放”构型之间的一个差异是销构件26是否附接到柱构件76。在“布置”构型中，销构件26仍然附接到柱构件76，进而允许通过多个致动构件50向远侧前进来将医用植入物14(和/或锚固构件或编织物40)解锁，如下面进一步描述的，从而例如将医用植入物14重新定位。在一些实施方式中，多个瓣膜小叶16的至少一部分可在沿锚固构件或编织物40的纵向中心轴线的共同位置轴向地或纵向地与扣件58的至少一部分重叠，由此在一些实施方式中，可确保医用植入物14具有较短的总长度或高度。
图2至3示出了一示范性扣件58。扣件58可包括近端和设置在近端的相反侧的远端60。在一些实施方式中，扣件58可包括从近端延伸到远端60的后壁64。在一些实施方式中，扣件58可包括沿轴向延伸的两个侧壁62，侧壁62径向向内朝纵向中心轴线延伸而远离后壁64和/或锚固构件或编织物40，当扣件58附接到锚固构件或编织物40时。在一些实施方式中，后壁64可配置成与锚固构件或编织物40的径向内表面配对地接合，因此后壁64被设置成相对于两个侧壁62径向远离医用植入物14的纵向中心轴线。在一些实施方式中，后壁64可包括弯曲的外表面，配置成与管状的锚固构件或编织物40的内表面配合并且/或者靠在其上。
在一些实施方式中，沿轴向延伸的两个侧壁62可包括第一侧壁62和第二侧壁62。在一些实施方式中，每个侧壁62可包括从其远离后壁64的顶部伸出的上部凸缘61，上部凸缘61向内侧往中心面延伸，该中心面通过扣件58(和/或纵向中心轴线)与后壁64正交。至少在一些实施方式中，上部凸缘61可被定向成大体上平行于后壁64和/或后壁64的内表面。
在一些实施方式中，扣件58可包括形成在沿轴向延伸的两个侧壁62中的至少一个上的锁扣74。在一些实施方式中，锁扣74可以形成为穿过两个侧壁62中的至少一个的孔、开口、或洞。在一些实施方式中，当从远端60观察，后壁64在下方且侧壁62向上延伸时，锁扣74可被设置在左边的侧壁62上。在一些实施方式中，当从远端60观察，后壁64在下方且侧壁62向上延伸时，锁扣74可被设置在右边的侧壁62上。在一些实施方式中，锁扣74可形成在两个沿轴向延伸的侧壁62的每一个上。如同将在下面更详细地讨论的，锁扣74可配置成与柱构件76的插销部80接合来阻止柱构件76相对于扣件58向远侧移动。至少在一些实施方式中，插销部80可被收容在锁扣74内。
在一些实施方式中，后壁64可延伸于两个侧壁62之间，从而两个侧壁62、后壁64、和/或上部凸缘61界定出沿轴向延伸穿过扣件58的通道70。在一些实施方式中，扣件58和/或通道70可包括槽72(例如大体上D形的槽)，槽72沿着两个侧壁62中的其中一个，从中沿轴向穿过。在一些实施方式中，当从远端60观察，后壁64在下方且侧壁62向上延伸时，槽72可沿着左边的侧壁62沿轴向穿过扣件58。在一些实施方式中，槽72可至少部分地与通道70重合。在本公开中，D形的槽72仅是示例性的，可适当地使用其他合适的形状和/或主要特征。在一些实施方式中，后壁64可包括开设于后壁64上并且位于两个侧壁62之间的一个或多个孔66。在一些实施方式中，紧固件96(例如，缝合线、细线、丝、长丝等)可穿过一个或多个孔66并将扣件58固定到锚固构件或编织物40。在一些实施方式中，后壁64可包括与一个或多个孔66的部分或全部和扣件58的远端60相通的凹入部68。在一些实施方式中，当柱构件76被设置在通道70和/或槽72内时，紧固件96可经由凹入部68往远离扣件58的方向延伸。
在一些实施方式中，扣件58可以是大致刚性的。在一些实施方式中，扣件58可由金属材料、聚合物材料、陶瓷材料、复合材料、或其他合适的材料或它们的组合制成。在一些实施方式中，扣件58可部分是刚性和/或部分是挠性。在一些实施方式中，扣件58可允许致动构件50和/或柱构件76可滑动地收容于通道70和/或槽72内并且/或者沿着通道70和/或槽72沿轴向平移。在一些实施方式中，扣件58可配置成阻止致动构件50和/或柱构件76径向向内往锚固构件或编织物40的纵向中心轴线离开扣件58，从而将致动构件50和/或柱构件76的运动限制在轴向平移。
图4至7示出了一示范性柱构件76。在一些实施方式中，柱构件76可包括近端和远端86。在一些实施方式中，柱构件76可包括主体部78和插销部80，插销部80朝远侧方向往侧向延伸远离主体部78。在一些实施方式中，插销部80可包括至少一个支柱，该支柱朝远侧方向成角度地往侧向并且/或者往周向远离主体部78。在一些实施方式中，插销部80可包括成角度地往第一方向远离主体部78的第一支柱、以及成角度地往第二方向远离主体部78的第二支柱，相对于主体部78，该第二方向和该第一方向相反。在一些实施方式中，插销部80可以是有弹性的并且/或者自偏置远离主体部78。
在一些实施方式中，柱构件76可包括在其远端86通过挠性的铰接部82连接的悬臂式支腿84。在一些实施方式中，悬臂式支腿84可从铰接部82和/或远端86向近侧延伸至悬臂式支腿84的自由端，该自由端被设置在主体部78和/或插销部80的径向内侧(相对于锚固构件或编织物40)。在一些实施方式中，该自由端可被设置在插销部80的近侧。在一些实施方式中，插销部80可被设置在远端86和/或铰接部82的近侧。
在一些实施方式中，铰接部82可具有并且/或者包括曲率半径。例如，在一些实施方式中，该曲率半径可在0和3毫米(mm)之间。在一些实施方式中，该曲率半径可以是在0和3毫米(mm)之间的内侧曲率半径。在一些实施方式中，该曲率半径可以是在0和3毫米(mm)之间的外侧曲率半径。也可考虑其他构型和曲率半径。在一些实施方式中，铰接部82可配置成将主体部78和悬臂式支腿84设置成相对于彼此成锐角。在一些实施方式中，该锐角可在约0度和约90度之间、在约3度和约60度之间、在约5度和约45度之间、在约8度和约30度之间、在约10度和约20度之间、在约12度和约16度之间、约14度、或者另一个合适的角度。至少在一些实施方式中，铰接部82将悬臂式支腿84可挠曲地附接到柱构件76的主体部78。在一些实施方式中，至少部分的悬臂式支腿84可沿处于“布置”构型的锚固构件或编织物40的纵向中心轴线与扣件58纵向地重叠。
在一些实施方式中，悬臂式支腿84可包括自由端和固定端，其中悬臂式支腿84可在固定端附接到柱构件76的主体部78，该固定端可直接地连接到铰接部82。在一些实施方式中，除了悬臂式支腿84和/或多个瓣膜小叶16以外，悬臂式支腿84的自由端可不附接(即，不直接地附接)到医用植入物14的任何其他结构。换句话说，在一些实施方式中，自由端可不直接地附接到医用植入物14的任何其他结构或特征(即，扣件58、锚固构件或编织物40等)。在一些实施方式中，柱构件76的最远端(至少在一些实施方式中可以是并且/或者包括铰接部82)可联结到锚固构件或编织物40的远端，例如通过紧固件(例如，缝合线、长丝、丝、或其他合适的手段)。因此，当柱构件76向近侧被拉动而与扣件58接合时，锚固构件或编织物40的远端也相对于扣件58向近侧被拉动，由此从“输送”构型转变到“布置”构型。
至少在一些实施方式中，多个瓣膜小叶16中的一个或多个可附接到悬臂式支腿84。在一些实施方式中，通过将多个瓣膜小叶16附接到悬臂式支腿84，可提供挠性并且/或者减少多个瓣膜小叶16到锚固构件或编织物40之间的压力。在一些实施方式中，可将多个瓣膜小叶16直接地固定到悬臂式支腿84。在一些实施方式中，多个瓣膜小叶16可以不是直接地固定到柱构件76的主体部78，而是经由悬臂式支腿84联结到柱构件76。在一些实施方式中，多个瓣膜小叶16可包绕在悬臂式支腿84的至少一部分的周围。在一些实施方式中，多个瓣膜小叶16的最远端可联结到锚固构件或编织物40的远端。在一些实施方式中，可利用一条或多条缝合线、细线、丝、长丝、或其他合适的元件将多个瓣膜小叶16联结并且/或者固定(即，到悬臂式支腿84、到锚固构件或编织物40、和/或往回到它们自身)。在一些实施方式中，可利用胶粘剂、粘合剂、或其他合适的固定手段将多个瓣膜小叶16联结并且/或者固定(即，到悬臂式支腿84、到锚固构件或编织物40、和/或往回到它们自身)。在一些实施方式中，可利用织物、纺织品、或其他薄的挠性材料将多个瓣膜小叶16联结并且/或者固定(即，到悬臂式支腿84、到锚固构件或编织物40，和/或往回到它们自身)。
在一些实施方式中，柱构件76可包括附接区段88，附接区段88从主体部78向锚固构件或编织物40的纵向中心轴线延伸。在一些实施方式中，附接区段88可包括往侧向延伸且穿过其中的附接点或洞90、以及钩部92，钩部92在附接区段88的与主体部78为相反侧的末端往回朝向主体部78和/或锚固构件或编织物40弯曲大约180度。在一些实施方式中，附接区段88和/或附接点或洞90可被设置在插销部80的近侧。在一些实施方式中，主体部78可包括一个或多个孔或洞，用于利用紧固件(例如缝合线)将柱构件76固定到锚固构件或编织物40。
在一些实施方式中，插销部80可配置成在扣件58内与锁扣74接合，由此阻止柱构件76相对于扣件58向远侧移动。在一些实施方式中，柱构件76的至少一部分是挠性的。在一些实施方式中，插销部80可相对于主体部78移动。在一些实施方式中，插销部80可在其近端相对于主体部78可枢转地移动，由此插销部80的远端可相对于主体部78向侧向平移。在一些实施方式中，插销部80可相对于主体部78和/或锚固构件或编织物40向周向平移。在一些实施方式中，插销部80的相对于锚固构件或编织物40的纵向中心轴线并且/或者远离锁扣74的周向平移可使插销部80脱离锁扣74。在一些实施方式中，悬臂式支腿84可在铰接部82并且/或者利用铰接部82朝向并远离主体部78移动。
在一些实施方式中，主体部78可与插销部80、铰接部82、悬臂式支腿84、和/或附接区段88为一体，和/或一体形成为单一材料件，和/或从单一材料件形成。在一些实施方式中，柱构件76可由单件的丝、扁材、或其他合适的材料构成，如同在本文中所讨论的。在一些实施方式中，柱构件76可通过对单件的丝、扁材、或其他合适的材料进一步加工(例如，通过机械加工、冲压、激光切割等)而形成。一些合适但非限制性的用于主体部78、插销部80、铰接部82、悬臂式支腿84、和/或附接区段88的材料，例如金属材料或聚合物材料，将在下面进行描述。
图8至9示出了一示范性致动构件50。致动构件50可包括近端和远端。在使用中，近端可被使用者操纵或者驱动而使医用植入物14从“输送”构型转变到“布置”构型，然后转变到“释放”构型。在一些实施方式中，致动构件50可包括细长杆52，例如在一侧具有平面的D形的细长杆52，因此从远端观察时，细长杆52具有“D”形的外观，而且该平面在细长杆52的左侧(或者从近端观察时，细长杆52具有倒“D”形的外观，而且该平面在右侧，如图9中所示)。在一些实施方式中，细长杆52可包括成角度的或锥形的远端。
在一些实施方式中，致动构件50和/或细长杆52可大体上呈多边形(即，两边、三边、四边、五边、六边等)的形状。也可考虑其他形状(规则和不规则)。在一些实施方式中，致动构件50可由单件的丝、圆料、或其他合适的材料构成，如同在本文中所讨论的。在一些实施方式中，致动构件50可通过对单件的丝、圆料、或其他合适的材料进一步加工(例如，通过机械加工、冲压、激光切割等)而形成。在一些实施方式中，当致动构件50与扣件58接合之后，可阻止致动构件50相对于扣件58旋转(即，是不可旋转的)。在一些实施方式中，当致动构件50与柱构件76接合之后，可阻止致动构件50相对于柱构件76旋转(即，是不可旋转的)。
致动构件50的远侧部可延伸穿过扣件58的通道70和/或槽72。细长杆52的该平面可配置成可滑动地与扣件58的侧壁62配合并且/或者接合。在一些实施方式中，当从远端60观察，后壁64在下方且侧壁62向上延伸时，细长杆52的该平面可以可滑动地与扣件58的左边的侧壁62配合并且/或者接合。致动构件50可相对于扣件58沿轴向平移。
在一些实施方式中，致动构件50可包括固定地附接到致动构件50的远侧部的被拉长的附接部54。在一些实施方式中，附接部54可以是从细长杆52往大体上平行于该平面的方向延伸的扁平的附接部54。在一些实施方式中，扁平的附接部54可具有横切地延伸穿过扁平的附接部54的纵向取向的细长的槽56。在一些实施方式中，当致动构件50延伸穿过扣件58的通道70和/或槽72时，扁平的附接部54可在从扣件58的两个侧壁62伸出的上部凸缘61之间径向向内朝纵向中心轴线延伸。一些合适但非限制性的用于致动构件50、细长杆52、和/或附接部54的材料，例如金属材料或聚合物材料，将在下面进行描述。
在一些实施方式中，致动构件50可以在附接点或洞90可释放地连接到柱构件76。在一些实施方式中，致动构件50的附接部54可以可滑动地与柱构件76的附接区段88配合并且/或者接合。在一些实施方式中，细长的槽56可与附接点或洞90对准。在一些实施方式中，心脏瓣膜锁定机构可包括销构件26，销构件26在附接点或洞90可释放地与致动构件50的扁平的附接部54上的细长的槽56和柱构件76的附接区段88接合，并且延伸穿过致动构件50的扁平的附接部54上的细长的槽56和柱构件76的附接区段88，如图10至21中所示。在一些实施方式中，钩部92和/或附接区段88可配置成与附接部54配对地接合，由此阻止致动构件50和柱构件76之间的相对旋转。
在一些实施方式中，销构件26可包括伸直的远侧区段28以及位于远侧区段28的末端的弯曲的远侧顶端部分30。在一些实施方式中，弯曲的远侧顶端部分30可被设置成在附接点或洞90穿过致动构件50的扁平的附接部54上的细长的槽56和柱构件76的附接区段88。在一些实施方式中，销构件26从远侧区段28沿单一方向弯曲至弯曲的远侧顶端部分30，从而形成大体上圆形或环形的环。换句话说，销构件26可不具有多个拐弯处、曲线、或从远侧区段28到弯曲的远侧顶端部分30的方向的改变(例如，S曲线或正弦波形状，或横向偏移)。与具有多个拐弯处、曲线、或其中的方向的改变的销构件相比，从远侧区段28沿单一方向弯曲至弯曲的远侧顶端部分30可有助于并且/或者可允许使用较少的拉力来解开。
图10至24示出了配置成将医用植入物14(和/或锚固构件或编织物40)锁定在“布置”构型的锁定机构的选定部件的关系以及这些部件的操作。为了简单和清楚的目的，仅图示并讨论联结器32的其中一个指状件34、多个致动构件50的其中一个、其中一个柱构件76、其中一个扣件58、其中一个套管36、以及其中一个销构件26(未示出整个医用植入物14和/或锚固构件或编织物40，以便于对锁定机构的理解)。然而，应当理解的是以下的讨论同样地可适用于在医用植入物14(即，多个致动构件50、扣件58、柱构件76、销构件26等)和/或医疗植入系统10内部的多于一个的任何和/或全部的部件。
如在图21至24中所见，各致动构件50延伸穿过相邻于并覆盖联结器32的指状件34的导向装置38，穿过将指状件34联结并且/或者锁定到扣件58的套管36，穿过扣件58，并且与柱构件76并排。致动构件50可穿过扣件58沿轴向平移。在一些实施方式中，致动构件50可包括配置成可滑动地且不可旋转地与纵向地延伸穿过柱构件76的通道70和/或槽72(例如D形的槽)配合的键接定位结构(例如平面)。
现在来看图10至20，致动构件50的远端可包括纵向取向的细长的槽56，其可与穿过柱构件76的附接区段88的附接点或洞90对准。当如此地对准时，销构件26可穿过附接点或洞90和致动构件50的细长的槽56而打成环。这可释放地将致动构件50联结或附接到柱构件76并且形成可在医用植入物14的输送期间采用的这些结构的构型。正如可以理解的，柱构件76的近端与扣件58的远端可纵向地分离(例如在图10中所见)，因此，医用植入物14可处于适合于经过患者解剖结构经皮平移到感兴趣区域和/或靶标部位的细长且通常为小外形的“输送”构型。
当医用植入物14到达在解剖结构内部的预期靶标部位或感兴趣区域时，临床医生可向近侧回撤致动构件50，由此使柱构件76的近端朝向扣件58的远端60移动，从而朝向“布置”构型而轴向地缩短和/或径向地扩张医用植入物14的锚固构件或编织物40。当向近侧回撤或拉动致动构件50时，通过柱构件76的附接区段88中的附接点或洞90而定位的销构件26被设置成穿过细长的槽56的远端，如在图10至16中所见。最后，可将致动构件50充分地回撤，远到足以利用扣件58的锁扣74来接合柱构件76的插销部80，从而阻止柱构件76相对于扣件58向远侧移动(例如在来自锚固构件或编织物40的回弹应力作用下)，由此将医用植入物14锁定在适合于植入到解剖结构内部的“布置”构型(例如图15至16和图21中所见)。换句话说，在一些实施方式中，致动构件50在近侧方向上的相对于扣件58的向近侧的轴向平移(而且柱构件76因此可释放地连接到其上)使附接点或洞90从远离扣件58的第一位置移动至接近扣件58的远端60的第二位置，从而可将锚固构件或编织物40从“输送”构型驱动到“布置”构型。
然而，此时致动构件50仍然连接到柱构件76，因此能够向远侧推动致动构件50而将医用植入物14“解锁”，由此允许医用植入物14的重新定位和/或回撤。当向远侧推动致动构件50时，如图17至20中所见，可使致动构件50相对于柱构件76和/或扣件58向远侧平移，由此将延伸穿过柱构件76的附接区段88中的附接点或洞90的销构件26定位在细长的槽56的近端，同时致动构件50与柱构件76并排地经过柱构件76和扣件58的左边的侧壁62之间。致动构件50的向远侧的轴向平移将造成细长杆52的一部分(例如，细长杆52的延伸向附接部54的远侧的成角度的或锥形的远端)与插销部80接触和/或接合。至少在一些实施方式中，细长杆52的延伸向附接部54的远侧的部分可配置成在致动构件50向远侧前进时使插销部80相对于纵向中心轴线向周向平移并且/或者远离锁扣74，从而使插销部80脱离锁扣74。
当致动构件50和/或细长杆52充分地向远侧轴向平移，而使插销部80脱离锁扣74之后，如图19中所见，销构件26可被定位在细长的槽56的近端。一旦销构件26被定位在细长的槽56的近端，柱构件76可相对于扣件58和致动构件50一起向远侧移动，如图20中所见。换句话说，通过致动构件50的向远侧的轴向平移可将锚固构件或编织物40从“布置”构型解锁。在销构件26被定位在细长的槽56的近端时，进一步向远侧推动致动构件50将造成通过销构件26而相互连接的致动构件50和柱构件76相对于扣件58向远侧平移，由此驱动锚固构件或编织物40从“布置”构型转变到“输送”构型。
替代地，如果临床医生对医用植入物14的定位和/或锁定(例如，在利用合适成像技术的医用植入物14的可视化之后)感到满意，便可拉动销构件26(例如，从柱构件76的附接区段88中的附接点或洞90和致动构件50的附接部54上的细长的槽56中取出)，以便从柱构件76分开致动构件50并且/或者使致动构件50脱离柱构件76，例如可由此允许将致动构件50从柱构件76向近侧回撤，如在图22中所见。
致动构件50的进一步回撤可导致致动构件50的附接部54与套管36接合，并且导致当致动构件50向近侧回撤时套管36沿联结器32的指状件34向近侧滑动。在这种情况下，联结器32的指状件34的具有形成在其中的凹槽的叉形端露出，并且可从扣件58的近端上的轨道分开，该轨道具有形成在其上的突出部，配置成与凹槽配对地接合，如图23中所示。在叉形端脱离轨道之后，至少一个致动构件50的进一步向近侧的回撤导致联结器32的指状件34从锁定机构和医用植入物14向近侧回撤，如图24中所见，例如可由此将处于“释放”构型的医用植入物14留置在靶标部位。
可用于医疗植入系统10(和/或本文中所公开的其他系统)的各种部件及其中的各种元件的材料可包括那些通常与医疗设备相关的材料。为了简单起见，以下的描述提到了输送系统12和/或医用植入物14。然而，这并非意图限制本文中所描述的设备和方法，因为该描述可适用于本文中所公开的其他元件、构件、部件、或设备，例如但不限于锚固构件或编织物40、致动构件50、柱构件76、扣件58、销构件26、和/或其中的其他元件或部件。
在一些实施方式中，输送系统12和/或医用植入物14和/或它们的部件可由金属、金属合金、聚合物(下面公开了聚合物的一些例子)、金属-聚合物复合材料、陶瓷、它们的组合等、或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，例如304V、304L、和316LV不锈钢；软钢；镍-钛合金，例如线弹性和/或超弹性镍钛合金；其他镍合金，例如镍-铬-钼合金(例如，UNS:N06625(例如625)、UNS:N06022(例如C-)、UNS:N10276(例如)、其他的合金等)、镍-铜合金(例如UNS:N04400(例如400、400、400等))、镍-钴-铬-钼合金(例如UNS:R30035(例如MP35-等))、镍-钼合金(例如UNS:N10665(例如ALLOY))、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:R30003(例如等))；富含铂的不锈钢；钛；它们的组合等；或者任何其他合适的材料。
如本文中所提到的，在市售的镍-钛或镍钛合金的家族中，是被指定为“线弹性”或“非超弹性”的类别，尽管在化学性质上可能类似于常规的形状记忆和超弹性品种，仍可显示独特和有用的机械性能。线弹性和/或非超弹性镍钛合金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在其应力/应变曲线中不显示明显的“超弹性坪区(superelastic plateau)”或“标志区(flag region)”，如同超弹性镍钛合金在其应力/应变曲线中会明显显示的。相反地，在线弹性和/或非超弹性镍钛合金中，当可恢复应变增加时，应力继续以大体上线性或稍微但不完全地线性关系增大，直到塑性变形开始或至少成为比在超弹性镍钛合金可看到的超弹性坪区和/或标志区更加线性的关系。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“大体上”线弹性和/或非超弹性镍钛合金。
在一些情况下，线弹性和/或非超弹性镍钛合金与超弹性镍钛合金的区别之处也在于：线弹性和/或非超弹性镍钛合金可接受高达约2-5％的应变同时仍然大体上保持弹性(例如在塑性变形之前)，而在塑性变形之前超弹性镍钛合金可接受高达约8％的应变。这两种材料可与其他线弹性材料例如不锈钢有所区别(也可基于其组成而有所区别)，不锈钢在塑性变形之前可接受仅约0.2至0.44％的应变。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金是不显示任何可通过差示扫描量热法(DSC)和动态金属热分析(DMTA)在大的温度范围内进行分析而可检测到的、马氏体/奥氏体相变的合金。例如，在一些实施方式中，在线弹性和/或非超弹性镍-钛合金中可不存在可通过DSC和DMTA在约-60摄氏度(℃)至约120℃范围内进行分析而可检测到的马氏体/奥氏体相变。因此，这种材料的机械弯曲性能通常不容易受在此非常大的温度范围内的温度影响。在一些实施方式中，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能与在体温下的机械性能是大致相同的，例如，它们不显示超弹性坪区和/或标志区。换句话说，在大的温度范围内，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/或性能。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金可含有约50至约60重量％范围内的镍，剩余的基本上是钛。在一些实施方式中，其组成是含有约54至约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的古河科技材料公司购得的FHP-NT合金。其他合适的材料可包括ULTANIUMTM(从Neo-Metrics公司购得)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)可用于获得期望的性能。
至少在一些实施方式中，部分或全部的输送系统12和/或医用植入物14和/或它们的部件也可用不透射线材料进行参杂、制成、或者包含不透射线材料。不透射线材料被理解成是在医疗程序期间能够在荧光屏上(或者通过另一种成像技术)形成相对较明亮的图像的材料。此相对较明亮的图像可帮助医疗植入系统10的使用者确定其位置。不透射线材料的一些例子可包括但不限于：金、铂、钯、钽、钨合金、用透射线填充剂加载的聚合物材料等。此外，也可将其他不透射线标记带和/或线圈并入医疗植入系统10的设计中，以获得相同的结果。
在一些实施方式中，医疗植入系统10被赋予一定程度的磁共振成像(MRI)兼容性。例如，输送系统12和/或医用植入物14和/或它们的部件或部分可由不会显着地使图像变形并且产生明显的伪影(即，图像中的不一致)的材料制成。举例来说，某些铁磁材料会是不合适的，因为它们可能会在MRI图像中产生伪影。输送系统12和/或医用植入物14和/或它们的各部分，也可由MRI机器能够成像的材料制成。显示这些特性的一些材料包括例如：钨、钴-铬-钼合金(例如UNS:R30003(例如等))、镍-钴-铬-钼合金(例如UNS:R30035(例如MP35-等))、镍钛合金等、以及其他。
可将护套或覆盖物(未图示)设置在部分或全部的输送系统12上，其可界定出用于医疗植入系统10的通常平滑的外表面。然而，在其他实施方式中，这种护套或覆盖物可从全部医疗植入系统10中的一部分去除，使得输送系统12可形成外表面。该护套可由聚合物或其他合适的材料制成。合适的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)、氟化乙丙烯(FEP)、聚甲醛(POM，例如从杜邦公司购得的)、聚醚嵌段酯、聚氨酯(例如聚氨酯85A)、聚丙烯(PP)、聚氯乙稀(PVC)、聚醚酯(例如，从DSMEngineering Plastics公司购得的)、基于醚或酯的共聚物(例如，邻苯二甲酸丁烯/聚(烷基醚)和/或其他聚酯弹性体，例如从杜邦公司购得的)、聚酰胺(例如，从Bayer公司购得的或从Elf Atochem公司购得的)、弹性体聚酰胺类、嵌段聚酰胺/醚类、聚醚嵌段酰胺(PEBA，例如以商品名称购得)、乙烯醋酸乙烯共聚物(EVA)、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(例如，从EMS American Grilon公司购得的)、全氟(正丙基乙烯基醚)(PFA)、乙烯-乙烯醇共聚物、聚烯烃、聚苯乙稀、环氧树脂、聚偏二氯乙稀(PVdC)、聚(苯乙稀-b-异丁稀-b-苯乙稀)(例如，SIBS和/或SIBS50A)、聚碳酸酯类、离子交联高分子、生物相容性聚合物、其他合适的材料、或混合物、组合、它们的共聚物、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，该混合物可含有多达约6％的LCP。
在一些实施方式中，可对医疗植入系统10的外表面(包括例如输送系统12的外表面)进行喷砂、喷丸、喷碳酸氢钠、用电解法抛光等。在这些实施方式以及一些其他实施方式中，可将涂层(例如，润滑的、亲水性、保护性、或其他类型的涂层)涂覆在部分或全部的护套上，或者涂覆在没有护套的实施方式中的部分的输送系统12上，或者涂覆在其他部分的医疗植入系统10上。可替代地，护套可包括润滑的、亲水性、保护性、或其他类型的涂层。疏水性涂层(例如含氟聚合物)提供改善设备处理和设备交换的干燥润滑性。润滑涂层改善可操纵性并且改善穿越病变能力。合适的润滑聚合物在本领域是众所周知的，并且可包括硅酮等，亲水性聚合物例如高密度聚乙烯(HDPE)、聚四氟乙烯(PTFE)、聚氧化芳撑、聚乙烯吡咯烷酮、聚乙烯醇、羟基烷基纤维素、褐藻胶、糖类、己内酯等、及它们的混合物和组合。亲水性聚合物可在它们自身中混合或者与配方量的水不溶性化合物(包括一些聚合物)混合以获得具有合适的润滑性、粘结性、和溶解性的涂层。
可例如通过涂覆、挤出、共挤出、中断层共挤出(ILC)、或端到端若干片段融合法来形成涂层和/或护套。该层可具有均匀的刚度或者从近端到其远端逐渐减小的刚度。刚度的逐渐减小可以是连续的例如通过ILC或者可以是阶梯形的例如通过将分离的挤出管状片段融合到一起。可用不透射线填充材料浸渍外层以促成射线照相可视化。本领域技术人员将认识到，在不偏离本发明范围的情况下这些材料可有广泛的变化。
应当理解的是本公开在许多方面只是说明性的。在不超过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、和步骤的布置方面。在适当的程度上，这可包括将一个示范性实施方式中的任何特征用于其他实施方式中。当然，本发明的范围被限定在所附权利要求所表述的用语中。

Claims (35)

1.一种置换心脏瓣膜锁定机构，包括：
扣件，其固定地附接到管状的锚固构件；
柱构件，其可相对于所述扣件沿轴向平移；以及
致动构件，其在附接点处可释放地连接于所述柱构件；
其中，所述柱构件包括插销部，配置成与形成在所述扣件的锁扣接合来阻止所述柱构件相对于所述扣件向远侧移动；
其中所述附接点被设置在所述插销部的近侧。
2.根据权利要求1所述的置换心脏瓣膜锁定机构，其进一步包括销构件，所述销构件在所述附接点可释放地与所述致动构件和所述柱构件接合，并且延伸穿过所述致动构件和所述柱构件。
3.根据权利要求2所述的置换心脏瓣膜锁定机构，其中，所述销构件包括伸直的远侧区段，以及位于所述远侧区段远侧的弯曲的远侧顶端部分。
4.根据权利要求3所述的置换心脏瓣膜锁定机构，其中，所述销构件从所述远侧区段沿单一方向弯曲穿过所述远侧顶端部分。
5.根据权利要求1至4中任一项所述的置换心脏瓣膜锁定机构，其中，所述柱构件的向近侧的轴向平移使所述附接点从远离所述扣件的第一位置移动至接近所述扣件的远端的第二位置。
6.根据权利要求1至5中任一项所述的置换心脏瓣膜锁定机构，其中，所述柱构件包括从所述柱构件的远端向近侧延伸的悬臂式支腿。
7.根据权利要求1至6中任一项所述的置换心脏瓣膜锁定机构，其中，所述扣件是大致刚性的，而且所述插销部能够相对于所述柱构件的主体部移动。
8.根据权利要求1至7中任一项所述的置换心脏瓣膜锁定机构，其中，所述柱构件包括主体部，而且所述插销部能够相对于所述主体部移动；
所述插销部相对于所述锚固构件的纵向中心轴线的周向平移使所述插销部脱离所述锁扣。
9.根据权利要求8所述的置换心脏瓣膜锁定机构，其中，所述扣件包括：轴向延伸的两个侧壁，往远离所述锚固构件的方向延伸；后壁，延伸于所述两个侧壁之间，并且界定出沿轴向延伸穿过所述扣件的通道；以及一个或多个孔，开设于所述后壁中且位于所述两个侧壁之间；
其中，紧固件穿过所述一个或多个孔并将所述扣件固定到所述锚固构件。
10.根据权利要求9所述的置换心脏瓣膜锁定机构，其中，所述扣件包括沿着所述两个侧壁中的其中一个，从中沿轴向穿过的槽；
所述槽至少部分地与所述通道重合。
11.根据权利要求9或10所述的置换心脏瓣膜锁定机构，其中，所述后壁被设置成相对于所述两个侧壁径向远离所述纵向中心轴线，所述后壁包括与所述一个或多个孔和所述扣件的远端相通的凹入部。
12.根据权利要求11所述的置换心脏瓣膜锁定机构，其中，当所述柱构件被设置在所述通道内时，所述紧固件经由所述凹入部往远离所述扣件的方向延伸。
13.根据权利要求9至12中任一项所述的置换心脏瓣膜锁定机构，其中，所述锁扣形成在所述两个侧壁中的至少一个中。
14.根据权利要求8至13中任一项所述的置换心脏瓣膜锁定机构，其中，所述致动构件包括固定地附接到D形细长杆的扁平附接部。
15.根据权利要求14所述的置换心脏瓣膜锁定机构，其中，所述细长杆的至少一部分延伸向所述附接部的远侧，并且配置成在所述致动构件向远侧前进时使所述插销部相对于所述纵向中心轴线向周向平移，以使所述插销部脱离所述锁扣。
16.一种置换心脏瓣膜锁定机构，包括：
扣件，其固定地附接到管状的锚固构件；
柱构件，其可相对于所述扣件沿轴向平移；以及
致动构件，其在附接点可释放地连接于所述柱构件；
其中，所述柱构件包括插销部，配置成与形成在所述扣件的锁扣接合来阻止所述柱构件相对于所述扣件向远侧移动；
所述附接点被设置在所述插销部的近侧。
17.根据权利要求16所述的置换心脏瓣膜锁定机构，其进一步包括销构件，所述销构件在所述附接点可释放地与所述致动构件和所述柱构件接合，并且延伸穿过所述致动构件和所述柱构件。
18.根据权利要求17所述的置换心脏瓣膜锁定机构，其中，所述销构件包括伸直的远侧区段，以及位于所述远侧区段的远侧的弯曲的远侧顶端部分。
19.根据权利要求18所述的置换心脏瓣膜锁定机构，其中，所述销构件从所述远侧区段沿单一方向弯曲穿过所述远侧顶端部分。
20.根据权利要求16所述的置换心脏瓣膜锁定机构，其中，所述柱构件的向近侧的轴向平移使所述附接点从远离所述扣件的第一位置移动至接近所述扣件的远端的第二位置。
21.根据权利要求16所述的置换心脏瓣膜锁定机构，其中，所述柱构件包括从所述柱构件的远端向近侧延伸的悬臂式支腿。
22.根据权利要求16所述的置换心脏瓣膜锁定机构，其中，所述扣件是大致刚性的。
23.根据权利要求16所述的置换心脏瓣膜锁定机构，其中，所述柱构件的至少一部分是挠性的。
24.根据权利要求22所述的置换心脏瓣膜锁定机构，其中，所述插销部能够相对于所述柱构件的主体部移动。
25.一种置换心脏瓣膜锁定机构，包括：
扣件，其固定地附接到管状的锚固构件，所述锚固构件界定了纵向中心轴线；
柱构件，其可相对于所述扣件在所述扣件内沿轴向平移；以及
致动构件，其在附接点可释放地连接于所述柱构件；
其中，所述柱构件包括主体部与插销部，所述插销部能够相对于所述主体部移动，且配置成与形成在所述扣件的锁扣接合来阻止所述柱构件相对于所述扣件向远侧移动；
其中所述插销部的相对于所述纵向中心轴线的周向平移使所述插销部脱离所述锁扣。
26.根据权利要求25所述的置换心脏瓣膜锁定机构，其中，所述扣件包括：轴向延伸的两个侧壁，往远离所述锚固构件的方向延伸；后壁，延伸于所述两个侧壁之间，并且界定出沿轴向延伸穿过所述扣件的通道；以及一个或多个孔，开设于所述后壁上且位于所述两个侧壁之间；
其中，紧固件穿过所述一个或多个孔并将所述扣件固定到所述锚固构件。
27.根据权利要求26所述的置换心脏瓣膜锁定机构，其中，所述扣件包括沿着所述两个侧壁中的其中一个，从中沿轴向穿过的槽。
28.根据权利要求27所述的置换心脏瓣膜锁定机构，其中，所述槽至少部分地与所述通道重合。
29.根据权利要求26所述的置换心脏瓣膜锁定机构，其中，所述后壁被设置成相对于所述两个侧壁径向远离所述纵向中心轴线，所述后壁包括与所述一个或多个孔和所述扣件的远端相通的凹入部。
30.根据权利要求29所述的置换心脏瓣膜锁定机构，其中，当所述柱构件被设置在所述通道内时，所述紧固件经由所述凹入部往远离所述扣件的方向延伸。
31.根据权利要求26所述的置换心脏瓣膜锁定机构，其中，所述锁扣形成在所述两个侧壁中的至少一个上。
32.根据权利要求25所述的置换心脏瓣膜锁定机构，其中，所述柱构件包括从所述柱构件的远端向近侧延伸的悬臂式支腿。
33.根据权利要求25所述的置换心脏瓣膜锁定机构，其中，所述致动构件包括固定地附接到D形细长杆的扁平附接部。
34.根据权利要求33所述的置换心脏瓣膜锁定机构，其中，所述细长杆的至少一部分延伸向所述附接部的远侧。
35.根据权利要求34所述的置换心脏瓣膜锁定机构，其中，所述细长杆的延伸向所述附接部的远侧的所述部分，是配置成在所述致动构件向远侧前进时使所述插销部相对于所述纵向中心轴线向周向平移，以使所述插销部脱离所述锁扣。
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