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CN111163729B - 医疗植入物锁定机构 - Google Patents

医疗植入物锁定机构 Download PDF

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CN111163729B
CN111163729B CN201880062074.4A CN201880062074A CN111163729B CN 111163729 B CN111163729 B CN 111163729B CN 201880062074 A CN201880062074 A CN 201880062074A CN 111163729 B CN111163729 B CN 111163729B
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locking portion
actuator element
anchor member
heart valve
expandable anchor
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CN111163729A (zh
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迈克尔·P·卡洛梅尼
塔卡什·H·伊诺
兰迪·S·加马拉
弗罗里扎·Q·埃斯帕诺拉
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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
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic 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)
  • Prostheses (AREA)

Abstract

一种医疗装置系统可包括替换心脏瓣膜植入物，所述替换心脏瓣膜植入物包括一可扩张锚定部件，所述可扩张锚定部件在递送配置和部署配置之间可逆地致动，其中所述替换心脏瓣膜植入物包括至少一个锁定机构，所述锁定机构配置为将所述可扩张锚定部件锁定在所述部署配置；和至少一个致动器元件，所述致动器元件配置为可释放地接合所述至少一个锁定机构且在所述递送配置和所述部署配置之间致动所述可扩张锚定部件。所述至少一个致动器元件可包括位于每一个致动器元件的远侧部分上的外部螺纹以及部署于所述外部螺纹近处的坡部。

Description

医疗植入物锁定机构
对于相关申请的交叉引用
本申请在35 U.S.C.§119下要求在2017年8月1日提交的、美国临时申请系列号No.62,539,717的优先权的权益，该申请整体通过引用结合至此。
技术领域
本申请涉及医疗装置、以及用于制造和/或使用医疗装置的方法。更特定地，本公开涉及医疗植入物和/或替换心脏瓣膜(replacement heart valve)的锁定机构。
背景技术
已经开发了各种医疗用，例如血管内使用，的体内医疗装置。这些装置中的一些包括导丝、导管、医疗装置递送系统(如，用于支架、移植物、替换瓣膜)等。用各种不同制造方法中的任一项来制造这些装置且可根据各种方法中的任一项而被使用。在已知医疗装置和方法中，各自具有特定优势和劣势。存在提供用于制造和使用医疗装置的可选医疗装置以及可选方法的持续需求.
发明内容
在第一方面，一种医疗装置系统可包括替换心脏瓣膜植入物，所述替换心脏瓣膜植入物包括可扩张锚定部件，所述可扩张锚定部件在递送配置和部署配置之间可逆地致动，其中所述替换心脏瓣膜植入物包括至少一个锁定机构，所述锁定机构配置为将所述可扩张锚定部件锁定在所述部署配置；和至少一个致动器元件，所述致动器元件配置为可释放地接合所述至少一个锁定机构且在所述递送配置和所述部署配置之间致动所述可扩张锚定部件。所述至少一个致动器元件可包括位于每一个致动器元件的远侧部分上的外部螺纹以及布置于所述外部螺纹近处的坡部(ramp)。
附加地或可选地，且在第二方面，所述至少一个锁定机构包括紧固至所述可扩张锚定部件的第一锁定部分和紧固至所述可扩张锚定部件的第二锁定部分，在所述递送配置中所述第一锁定部分和所述第二锁定部分相对于彼此可纵向地移动。
附加地或可选地，且在第三方面，所述第一锁定部分非可释放地固定至所述可扩张锚定部件的远侧部分，且所述第二锁定部分固定地紧固至所述可扩张锚定部件的近侧部分。
附加地或可选地，且在第四方面，所述第二锁定部分配置为将所述第一锁定部分可滑动地容纳于通过所述第二锁定部分延伸的纵向通道(channel)内。
附加地或可选地，且在第五方面，当所述第一锁定部分至少部分地布置在所述纵向通道内时所述第一锁定部分相对于所述第二锁定部分是非可旋转的。
附加地或可选地，且在第六方面，所述第一锁定部分包括至少部分地通过所述第一锁定部分的纵向取向通路(passageway)，所述纵向取向通路被配置为容纳所述至少一个致动器元件的所述远侧部分。
附加地或可选地，且在第七方面，所述纵向取向通路包括对应于所述外部螺纹的内部螺纹。
附加地或可选地，且在第八方面，所述至少一个锁定机构的每一个的所述第二锁定部分包括至少一个弹簧臂，所述弹簧臂配置为相对于所述可扩张锚定部件的中心纵向轴周向地偏转。
附加地或可选地，且在第九方面，当所述坡部纵向地平移通过所述第二锁定部分时所述坡部被配置为周向地偏转所述至少一个弹簧臂的每一个。
附加地或可选地，且在第十方面，所述第一锁定部分包括对应于所述至少一个弹簧臂的每一个的至少一个孔隙，且所述至少一个孔隙以相对于所述中心纵向轴为非零角度延伸通过所述第一锁定部分且配置为容纳其对应的弹簧臂的一部分。
附加地或可选地，且在第十一方面，所述至少一个弹簧臂的每一个配置为在所述至少一个致动器元件从所述至少一个锁定机构脱离后防止所述第一锁定部分相对于所述第二锁定部分的远处移动。
附加地或可选地，且在第十二方面，医疗装置系统可包括外部护套；把手部，所述把手部布置在所述外部护套的近端处；替换心脏瓣膜植入物，所述替换心脏瓣膜植入物包括可扩张锚定部件，所述可扩张锚定部件在递送配置和部署配置之间可逆地致动，其中所述替换心脏瓣膜植入物包括至少一个锁定元件，所述锁定元件配置为将所述可扩张锚定部件锁定为所述部署配置；以及至少一个致动器元件，所述致动器元件配置为可释放地接合所述至少一个锁定机构且在所述递送配置和所述部署配置之间致动所述可扩张锚定部件。所述至少一个致动器元件可包括位于每一个致动器元件的远侧部分上的外部螺纹以及布置于所述外部螺纹近处的坡部(ramp)。所述至少一个致动器元件可从所述把手部延伸至所述替换心脏瓣膜植入物，所述替换心脏瓣膜植入物布置在所述外部护套的远端处。
附加地或可选地，且在第十三方面，所述至少一个致动器元件配置为当所述至少一个致动器元件与所述至少一个锁定机构接合时在所述递送配置和所述部署配置之间可逆地致动所述可扩张锚定部件。
附加地或可选地，且在第十四方面，所述把手部配置为在所述部署配置中相对于所述至少一个锁定机构来旋转所述至少一个致动器元件的每一个。
附加地或可选地，且在第十五方面，在所述部署配置中所述至少一个致动器元件相对于所述至少一个锁定机构的旋转将所述至少一个致动器元件与所述至少一个锁定机构脱离并释放所述替换心脏瓣膜植入物。
附加地或可选地，且在第十六方面，一种医疗装置系统可包括外部护套；把手部，所述把手部布置在所述外部护套的近端处；替换心脏瓣膜植入物，所述替换心脏瓣膜植入物包括可扩张锚定部件，所述可扩张锚定部件在递送配置和部署配置之间可逆地致动，其中所述替换心脏瓣膜植入物包括多个锁定机构，所述锁定机构配置为将所述可扩张锚定部件锁定为所述部署配置；以及多个致动器元件，所述致动器元件与所述多个锁定机构对应且配置为可释放地接合所述多个锁定机构并在所述递送配置和所述部署配置之间致动所述可扩张锚定部件。所述多个锚定元件可包括接近每一个致动器元件的远端的外部螺纹以及布置在所述外部螺纹近处的坡部。所述多个致动器元件可从所述把手部延伸至所述替换心脏瓣膜植入物，所述替换心脏瓣膜植入物布置在所述外部护套的远端处。
附加地或可选地，且在第十七方面，所述可扩张锚定部件是管状的且界定一腔体，所述腔体沿所述替换心脏瓣膜植入物的中心纵轴线同轴地延伸。
附加地或可选地，且在第十八方面，所述把手部配置为在所述部署配置中相对于所述外部护套来旋转所述多个致动器元件的每一个。
附加地或可选地，且在第十九方面，所述多个致动器元件中的每一个界定其自身纵向致动器轴且配置为绕其自身纵向致动器轴而旋转。
附加地或可选地，且在第二十方面，所述多个锁定机构各自包括：
第一锁定部分，所述第一锁定部分紧固至所述可扩张锚定部件且具有附连至所述第一锁定部分的至少一个瓣叶；和
第二锁定部分，所述第二锁定部分紧固至所述可扩张锚定部件；
其中对应于所述多个锁定机构的每一个的所述多个致动器元件的所述致动器元件在所述递送配置中纵向地延伸通过其锁定机构的所述第二锁定部分。
所述第一锁定部分和所述第二锁定部分在所述递送配置中相对于彼此纵向地可移动。
一些实施例、方面、和/或示例的上述概述并非意在描述本公开的每一个实施例或全部实现。下述的附图和详细描述特定地示例化这些实施例。
附图简述
接合所附附图，考虑到各实施例的下述详细描述，可更完整地理解本公开，在附图中：
图1示出一示例性医疗装置系统；
图2是一示例性医疗植入物的立体图；
图3示出一示例性致动器元件；
图4示出一示例性柱状部件；
图4A是沿线4A-4A所取的图4的示例性柱状部件的截面视图；
图5示出一示例性锁扣部件；
图6示出与处于递送配置的一示例性医疗装置系统相关联的一示例性医疗植入物的所选组件；
图7是图6的所选组件的部分截面视图；
图8示出与处于部署配置的一示例性医疗装置系统的一示例性医疗植入物的所选组件；
图9是图8的所选组件的部分截面视图；
图10示出与从部署配置过渡至释放配置的一示例性医疗装置系统相关联的一示例性医疗植入物的所选组件；
图11是图10的所选组件的部分截面视图；和
图12示出与处于释放配置的一示例性医疗装置系统相关联的示例性医疗植入物的所选组件。
尽管本公开的各方面可修改为各种变型和替换形式，已经通过附图的方式示出且将详细描述其中的一些细节。然而，应该理解的是，并非意在将本公开的各方面限制为所描述的特定实施例。反之，意在覆盖落在本公开的精神与范围内的所有变型、等效物、和替换物。
详细描述
应参看附图来阅读以下描述，附图并不一定成比例，其中在数个视图中类似的附图标记指示类似元件。详细描述和附图意在描述而非限制所要求保护的发明。本领域技术人员将了解，在不背离本公开范围的情况下，所描述和/或示出的各元件可安排为各种组合与配置。详细描述与附图说明所要求保护的发明的示例性实施例。
对于下述所定义的术语，将适用这些定义，除非在权利要求中或说明书其他地方给出不同的定义。
不论是否明示，所有数值此处被认定为由术语“约”所修改。术语“约”，在数值的上下文中，一般是指本领域技术人员将认为等效于所引用的值(如，具有相同功能或效果)的数字范围。在很多实例中，术语“约”可包括四舍五入到最近有效数字的数字。除非另外指出，如从本说明书的上下文中所理解且与之一致，术语“约”的其他用途(如，在数值外的上下文中)可被认定为具有它们的一般且惯常的定义。
由端点引用的数字范围包括该范围内的所有数字(如，1到5包括1、1.5、2、2.75、3、3.80、4、和5)。
尽管公开了涉及各组件、特征和/或说明书的一些合适的尺寸、范围、和/或值，本领域技术人员，受到本公开所启示(incite)，将理解期望的尺寸、范围、和/或值可偏离所明确公开的那些。
如本说明书和随附权利要求中所使用地那样，除非上下文清楚地另有陈述，单数形式“一(a)”、“一个(an)”、和“该(the)”包括复数形式。如本说明书和随附权利要求中所使用地那样，除非上下文清楚地另有陈述，术语“或(or)”一般地采用其包括“和/或(and/or)”的意义。要注意的是，为了便于理解，可用单数来描述本公开的特定特征，即使这些特征可以是复数或在所公开的实施例(多个)中反复出现。除非明确地相反陈述，特征的每一个实例可包括和/或由单数形式的公开(多个)所包含。为了简洁和清楚目的，并非所公开的发明的所有元件一定被图示在每一个附图中或在下述详细讨论。然而，除非明确地相反陈述，将理解的是对于存在多于一个组件的情况，下述讨论相同地适用于组件的任意和/或所有。附加地，为清楚起见，没有将一些元件或特征的所有实例可图示在每一个附图中。
相关术语，诸如“近”、“远”、“前进”、“撤回”、其变型等，可整体地参看各元件相对于装置的用户/操作者/操纵者的放置、方向、和/或操作来考虑，其中“近”和“撤回”指示或涉及更接近或向着用户且“远”或“前进”指示或涉及更远离或离开用户。在一些实例中，为了帮助理解本公开，术语“近”和“远”可任意分配，并且这些实例对于本领域技术人员来说是显而易见的。其他相关术语，如“上游”、“下游”、“流入”和“流出”涉及腔体内或装置内的流体流动方向，腔体诸如是如体腔、血管。
术语“范围(extent)”可被理解为意味着所陈述或标识的尺寸的最大测量。例如，“外部范围”可理解为意味着最大外部尺寸，“径向范围”可被理解为最大径向尺寸，“纵向范围”可被理解为最大纵向尺寸等。“范围”的每一个实例可不同(如，轴向、纵向、横向、径向、周向等)且对于本领域技术人员从每个用途的上下文而言是显而易见的。一般地，“范围”可被认为根据所意向用途所测得的最大可能的尺寸。在一些实例中，“范围”可在平面和/或截面中正交地测得，但可以是，如从特定上下文中明显可见地，被不同地测得—诸如，但不限于，成角度地、径向地、周向地(如，沿着弧)等。
要注意的是说明书中对于“一实施例”、“一些实施例”、“其他实施例”等的引用指示着所描述的实施例(多个)可包括特定特征、结构、特性等，但是每一个实施例可并不必然包括所述特定特征、结构、或特性。此外，这样的短语并不必然涉及相同的实施例。进一步，当结合一实施例描述额定特征、结构、或特性时，不论是否明示描述，除非清楚地相反陈述，将在本领域技术人员的认知内结合其他实施例来实现该特定特征、结构、或特性。即，下述各种各元件，即使没有明确图示为特定组合，无论如何可被构想为彼此可组合或可设置以形成其他附加实施例或来实现和/或丰富所描述的实施例(多个)，如本领域普通技术人员将理解地那样。
为清楚起见，特定标识的数字命名(如，第一、第二、第三、第四等)可在整个描述和/或权利要求中使用来命名和/或区分各个所描述和/或要求保护的特征。将理解的是，数字命名并不意味着限制且仅仅是示例性的。在一些实施例中，为了简洁和清楚的原因，可做出与之前所用数字命名的变型和偏离。即，标识为“第一”元件的特征在下文中可认为是“第二”元件、“第三”元件等或可被完全省略，和/或可将不同的特征认为是“第一”元件。每个实例中的含义和/或名称(designation)对熟练的从业人员都是显而易见的。
影响心血管系统的疾病和/或医疗病况在全世界普遍存在。传统地，通常是通过直接进入系统的受影响部分来进行心血管系统的治疗。例如，传统地采用冠状动脉搭桥手术来治疗一条或多条冠状动脉阻塞的治疗。如可被容易理解地，这样的治疗对患者是非常侵入性的且需要大量的恢复时间和/或治疗。最近，已经研发出来了较少侵入性的治疗，例如，可经由经皮导管(如，血管成形术)进入和治疗阻塞的冠状动脉。这样的治疗已在患者和医师间得到广泛接受。
一些相对常见的病况可包括或是心脏内一个或多个瓣膜的低效(inefficiency)、无效(ineffectiveness)或完全衰竭的原因。例如，主动脉瓣或二尖瓣的衰竭可对人体产生严重影响，且如果处理不当可导致严重健康状况和/或死亡。对有缺陷的心脏瓣膜的治疗带来了其他的挑战，在于，这样的治疗经常需要修复或彻底替换有缺陷的瓣膜。这种疗法可对患者是高度侵入性的。此处公开的是用于将医疗装置递送至心血管系统的一部分从而诊断、治疗、和/或修复心血管系统。此处公开的医疗装置的至少一些可被用于递送或植入一替换心脏瓣膜(如，替换主动脉瓣、替换二尖瓣等)。此外，此处所公开的装置可经皮地递送替换心脏瓣膜，且因此可对于患者是侵入性要少得多的。此处所公开的装置还可以提供如下所述的其他期望的特征和/或优势。
附图示出一医疗装置系统10的所选组件和/或配置，例如图1中示意性地示出那样。应该注意的是在任何给定附图中，为简洁起见，可未示出、或可示意性地示出医疗装置系统10的一些特征。在其他附图中可更详细地示出与医疗装置系统10的一些组件有关的附加细节。医疗装置系统10可被用于递送和/或部署各种医疗装置和/或植入物至人体器官(anatomy)内的一个或多个位置。在至少一些实施例中，医疗装置系统10可包括替换心脏瓣膜递送系统(如，替换主动脉瓣递送系统)，可被用于经皮递送医疗或替换心脏瓣膜植入物16。然而，此举并非意在限制，因为医疗装置系统10还可被用于其他干预措施，包括瓣膜修复、瓣膜成形术等，或其他类似干预措施。
图1示出医疗装置系统10，所述医疗装置系统10包括16被配置为布置在原生心脏瓣膜(如二尖瓣、主动脉瓣等)内的医疗或替换心脏瓣膜植入物16，其中替换心脏瓣膜植入物16在递送配置中可被布置在医疗装置系统10的腔体内用于递送至原生心脏瓣膜，在此处替换心脏瓣膜植入物16可被切换至部署配置。在一些实施例中，医疗装置系统10可包括外部壳体12，所述外部壳体12具有从所述外部壳体12的近侧部分和/或近端延伸至所述外部壳体12的远端的腔体。在递送配置中，医疗或替换心脏瓣膜植入物16可被布置在所述外部壳体12的腔体内，接近所述外部壳体12的远端。在一些实施例中，医疗装置系统10可包括把手部18，所述把手部18布置为接近所述外部壳体12的近端和/或位于所述外部壳体12的近端处。
医疗装置系统10可包括内部护套或导管14，所述内部护套或导管14布置在所述内部护套12的腔体内和/或在所述外部护套12内的腔体内相对于所述外部护套12是可滑动的。在一些实施例中，把手部18可被布置在接近所述内部护套或导管14和/或位于所述内部护套或导管14的近端处。在一些实施例中，所述内部护套或导管14可以是具有在其中延伸的一个或多个腔体的柱状结构，所述内部护套或导管14可以是实心轴，或所述内部护套或导管14可以是其组合。在一些实施例中，所述医疗装置系统10可包括至少一个致动器元件15，所述致动器元件15可释放地将所述医疗或替换心脏瓣膜植入物16连接至所述把手部18。例如，所述至少一个致动器元件15可从所述把手部18延伸至所述医疗或替换心脏瓣膜植入物16，所述医疗或替换心脏瓣膜植入物16布置在所述外部护套12的腔体的远端处。所述至少一个致动器元件15可从所述内部护套或导管14向远处延伸至所述医疗或替换心脏瓣膜植入物16。在一些实施例中，所述至少一个致动器元件15可滑动地布置在所述内部护套或导管14内或可滑动地延伸通过所述内部护套或导管14。
所述把手部18和/或所述至少一个致动器元件15可配置为操纵所述外部护套12相对于所述内部护套或导管14的位置和/或有助于所述医疗或替换心脏瓣膜植入物16的部署。例如，所述内部护套或导管14和/或所述至少一个致动器元件15可被用于可被用于将所述医疗或替换心脏瓣膜植入物16相对于所述医疗装置系统10的所述外部护套12进行移动。在一些实施例中，所述内部护套或导管14和/或所述至少一个致动器元件15可在所述外部护套12的所述腔体内向远处前进从而将所述医疗或替换心脏瓣膜植入物16推出所述外部护套12和/或所述医疗装置系统10外从而将所述医疗或替换心脏瓣膜植入物16部署在所述原生心脏瓣膜内。可选地，所述内部护套或导管14和/或所述至少一个致动器元件15可相对于所述医疗或替换心脏瓣膜植入物16被维持在固定位置，且所述外部护套12可相对于所述内部护套或导管14、所述至少一个致动器元件15、和/或所述医疗或替换心脏瓣膜植入物16向近处撤离(withdrawn)，从而将所述医疗或替换心脏瓣膜植入物16部署在所述原生心脏瓣膜内。以下将描述所述医疗装置系统10、所述外部护套、所述内部护套或导管14、所述至少一个致动器元件15、所述把手部18、和/或其组件或元件的合适但非限制性材料的一些示例。
在一些实施例中，所述医疗装置系统10可包括布置在导线延长管的远端处的鼻锥体，其中所述导线延长管可从所述内部护套或导管14和/或所述外部护套12向远处延伸。在至少一些实施例中，所述鼻锥体可被设计为具有防损伤形状和/或可包括脊部或凸台，其被配置成在递送所述医疗或替换心脏瓣膜植入物16期间紧靠(abut)所述外部护套12的远端。
在使用中，所述医疗装置系统10可经皮前进通过血管到感兴趣的区域或目标位置。例如，所述医疗装置系统10可前进通过血管并穿过主动脉弓到达有缺陷的心脏瓣膜(如主动脉瓣、二尖瓣等)。也可构想用所述医疗装置系统10来治疗有缺陷的心脏瓣膜的可选方式。递送期间，所述医疗或替换心脏瓣膜植入物16可在所述外部护套12的所述腔体内被布置为细长且低轮廓的“递送”配置。一旦被放置，所述外部护套12可相对于所述医疗或替换心脏瓣膜植入物16被撤回从而暴露出所述医疗或替换心脏瓣膜植入物16。在至少一些实施例中，在被布置在所述外部护套12的所述腔体内的同时和/或一旦撤回所述外部护套12而暴露后立即，所述医疗或替换心脏瓣膜植入物16可被布置为“外翻”配置或部分外翻配置。在一些实施例中，所述医疗或替换心脏瓣膜植入物16可在“递送”配置中被外翻。“外翻”配置可涉及在递送期间所述医疗植入物16的瓣叶(下文讨论)的至少一部分被布置在所述医疗植入物16的可扩张锚定部件(下文讨论)的外部，藉此允许所述医疗植入物16的更小的径向轮廓以及使用更小整体轮廓的外部护套12和/或医疗装置系统10。在一些实施例中，“递送”配置和“外翻”配置可基本是类似的和/或可在此处被互换地使用。
可使用所述把手部18和/或至少一个致动器元件15来致动所述医疗或替换心脏瓣膜植入物16从而将所述医疗或替换心脏瓣膜植入物16平移到径向扩张且较大轮廓的“部署”配置，适于植入到感兴趣的区域处或目标位置处的人体结构内。当所述医疗或替换心脏瓣膜植入物16被适当地部署在人体结构内时，所述外部护套12和/或所述医疗装置系统10可从血管中移除，将所述医疗或替换心脏瓣膜植入物16处于“释放”配置中用作，例如，原生心脏瓣膜的合适替换物。在至少一些干预中，所述医疗或替换心脏瓣膜植入物16可被部署在原生心脏瓣膜中(如，原生心脏瓣膜被留在原位且未被切除)。可选地，可移除原生心脏瓣膜且所述医疗或替换心脏瓣膜植入物16可被部署在原生心脏瓣膜的位置作为替换物。
布置在所述内部外壳或导管14内的可以是至少一个致动器元件15，可被用于在“递送”配置与“部署”配置之间致动和/或平移(如，扩展和/或拉长)所述医疗或替换心脏瓣膜植入物16。在一些实施例中，至少一个致动器元件15可被包括或包含多个致动器元件15、两个致动器元件15、三个致动器元件15、四个致动器元件15、或另一个合适或期望数量的致动器元件15。在一些实施例中，至少一个致动器元件15的每一个可布置在所述内部护套或导管14的独立腔体内。仅为了说明目的，所述医疗装置系统10和所述医疗或替换心脏瓣膜植入物16被图示为具有三个致动器元件15。在这样的示例中，三个致动器元件15可要求和/或布置在所述内部护套或导管14的三个独立腔体(如，第一腔体、第二腔体、第三腔体)内。
要注意的是，为了帮助理解，可用单数形式来描述本公开的特定特征，即使在所公开的实施例(多个)中这些特征可以是复数或重复的。除非有相反陈述，特征的每一个实例可包括和/或包含在单数的公开(多个)。例如，对于“致动器元件”的引用可等效地涉及“至少一个致动器元件”的一个之外的所有实例和数量。
图2示出所述医疗装置系统10和/或所述医疗或替换心脏瓣膜植入物16，图示为“部署”配置。所述医疗或替换心脏瓣膜植入物16可包括可扩张锚定部件70，所述可扩张锚定部件70在拉长的“递送”配置和径向扩展和/或轴向缩短的“部署”配置之间是可逆地可致动的。在一些实施例中，所述可扩张锚定部件70可以是管状的且界定一腔体，所述腔体沿着一中心纵轴线同轴地延伸，所述中心纵轴从所述可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16的远端或流入端到所述可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16的近端或流出端。
在一些实施例中，所述可扩张锚定部件70可包含支架结构和/或框架。在一些实施例中，所述可扩张锚定部件70可包含自膨胀编织(braided)和/或织编(woven)网格结构，网格结构由周向围绕(circumferentially about)可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16的所述腔体布置和/或交织的一个或多个细丝构成。也可构想非自扩张、机械扩张、和/或辅助自扩张锚定部件。在至少一些实施例中，所述可扩张部件70可形成为单片结构(如，由由一细丝或一股金属丝制成、从单个管状构件上切割等)。在一些实施例中，所述可扩张锚定部件70在部署配置中可界定基本是圆柱体的外表面。其他配置也是可能的——例如，定义基本是椭圆形的外表面的横截面。下文描述所述医疗或替换心脏瓣膜植入物16、所述可扩张锚定部件70、和/或其组件或元件的合适但非限制性材料的一些示例。
也在图2中示出，但是为了简洁起见从其他视图中省略，所述医疗或替换心脏瓣膜植入物16可包括多个瓣叶68，布置于所述医疗或替换心脏瓣膜植入物16和/或所述可扩张锚定部件70的腔体内。在一些实施例中，多个瓣叶68可在所述医疗或替换心脏瓣膜植入物16和/或所述可扩张锚定部件70的腔体内的多个位置处附连和/或紧固至所述可扩张锚定部件70。在一些实施例中，多个瓣叶68可使用缝线、粘合剂或其他合适手段附连和/或紧固至所述可扩张锚定部件70。
在一些实施例中，多个瓣叶68可按需包括两个瓣叶、三个瓣叶、四个瓣叶等。所述医疗或替换心脏瓣膜植入物16的多个瓣叶可配置为在打开配置和闭合配置之间移动，所述打开配置允许顺行流体流过所述医疗或替换心脏瓣膜植入物16和/或所述医疗或替换心脏瓣膜植入物16的腔体和/或所述可扩张锚定部件70，所述闭合配置防止逆行流体流过所述医疗或替换心脏瓣膜植入物16和/或所述医疗或替换心脏瓣膜植入物16的腔体和/或所述可扩张锚定部件70。多个瓣叶68可各自具有自由边缘，其中在闭合配置中，多个瓣叶68的自由边缘包裹在所述医疗或替换心脏瓣膜植入物16、可扩张锚定部件70、和/或延伸通过所述医疗或替换心脏瓣膜植入物16和/或可扩张锚定部件70内。多个瓣叶68的合适但非限制性材料的一些示例可包括牛心包、聚合物材料、或其他合适的柔性生物兼容材料。
多个瓣叶68可包括瓣叶连合，该连合从相对于递送配置中相近端或下游端的所述医疗或替换心脏瓣膜植入物16和/或可扩张部件70的腔体内的第一纵向位置可移动到相对于部署配置中近端或下游端的所述医疗或替换心脏瓣膜植入物16和/或可扩张部件70的腔体内的第二纵向位置。在一些实施例，多个瓣叶68可包括一个以上的瓣叶连合。例如，每一相邻对的瓣叶68可形成合/或界定一个瓣叶连合。因此，瓣叶连合的数量可与瓣叶68的数量直接相关(如，三个瓣叶68形成或界定三个瓣叶连合，两个瓣叶68形成或界定两个瓣叶连合等)。
在一些实施例中，所述医疗或替换心脏瓣膜植入物16可包括至少一个锁定机构58，所述锁定机构58被配置为将所述可扩张锚定部件70锁定在“部署”配置。在一些实施例中，所述至少一个锁定机构58可包括或包含多个锁定机构58、两个锁定机构58、三个锁定机构58等。在一些实施例中，每一个瓣叶连合可对应于合/或包括一个对应的锁定机构58。每一个锁定机构58可包括紧固至所述可扩张锚定部件70的第一锁定部分或柱状部件96，配置为接合紧固至所述可扩张锚定部件70的第二锁定部分或锁扣部件76，如下文将更详细描述地。
在一些实施例中，至少一个致动器元件15可配置为可释放地接合至少一个锁定机构58和/或在所述至少一个致动器元件15与所述至少一个锁定机制58接合的同时在“递送”配置和“部署”配置和/或“释放”配置之间可逆地致动所述可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16。在一些实施例中，一个致动器元件15可对应于，接合、和/或致动一个锁定机构58。在一些实施例中，一个致动器元件15可对应于、接合、和致动一个以上的锁定机构58。还可构想其他配置。
在一些实施例中，在“递送”配置和/或在“递送”配置与“部署”配置之间，所述第一锁定部分或柱状部件96和第二锁定部分或锁扣部件76沿所述可扩张锚定部件70的内表面相对于彼此是可移动的。在一些实施例中，所述第一锁定部分或柱状部件96可沿所述可扩张锚定部件70的内表面不可释放地固定至所述可扩张锚定部件70的远侧部分和/或邻近远端或上游端。在一些实施例中，第二锁定部分或锁扣部件76可与所述可扩张锚定部件70的内表面固定地紧固至所述可扩张部件70的近侧部分和/或邻近近端或下游端。第二锁定部分或锁扣部件76可配置为可滑动地在其中容纳所述第一锁定部分或柱状部件96的至少一部分。
在一些实施例中，所述医疗或替换心脏瓣膜植入物16可包括布置在所述可扩张锚定部件70的外部表面的至少一部分上和/或附近的密封部件20(显示部分截面图)。在一些实施例中，所述密封部件20可耦合至和/或紧固至所述可扩张锚定部件70和/或多个瓣叶68。所述密封部件20可以足够灵活和/或柔韧从而在部署配置中符合和/或围绕原生瓣叶和/或原生瓣膜，藉此将所述医疗或替换心脏瓣膜植入物16和/或所述可扩张锚定部件70的外部密封在原生瓣膜和/或原生瓣膜内和/或相对原生瓣膜和/或原生瓣膜来密封所述医疗或替换心脏瓣膜植入物16和/或所述可扩张锚定部件70的外部，且防止所述医疗或替换心脏瓣膜植入物16和/或所述可扩张锚定部件70周围的泄露。
在一些实施例中，所述密封部件20可包括多个聚合物材料层。一些合适的聚合物材料可包括，但并不必然限于，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。还考虑了其他合适的聚合物材料，其中一些材料将在下文讨论。
图3示出一示例性致动器元件15。在一些实施例中，每一个致动器元件15可包括近端和远端。在使用中，近端可操作地连接至把手部18、和/或由用户使用把手部18来操纵或以其他方式致动，来将所述医疗或替换心脏瓣膜植入物16在“递送”配置和“部署”配置，以及之后的“释放”配置，之间可逆地变化。在一些实施例中，致动器元件15可相对于所述医疗或替换心脏瓣膜植入物16的第一锁定部分或柱状部件96或第二锁定部分或锁扣部件76轴向地可平移(translate)和/或可转动。
在一些实施例中，每一个致动器元件15可包括细长杆84，所述细长杆84在远侧部分处和/或靠近远端具有外部螺纹，还有布置在靠近所述外部螺纹86的远侧部分上的坡部88。在一些实施例中，致动器元件15和/或远侧部分可释放地连接和/或耦合至柱状部件86，如下文所述。在一些实施例中，远侧部分、外部螺纹86、和/或坡部88可与细长杆84一体形成或作为单个单片结构成为细长杆84的一部分。
至少一个致动器元件15的每一个(如，多个致动器元件15的每一个，等)界定其自身纵向致动器轴且配置为沿其自身纵向致动器轴而旋转。在一些实施例中，坡部88可相对于致动器元件15的纵向致动器轴横向地从和/或径向地向外延伸，以使得斜坡88具有比细长杆84更大的外径或外部范围。在一些实施例中，远侧部分可包括对于致动器元件15的纵向致动器轴横向地从和/或径向地向外延伸的一个以上的坡部88。在一些实施例中，致动器元件15可包括与所述坡部88相对延伸的第二坡部，或者围绕致动器元件15的纵向致动器轴的周向间隔的多个坡部。在具有多个坡部的实施例中，多个坡部88一起界定相对于所述细长杆84的多个坡部88的外径或外部范围。
在一些实施例中，致动器元件15的远侧部分可与第一锁定部分或柱状部件96对齐或可释放地耦合至与第一锁定部分或柱状部件96。在一些实施例中，远侧部分可旋转地容纳在第一锁定部分或柱状部件96的纵向取向的通道内，如下文所述。在一些实施例中，外部螺纹86可配置为接合、或被容纳、和/或延伸至形成在第一锁定部分或柱状部件96内的内部螺纹内。把手部18可配置为在“部署”配置中相对于所述外部护套12、所述医疗或替换心脏瓣膜植入物16、对应的锁定机构(如，至少一个锁定机构58等)、和/或第一锁定部分或柱状部件96来旋转至少一个致动器元件15的每一个(如，多个致动器元件15的每一个，等)。
在一些实施例中，至少一个致动器元件15的每一个可操作地连接至从所述内部护套或导管14内的把手部向远处延伸的中心轴。所述中心轴可由把手部18和/或布置于把手部18内的旋转机构进行旋转。在一些实施例中，至少一个致动器元件15的每一个可从内部护套或导管14内的把手部18向远处延伸。至少一个致动器元件15的每一个可操作地且独立地接合布置在把手部18内的中心丝杆。所述中心丝杆可配置为旋转至少一个致动器元件15的每一个。在至少一些实施例中，中心丝杆可配置为同时旋转至少一个致动器元件15的每一个。
在一些实施例中，致动器元件15和/或细长杆84可大体是圆形、长圆形、卵球形、矩形、多边形(即双面、三面、四边、五面、六面等)和/或其形状的组合。还可构想其他形状，包括规则和不规则两者。在一些实施例中，致动器元件15可由一金属丝、圆形坯料或其他合适的材料制成，如此处所述。在一些实施例中，致动器元件15可通过进一步加工所述金属丝、圆形坯料或其他合适的材料来形成，诸如通过机械加工、冲压、激光切割等。如下文所述，致动器元件15、细长杆84、远侧部分、外部螺纹86、和/或坡部88的一些合适但非限制性的材料例如金属材料或聚合物材料。
图4和4A示出示例性的第一锁定部分或柱状部件96。在一些实施例中，所述第一锁定部分或柱状部件96可包括细长部件，配置为接合he/huo可释放地耦合至致动器元件15的远侧部分和/或外部螺纹86。在一些实施例中，锁定部分或柱状部件96可包括至少部分地通过第一锁定部分或柱状部件96延伸的纵向取向的通路98。在一些实施例中，纵向取向的通路98可完全延伸通过第一锁定部分或柱状部分96。在一些实施例中，纵向取向的通路98和/或第一锁定部分或柱状部件96的纵轴可设置为基本平行于可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16的中心纵轴线。
纵向取向的通路98可配置为将至少一个致动器元件15的远侧部分和/或外部螺纹86容纳在其中。纵向取向的通路98可包括与致动器元件15的外部螺纹86对应的内部螺纹。在一些实施例中，例如，通过将位于致动器元件15的远侧部分处、邻近远侧部分、和/或在远侧部分上的外部螺纹86可旋转地接合纵向取向的通路98的内部螺纹，致动器元件15的远侧部分可旋转地布置在纵向取向的通路98内和/或可释放地耦合至第一锁定部分或柱状部件96。在一些实施例中，例如，处于拉长的“递送”配置和/或“外翻”配置中，当至少一个致动器元件15与第一锁定部分或柱状部件96接合时，至少一个致动器元件15的远侧部分和/或外部螺纹86的至少一部分可延伸到纵向取向的通路98内。在一些实施例中，当所述可扩张锚定部件70处于拉长的“递送”配置和/或“外翻”配置时，第一锁定部分或柱状部件96可布置在所述医疗或替换心脏瓣膜植入物16和/或可扩张锚定部件70的腔体内邻近所述医疗或替换心脏瓣膜植入物16和/或可扩张锚定部件70的远端或流入端。在一些实施例中，当所述可扩张锚定部件70处于拉长的“递送”配置和/或“外翻”配置时第一锁定部分或柱状部件96的至少一部分可被布置在可扩张锚定部件70的远侧处。
在一些实施例中，第一锁定部分或柱状部件96可包括位于第一锁定部分或柱状部件96的远端处的一个或多个横向延伸的条状物97，所述一个或多个横向延伸的条状物97被配置为接合一对连合柱72(如，图2)的每一个的近端，藉此限制和/或防止它们之间的相对移动。在至少一些实施例中，多个瓣叶68可紧固至一对连合柱72来界定瓣叶连合(多个)。例如，多个瓣叶68的至少一个可经由每一对连合柱72附连至第一锁定部分或柱状部件96。在一些实施例中，多个瓣叶68的两个相邻瓣叶68可经由每一对连合柱72附连至第一锁定部分或柱状部件96。
在一些实施例中，第一锁定部分或柱状部件96可包括可包括大体横向延伸至纵向取向的通路98的纵轴和/或第一锁定部分或柱状部件96的至少一个孔隙95。在一些实施例中，所述至少一个孔隙95可包括或包含多个孔隙95、两个孔隙95、三个孔隙95等。在一些实施例中，至少一个孔隙95可布置在近邻第一锁定部分或柱状部件96的近端处。至少一个孔隙95可相对于可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16的中心纵轴线成非零角度地各自延伸通过第一锁定部分或柱状部件96。在至少一些实施例中，至少一个孔隙95可横贯地(transversely)和/或横向地(laterally)延伸通过第一锁定部分或柱状部件96的璧进入纵向取向的通路98。在一些实施例中，至少一个孔隙95可大体上与一个或多个横向延伸的条状物97对齐和/或平行。
在一些实施例中，第一锁定部分或柱状部件96可包括平坦侧99，所述平坦侧99形成在第一锁定部分或柱状部件96的长度和/或外表面中或沿第一锁定部分或柱状部件96的长度和/或外表面纵向地延伸。在一些实施例中，平坦侧99可沿第一锁定部分或柱状部件96的整个长度而延伸。如将变得明显地，平坦侧99可用作相对于第二锁定部分或锁扣部件76对齐和/或防止旋转的特征。例如，当第一锁定部分或柱状部件96与第二锁定部分或锁扣部件76接合时，平坦侧99可防止第一锁定部分或柱状部件96与第二锁定部分或锁扣部件76之间的相对旋转。
在一些实施例中，外部螺纹86与纵向取向的通路98的内部螺纹之间的可旋转和/或螺纹接合可允许至少一个致动器元件15相对于第二锁定部分或锁扣部件76来轴向地平移第一锁定部分或柱状部件96。下文描述第一锁定部分或柱状部件96的一些合适但非限制性的材料，例如金属材料或聚合物材料。
图5示出一示例性第二锁定部分或锁扣部件76。在一些实施例中，第二锁定部分或锁扣部件76可包括延伸通过第二锁定部分或锁扣部件76的本体部分75的纵向通道74。在一些实施例中，第二锁定部分或锁扣部件76可包括位于第二锁定部分或锁扣部件76的本体部分75的近端处的突出部分73，所述突出部分73配置为将所述医疗或替换心脏瓣膜植入物16可释放地附连至所述医疗装置系统10和/或所述内部护套或导管14。在至少一些实施例中，纵向通道74可具有钥匙状(keyed)、定向、或非圆的截面轮廓或形状，配置为可滑动地容纳第一锁定部分或柱状部件96。第一锁定部分或柱状部件96可具有与纵向通道74的钥匙状(keyed)、定向、或非圆的截面轮廓或形状相对应的截面轮廓或形状。例如，纵向通道74和/或突出部分73可包括对应于第一锁定部分或柱状部件96的平坦侧99的平坦表面71。由此，第一锁定部分或柱状部件86与第二锁定部分或锁扣部件76内的纵向通道74接合和/或至少部分地布置在第二锁定部分或锁扣部件76内的纵向通道74内时和/或当第一锁定部分或柱状部件96的平坦侧99与第二锁定部分或锁扣部件76的平坦表面71对齐和/或处于面对接合(in facing engagement)时，第一锁定部分或柱状部件96可相对于所述第二锁定部分或锁扣部件76是不可旋转的。
在一些实施例中，至少一个锁定机构58的每一个的第二锁定部分或锁扣部件76的本体部分75可包括至少一个弹簧臂77，配置为相对于可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16的中心纵轴线来横向地和/或周向地偏转。如从下述讨论中将变得更为明显地，当坡部88(以及接合至其的第一锁定部分或柱状部件96)纵向平移通过第二锁定部分或锁扣部件76的本体部分75的纵向通道74时，至少一个致动器元件15的坡部88可配置为横向地和/或周向地偏转至少一个弹簧臂77中的至少一个。在一些实施例中，至少一个弹簧臂77可被偏压或自偏压向与本体部分75对齐的中间位置和/或可被偏压或自偏压到纵向通道74内。
简要地参看上述图4，第一锁定部分或柱状部件96还包括对应于第二锁定部分或锁扣部件76的至少一个弹簧臂77的至少一个孔隙95。至少一个孔隙95可配置为在至少一个致动器元件15脱离至少一个锁定机构58和/或第一锁定部分或柱状部件96且坡部88从纵向通道74内向近处移除后容纳其相应弹簧臂77的一部分。在至少一个致动器元件15脱离至少一个锁定机构58和/或第一锁定部件96，且坡部88从纵向通道74内向近处移除后，在“部署”配置中，至少一个弹簧臂77的每一个配置为限制或防止第一锁定部分或柱状部件96相对于第二锁定部分或锁扣部件76的向远处移动和/或轴向平移。下文将描述第二锁定部分或锁扣部件76的一些合适的但是非限制性材料，例如金属材料或聚合物材料。
返回图2，在一些实施例中，可通过使用耦合器78来实现所述医疗或替换心脏瓣膜植入物16与所述内部护套或导管14之间的附连。耦合器78可大体上包括可附连至所述内部护套或导管14的远端的底座(未示出)。从底座向远处突出的是多个指部79(如，二、三、四等)，所述指部79各自配置为与位于至少一个锁定机构58的第二锁定部分或锁扣部件76处的所述医疗或替换心脏瓣膜植入物16相接合。在一些实施例中，多个指部79的每一个可从底座和/或内部护套或导管14的远端延伸至所述医疗或替换心脏瓣膜植入物16。在一些实施例中，每一个指部79可包括套箍(collar)80，所述套箍80围绕各自指部79和各自第二锁定部分或锁扣部件76的突出部分73可滑动地布置。引导部82可布置在每一个指部79上、近(proximal)套箍80，且引导部82可用于将耦合器78的指部79保持与各自致动器元件15相关联、延伸到耦合器78的指部79邻近(adjacent to)(且相对于耦合器78的指部79可轴向地滑动)。
递送期间，通过由套箍80与第二锁定部分或锁扣部件76的突出部分74适配地耦合的耦合器78的指部79的两个细长尖齿、且通过耦合至其对应的第一锁定部分或柱状部件96的至少一个致动器元件15，所述医疗或替换心脏瓣膜植入物16可紧固在耦合器78和/或内部护套或导管14的远端处。当所述医疗或替换心脏瓣膜植入物16在人体结构内前进到感兴趣的区域时，外部护套12可向近处平移和/或致动从而暴露出所述医疗或替换心脏瓣膜植入物16。然后，例如使用把手部18，通过向近处撤回和/或平移至少一个致动器元件15来将第一锁定部分或柱状部件96拉动接合到第二锁定部分或锁扣部件76内，可致动至少一个致动器元件15(如，向近处撤回)从而轴向地缩短和/或径向地扩张所述医疗或替换心脏瓣膜植入物16和/或所述可扩张锚定部件70从“递送”配置到“部署”配置。诸如通过合适的成像技术，在验证所述医疗或替换心脏瓣膜植入物16的令人满意的放置后，至少一个致动器元件15可各自相对于第一锁定部分或柱状部件96旋转且脱离耦合，此举允许至少一个致动器元件15的远侧部分向近处拉动到第二锁定部分或锁扣部件76外，此处坡部88继而接合套箍80且藉此将套箍80从两个细长尖齿和突出部分73撤回。一旦套箍80被撤回，两个细长尖齿与突出部分73脱离耦合，且耦合至78的指部79可从所述医疗或替换心脏瓣膜植入物16取出，藉此将所述医疗或替换心脏瓣膜植入物16(和/或可扩张锚定部件70)以“释放”配置留在感兴趣的区域处的人体结构内。
图6-12示出配置为将所述医疗或替换心脏瓣膜植入物16(和/或可扩张锚定部件70)可逆地锁定在“部署”配置和/或“释放”配置中的示例性锁定机构的所选组件，以及这些组件的大体上的操作。为了简洁和清楚目的，示出和讨论仅一个致动器元件15、第一锁定部分或柱状部件86、第二锁定部分或锁扣76(为了帮助理解锁定机构(多个)58，未示出所述医疗或替换心脏瓣膜植入物16)。然而，将理解的是，除非明确地相反陈述，下述讨论也同等地适用于在所述医疗或替换心脏瓣膜植入物16和/或医疗装置系统10内有一个以上的组件(即，至少一个致动器元件15、第二锁定部分或锁扣部件76、第一锁定部分或柱状部件96等)的任何和/或全部。
如图6-12中所见，至少一个致动器元件15的每一个延伸通过邻近且围绕耦合器78的指部79的引导部82，通过套箍80，通过第二锁定部分或锁扣部件76，并接合到第一锁定部分或柱状部件96内。例如，在“递送”配置中，对应于至少一个锁定机构58(如，多个锁定机构58)的每一个的至少一个致动器元件15(如，多个致动器元件15)的致动器元件15纵向延伸通过各锁定机构58的第二锁定部分或锁扣部件。
至少一个致动器元件15可轴向地和/或可旋转地平移通过引导部82、套箍80、和/或第二锁定部分或锁扣部件76和/或相对于引导部82、套箍80、和/或第二锁定部分或锁扣部件76可轴向地和/或可旋转地平移。至少一个致动器元件15在第一锁定部分或柱状部件96的纵向取向的通路98内是可旋转的。如上所述，至少一个致动器元件15的远侧部分可包括外部螺纹86，所述外部螺纹86配置为可旋转地接合和/或延伸到第一锁定部分或柱状部件96的纵向取向的通路98内。
外部螺纹86可释放地将至少一个致动器元件15的远侧部分接合至第一锁定部分或柱状部件96且形成这些结构的配置，这配置可在所述医疗或替换心脏瓣膜植入物16的递送期间被利用。如可被理解地，第一锁定部分或柱状部件96的近端和第二锁定部分或锁扣76的远端可纵向地分离和/或间隔(例如，如图6-7中可见)且相应地，所述医疗或替换心脏瓣膜植入物16和/或可扩张锚定部件70可处于细长且大体上较低轮廓的“递送”配置，适于经皮平移通过患者的人体结构到感兴趣的区域(如，原生心脏瓣膜)。在至少一些实施例中，在“递送”配置中，第一锁定部分或柱状部件和第二锁定部分或锁扣部件76可相对彼此纵向移动和/或平移。
当所述医疗或替换心脏瓣膜植入物16到达人体结构内的感兴趣的区域时，医师可致动(如，向近处撤回)至少一个致动器元件15，例如使用把手部18，藉此将第一锁定部分或柱状部件96的近端向第二锁定部分或锁扣部件76移动和/或平移并进入第二锁定部分或锁扣部件76的纵向通道74从而向着“部署”配置来轴向缩短和/或径向扩张所述可扩张锚定部件70和/或所述医疗或替换心脏瓣膜植入物16。最终，至少一个致动器元件15可被充分地撤回足够远从而当坡部88穿过第二锁定部分或锁扣部件76的纵向通道74时将至少一个致动器元件15的坡部88平移经过第二锁定部分或锁扣部件76的至少一个弹簧臂77，藉此使至少一个弹簧臂77横向和/或周向地位移和/或偏转离开第二锁定部分或锁扣部件76的纵向通道74，其中所述医疗或替换心脏瓣膜植入物16和/或可扩张锚定部件70处于对应于“部署”配置(如，如图8-9中可见)的轴向和/或纵向位置(沿和/或相对于可扩张锚定部件70的中心纵轴线)，适于植入感兴趣区域处的人体结构内。
在一些实施例中，至少一个致动器元件15在第一(如，近侧)方向的轴向前行可致动可扩张锚定部件70远离“递送”配置向着“部署配置”。如上所述，在一些实施例中，至少一个致动器元件15可包括从细长杆84向外横向和/或径向延伸的坡部88。在一些实施例中，至少一个致动器元件15的坡部88可配置为在至少一个致动器元件15与第一锁定部分或柱状部件96解除耦合前，防止第二锁定部分或锁扣部件76的至少一个弹簧臂77与至少一个致动器元件15的至少一个孔隙95接合，例如图8-9中所见。在部署过程中的这个点，可使用合适的成像技术来验证所述医疗或替换心脏瓣膜植入物16在感兴趣区域处的合适放置。
在一些实施例和/或一些步骤中，可期望的是移除和/或重新放置所述医疗或替换心脏瓣膜植入物16和/可扩张锚定部件70。为了这样做，医师可将至少一个致动器元件15在第二(如，远侧)方向促进和/或平移从而向着“递送”配置来延伸和/或拉长可扩张锚定部件70。至少一个致动器元件15在第二(如，远侧)方向相对于至少一个锁定机构58(如，第一锁定部分或柱状部件96和/或第二锁定部分或锁扣部件76)的轴向前行可滑动地将至少一个致动器元件15的坡部88与第二锁定部分或锁扣部件76的至少一个弹簧臂77接合，藉此将第二锁定部分或锁扣部件76的至少一个弹簧臂77偏转离开至少一个致动器元件15的纵向驱动器轴和/或相对于可扩张锚定部件70的中心纵轴线横向地或周向地偏转第二锁定部分或锁扣部件76的至少一个弹簧臂77，且允许第一锁定部分或柱状部件96穿回通过和/或穿出第二锁定部分或锁扣部件76的纵向通道74。
可选地，如果医师对于所述医疗或替换心脏瓣膜植入物16的放置满意(如，在经由合适的成像技术对于所述医疗或替换心脏瓣膜植入物16的可视化之后)，可进一步致动至少一个致动器元件15(如，相对于第一锁定部分或柱状部件96进行旋转)从而将外部螺纹86和/或至少一个致动器元件15与第一锁定部分或柱状部件96的内部螺纹解除耦合，例如，图10-11中可见。在“部署”配置中至少一个致动器元件15相对于至少一个锁定机构58(如，第一锁定部分或柱状部件96和/或第二锁定部分或锁扣部件76)、所述可扩张锚定部件70、所述医疗或替换心脏瓣膜植入物16的旋转，可将至少一个致动器元件15脱离至少一个锁定机构58(如，第一锁定部分或柱状部件96和/或第二锁定部分或锁扣部件76)且释放所述医疗或替换心脏瓣膜植入物16。
一旦至少一个致动器元件15脱离和/或脱卸于第一锁定部分或柱状部件96，且坡部88轴向平移离开至少一个锁定机构58(如，第一锁定部分或柱状部件96和/或第二锁定部分或锁扣部件76)，第二锁定部分或锁扣部件76的至少一个弹簧臂77至少部分地延伸进入第一锁定部分或柱状部件96的至少一个孔隙95内并将所述医疗或替换心脏瓣膜植入物16和/可扩张锚定部件70锁定在“部署”配置，例如，图10-11中所见，藉此限制和/或防止第一锁定部分或柱状部件96相对于第二锁定部分或锁扣部件76的向远处移动和/或轴向平移。
至少一个致动器元件15的进一步致动和/或撤回可导致至少一个致动器元件15的坡部88接合套箍80且沿指部79向近处拉动/滑动套箍80，同时将至少一个致动器元件15进一步撤离第一锁定部分或柱状部件96。这样做时，指部79的两个拉长尖齿可暴露出，在图10中可见，并且于第二锁定部分或锁扣部件的突出部分73解除耦合，在图12中可见。将至少一个致动器元件15从第一锁定部分或柱状部件96的完全撤离，将可扩张锚定部件70从至少一个致动器元件15释放且使得布置在感兴趣区域处的所述医疗或替换心脏瓣膜植入物16处于“释放”配置。
可用于医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等(和/或此处所公开的其他系统)的各组件以及此处所公开的其中各种元件的材料可包括与医疗装置通常相关联的那些材料。为简洁目的，参看医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等做出下述描述。然而，这并非意在限制此处所描述的装置与方法，因为这些讨论可应用于此处所公开的其他元件、部件、组件、或装置，诸如，但非限制于，致动器元件15、密封部件20、瓣叶68、可扩张锚定部件70、连合柱72、第二锁定部分或锁扣部件76、套箍80、引导部82、第一锁定部分或柱状部件96等，和/或其元件或组件。
在一些实施例中，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18、和/或其组件(诸如，但不限于致动器元件15、密封部件20、瓣叶68、可扩张锚定部件70、连合柱72、第二锁定部分或锁扣部件76、套箍80、引导部82、第一锁定部分或柱状部件96)可由金属、金属合金、聚合物(下文公开其中一些示例)、金属聚合物复合物、陶瓷、其组合等或其他合适的材料。合适的金属和金属合金的一些示例包括不锈钢，诸如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，诸如镍铬钼合金(如，UNS:N06625诸如
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625,UNS:N06022诸如
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UNS:N10276诸如
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其他
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合金等)、镍铜合金(如UNS:N04400诸如
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400,
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400,
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400等)、镍钴铬钼合金(如，UNS:R44035诸如
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等)、镍钼合金(如UNS:N10665诸如
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ALLOY
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)、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(如UNS:R44003诸如
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Figure BDA00024237381200002312
等)；富铂不锈钢；钛；铂；钯；金；其组合；或任何其他适当材料。
如本文所述，在市售镍钛或镍钛合金家族中，是一个被指定为“线弹性”或“非超弹性”的类别，尽管在化学上可能类似于传统形状记忆和超弹性品种，但可能表现出明显不同且有用的机械性能。线弹性和/或非超弹性镍钛醇可在如下方面区别于超弹性镍钛醇：线弹性和/或非超弹性镍钛醇在其应力/应变曲线中不像超弹性镍钛醇那样显示出实质性的“超弹性平台”或“旗帜区”。而是，在线性弹性和/或非超弹性镍钛醇中，随着可恢复应变的增加，应力继续以基本线性或某种程度的线性而增加，但在直到塑性变形开始前不必然是完全线性关系，或者至少是处于比可用超弹性镍钛合金所看到的超弹性平台和/或旗帜区域更线性的关系中。因此，为了本公开目的，线弹性和/或非超弹性镍钛醇也可称为“实质上”线弹性和/或非超弹性镍钛醇。
在一些情况下，线弹性和/或非超弹性镍钛醇也可与超弹性镍钛醇区别开来，因为线弹性和/或非超弹性镍钛醇可接受高达约2-5％的应变，同时保持基本弹性(如，在塑性变形前)而超弹性镍钛醇在塑性变形前可接受高达8％的应变。这两种材料都可以与其他线弹性材料诸如不锈钢(也可以根据其成分来区分)区别开来，后者在塑性变形之前可能只接受约0.2％到0.44％的应变。
在一些实施例中，线弹性和/或非超弹性镍钛合金是一种合金，其在大温度范围内并不示出可由差示扫描量热(DSC)和动态金属热分析(DMTA)所检测到的任何马氏体/奥氏体相变化。例如，在一些实施例中，在线弹性和/或非超弹性镍钛合金中，在大约-60摄氏度(℃)到大约120℃的范围内，可能没有由DSC和DMTA分析可检测到的马氏体/奥氏体相变。因此，这种材料的机械弯曲性能在这个非常宽的温度范围内对温度的影响是基本惰性的。在一些实施例中，线弹性和/或非超弹性镍钛合金在室温或室内温度下的机械弯曲性能与体温下的机械性能基本相同，例如，在于它们不显示超弹性平台和/或旗帜区域。换言之，在较宽的温度范围内，线弹性和/或非超弹性镍钛合金保持其线弹性和/或非超弹性特性和/或性质。
在一些实施例中，线弹性和/或非超弹性镍钛合金可在约50至约60重量百分比镍的范围内，其余基本上为钛。在一些实施例中，组分是在约54到约57重量百分比镍的范围内。合适的镍钛合金的一个示例是从日本神奈川的Furukawa Techno Material Co.购买的HP-NT合金。其他合适的材料可包括ULTANIUMTM(可从Neo Metrics获得)和GUM METALTM(可从丰田获得)。在一些其它实施例中，超弹性合金，例如超弹性镍钛醇，可用于实现所需的性质。
在至少一些实施例中，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18、和/或其组件，还可由不透辐射的材料掺杂、由不透辐射的材料制成、或包括不透辐射的材料。不投辐射的材料被理解为能在医疗步骤期间在能够在荧光屏或其他成像技术上产生相对明亮图像的材料。这个相对明亮的图像帮助用户确定医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等的位置。不透辐射的材料的一些示例可包括，但不限于加载不透光填料的金、铂、钯、钽、钨合金、聚合物材料等。附加地，还可将其他不透辐射的标记物带和/或线圈结合到医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等的设计中来实现相同效果。
在一些实施例中，将一定程度的磁共振成像(MRI)兼容性施加到医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等。例如，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等，和/或其组件或部分，可由基本不扭曲图像和创建大量伪像(如，图像中的间隙)的材料制成。例如，某些铁磁性材料可能不合适，因为它们可能在MRI图像中创建伪影。医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等，或其各部分，还可由MRI图像可成像的材料制成。展现出这些特性的一些材料包括，例如，钨、钴铬钼合金(如UNS:R44003诸如
Figure BDA0002423738120000251
等)、镍钴铬钼合金(如UNS:R44035诸如
Figure BDA0002423738120000252
等)、镍钛醇等，以及其他。
在一些实施例中，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等、和/或其各部分，可由聚合物或其他合适材料制成或包含聚合物或其他合适材料。合适的聚合物的一些示例可包括聚四氟乙烯(PTFE)、四氟乙烯(ETFE)、氟化乙烯丙烯(FEP)、聚甲醛(POM，例如
Figure BDA0002423738120000253
从下述厂商可获得：DuPont)、聚醚嵌段酯、聚氨酯(例如，Polyurethane 85A)、聚丙烯(PP)、聚氯乙烯(PVC)、聚醚酯(例如
Figure BDA0002423738120000254
从下述厂商可获得：DSM Engineering Plastics)、醚或酯基共聚物(例如丁烯/聚(亚烷基醚)邻苯二甲酸酯和/或其他聚酯弹性体诸如
Figure BDA0002423738120000255
从下述厂商可获得：DuPont)、聚酰胺(例
Figure BDA0002423738120000256
从下述厂商可获得：Bayer，或
Figure BDA0002423738120000257
从下述厂商可获得：Elf Atochem)、弹性聚酰胺、嵌段聚酰胺/醚、聚醚嵌段酰胺(PEBA,例如可从以下商用名获得：
Figure BDA0002423738120000258
)、乙烯-醋酸乙烯酯共聚物(EVA)、硅酮、聚乙烯(PE)、马利克斯高密度聚乙烯、马利克斯低密度聚乙烯、线性低密度聚乙烯(例如
Figure BDA0002423738120000259
)、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)、聚对苯二甲酸丙二醇酯(例如,
Figure BDA00024237381200002511
)、聚砜、尼龙、尼龙-12(诸如
Figure BDA00024237381200002512
从下述厂商可获得：EMS American Grilon)、全氟(丙基乙烯基醚)(PFA)、乙烯-乙烯醇、聚烯烃、聚苯乙烯、环氧树脂、聚偏二氯乙烯(PVdC)、聚(苯乙烯-b-异丁烯-b-苯乙烯)(例如,SIBS和/或SIBS50A)、聚碳酸酯、离聚物、聚氨酯-有机硅共聚物(例如，来自Aortech Biomaterials的
Figure BDA00024237381200002513
或者来自AdvanSourceBiomaterials的
Figure BDA00024237381200002510
)、生物相容性聚合物、其他适当材料或其混合物、组合、共聚物、聚合物/金属复合物等。在一些实施例中，护套可与液晶聚合物(LCP)混合。例如，混合物可包含高达约6％的LCP。
在一些实施例中，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等、和/或此处所公开的其他元件可包括布置在结构上或结构内的纤维材料。该纤维材料可包括生物相容性材料，诸如聚合物材料或生物材料，该材料适于促进组织的生长。在一些实施例中，纤维材料可包括生物可吸收材料。合适的纤维材料的一些示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，诸如聚乙烯、聚丙烯、聚酯、聚氨酯和/或其混合物或组合。
在一些实施例中，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等可包括和/或由纺织材料制成。合适的纺织材料的一些示例可包括扁平、成形、扭曲、变形、预缩或未缩水的合成纱线。适于用在本发明中的合成生物相容性的纱线包括，但不限于，聚酯，包括聚对苯二甲酸乙二醇酯(PET)聚酯、聚丙烯、聚乙烯、聚氨酯、聚烯烃、聚乙烯醇、聚乙酸乙酯、聚酰胺、萘二甲酸衍生物、天然丝和聚四氟乙烯。另外，合成纱线的至少一项可以是金属线或玻璃或陶瓷线或纤维。有用的金属线包括包括由不锈钢、铂、金、钛、钽或镍钴铬基合金制成的纱线。纱线可进一步包括碳、玻璃或陶瓷纤维。期望地，纱线由热塑性材料制成，包括但不限于聚酯、聚丙烯、聚乙烯、聚氨酯、聚萘、聚四氟乙烯等。纱线可以是复丝、单丝或纺纱类型。所选择的纱线的类型和细度可以形成具有期望性质的生物相容性的且可植入的假体(且更特定地，血管结构)的方式来选择。
在一些实施例中，医疗装置系统10、外部护套12、内部护套或导管14、所述医疗或替换心脏瓣膜植入物16、把手部18等可包括合适的治疗剂和/或由合适的治疗剂所处理。合适的治疗剂的一些示例可包括抗血栓形成剂(诸如肝素、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))；抗增殖剂(诸如依诺肝素、血管肽、能促进平滑肌细胞增殖的单克隆抗体、水蛭素和乙酰水杨酸)；抗炎药(诸如地塞米松、强的松龙、皮质酮、布地奈德、雌激素、柳氮磺吡啶和美沙拉胺)；抗肿瘤/抗增殖/抗有丝分裂药(诸如紫杉醇、5-氟尿嘧啶、顺铂、长春花碱、长春新碱、埃博霉素、内皮抑制素、血管抑制素和胸腺嘧啶激酶抑制剂)；麻醉剂(诸如利多卡因、布比卡因和罗哌卡因)；抗凝剂(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)；血管细胞生长促进剂(诸如生长因子抑制剂、生长因子受体拮抗剂、转录激活剂和翻译促进剂)；血管细胞生长抑制物(诸如生长因子抑制剂、生长因子受体拮抗剂、转录抑制剂、翻译抑制剂，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；降胆固醇剂；血管舒张剂；和干扰内源性血管促动剂。
应该理解的是，本公开，在很多方面，仅仅是说明性的。在不超出本发明范围的情况下，可对于细节，特别是形状、大小、和步骤安排方面做出改变。此举可包括，至合适的程度，将一个实施例的任何特征用在其他实施例中。本发明的范围，当然，界定在其中随附权利要求所表达的语言中。

Claims (12)

1.一种医疗装置系统，包括：
替换心脏瓣膜植入物，所述替换心脏瓣膜植入物包括可扩张锚定部件，所述可扩张锚定部件在递送配置和部署配置之间能可逆地致动；
其中所述替换心脏瓣膜植入物包括至少一个锁定机构，所述至少一个锁定机构配置为将所述可扩张锚定部件锁定在部署配置；和
至少一个致动器元件，所述至少一个致动器元件配置为可释放地接合所述至少一个锁定机构并在递送配置和部署配置之间致动所述可扩张锚定部件；
其中所述至少一个致动器元件包括位于每一个致动器元件的远侧部分上的外部螺纹以及布置在所述外部螺纹的近处的坡部，
其中所述至少一个锁定机构包括紧固至所述可扩张锚定部件的第一锁定部分以及紧固至所述可扩张锚定部件的第二锁定部分，所述第一锁定部分和所述第二锁定部分在递送配置中相对于彼此是纵向可移动的，
其中所述至少一个锁定机构的每一个的所述第二锁定部分包括至少一个弹簧臂，所述弹簧臂配置为相对于所述可扩张锚定部件的中心纵轴线周向地偏转，
其中所述坡部配置为随着所述坡部纵向地平移通过所述第二锁定部分，周向地偏转所述至少一个弹簧臂中的每一个。
2.如权利要求1所述的医疗装置系统，其中所述第一锁定部分不可释放地紧固至所述可扩张锚定部件的远侧部分，且所述第二锁定部分固定地紧固至所述可扩张锚定部件的近侧部分。
3.如权利要求1所述的医疗装置系统，其中所述第二锁定部分配置为将所述第一锁定部分可滑动地容纳于延伸通过第二锁定部分的纵向通道内。
4.如权利要求3所述的医疗装置系统，其中当所述第一锁定部分至少部分地布置在所述纵向通道内时，所述第一锁定部分相对于所述第二锁定部分是不可旋转的。
5.如权利要求1-4中任一项所述的医疗装置系统，其所述第一锁定部分包括至少部分地延伸通过所述第一锁定部分的纵向取向的通路，所述纵向取向的通路配置为容纳所述至少一个致动器元件的远侧部分。
6.如权利要求5所述的医疗装置系统，其中所述纵向取向的通路包括对应于所述外部螺纹的内部螺纹。
7.如权利要求1所述的医疗装置系统，其中所述第一锁定部分包括对应于所述至少一个弹簧臂的每一个的至少一个孔隙，所述至少一个孔隙以相对于所述中心纵轴线非零的角度延伸通过所述第一锁定部分且配置为容纳其对应弹簧臂的一部分。
8.如权利要求1或7所述的医疗装置系统，其中在所述至少一个致动器元件从所述至少一个锁定机构脱离后，所述至少一个弹簧臂中的每一个配置为防止所述第一锁定部分相对于所述第二锁定部分的向远处移动。
9.一种医疗装置系统，包括：
外部护套；
布置在所述外部护套的近端处的把手部；
替换心脏瓣膜植入物，包括可扩张锚定部件，所述可扩张锚定部件在递送配置和部署配置之间能可逆地致动；
其中所述替换心脏瓣膜植入物包括至少一个锁定机构，所述至少一个锁定机构配置为将所述可扩张锚定部件锁定在所述部署配置中；和
至少一个致动器元件，所述致动器元件配置为可释放地接合所述至少一个锁定机构并在递送配置和部署配置之间致动所述可扩张锚定部件；
其中所述至少一个致动器元件包括位于所述每一个致动器元件的远侧部分上的外部螺纹以及布置在所述外部螺纹的近处的坡部；
其中所述至少一个致动器元件从所述把手部延伸到所述替换心脏瓣膜植入物，所述替换心脏瓣膜植入物布置在所述外部护套的远端，
其中所述至少一个锁定机构包括紧固至所述可扩张锚定部件的第一锁定部分以及紧固至所述可扩张锚定部件的第二锁定部分，所述第一锁定部分和所述第二锁定部分在递送配置中相对于彼此是纵向可移动的，
其中所述至少一个锁定机构的每一个的所述第二锁定部分包括至少一个弹簧臂，所述弹簧臂配置为相对于所述可扩张锚定部件的中心纵轴线周向地偏转，
其中所述坡部配置为随着所述坡部纵向地平移通过所述第二锁定部分，周向地偏转所述至少一个弹簧臂中的每一个。
10.如权利要求9所述的医疗装置系统，其中所述至少一个致动器元件配置为在所述至少一个致动器元件与所述至少一个锁定机构接合的同时在递送配置和部署配置之间可逆地致动所述可扩张锚定部件。
11.如权利要求9或10所述的医疗装置系统，其中所述把手部配置为在部署配置中相对于所述至少一个锁定机构来旋转所述至少一个致动器元件的每一个。
12.如权利要求11所述的医疗装置系统，其中在部署配置中所述至少一个致动器元件相对于所述至少一个锁定机构的旋转将所述至少一个致动器元件与所述至少一个锁定机构脱离并释放出所述替换心脏瓣膜植入物。
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