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CN112804966B - 人工心脏瓣膜装置、系统和方法 - Google Patents

人工心脏瓣膜装置、系统和方法 Download PDF

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CN112804966B
CN112804966B CN201980065767.3A CN201980065767A CN112804966B CN 112804966 B CN112804966 B CN 112804966B CN 201980065767 A CN201980065767 A CN 201980065767A CN 112804966 B CN112804966 B CN 112804966B
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valve
frame structure
valve prosthesis
prosthesis
native
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CN112804966A (zh
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C·阿金托
A·贝卡斯
A·杨
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Shifamed Holdings LLC
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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
    • A61F2/2412—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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (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

一种用于置换患者内的病变自体瓣膜的心脏瓣膜假体。瓣膜假体包括可压缩和可扩张框架结构和连接到框架结构的外周边的锚固件。锚固件包括具有自由端的螺旋丝。瓣膜还可包括安装在框架结构内并与框架结构一起扩张的瓣膜段。框架结构可被构造成接收瓣膜段。

Description

人工心脏瓣膜装置、系统和方法
交叉参考
本申请要求2018年8月21日提交的题为“Prosthetic Cardiac Valve Devices,Systems,and Methods”的美国临时专利申请No.62/720,853(律师案卷No.41702-704.101)的权益，该申请出于所有目的整体合并于此。
通过引用合并
本文中提及的所有公开文献和专利申请通过引用以相同程度合并于此，似乎是每篇单独公开文献或专利申请被特别和单独指明来通过引用合并。
技术领域
本发明总体涉及心脏疾病的治疗，并且更特别是涉及可植入瓣膜假体和心脏瓣膜疾病的治疗。
背景技术
参考图1和2，心脏2包括通过四个瓣膜连接的四个腔室。心脏2的上部包括左心房25和右心房5。下部包括左心室26和右心室6。心脏2和心血管系统类似于闭合回路操作。心脏2的右侧接收来自身体的脱氧血液，并递送血液经过肺动脉7至肺部，在肺部，血液变得再充氧。充氧的血液返回到心脏2的左侧，称为系统侧，其将充氧的血液递送到整个身体。
心脏腔室之间的血液流动通过瓣膜调节。在心脏的左侧，二尖瓣4位于左心房25和左心室26之间，而主动脉瓣9位于左心室26和主动脉1之间。在心脏2的右侧，肺动脉瓣3位于右心室6和肺动脉7之间，而三尖瓣8位于右心室6和右心房5之间。
所有四个心脏瓣膜都是被动单向瓣膜，带有“小叶”，小叶响应于差压而打开和闭合。例如，在健康心脏收缩期间，左心室26收缩，并将血液从主动脉瓣9中排出。继而，左心室26中的压力导致二尖瓣4关闭，从而防止血液在收缩期间返回左心房25。
相当的群体在其一生中会得瓣膜疾病。先天性心脏疾病也是重要的问题。具有瓣膜疾病的患者具有至少一个瓣膜的解剖结构和/或功能异常。先天性瓣膜异常在数年后发展为危及生命的问题之前会被常年忍受和/或被治标不治本地治疗。然而，先天性心脏疾病会在不注意的情况下存在危及生命的风险。患者会从风湿热、心力衰竭、退化小叶组织、细菌感染等导致瓣膜疾病。
瓣膜疾病可由图3-5所示的多种因素造成。图3示出健康的二尖瓣4。参考图4-5，其示出病变的二尖瓣4。图4的瓣膜4患有功能不全，也称为反流。这种瓣膜4不能完全闭合，并允许血液逆行。在这种情况下，血液将在收缩期流回左心房25。图5示出二尖瓣4狭窄。这种瓣膜4不能正常打开。一些瓣膜4会伴有瓣膜功能不全和狭窄。也可能存在其他疾病，如巴洛氏病，这会防止瓣膜4正常工作。这些疾病会降低心脏2的输出，并迫使心脏2更加努力工作，从而增加心力衰竭和脉络膜衰竭的风险。
虽然药物可以用来治疗这种疾病，在许多情况下，有缺陷的瓣膜会需要在患者寿命期间的某个时刻进行修复或置换。自体瓣膜可以通过机械瓣膜或组织瓣膜置换。机械瓣膜具有可以打开和闭合的盘或其他构件。虽然机械瓣膜由生物相容性材料制成，它们带有增加凝血的风险。因此，患者在寿命的剩余部分中通常需要服用抗凝剂，这会带来额外的并发症。组织瓣膜可以由人或动物组织以及聚合材料形成。与机械瓣膜不同，组织瓣膜通常不需要长期使用抗凝剂，但由于它们由活组织形成，它们的应用范围不广，使用寿命也不如机械瓣膜长。常见的组织瓣膜包括安装在支架状结构内的猪主动脉瓣膜。
最近，对用于人工瓣膜植入的微创手术越来越感兴趣。一种经皮手术涉及使用导管将人工瓣膜放置在病变或受伤的心脏瓣膜内。
现有的经皮瓣膜修补术仍面临许多挑战。这些挑战对于某些患者群体和解剖结构来说限制了经导管手术的应用。到目前为止，经导管装置主要集中在主动脉瓣膜手术和可能无法耐受外科手术的重病患者群体。目前仍然需要改进的经导管装置，以满足或超过外科瓣膜的性能和安全性。经皮瓣膜置换也仅限于主动脉瓣手术。虽然大部分群体患有三尖瓣和二尖瓣疾病，但这些瓣膜的解剖结构和功能对于经导管置换来说提出了挑战。主动脉瓣膜可以通过股动脉进入，而二尖瓣例如通常需要经间隔入路。对于经导管手术来说，二尖瓣解剖结构比主动脉瓣膜更复杂。例如，如图4所示，二尖瓣4包括两个不对称的小叶4a、4b和不规则形状的环4c。根据患者，二尖瓣4也比主动脉瓣膜变化更大。由于这些和其他原因，外科置换和经皮修复因此目前为止是二尖瓣疾病的唯一广泛应用的商业治疗方法。
发明内容
因此期望提供一种用于包括二尖瓣的心脏瓣膜的修复和置换的微创手术、更快的外科方法、适应不同患者需求的各种不同的瓣膜组件和/或可适应各种个体患者的人工瓣膜。并非所有这些方面或优点都必须通过任何特定实施方式来实现。因此，可以以实现或优化本文所教导的一个优点或一组优点的方式来实施各种实施方式，而不必实现本文所教导或建议的其他方面或优点。
本发明涉及人工心脏装置，并且在一些实施方式中，涉及人工心脏瓣膜，诸如基于导管的二尖瓣。
在第一方面，提供一种用于置换患者内的病变自体瓣膜的心脏瓣膜假体。心脏瓣膜假体包括可压缩和可扩张框架结构和连接到框架结构的外周边的锚固件。锚固件包括具有自由端的螺旋丝。瓣膜还可包括位于框架结构内的瓣膜段。瓣膜段可包括生物相容单向瓣膜。
在第二方面，提供一种用于置换患者心脏内的病变自体瓣膜的心脏瓣膜假体。瓣膜假体包括可压缩和可扩张框架结构、布置在框架结构内的瓣膜段，瓣膜段包括生物相容单向瓣膜以及连接到框架结构的外周边的锚固件，其中锚固件包括具有自由端的螺旋丝。
在一些实施方式中，螺旋丝的自由端可被构造成引导螺旋丝穿过患者的自体瓣膜的连合部。
在一些实施方式中，自由端可包括非创伤末端。例如，自由端可包括球末端。
在一些实施方式中，自由端可被构造成穿刺组织。
在一些实施方式中，锚固件可包括第一部分和另一部分，第一部分具有螺旋丝。
在一些实施方式中，锚固件可包括多个锚固件。多个锚固件可包括具有不同直径的至少两个螺旋丝。替代地，或组合地，多个锚固件可包括具有不同卷绕节距的至少两个螺旋丝。
在一些实施方式中，螺旋丝可具有大致管状形状。螺旋丝的自由端可从管状形状径向向外延伸。
在一些实施方式中，螺旋丝可具有大致截锥形状。螺旋丝的自由端可从截锥形状径向向外延伸。
在一些实施方式中，框架结构可被构造成在患者的自体瓣膜内扩张。
在一些实施方式中，框架结构可具有其尺寸和大小被设置成用于经皮插入的压缩状态和其尺寸和大小被设置成用于植入患者的自体瓣膜内的扩张状态。
在一些实施方式中，框架结构可包括相对的第一端部和第二端部，在瓣膜假体横过自体瓣膜定位时，第一端部在自体瓣膜的上方延伸，并且第二端部在自体瓣膜的下方延伸。
在一些实施方式中，框架结构可包括可扩张支架。
在一些实施方式中，框架结构可包括大致管状的扩张形状。
在一些实施方式中，框架结构可包括扩张的外周边和在受到外部径向力时压缩的外周边。压缩的外周边的直径可略微小于扩张的外周边。
在一些实施方式中，框架结构可以是可囊体扩张的。
在一些实施方式中，框架结构可以是自扩张的。
在一些实施方式中，瓣膜段的至少一部分可定位在框架结构的至少一部分内。
在一些实施方式中，瓣膜段可包括具有内层和外层的至少一个小叶。框架结构可在框架结构的一个或多个端部处附接到外层。
在一些实施方式中，瓣膜段可包括多个小叶。例如，瓣膜段可包括两个小叶。
在一些实施方式中，螺旋丝可包括第二端部，并且其中第二端部附接到框架结构。螺旋丝可只在第二端部的位置处附接到框架结构。
在一些实施方式中，锚固件和框架结构可适于独立和分离地扩张。
在另一方面，提供一种置换患者的病变自体瓣膜的方法。该方法包括将瓣膜假体装载到递送导管内，瓣膜假体包括承载可生物相容瓣膜段的可扩张框架结构和附接到框架结构的外周边的锚固件，锚固件包括具有自由端的丝；将瓣膜假体递送到自体瓣膜上方的目标位置处；插入瓣膜假体穿过自体瓣膜到自体瓣膜前方的位置；转动丝，使得自由端在瓣膜下方围绕腱索的至少一部分卷绕；并且在自体瓣膜内扩张包括瓣膜段的框架结构。
在一些实施方式中，该方法还可包括通过转动丝直到框架结构定位在自体瓣膜的小叶内来锚固瓣膜假体。
在一些所述实施方式中，该方法还可包括通过转动丝直到丝围绕腱索紧固来锚固瓣膜假体。
在一些实施方式中，框架结构可以是可囊体扩张的。扩张框架结构可包括在框架结构内扩张囊体。
在一些实施方式中，框架结构可以是自扩张的。扩张框架结构可包括从框架结构移除递送装置的护套。
在一些实施方式中，丝可以是螺旋丝。
在一些实施方式中，插入瓣膜假体可包括引导丝的自由端穿过自体瓣膜的连合部。在一些实施方式中，转动丝可包括转动丝穿过连合部。
在另一方面，提供一种置换患者的病变自体瓣膜的心脏瓣膜假体。瓣膜假体包括可压缩和可扩张框架结构、布置在框架结构内并包括可生物相容单向瓣膜的瓣膜段以及连接到框架结构并从框架结构径向向外布置的锚固件，其中锚固件包括具有自由端的螺旋构件。
在一些实施方式中，锚固件的第二端部可连接到框架结构。
在一些实施方式中，螺旋构件可包括丝或扁平带。
相对于附图，在以下描述中更加详细地描述这些和其他实施方式。
附图说明
特别在所附权利要求书中提出本发明的新颖特征。本发明的特征和优点的更好理解将通过参考示例性实施方式提供的以下详细描述来获得，在这些实施方式中采用了本发明的原理，并且附图中：
图1是人类心脏的示意图，示出血液流过心脏的路径。
图2是通过二尖瓣、主动脉瓣膜和主动脉向下看的心脏横截面图。
图3是健康二尖瓣的示意图。
图4和5是病变二尖瓣的示意图。
图6-10是根据本发明用于置换病变自体瓣膜的经皮瓣膜的多个视图。
图11是根据多种实施方式的图6的瓣膜的人工瓣膜小叶的透视图。
图12-18是根据多种实施方式的图6的瓣膜的框架结构的多个视图。
图19-26是根据多种实施方式植入图6的瓣膜的方法的多个视图。
图27-28根据多种实施方式示出使用囊体的框架结构的扩张。
图29是根据多种实施方式类似于图6的瓣膜的另一经皮瓣膜的前视图。
图30A-30F是根据多种实施方式类似于图6的瓣膜的其他经皮瓣膜的前视图。
本发明的装置和方法具有将从附图明白或更加详细地给出的其他特征和优点，这些特征和优点结合到此说明书以及随后的具体实施方式中并形成其一部分，并一起用来解释本发明的原理。
具体实施方式
在一些详细描述中，参考形成其一部分的附图。在附图中，类似的附图标记通常表示类似的部件，除非本文另外指明。详细描述、附图和权利要求中描述的示例性实施方式不是限制性的。可以采用其他实施方式，并且可以进行其他改变，而不偏离本文给出的主题的范围。将容易理解到本文总体描述和附图示出的本发明的各个方面可以广泛不同构型布置、替代、组合、分离和设计，所有这些均在本文中得到明确考虑。
尽管下面公开某些实施方式和例子，本发明的主题延伸超过具体公开的实施方式到其他替代实施方式和/或应用及其改型和等同。因此，所附权利要求的范围不被下面描述的任何特定实施方式所限制。例如，在本文公开的任何方法或过程中，方法或过程的动作或操作可以任何适当顺序执行，并且不必须局限于任何特别公开的顺序。多种操作可描述为依次的多个离散操作，这种方式会有助于某些实施方式的理解，但是所描述的顺序不应该隐含这些操作是依赖于顺序的。另外，本文公开的结构、系统和/或装置可以体现为一体部件或分离部件。
出于比较多种实施方式的目的，将描述这些实施方式的某些方面和优点。不需要所有这些方面或优点通过任何特定实施方式实现。因此，例如，多种实施方式可以实现或优化本文所教导的一个优点或成组优点的方式执行，而不需要实现本文同样教导或暗示的其他方面或优点。
本发明针对心脏的例如二尖瓣的病变自体瓣膜的治疗的系统的部署、装置或方法来进行描述。但是，本领域普通技术人员将理解到这不意图是局限性的，并且本文公开的装置和方法可以用于其他解剖区域以及其他外科手术中。
为了便于在所附权利要求中解释和准确定义，术语“上”或“上方”、“下”或“下方”、“内侧”和“外侧”用来参考附图中所展示的这些特征的位置来描述各个实施方式的特征。
在许多方面中，不同附图的变型类似于后前面变型的那些，并且通过相同的附图标记加上后缀“a”、“b”和“d”来表示相应的部件。
现在转向附图，注意到图1-5，其中相同的部件在所有不同的附图中通过类似的附图标记表示。图1示出人类心脏2和经过心脏的四个腔室的血液流动路径。图2是人类心脏2，示出二尖瓣4、主动脉瓣9和主动脉1。二尖瓣4包括两个小叶4a，4b。前(主动脉)小叶4a与主动脉1相邻。后(壁)小叶4b远离主动脉1。主动脉瓣9包括三个小叶。在当前视图中，心脏2处于收缩状态，其中主动脉瓣9打开，并且二尖瓣4闭合。而图1所示为健康心脏2，图2-5示出了可以通过根据本发明的人工瓣膜解决的示例性二尖瓣4疾病状态。人工瓣膜也可用于治疗功能性反流，如功能性二尖瓣反流(FMR)。
图6-18示出根据本发明用于置换病变二尖瓣的示例性瓣膜假体10(本文也称为“瓣膜装置”)。所示的瓣膜假体10包括框架结构12、瓣膜段14以及锚固件15。图6-10示出处于扩张、部署状态的瓣膜假体10。图12-18示出没有瓣膜段14的框架结构12。框架结构12在图12-15中处于塌缩状态，并且在图16-18处于扩张状态。锚固件15示出处于部署状态。
现在将参考图6-11来描述示例性瓣膜假体10。在所示实施方式中，瓣膜假体10被构造成置换自体二尖瓣。瓣膜10包括框架结构12、瓣膜段14和锚固件15。在所示实施方式中，锚固件包括围绕框架结构形成螺旋或盘旋形状的丝20。
示例性框架即可12被构造成支架。框架具有扩张状态和塌缩或压缩状态。压缩状态的尺寸和大小被设置成用于经皮插入，并且扩张状态的尺寸和大小被设置成用于植入患者的自体瓣膜。在多种实施方式中，框架结构12包括扩张的外周边和在受到外部径向力时压缩的外周边，压缩的外周边的直径略微小于扩张的外周边。框架结构12在图6中示出处于扩张、部署状态。框架结构12在图12中示出处于塌缩、递送状态。
示例性框架结构12是由形状记忆材料(例如NiTi)形成的菱形图案形式的支架。本领域普通技术人员将从本文的描述中理解许多其他结构、材料和构型可用于框架结构12。例如，框架结构12可以由具有足够弹性的聚合物形成。框架结构12可以由金属和聚合物的组合形成，例如被覆盖在聚合物中的金属(例如形状记忆材料)。框架结构12可以包括除菱形以外的各种图案。
瓣膜假体10包括位于框架结构12内的瓣膜段14。示例性瓣膜段14是可扩张和可塌缩的。在所示实施方式中，瓣膜段14固定在框架结构12内，并与框架结构12一起扩张和塌缩。瓣膜段在某种程度上可与人工瓣膜小叶互换使用，并通常指人工小叶和框架。如本文所用，“人工瓣膜”可指各种各样的人造和人工替代瓣膜，包括组织(生物)瓣膜、组织工程瓣膜、聚合物瓣膜(例如，可生物降解聚合物瓣膜)，并且甚至某些机械瓣膜。
在所示实施方式中，框架结构12是闭合框架，使得血液流动被迫经过其中的瓣膜段14。一个或多个裙部和/或密封件可有助于迫使血液经过瓣膜段14。
瓣膜段14可以如同本领域普通技术人员从本文描述中理解那样构造。瓣膜段14可类似于现有的经导管瓣膜。瓣膜段14可类似于现有的外科组织瓣膜和机械瓣膜。在多种实施方式中，对于优先功能来说，瓣膜段14包括由多层材料形成的小叶16。至少一个小叶16可具有内层和外层。在多种实施方式中，小叶16被固定到瓣膜结构，瓣膜结构继而连接到框架结构12。瓣膜结构可在框架结构12邻近自体瓣膜之前或之后连接到框架结构12。在多种实施方式中，小叶16直接附接到框架结构12。小叶16可具有内层和外层，其中外层附接到框架结构12。小叶16可附接到框架结构12的端部。替代地，或组合地，小叶16可附接到框架结构12的中间部分。在多种实施方式中，瓣膜段14包括多个小叶16，诸如两个、三个或更多个小叶。在所示实施方式中，瓣膜段14包括附接到框架结构12的三个小叶16。示例性小叶16在图11中示出。小叶16是凹入的，以允许在一个方向上流动。特别是，在一个方向上流动造成小叶16偏转打开，而在相反方向上流动造成小叶16闭合。
返回图6-18，更特别是图12-18，示例性锚固件15包括具有自由端22的螺旋构件，诸如丝20。丝20的另一端附接到框架结构12的顶端。在所示实施方式中，丝20的一端固定到框架结构12的支柱。此端可通过本领域普通技术人员从本文描述理解那样的适当装置附接，包括但不局限于焊接、粘合剂和机械紧固件。在多种实施方式中，螺旋丝20只在第二端部的位置处附接到框架结构。
虽然指的是锚固件，人们将理解到锚固件15不需要执行传统含义上的锚固功能。如下面更详细描述，锚固件引导瓣膜假体10进入自体瓣膜内的期望位置。锚固件15也可抵消对于腱索以及二尖瓣的瓣膜小叶的不期望缠绕和干扰。
丝20由具有足够刚性的材料形成，以便保持预定形状。在示例性实施方式中，丝20由形状记忆材料(例如，NiTi)形成。可以期望至少端部是相对刚性的，使其可以施加力从而移动腱索，同时始终保持柔性从而在导管内塌缩。在多种实施方式中，端部(包括自由端22)只需要足够刚性，从而保持其形状，并将在载荷下变形。例如，端部可以被构造有与导丝类似的刚性或略微更硬。
在多种实施方式中，锚固件15包括螺旋构件。螺旋构件可包括螺旋丝或扁平带。螺旋构件可包括本文描述的三维表面。
在多种实施方式中，锚固件15可包括第一部分和另一部分，第一部分具有螺旋丝20。替代地，或组合地，锚固件15可包括多个螺旋丝20。例如，锚固件15可包括具有相同或不同直径的至少两个螺旋丝20。替代地或组合地，锚固件15可包括具有相同或不同卷绕节距的至少两个螺旋丝20。
在多种实施方式中，锚固件15可包括多个锚固件，例如本文描述的多个螺旋丝20。
在所示的实施方式中，瓣膜假体10被构造成用于置换二尖瓣，并且自由端22被构造成插入穿过连合部。图1是具有二尖瓣4的人类心脏2。图2和4示出示例性的二尖瓣4。如附图所示，多个连合点(前外侧连合部4d和后内侧连合部4e)存在于瓣膜小叶4a、4b的端部处。
继续参考图6-18，示例性自由端22的尺寸和大小被设置成用于插入穿过连合部之一。在多种实施方式中，自由端22被构造成非创伤的，以避免伤害瓣膜组织和小叶的危险。自由端22可以是钝端部、球末端、弯曲末端(例如J末端或猪尾)和其他非创伤形状。在多种实施方式中，自由端22被构造有穿刺组织的锋利端部。
在多种实施方式中，丝20沿着其长度具有变化的刚度。丝20可具有包括不同刚度的两个或更多个段，和/或刚度可在其长度上过渡。在多种实施方式中，丝20在多个点处附接到框架12，使得自由端22相对柔性，并且丝20沿着其附接到框架结构12的部分更加刚硬。
在多种实施方式中，自由端22从过框架结构12且特别是丝20的剩余部分径向向外延伸。如下面描述，自由端22被构造成比丝20的主线圈环绕更大半径。例如，在丝20的主线圈具有大致管状形状时，自由端22可从管状形状径向向外延伸。在丝20的主线圈具有大致螺旋形状时，自由端22可从螺旋形状径向向外延伸。在丝20的主线圈具有大致截锥形状时，自由端22可从截锥形状径向向外延伸。加大直径有助于在转动期间将瓣膜小叶和/或腱索捕获在自由端22的范围内，这将在下面更加详细描述。
根据本发明植入瓣膜假体10的方法将参考图19-28描述。虽然相对于二尖瓣表示和说明，人们将理解到本文描述的原理可以同样适用于其他房室瓣膜。过程、递送工具和植入瓣膜假体的各个方面类似于美国专利No.9,034,032、9,005,273、8,323,336、8,075,615、7,621,948和7,175,656以及美国公开No.2011/0288637中描述的那些，这些文献出于所有目的整体合并于此。
在植入之前，瓣膜假体10被塌缩且装载到递送装载30内，例如递送导管。瓣膜系统任选地在加载到递送导管30之前或之后准备完毕。图19示出在其房间隔内具有经中隔穿孔27的心脏2的横截面侧视图。瓣膜4的小叶42没有完全脱垂，并且患者经历着反流。
接着，递送导管30插入穿过导引器进入血管。递送导管30可使用Seldinger技术在导丝上引导到目标位置。在所示实施方式中，递送导管30以图20所示的传统方式经过经中隔穿孔27引导到左心房25。
转向图21-22，此时，递送导管30的端部指向二尖瓣4。瓣膜假体10接着被推出递送导管30的远侧端部。递送装置30可包括外导管50和内导管或轴52。在一些实施方式中，一旦递送装置30就位，递送管52延伸离开外导管50，以便朝着自体瓣膜4向远侧运动瓣膜装置10。随着瓣膜假体10从递送导管30离开，诸如丝20的锚固件15被部署(例如从递送装置30内的笔直形状)到其预成型部署形状并围绕框架12卷绕，框架12保持在图22所示的其塌缩状态。瓣膜假体10接着与目标自体瓣膜4对准，使得人工瓣膜10的轴线与自体瓣膜4的中心轴线对准。
转向图23-24，瓣膜10使用示例性螺旋丝20被锚固到自体瓣膜4。瓣膜假体10(框架12、丝20和瓣膜段14)缓慢转动到自体二尖瓣4。在所示实施方式中，扭力器设置在递送导管30内以转动瓣膜10。丝20的自由端22转动经过连合部，并在自体瓣膜4环的下方延伸。瓣膜假体4进一步转动，使得自由端22捕获腱索(也称为“乳头肌”)40和/或自体瓣膜小叶42。随着丝20继续转动，腱索40被收集并向内径向拉动。自由端22具有大于螺旋线圈的主体的半径，以有助于腱索40在瓣膜假体10的转动期间捕捉。框架结构12同样随着丝20的转动而运动到自体瓣膜4内。瓣膜假体10在腱索40已经捕捉到充分程度和/或框架结构12在自体瓣膜40内位于期望位置时位于正确位置。该装置穿过自体瓣膜插入可通过在心动周期期间自体瓣膜的自然打开和闭合来辅助。在所示实施方式中，腱索40被向内拉动成束状(图25清楚示出)。自体瓣膜小叶42也与螺旋线圈20连通。在此阶段，瓣膜装置10邻近自体瓣膜40环刚性地锚固。
如果医生期望移除或重新定位瓣膜，螺旋丝20可以从自体瓣膜4反向转动离开装置10。植入转动过程接着可以重复。
一旦瓣膜10位于图25所示的期望位置，框架结构12被扩张。框架结构12可包括相对的第一端部和第二端部，在框架结构12锚固到自体瓣膜4时，第一端部在自体瓣膜的上方延伸，并且第二端部在自体瓣膜的下方延伸。在所示实施方式中，框架结构12通过图27-28所示的囊体48扩张。在多种实施方式中，框架结构12是自扩张的。自扩张的示例性框架结构12由形状记忆材料或具有超弹性性能的任何材料形成。自扩张的框架结构12以类似于自扩张支架或支承架的方式构造和扩张。扩张框架结构12包括从框架结构12移除递送装置30的护套(例如，外护套50)。
一旦框架结构12扩张，整个瓣膜组件10从递送导管30释放，并且递送导管30如图26所示移除。在一些实施方式中，框架结构12的扩张可与框架结构12从递送导管30的释放同时进行。
在所示实施方式中，瓣膜结构14和框架结构12被一起部署。但是，本领域普通技术人员将理解到框架结构12可首先部署并接着接收人工瓣膜段14。
在多种实施方式中，瓣膜假体10不包括瓣膜段14。相反，框架结构12和锚固件15定位在自体瓣膜4内。框架结构12被构造成接收单独递送的瓣膜段14。在某些实施方式中，框架结构12可被构造成接收多种瓣膜尺寸和类型中的一种。以此方式，医生可选择用于单个患者的适当瓣膜。
在所示实施方式中，锚固件15的螺旋丝20沿着期望轴线引导瓣膜系统10进入邻近自体瓣膜4的位置。丝20也提供最初的锚固。瓣膜假体10在框架结构12在自体瓣膜4内扩张时最终锚固。框架结构12扩大瓣膜小叶14，并且压缩力将瓣膜假体10固定就位。随后，组织内生长确保瓣膜假体10保持就座并不迁徙。
根据本发明的瓣膜装置相对于传统瓣膜系统提供多种优点。本文描述的实施方式提供易于使用、可重新定位的装置。不同于传统瓣膜系统，本文描述的瓣膜假体减小伤害或撕裂腱索的危险。典型的二尖瓣置换系统涉及围绕瓣膜植入假体环或环体。环增加瓣膜的圆周，并有阻塞主动脉瓣入口的危险。本文描述的瓣膜装置克服了这些和其他问题。
图29示出根据本发明的另一实施方式。瓣膜假体10’包括螺旋丝20’和框架结构12’。瓣膜结构10’类似于瓣膜10，只是瓣膜段14’固定在框架结构12’的分离端部。丝20’围绕框架结构12的下部卷绕，该下部具有小于框架结构12的固定瓣膜段14’的上部的直径。
图30A-30F示出根据本发明的多种其他实施方式。每个瓣膜10a-10f包括螺旋丝和框架。每个可任选地包括位于框架内的瓣膜段。
图30A示出类似于瓣膜假体10的瓣膜假体10a，只是自由端22a包括非创伤球末端。同样，丝20a具有位于一端处的管状形状和位于另一端处的截锥形状。框架结构12a大致类似于框架结构12。
图30B示出类似于瓣膜假体10的瓣膜假体10b，只是自由端22具有猪尾末端。同样，丝20b附接到框架结构12b的中间部分，而不是框架结构12b的端部。框架结构12b大致类似于框架结构12。
图30C示出类似于瓣膜假体10的瓣膜假体10c，只是框架结构12c是管状结构，而不是支承架或支架结构。框架结构12c可由诸如聚氨酯或聚碳酸酯聚氨酯的可扩张材料形成。丝20c大致类似于丝20。自由端22c大致类似于自由端22。
图30D示出类似于瓣膜假体10的瓣膜假体10d，只是锚固件15由三维表面20d形成，而不是丝20。三维表面20d包括自由端22d，其大致类似于本文描述的任何自由端。框架结构12d大致类似于框架结构12。
图30E示出类似于瓣膜假体10的瓣膜假体10e，只是框架结构12e具有锥形形状，而不是管状形状。人们将从本文描述中理解到框架结构12可根据本发明采用多种形状。丝20e大致类似于丝20。自由端22e大致类似于自由端22。
图30F示出类似于瓣膜假体10的瓣膜假体10f，只是瓣膜装置10f包括多个丝20f和20f’。使用多个丝20f和20f’提供增加的锚固安全性。由于难以插入两个自由端22f和22f’，一个或两个自由端22f和22f’可包括锋利尖头，以穿刺组织。以此方式，锋利端部可穿刺瓣膜环或小叶。倒刺或其他机构可用来增加丝的锚固。例如，一个或多个丝20f和20f’可包括编制表面或倒刺，以便在其旋入就位时防止轴向脱位。
在特征或元件在本文中被描述成“位于”另一特征或元件“上”时，它可以直接位于其他特征或元件上，或者也可以存在介入特征和/或元件。相比之下，在特征或元件被描述成“直接位于”另一特征或元件“上”时，将不存在介入特征或元件。还将理解到，在特征或元件被描述成“连接”、“附接”或“联接”到另一特征或元件时，它可以直接连接、附接或连接到其他特征或元件，或者可以存在介入特征或元件。相比之下，在特征或元件被描述成“直接连接”、“直接附接”或“直接联接”到另一特征或元件时，将没有接入特征或元件。虽然相对于一种实施方式进行描述或表示，本领域普通技术人员也将理解到对于“邻近”另一特征布置的结构或特征的参考可具有与相邻特征重叠或重复的部分。
本文使用的术语只出于描述特定实施方式的目的，而不意图限制本发明。例如，如本文使用，单数“一”、“一个”和“该”旨在也包括复数形式，除非本文另外明确指明。将进一步理解到说明书中使用的术语“包括”和/或“包含”明确所引用特征、步骤、操作、元件和/或部件的存在，但是并不排除一个或多个其他特征、步骤、操作、元件、部件和/或其组合的存在或添加。如本文使用，术语“和/或”包括相关列举项目的一个或多个的任何组合和所有组合，并且可以缩写成“/”。
诸如“之下”、“下方”、“以下”、“之上”、“上方”等空间相关术语可在本文中用来便于描述，从而描述一个元件或特征相对于附图所示的另一或特征的关系。将理解到空间相关术语旨在包括装置在使用或操作中除了附图所描述的定向之外的不同定向。例如，如果附图中的装置颠倒，那么被描述成位于其他元件或特征“之下”或“下方”的元件可定向在所述其他元件或特征“之上”。因此，示例性术语“下方”可包括上方和下方的两种定向。装置可通过其他方式定向(转动90度或位于其他定向上)，并且本文使用的空间相关描述相应地进行解释。类似地，术语“向上”、“向下”、“竖直”、“水平”等在本文中只用于说明目的，除非另外明确指明。
虽然术语“第一”和“第二”可在本文中用来描述多种特征/元件(包括步骤)，这些特征/元件不应该被这些术语限制，除非本文另外指明。这些术语可以用来使一个特征/元件与另一特征/元件区分。因此，下面描述的第一特征/元件可以称为第二特征/元件，并且类似地，下面描述的第二特征/元件可以称为第一特征/元件，而不偏离本发明的教导。
在此说明书以及随后的权利要求中，除非本文另外要求，词语“包括”以及诸如“包含”和“具有”的变型指的是多种部件可以结合起来用于所述方法和物品中(例如，包括该装置和方法的组成和设备)。例如，术语“包括”将理解为指的是包括任何列举的元件或步骤，但是不排除任何其他元件或步骤。
在特征或元件在本文中被描述成“位于”另一特征或元件“上”时，它可以直接位于其他特征或元件上，或者也可以存在介入特征和/或元件。相比之下，在特征或元件被描述成“直接位于”另一特征或元件“上”时，将不存在介入特征或元件。还将理解到，在特征或元件被描述成“连接”、“附接”或“联接”到另一特征或元件时，它可以直接连接、附接或连接到其他特征或元件，或者可以存在介入特征或元件。相比之下，在特征或元件被描述成“直接连接”、“直接附接”或“直接联接”到另一特征或元件时，将没有接入特征或元件。虽然相对于一种实施方式进行描述或表示，本领域普通技术人员也将理解到对于“邻近”另一特征布置的结构或特征的参考可具有与相邻特征重叠或重复的部分。
本文使用的术语只出于描述特定实施方式的目的，而不意图限制本发明。例如，如本文使用，单数“一”、“一个”和“该”旨在也包括复数形式，除非本文另外明确指明。将进一步理解到说明书中使用的术语“包括”和/或“包含”明确所引用特征、步骤、操作、元件和/或部件的存在，但是并不排除一个或多个其他特征、步骤、操作、元件、部件和/或其组合的存在或添加。如本文使用，术语“和/或”包括相关列举项目的一个或多个的任何组合和所有组合，并且可以缩写成“/”。
诸如“之下”、“下方”、“以下”、“之上”、“上方”等空间相关术语可在本文中用来便于描述，从而描述一个元件或特征相对于附图所示的另一或特征的关系。将理解到空间相关术语旨在包括装置在使用或操作中除了附图所描述的定向之外的不同定向。例如，如果附图中的装置颠倒，那么被描述成位于其他元件或特征“之下”或“下方”的元件可定向在所述其他元件或特征“之上”。因此，示例性术语“下方”可包括上方和下方的两种定向。装置可通过其他方式定向(转动90度或位于其他定向上)，并且本文使用的空间相关描述相应地进行解释。类似地，术语“向上”、“向下”、“竖直”、“水平”等在本文中只用于说明目的，除非另外明确指明。
虽然术语“第一”和“第二”可在本文中用来描述多种特征/元件(包括步骤)，这些特征/元件不应该被这些术语限制，除非本文另外指明。这些术语可以用来使一个特征/元件与另一特征/元件区分。因此，下面描述的第一特征/元件可以称为第二特征/元件，并且类似地，下面描述的第二特征/元件可以称为第一特征/元件，而不偏离本发明的教导。
在此说明书以及随后的权利要求中，除非本文另外要求，词语“包括”以及诸如“包含”和“具有”的变型指的是多种部件可以结合起来用于所述方法和物品中(例如，包括该装置和方法的组成和设备)。例如，术语“包括”将理解为指的是包括任何列举的元件或步骤，但是不排除任何其他元件或步骤。
如本文在说明书和权利要求中使用，包括例子中所使用的，并且除非另外明确表示，所有数字可以读成似乎前缀为表述“大约”或“约”，即使该术语没有明确出现。表述“大约”或“约”可以在描述指示所描述的数值和/或位置在数值和/或位置的合理期望范围内的幅值和/或位置时使用。例如，数值可以具有所述数值(或数值范围)的+/-0.1％、所述数值(或数值范围)的+/-1％的值、所述数值(或数值范围)的+/-2％的值、所述数值(或数值范围)的+/-5％的值、所述数值(或数值范围)的+/-10％等的值。本文给出的任何数值还应该理解为包括大约或约所述值，除非本文另外指明。例如，如果公开了值“10”，那么也公开了“大约10”。本文引用的任何数值范围旨在包括其中所包含的所有子范围。同样理解到在公开数值“小于或等于”某个数值时，同样公开了“大于或等于某个数值”以及该数值之间的可能范围，如本领域普通技术人员所理解那样。例如，如果公开数值“X”，也公开了“小于或等于X”以及“大于或等于X”(例如，其中X是数值)。同样理解到在本申请中，数据以多种不同的格式提供，并且这些数据表示端点和起点，以及用于数据点的任何组合的范围。例如，如果公开了特别数据点“10”和特别数据点“15”，理解到考虑公开了大于、大于或等于、小于、小于或等于以及当于10和15以及10和15之间的情况。还理解到同样公开了两种特定单元之间的每个单元。例如，如果公开了10和15，那么也公开了11、12、13和14。
出于说明和描述的目的给出本发明的特定实施方式的以上描述。它们不意图是穷尽的，或将本发明限制在所公开的具体形式，并且明显地，许多变型、改变、替代、替换和改型在以上教导下也是可以的。各种实施方式被选择和描述成最佳地解释本发明的原理及其实际应用，由此使得本领域其他普通技术人员能够最佳地应用本发明，并且具有多种变型的多种实施方式适用于所设想的特定应用。意图在于本发明的范围通过所附权利要求及其等同物限定。

Claims (16)

1.一种用于置换患者心脏内的病变自体瓣膜的心脏瓣膜假体，瓣膜假体包括：
可压缩和可扩张框架结构，可压缩和可扩张框架结构具有框架轴线；
瓣膜段，瓣膜段布置在框架结构内，瓣膜段包括可生物相容单向瓣膜；以及
可压缩和可扩张的锚固件，锚固件永久地附接到框架结构的外周边，并被构造成能够环绕框架结构的外周边，其中锚固件具有螺旋丝并具有自由端，自由端具有大于螺旋丝的曲率半径；
其中，瓣膜假体具有锚固构型，在锚固构型，锚固件处于扩张状态，框架结构处于塌缩状态，并且框架轴线对中地定位在螺旋丝中；以及
其中，在心脏瓣膜假体处于锚固构型时，螺旋丝的转动能够引导框架结构进入自体瓣膜。
2.根据权利要求1所述的瓣膜假体，其中，螺旋丝的自由端被构造成使螺旋丝引导穿过患者的自体瓣膜的连合部。
3.根据权利要求1所述的瓣膜假体，其中，自由端包括非创伤末端。
4.根据权利要求3所述的瓣膜假体，其中，自由端包括球末端。
5.根据权利要求1所述的瓣膜假体，其中，自由端被构造成穿刺组织。
6.根据权利要求1所述的瓣膜假体，其中，框架结构被构造成在患者的自体瓣膜内扩张。
7.根据权利要求1所述的瓣膜假体，其中，框架结构具有压缩状态，在压缩状态下，框架结构具有尺寸和大小被设置成用于经皮插入，并具有尺寸和大小被设置成用于植入患者的自体瓣膜的扩张状态。
8.根据权利要求1所述的瓣膜假体，其中，框架结构包括相对的第一端部和第二端部，在瓣膜假体横过自体瓣膜定位时，第一端部在自体瓣膜的上方延伸，并且第二端部在自体瓣膜的下方延伸。
9.根据权利要求1所述的瓣膜假体，其中，框架结构包括可扩张支架。
10.根据权利要求1所述的瓣膜假体，其中，框架结构包括大致管状的扩张形状。
11.根据权利要求1所述的瓣膜假体，其中，框架结构包括扩张的外周边和在受到外部径向力时压缩的外周边，其中压缩的外周边的直径略微小于扩张的外周边。
12.根据权利要求1所述的瓣膜假体，其中，框架结构是自扩张的。
13.根据权利要求1所述的瓣膜假体，其中，瓣膜段包括具有内层和外层的至少一个小叶，并且其中框架结构在框架结构的一个或多个端部处附接到外层。
14.根据权利要求1所述的瓣膜假体，其中，瓣膜段包括多个小叶。
15.根据权利要求14所述的瓣膜假体，其中，瓣膜段包括两个小叶。
16.根据权利要求1所述的瓣膜假体，其中，锚固件和框架结构适于独立和分离地扩张。
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