CN114144144A - 低轮廓假体二尖瓣 - Google Patents

低轮廓假体二尖瓣 Download PDF

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CN114144144A
CN114144144A CN202080052112.5A CN202080052112A CN114144144A CN 114144144 A CN114144144 A CN 114144144A CN 202080052112 A CN202080052112 A CN 202080052112A CN 114144144 A CN114144144 A CN 114144144A
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valve
prosthetic valve
ventricular
native
prosthetic
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埃里克·松-桑·冯
卡伦·特索克-基·黄
伊弗雷姆·本-亚伯拉罕
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Neovasc Tiara 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
    • A61F2/2412—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
    • 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
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • 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
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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  • Health & Medical Sciences (AREA)
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Abstract

一种用于治疗天然瓣膜的低轮廓假体瓣膜，该假体瓣膜包括具有扩张构型和收缩构型的径向可扩张框架。假体瓣膜的心房端部形成与天然瓣膜的心房表面接合的张开形状。张开形状在最初扩张时朝向天然瓣膜的心室向下张开，然后在完全扩张时使张开形状倒置以形成朝向心室渐缩并且朝向天然瓣膜的心房张开的渐缩形状。假体瓣膜还具有多个假体瓣膜小叶，多个假体瓣膜小叶打开以及闭合以控制流体流动通过假体瓣膜。

Description

低轮廓假体二尖瓣
优先权要求
本申请是非临时的并且要求于2019年6月20日提交的美国临时专利申请No.62/864,008(代理案卷号5131.019PRV)的权益；该美国临时专利申请的全部内容通过参引并入本文中。
背景技术
二尖瓣反流、也称为二尖瓣功能不全，是严重的心脏疾病，其中，二尖瓣不能正常关闭并且阻止逆行血流通过天然二尖瓣。这种情况会损害心脏功能并且会使人衰弱或危及生命。
目前用于二尖瓣功能不全的治疗包括传统的天然瓣膜外科手术修复。侵入性较小的经导管治疗正在开发。
附图说明
在不一定按比例绘制的附图中，相似的附图标记可以描述不同视图中的类似的部件。具有不同字母后缀的相似的附图标记可以表示类似部件的不同实例。附图总体上通过示例而非限制的方式来图示本文中论述的各种实施方式。
图1是心脏的左心室的示意图，其示出了心缩期间的血流。
图2是在二尖瓣中具有脱垂小叶的心脏的左心室的示意图。
图3A是患有心肌病的患者中的心脏的示意图，其中，心脏扩张并且小叶不相接。
图3B示出了小叶的正常闭合。
图3C示出了扩张心脏中的异常闭合。
图4图示了具有受损的乳头肌的心脏的左心室中的二尖瓣反流。
图5A至图5B图示了二尖瓣的解剖结构。
图6A示出了低轮廓假体瓣膜的示例的俯视图。
图6B示出了图6A中的示例的心室锚固件。
图6C示出了可以附接至图6A中的瓣膜的心室锚固件的覆盖物。
图6D示出了图6A中的瓣膜的立体图。
图7A示出了低轮廓假体瓣膜的另一示例的俯视图。
图7B示出了图7A中的示例的心室锚固件。
图7C示出了可以用在图7B的心室锚固件上的覆盖物的示例。
图7D示出了图7A中的示例的立体图。
图8A示出了低轮廓假体瓣膜的另一示例的俯视图。
图8B示出了图8A的处于部分部署构型的假体瓣膜。
图8C示出了图8A的处于完全部署构型的假体瓣膜。
图8D示出了图8A的假体瓣膜布置在天然二尖瓣中。
图9A至图9F示出了以可释放的方式联接至假体瓣膜的输送导管。
图10A至图10C示出了用于以可释放的方式将假体瓣膜与输送导管联接的锁定机构。
图11示出了用于以可释放的方式将假体瓣膜与输送导管联接的锁定机构的侧视图。
图12A至图12B示出了用于以可释放的方式将假体瓣膜与输送导管联接的锁定机构。
图13A至图13D图示了用于将假体瓣膜部署在天然瓣膜中的方法的示例。
图14示出了假体瓣膜在天然瓣膜中的示例。
图15A至图15D示出了用于将假体瓣膜部署在天然瓣膜中的方法的另一示例。
具体实施方式
传统的二尖瓣外科手术修复可能是有效的治疗，但需要心脏直视手术、较长的住院时间和恢复期。侵入性较小的经导管治疗正在开发并且很有前景，但植入可能具有挑战性而且许多尚未获得进行商业流通的监管批准。因此，需要改进的装置来治疗二尖瓣功能不全。这些挑战中的至少一些挑战通过本文中所公开的示例得以解决。
虽然本文中公开的示例涉及用于治疗二尖瓣反流的可植入假体二尖瓣，但本领域技术人员将理解的是这并非意在限制，并且本文中公开的装置和方法也可以用于治疗其他心脏瓣膜比如三尖瓣、主动脉瓣、肺动脉瓣等以及身体中的其他瓣膜比如静脉瓣膜或者用于控制流体或其他物质流动的任何解剖结构。
心脏解剖学
图1中图示了正常心脏H的处于心缩的左心室LV。左心室LV正在收缩并且血液沿箭头方向向外流动穿过主动脉瓣AV、三尖瓣。由于二尖瓣构造为当左心室中的压力高于左心房LA中的压力时防止回流的“止回阀”，因此防止了血液通过二尖瓣MV的回流或“反流”。如图1中图示的，二尖瓣MV包括一对小叶，所述一对小叶具有均匀地相接以闭合的自由边缘FE。小叶LF的相反端部沿着称为瓣环AN的环形区域附接至周围的心脏结构。小叶LF的自由边缘FE通过腱索CT(本文中也称为腱)紧固至左心室LV的下部部分，腱索CT包括紧固在瓣膜小叶LF中的每个瓣膜小叶的下表面上方的多个分支腱。腱CT又附接至从左心室的下部部分向上延伸的乳头肌PM以及室间隔IVS。
现在参照图2至图4，心脏中的许多结构缺陷可以导致二尖瓣脱垂，因为不足的张力经由腱传递至小叶。当另一小叶LF1保持正常轮廓时，两个瓣膜小叶没有适当地相接，并且将发生如由箭头所示的从左心室LV到左心房LA中的泄漏。
在心脏扩张并且增大的尺寸阻止瓣膜小叶LF适当地相接的患有心肌病的患者中也会发生反流，如图3A中所示。心脏的扩大导致二尖瓣环变大，从而使得自由边缘FE在心缩期间不能相接。前小叶的自由边缘和后小叶的自由边缘通常沿着如图3B中所示的接合线C相接，但在患有心肌病的患者中可能会留有明显的间隙G，如图3C中所示。
在乳头肌PM的功能受损的患有缺血性心脏病的患者中也可能发生二尖瓣反流，如图4中图示的。当左心室LV在心缩期间收缩时，乳头肌PM不能充分收缩以实现适当的闭合。如图示的，小叶LF1和小叶LF2于是脱垂。再次发生如由箭头所示的从左心室LV至左心房LA的泄漏。
图5A更清楚地图示了二尖瓣MV的解剖结构，二尖瓣MV是具有前侧部ANT和后侧部POST的二叶瓣。瓣膜包括前(主动脉)小叶AL和后(壁侧)小叶PL。腱索CT将瓣膜小叶AL、PL与前外侧乳头肌ALPM和后内侧乳头肌PMPM联接。瓣膜小叶AL、PL沿着称为前外侧连合ALC和后内侧连合PMC的线彼此连结。瓣环AN外接瓣膜小叶，并且在前小叶的相对侧部上的与瓣环的前部部分相邻的两个区域称为左纤维三角区LFT和右纤维三角区RFT。这些区域通常由实线三角形表示。图5B更清楚地图示了左纤维三角区LFT和右纤维三角区RFT。
假体瓣膜
假体瓣膜作为对二尖瓣反流的治疗已经通过手术植入心脏中。这些瓣膜中的一些瓣膜是从动物中获得的瓣膜、比如猪瓣膜，并且其他瓣膜是具有或不具有组织覆盖物的假体机械瓣膜。最近，已经使用微创导管技术来将假体瓣膜输送至心脏。这些瓣膜通常包括用于将假体瓣膜紧固至患者心脏的锚固件以及联接至锚固件的瓣膜机构。瓣膜机构通常是机械瓣膜、具有动物组织的瓣膜或其组合。假体瓣膜一旦植入，就会接管发生故障的天然瓣膜，从而减少或消除瓣膜功能不全。这些瓣膜中的一些瓣膜难以输送并且一些瓣膜难以准确地锚固。其他尺寸较大的瓣膜可能阻塞心脏的室。虽然这些瓣膜中的一些瓣膜看起来很有前途，但仍需要改进瓣膜以解决这些挑战中的至少一些挑战。以下说明书公开了假体瓣膜、用于假体瓣膜的输送系统以及将瓣膜输送的方法的示例，这些示例可以克服与现有假体瓣膜相关联的挑战中的一些挑战。
图6A图示了以平面剖视图示出的低轮廓假体二尖瓣600的示例。假体二尖瓣600是由多个相互连接的支柱形成的可扩张框架并且可以从诸如不锈钢、镍钛合金或其他生物兼容材料的平坦的片材材料切割。假体二尖瓣600可以是可球囊扩张或自扩张的。可扩张框架在从片材材料切割后处于平坦平面构型并且可以进行热处理并且定形成如将在以下描述的期望的形状。平面图案包括多个同心环形环602、604，同心环形环602、604由围绕假体的周边延伸的多个支柱形成。随着环更接近假体瓣膜的中心，环的直径和周长更小。因此，环602比环604具有更大的直径和更大的周长。相邻环与多个径向延伸的支柱612联接在一起以形成围绕假体瓣膜周向布置的多个封闭单元，其中，相邻的封闭单元共用至少一个公共支柱。每个环602、604可以包括全部具有相同几何结构的多个周向定向的支柱。例如，最外环602包括联接在一起以形成环形环的多个叉骨形支柱。叉骨形支柱在环602中可以全部相同并且叉骨形支柱可以包括与弧形支柱联接在一起的两个相对倾斜的支柱，弧形支柱在两个相对倾斜的支柱之间的拐点处形成叉骨形支柱中的突起或峰。
从环602径向向内布置的下一相邻环604类似地由联接在一起的多个叉骨形支柱形成。环604中的叉骨形支柱可以在环604中全部相同并且它们可以类似地由与弧形支柱联接在一起的两个相对倾斜的支柱形成，弧形支柱在两个相对倾斜的支柱之间的拐点处形成叉骨形支柱中的突起或峰。环604中的支柱的尺寸和角度可以与环602不同，这是因为这两个环彼此同心并且环604比外环602具有更小的直径和周长。从假体的中心径向地向外延伸的多个线性支柱612将环602和环604联接在一起以形成封闭单元610。形成在环602与环604之间的封闭单元610可以全部具有相同的几何结构，或者封闭单元610可以变化。
支柱可以是叉骨形状以远离叉骨的顶点转移应力和应变，从而允许对于给定的最大应变实现更大的角度运动范围，或者允许对于相同的给定运动范围发生更低的最大应变。
Y形支柱616联接至叉骨形第二环604，其中，Y的尾部朝向假体的中心径向地向内延伸，从而形成柠檬形的封闭单元，该封闭单元在封闭单元的相反侧部上具有峰和谷并且在封闭单元的另外两个侧部上具有尖端部。Y的尾部可以联接在一起以限定假体中的中心开孔618。在该示例中，中心开孔618是星形的，其中，三个尖臂径向地向外延伸以形成星形状。
多个内部封闭单元620、此处为三个封闭单元620由在封闭单元620的相反侧部上的两个V形支柱622形成，V形支柱622联接至相邻Y形支柱616的尾部以形成封闭单元620。每个封闭单元620包含连合突部606和两个心室锚固支柱614。
连合突部606可以邻近假体的中心并且可以包括多个缝合孔，使得假体瓣膜小叶可以缝合至连合突部。连合突部606可以是具有穿过中间的用于接纳假体小叶的狭缝的矩形形状支柱。在该示例中，存在附接至连合突部的三个假体瓣膜小叶(未示出)，从而形成三尖瓣假体瓣膜。假体瓣膜小叶未图示以便观察可扩张框架。连合突部布置在形成心室锚固突部的支柱614之间，心室锚固突部将假体锚固至天然瓣膜的心室部分、比如天然瓣膜的前部分(比如纤维三角区)和天然瓣膜的后部分。支柱614形成心室锚固件的部分。两个支柱614布置在连合突部606的两侧上。支柱614的一个端部联接至Y形支柱616的尾部，并且支柱614的相反端部是可以径向向外弯曲的自由端部。自由端部可以包括用于附接覆盖物的通孔(未示出)。覆盖物可以是任何材料比如像涤纶的聚合物，并且覆盖物形成用于接合组织的柔软的无损伤梢部的脚部。涤纶或其他聚合物覆盖物材料提供了更大的表面积并且因此减少了心室锚固突部刺穿组织的机会。在扩张期间，心室突部于是可以远离瓣膜框架成角度以允许锚固在天然瓣膜的纤维三角区上或心室侧的任何其他前部分上或者天然瓣膜的后瓣环上的任何部分上。
多个锚固突部608可以径向地向内面向装置的中心，锚固突部608此处为蘑菇头形状的突部608或T形头部，锚固突部608允许假体附接至如将在下面进行描述的输送导管。在该示例或任何其他示例中，T形或蘑菇头锚固突部可以省略并且简单地具有穿过突部的开孔，这允许销或其他连接器元件布置在开孔中以用于与输送导管进行可释放联接，如将在下面进行更详细描述的。锚固突部608布置在将Y形支柱616的两个尾部连结在一起的支柱的一部分上。因此，在该示例中，存在可以与输送导管进行作用的三个连接点。
图6B图示了假体瓣膜600，其中，覆盖物624布置在支柱614和假体框架的上方以形成有助于形成心室锚固件的脚部。这是由阴影区域示出的。脚部包括扩大的头部区域和较窄的本体。同样，扩大的头部提供了更大的表面积并且因此使锚固期间施加至组织的压力最小化以消除或减少组织创伤。图6B的其他方面与图6A相同。
图6C示出了覆盖物624的示例，该覆盖物624可以附接至支柱614以形成心室锚固件的无损伤梢部。覆盖物可以是涤纶或其他聚合物或具有期望机械性能的任何材料。覆盖物624具有扩大的头部区域和细长形的本体区域。扩大的头部区域提供了较大的表面积以减少锚固期间与组织的接触压力，以便消除或减少组织刺穿和创伤。
图6D是图6A至图6B中示出的假体瓣膜600的立体图，但其中覆盖物630被示出布置在可扩张框架的上方并且在定形之后布置在可扩张框架的上方。除了布置在心室锚固件614的上方以形成无损伤锚固突部的覆盖物外，相同的材料或类似材料还可以布置在支柱和封闭单元中的任一者或全部的上方，以使瓣周泄漏最小化并且促进组织向内生长。图6D示出了定形之后的处于完全部署构型的假体瓣膜600，其中，假体沿心房方向向上张开(或沿心室方向渐缩)并且作为假体的流入端部的上心房端部直径最大并且瓣膜在作为流出端部的心室端部上渐缩至较小直径。框架的漏斗形状也可以描述为抛物面状，其中，抛物面的凹面部分向上面向心房并且抛物面的凸面部分向下面向心室。假体瓣膜具有中间扩张构型，在中间扩张构型中，抛物面是倒置的使得假体从上端部至下端部向外张开，因此沿心室的方向张开或者沿心房的方向渐缩。如果呈抛物面形状，则于是抛物面的凹面部分向下面向心室而抛物面的凸面部分向上面向心房。下面更详细地说明和描述了该中间扩张构型。假体瓣膜600还包括三个连合柱，其中，三个假体瓣膜小叶632联接至连合柱以形成假体瓣膜机构。
图7A图示了以平面剖视图示出的低轮廓假体二尖瓣700的示例。假体二尖瓣700是由多个相互连接的支柱形成的可扩张框架并且可以从诸如不锈钢、镍钛合金或其他生物兼容材料的平坦的片材材料切割。假体二尖瓣700可以是可球囊扩张或自扩张的。可扩张框架在从片材材料切割后处于平坦平面构型并且可以进行热处理并且定形成如将在以下描述的期望的形状。平坦图案包括多个同心环形环702、704，同心环形环702、704由围绕假体的周边延伸的多个支柱形成。随着环更接近假体瓣膜的中心，环的直径和周长更小。因此，环702比环704具有更大的直径和更大的周长。相邻环与多个径向延伸的支柱712联接在一起以形成围绕假体瓣膜周向布置的多个封闭单元，其中，相邻的封闭单元共用至少一个公共支柱。每个环702、704可以包括全部具有相同几何结构的多个周向定向的支柱。例如，最外环702包括联接在一起以形成环形环的多个叉骨形支柱。叉骨形支柱在环702中可以全部相同并且叉骨形支柱可以包括与弧形支柱联接在一起的两个相对倾斜的支柱，弧形支柱在两个相对倾斜的支柱之间的拐点处形成叉骨形支柱中的突起或峰。
从环702径向向内布置的下一相邻环704类似地由联接在一起的多个叉骨形支柱形成。环704中的叉骨形支柱可以在环704中全部相同并且它们可以类似地由与弧形支柱联接在一起的两个相对倾斜的支柱形成，弧形支柱在两个相对倾斜的支柱之间的拐点处形成叉骨形支柱中的突起或峰。环704中的支柱的尺寸和角度可以与环702不同，这是因为这两个环彼此同心并且环704比外环702具有更小的直径和周长。从假体的中心径向地向外延伸的多个线性支柱712将环702和环704联接在一起以形成封闭单元710。形成在环702与环704之间的封闭单元710可以全部具有相同的几何结构，或者封闭单元710可以变化。连接支柱的使环联接在一起以形成封闭单元的构型产生了格子结构，该格子结构一旦定形就提供例如类似于雏菊的花状形状。
支柱可以是叉骨形状以远离叉骨的顶点转移应力和应变，从而允许对于给定的最大应变实现更大的角度运动范围，或者允许对于相同的给定运动范围发生更低的最大应变。
Y形支柱716联接至叉骨形第二环704，其中，Y的尾部朝向假体的中心径向地向内延伸，从而形成数个泪滴形的封闭单元以及与图6A中的示例大致相同的数个柠檬形的封闭单元，泪滴形的封闭单元在泪滴形状的相反侧部上具有尖端部。Y的尾部可以与V形支柱联接在一起以限定假体中的内部封闭单元720与中心开孔718。在该示例中，中心开孔718具有中心圆孔，中心圆孔具有从中心圆孔径向地向外延伸的多个尖臂。
内部封闭单元720由V形支柱722形成，V形支柱722联接至相邻Y形支柱716的尾部以形成封闭单元720。封闭单元720包含三个连合突部706并且三个V形支柱从封闭单元720径向地向外延伸，三个V形支柱形成构造成与天然瓣膜的心室下表面接合的心室锚固件724。心室锚固件的腿部可以联接至Y形支柱的尾部，并且V的顶点(或V的槽或V的自由端部)可以包括延伸穿过该顶点的定尺寸成接纳缝合线的孔，使得与图6C中的覆盖物类似的覆盖物可以附接至锚固件以形成无损伤梢部。
连合突部706可以邻近假体的中心并且可以包括多个缝合孔，使得假体瓣膜小叶可以缝合至连合突部。连合突部706可以是具有穿过中间的用于接纳假体小叶的狭缝的矩形形状支柱。在该示例中，存在附接至连合突部的三个假体瓣膜小叶(未示出)，从而形成三尖瓣假体瓣膜。假体瓣膜小叶未图示以便观察可扩张框架。连合突部布置在相邻的心室锚固件724之间，心室锚固件724将假体锚固至天然瓣膜的心室部分、比如天然瓣膜的前部分(比如纤维三角区)和天然瓣膜的后部分。心室锚固件的自由端部可以径向地向外弯曲。自由端部可以包括用于附接覆盖物的通孔(未示出)。覆盖物可以是任何材料比如像涤纶那样的聚合物，并且覆盖物形成用于接合组织的柔软的无损伤梢部的脚部。涤纶或其他聚合物覆盖物材料提供了更大的表面积并且因此减少了心室锚固突部刺穿组织的机会。在扩张期间，心室突部于是可以远离瓣膜框架成角度以允许锚固在天然瓣膜的纤维三角区上或心室侧的任何其他前部分上或者天然瓣膜的后瓣环上的任何部分上。
联接至连合706的多个锚固突部708可以径向地向内面向装置的中心，锚固突部708此处为蘑菇头形状的突部708或T形头部，锚固突部708允许假体附接至如将在下面进行描述的输送导管。除了连合上的三个锚固突部708外，还有三个附加锚固突部726联接至将两个相邻Y形支柱716的尾部连结的支柱，并且锚固突部726径向地向内面向假体的中心。锚固突部726也可以是蘑菇头形状或T形状或其他形状。两个锚固突部708、726都可以用于以可释放的方式将假体与输送导管联接。因此，在该示例中，存在可以与输送导管进行作用的六个连接点。图7A中的示例的其他方面可以与图6A中的示例基本类似。
图7B图示了假体瓣膜700，其中，覆盖物730布置在心室锚固件714和假体框架的上方以形成有助于形成心室锚固件的脚部。脚部包括扩大的头部区域和较窄的本体。同样，扩大的头部提供了更大的表面积并且因此使锚固期间施加至组织的压力最小化以消除或减少组织创伤。图7B的其他方面与图7A相同。
图7C示出了覆盖物730的示例，该覆盖物730可以附接至心室锚固件714以形成心室锚固件的无损伤梢部。覆盖物可以是涤纶或其他聚合物或具有期望机械性能的任何材料。覆盖物730具有扩大的头部区域和细长形的本体区域。扩大的头部区域提供了较大的表面积以减少锚固期间与组织的接触压力，以便消除或减少组织刺穿和创伤。
图7D是图7A至图7B中示出的假体瓣膜700的立体图，但其中为了观察可扩张框架的支柱并且在定形之后移除了覆盖物。除了布置在心室锚固件的上方的覆盖物外，相同的材料或类似材料还可以布置在支柱和封闭单元中的任一者或全部的上方。图7D示出了定形之后的处于完全扩张构型的假体瓣膜700，其中，假体沿心房方向张开(或朝向心室渐缩)并且作为假体的流入端部的上心房端部直径最大并且瓣膜在作为流出端部的心室端部上渐缩至较小直径。框架的漏斗形状也可以描述为抛物面状，其中，抛物面的凹面部分向上面向心房并且抛物面的凸面部分向下面向心室。假体瓣膜具有中间扩张构型，在中间扩张构型中，假体朝向心房渐缩或朝向心室张开，并且如果呈抛物面形状，则抛物面是倒置的使得假体从上端部至下端部向外张开并且抛物面的凹面部分向下面向心室而抛物面的凸面部分向上面向心房。下面更详细地说明和描述了该中间扩张构型。
图8A图示了以平面剖视图示出的低轮廓假体二尖瓣800的另一示例。假体瓣膜800与图6A至图6D中的假体瓣膜600基本类似，其中主要区别在于增加了心室瓣830或心室翼830以帮助将假体锚固至天然瓣膜的心室侧部并且捕获相邻的天然瓣膜小叶。假体二尖瓣800是由多个相互连接的支柱形成的可扩张框架并且可以从诸如不锈钢、镍钛合金或其他生物兼容材料的平坦的片材材料切割。假体二尖瓣800可以是可球囊扩张或自扩张的。可扩张框架在从片材材料切割后处于平坦平面构型并且可以进行热处理并且定形成如将在以下描述的期望的形状。平坦图案包括多个同心环形环802、804，同心环形环802、804由围绕假体的周边延伸的多个支柱形成。随着环更接近假体瓣膜的中心，环的直径和周长更小。因此，环802比环804具有更大的直径和更大的周长。相邻环与多个径向延伸的支柱812联接在一起以形成围绕假体瓣膜周向布置的多个封闭单元，其中，相邻的封闭单元共用至少一个公共支柱。每个环802、804可以包括全部具有相同几何结构的多个周向定向的支柱。例如，最外环802包括联接在一起以形成环形环的多个叉骨形支柱。叉骨形支柱在环802中可以全部相同并且叉骨形支柱可以包括与弧形支柱联接在一起的两个相对倾斜的支柱，弧形支柱在两个相对倾斜的支柱之间的拐点处形成叉骨形支柱中的突起或峰。
从环802径向向内布置的下一相邻环804类似地由联接在一起的多个叉骨形支柱形成。环804中的叉骨形支柱可以在环804中全部相同并且它们可以类似地由与弧形支柱联接在一起的两个相对倾斜的支柱形成，弧形支柱在两个相对倾斜的支柱之间的拐点处形成叉骨形支柱中的突起或峰。环804中的支柱的尺寸和角度可以与环802不同，这是因为这两个环彼此同心并且环804比外环802具有更小的直径和周长。从假体的中心径向地向外延伸的多个线性支柱812将环802和环804联接在一起以形成封闭单元810。形成在环802与环804之间的封闭单元810可以全部具有相同的几何结构，或者封闭单元810可以变化。
支柱可以是叉骨形状以远离叉骨的顶点转移应力和应变，从而允许对于给定的最大应变实现更大的角度运动范围，或者允许对于相同的给定运动范围发生更低的最大应变。
Y形支柱816联接至叉骨形第二环804，其中，Y的尾部朝向假体的中心径向地向内延伸，从而形成柠檬形的封闭单元，该封闭单元在封闭单元的相反侧部上具有峰和谷并且在封闭单元的另外两个侧部上具有尖端部。Y形支柱还可以联接至叉骨形第二环804，其中，Y的尾部朝向假体的中心径向地向内延伸以形成数个泪滴形的封闭单元，泪滴形的封闭单元在泪滴形状的相反侧部上具有尖端部。Y的尾部可以联接在一起以限定假体中的中心开孔818。在该示例中，中心开孔818是星形的，其中，三个尖臂径向地向外延伸以形成星形状。
多个内部封闭单元820、此处为三个封闭单元820由在封闭单元820的相反侧部上的两个V形支柱822形成，V形支柱822联接至相邻Y形支柱816的尾部以形成封闭单元820。每个封闭单元820包含连合突部806和两个心室锚固支柱814。
连合突部806可以邻近假体的中心并且可以包括多个缝合孔，使得假体瓣膜小叶可以缝合至连合突部。连合突部806可以是具有穿过中间的用于接纳假体小叶的狭缝的矩形形状支柱。在该示例中，存在附接至连合突部的三个假体瓣膜小叶(未示出)，从而形成三尖瓣假体瓣膜。假体瓣膜小叶未图示以便观察可扩张框架。连合突部布置在形成心室锚固突部的支柱814之间，心室锚固突部将假体锚固至天然瓣膜的心室部分、比如天然瓣膜的前部分(比如纤维三角区)和天然瓣膜的后部分。支柱814形成心室锚固件的部分。两个支柱814布置在连合突部806的两侧上。支柱814的一个端部联接至Y形支柱816的尾部，并且支柱814的相反端部是可以径向向外弯曲的自由端部。自由端部可以包括用于附接、比如缝合覆盖物(未示出)的通孔。覆盖物可以是任何材料比如像涤纶那样的聚合物，并且覆盖物形成用于接合组织的柔软的无损伤梢部的脚部。涤纶或其他聚合物覆盖物材料提供了更大的表面积并且因此减少了心室锚固突部刺穿组织的机会。在扩张期间，心室突部于是可以远离瓣膜框架成角度以允许锚固在天然瓣膜的纤维三角区或心室侧的任何其他前部分上或者天然瓣膜的后瓣环上的任何部分上。心室锚固件还可以有助于捕获心室锚固件与可扩张框架的外表面之间的天然瓣膜小叶。如果假体瓣膜具有心室翼或心室瓣(如下所述)，则天然瓣膜小叶还可以由翼或瓣捕获并且这可能有助于将天然瓣膜小叶保持在流动路径之外。可以存在任意数目的心室锚固件，但在该示例中存在三个心室锚固件。
多个锚固突部808可以径向地向内面向装置的中心，锚固突部808此处为蘑菇头形状的突部或T形头部，锚固突部808允许假体附接至如将在下面进行描述的输送导管。锚固突部808布置在将Y形支柱816的两个尾部连结在一起的支柱的一部分上。因此，在该示例中，存在可以与输送导管进行作用的三个连接点。
假体瓣膜800还包括弧形支柱830，该弧形支柱830具有沿相反方向倾斜的相反端部并且在拐点处具有弯曲连接器。在此，存在三个弧形支柱830并且弧形支柱的每个端部联接至Y形支柱818的臂以形成瓣或翼。瓣或翼在假体的心室侧部上形成第二心室锚固件，也有助于捕获天然瓣膜小叶。瓣或翼在输送和初始部署期间可以朝向心室向下延伸远离假体然后瓣或翼在完全扩张构型中径向地向外并远离锚固件延伸以形成围绕可扩张框架周向布置的凸缘，凸缘可以与天然瓣膜的瓣环正下方的心室部分接合使得瓣环被捕获在瓣或翼与上环之间。上心房的张开区域和下心室的翼或瓣因此提供了可以用作夹持件的上肩部和下肩部，上肩部和下肩部可以将天然瓣膜瓣环捕获或夹置在上肩部与下肩部之间，从而为将假体锚固到天然解剖结构中提供了良好的组织紧抓。此外，心室翼或心室瓣还可以有助于捕获天然瓣膜小叶并且将天然瓣膜小叶移出流动通道以确保最佳的瓣膜功能。在此，示出了三个支柱830，但可以使用任意数目的支柱830。心室锚固件814与先前在图6A中所描述的基本相同并且可以结合瓣或翼使用以便进一步有助于将假体瓣膜紧固至天然瓣膜。
图8B图示了定形之后的并且处于部分部署构型的图8A的假体瓣膜800，在部分部署构型中，随着心房直径朝向心室增大以形成锥体区域或张开区域，心房端部已经扩张成锥形形状。扩张构型可以是具有向下面向心室但仍布置在瓣膜瓣环850上方的凹面部分的抛物面。为方便起见，未示出输送导管。瓣830或翼830从可扩张框架轴向地向下延伸并且穿过瓣环850通过天然瓣膜孔口。瓣830或翼830在该部分部署构型中大致平行于假体的纵向轴线延伸。与图6B中的覆盖物624类似的覆盖物(未示出)可以布置在支柱814和假体框架的任何部分或所有部分的上方以形成有助于形成心室锚固件的脚部。脚部可以包括扩大的头部区域和较窄的本体。同样，扩大的头部提供了更大的表面积并且因此在锚固期间使施加至组织的压力最小化以消除或减少组织创伤。图8B的其他方面与图8A相同。
图8C示出了图8B的处于完全部署构型的假体瓣膜800，在完全部署构型中，心房锥体已经倒置以形成现在的具有向上面向心房但位于瓣环850上方的凹面部分的抛物面。然后，锥体可以配装到天然瓣膜中并且张开的锥体的壁可以防止瓣膜滑动通过天然瓣膜孔口。另外，瓣830或翼830现在已经径向地向外扩张，所以瓣830或翼830正交或者否则横向于假体的纵向轴线以形成凸缘，该凸缘可以锚固抵靠天然瓣膜的心室侧部上的下表面。另外，假体瓣膜还具有心室锚固件并且示出的心室锚固件径向地向外延伸以与瓣环的下侧部接合，例如在天然瓣膜的前侧部上的纤维三角区上或者在天然瓣膜的后部分上接合。同样，可以在心室锚固件814上方布置像图6B中的覆盖物624那样的覆盖物以形成心室锚固件的无损伤梢部。覆盖物可以是涤纶或类似聚合物或具有期望机械性能的任何材料。覆盖物可以具有扩大的头部区域和细长形的本体区域。扩大的头部区域提供了更大的表面积以减少锚固期间与组织的接触压力，以便消除或减少组织刺穿和创伤。
图8D示出了图8A的假体瓣膜800完全部署在天然二尖瓣MV中。当完全部署时，张开部的较大直径部分静置在左心房LA中并且防止假体迁移到左心室LV中。心室锚固突部814可以包括两个前锚固突部和后锚固突部，前锚固突部用于锚固在天然瓣膜的前部分上的纤维三角区上，后锚固突部锚固在天然瓣膜的后部分比如后架上。心室翼830或心室瓣830还布置在心室侧部上以进一步有助于锚固在天然瓣膜的心室侧部上。图8D示出了联接至可扩张框架的覆盖物860比如涤纶或类似聚合物、织物、或组织。示出了附接至连合柱的假体小叶862。连合柱上的锚固突部808用于以可释放的方式将假体与输送导管联接。在此，存在三个锚固突部。
与输送导管的可释放联接
图9A至图9F图示了可以用于携带本文中公开的假体瓣膜中的任一假体瓣膜的输送导管。输送导管能够以可释放的方式联接至假体使得一旦假体已经被正确地定位和部署，假体瓣膜就从输送导管中释放并且留在适当位置，同时从患者移除输送系统。
图9A示出了包括外护套902和渐缩的无损伤远端梢部904的输送导管900的外表面。可以在插入和扩张假体瓣膜之前移除渐缩的无损伤远端梢部904。
图9B示出外护套902总体上为具有单个腔906的管状轴，腔906延伸穿过该轴。腔906构造成容纳本文中公开的假体瓣膜中的任一假体瓣膜并且提供使假体瓣膜在输送期间保持在折叠构型中的约束。
图9C示意性地示出了布置在外护套902的腔906中的假体908。假体908可以是本文中公开的假体瓣膜中的任一假体瓣膜并且被约束在折叠构型中。
图9D示出了外护套902向近端收回将假体908的约束移除并且允许假体部分地自扩张，但护套仍布置在假体的以可释放的方式与输送导管接合的部分的上方并且这提供了防止假体倒置和完全扩张的约束。在此，仅图示了假体的以可释放的方式联接至输送导管的部分。为方便起见，从图9D至图9F中已经省略了假体瓣膜的其余部分。当外护套906向近端收回时，假体自扩张以形成部分部署的假体，在部分部署中，形成具有向下面向患者心脏的心室的凹部部分的抛物面。因此，形成了倒锥体形状，其中，锥体的小端部面向心房并且锥体的大端部向下面向心室。仅具有连接器突部的假体臂保持联接至输送导管。突部的示例包括先前在上面描述的蘑菇头形突部或T形突部。在该输送和扩张阶段，假体在心房中保持于天然瓣膜的上方。
图9E示出了外护套902进一步向近端收回(或布置在外护套902的腔906中的中间轴910向远端前进)允许假体瓣膜继续打开和倒置，使得在抛物面的凹面部分面向心房的情况下抛物面面向相反的方向。假体瓣膜908保持联接至输送导管900。
图9F示出了一旦假体瓣膜已经被正确地定位并扩张到天然瓣膜中，假体瓣膜908就从输送导管900中释放。在此，内轴912以可滑动的方式布置在中间轴910的腔中。当内轴912向远端前进时，盘914或帽914移动远离联接至中间轴910的毂。毂包括捕获假体的蘑菇头部或T形头部的槽916。因此，当帽914移动远离毂和槽914时，蘑菇头部或T形头部变得不受约束并且可以自由地自扩张离开槽914。一旦离开槽，假体908然后与输送导管900分离。以下描述了关于联接机构的其他细节。
在图9A至图9F的示例中，在假体瓣膜与输送导管之间仅存在3个连接件。可以使用附加的连接点，比如通过如图7A中所看到的在心室锚固件上增加突部使得存在6个连接点。可以使用任意数目的连接点，可以使用连合上的连接器或心室锚固件上的连接器的任意组合。此外，在该示例中或在假体与输送导管之间存在多个可释放连接件的任何示例中，连接件可以全部同时地、以连续的方式一个接一个单独地并且彼此独立地、或者按期望的分组或分阶段地被释放。
图10A至图10C示出了可以用于以可释放的方式将假体瓣膜与输送系统联接的联接机构的另一示例。该示例与图9A至图9F中示出的示例类似，其中主要区别在于，毂上的槽区域与盘或帽是反向的。为了方便起见，图10A至图10C中省略了外护套。
在图10A中，输送导管包括内轴1006和以可滑动的方式布置在内轴1006上的中间轴1004。假体瓣膜1002以可释放的方式联接至输送导管。同样，仅示出了假体瓣膜的联接至输送导管的部分。假体瓣膜1002可以是本文中公开的假体瓣膜中的任一假体瓣膜。此外，在该视图中，假体部分地部署并且扩张以形成具有凹面部分向下面向心室的抛物面。抛物面也可以被描述为倒锥体，其中，锥体的小端部面向心房并且锥体的大端部向下面向心室。
在图10B中，外护套(未示出)进一步收回允许假体继续扩张和倒置使得假体形成锥体，其中，较大直径端面向心房并且较小直径端面向心室。具有槽1010的毂1008联接至内轴1006。槽1010定尺寸成接纳假体上的T形头部或蘑菇头部并且在盘1012或帽1012与毂1008对接时保持假体上的T形头部或蘑菇头部。盘1012或帽1012联接至中间轴1004。
在图10C中，内轴1006向远端前进使毂1008移动远离帽1012或盘1012，从而暴露槽1010并且允许假体的蘑菇头部或T形头部从输送导管释放。或者可以将中间轴1004向近端收回以使盘或帽与毂分开，或者可以使用中间轴1004向近端收回与内轴1006向远端前进的组合以使两者分开并且将假体瓣膜从输送导管释放。
在图10A至图10C的示例中，在假体瓣膜与输送导管之间仅存在3个连接。可以使用附加的连接点，比如通过如图7A中所看到的在心室锚固件上增加突部使得存在6个连接点。可以使用任意数目的连接点，可以使用连合上的或心室锚固件上的连接器的任意组合。
图11示出了假体瓣膜与输送导管之间的可释放连接的侧视图并且突出了锁定机构的示例，该锁定机构允许假体瓣膜以可释放的方式与输送导管联接。
输送导管1100包括外护套1102，外护套1102以可滑动的方式布置在中间轴1104上，中间轴1104以可滑动的方式布置在内轴1106上。所有三个轴可以相对于彼此向近端或向远端移动。外护套1102包括容纳假体瓣膜1116的腔。假体瓣膜1116可以是本文中公开的假体瓣膜中的任一假体瓣膜。该图仅示出了假体瓣膜的以可释放的方式联接至输送导管的部分。为了方便起见，已经省略了瓣膜的其余部分。具有槽1110的毂1108联接至中间轴。帽1112或盘1112联接至内轴1106。比如蘑菇头部或T形头部的突部1114可以配装在毂中的槽1110中并且当帽1112与毂对接时，突部1114被捕获并且因此假体瓣膜联接至输送导管。一旦假体瓣膜完全部署和定位，内轴1106就可以相对于中间轴1104移动使得帽移动远离毂，从而允许突部1114从槽1110释放并且使假体瓣膜与输送导管解除联接。
图12A至图12B图示了用于以可释放的方式将假体瓣膜与输送导管联接的锁定机构的另一示例。
图12A示出了输送导管1200，该输送导管1200包括：外护套(未图示)，外护套用于容纳假体瓣膜；中间轴1202，中间轴1202以可滑动的方式布置在外护套中；以及内轴1210，内轴1210以可滑动的方式布置在中间轴1202中。帽1206联接至中间轴1202并且毂1208具有销1212，销1212从毂向近端延伸并且与输送导管1200的纵向轴线平行。在此，仅示出了假体瓣膜1204的以可释放的方式与输送导管联接的臂或部分。假体瓣膜1204可以是本文中公开的示例中的任一示例，并且包括具有穿过突部梢部的开孔的突部1214。销1212可以布置在开孔中以在帽与销对接时以可释放的方式将假体瓣膜与输送导管联接。
图12B示出了假体瓣膜1204从输送导管1200的释放。在此，中间轴1202向近端收回或内轴1210向远端前进，或者轴1202向近端运动和轴1210向远端运动两者的组合使帽1206移动远离销1212，从而允许假体瓣膜1204上的连接器突部中的开孔1214滑动脱离销，由此使假体瓣膜与输送导管解除联接。
在用于使假体与输送导管联接以及解除联接的锁定机构的示例中的任一示例中，可能期望重新捕获假体瓣膜。这可以在假体瓣膜从输送导管释放之前的任何时间完成。因此，如果假体需要重新定位或者出于一些其他原因，医生决定不植入假体，则操作者可以允许假体返回至假体的具有面向下游的凹面的无偏置形状并且假体可以被重新套上和约束在其收缩构型中。一旦重新定位假体或者做出部署假体的决定，就可以重新开始部署程序。
输送方法
图13A至图13D图示了将假体瓣膜输送至患者中的二尖瓣的方法的示例。
在图13A中，使用本领域已知的技术比如经皮穿过腹股沟中的静脉或经由切口并通过导引丝将护套1302引入到患者的心脏中。护套1302穿过隔膜壁从右心房RA经隔膜前进至左心房LA。承载假体瓣膜1306比如本文中描述的假体瓣膜中的任一假体瓣膜的输送导管1304穿过护套1302前进到左心房中。将输送导管的远端梢部定位或操纵成使得远端梢部邻近天然二尖瓣MV。护套可以向近端收回或者输送导管向远端前进经过护套，以部分地暴露假体瓣膜1306。
在图13B中护套从假体瓣膜1306移除，由此移除约束并且允许假体瓣膜1306扩张成中间构型。中间构型是凹面表面向下面向心室的锥体形状或抛物面。锥体的较小直径部分面向左心房并且锥体的较大直径部分面向心室。假体瓣膜仍然联接至输送导管并且在左心房LA中布置于二尖瓣MV上方。
在图13C中假体瓣膜1306进一步扩张并且可选地在向假体施加远端压力而抵靠二尖瓣MV的情况下，假体1306倒置使得锥体现在的大直径部分面向左心房LA并且小直径部分面向左心室LV。锥体可以是抛物面形状，其中凹面部分面向左心房LA并且凸面部分面向左心室。心室锚固突部还径向地向外扩张以接合天然瓣膜的心室部分。例如，假体瓣膜可以具有与天然二尖瓣的前部分上的纤维三角区接合的两个前心室锚固件1308和与心室侧部上的天然瓣膜的后部分接合的后心室锚固件1310。如果后部分具有瓣环后架区域，则后心室锚固件可以着落在那里。
在图13D中，假体瓣膜1306完全部署且锚固到天然瓣膜中并且输送导管和护套已经从患者移除。
图14示出了布置在天然二尖瓣MV中的假体瓣膜1402。当完全部署时，锥体的较大直径部分静置在左心房LA中并且防止假体迁移到左心室中。心室锚固突部可以包括后锚固突部1404和两个前锚固突部1406，前锚固突部1406用于锚固在天然瓣膜的前部分上的纤维三角区上，后锚固突部1404锚固在天然瓣膜的后部分比如后架上。图14示出了不具有覆盖物并且不具有假体小叶的情况以便示出心室锚固突部1404、1406的支柱和连合突部1408的支柱。在该示例中，所有三个心室锚固件和所有三个连合突部均包括用于与比如先前描述的那些输送导管进行可释放联接的锚固突部。
图15A至图15D图示了部署比如图8A至图8C中的示例的假体瓣膜的另一示例。
在图15A中，使用本领域已知的技术比如经皮穿过腹股沟中的静脉或经由切口并通过导引丝将护套1502引入到患者的心脏中。护套1502穿过隔膜壁从右心房RA经隔膜前进至左心房LA。承载假体瓣膜1506比如图8A至图8C中的瓣膜的输送导管1504穿过护套1502前进到左心房中。将输送导管的远端梢部定位或操纵成使得远端梢部邻近天然二尖瓣MV。护套可以向近端收回或者输送导管向远端前进经过护套，以部分地暴露假体瓣膜1506。
在图15B中护套从假体瓣膜1506移除，由此移除约束并且允许假体瓣膜1506扩张成中间构型。中间构型是凹面表面向下面向心室的锥体形状或抛物面。锥体的较小直径部分面向左心房并且锥体的较大直径部分面向心室。假体瓣膜仍然联接至输送导管并且左心房LA中布置于二尖瓣MV上方。翼1508或瓣1508从假体瓣膜1506轴向地向下延伸并且可以与假体瓣膜的纵向轴线大致平行。翼或瓣穿过天然瓣膜的孔口。
在图15C中假体瓣膜1506进一步扩张并且可选地在向假体施加远端压力而抵靠二尖瓣MV的情况下，假体1506倒置使得锥体现在的大直径部分面向左心房LA并且小直径部分面向左心室LV。锥体可以是抛物面形状，其中凹面部分面向左心房LA并且凸面部分面向左心室。心室锚固突部在存在的情况下还径向地向外扩张以接合天然瓣膜的心室部分。例如，假体瓣膜可以具有与天然二尖瓣的前部分上的纤维三角区接合的两个前心室锚固件和与心室侧部上的天然瓣膜的后部分接合的后心室锚固件。如果后部分具有瓣环后架区域，则后心室锚固件可以着落在那里。翼1508或瓣1508径向地向外扩张使得翼1508或瓣1508垂直或者否则横向于假体的纵向轴线以形成下凸缘，该下凸缘可以接合心室表面上的二尖瓣的底部以进一步锚固装置，同时也有助于捕获天然小叶。
在图15D中，假体瓣膜1506完全部署且锚固到天然瓣膜中并且输送导管和护套已经从患者移除。
覆盖物
附图中的许多附图仅图示了可扩张假体瓣膜框架，没有附接至框架的假体瓣膜小叶，并且也没有附接至框架的覆盖物。然而，如上面所描述的，可以将覆盖物比如组织、聚合物或织物应用于心室锚固件以有助于形成脚部，脚部能够在不刺穿组织或对组织造成创伤的情况下与天然瓣膜中的组织接合。
另外，在本文中公开的示例中的任一示例中，覆盖物可以应用于框架的全部或框架的部分。覆盖物可以是织物比如涤纶、或组织比如心包组织、或任何其他生物相容性材料。覆盖物可以应用于框架以防止框架周围的瓣周泄漏，以及促进组织向内生长以有助于将假体进一步锚固并紧固至天然解剖结构。例如，覆盖物可以应用于搁置抵靠心房底的锥形凸缘，或者覆盖物可以应用于搁置抵靠瓣环的心室部分的心室凸缘，或者覆盖物可以应用于两者。整个框架可能被覆盖，或者仅部分被覆盖。
此外，如所讨论的，为方便起见，这些示例总体上未图示附接至假体瓣膜框架的假体瓣膜小叶。然而，假体瓣膜小叶在本领域是已知的并且通常两个假体小叶或三个假体小叶可以应用于框架以形成二尖瓣假体瓣膜或三尖瓣假体瓣膜。当然，可以使用任意数目的小叶比如单个假体小叶，或四个小叶或多于四个小叶。假体瓣膜小叶可以是组织比如心包组织，或者假体瓣膜小叶可以是织物、聚合物或本领域已知的其他材料。
注释和示例
以下非限制性示例详细说明本主题的一些方面以解决挑战并提供本文中讨论的益处等。
在示例1中，一种用于治疗患者中的天然瓣膜的低轮廓假体瓣膜包括：径向可扩张框架，所述可扩张框架具有扩张构型、收缩构型、心房端部和心室端部，其中，在所述收缩构型中，所述可扩张框架定尺寸和定形状成用于微创性地输送至所述天然瓣膜，其中，在所述扩张构型中，所述可扩张框架构造成与所述天然瓣膜接合，其中，所述心房端部在所述扩张构型中形成张开形状并构造成与所述天然瓣膜的心房表面接合，其中，所述张开形状在最初扩张时朝向所述天然瓣膜的心室向下张开，然后在完全扩张时将所述张开形状倒置以形成朝向所述天然瓣膜的所述心室渐缩并且朝向所述天然瓣膜的心房张开的渐缩形状；以及多个假体瓣膜小叶，所述多个假体瓣膜小叶具有自由端部和联接至所述可扩张框架的内部部分的相反端部、打开构型和闭合构型，其中，在所述打开构型中，所述多个假体瓣膜小叶的所述自由端部远离彼此布置，从而形成供流体沿顺行方向流动穿过的开孔，并且其中，在所述闭合构型中，所述自由端部布置成比在所述打开构型中更靠近在一起，从而基本上使所述开孔闭合并且防止流体沿逆行方向流动穿过所述开孔。
示例2是根据示例1所述的假体瓣膜，所述假体瓣膜还包括多个连合柱，所述多个连合柱各自具有自由端部和相反端部，所述相反端部联接至所述可扩张框架，所述自由端部在所述可扩张框架处于所述扩张构型时面向所述心室，并且其中，所述多个假体瓣膜小叶联接至所述多个连合柱。
示例3是根据示例1至2中的任一项所述的假体瓣膜，其中，所述自由端部包括延伸穿过所述自由端部的多个开孔，所述多个开孔定尺寸成接纳将所述多个假体瓣膜小叶紧固至所述多个连合柱的缝合丝状件。
示例4是根据示例1至3中的任一项所述的假体瓣膜，其中，所述多个连合柱各自具有联接至所述自由端部的锁定突部，所述锁定突部构造成以可释放的方式将所述假体瓣膜与输送导管联接。
示例5是根据示例1至4中的任一项所述的假体瓣膜，所述假体瓣膜还包括多个心室锚固件，所述心室锚固件联接至所述可扩张框架的所述心室端部，所述心室锚固件在所述扩张构型中从所述可扩张框架径向地向外延伸，并且所述心室锚固件构造成与所述天然瓣膜的心室侧部接合。
示例6是根据示例1至5中的任一项所述的假体瓣膜，其中，所述多个心室锚固件中的至少一个心室锚固件和所述多个连合柱中的至少一个连合柱布置在所述可扩张框架中的由多个支柱界定的公共的封闭单元中。
示例7是根据示例1至6中的任一项所述的假体瓣膜，其中，所述多个心室锚固件各自包括联接至所述心室锚固件的下部分的锁定突部，所述心室锚固件上的所述锁定突部构造成以可释放的方式将所述假体瓣膜与输送导管联接。
示例8是根据示例1至7中的任一项所述的假体瓣膜，其中，所述多个心室锚固件包括前心室锚固件和后心室锚固件，所述前心室锚固件构造成与天然心脏中的天然二尖瓣的前部分上的纤维三角区接合，所述后心室锚固件构造成与所述二尖瓣的瓣环的后部分或所述天然瓣膜的后心室部分接合。
示例9是根据示例1至8中的任一项所述的假体瓣膜，其中，所述多个心室锚固件包括覆盖元件，所述覆盖元件布置在联接至所述可扩张框架的至少两个支柱的上方。
示例10是根据示例1至9中的任一项所述的假体瓣膜，其中，所述多个心室锚固件包括联接至所述可扩张框架的V形支柱，其中，所述V形支柱的顶点构造成与组织接合，所述假体瓣膜还包括布置在所述V形支柱上方的覆盖元件。
示例11是根据示例1至10中的任一项所述的假体瓣膜，其中，所述可扩张框架包括联接在一起以形成抛物面形状的多个环形环。
示例12是根据示例1至11中的任一项所述的假体瓣膜，其中，所述多个环形环包括联接在一起的具有减小的直径的多个同心环。
示例13是根据示例1至12中的任一项所述的假体瓣膜，其中，相邻的环形环联接在一起以形成围绕所述可扩张框架周向地延伸的多个封闭单元。
示例14是根据示例1至13中的任一项所述的假体瓣膜，所述假体瓣膜还包括所述心室端部上的多个心室翼，其中，所述多个心室翼具有扩张构型和收缩构型，其中，在所述收缩构型中，所述多个心室翼与所述假体瓣膜的纵向轴线大致平行，并且其中，在所述扩张构型中，所述多个心室翼从所述纵向轴线径向地向外延伸以形成构造成与所述天然瓣膜的心室表面接合的凸缘。
示例15是一种用于治疗患者中的天然瓣膜的低轮廓假体瓣膜系统，所述系统包括：示例1至14中的任一项所述的假体瓣膜；以及输送导管，所述输送导管以可释放的方式联接至所述假体瓣膜，所述输送导管构造成将所述假体瓣膜输送至所述天然瓣膜。
示例16是根据示例15所述的系统，其中，所述输送导管包括用于以可释放的方式接合所述假体瓣膜的锁定元件。
示例17是一种用于将假体瓣膜输送至患者心脏中的天然瓣膜的方法，所述方法包括：提供承载所述假体瓣膜的输送导管；将所述假体瓣膜定位成邻近所述天然瓣膜；部分地部署所述假体瓣膜，使得所述假体瓣膜形成布置在所述天然瓣膜上方并且朝向所述心脏的心室张开的张开形状；将所述张开形状倒置，使得最初的张开形状变成布置在所述天然瓣膜上方并且朝向所述心室渐缩的渐缩形状；使所述假体瓣膜的心室端部上的多个心室锚固件或多个心室翼径向地扩张以与所述天然瓣膜的心室表面接合；以及将所述假体瓣膜从所述输送导管释放。
示例18是根据示例17所述的方法，其中，使所述多个心室锚固件或所述多个心室翼径向地扩张包括将所述多个心室锚固件中的至少一些心室锚固件锚固在所述天然瓣膜的纤维三角区或者所述天然瓣膜的后心室部分上。
示例19是根据示例17至18中的任一项所述的方法，其中，使所述多个心室锚固件或所述多个心室翼径向地扩张包括使所述多个心室翼从与所述假体瓣膜的纵向轴线大致平行的位置径向地扩张至从所述纵向轴线径向地向外延伸的位置，以及使所述多个心室翼与所述天然瓣膜的心室表面接合。
示例20是根据示例17至19中的任一项所述的方法，所述方法还包括减少或消除通过所述假体瓣膜的反流。
示例21是根据示例17至20中的任一项所述的方法，其中，所述天然瓣膜是二尖瓣。
示例22是根据示例17至21中的任一项所述的方法，其中，将所述假体瓣膜从所述输送导管释放包括将所述假体瓣膜上的多个连合柱与所述输送导管断开接合。
示例23是根据示例17至22中的任一项所述的方法，其中，将所述假体瓣膜从所述输送导管释放包括将所述多个心室锚固件上的多个锁定突部与所述输送导管断开接合。
在示例24中，示例1至23中的任一者或任何组合的设备或方法可以可选地构造成使得所有列举的元件或选项是可供使用或从中选择的。
以上详细描述包括对附图的参照，附图形成了详细描述的一部分。附图通过图示的方式示出了可以实施本发明的具体实施方式。这些实施方式在本文中也称为“示例”。这样的示例可以包括除了所示出或所描述的那些元件之外的元件。然而，本发明人还设想了仅提供所示出或所描述的那些元件的示例。此外，本发明人还设想关于本文中所示出或所描述的特定示例(或其一个或更多个方面)或关于本文中示出或描述的其他示例(或其一个或更多个方面)而使用所示出或所描述的那些元件(或其一个或更多个方面)的任何组合或置换的示例。
在本文件与通过引用并入的任何文件之间的使用不一致的情况下，则以本文件中的用法为准。
在本文件中，如在专利文献中是常见的术语“一”或“一个”独立于“至少一个”或“一个或更多个”的任何其他实例或用法而用于包括一个或多于一个。在本文件中，除非另有说明，否则术语“或”用于表示非排他性的，使得“A或B”包括“A但无B”、“B但无A”以及“A和B”。在本文件中，术语“包括”和“在……中”用作相应的术语“包含”和“其中”的普通英文等同物。另外，在所附权利要求中，术语“包括”和“包含”是开放式的，也就是说，权利要求中的包括除在这些术语之后列举的那些元件之外的元件的系统、装置、物品、组合物、配方、或过程仍然被认为是落入该权利要求的范围内。此外，在所附权利要求中，术语“第一”、“第二”、以及“第三”等仅用作标记，并非意在对其对象规定数量要求。
以上描述意在为说明性的而非限制性的。例如，以上描述的示例(或其一个或更多个方面)可以以彼此组合的方式使用。比如由本领域普通技术人员在查阅以上描述后，可以使用其他实施方式。提供摘要以允许读者快速确定本技术公开的本质。递交的摘要应理解为不用于解释或限制权利要求的范围或意义。另外，在以上详细描述中，各种特征可以被组合在一起以精简本公开。这不应被解释为意指未要求保护的公开特征对于任何权利要求都是必须的。相反，发明主题可以在于比特定的公开实施方式的所有特征少。因此，所附权利要求作为示例或实施方式在此并入到具体实施方式中，其中每个权利要求单独本身作为单独的实施方式，并且可以预期的是，这些实施方式可以以各种组合或置换而彼此组合。本发明的范围应参照所附权利要求以及这些权利要求所授权的等同方案的全部范围来确定。

Claims (23)

1.一种用于治疗患者中的天然瓣膜的低轮廓假体瓣膜，所述瓣膜包括：
径向可扩张框架，所述可扩张框架具有扩张构型、收缩构型、心房端部和心室端部，
其中，在所述收缩构型中，所述可扩张框架定尺寸和定形状成用于微创性地输送至所述天然瓣膜，
其中，在所述扩张构型中，所述可扩张框架构造成与所述天然瓣膜接合，
其中，所述心房端部在所述扩张构型中形成张开形状并构造成与所述天然瓣膜的心房表面接合，
其中，所述张开形状在最初扩张时朝向所述天然瓣膜的心室向下张开，然后在完全扩张时使所述张开形状倒置以形成朝向所述天然瓣膜的所述心室渐缩并且朝向所述天然瓣膜的心房张开的渐缩形状；以及
多个假体瓣膜小叶，所述多个假体瓣膜小叶具有自由端部和联接至所述可扩张框架的内部部分的相反端部、打开构型和闭合构型，
其中，在所述打开构型中，所述多个假体瓣膜小叶的所述自由端部远离彼此布置，从而形成供流体沿顺行方向流动穿过的开孔，并且
其中，在所述闭合构型中，所述自由端部布置成比在所述打开构型中更靠近在一起，从而基本上使所述开孔闭合并且防止流体沿逆行方向流动穿过所述开孔。
2.根据权利要求1所述的假体瓣膜，还包括多个连合柱，所述多个连合柱各自具有自由端部和相反端部，所述相反端部联接至所述可扩张框架，所述自由端部在所述可扩张框架处于所述扩张构型时面向所述心室，并且其中，所述多个假体瓣膜小叶联接至所述多个连合柱。
3.根据权利要求2所述的假体瓣膜，其中，所述自由端部包括延伸穿过所述自由端部的多个开孔，所述多个开孔定尺寸成接纳将所述多个假体瓣膜小叶紧固至所述多个连合柱的缝合丝状件。
4.根据权利要求2所述的假体瓣膜，其中，所述多个连合柱各自具有联接至所述自由端部的锁定突部，所述锁定突部构造成以可释放的方式将所述假体瓣膜与输送导管联接。
5.根据权利要求1所述的假体瓣膜，所述假体瓣膜还包括多个心室锚固件，所述心室锚固件联接至所述可扩张框架的所述心室端部，所述心室锚固件在所述扩张构型中从所述可扩张框架径向地向外延伸，并且所述心室锚固件构造成与所述天然瓣膜的心室侧部接合。
6.根据权利要求5所述的假体瓣膜，其中，所述多个心室锚固件中的至少一个心室锚固件和所述多个连合柱中的至少一个连合柱布置在所述可扩张框架中的由多个支柱界定的公共的封闭单元中。
7.根据权利要求5所述的假体瓣膜，其中，所述多个心室锚固件各自包括联接至所述心室锚固件的下部分的锁定突部，所述心室锚固件上的所述锁定突部构造成以可释放的方式将所述假体瓣膜与输送导管联接。
8.根据权利要求5所述的假体瓣膜，其中，所述多个心室锚固件包括前心室锚固件和后心室锚固件，所述前心室锚固件构造成与天然心脏中的天然二尖瓣的前部分上的纤维三角区接合，所述后心室锚固件构造成与所述二尖瓣的瓣环的后部分或所述天然瓣膜的后心室部分接合。
9.根据权利要求5所述的假体瓣膜，其中，所述多个心室锚固件包括覆盖元件，所述覆盖元件布置在联接至所述可扩张框架的至少两个支柱的上方。
10.根据权利要求5所述的假体瓣膜，其中，所述多个心室锚固件包括联接至所述可扩张框架的V形支柱，其中，所述V形支柱的顶点构造成与组织接合，所述假体瓣膜还包括布置在所述V形支柱上方的覆盖元件。
11.根据权利要求1所述的假体瓣膜，其中，所述可扩张框架包括联接在一起以形成抛物面形状的多个环形环。
12.根据权利要求11所述的假体瓣膜，其中，所述多个环形环包括联接在一起的具有减小的直径的多个同心环。
13.根据权利要求11所述的假体瓣膜，其中，相邻的环形环联接在一起以形成围绕所述可扩张框架周向地延伸的多个封闭单元。
14.根据权利要求1所述的假体瓣膜，所述假体瓣膜还包括所述心室端部上的多个心室翼，其中，所述多个心室翼具有扩张构型和收缩构型，
其中，在所述收缩构型中，所述多个心室翼与所述假体瓣膜的纵向轴线大致平行，并且
其中，在所述扩张构型中，所述多个心室翼从所述纵向轴线径向地向外延伸以形成构造成与所述天然瓣膜的心室表面接合的凸缘。
15.一种用于治疗患者中的天然瓣膜的低轮廓假体瓣膜系统，所述系统包括：
权利要求1所述的假体瓣膜；以及
输送导管，所述输送导管以可释放的方式联接至所述假体瓣膜，所述输送导管构造成将所述假体瓣膜输送至所述天然瓣膜。
16.根据权利要求15所述的系统，其中，所述输送导管包括用于以可释放的方式接合所述假体瓣膜的锁定元件。
17.一种用于将假体瓣膜输送至患者心脏中的天然瓣膜的方法，所述方法包括：
提供承载所述假体瓣膜的输送导管；
将所述假体瓣膜定位成邻近所述天然瓣膜；
部分地部署所述假体瓣膜，使得所述假体瓣膜形成布置在所述天然瓣膜上方并且朝向所述心脏的心室张开的张开形状；
使所述张开形状倒置，使得最初的张开形状变成布置在所述天然瓣膜上方并且朝向所述心室渐缩的渐缩形状；
使所述假体瓣膜的心室端部上的多个心室锚固件或多个心室翼径向地扩张以与所述天然瓣膜的心室表面接合；以及
将所述假体瓣膜从所述输送导管释放。
18.根据权利要求17所述的方法，其中，使所述多个心室锚固件或所述多个心室翼径向地扩张包括将所述多个心室锚固件中的至少一些心室锚固件锚固在所述天然瓣膜的纤维三角区或者所述天然瓣膜的后心室部分上。
19.根据权利要求17所述的方法，其中，使所述多个心室锚固件或所述多个心室翼径向地扩张包括使所述多个心室翼从与所述假体瓣膜的纵向轴线大致平行的位置径向地扩张至从所述纵向轴线径向地向外延伸的位置，以及使所述多个心室翼与所述天然瓣膜的心室表面接合。
20.根据权利要求17所述的方法，所述方法还包括减少或消除通过所述假体瓣膜的反流。
21.根据权利要求17所述的方法，其中，所述天然瓣膜是二尖瓣。
22.根据权利要求17所述的方法，其中，将所述假体瓣膜从所述输送导管释放包括将所述假体瓣膜上的多个连合柱与所述输送导管断开接合。
23.根据权利要求17所述的方法，其中，将所述假体瓣膜从所述输送导管释放包括将所述多个心室锚固件上的多个锁定突部与所述输送导管断开接合。
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