CN111031967A - 具有系带连接特征的人造心脏瓣膜 - Google Patents
具有系带连接特征的人造心脏瓣膜 Download PDFInfo
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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
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
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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
- 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
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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
- 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
-
- 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
Abstract
本文描述了具有系带固定特征的人造心脏瓣膜的各种实施例的装置和方法,该系带固定特征可用于将锚定系带固定到人造心脏瓣膜,使得系带可以在心脏正常工作期间,在系带上施加的高拉力下,将人造心脏瓣膜保持在心脏内所需的位置。在一些实施例中,系带固定特征还可包括可用于帮助将人造心脏瓣膜定位在心脏内的接合构件。这样的接合构件可以由定位装置配合地接合,该定位装置可以在人造心脏瓣膜的输送和展开期间用于帮助人造心脏瓣膜的径向定位。
Description
相关申请的交叉引用
本申请要求2017年8月28日提交的题为“具有系带连接特征的人造心脏瓣膜”的美国临时专利申请No.62/550,967的优先权和权益,其全部公开内容通过引用合并于此。
背景技术
本文描述的实施例涉及用于输送和展开人造心脏瓣膜的装置和方法,特别是涉及用于具有系带固定部以将锚定系带固定到人造心脏瓣膜的装置和方法。
人造心脏瓣膜可对心脏内的输送和展开带来特殊的挑战。瓣膜性心脏病,并且特别是主动脉瓣膜和二尖瓣膜疾病在美国是一个重大的健康问题,每年在美国大约有90,000个瓣膜进行更换。涉及心脏瓣膜原位更换的传统瓣膜更换手术被认为是一种“打开心脏”外科手术。简而言之,该手术需要外科开胸,用心肺机启动体外循环,停止和打开心脏,切除并更换患病的瓣膜以及重新启动心脏。虽然通常瓣膜更换手术在其他健康人群中具有1-4%的死亡率风险,但在很大程度上由于体外循环的必要性,该手术的发病率明显较高。此外,老年患者对开心手术的耐受性通常较差。因此,排除手术中的体外部分可导致发病率降低,并且可显著降低瓣膜更换疗法的成本。
虽然以经导管的方式替换主动脉瓣膜是一个热点研究课题,但对二尖瓣膜的关注较少。这部分地反映了与原生二尖瓣膜装置相关的更大程度的复杂性,因此,对于插入和锚定更换假体而言,难度更大。存在对经导管二尖瓣膜更换术的输送装置和方法的需求。
一些已知的输送方法包括通过心尖穿刺点输送人造二尖瓣膜。在这种手术中,瓣膜被放置在例如34-36Fr(即外径约为11-12mm)的输送导管的内腔中的压缩配置中。例如,可通过经股动脉途径、经心房直接进入心脏的左心房或通过颈静脉途径来实现向心脏心房输送人造瓣膜。当人造心脏瓣膜被展开后,各种已知的锚定技术得到了应用。例如,一些人造心脏瓣膜利用与瓣膜附接的锚定装置如倒钩或利用可与心脏中的周围组织接合并将人造瓣膜保持在心脏内的所需位置的其他特征在心脏内锚定。一些已知的锚定技术包括锚定系带的应用,该系带附接到瓣膜上并锚定到心脏上的某个位置,例如心脏的内壁或外壁。
需要一种用于将锚定系带固定到人造心脏瓣膜上的改进技术,该技术可提供将锚定系带连接到瓣膜的固定附件,并且还提供了在心脏功能正常时,保持人造心脏瓣膜在心脏所需的位置。还需要用于辅助心脏内人造心脏瓣膜的输送和定位的装置和方法。
发明内容
本文描述了具有系带固定特征的人造心脏瓣膜的各种实施例的装置和方法,该系带固定特征可用于将锚定系带固定到人造心脏瓣膜,使得系带可以在心脏正常工作期间,在系带上施加的高拉力下,将人造心脏瓣膜保持在心脏内所需的位置。在一些实施例中,系带固定特征还可包括可用于帮助将人造心脏瓣膜定位在心脏内的接合构件。这样的接合构件可以由定位装置配合地接合,该定位装置可以在人造心脏瓣膜的输送和展开期间用于帮助人造心脏瓣膜的径向定位。
附图说明
图1为根据一个实施例的人造心脏瓣膜的示意图。
图2A和图2B分别为图1中的人造心脏瓣膜的一部分和定位装置的示意图。
图3-图5为根据一个实施例的人造心脏瓣膜的正视图、俯视图和仰视图。
图6为图3-图5中的人造心脏瓣膜的内框架处于未扩展配置下的打开和展平图。
图7和图8分别为图6中的内框架处于扩展配置下的侧视图和底部视图。
图9为图3-图5中的瓣膜的外框架处于未扩展配置下的打开和展平视图。
图10和图11分别为图9中的外框架处于扩展配置下的侧视图和俯视图。
图12-图14为图6-图8中的内框架组件和图9-图11的外框架组件的侧视图、正视图和俯视图。
图15为根据一个实施例以偏置扩展配置显示的内框架组件和外框架组件的侧面透视图。
图16为图15的组件中外框架倒置显示时的侧面透视图。
图17为图16中的组件以在输送护套的内腔内的折叠配置显示的侧面透视图。
图18为示出图17中的组件处于第一部分展开配置下的侧视图。
图19为示出图17中的组件处于第二部分展开配置下的侧视图。
图20为示出图17中的组件处于第三部分展开配置下的侧视图,其中倒置的外框架基本上展开在输送护套的外部。
图21为示出图17中的组件处于第四部分展开配置下的侧视图,其中外框架已被还原并呈现偏置扩展配置。
图22-图24示出了输送图15-图21中的人造瓣膜到心脏的心房和原生二尖瓣环内的方法的一部分步骤。
图25A为根据另一实施例的人造心脏瓣膜的内框架的局部侧视图。
图25B为图25A中的人造瓣膜的系带连接部中的支柱的放大图。
图26为图25A中的人造心脏瓣膜的内框架在未扩展配置下的打开并展平视图。
图27为图25A中的人造心脏瓣膜的内框架连接到系带的局部侧视图。
图28为图27中的内框架和系带的局部放大图,该图示出了内框架与系带通过缝合线连接。
图29为图28中的内框架和系带的局部放大图,该图示出了内框架与系带通过缝合线连接。
图30为根据一个实施例在系带连接部处具有正向接合特征的人造心脏瓣膜的内框架的局部侧视图。
图31为图30中的人造心脏瓣膜的内框架处于未扩展配置下的打开并展平视图。
图32为图30中的内框架和系带的局部放大图,该图示出了内框架与系带之间通过缝合线连接。
图33为图32中的内框架和系带的局部放大图,该图示出了内框架与系带之间通过缝合线连接。
具体实施方式
本文描述了人造心脏瓣膜例如人造二尖瓣膜的装置和方法,其可包括可用于将锚定系带固定到人造心脏瓣膜的系带固定部或连接部。如本文所述,在一些实施例中,人造心脏瓣膜包括外框架和连接到外框架的内框架。内框架可包括设置在人造心脏瓣膜的近端部的系带连接部。人造心脏瓣膜可由例如形状记忆材料形成以及锚定系带可由例如编织细丝线形成。在一些实施例中,锚固系带可利用压缩力连接至瓣膜的系带连接部。在一些实施例中,一条或更多条缝合线可用于将系带连接部固定到锚定系带。在一些实施例中,系带连接部可包括接合特征,该接合特征可通过定位装置的接合部匹配地且可释放地接合,该定位装置可被用于帮助将人造心脏瓣膜定位在心脏内所需的位置。
在一些实施例中,人造心脏瓣膜,包括外框架和连接到外框架的内框架。内框架包括设置在人造心脏瓣膜的近端部的系带连接部。锚定系带通过至少一条缝合线连接到内框架的系带连接部。锚定系带被配置成固定到患者心壁上以固定在患者心脏内的人造心脏瓣膜的位置。
在一些实施例中,配套设备,包括人造心脏瓣膜和定位装置。人造瓣膜包括包括外框架、与外框架连接的内框架,以及与内框架连接的锚定系带。内框架包括设置在人造心脏瓣膜的近端部处的系带连接部。锚定系带利用至少一条缝合线连接到内框架的系带连接部并被配置成固定到患者心壁上以固定在患者心脏内的人造心脏瓣膜。定位装置被配置成与内框架的系带连接部接合并用于帮助将人造心脏瓣膜定位在患者心脏内。
人造心脏瓣膜可使用用于输送人造心脏瓣膜(例如,人造二尖瓣膜)的各种不同输送途径被输送到患者的心脏。例如,本文描述的人造心脏瓣膜可以使用PCT国际申请号PCT/US15/14572(本文中称为'572PCT申请)和国际申请号PCT/US2016/012305(本文中称为'305PCT申请)中描述的经股动脉输送途径来输送,或通过由例如美国专利申请公开号2017/0079790('290公开)中描述的经心房途径或经颈静脉途径来输送,以上专利的公开内容通过引用整体并入本文中。如果需要,本文描述的人造瓣膜也可以在顶端输送。
在一个示例中,在人造心脏瓣膜是人造二尖瓣膜的情况下,瓣膜通过折叠配置被放置在输送护套的内腔中。输送护套的远端部可以设置在心脏的左心房内,并且人造瓣膜可从输送护套的内腔中移出并允许移动到偏置扩展配置。人造二尖瓣膜可定位在心脏的二尖瓣环内。如本文所述,在一些实施例中,瓣膜的系带连接部可包括可由定位装置匹配地接合的接合部。定位装置可以通过心尖部的开口插入,并移动到与瓣膜的接合部接合。然后,定位装置可用于帮助瓣膜定位在心脏二尖瓣环内。
图1是根据一个实施例的人造心脏瓣膜100的示意图,并且图2A和图2B是根据一个实施例的人造心脏瓣膜的系带连接部和定位装置190的示意图。例如,人造心脏瓣膜100(这里也称为“人造瓣膜”或“瓣膜”)可以是人造二尖瓣膜。瓣膜100可使用各种不同的输送途径在心脏的心房内输送和展开,该输送途径包括例如'572PCT申请和'305PCT申请中描述的经股动脉输送途径,或'290公开中描述的经心房途径或经颈静脉途径。定位装置190可用于帮助将瓣膜100定位在心脏的心房内。例如,定位装置190可通过顶部入口插入心脏,并且定位装置190的远端部可与瓣膜100接合并可释放地连接至瓣膜100,使得定位装置190可用于更好地控制和操纵瓣膜100。在一些实施例中,人造瓣膜100和定位装置190可以配套设备的形式来一起提供。在一些实施例中,这样的配套设备可包括其他装置,例如瓣膜输送装置。
瓣膜100包括具有外框架120的外框架组件和具有内框架150的内瓣膜组件。每个外框架120和内框架150均可形成管状结构,例如下面参照图3-图14更详细的描述。外框架120和内框架150可以在围绕内框架150的周边和外框架120的周边的多个连接接头(未示出)处连接在一起。瓣膜100还可包括其它特征,例如下面关于图3-图14描述的那些特征。为了说明目的,仅关于图1和图2讨论了内框架150和外框架120。关于图1和图2描述的瓣膜100的各种特性和特征可适用于此处描述的任何人造瓣膜。
外框架120被配置成具有偏置的扩展或未变形形状,并且可被操纵和/或变形(例如,压缩或约束),并且当释放时,返回到其原始形状(扩展或未变形)。例如,外框架可由具有形状记忆特性的材料(例如金属或塑料)形成。关于金属,已发现特别有用,因为它可被加工成奥氏体、马氏体或超弹性材料。也可使用其他形状记忆合金,如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。内框架可由激光切割的镍钛合金管形成。内框架150还可具有偏置扩展或未变形的形状,并且可被操纵和/或变形(例如,压缩和/或约束),并且当释放时,返回到其原始形状(扩展或未变形)。关于内框架和外框架的进一步细节在下面参考瓣膜200和图3-图14进行描述。
如关于内框架250更详细地示出的(例如,参见图6-图8),内框架150可由激光切割管形成。内框架150可分为四个部分,对应于最终形式的内框架150的不同功能部分,:心房部147、主体部142、支柱部143和系带夹或连接部144。在图1的示意图中,心房部和主体部(147和142)位于外部框120内,用虚线表示。
内框架150的支柱部143可包括将主体部142连接到系带连接部144的适当数量的单体支柱。例如,图6示出了类似于图1的内框架150的实施例的内框架250。内框架150可以以相同或相似的方式形成,并且包括与图6所示的内框架250相同或相似的部分和/或功能。
内框架150的支柱部143可包括将主体部142与系带连接部144连接的支柱(图1、图2A和图2B中未示出)(例如,参见图6中的支柱243a)。在一些实施例中,系带连接部144可包括支柱部143的支柱的纵向延伸部,其可通过成对相对的、略呈V形的连接构件(或“微型V”)沿周向连接(例如,参见在图6中的内框架250)。例如,在一些实施例中,支柱部143可包括六个支柱,其延伸以形成系带连接部144的六个支柱,其中系带连接部144的六个支柱中的每一个通过微型V形件而周向连接。
如下面参照瓣膜200和内框架250更详细地描述,系带连接部或连接部144(也称为内框架150的第一端部)可配置为通过施加压缩力而径向折叠。因此,系带连接部144可配置成压缩地夹紧或紧握系带136(例如,编织细丝线)的一端,要么直接连接到系带136上,要么连接到中间结构上,例如聚合物或金属片,该中间结构进而被牢固地固定在系带136上(未示出)。系带连接部144还可包括开口(图1、图2A和图2B中未示出),缝合线或金属丝可通过该开口插入以固定在折叠的支柱周围和系带136的端部周围,从而将系带136连接至系带连接部144。
如上所述,在一些实施例中,支柱部143可包括例如六个支柱,每个支柱延伸以形成系带连接部144的六个支柱。在其他实施例中,如下面更详细地描述的,支柱部143可包括不同数量的支柱和/或可包括不同配置和构造的支柱。
例如,在一些实施例中,瓣膜100可包括支柱部143,该支柱部包括六个支柱,其中六个支柱中的每两个支柱汇聚在一起或融合成系带连接部144的单个支柱。换句话说,支柱部143包括三对支柱,并且系带连接部144包括三个支柱。系带连接部144的三个支柱中的每一个可以界定用于插入缝合线的开口,以将系带136固定到系带连接部144。将来自支柱部143的一对支柱组合以形成系带连接部144的单个支柱,可在系带连接部144的端部提供增加的壁厚,从而提供具有高拉伸性能的坚固系带连接部144以在缝合时保持系带136。
在一些实施例中,六个支柱可以组合以形成三对组合的或融合的系带支柱,其具有为缝合线和/或金属丝提供的开口。在其他实施例中,只有成对的支柱的子集可以汇聚在一起,而其它的则保持单独延伸到系带连接部144。例如,一对或两对可汇聚在一起,而其余的两个或更多个支柱单独延伸至系带连接部。
此外,连接以形成系带连接部的支柱的成对支柱可以在连接或融合状态下预成形,或者形成单独支柱,并与适当的紧固机构连接在一起以形成单个系带连接部支柱。例如,支柱部的支柱可以可释放地或固定地连接在一起以形成系带连接部的组合支柱。支柱部的支柱也可以被配置为分离的,直到被连接到系带136上时而缝合在一起。
如图2A和图2B所示,系带连接部144还可包括接合特征122,该接合特征122可以与定位装置190上对应的接合特征123匹配地接合或可释放地连接。图2A和图2B分别示出了分离的接合特征122和接合的接合特征123。接合特征122和接合特征123可用于将瓣膜100可释放地连接到定位装置190,使得定位装置190可在瓣膜100展开期间用于帮助瓣膜100在心脏内的定位。例如,定位装置190可界定内腔,系带136可通过该内腔被接收,定位装置190可穿过心尖插入并通过接合特征122、接合特征123向远端移动以与瓣膜100接合。在接合时,经心尖定位装置190可用于通过施加扭矩而使瓣膜100绕系带136的轴线转动来将瓣膜100径向定位在心脏内。
图2A和图2B中的示例示出了系带连接部144上为延伸或突出的接合特征122,而定位装置190(例如,经心尖定位装置)上的反向接合特征123为孔或狭槽,以与接合特征122配合连接。例如,接合特征122可被配置为系带连接部144的一个或更多个支柱的延伸部。以下关于瓣膜400描述了这样的实施例。在其他实施例中,接合特征122可以是狭槽或孔,而定位装置190上的反向接合特征123为将被接收在狭槽或孔内的延伸部。可替代地,可以使用其他类型的合适配置以使定位装置190可释放地附接到系带连接部144上,以便于通过在系带136轴线上施加扭矩实现径向定位。尽管图2A和图2B示出了单个接合特征122和单个接合特征123,在其他实施例中,系带连接部144可包括多个接合特征122,并且定位装置190可包括对应数量以与其匹配地连接的接合特征123。
图3至图14示出了人造心脏瓣膜的另一实施例,其可使用多种不同的输送途径在心脏的左心房内输送和展开,该输送途径例如包括经股动脉输送途径或经心房输送途径。图3-图5分别是根据一个实施例的人造心脏瓣膜200的正视图、仰视图和俯视图。人造心脏瓣膜200(在本文中也称为“瓣膜”或“人造瓣膜”)被设计用来更换受损或患病的原生心脏瓣膜,例如二尖瓣膜。瓣膜200包括外框架组件210和连接到外框架组件210的内瓣膜组件240。
如图所示,外框架组件210包括外框架220,用外盖230覆盖其全部或部分外表面,并用内盖232覆盖其全部或部分内表面。外框架220可为人造心脏瓣膜200提供多种功能,包括作为主要结构、作为锚定机构和/或用于将瓣膜锚定到原生心脏瓣膜装置的单独锚定机构的附接点、支撑内部瓣膜组件240的支架和/或用作抑制人造心脏瓣膜200与原生心脏瓣膜装置之间的瓣膜周围渗漏的密封件。
外框架220具有偏置扩展配置,并且可被操纵和/或变形(例如,压缩和/或约束),并且当释放时,返回到其原始的无约束形状。为了实现这一点,外框架220可由具有形状记忆特性的例如金属或塑料等材料形成。关于金属,已发现特别有用,因为它可以被加工成奥氏体、马氏体或超弹性材料。也可使用其他形状记忆合金,如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。
如图3中最佳所示,外框架组件210具有上端(例如,在心房部216处),下端(例如,在心室部212处)以及在它们之间的中部(例如,在环状部214处)。上端或心房部216(也称为“外部自由端部”)界定了外框架组件210的开口端部。外框架组件210的中部或环状部214具有被配置成(例如,大小,形状)适合原生心房与心室的瓣膜的环的边缘。外框架组件210的上端具有大于中部边缘的边缘。在一些实施例中,外框架组件210的上端边缘具有实质上大于中部边缘的边缘。如图5中最佳所示,外框架组件210的上端和中部具有D形横截面。以此方式,外框架组件210促进了适当地适配到原生心房与心室的瓣膜的环中。
内瓣膜组件240包括内框架250、外壳(未示出)和瓣叶270。如图所示,内瓣膜组件240包括具有形成有多个弓形的边缘的上部。内框架250包括支撑内瓣膜组件的外盖和瓣叶270的六个轴向杆或框架构件。瓣叶270沿着其中的三个杆附接,显示为连合杆252(图4中最佳示出),并且内瓣膜组件240的外盖附接在其他三个杆254上(图4中最佳示出),并且可选地附接在连合杆252上。内瓣膜组件240和瓣叶270的每个外壳由近似矩形的材料片形成,它们在其上端或心房端连接在一起。外盖的下端、心室端可连接至外框架组件210的内盖232,并且瓣叶270的下端、心室端可形成自由边缘275,尽管其连接到连合杆252的下端。
尽管内瓣膜组件240显示为具有三个瓣叶,但是在其他实施例中,内瓣膜组件可包括任何合适数量的瓣叶。瓣叶270可在开启配置和闭合配置之间移动,在闭合配置中瓣叶270在密封支座处接合或汇合。
外框架组件210的外盖230和外框架组件210的内盖232,以及内瓣膜组件240的外盖和内瓣膜组件240的瓣叶270可由任何合适的材料或材料组合(如上所述)形成。在本实施例中,外框架组件210的内盖232、内瓣膜组件240的外盖和内瓣膜组件240的瓣叶270至少部分地由猪心包膜形成。此外,在本实施例中,外框架组件210的外盖230至少部分地由聚酯纤维形成。
图6-图8更详细地示出了内框架250。具体来说,图6-图8分别示出了根据一个实施例的处于未变形的初始状态下的内框架250(图6)、处于扩展配置中的内框架250的侧视图(图7)以及处于扩展配置中的内框架250的仰视图(图8)。
在本实施例中,内框架250由的激光切割管形成。图6示出了处于未变形的初始状态下的内框架250,即作为激光切割,但为了便于示例将其切割并展开成平板。内框架250可分为四个部分,对应于最终形式的内框架250的不同功能部分:心房部247、主体部242、支柱部243和系带夹或连接部244。支柱部243包括将主体部242连接到系带连接部244的六个支柱,例如支柱243A。
系带连接部244(也被称为内框架的第一端部)包括支柱的纵向延伸部,其通过成对的、相对的且略呈V形的连接构件(或“微型V”)周向连接。系带连接部244被配置成通过施加压缩力而径向折叠,该压缩力使得微型V变成更深的V形,顶点在纵向方向上靠得更近,并且V形的开口端在周向方向上靠得更近。因此,系带连接部244可被配置成压缩地夹紧或紧握系带的一端,或者直接连接到系带线(例如编织细丝线)上,或者连接到中间结构上,例如聚合物或金属片,该中间结构进而牢固地固定到系带线上。
与系带连接部244相比,心房部247(也称为“内框自由端部”)和主体部242被配置成径向扩张。支柱部243在膨胀体部和压缩系带连接部244之间形成纵向连接和径向过渡。主体部242提供了包括六个纵向杆(例如杆242A)的内框架连接部245。内框架连接部245可用于将瓣叶270连接到内框架240,和/或可用于将内框架240连接到外框架210,例如通过将内框架250连接到外框架220。在所示的实施例中,杆包括开口,连接构件(例如缝合线和/或金属丝)可穿过这些开口以将杆连接到其他结构。
图7和图8分别示出了处于完全变形即最终的展开配置的内框架240的侧视图和仰视图。
图9-图11更详细地示出了瓣膜200的外框架220。在本实施例中,外框架220也由的激光切割管形成。在图9中示出了处于未变形的初始状态(即激光切割)下的外框架220,但为了便于示例将其切割并展开成平板。如图9所示,外框架220可分为外框架连接部271、主体部272和袖口部273(包括心房或自由端部216)。如下面更详细地讨论的,外框架连接部271包括多个开口或孔,例如271A,通过这些开口或孔可将外框架220连接到内框架250。
图10和图11分别示出了处于完全变形即最终的展开配置的外框架220的侧视图和俯视图。如图11中最佳所示,外框架连接部271的下端形成近似圆形的开口(在图11中由“O”标识)。该开口的直径优选近似对应于内框架250的主体部分242的直径,以便于瓣膜200的两个部件的连接。
图12-图14分别示出了外框架220和内框架250连接在一起的正视图、侧视图和俯视图。这两个框架共同形成人造瓣膜例如瓣膜200的结构支撑。框架以与原生瓣膜环期望的关系来支撑瓣膜瓣叶结构(例如瓣叶270),支撑两个框架的盖(例如,外框架组件210的外盖230和内盖232,内瓣膜组件240的外盖),以为心房和心室之间的血液渗漏提供屏障,并通过内框架250连接到系带(图3-图14中未显示)(例如,关于上述图1、图2A和图2B中描述的系带136),以便通过与心室壁的系带连接来帮助将人造瓣膜200固定在原生瓣膜环中的适当位置。外框架220和内框架250在六个连接点处连接(代表点在图12-图14中被标识为“C”)。在本实施例中,连接点通过机械紧固件(例如短长度的金属丝)穿过外框架连接部271中的孔(例如孔271A)和内框250的主体部分242中的内框架连接部245中的相应孔(例如,纵向杆,例如杆242A)来实现。因此,内框架250设置在外框架220内并与之牢固地连接。
图15-图21示出了在将人造心脏瓣膜300插入输送护套326(例如,参见图17-图21)以输送至心脏的心房之前重新配置人造心脏瓣膜300(例如人造二尖瓣膜)的方法。人造心脏瓣膜300(在本文中也被称为“瓣膜”)可被构建成与上述瓣膜100和瓣膜200相同或相似,并且功能与上述瓣膜100和瓣膜200相同或相似。因此,关于瓣膜300的一些细节将不在下面描述。应当理解,对于未具体讨论的特征和功能,这些特征和功能可与瓣膜200相同或相似。
如图15所示,瓣膜300具有外框架320和内框架350。如上文关于瓣膜100和瓣膜200所讨论的,瓣膜300的外框架320和内框架350均可由形状记忆材料形成并具有偏置扩展配置。外框架320和内框架350可移动至折叠配置以将瓣膜300输送至心脏。在该准备输送至心脏的瓣膜300的示例性方法中,如图16所示,瓣膜300的外框架320首先以下垂或倒置的配置来设置。具体地,瓣膜300的外框架320的弹性或超弹性结构允许在将瓣膜300插入输送护套326的内腔中之前将外框架320以下垂或倒置的配置来设置。如图16所示,为了将外框架320设置成倒置配置,将外框架320向远侧折叠或倒置(在图16中的右侧),使得外框架320的开放自由端316指向远离内框架350的开放自由端347。如上关于瓣膜100的描述,在该倒置配置中,瓣膜300的总外周长或外径减小且总长度增加。例如,图15中所示的直径D1大于图16中所示的直径D2,且长度L1(图12中所示的瓣膜200)小于图16中所示的瓣膜300的长度L2。在外框架320相对于内框架350处于倒置配置的情况下,如图17所示,瓣膜300可放置在输送护套326的内腔内,用于将瓣膜300输送到心脏的左心房。相比于图15中所示配置的瓣膜300在没有倒置的情况下径向折叠,通过将外框架320相对于内框架350设置成倒置配置,可将瓣膜300折叠成更小的总直径,即当瓣膜300放置在较小直径的输送护套中时。这是因为在图15所示的配置中,两个框架是同心或嵌套的,因此外框架320必须围绕内框架350折叠,而在图16所示的配置中,两个框架基本上是同轴的但不是同心的或嵌套的。因此,如图16所示的配置中,外框架320可以折叠而无需将内框架350接收在其内部。换句话说,在内框架350主要设置在外框架320的内部或嵌套在外框架320内的情况下,框架结构的层或体积不能被压缩至较小的直径。此外,如果框架是嵌套的,则该结构的柔性较差,因此需要更大的力来弯曲瓣膜,例如穿过弯曲的脉管系统或者在穿过心房隔膜之后在左心房中急转以便正确定向而插入二尖瓣环中。
图22-图24示出了将瓣膜300输送至心脏的一部分步骤。在该实施例中,例如以上通过引用并入的'305PCT申请中所描述的,瓣膜300示出为经股动脉输送途径输送。在如图17所示的瓣膜300设置在输送护套326的内腔内且处于倒置配置的情况下,输送护套326可插入股部穿刺,经股静脉,经下腔静脉,进入右心房,经隔膜Sp并进入心脏左心房LA。通过将输送护套326的远端部布置在心脏的左心房内,瓣膜300可被展开在输送护套326的远端部的外部。例如,在一些实施例中,推动装置338可用于将瓣膜300移出或推出输送护套326的远端部。如图22-图24所示,系带336可以附接到瓣膜300上,并延伸穿过二尖瓣环,穿过左心室LV,并在顶点Ap处穿出穿刺部位。在一些实施例中,瓣膜300可通过在系带336上向近端拉动而移出输送护套326。在一些实施例中,瓣膜300可通过用推动装置推动并用系带拉动而展开。
如图18-图20中的进展所示,当瓣膜300离开输送护套326的内腔时,外框架组件310首先在其倒置配置中退出(另见图22)。如图21、图23和图24所示,在外框架组件310完全位于输送护套326的内腔外部之后,外框架320可以恢复到其扩展或展开配置。在一些实施例中,外框架320由于其形状记忆特性而能够在完全退出输送护套的内腔后自动恢复。在一些实施例中,输送护套或另一装置的部件可用于辅助外框架组件310的恢复。在一些实施例中,推动装置和/或系带可用于辅助外框架组件310的恢复。瓣膜300可以继续展开直到内框架350与左心房完全展开,并且瓣膜300处于扩展或展开配置(例如,如图15和图24所示)。然后,如图24所示且如在'572PCT申请和'305PCT申请中更详细描述的,可通过心外膜垫装置339将瓣膜300和系带336固定到心尖。
图25A示出了人造心脏瓣膜400的另一实施例。瓣膜400可与上面描述的其他人造心脏瓣膜基本相似。例如,瓣膜400可被构建成与上述瓣膜100和瓣膜200相同或相似,并且其功能也可与上述瓣膜100和瓣膜200相同或相似。瓣膜400包括外框架组件(未示出)和连接到外框架组件的内瓣膜组件(其中一部分如图25A-图26所示)。内瓣膜组件包括内框架450(其中一部分如图25A-图26所示)。一些关于瓣膜400的细节将不在下面描述。应当理解,对于未特别讨论的特性和功能,这些特性和功能可与瓣膜100或瓣膜200相同或相似。例如,瓣膜400还可包括例如上述瓣叶270等瓣叶(未示出)。
图25A示出了处于扩展配置的瓣膜400的内框架450的一部分,以及图26是处于未扩展配置的内框架450的打开并展平视图。如上面关于瓣膜100和瓣膜200的描述,瓣膜400的内框架450可由形状记忆材料形成且具有偏置扩展配置。例如,瓣膜400的内框架可由的激光切割管形成。此外,内框架450可分为四个部分,对应于最终形式的内框架450的不同功能部分:心房部、主体部、支柱部和系带夹或连接部。主体部442、支柱部443和系带夹或连接部444的一部分如图25A所示。
在本实施例中,例如支柱部443可包括六个支柱453,如图25A和图25B中所示的支柱453A和支柱453B。如上面对瓣膜100的描述,支柱453可延伸以形成系带连接部444,如下面更详细地描述。支柱部443还可包括开口,连接构件(例如缝合线和/或金属丝)可穿过该开口以将支柱453(以及内框架)连接到其他结构(例如,连接到外框架组件),如上面关于瓣膜100和瓣膜200的描述。而图25A-图26示出了支柱部分443包括六个支柱453(三对支柱453A和支柱453B),其他实施例可包括更少或更多的支柱453。
在本实施例中,六个支柱453中的两个支柱453(即支柱453A和支柱453B)可汇聚在一起形成系带连接部444的支柱448。换句话说,第一支柱部453A和第二支柱部453B可汇聚在一起以形成第三支柱部448。例如,如图25B所示,两个支柱453A和支柱453B汇聚在一起以形成支柱448A。因此,对于支柱部443的六个支柱453,系带连接部444有三个支柱448。系带连接部444的支柱448可界定开口451(例如,参见图25A和图25B),如下面更详细地描述的,该开口可用于使用缝合线将系带436(如图26所示)固定到内框架450。
两个或更多个支柱(例如,453A和453B)的组合以形成系带连接支柱448可以导致系带连接支柱448的壁厚增加。例如,支柱448在开口451旁边的部分的壁厚或宽度"w"(如图25B所示)可以增加(例如当与图6中的瓣膜200的连接部244的开口周围的壁厚相比时),如果连接部444的轮廓/直径保持与瓣膜200中的轮廓/直径基本相同,则可导致组合系带连接部444的拉伸能力增加。这种增加的拉伸能力可以使系带连接部分444和内框架450的结构完整性增加。在一些实施例中,拉伸能力可被保持(当与瓣膜200相比时),而同时减小连接部444的轮廓/直径(相对于瓣膜200)。例如,如图26所示,内框架450不包括如对内框架250描述的"微型V",其可以允许较小的轮廓,或者替代地,在保持相同轮廓的同时增加宽度"w"以及增加拉伸强度的能力。
如上面关于瓣膜100的描述,将两个(或更多个)支柱(例如,图25A和图25B中所示的453A和453B)组合以形成单个系带连接支柱448,可整体组合并成形,或以预成型方式熔融(如图25A和图25B所示)或可形成为分离的部件并连接在一起以形成系带连接部444的单个支柱448。
图27-图29示出了用一条或更多条缝合线435(称为“缝合线”)在系带连接部444处将人造瓣膜400的内框架450连接到系带436一端,以压缩地夹紧或握紧系带436的端部,从而将系带436连接到内框架450和瓣膜400。例如,缝合线435穿过在连接部444中界定的开口451,并缠绕系带连接部444的一部分和系带436的位于内部区域456内的部分(参见例如图25A),该内部区域456由连接部444的支柱453/448共同界定。
在一些实施例中,人造瓣膜的内框架的支柱部分可包括正向接合特征以帮助人造心脏瓣膜的定位。更具体地,如上所述,人造瓣膜可包括接合特征,该接合特征被配置成与如上所述的定位装置190等定位装置的接合特征匹配地接合。图30-图33示出了心脏瓣膜500的内框架550的另一实施例。图30示出了处于扩展配置并连接至系带536一端的内框架550的一部分,以及图31是处于未扩展配置的内框架550的打开并展平视图。人造心脏瓣膜500可构造成与如上述瓣膜100、瓣膜200和/或瓣膜400相同或相似,且功能与如上所述的瓣膜100、瓣膜200和/或瓣膜400相同或相似。例如,瓣膜500可包括外框架组件(未示出)和连接至外框架组件的内瓣膜组件。瓣膜500的内瓣膜组件可包括内框架550,内框架550包括如上面关于瓣膜100、瓣膜200和瓣膜400以及内框架150、内框架250和内框架450所描述的心房部(未示出)、主体部542、支柱部543和系带夹或连接部544。
如图30-图33所示,瓣膜500的内框架550通过系带连接部544处的缝合线535连接到系带536。如上所述,支柱部543的一对支柱553可以组合在一起或汇聚成系带连接部544的单个支柱548,其可用于在系带536周围压缩夹紧以将系带536连接到内框架550。在该实施例中,内框架550包括由系带连接部544的支柱548提供的接合特征522,该接合特征522可匹配地接合定位装置的相应接合部(未示出)(例如,定位装置190)。更具体地说,其中一个支柱548比其余的支柱548更长(例如,当植入心脏内时向近端延伸得更远)。接合特征522可用于与定位装置(未示出)中的相应开口接合,该定位装置可用于径向定位内框架550(和瓣膜500)。
如上所述,定位装置可界定内腔,系带536可通过该内腔被接收,并且定位装置可穿过心尖插入并通过接合特征522向远端移动以与瓣膜500接合。例如,在瓣膜500的展开期间且当瓣膜500至少部分地设置在例如心脏的心房内时,定位装置可穿过心尖插入且定位装置的远端部可与瓣膜500的连接部544接合。在接合时,经心尖定位装置可用于通过施加扭矩使瓣膜500绕系带536的纵向轴线转动或旋转以将瓣膜500径向定位在心脏内。
尽管图30-图33示出了一个实施例,其中系带连接部544的一个支柱548更长并提供接合特征522,在其他实施方式中,一个以上的支柱548可提供或形成接合特征522。此外,尽管图30-33示出了通过提供更长的支柱548而形成的接合特征522,在其他实施例中,内框架可以包括以下接合特征:其中一个或更多个支柱在系带连接部544处的长度减小,从而形成狭槽或孔。这样的孔可与定位装置连接,该定位装置具有以细长结构或凸起形式的相对接合特征以与孔配合。
虽然上面已经描述了各种实施例,但是应当理解,它们仅以示例的方式呈现,而不是限制。在上述方法指示特定事件以特定顺序发生的情形下,可以修改特定事件的顺序。另外,在可能的情况下,某些事件可以并行处理的方式来同时执行,也可以如上所述顺序执行。
如果上面描述的示意图和/或实施例指示某些部件以特定方向或位置布置,则可以修改部件的布置方式。虽然具体地示出和描述了实施例,但是应当理解,可以在形式和细节上进行各种改变。本文描述的装置和/或方法的任何部分可以任何组合方式(互斥组合除外)进行组合。本文描述的实施例可包括所描述的不同实施例的功能、部件和/或特征的各种组合和/或子组合。
另外,本文描述的系统和方法也可适用于与人造三尖瓣膜一起使用。例如,在这种情况下,可以将手术导管插入心脏的右心室,并且将输送护套直接(经心房)或经由颈静脉或股静脉输送到心脏的右心房。
Claims (18)
1.一种人造心脏瓣膜,包括:
外框架;
内框架,其连接到所述外框架,所述内框架包括设置在所述人造心脏瓣膜的近端部的系带连接部;
锚定系带,其通过至少一条缝合线连接到所述内框架的系带连接部,所述锚定系带被配置成固定到患者心壁上以固定在所述患者的心脏内的所述人造心脏瓣膜的位置。
2.根据权利要求1所述的人造心脏瓣膜,其中,所述系带连接部界定内部区域,所述锚定系带的远端部设置在所述内部区域内。
3.根据权利要求1所述的人造心脏瓣膜,其中,所述内框架的系带连接部包括多个支柱,所述多个支柱中的每个支柱界定至少一个开口,所述至少一条缝合线通过所述至少一个开口接收并包裹在所述系带连接部的至少一部分和所述锚定系带的一部分的周围,以将所述锚定系带固定到所述系带连接部。
4.根据权利要求3所述的人造心脏瓣膜,其中,所述多个支柱中的每一个均包括第一部分、第二部分和第三部分,所述第一部分和所述第二部分汇集到所述第三部分,所述第三部分界定所述至少一个开口。
5.根据权利要求3所述的人造心脏瓣膜,其中,所述多个支柱共同界定内部区域,所述锚定系带的远端部设置在所述内部区域内。
6.根据权利要求1所述的人造心脏瓣膜,其中,所述系带连接部包括被配置成与定位装置的第二接合特征匹配地且可释放地接合的第一接合特征,所述定位装置被配置成有助于将所述人造心脏瓣膜定位在所述患者的心脏内。
7.根据权利要求6所述的人造心脏瓣膜,其中,所述内框架的系带连接部包括多个支柱,所述第一接合特征包括所述多个支柱中的第一支柱,所述第一支柱比所述多个支柱中的其余支柱长,所述第一支柱被配置成匹配地接收在由所述定位装置界定的开口内,以可释放地将所述内框架连接到所述定位装置。
8.根据权利要求1所述的人造心脏瓣膜,其中,所述锚定系带由柔性编织物形成。
9.根据权利要求4所述的人造心脏瓣膜,其中,所述多个支柱中的第一部分、第二部分和第三部分整体成型。
10.一种配套设备,包括:
人造心脏瓣膜,包括外框架、与所述外框架连接的内框架,以及与所述内框架连接的锚定系带,
所述内框架包括设置在所述人造心脏瓣膜的近端部的系带连接部,所述锚定系带通过至少一条缝合线连接到所述内框架的系带连接部,所述锚定系带被配置成固定到患者的心壁上以固定在所述患者的心脏内的人造心脏瓣膜;以及
定位装置,其配置成与所述内框架的系带连接部接合并用于帮助将所述人造心脏瓣膜定位在患者心脏内。
11.根据权利要求10所述的配套设备,其中,所述系带连接部包括配置成与所述定位装置的第二接合特征匹配地接合的第一接合特征。
12.根据权利要求10所述的配套设备,其中,所述内框架的系带连接部包括多个支柱,所述第一接合特征包括所述多个支柱中的第一支柱,所述第一支柱比所述多个支柱中的其余支柱长,所述第一支柱被配置成匹配地接收在由所述定位装置界定的狭槽内,以可释放地将所述内框架连接到所述定位装置。
13.根据权利要求10所述的配套设备,其中,所述系带连接部界定内部区域,所述锚定系带的远端部设置在所述内部区域内。
14.根据权利要求10所述的配套设备,其中,所述内框架的系带连接部包括多个支柱,所述多个支柱中的每个支柱界定至少一个开口,所述至少一条缝合线通过所述至少一个开口接收并包裹在所述系带连接部的至少一部分和所述锚定系带的一部分的周围,以将所述锚定系带固定到所述系带连接部。
15.根据权利要求14所述的配套设备,其中,所述多个支柱中的每一个均包括第一部分、第二部分和第三部分,所述第一部分和所述第二部分汇集到所述第三部分,所述第三部分界定所述至少一个开口。
16.根据权利要求14所述的配套设备,其中,所述多个支柱共同界定内部区域,所述锚定系带的远端部设置在所述内部区域内。
17.根据权利要求10所述的配套设备,其中,所述锚定系带由柔性编织物形成。
18.根据权利要求15所述的配套设备,其中,所述多个支柱中的第一部分、第二部分和第三部分整体成型。
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EP3675774A1 (en) | 2020-07-08 |
US20200205968A1 (en) | 2020-07-02 |
US11191639B2 (en) | 2021-12-07 |
CN111031967B (zh) | 2022-08-09 |
WO2019046099A1 (en) | 2019-03-07 |
EP3675774B1 (en) | 2023-06-21 |
JP7291124B2 (ja) | 2023-06-14 |
AU2018323900A1 (en) | 2020-02-27 |
JP2020531178A (ja) | 2020-11-05 |
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