CN101484093B - 用于改善心瓣膜功能的人工***物 - Google Patents
用于改善心瓣膜功能的人工***物 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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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
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
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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
- A61F2/2466—Delivery devices therefor
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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
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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
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0817—Structure of the anchor
- A61F2002/0823—Modular anchors comprising a plurality of separate parts
- A61F2002/0835—Modular anchors comprising a plurality of separate parts with deformation of anchor parts, e.g. expansion of dowel by set screw
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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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
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
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- Engineering & Computer Science (AREA)
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Abstract
公开了用于改善心瓣膜如主动脉瓣功能的装置和方法。在一个实施方式中,所述装置包括***部件,其配置用于***主动脉瓣的小叶之间。***部件优选地包括三个从中心部分向外延伸的径向臂状物。该装置还包括锚定部件,其与***部件连接并被配置用于将***部件保持在心瓣膜内。在工作时,每个臂状物可填补心瓣膜小叶之间的间隙,从而最大限度地减少或防止通过心瓣膜的反流。
Description
相关申请的交叉参考
本申请要求2006年6月1日提交的美国临时专利申请号60/810,085的权益,在此以其整体并入作为参考。
技术领域
本公开涉及可植入心脏修复学(implantable cardiacprosthetics)领域,具体而言,涉及心脏人工***物,用于减少通过心瓣膜如主动脉瓣的反流,以及涉及植入心脏人工***物的方法。
背景技术
心瓣膜反流,或从心瓣膜流出侧到流入侧的泄漏,是当心瓣膜无法正常关闭时发生的状况。心瓣膜反流降低心脏的效率,减少血液循环,并增加对心脏的压力。在早期,心瓣膜反流使人感到疲劳和呼吸急促。如果任其发展,这一问题可导致充血性心力衰竭、心律失常或死亡。
通过主动脉瓣的反流,有时也被称为主动脉瓣关闭不全(aortic insufficiency),是影响到数百万成年人健康的严重问题。主动脉瓣位于心脏左侧,在左心室与主动脉之间。心室收缩期间,健康的主动脉瓣打开,以允许血液从左心室流进主动脉;然后在心室舒张期间关闭,以防止血液从主动脉回流进入左心室。但是,随着时间推移,主动脉环的几何构造发生变化,或其它原因,如钙化、感染和损伤,可能会影响到主动脉瓣的功能性。结果是,主动脉瓣可能无法在心室舒张时完全关闭,从而导致反流。
主动脉瓣关闭不全典型地通过在心内直视手术过程中用人工瓣膜替换有缺陷的天然瓣膜来治疗。但是,心内直视手术具有高度创伤性,因此对于许多高危患者来说并非一种选择。因此,近年来,微创方法(less invasive method),如经皮瓣膜置换术(percutaneous valvereplacement),已经发展用于替换主动脉瓣。在一个实例中,包括支架和瓣膜的人工修复物(prosthesis)被卷曲成较小外形,然后通过经皮途径被递送到心脏中。一旦定位于治疗部位,人工修复物被扩张用以代替天然主动脉瓣的功能。虽然经皮瓣膜置换术已显示出大有前景,但是在递送技术、瓣周漏(perivalvular leakage)和瓣膜耐用性方面仍然存在挑战。此外,如果可能,修复而不是替换天然瓣膜是期望的。
发明概述
因此,在此处公开的是用于治疗心瓣膜疾病的装置和方法,其包括示例性实施方式,一种不需要体外循环的微创方法。这种装置和方法的某些实施方式期望能够减少或消除通过心瓣膜的反流。还期望的是,这种装置和方法的实施方式非常适合用于在经皮或微创方法中递送。还期望的是,这种装置和方法的实施方式非常适合用于修复主动脉瓣。还期望的是,这种装置的递送是安全、可靠和容易的。还期望的是,这种装置和方法的实施方式适用于针对广泛多样化的心瓣膜缺损而改善心瓣膜功能。还期望的是,这种装置和方法的实施方式能够不用替换天然瓣膜就可改善瓣膜功能。
本公开的各种实施方式提供了用于改善有缺陷的心瓣膜功能的改进的装置和方法。具体实施方式可被配置为采用经皮或微创的方法植入心脏,其中体外循环不是必需的。
在本公开一个代表性实施方式中,人工装置包括锚定部件和***部件,所述***部件被配置用于在天然瓣膜如主动脉瓣的小叶之间展开。***部件期望被成形为填补小叶之间的间隙(一个或多个),以在心室舒张期间产生紧密密封,从而最大限度地减少或防止通过主动脉瓣的反流。***部件期望被制造成使得天然小叶与***部件表面啮合的尺寸。当被配置用于典型的主动脉瓣时,***部件期望包括三个臂状物,它们从中心区域径向向外延伸。每个臂状物被成形为放置在主动脉瓣的邻近小叶之间。锚定部件被提供用于将***部件稳固在其展开的位置。在示例性实施方式中,锚定部件采用支架的形式,所述支架被配置用于在升主动脉(ascending aorta)内的展开。在一种变体中,***部件可以被配置(例如,具有两个臂状物)用于只有两个小叶的主动脉瓣。在另一种变体中,***部件可以被配置在肺动脉瓣中使用,用于治疗肺动脉瓣闭锁不全。
在本公开另一代表性实施方式中,人工装置包括由支架形成的锚定部件,和***部件——其被配置用于在天然主动脉瓣的小叶之间展开。锚定部件期望包括用于提供单向流动的瓣膜部件。锚定部件期望被配置用于递送至升主动脉。支架通过自扩张或球囊扩张进行扩张,使得支架被锚定在主动脉中。展开之后,在支架里的瓣膜部件防止或最大程度地减少通过主动脉的血液回流。***部件被递送到天然主动脉瓣中,以改善天然瓣膜的功能。因此,两个单独的瓣膜(例如支架瓣膜和天然瓣膜)协同工作,以防止通过主动脉环的反流。通过在天然瓣膜内展开***部件,使天然瓣膜发挥它应有的功能,并且血液以基本自然方式进入冠状动脉。该支架瓣膜补充了天然瓣膜的功能。如果期望,该支架瓣膜可建造成在天然瓣膜之前或之后(期望的是之后)关闭,以进一步影响和改善天然瓣膜的功能,并改善血液动力学。
在一个代表性实施方式中,提供了用于治疗有缺陷的心瓣膜的***和方法。所述***包括人工装置,其包括锚定部件和***部件。所述***进一步包括递送导管,用于通过经皮途径将人工装置递送至心脏中。递送导管期望包括具有腔的伸长护套(外壳,sheath),该腔的大小适于容纳人工装置。在示例性实施方式中,在通过对象脉管***推进的过程中,人工装置以收缩的构造被容纳在护套内。在一种变体中,外壳被配置用于逆行推进,并可以配置有可偏转的末端部分,用于促进在主动脉弓周围的导向(navigation)。达到治疗部位后,护套被移动至相对人工装置近端,以便从外壳弹出该装置。该装置随后被允许扩张,使得***与主动脉瓣中的间隙相符,锚定部件与主动脉内壁啮合。
在本公开另一个代表性实施方式中,人工装置包括锚定部件和具有三个可扩张臂状物的***部件,所述***部件被配置用于在闭锁不全的主动脉瓣中的间隙之间展开。每个臂状物期望包括可扩张区域,其以有些类似降落伞的方式打开,以防止反流。在心室收缩期间,每个可扩张区域会收缩以使通过主动脉瓣的血液流动不受阻碍。
在本公开某个代表性实施方式中,人工装置包括:***部件,其被配置用于在主动脉瓣内展开:和锚定部件,其被配置用于固定在左心室内。伸长的主体部分被提供用于连接***部件与锚定部件。在一种变体中,人工装置可以以多个阶段被递送。在第一阶段,锚定部件被递送,然后使其生长至心脏壁中。在第二阶段,在充分的向内生长发生后,***部件被附着至锚定部件。
在本公开另一代表性实施方式中,人工装置包括锚定部件和***部件,所述***部件被配置用于在二尖瓣的前叶和后叶之间展开。***部件期望被成形为填补天然小叶之间的间隙,以防止通过二尖瓣的反流。***部件的大小使得在心室收缩期间二尖瓣小叶与***部件表面啮合以产生紧密密封。作为本实施方式的变体,提供一个或多个通过***部件的通道以允许血液在一个方向通过装置流动,而进一步改善瓣膜功能。
上述和其它特征根据以下对几个实施方式的详细描述将变得更加明显,所述描述参考附图来进行。
附图说明
图1显示了心脏的横截面图。
图2是人工装置的透视图,其包括锚定部件和***部件,所述***部件被配置用于在天然主动脉瓣的小叶之间展开。
图3是***部件的横截面图,其带有生物相容性材料的外涂层。
图4是放置在主动脉瓣内的图2***部件的横截面图。
图5是主动脉的部分剖视图,图解在治疗主动脉瓣关闭不全的对象内展开的图2的人工装置。
图6是透视图,其图解人工装置的一种实施方式,其中***部件被直接附着到锚定部件。
图7是收缩状态下包含在外壳内的图6***部件的横截面图,用于递送至治疗部位。
图8图解从护套弹出并扩张成扩张状态后的图6的***部件。
图9A是人工装置的透视图,该人工装置包括用于在主动脉瓣里展开的***部件和带有用于稳固到左心室的啮合部件的锚定部件。
图9B是以扩张状态显示的多个啮合部件的示例性实施方式的分解图。
图9C是以压缩状态显示的图9B的多个啮合部件的透视图,用于递送到心脏。
图10是图9A所示的实施方式的变体,其中提供可选的锚定部件。
图11是类似于图2所示的实施方式的人工装置的透视图,其中所述锚定部件包括支架和用于在升主动脉里展开的瓣膜部件。
图12是类似于图2所示的实施方式的人工装置的透视图,其中***部件以两个臂状物形成。
图13是人工装置的透视图,该人工装置包括锚定部件和在心脏中展开的***部件,用于治疗闭合不全的二尖瓣。
图14是图13***部件的横截面图。
图15是横截面图,图解说明带有通道和瓣膜部件的***部件,以允许血液在一个方向通过***部件流动。
具体实施方式详述
I.术语解释
除非另有说明,此处使用的所有技术和科学术语,具有与本公开所属领域普通技术人员通常理解的相同含义。为了便于查阅本公开各种实施方式,提供下列术语解释:
单数术语“一(a)”、“一(an)”和“所述(the)”包括复数指称,除非上下文另有明确表示。术语“或(or)”指所陈述的可选要素的单个要素或两个或更多要素的组合,除非上下文另有明确表示。
术语“包括”(“include”)是指“包含”(“comprises”)。举例来说,包括或包含A和B的装置含有A和B,但可以任选地含有C或除A和B之外的其它组分。另外,包含或包括A或B的装置可以含有A或B或者A和B,并任选地含有一个或多个其它组分,如C。
术语“近端(proximal)”是指更靠近操作者的设备部分,而“远端”(distal)是指远离操作者的设备部分。
术语“对象”是指人和其它动物对象。在某些实施方式中,对象是人或其它哺乳动物,如灵长类动物、猫、狗、牛、马、啮齿类动物、绵羊、山羊或猪。在具体实例中,所述的对象是人类患者。
虽然与此处所述类似或等同的方法和材料可用于本公开的实践或测试中,但是合适的方法和材料描述如下。在冲突的情况下,遵循包括术语在内的本说明书。此外,材料、方法和实施例仅仅是说明性的,而不意图是限定性的。
II.人类心脏的解剖学概述
参考图1,提供了心脏1的横截面图。血液流经上腔静脉2和下腔静脉4进入心脏1的右心房6。三尖瓣8控制右心房6和右心室15之间的血液流动。当血液从右心室15泵出至肺部时,三尖瓣8关闭。此后,三尖瓣8开放,将来自右心房6的血液再填充右心室15。三尖瓣8小叶的游离缘通过腱索10连接至右心室15内的***肌12,用于控制三尖瓣8的运动。血液从右心室15被泵送通过肺动脉瓣20到达肺动脉22,其分支进入伸向肺部的动脉。
离开肺后,充氧的血液流经肺静脉28,进入心脏1的左心房26。二尖瓣30控制血液在左心房26和左心室17之间的流动。二尖瓣30在心室收缩期关闭,此时血液从左心室17流出进入主动脉34。此后,二尖瓣30开放,将来自左心房26的血液再填充左心室17。二尖瓣30小叶的游离缘通过腱索11连接至左心室的***肌13,用于控制二尖瓣30的运动。来自左心室17的血液经主动脉瓣32被泵送至主动脉34,其分支进入通向身体各个部位的动脉。主动脉瓣32包括三个小叶(也称为皮瓣或尖),其被统称为36。当心脏跳动时,小叶36开启和关闭来控制血液从心脏的左心室17流至主动脉34中。
III.用于减少通过心瓣膜的反流的人工装置
如果心瓣膜的任何部分不能正常发挥功能,心脏的效率可能会受到严重损害。例如,心瓣膜可能会失去正常关闭的能力,原因在于瓣膜周围的环面或松弛下垂的小叶的扩张。小叶还可由于疾病如风湿性疾病而收缩,从而在瓣膜内小叶之间留下间隙。心瓣膜关闭能力的丧失导致血液回漏(与正常血液流动相反),通常被称为反流,其通过主动脉瓣进入左心室。反流可严重损害心脏功能,因为更多的血液不得不通过反流瓣膜被泵出,以保持足够的循环。
本公开的实施方式提供用于改善有缺陷的心瓣膜如主动脉瓣的功能的装置和方法。此处公开的装置和方法期望采用经皮或微创手术方法被递送到对象的心脏中。因此,此处所述的期望递送方法不需要体外循环(例如,来自对象的循环血液被发送至机体以外的路线,以对其进行处理,然后返回至对象的循环)。例如,在一个实施方式中,递送导管(或类似的递送装置)通过胸壁切口***,然后通过心脏组织(例如,通过心尖)进入患者跳动心脏的腔体。递送导管可允许人工装置以收缩的结构被递送到心脏中,然后在心脏内扩张用于治疗有缺陷的心瓣膜。因为期望传送方式不需要体外循环,所以与传统的心内直视手术相比,并发症大大减少。
图2图解了人工装置100的实施例,其可被用于减少或消除通过心瓣膜如主动脉瓣的反流。人工装置100包括***部件102和锚定部件110。***部件102期望包括用于接触天然瓣膜小叶如天然主动脉瓣小叶的实体外表面。在此处使用,“实体(实心,无孔,solid)”表面是指非穿孔表面,其不包含血液可以通过的任何开口。如图2所示,***部件102包含第一延伸部分或臂状物104,第二延伸部分或臂状物106,和第三延伸部分或臂状物108。延伸部分104、106、108期望在***部件102的中心部分112周围,以相同角度间隔,并从此处向外径向延伸。人工装置100可包括多个间隔物(spacer)或连接部件120,用于在与锚定部件110隔开的位置安装***部件102。如图2所示,三个这样的间隔物或连接部件在图解的实施方式中被提供,用于将***部件102连接至锚定部件110。
在图解的实施方式中,锚定部件110采取自扩张或球囊扩张支架的形式,其具有开放式框架结构,如图2所描绘。所述锚定部件可用各种合适的扩张材料和/或弹性材料制造,如不锈钢、钛、形状记忆合金或其它生物相容性金属。在一个实施例中,锚定部件110是自扩张式的,并用形状记忆合金制造,如镍钛(nickel titanium,NiTi)形状记忆合金,例如如以商品名称Nitinol销售。在另一个实施例中,锚定部件110是球囊扩张式的,并用不锈钢或其它合适的材料制造。
在具体实施方式中,所述的锚定部件110包括支架,该支架具有多个成角度间隔的轴向支柱,或支撑部件,其沿部件轴向(纵向)延伸。锚定部件110也可包括多个轴向间隔的圆周带或支柱,其附着至轴向支柱。圆周形支柱形成有多个弯曲,这些弯曲允许锚定部件110被压缩到较小的直径以便递送到植入部位,并扩张至其发挥功能的大小,以便将***部件102锚定至心脏。圆周形支柱可包括多个以Z字形(zig-zag)或锯齿(saw-tooth)构造排列的线型支柱部件,其形成确定相邻支柱部件之间的弯曲。在其它实施例中,一个或一个以上的圆周带可具有弯曲或蜿蜒的形状,而不是Z字形形状。在变体中,锚定部件110可进一步包括固定或附着部件,如倒钩、钉、凸缘、吊钩等等,其沿锚定部件110的外部分布,用于提高锚定部件110在主动脉内锚定***部件的能力。对可以在此处公开的实施方式中使用的示例性支架的进一步详述,在美国专利号6730118、美国专利号6767362和美国专利号6908481中公开,在此处每篇专利都以其全部并入作为参考。
虽然锚定部件主要以支架的形式进行描述,应该可以理解广泛多样的锚定机构都可以使用,同时保留在本公开范围之内。例如,锚定部件可以由一个或一个以上固定器形成。在一个具体实施例中,锚定部件可以是多个间隔分开的固定器,其向外延伸以接触心瓣膜环附近或心瓣膜环内的组织。固定器的尺寸和配置适于将主体稳固至心瓣膜环。例如,所述一个或多个固定器可以是环形带,其由聚乙烯、聚丙烯、聚碳酸酯、尼龙、聚四氟乙烯、聚氨基甲酸酯、不锈钢、Nitinol、钛、聚酰亚胺、聚酯、形状记忆材料或它们的混合物制成。所述一个或多个固定器可包括突起、倒钩、针和吊钩等等啮合部件,用于辅助将人工装置锚定在心瓣膜内。
***部件102被配置用于***闭锁不全的主动脉瓣的小叶之间,以填补小叶之间的间隙。在一个具体实施例中,***部件102显示出足够的刚性,以基本保持其展开的形状,并具有足够的弹性和/或柔性,以便被压缩到减小的直径,用于在递送护套中递送。***部件可由塑料、金属(如形状记忆金属)或适于植入到对象内的其它生物相容性材料制造。在具体实施例中,如图3所图解,***部件102可包括内支撑层127和外层或护套128。外层128可由生物相容性材料制造,如布类或织物材料(天然或合成)或生物材料,如胶原或生物组织材料,以保护天然小叶免受损害(例如,阻止响应小叶接合和解除接合可能发生的磨损)。例如,与天然小叶相容的平滑的动物心包(smooth animal pericardium),如马、牛、猪或其它动物的心包组织,可以包括在外层128内。这些组织可以通过适当的鞣革环境来鞣制或固定,或心包可以与通过解毒方法结合的戊二醛和肝素交联。在某个实施例中,生物组织材料可以是天然组织产品之一,其显示出改进的生物相容性,并减轻钙化及血栓形成。外层128可覆盖内层127的整个外表面或经选择的一部分的外表面,如那些接触天然瓣膜的部分。
在某些实施例中,***部件102的直径与天然主动脉瓣的直径相似,这样,每个延伸部分就延伸进入主动脉瓣小叶之间的尖端中。因此,装置100的***部件102在展开后保持在主动脉瓣内居中。在某些实施例中,***部件的直径约18mm至约26mm,其中约22毫米为具体实施例。与锚定部件110的直径相比,***部件102的直径可以略小。此构造允许***部件收缩或折叠成较小直径,用于在递送护套中递送。此外,***部件的长度可以有所变化。例如,在一个实施方式中,***部件的长度与锚定部件长度大致相同。在其它实施例中,***部件的长度大于或小于锚定部件的长度。在某些实施例中,***部件的长度为约20mm到约30mm,其中约25mm为具体实施例。
如图4所示,***部件102的横截面轮廓可以成形为使得天然小叶36a、36b、36c能够接触***部件102的侧面,以在心室舒张期建立紧密密封。例如,三个间隔开的延伸或臂状物104、106和108从***部件102的中心区域112径向向外延伸。在某些实施例中,臂状物在宽度上从中心部分向延伸部分外端逐渐变细。例如,每个臂状物包括第一末端114和第二末端116。所述的第一末端114比第二末端116宽。每个臂状物都包括第一侧面122和第二侧面124,每一个侧面被配置为与天然小叶接触。末端114、116和侧面122、124可被配置为具有平滑边缘,以尽量减少或消除溶血效应。此外,每个臂状物被配置为填补主动脉瓣的相邻小叶之间的间隙,从而防止通过主动脉瓣的反流。臂状物的接触表面可以显示出足够的顺应性和/或柔韧性,以允许天然小叶与***部件102啮合,产生紧密密封而不损坏小叶。例如,如上所述,每个臂状物可包括生物相容性材料,如胶原或心包组织,以阻止响应臂状物与天然小叶啮合或接合而可能发生的磨损。
当用于治疗主动脉瓣时,***部件的横截面轮廓可以被最小化,以便当主动脉瓣完全开放时限制从左心室到主动脉的血流阻力。此外,***部件的一个端部或两个端部可以是锥形或圆形的,这样就不存在垂直面对血液流动的平面。关于图解的实施方式,应当理解人工装置能够最大限度地减少或防止反流,而不利用任何移动部件。因此,与需要利用移动部件的可选心瓣膜修复和更换技术相比,该装置可以获得更大的耐用性。
***部件102可被配置以可扩张的结构,如可移动的薄片(flap),以进一步阻止通过主动脉瓣的反流。每个可扩张的结构可被配置用于填补相邻天然瓣膜小叶之间的空隙。在一个实施例中,可移动的薄片可以被配置为以类似于降落伞的方式打开,以阻止天然主动脉瓣小叶之间的血液反流。在心室收缩期,可移动薄片收缩,以使血液以基本无阻碍的方式,从左心室经天然主动脉瓣流进主动脉。关于可扩张***部件(例如瓣膜部分)的另外详细说明,可以在申请人于2006年4月19日提交的共同未决的美国申请号11/407,582(美国专利公布号2006/0241745)中找到,其在此以全文并入作为参考。在′528申请中所述的、被配置用于二尖瓣的可扩张人工装置的原理和特点,也适用于此处所述的在主动脉瓣里使用的装置。
如上所述,并如图2所示,人工装置100包括多个间隔物或连接部件120。每个连接部件通常可以为圆柱形状,尽管可使用任何其它合适的形状。在某些实施例中,每个连接部件的长度为约6mm到约14mm,其中约10mm为具体实施例。每个连接部件优选地将***部件102的臂状物结合至锚定部件110。连接部件120可协助稳定***部件102。每个连接部件期望显示出足够的刚性,以基本将***部件保持在相对于锚定部件的固定位置。连接部件可由塑料、金属或其它生物相容性材料制成,其适于植入到对象中。连接部件120也最大限度地减少人工装置对流向冠状动脉血流的干扰,这是通过使锚定部件110定位于冠状动脉口之上以及***部件102定位在天然主动脉瓣内来实施。
正如图4中最佳图解,主动脉瓣32的天然小叶36a、36b、36c在心室舒张期与***部件102接触而产生紧密密封。通过使主动脉瓣32产生紧密密封,可以最大限度地减少或避免从主动脉进入左心室的反流。在心室收缩期,天然小叶开放——正如它们自然而为,使血液从左心室被泵至主动脉。从图4可以看出,***部件102的横截面面积与通过主动脉瓣环的流通面积相比,相对较小。因此,在图解的实施方式中,***部件102基本不会在心室收缩期阻碍血液经主动脉瓣的流动。
参考图5,其图解了在对象中展开后的人工装置100。如图5所示,锚定部件110在主动脉瓣上方如冠状动脉口38上方的主动脉中展开,以便不干扰通过冠状动脉的血液流动。***部件102在天然主动脉瓣中展开,以改善主动脉瓣的功能。例如,***部件102位于天然主动脉瓣内,其每个臂状物104、106和108在两个小叶的相邻边缘之间延伸,这样,主动脉瓣32的小叶与臂状物104、106和108接合。连接部件120从锚定部件110延伸至***部件102,以保持***部件102处于充分固定的位置。在心室舒张期,主动脉瓣32的小叶关闭并挤压***部件的壁而产生一个紧密密封。虽然闭锁不全或有缺陷的主动脉瓣中的天然小叶可能无法完全关闭,但是***部件102的臂状物填充间隙,使得很少或没有血液能够从主动脉回流至左心室。
正如所示,天然主动脉瓣不被切除,并继续以基本正常的方式发挥作用。因此,随着时间推移,如果天然瓣膜能够自身治愈或如果发现可替代治疗,有可能去除人工装置。
参考图6,显示了根据另一实施方式的人工装置200。人工装置200包括***部件102和锚定部件110。在图解的实施方式中,***部件102直接与锚定部件110连接,而不通过连接部件120。例如,***部件可以通过***部件102的近端118连接到锚定部件110,例如***部件102的近端被部分容纳在锚定部件110的末端部分内并被其环绕。在图解的实施方式中,***部件102的直径小于锚定部件110的直径。此结构允许***部件102在植入过程中收缩或折叠,并随后在瓣膜里展开。
所公开的人工装置可被配置用于以经皮或微创方法递送,其中只需要小的进入切口。在一个实施例中,人工装置可被配置以便其能够被卷曲或以其它方式收缩成较小外形,然后放置在递送护套中,用于推进至治疗部位。例如,图7图解了在收缩状况下护套(sheath)142内的人工装置200。如所示,***部件102可被配置具有足够的柔韧性,以使臂状物可以折叠,或者使其呈现弯曲外形,以便在递送过程中暂时减小***外形。从护套142中弹出后,锚定部件110和***部件102扩张到完全扩张的状态,如图8所示。当以经皮方法被递送到主动脉瓣后,期望利用可偏转护套,以便于通过病人的血管和在主动脉弓周围的导向。关于被配置用于将治疗装置递送到主动脉瓣的可偏转护套的各种实施方式的详细说明,可以在申请人于2005年6月13日提交的共同未决的美国申请号11/152,288中找到,其名称为“心瓣膜递送***”,其此处以全文引用的方式并入。
图9A显示人工装置300,其可用于减少或消除心瓣膜反流,如主动脉瓣反流。在此实施方式中,人工装置包括***部件102——其被配置用于***主动脉瓣中,和锚定部件302——其被配置用于固定至左心室内的肌肉壁。锚定部件302可以包括多个啮合部件304,如钩或指状物,其沿肌肉壁穿透组织,以将***部件102固定至心脏。啮合部件304可用任何生物相容性材料制成,如生物相容性的金属或塑料,其能穿透左心室肌肉壁,以将***部件102固定至心脏,而不会基本损伤该壁。锚定部件302可包括伸长的主体部分或轴306,其连接啮合部件304与***部件102。在一个实施例中,伸长主体部分306和啮合部件304可由单块材料制成。另一个实施例中,伸长主体部分306和啮合部件304可以各自单独制造,随后通过任何合适的方法如焊接而彼此结合。伸长主体部分306和啮合部件304可以由相同或不同的材料制成,这取决于装置300的每一部分所期望的材料特性(弹性、刚性、收缩性等)。
通过将多个啮合部件304放置在左心室心尖附近的左心室内,人工装置300可放置在心脏内,以最大限度减少主动脉瓣反流。在图解的实施方式中,多个指状物或钩沿左心室心尖附近的左心室肌肉壁穿透组织。***部件102定位在主动脉瓣环内,以使其上部和下部可在天然主动脉瓣的上面和下面延伸,并且***部件102的臂状物被调整为与主动脉瓣的三个尖端接合,因此,每个小叶可在***臂状物之间上下移动。
图9B和9C显示了锚定部件302的下端部分,其具有用伸长尖头物制成的多个啮合部件304。伸长尖头物304期望被配置为,当其被推离递送护套时,从图9C压缩构造自扩张成图9B的“开花的”或扩张的构造。此开花式构造借助自弯曲区域304a期望实现,其使尖头物304从主体502的中心径向向外并向后朝向主体的第二末端偏转。尖头物304期望有尖角或有刺,以促进与心脏肌肉壁渗透和啮合。
锚定部件302可由单管形状记忆材料制成,例如,举例来说,Nitinol。在制造过程中,形状记忆材料可以用机械或激光切割工具来切割。切割管后,扩张或开花式形状可以采用本领域已知的技术(如热定形形状)被赋予形状记忆材料的记忆。制造锚定部件的方法在申请人共同未决的美国申请号11/750,272(以下简称“′272申请”)中详细描述,其在此以引用方式并入。在一个优选的实施方式中,锚定部件被制成具有延伸的构造,其符合在锚定部件将被展开的位置处心脏特定表面区域的轮廓,如′272申请所述。
包括尖头物304在内的锚定部件302的表面,期望被配置用于促进组织在其表面甚至进入其中生长。在一个实施例中,通过给锚定部件提供相对粗糙和/或多孔表面来实现这种生长。此外,本领域已知的生物涂层类型可被包括在锚定部件302的表面上,以促进愈合和组织生长。
图10显示了锚定部件402的另一种变体,其中一个或多个锚如图示的板404,位于心脏肌肉壁的相对侧上,用于将人工装置400锚定至心脏。板404可由任何生物相容性材料制成,如生物相容性金属或塑料。锚定部件402包括轴406,其具有被连接到***部件102的上端部分和延伸通过心脏壁的下端部分。一块板404被安置于左心室内的轴上,另一块板404被安置于左心室外的轴上,以将轴稳固在适当的位置。
如果期望,人工装置可以以多个阶段展开,其中,在第一阶段,***部件被递送之前,锚定部件附着到主动脉(或心室壁)。在第二阶段,该装置的***部件后来(如几个小时、几天或几周后)被连接到锚定部件。第一阶段和第二阶段之间的时间间隔有利于组织愈合,甚至在锚定部件上生长,从而进一步在心脏内嵌入锚定部件。在不存在装置的***部件可赋予组织额外压力的情况下,愈合和过度生长可以更迅速地进行,其具有较小的副作用(例如不必要的疤痕)。关于示例性锚定部件、可扩张***部件和两阶段展开的附加详细说明可在‘272申请中找到。
图11显示了人工装置的另一种可选实施方式,以500表示。锚定部件110可以是支架,并且可以包括安装在支架内的瓣膜部件130。在图解的实施方式中,瓣膜部件130是有三小叶式生物人工瓣膜。在具体实施例中,锚定部件和瓣膜部件可采取Cribier-Edwards瓣膜的形式,由加利福尼亚的Edwards Lifesciencea of Irvine制造。关于有支架瓣膜示例性实施方式的附加详细说明可以在美国专利号6,893,460中找到,其在此以全文引用的方式并入。
支架中的瓣膜部件130确保通过支架的单向流动。支架期望被配置用于递送到升主动脉中。支架以自扩胀或球囊扩张的方式扩张,以使支架被锚定在主动脉内。展开后,支架内的瓣膜部件防止血液经主动脉回流。***部件被递送到天然主动脉瓣中,以改善天然瓣膜的功能。因此,两个单独的瓣膜(即支架瓣膜和天然瓣膜)协同运作,以阻止经主动脉环的反流。通过***部件在天然瓣膜内的展开,天然瓣膜被允许发挥它应有的功能,血液被允许以基本自然的方式流入冠状动脉。该支架瓣膜补充了天然瓣膜的功能。如果期望,支架瓣膜可被建造成在天然瓣膜之前或之后闭合,以进一步影响和改善天然瓣膜功能,并改善进入冠状动脉的血流动力学和/或灌注。
参考图12,提供了根据又一种实施方式的人工装置600。人工装置600被配置用于在只有两个小叶的异常主动脉瓣中使用。为了治疗这部分人群,***部件602具有两个臂状物604、606,用于填补小叶之间的间隙。此外,在某些具有三个小叶的主动脉瓣中,可能没有必要填补三个小叶各个之间的间隙。因此,使用图12所示类型的***部件可以是期望的,用于防止或减少在三个小叶瓣膜中的反流。
为了说明起见,人工装置的期望实施方式已在上文描述,用于用在通常具有三个小叶的瓣膜如主动脉瓣中。但是,本领域普通技术人员应该认识到,装置的变体也可以一种类似的方式用于治疗另一种具有三个小叶的瓣膜,如肺动脉瓣。用于治疗肺动脉瓣时,锚定部件(例如支架)可被配置用于在肺动脉干或肺动脉内展开。可选地,锚定部件可被固定在右心室内。
参考图13到15,人工装置700被配置用于治疗二尖瓣,如缺陷型二尖瓣。如图13所示,人工装置700包括***部件702和锚定部件704。***部件702包括一个主体,其尺寸和形状适于填补闭锁不全的二尖瓣前小叶与后小叶之间的间隙。
在一种具体实施方式中,***部件702显示出足够的刚性,以基本保持其展开的形状,并具有足够的弹性和/或柔性,以便被压缩到减小的直径,用于在递送护套中递送。***部件可由塑料、金属或适于植入到对象内的其它生物相容性材料制造。在具体实施例中,如上所述,***部件可包括基本由生物相容性材料制成的外层或护套,所述生物相容性材料如布类或织物材料(天然或合成)或生物材料,如胶原或生物组织材料,以保护天然小叶免受损害(例如,阻止响应小叶接合和解除接合可能发生的磨损)。例如,与天然小叶相容的平滑的动物心包,如马、牛、猪或其它动物的心包组织,可以包括在外层内。这些组织可以通过适当的鞣革环境来鞣制或固定,或心包可以与通过解毒方法结合的戊二醛和肝素交联。在某个实施例中,生物组织材料可以是天然组织产品之一,其显示出改进的生物相容性,并减轻钙化及血栓形成。外层可覆盖***部件102的整个外表面或外表面的选定部分,例如那些接触到天然小叶的部分。***部件702的形状可为锥形和/或平滑边缘,以最大程度地减少或消除溶血作用。
***部件702的横截面轮廓被成形为使得天然小叶能够接触***部件702的侧面703a和703b,以产生紧密密封。如图13-15所示,***部件702优选地具有月牙形横截面轮廓,以更好地符合天然小叶的弯曲。***部件702的表面具有顺应性,其允使得天然小叶能够与***部件702啮合,以产生紧密密封,而不损坏小叶。例如,如上所述,表面可包括生物相容性材料,如胶原或心包组织,以阻止响应***部件表面与天然小叶啮合或接合时可能发生的磨损。在工作中,二尖瓣的天然小叶在心室收缩期挤压***部件的壁,以产生紧密密封,并防止血液从左心室到左心房的反流。
在图解的实施方式中,人工装置700的锚定部件704包括轴或伸长的主体部分706,其下端部分形成穿透部分708。板709可以在心脏壁的相对侧上安置在穿透部分708之上,以将轴固定在适当的位置。锚定部件704的主体部分706和穿透部件708可以是任何合适的形状和材料,其赋予装置700每个部分所期望的材料特性(弹性、刚性、收缩性等等)。例如,穿透部件708可以由任何生物相容性材料制造,如生物相容性的金属或塑料,其能穿透左心室肌壁以将***部件702固定至心脏,而不会基本损害该壁。
在一个实施例中,锚定部件704可被配置为在左心室内展开。图14是图13所示***部件702的横截面图。在此实施方式中,***部件702具有基本实心的横截面。在一种变体中,如图15所示,***部件702可以包括沿纵轴延伸的通道。该通道可适合于使血液在一个方向经***部件流动。瓣膜部件可被包括在***内,以确保血液仅在一个方向流动。在一个具体实施例中,瓣膜部件可以包括一个或多个薄片部件712,其界定出狭缝或开口710。通过使血液仅在一个方向流动,瓣膜部件模仿目标瓣膜的功能。因此,从一个方向流动进入通道的血液打开薄片,从而流经***部件,而从相反方向流动进入通道的血液被瓣膜阻止。
IV.用于减少通过心瓣膜反流的***和方法
此处公开的是用于治疗有缺陷的心瓣膜的***和方法。在一种实施方式中,所述的***包括人工装置,其包括锚定部件如自扩张式锚定部件和***部件。该***可进一步包括递送导管,用于通过经皮方法将人工装置递送至心脏。例如,该导管可被经皮引入患者的脉管***中(例如引入外周动脉如股动脉中)并推进至植入部位。在某些实施方式中,例如,导管的尺寸适于通过在腹股沟内的小切口***,并具有至少约80cm通常为90-100cm的长度,以使轴以逆向途径实现从股动脉和髂动脉到升主动脉的经腔定位。可选地,导管以具有较短的长度,例如约20-60cm,用于通过其它***点导入,如,例如髂动脉、肱动脉、颈动脉或锁骨下动脉。在股骨途径中,导管期望具有足够长度和柔韧性,以穿过经股动脉、髂动脉、降主动脉和主动脉弓的路径。与此同时,导管期望具有足够的可推性,以通过在近端的推动使其推进至升主动脉;并具有足够的轴向、弯曲和扭转硬度,以便于即使导管位于曲折的血管结构内,医生也可控制远端的位置。可选地,导管可经肋骨之间的通道穿过。在一种技术中,导管以所谓微创的方法通过患者心脏以上的胸腔并穿过主动脉弓内的切口推进。在另一项技术中,导管通过心脏壁中的切口推进,优选地是沿心尖。人工装置被推进至将被治疗的心瓣膜,并且其被定位为跨过瓣膜延伸,其中该装置的臂状物被***小叶之间,使得瓣膜小叶关闭并挤压***部件的壁而产生紧密密封。
在某些实施方式中,递送导管包括伸长的护套,其具有大小适于容纳人工装置的腔。在推进通过对象的脉管***的过程中,人工装置以收缩的构造被容纳在护套中。例如,在推进至左心室的过程中,该装置最初被包含在递送护套中,其中锚定部件保持处于径向压缩状态。在一种变体中,递送护套的远端部分被配置用于逆向推进,并可以被配置有可偏转的末端部分,用于促进主动脉弓周围的导向。到达治疗部位后,护套被移至相对人工装置近端,以便从护套中弹出该装置。随后,该装置被允许扩张,使得其***与主动脉瓣内的间隙相符,并且锚定部件与主动脉内壁啮合。
尽管本发明实施方式优选地被配置用于经皮或微创递送方法,但是,在某些情况下,***部件可通过心脏直视外科手术而展开。在这些实施方式中,递送导管可能不是必需的,因为有缺陷的天然瓣膜可被直接进入。
尽管本公开已在具体实施方式和应用方面进行描述,但是本领域普通技术人员根据该教导可以创造出另外的实施方式和修改,而不偏离所要求包含的发明的精神或超出其范围。因此,应当理解,此处附图和描述以实施例的方式提供,以便于对本公开的理解,其不应被理解为限制其范围。
Claims (26)
1.用于改善心瓣膜功能的装置,其包括:
***部件,包括主体,所述***部件被配置用于***所述心瓣膜的小叶之间,其中所述主体包括三个成角度间隔的延伸部分,其从所述***部件的中心部分径向向外延伸,所述延伸部分界定出实体小叶接触表面;和
锚定部件,其与所述***部件连接,所述锚定部件包括支架,其具有开放式框架结构,被配置为可径向压缩到压缩状态用于递送到所述心瓣膜附近的展开部位,并在展开部位可径向扩张到扩张状态。
其中,每个所述小叶接触表面都被配置为,当所述心瓣膜关闭时接触所述心瓣膜的小叶,以最大限度减少通过所述心瓣膜的反流。
2.根据权利要求1所述的装置,其中所述锚定部件被制造成当处于扩张状态时与主动脉内壁相啮合的尺寸。
3.根据权利要求1所述的装置,其进一步包括至少一个间隔物,用于将所述***部件连接至所述锚定部件,所述至少一个间隔物具有足够的长度以允许所述锚定部件在具有***在主动脉瓣中的***部件的主动脉内展开,使得所述锚定部件和***部件位于冠状动脉口的相对侧上。
4.根据权利要求3所述的装置,其中所述至少一个间隔物的长度是至少6mm。
5.根据权利要求1所述的装置,其中所述实体小叶接触表面被配置用于当心瓣膜关闭时接触主动脉心瓣膜小叶,以最大限度减少通过主动脉心瓣膜的反流。
6.根据权利要求1所述的装置,其中每一个所述延伸部分在宽度上是逐渐变细的。
7.根据权利要求1所述的装置,其中所述主体被配置以便可径向压缩到压缩状态,用于递送到心瓣膜附近的所述展开部位,并在所述展开部位可径向扩张到扩张状态。
8.根据权利要求1所述的装置,其中所述支架是自扩张式的。
9.根据权利要求1所述的装置,其中所述支架是球囊扩张式的。
10.根据权利要求1所述的装置,其中所述支架支撑人工瓣膜,用于堵塞经所述支架的一个方向的血流。
11.根据权利要求1所述的装置,其中所述锚定部件由形状记忆合金制造。
12.根据权利要求1所述的装置,其中所述主体包括内部支撑和界定所述小叶接触表面的外层,所述外层包括生物材料,用以当所述心瓣膜小叶接触所述***部件主体上的所述小叶接触表面时,抑制所述心瓣膜小叶的磨损。
13.根据权利要求12所述的装置,其中所述生物材料包括动物心包组织。
14.根据权利要求12所述的装置,其中所述内部支撑包括形状记忆材料。
15.根据权利要求1所述的装置,其中所述***部件的主体部分地延伸进入所述支架。
16.用于改善主动脉瓣功能的装置,其包括:
***部件,包括主体,所述***部件被配置用于***所述主动脉瓣小叶之间,所述主体具有中心部分和三个成角度间隔的臂状物,所述臂状物从所述中心部分径向向外延伸;和
锚定部件,其配置用于固定至心室内部的肌肉壁,所述锚定部件包括至少一个啮合部件,被配置用于啮合所述肌肉壁,
其中,所述锚定部件包括伸长轴,其具有连接到所述***部件的第一末端和连接到所述至少一个啮合部件的第二末端。
17.根据权利要求16所述的装置,其中所述心室是左心室。
18.根据权利要求16所述的装置,其中所述主体具有至少一个逐渐变细的末端区域。
19.根据权利要求16所述的装置,其中所述至少一个啮合部件包括多个可扩张的指状物,其配置用于穿透和啮合心脏肌肉壁。
20.根据权利要求16所述的装置,其中所述至少一个啮合部件包括第一板和第二板,所述第一板和第二板位于心脏肌肉壁的相对侧,其中,所述第一板被安置在心脏腔体内的伸长轴上,所述第二板被安置在心脏腔体外的伸长轴上。
21.用于改善主动脉瓣功能的装置,其包括:
***部件,包括主体,所述主体具有三个成角度间隔的臂状物并径向向外延伸,所述***部件用于在主动脉瓣小叶之间***,所述三个成角度间隔的臂状物被成形为防止通过主动脉瓣的反流;和
可扩张的锚定部件,其与所述***部件相连,所述锚定部件被配置用于在主动脉内展开。
22.根据权利要求21所述的装置,其进一步包括至少一个在所述***部件和所述锚定部件之间延伸的间隔物。
23.根据权利要求22所述的装置,其中所述至少一个间隔物具有足够的长度以允许所述锚定部件在主动脉里展开,而所述***部件在主动脉瓣里展开,使得所述锚定部件和所述***部件位于冠状动脉口的相对侧上。
24.根据权利要求22所述的装置,其中所述至少一个间隔物是伸长杆。
25.根据权利要求21所述的装置,其中所述锚定部件是可扩张的支架,其具有开放式框架结构。
26.根据权利要求22所述的装置,其中所述间隔物包括多个伸长杆,其在所述锚定部件和所述***部件之间延伸并被连接至所述锚定部件和所述***部件。
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CN102283721A (zh) | 2011-12-21 |
CN102283721B (zh) | 2015-08-26 |
US20220023033A1 (en) | 2022-01-27 |
US8968395B2 (en) | 2015-03-03 |
AU2007266448B2 (en) | 2013-07-18 |
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US20160089239A1 (en) | 2016-03-31 |
WO2007140470A2 (en) | 2007-12-06 |
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EP2032080A2 (en) | 2009-03-11 |
US20210015608A1 (en) | 2021-01-21 |
US10799361B2 (en) | 2020-10-13 |
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