CN101969885A - 具有延迟的叶片展开的瓣 - Google Patents

具有延迟的叶片展开的瓣 Download PDF

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CN101969885A
CN101969885A CN2008801252708A CN200880125270A CN101969885A CN 101969885 A CN101969885 A CN 101969885A CN 2008801252708 A CN2008801252708 A CN 2008801252708A CN 200880125270 A CN200880125270 A CN 200880125270A CN 101969885 A CN101969885 A CN 101969885A
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lobe
framework
described lobe
aforementioned
biodegradable adhesive
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P·J·斯托克
J·C·瓦尔克
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Boston Scientific Ltd Barbados
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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
    • A61F2/2427—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
    • A61F2/02—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
    • 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
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • 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
    • 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
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Abstract

一种在身体内腔中使用的瓣(100)，其中所述瓣包括相对于体内植入时间具有延迟的叶片展开的瓣叶片(104)。所述瓣包括瓣框架(102)、联接到瓣框架的瓣叶片(104)。瓣叶片包括：接合处(106)，所述接合处能够可逆地密封，以用于通过瓣的液体的单向流动；和位于瓣叶片和瓣框架之间的生物可降解粘合剂(122)，一旦植入体内，在预定时间内，所述生物可降解粘合剂将瓣叶片的至少接合处保持在相对于瓣框架的静态关系中。

Description

具有延迟的叶片展开的瓣
技术领域
本发明一般涉及一种在身体内腔中使用的瓣(valve)，并且更具体地涉及一种具有瓣叶片(leaflet)的瓣，所述瓣叶片具有相对于体内植入时间延迟的叶片展开(deployment)。
背景技术
心力衰竭快速变成最常见的心血管障碍之一。不幸的是，至今仍未确定用于心力衰竭的最佳治疗。
通常，心力衰竭被分类为由于心脏疾病而形成的综合症，并且在临床上通过由对心脏功能障碍的复杂血循环和神经激素响应产生的不同迹象和症状识别。
心脏的心脏收缩功能和/或心脏舒张功能的一个或两个中的功能障碍可能会导致心力衰竭。例如，左心室心脏舒张功能障碍被识别为导致病态、住院治疗和死亡的情况。左心室心脏舒张功能障碍是心脏的左心室展示减小的功能性的情况。这个减小的功能可能会导致充血性心力衰竭或心肌梗塞，以及心脏血管疾病。
左心室心脏舒张功能障碍的治疗可包括使用药物。尽管有这些治疗，但改善治疗心脏舒张功能障碍的方法仍然是医疗机构的目标。
附图说明
图1示出了本发明的瓣的实施例。
图2A示出了具有本发明的瓣的系统的实施例。
图2B示出了具有本发明的瓣的系统的实施例。
具体实施方式
本发明的实施例涉及一种具有瓣叶片(valve leaflet)的瓣、一种包括该瓣的系统和一种制造和/或使用该瓣的方法。对于实施例，瓣叶片具有相对于瓣的体内植入时间的延时展开(deployment)。对于实施例，延时展开可以通过使用生物可降解粘合剂(例如，生物可降解材料)而实现，其中该生物可降解粘合剂在预定时间内将瓣叶片保持在相对于瓣框架的静态关系。一旦植入体内，生物可降解粘合剂经过预定时间后而降解和/或腐蚀到至少瓣叶片从其相对于瓣框架的静态关系释放的程度。一旦被释放，瓣叶片随后就可以操作，以以基本上单向的方式控制通过瓣的流体的流动。
如这里所使用的那样，术语“一个(a)”、“一个(an)”、“所述”、“一个或多个”和“至少一个”被可互换地使用，并且包括多个指示物，除非在上下文中以其它方式清楚地限定。除非以其它方式限定，所有的科学和技术术语应被理解为具有如它们所属技术领域中常用的相同含义。为了本发明的目的，在整个公开中限定另外的特定术语。
如在这里所使用的那样，“瓣”可以由许多金属、金属合金、生物材料和/或合成材料形成。例如，瓣叶片可以由具有合适的机械和材料性质的一种或多种生物材料(例如，非自体同源材料)和/或合成材料(例如，合成聚合物)形成。此外，瓣框架可以由具有合适的机械和材料性质的合成材料、金属和/或金属合金形成。也可以使用其它材料。在这里将更充分地讨论用于形成瓣的材料。
本发明的瓣可以植入在哺乳动物(例如，人)身体的一个或多个脉管(vessel)中，在所述一个或多个脉管处，期望允许瓣框架首先安置(例如，锚定)在植入点处并且在将瓣暴露到通过瓣叶片的打开和关闭而施加的力之前至少部分地在该植入点向内生长。对于各种实施例，如在这里所讨论的那样，瓣叶片通过使用生物可降解粘合剂而维持它们的“打开”构造(即，它们相对于瓣框架的静态关系)。在这种“打开”构造中，可以最小化通过瓣的纵向剪切应力，从而允许瓣框架安置在植入点处，并且在预定时间内在植入点处向内生长。
如在这里所使用的那样，一个或多个“脉管”可包括：心血管系统的脉管(例如动脉和静脉)，其可以包括冠状和/或外围脉管系统；淋巴系统的脉管；泌尿系统的脉管和/或导管；和/或肾脏系统的脉管和/或导管。用来植入本发明的瓣的哺乳动物身体内的其它脉管部位也是可能的。
本文中的附图遵循这样的编号惯例，其中第一数字或第一多个数字对应于附图编号，而其余的数字表示图中的元件或部件。不同的图之间的类似元件或部件可以通过使用类似数字来标识。例如，110可指示图1中的元件“10”，并且在图2中类似元件可用210来指示。如将理解的那样，可以添加、交换和/或消除在本文中的各种实施例中示出的元件，以便提供瓣和/或系统的任何数量的额外实施例。此外，如将理解的那样，图中提供的元件的比例和相对尺度意在于例示本发明的实施例，而不应当理解为限制性意义。
图中示出了本发明的各种非限制性实施例。通常，瓣可以植入到脉管内，以沿单个方向调节通过身体内腔的体液的流动。
图1示出了瓣100的实施例，所述瓣100包括瓣框架102和联接到瓣框架102的瓣叶片104。如所示的那样，瓣100可以形成有具有接合处106的瓣叶片104，该接合处106能够可逆地密封，用于通过瓣100的液体的单向流动。如在这里所讨论的那样，瓣100的实施例可以具有一个叶片104或多于两个叶片104。
瓣框架102还包括框架构件108，该框架构件108有助于限定内腔110。对于各种实施例，瓣框架102可以具有细长管状结构，该细长管状结构具有近端112和远端114。对于各种实施例，框架构件108的若干部分限定瓣框架102的近端和远端112、114。
瓣叶片104还具有近端116和远端118。如所示的那样，叶片104的近端116可以通过许多不同的技术联接到瓣框架102。例如，可以将形成叶片104的材料120缝合、粘接、胶合或以其它方式固定到瓣框架102，以便形成瓣叶片104的近端116。在一个实施例中，材料120可以在近端112处或邻近近端112的位置处固定到瓣框架102。替代地，材料120可以在位于瓣框架102的近端和远端112、114之间的位置处固定到瓣框架102。对于各种实施例，形成瓣叶片104的材料120可以限定瓣100的内腔110的至少一部分。
如所示的那样，瓣叶片104的远端118包括接合处106，该接合处能够可逆地形成，以控制通过瓣100的流体流动。如在这里所使用的那样，接合处106是可释放地连接且密封以允许通过瓣100的单向流动的瓣叶片104的部位。如所示的那样，接合处106大致邻近瓣叶片104的远端118。
如所示的那样，瓣叶片104处于打开位置。对于各种实施例，可以借助于生物可降解粘合剂122将瓣叶片104以可释放的方式连接而被保持在这个打开位置，使得在瓣已经植入身体的脉管中之后的至少预定时间内，接合处106不帮助防止倒流(retrograde flow)。如在这里所使用的那样，“生物可降解粘合剂”包括当暴露于生物环境(例如，体内)时通过一种或更多种机理化学和/或物理地降解的那些材料。这些机理可包括但不限于生物可降解材料的水解和/或酶裂解(例如，聚合物骨架(backbone)的裂变)。
对于瓣100，生物可降解粘合剂122可以布置在瓣叶片104和瓣框架102之间，以至少将瓣叶片104的接合处106保持在相对于瓣框架102的静态关系中。对于各种实施例，生物可降解粘合剂122最初可以处于液体和/或固体(包括凝胶体)的形式，该液体和/或固体可用于将瓣叶片104连接到瓣框架102。例如，生物可降解粘合剂122可以施加到瓣叶片104和瓣框架102的一个或两个相邻表面，其中使这些表面靠在一起，以通过生物可降解粘合剂122连接它们。用于生物可降解粘合剂122的其它形式也是可能的。
对于各种实施例，使用生物可降解粘合剂122将瓣叶片104保持在打开位置的一个或多个部位和/或表面区域可以从近端116变化到远端118(反之亦然)和/或径向围绕瓣100。例如，生物可降解粘合剂122可以布置成将瓣叶片104保持在叶片104和框架102之间的一个或多个离散的连接点处。在另外的例子中，生物可降解粘合剂122可以布置成完全沿瓣框架102的远端114保持至少瓣叶片104。换句话说，生物可降解粘合剂122能够可释放地沿着瓣叶片104到瓣框架102的外围边缘将瓣叶片104的至少一部分连接到瓣框架102。对于各种实施例，可释放地将瓣叶片104的外围边缘的所述部分连接到瓣框架102包括可释放地将外围边缘整体连接到瓣框架102。替代地，可释放地将瓣叶片104的外围边缘的所述部分连接到瓣框架102可以是在与瓣框架102的纵向轴线等距间隔开的连接点处。对于这些实施例，在植入到身体的内腔中之后的预定时间内，生物可降解粘合剂122可以将至少瓣叶片104的接合处106保持在相对于瓣框架102的静态关系中。
对于各种实施例，生物可降解粘合剂122可以布置在瓣叶片104的外表面(与内腔表面相对)和框架构件108之间。此外，生物可降解粘合剂122可以位于瓣叶片104的基本上整个外表面的上，以允许生物可降解粘合剂122跨越(span)框架构件108限定的开口。
对于各种实施例，用于将瓣叶片104保持在打开位置的生物可降解粘合剂122的一种或多种浓度、类型和/或混合物(例如，两种或更多种不同的生物可降解粘合剂与其它可任选物质一起)也可以变化。如在这里所使用的那样，术语“浓度”包括混合物和/或形成粘合剂的溶液中的每一种生物可降解粘合剂的量(例如，按照重量)。
对于各种实施例，选择一种或多种生物可降解粘合剂、它们的浓度和/或它们的用于保持瓣叶片104相对于瓣框架102静止的位置能够允许瓣叶片104以多种方式从瓣框架释放。例如，生物可降解粘合剂122可以以允许瓣叶片104从瓣框架102的近端112和/或远端114中的一个渐进地释放的方式使用。在一种方法中，这可以通过以下途径实现：改变一种或多种生物可降解粘合剂122的浓度和/或使生物可降解粘合剂122具有从瓣框架102的近端112和/或远端114中的一个或两个端部延伸的梯度。
替代地，可以以允许每一个瓣叶片104基本上在相同的时间基本上全面地从它们的静态关系释放的方式来选择一种或多种生物可降解粘合剂122、它们的浓度和/或它们的位置。例如，不同类型的生物可降解粘合剂122可以用于不同的区域(例如，离散的区域)，以便允许瓣叶片104的渐进释放。
对于各种实施例，生物可降解粘合剂的类型可以包括但不限于腐蚀(例如，生物可腐蚀或生物可降解)以便被身体吸收的那些化合物。如在这里所使用的那样，“腐蚀”或“侵蚀”包括这样的过程，通过该过程，在水中不能溶解的材料转化为在水中能溶解的材料。其它类型的生物可降解粘合剂可以包括各种各样的生物可降解的天然的、合成的和生物合成的聚合物，诸如具有至少含杂原子的聚合物骨架的那些聚合物。这些生物可降解粘合剂可以包括具有化学键的那些粘合剂，尤其诸如酐、酯或酰胺结合。然后，这些化学键可以通过水解和/或酶裂解的一个或两个而经历降解，导致聚合物骨架的裂变。
生物可降解粘合剂122的例子是包括基于聚交酯(PLA)、聚乙交酯(PGA)、聚己酸内酯(PCL)及它们的共聚物的聚(酯)的那些粘合剂。其它的生物可降解粘合剂122可以包括这些粘合剂，其具有PHB-PHV类的聚(羟基脂肪酸酯)、另外的聚(酯)和天然聚合物(诸如改性的聚(糖化物)，例如淀粉、纤维素和壳聚糖)它们在进一步水解后能够获得低分子量的低聚糖。聚(环氧乙烷)、PEO和/或聚(乙二醇)、PEG也可以用作生物可降解粘合剂。聚(环氧乙烷)(PEO)和聚(丁二醇酯)(PBT)的多嵌段共聚物也可以用在本发明的生物可降解粘合剂中，其中可以通过PEO分子量和含量影响降解速率。
对于各种实施例，在植入到身体内腔中之后的预定时间内，生物可降解粘合剂122可以将至少瓣叶片104的接合处106保持在相对于瓣框架102的静态关系中。对于各种实施例，由于对于各个患者，生物可降解粘合剂122的降解将很有可能以不同的速率进行，因此植入之后的预定时间可以是估计时间的范围。因而，用于任何特定的瓣100的生物可降解粘合剂122的一种或多种类型、一种或多种浓度和/或一个或多个位置对患者和/或植入位置是特有的。
例如，生物可降解粘合剂122可以在不少于一周(即7天)内保持瓣叶片104的至少一部分相对于瓣框架102静止。在这个预定时间之后，生物可降解粘合剂122可以已经降解和/或腐蚀到生物可降解粘合剂122不再能够保持瓣叶片104的至少一部分相对于瓣框架102静止的程度。然后，从瓣框架102的具有生物可降解粘合剂122的部分释放瓣叶片104。在被释放之后，瓣叶片104随后可以操作，从而以基本上单向的方式控制通过瓣的流体(例如，血液)的流动。
对于各种实施例，所述预定时间还允许瓣框架102在将瓣100暴露于通过瓣叶片104的打开和关闭而施加的力之前至少部分地在植入点(例如，锚定)向内生长。在一个实施例中，瓣框架102可以具有促进和/或阻碍周围组织的向内生长和/或过度生长的一个或多个表面处理和/或涂层。例如，瓣框架102可以具有一个或多个表面处理和/或涂层，该表面处理和/或涂层促进组织在瓣叶片104的不利用生物可降解粘合剂122连接到瓣框架102的瓣100的区域中向内生长。类似地，生物可降解粘合剂122连接瓣叶片104和瓣框架102的区域可以包括一个或多个表面处理和/或涂层，该表面处理和/或涂层至少在生物可降解粘合剂122降解和/或腐蚀所花费的时间内阻碍周围组织的向内生长和/或过度生长。
对于各种实施例，生物可降解粘合剂122和/或瓣框架102也可以具有预定的结构和/或形状，所述预定的结构和/或形状允许瓣100的组织向内生长，同时在瓣叶片104处于其相对于瓣框架102的静态关系时防止在瓣叶片104周围向内生长。例如，布置在瓣叶片104和瓣框架102之间的生物可降解粘合剂122可以具有这样的部分或层，所述部分或层的孔隙度促进和/或允许组织向内生长，而生物可降解粘合剂122的相邻部分可以不设计成促进这种向内生长。换句话说，生物可降解粘合剂122可以具有分层结构，在该分层结构中，由于生物可降解粘合剂122的物理结构和/或形态，不同的层和/或区域可以潜在地促进来自身体的不同的向内生长响应。替代地，为了设法引起在这里讨论的向内生长响应，不同类型的生物可降解粘合剂122可以用于具有相同和/或不同形态(例如，诸如多孔的结构)的层和/或图案。
在一些实施例中，瓣框架102的框架构件108可以由各种材料形成。这些材料包括但不限于金属、金属合金和/或聚合物。瓣框架102的设计和构造可以使得它是可以通过气囊膨胀(完全地或至少部分地)和/或自膨胀形状记忆材料。形状记忆材料的例子包括插在身体内的形状记忆的塑料、聚合物、热塑性材料和金属合金。一些形状记忆材料(例如，镍钛合金)可以是温度敏感的，并且在指定的温度或温度范围内改变形状。在一个实施例中，形状记忆金属合金包括通常称为镍钛记忆合金的由镍和钛以特定的比率制成的那些合金。其它材料也是可以的。
对于各种实施例，框架构件102沿它们的长度可以具有类似和/或不同的横截面几何形状。可以基于要从瓣框架102的每个部分得出的一个或多个期望的功能来选择横截面几何形状的类似性和/或差异。横截面几何形状的例子包括矩形、非平面构造(例如，弯曲的)、圆的(例如，圆形的、卵形的和/或椭圆形的)、多边形的、拱形的和管状的。其它横截面几何形状是可以的。
瓣100还可以包括一种或多种不透射线的标记(例如，突出部、衬套、焊接)。例如，瓣框架102的一个或多个部分可以由不透射线的材料形成。不透射线标记可连接到和/或涂覆到沿瓣框架102的一个或多个位置上。不透射线的材料的例子包括但不限于金、钽和铂。一个或多个不透射线标记的位置可以选择成在瓣100的植入期间提供关于瓣100的位置、部位和定向的信息。
瓣100还包括瓣叶片104，该瓣叶片104具有限定能够可逆地密封的开口(例如，接合处106)的多个表面，所述开口用于液体通过瓣100单向流动。每一个瓣叶片104都联接到瓣框架102，其中，在生物可降解粘合剂122已经降解且/或腐蚀到瓣叶片104从它们的与瓣框架102的静态关系被释放的程度之后，瓣叶片104可以在打开状态和关闭状态之间重复运动，用于液体通过瓣100的内腔单向流动。在本例子中，瓣100包括用于双叶片构造的瓣叶片104中的两个。如能够理解的那样，单叶片、三叶片和/或其它多个叶片构造也是可以的。
在一些实施例中，叶片104可以由自体同源的、异源的或异种移植的材料得到。如将理解的那样，用于异种移植的材料的源(例如，贲门瓣)包括但不限于诸如猪、马和羊的哺乳动物源。形成瓣叶片104的另外的生物材料包括但不限于移植的静脉、心包膜、面部突变体(facialata)、收获的贲门瓣、膀胱、静脉壁、各种胶原类型、弹性蛋白、肠黏膜下层(intestinal submucosa)和脱细胞基膜材料，诸如小肠黏膜下层(SIS)、羊膜组织或脐静脉。
替代地，叶片104可以由合成材料形成。可能的合成材料包括但不限于：膨体聚四氟乙烯(ePTFE)、聚四氟乙烯(PTFE)、聚苯乙烯-聚异丁烯-聚苯乙烯(SIBS)、聚氨酯、嵌段聚(碳酸盐-尿烷)、聚酯、聚乙烯(PE)、聚对苯二甲酸乙二醇酯(PET)、丝绸、尿烷、人造纤维、硅树脂或类似物。在另外的实施例中，合成材料还可以包括金属，诸如不锈钢(例如，316L)和镍钛诺。这些合成材料可以是纺织的、编织的、铸造的或其它已知物理的流体不可渗透或可渗透的构造。此外，镀金金属可以嵌入到叶片104的材料中(例如，夹层结构)，以允许叶片104在放置后可视。
如将理解的那样，可以通过任意数量的表面或材料处理来处理和/或涂覆瓣100(例如，瓣框架102和/或瓣叶片104)。这些处理的例子包括但不限于生物活性剂，包括调节血栓形成的那些、促进细胞向内生长、贯穿生长(through-growth)和内皮化的那些、抵抗感染的那些、抗血栓形成(anti-thromobogenic)涂层和减小钙化的那些。用于至少瓣框架102的适合的涂层的一个例子是由Boston Scientific以商标Taxus
Figure BPA00001185027300091
提供的支架框架涂层。
现在参考图2A-2B，图中示出了根据本发明的系统230的不同的实施例。对于每个系统230，存在如在这里描述的至少一个瓣200，所述瓣至少部分地布置在细长递送导管232上。如所示的那样，细长递送导管232可以包括用来容纳和穿过导丝236的导丝内腔234。
图2A中示出的系统230的实施例还包括可膨胀气囊238，该可膨胀气囊绕细长递送导管232的至少一部分布置，并且其中瓣200至少部分地布置在可膨胀气囊238上。对于这个实施例，细长递送导管232还包括膨胀内腔240，该膨胀内腔从膨胀端口242到可膨胀体积贯穿细长递送导管232，该可膨胀体积至少部分地由可膨胀气囊238和细长递送导管232限定。然后，通过膨胀端口242在压力下被递送的流体可以用于膨胀可膨胀气囊238，由此至少部分地或完全地将瓣200递送到期望部位。
在一些实施例中，可膨胀气囊238可以是灌注气囊。当瓣200布置在脉管系统中时，灌注气囊可以用于径向膨胀瓣200的瓣框架，同时允许例如血液的流体穿过递送导管232和瓣200。
在替代实施例中，图2B示出了系统230，该系统230包括绕细长递送导管232的至少一部分布置的能够缩回的护套250。此外，瓣200的至少一部分可以布置在细长递送导管232和能够缩回的护套250之间，以将瓣200保持在递送状态。例如，图2B示出了这样的实施例，其中能够缩回的护套250绕递送导管232的至少一部分布置，以能够释放地保持瓣200处于它的被压缩的递送(即未递送的)状态。能够缩回的护套250可以缩回，以允许瓣200从细长递送导管232径向膨胀，其中瓣框架202至少部分地由诸如镍钛记忆合金的形状记忆材料形成。
替代地，瓣框架202可以由带弹簧偏压的材料形成，其中，当护套250已经被移除时，瓣200可以膨胀。具有弹簧偏压的材料的例子可以包括但不限于医用等级的不锈钢(例如，316L)、钛、钽、铂合金、铌合金、钴合金、藻酸盐或它们的组合。
在一个实施例中，能够缩回的护套250可以与细长递送导管232共轴地延伸，其中护套250能够相对于细长递送导管232纵向地运动(例如，滑动)，以允许瓣200从其递送状态径向膨胀到其展开状态。在一些实施例中，使能够缩回的护套250相对于递送导管232运动可以通过相对于递送导管232的近端258拉动护套250的近端256来实现。
如图2A和2B中所示，瓣200也示出了本发明的实施例，其中生物可降解粘合剂可以用于将瓣叶片204保持在到瓣框架202的一个或多个离散连接点254处。如所示的那样，瓣叶片的外围边缘的多个部分可以在与瓣框架的纵向轴线260等距间隔开的多个连接点处能够释放地连接到瓣框架。
如如图2A和2B中示出的被压缩的状态下，当瓣框架202处于绕可膨胀气囊238被径向压缩的状态或被压缩在能够缩回的护套250和细长导管232之间时，在一个或多个离散连接点254处将瓣叶片204连接到瓣框架202允许瓣叶片204的接合处206的至少一部分向着纵向轴线260聚集。
在另外的实施例中，所述系统可以包括细长递送导管和绕能够缩回的护套布置的可膨胀气囊两者。瓣框架可以是至少部分地自膨胀的(或者完全自膨胀的)，其中缩回护套允许瓣从其递送状态向着其展开状态膨胀。然后，可膨胀的气囊可以用于在期望的植入部位完全展开、固定和/或更完全地安置瓣框架。
递送导管232和/或可缩回的护套250中的每一个都可以由许多材料形成。这些材料包括聚合物，诸如PVC、PE、POC、PET、聚酰胺、它们的混合物和嵌段共聚物。此外，递送导管232和/或可缩回的护套250中的每一个都可以具有足以允许结构如在这里描述的那样相对于彼此纵向滑动且如在这里论述的那样将瓣200维持在递送状态的壁厚度和内径。
在另外的实施例中，本发明的瓣200可以包括连接到瓣框架或框架构件的锚定构件。锚固构件可以包括倒刺、钩等。
对于各种实施例，本发明的瓣可以用于已经被诊断出具有某些形式的心力衰竭的患者，诸如具有基本上正常的射血分数但显示心力衰竭的迹象和症状的那些患者。例如，在处理左心室(LV)舒张功能障碍时，改善左心房(LA)心脏收缩可以有助于填充僵硬左心室(虽然不是完全地，这是由于血液倒流回到肺静脉循环中)。本发明的瓣在植入在肺静脉与LA相遇的连接处时能够有助于改善LA心脏收缩对LV心脏舒张填充的贡献。潜在地，在心脏舒张期间，这些瓣将帮助改善在将大得多的百分比的血液向前输入到LV时由LA心脏收缩所完成的工作。
此外，布置如在这里论述的具有瓣的系统包括使用微创经皮或经腔技术将该系统引入到患者的心脏血管系统中。例如，导丝可以布置在患者的包括预定部位的心脏血管系统内。包括如在这里描述的瓣的本发明的系统可以布置在导丝上，并且该系统前进，以便将瓣布置在预定部位处或预定部位附近。在一个实施例中，如在这里所描述的那样，导管和/或瓣上的不透射线标记可以用于帮助定位和布置瓣。
如在这里所描述的那样，瓣可以以许多种方式从该系统在预定部位处展开。在一个实施例中，本发明的瓣可以展开并放置在任何数量的心脏血管部位中。例如，瓣可以展开并放置在患者的动脉和/或静脉(例如，肺静脉)内。在一个实施例中，患者的动脉和/或静脉包括外围脉管系统和/或心脏脉管系统的那些动脉和/或静脉。例如，本发明的一个或多个瓣到肺静脉的递送可以通过从右心房到左心房中的经中隔刺穿而实现。此外，瓣的实施例具有用于期望对流体运动进行更严格地控制的许多不同脉管(例如，泌尿和/或淋巴)的可能。其它部位也是可能的。
瓣的递送可以通过许多不同的植入技术来实现。例如，本发明的瓣可以通过使用经皮递送技术而植入，其中，如在这里论述的那样，瓣可以借助于递送导管而布置在预定部位处。然后，瓣可以在预定部位处从递送导管展开。然后，可以从预定部位移除导管。
该瓣一旦植入后就维持其打开的内腔构造，其中，在移除递送导管后，瓣叶片的近端部和远端部保持在相对于瓣框架的静态关系中。换句话说，如在这里论述的那样，一个或多个瓣叶片通过使用生物可降解粘合剂而保持在它们的“打开”位置。一旦植入，生物可降解粘合剂就暴露于体液(例如，血液)，在预定时间之后，所述体液导致生物可降解粘合剂降解和/或腐蚀到瓣叶片从其相对于瓣框架的静态关系释放的程度。
然而，在预定时间期间，打开的内腔构造允许通过瓣的不受控制的血液流动。由于瓣叶片不打开和关闭以用于通过瓣的单向流动，因此保持瓣叶片以产生这种打开的内腔构造允许瓣框架上的纵向剪切应力在预定时间期间最小化。在这个预定时间期间，组织可以绕瓣框架向内生长。在预定时间期间，通过使用诸如在这里讨论的那些涂层和/或表面处理，可以促进该组织向内生长。
虽然在上文中已经详细示出并描述了本发明，但是对于本领域技术人员清楚的是，在不背离本发明的精神和范围的前提下，可以作出改变和修改。因此，在前面描述和附图中阐述的内容仅以例示的方式给出，并且不作为限制。本发明的实际范围意图由所附权利要求连同这种权利要求所给予的等同物的全部范围一起限定。此外，本领域技术人员在阅读和理解本发明的情况下将理解，在这里描述的本发明的其它变型可以被包括在本发明的范围内。
在前述具体实施方式中，为了组织本发明，各种特征在若干个实施例中集中在一起。本发明的这个方法不解释为反映本发明的实施例需要比在每个权利要求中明确列举的更多的特征的意图。更确切地，如以下权利要求所反映的那样，发明主题在于少于单个公开的实施例的所有特征。因此，所附权利要求由此结合到具体实施方式中，其中每个权利要求独立地作为分离的实施例。

Claims (25)

1.一种瓣(100，200)，包括：
瓣框架(102，202)；
联接到所述瓣框架(102，202)的瓣框架(104，204)，其中所述瓣框架(104，204)包括接合处(106，206)，所述接合处能够可逆地密封，以用于通过所述瓣(100，200)的液体的单向流动；和
位于所述瓣框架(104，204)和所述瓣框架(102，202)之间的生物可降解粘合剂(122)，所述生物可降解粘合剂用于将所述瓣框架(104，204)的至少接合处(106，206)保持在相对于所述瓣框架(102，202)的静态关系中。
2.根据前述权利要求中的任一项所述的瓣(100，200)，其中，所述生物可降解粘合剂(122)在一个或多个离散连接点(254)处保持所述瓣框架(104，204)，以将每个瓣框架(104，204)保持在相对于所述瓣框架(102，202)的所述静态关系中。
3.根据前述权利要求中的任一项所述的瓣(100，200)，其中，所述瓣框架(102，202)包括远端(114)，并且其中所述生物可降解粘合剂(122)沿所述瓣框架(102，202)的所述远端(114)完全保持所述瓣框架(104，204)。
4.根据前述权利要求中的任一项所述的瓣(100，200)，其中，在植入到身体内腔中之后的预定时间内，所述生物可降解粘合剂(122)将所述瓣框架(104，204)的至少接合处(106，206)保持在相对于所述瓣框架(102，202)的所述静态关系中。
5.根据前述权利要求中的任一项所述的瓣(100，200)，还包括在所述瓣框架(102，202)处于径向压缩的状态时允许所述瓣框架(104，204)的接合处(106，206)的至少一部分向着纵向轴线(260)聚集。
6.根据前述权利要求中的任一项所述的瓣(100，200)，其中，所述瓣框架(104，204)包括抗血栓形成涂层。
7.根据前述权利要求中的任一项所述的瓣(100，200)，其中，一旦在体内不少于一周的预定时间内，所述生物可降解粘合剂(122)保持所述瓣框架(104，204)的至少一部分相对于所述瓣框架(102，202)静止。
8.一种瓣(100，200)，包括：
瓣框架(102，202)；
联接到所述瓣框架(102，202)的瓣框架(104，204)，其中所述瓣框架(104，204)包括接合处(106，206)和抗血栓形成涂层，所述接合处能够可逆地密封，以用于通过所述瓣(100，200)的液体的单向流动；和
位于所述瓣框架(104，204)和所述瓣框架(102，202)之间的生物可降解粘合剂(122)，在植入到身体内腔中之后的不少于一周的预定时间内，所述生物可降解粘合剂将所述瓣框架(104，204)的至少接合处(106，206)保持在相对于所述瓣框架(102，202)的静态关系中。
9.一种系统，包括：
细长递送导管(232)(232)；和
瓣(100，200)，所述瓣至少部分地布置在所述细长递送导管(232)(232)上，其中所述瓣(100，200)包括：
具有限定内腔的框架构件的瓣框架(102，202)；
连接到所述瓣框架(102，202)的一部分的瓣框架(104，204)，
所述瓣框架(104，204)具有接合处(106，206)；和
位于所述瓣框架(104，204)和所述瓣框架(102，202)之间的生物可降解粘合剂(122)，所述生物可降解粘合剂将所述瓣框架(104，204)的至少接合处(106，206)保持在相对于所述瓣框架(102，202)的静态关系中。
10.根据前述权利要求中的任一项所述的系统，其中，所述细长递送导管(232)(232)包括绕所述细长递送导管(232)(232)的至少一部分布置的能够膨胀的气囊(238)，并且其中所述瓣(100，200)至少部分地布置在所述能够膨胀的气囊(238)上。
11.根据前述权利要求中的任一项所述的系统，其中，所述细长递送导管(232)(232)包括布置在所述瓣(100，200)的至少一部分上的能够缩回的护套(250)，其中所述能够缩回的护套(250)能够缩回，以从所述细长递送导管(232)(232)释放所述瓣(100，200)。
12.根据前述权利要求中的任一项所述的系统，其中，所述生物可降解粘合剂(122)在一个或多个离散的连接点(254)处将所述瓣框架(104，204)保持到所述瓣框架(102，202)上。
13.根据前述权利要求中的任一项所述的系统，其中，所述瓣框架(102，202)包括远端(114)，并且其中所述生物可降解粘合剂(122)沿所述瓣框架(102，202)的远端(114)完全保持所述瓣框架(104，204)。
14.一种方法，包括：
形成瓣(100，200)，所述瓣具有瓣框架(102，202)和瓣框架(104，204)，所述瓣框架具有接合处(106，206)；和
借助于生物可降解粘合剂(122)，将所述瓣框架(104，204)的至少一部分能够释放地连接到所述瓣框架(102，202)，使得在所述瓣(100，200)植入到身体的脉管中之后的至少预定时间内，所述接合处(106，206)不帮助防止倒流。
15.根据前述权利要求中任一项所述的方法，其中，将所述瓣框架(104，204)的至少一部分能够释放地连接到所述瓣框架(102，202)包括将所述瓣框架(104，204)的外围边缘的至少一部分能够释放地连接到所述瓣框架(102，202)。
16.根据前述权利要求中任一项所述的方法，其中，将所述瓣框架(104，204)的外围边缘的所述部分能够释放地连接到所述瓣框架(102，202)包括在与所述瓣框架(102，202)的纵向轴线(260)等距间隔开的连接点(254)处能够释放地连接所述外围边缘和所述瓣框架(102，202)。
17.根据前述权利要求中任一项所述的方法，还包括当所述瓣框架(102，202)处于径向压缩的状态时，允许所述瓣框架(104，204)的外围边缘的至少一部分向着纵向轴线(260)聚集。
18.根据前述权利要求中任一项所述的方法，其中，将所述瓣框架(104，204)的外围边缘的所述部分能够释放地连接到所述瓣框架(102，202)包括将所述外围边缘整体地能够释放地连接到所述瓣框架(102，202)。
19.根据前述权利要求中任一项所述的方法，包括：利用促进至少组织向内生长的涂层至少部分地涂覆所述瓣框架(102，202)；和
利用抗血栓形成涂层至少部分地涂覆所述瓣框架(104，204)。
20.一种方法，包括：
借助于递送导管(232)，将瓣(100，200)布置在预定部位处，所述瓣(100，200)包括瓣框架(104，204)和瓣框架(102，202)，所述瓣框架具有近端(112)部分和相对于所述近端(112)部分的远端(114)部分；
在所述预定部位处借助于所述递送导管(232)展开该瓣(100，200)；
从所述预定部位移除所述递送导管(232)；
在移除所述递送导管(232)之后，将所述瓣框架(104，204)的近端(112)部分和远端(114)部分保持在相对于所述瓣框架(102，202)的静态关系中，以允许血液不受控制地流过所述瓣(100，200)；和
在预定时间之后，允许所述瓣框架(104，204)从其静态关系释放。
21.根据前述权利要求中的任一项所述的方法，其中，将所述瓣(100，200)布置在所述预定部位处包括将所述瓣(100，200)布置在肺静脉中。
22.根据前述权利要求中的任一项所述的方法，其中，保持所述瓣框架(104，204)包括在不小于一周的时间间隔内将生物可降解粘合剂(122)至少部分地保持在所述瓣框架(104，204)和所述瓣框架(102，202)之间。
23.根据前述权利要求中的任一项所述的方法，其中，允许所述瓣框架(104，204)从其静态关系释放包括将所述生物可降解粘合剂(122)暴露于引起所述生物可降解粘合剂(122)降解的体液。
24.根据前述权利要求中的任一项所述的方法，其中，保持所述瓣框架(104，204)包括在所述预定时间期间最小化所述瓣框架(102，202)上的纵向剪切应力。
25.根据前述权利要求中的任一项所述的方法，包括在所述预定时间期间，促进组织绕所述瓣框架(102，202)向内生长。
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CA2709355C (en) 2016-04-12
US8137394B2 (en) 2012-03-20
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US20120165927A1 (en) 2012-06-28
US20110118831A1 (en) 2011-05-19
US7892276B2 (en) 2011-02-22
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