CN101155567A - 具有复合结构的血管塞 - Google Patents

具有复合结构的血管塞 Download PDF

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CN101155567A
CN101155567A CNA2006800026378A CN200680002637A CN101155567A CN 101155567 A CN101155567 A CN 101155567A CN A2006800026378 A CNA2006800026378 A CN A2006800026378A CN 200680002637 A CN200680002637 A CN 200680002637A CN 101155567 A CN101155567 A CN 101155567A
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R·S·吉恩
T·J·帕勒莫
P·奥尔森
T·哈特里奇
A·施弗利
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Ensure Medical Inc
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Abstract

本发明涉及用于密封血管穿刺部位的器件和方法，特别是作为导管插入或其它插入过程的结果的穿刺部位。在若干优选实施例中，该密封器件包括一个密封构件和一系绳。该密封构件通常起到占据切口、穿刺、或其它伤口的空间的作用并密封它所占据的切口、穿刺、或伤口的空间，以防止血再流。该系绳典型地以某种方式附着到密封构件上，同时如果需要给使用者提供拉出密封构件的可能性。在一个特别优选的形式中，该密封器件还包括一个限制性构件，它还提供更可靠地限制密封构件的可能性，以防止它从组织区域内的展开位置移动。

Description

具有复合结构的血管塞
发明领域
本发明总的涉及密封或闭合经过组织的通道的器件和方法，同时更具体地涉及密封与诸如血管的体腔沟通的穿刺或其它开口。
发明背景
导管插入术和插入过程，诸如血管成形术或扩张，通常是由将一根空心针经病人的皮肤和肌肉组织插入到血管系统中来完成。然后一根引导线可以穿过针腔进入病人的由针进入的血管。可以除去该针，同时一个引入器鞘可以在引导线上面进入血管，例如，连同或在扩张器之后。然后导管或其它装置经引入器鞘腔并在引导线上面推进到一个位置以完成医疗过程。因此，该引入器鞘可以便于各种装置引入到血管中，同时在过程当中最小化外伤血管壁和/或最小化血液损失。
在过程完成时，可以去除装置和引入器鞘，在血管壁中留下穿刺部位。在凝结和伤口密封出现之前外压力可能作用到穿刺部位。但是，这一过程可能费时和昂贵，需要医生或护士的一小时的时间。对病人也不舒服，并要求病人在手术室中、导管实验室中、或观察区保持不动。此外，在止血出现之前存在血肿的危险。
对于通过闭合穿刺部位经皮肤的密封血管的穿刺已经提出多种装置。例如，授予Kensey等的美国专利NO.5192302和5222974介绍了可以经过一个引入器鞘放入穿刺部位的可生物降解塞的使用。当使用时，该塞子可以密封血管并提供止血。但是，这种装置可能难以正确地相对血管定位，这一点特别重要因为通常不希望在血流内暴露塞子的材料，例如胶原蛋白，在该处可能抖动下游和导致栓塞的危险。
曾经提出涉及经皮肤的缝合穿刺部位的另一种技术，诸如授予Hathaway等的美国专利NO.5304184所公开的。但是，经皮肤的缝合器件可能要求使用者的有效的技术，同时可能是机械的复杂且制造昂贵。
也曾经提出U型钉和手术卡子用以封闭伤口或组织中的其它开口。例如，授予Brown的美国专利NO.5007921和5026390公开了可用于封闭伤口或切口的U型钉。在一个实施例中，公开了“S”形的钉子，它包括可以被结合到伤口任一侧上的组织的倒刺。在另一实施例中，公开了环形钉，它包括从环凸出的倒刺。但是，这些钉子具有大的横截面轮廓因此不易于经皮肤的部位送进以封闭血管壁的开口。
授予Lee的美国专利NO.6033427公开了一种密封内穿刺部位的方法和器件，在一个实施例中，该方法使用一个双腔血回流系统，在该系统中远端血回流部分轴向地彼此隔开，这样当填塞器处于某个位置时，将经过一个腔回流血，而不经过另一个腔。
此外，曾经建议皮肤的密封可以穿入皮肤的开口中，例如，授予Rudd等的美国专利NO.5645565公开一种手术塞，它可以拧入穿刺以密封该穿刺。该手术塞包括一个扩大的帽和从帽延伸的穿线杆。在内窥镜检查过程中，塞子可以经皮肤穿入开口中直到该帽咬合皮肤的表面。该塞子试图密封与体腔沟通的开口以防止吹入剂流体从体腔泄漏。但是，这种塞子仅能用于皮肤的表面，同时不能经组织被引入，例如，以密封血管壁中的开口或其它皮下区域。
已经提出各种为确定闭合器件远端位置的方法和器械，包括“血液回流”方法，诸如在授予Magro等的美国专利NO.4738658中公开的。但是，现今的血液回流器械构造成病人流出的血在使用该密封器械过程中要持续一个比所要求的更长的时间。
在出版的美国专利申请2004/0019330中公开了血液回流技术的进一步发展，其中具有的扩大的远端的控制元件用于控制经血管穿刺部位的血流以及通过从进入血管壁中的穿刺的血管腔抽出扩大的远端以提供引入器鞘的远端位置的指示二者，这样，根据此出版的申请，血液回流停止。
Leschinsky专利NO.5871501公开了引导线上的钩子的使用以提供血管壁位置的指示以有助于止血材料的放置以阻止血液流出血管中的穿刺。
虽然已提出这些和其它使用塞子以防止血液从血管的穿刺流动的方法和器件，但是为此目的使用塞子，以及对于更容易使用的和提供改善的防止血流的塞子仍然需要安全和有效的器件和方法。
发明概述
本发明指向用于密封切口和/或血管穿刺的改进的血管密封器件，并指向使用该器件的方法，血管密封器件对于密封由导管插入或插入过程造成的切口和穿刺是特别有用的，诸如血管成形术或扩张。虽然它们不局限于这些使用。这些切口和穿刺通常是对股骨动脉进行的，同时此处描述的器件特别适用于这些目的。但是，应该理解这些器件特别也可用于密封在其它血管或组织的切口和/或穿刺。
在几个优选实施例中，该密封器件包括一个密封构件和系绳。该密封器件通常完成占据切口、穿刺、或其它伤口中空间的功能并密封它占据的切口、穿刺、或伤口中的空间以防止进一步的血液流动。该系绳典型地以某种方式附着到密封构件并且如果需要的话提供使用者拉出密封构件要可能性。在某些实施例中，系绳还提供使用者为要求的效果操纵该密封构件的可能性，诸如在切口内径向膨胀密封构件。在特别优选的形式中，该密封器件还包括一个与密封构件相关的限制性构件。该限制性构件提供更可靠地约束构件密封的可能性以防止它从组织区域内的使用位置移动。该约束构件可以提供在使用之后操纵密封构件的附加功能。
在几个优选实施例中，还希望当使用密封构件并暴露在来自目标血管的血流中时具有密封构件材料的膨胀。此膨胀可以造成密封构件，并因此密封器件，在使用时径向膨胀并因而更牢固地咬合组织，因此趋于防止密封器件的移动以及增加密封的效果。
根据打算使用的特性、制造该器件的材料、以及其它因素该密封器件可以采取许多不同型式与形状的任意一种。例如，密封器件可以采取不确定的团状形状，在这种情况中密封器件的尺寸和/或形状不是重点或者器件的密封部分由约束部分来限制。在另外的例子中密封器件采取圆盘的形状，它适合于占据切口或穿刺伤口。其它例子包括多圆盘密封构件，以及一对圆盘起到端帽的作用以分开管形构件。还是另外的例子包括实心或辊状管予以及一个机械的花。其它和另外的形状是可能的，如同是这些形状和尺寸的任意组合。
最好是，系绳附着到密封构件并适合于近似地从密封构件延伸，经过并穿出切口，因而允许由使用者操纵。在它展开之后可以使用系绳以调节密封构件，诸如通过增加密封构件的有效径向尺寸，或者如果需在的话与密封构件一起除去。
在几个优选的实施例中，密封器件具有复合的结构，如上所述，它包括一或几个密封构件，和一或几个限制性构件。最好是，该限制性构件提供更易发送密封构件的能力以及降低密封构件在其展开之后将移动的可能的能力。在一个特殊优选的型式中，限制构件包括一个编织的“短袜”，它包围密封构件并允许密封构件更容易地发送到切口区域。
在几个优选实施例中，密封构件、限制性构件、以及血管密封器件的系绳最好由生物可吸收的材料构成，诸如胶原蛋白、聚二醇酸(PGA)、聚丙交酯(PLA)、水凝胶、或凝胶泡沫。这些材料可以固态、凝胶、毡、或其它型式提供。诸如羟脯氨酰纤维素(HPC)水凝胶的这些水凝胶由于它们的几个物理性能特别优选用于制造密封构件。特别是，水凝胶是高的吸附剂并且在吸附大量的液体后展现高的机械强度。
在几个可选的实施例中，如上所述，该密封器件具有复合结构，它包括一或几个密封构件，和一或几个限制性构件。在几个可选择的实施例中，密封构件或限制性构件由非生物可吸收的材料构成，而其它构件由生物可吸收的材料构成。因此，在几个可选的实施例中，生物可吸收的密封构件可以与非生物可吸收的限制性构件相关联，或者非生物可吸收的密封构件与生物可吸收的限制性构件相关联。适合在密封构件或限制性构件中使用的非生物吸收的材料包括尼龙、不锈钢、陶瓷材料、钛、金、铂、镍、镍-钛合金、其它金属和金属合金、以及其它适合于医用的普通材料。例如，限制性构件可以由尼龙网、或尼龙网的或不锈钢细丝编织物构成。
此处描述的血管密封器件可以被任何适合的机构使用。在题为“Locator and Delivery Device and Method of Use”，美国专利申请系列NO.10/850795，2004年5月21日提出的，授予Ensure Medical，Inc.(此处的受让人)的专利中介绍了在由导管插入或插入过程产生的切口中特别适合于使用这种器件的一种这种机构。前述申请通过参考其全部内容被包括，如此处所述。
此处的描述特别指向密封在导管插入或插入过程中产生的穿刺伤口，特别是股骨动脉中的这种伤口，但是应该理解本发明的血管密封器件可以被用到它们中的其它血管和穿刺伤口。以那种理解，我们转向优选实施例的更详细的描述。
附图描述
图1A是根据本发明的血管密封器件的说明。
图1B是图1A所示的，表示指示膨胀状态的器件的说明。
图2A(缺)。
图2B是图2A所示的，表示非膨胀状态的器件的说明。
图2C是图2A所示的，表示膨胀状态的器件的说明。
图3A是根据本发明的另一血管密封器件的说明，表示在展开前处在发送管内。
图3B是图3A所示的血管密封器件，表示被发送管展开之后。
图3C是图3A所示的血管密封器件，表示包含在器件上的圆盘对准和挤压之后。
图4A是根据本发明的另一血管密封器件的说明，表示被发送管展开之后。
图4B是图4A所示的血管密封器件的说明，表示包含在该器件上的端盖挤压之后。
图5A是根据本发明的另一血管密封器件的说明。
图5B是图5A所示的进入发送管的安装密封器件过程的说明。
图5C是图5A所示的密封器件的说明，表示从发送管展开之后。
图5D是根据本发明的制造另一种血管密封器件过程的说明。
图5E是图5D所示过程的产品的血管密封器件的说明。
图5F是图5E所示的，表示成安装到发送管中的，血管密封器件的说明。
图5G是图5E所示的血管密封器件的说明，表示从发送管展开之后。
图6A是根据本发明的另一种血管密封器件的说明。
图6B是图6A所示的器件的说明，表示处在膨胀状态。
图7A是根据本发明的另一种血管密封器件的说明。
图7B是图7A所示的器件的说明，表示处于膨胀状态。
图8A是根据本发明的另一种血管密封器件的说明。
图8B是图8A所示的血管密封器件的说明，表示处于膨胀状态。
图9A是用作密封构件初始材料的垫的说明。
图9B是挤压图9A所示的垫的过程的说明。
图9C是挤压图9A所示的垫，挤压之后，的说明，表示部分地成带卷的形式。
图9D是适于用作根据本发明的限制性构件的编织材料管的说明。
图9E是将图9A所示的处于其带卷形式的垫插入图9D所示的管中的部分过程。
图9F是根据本发明的血管密封器件的说明。
图9G是图9F所示的器件的说明，表示处于膨胀状态。
图9H是类似于图9F所示的血管密封器件的说明，还包括一个分开的系绳构件。
图9I是图9H所示器件的说明，表示处于膨胀状态。
优选实施例的详述
图1A和1B是根据本发明的血管密封构件的基本的说明，该器件20包括一个保持在系绳24上的密封构件22。该密封构件22最好保持在靠近其远端点系绳24上，由在系绳24的远端处形成的止动构件26保持。该止动构26最好是在系绳24的远端处形成的一个结。图1A表示处于其非膨胀、预使用状态的器件。图1B表示由于流体暴露它已经膨胀之后的器件。
该密封构件22由能膨胀，或能被膨胀的材料构成，一旦该密封构件展开以使用。该密封构件最好由生物可吸收的材料构成，但是，在几个可选实施例中，密封构件可以由非生物可吸收的材料构成。合适的生物可吸收的材料包括生物可吸收的胶原蛋白、聚二醇酸(PGA)、聚丙交酯(PLA)、聚二醇——丙交酯(PGLAs)、水凝胶、和凝胶泡沫。这些材料可以固态、凝胶、泡沫、毡、或其它适于特殊应用的形式提供。由于其几个物理性质特别优选这些材料的水凝胶。水凝胶是一种吸附剂，微孔水凝胶包括交叉链结的具有分布在其整个质量中的互连流体晶粒的聚合物。水凝胶吸收流体非常快，并展现高的机械强度即使在吸收大量的流体之后。此外，水凝胶典型地各向同性地膨胀，意味着它们由于吸收流体在膨胀过程和之后能够保持它们的初始形状。有关适合于此处描述的血管密封器件中使用的水凝胶的另外的信息可以在美国专利NO.5573994和6030442中找到，该专利的每一个此处通过参考其全部内容予以结合，就如此处充份表述的。
可用于构成密封构件22的非生物可吸收的材料的例子包括尼龙、不锈刚、陶瓷材料、钛、金、铂、镍、镍-钛合金、其它金属和金属合金以及其它适合于医用的普通材料。
图1A所示的器件的密封构件22具有一般的管子形状，在靠近其端部包围系绳24。该密封构件22可以用常用方法松或紧地固定到系绳24，或者可以允许它沿系绳24的长度的至少一部分滑动。
图1A所示的系绳24密封器件如果需要至少完成提供使用者从其使用状态纠正密封构件20的可能性的功能。该系绳24最好由普通的缝合材料构成，诸如具有足够拉伸强度的可生物降解的聚合物以完成以上功能。这种材料的例子包括PGA、PLA、和PGLA聚合物。另一种选择，该系绳可以由上述那些非生物可吸收的材料构成。
图1A所示的止动构件26密封器件至少完成将密封构件22保持在系绳24上的功能。该止动构件26可以由任何适合于完成此目的任何生物兼容的材料构成。另一选择，如图1A和1B所示的器件20，该止动构件26可以包括一个处于系绳24一端的结。
该密封器件20特别适合于用到密封在病人身体上发现的切口、穿刺或其它伤口，典型地人或其它哺乳动物。该器件20可以通过任何合适的方法发送到伤口部位。例如，在为获得进入到股骨动脉以便导管插入或其它插入程序产生的切口的情况该器件可以使用发送器械发送到切口区域，该发送器械在2004年5月1日申请并授予EnsureMedical Inc.，此处的受让人，题为“Locator and Delivery Device andMethod of Use”的美国专利申请系列NO.10/850795中介绍(此后称作“759申请”)。在“795申请介绍的该发送器械适合于将血管塞或其它密封器件发送到切口区域中靠近血管的一点。在此处图1A所示的血管密封器件20的例子中，一旦使用，该密封构件22就被暴露到来自血管的血流中。这一暴露造成密封构件22由于血液的吸收而膨胀，如图1B所示。已经插入到切口区域中的密封构件的膨胀导致该密封构件22牢固使它自己进入切口区域中，因而防止密封器件20移出位置并产生防止血液管流动的有效的密封。
构成该密封器件20的元件可以完全由生物可吸收的材料构成，或者它们可以被生物可吸收的材料与非生物可吸收的材料的组合构成。例如，密封构件22可以由一或几种生物可吸收的材料构成，而系绳24由一种非生物可吸收的材料构成。其它组合也是可能的。
可选择地，凝结剂或其它止血促进材料——诸如促凝血酶或其它常用的凝血剂——可以结合进来，添加到，或者与密封器件20组合使用。
图2A到图2C是一个可选的血管密封器件20的实施例，其中系绳24用于包围和保持密封构件22。参照图2A，该器件20包括一个密封构件22和一系绳24。该密封构件22和系绳24可以由任何与上述有关图1A和1B所示的密封器件20的相同的材料构成。该系绳24构成为在其远端的手术结以便不紧地包围密封构件22。在图2B中，该器件20与隐藏的手术结25一起表示，以便在器件展开之前更牢固地包围并保持密封构件22。当使用进入到切口区域中时，密封构件22进入与来自血管的血流接触并膨胀，提供密封，如图2C所示。
参照图3A到3C，血管密封器20的一个可选实施例包括若干个盘形密封构件22a-d，它们可滑动地相连到系绳24的一端。止动构件26，最好是在系绳远端处构成的结，将密封构件22a-c保持在系绳24上。该盘形密封构件22a-d和系绳24可以由任何与上述有关图1A和1B所示的密封器件20的相同材料构成。
首先参照图3A，密封器件20表示成安装到发送器件100中，该发送器件的远端表示在图中，该发送器件具有一个圆柱形发送管102，以图3A中的横剖面表示的。由发送管102的内部限定的内空间适合于接纳和保持密封器件20以便发送到切口。一旦将发送器件100放置到切口的适当位置以便发送密封器件20，经过开口104展开密封器件20(通过柱塞，通过发送管102的缩回，或者通过与发送器件相关的另外的机构)并进入邻近血管开口区域。
如图3A所示，盘形密封构件22a-c稍微地在系绳上被分开以便当它们安装进并保持在发器件内时相对于由系绳24限定的轴线倾斜一个角度。此倾斜减小盘形密封构件22a-c径向轮廓，如果该密封构件22a-c被安装而不倾斜则允许它们被安装到此必需的要小的直径的发送管中。
图3B表示密封器件20在切口区域发送之后并退出发送器件100。在此点上，密封构件22a-d仍然处在倾斜、分开的方位，它们占据在发送管102内部里。还在此点，盘形密封构件22a-d被暴露到血流中并开始膨胀。如图3c所示，可能并希望通过向上支持发送管102靠住最接近放置的圆盘22d对准和挤压各盘形密封构件22a-c，同时拉动系绳24(见图3B中的箭头“A”)以造成各个盘22a-d彼此对准并压靠同时被保持在系绳24上。效果就是以构成具有事实上较大径向尺寸的径向挤压的密封构件22a-d。该挤压的密封构件22a-d因而被牢固地装进切口区域里，密封该区域阻止血液从血管流动，并促进止血。
图4A和4B仍表示密封器件20的另一可选的实施例。此实施例中，该器件包括一个形成为包围系绳24的一部分的管子的密封构件22。第一端盖28连接到系绳24的一端，同时第二端盖29被可滑动地连接到系绳24刚好最接近管状密封构件22。该管状密封构件22和系绳24可以由任何与上述有关图1A和1B所示的密封器件20的相同材料构成。该端盖28和29最好是实心或半实心圆盘的形式。端盖既可由生物可吸收的材料或非生物可吸收的材料构成。在优选实施例中，端盖由生物可吸收的材料最好是聚合物构成。
图4A和4B所示的器件20可以与图4A所示的发送器件100一起发送。器件20可以由柱塞106经在其远端的开口104从发送管102排出，或者，另一种选择，该发送管102被从密封器件20周围拉出，由于密封器件20保持在切口区域中的适当位置。在任意情况中，该密封器件20和发送器件100被分开，留下密封器件在切口区域内的适当位。
在发送之后，以类似于上述有关图3A至3C的方式可挤压密封器件20。参照图4B，柱塞106、发送管102、或者某些其它构件可以靠住第二端盖29放置提供备用，然后拉紧系绳24(见箭头“A”)以便驱动二端盖28、29彼此相向并挤压管状密封构件22。另一种选择，可以简单地保持系绳24紧绷，然后通过柱塞106、发送管102、或其它构件迫使第二端盖29向下朝着第一端盖28(见箭头“B”)，在过程中挤压管状密封构件22。在任何情况中，最终结果如图4B所示，径向地挤压管状密封构件22(见箭头“E”)以造成密封器件牢固地进入切口区域并提供密封防止血液从血管流动。
下面参照图5A到5B，表示仍是一个可选的密封器件20的实施例。参照图5A，密封器件20包括一对盘形密封构件22a-b，它们被安装到系绳24的远端附近。该盘形密封构件22a-b和系绳24可以由与上述有关图1A和1B所示的密封器件20的任何相同的材料构成。此处，虽然在图中表示二个盘形密封构件22a-b，但是可以设置较多或较少的盘形密封构件。
如图所示，几个盘仅由少量的间隔分开，不像图3A-3B所示的实施例。因此，如图5B所示，为了将盘形密封构件22a-b安装到发送器件100的发送管102内(见图5B的箭头“L”)，在安装过程当中(见图5B箭头“C”)径向地挤压该盘形封构件22a-b。在许多情况中，此径向挤压的一个结果是在发送之后，即退出发送管之后，盘形密封构件22a-b保留它们的被挤压状态。此效果在图5C中表示，在该处通过在柱塞106的近端上作用一个力(见箭头“F”)所示的与发送器100相关连的柱塞106展开密封器件20。在展开之后，密封器件20的密封构件22a-b的径向尺寸(见箭头“d”)近似地与发送管102的内直径(箭头“d”)相同。此效果在许多情况可能是有问题的，在该情况中盘形密封构件22a-b由一种当在切口区域中展开时不明显膨胀的材料构成，以及在一些情况形成切口区域的组织由于，例如，在任何手术过程中多鞘交换，已经变得无弹性。在那些情况中，密封构件22a b将趋于具有可能比切口直径略小的径向尺寸(有效直径)，同时包围切口的组织具有不充分的弹性以便在密封构件22a-b周围充份萎陷以造成它牢固进入适当位置。
此处提出的一个解决办法是提供一个与密封构件相关连的体积膨胀构件。在图5D到5G中表示一个例子。参照图5D，一对盘形密封构件22a-b的每一个在其中央设置一个圆柱空洞空间。该密封构件22a-b(与上述水凝胶有膨胀性能相比)当暴露在流体中时最好由展现较小膨胀性的材料构成。合适的材料的一个例子是PGA毡材料。一个分立的体积膨胀构件30尺寸定成能插入到在密封构件22a-b中形成的空洞空间中。如图5D所示，该膨胀构件30可以构成为高度可膨胀材料卷起的薄片，诸如水凝胶泡沫垫，它被构成以包围系绳24。例如，如图5E所示，然后可以将该膨胀元件30插入到在密封构件22a-b中形成的空洞空间中。
然后将密封器件20安装到发送器件中，如图5F所示。像此处别的地方描述的，该发送器件100包括一个发送管102和一个柱塞106，它用于经过在发送器件100的远端的开口排出密封器件20，或者保持密封器件20的位置而拉出发送管102。当展开时，包括体积膨胀构件30的密封构件22a-b暴露到来自血管的血流中。而当暴露到流体中时盘形密封构件22a-b仅趋于稍微地膨胀，与密封构件22a-b相关连的膨胀构件径向地膨胀到很大程度，如图5G中箭头“E”所示。这增大了盘形密构件22a-b的膨胀，造成该密封构件22a-b更有效地密封切口区域防止血液进一步流动并促进止血。
虽然在图5D到5G中表示体积膨胀构件30相对于密封构件密封22a-b的特殊方位，但是应该理解，其它和不同方位也是可能的。例如，膨胀构件可以设置在密封构件的内部，或者它可以嵌在密封构件内的别的地方。该膨胀构件也可以取不是卷起的薄片的形式，同时密封构件可以取不是图中所示的盘形构件的形式，这些和其它变化是可能的同时获得由复合结结提供的优点，该复合结构包括一或多个由第一种材料构成的密封构件，以及一或多个第二种材料构成的体积膨胀构件，该第二种材料具有比第一种材料大得多的膨胀性能，该密封构件和体积膨胀构件可以完全由一种生物可吸收的材料组合构成，或者由生物可吸收的材料与非生物可吸收的材料的组合构成。
下面参照图6A和6B，密封器件20的另一实施例包括机械花朵形式的密封构件22。该密封构件22最好由水凝胶或者此处介绍的任何其它材料构成。该机械花朵包括许多花瓣32，它们径向地远离花芯34伸出。系绳24连接到花芯34并且当密封器件20在切口区域展开时能够延伸出切口。
由于其在展开和暴露到血流中之后它的膨胀性能来选择机械花朵的形状。例如，如图6A所示，在展开之前(例如，当安装到发送器件100中时)，可以挤压该机械花朵，这样所有的花瓣34在单一总的方向延伸同时每一个花瓣彼此靠得很近。但是，当展开时该机械花朵能够“开放”，也就是延伸使得花瓣34彼此分开，如图示，例如在图6B中。这一膨胀可由一综合原因造成，即从发送器约束的释放和基于超吸收剂密封构件22暴露到切口区域50中的血流的膨胀的组合。这一膨胀对密封器牢固地进入组织区域内并密封该区域防止血液从血管52流动提供可能性。
下面参照图7，密封器件20的可选实施例包括由中央系绳38夹紧的单根纤维36约束。该纤维36最好由水凝胶或其它此处提到的那些膨胀材料构成。中央系绳38也由上述一种材料构件成，但最好是较刚性的材料以便对形成密封构件22的纤维36束提供牢固的接合。系绳24从中央系绳38延伸同时一旦展开封密器件20就从切口区域向外。
特别优选的密封器件的一种结构是复合的结构，它包括系绳、密封构件、和分立的限制性构件。这一结构的一个例子表示在图8A和8B所示的实施例中，在此实施例中，密封构件22最好包括诸如水凝胶或此处讨论的其它那些材料的束或其它实体。该密封构件22可以是毡、凝胶、泡沫或其它固体或半固材料的形式。限制性构件40包围并保持该密封构件22。在图8A和图8B所示的实施例中，该限制性构件40包括一个多孔篮，诸如编织的、网状的、或纺织、的纤维，它包围和/或封装该密封构件22。限制性构件40最好由多孔但良好刚性和/或具有很高拉伸强度的材料构成，以便充分地约束密封构件22。该限制性构件可以包括很松的织物、编织结构、紧密地纺织纤维，或它们之间的某些织物。最好是，密封构件22与限制性构件40二者都由生物可吸收的材料构成。但是，在另一实施例中，密封构件22的一个和限制性构件40由生物可吸收的材料构成，而另一个由非物可吸收的材料构成。合适的生物可吸收的材料和非生物可吸收的材料是上述的那些材料。
图8A和8B所示的限制性构件包括一个为选择性地挤压和径向地膨胀包围在限制性构件40内的密封构件22的机构。该机构包括一扭紧的线42，它穿过在限制性构件40的上周边形成的通道44。在通道44中的扭紧的线42上形成一圈套结46并提供拉紧扭紧线的可能以便挤压包围在限制性构件40中的密封构件22。当扭紧的线42被拉紧时(见图8B中的箭头“T”)，它通过减少其高度改变构成限制性构件40的多孔篮的形状，导致包围在限制性构件40内的密封构件22的体积径向地膨胀，如图8B所示。制成限制性构件40的材料最好以这样的方式构造，如通过沿限制性构件40的边提供较松的或更柔性的编织、纺织、或针织结构。该扭紧的线42和圈套结46通过系绳24的方法，或通过一分开的从限制性构件40延伸的线，是可以进入的。
图8A和8B所示的密封器件20以与此处在别的地方介绍的那些类似的方式可以被展开。例如，可以通过使用发送器件在切口区域中展开密封器件20，该发送器件具有一旦正确地位于切口区域内从其远端排出密封器20的发送管。一旦展开，该密封器件20将遇到来自被密封的血管的血流，因而导致由限制性构件40包围的密封构件22膨胀，包括径向的膨胀。此处，使用者可以选择地拧扭紧的线42以挤压密封构件22以提供附加的径向膨胀。这样，密封器件20可以被膨胀以便使器件牢固地进入切口区域内以防止它移出该区域并密封该区域防止血流。
参照图9A到9I，表示密封器的另一实施例，由于是制造密封器件的方法。图9A到9I所示的密封器件构造成包括系绳、密封构件、和限制性构件。
首先参照图9A，在优选实施例中密封构件22是一个水凝胶泡沫垫，虽然同样可以使用其它生物可吸收的、高膨胀的材料。在其它实施例中，密封构件22可以由非生物可吸收的材料构成。该泡沫垫最好具有这样的尺寸，即允许它被挤压并卷成(如下所述)适合于接受到发送器件中并适合于其最终作为切口区域中的密封器件的形状与尺寸。为了优化密封构件22的体积与功能，在安装到密封件中之前最好挤压泡沫垫。完成这一挤压步骤的一个方法是使用一挤压辊子110对该垫施加挤压力，很像一个滚动销。此方法由图9B中箭头“R”所示。挤压步骤的结果是获得高度挤压的、水凝胶或其它生物可吸收的(或非生物可吸收的)材料的平坦的泡沫垫。
参照图9C，在优选实施例中，密封构件被卷成一个卷。优选该卷形状因为它产生在干燥状态下的小轮廓密封件，当该密封构件暴露到血流中时它能高度地径向膨胀。干燥状态下的小轮廓对于密封器件的易于发送是有用的，同时当暴露到流体中时高度的径向膨胀对促进牢固地将密封器件放进切口区域并密封该区域防止血流是有用的。其它和不同的形状与尺寸也是可能的，同时每一种对于这些目的多少可以起一些作用。例如，该密封构件可以是卷成一卷的或者否则的话是挤压的质量。卷成的薄片形是一个优选实施例。
图9D表示优选的用于密封器件的限制性构件40。该限制性构件40是针织、纺织或编织材料的多孔、管状构件。管状限制性构件40的组成最好是生物可吸收的材料。诸如由PGA、PLA或PGLA构成的缝合材料。在另一实施例中，限制性构件40可以由非生物可吸收的材料构成，诸如尼龙或不钢锈细丝网。针织或编织的结构当需要将密封构件22包括在其内部时允许限制性构件40膨胀。
图9E提供为将密封构件22插入限制性构件40的过程的说明，在此情况中该密封构件是水凝胶材料的挤压和卷成的薄片。箭头“A”指示密封构件22进入由限制性构件40确定的内部空间的通道，密封构件被包围并保持在该内部空间里。如图所示，限制性构件40的材料的纺织、编织或针织结构允许限制性构件40的膨胀以包容密封构件22。在将密封构件22插入限制性构件40之后，限制性构件40的开放端(该密封构件经该开放端已经通过)可能被关闭或密封以完全包围密封构件22，如图9F所示。此处，靠近密封构件22延伸的限制性构件40的邻近部分41可以用来代替，或者作为此处所述的其它实施例中使用的系绳的置换。因此，在密封器件20展开之后，该限制性构件40的邻近部分41延伸出切口区域并可用于操纵密封器件20和/或者如果需要的话以去除该密封器件20。
图9F表示处于其预展开、非膨胀胫状态的完成的密封器件20的一个实施例。在密封器件20已经减少轮廓的此状态适合于将器件20安装到适当的发送器件中，诸如此处之前所介绍发送器件。然后该密封器件就可以被发送，例如，通过将器件排出发送管的开放远端，进入切口区域并靠近目标血管中的开口。当暴露到血流中时，密封器件内的密封构件22将膨胀，如图9G中的箭头“E”所示的。此膨胀将造成密封器件20牢固地进入口区域内，密封切口防止血流。
图9H和9I表示一个类似于上述有关图9F和9G的密封器件20，但是还包括系绳24。该系绳24最好连接到密封构件22和限制性构件40，并可用于操纵展开之后的密封器件，或者如果必需从切口去除密封器20。例如，如图9I所示，该系绳24可以以一种方式连接到密封构件22和限制性构件40。即允许使用者上在系统上作用一个向上的力(见箭头“F”)，该力增加密封构件22在限制性构件40内的径向膨胀(箭头“E”)。此增加的由于密封器件的机械操纵的径向膨胀将增加该器件牢固地进入切口区域的功能，密封该切口防止血流，并促进止血。
如上所述，此处描述的密封器件的几个实施例优选地由完全由生物可吸收的材料构成的元件构造。但是，前述实施例的每一个也可以由一或几个元件的组合构造成，这些元件由生物可吸收的材料构成，以及一或几个元件由非生物可吸收的材料构成。
尽管本发明可设想到各种修改和另外的形式，但是在附图中已经表示其几个具体的例子并在此详细描述。但是应该理解本发明不局限于公开的特殊形式或方法，而且相反，本发明涵盖所有处于所附权利要求的精神和范围以内的修改、等效形式和可选形式。

Claims (22)

1.一种用于基本上密封经组织到体腔中开口延伸的伤口的器件，包括：
限制性构件，包括第一种生物可吸收的材料和限定其中的内部空间，以及
密封构件，包括第二种生物可吸收的材料，至少部分地位于所述限制性构件的内部空间内。
2.权利要求1的器件还包括在第一端连接所述密封构件的系绳。
3.权利要求1的器件，其中所述第一种生物可吸收的材料与所述第二种生物可吸收的材料相同。
4.权利要求1的器件，其中所述第一种生物可吸收的材料是从包括聚二醇酸、聚丙酯、聚二醇一丙酯酸、胶原蛋白和水凝胶组中选择。
5.权利求1的器件，其中所述限制性构件包括一个多孔的构件。
6.权利要求5的器件，其中所述限制性构件包括具有针织、编织或纺织结构的材料。
7.权利要求5的器件，其中所述限制性构件是一个管状纤维构件同时所述密封构件是一卷起的被所述管状纤维构件包围的泡沫垫。
8.权利要求7的器件，其中所述卷起形式的垫包括水凝胶。
9.一种为基本上密封经组织到体腔中开口延伸的伤口的方法，包括：
提供包括水凝胶材料的密封器件，以及
在伤口中展开该密封器件。
10.权利要求9的方法，其中所述密封器件包括一个限制性构件，它包括第一种生物可吸收的材料并限定在其中的内部空间，以及一个密封构件，它包括第二种生物可吸收的材料，至少部分地处在所述限制性构件的内部空间里。
11.权利要求10的方法，其中所述密封器件还包括在第一端连接到所述密封构件的系绳。
12.权利要求10的方法，其中所述第一种生物可吸收的材料从包括聚二醇酸、聚丙交酯、聚二醇-丙交酯酸、胶原蛋白和水凝胶的组中选择。
13.权利要求10的方法，其中所述限制性构件包括具有针织、编织、或纺织结构的材料。
14.权利要求13的方法，其中所述限制性构件是管状纤维构件同时所述密封构件是被所述管状纤维构件包围的卷成的泡沫垫。
15.权利要求14的方法，其中所述卷成的泡沫包括水凝胶。
16.一种为基本上密封经组织到体腔中的开中延伸的伤口的器件，包括：
密封构件，该构件的至少一部分具有第一径向尺寸用以将所述密封构件发送到伤口中以及当发送到所述伤口中并暴露到与所述伤口相关的流体流中时的第二径向尺寸，该第二径向尺寸比第一径向尺寸大，以及其中所述密封构件包括水凝胶。
17.权利要求16的器件，还包括连接到所述密封构件并具有在密封构件的发送之后足以向外延伸的长度的系绳。
18.权利要求17的器件，包括一个在系绳的终端的止动构件，所述止动构件适合将密封构件保持在系绳上。
19.权利要求17的器件，还包括位于所述密封构件的第一侧上的系绳上的第一盖板，以及位于所述密封构件的第二侧处的系绳子上的第二盖板。
20.权利要求16，其中所述密封构件包括若干个盘形构件。
21.权利要求16，还包括限制性构件，它包括第一种生物可吸收的材料并在其中限定一内部空间，所述密封构件至少部分处于所述限制性构件的内部空间内。
22.权利要求21的器件，其中所述第一种生物可吸收的材料从包括聚二醇酸、聚丙交酯、聚二醇——丙交酸酸、胶原蛋白和水凝胶。
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CN115397377A (zh) * 2020-04-07 2022-11-25 雷德助莱斯有限公司 血液提取
CN115397377B (zh) * 2020-04-07 2023-08-29 雷德助莱斯有限公司 血液提取
CN115517725A (zh) * 2022-11-25 2022-12-27 苏州美创医疗科技有限公司 血管创口密封装置及方法

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US20120101520A1 (en) 2012-04-26
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AU2006206655A1 (en) 2006-07-27
US20050267528A1 (en) 2005-12-01
WO2006078578A3 (en) 2007-10-18
WO2006078578A2 (en) 2006-07-27
CN104107071B (zh) 2017-04-12
CN104107071A (zh) 2014-10-22
US8083768B2 (en) 2011-12-27
EP1841366A2 (en) 2007-10-10
US9655602B2 (en) 2017-05-23
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CA2593665A1 (en) 2006-07-27
MX2007008531A (es) 2008-02-15

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