CN1633264A - 开口内假体和输送*** - Google Patents

开口内假体和输送*** Download PDF

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Publication number
CN1633264A
CN1633264A CNA038027542A CN03802754A CN1633264A CN 1633264 A CN1633264 A CN 1633264A CN A038027542 A CNA038027542 A CN A038027542A CN 03802754 A CN03802754 A CN 03802754A CN 1633264 A CN1633264 A CN 1633264A
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China
Prior art keywords
prosthese
expanding
self
balloon
interior
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CNA038027542A
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CN100473368C (zh
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R·J·科托尼
G·J·贝克尔
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Orbus Medical Technologies Inc
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Orbus Medical Technologies Inc
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Abstract

公开了一种管腔内的内假体，具有圆锥形的第一端和管状的气囊可膨胀的支架作为主体。该圆锥形的第一端可对着主体形成开口，特别适用于开口用途。该第一端优选是自膨胀的，而该主体优选是气囊可膨胀的。还公开了一种输送装置，用来将管腔内的开口内假体装置，特别是在此公开的那些，输送到要展开的部位。该输送装置可包含越线***或可包含快速交换梭***。该内假体的自膨胀部分被包封在鞘中或其它在输送装置上的约束器中。内假体的气囊可膨胀支架部分被卷在气囊输送装置上。本发明输送***和内假体使得内假体能够部分膨胀，如果确定了它不是处在适当的位置，可以重新放置。为了帮助定位，该输送装置可包含记号带。

Description

开口内假体和输送***
                            发明背景
发明领域
本发明涉及管腔内的内假体装置。具体地，本发明涉及开口的管腔内的内假体装置和输送***以及展开它们的方法。
相关技术的描述
支架是植入于身体内的血管腔中的假体装置，为血管壁提供支撑。通常，支架植入于血管***中，用于增强部分闭塞的、萎陷的、弱化的或反常扩张的血管。在某些情况下，支架可用来在肾脏的、锁骨下的、颈动脉的、LCA、RCA、和SVG冠状旁路移植物吻合位点以及其它部位的开口损伤进行定位。更一般地，支架可在任何生理导管或管道中使用，包括例如动脉、静脉、胆管、尿道、消化道、气管支气管树、大脑水管或生殖泌尿***。支架可用于人和动物。
一般有两类支架：自膨胀支架和气囊可膨胀的支架。自膨胀支架在被释放后自动膨胀并采取展开的扩张状态。气囊可膨胀的支架可充气的气囊导管或其它气囊输送装置来膨胀。使气囊充气以便使支架可塑地变形。气囊可膨胀的支架可以通过将支架以未扩张或被卷住的状态固定在导管的气囊段来植入。在已经把夹住的支架放在其上之后，通过穿刺将该导管***血管壁中，并通过血管移动，直到它被定位在需要修补的血管的部分。然后通过对着血管内壁使气囊导管充气，将支架膨胀。支架被气囊的充气所塑性地变形，其直径增大并保持在增大的状态。在某些情况下，当支架被膨胀时，植入支架的血管可被支架本身膨胀。
因为气囊可膨胀的支架可被缓慢地、均匀地扩张而不会在放置的过程中发生不适当的轴向移动，所以它们可更容易和更精确地定位。即使气囊可膨胀的支架已经开始膨胀，它仍能在血管内移动。相反，自膨胀支架一旦开始膨胀就更难定位并更难移动。虽然自膨胀的支架更难以在血管中排布和精确定位，但它确有某些优点，特别是当在血管中指定位开口损伤时是这样。自膨胀支架发出连续的向外的径向力并形成“预先确定”的形状或直径。当试图定位开口的损伤时，这是特别有用的。
                            发明概述
本发明涉及管腔内的内假体装置，它们具有开口的或圆锥形的远端区域，还涉及在血管腔内将它们定位的输送***。在一个实施方案中，本发明包含与自扩张开口区偶联的气囊可膨胀的支架。当该内假体被张开时，其自膨胀区域形成圆锥形或开口形状。自膨胀区用包封材料或膜与气囊可膨胀的支架偶联。在一些实施方案中，包封材料覆盖自扩张区以及气囊可膨胀的支架的一部分，或将二者全部覆盖和/或包封。
本发明还提供用于开口的管腔内口内假体装置的输送***。在一个实施方案中，用具有远端区的输送器将管腔内口内假体输送到位。气囊输送装置固定在输送器远端区上方将它包封，或至少包封其一部分。气囊膨胀区(包含气囊可膨胀的支架)卷在气囊输送装置上。将鞘或保留装置(如环)固定在该内假体的自膨胀区的上方。本发明的输送装置可沿着导线来回移动，通过快速交换梭被输送到感兴趣的位点，或可以是一种“越线”(over-the-wire)型装置。在某些实施方案中，希望在输送器的远端区域包括记号带，使得在展开的过程中可以确定固定在其上的内假体的位置和/或取向。在一个实施方案中，输送装置有三个记号带：一个远端记号带、一个近端记号带和一个中间的记号带。远端记号带是三个记号带中最远端的，而近端记号带则是三个中最近的。
一旦内假体被输送到准备植入的一般区域，气囊装置部分充气。常常需要使用放射学的技术或其它技术来确定内假体的准确位置。如果它没有被定位在适当的位置，即使是处于部分充气的状态，也可以被重新放置。在确信它已经处在合适的位置后，气囊完全充气。该充气使得内假体的气囊可膨胀部分塑性地变形。在一个实施方案中，由于气囊膨胀，鞘开始从自扩张区拉回，同时自膨胀区张开到它的预定的尺寸。然后将输送气囊放气，从血管中取出输送器。
在另一个实施方案中，气囊被充气然后从内假体的自扩张区取出捕获鞘、环或其它合适的约束器。该约束器可以在张开过程的任何时候被取出。在一个实施方案中，它在气囊完全充气后取出。在其它的实施方案中，它在气囊充气之前或气囊刚刚部分充气之后从自扩张区取出。
                              附图简述
本临时专利申请含有至少一幅用颜色表示的图。
图1表示本发明一个内假体当用来定位肾动脉适应证时处于“张开”的状态。
图2a-2f表示示例性的本发明内假体的开口部分。
图3a-3j表示示例性的本发明的内假体的开口部分的网筛状图形。
图4a-4b表示本发明的一个实施方案的支持结构的网筛状图形。
图5说明在固定到本发明输送装置上以后的本发明的内假体。
图6-12说明使用输送装置张开一个开口的管腔内的内假体。
图13-18说明已经在开口中张开后的本发明的内假体。
图19-118说明本发明内假体装置、输送装置、和张开内假体装置的方法的各种方案的各个方面。
                            发明详述
本发明涉及用于管腔内的张开的开口内假体装置。如表示本发明的内假体的一个实施方案的图1所示，当它在从主动脉95分支的肾动脉中张开时，该内假体可具有气囊可膨胀的支架区100和自扩张终端区200，其中当内假体被张开时，自扩张区采取张开的状态。气囊可膨胀的支架区优选具有一个能够产生高的支架对血管的比例的设计。在某些实施方案中，气囊可膨胀的支架区100将包含多个螺旋段，并且优选具有一种几何结构，允许气囊可膨胀的支架区能够被卷到输送装置上。本领域已知许多设计，可用于气囊可膨胀区。例如，共同待审查申请10/014,705(Addonizio等，2001年12月11日)和临时申请60/267,778(Pazienza等，2001年2月2日)公开的设计很适用于本气囊可膨胀区。二者都提供了具有高的支架对血管的比例的支架，二者都使用许多螺旋段，当支架被气囊装置膨胀时，这些螺旋段圆周状地膨胀。本领域公知的其它气囊可膨胀支架装置也可使用。
在某些实施方案中，可能希望气囊扩张支架区的一端具有正方形边缘110。(见图1)。通常可将具有正方形边缘的端区添加在气囊扩张区上。在某些情况下，可能希望在正方形末端的前面在气囊可膨胀的支架区添加一个过渡区。压杆或其它结构元件可被用来将端区与气囊扩张区的其余部分连接起来。
自膨胀区200可用NiTi、SST弹性钢、聚合物、形状记忆材料或其它合适的支架材料制造，当从约束器释放时采取预先确定的形状和尺寸。当膨胀时，自膨胀区200优选具有一般开口形状的或一般圆锥形的形状，并可采取多种形式，包括但不限于图2a-2f所示的那些。自膨胀区200可有采取多种形状(包括但不限于在图3a-3j中所示那些)的网筛状图形构成。在一些实施方案中，在开口的自膨胀区带钩的复合角度几何结构可用来改善与脉管***和开口分支的再造的接触。(见，例如，图4a和4b)。
如图1所示，自膨胀区200用包封膜300与气囊可膨胀支架区100偶联。在一个实施方案中，膜300部分或完全地覆盖自膨胀区200和气囊可膨胀区100二者。膜300优选用气囊可膨胀的或可塑性地变形的材料，如PTFE、氟聚合物、聚乙烯醇(PVA)交联的水凝胶，或其它货物市的材料制造。在本发明的一个实施方案中，构成膜的材料是剪材(shear)。在一些实施方案中，包封膜300的一段，或全部，被预张开成自扩张段形状，然后组装。该膜也可用于均匀地再造动脉粥样硬化斑，并不使该材料通过支架压杆和端区压杆和丝状体(filament)中凸出来。
本发明内假体也可作为药物输送***。在本发明的一个实施方案中，可使用一种可侵蚀的基质作为药物输送的平台。可侵蚀的基质可由可侵蚀的生物相容性聚合物***构成。在许多可通过在此叙述的移植物平台输送的可用的药物中，是抗再狭窄药物。
本发明还提供用于管腔内开口内假体装置的输送***。该输送***可包含越线输送器或快速交换梭***。如果使用越线***，输送器可沿着导线500上方(如0.010-0.038英寸导线)来回移动到达展开的位点。(见图5)。如图6所示，输送器上的记号带510、512、514表明在脉管***中装置部分的展开位置。最后的结果是内假体被输送到损伤的部位。
在一个实施方案中，如图5-12所示，本发明输送***使用拉回鞘520，这是拉回或约束***的管状部分，它使自膨胀部分200不发生过早的展开。这也使得整个装置在开口中精确展开。环或其它合适的约束器可用来代替鞘520或添加在鞘520上。
管腔内的开口内假体的气囊扩张支架区100被固定在气囊输送装置530上。如图6所示，随着气囊开始充气，气囊可膨胀部分开始展开。随着气囊530充气，自膨胀区200开始从拉回鞘520拉出。如图7所示，在气囊膨胀支架区100完全被展开时，自膨胀区200从拉回鞘520退出。自膨胀区200开始弹性变形至预定的尺寸。(见图8-11)。气囊然后被放气(见图12)，取出输送器。结果是管腔内的内假体被固定在开口内，如图13-18所示。
虽然在上述的实施方案中，在气囊可膨胀的支架部分膨胀到某个点时，自膨胀区可自动地退出约束器，但可能希望自膨胀部分仍被约束在鞘、环、或其它合适的约束工具内，直到植入医学专家希望使它自膨胀。因此，在某些实施方案中，在自膨胀部分发生自膨胀之前，必须采取肯定的行动，如取出约束工具。
本发明使得输送器管腔内的内假体能够定位和(如果需要)从新定位，即使在支架100的气囊可膨胀的部分充气之后。
图19-118清楚地表明了附加的细节或提供了本发明示例性的实施方案的不同方面，在此它们是作为说明的目的，绝非对本发明范围的限制。

Claims (30)

1.管腔内的内假体，其特征在于，所述内假体包含：
自膨胀部分，当膨胀时，该自膨胀部分具有张开的形状；
气囊可膨胀的支架部分；和
至少部分覆盖所述自膨胀部分和和所述气囊可膨胀的支架部分并将该气囊可膨胀的支架与该自膨胀部分连接起来的膜。
2.如权利要求1所述的内假体，其特征在于，所述膜作为药物输送平台。
3.如权利要求1所述的内假体，其特征在于，所述其暴露的部分作为治疗剂的输送平台。
4.如权利要求1所述的内假体，其特征在于，所述膜是氟聚合物。
5.如权利要求1所述的内假体，其特征在于，所述膜是可侵蚀的。
6.如权利要求1所述的内假体，其特征在于，所述膜是用PTFE制造的。
7.如权利要求1、2、3、4、5或6所述的内假体，其特征在于，当它被张开时，所述自膨胀部分外边缘的半径大于所述气囊可膨胀的支架的膨胀半径。
8.如权利要求1所述的内假体，其特征在于，所述自膨胀部分是用NiTi制造的。
9.如权利要求1所述的内假体，其特征在于，所述自膨胀部分是用弹性不锈钢制造的。
10.如权利要求1所述的内假体，其特征在于，在所述自膨胀部分的外端还包含钩子。
11.如权利要求10所述的内假体，其特征在于，所述气囊可膨胀部分包含多个螺旋节段。
12.一种用于将内假体输送到管腔内部位的装置，该内假体具有自膨胀区和气囊可膨胀部分，所述装置包含：
远端区；
气囊输送装置，它包封该远端区的至少一部分，并且气囊可膨胀的支架部分被卷在该远端区上；
拉回鞘，用来包封自膨胀区的至少一部分，该拉回鞘包围所述装置远端区的一部分；
位于远端区的一个或多个记号带，当所述内假体处在血管管腔中时，用来定位所述气囊膨胀部分的位置。
13.如权利要求12所述的装置，其特征在于，当所述输送装置处于血管的管腔中时，其中一个记号带可以和其它记号带区别开来。
14.如权利要求12或13所述的装置，其特征在于，还包含导线，且其中所述远端区在途中沿所述导线来回移动至所述部位。
15.如权利要求12或13所述的装置，其特征在于，还包含快速交换梭，其中所述远端区在途中沿所述快速交换梭移动至所述部位。
16.如权利要求12或13所述的装置，其特征在于，所述记号带的数目是三。
17.一种用于展开张开的管腔内开口内假体装置的方法，所述方法包含以下步骤：
将气囊可膨胀部分固定在气囊输送装置上；
将自膨胀部分的至少一部分包封在鞘中；
将所述假体***到靠近开口区的管腔区；
用放射学方法确定所述输送装置的远端区的位置(所述假体被固定在该远端区上)；
使气囊输送装置部分充气；
用放射学的方法确证所述内假体是处于适当的位置；
在确定了内假体不是处在适当的位置后，将该内假体移动至适当位置；
再次使气囊装置充气；
使鞘从自膨胀区移开；
从所述管腔取出鞘和气囊输送装置。
18.一种用于输送具有气囊可膨胀部分和自膨胀部分的开口内假体的方法，所述方法包含：
将所述内假体输送到管腔内部位，以便在输送装置上展开；
确证该输送装置的位置；
使所述内假体的一部分部分膨胀；
通过在输送器上的不透射线的记号带确证所述内假体是处在所需部位的位置上；
如果它不在所需的位置上，重新放置所述内假体；和
使所述内假体的其余部分膨胀。
19.如权利要求18所述的方法，其特征在于，使内假体的一部分部分膨胀的步骤包含将气囊装置充气。
20.如权利要求19所述的方法，其特征在于，使所述内假体的其余部分膨胀的步骤包括，用气囊使内假体的部分充气并使得约束组件从内假体的自膨胀部分移开，由此使得自膨胀部分发生膨胀。
21.一种管腔内的内假体装置，所述装置包含：
第一自膨胀端，当所述内假体被展开时，该自膨胀端形成一般为圆锥形的结构；
具有正方形边缘的第二端；
管状的气囊可膨胀的支架体，放置在第二端和第一自膨胀端之间；和
包封材料，将第一自膨胀端和气囊可膨胀的支架体连接在一起。
22.如权利要求21所述的内假体，其特征在于，在所述支架体和所述正方形端之间还包含过渡区。
23.如权利要求21所述的内假体，其特征在于，所述第一自膨胀区有一个张开的部分。
24.如权利要求23所述的内假体，其特征在于，所述张开的部分包含钩子。
25.如权利要求24所述的内假体，其特征在于，所述钩子形成复合的角度。
26.如权利要求21所述的内假体，其特征在于，所述自膨胀区的包封部分是在将该内假体固定在输送导管中之前形成的。
27.一种用于展开具有自膨胀部分和气囊可膨胀部分的管腔内的内假体的方法，所述方法包括：
通过输送器将所述内假体输送到某一部位；
使内假体的气囊可膨胀部分至少部分膨胀；
用放射学方法确证所述输送器是处在适当的位置；和
从内假体的自膨胀部分移去约束装置。
28.如权利要求27所述的方法，其特征在于，所述方法还包括使气囊可膨胀部分进一步充气的步骤。
29.如权利要求27或28所述的方法，其特征在于，所述输送器在途中沿着导线移动至所述部位。
30.如权利要求27或28所述的方法，其特征在于，所述输送器包含快速交换梭。
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KR20040090990A (ko) 2004-10-27
US20130166013A1 (en) 2013-06-27
AU2003239881A1 (en) 2003-09-02
CN100473368C (zh) 2009-04-01
US20040093058A1 (en) 2004-05-13
ATE425720T1 (de) 2009-04-15
JP2005515829A (ja) 2005-06-02
WO2003063729A2 (en) 2003-08-07
EP1469794A4 (en) 2007-03-21
EP1469794A2 (en) 2004-10-27
WO2003063729A3 (en) 2003-11-06
DE60326699D1 (de) 2009-04-30
EP1469794B1 (en) 2009-03-18

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