CN103584929A - 血管内袖带和防止在假体瓣膜和血管壁之间的泄漏的方法 - Google Patents

血管内袖带和防止在假体瓣膜和血管壁之间的泄漏的方法 Download PDF

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CN103584929A
CN103584929A CN201310511457.4A CN201310511457A CN103584929A CN 103584929 A CN103584929 A CN 103584929A CN 201310511457 A CN201310511457 A CN 201310511457A CN 103584929 A CN103584929 A CN 103584929A
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prosthetic valve
intravascular
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blood vessel
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R·F·威尔逊
J·盖诺
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HEART LEAFLET TECHNOLOGIES Inc
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    • 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
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    • 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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    • 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
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Abstract

一种血管内袖带，它作为原生血管和血管内假肢器官之间的衬层。在展开期间，袖带的端部在它们自身上回卷，能够截留住位于端部之间的原生组织，例如瓣膜小叶组织。该袖带在血管和假体瓣膜之间形成密封，由此防止假体瓣膜周围的泄漏。在假体瓣膜的扩展期间，袖带还截留住从血管中移出的任何栓塞物材料。

Description

血管内袖带和防止在假体瓣膜和血管壁之间的泄漏的方法
本申请是一项发明申请的分案申请，其母案的发明名称是血管内袖带，申请日是2006年5月30日，申请号是200680027665.5(国际申请号：PCT／US2006／020975)
技术领域
本发明涉及并要求由Wilson等人于2005年5月27日提交的、名称为“血管内袖带(或环带)”的美国临时专利申请No.60/685433的优先权，并且通过引用而将其包含在此。本申请还包含与此同一日期提交的、发明名称为“无展伸件的支撑构件”的美国专利申请No.__和于2005年5月27日提交的、发明名称为“无展伸件的支撑构件”的美国临时专利申请No.60／685349以及于2005年8月18日提交的、发明名称为“无展伸件的支撑构件”的美国临时专利申请No.60／709595。
背景技术
使用一种经由皮肤的方法来改进和实行心血管外科手术一直存在着相当大的倾向。通过使用一个或多个引导通过例如股动脉的导管，能将工具和器械输送到心血管系统中的所希望的区域，以执行大量的复杂疗法(或复杂的程序)，这些复杂疗法本来通常需要侵入式外科手术疗法来完成。这种方法极大地减轻了病人所经受的创伤并能相当大地缩短恢复周期。作为实行心内直视手术的替代方案，这种经由皮肤的方法是特别有吸引力的。
瓣膜替换手术提供了正在发展中的经由皮肤的解决方案领域的一个示例。许多疾病导致心脏瓣膜小叶的变厚、和随后的不活动性或活动性降低。瓣膜不活动性还可能导致通过瓣膜的通道变窄或狭窄。变窄的瓣膜所呈现的对血流增大的阻力最终可能导致心力衰竭并且最后死亡。
目前治疗严重的瓣膜狭窄或回流包括完全取走现存的原生瓣膜，然后植入假体瓣膜(prosthetic valve)。当然，这是严重的侵入程序，会对身体造成重大的损伤，而这通常会导致很大的不适和相当长的复原时间。它也是一个很复杂的程序，执行这种程序需要良好的专门技术和才能。
历史上，这种瓣膜置换手术是使用传统的心内直视手术来进行的，此时胸腔被打开，心脏停止，病人置于心脏转流状态，切除原生瓣膜并附上置换瓣膜。所提出的一种经由皮肤地瓣膜置换的可选方法在授权给Andersen等人的美国专利No.6168614(其全部内容通过引用包含在此)中公开。在此申请中，将假体瓣膜折叠成适合容纳在一导管内的尺寸。然后将导管插入到病人的脉管系统，并移动该导管以便将该折叠的瓣膜放置在原生瓣膜的位置。启动一展开机构，其沿着体腔的壁展开置换瓣膜。该展开力沿着腔壁推动现存的原生瓣膜的小叶，从而对所有意图和目的而言，基本上“切除”了原生瓣膜。然后将该展开构形从导管释放，开始承担原生瓣膜的作用，所述展开构形包括支架，其设置为具有瓣膜小叶支承的瓣膜形状。由此，完全的瓣膜置换得以实现，并且是以明显降低对病人的身体影响的方式实现。
然而，这种方法具有很明显的缺点。在Andersen的’614专利中公开的经由皮肤地方法的一个特别的缺点是防止移植后新瓣膜周边附近的泄漏的困难。由于原生瓣膜组织位于腔内，瓣膜组织的接缝连接处和熔点(当沿着腔壁推动时)将使位于腔和假体瓣膜之间的接合处附近的假体瓣膜的密封变得很困难，这一点是很可能的。
Andersen’614的方法的另一缺点在于它依靠支架作为用于假体瓣膜的支承架。首先，当它们展开时支架能够形成栓塞物。第二，在展开期间或展开之后，在截留它们移走的栓塞物方面支架通常是无效的。第三，支架通常与它们被放置的原生腔的特征不一致，使得容纳在支架内的假体瓣膜遭受瓣周漏。第四，支架很难置于腔的中心。
关于第一个缺点，支架通常属于两种类型之一：自展开支架和可展开支架。当装入导管中时，自展开支架被压缩，当从导管中释放时，自展开支架展开成它们的最初非压缩尺寸。可展开气囊支架在压缩但松弛的状态下装入导管中。气囊置于支架内。在展开时，导管缩回，气囊膨胀，由此将支架展开到期望尺寸。这两种类型的支架在展开时都具有较大的力。该力通常足够强大能够使血栓裂化或破裂，从而使得多片动脉粥样硬化血小板移动并成为栓塞物。如果要植入支架以治疗狭窄血管，一定程度的这种扩张是合适的。然而，如果植入支架仅仅是置换原生瓣膜，那么较小的力是更合适的，以减少形成栓塞物的机会。
关于第二个缺点，如果形成了栓塞物，那么扩展开的支架通常具有间隔太开的构件，从而不能有效地截留任何移动材料。通常，必须采取第二预案，包括使用网和注水口。
第三个缺点是由于支架的相对非柔性。支架依靠原生血管的弹性特性以与支架的周边相适应。用于打开受限血管的支架在血管和支架之间不需要密封。然而，当使用支架置换原生血管和容纳假体瓣膜时，支架和血管之间的密封是必须的，以防止瓣周漏。由于支架的非顺应特性，这种密封很难实现，特别是当置换狭窄瓣膜小叶时。
第四个缺点是支架很难置于腔的中心。狭窄瓣膜可能具有很不规则的形状。当将支架放在一不规则形状的硬化瓣膜中时，传输导管可能发生方向偏离，使得支架被传送到一偏心位置，例如在两个硬化瓣膜小叶之间。将处于这样的位置的支架扩展开可能导致沿腔壁形成很差的支座和明显的瓣周漏或无功效的假体瓣膜。
发明内容
通过提供一种管形或环形袖带，其环绕原生(或天生)血管并为支架建立理想的植入位置，本发明解决了上述的缺点。该袖带由至少一个具有超弹性或形状记忆特性材料例如镍钛诺的特性的编织的细股线构成。当在传输导管内处于伸长构形时，该袖带是管形的。当从传输导管中释放时，袖带的端部在其自身上回卷，截留位于卷曲端部之间的原生瓣膜小叶。袖带的中心不像端部展开的那么多，从而保持较小直径的内腔，其适合于接纳血管内器械。
附图说明
图1是本发明的优选器械的侧视图；
图2是图1所示器械的端视图；
图3-7是在原生血管中展开的本发明的器械的剖视图；
图8是本发明的优选器械的侧视图；
图9是处于展开状态的图1所示器械的端视图；以及
图10是处于展开状态的图1所示器械的侧视图。
具体实施方式
现在参照附图，首先参照图1和图2，其示出了本发明的血管内袖带10。所示的袖带10处于其松弛、展开的构形中，包括具有两个扩口端12和13以及一狭窄的管状本体14的管状结构。用于构造袖带10的该细长的管由至少一个编织的、具有超弹性或形状记忆的股线制成。在一个实施例中，将该细长管自身对折，使得第一端12变成一折叠端，而第二端13包括多个未编织的股线。因此管状本体是双层的。股线可以是织物纤维的，非织物纤维的，多丝的或单丝的。镍钛诺是用于股线的优选材料的一个实例。将股线编织起来以使得器械能够纵向展开成一很长很细的管，其能够放置在很小的传输导管中。优选地，袖带10可插入到尺寸为16FR或更小的传输导管中。编织带足够紧，能够拉紧可能从腔壁移出的栓塞物，同时仍允许该很细很长的构形。
袖带10包括一中心腔16，其贯穿整个袖带10延伸。该中心腔16的尺寸设定成接纳用于假肢器官例如支架(或展伸件)的传输导管。优选地，腔16具有逐渐地张开或扩展开的端部，从而形成一漏斗，用于引导传输导管进入腔16的中心。
图1和图2显示出，即使当袖带10处于径向展开的松弛构形，腔16也是很小并且很明显。因此，当展开时，类似蘑菇状的端部12和13张开，且与目标血管腔的形状一致，而袖带腔16保持很明显，并且在袖带10内相对居中。因此，袖带10为医师将假体瓣膜或支架植入袖带中提供了理想的目标和引导。优选地，袖带10是不透射线的，使得它导向的目标更容易进入。
袖带10的展开在图3-7中示出。以图3开始，经过传输导管20袖带10被经由皮肤地传送到目标的狭窄瓣膜18。使导管20前进直到导管的远端22通过目标瓣膜18。
如图4所示，然后传输导管20相对袖带10缩回。这样做将释放远端12，其迅速向外展开。由于远端12与血管壁接触，医师可以逐渐将导管20和袖带10抵靠狭窄瓣膜18拉到袖带10的远端12附近，从而确保袖带10的恰当放置。
接下来，如图5所示，导管20完全缩回，使得袖带10的近端13能够抵靠狭窄瓣膜18的邻近侧上的血管壁张开。现在该狭窄瓣膜18被完全包围在袖带10的编织的网状物中，袖带准备接纳假肢器官例如支架假体瓣膜26(图6和图7)。值得注意的是，尽管狭窄瓣膜18的形状不规则，但袖带的中心腔16提供了通过该目标位置的路径，并为假体瓣膜26提供了理想的接纳座。
在图6中，经支架的假体瓣膜26通过导管28经由皮肤地传送到袖带10。使用漏斗状的端部13作为引导将该导管28直接插入到袖带腔16中。
在图7中，假体瓣膜26被展开，并将导管28取走。展开支架假体瓣膜26必须扩展开中心腔16。这使得袖带10缩短，且扩口的端部12和13进一步折叠起来，对狭窄瓣膜18设置了更可靠的夹持。此外，在假体瓣膜26的展开期间移位的任何血小板和其它材料都被端部12和13截留住。袖带10为假体瓣膜26提供了最佳的座，并且防止任何血液在假体瓣膜26的周围泄漏。经过一段时间后，编织股线促进向内生长，进一步改进了袖带10所提供的密封。
本发明的一个实施例使用非织造物以进一步加强形成在袖带10和血管壁之间的密封。图8示出了具有双层本体的袖带10，材料32被截留在两层之间。非织造纤维易于扩展，使得袖带10的扩展特性不受影响。而且，材料32可充有治剂混合物。材料32可包括非织造材料，织造纤维，聚合物或其它材料。
现在参照图9和图10，最初在图1和图2中图示的袖带10在此示出，其中塞子30使袖带10的中心腔16张开。这显示了当腔16扩展时，袖带10是如何缩短，以及端部12和13是如何折叠起来的。因而中心腔16的扩展使得端部12和13能够对位于端部12和13之间的原生组织例如瓣膜小叶形成可靠的夹持。
在另一实施例中，在从导管展开时，细长导管的端部朝着器械的中间向外滚动。可选地，该端部也可朝着器械的中间向内滚动。超弹性或形状记忆材料例如镍钛诺的使用将使这个动作更容易。
尽管已经根据特定的实施例和应用对本发明进行了说明，按照这种说明，本领域的任何普通技术人员都能够在不偏离或超出本发明权利要求的精神和范围的情况下形成另外的实施例和变型。因而，应当理解地是此处通过实例提供的附图和说明书仅仅是为了便于理解本发明，而不应当被认为是限定本发明的范围。

Claims (29)

1.一种用于接纳假体的血管内袖带，其包括：
至少一个股线，所述股线编织成具有伸长构形和展开构形的管状结构；
由此在所述伸长构形中，所述管状结构包括：
第一端部和第二端部；
位于所述第一端部和第二端部之间的管状本体，所述管状本体具有至少两层；
延伸通过所述本体的内腔；
由此在展开构形中，第一和第二端部扩展以形成在所述至少两层之间的间隙。
2.根据权利要求1所述的用于接纳假体的血管内袖带，其中所述至少一个股线包括形状记忆材料。
3.根据权利要求1所述的用于接纳假体的血管内袖带，其中所述至少一个股线包括超弹性材料。
4.根据权利要求2所述的用于接纳假体的血管内袖带，其中所述至少一个股线包括镍钛诺。
5.根据权利要求1所述的用于接纳假体的血管内袖带，其还包括夹在第一和第二层之间的材料。
6.根据权利要求5所述的材料，其中所述材料选自由非织造材料，织造材料，编织织物和聚合物组成的组。
7.根据权利要求1所述的用于接纳假体的血管内袖带，其中端部的展开形状包括蘑菇状。
8.根据权利要求1所述的用于接纳假体的血管内袖带，其中所述内腔在展开构形中包括漏斗状的端部。
9.根据权利要求1所述的用于接纳假体的血管内袖带，其中在展开构形中，位于所述第一端部和第二端部之间的管状本体保持相对未展开的状态。
10.根据权利要求1所述的用于接纳假体的血管内袖带，其中当从展开状态中展开时，所述管状本体缩短。
11.一种防止在假体瓣膜和血管壁之间泄漏的方法，其包括：
在植入所述假体瓣膜前在血管中展开具有至少两层的自扩展网状袖带，所述网状袖带包括中心本体部分和在所述中心本体部分各个侧上的两个端部部分；
允许端部部分扩展并且形成抵靠所述血管壁的密封，同时所述袖带的中心本体部分形成向内弯曲侧壁；
在允许端部扩展步骤之后植入所述假体瓣膜至所述向内弯曲侧壁；
其中所述端部部分的至少一个端部部分呈蘑菇状扩展，使得在端部部分的层之间形成间隙，从而形成漏斗，所述漏斗用于将传输导管引导进入所述袖带中的内腔中心，并且允许外层倚靠原生组织与所述原生组织一致，而内层形成所述漏斗；以及
其中扩展所述袖带的所述内腔导致所述端部部分中的至少一个端部部分折叠。
12.根据权利要求11所述的方法，其还包括在所述袖带的内腔内扩展开所述假体瓣膜。
13.根据权利要求12所述的方法，其中在所述袖带的所述内腔内扩展开所述假体瓣膜导致所述袖带的本体部分扩展开。
14.根据权利要求13所述的方法，其中使本体部分扩展开导致所述本体部分纵向缩短，
15.一种血管内袖带，其包括：
至少一个股线，所述股线编织成管形器械，所述管形器械具有第一层和第二层和穿过所述管形器械延伸的内腔，所述器械具有细长、松弛和展开构形；
由此在细长结构中，所述管形器械能够插入导管中；
由此在松弛结构中，所述管形器械具有第一端部和第二端部，所述第一端部和第二端部具有比位于第一端部和第二端部之间的本体部分更大的直径，所述管形器械还具有形成在所述管形器械中、在所述第一层和所述第二层之间的间隙。
16.根据权利要求15所述的血管内袖带，其中所述至少一个股线包括镍钛诺。
17.根据权利要求17所述的用于接纳假体的血管内袖带，其中通过将所述管形器械在其自身内倒转来形成所述第一层和所述第二层。
18.根据权利要求17所述的血管内袖带，其还包括置于所述第一层和所述第二层之间的材料。
19.根据权利要求18所述的血管内袖带，其中所述材料包括织物。
20.根据权利要求15所述的血管内袖带，其中为了形成所述间隙，在松弛结构中所述端部中的至少一个端部在其自身上折叠起来。
21.根据权利要求15所述的血管内袖带，其中在松弛结构中，所述内腔在接近第一和第二端部处向外展开。
22.一种防止在假体瓣膜和血管壁之间泄漏的方法，其包括：
在植入所述假体瓣膜前在血管中展开自扩展袖带，所述袖带具有两层的本体和被截留于两层之间的非织造织物层；
允许所述袖带的端部扩展并且形成抵靠所述血管壁的密封，同时所述袖带的中心本体部分包括向内弯曲侧壁，其中所述端部中的至少一个端部呈蘑菇状扩展，使得在端部的层之间形成间隙，从而形成漏斗，所述漏斗用于将传输导管引导进入所述袖带中的内腔中心，并且允许外层倚靠原生组织与所述原生组织一致，而内层形成所述漏斗；
在允许端部扩展步骤之后植入所述假体瓣膜至所述向内弯曲侧壁；
使得所述袖带形成在所述血管壁和所述假体瓣膜之间的密封；
其中扩展所述袖带的所述内腔导致所述端部中的至少一个端部折叠。
23.根据权利要求22所述的方法，其还包括在所述袖带的内腔内扩展开所述假体瓣膜。
24.根据权利要求23所述的方法，其中在所述袖带的所述内腔内扩展开所述假体瓣膜导致所述袖带的本体部分扩展开。
25.根据权利要求24所述的方法，其中使本体部分扩展开还包括使所述本体部分纵向缩短。
26.一种防止在假体瓣膜和血管壁之间泄漏的方法，其包括：
在植入所述假体瓣膜前在血管中展开自扩展两层袖带；
允许所述袖带的端部扩展并且形成在所述端部的所述层之间的间隙，使得外层形成抵靠所述血管壁的密封，同时所述袖带的中心本体部分包括向内弯曲侧壁，其中所述端部中的至少一个端部呈蘑菇状扩展以形成所述间隙，而内层形成漏斗，所述漏斗用于将传输导管引导进入所述袖带中的内腔中心；
在允许端部扩展步骤之后植入所述假体瓣膜至所述向内弯曲侧壁；
其中当所述内腔扩展开时所述袖带的端部被构造和设置成折叠。
27.根据权利要求26所述的方法，其还包括在所述袖带的内腔内扩展开所述假体瓣膜。
28.根据权利要求27所述的方法，其中在所述袖带的所述内腔内扩展开所述假体瓣膜导致所述袖带的本体部分扩展开。
29.根据权利要求28所述的方法，其中使本体部分扩展开还包括使所述本体部分纵向缩短。
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AU2013242857A1 (en) 2013-10-31
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AU2011253834B2 (en) 2013-07-11
EP3005979B1 (en) 2018-03-28
CN101247774B (zh) 2013-11-20
US20170265999A1 (en) 2017-09-21
US20060276874A1 (en) 2006-12-07
US10368985B2 (en) 2019-08-06
US20140155996A1 (en) 2014-06-05
CA2614492C (en) 2014-08-05
CA2614492A1 (en) 2006-11-30
WO2006128185A3 (en) 2007-04-05
US9180003B2 (en) 2015-11-10
AU2006251990A1 (en) 2006-11-30
US20160051363A1 (en) 2016-02-25
AU2006251990B2 (en) 2012-02-23
EP3005979A1 (en) 2016-04-13
CN101247774A (zh) 2008-08-20
US9877829B2 (en) 2018-01-30
JP2008541886A (ja) 2008-11-27
AU2013242857B2 (en) 2016-07-14
AU2011253834A1 (en) 2012-01-12
CN103584929B (zh) 2017-07-21
US8663312B2 (en) 2014-03-04
WO2006128185A2 (en) 2006-11-30
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EP1954212A2 (en) 2008-08-13
EP1954212A4 (en) 2013-01-23

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