CN108348323A - 植入物固位、脱离以及递送系统 - Google Patents

植入物固位、脱离以及递送系统 Download PDF

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CN108348323A
CN108348323A CN201680063495.XA CN201680063495A CN108348323A CN 108348323 A CN108348323 A CN 108348323A CN 201680063495 A CN201680063495 A CN 201680063495A CN 108348323 A CN108348323 A CN 108348323A
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propeller
retention system
implantation material
holder
delivery system
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CN108348323B (zh
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I·塞佩特卡
C·雷
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Micro Cents America Ltd
MicroVention 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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Abstract

描述了一种医用植入物递送系统。所述系统可以用于递送各种植入物，包括支架和/或支架移植物。所述递送系统在靶位置递送和脱离植入物中固位植入物。

Description

植入物固位、脱离以及递送系统
相关申请
本申请要求2015年9月18日递交的、题目为“Implant Retention,Detachment,andDelivery System”的美国临时申请序列号62/220,905和2015年9月22日递交的、题目为“Implant Retention,Detachment,and Delivery System”的美国临时申请序列号62/222,063的权益，其两者通过引用以其整体并入本文。
背景技术
医用植入物诸如支架有时用于打开血管以缓解血小板积聚的影响，用于防止动脉瘤内的栓塞物质逃脱，作为分流器以限制血液流向某些区域，或出于其他原因。这些植入物能够通过植入物递送系统递送，其中使用细长推进器以将植入物推进通过导管或护套至治疗位点。
递送植入物诸如支架可能是具有挑战性的，因为许多递送系统在植入物初次部署后并不允许将其再次定位。因此，如果植入物初次部署到非期望位置，医师没有办法调整植入物的部署位置。所以，需要这样一种植入物递送系统，其提供了植入物的再定位能力，以及可靠的释放结构以部署植入物。
发明内容
描述了一种植入物递送系统。所述植入物递送系统能够用于支架、支架移植物、栓塞线圈、塞、堵闭器或其他植入物。
在一个实施例中，植入物递送系统包括植入物和固位结构。
在另一实施例中，植入物递送系统包括植入物和固位结构。固位结构布置在细长推进器远端部分，且由筛或环结构组成。
在另一实施例中，植入物递送系统包括植入物和固位结构。植入物固定于所述固位结构。
在另一实施例中，植入物递送系统包括植入物和固位结构。固位结构包括夹紧植入物的元件。
在另一实施例中，植入物递送系统包括植入物和固位结构，其中所述固位结构与植入物分离且在植入物从递送系统脱离后保留于递送系统。
在另一实施例中，植入物递送系统包括植入物、固位结构和一个或多个系链。
在另一实施例中，植入物递送系统包括细长推进器构件，所述推进器构件具有布置在推进器构件的远端部分并与植入物接合的固位结构。推进器、固位结构和植入物布置在导管或护套内，并且可以前行到在导管的远端的之外。固位结构可以是锥形筛，其围绕植入物的近端而设置。固位结构也可以是多个环，其围绕植入物的近端而布置或穿过植入物上的环而设置。植入物还可以通过一个或多个系链进一步连接于推进器，所述系链可以通过至少部分位于推进器内的机构而断裂。
附图说明
本发明的实施例能够的这些和其他方面、特征和优点将通过以下对本发明的实施例的描述变得清楚和阐明，参考附图，其中：
图1示出了与本发明的递送系统一起使用的梭织支架的示例实施例。
图2示出了与本发明的递送系统一起使用的梭织双层支架的示例实施例。
图3示出了具有筛或梭织固位结构的递送系统的实施例的侧视图。
图4和5示出了图3的递送系统在多种部署状态下的侧视图。
图6示出了具有筛或梭织固位结构和系链的递送系统的另一实施例的侧视图。
图7示出了与本发明的不同实施例一起使用的推进器的侧视图。
图8示出了具有包括固位结构的多个环的递送系统的另一实施例的侧视图。
图9示出了图8的环状固位结构和推进器的侧视图。
具体实施方式
现在将参照附图描述本发明的具体实施例。然而，本发明可以以许多不同的形式来实施，并且不应该被解释为限于本文阐述的实施例；相反，提供这些实施例是为了使本公开透彻和完整，并且将本发明的范围充分地传达给本领域技术人员。在附图中示出的实施例的详细描述中使用的术语不旨在限制本发明。在附图中，相似的数字表示相似的元件。
美国专利No.8,182,506、8,192,480、8,460,332和美国专利公开No.US20060200192、US20090062812、US20090163780、US20100268204、US20110301686、US20150289879通过引用以其整体并入本文。这些参考文献公开了能够与本文所描述的植入物递送系统结合使用的植入物脱离系统。这些参考文件一般地公开了热脱离系统，其中系链连接于植入物且通过激活加热线圈而选择性断裂从而引发植入物部署。
本发明总体上涉及一种具有植入物固位结构的植入物递送系统，所述植入物固位结构能够改善植入物部署以及取回没有充分部署的植入物。本发明的植入物固位结构特别用于部署和重新定位支架，诸如图1和2中所示的以及下文更加详细描述的那些。
图1示出了由一根或多根线2梭织或编织到一起的支架1，形成了具有围绕支架1两端周长的多个环4的大体上的圆柱形。线2的端可以通过熔接、粘合剂、或类似的粘结机制彼此连接。一旦端被熔接或粘合，线2没有“自由”端。
环4中的每一个可以包括一个或多个线圈构件6。优选地，线圈构件6围绕环4的线2而布置，并由不透射线的材料组成以指示支架1的近端和远端。此外，这些线圈构件6可以在递送设备中提供额外的锚固力，如下面的更详细的介绍。
在一个实例中，支架1的远端包括至少两个环4，每个环4具有两个线圈构件6，且支架1的近端包括至少两个环4，每个环4具有一个线圈构件16。但是，应当理解，支架1能够在任意数量的环4上包括任意数量的线圈构件6。
优选地，这些线圈构件6位于靠近环4的中央区域，以使得当支架1处于折叠状态(collapsed state)时，线圈构件6位于支架1的极近端和极远端附近。
优选地，每个线圈构件6由将围绕一部分环4的钽线5组成。每个线圈构件6可以由独立的钽线5组成或者单个钽线5可以形成多个线圈构件6(如图1所示)。如图1所示，线5可以通过定位在支架1的内部和内腔内而连接于在支架100的每端的线圈构件6。或者，线5可以梭织入支架1的线2。
用于在撤回期间使远侧线圈6的暴露最小化的一个具体技术，是梭织支架1，使得部分线2与具有线圈6的环4的侧面重叠(即位于更大外径的位置)。梭织一些更小的次级环7以重叠包括线圈6的环4的第一侧面，同时其他次级环7梭织在环4的第二侧面的下方。
图2示出了根据本发明的双侧支架20的优选实施例。通常，双侧支架20包括类似于图1中所示的前面描述的支架1的外锚固支架1。双侧支架20也包括布置在锚固支架1的内部的腔和通道内的内流动转移层22。内流动转移层22优选由线24制成以形成筛类结构。
双层支架20的近端包括多个附接构件26，其将流动转移层22与锚固支架1连接。附接构件26可以由钽线(在这种情况下直径是0.001")组成且附接于部分线2和线24。在另一实施例中，流动转移层22的近端能够卷曲到锚固支架1的线2上。在另一实施例中，为了附接目的，部分支架1和流动转移层22可以梭织成相互交织。
每个支架1和20的其他细节可以在美国专利公开号No.2013/0245745中找到，通过引用以其整体并入本文。
图3示出了植入物递送系统100的一个实施例，所述植入物递送系统具有细长推进器110和从所述推进器110的远端部分延伸的固位结构102。推进器110、固位结构102和支架1(或者另外的植入物设备)位于导管112内，使得至少一部分固位结构102重叠于支架1的近端部分。导管112阻止固位结构102和支架1从在部署之前的径向压缩配置而扩张。
参考图4和5，因为推进器110朝向导管112的远端前行，因此固位结构102向远端开成圆锥形，从而允许支架1类似地打开。如果支架1在病人内的位置并不理想，推进器110和附接的固位结构102可以近似地退回至导管112内，引起支架1类似地压缩并退回至导管112内，用于再次定位和再次部署。固位结构102允许撤回支架1，即便在支架1完全在导管112以外之后。这很重要，因为直到支架1完全在导管112以外，也不知道在缩短后支架1的确切位置和支架1的真实长度。固位结构102允许准确放置支架1的更多机会，因此医师有更多机会将支架1重新设置到期望的位置，如果支架1的初次部署不理想。
在一个实施例中，固位结构102为筛管形状，由一个或多个编织或梭织的线(例如镍钛合金线)形成。或者，筛可以由激光切割或蚀刻固体管结构而形成。固位结构102的近端固定或安装于推进器110的远端部分，通过熔接、粘结剂、机械固定或这些方法的任意组合。
固位结构102还可以包括一个或多个固定于其筛104的接合元件106，以在接合支架1中协助固位结构102。接合元件106可以采用聚合或金属突出物的形式，其为以下一种或多种形状：球形、椭圆形、卵形、棱锥形、矩形、圆锥形、截锥形、截棱锥形、正方形或类似形状。这些接合元件106可以通过粘结剂、线或纤维带或熔接而附接，以使得他们从固位结构102径向向内突出。调整接合元件106的尺寸并将其置于筛104上，从而至少部分地适配在支架1中的缝隙内。例如，接合元件106可以与端环4、次级环7或支架1的梭织线之间形成的缝隙对准。在这方面，当固位结构102和支架1径向压缩在导管112(或递送护套)内时，接合元件106阻止支架1在导管112内横向或轴向移动，阻止支架1脱离直到固位结构102暴露并径向扩张。
图3中示出的固位结构102具有喇叭形或圆锥形远端部分，其可有助于确定支架1在递送和部署期间是锁住或接合的。在连接于推进器110之前，筛104可以热定型以形成径向扩张的管形，使得一旦筛104的近端连接于推进器110，筛104扩张成圆锥形。或者，在连接于推进器110之前，筛104可以热定型以形成喇叭形/圆锥形。在另一个替换实施例中，筛104可以热定型以形成圆锥形，在其远端处具有突然向内形成锥形的锥形形状，以用作抵靠支架1的钩或环形脊。在另一个替换实施例中，筛104可以形成沿其长度在直径上增加和减少的波浪形。
在图2-5的递送系统100的实施例中，推进器110可以是细长的构件，其足够柔软以前行穿过患者的血管系统，同时维持足够的可推性以将固位结构102和支架1推出导管112。
参考图2-5，在操作中，导管112的远端前行至患者的血管系统内的靶治疗位置(或该位置附近)。该定位通过以下方法实现：首先使引线前行，使得引线的远端位于或在靶治疗位置附近。递送护套可以在引线上前行，使得其远端位于靶治疗位置，或者导管112可以在引线上前行而无需递送护套。在病人的脉管系统中定位导管的多种不同技术是本领域公知的，并且可以用于本发明的实施例中。
一旦导管112的远端位于期望位置，推进器110向远侧前行。如图4所示，支架1的远端部分被推出导管112并开始径向扩张。随着支架1继续向远侧前行，固位结构102也向远侧前行而离开导管112，虽然全部处于在导管112之外，支架1的至少一部分近端维持为径向压缩(或部分压缩)配置。
如果支架1的远端部分没有部署到血管中的期望的靶位置，推进器110可由医师从近端退回。因为固位结构102退回，其径向压缩，因此压缩支架1的近端以允许其重新进入导管112的内腔。接合元件106帮助固位结构102抓紧并推支架1，确保支架1不会滑出固位结构102。一旦一部分支架1重新进入导管112，支架1的剩余部分同样也可以退回到导管112中。
最后，重新定位导管112，并且将推进器110向远侧前行以如上所描述的部署支架1。一旦固位结构102已经充分前行到导管112之外，如图5所示，其径向扩张至足够的尺寸以与支架1脱离。推进器110和固位结构102从近端退回至导管内112，并且导管112从病人退回。
图6示出了递送系统120的另一个实施例，其通常在结构上和功能上与上面描述的递送系统100类似。但是，递送系统120进一步包括系链122，其连接于推进器110并能够当完全部署在期望的靶位置时选择性地从支架1释放。系链122可以是固定于推进器110并附接于支架1(例如通过粘结剂、机械连接或熔接)的近端环的单丝。在图6中(以及可选地在图8和9中)描述的系链特征可以用于与固位结构102连接或代替固位结构102。
图7示出了图6的推进器110的实施例，其示出了解连接功能。如图7所示，支架1可以通过系链122连接于推进器110，并且能够选择性激活从而断裂系链122继而释放支架1。更具体地，电阻加热线圈130连接于从近端电源选择性供电的电线131和132。当供电时，加热线圈130被加热，系链122断裂。隔热罩134和加强环136布置在推进器110的外部分以热隔离并加固推进器110的结构。
在图7的实施例中，系链122延伸穿过支架1的指向近侧的线圈部分130和线圈140，并且通过粘结剂140进一步粘结。但是，系链122也可以附接于推进器110的两端，形成围绕支架1的端环4中的一个或多个的环。
图8示出了推进器110的另一实施例，其具有由多个环152组成的固位结构150。环152可以压靠在端环4的每一个的外表面以帮助维持支架1的近端部分处于与所描述的固位结构102相似的压缩配置。或者，环152的每一个可以放置成穿过支架环4或7的每一个。
如果环152位于支架环4的外侧(即不穿过环4)，该递送方法与图4和5所示的递送系统100相似。如果环152放置成穿过支架环4(即以“锁链状”链锁方式)，该递送方法与图6所示的递送系统120相似，相对于图7所示的脱离。
虽然示出固位结构150具有三个环152，但是也可以使用不同数量的环152，诸如2、4、5、6、7、8、9或10个。在一个实施例中，环152的数量等于在支架1的端部的支架环4的数量。在另一个实施例中，环152的一个或多个可以穿过多于一个支架环4。
如果环152位于支架环4的外侧(即不穿过环4)，它们可以由形状记忆合金组成。如果环152放置成穿过支架环4(即以“锁链状”链锁方式)，环152优选由能够通过在推进器110中的机构脱离或断裂的聚合物组成。例如，推进器110可以是图7所显示的，并且因此配置为产生热量以沿着环152断裂至少一个链或位置。
如图9所示，每个环152也能够具有两个自由端，两个自由端均向内固定于推进器110(即，最初为线性配置)，或者每个环152最初能够形成完整的环丝，其中环上的单个位置固定在推进器110内。在具有两个自由端的布置中(即线性链)，优选环152的每个链的仅一个端部或部分穿过加热线圈130而在链的相反端的一部分位于加热线圈130的外部。该链也可以穿过接近加热线圈130的绝热套管160以将其热隔绝于加热线圈130产生的热。在该方面，一旦切断环152，在断裂后，环152的链的剩余部分仍然通过加热线圈130连接于推进器110，并且支架环4从推进器110释放。
推进器110的其他实施例使用了多个腔结构，其中加热线圈130和环152的第一部分位于一个内腔内，且环152的第二部分位于分开的外腔中。该分开的腔可避免环152的第二部分与加热线圈130有任何接触。
另外的实施例可以使用多个环结构，诸如一个抓紧所有支架环4的递送环152以及仅抓紧一个支架环4的分开的、单独的递送环152。另外的变体可以使用小于所提供的支架环4的总数的递送环152。因此，例如，三个支架环4可以与两个递送环152一起使用。在另一实施例中，一个递送环152接合两个支架环4，且其他递送环152接合仅一个支架环。另外的实施例可以针对每个支架环4使用多个环结构152(例如两个递送环152捕捉每个支架环4)以进一步增强固位。变体也是可能的，其中使用多种所描述的实施例中的每一个的组合(例如，一些支架环4使用多个递送环152，一些支架环4仅使用单个递送环152，以及一些递送环152抓紧多个支架环4)。
应当理解，来自本文所呈现的多个实施例的元件或方面可以以广泛的不同配置而组合。例如，一个实施例可以使用筛固位结构102、递送环固位结构150和系链122而进一步增强植入物递送系统的固位能力。
一个或多个系链122的存在并不必然地防止支架1从导管112退出后扩张，因为支架1当递送时一般具有较强的形状记忆并且很快采用他们的扩张状态。但是，如果系链122张力足够高，系链122的张力可以防止支架1的近端部分扩张，并且因此保持支架1连接于固位结构102。弹簧、线圈或管可以用来保持系链122处于紧张状态以进一步增强系链122的张力。
对于使用一个或多个系链122的实施例，延迟系链122的脱离直到支架1完全扩张之后可以允许支架1在附接(多个)系链122的同时重新定位，因为(多个)系链122连接支架1以递送推进器110(一些其他变体可仍然影响重新定位能力诸如支架1的尺寸和种类以及血管的狭窄度)。一旦固位结构102与系链122脱离，支架1从推进器110完全脱离并且在这点后可能不能重新定位。
所描述的递送系统实施例可以用于递送一个或多个植入物，诸如支架、支架移植物、栓塞线圈、堵闭器、塞和类似设备。虽然在该说明书的实施例中描述了支架的实例，但是可以类似地使用这些其他任意植入物。例如，为了递送栓塞线圈，筛状固位结构102支承栓塞线圈的近端部分以用于可释放递送。栓塞线圈的近端部件可以具有接收结构以容纳固位结构102的接合元件106。其他植入物还可以包括在那些植入物的近端区域中的环结构4。
所示和/或描述的任何附图并不意味着仅限于所示的内容，而是本质上是说明性的。类似地，对材料的任何测量和/或描述都意味着表示，近似和示例，而不是明确限制。
尽管已经根据特定实施例和应用描述了本发明，但是本领域普通技术人员根据该教导可以产生另外的实施例和修改而不偏离所要求保护的发明的精神或超出范围。因此，应该理解，本文的附图和描述是通过举例的方式提出的，以便于理解本发明，并且不应该被解释为限制其范围。

Claims (19)

1.一种用于植入物的递送系统，包括：
细长推进器，所述推进器具有远推进器端和近推进器端；
固位结构，所述固位结构具有固定于所述推进器靠近所述远推进器端的近结构端，以及从所述远推进器端向远侧延伸的远结构端；所述固位结构具有径向压缩配置和径向扩张配置；以及
植入物位于靠近所述远推进器端且与所述固位结构相接触；其中所述固位结构在所述径向压缩配置下接合所述植入物并且在所述径向扩张配置下释放所述植入物。
2.根据权利要求1所述的递送系统，其中所述固位结构由一个或多个由编织线形成的筛组成。
3.根据权利要求2所述的递送系统，其中所述固位结构在所述径向压缩配置下具有管状形状且当处于所述径向扩张配置时具有相对于所述细长推进器向远端开口的锥形形状。
4.根据权利要求3所述的递送系统，进一步包括多个固定于所述固位结构、并且径向朝向所述固位结构内突出的接合元件。
5.根据权利要求4所述的递送系统，其中所述植入物为具有从其近端伸出的多个环的支架。
6.根据权利要求5所述的递送系统，其中所述固位结构与所述支架的近端部分重叠。
7.根据权利要求6所述的递送系统，进一步包括连接于所述支架和连接于所述细长推进器的系链，所述细长推进器配置为选择性断裂所述系链。
8.根据权利要求1所述的递送系统，其中所述固位结构与所述支架的近端部分重叠。
9.根据权利要求8所述的递送系统，其中所述多个环与所述植入物径向重叠。
10.根据权利要求8所述的递送系统，其中所述植入物为支架且所述多个环延伸穿过所述支架的部分。
11.根据权利要求8所述的递送系统，进一步包括连接于所述细长推进器和所述植入物的系链。
12.一种用于植入物的递送系统，包括：
导管，所述导管具有经由远导管端和近导管端之间的通道；
细长推进器，所述细长推进器具有远推进器端和近推进器端；所述细长推进器布置在所述导管的所述通道中，以在长度上相对于所述导管而移动；
固位结构，所述固位结构具有固定于所述推进器靠近所述远推进器端的近结构端，以及从所述远推进器端向远侧延伸的远结构端；所述固位结构具有径向压缩配置和径向扩张配置；以及，
植入物位于靠近所述远推进器端且与所述固位结构相接触；其中所述固位结构在所述径向压缩配置下在所述导管的所述通道内接合所述植入物并且当向远侧前行到所述远导管端的外部时在所述径向扩张配置下释放所述植入物。
13.根据权利要求12所述的递送系统，其中所述固位结构由多个或多个由编织线形成的筛组成，并且其中所述固位结构在所述径向压缩配置下具有管状形状且当处于所述径向扩张配置时具有相对于所述细长推进器向远端开口的锥形形状。
14.根据权利要求12所述的递送系统，其中所述固位结构由多个环组成，并且其中所述多个环与所述植入物径向重叠。
15.根据权利要求12所述的递送系统，其中所述固位结构还包括：
筛，所述筛由多个或多个编织线形成；以及
多个接合结构，所述接合结构连接于所述筛并从其突出；
其中所述多个接合结构接合在所述植入物上的一个或多个环。
16.一种递送支架的方法，包括：
在导管的通道内向远侧前行的细长推进器；所述细长推进器在其远端具有植入物固位结构，所述植入物固位结构与所述支架接合并位于其上方；以及，
将所述支架向远侧前行到完全在所述导管之外，同时维持所述植入物固位结构域所述支架的结合。
17.根据权利要求16所述的方法，进一步包括向近侧退回所述细长推进器，以使得所述支架从近侧退回到所述导管内。
18.根据权利要求16所述的方法，其中所述固位结构为围绕所述支架的近端部分放置的圆锥形筛。
19.根据权利要求18所述的方法，进一步包括断裂连接于所述细长推进器和所述植入物的系链。
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