CN105208950A - 一种用于从血管去除堵塞凝块的凝块收取装置 - Google Patents
一种用于从血管去除堵塞凝块的凝块收取装置 Download PDFInfo
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- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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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
一种用于从血管去除堵塞凝块的凝块收取装置(1),所述装置包括内侧细长体(3),其具有塌缩的递送形态和扩张的布署形态,和外侧细长体(2),其至少部分地包叠内侧细长体(2)。外侧细长体(2)在布署形态可扩张到比内侧体(3)的径向尺寸大的径向尺寸以限定出凝块接纳空间(11)。外侧细长体(2)包括远端部分(24,49),内侧细长体(3)包括主体部分(10)和远侧部分,所述远侧部分在布署形态朝向外侧细长体(2)延伸到比主体部分大的尺寸。内侧细长体(3)的远侧部分(10)和外侧细长体(2)的远端部分(24,49)一起限定出三维保护结构,用以实质上防止凝块或凝块碎片从所述装置向远侧放出。
Description
技术领域
本发明涉及从血管去除急性阻塞物的装置和方法。本发明尤其涉及从血管去除急性阻塞体。急性阻塞体可包括凝块,错置的器件,迁移的器件,大血栓等等。血栓的一部分或全部从血管壁上碎裂离开时,会发生血栓栓塞。这种凝块(现在称作血栓)会被沿血流方向携载。如果凝块沉积在脑血管中,可能会导致缺血性脑卒中。如果凝块起源于静脉系统或心脏右侧并且沉积于肺动脉或其支脉,可能引起肺血栓。凝块还可能局部生长和堵塞血管,而未增大到血栓的形式--这种机制在冠状脉阻塞物的形成中是常见的。本发明特别适合于从患有急性缺血性脑卒中(AIS)的患者脑动脉去除凝块,从患有肺血栓(PE)的患者的肺动脉去除凝块,从患有心肌梗死(MI)的患者的自身或移植冠状血管中去除凝块,以及从其中凝块正在引起阻塞的其它外周动脉和静脉血管去除凝块。
背景技术
在设计能够传递高级性能的凝块去除装置方面,存在很大的挑战:
在导入方面有多种挑战,使得难以导入装置。在导入涉及导引通过主动脉弓(例如冠状脉或脑阻塞物)的情况下,一些患者的动脉弓的形态导致难以定位导管。这些造成困难的动脉弓形态被分级为2型或3型主动脉弓,其中3型动脉弓表示难度最大。在接近脑的动脉中,转弯曲造成的挑战更为严重。例如,不难遇到的是,在颈内动脉的远端,所述装置需要导引通过在血管的几厘米长度内急剧连续存在180°转弯、90°转弯和360°转弯的血管段。在肺血栓的情况下,可以通过静脉系统然后穿过心脏的右侧心房实现导入。右心室流出道和肺动脉是很纤弱的血管,很容易被柔性不够或大轮廓的装置损伤。出于这些原因,希望凝块收取装置尽可能在小轮廓与柔性的导入和支撑导管方面兼容。
位于其中可能沉积了凝块的区域中的血管常是脆弱和纤细的。例如,神经血管比身体其它部位的类似尺寸的血管更脆弱,并且位于软组织床中。施加到这些血管的过大的张力可能导致穿孔和出血。肺血管大于脑血管系统中的血管,但本质上也是脆弱的,特别是那些位于更远侧的血管。
凝块可包括任何形态和一致性范围内的凝块。较软的凝块材料的长链可能倾向于沉积在双岔口或三岔口,导致多根血管被同时堵塞很大的长度。更为成熟和组织化的凝块材料常常具有比较软的新鲜凝块更不容易挤压,并且在血压作用下可能导致被其堵塞的顺应性血管肿胀。此外,发明人发现,在受到与其交互作用的所述装置的影响时,凝块的特性会显著变化。特别是,挤压血液凝块导致凝块失水,并且引起凝块硬度和摩擦系数两方面的剧增。
凝块不但在形状和一致性方面存在很大范围,而且长度可能有很大不同,即使是在任何一个给定的解剖学区域中。例如,堵塞缺血性脑卒中患者的中脑动脉的凝块的长度可能从仅有几毫米到几厘米。
支架状凝块提取器被越来越多地使用来从急性中风患者的脑血管去除凝块。它们是自扩张装置,外形类似于附连在长轴杆端部的支架,并且被进给通过微导管,且被布署贯穿凝块阻塞体以便捕获和提取阻塞体。它们基于钉入机构通过将凝块捕获在自扩张支架本体和血管壁之间来抓住凝块。这种措施存在多种缺点:
支架状凝块提取器利用其向外径向力(RF)来保持其抓在凝块上。如果RF太低,支架状凝块提取器将丧失其在凝块上的抓持能力,但是如果RF太高,支架状凝块提取器可能损伤血管壁并且可能需要太高的力来撤出。因此,具有足够的径向力以便应对所有凝块类型的支架状凝块提取器可能引起血管创伤和严重患者伤害,并且具有适宜的径向力以防止外伤的支架状凝块提取器可能不能有效地处理全部凝块类型。
支架状凝块提取器的钉入机构趋向于挤压捕获的凝块。这种挤压力将趋向于导致凝块失水,这反过来又趋向于增大其摩擦系数,使得难以从血管去除。
对于传统支架状凝块提取器设计,在以张紧状态放置于转弯中时,由于它们的支杆元件被连接到彼此这种方式,不能很好地维持其扩张形状。这可能导致在支架状凝块提取器绕着转弯血管中的转弯向近侧撤出时丧失对凝块的抓持能力,有捕获的凝块逃逸的潜在可能。这种现象是因为支架状凝块提取器支杆在缩回时处于张紧状态。这种张紧是由于所述装置和血管之间的摩擦力,并且如果有额外的负载被施加,例如由凝块施加的负载,张紧力会增大。在转弯中,位于转弯外侧的支杆承受比转弯内侧的支杆更高的张力。为了达到最低可行能量状态,支架的外表面朝向转弯的内表面移动,这降低了支杆的张力,但也会减小支架状凝块提取器的扩张直径。
上述措施的另一缺点在于将凝块钉在支架状凝块提取器和血管壁之间,并且因此在经过分支血管或在进入比支架状凝块提取器的完全扩张直径大的血管时,可能不能有效地保持住凝块。
将凝块钉在支架状凝块提取器和血管壁之间以便将其从血管去除,还导致在凝块移动时在凝块侧面上产生高剪力,潜在地可能释放凝块碎片。如果这些碎片脱离所述装置的约束,它们被释放可能导致远侧血管进一步阻塞。
在试图去除长凝块时遇到的特别难题是,传统装置可能比凝块自身短。比凝块短的装置在布署后有可能不能够使血液恢复流过堵塞区域,并且因此凝块两侧的压力梯度造成对凝块去除的显著阻碍。简单地将装置制作成较长,容易导致装置难以被引导通过转弯解剖学组织并且可能创伤血管,需要更大的力撤出,潜在地可能造成滞留且需要手术去除。
出于许多原因,包括前面描述的限制中的一些或全部,常需要医师多次将凝块收取装置穿过血管以便完全去除堵塞性凝块。然而,每次撤出凝块收取装置后,通向目标位置的进入通道就失去了。这就必须重新进给导丝和微导管以到达并重新传入凝块,然后撤回导丝并且使得凝块收取装置经过微导管。将导丝和微导管到引导凝块可能要消耗很长的时间,尤其在血管是转弯的时。这种额外的时间和装置操控都增加了患者面临的危险。
对于任何上述装置,都要克服上面描述的挑战,以提供去除凝块时高级别的成功性,恢复血流,并且实现患者的良好预后。现有的装置不能适当地解决这些挑战。
发明内容
根据本发明,提供了一种用于从血管去除堵塞凝块的凝块收取装置,所述装置包括:
内侧细长体,其具有塌缩的递送形态和扩张的布署形态;
外侧细长体,其至少部分地包叠内侧细长体;
外侧细长体在布署形态可扩张到比内侧体的径向尺寸大的径向尺寸以限定出凝块接纳空间;
其中,外侧细长体包括远端部分;并且
其中,内侧细长体包括主体部分和远侧部分,所述远侧部分在布署形态朝向外侧细长体延伸到比主体部分大的尺寸,
内侧细长体的远侧部分和外侧细长体的远端部分一起限定出三维保护结构,用以实质上防止凝块或凝块碎片从所述装置向远侧放出。
在本发明的这个方面,通过朝向所述装置的远端提供远侧网或支护架区贯穿血管管腔,栓塞危险被减小。在这种情况下,该支护架附存于内侧件或外侧件或二者,并且是三维的,因为具有深度以及表面面积。将内侧和外侧件二者的支护架组合,提供了比采用单个件时更为有效的过滤器。在一些情况下,利用纤维或细丝来提供附加的支护架,而对装置轮廓或传导性能的影响最小。
在一种实施方式中,内侧细长体的远侧部分包括多个支杆,它们被构造成体积模式。
在一种情况下,内侧细长体的远侧部分包括鼓出的或喇叭口形的支杆构架。
在一种实施方式中,外侧细长体的远端部分包括远侧支杆。在一种情况下,外侧细长件的远端部分的远侧支杆被构造成大体圆锥形。
在一种实施方式中,中的至少一些所述支杆包括附连点,所述支杆中的至少一些包括附连点,例如孔眼,用于接纳纤维。保护结构可包括多个纤维以提供远侧网。
在一种实施方式中,外侧细长体包括第一单体结构。
在一种实施方式中,内侧细长体包括第二单体结构。
在一种情况下,其中,内侧细长体在外侧细长体的近端的近侧延伸。
在一种实施方式中,外侧细长体包括多个凝块接收开口和多个凝块接合区,并且其中,凝块接合区被配置成在与凝块接合时朝向凝块接收开口推动凝块并且使其进入到外侧细长体和内侧细长体之间的接纳空间中。
外侧细长体的凝块接合区包括支护开口,凝块接收开口远大于支护开口。
在一种实施方式中,外侧细长体包括至少两个纵向相隔的区段。可有至少一个铰链提供在所述区段之间。
所公开的设计克服了现有机械式血栓去除方案中的许多缺点。
这里使用了各种可互换的术语来描述本发明的那些被构造成与凝块接合、大体布署在凝块内部并与其接合的部件。这些术语包括“凝块接合部分”,“可扩张件”,“可扩张本体”,“凝块接合元件”;同时,术语“细长篮体”,“接合篮体”和“支架篮体”,也可被用于描述所述装置的这个部分。
公开了这样的设计,其中所述装置的凝块接合部分被构造成在血管中的堵塞凝块中扩张,以使得随着接合部扩张,正在扩张的接合部允许凝块迁移到接合部本体中的接纳空间中。接合部被传递通过导管到达堵塞位置并且定位在凝块内。接合部在堵塞位置可扩张并且随着其扩张挤压凝块。接合部表面包括入口开口,通过使得凝块的很大部分移动通过接合部壁中的入口开口,该入口开口允许凝块‘逃脱’挤压。由于凝块的很大部分被推动通过接合部中的入口开口,这最小化了凝块的挤压,并且因此最小化了所导致的凝块摩擦系数的增加。这还减小了在凝块区域施加于血管的径向力,这意味着撤出捕获的凝块仅需要较小的力,这又导致血管创伤较小且远侧血管床上的张力较小。还公开了所述装置被构造成使得所述装置的径向力强力作用在小直径上以便接合和抓取凝块,但柔和地作用在大直径上以便轻柔地接触血管壁。
具有双可扩张件的设计被公开,由此所述装置包括第一内侧可扩张件和第二外侧可扩张件内侧件基本上被布置在外侧件的管腔内。内侧和外侧件的特性可以彼此独立地定制。内侧件可具有与外侧件非常不同的径向力。内侧件可具有与外侧件非常不同的孔隙度级别。内侧件可具有与外侧件非常不同的完全扩张直径。内侧件的长度可以不同于外侧件。内侧件的支杆的形状可以不同于外侧件的支杆的形状。在扩张形态内侧件和外侧件之间可存在间隙。在塌缩形态内侧件和外侧件之间可存在间隙。内侧和外侧件之一或二者可具有沿着该件的壁的至少一部分纵向延伸的接缝,或者都不具有接缝。内侧和外侧件之一或二者可包括激光切割件、编织件、针织件、挤出件、拉挤件,内侧和外侧件之一或二者可以通过涉及激光切割步骤、编织步骤、针织步骤、挤出步骤、拉挤步骤、电抛光步骤、热处理步骤的工艺制造。内侧和外侧件之一或二者可包括带锥度的部位、喇叭口形部位、带封闭端的部位或中部封闭的部位。所述件之一或二者可包括大致管状或圆柱形部位。
这些双可扩张件装置具有多种益处。(1)内侧件可被构造成提供强张开力以产生通过凝块的管腔并且在布署后立即恢复血流。这种血流管腔减小了凝块两侧的压力梯度,使得容易去除凝块。(2)内侧件扩张达到的直径可被定制从而降低再灌注伤害的危险。利用这种实施方式,内侧件扩张至远小于紧邻堵塞部且位于其远侧的血管的直径的直径。这种小直径内侧件产生跨越堵塞部的小流动管腔,并且限制向脑的受影响部位的初始血流。这种受限的血流确保流动恢复马上施加到血管的压力低于常规压力,并且这减小了缺血性血管床流血的危险。通过去除所述装置和凝块,全灌注随后被恢复。(3)内侧件可被构造成扩张到比外侧篮体小的直径和扩张到比任何其中将要布署它的血管小的直径。这意味着强径向力可以安全地施加到凝块以打开流动管腔。但不需要施加到血管。(4)内侧件可用于支护穿过凝块产生的管腔,防止栓子从凝块释放到所产生的快速流动的血液流中。(5)内侧件可至少部分地包括支架并且能够在凝块上提供用于凝块从血管脱离的关键初始步骤的强抓力,使得外侧篮体可被构造成具有低径向力。(6)外侧件可被构造成具有大入口开口,从而推动凝块穿过外侧件的壁。另一方面,内侧件可被构造成防止凝块横贯外侧件的壁向远侧迁移或破碎或栓塞。通过构造外侧件从而促进凝块至横贯外侧件的壁,所述装置能够更有效地从血管的壁脱离凝块,并且所述装置还利用具有能够提供支护架的形状和子结构的内侧件有效地防止损失凝块材料。
还提供了这样的设计,其进一步降低这种栓塞危险通过提供跨越血管管腔朝向所述装置的远端的远侧网或支护架区。该支护架可以附存于内侧或外侧件中的任一个或附存于二者,并且可以是三维的,因为其具有深度以及表面面积。将内侧和外侧件二者的支护架组合,可提供比仅利用单件时更有效的过滤器。公开了这样的设计,其利用纤维或细丝来提供附加的支护架,而对装置轮廓或传导性能的影响最小。
公开了这样的装置设计,具有长且高柔性内侧件,其可明显地朝向外侧件近侧延伸,使得所述装置能够被用于提取特别长的凝块。小直径和具有柔性的内侧件扩张至提供通过凝块的流动管腔(减小压力梯度且使得凝块更容易去除)但不扩张到在其中布署它的血管的直径。因此,同其直径被构造成在全长范围与血管接合的类似长度的装置相比,所产生的装置可被更安全地递送和撤回(以小得多的力)。
还提供了这样的凝块收取结构设计,一些部分可从其脱开并且留在原位构成植入物。在所述装置遇到卡滞在某位置并且医师感觉到需要施加到提取装置的力太高而不能施加的事件时,可能希望以弹出选项而实现上述脱开。在堵塞部形成血栓或动脉粥状硬化的条件下这也可能是希望的--在这种情况下,外侧件可以脱开并且作为支架留下就位以维持通过凝块的流动管腔并且支护损伤部位。公开了这样的可脱开设计,其中外侧件可以从内侧件脱开,并且其中外侧件两端之一或二者可被重构成允许外侧件扩张到大体管状形状并且可位于损伤部位和/或血管壁对面。
本发明的各式各样的实施方式将在下面更详细地描述。在这些描述中,用于所述装置各部分的各种术语可以互换使用,如前所述。所描述的实施方式中的每个的后面都跟随着一系列进一步的属性(以词语“其中”引导),以描述前面的根本实施方式的更为细节的版本。预期任何这些属性可以与任何根本实施方式组合。但为了保持清楚和简明,不是所有的排列组合都被列出。
在一种实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,可扩张的凝块接合元件包括第一单体结构和第二单体结构,第一单体结构包围第二单体结构的长度的至少一部分,第二单体结构包括近侧部位、中间部位和远侧部位,远侧部位包括膨胀部。
这种实施方式的一些可选特征包括:
其中,第一单体结构被构造成实质上包封第二单体结构;
其中,第一单体结构包括近侧部位、中间部位和远侧部位,远侧部位包括围拢远端;
其中,凝块接合元件的远端包括围拢远端,所述围拢远端构造成捕获凝块碎片和/或防止凝块碎片向远侧迁移;
其中,扩张结构被构造成防止凝块碎片迁移;
其中,第一单体结构的远端包括围拢远端,所述围拢远端限定一表面,该表面构造为凝块碎片屏障面;
其中,凝块碎片屏障面包括支杆的互连网络;
其中,凝块接合元件的远侧部位被构造成提供三维屏障以阻止凝块迁移;
其中,所述装置还包括细长连接器元件,所述细长连接器元件包括近端和远端,近端连接到第二单体结构而远端连接到第一单体结构;
其中,细长连接器元件包括弹簧元件,并且所述弹簧元件与第二单体结构集成为一体;
其中,第一单体结构和第二单体结构在它们的远端相连;
其中,第一单体结构和第二单体结构不在它们的远端相连;和/或
其中,所述第一和第二单体结构的近侧部位被连接到细长件的远端。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,可扩张的凝块接合元件包括近侧区段、凝块接合区段和远侧区段,近侧区段构造成在使用时在凝块近侧延伸,并且远端构造成在使用时在凝块的远侧延伸,凝块接合区段构造成在其扩张状态与凝块接合,远端包括碎片保护结构,碎片保护结构包括构造成体积模式的多个支杆。
这种实施方式的一些可选特征包括:
其中,体积模式包括至少部分地锥形形状的体积模式;
其中,体积模式包括至少部分地圆柱形体积模式;
其中,体积模式包括至少一个多个互连支杆;
其中,体积模式包括至少两组互连支杆;
其中,体积模式包括围绕第一轴线布置的第一组支杆和围绕第二轴线布置的第二组支杆;
其中,第一轴线的位置可移动相对于第二轴线的位置;
其中,第一轴线和第二轴线包括中心线,并且在使用时所述中心线可包括直的和/或弯曲的中心线;
其中,各中心线相对于彼此可偏移;
其中,体积模式包括终止端;
其中,终止端包括终端连接部,用于所述多个支杆中的至少一些;
其中,终止端包括连接点,在此所述多个支杆被端接和/或连接;
其中,体积模式包括第一组支杆,和第二组支杆;
其中,第二组支杆被第一组支杆至少部分地包绕;
其中,第二组支杆围绕第一组支杆;
其中,第一组支杆是围绕第一轴线布置的,第二组支杆是围绕第二轴线布置的,并且所述第一和第二轴线大致平行;
其中,第一组支杆是围绕第一轴线布置的,第二组支杆是围绕第二轴线布置的,并且所述第一和第二轴线大致平行;
其中,第一组支杆具有圆锥形形状;和/或
其中,第二组支杆具有球形形状、扁球形形状、圆柱形形状或纺锤圆环面形状。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及可扩张的凝块接合元件,其包括第一管状结构和第二管状结构,第一管状结构至少部分地包围第二管状结构,第一管状结构包括近端、远端、近侧终止部和远侧终止部,第二管状结构包括近端、远端、近侧终止部和远侧终止部,第一和第二管状结构的近侧终止部被连接到细长件,第一和第二管状结构的远侧终止部被连接到彼此。
这种实施方式的一些可选特征包括:
其中,第一管状结构和第二管状结构包括互连支杆的单体结构;
其中,第一管状结构和第二管状结构包括纵向延伸结构;
其中,第一管状结构和第二管状结构均包括塌缩的递送形态和扩张的布署形态,并且第一管状结构在扩张形态和塌缩形态都是至少部分地包围第二管状结构;
其中,第一管状结构和第二管状结构之一或二者包括近侧套环,用于将第一管状结构和第二管状结构之一或二者连接至细长件的远端;
其中,至少一个近侧套环包括局部套环;和/或
其中,至少一个近侧套环是从海波管(hypotube)切割出的,并且围绕细长件的远端的至少一部分。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及可扩张的凝块接合元件,其包括第一管状结构和第二管状结构,第一管状结构至少部分地包围第二管状结构,第一管状结构和第二管状结构在连接点连接到细长件的远端,第一管状结构包括第一近侧连接支杆和第一连接器元件,第二管状结构包括第二近侧连接支杆和第二连接器元件,第一连接器元件在所述连接点包围第二连接器元件。
这种实施方式的一些可选特征包括:
其中,第一连接器包括套环;
其中,第二连接器包括套环或局部套环;和/或
其中,细长件包括远侧安全止挡,其构造成防止第一连接器和/或第二连接器朝向远侧运动。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,可扩张的凝块接合元件包括第一管腔式结构和第二管腔式结构,第一管腔式结构的直径大于所述第二管腔式结构,所述第一管腔式结构的远端包括朝向第一管腔式结构的轴线会聚的多个支杆,所述第二管腔式结构的远端包括从所述第二管腔式结构的轴线发散的多个支杆。
这种实施方式的一些可选特征包括:
其中,所述第一和第二管腔式结构的远端被构造成形成三维凝块碎片迁移屏障;
其中,所述第二管腔式结构的远端还包括曲折区,在此所述多个支杆的切线大致平行于所述第二管腔式结构的轴线;
其中,所述第二管腔式结构的远端还包括会聚区,在此所述多个支杆会聚到所述第二管腔式结构的轴线;
其中,所述第二管腔式结构的远端还包括第二远侧连接部,在此所述多个支杆终止(端接);
其中,所述第一管腔式结构的远端还包括第一远侧连接部,在此所述多个支杆终止(端接);
其中,第一远侧连接部位于第二远侧连接部的远侧;和/或
其中,第一远侧连接部通过连接器元件被连接到第二远侧连接部。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及凝块接合元件,其包括塌缩的递送状态和扩张的凝块接合状态,所述凝块接合元件构造成在其扩张状态延伸贯穿凝块,凝块接合元件包括近侧部位、中间部位和远侧部位,中间部位包括管腔式结构,远侧部位包括膨胀区。
这种实施方式的一些可选特征包括:
其中,在扩张状态膨胀区的直径大于中间部位的直径;
其中,凝块接合元件包括在单体结构中连接的多个支杆;
其中,膨胀区包括发散区和会聚区;
其中,膨胀区包括位于发散区和会聚区之间的曲折点;
其中,膨胀区与中间部位集成为一体;
其中,膨胀区包括过渡部位,所述过渡部位包括多个支杆,将膨胀区连接至中间部位;
其中,膨胀区包括带锥度远端;
其中,所述装置包括细长件,其连接到膨胀区的远端;和/或
其中,在扩张状态管腔式结构被构造成限定出穿过凝块的流动管腔。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及凝块接合元件,其包括塌缩的递送状态和扩张的凝块接合状态,所述凝块接合元件构造成在其扩张状态延伸贯穿凝块,凝块接合元件包括近侧部位、中间部位和远侧部位,近侧部位和中间部位包括管腔式结构,近侧部位具有比中间部位小的直径。
这种实施方式的一些可选特征包括:
其中,近侧部位的直径小于中间部位的直径的60%;
其中,近侧部位的直径小于中间部位的直径的50%;
其中,近侧部位的直径小于中间部位的直径的40%;
其中,近侧部位的直径小于中间部位的直径的30%;
其中,近侧部位的直径小于中间部位的直径的25%;
其中,近侧部位的直径小于中间部位的直径的20%;
其中,近侧部位包括近侧轴线,远侧部位包括远侧轴线,在扩张状态近侧轴线远侧轴线相对于偏置。
其中,近侧部位包括第一子结构,中间部位包括第二子结构;
其中,近侧部位的管腔式结构延伸通过中间部位的管腔式结构;
其中,近侧部位的管腔式结构与中间部位的管腔式结构互连;
其中,凝块接合元件包括过渡部位散布于近侧部位和中间部位之间,并且构造成提供近侧部位和中间部位之间的平滑过渡;和/或
其中,远侧部位包括构造成封闭远端的多个支杆。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括:细长件,以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,可扩张的凝块接合元件包括第一管腔式结构和第二管腔式结构,第一管腔式结构的直径大于所述第二管腔式结构并且包围第二管腔式结构的至少一部分,第二管腔式结构基本上在第一管腔式结构的近侧延伸。
这种实施方式的一些可选特征包括:
其中,第一管腔式结构包括近侧部位、中间部位和远侧部位和第二管腔式结构包括近侧部位、中间部位和远侧部位;
其中,第二管腔式结构的中间部位大致在第一管腔式结构的中间部位的近侧延伸;
其中,第二管腔式结构的近侧部位包括与细长件的远端之间的连接部;
其中,第一管腔式结构的近侧部位包括与细长件的远端之间的连接部;
其中,第一管腔式结构的近侧部位包括与第二管腔式结构之间的连接部;
其中,第一管腔式结构的近侧部位包括连接器,其从中间部位延伸至与细长件之间的连接点;和/或
其中,与细长件之间的连接点位于第二管腔式结构的近侧。
在另一实施方式中,本发明的处置设备包括一种用于从血管去除凝块的装置包括:细长件,以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,可扩张的凝块接合元件包括第一管腔式结构和第二管腔式结构,第一管腔式结构的直径大于所述第二管腔式结构并且包围第二管腔式结构的至少一部分,第二管腔式结构在其远端包括凝块捕获结构,凝块捕获结构包括喇叭口形部位。
这种实施方式的一些可选特征包括:
其中,凝块捕获结构包括多个支杆,并且至少一个纤维构造于过滤器中;
其中,在扩张状态凝块捕获结构的至少一部分的直径近似于血管的直径;
其中,在扩张状态凝块捕获结构的至少一部分的直径大于第二管腔式结构的直径;和/或
其中,在扩张状态凝块捕获结构的至少一部分的直径近似于第一管腔式结构的直径。
在另一实施方式中,本发明的处置设备包括凝块收取装置,其包括细长件、第一可扩张件和第二可扩张件;这两个可扩张件分别具有近侧部位、本体部位和远侧部位,第一可扩张件的本体部位在自由扩张状态下的直径大于第二可扩张件在自由扩张状态下的直径,并且第一可扩张件的近侧部位位于第二可扩张件的近侧部位的远侧。
这种实施方式的一些可选特征包括:
其中,第一可扩张件的远侧部位包括凝块捕获结构;
其中,第二可扩张件的远侧部位包括凝块捕获结构;
其中,凝块捕获结构包括多个支杆;
其中,凝块捕获结构包括多个支杆,并且至少一个纤维构造于过滤器中;
其中,第一可扩张件的近端被连接到细长轴的远侧部位;
其中,第一可扩张件的近端被连接到第二可扩张件;
其中,第二可扩张件的近端被连接到细长轴的远侧部位;
其中,第一可扩张件的远端不连接到第二可扩张件的远端;
其中,第一可扩张件的远端被连接到第二可扩张件的远端;
其中,第二可扩张件的本体部位在自由扩张状态小于第一可扩张件的本体部位在自由扩张状态的直径的50%;
其中,第二可扩张件的本体部位在自由扩张状态小于第一可扩张件的本体部位在自由扩张状态的直径的40%;
其中,第二可扩张件的本体部位在自由扩张状态小于第一可扩张件的本体部位在自由扩张状态的直径的30%;和/或
其中,第二可扩张件的本体部位在自由扩张状态小于第一可扩张件的本体部位在自由扩张状态的直径的20%。
还公开了一种利用凝块收取装置从血管提取凝块的方法,所述凝块收取装置包括可扩张本体和细长轴,所述方法包括:将所述装置通过微导管传递至目标位置,后撤微导管以将所述装置至少部分地布署在凝块内或下面,将可扩张件的近侧部位在凝块的近侧部位内扩张至直径小于血管直径,将可扩张件的远侧部位在凝块的远侧扩张至直径大致等于血管直径,向近侧撤回所述装置和凝块并去除从患者二者。
这种实施方式的一些可选特征包括:
其中,可扩张本体包括内侧可扩张件和外侧可扩张件;
其中,内侧可扩张件的扩张直径小于外侧可扩张件的扩张直径;
其中,内侧可扩张件的至少一部分在外侧可扩张件的至少一部分内延伸;
其中,内侧可扩张件的至少一部分在外侧可扩张件的近侧延伸;
其中,可扩张本体的远侧部位包括凝块捕获结构;
其中,凝块捕获结构被连接到内侧可扩张件;
其中,凝块捕获结构被连接到外侧可扩张件;和/或
其中,在使用时细长轴延伸到患者外侧。
一种凝块收取装置用于从血管去除堵塞凝块,所述装置包括:细长轴;内侧细长体,其具有塌缩的递送形态和扩张的布署形态;外侧细长体,其至少部分地包叠内侧细长体;在布署形态外侧细长体相对于内侧细长体可扩张至比内侧体的径向尺寸大的径向尺寸;外侧细长体的近端可脱开地固定于细长轴的远端。
这种实施方式的一些可选特征包括:
其中,外侧细长体的近端包括两个或更多个支杆;
其中,通过外侧细长体的近端从细长轴的远端脱开,将近侧支杆解放而扩张到分开;
其中,外侧细长体通过脱开而呈现大致圆柱形或管状形状;
其中,外侧细长体还包括封闭远侧凝块捕获结构,其包括在终端连接部会聚的多个支杆;
其中,所述多个支杆的远端可从终端连接部脱开;
其中,通过将所述多个支杆从终端连接部脱开,将所述支杆解放而扩张到分开;
其中,所述装置还包括脱开系统;和/或
其中,脱开系统包括牵引丝,生物吸收型套环或纤维,电解系统或电阻加热系统。
附图说明
通过下面参照附图对本发明一些仅以示例的方式给出的实施方式的描述,本发明可更清楚地展现出来,在附图中:
图1a示出了本发明的凝块收取装置的立体图;
图1b示出了图1a中的凝块收取装置的近侧结合部局部组装立体图;
图1c是图1a中的凝块收取装置的近侧结合部的立体图;
图1d是穿过所图1c中的装置所作的剖视图;
图1e是图1a中的凝块收取装置的端视图;
图1f是图1a中的凝块收取装置的远端的立体图;
图1g是图1a中的凝块收取装置的外侧件的俯视图;
图1h是图1a中的凝块收取装置的外侧件的侧视图;
图1i是图1a中的凝块收取装置的内侧件的侧视图;
图1j是图1a中的装置的内侧件的远端的立体图;
图2a至2f示出了使用本发明的装置的方法;
图3a示出了本发明的凝块收取装置的远端;
图3b示出了本发明的凝块收取装置的远端;
图4a是本发明的凝块收取装置的远端的立体图;
图4b是图4a中的装置的侧视图;
图5a是本发明的凝块收取装置的立体图;
图5b是本发明的凝块收取装置的立体图;
图6是本发明的凝块收取装置的立体图;
图7a至7e示出了使用本发明的装置的方法;
图8示出了布署在血管中的凝块中的凝块收取装置。
图9是本发明的凝块收取装置的侧视图;
图10a示出了本发明的凝块收取装置的远端;
图10b是图10a中的装置的端视图;
图10c是一种附连特征的详图;
图11a示出了本发明的凝块收取装置的一部分的远端;
图11b是图11a中的装置的端视图;
图12示出了本发明的凝块收取装置的远端;
图13a示出了本发明的凝块收取装置的远端;
图13b是图13a中的装置的端视图;
图14a是本发明的凝块收取装置的侧视图;
图14b至14d示出了图14a中的凝块收取装置在使用时的侧视图;
图15a至15d示出了使用本发明的装置的方法;
图16是本发明的凝块收取装置的近侧结合部的立体图;
图17a是本发明的凝块收取装置的侧视图;
图17b是图17a中的装置的一部分的详图;
图18示出了本发明的凝块收取装置的一部分的远端;
图19示出了部分地约束在加载工具中的本发明的凝块收取装置;
图20示出了本发明的凝块收取装置的一部分;
图21a是本发明的凝块收取装置的一部分的侧视图;以及
图21b示出了图20a中的部分的展开图。
具体实施方式
下面参照附图详细描述本发明的具体实施方式,其中,相同的附图标记表示相同或功能相似的元件。术语“远”或“近”在下面的描述中是参照相对于处置医师的位置和方向使用的。“远侧的”或“向远侧”是远离或背离医师的位置或方向。“近侧的”或“向近侧”或“近”是靠近或朝向医师的位置或方向。
进入脑、冠状和肺血管涉及使用多种商业提供的产品和传统处理步骤。用于进入的制品例如导丝、导管、血管造影术导管和微导管在各种地方都被描述过,并且常规地用于各种导管插入实验程序。在下面的描述中假定这些制品和方法被与本发明的装置和方法结合使用,并且不需要描述其细节。
下面的详细描述实质上仅仅是示例性的,并且不意于限制本发明或本发明的应用和使用。尽管对本发明的描述在很多情况下着笔于颅内动脉的处置,但本发明也可被用于前面提及的其它体内通道。
贯穿这里公开的很多设计的公共主题是一种双层构造,其中所述装置包括外侧可扩张件,在其内延伸着内侧可扩张件,这两个件被直接或间接连接到细长轴,和远侧网或支护架构造在所述装置的远端以防止凝块碎片逃逸。这种远侧网可以附存于轴杆、内侧或外侧件中的任一个或附存于它们中的多个。针对这些元件中的每个可构想出一定范围的设计,如本申请文件之外所描述的,并且意味着任何这些元件可以与任何其它元件结合使用,尽管为了避免重复不在这里显示它们的全部可行组合。例如,预计图1中的外侧可扩张件/外侧笼体可以与图4中的内侧可扩张件结合使用,或者图13中的远侧网可以连接到图5中的内侧可扩张件的远端以取代所示的网205。
内侧和外侧可扩张件二者可理想地由这样的材料支撑,即一旦从高度约束的递送形态释放,就能自动恢复其形状。超塑性材料例如镍钛诺(Nitinol)或具有类似特性的花键特别适合。该材料可以构造成各种形式,例如丝或条或片或管。一种特别适合的制造工艺是激光切割镍钛诺管,然后热固和电抛光所产生的结构,以产生支杆构架和连接元件。该构架可具有任何大范围的形状,如这里描述的,并且可以通过添加合金化元件(例如铂等等)或通过各式各样的涂层或标记带而在荧光透镜下可见。
在一些情况下内侧可扩张件可形成大体管状结构,并且理想地构造成扩张到比其中将要使用它的最小血管小的直径。该直径典型地小于外侧可扩张件的50%,可以最小达到外侧件直径的20%或以下。
一定范围的不同远侧网或远侧支护架区设计别公开,它们中的一些组合了来自外侧和/或内侧可扩张件的构架的支杆元件,并且它们中的一些组合了细丝或纤维以提供附加的支护架,而对整个装置轮廓或传导性能的影响最小。适宜的材料理想地具有高拉伸强度,以使得能够制造出具有足够的完整性以实现制造能力和使用性的非常精细的丝或纤维,例如,聚合物材料,如UHMWPE、芳纶、LCP、PET或PEN,或金属,如钨、MP35N、不锈钢或镍钛诺,等等。
图1a示出了本发明的凝块收取装置的一种实施方式。凝块收取装置1具有细长轴6,其具有远端和近端,所述远端延伸于动脉内部,近端延伸于动脉外部,凝块接合部分,其构造在细长轴6的远端,具有外侧可扩张件2和内侧可扩张件3以便于在凝块收取装置1被布署在堵塞位置后立即恢复血流通过凝块。外侧件2和内侧管状件3包括用于递送的塌缩形态和用于凝块收取、流动恢复和破碎保护的扩张形态。在一种实施方式中,内侧可扩张件包括大致管状本体部位。
内侧和外侧件优选由超弹性或伪弹性材料例如镍钛诺或具有高可恢复应变的其它这样的合金制成。轴杆6可以是带锥度的丝轴杆,并且可以由不锈钢、MP35N、镍钛诺或具有适宜高模量和拉伸强度的其它材料制成。轴杆6可具有位于轴杆上的指示带7以向使用者指示在插入过程中何时所述装置的远端接近微导管的端部。这些带被定为成使得随着它们接近微导管套或止血阀,它们指示所述装置的远侧末端接近微导管的端部。这些指示带可以通过印刷或去除或标记轴杆涂层的一些区域而形成,以使得它们在视觉上不同于轴杆的其它部位。在另一实施方式中,指示带7凹入到轴杆表面下,以在它们接近微导管时给出使用者触感提示。
轴杆6具有邻近其远端且位于外侧件2和内侧管状件3近侧的线圈4。该线圈4可以是金属的,并且可以由不锈钢或由不透辐射的材料例如铂或金等等或包含这些材料的合金形成。在另一实施方式中,线圈4可以涂覆有低摩擦率材料或具有聚合物护套安置在线圈外表面上。邻近于该线圈4,套筒5可以布置在轴杆6上。该套筒5可以是聚合物的并且可以定位在轴杆的带锥度的部位上。通过添加过滤材料例如钨或硫酸钡,套筒5可以构造成不透辐射的。套筒5和轴杆6可以涂覆有材料以降低摩擦率和促凝性。涂层可包含聚合物,低摩擦率润滑剂例如硅酮,亲水或厌水涂层。该涂层还可以施加到外侧件2和内侧管状件3上。
特别参看图1b至1d,轴杆6可具有一体的套环或台阶特征15以有助于轴杆的远端和内侧管状件3和外侧件2的近端之间的结合部整体性。外侧件2的近端可包括套环12,内侧件3的近端可包括局部套环13。内侧件局部套环13可以布置在轴杆6上,接近于台阶特征15,外侧件可以的套环12组装到这些特征上面,以形成机械式锁,用以防止结合部在张力作用下解体。图1b和1c示出了接合部的组件,图1d是结合部的剖视图,示出了机械式锁。该锁被这样形成,即外侧件12的套环偏心于轴杆6,并且只要内侧管状件13的局部套环就位,套环就能够不在轴杆的台阶15上滑动。粘合剂可以添加到组合的结合部以进一步加强结合部,并且防止在挤压或其它负载下解体。在另一实施方式中,可以在组合的结合部添加熔接、焊接或钎焊。
外侧件12的套环偏心于轴杆6,因此,在这种实施方式中,支杆14被形成为附连到内侧件13的局部套环。该支杆14向近侧突伸,并且用作近侧线圈4的定位元件。当近侧不透辐射的线圈4定位在近侧支杆14和轴杆6上时,线圈大致与外侧件的套环12同心。粘合剂可以在近侧线圈和外侧件套环之间施加到结合部,以维持结合部整体性。在另一实施方式中,熔接、焊接或钎焊工艺可以用于该结合部。
外侧件2被构造成在从约束鞘(例如微导管)后自扩张(膨胀)至直径大于内侧管状件3。外侧件2的扩张引起凝块在扩张过程中挤压和/或移位。当可扩张本体提供高级别的支护时,凝块被挤压。当可扩张本体提供逃逸路径或开口时,扩张的本体将朝向开口推动凝块。然而,如果可扩张本体仅提供中度支护时,凝块将被移动,但由于凝块具有很多运动自由度,它可沿多个方向移动,并且因此不受控制。通过提供管状可扩张本体,其中管状可扩张本体的长度大致只为堵塞凝块的长度或更长,提供给凝块的许多运动自由度被除去。利用本发明,当入口开口22(示出于例如图1g)被提供在外侧件2中时,这些入口22提供可供凝块使用的主运动自由度,并且因此外侧件2的扩张推动凝块进入接纳空间11。外侧件2具有多重入口口部22以接纳凝块。以这种方式,入口口部22允许凝块的各部分进入外侧件2的接纳空间11,并且因此允许凝块被提取而不被过度挤压。这是有益的,因为我们发现挤压凝块会引起它失水,失水又导致凝块的摩擦率特性增大,并且其硬度增大,所有这些因素导致凝块更难以从血管脱离并去除。如果随着孔隙结构向外朝向血管壁迁移而凝块通过外侧件2的壁向内迁移,该挤压可以避免。
图1g示出了外侧件2的俯视图,图1h示出了其正视图。入口口部22提供附加的益处,即允许外侧件2在后撤时沿着大致平行于凝块被从血管拉出的方向的方向(即大致平行于血管中心轴线)向凝块施加力。这意味着施加到血管的向外径向力可以保持最小,这又意味着凝块收取装置1在凝块上的作用不引起增大凝块从血管脱离所需的力,因此,可保护细弱的脑血管不受到有害的径向力和张力。
外侧件2包括近侧支杆20,近侧支杆在它们的近端连接至套环12,并且在它们的远端连接至第一可扩张件26。近侧支杆20可具有带锥度的轮廓,以确保从轴杆6向所述装置的凝块接合部位逐渐的硬度渐变。第一可扩张件26通过两个连接臂29被连接到第二可扩张件27,所述连接臂从近侧连接部39至远侧连接部40。在一种实施方式中,这些连接臂包括平行于所述装置的中心轴线延伸的大致直的支杆。在其它实施方式中,这些连接臂可包括构造成一或多个格子的多个支杆,或可包括弯曲或螺旋臂。第一和第二可扩张件之间的区域包括两个入口口部22,凝块可经过它们且进入到内侧和外侧件之间的区域限定的接纳空间11中。
第二可扩张件27接下来通过两个连接臂30连接到第三可扩张件28,所述连接臂从近侧连接部41延伸至远侧连接部42。在一种实施方式中,这些连接臂包括平行于所述装置的中心轴线延伸的大致直的支杆。在其它实施方式中,这些连接臂可包括构造成一或多个格子的多个支杆,或可包括弯曲或螺旋臂。第二和第三可扩张件之间的区域包括两个入口口部22,凝块可经过它们且进入到内侧和外侧件之间的区域限定的接纳空间11中。第一可扩张件26和第二可扩张件27之间的连接臂可以大致与第二和第三可扩张件27、28之间的连接臂对准,以便在转弯过程中对准可扩张件26,27,28的中轴线。在另一实施方式中,第一可扩张件26和第二可扩张件27之间的连接臂可以定位在与第二和第三可扩张件27、28之间的连接臂成一个角度,例如90°。
第一可扩张件26包括一系列互连支杆,其中某些支杆,例如支杆43,终止于冠部而不带远侧连接元件,而其它支杆,例如44,终止于连接点例如45和46。第二可扩张件27包括一系列互连支杆,其中某些支杆,例如支杆47,终止于冠部而不带远侧连接元件,而其它支杆,例如48,终止于连接点。一或多个可扩张件可包括标记带或不透辐射的特征,例如金或铂标记或线圈。在这种实施方式中,椭圆形金标记25被示出为固定在第三可扩张件28中的支杆上的孔眼中。金标记被定为成向使用者指示外侧件的筒形部位的远端以有助于布署精度。可扩张件中的支杆可构造成使得在加载过程中,多个冠部不排列在与近侧套环相隔同样的距离,例如,45和50。在加载或重新入鞘过程中,大致要求比将支杆插入鞘中更高的力来加载冠部,因此,如果多个冠部在同时被加载,使用者可注意到加载力的升高。通过将替代性支杆44和51偏置到不同的长度,加载力可以降低,并且使用者体验会提高。
第三可扩张件24的远端包括的支杆23圆周环,其连接到最终终止于远侧连接点9的一系列支杆24,因此,为外侧件限定封闭端。该系列支杆可具有大致圆锥形形状,如示于图1a、1f、1g和1h,或在其它实施方式中可包括大致平坦的面,该面可以倾斜于或者可以正交于所述装置的纵向轴线。在一种实施方式中(如图所示),远侧连接点9包括套环。支杆24和49可以是带锥度的,从而同包括第一和第二可扩张件的本体的更近侧的那些支杆相比具有更窄的宽度,因此产生所述装置在扩张和塌缩两种状态下的硬度的渐变。
图1e示出了外侧可扩张件2的封闭端,其防止已经进入内侧和外侧件之间的接纳空间11的凝块或凝块碎片的脱出。内侧件的扩张的远侧支杆10与外侧件2的封闭远端相组合用作附加的三维过滤器,以进一步防止凝块或凝块碎片的脱出。在某些实施方式中,该远侧部位可包括纤维附连点例如孔眼17或其它纤维附连特征,并且纤维可以在这些附连点连接到远侧部位以产生远侧网。
图1i和1j示出了内侧管状件3的视图。内侧管状件3包括用于递送的塌缩形态和用于流动恢复和破碎保护的扩张形态。内侧管状件3可包括弹性或超弹性或形状记忆金属结构,并且可还包括抛光表面,例如电抛光表面。内侧管状件3被构造成使得提供穿过所述装置1的流动管腔,以便于在布署后立即恢复血流经过凝块。在一种实施方式中,内侧管状件3被构造成支护所述通过凝块的流动管腔,以防止碎片释放,否则这种碎片释放可能滞塞于远侧血管中。内侧管状件3包括一系列连接支杆31,它们在初始在目标血管中布署于凝块内时可接触凝块。内侧管状件3的支杆31与凝块的接触提供了附加的抓取,且当所述装置被撤出时有助于凝块从血管初始脱落。
内侧管状件3包括互连支杆31的大致圆柱形段,其在近端通过支杆34被连接至局部套环13。内侧管状件3的远端包括由扩张支杆10形成的可扩张段,其直径大于内侧管状件3的本体部位的直径。这些扩张支杆被连接到线圈段18,在这种实施方式中,线圈段是从管件激光切割出来的,内侧管状件3也是在加工过程中从这个管件切出的。线圈18的远端具有城堡形轮廓35,其在组装过程中结合到外侧件2的远侧套环9。内侧管状件3上的线圈18的远端通过粘合剂连结至外侧件2的远侧套环。内侧管状件3上的城堡形特征35促进了该粘合剂的粘合,并且通过在套环中提供用于粘合剂的接纳空间38并且防止其吸入线圈区域中,从而提高了连结强度。在另一实施方式中,该结合部可以通过熔接、焊接或钎焊工艺组装。
外侧件2和内侧管状件3在它们的组装过程中在近侧和远侧端结合,以最小化使用中各个件之间的张力,在自由扩张形态和加载形态下外侧件2的长度应当大致与内侧管状件3的长度相同。内侧管状件3的扩张支杆10在加载过程中延长,以使得当完全加载于微导管中时内侧和外侧件的长度相等。当所述装置被布署在小血管中时或在加载或布署过程中,内侧管状件3和外侧件2之间的长度差异仍可能出现。位于内侧管状件3的远端的线圈18可通过拉伸而适应于小量长度差异,而不会向所述装置施加明显的张力或挤压力。在另一实施方式中,该线圈可以与内侧管状件3分开形成,然后组装到其上。线圈可以由不锈钢材料、聚合物或由更加不透辐射的金属例如金或铂或这些材料的任何合金形成。线圈还可以被替换为一段纵向长度的弹性材料例如低模量聚合物或弹性体。
图1f示出了组装好的装置1的远端,图1j示出了内侧管状件3的远端。内侧管状件3的远端还包括远侧臂32。臂可以作为内侧管状件的剩余部分由相同的管件激光加工出来。不透辐射的线圈8(其可以是铂或金或同样属性的合金的)被套在远侧臂32上并且抵接外侧件2的远侧套环9,在此它通过粘合剂结合部被连接至套环9和臂32。臂32的远侧末端和不透辐射的线圈8的远端也通过粘合剂结合部连接。远侧臂32在远侧末端具有轮廓37,其通过在不透辐射的线圈8中提供用于粘合剂的接纳空间36并且防止粘合剂被吸到线圈上而促进了粘合剂结合部。该粘合剂结合部构成基板用以施用附加的粘合剂,以在所述装置的远端上形成半球形防伤末端19。
在其它实施方式中,内侧管状件可以根本不连接到外侧件的远端,或者可以约束在外侧件内而不是被固定附连。在其它实施方式中,内侧管状件可具有非圆柱形横截面,可以在直径上是非均匀的,并且可具有定制支杆模式,以提供具有不同径向力或柔性的区域。
图2a-2f示出了一种使用本发明的装置的方法。导丝63和微导管62利用传统已知的技术被插入动脉60中并且被进给贯穿堵塞性凝块61。当微导管62被定位在堵塞凝块61的远侧后,导丝63被从动脉60撤除以允许凝块收取装置1被进给通过微导管62。所述装置1被以塌缩形态进给,直至所述装置1的远侧末端到达微导管62的远端。微导管62被后撤,同时装置1的位置维持,以将凝块收取装置1以这样的方式布署成跨越凝块61,即所述装置1的远端优选定位在凝块61的远侧。所述装置1扩张,以使得外侧件2与堵塞凝块接合,且内侧管状件3扩张以接合凝块并且提供流动通道以便以受控方式恢复血流通过堵塞凝块61。如果希望的话,可允许所述装置1在凝块61中逐渐发展一个时间段,因为受控的血流已经恢复流经内侧管状件3。后撤所述装置1使得凝块从其在动脉60中的位置脱落,并且进一步回撤所述装置可实现提取凝块61,直至凝块可被提取到导管64或导入鞘中。图2f展示了凝块在被收取到导管64中的过程中与所述装置接合。凝块局部地定位在所述装置1的入口开口22中,也被局部安置在内侧和外侧件之间的区域限定的接纳空间11中。凝块碎片65被显示为捕获在所述装置1的远端中,在此外侧件的封闭端和内侧件的扩张支杆已经防止碎片释放到血流中。阻流、抽吸和其它标准技术可以在凝块收取过程中被使用。所述装置1在重新加载到插入工具中之前可以在盐水中漂洗并且轻柔地清洁。如果需要的话,所述装置1可以重新引入微导管中以便布署在堵塞凝块的附加区段中。
类似于装置1的另一实施方式中的凝块收取装置的远端的立体图显示于图3a。在这种实施方式中,外侧件82和内侧管状件83之间没有固定的远端连接部。扩张支杆80或内侧管状件83的本体部位的远端终止于套环87,套环可在丝86上滑动以适应于当所述装置扩张、塌缩或被布署在小血管中时可能出现的内侧和外侧件之间的长度差异。丝86可以通过粘合剂、熔接、焊接或钎焊结合部在套环89处结合于外侧件82。丝86包括台阶、套环或喇叭口形特征88,以防止内侧管状件83的套环87从丝86脱离。丝86可以是金属的,并且由不锈钢或镍钛诺形成,替代性地,可以由高硬度值聚合物例如PEEK或聚酰亚胺形成,或形成为带聚合物护套的金属丝。丝86还可以通过激光切割形成,并且可从加工出外侧件82的相同管件切割出来。在这种情况下,丝86可以是外侧件82的一体部分,并在远侧套环89连接。为了组装内侧管状件83和丝86,可以在内侧管状件83的套环87中切出沟槽。丝86的近端上的台阶88具有带圆角的防伤近端,并且可以通过纤维连接至所述装置的另一部分,以最小化丝的自由度以便当所述装置处于弯曲形态时防止丝的近端突伸穿过外侧件82。该纤维可以连接到内侧或外侧件的近侧套环,并且可以由弹性材料形成。
类似于装置1的另一实施方式中的凝块收取装置的远端的立体图显示于图3b。在这种实施方式中,内侧和外侧可扩张件83、82的远端之间没有远侧连接部。在这种实施方式中,内侧可扩张件83的鼓出的或喇叭口形的端部80用作导向件以将内侧件保持在外侧件内。这种实施方式不同于装置1之处在于其没有远侧末端--相反,倒圆的端部89设置在外侧件的最远点以使其避免伤及在其中使用它的血管。在其它类似实施方式中,内侧件的鼓出或喇叭口形部位80包括构造成螺旋形状或构造于格子模式中的支杆,以使得鼓出或喇叭口形部位的支杆不平行于外侧件的邻近部分中的那些。理想地,鼓出或喇叭口形部位的支杆垂直或近乎垂直于、而非平行于外侧件的邻近部分中的那些。以这种方式,当所述装置被置于转弯中时可防止鼓出或喇叭口形部位从外侧件移出。
所述装置的另一实施方式显示于图4a和4b,其中图4b是所述装置的侧视图,图4a是该实施方式的远端的立体图。在这种实施方式中,弹性纤维89可以连接到外侧件2的近侧套环12或内侧管状件的近端,并且连接到外侧件2的远侧套环9。该纤维89布置在内侧件3的远侧套环90的内径内侧,并且促进了套环90在弹性纤维89上向近侧或向远侧滑动。因此,当所述装置扩张\塌缩或布署在小血管中时,随着外侧件2和内侧件3之间的长度差在使用中改变,纤维89可按需要伸长或收缩以维持内侧件3的套环90位于侧件2中的大体中央位置。纤维可以由低硬度值聚合物材料、橡胶或弹性体形成,或者是高硬度值纤维和小直径线圈弹簧的组合。线圈弹簧可以由金属材料或聚合物或二者的组合形成,例如带聚合物护套的丝。
现在参看图5a,图中示出了凝块收取装置150包括细长轴151,内侧可扩张件153,和外侧可扩张件154。外侧可扩张件包括多个支杆158和连接元件157,并且还包括远侧支护架区155和远侧末端156。在所示的实施方式中,外侧可扩张件通过连接臂159在连接结合部160被连接到内侧可扩张件。在另一实施方式中,轴杆151可延伸穿过内侧可扩张件,并且外侧可扩张件可以连接到所述轴杆的远侧区域。在又一实施方式中,内侧可扩张件的接近于外侧可扩张件的部分可以由外侧可扩张件的同一块材料(例如,单块镍钛诺管件)形成,并且内侧可扩张件远离外侧可扩张件近端的部分可以由分开的一块材料形成。内侧可扩张件在连接点152被连接到轴杆151。细长轴的近端被构造成延伸到患者外侧,以使得使用者可以用它来控制凝块收取装置在患者体内的位置。
轴杆和内侧和外侧可扩张件中的每个可以以这里公开的各式各样的方式构成。该双层构造适合于允许凝块通过外侧可扩张件的大开口161进入并且就位于两个可扩张件之间提供的接纳空间162中。内侧件具有比外侧件更密集的支护以使得凝块被防止进入其管腔,因此,一旦所述装置被布署贯穿凝块,就能产生贯穿凝块的流动通道。内侧件的长近侧部分可以用非常小体积的材料构成,因为它只是扩张至外侧件的直径的一部分,并且能够因此在塌缩和扩张状态都是高柔性的。这个向近侧延伸件的一个显著益处是它允许产生贯穿非常长凝块的流动通道,而不会过度挤压凝块或接合血管壁。
远侧支护架区可包括外侧件的远端的由多个支杆元件限定的大致圆锥形部。在一种实施方式中,一或多个纤维附连于外侧件的远侧区域以通过减小开口的孔径尺寸增大支护,类似于图12所示的方式。在另一实施方式中,外侧件可以以更陡峭的方式终止,类似于图10a所示的方式,在这种设计中,纤维或丝可以连接到外侧件以扩展其远端并且产生碎片捕获区。这些纤维或丝还可以连接到内侧件,或者实际上在又一实施方式中,类似于图5b所示的,远侧支护架区或远侧网可以只连接至内侧件。
图5b示出了本发明的另一凝块收取装置200,类似于图5a中的装置150,但其中远侧网或支护架区附连于内侧可扩张件而非外侧件,并且其中外侧可扩张件附连于轴杆201而非附连至内侧件。内侧可扩张件203在连接部202附连于细长轴201。该连接部可包括套环。外侧可扩张件204通过连接臂206在点209被连接至轴杆201的远侧区段207。不透辐射的标记208附连于外侧件204的远端。远侧网205附连于内侧件203的远端。
外侧可扩张件204包括凝块支护区210和入口开口211,以使得凝块被支护区推动而流经开口进入内侧和外侧件之间的接纳空间212,如本申请其它地方更详细描述的。
在其它实施方式中,内侧和外侧件和远侧网可包括本申请其它地方为这些元件描述的任何设计。在这种实施方式中,外侧件的连接臂206穿过内侧件203的构架中的开口并且结合到轴杆,而在其它实施方式中外侧件可以直接附连至内侧件。在又一实施方式中,内侧可扩张件的接近于外侧可扩张件的部分可以由外侧可扩张件的同一块材料(例如,单块镍钛诺管件)形成,而内侧可扩张件的远离外侧可扩张件近端的部分可以由分开的一块材料形成。
图6示出了本发明的另一凝块收取装置250,其中内侧可扩张件和外侧可扩张件不相互嵌套(叠置),而是形成为连续构架,其可以由单块材料制成为单体结构。可扩张本体257包括近侧部分252,其扩张直径小于远侧部位253,以使得远侧部位253可被构造成与其中所述装置预期被使用的血管的壁接合,而近侧部位253可被构造成扩张到直径小于所述血管,以使得近侧和远侧部分以在一定程度上类似于前面描述的内侧和外侧件的方式发挥作用。可扩张本体257的近侧部分252附连于细长轴251的远侧部分。在其它实施方式中可扩张本体的远侧支杆255可终止于锥形支护区,类似于图1a所示的,或者可以附连至远侧网,例如图4等所示的。
图7a-7e示出了一种使用本发明装置的方法。为了展示,图5中的装置200被示出为用于从血管300提取长堵塞凝块301。在颅内堵塞的情况下,多种导入路径是可行的,包括直接刺入颈动脉,肱动脉方式,或股动脉进入。一旦利用传统且很好地理解的技术获得了进入动脉系统的入口,导管或长鞘307(未示于图7a-d)典型地置于实际可行的靠近堵塞凝块的位置。在中脑动脉堵塞的情况下,导管可被靠近颈动脉虹吸部安置在颈内动脉中。微导管302然后借助于导丝303的辅助作用被进给贯穿凝块301。在一些情况下,附加的导管(可被称作远侧进入导管即DAC)可以用于三轴系统中以使得微导管被进给通过DAC,接下来进给通过导管或长鞘。一旦微导管末端已被进给贯穿且到达凝块的远侧,导丝被撤除而凝块收取装置200被进给通过微导管,直至到达其远端,如示于图7c。微导管然后后撤,以使得凝块收取装置200在凝块中和任一侧扩张,如示于图7d。由于所述装置配备有长内侧可扩张件203,这个件可延伸到甚至非常长凝块的近侧,并且通过装置展开,这个件的扩张产生通过凝块的流动通道,恢复向凝块远侧的血管床的血流,并且减小凝块两侧的压力梯度。该压力梯度的减小导致凝块从血管壁脱离并将其向近侧撤出所需的力。外侧可扩张件204的支护区210在凝块的远侧部分内扩张,以向凝块的各离散区域施加挤压力,因此,推动凝块从这些区域流走,通过入口开口211并且进入到内侧和外侧件之间的接纳空间212中。这引起凝块离散区域304中的挤压,但引起凝块的区域305中或在位于外侧件近侧区域中的最小挤压力。以这种方式最小化凝块上的挤压力,可以最小化径向向外施加至血管壁的力,这又减小了当凝块后撤时需要克服的摩擦力。由于内侧件已经产生了通道,通过该通道血液可向远侧血管床流动,所述装置能够安全地留下原位一段驻留时间,然后才被撤出。该驻留时间理想地大于一分钟,并且可以长达30分钟或以上。使得所述装置以这种方式就位,允许凝块流入所述装置中,促进了牢固抓取凝块以便收取。还允许远侧血管床被轻柔灌注新鲜含氧血液,而非像在凝块被立即去除或是所述装置挤压凝块到在布署后产生非常大流动通道的程度的情况下那样暴露于压力和流量突升。一旦经过了驻留时间,所述装置和微导管(未示出)可以向后撤到DAC或导管/鞘中,如示于图7e。这可以借助于通过导管/鞘或DAC抽吸的辅助作用实现,以有助于维持牢固抓持凝块和避免碎片损失,然而,能够牢固抓取凝块且将凝块安全地容纳在接纳空间中并且还包括远侧网或支护区的这种所公开的设计还具有的优点是,也能够安全地使用而不抽吸。远侧网211可以与外侧件的远端分隔,如图所示,以使得其最佳地定位以便捕获在后撤过程中任何从凝块释放的碎片,即使这些碎片源于凝块的没有被完全容纳在接纳空间212中的部分。这样的碎片308显示于图7e。
图8示出了本发明的另一凝块收取装置350,其中内侧可扩张件352被设计成是特别柔性的。所述装置包括内侧可扩张件352,外侧可扩张件353,远侧保护网356和细长轴357。内侧和外侧可扩张件附连于轴杆的远侧部位,并且远侧保护网附连于内侧可扩张件的端部。所述装置被示出为布署在血管351内位于凝块354和355中。顺应性内侧件被凝块的一部分354朝一个方向移动,并被凝块第二部分355朝不同方向移动。
在所示的实施方式中,内侧件的顺应性可以通过形成内侧件的支杆构架和连接器的设计实现。示于图8的内侧件包括一系列大致圆柱形环358,它们通过支杆359形成并且通过连接器360连接到相邻的环。为了最优化凝块支护架的特性,每个环359的所有冠部中的所有成员通过连接器360被连接到另一冠部,因此,产生密集的闭式格子结构。然而,这样的结构的柔性显著小于其中不是所有冠部都被连接的开式格子结构。这个问题可以这样解决,即通过使连接器相对于内侧件的轴线倾斜一角度,以使得当内侧件置于转弯中时,连接器上所产生的负载是弯曲负载,而非轴向挤压或张力负载。对于给定的转弯角度,同连接器与内侧件的轴线对正时的可能出现的情况相比,该弯曲负载伴随着小得多的应变级别,因此,所产生的内侧件同传统轴向对正的连接器的情况相比可被容易得多地弯曲和弯折。
在又一实施方式中,内侧件被以类似于前面描述的方式构成,但各连接器沿着相邻环之间的方向交替地布置--例如,第一和第二环之间的所有连接器可以顺时针定向,第二和第三环之间的所有连接器可以逆时针定向。因此,当所述装置扩张或收缩时,每个环相对于其相邻环扭曲,但每个扭曲与下一扭曲取得平衡,以使得内侧件的远端相对于近端出现最小扭曲。
在又一实施方式中,内侧件包括由格子组成的闭式格子模式,每个格子通过支杆结合,并且各格子围绕内侧件的圆周以大体螺旋模式构造。
在另一实施方式中,内侧件包括编织结构,由一或多个丝形成。编织结构包括一系列对置螺旋,具有多个重叠点,在此一个丝与另一个丝交叉。这些交叉点中的至少一些不是固定附连点,从而通过在这些交叉点处一个丝相对于另一个丝的滑动的作用,内侧件更容易适应于转弯。
在又一实施方式中,内侧件包括支杆和连接器的开式格子构架。
图9示出了本发明的另一凝块收取装置400,其中内侧可扩张件406相对于外侧可扩张件403偏置。出于若干原因,这样的构造可能是理想的。一个原因是在下述情况下有助于制造性能,其中,外侧件由大直径管或由平坦片形成,并且因此具有近端或顶点407,其从外侧件中心线偏置并且位于该件的外表面限定的圆柱面中或附近。在所示的实施方式中,内侧件406和外侧件403在它们的近端在连接点407连接至轴杆401的远端,该连接点从扩张外侧件的中心轴线偏置,并且因此从其中所述装置预期被布署的血管的中心轴线偏置。远侧网405附存于外侧件403的远端。
图10a(侧视图)和10b(端视图)示出了本发明的另一凝块收取装置450的远侧区域,其中通过将成形的丝或纤维455附连于外侧件452的冠部456上的孔眼453和内侧件451的冠部457上的孔眼454之间,远侧碎片保护特征被产生。成形的丝或纤维可以形成为各式各样的形状,以最优化所述装置的端部的孔洞覆盖率。在所示的实施方式中,其形状为大致二维正弦曲线模式。在另一实施方式中,该形状可为三维的并且更类似于图12所示的。丝或纤维可以由聚合物材料制成,如UHMWPE、芳纶、LCP、PET或PEN,或由例如钨、MP35N、不锈钢或镍钛诺制成。使用镍钛诺或类似形状记忆材料的一个优点是,在布署后丝可以恢复其形成的“记忆”形状。在其它实施方式中丝或纤维可附连至内侧或外侧件的构架上的特征,而非冠部中的孔眼,或者可以简单地穿过任一个件的格子以产生附连位置。
图10c绘示了替代性连接钩477的设计,其可以组合于内侧或外侧可扩张件的支杆475,以允许附连丝或纤维,而不需扣将丝或纤维的一端穿过孔眼。相反,丝或纤维可以卡到槽中就位。唇缘476和478产生的凹槽有助于保持丝或纤维就位。
图11a(侧视图)和11b(端视图)示出了本发明的另一凝块收取装置500的远侧区域,其中三维远侧碎片保护特征通过鼓出的支杆构架被产生。可扩张件501包括多个冠部504,它们上连接着多个过滤器臂502,这些过滤器臂端接于连接点503。过滤器臂是径向向外喇叭口形的,以形成具有可扩张件501的本体大的直径的鼓出形状,该可扩张件在一些实施方式中可以是凝块收取装置的内侧可扩张件。喇叭口形的过滤器臂502还是螺旋的,以使得在端视图中彼此至少在点505处交叉,如示于图11b。该螺旋用于降低开口506的面积,否则凝块碎片有可能通过所述开口逃逸。在另一实施方式中,过滤器臂不是螺旋的。在又一实施方式中,过滤器臂起始于冠部,这些冠部本身可扩张至鼓出部的直径。在又一实施方式中,形成在过滤器臂的鼓出部下面的包围空间507中填充有第二材料。在一种实施方式中,该第二材料包括过滤器网格,其可由一或多段长度的材料丝制成,例如镍钛诺,类似于图13a和13b中所示的设计。
图12示出了本发明的另一凝块收取装置550的远侧区域,其中组合有三维远侧碎片保护特征500(如前面示出和描述的)的内侧可扩张件容纳在包括圆锥形远端552的外侧可扩张件551的。所产生的结构提供了多层破碎保护,并且特别适合于有效地应对大碎片和大量碎片,而不需要将碎片在一个点处收集到一起,并且不会阻碍通过所述装置的流动。外侧可扩张件551的远侧锥形段包括多个支杆552,它们又包括多个孔眼554,一或多个纤维555穿过这些孔眼以产生贯穿其中所述装置被布署的血管的管腔支护架网。
图13a(侧视图)和13b(端视图)示出了本发明的另一凝块收取装置600的远侧区域。所述装置包括外侧可扩张件601和内侧可扩张件606。内侧可扩张件606组合有鼓出的或喇叭口形的远侧部位602,类似于件500上的,在其中维持着由丝或纤维形成的网状结构603。在一种实施方式中,内侧和外侧可扩张件的格子开口角度被构造成使得在扩张时外侧件按照透视法缩短的程度大于内侧件,结果是,当处在用于递送的塌缩/卷入形态时鼓出的过滤器段602安置在外侧件的远侧冠部604下面或附近,但在扩张形态安置成远离冠部604。这种相对位置的变化的益处在于,最小化装置在递送和布署时的长度和贮存空间,并且最大化收取过程中碎片保护过滤器的效用。在一种实施方式中,网状结构603由随机卷曲的细丝形成,其中该丝优选为镍钛诺丝,且优选直径小于50微米,最优选直径小于25微米。在另一实施方式中,网状结构603由聚合物纤维形成,其中纤维优选为芳纶、LCP、UHMWPE、PET或PEN,且优选直径小于50微米,最优选直径小于25微米。纤维或丝可以随机地卷曲和/或扭转以占据鼓出部中的空间,或者它们可以成行为具体模式。纤维或丝可以附连至内侧件,或者可以简单地由构成鼓出部602外周的支杆约束。鼓出部602可以由三个或更多个支杆形成,并且这些支杆可以与所述装置的中心轴线大致对正,或者可以围绕该轴线是弯曲的或螺旋的,如前面所展示。
图14a示出了本发明的另一凝块收取装置650,其中外侧可扩张件653可从所述装置的其余部分脱开。图14b示出了外侧件脱开后的该装置。图14c和14d一起示出了内侧可扩张件从患者撤出,留下外侧可扩张件在后面。该脱开特征使得使用者能够选择将外侧件留下布署在血管中作为植入物,这在动脉粥状硬化或形成血栓堵塞的情况下,或者在所述装置变得牢固嵌在凝块中而使得使用者感觉更加用力将整个装置拉出会是不安全时,可能是有益的。所示出的原理可以应用到在本申请中各种地方展示的任何内侧和/或外侧可扩张件。装置650包括外侧可扩张件653和内侧可扩张件656,二者在近侧结合部657连接到细长轴651的远端。外侧可扩张件包括多个支杆658和连接器659,带有一系列近侧终止部652和远侧终止部655。在脱开之间的形态下,近侧终止部652在近侧结合部657一起附连于轴杆651,而远侧终止部655在远侧结合部660附连在一起。
在所示的实施方式中,近侧结合部657与所述装置大致同心,并且从血管的侧壁径向偏移。因此,如果不加改动地留下的话,近侧支杆662将阻碍血管管腔,引起潜在的再穿入困难并且会作为潜在的巢用于将来的凝块形成。为了解决这个问题,近侧终止部652通过脱开而从近侧结合部657分离,解放了近侧支杆(它们被热固而恢复优选的径向向外突伸形态)使其扩张且与血管壁或凝块并置。各式各样的措施可用于脱开近侧结合部和终端,包括电解,电阻加热低熔点结合材料,或其它机械式牵引丝或扭转机构。牵拉丝结合部的一个例子显示于图16。在另一实施方式中,近侧结合部657从所述装置和血管的中心线偏置,并且大致对正外侧件的外周面,在这种情况下,不需要分开近侧支杆662,因为它们在近侧结合部脱开时能够本身自动对正凝块和/或血管壁。
在一种实施方式中,远侧终止部655通过生物吸收型纤维或套环保持在一起,该纤维或套环被构造成与血液接触一段时间后被溶解,并且因此允许各终端分开且远侧锥部朝圆柱形形状扩张且与血管壁并置。该时间段大于30分钟且小于7天,最优选在1和3小时之间。在其它实施方式中,远侧结合部被以这样的方式连接到内侧可扩张件的远端661,即内侧可扩张件相对于外侧可扩张件的后退致使远侧结合部脱开,并且允许外侧件的远侧锥部扩张。在又一实施方式中,远侧终止部以类似于前面描述的用于释放近侧终止部的措施被释放。
图15a-15d示出了一种使用类似于前面描述的装置650的可脱开装置700的方法。装置700包括外侧可扩张件704,内侧可扩张件705,轴杆709和远侧网706。远侧网706附连于内侧可扩张件705的远端,且内侧件的近端附连于轴杆709的远侧区域。外侧可扩张件的近端在近侧结合部708附连于轴杆709的远端,并且能够以与前面描述的用于装置650的相同方式脱开。外侧可扩张件的远端不同于装置650之处在于,其终止于冠部710而不是终止于锥形段,并且因此,如果所述装置将被留在原位作为植入物的话不需要脱开和进一步扩张。
一种使用方法类似于前面参照图2和图7所描述的,其中导入口被获得,且微导管703被进给通过血管701至凝块702且贯穿凝块702,如示于图15b。装置700然后被进给通过微导管且通过将微导管后撤至所述装置的可扩张部分近侧的位置而布署在凝块内,如示于图15c。所述装置和凝块现在可以一起后撤并从患者去除,或如果需要的话,使用者可选择将外侧可扩张件在这此点从所述装置的其余部分脱开。脱开过程可以是前面关于图14b描述的,并且导致外侧可扩张件与血管壁和/或凝块并置,如示于图15d,在此点,所述装置的其余部分被后撤并从患者去除。
图16示出了本发明的装置的可脱开近侧结合部的一种实施方式,例如,其可以用于前面描述的装置650或700中。内侧可扩张件的近侧支杆756在近侧终止(端接)于半套环757,该半套环被连接(熔接、焊接或钎焊或其它方式)至轴杆750的远端。外侧可扩张件的近侧支杆752和753在近侧终止(端接)于半套环754和755,该所述套环套在轴杆750的远端上,并且通过牵引丝套环703被防止向外分开,并且通过轴杆远侧台阶751被防止向远侧滑动。牵引丝758终止(端接)于牵引丝套环760并且向近侧向着在患者外侧邻近于细长轴750近端的点延伸。将牵引丝相对于后撤轴杆使得牵引丝套环后退,这允许半套环754和755脱开且分离,因此释放外侧可扩张件。在另一实施方式中,半套环757被替换为整套环,并且取代751的地位而形成远侧抵接面,外侧可扩张件的拼合式套环754和755抵靠于该抵接面。
图17a示出了装置800的侧视图,该装置是可扩张的凝块收取装置,构造成自扩张到占据至少两个平面的形状。在所示的实施方式中,轴杆801被连接到可扩张本体,其包括近侧部位802,中间部位804,和远侧网部位805。中间部位804包括大致圆柱形本体,其包括格子806,凝块接合瓣803从所述格子突伸。整个可扩张本体可以由支杆和连接器的单体结构形成,并且远侧网可以由同一结构形成、或者可组合纤维或丝或薄膜以减小其开口的孔洞尺寸并且增大其支护架密度。近侧部位802可以构造成其扩张直径小于中间部位804本体的扩张直径。瓣803可被构造成向外扩张到比中间本体部位大的直径。
图17b示出了中间部位804在扩张之前展示的一部分的剖面详图。瓣803配合在格子808中,并在近侧在连接器808处被连接到格子和本体,而在远侧冠部807是不连接的。该设计使得单块管件能够被用于制造三维装置,其在扩张时能够占据多重平面。因此,这里描述的双层内侧和外侧可扩张件设计的许多特征和益处可以组合到单件式部件中。在一种实施方式中,近侧部位801和中间本体部位804以与前面描述的内侧可扩张件类似的方式具有相同的直径和功能,产生通过凝块的流动通道并且减小凝块两侧的压力梯度,而不会抓取或施加任何显著的力于血管壁;而瓣803接合并抓取凝块以便牢固地保持凝块以便撤出。
图18示出了类似于装置1的件3的内侧可扩张件的远端。该件包括支杆854和连接器855的构架,构成近侧本体部位853,该部位上被连接了构造成螺旋形状和终止于远侧套环851的一或多个细长支杆852。该设计产生顺应性非常好的弹簧,以适应于内侧可扩张件和外侧可扩张件或其上可能连接的其它件之间的相对运动,而不会向本体部位853施加强轴向力,这种强轴向力可能趋向于导致其塌缩或减小其直径。螺旋部位852的节距、支杆数量和圈数可以改变以改动此部位的顺应性和按照透视法缩短。在一些实施方式中该螺旋部位的直径可以不同于本体部位853。在一种特别实施方式中,螺旋部位的直径大于本体部位853的直径并且类似于外侧可扩张件的直径。这种实施方式可以以针对件500和606所描述的类似方式使用,并且用作碎片保护过滤器。
图19示出了部分地约束在加载工具875中的凝块收取装置877。加载工具875包括大致管状本体,其第一材料880和第二材料876构成。在所示的实施方式中,第一材料是透明的,第二材料是带颜色的和/或不透明的,并且构造成围绕或穿过第一材料的螺旋条。该加载工具可用于将凝块收取装置缩入或用于在插入微导管以便递送到患者体内目标位置之前将凝块收取装置保持在塌缩状态。如果需要去除顽固凝块的话,该工具还可以用于重新加载凝块收取装置以便二次使用,在这种情况下,有利的是该工具容易识别,因为它可能已落到无菌台上或与其它各种物品挂在一起。清晰的螺旋图案可被快速识别,即使是紧张的和匆忙的使用者。还有一个益处是,第一材料880是透明的或至少半透明的,以使得凝块收取装置的位置可透过工具的壁识别。在将所述装置从加载工具向微导管中进给时,该一点特别特别有用。如果管的外表面由相对高摩擦系数材料构成而内表面由相对低摩擦系数材料构成时,这一点是进一步有益的。高摩擦系数外表面意味着容易被使用者抓取和在使用时旋转止血阀,而低摩擦系数内表面促进了容易将凝块收取装置进给通过该工具。这可以如此实现,即通过由低摩擦系数材料例如PTFE挤出基管、然后糙化该表面(通过蚀刻或喷砂或研磨或其它措施),或添加高摩擦系数材料例如PET或聚烯烃等等的外套筒。优选地,该套筒或糙化不施加到工具远侧几厘米处,以避免损害其透明性。
图20示出了在一定程度上类似于装置1的件3的内侧可扩张件的本体部位的一部分。该本体部位包括一系列环元件901,它们通过连接器元件902连接到彼此,形成闭式格子908。每个格子具有近侧顶点900和远侧顶点907。每个环元件从每个相邻环元件偏置以使得各顶点900和907相对于该件的中心轴线彼此偏置。该偏置在该件中提供了更大的转弯柔性,这是因为除了构成每个格子的支杆的柔性以外,连接器本身可以弯曲以适应于这种偏置设计中的转弯。线905是穿过格子908近侧顶点的轴线,平行于所述件的轴线。线904是穿过格子908远侧顶点的轴线,平行于所述件的轴线。因此,线904和905之间的垂直距离代表邻近环元件之间的偏置距离。线909和910是穿过连接器902近侧和远侧端的线,垂直于可扩张件的中心轴线。因此,线909和910之间的垂直距离代表环元件之间的轴向间隔。在一种实施方式中,线904和905之间的距离小于线909和910之间的距离。在另一实施方式中,线904和905之间的距离等于线909和910之间的距离。在一种实施方式中,线904和905之间的距离大于线909和910之间的距离。总体而言,希望最大化偏置距离和最小化该间隔,以实现凝块支护和装置柔性之间的最佳平衡。
图21a和21b示出了外侧可扩张件例如图1中的件2的替代性实施方式。图21a展示了外侧件的侧视图,图21b示出了外侧件的筒形部位展开成2D形态。在这种实施方式中,近侧套环970被连接到近侧支杆,近侧支杆又被连接到沿着所述装置的本体部位构成格子的一系列支杆。这些格子被构造成用作大的入口窗973、978、979、983、984、985,或较小的高支护性格子972、977、980、981、982。大的入口窗格子便于凝块移入外侧件中并且进入到外侧件和内侧管状件之间的接纳空间中。较小的高支护性格子接合凝块并且有助于将凝块从血管脱落。它们还促进凝块从高度支护区域移动到所述装置的入口窗中。
大的入口窗和较小格子的分布对于所述装置的性能来说是至关重要的,并且在这种形态下大的入口窗和较小支护性格子沿着所述装置的长度大致交替布置,例如,沿着所述装置的长度,大格子973邻近于较小格子977,较小格子977邻近于较大格子978,较大格子978又邻近于较小格子980。在这种形态下,校大入口窗和成对的较小支护性格子也围绕所述装置的圆周大致径向交替布置。例如,围绕外侧件的圆周,大的入口窗978邻近于较小格子981和982,较小格子981和982又邻近于大的入口窗983。
在这种实施方式中,近侧支杆971被连接到围绕外侧件近端的较小支护性格子972的环。本体部位的远端可以连接到支杆974的环,这些支杆974提供足够的径向力以防止在从血管撤出过程中凝块移出所述装置的远端。支杆974的远侧环被连接到一系列支杆975,这些支杆975在外侧件上构成封闭端并且终止于远侧套环976。
从前面的描述显然可以看出,虽然本发明的特定实施方式被显示和描述,但各式各样的改型可以做出,而不脱离本发明的主旨和范围。因此,本发明并不意于是局限性的,而是应当根据权利要求及其等同替换而限定。
Claims (24)
1.一种凝块收取装置,用于从血管去除堵塞凝块,所述装置包括:
内侧细长体,其具有塌缩的递送形态和扩张的布署形态;
外侧细长体,其至少部分地包叠内侧细长体;
外侧细长体在布署形态可扩张到比内侧体的径向尺寸大的径向尺寸以限定出凝块接纳空间;
其中,外侧细长体包括远端部分;并且
其中,内侧细长体包括主体部分和远侧部分,所述远侧部分在布署形态朝向外侧细长体延伸到比主体部分大的尺寸,
内侧细长体的远侧部分和外侧细长体的远端部分一起限定出三维保护结构,用以实质上防止凝块或凝块碎片从所述装置向远侧放出。
2.如权利要求1所述的凝块收取装置,其中,内侧细长体的远侧部分包括多个支杆,它们被构造成体积模式。
3.如权利要求1或2所述的凝块收取装置,其中,内侧细长体的远侧部分包括鼓出的或喇叭口形的支杆构架。
4.如权利要求1至3中任一项所述的凝块收取装置,其中,外侧细长体的远端部分包括远侧支杆。
5.如权利要求4所述的凝块收取装置,其中,外侧细长件的远端部分的远侧支杆被构造成大体圆锥形。
6.如权利要求2至5中任一项所述的凝块收取装置,其中,所述支杆中的至少一些包括附连点,例如孔眼,用于接纳纤维。
7.如权利要求6所述的凝块收取装置,其中,保护结构包括多个纤维以提供远侧网。
8.如权利要求1至7中任一项所述的凝块收取装置,其中,外侧细长体包括第一单体结构。
9.如权利要求1至8中任一项所述的凝块收取装置,其中,内侧细长体包括第二单体结构。
10.如权利要求1至9中任一项所述的凝块收取装置,其中,内侧细长体在外侧细长体的近端的近侧延伸。
11.如权利要求1至10中任一项所述的凝块收取装置,其中,外侧细长体包括多个凝块接收开口和多个凝块接合区,并且其中,凝块接合区被配置成在与凝块接合时朝向凝块接收开口推动凝块并且使其进入到外侧细长体和内侧细长体之间的接纳空间中。
12.如权利要求11所述的凝块收取装置,其中,外侧细长体的凝块接合区包括支护开口,凝块接收开口远大于支护开口。
13.如权利要求1至12中任一项所述的凝块收取装置,其中,外侧细长体包括至少两个纵向相隔的区段。
14.如权利要求13所述的凝块收取装置,其中,至少一个铰链提供在区段之间。
15.一种凝块收取装置,包括:
细长件,
以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,
可扩张的凝块接合元件包括第一单体结构和第二单体结构,第一单体结构包围第二单体结构的长度的至少一部分,
第二单体结构包括近侧部位、中间部位和远侧部位,远侧部位包括膨胀部。
16.一种凝块收取装置,包括:
细长件,
以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,
可扩张的凝块接合元件包括近侧区段、凝块接合区段和远侧区段,
近侧区段构造成在使用时在凝块近侧延伸,并且远端构造成在使用时在凝块的远侧延伸,
凝块接合区段构造成在其扩张状态与凝块接合,远端包括碎片保护结构,碎片保护结构包括构造成体积模式的多个支杆。
17.一种凝块收取装置,包括:
细长件,
以及可扩张的凝块接合元件,其包括第一管状结构和第二管状结构,第一管状结构至少部分地包围第二管状结构,
第一管状结构包括近端、远端、近侧终止部和远侧终止部,
第二管状结构包括近端、远端、近侧终止部和远侧终止部,
第一和第二管状结构的近侧终止部被连接到细长件,第一和第二管状结构的远侧终止部被连接到彼此。
18.一种凝块收取装置,包括:
细长件,
以及可扩张的凝块接合元件,其包括第一管状结构和第二管状结构,第一管状结构至少部分地包围第二管状结构,
第一管状结构和第二管状结构在连接点连接到细长件的远端,
第一管状结构包括第一近侧连接支杆和第一连接器元件,第二管状结构包括第二近侧连接支杆和第二连接器元件,第一连接器元件在所述连接点包围第二连接器元件。
19.一种凝块收取装置,包括:
细长件,
以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,
可扩张的凝块接合元件包括第一管腔式结构和第二管腔式结构,第一管腔式结构的直径大于所述第二管腔式结构,
所述第一管腔式结构的远端包括朝向第一管腔式结构的轴线会聚的多个支杆,
所述第二管腔式结构的远端包括从所述第二管腔式结构的轴线发散的多个支杆。
20.一种凝块收取装置,包括:
细长件,
以及凝块接合元件,其包括塌缩的递送状态和扩张的凝块接合状态,所述凝块接合元件构造成在其扩张状态延伸贯穿凝块,
凝块接合元件包括近侧部位、中间部位和远侧部位,
中间部位包括管腔式结构,远侧部位包括膨胀区。
21.一种凝块收取装置,包括:
细长件,
以及凝块接合元件,其包括塌缩的递送状态和扩张的凝块接合状态,所述凝块接合元件构造成在其扩张状态延伸贯穿凝块,
凝块接合元件包括近侧部位、中间部位和远侧部位,
近侧部位和中间部位包括管腔式结构,近侧部位具有比中间部位小的直径。
22.一种凝块收取装置,包括:
细长件,
以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,
可扩张的凝块接合元件包括第一管腔式结构和第二管腔式结构,第一管腔式结构的直径大于所述第二管腔式结构并且包围第二管腔式结构的至少一部分,
第二管腔式结构基本上在第一管腔式结构的近侧延伸。
23.一种用于从血管去除凝块的装置,包括:
细长件,
以及可扩张的凝块接合元件,其构造成在其扩张状态延伸贯穿凝块,
可扩张的凝块接合元件包括第一管腔式结构和第二管腔式结构,第一管腔式结构的直径大于所述第二管腔式结构并且包围第二管腔式结构的至少一部分,
第二管腔式结构在其远端包括凝块捕获结构,凝块捕获结构包括喇叭口形部位。
24.一种凝块收取装置,包括细长件、第一可扩张件和第二可扩张件;这两个可扩张件分别具有近侧部位、本体部位和远侧部位,第一可扩张件的本体部位在自由扩张状态下的直径大于第二可扩张件在自由扩张状态下的直径,并且第一可扩张件的近侧部位位于第二可扩张件的近侧部位的远侧。
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