CN114845648A - 用于治疗血管闭塞的系统，装置，和方法 - Google Patents

用于治疗血管闭塞的系统，装置，和方法 Download PDF

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CN114845648A
CN114845648A CN202080087833.XA CN202080087833A CN114845648A CN 114845648 A CN114845648 A CN 114845648A CN 202080087833 A CN202080087833 A CN 202080087833A CN 114845648 A CN114845648 A CN 114845648A
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clot
catheter
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詹姆斯·曲昂·丁哈
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/22038—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 with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/22079—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 with suction of debris

Abstract

本文公开了用于对人类患者血管内的凝块物质进行血管内处理的系统和方法。根据本技术实施例的装置可包括例如，形成具有近侧部分和远侧部分的整体结构的多个互连支柱。该支柱可在该近侧部分中形成多个第一单元并且在该远侧部分中形成多个小于该第一单元的第二单元。该装置可被拉向血管内的凝块物质以配合，破坏，和/或捕获该凝块物质。

Description

用于治疗血管闭塞的系统，装置，和方法
相关申请交叉引用
本申请要求于2019年10月16日提交的名称为“用于治疗血管闭塞的系统，装置，和方法”的美国临时专利申请号62/916,044的权益，其通过引用整体并入本文。
技术领域
本技术大体上涉及用于对人类患者血管内的凝块物质(例如，栓塞和/或血栓)进行血管内处理(treatment)的系统，装置，和方法。特别地，本技术的一些实施例涉及用于配合并移除凝块物质的可扩展装置。
背景技术
血栓栓塞事件的特征是血管的闭塞。血栓栓塞病症(诸如中风，肺栓塞，心脏病发作，外周血栓形成，动脉粥样硬化等)影响着许多人。这些病症是发病率和死亡率的主要原因。
当动脉被凝块闭塞时，会形成组织缺血。如果闭塞持续存在，则缺血将发展成组织梗塞。然而，如果血流迅速地重建，则不会形成梗塞或极大地限制梗塞。未能重建血流可相应地导致截肢，心绞痛，心肌梗塞，中风，或甚至死亡。
在静脉循环中，闭塞物质还可造成严重危害。血凝块可在腿部和骨盆的大静脉中形成，这是被称为深静脉血栓形成(DVT)的常见情况。DVT通常发生在有血液停滞(例如，长途飞行，不动等)和结块(例如，癌症，近期外科手术，诸如整形外科手术等)倾向的地方。DVT可能阻碍静脉血从腿部的引流，从而导致肿胀，溃疡，疼痛和感染。DVT还可能形成储层，血凝块可能在该储层中聚集并且然后行进到身体的其他部位，包括心脏，肺，大脑(中风)，腹部器官，和/或四肢。
在肺循环中，不合需要的物质可通过阻塞肺动脉而造成伤害，这是被称为肺栓塞的情况。如果阻塞在主肺动脉或大分支肺动脉中的上游，则它会严重危及肺内的总血流量，并且因此危及整个身体。这可导致低血压和休克。如果阻塞在大至中肺动脉分支中的下游，则它会阻止很大一部分肺参与将气体交换到血液，从而导致低血氧和血液二氧化碳的积聚。
许多现有技术可重建通过闭塞血管的血流。例如，栓塞切除术是涉及切开血管并在闭塞的位置放置末端带球囊的装置(诸如Fogarty导管)的外科技术。然后在凝块外的点处使球囊充胀当并用于将阻塞物质抽回到切口点。然后外科医生移除阻塞物质。尽管这种外科技术是有用的，但让患者接受外科手术可能会造成精神创伤并且最好尽可能避免。另外地，使用Fogarty导管可能会出现问题，因为在抽出导管时可能有损坏血管的内壁的风险。
经皮方法也用于重建血流。常见的经皮技术被称为球囊血管成形术，其中将末端带球囊的导管引入到血管(例如，通常通过引入导管来引入)。然后使末端带球囊的导管前进到闭塞的点并充胀以使狭窄扩张。球囊血管成形术适用于治疗(treat)血管狭窄，但它通常对治疗急性血栓栓塞无效，因为没有移除任何闭塞物质并且在扩张后经常发生再狭窄。另一种经皮技术涉及在凝块附近放置导管并注入链激酶，尿激酶，或其他溶栓剂以溶解凝块。不幸的是，溶栓通常需要数小时到数天才能成功。另外地，溶栓剂可能会引起出血，并且对于许多患者，根本无法使用溶栓剂。
存在用于执行血栓切除术或移除其他异物的各种装置。然而，已经发现，此类装置具有高度复杂，会对治疗血管造成创伤，或缺乏抵向血管合适地固定的能力的结构。此外，许多装置具有高度复杂结构，这种高度复杂结构在通过曲折或小直径导管时会导致制造和质量控制困难以及递送问题。不太复杂的装置可允许用户拉出凝块，特别是对于没有经验的用户，并且此类装置可能无法完全捕获和/或收集所有凝块物质。
因此，需要用于栓塞提取的改进的系统和方法。
附图说明
参考以下附图可更好地理解本技术的很多方面。附图中的部件不一定按比例绘制。反而，重点在于清楚地说明本技术的原理。
图1A和图1B分别是根据本技术的实施例配置的处于展开前配置和展开配置的凝块处理系统的侧视图。
图1C是根据本技术的实施例配置的图1B所示的凝块处理系统的远侧部分的放大立体图。
图2A至图2C分别是根据本技术的实施例配置的图1A至图1C的凝块处理系统的凝块处理装置的侧视图，面向近侧的立体图，和面向远侧的立体图。
图3是根据本技术的实施例的用于操作凝块处理系统以从人类患者的血管内移除凝块物质的过程或方法的流程图。
图4A至图4F是根据本技术的实施例的凝块处理系统的远侧部分在从人类患者的血管中移除凝块物质的手术期间的示意图。
具体实施方式
本技术大体上涉及用于从人类患者的血管中移除凝块物质的系统，装置，和方法。在一些实施例中，凝块移除系统可包括输送导管和凝块处理装置。凝块处理装置可包括多个互连支柱，该多个互连支柱形成可在压缩配置和扩展配置之间移动的整体结构。在扩展配置中，整体结构可包括(i)近侧连接区域，(ii)从近侧连接区域延伸的近侧锥形区域，(iii)从近侧锥形区域延伸的圆柱形区域，(iv)从圆柱形区域延伸的远侧锥形区域，以及(v)从远侧锥形区域延伸的远侧连接区域。在一些实施例中，支柱的第一部分在近车锥形区域中形成第一单元，并且支柱的第二部分在远侧锥形区域中形成第二单元，该第二单元小于第一单元。
在一些实施例中，该系统还包括被配置为由操作者抓握的把手，以及耦合在把手与凝块处理装置的近侧连接区域之间的第一套管。凝块处理装置可在输送导管的腔内且在输送导管的远侧终端附近保持压缩配置。为了将凝块处理装置移动到扩展配置，操作者可移动手柄以使第一套管前进，从而使凝块处理装置前进经过远侧终端并离开输送导管的腔。当凝块处理装置不再受输送导管约束时，凝块处理装置可扩展(例如，自扩展)至扩展配置。在一些实施例中，该系统还包括第二套管，该第二套管至少部分地延伸穿过第一套管并且耦合至凝块处理装置的远侧连接区域。第一套管和第二套管之间的相对移动可允许凝块处理装置伸长/缩短并且对应地径向扩展/压缩。
在从人类患者的血管中移除凝块物质的手术期间，凝块处理装置可在血管内的凝块物质的远侧扩展，并且然后向近侧缩回至凝块物质中以捕获/破坏凝块物质。在本技术的一个方面，凝块处理装置的较大的第一单元被配置为在凝块处理装置被拉向凝块物质时接纳从中穿过的凝块物质，并且凝块处理装置的较小的第二单元被配置为将凝块物质保留在凝块处理装置内。在本技术的另一个方面，凝块处理装置具有足够的径向刚度(例如，在圆柱形区域处)以在凝块处理装置被拉向凝块物质时抑制凝块处理装置从凝块物质滑动(例如，不与凝块物质配合)。因此，凝块处理装置可用于捕获/破坏原本将难以移除的粘附的，聚集的，和/或慢性的凝块。
尽管下文关于用于治疗肺栓塞的系统，装置，和方法描述了许多实施例，但除了本文描述的那些应用和其他实施例之外的其他应用和其他实施例也在本技术的范围内(例如，除了栓塞以外的血管内手术，用于治疗脑栓塞的血管内手术，用于治疗深静脉血栓形成(DVT)的血管内手术等)。另外地，该技术的几个其他实施例可具有与本文描述的那些配置，状态，部件，或过程不同的配置，状态，部件或过程。此外，应理解，参考图1至图4F描述的实施例的特定元件，子结构，优点，用途，和/或其他特征可根据本技术的附加实施例适合地彼此互换，替换或以其他方式配置。此外，参考图1至图4F描述的实施例的合适元件可用作独立式和/或自足式装置。因此，本领域普通技术人员将相应地理解，该技术可具有带有附加元件的其他实施例，或者该技术可具有没有以下参考图1至图4F示出和描述的几个特征的其他实施例。
关于本说明书中的术语“远侧”和“近侧”，除非另有说明，否则这些术语可指代导管子系统的各部分相对于操作者的相对位置和/或脉管系统中的位置。另外，如本文所使用，“向后”，“向前”，“向上”，“向下”等名称并不意味着将所提及的部件限制为在特定方向上使用。应理解，这样的名称是指如附图中所示的所提及的部件的取向；本技术的系统和装置可在适合用户的任何取向上使用。
图1A和图1B是根据本技术的实施例配置的凝块处理或凝块移除系统100(“系统100”)的侧视图。在图1A中，系统100处于约束/展开前配置，并且在图1B中，系统100处于扩展/展开配置。一起参考图1A和图1B，在所示实施例中，系统100包括限定腔并且具有近侧端部部分103a和远侧端部部分103b的输送导管102(例如，管，套管等；在本文中也可称为外套管)。输送导管102的近侧端部部分103a耦合至毂110，例如可密封毂，阀等。输送导管102的腔可经由毂110流体耦合至端口组件112。
在所示实施例中，端口组件112包括流体控制装置114，该流体控制装置流体地耦合在以下项之间：(i)端口连接器116(例如，鲁尔连接器/配件)，以及(ii)耦合至毂110(例如，耦合至毂110的分支或侧端口)的管道区段118。流体控制装置114是可致动的以将输送导管102的腔流体地连接到端口连接器116。在所示实施例中，流体控制装置114是旋塞阀，而在其他实施例中，流体控制装置114可以是夹具，阀，和/或其他合适的流体控制装置。在使用系统100的凝块移除手术期间，各种部件(例如，注射器，真空源等)可耦合至端口连接器116以从输送导管102的腔移除流体和/或将流体注射到该腔中。例如，在一些实施例中，注射器或其他压力源可耦合至端口连接器116并且用于在流体控制装置114关闭时抽真空，并且流体控制装置114可打开以瞬间或几乎瞬间向输送导管102的腔施加真空(例如，以在远侧部分103b产生吸力来移除凝块物质)。在其他实施例中，恒定真空源(例如，泵)可耦合至端口组件112以提供对输送导管102的腔的恒定抽吸。在一些实施例中，可通过端口组件112注射冲洗流体(例如，盐水)以冲洗输送导管102的腔。
在所示实施例中，系统100还包括至少部分地延伸通过输送导管102的腔并限定腔的中间套管104(例如导管，管等)，以及至少部分地延伸穿过中间套管104的腔的内套管106(例如，导管，管等)。因此，在一些实施例中，输送导管102，中间套管104，和内套管106同轴地对准和/或布置。系统100还包括耦合至中间套管104和内套管106的凝块处理装置130。输送导管102，中间套管104，内套管106，和凝块处理装置130可统称为系统100的处理部分111(例如，插入部分))。如下文参考图3至图4F更详细地描述，处理部分111被配置为插入穿过导引导管以在凝块移除手术期间将凝块处理装置130的位置设置在处理部位处。
如下文参考图2A至图2C更详细地描述，凝块处理装置130可以是包括多个互连支柱的自扩展的整体结构。在图1A所示的展开前配置中，凝块处理装置130被约束在输送导管102内并因此被遮蔽。在图1B所示的展开配置中，凝块处理装置130延伸经过输送导管102的远侧端部部分103b(例如，输送导管102的远侧终端)并且径向地扩展。
图1C是根据本技术的实施例配置的图1B所示的系统100的远侧部分的放大立体图。在所示实施例中，中间套管104包括耦合至凝块处理装置130的近侧部分131a的远侧端部部分105b。在一些实施例中，凝块处理装置130的近侧部分131a包括多个支柱，该多个支柱聚集在一起并固定到中间套管104的远侧端部部分105b。例如，在凝块处理装置130的近侧部分131a处的支柱可经由粘合剂，紧固件，毂，或其他装置等固定到中间套管104的外表面。内套管106包括耦合至凝块处理装置130的远侧部分131b的远侧端部部分107。在一些实施例中，凝块处理装置130的远侧部分131b包括多个支柱，该多个支柱聚集在一起并经由内套管106与远侧末端108(例如，防止损伤的末端)之间的摩擦配合，压力配合等固定到内套管106的远侧端部部分107。在其他实施例中，在凝块处理装置130的远侧部分131b处的支柱可经由粘合剂，紧固件，毂，或其他装置等固定到内套管106的外表面。
再次一起参考图1A和图1B，中间套管104包括近侧端部部分105a，该近侧端部部分耦合至手柄120(例如，耦合至手柄120的远侧部分)以将手柄120可操作地耦合至凝块处理装置130。因此，中间套管104在把手120和凝块处理装置130之间延伸并且可操作地耦合该把手和该凝块处理装置。在一些实施例中，内套管106的近侧端部部分(在图1A和图1B中被遮蔽)不耦合至系统100的任何部分并且在中间套管104的腔内浮动。在本技术的一个方面，这种布置允许内套管106响应于凝块处理装置130上的外力而相对于中间套管104移动，从而允许凝块处理装置130纵向地伸长/缩短并且相应地径向地压缩/扩展。在其他实施例中，内套管106的近侧端部部分可耦合至手柄120的致动机制122(在图1A和图1B中以虚线示出)。致动机制122可被配置为向近侧和/或向远侧驱动内套管106以分别缩短和/或伸长凝块处理装置130。更特别地，在一些实施例中，致动机制122相对于手柄120的远侧移动可使内套管106相对于中间套管104向远侧移动以伸长并径向地压缩凝块处理装置130，而致动机制122相对于手柄120的近侧移动可使内套管106相对于中间套管104向近侧移动以缩短并径向地扩展凝块处理装置130。
在所示实施例中，手柄120还包括被配置为接纳从中穿过的导丝(未示出)的近侧毂124，诸如鲁尔毂。手柄120，内套管106，和末端108可一起限定用于接纳从中穿过的导丝的腔。在一些实施例中，导丝可具有约0.035英寸，约0.018英寸，小于约0.1英寸，小于约0.05英寸等的直径。在一些实施例中，手柄120还包括锁特征126，例如，诸如自旋锁或推入转动锁。锁特征126被配置为与毂110的配合特征115选择性地配合(例如，锁定地配合)。经由锁特征126和配合特征115将手柄120锁定到毂110固定了中间套管104相对于输送导管102的位置。在所示实施例中，中间套管104比输送导管102长，使得当手柄120与毂110锁定地配合时，中间套管104的一部分和凝块处理装置130从输送导管102的远侧端部部分103b向远侧延伸。
为了将凝块处理装置130从展开前配置(图1A)展开到展开配置(图1B)，操作者可将手柄120向远侧朝向毂110移动和/或可将毂110朝向手柄120移动。这种移动使中间套管104向远侧前进穿过输送导管102并且将凝块处理装置130向远侧推出输送导管102。凝块处理装置130在它从输送导管102的腔释放时可自扩展。当手柄120邻接毂110时，操作者可致动锁特征126以固定中间套管104相对于输送导管102的位置，以便例如将凝块处理装置130保持在展开配置。
在一些实施例中，手柄120的近侧移动和/或毂110的远侧移动(例如，从图1B所示的位置到图1A所示的位置)可将凝块处理装置130缩回到输送导管102中。也就是说，在一些实施例中，凝块处理装置130可重新套入输送导管102内。在此类实施例中，凝块处理装置130可反复地扩展且然后缩回并压缩到输送导管102中。在一些实施例中，末端108被配置(例如，设定大小和形状)为在展开前配置(图1A)中邻接输送导管102的远侧端部部分103b。这可抑制或甚至防止凝块处理装置130被完全拉过输送导管102，并且在一些实施例中，可基本上密封输送导管102的腔。在其他实施例中，末端108被设定大小和形状以允许末端108以及因此整个凝块处理装置130通过输送导管102缩回。
图2A至图2C分别是根据本技术的实施例配置的凝块处理装置130的扩展配置的侧视图，面向近侧的立体图，和面向远侧的立体图。一起参考图2A至图2C，凝块处理装置130包括多个支柱240，该多个支柱共同限定多个第一单元250(例如，空隙，孔，开口等)和多个第二单元252。支柱240可具有多种形状和大小，并且在一些实施例中，支柱240可具有在约0.0125英寸至0.150英寸之间，在约0.075英寸至0.125英寸之间，在约0.090英寸至0.150英寸之间，和/或其他尺寸的厚度和/或直径。一般而言，支柱240共同形成被配置为配合，捕获，破坏，和/或将血栓(例如，血管血栓)的一部分与包含血栓的血管分离的整体结构。
在所示实施例中，(i)第一单元250通常面向近侧，而第二单元252通常面向远侧，并且(ii)第一单元250大于第二单元252。如图2A最佳地示出，凝块处理装置130包括：(i)包括近侧部分131a的第一区域242，(ii)在第一区域242远侧的第二区域243，(iii)在第二区域243远侧的第三(例如，中心)区域244，(iv)在第三区域244远侧的第四区域245，以及(v)在第四区域245远侧并且包括远侧部分131b的第五区域246。在所示实施例中，支柱240在第一区域242和第五区域246处聚集在一起(例如，靠近彼此设置位置)，以促进它们分别连接到中间套管104和内套管106，如图1C所示。第二区域243可具有在近侧方向上渐缩(例如，径向变窄)的大体锥形形状。类似地，第四区域245可具有在远侧方向上渐缩的大体锥形形状。第三区域244可具有包括例如大体平坦外支柱表面/边界248的大体管状/圆柱形状。此外，在所示实施例中，第一区域242和第二区域243具有比第四区域245和第五区域246更少的支柱240，从而限定更大的第一单元250。相反，第四区域245和第五区域246具有比第一区域242和第二区域243更多的支柱240，从而限定更小的第二单元252。第三区域244可以是过渡区域，其中支柱240的数量在近侧方向上(例如，朝向第四区域245)增加，使得第一单元250中的一些邻接第三区域244中的第二单元252中的一些。在其他实施例中，第一单元250可仅形成在第二区域243中，可占据整个第三区域244，可延伸到第四区域245中等。
在一些实施例中，凝块处理装置130由形状记忆材料(诸如形状记忆合金和/或形状记忆聚合物)制成。例如，凝块处理装置130可包括镍钛诺和/或镍钛诺合金。类似地，凝块处理装置130可使用多种技术制造，包括焊接，激光焊接，切割，激光切割，扩展等。例如，在一些实施例中，可首先从一块镍钛诺(例如，镍钛诺管)激光切割凝块处理装置130，并且然后使用热定型工艺进一步成形，使得凝块处理装置130在扩展配置具有所示的形状。例如，如在热定型镍钛诺结构的领域中已知，可使用夹具，心轴，或模具来使凝块处理装置130保持其期望配置，并且然后可以，使凝块处理装置130经受适合的热处理，使得凝块处理装置130的支柱240呈现或以其他方式定形为心轴或模具的外轮廓。众所周知，热定型过程可在烘箱或流化床中进行。因此，热定型过程可在用于形成凝块处理装置130的一种或多种超弹性和/或形状记忆材料中赋予期望的形状，几何形状，弯曲，曲线，锯齿，扇形，空隙，孔等。因此，凝块处理装置130可在没有塑性变形的情况下被径向地约束，并且将在释放径向约束后自扩展。
一般而言，凝块处理装置130的大小可基于要从中提取血栓的血管的大小(例如，直径)来选择。在一些实施例中，在未被约束于血管内的完全扩展配置中，凝块处理装置130可具有在约0.025英寸至1.50英寸之间，在约0.70英寸至1.15英寸之间等的长度L(图2A)。在一些实施例中，在未被约束于血管内的完全扩展位置，凝块处理装置130可具有在约0.025英寸至1.5英寸之间，在约0.71英寸至1.34英寸之间等的最大直径D(图2A；例如，在第三区域244处)。
凝块处理装置130被配置(例如，被设定形状，被设定大小，成角度，成形等)为当凝块处理装置130在扩展配置下穿过/抵向凝块物质缩回时配合，破坏，和/或从血管内捕获凝块物质。例如，如下文参考图3至图4F更详细地描述，凝块处理装置130可向近侧穿过/抵向凝块物质抽出。在本技术的一个方面，较大的第一单元250被配置为在凝块处理装置130被拉向凝块物质时接纳从中穿过的凝块物质，并且较小的第二单元252(和相关联的支柱240)被配置为将凝块物质保留在凝块处理装置130内。在本技术的另一个方面，凝块处理装置130具有足够的径向刚度(例如，在第三区域244处)以在凝块处理装置130被拉向凝块物质时抑制凝块处理装置130从凝块物质滑动(例如，不与凝块物质配合)。因此，凝块处理装置130可用于捕获/破坏粘附的，聚集的，和/或慢性的凝块。在一些实施例中，支柱240的部分(例如，在第二区域243处)可以是尖锐的和/或可包括附接到该部分或以其他方式与之集成的切割元件(例如，刀或刀刃)以进一步促进对凝块物质的破坏/切割。
图3是根据本技术的实施例的用于操作系统100以从患者(例如，人类患者)的血管(例如，肺血管)内移除凝块物质的过程或方法360的流程图。图4A至图4F是根据本技术的实施例的插入穿过导引导管470的系统100的远侧部分在从人类患者的血管BV中移除凝块物质PE的手术期间的示意图。尽管为了说明起见在图4A至图4F所示的实施例的上下文中描述了方法360的一些特征，但本领域技术人员将容易理解，可使用本文所述的其他合适的系统和/或装置来执行方法360。
参考图3和图4A，在框361处，方法360可包括将导引导管470的远侧部分471的位置设置为在血管BV内的凝块物质PE附近(例如，在处理部位处)。在所示实施例中，导引导管470的远侧终端的位置设置为在凝块物质PE的近侧部分附近。然而，在其他实施例中，导引导管470的远侧终端的位置可至少部分地设置在凝块物质PE内，或者导引导管470的远侧终端的位置可设置在凝块物质PE的远侧。可通过患者的脉管系统(例如，经由股静脉)来实现进入血管BV。在一些实施例中，诸如当血管BV是肺血管时，引导器(例如，具有止血阀的Y形连接器；未示出)连接到导引导管470并且可部分地插入股静脉中。导丝472可通过导引器被引导到股静脉中并且被引导穿过右心房，三尖瓣，右心室，肺动脉瓣，并进入主肺动脉。根据凝块物质PE的位置，可将导丝472引导至右肺动脉和/或左肺动脉的一个或多个分支。在一些实施例中，导丝472可完全或部分地延伸穿过凝块物质PE。在其他实施例中，导丝472可延伸到刚好在凝块物质PE近侧的位置。在设置导丝472的位置之后，可将导引导管470放置在导丝472上方并且使其前进到凝块物质PE的位置附近，如图4A所示。
在一些实施例中，压力源可耦合至导引导管470并且用于抽吸导引导管470的腔以例如产生力(例如，如箭头A所指示)来将凝块物质PE的全部或一部分吸入/抽入导引导管470中。例如，在一些实施例中，可对真空进行预充(例如，在流体地耦合至导引导管470的腔的注射器中)，并且可将真空施加到导引导管470的腔以瞬间或几乎瞬间在导引导管470的远侧部分471处产生吸力(例如，以在导引导管470的远侧部分471处产生吸出脉冲)。此类方法和相关装置的具体细节在2019年8月8日提交的名称为“用于治疗栓塞的系统及相关装置和方法”的美国专利申请号16/536,185中公开，其通过引用整体并入本文。
然而，即使在施加吸力以从血管BV中移除/取出凝块物质PE的情况下，吸力也可能不足以取出/破坏所有凝块物质PE。例如，许多慢性(例如，聚集的)凝块可能会强力地粘附在血管BV的壁，从而使得难以移除这些凝块。在本技术的一个方面，系统100可在经由导引导管470施加吸力以配合，破坏，和/或捕获凝块物质PE之前，期间，和/或之后插入穿过导引导管470，即使在凝块物质PE强力地粘附在血管BV内的情况下也是如此。
例如，参考图3和图4B，在框362处，方法360可包括使凝块处理装置130(被压缩在输送导管102内并且因此在图4B中被遮蔽)前进穿过导引导管470以在凝块物质PE附近。更特别地，在压缩的展开前配置下，可使系统100的处理部分111前进穿过导引导管470，直到末端108的位置设置在(i))导引导管470的远侧部分471的远侧和(ii)血管BV内的凝块物质PE的远侧。在其他实施例中，末端108的位置可设置在凝块物质PE内。在一些实施例中，可使处理部分111在导丝472上方前进，而在其他实施例中，可省略导丝472。
参考图3和图4C，在框363处，方法360可包括将凝块处理装置130从压缩的展开前配置移动到扩展的展开配置，使得凝块处理装置130在凝块物质PE的远侧扩展和/或部分地在其内扩展。例如，如上面参考图1A和图1B详细地描述，系统100的操作者可使手柄120向远侧朝向毂110前进和/或使毂110朝向手柄120缩回，以使中间套管104相对于输送导管102移动来使凝块处理装置130前进到输送导管102之外，从而允许凝块处理装置130在血管BV内扩展(例如，自扩展)。在所示实施例中，凝块处理装置130(例如，第三区域244的外支柱表面248)与血管BV的壁接触(例如，配合，并置等)。在一些实施例中，凝块处理装置130相对于血管BV尺寸过大，使得凝块处理装置130在血管BV的壁上施加径向向外的力。在其他实施例中，凝块处理装置130可被设定大小，使得其不接触血管BV的壁。
参考图3和图4D，在框364处，方法360可包括将凝块处理装置130向近侧(例如，在箭头B的方向上)缩回到凝块物质PE/朝向凝块物质缩回。更特别地，参考图1A和图1B，操作者可以，向近侧拉整个系统100(例如，通过抓握毂110来拉动)以使处理部分111穿过导引导管470的腔缩回。在凝块处理装置130缩回时，凝块处理装置130配合凝块物质PE以捕获/破坏凝块物质PE。例如，凝块物质PE可通过第一单元250(图2A至图2C))进入并且被较小的第二单元252(图2A至图2C)保留在凝块处理装置130内。在本技术的一个方面，凝块处理装置130可从血管BV的壁中剪切凝块物质PE，即使在凝块物质PE强力地粘附到血管BV的壁时也是如此。
在一些实施例中，在内套管106在中间套管104的腔内浮动的情况下，凝块处理装置130的长度L(图2A)可随着凝块处理装置130被拉入凝块物质PE/拉向该凝块物质并且中间套管104相对于内套管106向近侧移动而增加。在其他实施例中，在系统100包括致动机制122的情况下，操作者可致动致动机制122以通过锁定或基本上锁定中间套管104和内套管106的相对位置来增加凝块处理装置130的纵向和/或径向刚度。
参考图3和图4E，在框365处，方法360可包括将凝块处理装置130和捕获到的凝块物质PE缩回到导引导管470的腔中。在一些实施例中，凝块处理装置130可从导引导管470完全移除。在一些实施例中，如果任何凝块物质PE留在血管BV中，则可清洁凝块处理装置130并且可重复框362至365以捕获剩余的凝块物质PE。替代地，可将新的凝块处理装置130重新插入穿过导引导管470以捕获剩余的凝块物质PE。在一些实施例中，凝块处理装置130可在不必捕获凝块物质PE的情况下打散凝块物质PE，并且在凝块处理装置130缩回之后或期间，可向导引导管470施加抽吸以将剩余的凝块物质PE吸入导引导管470中。最后，参考图3和图4F，在框366处，方法360可包括在从患者身上移除凝块物质的足够部分之后，从血管BV和从患者身上移除导引导管470。
本技术的几个方面在以下附加示例中阐述：
1.一种凝块处理系统，包括：
外导管，所述外导管限定腔；
内导管，所述内导管的位置至少部分地设置在所述外导管的所述腔中；和
凝块处理装置，所述凝块处理装置包括多个互连支柱，所述多个互连支柱形成可在压缩配置与扩展配置之间移动的整体结构，其中在所述扩展配置中，所述整体结构包括—
近侧连接区域，所述近侧连接区域耦合至所述外导管；
近侧锥形区域，所述近侧锥形区域从所述近侧连接区域延伸，其中所述支柱的第一部分在所述近侧锥形区域中形成第一单元；
圆柱形区域，所述圆柱形区域从所述近侧锥形区域延伸；
远侧锥形区域，所述远侧锥形区域从所述圆柱形区域延伸，其中所述支柱的第二部分在所述远侧锥形区域中形成第二单元，并且其中所述第二单元小于所述第一单元；和
远侧连接区域，所述远侧连接区域从所述远侧锥形区域延伸并且耦合至所述内导管。
2.如示例1所述的凝块处理系统，其中所述内导管具有(a)耦合至所述凝块处理装置的所述远侧连接区域的远侧端部部分和(b)被配置为在所述外导管的所述腔内浮动的近侧端部部分。
3.如示例1或示例2所述的凝块处理系统，其中所述内导管和所述外导管被配置为接纳从中穿过的导丝。
4.如示例1–3中任一项所述的凝块处理系统，还包括手柄，所述手柄耦合至所述外导管的近侧端部部分，其中所述手柄包括耦合至所述内导管的近侧端部部分的致动机制，并且其中所述致动机制的致动被配置为将所述内导管相对于所述外导管平移以纵向地压缩或纵向地伸长所述凝块处理装置。
5.如示例1–4中任一项所述的凝块处理系统，还包括：
输送导管，所述输送导管限定腔；和
手柄，所述手柄耦合至所述外导管的近侧端部部分并且可相对于所述输送导管在第一位置与第二位置之间移动，其中—
在所述第一位置，所述凝块处理装置以所述压缩配置被约束在所述输送导管的所述腔内，并且
在所述第二位置，所述凝块处理装置以所述扩展配置将其位置设置在所述腔的远侧。
6.如示例5所述的凝块处理系统，还包括毂，所述毂耦合至所述输送导管的近侧端部部分，其中所述手柄包括被配置为在所述第二位置将所述手柄固定到所述毂的锁特征。
7.如示例5或示例6所述的凝块处理系统，其中所述手柄，所述输送导管，所述外导管，和所述内导管被配置为接纳从中穿过的导丝。
8.如示例1–7中任一项所述的凝块处理系统，其中在所述扩展配置中，所述圆柱形区域具有在约0.71英寸至约1.34英寸之间的直径。
9.如示例1–8中任一项所述的凝块处理系统，其中所述凝块处理装置的所述支柱被配置为在不受约束时从所述压缩配置自扩展到所述扩展配置。
10.如示例1–9中任一项所述的凝块处理系统，其中所述凝块处理装置的所述支柱包括形状记忆材料。
11.如示例1–10中任一项所述的凝块处理系统，其中所述整体结构包括(a)在所述近侧锥形区域中的第一数量的所述支柱和(b)在所述远侧锥形区域中大于所述第一数量的支柱的第二数量的所述支柱。
12.一种凝块移除的方法，所述方法包括：
将导引导管的远侧部分的位置设置在人类患者血管内的凝块物质附近；
使凝块处理装置前进穿过所述导引导管以在所述凝块物质附近；
在所述凝块物质远侧的所述血管内扩展所述凝块处理，其中所述凝块处理装置包括形成具有近侧部分和远侧部分的整体结构的多个互连支柱，其中所述支柱在所述近侧部分中形成多个第一单元，在所述远侧部分中形成多个第二单元，并且其中所述第一单元大于所述第二单元；
在所述导引导管的所述远侧部分处产生吸力；和
使所述凝块处理装置穿过所述凝块物质向近侧缩回。
13.如示例12所述的方法，其中使所述凝块处理装置前进穿过所述导引导管包括使所述凝块处理装置在导丝上方前进。
14.如示例12或示例13所述的方法，其中所述整体结构的所述近侧部分耦合至至少部分地延伸穿过所述导引导管的外导管，并且其中所述整体结构的所述远侧部分耦合至至少部分地延伸穿过所述外导管的内导管。
15.如示例14所述的方法，其中使所述凝块处理装置前进穿过所述导引导管包括使所述凝块处理装置在延伸穿过所述导引导管，所述外导管，和所述内导管的导丝上方前进。
16.如示例12–15中任一项所述的方法，其中在所述导引导管的所述远侧部分处产生吸力包括在使所述凝块处理装置向近侧缩回之前产生吸力，以将所述凝块物质的第一部分抽入所述导引导管。
17.如示例16所述的方法，其中使所述凝块处理装置向近侧缩回包括使所述凝块处理装置穿过所述凝块物质留在所述血管中的第二部分向近侧缩回，以捕获所述凝块物质的所述第二部分。
18.如示例12–17中任一项所述的方法，其中使所述凝块处理装置穿过所述凝块物质向近侧缩回包括捕获所述凝块物质的至少一部分，并且其中所述方法还包括使所述凝块处理装置和所述捕获到的凝块物质缩回到所述导引导管中。
19.一种凝块处理系统，包括：
外套管，所述外套管限定腔；
内套管，所述内套管的位置至少部分地设置在所述外套管的所述腔中；和
多个互连支柱，所述多个互连支柱形成具有近侧部分和远侧部分的整体结构，其中所述近侧部分耦合至所述外套管，其中所述远侧部分耦合至所述内套管，并且其中所述支柱在所述近侧部分中形成多个第一单元，在所述远侧部分中形成多个第二单元，并且其中所述第一单元大于所述第二单元。
20.如示例12所述的凝块处理系统，其中所述外套管和所述内套管被配置为接纳从中穿过的导丝。
21.一种凝块处理装置，包括：
多个互连支柱，所述多个互连支柱形成可在压缩配置与扩展配置之间移动的整体结构，其中在所述扩展配置中，所述整体结构包括—
近侧连接区域；
近侧锥形区域，所述近侧锥形区域从所述近侧连接区域延伸，其中所述支柱的第一部分在所述近侧锥形区域中形成第一单元；
圆柱形区域，所述圆柱形区域从所述近侧锥形区域延伸；
远侧锥形区域，所述远侧锥形区域从所述圆柱形区域延伸，其中所述支柱的第二部分在所述远侧锥形区域中形成第二单元，并且其中所述第二单元小于所述第一单元；和
远侧连接区域，所述远侧连接区域从所述远侧锥形区域延伸。
22.如示例21所述的凝块处理装置，还包括：
第一套管，其耦合至所述近侧连接区域并限定腔；和
第二套管，其耦合至所述远侧连接区域并且至少部分地延伸穿过所述第一套管的所述腔。
23.如示例21或示例22所述的凝块处理装置，其中所述第二套管具有(a)耦合至所述远侧连接区域的远侧端部部分和(b)被配置为在所述第一套管的所述腔内浮动的近侧端部部分。
24.如示例21–23中任一项所述的凝块处理装置，其中所述支柱被配置为在不受约束时从所述压缩配置自扩展到所述扩展配置。
25.如示例21–24中任一项所述的凝块处理装置，其中所述支柱由形状记忆材料制成。
26.一种凝块处理装置，包括：
多个互连支柱，所述多个互连支柱形成具有近侧部分和远侧部分的整体结构，其中所述支柱在所述近侧部分中形成多个第一单元，在所述远侧部分中形成多个第二单元，并且其中所述第一单元大于所述第二单元。
上面对本技术实施例的详细描述并非旨在穷尽或将本技术限制为上面公开的精确形式。尽管为了说明的目的在上面描述了本技术的具体实施例和示例，但是如相关领域的技术人员将认识到的，在本技术的范围内可以进行多种等同修改。例如，虽然步骤以给定顺序呈现，但是替代实施例可以用不同顺序执行步骤。本文描述的多个实施例也可以被组合以提供进一步的实施例。
根据前述内容将理解的是，本技术的具体实施例是出于说明的目的在本文进行描述，但是为避免不必要地模糊本技术的实施例的描述，没有示出或详细描述公知的结构和功能。在情境允许的情况下，单数或复数术语也可以分别包括复数或单数术语。
此外，除非“或”一词明确限定为仅指两个或两个以上项目列表中不包括其他项目的单个项目，否则在此类列表中使用“或”应解释为包括(a)列表中的任何单个项目，(b)列表中的所有项目，或(c)列表中项目的任何组合。另外，术语“包括”通篇是指包括至少一个或多个所述特征，使得不排除任何更多数量的相同特征和/或其他特征的附加类型。还将理解，为了说明的目的，本文描述了特定实施例，但是可以在不偏离本技术的情况下进行多种修改。此外，虽然已经在这些实施例的情境中描述了与本技术的某些实施例相关联的优点，但是其他实施例也可以表现出这些优点，并且并非所有实施例都需要表现出这些优点才能落入本技术的范围内。因此，本公开和相关技术可以包括本文未明确示出或描述的其他实施例。

Claims (20)

1.一种凝块处理系统，包括：
外导管，所述外导管限定腔；
内导管，所述内导管的位置至少部分地设置在所述外导管的所述腔中；和
凝块处理装置，所述凝块处理装置包括多个互连支柱，所述多个互连支柱形成可在压缩配置与扩展配置之间移动的整体结构，其中在所述扩展配置中，所述整体结构包括—
近侧连接区域，所述近侧连接区域耦合至所述外导管；
近侧锥形区域，所述近侧锥形区域从所述近侧连接区域延伸，其中所述支柱的第一部分在所述近侧锥形区域中形成第一单元；
圆柱形区域，所述圆柱形区域从所述近侧锥形区域延伸；
远侧锥形区域，所述远侧锥形区域从所述圆柱形区域延伸，其中所述支柱的第二部分在所述远侧锥形区域中形成第二单元，并且其中所述第二单元小于所述第一单元；和
远侧连接区域，所述远侧连接区域从所述远侧锥形区域延伸并且耦合至所述内导管。
2.如权利要求1所述的凝块处理系统，其中所述内导管具有(a)耦合至所述凝块处理装置的所述远侧连接区域的远侧端部部分和(b)被配置为在所述外导管的所述腔内浮动的近侧端部部分。
3.如权利要求1所述的凝块处理系统，其中所述内导管和所述外导管被配置为接纳从中穿过的导丝。
4.如权利要求1所述的凝块处理系统，还包括手柄，所述手柄耦合至所述外导管的近侧端部部分，其中所述手柄包括耦合至所述内导管的近侧端部部分的致动机制，并且其中所述致动机制的致动被配置为将所述内导管相对于所述外导管平移以纵向地压缩或纵向地伸长所述凝块处理装置。
5.如权利要求1所述的凝块处理系统，还包括：
输送导管，所述输送导管限定腔；和
手柄，所述手柄耦合至所述外导管的近侧端部部分并且可相对于所述输送导管在第一位置与第二位置之间移动，其中—
在所述第一位置，所述凝块处理装置以所述压缩配置被约束在所述输送导管的所述腔内，并且
在所述第二位置，所述凝块处理装置以所述扩展配置将其位置设置在所述腔的远侧。
6.如权利要求5所述的凝块处理系统，还包括毂，所述毂耦合至所述输送导管的近侧端部部分，其中所述手柄包括被配置为在所述第二位置将所述手柄固定到所述毂的锁特征。
7.如权利要求5所述的凝块处理系统，其中所述手柄，所述输送导管，所述外导管，和所述内导管被配置为接纳从中穿过的导丝。
8.如权利要求1所述的凝块处理系统，其中在所述扩展配置中，所述圆柱形区域具有在约0.71英寸至约1.34英寸之间的直径。
9.如权利要求1所述的凝块处理系统，其中所述凝块处理装置的所述支柱被配置为在不受约束时从所述压缩配置自扩展到所述扩展配置。
10.如权利要求1所述的凝块处理系统，其中所述凝块处理装置的所述支柱包括形状记忆材料。
11.如权利要求1所述的凝块处理系统，其中所述整体结构包括(a)在所述近侧锥形区域中的第一数量的所述支柱和(b)在所述远侧锥形区域中大于所述第一数量的支柱的第二数量的所述支柱。
12.一种凝块移除的方法，所述方法包括：
将导引导管的远侧部分的位置设置在人类患者血管内的凝块物质附近；
使凝块处理装置前进穿过所述导引导管以在所述凝块物质附近；
在所述凝块物质远侧的所述血管内扩展所述凝块处理，其中所述凝块处理装置包括形成具有近侧部分和远侧部分的整体结构的多个互连支柱，其中所述支柱在所述近侧部分中形成多个第一单元，在所述远侧部分中形成多个第二单元，并且其中所述第一单元大于所述第二单元；
在所述导引导管的所述远侧部分处产生吸力；和
使所述凝块处理装置穿过所述凝块物质向近侧缩回。
13.如权利要求12所述的方法，其中使所述凝块处理装置前进穿过所述导引导管包括使所述凝块处理装置在导丝上方前进。
14.如权利要求12所述的方法，其中所述整体结构的所述近侧部分耦合至至少部分地延伸穿过所述导引导管的外导管，并且其中所述整体结构的所述远侧部分耦合至至少部分地延伸穿过所述外导管的内导管。
15.如权利要求14所述的方法，其中使所述凝块处理装置前进穿过所述导引导管包括使所述凝块处理装置在延伸穿过所述导引导管，所述外导管，和所述内导管的导丝上方前进。
16.如权利要求12所述的方法，其中在所述导引导管的所述远侧部分处产生吸力包括在使所述凝块处理装置向近侧缩回之前产生吸力，以将所述凝块物质的第一部分抽入所述导引导管。
17.如权利要求16所述的方法，其中使所述凝块处理装置向近侧缩回包括使所述凝块处理装置穿过所述凝块物质留在所述血管中的第二部分向近侧缩回，以捕获所述凝块物质的所述第二部分。
18.如权利要求12所述的方法，其中使所述凝块处理装置穿过所述凝块物质向近侧缩回包括捕获所述凝块物质的至少一部分，并且其中所述方法还包括使所述凝块处理装置和所述捕获到的凝块物质缩回到所述导引导管中。
19.一种凝块处理系统，包括：
外套管，所述外套管限定腔；
内套管，所述内套管的位置至少部分地设置在所述外套管的所述腔中；和
多个互连支柱，所述多个互连支柱形成具有近侧部分和远侧部分的整体结构，其中所述近侧部分耦合至所述外套管，其中所述远侧部分耦合至所述内套管，并且其中所述支柱在所述近侧部分中形成多个第一单元，在所述远侧部分中形成多个第二单元，并且其中所述第一单元大于所述第二单元。
20.如权利要求12所述的凝块处理系统，其中所述外套管和所述内套管被配置为接纳从中穿过的导丝。
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US20210113224A1 (en) 2021-04-22
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EP4044938A1 (en) 2022-08-24
CA3157521A1 (en) 2021-04-22

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