CN113576558B - 具有导丝隔离衬套的组织移除导管 - Google Patents
具有导丝隔离衬套的组织移除导管 Download PDFInfo
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Abstract
用于移除体腔中的组织的组织移除导管(10)包括细长主体(12)和安装在细长主体(12)的远端部分上的组织移除元件(20)。组织移除元件(20)构造成随着该组织移除元件(20)在体腔内由细长主体(12)旋转而移除组织。内衬套(14)被接纳在细长主体(12)内,并且在内衬套(14)的近端处联接于手柄(40)。内衬套(14)限定有导丝(26)的内腔。内衬套(14)使导丝(26)内腔的内部与细长主体(12)和组织移除元件(20)隔离,使得当在组织移除导管(10)的操作期间使细长主体(12)和组织移除元件(20)旋转时,旋转力和扭转力不会从细长主体(12)和组织移除元件(20)传递至导丝(26)内腔的内部。
Description
本发明专利申请是国际申请号为PCT/US2018/030939、国际申请日为2018年5月3日、进入中国国家阶段的申请号为201880029498.0、名称为“具有导丝隔离衬套的组织移除导管”的发明专利申请的分案申请。
技术领域
本公开总体地涉及一种组织移除导管,并且更具体地,涉及一种用于组织移除导管的隔离衬套。
背景技术
组织移除导管用于移除体腔中不想要的组织。作为示例,旋切术导管用于从血管中移除材料以打开血管并改善通过血管的血液流动。该过程可以用于为患者冠状动脉内的病变作准备,以有助于在患有严重钙化冠状动脉病变的患者体内进行经皮冠状动脉成形术(PTCA)或支架递送。动脉粥样硬化切除术导管通常采用旋转元件,该旋转元件用于磨削或以其它方式破坏不想要的组织。
发明内容
在一个方面,一种用于移除体腔中的组织的组织移除导管通常包括细长主体,该细长主体具有轴线以及沿着该轴线彼此间隔开的近端部分和远端部分。细长主体的尺寸和形状设定成其被接纳在体腔中。手柄安装在细长主体的近端部分上并且可操作成引起细长主体的旋转。组织移除元件安装在细长主体的远端部分上。组织移除元件构造成,随着该组织移除元件在体腔内由细长主体旋转而移除组织。内衬套被接纳在细长主体内,并且在内衬套的近端处联接于手柄。内衬套限定有导丝内腔。内衬套使导丝内腔的内部与细长主体和组织移除元件隔离,使得当在组织移除导管的操作期间使细长主体和组织移除元件旋转时,旋转力和扭转力不会从细长主体和组织移除元件传递至导丝内腔的内部。
在另一个方面,一种用于移除体腔中的组织的组织移除导管通常包括细长主体,该细长主体具有轴线以及沿着该轴线彼此间隔开的近端部分和远端部分。细长主体的尺寸和形状设定成其被接纳在体腔中。组织移除元件安装在细长主体的远端部分上。组织移除元件构造成,随着该组织移除元件在体腔内由细长主体旋转而移除组织。内衬套被接纳在细长主体内,并且可相对于细长主体运动。内衬套限定有导丝内腔。内衬套使导丝内腔的内部与细长主体和组织移除元件隔离,使得当在组织移除导管的操作期间使细长主体和组织移除元件旋转时,旋转力和扭转力不会从细长主体和组织移除元件传递至导丝内腔的内部。
在又一个方面,一种移除体腔中的组织的方法总体上包括:使组织移除导管在导丝上前进到体腔中,以将导管的远端定位成与组织相邻,并将导管的近端部分定位在体腔的外部。导管包括细长主体和安装在细长主体的远端部分上的组织移除元件。内衬套配置在细长主体内。内衬套限定有导丝内腔,在导管前进期间导丝配置在导丝内腔中。该方法还包括致动马达,以使导管的细长主体和组织移除元件旋转,从而移除组织。并且,利用内衬套使导丝与细长主体和组织移除元件隔离,使得在细长主体和组织移除元件的旋转期间,旋转力和扭转力不会从细长主体和组织移除元件传递至导丝。
附图说明
图1是本公开的导管的正视图;
图2是导管的远端部分的放大正视图;
图3是导管的近端部分的放大正视图;
图4是图2中的导管的远端部分的放大局部纵向剖视图;
图5是通过图2的线5-5剖取的剖视图;
图6是导管的隔离衬套的局部正视图,其中一些部分被剖开以显示内部细节;
图7是导管的远端部分的放大正视图,示出了内衬套上的无创伤末端;
图8是导管的远端部分的放大正视图,示出了内衬套上的渐缩末端;以及
图9是导管的组织移除元件的放大纵向剖视图。
在附图中对应的附图标记表示对应的部件。
具体实施方式
参照附图,并且具体地是图1,用于移除体腔中的组织的旋转组织移除导管总体上以附图标记10表示。图示的导管10是旋切术装置,其适合于从血管壁移除(例如,磨削、切割、切除、消融等)闭塞组织(例如,栓塞组织、斑块组织、动脉粥样硬化、溶栓组织、狭窄组织、增生组织、赘生性组织等)。导管10可用于促进经皮冠状血管成形术(PTCA)或随后的支架递送。所公开的实施例的特征还可适合于治疗血管的慢性完全闭塞(CTO),以及其它体腔的狭窄和在其它体腔中的其它增生和赘生性疾病的狭窄,其它体腔比如是输尿管、胆道、呼吸道、胰管、淋巴管等。围绕并侵入体腔的肿瘤常常会导致赘生性细胞的生长。因此,移除这种材料可以有益于维持体腔的通畅。
导管10的尺寸设计成被接纳在对象的血管中。因此,导管10的最大尺寸可为3、4、5、6、7、8、9、10或12弗伦奇(French)(1、1.3、1.7、2、2.3、2.7、3、3.3或4毫米),并且根据体腔,工作长度可为20、30、40、60、80、100、120、150、180或210厘米。虽然其余的讨论针对的是用于移除血管中的组织的导管,但应当理解的是,本公开的教导还适用于其它类型的组织移除导管,包括但不限于用于从各种体腔中的各种闭塞、狭窄或增生材料中穿透和/或移除组织的导管。
参照图1和2,导管10包括绕细长内衬套14配置的细长外层12(广义上说是细长主体)。外层12和内衬套14沿着导管的纵向轴线LA从导管的近端部分16延伸至远端部分18。组织移除元件20配置在外层12的远端上,并且构造成旋转,以从体腔移除组织,如以下将更详细地说明的。套管22(图1)绕外层12配置。外层12和内衬套14两者构造成相对于套管22平移。外层12和内衬套14还构造成相对于彼此平移。导管10的尺寸和形状设计成,其可插入到对象的体腔中。套管22将体腔与外层12和内衬套14的至少一部分隔离。内衬套14限定有导丝内腔24(图5),用于在导丝内腔24中可滑动地接纳导丝26,使得导管10可以通过沿着导丝行进而前进穿过体腔。导丝可以是标准的0.014英寸外径、300厘米长的导丝。在某些实施例中,内衬套14可具有用于在导丝26上滑动的润滑内表面(例如,润滑表面可由润滑聚合物层或润滑涂层来提供)。在所示的实施例中,导丝内腔24从导管10的近端部分16延伸穿过远端部分18,使得导丝26可沿着导管10的整个工作长度延伸。在一种实施例中,导管10的总工作长度可在大约135厘米(53英寸)至大约142厘米(56英寸)之间。
导管10还包括固定在导管的近端部分16处的手柄40。手柄40支承致动器42(例如,杆、按钮、拨盘、开关或其它装置),该致动器42构造成用于选择性地致动配置在手柄中的马达43,以驱动外层12以及安装在外层的远端处的组织移除元件20旋转。马达43通过齿轮组件44和由手柄40支承的驱动器48来联接于外层12。滑动件或前进件45定位在手柄40上,并且可操作地联接于外层12,以使外层相对于手柄运动,从而使外层和组织移除元件20前进和后退。手柄40限定有狭槽(未示出),该狭槽限制滑动件45相对于手柄的运动。因此,狭槽的长度确定了外层12与手柄40之间的相对运动量。灌注端口46可配置在导管10的近端16处。端口46与套管22和外层12之间的空间连通,用于递送流体(例如盐水),以在使用期间冷却旋转的外层。近侧端口47允许导丝26和内衬套14通过手柄40的近端。可以在手柄40上提供导丝锁定件(未示出),以将导丝26相对于手柄锁定就位。
应当理解的是,在其它实施例中,其它合适的致动器,包括但不限于触摸屏致动器、无线控制致动器、由控制器引导的自动致动器等,可适合于选择性地致动马达。在一些实施例中,动力供应可来自于容纳在手柄40内的电池(未示出)。在其它实施例中,动力供应可来自外源。
参照图1和图3,外套管22包括管状套筒,该管状套筒被构造成将对象体腔内的动脉组织与旋转的外层12隔离并进行保护。套管22在套管的近端处固定于手柄40并且不旋转。安装在套管22的近端上的接口52将套管附连至手柄40。接口52包括锁定特征部54(例如,螺纹鲁尔锁),该锁定特征部54用于配合手柄40以将套管22附连至手柄。套管22为外层12和内衬套14在套管内运动提供了部分封闭。套管22的内径的尺寸设计成,为外层12提供间隙。套管22与外层12之间的空间允许外层在套管内旋转,并为套管与外层之间的盐水灌注提供区域。套管22的外径的尺寸设计成,提供与引导导管(未示出)的内径的间隙,该引导导管用于将导管10递送至体腔中的期望位置。应变释放件56设置在套管22的近端处,以当套管在导管10的使用期间弯曲时,减轻施加至套管22的近端的张力。在一种实施例中,套管22具有约0.050英寸(1.27毫米)的内径、约0.055英寸(1.4毫米)的外径和约1500毫米(59英寸)的长度。套管22可以具有其它尺寸,而不脱离本公开的范围。在一种实施例中,外套管22由聚四氟乙烯(PTFE)制成。替代地,外套管22可包括多层构造。例如,外套管22可包括全氟烷氧基(PFA)的内层、中间编织线层以及Pebax的外层。替代地,外层可以由聚酰亚胺或PEEK形成。
参照图1、2、4和5,外层12可包括管状不锈钢线圈,该管状不锈钢线圈构造成将旋转和扭矩从马达43传递至组织移除元件20。将外层12构造为盘绕结构为外层提供了柔性,该柔性有助于将导管10递送通过体腔。此外,当导管10横穿弯曲路径时,线圈构造允许外层12的旋转和扭矩被施加至组织移除元件20。外层12的刚度还影响线圈横穿体腔的容易程度以及线圈有效地将扭矩传递至组织移除元件20的能力。在一种实施例中,外层12是相对刚性的,使得在导管10穿过体腔的运动期间,线圈的轴向压缩和延伸被最小化。例如,外层可具有在约2至约10牛/毫米之间的轴向压缩刚度。外层12的线圈构造还构造成,当线圈旋转时扩大其内径,使得在导管10的操作期间外层与内衬套14保持间隔开。在一种实施例中,外层12具有大约0.023英寸(0.6毫米)的内径和0.035英寸(0.9毫米)的外径。外层12可具有单层构造。例如,外层可包括具有约30度的布设角度的7丝(即,线)线圈。替代地,外层12可以由多层构造成,而不脱离本公开的范围。例如,外层12可包括基础线圈层和配置在该基础层之上的护套(例如,TecothaneTM)。在一种实施例中,外层包括具有约45度的布设角度的15丝线圈。TecothaneTM护套可配置在该线圈之上。替代地,外层12可包括双线圈层构造,该双线圈层构造还包括在两个线圈层之上的附加护套层。例如,外层可包括内线圈层和外线圈层,内线圈层包括具有约45度的布设角度的15丝线圈,外盘绕件层包括具有约10度的布设角度的19丝盘绕件。还可以设想具有其它构造的外层。
参照图1、2和4-6,内衬套14包括多层管状主体,所述多层管状主体构造成将导丝26与外层12和组织移除元件20隔离。内衬套14可从手柄近侧的位置延伸穿过手柄40至手柄远侧的位置。在一种实施例中,内衬套14联接于手柄40,但并未固定地附连于手柄40,以允许内衬套相对于手柄平移。在该实施例中,并不防止内衬套14的旋转。然而,内衬套14与外层12之间的间隙防止了由外层的旋转引起的内衬套的任何旋转。在该实施例中,内衬套14和外层12均被允许相对于手柄40平移。当向外层施加力以使外层在体腔内运动时,允许内衬套14和外层12的这种共同平移使盘绕的外层14的压缩和延伸最小化。在另一种实施例中,内衬套14可固定地附连于手柄40,以防止内衬套与手柄之间的相对运动。因此,在该实施例中,内衬套14保持静止并且防止内衬套14相对于手柄40平移。此外,防止了内衬套14的所有旋转。在该实施例中,外层12在静止的内衬套14上平移。
内衬套14具有内径,该内径的尺寸设计成使导丝26经过。内衬套14通过使导丝与可旋转的外层隔离而保护导丝免受由外层12的旋转造成的损坏。内衬套14还延伸经过组织移除元件20,以保护导丝26免受旋转的组织移除元件的伤害。因此,内衬套14构造成防止导丝26与导管10的旋转部件之间的任何接触。因此,内衬套14消除了任何金属与金属的配合。外层12和组织移除元件20与导丝26的这种隔离还确保了外层和组织移除元件的旋转不被传递或传输至导丝。结果,标准导丝26可以与导管10一起使用,因为导丝不必构造成承受旋转部件的扭转作用。此外,通过延伸穿过组织移除元件20并经过组织移除元件的远端,内衬套14通过提供用于使组织移除元件绕内衬套旋转的定心轴线来稳定组织移除元件。
在所示的实施例中,内衬套14包括内PTFE层60、由不锈钢组成的中间编织层62和聚酰亚胺的外层64。PTFE内层60为内衬套14提供了润滑的内部,该润滑的内部有助于使导丝26穿过内衬套。编织的不锈钢中间层62为内衬套14提供刚性和强度,使得衬套可以承受由外层12施加在内衬套上的扭转力。在一种实施例中,中间层62由304不锈钢形成。外聚酰亚胺层64提供耐磨性并且具有润滑性,该润滑性减小了内衬套14与外层12之间的摩擦。此外,可将诸如硅树脂之类的润滑膜添加至内衬套14,以减少内衬套与外层12之间的摩擦。在一种实施例中,内衬套14具有约0.016英寸(0.4毫米)的内径ID、约0.019英寸(0.5毫米)的外径OD和约59英寸(1500毫米)的长度。内衬套14的内径ID为标准的0.014英寸导丝26提供间隙。内衬套14的外径OD为外层12和组织移除元件20提供间隙。在内衬套14与外层12之间具有的空间减小了两个部件之间的摩擦并且允许部件之间的盐水灌注。
在所示的实施例中,标记带66设置在内衬套14的远端的外表面上。标记带66将内衬套14的末端构造成在荧光透视下可见,这允许医师在医疗程序中验证衬套的位置。在该实施例中,可对内衬套14的远端进行激光切割以提供低轮廓的末端。在一种实施例中,标记带66包括铂铱条带。
在不脱离本公开的范围的情况下,还可以设想内衬套14的远端可以具有其它构造。例如,无创伤末端68可附连于内衬套14的远端(图7)。无创伤末端68提供柔软的低轮廓远端,以有助于内衬套14通过体腔的递送而不引起创伤。无创伤末端68可具有约0.02英寸(0.6毫米)的最大外径。还可以设想无创伤末端的其它尺寸。在另一种实施例中,可将渐缩末端70附连于内衬套14的远端(图8)。渐缩末端70可由构造成保护内衬套14的远端的材料层形成。
参照图1、2和9,组织移除元件20沿着纵向轴线LA从与外层12的远端部分相邻的近端延伸至相对的远端。组织移除元件20可操作地连接于马达43,以由马达旋转。当将导管10插入到体腔中并且马达43使组织移除元件20旋转时,组织移除元件构造成移除体腔中的闭塞组织,以将组织与体腔壁分开。在一种或多种实施例中,可使用用于在体腔旋转时移除体腔中的组织的任何合适的组织移除元件。在一种实施例中,组织移除元件20包括磨削锉具,该磨削锉具构造成当马达43使磨削锉具旋转时磨削体腔中的组织。磨削锉具20可具有例如通过金刚石砂砾涂覆、表面蚀刻等形成的磨削外表面。在一种实施例中,组织移除元件包括不锈钢球状主体,该球状主体的外表面包括5微米的暴露的金刚石晶体。组织移除元件20还可以是不透射线的,以允许组织移除元件在荧光透视下可见。在其它实施例中,组织移除元件可以包括一个或多个具有平滑或锯齿状切割边缘的切割元件、浸渍器、血栓切除线等。
空腔72纵向延伸穿过组织移除元件20,使得组织移除元件在其近端和远端处限定有开口。空腔72接纳外层12的一部分,以用于将组织移除元件20安装至外层。空腔72包括从组织移除元件20的近端延伸的第一直径部分74、从第一直径部分朝向组织移除元件的远端延伸的渐缩直径部分76、以及从渐缩直径部分延伸至组织移除元件的远端的第二直径部分78。第一直径部分74和第二直径部分78的直径沿着它们的长度是恒定的。在所示的实施例中,第一直径部分74的直径D1大于第二直径部分78的直径D2。在一种实施例中,第一直径部分74的直径D1约为0.035英寸(0.9毫米),并且第二直径部分78的直径D2约为0.022英寸(0.56毫米)。渐缩直径部分76提供第一直径部分74与第二直径部分78之间的过渡。外层12被接纳在第一直径部分74中,并且外层的远端邻接渐缩直径部分76。组织移除元件20可以通过任何合适的方式固定地附连于外层12的远端。在一种实施例中,粘合剂将组织移除元件20结合至外层12。内衬套14延伸穿过外层12和组织移除元件20的第二直径部分78。第二直径部分78的尺寸设计成,使内衬套14以小间隙地通过。内径D2在组织移除元件20与内衬套14之间提供间隙,以减小部件之间的摩擦并允许有盐水灌注的空间。因此,组织移除元件20的成形为并布置成绕内衬套14和外层12的至少一部分延伸,并因此提供了相对紧凑的组件,用于在导管10的远端部分处磨削组织。
组织移除元件20的外表面包括近侧部段80、中间部段82和远侧部段84。近侧部段80的直径从组织移除元件20的近端增大至中间部段82。中间部段具有恒定的直径,并且从近侧部段80延伸至远侧部段84。远侧部段84的直径从中间部段82渐缩至组织移除元件20的远端。渐缩的远侧部段84为组织移除元件20提供大致楔形的形状,以将收窄的组织通道楔开,因为它同时通过使用组织移除元件的磨削作用移除组织而打开通道。组织移除元件20的远端还被磨圆,以为组织移除元件提供钝的远端。
参照图1和图2,为了移除对象的体腔中的组织,医师将导丝26插入到对象的体腔中至要移除的组织远侧的位置。随后,医师将导丝26的近端部分插入穿过内衬套14的导丝内腔24并穿过手柄40,使得导丝延伸穿过手柄中的近侧端口47。内衬套14还可延伸穿过手柄40并从近侧端口47延伸出来。在将导管10加载到导丝26上的情况下,医师使导管沿着导丝前进,直到组织移除元件20定位在组织的近侧并与组织相邻。当组织移除元件20定位在组织的近侧并且与组织相邻时,医师使用致动器42来致动马达43,以使外层12和安装在外层上的组织移除元件旋转。随着组织移除元件的旋转,组织移除元件20磨削(或以其它方式移除)体腔中的组织。在组织移除元件20旋转的同时,医师可选择性地使外层12和内衬套14沿着导丝26向远侧运动以磨削组织,并且例如增大通过体腔的通道的尺寸。医师还可使外层12和内衬套14沿着导丝26向近侧运动,并且可使部件沿远侧方向和近侧方向重复地运动,以获得组织移除元件20在整个组织上的来回运动。在磨削过程期间,内衬套14将导丝26与旋转的外层12和组织移除元件20隔离,以保护导丝不受旋转部件的损坏。由此,内衬套14构造成承受旋转的外层12和组织移除元件20的扭转和摩擦作用,而不将那些作用传递至导丝26。当医师完成使用导管10的操作时,可以通过使导管沿着导丝向近侧滑动来将导管从体腔中抽出并从导丝26上卸下。用于磨削过程的导丝26可保留在体腔中,以用于后续程序。
当介绍本发明的元件或其一种或多种实施例时,冠词“一”、“一个”、“该”和“所述”意在表示存在一个或多个元件。术语“包括”、“包含”和“具有”意在为包含性的并表示可能有除所列元件外的附加元件。
由于在不脱离本发明的范围的情况下可以对上述设备、系统和方法进行各种改变,所以意味着包含在以上描述中并且在附图中示出的所有内容应被诠释为说明性的而非限制性含义。
Claims (14)
1.一种用于移除体腔中的组织的组织移除导管,所述组织移除导管包括:
细长主体,所述细长主体具有轴线以及沿着所述轴线彼此间隔开的近端部分和远端部分,所述细长主体的尺寸和形状设计成容纳在所述体腔中;
手柄,所述手柄安装在所述细长主体的所述近端部分上,并且能够操作成引起所述细长主体的旋转,所述细长主体能够相对于所述手柄运动;
组织移除元件,所述组织移除元件安装在所述细长主体的所述远端部分上,所述组织移除元件构造成,当所述细长主体在所述体腔内使所述组织移除元件旋转时,移除所述组织;以及
内衬套,所述内衬套被接纳在所述细长主体内,并在所述内衬套的近端处联接于所述手柄,所述内衬套限定有导丝内腔,所述内衬套将所述导丝内腔的内部与所述细长主体和所述组织移除元件隔离,使得当在所述组织移除导管的操作期间所述细长主体和所述组织移除元件旋转时,旋转力和扭转力不从所述细长主体和所述组织移除元件传递至所述导丝内腔的内部,其中所述内衬套可动地联接于所述手柄,使得所述内衬套构造成相对于所述手柄平移并且防止所述内衬套的由所述细长主体的旋转而引起的旋转,且其中所述内衬套没有在所述内衬套中的径向孔。
2.如权利要求1所述的组织移除导管,其特征在于,所述内衬套包括内层、外层以及配置在所述内层与所述外层之间的中间层。
3.如权利要求2所述的组织移除导管,其特征在于,所述内层包括聚四氟乙烯(PTFE),所述中间层包括不锈钢,并且所述外层包括聚酰亚胺,所述内衬套的各层通过将导丝与可转动的所述细长主体隔离开而保护所述导丝不被所述细长主体的旋转所损坏。
4.如权利要求1所述的组织移除导管,其特征在于,还包括在所述内衬套的远端部分上的标记带,所述标记带将所述远端部分构造成在荧光透视下可见。
5.如权利要求4所述的组织移除导管,其特征在于,还包括无创伤末端,所述无创伤末端配置在所述内衬套的所述远端部分上。
6.如权利要求4所述的组织移除导管,其特征在于,还包括渐缩末端,所述渐缩末端配置在所述内衬套的所述远端部分上。
7.如权利要求1所述的组织移除导管,其特征在于,所述内衬套的远端向所述组织移除元件的远侧延伸。
8.如权利要求7所述的组织移除导管,其特征在于,所述导丝内腔延伸穿过所述内衬套的所述远端。
9.如权利要求1所述的组织移除导管,其特征在于,所述组织移除元件包括磨削锉具。
10.如权利要求1所述的组织移除导管,其特征在于,还包括马达,所述马达在所述手柄中并与所述细长主体能够操作地相配合,以驱动所述细长主体和安装在所述细长主体上的所述组织移除元件的旋转。
11.如权利要求10所述的组织移除导管,其特征在于,还包括致动器,所述致动器定位在所述手柄上并且构造成选择性地致动所述马达,以驱动所述细长主体和所述组织移除元件的旋转。
12.如权利要求1所述的组织移除导管,其特征在于,还包括前进件,所述前进件安装在所述手柄上并且能够操作地联接于所述细长主体,以使所述细长主体相对于所述手柄运动。
13.如权利要求1所述的组织移除导管,其特征在于,所述内衬套和所述细长主体之间的间隙防止所述内衬套随所述细长主体的旋转而旋转。
14.如权利要求1所述的组织移除导管,其特征在于,还包括:绕所述细长主体配置的套管;以及灌注端口,所述灌注端口配置在所述导管的近端处并且与所述导管和所述细长主体之间的空间连通,用于在使用中递送流体以冷却旋转的所述细长主体。
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