CN103281964A - 具备成像能力的柔性减灭导管及其使用和制造方法 - Google Patents
具备成像能力的柔性减灭导管及其使用和制造方法 Download PDFInfo
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- CN103281964A CN103281964A CN2011800626058A CN201180062605A CN103281964A CN 103281964 A CN103281964 A CN 103281964A CN 2011800626058 A CN2011800626058 A CN 2011800626058A CN 201180062605 A CN201180062605 A CN 201180062605A CN 103281964 A CN103281964 A CN 103281964A
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- G01R33/285—Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
- G01R33/287—Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR involving active visualization of interventional instruments, e.g. using active tracking RF coils or coils for intentionally creating magnetic field inhomogeneities
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- G—PHYSICS
- G10—MUSICAL INSTRUMENTS; ACOUSTICS
- G10K—SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR
- G10K11/00—Methods or devices for transmitting, conducting or directing sound in general; Methods or devices for protecting against, or for damping, noise or other acoustic waves in general
- G10K11/004—Mounting transducers, e.g. provided with mechanical moving or orienting device
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Abstract
本发明提供了导管和方法,所述导管和方法用于从身体管腔移除物质,同时对由物质构成的区域进行成像。能够在身体管腔中使用导管,包括但不局限于血管内管腔,诸如冠状动脉或外周动脉。导管包括壳体(122)或者其它结构,以安装或者保护成像变换器(40)。通常减灭导管包括:近侧部分;具有开口的远侧部分;切割元件(4),所述切割元件可以通过开口暴露出,以便与身体管腔中的物质接触;以及具有相关电路和显示装置的成像变换器。导管在其运动时减灭身体管腔,同时切割元件与身体管腔中的物质接触,而且由物质构成的区域在导管移动之前、之后或者移动期间成像。
Description
本申请要求2011年7月20日提交的名为“具备成像能力的柔性减灭导管和其使用方法”的美国临时专利申请No.61/509,866,和2010年11月11日提交的名为“具备成像能力的柔性减灭导管和其使用方法”的美国临时专利申请No.61/412,674的优先权,其中的每一个的全部内容在此均以援引的方式并入本申请。
技术领域
本发明整体涉及用于减灭身体管腔的系统和方法。更加具体地,本发明涉及用于治疗血管疾病的粥样斑块切除导管。
背景技术
心血管疾病通常因粥样物质聚集在脉管管腔的内壁上,尤其是冠状脉管和其它脉管系统的动脉管腔上而形成,从而导致已知为动脉粥样硬化的状况。动脉粥样硬化的状况因衰老而自然发生,但是也可以因诸如饮食、高血压、遗传、血管损伤等因素而加剧。粥样沉积物的性能具有很大差异,其中一些沉积物相对较软,而其它沉积物是纤维化的和/或钙化的。在后者情况中,沉积物通常称作斑块。
能够以多种方式来治疗血管疾病、尤其是动脉粥样硬化的状况,所述方式包括药物、绕道手术和多种基于导管的方法。一种基于导管的方法是在血管内减灭或者移除闭塞血管的粥样物质或者其它物质。本发明尤为关注的是,已经提出用于切割或者取出物质以及从血管移除这种物质的各种方法,所述方法通常称作粥样斑块切除手术。旨在从血管管腔切除物质的粥样斑块切除导管通常应用可旋转和/或轴向可平移的刀片,所述刀片能够行进到闭塞物质内或者越过闭塞物质,以从血管腔切割和分离这种物质。特别地,侧切割的粥样斑块切除导管通常采用在一侧具有孔的壳体以及旋转或者平移通过孔的刀片。
尽管已经认为粥样斑块切除导管在治疗多种类型的动脉粥样硬化和再狭窄中是成功的,但是仍然不断追求改进的粥样斑块切除导管和方法。例如,多种当前可获得的粥样斑块切除导管具有刀具,所述刀具包封在相对较大直径的远侧壳体中,以便确保能够将刀具安全地运送到血管中。为了提供存储足够体积物质的贮存能力、同时治疗血管,通常加长刀具壳体。还建议的是,将成像能力结合到粥样斑块切除导管中。成像变换器(如果提供的话)可以影响远侧导管区域的柔性,原因在于变换器通常为刚性的。柔性的减小和远侧导管区域长度的增加使得难以通过脉管系统的迂曲区域引入和收回导管的远端。
本发明克服了与现有装置相关的这些问题中的一些。特别地,本发明涉及用于组织成像以及从身体管腔(诸如血管或者其它脉管位置)移除组织的方法和装置。尽管本发明可以用于从脉管位置移除物质,但是本发明还可以使用在其它身体管腔中。应当理解的是,尽管可以关于血管中的使用描述本发明,但是可以在任何身体管腔中实践本发明的方法和装置。
发明内容
在此公开多种导管实施例和使用和制造它们的方法。结合具体实施例或者方法在下文描述了可以包括在这些导管实施例和方法中的不同特征。意图是在此描述的导管和方法可以包括单独或者组合的这些特征中的一个或多个,并且并不旨在这种公开并不限制于结合在此公开的实施例或者方法描述的特征的具体组合。
在此公开的实施例涉及导管和方法,所述导管和方法用于从身体管腔移除(或“减灭”)物质,同时使得身体管腔成像,并且涉及一种制造导管的方法。这些导管具有显著的柔性、扭转能力和拉伸强度,以使用在多种身体管腔中,包括但不局限于血管内管腔,诸如冠状和外周脉管系统。减灭导管用于从脉管腔移除闭塞物质,诸如粥样硬化斑块,但是它们可以替代性地用于移除其它材料。通常,减灭导管包括:近侧部分;具有开口(或者“窗口”)的远侧部分;切割元件(或者“组织减灭组件”),所述切割元件可以通过开口暴露出,以便接触身体管腔内的物质;和具有相关电路和显示装置的成像变换器。导管在其运动时减灭身体管腔,同时切割元件与管腔内的物质接触,并且在导管运动之前、之后或者期间对管腔15成像。
在此公开的实施例包括导管,所述导管具有位于壳体内的成像变换器。壳体设计成在使用导管期间保护变换器和/或连接到变换器的线材或者线材连接件免受损坏,而允许在导管使用时对导管适当地成像。这些导管还设置有其它特征,所述其它特征允许将变换器安装在导管本体内,从而保护变换器和/或将变换器连接到控制手柄的线材或者线材连接件,而且允许导管本体保持理想的柔性和图像质量。这些特征包括使用柔性填充件、亲水材料、可传送材料、封装材料、多种接套和附接到变换器或者与变换器相联的其它防护性结构。
为了进一步理解本发明的本质和优势,应当参照结合以下附图给出以下描述。
附图说明
图1是粥样斑块切除导管的局部等距视图;
图2是图1的粥样斑块切除导管的一部分的等距剖视图,其中,切割元件示出为部分暴露出;
图3是图1的粥样斑块切除导管的一部分的等距剖视图,其中,切割元件处于工作位置中;
图4是切割元件的实施例的等距视图;
图5是具有超声成像能力的导管的一部分的侧视图;
图6是图5的粥样斑块切除导管的一部分的局部剖视图,其中,切割元件处于贮存位置中;
图7是变换器的等距视图;
图8A和图8B是用于与变换器一起使用的接套的实施例的等距视图;
图9A和9B是用于与变换器一起使用的接套一起使用的另一个实施例的局部侧剖视图;
图10A、10B、10C、10D、10E和10F是粥样斑块切除导管的一部分的侧剖视图;
图11是安装到导管中的变换器的局部侧剖视图;
图12是安装到导管中的变换器的局部侧剖视图;
图13A和13D是在图12中图解的导管的一部分的侧视图;
图13B是图12中图解的导管的一部分沿着图13A中的截面13B的局部剖视端视图;
图13C是在图12中图解的导管的一部分的局部侧剖视图;
图14是在使用中的具有成像变换器导管的粥样斑块切除导管的局部剖视图;
图15是粥样斑块切除导管的一部分的局部侧剖视图;
图16A至图16C是本发明的导管的替代实施例的侧视图;
图16D是图16A至16C中示出的导管的一部分的侧剖视图;
图17A至图17D是图16A至16C的导管的变换器壳体的侧视图、俯视图和剖视图;
图18A至图18D是图16A至16C的导管的变换器壳体的替代实施例的侧视图、俯视图和剖视图;
图19A至图19D是图16A至16C的导管的变换器壳体的侧视图、俯视图和剖视图;
图20是在身体管腔中使用期间粥样斑块切除导管的示意图。
具体实施方式
在此描述的实施例的导管和方法设计成从患病身体管腔、尤其是外周动脉中的病变区减灭粥样斑和其它闭塞物质。该导管和方法还适于治疗身体管腔狭窄和在其它身体管腔(诸如输尿管、胆管、呼吸道、胰管、淋巴管等)中的其它增生和赘生状况。由于肿瘤围绕身体管腔或侵入到身体管腔中,因此通常生长赘生性细胞。减灭这种物质因此能够有益于保持身体管腔开放。尽管其余的讨论针对减灭和通过外周动脉中的粥样或者血栓闭塞性物质,但是应当理解的是,本发明的系统和方法也能够用于移除和/或通过各种身体管腔中的多种闭塞物质、狭窄物质、增生物质。
根据本发明的设备将通常包括导管,所述导管具有导管本体,所述导管本体适于腔内引入到目标身体管腔。导管本体的尺寸和其它物理特征将根据待进入的身体管腔而显著不同。在用于血管内引入的粥样斑块切除导管的示例性情况中,导管本体的远侧部分将通常非常具有柔性而且适于在导丝上引入到脉管系统内的目标位置。特别地,当导丝通道完全延伸通过导管本体时,导管能够用于“在导丝上”引入,或者在导丝通道仅仅延伸通过导管本体的远侧部分的情况下用于“快速交换”引入。在其它情况中,能够在导管的远侧部分上提供一种固定或者整体的线圈末端或者导丝末端,乃至完全省略导丝。为了解释方便起见,在所有实施例中没有示出导丝,但是应当理解的是导丝能够包含在这些实施例中的任意一个中。
在这些实施例中描述的导管的远侧部分可以具有多种形式和结构。在多个实施例中,导管的远侧部分较近侧部分更具有柔性,但是在其它实施例中,远侧部分的柔性与近侧部分相同、乃至较近侧部分更有刚性。本发明的一方面提供了一种导管,所述导管具有带减小的刚性长度的远侧部分。减小的刚性长度能够允许导管进入并且处理迂曲的血管和小直径的身体管腔。在大多数实施例中,导管本体的刚性远侧部分或者壳体的直径通常匹配导管本体的近侧部分,然而,在其它实施例中,远侧部分可以比导管的柔性部分更大或者更小。另外,多种实施例包括柔性远侧末端。
导管的柔性近侧部分通常是转矩轴,而远侧部分通常是刚性管。转矩轴有助于将导管本体和刀具输送到患病部位。通过连接组件,转矩轴的近端联接到手柄而转矩轴的远端附接到导管的远侧刚性部分。驱动轴能够运动地定位在转矩轴内,以便在转矩轴内旋转及轴向运动。驱动轴和转矩轴成适当的尺寸,以便允许每根轴相对运动,而不干扰另一根轴的运动。导管本体将具有可推动能力和可扭动能力,使得近端的扭动和推动将运动传递到导管本体的远侧部分。
导管本体的远侧部分包括侧开口窗口,所述侧开口窗口可以具有大约2mm的长度。然而,在其它实施例中,侧开口切割窗口能够更大或者更小,但是应当大到足以允许刀具突出预定距离,所述预定距离足以从身体管腔减灭物质。
可旋转的刀具或者其它组织减灭组件可以布置在导管的远侧部分中,以便切下毗邻切割窗口或者接收在切割窗口内的物质。在示例性实施例中,刀具能够运动地布置在导管本体的远侧部分中并且可运动穿过侧开口窗口。笔直或者锯齿状刀片或者其它元件能够沿着切割窗口的远侧边缘或者近侧边缘整体形成,以有助于从身体管腔切下物质。在一个特殊实施例中,刀具的直径大约为1.75mm。然而,应当理解的是,刀具的直径将主要取决于导管本体的远侧部分的直径。刀具通常能够在远侧部分内围绕轴线旋转并且能够沿着纵向轴线运动,所述轴线平行于导管的远侧部分的纵向轴线。
通过使得刀具在切割窗口外侧运动超过导管的远侧部分的外径,刀具能够接触和切下通过切割窗口无法收入的物质。通过使得旋转刀具运动到切割窗口外侧并且沿整个导管本体向远侧推进,能够移除大量闭塞物质。结果,能够移除的物质数量不受限于切割窗口的尺寸。
根据本发明的原理构造的导管包括导管本体,所述导管本体具有近侧部分和远侧部分。近侧部分能够利用连接组件联接到远侧部分,以便允许远侧部分相对于近侧部分枢转或者偏转。在在此公开的一些实施例中,变换器壳体连接在近侧导管部分和远侧导管部分之间。在一些实施例中,除了容置变换器以外,壳体还作为连接组件。导管本体的近端能够具有用于由用户操纵的手柄,以及用于连接到抽吸或者流体输送通道的鲁尔接口等。
在在此公开的实施例中描述的导管另外包括血管成像能力,且和与基于非导管的控制件和一种或多种用户界面结合使用。例如,成像变换器可以位于导管上并且使用线材、电缆、连接件、无线通信或其它装置连接到基于非导管的控制件。基于导管或基于非导管的信号处理部件或者信号调节部件可以散置在变换器和控制件之间,或者可以整合在变换器、控制件或它们的任何组合上。用户界面可以由视觉显示、听觉信号、触觉信号或者其它手段构成,而且能够基于导管、基于非导管、或者即基于导管又基于非导管。成像变换器是基于导管的并且可以转换超声能量、光能、红外线能、磁能或者它们的组合。适于应用在本发明的导管中的已知成像模态的一些示例包括血管内超声(IVUS)、光学相干断层成像(OCT)和核磁共振成像(MRI)。尽管下文讨论针对血管内超声,但是应当理解的是本发明的导管、系统和方法能够由血管内超声、光学相干断层成像和核磁共振成像中的任意一个构成。
参照图1至4,示出了粥样斑块切除导管2,所述粥样斑块切除导管2具有切割元件4,所述切割元件4用于从血流管腔切割物质。切割元件4能够相对于导管2的本体8中的侧开口6在贮存位置(图6)和切割或者工作位置(图3)之间运动。切割元件4相对于开口6向外运动,以便元件4的一部分从本体8向外延伸通过开口6。切割元件4可以相对于本体8和开口6定位成使得,切割元件4暴露出小于90度来切割组织。当然,切割元件4可以暴露出更多,而同时又没有背离本发明的多个方面。
导管2的尺寸可以是3、4、5、6、7、8、9、10或12French,以便其能够兼容标准护套尺寸,并且尤其为6、7或者8French的护套尺寸。导管2的工作长度可以根据导管计划使用的解剖学位置的要求而介于20至210cm之间,并且更加特别地为100、110、113、120、133、135、136、145、150、180或者210cm。刀具4的直径优选地略微小于导管2的最大尺寸的直径,通常小0.010″、0.015″、0.20″、0.25″或者0.30″。然而,这些相对尺寸并不意味着限制。
在切割手术期间,导管2运动通过血管,其中切割元件4位于工作或者切割位置中,如在下文更加详细描述的那样。当导管2运动通过管腔时,组织由切割元件4切割并且被引导到组织室12中,所述组织室12定位在切割元件4远侧。组织室12略微细长,以在导管操作期间容纳所收集的组织。
切割元件4从图6示出的贮存位置向近侧运动,以便切割元件4上的凸轮表面14接合导管2的本体8上的斜面16,如图13所示。凸轮表面14和斜面16之间的相互作用致使切割元件4运动到切割位置,而且还致使导管2的远侧末端18偏转,这趋于使得切割元件4向待切割的组织运动。切割元件4可以具有位于杯状表面24上的一个或多个凸起元件38和尖锐的最外侧边缘22。
如图2所示,切割元件联接到轴20,所述轴20延伸通过导管2中的管腔21。导管2联接到图1示出的示例性刀具驱动件5。刀具驱动件5包括电机11、电源15(例如一块或多块电池)、微型开关(未示出)、壳体17(如图所示移除了壳体的上半部)、操作杆13、和将轴20连接到驱动件电机11的连接组件(未示出)。刀具驱动件5能够作为用户操纵导管2的手柄。当致动操作杆13以闭合微型开关时,所述操作杆13将电源15电连接到电机11,从而致使切割元件4旋转。当轴20旋转时,切割元件4围绕纵向轴线LA旋转。切割元件4以大约1至160,000rpm转速旋转,但是也可以根据具体应用以任何其它适当的速度旋转。
开口6作为切割窗口,其可为在导管的远侧部分中的切出开口。如先前所述,切割窗口应当足够长以收集组织,并且周向足够宽以允许刀具在切割期间运动离开切割窗口,并且尺寸和形状被设计成不能将栓子排入到脉管系统中。
如图3所示,柔性结合部FJ位于切割窗口近侧,以便提供用于远侧部分相对于近侧部分做凸轮运动的枢转点。如先前所述,通过凸轮或者斜面与刀具的相互作用和由驱动轴提供的张力致使在柔性结合部FJ处发生弯曲。在示例性实施例中,远侧壳体能够使得导管的近侧部分的轴线偏转通常在0度和30度之间,通常在5度和20度之间,而且更为优选地在5度和10度之间。偏转的角度与驱使力直接相关。通过导管的位于柔性结合部近侧的区域中的预成形曲率(未示出),以及结合远侧部分相对于近侧部分的偏转度,可以产生推动切割窗口抵靠在血管的腔壁上的力。例如,偏转角度越大,则轮廓更大且能够治疗的管腔越大。上述范围允许在部件机械设计的极限内治疗介于小于2mm至大于7mm之间的血管。然而,应当理解的是,偏转角度将根据正在治疗的身体管腔的尺寸、导管的尺寸等发生变化。
在一些实施例中,导管的远侧部分的预成形曲率驱动刀具抵靠血管腔表面就位,使得向远侧推进整个导管本体能够使得旋转刀具运动通过闭塞物质。因为刀具运动一段距离越过导管的远侧部分的外径且运动到切割窗口的外侧,使用者不必将组织收进切割窗口中。
推动整个导管穿过病变区将从身体管腔移除所有或者部分病变区。通过引导从病变区切下的组织沿着刀具4的杯状表面进入到远侧末端18的收集室中,来收集所述切下的组织。一旦导管和刀具已运动通过病变区,就能够向远侧推进刀具至如下的位置:在所述位置中,刀具通过切割窗口运动返回并进入到收集室中。当经由刀具和导管的远侧运动将组织所切下的片引导到收集室中时,组织得到收集。
导管可以构造成诸如图16C所示的在导丝上导管或者快速交换或者单轨导管。例如,导管的末端能够包括管腔,所述管腔具有远侧开口和近侧开口,所述近侧开口成适当的尺寸以接收导丝,所述导丝的直径为大约0.014in.,大约为0.018in.,大约0.035in.,或者任何其它适当的直径。
图5、6和7图解了导管2,所述导管2具有位于刀具4近侧的超声成像能力。如图5所示,导管2包括尾线(pigtail)60和导管本体8,所述导管本体8附接到具有操作杆13的手柄50。手柄50能够滑动地接收到刀具驱动件5中。尾线60包括电缆62和连接件64。电缆62包括在电缆62、连接件64和导管本体8的管腔47内行进的一根或多根导电线材48,以便将连接件电连接到变换器40,如图7所示。线材48可以由绝缘的金属线材、印刷电路板印制线或者其它绝缘的导体构成。连接件64可以将线材48电连接到一个或多个基于非导管的部件,诸如控制件、信号处理部件、信号调节部件、患者界面模块(PIM′s)、用户界面、电缆或者其它部件。
如图7所示,示例性变换器40包括本体53、屈曲框架42和管51,所述管51具有管腔56,通过所述管腔56可滑动地接收驱动轴20。管51由不锈钢构成并且延伸越过本体53的远端和近端。屈曲框架42延伸越过本体53的近端且将线材48电连接到变换器40的内电路(未示出)。本体53在其中容置电子电路并且具有附接到其的变换器元件55。变换器元件55(在一些示例中为压电晶体)有助于图像引发声脉冲(image provoking sound pulse)的发射和图像信号的接收。在一些实施例中,声波或者脉冲的频率介于1MHz至70MHz之间,在其它实施例中介于10至30MHz,或者在另外的实施例中为20MHz。通常,在构造的材料的杨氏模量介于1,000,000psi至30,000,000psi的范围的情况下,变换器本体55的刚度类似于钢或者工程塑料的刚度,并且当通过常规手段将所述变换器本体55安装到导管中时,导管可能在变换器的区域中丧失柔性。
在一些变换器中,当变换器40安装到诸如导管2的柔性导管中时,屈曲框架42易被损坏,尤其在屈曲框架弯曲的情况下。图8A和图8B图解了用于与变换器40一起使用的可选接套(adapter)80。接套80包括管82、可选套箍84、可选环形件86、和支柱88;接套88可以由诸如钢、钛、聚酰亚胺、聚酯、工程塑料的刚性材料或者其它材料制成;并且通过机械加工、模制或者由其它工艺制造而成。在使用中,接套80的管82在变换器40的管51上滑动并且使用粘合剂、焊接、型锻、压接或者其它工艺刚性地附接到管51。接下来,将封装材料83施加到接套80,以便包封屈曲框架42并且填充支柱88、管82、可选套箍84和可选环形件86之间的间隙87。适当的封装材料83包括柔性丙烯酸、硅酮、尿烷、以及杨氏模量通常处于10,000psi至50,000psi的范围内、在一些情况中大约为30,000psi的其它材料。在图8B中示出的接套/变换器组合支撑屈曲框架,以便在导管2屈曲时所述屈曲框架不能屈曲,从而防止屈曲框架断裂。另外,接套80的管82能够延伸越过封装物质,以便提供了用于如将在下文描述的其它导管结构的附接点。
图9A和图9B图解了用于与变换器40一起使用的替代性可选接套90。接套90包括内管92、套箍94和填充件96,所述内管92、套箍94和填充件96中的每一个均可以由诸如钢、钛、聚酰亚胺、聚酯、工程塑料的刚性材料或者其它材料制成;并且可以机械加工、模制或者由其它工艺制造而成。在使用中,接套90的内管92在变换器40的管51上滑动且使用粘合剂、焊接、型锻、压接或者其它工艺刚性附接到管51。然后,套箍94在变换器40的屈曲框架42上滑动且使用粘合剂、焊接、型锻、压接或者其它工艺附接到变换器40的本体53。接下来,将填充件96施加到内管92和套箍94的端部,以便包封屈曲框架42和变换器线材48。适当的填充件96包括氰基丙烯酸盐粘合剂、硬丙烯酸聚合物、硅酮聚合物、尿烷聚合物、或者杨氏模量通常处于30,000psi至70,000psi的范围内、在一些情况中大约为50,000psi的其它材料。在图9B中示出的接套/变换器组合支撑屈曲框架,以便在导管2屈曲时所述屈曲框架不能屈曲,从而防止屈曲框架断裂。而且,接套90的内管92能够延伸越过变换器40的管51,以便提供用于附接其它导管结构的承插件,如将在下文描述。
再次参照图6,在一个实施例中,借助柔性填充件41、热收缩件43、屈曲框架罩管45、可选可传送材料44和粘合剂46,超声变换器40通常平行于导管轴线LA安装在导管2内。热收缩件43作为用于线材48的应力释放件,所述线材48卷绕在热收缩件43上,以便导管本体8在热收缩件43近侧的运动不会传递到屈曲框架42。热收缩件可以由聚酯或者其它材料构成。屈曲框架罩管45包围变换器40和屈曲框架42。管45可以由聚酯或者其它材料构成的热收缩件制成,并且有助于防止在导管弯曲期间损坏屈曲框架42。柔性粘合剂41填充变换器40和屈曲框架罩管45之间的间隙G以及导管本体8内的位于变换器40和热收缩件43附近的任何空隙,以便空隙中的空气或者污染物不会被引入到脉管系统中且向安装好的变换器提供柔性,如在下文进一步描述的那样。柔性填充件41可以由柔性丙烯酸、硅酮、尿烷、和杨氏模量通常处于1,000psi至30,000psi的范围内、在一些情况中大约为4,000psi的其它材料构成。粘合剂46附着至变换器本体53和导管本体8中的一个或多个。适合的粘合剂材料包括氰基丙烯酸盐粘合剂、硬丙烯酸聚合物、硅酮聚合物、尿烷聚合物、或者杨氏模量通常处于30,000psi至70,000psi的范围内、在一些情况中大约为50,000psi的其它材料。可传送材料44允许图像引发声脉冲和图像信号传送穿过其中,将变换器40的直径增加至导管本体8的直径以便最小化沿着导管的突出部分、角度或其它捕获点,并且附着到变换器元件55和导管本体8中的一个或多个。在超声成像的示例中,用于血管内观察的适当的可传送材料匹配血液和脉管组织的声阻抗(近似水的声阻抗,1.5MRayl)并且具有低损耗系数。在以下表格1中列出了用于在此公开的实施例中的任意一个的适当可传送材料的示例(转载自邮编为94089、加利福尼亚州Sunnyvale的Suit7,592Weddell Drive的Onda公司(courtesy of Onda Corporation,592Weddell Drive,Suite7,Sunnyvale,CA94089))。
可选地,可传送材料44可以涂敷有亲水涂层49。尤其在可传送材料不能全部浸润有血液的情况中,例如当可传送材料可以具有良好的声学性能但具有疏水性时,亲水涂层49确保可传送材料44良好地声耦合到导管2所使用的水相环境(诸如血液)中。在一些示例中,亲水涂层49可以由聚乙烯吡咯烷酮(PVP)、聚乙烯醇(PVA)、聚乙二醇(PEG)、聚氧化乙烯(PEO)、生物活性肝素、抗凝剂或者它们的组合构成,并且可以离子结合或者共价结合到下层材料。这种可生物相容的亲水涂层49还可以通过将表面从身体组织遮蔽开来提高可传送材料表面的生物相容性。
在图6的实施例中,柔性填充件41较变换器本体53更具有柔性,柔性填充件41附着到导管本体8和变换器本体53的近端并且填充间隙G。为了图解通过使用柔性填充件41实现的优势,图10A中示出了导管2具有桥接间隙G的常规非柔性填充件,而在图10B中示出的导管2具有柔性填充件41。如图10A和图10B示意性示出的那样,当导管2沿着横向于轴线LA的方向屈曲时,柔性填充件41将根据需要压缩及伸长,以便允许增加导管在变换器40附近的弯曲柔性(图10B),而使用常规非柔性填充件在变换器40附近呈现出较小的柔性(图10A)。附图图解了针对图6的实施例的变换器附近的刚性区段RS′(如图10B所示)比通过使用常规非柔性填充件产生的刚性区段RS短(如图10A所示)。由于变换器本体和导管本体8之间的粘合剂连接,因此保持导管区段的拉伸强度和扭转强度。
在替代性的实施例中,变换器40的端部中的一个可以焊接到柔性结合部FJ的近端。例如,变换器管51的远端可以焊接到柔性结合部FJ的近端,变换器管51的近端可以柔性结合到导管本体8,如图10B所示。当导管2屈曲时,填充件41将根据需要压缩和伸长,以便允许增加导管在变换器40近端处的柔性,而变换器40的远端处的柔性结合部FJ也将允许导管在结合部的附近处弯曲。因为变换器本体和导管本体8之间的粘合剂连接以及变换器40的远端和结合部之间的焊接,将维持导管区段的拉伸强度和扭转强度。
图10C、10D、10E和10F图解了导管2的其它实施例。图10C和图10D示出了导管2的实施例,其中,填充件41将变换器本体53的两个端部结合到导管本体8,并且没有在变换器本体53和导管本体8之间的环形间隙G的整个长度上延伸。当导管2弯曲时,与图10A和10B中示出的实施例相比,间隙G中较少的填充件41需要被拉伸或者压缩。图10E和10F示出导管2的一个实施例,其中,导管本体8的壁厚度沿着变换器本体53附近的区域101减小,以便允许在变换器40附近增加导管的柔性并且建立更长的间隙G。
图11图解了导管2,所述导管具有:超声成像能力;变换器40和驱动轴应力释放件110,使用粘合剂、焊接、型锻、压接或者其它工艺将所述驱动轴应力释放件110附接到变换器40的管51、接套80的内管82或者接套90的内管92中的一个或多个。应力释放件110与图6、7、8A、8B、9A、9B、10B、10C、10D、10E、15的实施例相配并且能够可选地与在此公开的其它实施例中的任意一个一起使用。应力释放件110可以由薄壁管构成,所述薄壁管由不锈钢、钛、镍钛诺或者其它材料制成,并且可以沿着其长度具有一个或多个狭缝或者孔以便改变其柔性。在非限制性示例中的应力释放件的长度介于变换器长度的25%至变换器长度的200%的范围内,且通常长度介于5mm至50mm的范围内。应力释放件的内径的尺寸设计成纵向及旋转滑动地装配在驱动轴20上,而且用光滑材料作衬里,所述光滑材料诸如PTFE、FEP、硅酮润滑剂或其它材料或者润滑剂,所述衬里构造成为涂层、管、滑脂或者其它构造。
应力释放件110用于防止驱动轴20在管51的端部处(在图11中的E处)突然弯曲,从而提高了旋转驱动轴20的疲劳寿命。应力释放件110还防止了驱动轴20抵靠导管管腔21的管腔壁的集中摩擦,从而防止局部加热驱动轴和导管本体8。由金属构成的应力释放件还能够通过传导或者通过辐射从管51的端部驱散热量。当导管2横向于纵向轴线LA弯曲时,应力释放件110还防止管51的端部磨损驱动轴20。
图12、13A、13B、13C和13D图解了导管2的替代实施例,在所述实施例中,变换器40保持在导管本体8中,使得允许变换器40基本浮在导管本体8内。如为局部侧剖视图的图12所示,导管2包括导管本体8、驱动轴20、变换器壳体122、托架124、变换器40和可选地亲水材料126和窗玻璃129。已经在上文描述了导管本体8、驱动轴20和变换器40。壳体122在近端和远端处使用粘合剂、焊接、型锻、压接或者其它工艺附接到导管本体8,且可以由不锈钢、镍钛诺、聚酰亚胺、可传送材料44或者其它材料构成。壳体122在其中具有一个或多个窗口128以及切过壳体122的壁的一个或多个细长开口132和内部涂层135。由细长开口132限定的支撑件134在窗口128附近连接壳体122的近侧部分和远侧部分。窗口128与变换器晶体55轴向对准,且允许超声声脉冲在变换器晶体55和容器壁之间行进,而细长开口132赋予壳体122柔性。支撑件134是壳体122组成部分或者可以由其它材料构成,所述其它材料通过焊接、结合、或者其它工艺附接到壳体。可以调整支撑件134厚度和构成材料,以横向于轴线LA在窗口128附近赋予壳体或多或少的刚度。内涂层135吸收或者分散超声声脉冲,且可以由硅橡胶、尿烷、或者其它材料构成。
在一些实施例中,窗口位置定位成允许对血管壁的预定部分成像。图14示出了这样的实施例,在所述实施例中,导管2定位在血管V的管腔L内,所述血管V具有粥样斑A附接到其上的管腔壁LW。在图12、13A、13B、13C和13D中公开的实施例中,由变换器40产生的超声声脉冲被内涂层135吸收或者分散,以便最小化由壳体的内表面反射回到变换器的反射,从而提高图像的信噪比。由变换器40产生的超声声脉冲将通过窗口128,直到接触血管V并且反射回变换器40为止。在一个实施例中,窗口128可以尺寸设计成且定位成使得在刀具4附近中产生宽周向图像11,而在导管的与刀具相对的一侧上产生较小的周向图像12、13。这种窗口构造的一个优势在于刀具4相对于图像I1的周向位置马上显现,原因在于这种位置通常位于最大窗口的中心。这种窗口构造的另一个优势在于能够看见与刀具4先前所切割的部分(如果存在)毗邻的粥样斑,且如果需要能够计划进一步移除粥样斑。针对在此公开的实施例中的任意一个,其它窗口数量和布置方案是可以的,以产生具有理想特征的图像。
回到图13A、13B、13C和13D,托架124包括支脚124a和支腿124b,所述支腿124b在其中具有孔125,如在图13C和13D中充分所见,并且所述托架124可以由不锈钢、镍钛诺、聚酰亚胺或者其它材料构成。孔125的尺寸设计成纵向及旋转滑动地装配在变换器40的管51上。在图12的实施例中,使用两个托架,其中一个位于变换器40的每个端部处并且使用粘合剂、焊接、型锻、压接或者其它工艺附接到壳体122。如图12所示,托架124通常将变换器的管51定位在导管本体8内的中心处,且在变换器40和壳体122的内表面之间建立间隙127。因此,托架124将壳体122保持成允许壳体122基本浮在导管本体8内。
在一些实施例中,窗口128设置有窗玻璃129,所述窗玻璃129由可传送材料44构成。亲水材料126填充变换器晶体55和可传送材料44之间的间隙127,并且可以附接到晶体55或者可传送材料44或者附接到二者。在其它实施例中,亲水材料126填充壳体122内没有被固体部件(诸如变换器40、接套80、90、托架124或者其它固体)占据的所有自由容积。亲水材料126将晶体55超声耦接到可传送材料44,从而减小或者消除从任意一个表面或者两个表面的声反射,而且亲水材料126可以由聚乙烯吡咯烷酮(PVP)、聚乙烯醇(PVA)、聚乙二醇(PEG)、聚氧化乙烯(PEO)或者它们的组合构成。在一些实施例中,在将导管2引入到患者体内之前,亲水材料与水介质(诸如为盐水、肝素化盐水或者其它介质)进行水合。
如图15所示,变换器40承载在变换器壳体122中的方式允许当在导管2横向于其纵向轴线弯曲时,变换器40径向浮在导管本体8内。由于壳体122和导管本体8之间的连接,将保持导管区段的拉伸强度和扭转强度。当弯曲时,如图12所示,导管2的间隙127通常在弯曲部的凸出侧和凹进侧减小。因为没有任何固体物质填充满间隙127,所以抗间隙减小或者间隙扩大的阻力较低。而且,在变换器附近的刚性区段RS(结合图10A和10B在前文描述)在导管弯曲部的范围上不存在,这是因为变换器40悬浮在托架124上。可选地,如先前所述,应力释放件110能够添加到变换器40的一个端部或者两个端部。
图16A至图16D图解了导管2的替代实施例,在所述替代实施例中,变换器40容置在导管本体8中的变换器壳体222内(如图17A至17D所示)。图16A至16C是对导管2的一部分从不同方向观察的侧视图,所述导管2包括连接在导管本体8的近侧段和远侧末端组件267之间的壳体222。图16D是通过导管2的中央轴线的侧截面图。通过壳体222承载或者传递变换器40周围的机械应力和作用力,壳体222容置在血管或者管腔中推进导管时易碎及易断裂的变换器40并且保护变换器40。因此,通过承载或者传递应力和作用力,壳体222旨在使得变换器40与导管中或者导管周围的应力和作用力隔离,并且将应力和作用力从壳体的近端通过壳体传递至壳体的远端,从而减小变换器承受的应力和作用力。壳体222在近端处附接到导管本体8。为了图解的目的,导管本体8的外层263示出为部分透明,以示出图16A至16C中的导管本体8的结构。为了增强壳体222近侧的导管本体8的柔性和强度,导管本体8由管265形成,所述管265设置有细长的开口266,以便增强管的柔性。管265可以由不锈钢海波管形成,所述海波管被激光切割以形成开口。可替代地,管265可由诸如钛、聚酰亚胺、聚酯、工程塑料的材料或者具有类似性能的其它材料形成。导管本体8的位于壳体222远侧的远侧末端组件267可以包括具有管265性能的管268。
在图17A、17B、17C和17D中分别以侧视图、俯视图、轴向剖视图和横向剖视图示出了壳体222。壳体222可以具有多部件构造,其包括近端部分269、远端部分270和本体部分271。近端部分269和远端部分270可以分别由第一材料和第二材料形成,所述第一和第二材料与形成本体部分271的第三材料不同。例如,第一和第二材料可以包括金属(诸如,钛或者不锈钢),本体部分271可以包括聚合物。在一个实施例中,远端部分270包括钛,近端部分269包括不锈钢,本体部分271包括丙烯腈-丁二烯-苯乙烯(ABS)。第一和第二材料被选择来提供在远端和近端处具有足够强度的变换器壳体222,并且使得壳体222能够固定地连接到导管本体8的近侧部分和远侧末端组件267。第三材料被选择来形成壳体222的本体部分271,以向壳体提供足够的柔性。第三材料还选自如下的材料:所述材料最小化了通过第三材料或者通过第三材料中的狭槽223发送或者接收的变换器信号或者图像的任何干扰或者失真。
在一个实施例中,变换器壳体222通过如下工艺形成:所述工艺使得本体部分271、远端部分270和近端部分269组合或者接合成单个整体部件。例如,可以利用注塑模制工艺形成变换器壳体,在所述注塑模制工艺中,本体部分271包覆模制到近端部分269和远端部分270上。这导致形成具有所需强度、柔性和可连接性的性能的单个集成壳体222。
图16D是连接到导管本体8的一部分的壳体222的剖视图。如图16D所示,变换器40的位于狭槽223近侧的一部分包含在管状构件272内。管状构件272由刚性材料形成,其用于在导管使用期间保护变换器40、屈曲框架42和线材48。在一个实施例中,管状构件272包括不锈钢海波管。管状构件272具有内径适合容纳变换器40的管腔。使用适当的封装材料将变换器40固定在管状构件272内。在组装期间变换器40和管状构件272插入在壳体222内,以便变换器40的变换器元件与狭槽223轴向对准。管状构件272和变换器40可以被整个包含在壳体22的内部空间中,或者如图16D所示可以定位成使得管状构件272和变换器40二者的至少远侧部分接收在壳体222内。管状构件272然后焊接到或者用其它方式附接到近端部分269,以便将管状构件272和变换器40固定在壳体222内。管265的远侧部分的尺寸设计成以重叠的布置接收在近端部分269的近侧部分内。然后在该重叠区域中将近端部分269焊接到或者用其它方式附接到管265。如图16D所示,管265可以整合到导管本体8,从而导致形成导管本体的材料接收在管265中的开口266内。例如,管265可以层压在导管本体8内,以便形成导管本体的材料渗入到管265中的细长孔中。
内径略微大于变换器40的端部51的过渡管273可以与变换器40的端部51重叠并且从所述端部51延伸。可以利用封装材料274将过渡管273封装在管状构件272内,以将过渡管272附接在壳体222内。过渡管273用于保护屈曲框架42和线材48并且使所述屈曲框架42和线材48与驱动轴20隔离,在图16D中省略了所述驱动轴20以更加明晰地示出在此描述的其它特征。穿过导管本体8、变换器40和过渡管273形成连续管腔,以便容纳驱动轴20,所述驱动轴20向远侧经过壳体222延伸通过管腔,以附接到定位在远侧末端组件267内的刀具元件4。
在图16A、16B和16C中示出的实施例中,通过铰接的连接部形成柔性结合部FJ,通过将变换器壳体222的远端部分270接合到远侧末端组件267形成所述铰接的连接部。如图17A所示,壳体222的远端部分270具有一对销孔260,所述销孔260定位在远端部分270的相对的侧部上。在组装期间,销孔260与远侧末端组件267中的相对的销孔262(如图16A至16C所示)对准。然后,销插入通过导管两侧上的对准的销孔并且焊接到远侧末端组件276。因此,销在销孔262中固定地连接到远侧末端组件267并且可运动接收在壳体222的销孔260中。结果是形成连接变换器壳体222的远端部分270和远侧末端组件267的铰接结合部,从而允许远侧末端组件267在铰接结合部处相对于壳体222和导管2的近侧部分枢转。
壳体的外壁的厚度可以通过允许变换器所产生的声学超声信号更好地穿透壳体,以最小化声衰减,从而提高成像质量,并且壳体的外壁可以例如具有0.008至0.020英寸的厚度。为了更好地保持壳体222的结构完整性,可以提供肋状件234。肋状件234可以是模制在壳体的外表面上或者通过焊接、结合、粘合剂等附接到壳体的外壁的零件或者部分。可替代地,壳体222和肋状件234可以整体形成,使得壳体222的外表面与形成肋状件的向外突出件成波状(contoured)。肋状件234加强或者加固了壳体222的壁并且增加壳体的外壁的转动惯量。因此,肋状件234增加壳体的结构完整性并且保护壳体免受在血管中使用导管2所产生的力的影响。肋状件还减小了作用在壳体上的应力并且减小了过度弯曲、断裂、卷曲等的可能性。可以调整肋状件234的结构材料和尺寸(即,长度、宽度和高度)以在狭槽223附近赋予壳体或多或少的刚度。还可以修改结构材料和尺寸以调整壳体222的外径或者周长。另外,不限制壳体222的外壁上的肋状件234的数量和间距,因此可以根据需要增加或者减小肋状件的数量以及肋状件的空间分离,并且能够是例如以相等或者不同的空间尺寸围绕壳体22的圆周的介于5个至8个的肋状件。肋状件可以是细长的并且定位成使得所述肋状件大体与壳体和导管的纵向轴线平行。无肋状件的表面的壳体222直径可以为0.083英寸宽,以便作为示例保持7French的引导导管或者护套的相容性。
壳体222的外壁具有狭槽223,所述狭槽223与变换器40的变换器晶体轴向对准,从而允许声学超声声脉冲在变换器晶体管和容器壁之间行进,以便最小化衰减或者干扰。变换器40将通过壳体222的外壁和狭槽223产生血管的360°图像。然而,通过狭槽223获得的360°成像的血管的径向成角度部分的质量高于剩余的通过壳体222的外壁获得的360°成像的血管的径向成角度部分的质量,因此优选是更大尺寸的狭槽。狭槽223的尺寸可以设计成使成像血管的径向扫描角度介于壳体圆周的60°至180°之间,并且更为具体地介于120°至150°之间而且如能够在图17D中所见的那样可以为130°。为了最小化失真的任何影响并且最小化图像中任何伪影(artifacts)的数量或者尺寸,狭槽223的开口的边缘部280可以成适当的形状或者成一定角度,以便符合导管的半径,如图17D充分所示的那样。
狭槽223可以直接定位在切割窗口的近侧,因此在切割元件处于工作位置中的情况下当在管腔中向远侧推进导管时,医生能够更清晰且准确地观察在血管或者管腔中的治疗部位处刚刚切割或者移除了什么。可替代地,狭槽223可以沿着导管本体定位在其它位置处。此外,在切割元件处于贮存位置中的情况下能够在管腔中向远侧推进导管,直到狭槽223与治疗部位毗邻对准为止,以便医生能够更为清晰且准确地观察将从治疗部位切割或者移除什么。
狭槽223提供了通向壳体的管腔中的开口,所述开口允许血液或者其它流体与变换器的外表面直接接触,从而通过改进从变换器通过流体并到达管腔壁的声波的声耦合来提高所产生的图像质量。通过导管2中的弯曲部产生的推动力可以导致壳体222被推动抵靠在血管壁上,从而可能使变换器产生的图像质量失真或者干扰由变换器产生的图像质量,特别在壳体的定位有狭槽223的区域处。肋状件234还使壳体免于因导管的推动力而与血管壁发生任何直接接触。当狭槽223与血管壁直接相对时,间隔开会允许血管中的流体在壳体和血管壁之间以及在变换器和血管壁之间更为自由地流动。这种间隔提高了图像质量和图像分辨率。
狭槽223可以具有0.070英寸的纵向宽度和0.055英寸的横向宽度。应当理解的是,壳体222的狭槽223根据应用能够具有任何理想的尺寸,并且壳体222可以具有位于壳体外壁中的多个狭槽。例如,壳体222能够根据需要具有2(如图18A至图18D的实施例示出的那样)、3或者4条狭槽。
导管2可以设置有盐水源,所述盐水源连接到位于导管(未示出)近端处的盐水泵或者滴注器,以便保持流动通过导管管腔的盐水的正压力。由盐水泵产生的正压力允许盐水流动/运动通过管腔,且防止空气被捕获或者包封在导管的管腔中。如果流体保持在壳体222内,则提高了由变换器的声学超声脉冲产生的图像质量。因此,导管2可以在壳体的外壁的内径和变换器的外径之间设置有间隙或者空间尺寸,从而允许盐水流入到壳体中。壳体的外壁的内径和变换器的外径之间的空间间隙可以额外地允许血液从血管通过狭槽223进入到壳体,从而防止气阱(airpockets)被捕获在壳体222中且在变换器上保持流体。壳体222和变换器40之间的间隙或者空间尺寸可以介于0.003英寸至0.009英寸之间,且进一步可以是0.007英寸,但是可以根据需要更宽或者更窄。壳体222还可以设置有泄水孔249,流体通过所述泄水孔249离开壳体,以改进通常通过导管的管腔、且尤其在壳体中的流体流。泄水孔249可以定位成远离变换器的晶体,或者与狭槽相对,以便避免图像的任何干扰或者衰减。
如图16C充分所见,导管2可以设置有位于壳体222远侧的导丝管腔250。两个肋状件234可以定位成与狭槽223直接相对。这两个肋状件234设置了与导丝管腔250对准的通道或者凹陷部。导丝可以位于通道或者凹陷部内。这种结构提供了至少两种功能。首先,该结构最小化了导丝GW在壳体上的横截面,原因在于导丝保持在肋状件之间。其次,将导丝限定在肋状件之间的与狭槽相对的位置中,这减少了导丝定位在狭槽处或者狭槽附近中可能发生的图像中的伪影和信号的衰减。除了最小化壳体的外径和导丝之间的距离之外,这种定位还防止图像振铃(ringing)或者失真,并且因此提高了所产生的图像的整体质量。软件还可以用于过滤及移除由导丝GW产生的任何振铃或者剩余伪影。
图18A至18D图解了导管2的壳体的替代实施例,在所述替代实施例中,变换器40被容置在壳体222a内。壳体222a的外壁的厚度可以通过允许变换器所产生的声学超声信号更好的穿透而最小化声衰减。然而,为了保持壳体222a的结构完整性,壳体可以设置有如先前所述的肋状件,或者可以具有减小的壁厚。变换器40将产生通过壳体222a的外壁和狭槽223a的360°图像,其中,通过狭槽223a获得的360°成像的血管的径向成角度部分的质量高于剩余的通过壳体222a的外壁获得的360°成像的血管的径向成角度的部分的质量。狭槽223a可以产生基本相同或者不同的成像血管的径向角,所述径向角介于所述血管的圆周的65°至180°的范围内,并且更为具体地在65°至85°的范围内,且进一步为73°。狭槽223a的纵向宽度可以为0.051英寸并且横向或径向宽度为0.041英寸。应当理解的是,壳体222a的狭槽223a根据应用能够具有任何理想的尺寸。已经发现的是,如果狭槽223a(或者关于其它实施例所述的其它狭槽)具有尖锐的边缘部或者拐角部,则能够导致某些信号失真。因此,为了最小化失真的任何影响并且为了最小化图像中的任何伪影的数量或者尺寸,狭槽223a的开口的边缘部可以削尖或者成一定角度,以便与导管的半径相符合。
图19A至图19D图解了变换器壳体222b的其它替代实施例。壳体222b与壳体222类似,除了所述壳体222b不具有肋状件234之外。壳体222b包括开口223b和销孔260b,所述开口223b和销孔260b在结构和功能上对应于壳体222的开口223和销孔260。因此,无须对壳体222b进一步描述这些元件。与壳体222相比,壳体222b可以具有更小的直径或者截面轮廓。
现在将描述本发明的一些示例性方法。本发明的一个方法包括将导管输送到身体管腔中的目标部位。如图20所示,使用常规介入技术,导管2能够在引入部位166处在常规导丝或成像导丝上引入通过引导导管或者护套。减灭导管能够在导丝上行进并且离开引导导管至病变区域。导管被推进至治疗部位,其中,如图6所示,刀具处于贮存位置中。如图3所示,导管2将通常具有至少一个柔性结合部,以允许围绕一个或多个旋转轴线枢转,从而增强将导管输送到迂曲解剖部,而不用去除引导导管或者其它护套。
当导管2在弧形部162上行进或者通过迂曲弯曲部164期间,显著的导管柔性将是有用的或者必需的。当导管2的包括成像变换器40的区域横向于纵向轴线LA弯曲时,例如图6、7、8A、8B、9A、9B、10B、10C、10D、10E、10F和15的变换器安装构造允许减小和/或扩大间隙G、127,从而使得变换器40的抗弯刚度与导管本体8解耦,且减小了在弯曲部162、164周围推进导管2所需的力。在一些实施例中,在此描述的变换器安装构造能够推进导管2穿过弯曲部(诸如弯曲部162、164)。而且,如在图16A至19D的实施例中,在本申请的其它实施例中存在推动力的区域中,壳体及其到近侧导管本体转矩轴的连接件可以产生纵向刚性长度段。这种刚性长度段可以抵抗血管管腔中在弯曲部周围推进导管所需的推动力。为了弥补这种增加刚性的长度段,必须调整导管本体中的弯曲程度。而且,必须调整并且变化导管本体在壳体近侧的半径,以将导管的推动位置移至一个替代位置,从而保持向远侧推动导管通过血管管腔的弯曲部以及通过血管管腔的弯曲部向近侧收回导管所需的推动力。
在跨过弧状部162、弯曲部164和/或其它迂曲部之后,导管2的刀具4能够定位在治疗部位(诸如粥样斑A)的近侧。可选地,能够激活变换器40,以及能够使用IVUS或者其它成像模态来验证刀具相对于血管V中的物质(例如,粥样斑)的位置,同时可以经过粥样斑A推进以及收回成像导管2,直到选择好治疗策略为止。
一旦确认导管的位置,就向近侧收回刀具并使其运动离开切割窗口到其暴露位置。在一些实施例中,刀具的运动能够偏转导管的远侧部分,以便增加导管在目标部位处的轮廓。通常,通过操纵杆13的向近侧运动和驱动轴20的拉紧来使刀具运动。当刀具向近侧运动时,所述刀具接触斜面或者凸轮表面,以便向上引导刀具并且至少部分地离开切割窗口。另外,导管本体的远侧部分围绕结合部旋转,以便向刀具(和导管本体)提供推动力,以朝向患病区域运动。
刀具能够旋转,并且能够通过向远侧推进导管2通过血管V来用暴露出的刀具减灭血管V。在一些实施例中,变换器壳体122的窗口图案用作引导件,以便确保刀具4与粥样斑A对准。优选地,导管的远侧部分围绕纵向轴线LA旋转,或者枢转或偏转以将刀具定位成毗邻目标物质。此后,导管和旋转的刀具能够运动通过身体管腔,以便从身体管腔移除目标物质,直到图像表示刀具已经移除足够或者所有粥样斑为止。
在一些实施例中,能够在切割元件处于贮存位置中的情况下推进导管2通过血管V,以使狭槽223与治疗部位相邻对准,以用于成像。然后能够向近侧收回导管一段距离,并且切割元件运动到工作位置以暴露出导管。然后能够再次向远侧推进导管2,以便利用刀具减灭治疗部位。在刀具减灭血管时,能紧靠刀具近侧定位的变换器使得治疗部位成像。在减灭之后,能够将切割元件运动到非工作位置或者贮存位置中,并且导管可以根据需要行进经过治疗部位或者收回经过治疗部位,且同时成像以证实刀具已经移除了足够的粥样斑。应当理解的是,使用导管的医生可以应用这些步骤中的任一个或者所有,并且应当注意到的是,在一些应用中,在减灭之前使得治疗部位成像不是必须的。还应当注意的是,利用在此公开的导管实施例中的任意一个可以实施这些步骤中的任一个或者所有。
在已经用导管2充分治疗血管之后,通过弧状部162、弯曲部164和/或其它迂曲部收回导管,在此期间,显著的导管柔性将是有用的或者必需的。例如图6、7、8A、8B、9A、9B、10B、10C、10D、10E、10F和15的变换器安装构造允许减小和/或扩大间隙G、117,由此使得变换器40的抗弯刚度与导管本体8解耦,且减小了在弯曲部162、164周围收回导管2所需的力。
以上描述和附图用于描述本发明的实施例,且并不旨在以任何方式限制本发明的范围。对于本领域的技术人员显而易见的是,能够在不背离本发明的精神或范围的前提下做出各种修改方案和变形方案。因此,本发明旨在涵盖本发明的所述修改方案和变形方案,只要它们落入附属权利要求和等效物的范围内。而且,尽管已经在上文中关于特定实施例描述了材料和构造的选择,但是本领域的技术人员将理解的是所描述的材料和构造可应用于所有实施例。
Claims (43)
1.一种用于部署在血管中的导管,所述导管包括:
控制手柄;
细长近侧区段,所述细长近侧区段具有近端和远端,近端连接到控制手柄;
远侧末端组件,所述远侧末端组件具有近端和远端;和
壳体,所述壳体具有:近端部分,所述近端部分包括第一材料;远端部分,所述远端部分包括第二材料;和本体部分,所述本体部分在近端部分和远端部分之间延伸,本体部分包括第三材料,第一材料和第二材料与第三材料不同,近端部分连接到细长近侧区段的远端,远端部分连接到远侧末端组件的近端,壳体具有内表面限定了管腔的管腔壁,管腔壁具有至少一个狭槽;和
变换器,所述变换器至少部分地安装在壳体的管腔内。
2.根据权利要求1所述的导管,其中,壳体的外表面具有至少一个肋状件。
3.根据权利要求2所述的导管,其中,位于管腔壁的外表面上的纵向延伸的至少一个肋状件处于5个肋状件至8个肋状件的范围内。
4.根据权利要求1所述的导管,其中,管腔壁中的至少一个狭槽是两个狭槽。
5.根据权利要求1所述的导管,其中,变换器处于与管腔壁间隔开的位置,以在变换器和管腔壁之间形成间隙。
6.根据权利要求1所述的导管,其中,变换器构造成具有通过壳体的管腔壁以及通过壳体的至少一个狭槽的对血管360°成像的能力,通过壳体的管腔壁中的至少一个狭槽由变换器成像的壳体的圆周的径向角介于60°至180°的范围内。
7.根据权利要求6所述的导管,其中,径向角处于120°至150°的范围内。
8.根据权利要求7所述的导管,其中,径向角为130°。
9.根据权利要求4所述的导管,其中,变换器构造成具有通过壳体的管腔壁以及通过壳体的至少一个狭槽的对血管360°成像的能力,通过壳体的管腔壁中的每个狭槽由变换器成像的壳体的圆周的径向角介于60°至180°的范围内。
10.根据权利要求9所述的导管,其中,径向角处于65°至90°的范围内。
11.根据权利要求10所述的导管,其中,径向角为73°。
12.根据权利要求1所述的导管,其中,第一材料和第二材料包括金属,而第三材料包括聚合物。
13.根据权利要求12所述的导管,其中,第一材料包括不锈钢,第二材料包括钨,第三材料包括丙烯腈-丁二烯-苯乙烯(ABS)。
14.根据权利要求12所述的导管,其中,细长近侧区段的连接到壳体的近端部分的远端包括不锈钢。
15.根据权利要求1所述的导管,所述导管还包括:
第一管状构件,所述第一管状构件具有近端和远端以及限定了管腔的壁,第一管状构件的至少一部分定位在壳体的管腔内且连接到壳体的近端部分。
16.根据权利要求15所述的导管,其中,第一管状构件的近侧部分从壳体的近端在细长近侧区段的管腔内向近侧延伸,使得第一管状构件的近端位于细长近侧区段的远端的近侧。
17.根据权利要求15所述的导管,所述导管还包括:
第二管状构件,所述第二管状构件具有近端和远端以及限定了管腔的壁,第二管状构件的至少一部分定位在第一管状构件的管腔内,第二管状构件的壁的外表面和第一管状构件的壁的内表面之间的距离限定了在第一管状构件和第二管状构件之间的间隙;并且
其中,变换器还包括向近侧延伸至控制手柄的线材,线材定位成延伸通过第一管状构件和第二管状构件之间的间隙。
18.根据权利要求1所述的导管,其中,第一管状构件的远端位于壳体中的狭槽的近侧。
19.根据权利要求17所述的导管,其中,第二管状构件的远端定位在第一管状构件的远端和近端之间,而第二管状构件的近端定位在第一管状构件的近端的近侧。
20.根据权利要求1所述的导管,其中,细长近侧区段的远端通过焊接连接到壳体的近端部分。
21.根据权利要求1所述的导管,其中,壳体的远端部分包括相对的销孔,所述销孔定位成与远侧末端组件中的相对的销孔对准,并且其中,导管还包括定位在对准的销孔中的销。
22.根据权利要求17所述的导管,所述导管还包括封装材料,所述封装材料包含在第一管状构件和第二管状构件之间的间隙内。
23.一种用于部署在血管中的导管,所述导管包括:
控制手柄;
细长近侧区段,所述细长近侧区段具有近端和远端,近端连接到控制手柄;
远侧末端组件,所述远侧末端组件具有近端和远端;和
壳体,所述壳体具有近端部分、远端部分以及在近端部分和远端部分之间延伸的本体部分,近端部分连接到细长近侧区段的远端,远端部分连接到远侧末端组件的近端,壳体具有至少一个狭槽;
第一管状构件,所述第一管状构件具有近端和远端以及限定了管腔的壁,第一管状构件的至少一部分定位在壳体的管腔内且连接到壳体的近端部分;和
变换器,所述变换器至少部分地安装在壳体的管腔内,变换器的至少一部分定位在第一管状构件的管腔内,变换器具有通过壳体的至少一个狭槽的对血管成像的能力,变换器包括向近侧延伸至控制手柄的线材。
24.根据权利要求23所述的导管,其中,第一管状构件的近侧部分在细长近侧区段中的管腔内从壳体的近端向近侧延伸,使得第一管状构件的近端位于细长近侧区段的远端的近侧。
25.根据权利要求23所述的导管,导管包括:
第二管状构件,所述第二管状构件具有近端和远端以及限定了管腔的壁,第二管状构件的至少一部分定位在第一管状构件的管腔内,第二管状构件的壁的外表面和第一管状构件的壁的内表面之间的距离限定了位于第一管状构件和第二管状构件之间的间隙,线材延伸通过第一管状构件和第二管状构件之间的间隙。
26.根据权利要求23所述的导管,其中,第一管状构件的远端位于壳体中的狭槽的近侧。
27.根据权利要求25所述的导管,其中,第二管状构件的远端定位在第一管状构件的远端和近端之间,而第二管状构件的近端定位在第一管状构件的近端的近侧。
28.根据权利要求25所述的导管,所述导管还包括封装材料,所述封装材料包含在第一管状构件和第二管状构件之间的间隙内。
29.一种制造导管的方法,所述导管具有细长本体,所述细长本体包括近侧区段、远侧区段和变换器壳体,所述方法包括:
由第一材料形成壳体的近端部分;
由第二材料形成壳体的远端部分;
由第三材料形成壳体的在近端部分和远端部分之间延伸的本体部分,第一材料和第二材料与第三材料不同,壳体具有内表面限定了管腔的管腔壁,管腔壁具有至少一个狭槽;
将变换器的至少一部分安装在壳体的管腔内;和
将壳体的近端部分连接到细长近侧区段的远端,且将壳体的远端部分连接到远侧区段的近端。
30.根据权利要求29的方法,其中,形成本体部分包括将第三材料注塑模制在第一材料和第二材料上。
31.一种制造导管的方法,所述导管具有控制手柄和细长本体,所述细长本体包括近侧区段、远侧区段和变换器壳体,所述方法包括:
将变换器的至少一部分安装在第一管状构件的管腔内;
将第一管状构件连接到变换器壳体的近端部分,使得第一管状构件和变换器至少部分地接收在变换器壳体的管腔中,且变换器上的信号发射元件与变换器壳体的壁中的狭槽对准;和
将壳体的近端部分连接到细长近侧区段的远端,且将壳体的远端部分连接到远侧区段的近端。
32.根据权利要求31的方法,所述方法还包括:
将第二管状构件定位在第一管状构件的管腔内,使得第二管状构件的壁的外表面和第一管状构件的壁的内表面之间的距离限定了第一管状构件和第二管状构件之间的间隙,并且使得从变换器延伸到控制手柄的线材延伸通过第一管状构件和第二管状构件之间的间隙,第二管状构件具有近端和远端以及限定了管腔的壁。
33.一种导管,所述导管包括:
管状本体,所述管状本体具有限定了管腔的内管腔壁;
变换器,所述变换器在与管腔壁间隔开的位置处安装到管腔内,以形成变换器和管腔壁之间的间隙;和
亲水材料,所述亲水材料桥接变换器和管腔壁之间的间隙。
34.根据权利要求33所述的导管,其中,变换器是超声变换器。
35.根据权利要求33所述的导管,其中,变换器相对于管状本体柔性地安装在管腔内。
36.根据权利要求33所述的导管,所述导管还包括切割元件,并且其中,变换器安装在管腔内的位于切割元件远侧和切割元件近侧中的其中一个的位置处。
37.根据权利要求36所述的导管,其中,管状本体包括侧开口,并且其中,切割元件构造成能够在贮存位置和切割位置之间运动,所述贮存位置位于管状本体的管腔内,在所述切割位置处,切割元件的至少一部分延伸通过侧开口越过管状本体的外径。
38.根据权利要求33所述的导管,其中,变换器包括电连接件,并且其中,导管还包括连接到变换器的接套,接套构造成在管状本体围绕管状本体的纵向轴线弯曲时保护电连接件免受损坏。
39.根据权利要求33所述的导管,其中,变换器具有在变换器的远端和近端之间延伸的管腔,并且其中,导管还包括:旋转轴,所述旋转轴延伸通过变换器的管腔;和应力释放元件,所述应力释放元件在变换器的近端和远端中的一个或两个处连接到变换器,应力释放件构造成在导管沿着横向于管状本体的纵向轴线的方向弯曲时保护旋转轴。
40.根据权利要求37所述的导管,其中,管状本体包括位于侧开口近侧和安装有变换器的位置的远侧处的柔性结合部。
41.一种柔性导管,所述柔性导管包括:
管状本体,所述管状本体具有纵向轴线和限定了管腔的内管腔壁;和
刚性变换器,所述刚性变换器包括具有外尺寸的本体,所述本体安装在管腔内并且与管腔壁间隔开,使得在变换器的本体的外尺寸和管腔壁之间形成间隙,变换器和管腔壁之间的距离限定了间隙的厚度,变换器定位成使得当导管沿着横向于纵向轴线的方向弯曲时间隙的厚度变化。
42.根据权利要求41所述的导管,其中,变换器是超声变换器。
43.根据权利要求41所述的导管,其中,变换器相对于管状本体柔性地安装在管腔内。
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US8808186B2 (en) | 2014-08-19 |
CN103281964B (zh) | 2015-09-30 |
JP2015119982A (ja) | 2015-07-02 |
CA2817213A1 (en) | 2012-05-18 |
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WO2012064966A3 (en) | 2013-01-03 |
EP2659840B1 (en) | 2017-02-01 |
EP2637567B1 (en) | 2017-03-08 |
US20150080700A1 (en) | 2015-03-19 |
RU2553930C2 (ru) | 2015-06-20 |
EP2637567A2 (en) | 2013-09-18 |
EP2659840A2 (en) | 2013-11-06 |
RU2013122590A (ru) | 2014-12-20 |
JP5688160B2 (ja) | 2015-03-25 |
BR112013011632A2 (pt) | 2016-08-09 |
US20120123352A1 (en) | 2012-05-17 |
KR20130090418A (ko) | 2013-08-13 |
EP2659840A3 (en) | 2014-04-30 |
CA2817213C (en) | 2016-06-14 |
WO2012064966A2 (en) | 2012-05-18 |
AU2011326420B2 (en) | 2014-11-27 |
KR101518151B1 (ko) | 2015-05-06 |
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