CN113164718B - 具有高关节运动的球囊导管 - Google Patents

具有高关节运动的球囊导管 Download PDF

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CN113164718B
CN113164718B CN201980082786.7A CN201980082786A CN113164718B CN 113164718 B CN113164718 B CN 113164718B CN 201980082786 A CN201980082786 A CN 201980082786A CN 113164718 B CN113164718 B CN 113164718B
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C·T·贝克勒
J·T·凯斯
K·J·埃雷拉
A·D·斯夸尔斯
K·M·奥卡尔斯其
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    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1068Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure

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Abstract

一种医疗探头包括轴、可膨胀膜和探头操纵组件(PMA)。该轴被构造成用于插入到患者的器官的腔体中。PMA位于可膨胀膜内部并且包括第一弹性元件,该第一弹性元件沿PMA的纵向轴线装配,并且被构造成通过缩短PMA来使膜膨胀并且通过伸长PMA来使膜塌缩。PMA还包括第二弹性元件,该第二弹性元件围绕第一弹性元件的至少一部分并且被构造成使膜相对于纵向轴线偏转。

Description

具有高关节运动的球囊导管
技术领域
本发明整体涉及医疗探头,具体地讲,涉及球囊导管。
背景技术
各种导管采用操纵机构以便操纵其远侧端部。例如,美国专利申请公布2015/0173772描述了一种利用一个或多个传感器的导管系统。导管可用作栓塞线圈系统、导丝系统或组合栓塞线圈/导丝系统的一部分,其中装置与导管系统相互作用。还描述了一种可变拆卸栓塞线圈系统和导丝系统,其中装置的一部分被拆卸以留下植入物。
作为另一示例,美国专利申请公布2004/0193032描述了一种诊断导管,该诊断导管具有操纵装置以在导管插入到血管时引导导管的远侧端部。导管可包括双向操纵机构或单向操纵机构。导管可体现为包括多个键齿的篮形导管。包括中央可回缩且可操纵的构件以提供膨胀力。也可通过相对于中央构件移动导管的近侧部分来提供膨胀力。形成篮形物的键齿中的每个键齿包括设置在其中的一定长度的弹性线,以提供致使键齿适形于被检查表面的共形力。
美国专利6,585,717描述了挠曲机构,该挠曲机构被定位成使得柔性主体诸如导管的部分在单个平面中以及多于一个平面中的多于一个方向上挠曲。该发明允许导管的远侧部分挠曲超过360度以提供套环。在一个实施方案中,导管的挠曲结构可由聚合物、弹性回火的不锈钢或超弹性合金制成,该挠曲结构在从护套释放时将迫使导管末端呈现期望的形状。可向牵拉线施加张力,从而导致挠曲结构弯曲。
美国专利5,395,327描述了一种操纵机构,该操纵机构包括联接到控制器的操纵轴,该控制器包括柄部和用于操纵该操纵轴的远侧端部的设备。该操纵轴包括柔性螺旋弹簧,该柔性螺旋弹簧具有在操纵轴的远侧端部中相对于其远侧端部固定在适当位置的前导弹簧。操纵线在其远侧端部处附连到前导弹簧。操纵线穿过操纵轴延伸到控制器,并且控制器的操纵设备用于将张力施加在操纵线上。操纵线的远侧端部与所附接的前导弹簧可彼此相对或者可偏移以用于提供更大的可操纵性。可通过横向于控制器壳体安装的楔形件或通过横向于控制器壳体安装的轴的旋转将张力施加在操纵线上,该操纵线附接到轴,使得沿一个方向的旋转张紧一根操纵线并且沿另一个方向的旋转张紧另一根操纵线。两个可独立旋转的轴可用于单独地控制两根操纵线。
发明内容
使球囊导管偏转是具有挑战性的,尤其是需要在左心房内操纵球囊时。球囊导管通常经由护套以收缩状态(通过导丝)馈送到左心房中,并且然后对其进行充胀或膨胀。为了在消融之前正确定位,球囊需要充胀或膨胀并偏转到心脏内的期望位置。然而,在离开导管护套时,左心房的相对小的尺寸限制了球囊偏转的运动自由度。认识到这一点,本发明人已设计出用于具有允许球囊充胀以及球囊偏转的机构的球囊的发明,并且这两个操作可独立地执行。
具体地,本发明的一个实施方案提供了一种医疗探头,该医疗探头包括轴、可膨胀膜和探头操纵组件(PMA)。该轴被构造成用于插入到患者的器官的腔体中。PMA位于可膨胀膜内部并且包括第一弹性元件,该第一弹性元件沿PMA的纵向轴线装配,并且被构造成通过缩短PMA来使膜膨胀并且通过伸长PMA来使膜塌缩。PMA还包括第二弹性元件,该第二弹性元件围绕第一弹性元件的至少一部分并且被构造成使膜相对于纵向轴线偏转。
在一些实施方案中,第二弹性元件的长度被构造成确定在PMA上的弯曲位置。
在一些实施方案中,医疗探头还包括在轴内部延伸的中空管,其中中空管的远侧边缘联接到PMA的远侧端部,以用于缩短或伸长PMA。
在一些实施方案中,医疗探头还包括一根或多根牵拉线,该一根或多根牵拉线连接到第二弹性元件以用于使膜偏转。
在一个实施方案中,该一根或多根牵拉线各自包括纱线。
在另一个实施方案中,纱线由超高分子量聚乙烯(UHMWPE)材料制成。
在一些实施方案中,医疗探头还包括导管柄部,该导管柄部包括棘轮机构,该棘轮机构被构造成旋转以便控制一根或多根牵拉线上的张力量。
在一个实施方案中,导管柄部包括摇臂,该摇臂被构造成使用一根或多根牵拉线使PMA偏转,其中摇臂的中心具有用于使中空管穿过的开口。
在一些实施方案中,第一弹性元件和第二弹性元件包括相应的第一弹簧和第二弹簧。
在一个实施方案中,第一弹簧和第二弹簧是螺旋状的,其中第一弹簧具有第一旋向,并且其中第二弹簧具有与第一旋向相反的第二旋向。
在一些实施方案中,第二弹性元件为柔性管。
在一些实施方案中,医疗探头还包括环,该环在柔性管上滑动并且连接到一根或多根牵拉线。
在一个实施方案中,柔性管的一部分在轴的远侧边缘处缠绕联接构件,其中联接构件将PMA联接到轴。
在另一个实施方案中,可膨胀膜的近侧边缘联接到柔性管。
根据本发明的实施方案,还提供了一种制造方法,该制造方法包括将探头操纵组件(PMA)安装在可膨胀膜内部,该探头操纵组件包括:(a)第一弹性元件,该第一弹性元件沿PMA的纵向轴线装配,并且被构造成通过缩短PMA来使膜膨胀并且通过伸长PMA来使膜塌缩;以及(b)第二弹性元件,该第二弹性元件围绕第一弹性元件的至少一部分并且被构造成使膜相对于纵向轴线偏转。使用联接构件在轴的远侧边缘处连接PMA和膜,以用于插入到患者的器官的腔体中。
根据本发明的实施方案,还提供了一种方法,该方法包括将探头插入到患者的器官的腔体中,该探头包括(a)轴、(b)可膨胀膜和(c)探头操纵组件(PMA),该探头操纵组件位于可膨胀膜内部,其中PMA包括:(i)沿PMA的纵向轴线装配的第一弹性元件,以及(ii)围绕第一弹簧的至少一部分的第二弹性元件。使用第一弹性元件,通过缩短PMA来使膜膨胀并且通过伸长PMA来使膜塌缩。使用第二弹性元件使膜相对于纵向轴线偏转。
结合附图,通过以下对本发明的实施方案的详细描述,将更全面地理解本发明,其中:
附图说明
图1为根据本发明的实施方案的包括可操纵球囊导管的球囊导管插入系统的示意性图解;
图2A和图2B为根据本发明的实施方案的包括探头操纵组件(PMA)的可操纵球囊导管的示意性详细图解;
图3为根据本发明的实施方案的图1的包括两个棘轮机构的导管的柄部的示意性图解;并且
图4为示意性地示出根据本发明的实施方案的使用配备有图2A-2B的PMA的球囊的球囊治疗方法的流程图。
具体实施方式
概述
应结合附图来阅读下面的具体实施方式,其中不同附图中相同元件的编号相同。附图(未必按比例绘制)示出所选择的实施方案,并不旨在限制本发明的范围。详细描述以举例的方式而非限制性方式示出本发明的原理。此描述将明确地使得本领域技术人员能够制备和使用本发明,并且描述了本发明的若干实施方案、适应型式、变型形式、替代形式和用途,包括目前据信是实施本发明的最佳方式。
如本文所用,针对任何数值或范围的术语“约”或“大约”指示允许部件或元件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地,“约”或“大约”可指列举值的值±10%的范围,例如“约90%”可指81%至99%的值的范围。另外,如本文所用,术语“患者”、“宿主”、“用户”和“受检者”是指任何人或动物受检者,并且不旨在将系统或方法局限于人使用,但本主题发明在人类患者中的使用代表优选的实施方案。同样,术语“近侧”是指更靠近操作者的位置,而“远侧”是指更远离操作者或医师的位置。
下文所述的本发明的实施方案提供了医疗探头,诸如具有探头操纵组件(PMA)的可膨胀球囊导管。在本发明所公开的描述的上下文中,PMA能够独立且同时地使球囊膜膨胀或塌缩,以及使球囊膜偏转,这是称为“操纵球囊”的操作模式。因此,本发明所公开的PMA的实施方案增加了运动自由度,以例如使球囊在患者的器官的小尺寸腔体内偏转,诸如在心脏的左心房内部偏转。
在一些实施方案中,提供了包括用于插入到腔体中的中空管的轴,其中中空管在中空轴内部延伸。在其近侧边缘处使用联接构件联接到轴的远侧边缘的PMA在包括在PMA的远侧边缘中的鼻部件处进一步联接到中空管的远侧边缘(即,中空管的远侧边缘联接到PMA的远侧端部)。PMA还包括:(a)第一弹性元件,该第一弹性元件沿PMA的纵向轴线装配,并且被构造成通过缩短PMA来使膜膨胀并且通过伸长PMA来使膜塌缩;以及(b)第二弹性元件,该第二弹性元件围绕第一弹性元件的至少一部分并且被构造成使膜相对于纵向轴线偏转。
在一些实施方案中,第一弹性元件和第二弹性元件为弹簧。在其他实施方案中,PMA包括柔性管代替第二弹簧作为第二弹性元件。通常,柔性管由可被挤压以形成管的聚合物材料制成。也可使用其他合适类型的弹性元件来实现第一弹性元件和/或第二弹性元件。
球囊的可膨胀膜围绕PMA,其中可膨胀膜的远侧边缘联接到鼻部件。可膨胀膜的近侧边缘联接到轴的远侧边缘。当牵拉或释放中空管时,可膨胀膜可分别膨胀或塌缩,而并行地,可通过牵拉一根或多根牵拉线来使可膨胀膜偏转。换句话讲,当PMA被缩短或伸长时,可膨胀膜分别膨胀或塌缩,并且当PMA被偏转时,可膨胀膜同时被偏转。
在一些实施方案中,第二(外)弹性元件在远侧方向上比第一(内)弹性元件短。这样,外弹性元件不约束内弹性元件的纵向运动(即,收缩或伸长)。两个弹性元件嵌套,并且中空管嵌套在内弹性元件内,以便使PMA的总直径最小化。在其中弹性元件为弹簧的一些实施方案中,这两个弹簧可具有相反的旋向,使得这两个弹簧的螺旋不重叠。
在其中第二弹性元件为柔性管的其他实施方案中,柔性管在轴的远侧边缘处缠绕联接构件并且覆盖第一弹性元件的至少近侧部分。金属环在柔性管的远侧边缘上滑动,其中牵拉线联接到金属环以使柔性管偏转。如下所述,牵拉线沿柔性管的壁插入穿过专用通道(例如,挤压件)。
PMA的部件的上述两种实施的布置允许球囊更靠近球囊的几何中心偏转。因此,偏转的弧长小于典型的左心房的长度,从而显著增加了这种操纵方法的实用性。
在一些实施方案中,牵拉线由超高分子量聚乙烯(UHMWPE)纱线制成。纱线与外弹簧的联接抵抗外弹簧的急剧弯曲(即,偏转),因为纱线不需要焊接到弹簧的远侧边缘,当弹簧弯曲时,该远侧边缘是其他类型的牵拉线剥离的潜在点。UHMWPE纱线直接端接在导管柄部中,端接在整合到模塑柄部中的棘轮机构中。棘轮机构允许装配者在制造期间通过旋转棘轮机构来精细地控制每根纱线上的松弛量。
中空管在柄部内部固定到块,该块在由旋钮限定的路径中滑动,该旋钮提供向后拉动位于远侧的鼻部件并压缩内弹簧所需的回缩,以便缩短PMA。在旋钮近侧为双向摇臂,该双向摇臂提供球囊的双向偏转。
在一个实施方案中,摇臂的中心具有开口以允许中空管穿过而不必进行急剧弯曲,这对于减小中空管所经受的插入/回缩力是至关重要的。
中空管被构造成从导管的柄部回缩或再收缩,以便使膜膨胀或塌缩。牵拉线被构造成平行于中空管的运动从柄部牵拉或释放,以便使膜平行偏转(即,一起操纵球囊,如上文所定义)。
在一些实施方案中,提供了一种相关的球囊治疗方法,以使得能够在腔体内部操纵球囊,以便利用可膨胀膜进入靶组织。这种附加的球囊操纵在膨胀膜和靶组织之间建立牢固的物理接触,此时例如通过使用设置在与组织物理接触的可膨胀膜上方的电极施加射频消融来治疗组织。
对于仅限于可用于没有本发明所公开的PMA和PMA操纵方法的导管的简单操纵的球囊治疗而言,本发明所公开的PMA以及相关的球囊治疗方法使医师能够利用球囊导管接触原本可能不易接触到或不能接触到的组织。此类可操纵性增加了成功完成诊断性和/或侵入性心脏治疗规程(诸如用于治疗房颤的从左心房内部进行的肺静脉隔离(PVI))的机率。
系统描述
图1为根据本发明的实施方案的包括可操纵球囊导管40的球囊导管插入系统20的示意性图解。系统20包括导管21,其中联接构件被安装到导管的轴的远端边缘(在下面的图2A-2B中示出)。医师30通过护套23将球囊导管40插入到位于台29上的患者28的心脏26的腔体45中,在图1的区域25中可见。为了到达腔体45(示出为心脏26的左心房45)内部的目标位置,医师30通过从护套23偏转来导航球囊导管40的远侧端部。
在球囊导管40的插入期间,球囊导管40由护套23保持在塌缩构型中。通过将球囊导管40包含在塌缩构型中,护套23还用于使目标位置沿途的血管创伤最小化。
然后,医师30使用导管柄部31在腔体45内部操纵导管40,以便进入并接触靶组织。在该过程中,如下所述,医师30同时且独立地操纵球囊40,该球囊被适配用于具有本发明所公开的PMA的这些操纵。
导管21的近侧端部连接到控制台24。在本文描述的实施方案中,导管21可用于任何合适的治疗和/或诊断目的,诸如心脏26中的组织的电感测、或球囊血管成形术和消融,以及可膨胀球囊导管的其他可能医疗用途。
控制台24包括:处理器41,通常为通用计算机,具有合适的前端;和接口电路38,用于接收来自导管21的信号,以及用于经由导管21对心脏26进行治疗,并用于控制系统20的其他部件。处理器41通常包括通用计算机,该通用计算机以软件编程以执行本文描述的功能。该软件可通过网络以电子形式被下载到计算机,例如或者其可另选地或另外地设置和/或存储在非临时性有形介质(诸如磁存储器、光存储器或电子存储器)上。
图1所示的示例性构型是完全为了使概念清楚而选择的。可使用其他系统部件和设置类似地应用本发明所公开的技术。例如,系统20可包括其他部件并执行非心脏治疗。
具有高关节运动的球囊导管
图2A为根据本发明的实施方案的包括探头操纵组件(PMA)的可操纵球囊导管40A的示意性详细图解。如图2A中所见,导管40A还包括可膨胀膜44,该可膨胀膜以塌缩状态可见,并且在其近侧端部处联接到联接构件22并在其远侧端部处联接到PMA 55A的鼻部51。
以下对图2A的描述描述了如何使用PMA 55A同时且独立地使球囊导管40的膜44膨胀或塌缩以及偏转。
如所见,PMA 55包括鼻部51和同心双弹簧机构53。同心双弹簧机构53的第二(外)弹簧52在其近侧端部处联接到联接构件22并且包围第一(内)弹簧50的一部分,以形成两个弹簧的同心布置(即,前述同心双弹簧机构53)。
鼻部51联接到内弹簧50的远侧边缘,并且可通过抵抗内弹簧50的膨胀力分别回缩或释放中空管54而向近侧拉动或向远侧延伸。因此,膜44可通过从导管柄部31在中空管54中分别牵拉或释放张力而膨胀或塌缩。
在一些实施方案中,当牵拉中空管54以压缩内弹簧50时,膜44膨胀成球形形状,这是可通过使盐溶液在压力下例如通过中空管54流入球囊中来进一步辅助的过程。在一些实施方案中,中空管54由厚壁聚酰亚胺管制成,该厚壁聚酰亚胺管也用作薄导丝可穿过的内腔。
如所见,牵拉线56在锚定点57A处附接到第二(外)弹簧52的远侧端部。当通过牵拉线56拉动时,外弹簧52弯曲,从而导致PMA 55弯曲并使可膨胀膜44偏转(即,使球囊导管偏转)。通常,外弹簧52被设计成比内弹簧50更短且更硬。在一个实施方案中,外弹簧52的长度被选择成使得球囊操纵组件55在弯曲点59A处、在距锚定点57A近侧的给定距离处弯曲。另一牵拉线(未示出)与牵拉线56直接相对地联接到外弹簧52,以实现球囊导管40的双向偏转。
在本说明书的上下文中,术语诸如“偏转(deflection)”、“偏转(deflect)”和“可偏转的”是指其中PMA的纵向轴线530相对于轴27的纵向轴线270成一些非零角度(例如,纵向轴线530指向不平行于纵向轴线的偏转方向530')的情况。
在其他实施方案中,锚定点57A位于沿外弹簧52(沿PMA的纵向轴线530)的给定位置处,诸如在外弹簧52的大约中心处。牵拉线锚定点57A越近,外弹簧52的弯曲半径越紧,并且越硬且越难以偏转。本领域的技术人员将想到点57A的最佳位置。
在一个实施方案中,为了向PMA 55A提供牢固的结构,弹簧50和弹簧52两者的尺寸被设定成在彼此和中空管54之间具有最小间隙。为了减小摩擦,将弹簧50和弹簧52被电抛光成圆角,并且它们的旋向为反向的,以便防止一个螺旋切口落在另一个弹簧的间隙内,从而避免阻碍球囊导管40的操纵。
图2B为根据本发明的另选的实施方案的包括PMA 55B的可操纵球囊导管40B的示意性详细图解。如图2B中所见,导管40B还包括可膨胀膜44,该可膨胀膜以塌缩状态可见,并且在其近侧端部处联接到缠绕联接构件22的远侧部分的柔性管62(而不是构件52),并且在其远侧端部处联接到PMA 55B的鼻部51。
图2B示出了如何使用PMA 55B同时且独立地使球囊导管40的膜44膨胀或塌缩以及偏转。如所见,PMA 55B包括鼻部51和同心双弹性元件机构53B。在所示的实施方案中,柔性管62覆盖在弹簧50上以限定(a)管62与弹簧50“同心”以及(b)管62和弹簧50构成双弹性元件。同心双弹性元件机构53B的柔性管62在其近侧端部处联接到联接构件22并且包围第一(内)弹簧50的一部分,以形成两个弹性元件的同心布置(即,前述同心双弹性元件机构53B)。
鼻部51联接到内弹簧50的远侧边缘,并且可通过抵抗内弹簧50的膨胀力分别回缩或释放中空管54而向近侧拉动或向远侧延伸。因此,膜44可通过从导管柄部31在中空管54中分别牵拉或释放张力而膨胀或塌缩。
如所见,牵拉线56在环66上的锚定点57B处附接到在柔性管62的远侧端部上滑动的环66。当通过牵拉线56拉动时,柔性管62弯曲,从而导致PMA 55弯曲并且使可膨胀膜44偏转(即,使球囊导管偏转)。通常,柔性管62被设计成比内弹簧50更短且更硬。在一个实施方案中,外弹簧52的长度被选择成使得球囊操纵组件55在弯曲点59B处、在距锚定点57B近侧的给定距离处弯曲。另一牵拉线(未示出)与牵拉线56直接相对地联接到环66,以实现球囊导管40B的双向偏转。
在一个实施方案中,为了向PMA 55B提供牢固的结构,柔性管62的壁用由织造金属线制成的网(未示出)编织。图2A和图2B中所示的示例性例证完全是为了概念清晰而选择的。在另选的实施方案中可使用其他机构解决方案。例如,另一个挠性部件(诸如穿孔的柔性梁)可替换弹簧52和柔性管62中的一者和/或弹簧50。
图3为根据本发明的实施方案的图1的包括两个棘轮机构60的导管的导管柄部31的示意性图解。如所见,来自PMA 55的鼻部51的中空管54结合到移动件58。当移动件58被柄部31中的旋钮(即,由医师30)拉回时,中空管54牵拉鼻部51并压缩内弹簧50。
两根牵拉线56被实现为UHMWPE纱线,或者可使用液晶聚合物或任何其他合适的聚合物。纱线56进入滑轮组件63,该滑轮组件包括旋钮以使球囊导管40双向偏转。然后将纱线56拴系到棘轮机构60,该棘轮机构整合到模塑柄部中。棘轮机构60允许在制造期间通过“一次点击”旋转棘轮机构等于L/N的长度来精细控制每根纱线上的松弛量,其中L为棘轮的周长,并且N为棘轮齿的数量。如进一步所见,滑轮组件62的中心具有开口以允许中空管54穿过而不必进行急剧弯曲,以便减小中空管所经受的插入/回缩力。另选地,牵拉线可由不锈钢或任何其他合适的线制成。纱线可附接到棘轮并围绕滑轮,并且然后固定到线。
图3所示的示例性例证完全是为了概念清晰而选择的。任何其他合适的构型可用于另选的实施方案中,例如,可使用多根牵拉线56来实现球囊40的多向偏转。
图4为示意性地示出根据本发明的实施方案的使用配备有图2A-2B的PMA 55的球囊的球囊治疗方法的流程图。治疗始于在球囊插入步骤70处医师30将球囊导管40插入患者的身体内。接下来,在球囊导航步骤72处,医师将球囊导管40导航到器官内。接下来,在球囊操纵步骤74处,使用柄部31操作PMA 55,医师30操纵小腔体(诸如心脏26的左心房45)内部的球囊,以便利用膜44进入靶组织。在步骤74期间,膜44可部分地膨胀,并且仅在操纵过程结束时膜44才将完全膨胀。
在球囊接触步骤76处,医师30然后使用PMA 55进一步操纵球囊,以便在膜44和靶组织之间建立牢固的接触。在球囊治疗步骤78处,医师接下来例如通过使用设置在膜44上的被操纵成与组织接触的电极的射频消融来治疗靶组织。
图4中所示的示例性流程图完全是为了概念清晰的目的而选择。有意高度简化的流程图省略了附加步骤,诸如球囊的完全膨胀、用加压盐水溶液使球囊充胀和冲洗操作,以及使球囊塌缩和回缩。
尽管本文所述的实施方案主要针对肺静脉隔离,但本文所述的方法和系统也可用于其他应用,诸如耳鼻喉或神经内科规程。
因此应当理解,上面描述的实施方案以举例的方式被引用,并且本发明不限于上文特定示出和描述的内容。相反,本发明的范围包括上文描述的各种特征的组合和子组合以及它们的变型和修改,本领域的技术人员在阅读上述描述时将会想到该变型和修改,并且该变型和修改并未在现有技术中公开。以引用方式并入本专利申请的文献被视为本申请的整体部分,不同的是如果这些并入的文献中限定的任何术语与本说明书中明确或隐含地给出的定义相冲突,则应仅考虑本说明书中的定义。

Claims (22)

1.一种医疗探头,包括:
轴,所述轴用于插入到患者的器官的腔体中;
可膨胀膜;
探头操纵组件(PMA),所述探头操纵组件位于所述可膨胀膜内部并且包括:
第一弹性元件,所述第一弹性元件沿所述探头操纵组件的纵向轴线装配,并且被构造成通过缩短所述探头操纵组件来使所述膜膨胀并且通过伸长所述探头操纵组件来使所述膜塌缩;和
第二弹性元件,所述第二弹性元件围绕所述第一弹性元件的至少一部分并且被构造成使所述膜相对于所述纵向轴线偏转;和
一根或多根牵拉线,所述一根或多根牵拉线连接到所述第二弹性元件,以用于使所述膜偏转。
2.根据权利要求1所述的医疗探头,其中所述第二弹性元件的长度被构造成确定所述探头操纵组件上的弯曲位置。
3.根据权利要求1所述的医疗探头,并且包括在所述轴内部延伸的中空管,其中所述中空管的远侧边缘联接到所述探头操纵组件的远侧端部,以用于缩短或伸长所述探头操纵组件。
4.根据权利要求1所述的医疗探头,其中所述一根或多根牵拉线各自包括纱线。
5.根据权利要求4所述的医疗探头,其中所述纱线由超高分子量聚乙烯(UHMWPE)材料制成。
6.根据权利要求1所述的医疗探头,并且包括导管柄部,所述导管柄部包括棘轮机构,所述棘轮机构被构造成旋转以便控制所述一根或多根牵拉线上的张力量。
7.根据权利要求6所述的医疗探头,并且包括在所述轴内部延伸的中空管,
其中所述中空管的远侧边缘联接到所述探头操纵组件的远侧端部,以用于缩短或伸长所述探头操纵组件,
其中所述导管柄部包括摇臂,所述摇臂被构造成使用所述一根或多根牵拉线使所述探头操纵组件偏转,并且
其中所述摇臂的中心具有用于使所述中空管穿过的开口。
8.根据权利要求1所述的医疗探头,其中所述第一弹性元件和所述第二弹性元件包括相应的第一弹簧和第二弹簧。
9.根据权利要求8所述的医疗探头,其中所述第一弹簧和所述第二弹簧是螺旋状的,其中所述第一弹簧具有第一旋向,并且其中所述第二弹簧具有与所述第一旋向相反的第二旋向。
10.根据权利要求1所述的医疗探头,其中所述第二弹性元件为柔性管。
11.根据权利要求10所述的医疗探头,并且包括:
环,所述环在所述柔性管上滑动并且连接到所述一根或多根牵拉线。
12.根据权利要求10所述的医疗探头,其中所述柔性管的一部分在所述轴的远侧边缘处缠绕联接构件,其中所述联接构件将所述探头操纵组件联接到所述轴。
13.根据权利要求10所述的医疗探头,其中所述可膨胀膜的近侧边缘联接到所述柔性管。
14.一种制造方法,包括:
将探头操纵组件(PMA)安装在可膨胀膜内部,所述探头操纵组件包括:
第一弹性元件,所述第一弹性元件沿所述探头操纵组件的纵向轴线装配,并且被构造成通过缩短所述探头操纵组件来使所述膜膨胀并且通过伸长所述探头操纵组件来使所述膜塌缩;和
第二弹性元件,所述第二弹性元件围绕所述第一弹性元件的至少一部分并且被构造成使所述膜相对于所述纵向轴线偏转;
使用联接构件在轴的远侧边缘处连接所述探头操纵组件和所述膜;以及
将一根或多根牵拉线连接到所述第二弹性元件以用于使所述膜偏转。
15.根据权利要求14所述的方法,其中安装所述探头操纵组件包括构造所述第二弹性元件的长度以确定在所述探头操纵组件上的弯曲位置。
16.根据权利要求14所述的方法,并且包括在所述轴内部延伸中空管,其中所述中空管的远侧边缘联接到所述探头操纵组件的远侧端部,以用于缩短或伸长所述探头操纵组件。
17.根据权利要求14所述的方法,其中所述一根或多根牵拉线各自包括纱线。
18.根据权利要求17所述的方法,其中所述纱线由超高分子量聚乙烯(UHMWPE)材料制成。
19.根据权利要求14所述的方法,其中所述第一弹性元件和所述第二弹性元件包括相应的第一弹簧和第二弹簧。
20.根据权利要求19所述的方法,其中所述第一弹簧和所述第二弹簧是螺旋状的,其中所述第一弹簧具有第一旋向,并且其中所述第二弹簧具有与所述第一旋向相反的第二旋向。
21.根据权利要求14所述的方法,其中所述第二弹性元件为柔性管。
22.根据权利要求21所述的方法,并且包括:
提供环,所述环在所述柔性管上滑动并且连接到所述一根或多根牵拉线。
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