CN102078187B - 具有压力测量头的导管 - Google Patents
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Abstract
本发明涉及一种医疗探针,包括柔性***管和远端头,所述柔性***管具有用于***到患者的体腔内的远端,所述远端头设置在所述柔性***管的远端处并且构造成与体腔中的组织接触。所述探针还包括耦合构件,所述耦合构件将所述远端头耦合至所述***管的远端,并且包括弹性材料制成的管状件,所述管状件沿着其长度的一部分具有切穿所述管状件的多个缠绕螺旋切削。
Description
技术领域
本发明一般地涉及入侵式医疗装置,具体地,本发明涉及用于***身体器官中的探针结构。
背景技术
在一些诊断和治疗技术中,导管被***心室中并与心脏内壁接触。在此类手术中,通常很重要的一点是导管远端头以足够的压力接合心内膜以确保良好的接触。然而,压力过大可能会对心脏组织造成不希望的损伤,甚至造成心壁穿孔。
例如,在心***频(RF)消融的情况下,在远端头处具有电极的导管经由病人的血管******心室。电极会与心内膜上的一个(或多个)位点接触,RF能量经导管施加到电极,以消融位点处的心脏组织。为了在对组织没有过度损伤的情况下达到所需的治疗效果,消融期间电极与心内膜之间必须有合适的接触。
许多专利出版物描述了具有用于感测组织接触的一体化压力传感器的导管。作为一个例子,Saurav等人的美国专利申请公开2007/0100332描述了评价用于组织消融的电极-组织接触的***和方法,其公开内容以引用方式并入本文中。导管轴内的机电式传感器产生对应于导管轴远端部分内电极移动量的电信号。输出装置接收用于评价电极与组织之间接触水平的电信号。
上述说明描述了本领域中相关技术的总体概述,不应当被解释为是对所包含的任何信息构成本专利申请的现有技术的一种承认。
发明内容
在本发明的实施例中,医疗探针包括柔性***管和远端头,所述柔性***管具有用于***到患者的体腔内的远端,所述远端头设置在所述***管的远端处并且构造成与体腔中的组织接触。探针还包括耦合构件,该耦合构件将远端头耦合至***管的远端,并且包括弹性材料制成的管状件,该管状件沿着其长度的一部分具有切穿管状件的多个缠绕螺旋切削。
典型地,螺旋切削中的至少一个包括扩大的终端,并且该扩大的终端可以包括部分椭圆。
在某些实施例中,多个螺旋切削包括n个切削,其中n是大于1的整数,并且切削可以构造成使得管状件绕管状件的轴线具有n重旋转对称。
在公开的实施例中,螺旋切削中的至少一个绕管状件的轴线对向360°至720°之间的角度。
在一个实施例中,耦合构件构造成当远端头接合组织时响应于施加在远端头上的压力而弯曲,并且螺旋切削中的至少一个的宽度选择成对耦合构件的初始弯曲提供预定的角度限制。
典型地,耦合构件包括管状部分,该管状部分通过固定连接而连接到管状件。管状件可以包括杆,并且固定连接可以包括焊接到管状部分的杆。
管状部分和管状件可以布置为形成它们的公共圆周,并且固定连接可以包括在靠近所述螺旋切削的相应终端的、其上不存在公共圆周区域上的焊接。
在另一个实施例中,位置传感器可以位于管状件中。典型地,位置传感器可以构造成感测远端头相对于***管的远端的位置,该位置响应于所述耦合构件的变形而变化。典型地,位置传感器可以构造成响应于磁场而产生信号,并且该信号表示所述远端头的位置。探针可以包括位于所述管状部分中用于产生磁场的磁场发生器。
典型地,***管、远端头和耦合构件构造成用于通过血管***到患者的心脏中。
根据本发明的可供选择的实施例,还提供了一种用于执行医疗手术的方法,包括:
将探针***患者的体腔中,该探针包括柔性***管、远端头和耦合构件,远端头设置在***管的远端处,耦合构件将远端头耦合至***管的远端并且包括弹性材料制成的管状件,管状件沿着其长度的一部分具有切穿管状件的多个缠绕螺旋切削;以及使得远端头与体腔中的组织接触。
典型地,所述方法包括消融与远端头接触的组织。
根据本发明的另一可供选择的实施例,还提供了一种用于生产医疗探针的方法,色括:
提供柔性***管和远端头,所述柔性***管具有用于***到患者的体腔内的远端,所述远端头设置在***管的远端处并且构造成与体腔中的组织接触;以及
利用耦合构件将远端头耦合至***管的远端,耦合构件包括弹性材料制成的管状件,管状件沿着其长度的一部分具有切穿管状件的多个缠绕螺旋切削。
通过以下结合附图的实施例的详细说明,将更全面地理解本发明。
附图说明
图1是心室的示意剖视图,其中根据本发明实施例的导管与心室内的心脏壁接触;
图2是根据本发明实施例的导管的示意剖视图;
图3是根据本发明实施例的耦合构件的一部分的示意侧视图;
图4A是根据本发明实施例的耦合构件的示意透视图;以及
图4B是根据本发明实施例的耦合构件的示意剖视图。
具体实施方式
概述
本发明的实施例提供了一种新型设计的入侵式探针,比如导管。探针包括柔性***管,该柔性***管用于***到患者的体腔中。探针的远端头通过耦合构件连接到***管的远端。耦合构件包括弹性材料的管状件,该管状件具有在该件的一部分中切削的多个缠绕螺旋,通常为双螺旋。
当远端头接合体腔中的组织时,该多个缠绕螺旋允许耦合构件响应于施加在远端头上的压力而弯曲。对于施加的相同的压力,该弯曲比在耦合构件中切削的单个螺旋的情况明显更大并且更加均匀。更大和更均匀的弯曲有助于改进引起弯曲的压力的测量。此外,与仅仅具有一个螺旋的耦合构件所需的尺寸相比,该螺旋的尺寸可以选择成显著地减小耦合构件的尺寸。
详细说明
图1是心室22的示意剖视图,其示出了根据本发明一个实施例的心脏内的导管20的柔性***管26。导管通常经由皮肤通过诸如腔静脉或主动脉的血管***到心脏中。导管的远端头24上的电极28接合心内膜组织30。由远端头对心内膜施加的压力使心内膜组织局部变形,使得电极28在相对大的范围内接触该组织。在图示的示例中,电极以一定角度而不是径直接合心内膜。因此,远端头24在弹性接头32处相对于导管的***管26弯曲。该弯曲有利于电极与心内膜组织之间的最佳接触。
因为接头32的弹性本质,接头的弯曲角度通常与组织30施加在远端头24上的压力(或者等效的是,远端头施加在组织上的压力)成比例。从而,弯曲角度的测量给出了该压力的指示。导管20的操作者可以利用该压力指示来确保远端头足够稳固地压靠心内膜,以便提供期望的治疗或诊断结果,但是压靠不要太强烈,以免引起不期望的组织破坏。2007年10月8日提交的Govari等人的美国专利申请20090093806描述了一种以这种方式使用压力感测导管的***,其公开内容以引用方式并入本文中。导管20可以用在这样的***中。
图2是根据本发明实施例的导管20的示意剖视图,示出了导管的远端的细节。耦合构件40在远端头24与***管26的远端之间形成接头32。以举例的方式,耦合构件40假设形成为两个部分,第一部分42和第二部分44,这两个部分固定地接合在一起。耦合构件40的两个部分通常为管状,并且接合成使得耦合构件也为管状形式。尽管耦合构件40没有必要形成为两个部分,但是两个部分的具体实施简化了将磁场发生器和磁位置传感器组装到该构件中,这将在下面更加详细地描述。通常将附接杆结合到其中一个部分中还有助于两个部分的具体实施,这也将在下面更加详细地描述。
耦合构件40具有沿着其第一部分42的长度的一部分切削的多个缠绕螺旋46。多个缠绕螺旋46包括多于一个的任意整数个单螺旋,例如但不限于两个、三个或四个螺旋。为了简化起见,除非有另外的说明,否则在以下的说明中,多个缠绕螺旋假定为包括两个切削的缠绕单螺旋,第一切削螺旋48和第二切削螺旋50,并且在本文中还称为双螺旋。本领域技术人员在没有过度实验的情况下能够改变具体实施方式,以便包含多个缠绕螺旋,其中多个是多于两个单螺旋。
耦合构件40(通常与导管20的远端一起)通常被柔性塑料外皮52覆盖。当导管20用于例如通过经由电极28传送RF(射频)电能消融心内膜组织时,在远端头24的区域中产生大量的热。为此,期望的是,外皮52包括耐热塑料材料,例如聚氨酯,其形状和弹性在暴露于热时基本不会受到影响。
导管20包括位于第一部分42的远端部中的位置传感器54。第一部分的远端部位于远端头24中。位置传感器经由导体56连接至***管26近端处的处理单元(未示出)。导体56通常可以包括双绞电缆。位置传感器54构造成感测远端头相对于***管26的远端的位置。如上所述,位置响应于耦合构件的变形而变化,从而,处理单元可以利用位置读数来给出施加在远端头上和由远端头施加的压力的指示。
对于心内操作,***管26和远端头24通常应当具有非常小的外径,通常为2-3mm量级。因此,导管20的所有内部元件,例如导体56,也都制成为尽可能的小而薄,并且尽可能地布置成避免由于小的机械应变而导致的损坏。
位置传感器54可以包括一个或多个线圈,该线圈构造成响应于磁场而产生信号。这些信号是远端头24的位置和取向的表示。磁场可以由位于耦合构件的第二部分44中的小型磁场发生器58产生。发生器58通常经由导体60由近端处理单元激发。从而,当耦合构件40弯曲时,位置传感器产生的信号发生变化,并且可以被处理单元分析,以便确定远端头上的压力。可以由患者身体外部的固定位置中的场发生器(未示出)产生额外的磁场。这些磁场使得位置传感器54产生额外的信号,该信号表示远端头24在外部场发生器的固定参考框架中的位置和取向。在上述美国专利申请11/868,733中详细描述了位置传感器54的操作的这些方面。它们在本发明的范围之外。
导管20通常包括一对拉线62、64,操作者在操纵控制导管时使用该对拉线。拉线穿过***管26,并且锚定在***管远端中的相应锚定点66、68处,该锚定点通常位于管的相对侧上。操作者拉紧所述拉线(通常是通过转动导管近端处的旋钮-未示出),以便“向上”或“向下”弯曲导管的远端。(“向上”和“向下”的参考仅仅涉及图2,并且并不解释为限制导管沿任意特定方向的运动。)当操作者释放拉线时,导管由于***管的弹性而伸直。
图3是根据本发明实施例的耦合构件40的第一部分42的示意侧视图。图4A是两个部分接合以形成耦合构件的示意透视图,图4B是根据本发明实施例的耦合构件的示意剖视图。
耦合构件40的两个部分通常包括由弹性材料制成的管状件,该弹性材料通常为金属材料。两个部分的材料通常是相同的弹性材料,例如,诸如镍钛(镍钛诺)的超弹性合金。对于心内应用,构件40的总长度可以为大致8.5mm,外径为大致2.0mm。第二部分44为圆筒体形式,长度为大致5.2mm,壁厚为大致0.08mm。第一部分42的壁厚为大致0.27mm。作为另外一种选择,在其它应用中,耦合构件40的各部分及其总体尺寸可以更大或更小。
如图3所述,并且如上所述,耦合构件40的第一部分42具有两个切入该部分中的缠绕单螺旋,第一螺旋48和第二螺旋50。这两个螺旋可以通过对第一部分进行激光加工而切出。对于上述尺寸,通常通过激光将各个螺旋开口至宽度为大约0.1mm。虽然各个螺旋切削的宽度通常是相同的,但是这种情况并不是必须的,在某些实施例中螺旋切削可以具有不同的宽度。此外,在某些实施例中,一个或两个切削的宽度可以沿着切削变化,这通常是为了增大构件40的强度。
为了对心内应用提供柔性与硬度之间的适当平衡,各个螺旋通常绕构件40的中心轴线70(图4A)对向大致360°与大致720°之间的角度。对于上述心内应用,并且如图3所示,各个螺旋对向大约450°,使得各个螺旋具有大致1.25转的角度范围。发明人已经发现,大致1.25转在构件40的矛盾需求之间提供了良好的平衡,例如,确保其相对于挠曲径向对称,并且确保构件具有足够的强度。作为另外一种选择,对于各个螺旋可以采用较大或较小的角度范围,并且根据应用的要求,角度范围可以不相同。
部分42的各个螺旋的终端可以扩大,以便减轻应变,使得该部分在使用期间不会断裂。该扩大通常为部分椭圆的形式。从而,螺旋48以第一部分椭圆72和第二部分椭圆74终止,并且螺旋50以第一部分椭圆76和第二部分椭圆78终止。在某些实施例中,该扩大可以实施为圆形的一部分,该圆形的直径大于螺旋的宽度。该扩大可以相对于它们各自的螺旋取向,以便使得部分42的长度最小,从而使得位置传感器54与发生器58之间的距离可以被最小化。
根据多螺旋的数量,多螺旋46绕轴线70旋转对称。从而,本文所述的双螺旋具有二重旋转对称。通常,如果多螺旋46包括n个螺旋,其中n是正整数,那么该螺旋构造成具有绕轴线70的n重旋转对称。
多重多螺旋46的构造可以与多螺纹螺钉的螺纹构造相比,该多螺纹螺钉也被称为多头螺钉。(同样,单螺旋可以与单螺纹或单头螺钉的螺纹相比。)利用这种比较,对于上面示出的实施例(其中构件40的总长度为大致8.5mm),多螺旋46对应于如下的双螺纹螺钉:该双螺纹螺钉的螺距为大致0.5mm,导程为这个值的两倍,即大致1.0mm。
第一部分42通常包括大体矩形的杆80,其用来将该部分42附接到第二部分44上。杆可以通过从用来生产部分42的管上切削材料而形成,使得杆的壁厚与部分42的剩余部分的壁厚相同。
如图4A所示,构件40通过将第一部分42滑动到第二部分44中而形成,使得杆80被部分44环绕,并且使得部分椭圆72和76大致接触部分44的边缘。一旦如图所示定位成具有公共圆周,则这两个部分通常通过将杆80的边缘键孔焊接到部分44的内表面上而固定地连接在一起。此外,为了额外的刚度,如图4B所示,这两个部分也焊接在一起,其中部分44的边缘接触部分42,即围绕公共圆周。圆周焊接是部分的,使得包含螺旋切削终端的区域82没有被焊接,其中螺旋切削终端包括部分椭圆76和72。部分焊接有助于使得耦合构件的两个部分之间的应力比单螺旋的情况分布地更加对称,并且借助两个构件减小了任意一个位置处的应力。
在耦合构件40中切削的多螺旋使得该构件用作弹簧,从而允许该构件弯曲。通过具有多于一个的螺旋切削,使得弯曲比具有单螺旋切削并且具有与多螺旋切削相同数量的转数的管的弯曲更加均匀(对于相同范围的外力而言)。与具有单螺旋切削的管相比,多螺旋切削还提供了更大的侧向硬度。弯曲延伸直至例如30°的角度,在该角度处弯曲内侧上的螺旋切削的侧面会彼此接触。在这一点上,接触的位置基本上变得“不起作用”,但是非接触的位置仍然能够进行弯曲。从而,螺旋切削的宽度可以选择成对耦合构件的初始弯曲提供期望的、预定的角度限制,这用来防止导管20的元件可能由于过度弯曲所引起的损坏。
此外,具有多个螺旋切削消除了单螺旋切削的耦合构件出现的单点故障。多螺旋46的螺旋切削需要耦合构件40的第一部分42有对应的多个故障才会断裂。
尽管以上在基于导管的心内手术的上下文中描述了导管20的操作和构造,但是本发明的原理可以类似地应用于在心脏和身体的其它器官中采用入侵式探针的其它治疗和诊断应用。此外,导管20和耦合构件40的具体实施的原理还可以用来增强其它类型的导管设计的柔韧性,例如套索和“Pentarray”型导管。在螺旋套索导管中,例如,类似耦合构件40的弹性元件可以结合到螺旋套索中,以便增强易用性和套索在心脏内期望位置上的对准精度。
因此,应当理解,上述实施例是以举例的方式进行阐述,并且本发明不受上文特别所示及所述内容的局限。并且,本发明的范围包括上述各种特征的组合和子组合以及本领域技术人员在阅读上述说明书时可能想到的并且现有技术中未公开的变型形式和修改形式。
Claims (19)
1.一种医疗探针,包括:
柔性***管,其具有用于***到患者的体腔内的远端;
远端头,其具有位于其上的电极,所述远端头设置在所述柔性***管的远端处,并且构造成与体腔中的组织接触;以及
与所述电极分开的耦合构件,其将所述远端头耦合至所述柔性***管的远端,并且所述耦合构件包括弹性材料制成的管状件,所述管状件沿着其长度的一部分具有切穿所述管状件的多个缠绕螺旋切削,其中,所述多个缠绕螺旋切削包括n个切削,其中n是大于1的整数,并且所述切削构造成使得所述管状件绕所述管状件的轴线具有n重旋转对称。
2.根据权利要求1所述的探针,其中所述螺旋切削中的至少一个包括扩大的终端。
3.根据权利要求2所述的探针,其中所述扩大的终端包括部分椭圆。
4.根据权利要求1所述的探针,其中所述螺旋切削中的至少一个绕所述管状件的轴线对向360°至720°之间的角度。
5.根据权利要求1所述的探针,其中所述耦合构件构造成当所述远端头接合组织时响应于施加在所述远端头上的压力而弯曲,并且所述螺旋切削中的至少一个的宽度选择成对所述耦合构件的初始弯曲提供预定的角度限制。
6.根据权利要求1所述的探针,其中所述耦合构件包括管状部分,所述管状部分通过固定连接而连接到所述管状件。
7.根据权利要求6所述的探针,其中所述管状件包括杆,并且所述固定连接包括焊接至所述管状部分的所述杆。
8.根据权利要求6所述的探针,其中所述管状部分和所述管状件布置为形成它们的公共圆周,并且所述固定连接包括在靠近所述螺旋切削的相应终端的、其上不存在公共圆周区域上的焊接。
9.根据权利要求6所述的探针,并且包括位于所述管状件中的位置传感器。
10.根据权利要求9所述的探针,其中所述位置传感器构造成感测所述远端头相对于所述***管的远端的位置,所述位置响应于所述耦合构件的变形而变化。
11.根据权利要求9所述的探针,其中所述位置传感器构造成响应于磁场而产生信号,并且其中所述信号表示所述远端头的位置。
12.根据权利要求11所述的探针,并且包括位于所述管状部分中用于产生磁场的磁场发生器。
13.根据权利要求1所述的探针,其中所述***管、所述远端头和所述耦合构件构造成用于通过血管***到患者的心脏中。
14.一种用于生产医疗探针的方法,包括:
提供柔性***管和远端头,所述柔性***管具有用于***到患者的体腔内的远端,所述远端头设置在所述柔性***管的远端处并且构造成与体腔中的组织接触;以及
利用耦合构件将所述远端头耦合至所述柔性***管的远端,所述耦合构件包括弹性材料制成的管状件,所述管状件沿着其长度的一部分具有切穿所述管状件的多个缠绕螺旋切削,其中所述多个螺旋切削包括n个切削,其中n是大于1的整数,并且包括将n个切削构造成使得所述管状件绕所述管状件的轴线具有n重旋转对称。
15.根据权利要求14所述的方法,其中所述螺旋切削中的至少一个包括扩大的终端。
16.根据权利要求15所述的方法,其中所述扩大的终端包括部分椭圆。
17.根据权利要求14所述的方法,其中所述螺旋切削中的至少一个绕所述管状件的轴线对向360°至720°之间的角度。
18.根据权利要求14所述的方法,包括将所述耦合构件构造成当所述远端头接合组织时响应于施加在所述远端头上的压力而弯曲,并且将所述螺旋切削中的至少一个构造成其宽度选择成对所述耦合构件的初始弯曲提供预定的角度限制。
19.根据权利要求14所述的方法,其中所述耦合构件包括管状部分,所述管状部分通过固定连接而连接到所述管状件。
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US20200324080A1 (en) | 2020-10-15 |
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US20110130648A1 (en) | 2011-06-02 |
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