CN102551877B - 实现光学接触感测的导管 - Google Patents

实现光学接触感测的导管 Download PDF

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CN102551877B
CN102551877B CN201110391640.6A CN201110391640A CN102551877B CN 102551877 B CN102551877 B CN 102551877B CN 201110391640 A CN201110391640 A CN 201110391640A CN 102551877 B CN102551877 B CN 102551877B
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optical contact
contact sensor
dielectric substrate
sheath
medical probe
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CN102551877A (zh
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A·戈瓦里
Y·埃夫拉思
C·T·比克勒
A·帕佩奥亚诺
A·加西亚
A·C·阿尔特曼
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Biosense Webster Israel Ltd
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Abstract

本发明涉及实现光学接触感测的导管。本发明提供了一种医疗探针，所述医疗探针包括生物相容性护套，所述护套具有近端和远端，并且在所述近端和所述远端之间具有至少一个透明带。所述探针还具有一个或多个设置在所述生物相容性护套内的功能元件。

Description

实现光学接触感测的导管
技术领域
本发明总体涉及侵入式探针，具体地讲涉及光学接触感测探针。
背景技术
大量医疗操作涉及将物体(例如传感器、管、导管、分配装置和植入物)设置在体内。已提出多种用于评估体内导管与组织之间接触质量的传感器。
导管-组织接触的质量(例如)可通过感测导管与组织之间的实际物理接触和/或接近度来验证。美国专利申请12/816,492(其公开内容以引用方式并入本文)描述了具有沿其远端集成的多个光学接触传感器的导管。每一个光学接触传感器都包括至少一个光学发光体(诸如发光二极管(LED))和接近该发光体的至少一个相应的光学检测器(诸如光电二极管或光电晶体管)的组合。在距组织较小距离处，光学检测器感测由光学发光体发出并被组织反射的光学辐射。光学检测器生成表征感测的反射的信号。当光学接触传感器与组织物理接触时，该信号将增大到最大电平。因此，光学检测器所生成的信号指示组织与导管远端之间的接触质量。
以上的描述给出了本领域中相关技术的总体概述，不应当被解释为承认了其包含的任何信息构成对抗本专利申请的现有技术。
发明内容
本发明的实施例提供了一种医疗探针，其包括：
生物相容性护套，该护套具有近端和远端，并且在近端和远端之间具有至少一个透明带；和
一个或多个设置在生物相容性护套内的功能元件。
通常，一个或多个功能元件的每一个都包括光学接触传感器，该光学接触传感器具有光学发光体和接近光学发光体的光学检测器。光学接触传感器可被构造成检测远端与身体组织的接近度，并检验远端和身体组织之间的接触。光学接触传感器通常面向至少一个透明带。在一个实施例中，探针包括一个或多个沿生物相容性护套设置的电极，所述电极被构造成执行消融，并且光学接触传感器被构造成提供控制消融的指示。光学接触传感器可被构造成提供评估消融质量的进一步指示。
根据本发明的实施例，还提供了一种医疗探针，其包括：
生物相容性护套，该护套具有近端和远端并且具有至少一个透明元件；
插入生物相容性护套内的介电基板；
一个或多个设置在介电基板上的电子元件；和
一条或多条设置在介电基板上的印刷布线，其连接到一个或多个电子元件的每一个。
所述至少一个透明元件可包括介于护套近端和远端之间的透明带。在本发明所公开的实施例中，一个或多个电子元件的每一个都包括光学接触传感器，该光学接触传感器具有光学发光体和接近光学发光体的光学检测器。光学接触传感器通常面向透明带。介电基板可包括柔性印刷电路板材料。一个或多个电子元件可设置在介电基板的外侧上，一条或多条印刷布线可设置在介电基板的内侧上。
根据本发明的实施例，还提供了一种方法，所述方法包括：
将至少一个透明带装配在生物相容性护套的近端和远端之间；以及
将一个或多个功能元件设置到生物相容性护套内。
根据本发明的实施例，还提供了一种方法，所述方法包括：
将至少一个透明元件装配在生物相容性护套的近端和远端之间；
在生物相容性护套内插入介电基板；
将一个或多个电子元件设置在介电基板上；
将一条或多条印刷布线设置在介电基板上；以及
将一条或多条印刷布线连接到一个或多个电子元件的每一个。
附图说明
本文参照附图，仅以举例说明的方式描述本发明，在附图中：
图1为根据本发明实施例的实现光学接触感测的医疗系统的示意图；
图2A为根据本发明实施例的具有透明带的光学接触感测探针的示意性侧视图；
图2B为根据本发明实施例的具有透明带的光学接触感测探针的示意性剖视图；
图3A为根据本发明实施例的具有光电子带的光学接触感测探针的示意性侧视图；
图3B为根据本发明实施例的光电子带的示意性侧视图；以及
图3C为根据本发明实施例的光电子带内侧的示意性俯视图。
具体实施方式
概述
诸如心内电标测和心脏消融之类的各种诊断和治疗手术使用了诸如导管的侵入式探针，其远侧顶端配有至少一个电极。电极通常在探针顶着体内组织时进行操作。在这些手术中，通常重要的是确定探针与体腔表面的接近度，并且确定探针的远侧顶端何时接触体腔表面。
在本发明的实施例中，探针的功能元件包封在生物相容性护套内，该生物相容性护套在探针的近端和远端之间装配了一个或多个透明带。除了一个或多个透明带外，生物相容性护套在其他部位可以是不透明的。可将诸如光学接触传感器的功能元件面向透明带(其充当窗口)设置在护套内。在一些实施例中，可在沿探针长度的不同位置处将多个光学接触传感器面向相同透明带设置在护套内。
本发明实施例还提供集成到探针内的光电子带，其上安装了多个传感器。光电子带包括长而窄的柔性介电基板(诸如柔性印刷电路板材料，其具有设置在(光电子带)外侧上的光学接触传感器)和沿(光电子带)内侧设置并连接到每一个传感器的印刷布线。在一些实施例中，光电子带可纵向集成到生物相容性护套内，并且如上文所述光学接触传感器面向透明带。
本发明实施例(包括装配了透明带和光电子带的生物相容性护套)使得能够可靠且低廉地制备光学接触感测探针。
系统说明
图1为根据本发明实施例的实现光学接近度感测的医疗系统20的示意图。系统20包括光学接触感测探针22(在本实例中为导管)和控制台24。在下文所述实施例中，假设探针22用于诊断或治疗处理，诸如在心脏26的肺静脉中周向标测电势，或进行静脉组织的消融。作为另外一种选择，加以必要的变通，探针22可以用于心脏中或其他身体器官中的其他治疗和/或诊断用途。
操作者28(诸如心脏病学家)将探针22穿过患者30的血管系统插入，以使得探针22的远端32进入患者心脏26的心室(如左心房)。操作者28推进探针22，以使得远侧顶端34(这里以“套环”或“套索”构型示出)接合在所需位置处的身体组织(如左上肺静脉中的静脉组织)。远侧顶端34包括电极36和光学接触传感器38。光学接触传感器38的构型在下图2A中更详细地示出。光学接触传感器在(例如)美国专利申请12/816,492中有所描述，其公开内容以引用方式并入本文。探针22通常由在其近端处的合适的连接器连接到控制台24。
利用来自探针22中所配备的光学接触传感器的信号，控制台24确定在介于远侧顶端34和静脉组织之间的接触质量。术语“接触质量”是指介于远侧顶端和组织之间的实际物理接触，以及远侧顶端与组织的接近度。在图1的实例中，控制台24也通过电缆40连接到身体表面电极，该电极通常包括粘合剂皮肤贴片42。控制台24根据探针和贴片42之间测得的阻抗来确定探针22在心脏26内部的位置坐标。尽管系统20使用基于阻抗的传感器来测量位置，但也可以使用其他位置跟踪技术(如基于磁性的传感器)。磁性位置跟踪技术在(例如)美国专利5,391,199、5,443,489、6,788,967、6,690,963、5,558,091、6,172,499、6,177,792中有所描述，其公开内容以引用方式并入本文中。基于阻抗的位置跟踪技术在(例如)美国专利5,983,126、6,456,864和5,944,022中有所描述，其公开内容以引用方式并入本文中。
控制台24包括处理器44，该处理器通常包括通用计算机，其具有合适的前端和接口电路，用于从探针22接收信号并控制控制台24的其他元件。输入/输出(I/O)通信接口46使控制台24能够与探针22和贴片42交互。根据从探针22以及从贴片42接收的信号，处理器44生成并显示标测图48，该标测图示出远侧顶端34在患者体内的位置、介于套环和身体组织之间的距离和/或接触指示、以及有关正在进行的手术的状态信息和指导。利用显示器50将标测图48显示给操作者28。可以将探针22的位置添加在标测图48上或心脏26的另一图像上。
具有透明带的探针
图2A为根据本发明实施例的光学接触感测探针22的示意性侧视图，图2B为根据本发明实施例的探针的示意性剖视图。探针22包括由生物相容性护套62覆盖的功能元件，诸如光学接触传感器38和管60。除了装配在探针近端66和远端32之间的透明(对光学辐射)带64外，护套62对光学辐射不透明。探针的近端和远端分别与生物相容性护套的近端和远端大致相同，因此术语近端66和远端32也是指护套的相应末端。透明带64在本文中也称为窗口64，其具有宽度68。
在图2A所示构型中，电极36沿远端32的长度设置。电极36通常由金属材料(例如铂/铱合金或另一种合适的材料)制成。
光学接触传感器38面向窗口64设置在护套62内，并且通常相对于窗口对称设置。光学接触传感器38包括光学发光体70(诸如发光二极管(LED))和接近光学发光体的光学检测器72(诸如光电二极管或光电晶体管)。虽然图2A所示光学接触传感器38的构型包括一个光学发光体70和一个光学检测器72，但光学接触传感器可被构造成包括不止一个光学发光体和/或不止一个光学检测器。装配了光学发光体70和光学检测器72的光学接触传感器在(例如)美国专利申请12/816,492中有所描述，其公开内容以引用方式并入本文。
窗口64的宽度68在方位角方向确定了传感器的视野74范围(即，光学接触传感器38能够绕探针22“看”到多远)。如果需要，窗口64可被构造得较窄，以确保光学接触传感器38仅对所需的较窄角范围(即视野74)内探针22和身体组织之间的接触灵敏。
窗口64可在制备生物相容性护套62的过程中采用共挤法制成，该方法为挤出的变型。在挤出过程中，挤出机使材料熔融，然后输送穿过模具，该模具被构造成提供所需外形的最终产品(例如管状护套)。模具被设计成使得熔融的材料均匀流动，形成产品的外形。为制备具有窗口64的护套62，用2台挤出机使稳定体积通量的不同生物相容性材料(即，分别用于不透明护套和透明带)熔融并将这些材料输送到单模具中，该模具将材料挤出为图2A所示的形式。在共挤法中设定宽度68可以使生产出的探针22具有所需的视野74。
虽然图2A是沿直探针区段示出探针22，但同种技术可用于弯曲元件，诸如图1所示套索导管的弯曲末端。在图1所示实例中，远侧顶端34包括配有电极36和光学接触传感器38的可调式套环。套环的构型使得能够同时对组织的周边区域(诸如肺静脉)进行标测或消融。
除此之外或作为另外一种选择，探针22可制备为具有多个平行窗口64。例如，在具有2个位于探针直径相对两端的窗口64的构型中(如下图3A所示)，单独的光学接触传感器38可面向2个窗口的每一个设置并对齐。作为另外一种选择，多个光学接触传感器38可相对于其窗口不对称设置，以使得传感器的视野具有不同角覆盖范围，同时涵盖大致相同的角宽度。为探针22配置多个窗口64(和相应光学接触传感器38)，便可以在与探针轴线正交的任何方向实现全方位感测，使得沿探针长度感测接触成为可能，而无需考虑探针哪一侧与组织接触。
具有光电子带的探针
图3A为根据本发明实施例的具有光电子带76的探针22的示意性侧视图，图3B为根据本发明实施例的光电子带的示意性侧视图，图3C为根据本发明实施例的光电子带内侧78的示意性俯视图。探针22装配了透明元件，这些透明元件在图3A所示构型中包括介于探针近端66和远端32之间的2个窗口64。探针22包括纵向插入探针的光电子带76，使得设置在光电子带外侧80上的光学接触传感器38面向一个窗口64。
光电子带76包括长而窄的柔性介电基板82(诸如柔性印刷电路板材料)，其具有设置在外侧80上的光学发光体70和光学检测器72以及沿内侧78的印刷布线84，所述印刷布线连接到每个光学发光体70和光学检测器72。在制备过程中，光电子带76可纵向集成到探针22中，可沿探针的一侧集成或包绕在两侧上，如图3A所示。作为另外一种选择，对于每个窗口64，单独的光电子带76都可纵向集成到探针22中。
操作探针的过程中，光学发光体70发射光学辐射，光学检测器72将表征身体组织所反射的光学辐射的信号传送到处理器44。根据接收到的信号，处理器44可确定远端32与身体组织的接近度，并可检验远端与身体组织之间的接触。
如上文所述，探针22可用于消融心脏26的静脉组织。消融手术过程中，沿远端32间隔分布的电极36可发出烧灼少量静脉组织的能量。由于烧灼和未烧灼组织通常具有不同反射性能，光学检测器72可被构造成根据烧灼和未烧灼静脉组织所反射的不同电平的光学辐射来传送不同信号。因此，处理器44可利用光学传感器38控制该消融手术和其他消融手术，以及评估已执行的消融的质量。
虽然图3A示出了设置在光电子带76上的光学发光体70和光学检测器72，但其他类型的电子元件也可设置在光电子带上，因此也应视为在本发明的精神和范围内。可设置在光电子带76上并连接到印刷布线84的电子元件的例子包括其他类型的压电换能器、电容式传感器和压力传感器。
另外，上文所述的光电子带假定布线84和电子元件(即，发光体70和检测器72)在光电子带76的相对侧。在可供选择的实施例中，至少一些布线84与电子元件位于(光电子带76)相同侧上。
应当理解上述实施例仅是举例方式的援引，本发明并不限于上文具体示出和描述的内容。更确切地说，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 (20)

1.一种医疗探针，包括：
生物相容性护套，所述护套具有近端和远端，并且在所述近端和所述远端之间具有至少一个透明带；和
一个或多个设置在所述生物相容性护套内的功能元件，
其中所述一个或多个功能元件的每一个包括光学接触传感器，
进一步包括：沿所述生物相容性护套设置的一个或多个电极，所述电极被构造成执行消融，并且其中所述光学接触传感器被构造成提供控制所述消融的指示。
2.根据权利要求1所述的医疗探针，其中所述光学接触传感器包括光学发光体和接近所述光学发光体的光学检测器。
3.根据权利要求2所述的医疗探针，其中所述光学接触传感器被构造成检测所述远端与身体组织的接近度，以及检验所述远端与所述身体组织之间的接触。
4.根据权利要求2所述的医疗探针，其中所述光学接触传感器面向所述至少一个透明带。
5.根据权利要求1所述的医疗探针，其中所述光学接触传感器被构造成提供评估所述消融的质量的进一步指示。
6.一种用于制造如权利要求1-5任一项的医疗探针的方法，包括如下步骤：
将至少一个透明带装配在生物相容性护套的近端和远端之间；以及
将一个或多个功能元件设置到所述生物相容性护套内。
7.根据权利要求6所述的方法，其中所述一个或多个功能元件的每一个包括光学传感器，所述光学传感器包括光学发光体和接近所述光学发光体的光学检测器。
8.根据权利要求7所述的方法，其中所述光学传感器面向所述至少一个透明带。
9.一种医疗探针，包括：
生物相容性护套，所述护套具有近端和远端并且具有至少一个透明元件；
插入所述生物相容性护套内的介电基板；
一个或多个设置在所述介电基板上的电子元件；和
一条或多条设置在所述介电基板上的印刷布线，所述印刷布线连接到所述一个或多个电子元件的每一个，
其中所述一个或多个电子元件的每一个包括光学接触传感器，
进一步包括：沿所述生物相容性护套设置的一个或多个电极，所述电极被构造成执行消融，并且其中所述光学接触传感器被构造成提供控制所述消融的指示。
10.根据权利要求9所述的医疗探针，其中所述至少一个透明元件包括介于所述护套的所述近端和所述远端之间的透明带。
11.根据权利要求10所述的医疗探针，其中所述光学接触传感器包括光学发光体和接近所述光学发光体的光学检测器。
12.根据权利要求11所述的医疗探针，其中所述光学接触传感器面向所述透明带。
13.根据权利要求9所述的医疗探针，其中所述介电基板包括柔性印刷电路板材料。
14.根据权利要求9所述的医疗探针，其中所述一个或多个电子元件设置在所述介电基板的外侧上，并且所述一条或多条印刷布线设置在所述介电基板的内侧上。
15.一种用于制造如权利要求9-14任一项的医疗探针的方法，包括如下步骤：
将至少一个透明元件装配在生物相容性护套的近端和远端之间；
在所述生物相容性护套内插入介电基板；
将一个或多个电子元件设置在所述介电基板上；
将一条或多条印刷布线设置在所述介电基板上；以及
将所述一条或多条印刷布线连接到所述一个或多个电子元件的每一个。
16.根据权利要求15所述的方法，其中所述至少一个透明元件包括介于所述护套的所述近端和所述远端之间的透明带。
17.根据权利要求16所述的方法，其中所述一个或多个电子元件的每一个包括光学接触传感器，所述光学接触传感器包括光学发光体和接近所述光学发光体的光学检测器。
18.根据权利要求17所述的方法，其中所述光学接触传感器面向所述透明带。
19.根据权利要求15所述的方法，其中所述介电基板包括柔性印刷电路板材料。
20.根据权利要求15所述的方法，其中所述一个或多个电子元件设置在所述介电基板的外侧上，并且所述一条或多条印刷布线设置在所述介电基板的内侧上。
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