CN107666888A - 血管内温度管理导管中温度传感器的近端安装 - Google Patents

血管内温度管理导管中温度传感器的近端安装 Download PDF

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CN107666888A
CN107666888A CN201680030647.6A CN201680030647A CN107666888A CN 107666888 A CN107666888 A CN 107666888A CN 201680030647 A CN201680030647 A CN 201680030647A CN 107666888 A CN107666888 A CN 107666888A
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J·马佐内
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As Cyclic Service Systems
Zoll Circulation Inc
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Abstract

血管内温度管理导管(12)包括轴(32)，工作流体能够通过该轴循环流通至轴上的近端位置以及从近端位置循环流通。导管从连接器毂(34)延伸。至少一个热交换构件(37)由轴的远端部分或导管的其它部分支撑，以接收来自近端位置的循环工作流体。温度传感器(30)支撑于导管上用于产生将发送至控制系统的代表血液温度的温度信号。温度传感器(30)包括第一和第二导电引线(42、44)，其中第一和第二导电引线(42、44)在导管轴上或在导管轴中分别具有第一和第二远端段(46、48)。第一和第二远端段(46、48)配置为当导管布置于患者的血管中时与流经导管(12)的血液热接触。此外，温度传感器(30)包括连接至第一和第二引线的近端段的接合体(52)。接合体(52)可以支撑于毂(34)中或支撑于邻近第一和第二导电引线的另一位置中。

Description

血管内温度管理导管中温度传感器的近端安装
技术领域
本申请大体涉及具有近端安装的机载(onboard)温度传感器的接合体或陶瓷部分的用于患者体温控制的热交换系统。
背景技术
已经引进患者体温控制系统来防止神经重症监护室中的患者由于患有蛛网膜下腔出血或诸如中风等的其它神经系统疾病而发热。此外，该系统已经用于诱导轻度或中度低体温以改善患有诸如中风、心搏停止、心肌梗塞、外伤性脑损伤和高颅内压等的疾病的患者的治疗效果。另外，该系统已经为了升温目的而用于诸如烧伤患者和可能遭受有害或意外的低体温的其它患者。血管内热交换导管的示例在以下美国专利中公开：No.6,419,643、No.6,416,533、No.6,409,747、No.6,405,080、No.6,393,320、No.6,368,304、No.6,338,727、No.6,299,599、No.6,290,717、No.6,287,326、No.6,165,207、No.6,149,670、No.6,146,411、No.6,126,684、No.6,306,161、No.6,264,679、No.6,231,594、No.6,149,676、No.6,149,673、No.6,110,168、No.5,989,238、No.5,879,329、No.5,837,003、No.6,383,210、No.6,379,378、No.6,364,899、No.6,325,818、No.6,312,452、No.6,261,312、No.6,254,626、No.6,251,130、No.6,251,129、No.6,245,095、No.6,238,428、No.6,235,048、No.6,231,595、No.6,224,624、No.6,149,677、No.6,096,068、No.6,042,559、No.8,888,729和USPPs2013/0178923、2013/0079855、2013/0079856、2014/0094880、2014/0094882、2014/0094883，其所有内容通过引入并入本文。
可以使用外部患者体温控制系统。该系统在以下美国专利中公开：No.6,827,728、No.6,818,012、No.6,802,855、No.6,799,063、No.6,764,391、No.6,692,518、No.6,669,715、No.6,660,027、No.6,648,905、No.6,645,232、No.6,620,187、No.6,461,379、No.6,375,674、No.6,197,045和No.6,188,930(共同地，“外部垫片专利”)，其所有内容通过引用并入本文。
一个或多个以上引用的导管可以在导管上配置温度传感器以感测流经导管的血液温度。该温度信号反馈回一个或多个以上引用的系统的控制器并且用于控制循环通过导管的工作流体的温度。
发明内容
如在本文中理解的，使导管的直径最小化的希求限制了导管的插管部上可供支撑温度传感器的空间。
因此，血管内温度管理导管包括导管轴，工作流体能够通过该导管轴循环流通至轴的近端位置并从轴的近端位置循环流通。导管从连接器毂(hub)延伸。至少一个热交换构件由例如轴的远端部的轴的一部分支撑或者由导管脊(spine)或其它导管部支撑，以接收来自近端位置的循环工作流体。在导管上或在导管中支撑有一个或多个温度传感器，用于产生将发送至控制系统的代表血液温度的温度信号。温度传感器包括第一和第二导电引线，该第一和第二导电引线在导管轴上或在导管轴中分别具有第一和第二远端段。当导管布置在患者的血管中时，第一和第二远端段配置为与流经导管的血液热接触。此外，温度传感器包括连接至第一和第二引线的近端段的接合体，其中温度传感器定位或定向为使得接合体所处的位置邻近第一和第二导电引线，例如，接合体可以支撑于毂上或毂中、支撑于电连接器上或电连接器中或支撑于其它邻近毂的位置。
在示例中，温度传感器可以是热敏电阻或其它类型的温度传感器或检测器，包括但不限于热电偶、电阻温度检测器(RTDs)或光纤温度传感器。温度传感器可以是负温度系数(NTC)热敏电阻或正温度系数(PTC)热敏电阻。接合体可以由各种材料制成，例如，聚合物或陶瓷。例如，接合体可以由烧结金属氧化物制成。或者，不受限制地，接合体可以由掺杂的多晶陶瓷制成。如果需要，当导管布置于患者的血管中时，导热的盖能够物理屏蔽第一和第二远端段与流经导管的血液的接触。
在另一方面，方法包括使安装在闭环血管内温度管理导管上或安装在闭环血管内温度管理导管中的一个或多个温度传感器的第一和第二引线的第一和第二远端段热暴露于流经导管的血液。该方法包括接收来自连接至引线的、例如陶瓷或聚合物接合体的接合体的代表血液温度的信号，其中温度传感器定位或定向为使得接合体布置于邻近第一和第二导电引线的至少一部分或引线的远端段的位置并且/或者布置于导管的近端毂上或毂中、布置于电连接器上或电连接器中、或者布置于邻近毂的位置，并且向控制系统发送信号用于控制在闭环中流经导管的工作流体的温度。
在另一方面，装置具有导管轴，工作流体能够通过该导管轴循环，并且支撑在该装置上或支撑在该装置中的一个或多个温度传感器用于产生温度信号。温度传感器包括分别具有第一和第二远端段的第一和第二导电引线，其中第一和第二远端段配置为当导管布置于患者的血管中时与流经导管的血液热接触。此外，温度传感器具有连接至第一和第二引线的近端段的接合体，而接合体支撑于邻近第一和第二引线的远端段的位置。温度传感器可以定位或定向为使得接合体所处的位置邻近第一和第二导电引线的远端段的至少一部分，例如，支撑于毂上或毂中、支撑于电连接器上或电连接器中，或者支撑于邻近毂的位置。
参照附图能够最佳地理解本文说明的各种实施方式和方面的关于其结构和操作的细节，在附图中，相同的附图标记指代相同的部分，其中：
附图说明
图1是根据本发明的实施方式的非限制性系统的示意图；
图2是示例导管的立体图；
图3是沿着图2的线3-3截取的截面；以及
图4是图3的圆4中示出的结构的顶部的近视图。
具体实施方式
首先参照图1，根据本原理，系统10可以包括由控制系统14控制的一个或多个血管内热交换导管12以控制患者体温；例如，防止患者16发热或者诱导患者16的治疗性低体温。在导管中，诸如但不限于盐水的工作流体或冷却剂在闭环中(典型地在控制系统中的泵“P”的影响下)从控制系统14、通过流体供给管路L1、通过导管12并通过流体返回管路L2返回至系统14地循环，使得没有工作流体或冷却剂进入身体。以这种方式，能够通过控制工作流体的温度适当地与血液交换热量来管理患者体温。不受限制地，导管12可以通过在专利文献中所公开的任意导管实现，该专利文献为通过引用将以下美国专利文献并入本文的专利文献，通过引用并入本文的所有美国专利文献为：USPN 5,486,208、5,837,003、6,110,168、6,149,673、6,149,676、6,231,594、6,264,679、6,306,161、6,235,048、6,238,428、6,245,095、6,251,129、6,251,130、6,254,626、6,261,312、6,312,452、6,325,818、6,409,747、6,368,304、6,338,727、6,299,599、6,287,326、6,126,684、8,888,729和USPPs 2013/0178923、2013/0079855、2013/0079856、2014/0094880、2014/0094882、2014/0094883。可以将导管12置于静脉系统中，例如，在上腔静脉或下腔静脉中。
取代导管12或除导管12之外，系统10可以包括一个或多个垫片18，其抵靠患者16的外部皮肤地定位(为了清楚，仅示出一个垫片18)。不受限制地，垫片18可以是外部垫片专利中所公开的垫片中的任何一个垫片。能够通过控制系统14控制垫片18的温度以与患者16交换热量，包括诱导患者的治疗性轻度或中度低体温，这些患者患有能够通过低体温减轻影响的例如心搏停止、心肌梗塞、中风、高颅内压、外伤性脑损伤或其它疾病。垫片18可以通过流体供给管路L3从系统14接收工作流体，并且通过流体返回管路L4使工作流体返回系统14。
控制系统14可以包括接收目标和患者体温作为输入和控制的一个或多个微处理器20，此外可以包括泵“P”、冷却剂压缩机22和/或能够打开以允许冷却剂绕过冷凝器的旁路阀24。如以下进一步说明的，冷却剂在控制系统14中循环通过热交换器。处理器20能够访问非瞬态计算机存储器26以执行存储器26上的指令而执行控制逻辑。
如在图2至图4的实施方式中示出的，可以使例如热敏电阻的温度传感器30支撑于导管12。如所示出的，导管12可以具有一个或多个中空多管腔轴部32(示出了仅具有单轴的导管)，其中工作流体能够通过中空多管腔轴部32循环流通至轴的近端位置并从轴的近端位置循环流通，在该近端位置导管轴从连接器毂34延伸。连接器毂34使导管轴32中的工作流体供给管腔和返回管腔分别与供给连接器配件和返回连接器配件36、38流体地互连，该连接器配件36、38可以经由各自的管路装置连接器连接至图1中示出的系统14，而在系统14中可以使工作流体如所期望地加热或冷却以管理患者体温。
在轴32的供给管腔和返回管腔中循环的工作流体循环进入和循环出由轴32的远端部或由导管的另一部分所支撑的一个或多个热交换构件37。可以使用在专利文献中所说明的任何热交换构件。
另外，温度连接器40可以提供温度传感器30与系统14之间的电通信。一个或多个电连接器可以从温度传感器30延伸到温度连接器40，该温度连接器40可以与和系统14接合的相应连接器接合，以提供从温度传感器30到系统14的用于电信号传输的路径。或者，可以例如在毂34中设置无线收发器以接收来自温度传感器30的温度信号并将该信号无线地发送至系统14。虽然示出了三个连接器36、38和40，但是应当理解，可以在毂34上设置额外的连接器。例如，可以设置使导管轴32中的输注管腔与药物源流体地连接的药物输注连接器。
图3和图4最佳地示出了温度传感器30包括至少第一和第二导电引线42、44，该第一和第二导电引线42、44在导管轴32上或在导管轴32中分别具有第一和第二远端段46、48(也在图2中示意性地示出)。可以将引线42、44模制到导管轴32的壁中并且向近侧地延伸到毂34，或者可以将可能除了远端段46、48之外的引线42、44布置在导管轴32的管腔中。
在示例中，当导管布置在患者的血管中时，第一和第二远端段46、48配置为与流经导管的血液热接触。在示出的示例中，远端段46、48位于导管轴上、与轴的轴线平行并且在轴的外表面上或附近。在一些实施方式中，远端段46、48可以模制到轴中并且可以位于外表面上，物理暴露并且因此热暴露于流经导管的血液。在其它实施方式中，远端段46、48可以由导热的盖50覆盖，以在远端段46、48与血液热耦合时使远端段46、48与血液物理地屏蔽。在示例中，盖50可以由超薄且柔性的金属箔创建，其中金属箔可以卷绕于导管轴32。可以使用其它材料，例如导热的塑料。在特定的实施方式中，温度传感器可以具有一根或多根引线。
如上所述，第一和第二导电引线42、44可以延伸至毂34并且如果需要可以延伸进入毂34，其中引线的近端段连接至可以支撑于毂或支撑于邻近毂的位置的接合体52或主体(图3)，例如，在诸如电连接器或温度连接器等的连接器中或者连接器上。应当理解的是，根据上述原理，代表患者体温的电信号取自接合体52并且(例如经由引线54和温度连接器40)发送至系统14。无论接合体是定位于导管、毂或其它邻近毂的位置上或定位于导管、毂或其它邻近毂的位置中，温度传感器都可以定位或定向成使得接合体所处的位置邻近或相对邻近例如引线的远端段的第一和/或第二导电引线的至少一部分的位置。在特定的实施方式中，接合体可以位于邻近或相对邻近第一和第二导电引线的至少一部分的位置，使得与导电引线的至少一部分的位置相比更靠近导管的近端、毂或其它连接器。
在本文说明的任何实施方式中，温度传感器30可以是热敏电阻或其它类型的传感器或检测器，包括但不限于热电偶、电阻温度检测器(RTDs)或光纤温度传感器。例如，热敏电阻可以是负温度系数(NTC)热敏电阻或者正温度系数(PTC)热敏电阻。热敏电阻可以包括可以在导管内电绝缘并与接合体52接合的第一和第二导电引线或电线42、44，其中接合体52可以是陶瓷体或聚合物体。例如，NTC热敏电阻可以具有由诸如烧结金属氧化物的铸造的半导体芯片、压盘、杆、板或珠制成的接合体，而PTC热敏电阻则可以具有由掺杂钛酸钡(BaTiO3)的多晶陶瓷制成的接合体。
虽然本文示出并详细说明了血管内温度管理导管中温度传感器的近端安装的各种实施方式，但是本发明的范围不受除了所附权利要求之外的任何限制。

Claims (21)

1.一种血管内温度管理导管，其包括：
至少一个导管轴，其中工作流体能够通过所述导管轴循环流通至所述轴上的近端位置以及从所述轴上的近端位置循环流通，所述导管从连接器毂延伸；
至少一个热交换构件，其被构造成接收来自所述近端位置的循环工作流体；
至少一个温度传感器，其支撑于所述导管上或支撑于所述导管中，用于产生将发送至控制系统的代表血液温度的温度信号，所述温度传感器包括：
至少第一和第二导电引线，其在所述导管轴上或在所述导管轴中分别具有第一和第二远端段，所述第一和第二远端段配置为当所述导管布置于患者的血管中时与流经所述导管的血液热接触，所述温度传感器还包括连接至所述第一和第二引线的近端段的接合体，其中所述接合体支撑于所述毂中或支撑于所述毂上或者支撑于邻近所述毂的位置。
2.根据权利要求1所述的导管，其特征在于，所述温度传感器是热敏电阻。
3.根据权利要求2所述的导管，其特征在于，所述热敏电阻是负温度系数热敏电阻，即NTC热敏电阻。
4.根据权利要求2所述的导管，其特征在于，所述热敏电阻是正温度系数热敏电阻，即PTC热敏电阻。
5.根据权利要求1所述的导管，其特征在于，所述接合体由聚合物制成。
6.根据权利要求1所述的导管，其特征在于，所述接合体由陶瓷制成。
7.根据权利要求1所述的导管，其特征在于，所述接合体由烧结金属氧化物制成。
8.根据权利要求1所述的导管，其特征在于，所述接合体由掺杂的多晶陶瓷制成。
9.根据权利要求1所述的导管，其特征在于，所述导管还包括导热的盖，以在所述导管布置于患者的血管中时物理屏蔽所述第一和第二远端段的至少一部分与流经所述导管的血液的接触。
10.一种方法，其包括：
使安装在闭环血管内温度管理导管上或安装在所述闭环血管内温度管理导管中的温度传感器的第一和第二引线的第一和第二远端段热暴露于流经所述导管的血液；
接收来自连接至所述引线的接合体的代表血液温度的信号，其中所述温度传感器定位成使得所述接合体布置于邻近所述第一和第二引线的至少一部分的位置；以及
发送所述信号至控制系统用于控制在闭环中流过所述导管的工作流体的温度。
11.根据权利要求10所述的方法，其特征在于，所述导管从连接器毂延伸并且所述接合体布置于所述毂上或布置于所述毂中或者布置于邻近所述毂的位置。
12.一种装置，其包括：
至少一个导管轴，其中工作流体能够通过所述导管轴循环流通；
至少一个温度传感器，其支撑在所述装置上或支撑在所述装置中用于产生温度信号，所述温度传感器包括：
至少第一和第二导电引线，其分别具有第一和第二远端段，所述第一和第二远端段配置为当所述导管布置于患者的血管中时与流经所述导管的血液热接触，所述温度传感器还包括连接至所述第一和第二引线的近端段的接合体，其中所述接合体支撑于邻近所述第一和第二引线的所述远端段的位置。
13.根据权利要求12所述的导管，其特征在于，所述导管从连接器毂延伸并且所述接合体布置于所述毂上或布置于所述毂中或者布置于邻近所述毂的位置。
14.根据权利要求12所述的导管，其特征在于，所述温度传感器是热敏电阻。
15.根据权利要求12所述的装置，其特征在于，所述热敏电阻是负温度系数热敏电阻，即NTC热敏电阻。
16.根据权利要求12所述的装置，其特征在于，所述热敏电阻是正温度系数热敏电阻，即PTC热敏电阻。
17.根据权利要求12所述的装置，其特征在于，所述接合体由聚合物制成。
18.根据权利要求12所述的装置，其特征在于，所述接合体由陶瓷制成。
19.根据权利要求12所述的装置，其特征在于，所述接合体由烧结金属氧化物制成。
20.根据权利要求12所述的装置，其特征在于，所述接合体由掺杂的多晶陶瓷制成。
21.根据权利要求12所述的装置，其特征在于，所述装置还包括导热的盖，以在所述导管布置于患者的血管中时物理屏蔽所述第一和第二远端段的至少一部分与流经所述导管的血液的接触。
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