CN101495826B - 用于控制患者体温的初级换热器 - Google Patents

用于控制患者体温的初级换热器 Download PDF

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CN101495826B
CN101495826B CN2006800242644A CN200680024264A CN101495826B CN 101495826 B CN101495826 B CN 101495826B CN 2006800242644 A CN2006800242644 A CN 2006800242644A CN 200680024264 A CN200680024264 A CN 200680024264A CN 101495826 B CN101495826 B CN 101495826B
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D·S·金巴尔
K·A·科林斯
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Zoll Circulation Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A61F2007/126—Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels

Abstract

本发明提供一种换热系统，其中初级冷却剂流经血管内导管(12)或外部应用垫(18)，以升高或降低患者体温。次级传热元件(24)可接合初级传热元件(22)，且在运行过程中当初级传热元件(22)完全接合次级传热元件(24)时不接地。相反，当初级传热元件(22)相对于次级传热元件(24)处于预定的脱开位置时，次级传热元件(24)接地。

Description

用于控制患者体温的初级换热器
发明领域
本发明大体涉及患者体温控制系统。
发明背景
人们已发现，如果将因撞击或心脏病抑或心动停止而罹患严重脑创伤或局部缺血的患者的体温冷却至正常体温(37℃)以下，便能改善患者的医疗结果。此外，对于此种患者，即使在决定不促使体温降低的情况下，防止患者高热(发烧)也很重要，这也已为人们所认可。而且，在某些应用中，例如在CABG手术后，可能希望使体温降低的患者重新恢复体温。
如本发明所认识到，通过冷却或加热患者的整个身体，可实现体温调节的上述优点。而且，本发明意识到，由于许多患者为达到任何其它得到临床认可的目的(例如输送药物及进行血液监控)而已经插入有中央静脉导管，因而对于这些患者而言，提供一也可冷却或加热血液的中央静脉导管并不需要进行额外的手术。以下各美国专利即揭示各种血管内导管/系统/方法：6,749,625，6,419,643，6,416,533，6,409,747,6,405,080，6,393,320，6,368,304，6,338,727，6,299,599，6,290,717，6,287,326，6,165,207，6,149,670，6,146,411，6,126,684，6,306,161，6,264,679，6,231,594，6,149,676，6,149,673，6,110,168，5,989,238，5,879,329，5,837,003，6,383,210，6,379,378，6,364,899，6,325,818，6,312,452，6,261,312，6,254,626，6,251,130，6,251,129，6,245,095，6,238,428，6,235,048，6,231,595，6,224,624，6,149,677，6,096,068，6,042,559，及序列号为10/355,776的美国专利申请，其全部以引用方式并入本文中。尽管欠佳，但也可使用表面冷却。以下编号的美国专利即揭示此种表面冷却系统：6,827,728，6,818,012，6,802,855，6,799,063，6,764,391，6,692,518，6,669,715，6,660,027，6,648,905，6,645,232，6,620,187，6,461,379，6,375,674，6,197,045，及6,188,930(统称为“外部垫专利”)，其均以引用方式并入本文中。在血管内导管与外部垫系统二者中，例如气体或盐水等冷却剂均是通过换热元件进行循环。
显然，无论对患者连接何种特定的换热元件，均须从流经换热元件的冷却剂中移除热量或者向其中添加热量。本发明利用以下重要观察结果。通常，来自所述导管或垫的冷却剂流经一传热装置，该传热装置使用次级流体对冷却剂进行加热或冷却。该传热装置可包括一使冷却剂从中流过的筒或袋抑或其它器件，且该筒或袋抑或其它器件可浸入于一次级流体浴槽中，由该浴槽中的次级流体与冷却剂进行换热。在上文所引用的某些专利中陈述了此种系统的实例。
如在本文中所认识到，当医疗人员将冷却剂袋或筒与次级流体浴槽进行连接时，可能会暴露出该次级流体浴槽，且出于此种原因，倘若在系统中存在单一的电气故障，则可能希望将该浴槽接地以保证操作人员的安全。然而，本发明迫切地认识到，一旦因初级冷却剂袋或筒与该浴槽相连接而不能再触及到该浴槽，从患者的角度来讲，便希望不将该浴槽接地，以防止可能因各种与故障相关的原因而有任何漏电流从所述垫或导管流出。
发明概要
本发明提供一种换热系统，其包含：初级冷却剂传热元件，初级冷却剂通过其自初级换热元件(例如血管内导管或外部应用垫)流出；次级传热元件，其含有次级换热流体浴槽；以及开关，其在所述初级冷却剂传热元件未浸没于所述浴槽中时将所述次级传热元件接地，另一方面，在所述初级冷却剂传热元件浸没于所述浴槽中时，所述开关将所述次级传热元件与地断开。
在非限定性实施例中，所述开关可安装于次级传热元件上，并在初级传热元件处于预定的脱开位置时被偏置至闭合位置，以将所述次级传热元件接地。此外，所述开关也可由初级传热元件移动至断开位置，以使次级传热元件不接地(电浮动)。在具体的非限定性实施例中，所述初级传热元件包括用于移动所述开关的中空套管，且所述套管环绕使初级冷却剂从中流过的中空盘管，而所述次级传热元件可包含护套及浴槽容器。所述初级传热元件的套管在初级传热元件完全接合次级传热元件时可设置于护套与次级传热元件的浴槽容器之间，其中所述盘管设置于容器中。所述容器容纳次级换热流体。可提供握把来支撑连接至盘管的供应及返回导管。可使罩壳元件附装至握把上，并可覆盖套管的顶端。
在本发明的另一方面中，提供一种系统，其用于与流经可与患者接合的换热元件的初级冷却剂进行换热。所述系统包含次级传热元件及可与所述次级传热元件接合的初级传热元件。在使用期间，在初级传热元件不完全接合次级传热元件时，不将次级传热元件接地。然而，在初级传热元件相对于次级传热元件处于脱开位置时，则将次级传热元件接地。
在本发明的又一方面中，提供一种用于与患者进行换热的方法，其包含：使初级冷却剂在闭合回路中流经初级换热元件及初级传热元件。所述方法还包含：使初级传热元件与次级传热元件进行热接合，以在其间进行传热。如在下文中所进一步说明，所述方法涵盖：当在初级传热元件与次级传热元件之间存在第一相对位置时，将次级传热元件接地，而在初级传热元件与次级传热元件之间存在第二相对位置时，使次级传热元件不接地。
附图简述
参照附图可最佳地理解本发明在其结构及运行两方面的细节，在附图中，类似的标号指代类似的部件，且其中：
图1为显示两种换热形式的示意图；
图2为换热系统的一种非限定性实施方式的方框图；以及
图3为根据本发明的初级-次级传热结构的非限定性图解的局部剖视图。
优选实施例详述
首先参见图1，其显示一种总体上标记为10的系统，该系统可包含与导管温控系统14进行流体连通的换热导管12，其中导管温控系统14包含处理器，以用于执行在本文所引用的一个或多个引用专利中所述的逻辑。
根据本发明的原理，系统10可用于使用导管在患者16体内引起治疗性体温降低，在所述导管中，例如但不限于盐水等冷却剂在闭合回路中循环，从而使冷却剂不会进入体内。尽管下文是揭示某些较佳导管，然而应了解，根据本发明的原理，也可使用其它导管，包括但不限于在下列美国专利中所揭示的任何导管：USPN5,486,208，5,837,003，6,110,168，6,149,673，6,149,676，6,231,594，6,264,679，6,306,161，6,235,048，6,238,428，6,245,095，6,251,129，6,251,130，6,254,626，6,261,312，6,312,452，6,325,818，6,409,747，6,368,304，6,338,727，6,299,599，6,287,326，6,126,684，这些美国专利以引用方式并入本文中。导管12可置于静脉系统中，例如置于上腔静脉或下腔静脉中。
取代导管12或者除导管12以外，系统10还可包含贴靠患者16的外皮肤放置的一个或多个垫18(为清楚起见，在图中仅显示一个垫18)。垫18可为(但不限于)在外部垫专利中所揭示的任何一种垫。垫18的温度可由垫控制器20根据在外部垫专利中所述的原理进行控制，以与患者16进行换热，包括对于患有例如心动停止、心肌梗塞、心脏病、高颅压、脑创伤、或其它可通过降低体温而得到缓解的疾病的患者，在患者体内引起轻微的或适度的治疗性体温降低。控制系统14、20可实作为具有一个或多个处理器的单个系统，以用于根据所引用专利执行温控算法。
现在参见图2，本发明的控制器可包含初级(primary)传热元件22，初级冷却剂通过初级传热元件22在初级传热元件22与初级换热元件(例如图1中所示的导管12或垫18)之间在闭合回路中流动。尽管对例如盐水等流经导管或垫的“初级”流体使用术语“冷却剂”，然而，应了解，冷却剂温度可能高于患者体温以对患者进行加热，或者低于患者体温以对患者进行冷却。在非限定性实施例中，可通过任何数量的方式来实作初级传热元件。例如，初级传热元件22可为袋子或筒(cartridge)，或者如下文在图3的非限定性实施例中所示，其可包含使冷却剂从中流过的盘管(coil)。
总之，初级传热元件22由医疗护理人员放置成与次级传热元件24进行热接触。在一实施例中，次级传热元件24可包含次级换热流体(例如水或乙二醇)浴槽，初级传热元件22即浸没于该浴槽(bath)中。次级传热元件24中次级换热流体的温度(且因而冷却剂本身的温度)是通过恰当地建立散热片26的运行来建立，其中次级换热流体在闭合回路中循环或者通过其它方式与散热片26进行热接触。在非限定性实施例中，可由热电冷却器(TEC)装置、或制冷回路、抑或其它适宜的换热引擎来建立散热片26。
现在参见图3，其显示初级传热元件22及次级传热元件24的非限定性实例。从次级传热元件24开始，外护套(jacket)28使内浴槽容器30封闭，且内浴槽容器30可容纳次级换热流体32，例如乙二醇。可在浴槽容器30中形成次级换热流体供给口及返回口34、36，以使次级换热流体32经过容器30循环。在图中所示的非限定性实施例中，浴槽容器32在径向上与外护套28间隔开，以在其间建立环形的中空排放环38(即当护套28及容器30二者均为圆筒形时为环形，在这些非限定性实例性实施例中，护套28及容器30即可为圆筒形)。可如图所示在次级传热元件24的底部中形成一个或多个排放连接器40，以排放掉可能自浴槽容器30泄露出的任何次级换热流体32。
再参见初级传热元件22的非限定性实例，如图所示配置中空套管(sleeve)42，其具有相对的开口端并可呈圆筒形，以推进于外护套28与次级传热元件24的浴槽容器30之间。套管42的壁与外护套28及容器30二者间隔开，并可如图所示更靠近护套28，以用于接合可能安装于其上面的下述开关，尽管该开关也可安装于浴槽容器30上且因而套管42可配置得更靠近容器30而非更靠近护套28。
总之，在图中所示的完全接合位置上，套管42的开口底端44如图所示与次级传热元件24的底部间隔开。另一方面，套管42的顶端46覆盖有罩壳，所述罩壳包含紧紧地贴合于套管42的壁内的下部元件48，且在下部元件48的顶上，上部元件50如图所示靠在套管42的顶边上并可通过所属领域中众所周知的手段熔合到所述顶边上，例如通过胶粘、铜焊、铅焊、rf密封等等。元件48、50可相互接触并可呈圆盘形，以完全封堵套管42的顶部，但以下说明例外。初级冷却剂入口及出口管52、54贯穿罩壳的元件48、50，应了解，管52、54连接至各自的引向导管或垫的管子(例如IV型管)。
在图中所示的非限定性实施例中，每一管52、54均包含各自的中空金属接头(fitting)56及各自的中空塑料接头58，中空金属接头56贯穿罩壳的上部元件50，中空塑料接头58则接合金属接头56，以使金属接头56与管的上部管状部分相连，该上部管状部分可为塑料的。各自的金属管子60分别接合金属接头56并穿过下部罩壳元件48向下悬垂至套管42内，在套管42内与金属或高热塑性盘管62的相对端交汇。
带有相对的握耳66的塑料握把64具有用以接纳管52、54的中空的支腿68、70，其中管52、54完全贯穿握把64。每一支腿68、70均如图所示靠在罩壳的下部元件48的顶上并熔合至上部及/或下部罩壳元件50、48上。相应地，将包含盘管62的初级传热元件22、套管42、罩壳元件48、50、及握把64作为一密封的整体结构提供给最终用户。现在便可理解，由于使用塑料接头58来接合金属接头56，且使用塑料握把64及管52、54的塑料上部部分，因而至少当在初级传热元件22中不存在初级冷却剂时，可在导管或垫与次级传热元件24之间实现电隔离。
现在再关注一个或多个开关72，每一开关72均通过接地线64进行电接地(例如接至控制器的底座或接地电位)。为可靠起见，可使用不止一个开关72。总之，开关72可如图所示靠近次级传热元件24的顶部安装于护套28的内壁上，或者其可安装于浴槽容器30的外壁上，抑或次级传热元件的任一位置上，只要其能如下文所述改变位置即可。当初级传热元件22从次级传热元件24抽出至使盘管62露出次级换热流体32的程度或更大程度时，开关72便会被偏置至关闭位置，从而使护套28接地。相反，当初级传热元件22推进至次级传热元件24内足够远、从而达到使盘管62接触次级换热流体32的程度时(包括图3中所示的完全接合位置)，套管42便通过机械方式使开关72偏转至其断开位置，从而使护套28不接地，即电浮动。
应了解，本开关也可为由控制系统14、20的处理器所操纵的软件开关。例如，可在例如次级传热元件24上安装光学或磁性传感器抑或其它存在性传感器，以感测初级传热元件22何时与其接合，其中所述传感器向处理器发送信号来指示这两个元件22、24的相对位置。根据该存在性传感器信号，处理器可根据下文所述的原理而使系统接地或浮动。
更具体而言，现在针对图3所示的非限定性机械操作开关72来说明本发明，当在图3所示的运行配置中初级传热元件22完全接合次级传热元件时，开关72断开且系统如图所示电浮动。相反，当将初级传热元件22自次级传热元件24移开而暴露出次级换热流体32时，开关72闭合，且护套28(更一般地说，次级传热元件24)电接地。
根据本揭示内容，如果有人在次级换热流体32暴露时接触次级换热流体32，且出现单一电气故障，则电流将通过开关72而非通过人体分流接地。相反，当初级传热元件22在运行期间与次级传热元件24接合时(防止人们触及容器30中的浴液)，如果出现单一电气故障，则原本会通过初级冷却剂且因此通过盘管及次级换热流体而到达次级传热元件24的任何泄露电流均不会如此流动，这是因为次级传热元件24在此种状态中处于浮动状态。
尽管本文所详细显示及说明的特定“用于控制患者体温的初级换热器”完全能够实现本发明的上述目的，然而应了解，其是本发明的当前较佳的实施例且因此是本发明所广泛涵盖的标的物的代表性实施例，本发明的范畴完全囊括所属领域的技术人员所显而易见的其它实施例，且本发明的范畴相应地仅受随附权利要求书限定，除非明确指明外，在权利要求书中所提及的单数形式的元件并非旨在意指“有且仅有一个”，而是指“一个或多个”。在使一种装置或方法囊括于本权利要求书中时，不必使其解决本发明所力图解决的每一问题。而且，本揭示内容中的任何元件、组件或方法步骤均不打算献给公众，无论该元件、组件或方法步骤是否在权利要求书中明确提及。在本文中未明确界定的情况下，应赋予各项权利要求所有不会违背本说明书及文件历史的一般的、通常的意义。

Claims (7)

1.一种换热系统，其包括：
初级传热元件(22)，来自初级换热元件(12/18)的初级冷却剂经其流过；
次级传热元件(24)，其含有次级换热流体浴槽；以及
至少一个开关(72)，其在所述初级传热元件(22)未浸没于所述浴槽中时将所述次级传热元件(24)实质接地，并在所述初级传热元件(22)浸没于所述浴槽中时将所述次级传热元件(24)实质与地断开。
2.如权利要求1所述的系统，其特征在于，所述初级换热元件包括血管内的导管(12)。
3.如权利要求1所述的系统，其特征在于，所述初级换热元件包括在体外敷设于患者皮肤上的至少一个垫(18)。
4.如权利要求1所述的系统，其特征在于，所述开关(72)安装于所述次级传热元件(24)上，并在所述初级传热元件(22)处于脱开位置时被偏置至闭合位置，以将所述次级传热元件(24)接地，其中在所述脱开位置上所述初级传热元件(22)未浸没于所述浴槽中，所述开关(72)由所述初级传热元件(22)移动至断开位置，以将所述次级传热元件(24)与地断开。
5.如权利要求4所述的系统，其特征在于，所述初级传热元件(22)包括用于移动所述开关(72)的中空套管(42)。
6.如权利要求5所述的系统，其特征在于，所述套管(42)环绕使初级冷却剂从中流过的中空盘管(62)。
7.如权利要求6所述的系统，其特征在于，所述次级传热元件(24)包含护套(28)及浴槽容器(30)，所述套管(42)在所述初级传热元件(22)完全接合所述次级传热元件(24)时设置于所述护套(28)与所述浴槽容器(30)之间，所述盘管(62)设置于所述容器(30)中，所述容器(30)容纳次级换热流体。
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WO2007005073A3 (en) 2009-04-09
EP2392298B1 (en) 2016-07-13
ATE537794T1 (de) 2012-01-15
AU2006266461A1 (en) 2007-01-11
EP1899661A2 (en) 2008-03-19
WO2007005073A2 (en) 2007-01-11
EP1899661B1 (en) 2011-12-21
EP2392298A1 (en) 2011-12-07
CN101495826A (zh) 2009-07-29
EP1899661A4 (en) 2011-05-11
JP2009500066A (ja) 2009-01-08
US7181927B2 (en) 2007-02-27
DE202006021055U1 (de) 2012-02-27
US20070000278A1 (en) 2007-01-04
JP4673409B2 (ja) 2011-04-20

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