CN101262813A - 顺应性隔膜医疗感测器及其使用技法 - Google Patents

顺应性隔膜医疗感测器及其使用技法 Download PDF

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CN101262813A
CN101262813A CNA2006800335780A CN200680033578A CN101262813A CN 101262813 A CN101262813 A CN 101262813A CN A2006800335780 A CNA2006800335780 A CN A2006800335780A CN 200680033578 A CN200680033578 A CN 200680033578A CN 101262813 A CN101262813 A CN 101262813A
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sensor
coating
framework
molectron
detector
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达赖厄斯·埃格巴尔
约瑟夫·科克利
乔治·L·马特洛克
威廉·拉里丹
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Nellcor Puritan Bennett LLC
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
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    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49885—Assembling or joining with coating before or during assembling
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49888—Subsequently coating
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49947—Assembling or joining by applying separate fastener

Abstract

本发明提供一种整体感测器，其包括可在其上安置电及光学组件的框架以及涂层，例如围绕所述框架提供的包覆模制涂层。所述整体感测器包括由所述涂覆材料的薄区域形成且大体上围绕至少一个光学组件安置的一个或多个隔膜结构。所述隔膜结构允许例如通过对所述感测器的侧部施加反向力来分开所述光学组件，从而可将所述感测器放置在患者身上。由此，可将所述感测器放置在患者手指、脚趾等上以获得脉搏血氧测定或其它生理测量值。

Description

顺应性隔膜医疗感测器及其使用技法
技术领域
本发明大体来说涉及医疗装置，且更确切来说，涉及用于感测患者生理参数的感测器。
背景技术
本章节旨在向读者介绍此项技术的各个方面，这些方面可涉及本发明的各个方面，将在下文阐述并请求这些方面。相信，本论述有助于向读者提供背景信息，以便更好地理解本发明的各个方面。因此，应理解，应以此种观点来阅读这些叙述，而非作为对现有技术的认可。
在医疗领域，医生常常希望监测其患者的某些生理特征。因此，人们已开发出各种用于监测生理特征的装置。这些装置可向医生及其他保健人员提供必要的信息，从而为其患者提供尽可能好的保健。因此，此类监测装置已变成了现代医疗中不可缺少的部分。
一种用于监测患者某些生理特征的技术通常称为脉搏血氧测定法，且建立在脉搏血氧测定技术基础上的装置通常称为脉搏血氧仪。脉搏血氧测定可用来测量各种血液流动特征，例如，动脉血液中血色素的血氧饱和度、供应给组织的个人血液搏动量及/或对应于患者每一次心跳的血液搏动速率。
脉冲血氧仪通常利用非侵入式感测器，所述非侵入式感测器可放在患者的充分灌注有血液的组织上，例如，患者的手指、脚趾、前额或耳垂。脉搏血氧仪感测器会发出光，并以光电方式感测光在通过所述灌注组织后的吸收及/或散射。然后，可使用所述感测器收集到的数据以基于光的吸收或散射来计算上述一个或多个生理特征。更具体来说，通常将发出的光选择成一个或多个波长，所述一个或多个波长光的吸收或散射量与血液中存在的氧化血色素与去氧化血色素相关。然后，可使用光的吸收及/或散射量，以便使用各种算法来估计组织中的含氧量。
在很多情况下，出于成本及/或方便，可能希望使用可重复使用的脉搏血氧感测器。然而，由于各种原因，患者可能会对此类可重复使用的感测器感到不舒服。例如，其构造所使用的材料可能不具有充分的顺应性或柔软性，或者其结构特征可能包含拐角或边缘。
此外，所述可重复使用的感测器应能够充分贴身地配合，以便患者无意的动作不会移开或移动所述感测器，但不应太紧以免其可能干扰脉搏血氧测定的测量。如果医疗人员方面不加以调节或不非常注意，则可能难以在患者生理学范围上实现此种贴合配合。另外，如果没有紧的或牢固的配合，就可能让来自周围环境的光到达感测器的光检测元件。此种环境光与患者的生理特征无关，且因此，可能会将误差引入到通过感测器所获数据而得到的测量中。
可重复使用的脉搏血氧感测器还通常重复地用于不止一个患者。因此，在感测器的使用寿命中，重复使用之后，屑粒及其它生物碎屑(脱落的皮肤细胞、干掉的流体、泥土等等)可聚集在感测器的表面上或聚集在感测器的缝隙和腔体中。因此，希望能够彻底地、快速地及/或定期地清洁所述感测器。然而，在带有多部件构造的感测器中，如在可重复使用的脉搏血氧感测器中所典型，可能难以实施此种快速及/或定期的清洁。例如，此种彻底的清洁可能需要拆开感测器并对拆开的部件进行单个的清洁，或者可能需要使用能够到达感测器腔体或缝隙的器具来进行小心的清洁。此种清洁很费力，而且在普通医院或门诊环境中可能行不通。
发明内容
下文将阐述在范围上与最初请求的发明相称的某些方面。应理解，提出这些方面仅旨在向读者简短地概述本发明可能采用的某些形式，且这些方面并不旨在限制本发明的范围。本发明的确可能包括未在下文阐述的各种方面。
本发明提供一种感测器组合件，其包括：包括环形结构的框架；安置在环形结构对置侧上的发射器及检测器；及提供在所述框架上的涂层，其中所述涂层包括至少一个隔膜结构，所述至少一个隔膜结构经安置以使所述发射器及检测器中的至少一者可沿所述发射器与检测器之间延伸的轴线移动。
本发明还提供一种感测器组合件，其包括：框架；安置在所述框架上的发射器；安置在所述框架上的检测器；及至少提供在所述框架上的涂层，以形成包括至少一个隔膜结构的感测器组合件。
本发明还提供一种制造感测器的方法，其包括：将发射器及检测器定位在框架上；及用涂覆材料涂覆所述框架，以形成包括至少一个隔膜结构的感测器组合件。
本发明还提供一种用于获取生理数据的方法，其包括：从包括至少一个隔膜结构的感测器组合件中的发射器发射出两个或更多个波长的光；使用感测器组合件的光电检测器来检测透射或反射的光；及基于所检测的光来确定生理参数。
本发明还提供一种感测器组合件，其包括：包括环形结构的骨干框架；至少一个附接到所述环形结构的生理感测器；及提供在所述框架及所述至少一个生理感测器上的涂层，以形成感测器组合件。
本发明还提供一种制造感测器本体的方法，其包括：用涂覆材料涂覆骨干框架以形成包括至少一个隔膜结构的感测器本体。
本发明还提供提供一种感测器本体，其包括：框架；提供在所述框架上的涂层，以形成包括至少一个隔膜结构的感测器本体。
本发明还提供一种感测器框架，其包括：环形结构，其中所述环形结构经配置以对存在时的上覆涂层提供支撑，以使所述上覆涂层形成一个或多个隔膜结构。
本发明还提供一种制造感测器框架的方法，其包括：形成包括环形结构的框架，其中所述至少一个环形结构经配置以对存在时的上覆涂层提供支撑，以使所述上覆涂层形成一个或多个隔膜结构。
本发明还提供一种施加感测器的方法，其包括：对感测器本体的侧部施加反向力，以分开所述感测器本体的顶部及底部；及在分开感测器本体的顶部及底部的同时，将所述感测器的本体定位在患者的手指或脚趾上。
附图说明
在阅读下文详细说明并参照图式之后，本发明的优点立即可变得明了，图式中：
图1图解说明根据本发明技术各方面的患者监测系统，所述患者监测系统耦合到多参数患者监测器及感测器；
图2图解说明根据本发明技术各方面用于在患者感测器中使用的内部框架的透视图；
图3图解说明根据本发明技术各方面的图2中的内部框架处于敞开配置时的透视图；
图4图解说明根据本发明技术各方面的经包覆模制的患者感测器的透视图；
图5图解说明沿视线5-5截取的图4中的经包覆模制的患者感测器的正视图；
图6图解说明根据本发明技术各方面的图4及5中用在患者手指上的经包覆模制的患者感测器；
图7图解说明根据本发明技术各方面的图4及5中的用在患者手指上的经包覆模制的患者感测器；
图8图解说明图4中所示经包覆模制的患者感测器沿剖线8-8截取的横截面；及
图9图解说明图4中所示经包覆模制的患者感测器沿剖线9-9所截取的横截面。
具体实施方式
下文将阐述本发明的一个或多个具体实施例。为提供关于这些实施例的简明描述，并不在说明书中阐述实际实施方案的所有特征。应了解，在开发任何此种实际实施方案时，如在任何工程或设计项目中，必须作出很多与实施方案具体相关的决定以实现开发者的具体目标，例如，与系统有关及商业有关的约束条件达成一致性。不同的实施方案，约束条件有所不同。此外，应了解，此类开发工作可能较复杂且费时，然而，对于受益于本发明揭示内容的所属技术领域的技术人员，则此类开发工作则是一项设计、制造及制作的常规工作。
人们希望提供一种舒适、贴合且可重复使用的患者感测器，例如，用于脉搏血氧测定或使用分光光度测定法的应用，所述患者感测器可容易地清洁并可抵抗环境光的透过。根据本发明技术的某些方面，提供一种可重复使用的患者感测器，所述患者感测器经包覆模制以为患者提供舒适且适当的可贴合配合。所述包覆模制材料可提供对体液及水或其它清洁流体的密封，从而允许在不拆开或无需特殊工具的情况下容易地进行清洁。根据本发明技术的某些方面，所述可重复使用的患者感测器包括一个或多个隔膜区域，所述一个或多个隔膜区域可提供围绕患者手指或脚趾的膨胀及一致性，由此便于将所述感测器牢固地放在患者身上。
在详细讨论此类例示性感测器之前，应了解，此类感测器通常设计用于与患者监测系统一同使用。例如，现在参照图1，根据本发明的感测器10可与患者监测器12结合使用。在这个所示实施例中，电缆14将感测器10连接到患者监测器12。如所属技术领域的技术人员应了解，感测器10及/或电缆14可包括或包含一个或多个集成电路装置或电学装置，例如，存储器、处理器芯片或可促进或增强感测器10与患者监测器12之间通信的电阻器。同样地，电缆14也可为带有或不带有集成电路或电学装置的适配器电缆，以便促进感测器10与各类监测器(其中包括较老型号或较新型号的患者监测器12或其它生理监测器)之间的通信。在其它实施例中，感测器10及患者感测器12可经由无线构件(例如，使用无线电、红外线或光学信号)进行通信。在此类实施例中，可将传输装置(未显示)连接到感测器10以促进感测器10与患者监测器12之间的无线传输。如所属技术领域的技术人员应了解，电缆14(或对应的无线传输)通常用以将控制信号或定时信号从监测器12传输到感测器10及/或将从感测器10获取的数据传输到监测器12。然而，在某些实施例中，电缆14可为光纤，从而可在监测器12与感测器10之间传导光学信号。
在一个实施例中，患者监测器12可为适合的脉搏血氧仪，例如，可从NellcorPuritan Bennett公司处购得的脉搏血氧仪。在其它实施例中，患者监测器12可为适于使用分光光度法或其它技术来测量组织水份或其它与体液相关的度量的监测器。此外，监测器12可为多用途监测器，其可适于使用经由感测器10获取的数据来实施脉搏血氧测定及测量组织水份或生理与/或生化监测过程的其它组合。此外，为升级监测器12所提供的传统监测功能来提供额外功能，可经由连接到感测器输入端口的电缆18及/或经由连接到数字通信端口的电缆20将患者监测器12耦合到多参数患者监测器16。
在图1中所示的实例中，感测器10经包覆模制以提供整体或封闭式组合件。感测器10包括任何适合类型的发射器22及检测器24。例如，发射器22可为适于发射一个或多个波长的光的一个或多个发光二极管，例如，红外范围的红光，且检测器24可为经选择以接收发射器22发光范围内的光的光电检测器(例如，硅光二极管封装)。在所示实施例中，感测器10耦合到电缆14，所述电缆负责从感测器10的发射器22及检测器24传输电及/或光信号，且/或负责将电及/或光信号传输到感测器10的发射器22及检测器24。电缆14可永久地耦合到感测器10，或者其可以可拆卸的方式耦合到感测器10-后一种选择在感测器10为可弃式感测器的情况下更为有用及成本有效。
上述感测器10通常配置成用于分光光度法应用的“透射型”感测器，但在某些实施例中，作为另一种选择，其可配置成“反射型感测器”。透射型感测器包括通常放在感测器位置对置侧的发射器及检测器。例如，如果所述感测器位置是在指尖，则将感测器10定位在患者的指尖，以使发射器及检测器位于患者甲床的任一侧上。例如，感测器10经定位以使发射器位于患者的指甲上且使检测器对置于发射器位于患者的指垫上。在操作期间，所述发射器会闪出穿过患者指尖或其它组织的一个或多个波长的光，并处理所述检测器所接收的光以确定患者的生理特征。
反射型感测器的操作原理通常与透射型感测器相同。然而，反射型感测器包括发射器及检测器，所述发射器及检测器通常放在感测器部位的同一侧上。例如，可将反射型感测器放在患者的指尖，以使发射器及检测器并排地定位。反射型感测器可引导光子散射回到检测器。
对于使用透射或反射型感测器的脉搏血氧测定应用，可使用两个或更多个波长(最常见的是红波长和近红外波长)的光来确定患者动脉血液的血氧饱和度。类似地，在其它应用中，可使用两个或更多个波长(最为常见的是介于约1,000nm与约2,500nm之间的近红外波长)的光来测量组织水份(或其它与体液有关的度量)或水成环境中一个或多个生化组分的浓度。应理解，本文使用的术语“光”可以指红外线、可见光、紫外线或甚至X-射线电磁辐射中的一者或多者，且还可包括红外线、可见光、紫外线或X-射线波谱内的任何波长。
脉搏血氧测定感测器及其它分光光度感测器，无论是透射型还是反射型，通常都放在患者身上有助于测量所需生理参数的位置处。例如，脉搏血氧感测器通常放在患者身上通常灌注有动脉血液的位置处，以便测量所需的血液特征，例如，动脉血氧饱和度测量(SaO2)。常见的脉搏血氧测定感测器的位置包括患者指尖、趾头、前额或耳垂。无论感测器10如何放置，脉搏血氧测定测量的可靠性都与是否能够精确地检测穿过灌注组织而并未被外光源不适当增补或被皮下组织结构调制的透射光有关。此种对感测器所透射光的不适当增补及/或调制会导致在获得脉搏血氧测定测量时的可变性。
如上文所述，本文论述的包覆模制感测器10可经配置以用于透射型感测或用于反射型感测。为简单起见，本文所述感测器10的例示性实施例适于用作透射型感测器。然而，如所属技术领域的技术人员应了解，此种论述仅为例示性而并不旨在限制本发明技术的范围。
现在参照图2，其中绘示感测器10的内部框架30。在所示实例中，内部框架30是感测器10的骨干框架，其中所述框架的一部分形成为环32。此种骨干框架可包括不同的结构或区域，所述结构或区域可或可不具有类似的刚性。例如，如下文参照图3-9论述，所示骨干框架包括环形结构32及其它结构支撑件34，当被涂覆时，其界定感测器10的大体形状。从其提供功能的结构来看，可将环形结构32及结构支撑件34构造成具有很大的刚性或半刚性。另外，环形结构32被涂覆时可充当弹簧或偏置机构，如下文论述，以将感测器10偏置成所希望的形状。
另外，骨干框架可包括电缆导向装置36，在组装时，电缆(例如，电学或光导电缆)可穿过所述电缆导向装置连接到附接到发射器22及/或检测器24的电学或光学导体。同样地，骨干框架(例如，所绘示的内部框架30)可包括经由(例如)环形结构32附接到骨干框架其余部分的组件外壳，例如，发射器外壳38及检测器外壳40。环形结构32可具有相对的挠性，从而允许发射器外壳38及/或检测器外壳40彼此垂直地移动(例如，沿各自外壳的光学轴线)。
在其中内部框架30骨干框架的实施例中，各种结构支撑件34、外壳38及40、环形结构32及其它结构可在所述骨干框架的结构周围及/或之间界定各种的开口及间隔。以此方式，所述骨干框架可在具体位置处为涂层或包覆模制件提供结构支撑。然而，在没有提供结构支撑的区域中，上覆涂层或包覆模制件可具有挠性及运动自由度。例如，在一个实施方案中，如图2及3中所示，可通过挠性环形结构32将发射器外壳38及/或检测器外壳40附接到骨干框架的其余部分。在此类实施方案中，紧邻发射器外壳38及/或检测器外壳40提供的涂层60可具有充分的挠性(例如，由于骨干框架敞开区域中涂覆材料的弹性及/或厚度)，以使外壳38及40可独立于框架30的其余部分沿外壳38及40之间的光学轴线移动。
在某些实施例中，内部框架30全部或部分地由聚合物材料(例如，热塑性材料)构造而成，从而能够为内部框架30的不同部分提供适合的刚性或半刚性。此类适合材料的实例包括：聚丙烯、聚氨酯及尼龙，但其它聚合物材料也可能适合。在其它实施例中，内部框架30全部或部分地由其它具有适合刚性或半刚性材料构造而成，从而提供所需的支撑及挠性，例如，不锈钢、铝、镁、石墨、玻璃纤维或其它金属、合金或具有充分延展性及/或强度的合成物。例如，可使用适于压铸、烧结、失蜡铸造、碾压及成型以及其它金属或合成物制造工艺的金属、合金或合成物来构造内部框架30。
另外，可将内部框架30构造成一体式结构或组合结构。例如，在一个实施例中，可将内部框架30构造成由单一材料或不同材料形成的单个件。作为另一选择，内部框架30可由两个或更多个单独形成的部件构造或组装而成。在此类实施例中，不同的部件可由相同或不同的材料来形成。例如，在其中不同部件是由不同材料形成的实施方案中，每一部件可由具有适合于所述部件的机械及/或化学性质的材料构造而成。例如，相比于框架30的结构支撑件34，可将环形结构32形成为具有更大的挠性。然后，可将不同部件结合或配合在一起以形成内部框架30。
另外，可将内部框架30模制、形成或构造成不同于最终感测器配置的配置。例如，与内部框架30在折叠起来形成感测器10(如图2中所示)时的相对闭合的配置相比，可先用一个或多个件将用于感测器10中的内部框架30形成为大致敞开或扁平的配置(如图3中所示)。在此类实施例中，可将内部框架30的顶部46及底部48形成为大致敞开或平整，并通过连接部分50将进行结合。
在这个实施方案中，顶部46、底部48及连接部分50可经模制或形成为呈敞开配置的单个件。在这个实施例中，如图2中所描绘，可使连接部分50断开或变形以将顶部46及底部48变成闭合配置。在这个实施方案中，可经由(例如)搭锁配合过程将顶部46及底部48固定在一起，在所述搭锁配合过程中互补连接器52(如图3中所描绘)搭锁在一起以形成机械连接。作为另一选择，可经由其它适于附接内部框架30中各自部分的技术(例如，超声波焊接或热熔或通过施加粘合剂或机械紧固件)将顶部46及底部48固定在一起。
作为另一选择，可将内部框架30形成为可结合在一起以形成内部框架30的多个部件。例如，可单独地模制或形成顶部46及底部48，并随后将其固定在一起以形成内部框架30。可使用以上所述一种或多种技术(例如，搭锁配合工艺、超声波焊接或热熔或通过施加粘合剂或机械紧固件)来将内部框架30的不同部件结合在一起。如图2中所描绘，如果以敞开的配置将内部框架30固定在一起，则可使连接部分50断开或变形以使顶部46及底部48变成闭合配置。作为另一选择，可通过单独模制或形成的部件(例如，顶部46及底部48)将内部框架30构造成闭合配置。
如上文所述，在本发明技术的某些实施例中，如图3-9中所示，对框架30(例如，骨干内部框架)进行覆盖以形成整体感测组合件。此类包覆模制实施例可获得其中内部框架30完全或大致被涂覆的感测器组合件。在其中内部框架30形成或模制成相对敞开或扁平结构的实施例中，可在将内部框架30弯曲闭合配置之前或之后实施包覆或包覆模制过程。
例如，可通过注射模制工艺来形成感测器10。在此种工艺的一个实例中，可将内部框架30定位在感测器10所需要形状的模子或模具内。然后，可将熔融或另外未凝固的包覆模制材料注射到所述模子或模具内。例如，在一个实施方案中，将约400°F与约450°F之间的熔融热塑性弹性体注入到模具中。然后，可通过(例如)冷却一分钟或几分钟或通过化学处理来使所述包覆模制材料凝固，从而形成围绕内部框架30的感测器本体。在某些实施例中，可将其它感测器组件(例如，发射器22及/或检测器24)附接或插入到经包覆模制的感测器本体上的各自外壳或位置中。
作为另一选择，可在包覆模制之前将光学组件(例如，发射器22及检测器24)及/或导电结构(例如，导线或挠性电路)放在内部框架30上。然后，如先前所述，可将内部框架30及相关联的组件定位在模子或模具内并对其进行包覆模制。为保护发射器22、检测器24及其它电组件，可使用用于保护此类组件以免受到过高温度的常规技术。例如，发射器22及/或检测器24可包括相关联的透明窗口，例如，塑料或水晶窗口，所述透明窗口与所述模具接触以防止将涂层施加在窗口上方。在一个实施例中，与所述窗口接触的材料可由例如铍铜等材料构成，所述材料防止注射模制过程的热穿过窗口传到光学组件。例如，在一个实施例中，先在约40°F下使铍铜材料和与发射器22及/或检测器24相关联的窗口接触，以防止涂覆窗口及防止热传到各自的光学组件。如所属领域的技术人员应了解，本文所述的注射模制工艺只是其中一种可借以涂覆框架30以形成感测器本体(其带有或不带有相关联的感测组件)的技术。可使用的其它技术包括(但不限于)：将框架30浸没到熔融或另外未凝固的涂覆材料内，以用熔融或另外非凝固的涂覆材料来涂覆框架30或喷涂框架30，从而对框架30进行涂覆。在此类实施方案中，然后可通过(例如)冷却或化学手段来使涂覆材料凝固以形成所述涂层。关于此类替代技术可能涉及高温这一点，如上所述，此类替代技术可包括通过使用铍铜或其它适合材料来对任何存在的光学组件进行热保护，以防止热传过与光学组件相关联的窗口。
通过此类技术，可将框架30以及光学组件和相关联的电路系统(如果需要的话)封装在涂覆材料60内，以形成一体式或整体组合件，而不会让内部框架30有暴露的或外部的移动部件。例如，如图4及5中所描绘，感测器10包括经完全或部分包覆模制的下伏内部框架30的特征，例如，经包覆模制的外部电缆导向装置62及光学组件外壳，例如，经包覆模制的发射器外壳64及检测器外壳66。另外，经包覆模制的感测器10包括经包覆模制的上部部分68及下部部分70，可将所述上部部分及下部部分配合在手指72周围(如图6及7中所描绘)或在适当时配合到患者的脚趾或其它适合的附属肢体。
在一个实施方案中，包覆模制件或涂层60是热塑性弹性体或其它适合的涂层或材料。在此类实施例中，所述热塑性弹性体可包括例如热塑性聚烯烃、热塑性硫化橡胶合金、热塑性聚氨酯、聚硅氧烷等合成物。在一个实施例中，所述包覆模制材料是肖氏硬度为约15至约25的热塑性弹性体。如所属领域的技术人员应了解，所述包覆模制合成物可根据不同程度的挠性、一致性、耐用性、可湿性或其它所需的物理及/或化学性质而有所不同。此外，可基于涂层60施加到经包覆模制感测器本体的上部部分68及下部部分70的闭合力来选择涂覆材料60。
此外，可基于内部框架30与涂覆材料60间化学键的需要来选择涂覆材料60。对于所获包覆模制感测器10的耐用性来说，可能希望此种化学键。例如，为防止涂层60与内部框架30分开，可选择用以形成涂层60的材料，以便涂层60在包覆模制过程期间与内部框架30的某些部分或全部部分键合。在此类实施例中，涂层60与涂层60所键合到的内部框架30的若干部分是不可分离的，也就是说，其形成一个连续且大体上不可分离的结构。
此外，在其中所使用的涂层60是不渗透液体或流体的实施例中，可通过将所述感测器浸没在消毒剂或清洁溶剂中或通过(例如)流动的水来冲洗便可容易地维护、清洁及/或消毒此种感测器10。确切来说，此种经包覆模制的感测器组合件可大体或大致没有缝隙、间隙、结面或其它通常与多部件构造相关联的表面不规则特征，这些表面不规则特征通常可能会聚集生物屑粒或残留物。不存在缝隙及其它不规则特征可进一步便于感测器10的清洁及维护。
现在转到图8及9，其中绘示经由横向光学平面(其分别由图4的剖线8及9代表)截取的经涂覆的感测器组合件10的横截面。图8及9在感测器10的其它方面中绘示了包覆模制材料60以及内部框架30的下伏部分，例如，发射器外壳38及检测器外壳40，以及各自发射器22、检测器40和信号传输结构(例如，用于传导电或光信号的导线或其它结构)。在所示实施例中，发射器22及检测器24经提供与感测器10中面朝患者的表面平齐，此可能适用于脉搏血氧测定应用。对于其它的生理监测应用(例如，测量组织水份或其它与体液相关的度量)，可能希望其它的配置。例如，在此类流体测量应用中，可能希望将发射器22及检测器24的一者或两者提供成相对于感测器10中面朝患者的表面凹陷。可通过适当地配置或设计对内部框架30包覆模制时所使用的模子或模具及/或通过适当地设计内部框架30的发射器外壳38或检测器外壳40来实现此类修改。
另外，如图8及9中所示，在某些实施例中，涂覆材料60的若干部分可具有挠性，例如，围绕框架30的区域安置且旨在进行弯曲的涂覆材料60的薄区域或隔膜区域。例如，在所示实例中，经包覆模制的检测器外壳66及发射器外壳64由形成隔膜结构76的比较薄且挠性的圆盘状区域所环绕。在所述所示实施例中，对置的共轴线隔膜结构76被提供在经包覆模制的感测器10的顶部68及底部70两者上。另外，隔膜结构76可为对称，例如，圆形或椭圆结构。在对感测器10的给定保持或加持力下，此类隔膜结构76能够容纳更大范围的手指或脚趾大小。例如，在其中各自涂层38及40以挠性方式附接到框架30的其余部分的实施例中，隔膜结构76可使得发射器22及/或检测器24沿所述光学轴线彼此地弯曲或扩张开。以此方式，感测器10可容纳不同大小的手指或脚趾。例如，对于相对较小的手指或脚趾，隔膜结构76可大致上不用变形或垂直移位，且因此发射器22及/或检测器大致上不会移位。然而，对于较大的手指或脚趾，隔膜结构76可变形或移位到较大的程度以容纳所述手指或脚趾，由此也移位发射器22及/或检测器24。另外，对于中等到大的手指或脚趾，隔膜结构76也可通过增大保持力所施加的表面区域来增大将感测器保持在所述手指或脚趾上的保持作用。
此外，当隔膜结构76变形时，施加到所述手指或脚趾的力会由于隔膜结构76的变形而扩展到所述手指或脚趾的较大区域上。以此方式，在给定的垂直力下，可使所有大小的手指或脚趾受到较低的压力。因此，可获得适合的贴合配合，其中可为维持发射器22及检测器24与手指或脚趾接触而无需施加集中及/或所不希望的力量，由此改善通过手指或脚趾的血液流动。
在一个实施例中，框架30的环形结构32及/或涂覆材料60将经包覆模制的感测器10的顶部68及底部70偏置成闭合。然而，可对经包覆模制的感测器10的侧部78施加反向力，以克服所述闭合力并将顶部68及底部70移动开。作为另一选择(或另外)，可对顶部68及顶部70的朝内表面80施加反向力，以克服所述闭合力并将顶部68及底部70移动开。例如，在此所示实施例中，可将侧部78捏或挤在一起，以克服框架30及涂覆材料60所提供的闭合力从而将顶部68及底部70分开。可通过对顶部68及底部70的朝内表面80施加反向力(例如，用手施加)可促进(或替代)所述过程，从而将顶部68及底部70分开。以此方式，便可敞开包含内部框架30的患者感测器10以将其放在患者手指、脚趾或其它附件上。
在图8及9中所示的实例中，所述包覆模制材料的侧部78可促进使环境或周围的光不进入感测器10的内部。以此方式，侧部78可帮助防止或减少检测到来自外界环境的光，否则这些光可能被感测器10不正确地检测为与SaO2相关。因此，脉搏血氧测定感测器可检测到与基础SaO2水平无关的信号调制差。此本身也可能影响红对红外调制比，且因此影响所测量的血氧饱和度(SpO2)值。因此，感测器10及侧部78的配合一致性可帮助防止或减少此类误差。
虽然前述实例涉及感测器10的对置面上提供有两个对置隔膜结构76的实施例，但本发明也涵盖其它实施例。例如，在一个替代实施例中，将单个隔膜结构76提供在顶部68或底部70上，其中所述对置部分相比于所述含有隔膜的部分具有相对较大的刚性。在这一实施例中，如上所述，所述含有隔膜的部分会回应于反向的侧部力而弯曲，以便在施加到患者身上时提供适合的及舒适的配合。
虽然本文论述的例示性医疗感测器10是某些关于经包覆模制或经涂覆的医疗装置，但本发明也涵盖其它此类装置且其它此类装置归属于本发明范围。例如，有利地，可使用本文论述的经包覆模制感测器本体来施加其它外部施加于患者的医疗感测器及/或接触装置。此类感测器或接触装置的实例可包括葡萄糖监测器或其它通常保持成毗邻于患者皮肤从而需要一种适合的及舒适的配合的感测器或接触装置。类似地，且如上所述，用于测量组织水份或与其它体液相关的度量的装置可使用本文所述的感测器。同样地，其它其中将探针附接到患者的分光光度法应用也可使用本文所述的感测器。
虽然易于对本发明作出各种修改及替代形式，但本文是以实例的方式在图式中显示特定实施例并对其进行了详细阐述。然而，应理解，本发明并非旨在限制于本文所揭示的具体形式。相反，本发明旨在覆盖属于以下随附权利要求书中所定义的本发明精神及范围内的所有修改、等效形式及替代方案。确实，本发明技术不仅可应用于透射型感测器，而且还可应用于反曲以及其它感测器设计。同样地，本发明并非局限于使用在手指及脚趾上，而还可应用于放在身体其它部位，例如在配置用于使用在耳朵或鼻子上的实施例中。

Claims (20)

1、一种感测器组合件，其包括：
框架，其包括环形结构；
发射器及检测器，其安置在所述环形结构的对置侧上；及
在所述框架上提供的涂层，其中所述涂层包括至少一个隔膜结构，所述至少一个隔膜结构经安置以使所述发射器及所述检测器中的至少一者可沿着所述发射器与所述检测器之间延伸的轴线移动。
2、如权利要求1所述的感测器组合件，其中所述发射器包括发光二极管。
3、如权利要求1所述的感测器组合件，其中所述检测器包括光电检测器。
4、如权利要求1所述的感测器组合件，其中所述涂层包括围绕所述发射器安置的第一隔膜结构及围绕所述检测器安置的第二隔膜结构。
5、如权利要求1所述的感测器组合件，其中所述感测器组合件包括脉搏血氧测定感测器、用于测量水份的感测器或其组合中的至少一者。
6、如权利要求1所述的感测器组合件，其中所述框架包括单个模制部件。
7、如权利要求1所述的感测器组合件，其中所述框架包括经结合以形成所述框架的两个或更多个部件。
8、如权利要求1所述的感测器组合件，其中所述涂层包括热塑性弹性体。
9、如权利要求8所述的感测器组合件，其中所述热塑性弹性体包括热塑性聚烯烃、热塑性硫化橡胶合金、热塑性聚氨酯、聚硅氧烷或其组合中的至少一者。
10、如权利要求1所述的感测器组合件，其中所述涂层包括适合的材料。
11、如权利要求1所述的感测器组合件，其中所述框架的移动部件不从所述涂层暴露出。
12、一种感测器组合件，其包括：
框架；
发射器，其安置在所述框架上；
检测器，其安置在所述框架上；及
涂层，其至少提供在所述框架上以形成包括至少一个隔膜结构的感测器组合件。
13、一种制造感测器的方法，其包括：
将发射器及检测器定位在框架上；及
用涂覆材料涂覆所述框架以形成包括至少一个隔膜结构的感测器组合件。
14、一种用于获取生理数据的方法，其包括：
从包括至少一个隔膜结构的感测器组合件的发射器发射两个或更多个波长的光；
使用所述感测器组合件的光电检测器检测所透射或反射的光；及
基于所述检测的光来确定生理参数。
15、一种感测器组合件，其包括：
骨干框架，其包括环形结构；
至少一个生理感测器，其附接到所述环形结构；及
涂层，其提供在所述框架及所述至少一个生理感测器上以形成感测器组合件。
16、一种制造感测器本体的方法，其包括：
用涂覆材料涂覆骨干框架以形成包括至少一个隔膜结构的感测器本体。
17、一种感测器本体，其包括：
框架；及
涂层，其提供在所述框架上以形成包括至少一个隔膜结构的感测器本体。
18、一种感测器框架，其包括：
环形结构，其中所述环形结构经配置以对存在时的上覆涂层提供支撑，以由所述上覆涂层形成一个或多个隔膜结构。
19、一种用于制造感测器框架的方法，其包括：
形成包括环形结构的框架，其中至少一个环形结构经配置以对存在时的上覆涂层提供支撑，以由所述上覆涂层形成一个或多个隔膜结构。
20、一种应用感测器的方法，其包括：
对感测器本体的侧部施加反向力，以便分开所述感测器本体的顶部及底部；及
在分开所述感测器本体的所述顶部及所述底部的同时，将所述感测器本体定位在患者的手指或脚趾上。
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US7574244B2 (en) 2009-08-11

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