CN101257839A - 医用传感器及其使用技术 - Google Patents
医用传感器及其使用技术 Download PDFInfo
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Abstract
本发明提供一种整体传感器，其包含：框架，电气和光学组件可安置在所述框架上；以及涂层，例如围绕所述框架提供的包覆模制涂层。所述整体传感器包含提供在所述框架上的弹簧，例如片簧或扭簧，所述弹簧为所述传感器提供闭合力。所述传感器可放置在患者的手指、脚趾、耳朵等上，以获得脉冲血氧定量法或其它生理测量值。
Description
技术领域
本发明大体上涉及医用装置，且更明确地说，涉及用于感测患者的生理参数的传感器。
背景技术
这一部分旨在向读者介绍可能与下文描述且/或主张的本发明的各个方面有关的此项技术的各个方面。相信这一论述内容有助于向读者提供背景信息，以促进对本发明的各个方面的更好理解。因此，应了解，将依此阅读这些陈述，且不作为对现有技术的承认。
在医学领域中，医生常常需要监视其患者的某些生理特征。因此，已经研发了各种各样的装置来监视生理特征。此类装置向医生和其它保健人员提供他们需要的信息以便为他们的患者提供最佳可能的保健。因此，此类监视装置已经成为现代医学不可缺少的一部分。
一种用来监视患者的某些生理特征的技术通常被称为脉冲血氧定量法，且基于脉冲血氧定量法技术而建立的装置通常被称为脉冲血氧计。脉冲血氧定量法可用来测量各种血流特征，例如动脉血中血红蛋白的血氧饱和度、供应给组织的单个血液脉动的体积和/或对应于患者每次心跳的血液脉动率。
脉冲血氧计通常利用非侵入性传感器，其放置在患者的良好布满血液的组织上或抵靠所述组织而放置，所述组织例如为患者的手指、脚趾、前额或耳垂。脉冲血氧计传感器发射光，并以光电方式感测穿过经布满组织之后的光的吸收和/或散射。接着可基于光的吸收或散射，使用传感器所收集到的数据来计算上述生理特征中的一者或一者以上。更具体地说，所发射的光通常被选择为具有一个或一个以上波长，吸收或散射与血液中的含氧对缺氧血红蛋白的存在有关的量的所述波长。接着，可通过使用各种算法，使用被吸收和/或散射的光的量来估计组织中的氧的量。
在许多情况下，出于成本和/或方便性的考虑，可能需要利用可重复使用的脉冲血氧计传感器。然而，由于各种原因，此类可重复使用的传感器可能使患者感到不舒服。举例来说，所述传感器的构造中所使用的材料可能不够温顺或柔软，或结构特征可能包含角度或边缘。
此外，可重复使用的传感器应足够贴身地配合，使得患者的偶然动作不会使传感器移位或移动，但又不会紧到可能干扰脉冲血氧定量法测量。在没有医务人员方面的调整或过多关注的情况下，这种符合要求的配合在患者生理学范围内可能难以实现。另外，缺乏紧密或安全配合可能允许来自环境的光到达传感器的光电检测元件。此类环境光与患者的生理特征无关，且因此可能将误差引入到使用由所述传感器获得的数据而得到的测量值中。
可重复使用的脉冲血氧计传感器还被重复地且通常对一个以上患者使用。因此，在传感器的使用寿命期间，在被重复使用之后，碎屑和其它生物碎屑(从皮肤细胞脱落的物质、变干的流体、污垢等等)可能累积在传感器的表面上或传感器的缝隙和腔中。因此，可能需要彻底地快速且/或定期清洗传感器。然而，在具有多部分构造的传感器(如在可重复使用的脉冲血氧计传感器中是典型情况的那样)中，可能难以执行这种快速和/或定期清洗。举例来说，此类彻底清洗可能要求拆卸传感器，并个别地清洗所拆卸的部分，或可能要求使用能够进入传感器的腔或缝隙中的器具仔细地清洗。此类清洗是耗费人力的，且在典型的医院或诊所环境中可能并不实用。
发明内容
下文陈述在范围方面与起初主张的本发明相称的某些方面。应了解，仅仅是为了向读者提供本发明可能采取的某些形式的简要概述而呈现这些方面，且这些方面无意限制本发明的范围。实际上，本发明可包含下文可能未陈述的多个方面。
提供一种传感器组合件，其包含：框架，其包括两个或两个以上结构支撑件；涂层，其提供在所述框架上，其中所述涂层包括安置在所述两个或两个以上结构支撑件之间的至少一个可变形区域；至少一个光学组件，其安置在所述至少一个可变形区域内，使得所述至少一个光学组件可相对于所述两个或两个以上结构支撑件移动；以及偏置组件，其附接到所述框架的一端，使得在没有足够的打开力的情况下，经涂覆框架的至少两个不同部分经偏置闭合。
还提供一种传感器组合件，其包含：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；偏置组件，其附接到所述框架的一端；以及涂层，其至少提供在所述框架上，以形成传感器组合件。
还提供一种传感器组合件，其包含：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；以及涂层，其至少提供在所述框架上，以形成传感器组合件，其中所述涂层提供闭合力，在没有反作用力的情况下，所述闭合力用以闭合所述传感器组合件的一端。
还提供一种制造传感器的方法，其包含：使发射器和检测器位于骨架框架上；以及用涂覆材料涂覆所述骨架框架，以形成整体传感器组合件。
还提供一种用于获取生理数据的方法，其包含：从夹到患者身上的整体传感器组合件的发射器发射两个或两个以上波长的光，其中所述整体传感器组合件包括包覆模制骨架框架；使用所述整体传感器组合件的光电检测器来检测所透射或反射的光；以及基于检测到的光来确定生理参数。
还提供一种传感器组合件，其包含：骨架框架，其包括经配置以相对于彼此而移动的至少一第一部分和一第二部分；附接到所述框架的至少一个生理传感器；以及涂层，其提供在所述框架和所述至少一个生理传感器上，以形成传感器组合件。
还提供一种制造传感器主体的方法，其包含：用涂覆材料来涂覆骨架框架以形成传感器主体。
还提供一种传感器主体，其包含：框架；偏置组件，其附接到所述框架；以及涂层，其提供在所述框架和所述偏置组件上，以形成传感器主体。
还提供一种传感器主体，其包含：框架；以及涂层，其提供在所述框架上，以形成传感器组合件，其中所述涂层提供闭合力，在没有反作用力的情况下，所述闭合力用以闭合所述传感器组合件的一端。
还提供一种传感器的骨架框架，其包含：两个或两个以上结构支撑部件，在所述两个或两个以上结构支撑部件之间具有一个或一个以上空间，其中所述两个或两个以上结构支撑部件经配置以向上覆涂层(在存在时)提供支撑。
还提供一种用于制造传感器的骨架框架的方法，其包含：形成传感器的骨架框架的两个或两个以上结构支撑部件，在所述两个或两个以上结构支撑部件之间具有一个或一个以上空间，其中所述两个或两个以上结构支撑部件经配置以向上覆涂层(在存在时)提供支撑。
附图说明
在阅读以下详细描述内容之后且在参看附图之后，本发明的优势可能变得明显，在附图中：
图1根据本技术的方面说明耦合到多参数患者监视器和传感器的患者监视系统；
图2根据本技术的方面说明用于患者传感器中的内部框架的透视图；
图3根据本技术的方面说明图2的呈闭合配置的内部框架的透视图；
图4A说明图3的内部框架的侧视图；
图4B根据本技术的方面说明与图2到图4A的内部框架一起使用的片簧；
图5A根据本技术的方面说明用于患者传感器中的另一内部框架的侧视图；
图5B根据本技术的方面说明与图5A的内部框架一起使用的扭簧；
图6根据本技术的方面说明包覆模制患者传感器的透视图；
图7根据本技术的方面说明图6的正用于患者的手指上的包覆模制患者传感器；
图8说明沿图6中所描绘的包覆模制患者传感器的剖面线8-8截取的横截面；以及
图9说明沿图6中所描绘的包覆模制患者传感器的剖面线9-9截取的横截面。
具体实施方式
下文将描述本发明的一个或一个以上特定实施例。为了提供这些实施例的简明描述，本说明书中未描述实际实施方案的所有特征。应了解，在任何此类实际实施方案的研发中，如在任何工程或设计项目中，必须作出大量实施方案特定的决策，以实现研发者的特定目标，例如符合与系统有关和与商业有关的约束条件，所述约束条件可能对于不同实施方案而具有变化。此外，应了解，此类研发工作可能是复杂且耗费时间的，但对受益于本发明的所属领域的技术人员来说，将是常规的设计、生产和制造任务。
需要提供一种舒适的和适合的可重复使用的患者传感器，例如用于脉冲血氧定量法或利用分光光度测定法的其它应用中，所述患者传感器容易清洗，且抵制环境光渗入。根据本技术的一些方面，提供一种可重复使用的患者传感器，其经包覆模制以向患者提供舒适和相称适合的配合。包覆模制材料提供防体液以及水或其它清洗流体的密封件，其允许在无拆卸或特殊工具的情况下，容易地进行清洗。根据本技术的一些方面，可重复使用的患者传感器包含提供偏置力的机构(例如金属片簧或扭簧)，以有助于将传感器安全地放置在患者身上。
在详细论述此类示范性传感器之前，应了解，此类传感器通常被设计成与患者监视系统一起使用。举例来说，现参看图1，根据本发明的传感器10可结合患者监视器12而使用。在所描绘的实施例中，电缆14将传感器10连接到患者监视器12。如所属领域的技术人员将了解，传感器10和/或电缆14可包含或并入有一个或一个以上集成电路装置或电气装置，例如存储器、处理器芯片或电阻器，其可有助于或增强传感器10与患者监视器12之间的通信。同样，电缆14可以是适配器电缆(具有或不具有集成电路或电气装置)，用于有助于传感器10与各种类型的监视器(包含较老或较新版本的患者监视器12或其它生理监视器)之间的通信。在其它实施例中，传感器10和患者监视器12可经由无线手段(例如无线电、红外线或光学信号)通信。在此些实施例中，传输装置(未图示)可连接到传感器10，以促进传感器10与患者监视器12之间的无线传输。如所属领域的技术人员将了解，电缆14(或对应的无线传输)通常用来将控制或定时信号从监视器12传输到传感器10，且/或用来将所获取的数据从传感器10传输到监视器12。然而，在一些实施例中，电缆14可以是光纤，其允许光学信号在监视器12与传感器10之间传导。
在一个实施例中，患者监视器12可能是合适的脉冲血氧计，例如那些可从NellcorPuritan Bennett Inc得到的脉冲血氧计。在其它实施例中，患者监视器12可以是适合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有关的度量的监视器。此外，监视器12可以是适合使用经由传感器10获取的数据来执行脉冲血氧定量法和组织水份的测量，或生理和/或生物化学监视过程的其它组合的多用途监视器。此外，为了升级监视器12所提供的常规监视功能以便提供额外功能，患者监视器12可经由连接到传感器输入端口的电缆18且/或经由连接到数字通信端口的电缆20而耦合到多参数患者监视器16。
在图1中所描绘的实例中，传感器10是经包覆模制以提供整体或封闭式组合件的夹式传感器。传感器10包含发射器22和检测器24，其可为任何合适类型。举例来说，发射器22可以是一个或一个以上发光二极管，其适合于传输一个或一个以上波长的光(例如在红光到红外线范围内)，且检测器24可以是光电检测器(例如硅光电二极管封装)，其被选择为接收从发射器22发射的范围内的光。在所描绘的实施例中，传感器10耦合到电缆14，电缆14负责将电和/或光学信号传输到传感器10的发射器22和检测器24，且传输来自传感器10的发射器22和检测器24的电和/或光学信号。电缆14可永久地耦合到传感器10，或电缆14可以可移除地耦合到传感器10，在传感器10是一次性的情况下，后一种替代方案更有用且更经济。
上文所述的传感器10通常经配置以用作用于分光光度法应用中的“透射型”传感器，尽管在一些实施例中，其可代替地经配置以用作“反射型传感器”。透射型传感器包含通常放置在传感器定位点的相对侧上的发射器和检测器。如果传感器定位点是(例如)指尖，那么将传感器10定位在患者的指尖上，使得发射器和检测器位于患者指甲床的任一侧。举例来说，传感器10经定位以使得发射器位于患者的指甲上，且检测器与发射器相对地位于患者的指垫上。在操作期间，发射器发出一个或一个以上波长的光穿过患者的指尖或其它组织，且检测器接收到的光经处理以确定患者的各种生理特征。
反射型传感器大体上在与透射型传感器相同的一般原理下操作。然而，反射型传感器包含通常放置在传感器定位点的同一侧上的发射器和检测器。举例来说，反射型传感器可放置在患者的指尖上，使得发射器和检测器并排定位。反射型传感器检测散射回到检测器的可见光子(light photon)。
对于使用透射型或反射型传感器的脉冲血氧定量法应用来说，可使用两个或两个以上波长(最常见的是红光和近红外线波长)的光来确定患者动脉血的氧饱和度。类似地，在其它应用中，可使用两个或两个以上波长(最常见的是在约1,000nm到约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量度)或一种或一种以上生物化学成分在水相环境中的浓度。应了解，如本文所使用，术语“光”可指红外线、可见光、紫外线或甚至X射线电磁辐射中的一种或一种以上，且还可包含红外线、可见光、紫外线或X射线光谱内的任何波长。
脉冲血氧定量法和其它分光光度法传感器(不管是透射型还是反射型)通常放置在患者身上有助于测量所需生理参数的位置中。举例来说，脉冲血氧定量法传感器通常放置在患者身上一般布满动脉血的位置中，以有助于测量所需的血液特征(例如，动脉氧饱和度测量值(SaO2))。常见的脉冲血氧定量法传感器定位点包含患者的指尖、脚趾、前额或耳垂。不管传感器10的位置如何，脉冲血氧定量法测量的可靠性与对已经穿过灌注组织且尚未不适当地由外部光源补充或由皮下解剖结构调制的透射光的准确检测有关。由传感器发射的光的此类不适当的补充和/或调制可能导致最终的脉冲血氧定量法测量值中的可变性。
如上文所述，本文所论述的包覆模制传感器10可经配置以用于透射型或反射型感测。为了简单起见，本文所描述的传感器10的示范性实施例适合用作透射型传感器。然而，如所属领域的技术人员将了解，此类论述内容仅仅是示范性的，且并非意欲本技术的范围。
现参看图2，描绘传感器10的内部框架26。在所描绘的实例中，内部框架26是传感器10的骨架框架。此类骨架框架可包含不同结构或区域，所述结构和区域可以或可以不具有类似刚性。
举例来说，所描绘的骨架框架包含在涂覆时界定传感器10的大体形状的结构支撑件28，如下文关于图6到图9所论述。鉴于其结构提供的功能，结构支撑件28可被构造成大致刚性或半刚性。另外，骨架框架可包含电缆导管32，电缆(例如电气或光学电缆)可穿过电缆导管32，以连接到组装后附接到发射器22和/或检测器24的电气或光学导体。同样，骨架框架(例如，所描绘的内部框架26)可包含：组件外壳，例如发射器外壳38和检测器外壳40；以及支杆42，其将所述外壳附接到骨架框架的其余部分。支杆42可以是相对柔性的，从而允许发射器外壳38和/或检测器外壳40相对于骨架框架的结构支撑件28(例如沿着相应外壳之间的光轴)垂直移动。或者，在其中支杆42是相对刚性的，其中使用多个支杆42来将外壳38和40附接到结构支撑件28，或其中内部框架实质上是实心的而不是骨架的实施例中，外壳38和/或40可相对于相应的结构支撑件28而固定，且因此与结构支撑件28一起移动。
在内部框架26是骨架的实施例中，各个结构支撑件28、外壳38和40、支杆42和其它结构可在骨架框架的结构之间且/或围绕所述结构界定各种开口和空间。以此方式，骨架框架在特定位置处为涂层或包覆模制层提供结构支撑。然而，在未提供结构支撑的区域中，上覆涂层或包覆模制层中的柔性和运动自由度是可能的。举例来说，在一个实施方案中，发射器外壳38和/或检测器外壳40可通过柔性支杆42附接到骨架框架的其余部分，如图2到图4中所描绘。在此类实施方案中，接近发射器外壳38和/或检测器外壳40而提供的涂层可具有足够的柔性(例如由于骨架框架的开口区域中的涂覆材料的弹性和/或薄度的缘故)，以使得外壳38和40可独立于框架26的结构支撑件28而沿着外壳38与40之间的光轴移动。
在某些实施例中，内部框架26整体地或部分地由能够为内部框架26的不同部分提供合适的刚性或半刚性的聚合材料(例如热塑塑料)构造。此类合适材料的实例包含聚丙烯和尼龙，尽管其它聚合材料也可能是合适的。举例来说，在一个实施例中，内部框架26由硬度为65Shore D的聚氨脂构造。在其它实施例中，内部框架26整体地或部分地由其它合适刚性或半刚性材料构造，例如不锈钢、铝、镁、石墨、玻璃纤维或其它金属、合金或具有足够可延展性和/或坚固的组合物。举例来说，可使用金属、合金或适合压铸、烧结、熔模铸造、冲压和成形的组合物以及其它金属或组合物制造过程来构造内部框架26。
另外，可将内部框架26构造为一体式结构或构造为复合结构。举例来说，在一个实施例中，内部框架26可由单种材料或由不同材料构造为单件。或者，内部框架26可由单独成形的两个或两个以上部分构造或组装。在此类实施例中，所述不同部分可由相同或不同材料形成。举例来说，在不同部分由不同材料形成的实施方案中，每个部分可由具有用于所述部分的合适机械和/或化学特性的材料构造而成。接着，不同部分可接合或配合在一起，以形成内部框架26。
另外，内部框架26可以与最终传感器配置不同的配置进行模制、成形或构造。举例来说，现参看图2，用于传感器10中的内部框架26与经折叠以形成传感器10时的内部框架26的相对闭合配合相比，最初可以大体上打开或平坦的配置形成。在此类实施例中，框架26的顶部46和底部48可以大体上打开或平面配置形成，其中两个部分46和48由连接部分50连接。
举例来说，在打开配置中，顶部46、底部48和连接部分50可模制或形成为单件。在此类实施例中，连接部分50可分开或变形以使顶部46和底部48进入闭合配置，如图3、图4A和图5A中所描绘。在此实施方案中，顶部46和底部48可(例如)经由搭扣配合工艺、超声波焊接或热熔或通过施加粘合剂或机械紧固件而固定在一起。
或者，内部框架26可形成为多个部分，所述部分接合在一起以形成内部框架26。举例来说，顶部46、底部48、突出部52和/或连接部分50可单独模制或成形，且随后固定在一起以形成内部框架26。可使用上文所述的技术中的一种或一种以上，例如搭扣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，来使内部框架26的不同部分接合在一起。如果内部框架26以打开配置固定在一起，那么连接部分50可分开或变形，以使顶部46和底部48进入闭合配置，如图3、图4A和图5A中所描绘。或者，内部框架26可由单独模制或成形的部分(例如顶部46、底部48和/或突出部52)以闭合配置构造。
在某些实施例中，内部框架26与弹簧或其它偏置组件(例如成形的片簧58(如图3、图4A和图4B中所描绘)或扭簧60(如图5A和图5B中所描绘))配合。如所属领域的技术人员将了解，此类偏置组件可包含弹性体或装置，其可扭曲，且当在扭曲之后释放时恢复其原始形状。类似地，可存储能量并释放所述能量以提供夹持力(如本文所描述)的组件或材料可充当弹簧或偏置组件。举例来说，如关于图6到图9所论述，在具有或不具有例如片簧58或扭簧60的组件所提供的额外夹持力的情况下，包覆模制材料或组合物可具有足够的弹性以充当如本文所论述的偏置组件。然而，出于此实例的目的，传感器10具备且被论述为包含片簧58(在图3和图4A中)或扭簧60(在图5A中)。
参看图3和图4A，片簧58配合在内部框架26与手指、脚趾或其它患者附器插入到经组装传感器中的位置相对的端部处或附近。在替代实施例中，片簧58连接内部框架26的两个不同部分或半部，以形成内部框架26。在所描绘的实施例中，在内部框架26中提供槽64，其由互补的弹簧突出部66啮合，以使片簧58配合到内部框架26。举例来说，在内部框架26被模制或形成为相对打开的单件(如图2中所描绘)的实施例中，内部框架26可从相对打开配置弯曲到闭合配置，如图3和图4A中所描绘。当在闭合配置中时，片簧58可配合或附接到内部框架26，以提供使内部框架26维持在闭合配置中的偏置力。现参看图5A，当在闭合配置中时，扭簧60可类似地配合或附接到内部框架26，以提供使内部框架26维持在闭合配置中的偏置力。
片簧58或扭簧60可由提供所需的弹性和夹紧力的多种材料或材料组合构造。举例来说，在某些实施例中，片簧58或扭簧60可由金属合金(例如不锈钢)构造。在一个此类不锈钢片簧实施例中，片簧58可由301高良率不锈钢制成，所述不锈钢的厚度为0.010英寸，且在手指垫间隔为约15mm的情况下，在光轴面(其为穿过发射器22和检测器24的平面)处产生约1.25磅的力。在其它实施例中，片簧58或扭簧60可由例如塑料、聚合物、复合物等提供所需弹力和弹性的材料构造。
可通过施加力使内部框架26的顶部46和底部48分开，来使并入有安置在内部框架26上的片簧58、扭簧60或其它偏置组件的包覆模制传感器10(如关于图6到图9所论述)打开，以放置在患者的手指、脚趾、耳朵或其它附器上。举例来说，片簧58(在图3和图4A中)或扭簧60(在图5A中)提供或有助于使框架26的顶部46和底部48偏置在一起的闭合力。然而，可施加反作用力，以迫使顶部46和底部48分开。在所描绘的实例中，可对提供在内部框架26的片簧58或扭簧60所配合的端部处的突起(例如突出部52)施加反作用力，以便克服相应弹簧所提供的力。以此方式，突出部52彼此面向地移动，而顶部46和底部48彼此分开地移动。
如上文所述，在本技术的某些实施例中，对框架26(例如骨架内部框架)进行涂覆，以形成整体或一体式传感器组合件，如图6到图9中所描绘。此类包覆模制实施例可产生内部框架26完全或大致被涂覆的传感器组合件。在内部框架26形成或模制为相对打开或平坦结构的实施例中，可在将内部框架26弯曲到闭合配置中之前或之后执行包覆模制或涂覆工艺。
举例来说，传感器10可由注射模制工艺形成。在这种工艺的一个实例中，内部框架26可定位在传感器10的所需形状的塑模或铸模内。接着，可将熔融的或以其它方式未凝固的包覆模制材料注射到塑模或铸模中。举例来说，在一个实施方案中，将温度在约400°F到约450°F的熔融热塑性弹性体注射到铸模中。接着，可(例如)通过冷却一分钟或一分钟以上或通过化学处理来使包覆模制材料凝固，以形成围绕内部框架26的传感器主体。在某些实施例中，其它传感器组件(例如发射器22和/或检测器24)可附接或插入到包覆模制的传感器主体上的其相应外壳或位置中。
或者，在包覆模制之前，可将光学组件(例如发射器22和检测器24)和/或传导结构(例如导线或柔性电路)放置在内部框架26上。接着，可将内部框架26和相关联的组件定位在塑模或铸模内，并对其进行包覆模制，如先前所描述。为了保护发射器22、检测器24和/或其它电气组件，可使用用于保护此类组件免受过高温度破坏的常规技术。举例来说，发射器22和/或检测器24可包含相关联的清除窗，例如塑料或晶体窗，其与铸模接触以防止涂层被施加到所述窗上。在一个实施例中，与此类窗接触的材料可包含例如铍铜的材料，其防止注射模制工艺的热量穿过所述窗而传递到光学组件。举例来说，在一个实施例中，温度起初为约40°F的铍铜材料与和发射器22和/或检测器24相关联的窗接触，以防止所述窗的涂层和热量转移到相应的光学组件。如所属领域的技术人员将了解，本文所述的注射模制工艺仅仅是一种在具有或不具有相关联的感测组件的情况下，可借此涂覆框架26以形成传感器主体的技术。可使用的其它技术包含(但不限于)：将框架26浸入熔融或以其它方式未凝固的涂覆材料中以涂覆框架26，或用熔融或以其它方式未凝固的涂覆材料喷涂框架26以涂覆框架26。在此类实施方案中，涂覆材料可随后(例如)通过冷却或化学手段凝固以形成涂层。此类替代技术(就其可能涉及高温来说)可(例如)通过使用铍铜或其它合适材料以防止热量转移穿过与光学组件相关联的窗(如上文所论述)，来热保护所存在的任何光学组件。
通过此类技术，框架26以及光学组件和相关联的电路(在需要的情况下)可被包入涂覆材料68中，以形成一体式或整体组合件，而不具有内部框架26的暴露或外部移动部分。举例来说，如图6中所描绘，传感器10包含下伏内部框架26的现在完全或部分包覆模制的特征，例如包覆模制的外部电缆导管70、突出部72、发射器外壳74和检测器外壳76。另外，包覆模制的传感器10包含包覆模制的顶部78和底部80，其可配合到患者的手指82(如图7中所描绘)，或在适当时配合到患者的脚趾、耳朵或其它附器。
在一个实施方案中，包覆模制层或涂层68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，热塑性弹性体可能包含例如热塑性聚烯烃、热塑性硫化产品合金、硅酮、热塑性聚氨脂等组合物。在一个实施例中，包覆模制材料是硬度为15Shore A的聚氨脂。如所属领域的技术人员将了解，依据所需要的贴合性、耐用性、可湿性或其它物理和/或化学特性的不同程度，包覆模制组合物可变化。此外，涂覆材料68可被选择为向偏置组件(例如片簧58或扭簧60)所提供的弹簧力提供额外的弹簧力。
此外，可基于内部框架26与涂覆材料68之间的化学结合的合意性来选择涂覆材料68。此类化学结合对所得的包覆模制传感器10的耐用性来说可能是合意的。举例来说，为了防止涂层68与内部框架26分离，用来形成涂层68的材料可经选择以使得在包覆模制工艺期间，涂层68与一些或所有内部框架26结合。在此类实施例中，涂层68和内部框架26的与涂层68结合的部分是不可分离的，即它们形成一个连续且大体上不可分离的结构。
此外，在所使用的涂层68是不透液体或流体的实施例中，可通过将传感器浸没到消毒剂或清洗溶液中或通过冲洗传感器10(例如在流水下)，而容易地维护、清洗此类传感器10且/或给此类传感器10消毒。具体地说，此类包覆模制传感器组合件可大体上或实质上不含缝隙、间隙、接合处或其它通常与一般可能允许累积生物碎屑或残留物的多部分构造相关联的表面不规则性。这样不存在缝隙和其它不规则性可进一步有助于传感器10的清洗和护理。
现转到图8和图9，描绘通过分别由图6的剖面线8和9表示的横向光学平面截取的经涂覆传感器组合件10的横截面。图8和图9描绘(在传感器10的其它方面中)包覆模制材料68以及内部框架26的下伏部分，例如发射器外壳38和检测器外壳40，以及相应的发射器22、检测器24，和信号传输结构(例如布线83或用于传导电或光学信号的其它结构)。在所描绘的实施例中，提供发射器22和检测器24，使其实质上与传感器10的患者面向的表面齐平，如可适合于脉冲血氧定量法应用。对于其它生理监视应用，例如测量组织水份或其它与体液有关的量度的应用，其它配置可能是需要的。举例来说，在此类流体测量应用中，可能需要提供相对于传感器10的患者面向的表面凹进的发射器22和检测器24中的一者或两者。可通过适当地配置或设计用于包覆模制内部框架26中的铸模或塑模，且/或通过适当地设计内部框架26的发射器外壳38或检测器外壳40来实现所述修改。
另外，如图8和图9中所描绘，在某些实施例中，涂覆材料68的部分84可以是柔性的，例如安置在骨架框架的结构支撑件28之间的涂覆材料68的较薄或膜状区域。此类柔性区域84允许针对传感器10的给定保持或夹持力而容纳较大范围的手指脚趾尺寸。举例来说，在相应的外壳38和40柔性地附接到框架26的其余部分的实施例中，柔性区域84可允许发射器22和/或检测器24沿光轴挠曲或彼此扩展分开。以此方式，传感器10可容纳不同尺寸的手指脚趾。举例来说，对于相对较小的手指脚趾，柔性区域84可实质上不变形或垂直移位，且因此发射器22和/或检测器24也实质上不移位。然而，对于较大的手指脚趾，柔性区域84可较大程度地变形或移位，以容纳所述手指脚趾，从而也使发射器22和/或检测器24移位。另外，对于中等到较大的手指脚趾，柔性区域84还可通过增加施加保持力的表面积来增加传感器10作用在手指脚趾上的保持力。
此外，当柔性区域84变形时，施加到手指脚趾的力由于柔性区域84变形的缘故而在手指脚趾上的较大面积上扩散开。以此方式，可针对给定的垂直力在所有尺寸的手指脚趾上提供较低的压力。因此，可获得合适的贴合配合，其中发射器22和检测器24保持与手指脚趾接触而不施加集中且/或不合需要量的力，从而改善经由手指脚趾的血液流动。
在图6到图9中所描绘的实例中，描绘位于传感器10的侧面上的涂覆材料68的舌片或侧延伸部分88，其有助于将环境或周围光排除在传感器10的内部之外。此类延伸部分有助于防止或减少对来自外部环境的光的检测，所述光可能被传感器10不适当地检测为与SaO2相关。因此，脉冲血氧定量法传感器可检测与基础SaO2水平无关的信号调制中的差异。又，这可能影响检测到的红光与红外线调制比率，且因此影响测量到的血氧饱和度(SpO2)值。因此，传感器10的配合的贴合性和侧部延伸部分88的使用可有助于防止或减少此类误差。
虽然本文所论述的示范性医用传感器10是包覆模制或经涂覆医用装置的一些实例，但也涵盖其它此类装置且其属于本发明的范围。举例来说，可使用如本文所论述的包覆模制传感器主体来有利地应用在外部向患者施加的其它医用传感器和/或接触件。此类传感器或接触件的实例可包含葡萄糖监视器，或其它大体上保持在患者的皮肤邻近处以使得需要适合且舒适的配合的传感器或接触件。类似地，且如上文所述，用于测量组织水份或其它与体液有关的量度的装置可利用如本文所述的传感器。同样，探针附接到患者的其它分光光度法应用可使用本文所述的传感器。
虽然本发明可容许各种修改和替代形式，但特定实施例已经在附图中以实例的方式展示，且已经在本文中详细描述。然而，应了解，不希望本发明限于所揭示的特定形式。相反，本发明意在涵盖属于如由所附权利要求书界定的本发明的精神和范围内的所有修改、均等物和替代物。实际上，本技术不仅可应用于在脉冲血氧定量法中使用的透射型传感器，而且还可应用于反射和其它传感器设计。同样，本技术不限于在手指和脚趾上使用，而是还可应用于放置在其它身体部位上，例如在经配置以用于耳朵或鼻子上的实施例中。
Claims (20)
1.一种传感器组合件，其包括：
框架，其包括两个或两个以上结构支撑件；
涂层，其提供在所述框架上，其中所述涂层包括安置在所述两个或两个以上结构支撑件之间的至少一个可变形区域；
至少一个光学组件，其安置在所述至少一个可变形区域内，使得所述至少一个光学组件可相对于所述两个或两个以上结构支撑件而移动；以及
偏置组件，其附接到所述框架的一端，使得在没有足够的打开力的情况下，所述经涂覆框架的至少两个不同部分经偏置而闭合。
2.根据权利要求1所述的传感器组合件，其中所述至少一个光学组件包括发光二极管或光电检测器中的至少一者。
3.根据权利要求1所述的传感器组合件，其中所述涂层包括安置在第一与第二结构支撑件之间的第一可变形区域，和安置在第三与第四结构支撑件之间的第二可变形区域。
4.根据权利要求3所述的传感器组合件，其中所述至少一个光学组件包括：发光二极管，其安置在所述第一可变形区域内，且能够相对于所述第一和第二结构支撑件而移动；以及光电检测器，其安置在所述第二可变形区域内，且能够相对于所述第三和第四结构支撑件而移动。
5.根据权利要求1所述的传感器组合件，其包括连接到所述至少光学组件的一个或一个以上信号传输结构。
6.根据权利要求1所述的传感器组合件，其中所述传感器组合件包括脉冲血氧定量法传感器、用于测量水份的传感器或其组合中的至少一者。
7.根据权利要求1所述的传感器组合件，其中所述框架包括单个模制部分。
8.根据权利要求1所述的传感器组合件，其中所述框架包括经接合以形成所述框架的两个或两个以上部分。
9.根据权利要求1所述的传感器组合件，其中所述涂层包括热塑性弹性体。
10.根据权利要求9所述的传感器组合件，其中所述热塑性弹性体包括热塑性聚烯烃、热塑性硫化产品合金、热塑性聚氨脂、硅酮或其组合中的至少一者。
11.一种传感器组合件，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；
偏置组件，其附接到所述框架的一端；以及
涂层，其至少提供在所述框架上以形成传感器组合件。
12.一种传感器组合件，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；以及
涂层，其至少提供在所述框架上以形成传感器组合件，其中所述涂层提供闭合力，在没有反作用力的情况下，所述闭合力用以闭合所述传感器组合件的一端。
13.一种制造传感器的方法，其包括：
将发射器和检测器定位于骨架框架上；以及
用涂覆材料涂覆所述骨架框架以形成整体传感器组合件。
14.一种用于获取生理数据的方法，其包括：
从夹在患者身上的整体传感器组合件的发射器发射两个或两个以上波长的光，其中所述整体传感器组合件包括包覆模制的骨架框架；
使用所述整体传感器组合件的光电检测器来检测透射或反射的光；以及
基于所述检测到的光来确定生理参数。
15.一种传感器组合件，其包括：
骨架框架，其包括经配置以相对于彼此而移动的至少第一部分和第二部分；
至少一个生理传感器，其附接到所述框架；以及
涂层，其提供在所述框架和所述至少一个生理传感器上以形成传感器组合件。
16.一种制造传感器主体的方法，其包括：
用涂覆材料涂覆骨架框架以形成传感器主体。
17.一种传感器主体，其包括：
框架；
偏置组件，其附接到所述框架；以及
涂层，其提供在所述框架和所述偏置组件上，以形成传感器主体。
18.一种传感器主体，其包括：
框架；以及
涂层，其提供在所述框架上以形成传感器组合件，其中所述涂层提供闭合力，在没有反作用力的情况下，所述闭合力用以闭合所述传感器组合件的一端。
19.一种传感器的骨架框架，其包括：
两个或两个以上结构支撑部件，在所述两个或两个以上结构支撑部件之间具有一个或一个以上空间，其中所述两个或两个以上结构支撑部件经配置以向存在时的上覆涂层提供支撑。
20.一种用于制造传感器的骨架框架的方法，其包括：
形成传感器的骨架框架的两个或两个以上结构支撑部件，在所述两个或两个以上结构支撑部件之间具有一个或一个以上空间，其中所述两个或两个以上结构支撑部件经配置以向存在时的上覆涂层提供支撑。
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-
2005
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-
2006
- 2006-07-28 US US11/494,838 patent/US7684843B2/en active Active
- 2006-07-28 US US11/495,490 patent/US7738937B2/en active Active
- 2006-08-07 EP EP06789546A patent/EP1921979A2/en not_active Withdrawn
- 2006-08-07 AU AU2006278363A patent/AU2006278363A1/en not_active Abandoned
- 2006-08-07 CA CA002618490A patent/CA2618490A1/en not_active Abandoned
- 2006-08-07 WO PCT/US2006/030807 patent/WO2007019474A2/en active Application Filing
- 2006-08-07 TW TW095128905A patent/TW200718392A/zh unknown
- 2006-08-07 JP JP2008526119A patent/JP2009504257A/ja active Pending
- 2006-08-07 CN CNA2006800326599A patent/CN101257839A/zh active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107257650A (zh) * | 2015-02-23 | 2017-10-17 | 皇家飞利浦有限公司 | 脉搏血氧计的多状态夹式固定方法 |
| CN107257650B (zh) * | 2015-02-23 | 2020-11-17 | 皇家飞利浦有限公司 | 脉搏血氧计的多状态夹式固定方法 |
| CN114364309A (zh) * | 2019-07-29 | 2022-04-15 | 美商心环科技股份有限公司 | 生物讯息量测装置 |
Also Published As
| Publication number | Publication date |
|---|---|
| US7738937B2 (en) | 2010-06-15 |
| CA2618490A1 (en) | 2007-02-15 |
| TW200718392A (en) | 2007-05-16 |
| WO2007019474A3 (en) | 2007-05-24 |
| US20070032709A1 (en) | 2007-02-08 |
| WO2007019474A2 (en) | 2007-02-15 |
| US20070032711A1 (en) | 2007-02-08 |
| EP1921979A2 (en) | 2008-05-21 |
| US20070032707A1 (en) | 2007-02-08 |
| US7657295B2 (en) | 2010-02-02 |
| US7684843B2 (en) | 2010-03-23 |
| AU2006278363A1 (en) | 2007-02-15 |
| JP2009504257A (ja) | 2009-02-05 |
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