CN101257849A - 双稳态医疗感测器 - Google Patents
双稳态医疗感测器 Download PDFInfo
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Abstract
本发明提供一种双稳态感测器,其包括其上可安置电及光学组件的框架及围绕所述框架提供的涂层(例如,包覆模制涂层)。将阻力提供组件与所述经涂布双稳态感测器一体地提供或提供于所述经涂布双稳态感测器外部,使得所述双稳态感测器具有两个可通过克服由所述阻力提供组件及/或由所述涂层提供的阻力而在其间进行转变的机械稳定配置。在一个实施例中,所述阻力提供组件包含围绕所述框架的铰链(在所述涂层之内或之外)提供的弹性带。在一个实施例中,可将所述感测器置于患者的手指、脚趾、耳朵等上以获得脉搏血氧测定或其它生理测量值。
Description
技术领域
一般来说,本发明涉及医疗装置,且更特定来说,涉及用于感测患者的生理参数的感测器。
背景技术
这一节希望向读者介绍可与本发明的各个方面有关的技术的各个方面,下文将阐述及/或主所述技术的各个方面。据信这一论述将有助于向读者提供背景信息,以便于更好理解本发明的各个方面。因此,应理解,应就此而论阅读所述陈述,而非作为对现有技术的认可。
在医学领域中,医生常常希望监视其患者的某些生理特征。因此,已研发了各种各样的用于监视生理特征的装置。这些装置向医生及其它健康护理人员提供其提供对其患者的最可能的健康护理所需的信息。因此,这些监视装置已变成现代医学不可缺少的部分
一种用于监视患者的某些生理特征的技术通常被称为脉搏血氧测定法,且基于脉搏血氧测定法技术所构建的装置通常被称为脉搏血氧计。脉搏血氧测定法可用于测量各种血流特征,例如动脉血液中的血红蛋白的血氧饱和度、供应组织的个体血液脉动的体积、及/或对应于患者每一次心跳的血液脉动速率。
脉搏血氧计通常利用非侵入式感测器,所述非侵入式感测器安置或倚靠在良好灌注有血液的患者组织(例如,患者的手指、脚趾、前额或耳垂)上。所述脉搏血氧计感测器发射光且光电感测光在通过所述经灌注组织之后的吸收及/或散射。然后,由所述感测器所收集的数据可用于基于所述光的吸收或散射计算一种或多种上述生理特征。更具体来说,所发射的光通常经选择以具有以与血液中充氧比去氧血红蛋白的存在率有关的量进行吸收或散射的波长。然后,吸收及/或散射光的量可用于使用各种算法估计所述组织中的氧量。
在许多情况中,为成本及/或方便起见,可希望采用可重复使用的脉搏血氧计感测器。然而,因各种原因,对患者来说这种可重复使用感测器并不舒适。举例来说,其构造中所用的材料可能不够贴合或柔软或所述结构特征可包括角度或边缘。
此外,所述可重复使用感测器应足够舒服地贴合以使偶然患者移动将不移位或移动所述感测器,又不紧密得使其可能干扰脉搏血氧测定。在没有医护人员的调整或额外关注的情况下,可难于在一系列患者生理上实现这种贴合配合。此外,缺少紧密或牢固贴合可允许光从环境到达所述感测器的光电检测元件。这种环境光与患者的生理特征无关且因此可能对使用由所述感测器获得数据所得到的测量引入错误。
可重复使用脉搏血氧计感测器还重复且通常地用于多于一个的患者上。因此,在所述感测器的使用寿命中,在重复使用之后,碎屑及其它生物碎片(脱落的皮肤细胞、干燥的流体、污垢等等)可积聚在所述感测器的表面上或所述感测器的缝隙及腔室中。因此,可需要以彻底的方式迅速及/或日常清洁所述感测器。然而在具有多部分构造的感测器中(可重复使用脉搏血氧计感测器中通常如此),可能难于实施这种快速及/或日常清洁。举例来说,这种彻底清洁可需要拆卸所述感测器并单个清洁所拆卸的部分或可需要使用能够到达所述感测器的腔室或缝隙内的器具小心清洁。这种清洁劳动强度大且在典型医院或诊所环境中是不切实际的。
发明内容
下文将阐述在范围上与独特主张的发明相当的某些方面。应理解,提供这些方面仅是为向读者提供本发明可采用的某些形式的简要概述,且不希望这些方面限制本发明的范围。实际上,本发明可包括下文可能未阐述的各种方面。
本发明提供一种感测器组合件,其包括:框架,其包含两个或抵制结构支撑;提供于所述框架上的涂层,其中所述涂层包含至少一个安置于所述两个或抵制结构支撑之间的可变形区域;及至少一个光学组件,其安置于所述至少一个可变形区域内,以便所述至少一个光学组件可相对于所述两个或抵制结构支撑移动。
本发明还提供一种感测器组合件,其包括:框架,其包含由铰链连接的第一部分及第二部分;安置于所述框架上的发射器;安置于所述框架上的检测器;涂层,其提供于所述框架、所述发射器及所述检测器上以形成整体感测器组合件;及通常围绕所述铰链安置的阻力提供组件。
另外,本发明还提供一种感测器组合件,其包括:框架;至少一个附接到所述框架的感测器组件;及涂层,其提供于所述框架及所述至少一个感测器组件上以形成具有至少两个机械稳定配置的感测器组合件。
本发明还提供一种制造感测器的方法,所述方法包括:将发射器及检测器定位于骨干框架上;及用于涂布材料涂布所述骨干框架以形成具有至少两个机械稳定配置的感测器组合件。
本发明还包括一种获得生理数据的方法,所述方法包括:从具有至少两个机械稳定配置的感测器组合件的发射器发射两个或抵制波长的光;使用所述感测器组合件的光电检测器检测所传输或反射的光;及基于所检测的光确定生理参数。
本发明还包括一种制造双稳态感测器主体的方法,所述方法包括:用涂布材料涂布骨干框架以形成具有至少两个稳定配置的感测器主体。
本发明还提供一种感测器主体,其包括:框架;涂层,其提供于所述框架上以形成感测器主体;及阻力提供组件,其经配置以抵制在所述感测器主体的第一稳定配置与第二稳定配置之间的转变。
本发明还提供一种感测器骨干框架,所述骨干框架包括:两个或抵制结构支撑部件,其具有一个或多个在所述两个或抵制结构支撑部件之间的空间,其中所述两个或抵制结构支撑部件经配置以对上覆涂层(当存在时)提供支撑;铰链,其连接一些或所有所述两个或抵制结构支撑部件;及阻力提供组件,其大体上围绕所述铰链而安置以使所述骨干框架具有两个或抵制机械稳定配置。
附图说明
当阅读下文详细说明且当参照图示时本发明的优点将变得显而易见,在所述图示中:
图1图解说明根据本技术的各个方面的耦合到多参数患者监视器及双稳态感测器的患者监视系统;
图2图解说明根据本技术的各个方面的供双稳态感测器中使用的闭合的内部框架;
图3图解说明呈打开配置的图2的内部框架的侧视图;
图4图解说明呈闭合配合的图2的内部框架的侧视图;
图5A图解说明呈闭合配置的图2的内部框架以及围绕铰链区域安置的弹性带的视图;
图5B图解说明呈打开配置的图2的内部框架以及围绕铰链区域安置的弹性带的侧视图;
图6图解说明根据本技术的各个方面的包覆模制的双稳态感测器;
图7图解说明呈打开配置的图6的包覆模制的双稳态感测器;
图8图解说明根据本技术各个方面的用于患者手指上的图6的双稳态感测器;
图9图解说明沿图6的剖面线9截取的剖面图;及
图10图解说明沿图6的剖面线10截取的剖面图。
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。为努力提供所述实施例的简洁说明,在本说明书中未阐述实际实施方案的所有特征。应了解,在研发任何这种实际实施方案时,如在任一工程设计或设计项目中,应作出众多实施方案特定决策以实现研发者的具体目标,例如与系统相关及商业相关的约束条件(其可从一个实施方案到另一个实施方案变化)达成一致性。此外,应认识到:此类研发工作可能比较复杂且耗费时间,然而,其对于获益于本揭示内容的所属技术领域的普通技术人员来说,则不过是一项常规的设计、制作及制造工作。
需要提供一种舒适的且可适于重复使用的患者感测器,其用于(例如)脉搏血氧测定法或其它利用分光光度测定法的应用,其易于被清洁且阻挡环境光渗透。根据本技术的一些方面,提供一种可重复使用的患者感测器,其经包覆模制以提供患者舒适且适合的贴合配合。所述包覆模制材料提供阻挡身体流体以及水或其它清洁流体(其允许在无拆卸或特殊工具的情况下进行简易清洁)的密封。
根据本技术的一些方面,所述可重复使用患者感测器具有多于一个的机械稳定配置,例如在机械双稳态实施方案中为两个稳定配置。如所属技术领域的技术人员应了解,这种多或双稳态配置抵制稳定配置之间的转变或移动,因此在没有足以克服这种阻力的外加力的情况下每一配置均是稳定的。以此方式,呈其一种稳定配置的双稳态装置将保持于这种稳定配置中直至施加力以克服阻力来转变到第二稳定配置。然而,一旦施加这种力且所述双稳态装置呈所述第二稳定配置,则阻力现在起作用以阻止转变回所述第一稳定配置。举例来说,对于具有打开及闭合配置的双稳态感测器来说,所述感测器将保持打开直至施加足够的力以闭合所述感测器,然而,一旦闭合,则在没有第二次施加足以重打开所述感测器的力的情况下所述感测器将保持闭合。
在详细论述这种实例性多或双稳态感测器之前,应了解,这种感测器可经设计以同典型的患者监视系统一起使用。举例来说,现在参照图1,根据本发明的双稳态感测器10可结合患者监视器12使用。在所描绘实施例中,电缆14将双稳态感测器10连接到患者监视器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可包括或并入一个或多个集成电路装置或电装置(例如存储器、处理器芯片或电阻器),其可促成或增强双稳态感测器10与患者监视器12之间的通信。同样地,电缆14可以是具有或不具有集成电路或电装置的适配器电缆以促成双稳态感测器10与各种类型的监视器(包括旧或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,双稳态感测器10及患者监视器12可经由使用(例如)无线电、红外线或光学信号的无线构件通信。在这种实施例中,可将传输装置(未显示)连接到双稳态感测器10以促成双稳态感测器10与患者感测器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(或相应的无线传输)通常用于从监视器12传输控制或时序信号到双稳态感测器10及/或从双稳态感测器10传输所获取的数据到监视器12。然而,在一些实施例中,电缆14可以是允许在监视器12与双稳态感测器10之间传导光学信号的光纤。
在一个实施例中,患者监视器12可以是合适的脉搏血氧计,例如可从NellcorPuritan Bennett公司购得的脉搏血氧计。在其它实施例中,患者监视器12可以是适合于使用分光光度测定或其它技术测量组织水份或其它身体流体相关度量的监视器。此外,监视器12可以是适合于使用经由感测器10所获取的数据实施脉搏血氧测定及组织水份测量或生理及/或生物化学监视过程的其它组合的多用途监视器。此外,为更新由监视器12所提供的常规监视功能以提供额外功能,患者监视器12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耦合到多参数患者监视器16。
在图1中所描绘的实例中,感测器10是经包覆模制以提供整体或封闭式组合件的双稳态感测器。双稳态感测器10包括可以是任一合适类型的发射器22及检测器24。举例来说,发射器22可以是适于发射一个或多个波长的光(例如在红色到红外线范围内)的一个或多个发光二极管,且检测器24可以是经选择以在发射器22的发射范围内接收光的光电检测器(例如硅光电二极管封装)。在所描绘实施例中,双稳态感测器10耦合到电缆14,电缆14负责将电及/或光学信号传输到双稳态感测器10的发射器22及感测器24及从双稳态感测器10的发射器22及感测器24传输电及/或光学信号。电缆14可以是永久地耦合到双稳态感测器10,或其可以可拆卸地耦合到双稳态感测器10,在其中双稳态感测器10为可弃式的情况中后一选择更为有用且成本高效。
上文所述的双稳态感测器10通常经配置以用作供分光光度测定应用中使用的“透射型”感测器,然而在一些实施例中其可改为经配置以用作“反射型感测器”。透射型感测器包括通常置于感测部位的对置侧上的发射器及检测器。如果所述感测部位是(例如)指尖,则将双稳态感测器10定位于患者的指尖上以使发射器及检测器各位于患者甲床的一侧上。举例来说,双稳态感测器10经定位以使发射器位于患者的指甲上且检测器对置于所述发射器位于患者的指垫上。在操作期间,所述发射器发出一个或多个波长的光穿过患者的指尖或其它组织,且由所述检测器所接收的光经处理以确定患者的各种生理特征。
反射型感测器通常在与透射型感测器大致相同的原理下运作。然而,反射型感测器包括通常置于感测部位的相同侧上的发射器及检测器。举例来说,可将反射型感测器置于患者的指尖上以使所述发射器及检测器并排定位。反射型感测器检测散射回所述检测器的光子。
对于使用透射或反射型感测器的脉搏血氧测定应用来说,可使用两个或抵制波长的光(最通常为红色或近红外波长)确定患者动脉血液的氧饱和度。同样地,在其它应用中,可使用两个或抵制波长的光(最通常为约1000nm到约2500nm之间的近红外波长)测量组织水份(或其它身体流体相关度量)或水性环境中一种或多种生化组分的浓度。应理解,如本文所用,术语“光”可以是指红外、可见、紫外或甚至X射线电磁辐射中的一者或多者,且还可包括所述红外、可见、紫外或X射线光谱中的任一波长。
脉搏血氧测定及其它分光光度测定感测器(无论是透射型还是反射型)通常置于患者身上有助于测量所需生理参数的位置内。举例来说,通常将脉搏血氧测定感测器置于患者身上通常灌注有动脉血液的位置以便于测量所需的血液特征,例如动脉氧饱和度测量(SaO2)。常见脉搏血氧测定感测部位包括患者的指尖、脚趾、前额或耳垂。无论如何安置双稳态感测器10,脉搏血氧测定的可靠性均与已穿过所述经灌注组织且尚未被外侧光源不适当地补充或被皮下解剖结构调制的所发射光的精确检测有关。由所述感测器所发射光的这种不适当的补充及/或调制可导致所得脉搏血氧测定的可变性。
如上文所提及,本文所论述的双稳态感测器10可经配置以进行透射或反射型感测。为简明起见,本文所述的双稳态感测器10的实例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,这种论述仅是实例性且不希望限制本技术的范围。
现在参照图2-5,其描绘双稳态感测器10的内部框架30。在所描绘的实例中,内部框架30是双稳态感测器10的骨干框架。这种骨干框架可包括可能具有或可能不具有类似刚性的不同结构或区域。举例来说,如下文关于图6-10所论述,所描绘的骨干框架包括结构支撑34,在涂布时,结构支撑34界定感测器10的大体形状。考虑到其结构提供功能,结构支撑34可经构造以大致是刚性或半刚性。此外,所述骨干框架可包括电缆引导件36,当装配时电缆(例如,电缆或光缆)可穿过所述电缆引导件以连接到附接于发射器22及/或检测器24的电或光导体。同样地,骨干框架(例如内部框架30所描绘)可包括组件外壳(例如发射器外壳38及检测器外壳40)及将这些外壳附接到所述骨干框架的剩余部分的支柱42。支柱42可以是相对挠性,从而允许发射器外壳38及/或检测器外壳40相对于所述骨干框架的结构支撑34垂直地(例如,沿各个外壳之间的光轴)移动。另一选择为,在其中支柱42是相对刚性的实施例中,其中若干支柱42用于将外壳38及40附接到结构支撑34,或其中所述内部框架大致是实心的而非骨干,外壳38及/或40可相对于各个结构支撑34是固定的且因此随结构支撑34一起移动。
在其中,内部框架30是骨干的实施例中,各种结构支撑34、外壳38及40、支柱42及其它结构可界定所述骨干框架的结构之间及/或周围的各种开口及空间。以此方式,所述骨干框架在特定位置提供结构支撑以供涂布或包覆模制。然而,在其中未提供结构支撑的区域中,上覆涂层或包覆模制的移动自由可以是可能的。举例来说,如图2中所描绘,在一个实施方案中,发射器外壳38及/或检测器外壳40可通过挠性支柱42附接到所述骨干框架的剩余部分。在这种实施方案中,邻近发射器外壳38及/或检测器外壳40所提供的涂层可具有足够挠性(例如,由于所述骨干框架的开口区域内涂布材料的弹性及/或单薄),以使外壳38及40可沿外壳38及40之间的光轴独立于框架30的结构支撑34移动。
在某些实施例中,内部框架30整体或部分由能够对内部框架30的不同部分提供合适的刚性或半刚性的聚合材料(例如,热塑性塑料)构造。这种合适的材料的实例包括聚氨酯、聚丙烯及尼龙,然而其它聚合材料也可以是合适的。在其它实施例中,内部框架整体或部分由其它合适的刚性或半刚性材料构造,例如不锈钢、铝、镁、石墨、玻璃纤维或其它材料、合金或具有足够延展性及/或强度的合成物。举例来说,金属、合金或适合于模铸、烧结、熔模铸造、冲压成形及其它金属或合成物制造过程的合成物可用于构造内部框架30。
此外,内部框架30可构造为整体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30可由单一材料或由不同材料构造为单一件。另一选择为,内部框架30可由两个或抵制单独地形成的部分构造或装配成。在这种实施例中,可由相同或不同的材料形成所述不同部分。举例来说,在其中由不同材料形成不同部分的实施方案中,可由具有适合于所述部分的机械及/或化学特性材料构造每一部分。然后,将所述不同部分结合或安装在一起以形成内部框架30。
另外,可以不同于最终感测器配置的配置模制、形成或构造内部框架30。举例来说,如图3中所描绘,最初可以大体打开或扁平配置形成供双稳态感测器10中使用的内部框架30。然后,如图4中所描绘,可将内部框架30从所述打开配置弯曲到相对闭合配置。
在某些实施例中,内部框架30安装有阻力组件,例如,如图5A及5B中所描绘,围绕铰链区域52所安装的弹性带50。如由大体指示施加于所述阻力组件的力(F)的方向的箭头大体描绘,所述阻力组件提供或增大在双稳态感测器10的配置之间的转变阻力。就是说,克服由所述阻力组件提供或增大的阻力以在两个机械稳定感测器配置之间的转变。举例来说,在图5A中,所述阻力组件提供力F,在没有更大反作用力(即,打开力)的情况下所述力F偏置经闭合的内部框架30的第一部分54及第二部分56。同样地,在图5B,所述阻力组件提供力F,在没有更大反作用力(即,闭合力)的情况下所述力F偏置分开的内部框架30的第一部分54及第二部分56。
如所属技术领域的技术人员应了解,阻力组件(例如弹性带50)可由提供所需弹性及阻力的材料或材料组合(例如聚合材料(橡胶、塑料等等)或金属)构成。同样地,所述阻力组件可采用除连续环(例如实例性弹性带50)以外的其它形式。举例来说,弹性带或条可配置有鸠尾榫状的末端或配置有狗骨形状以便于连接到框架30,例如以与作为框架30的组成部分的互补附接区域相符。
尽管本实例将所述阻力组件(呈弹性带50的形式)描绘为直接安置于框架30上,但所属技术领域的技术人员应了解,其它配置也是可能的。举例来说,可将所述阻力组件(例如弹性带50)安置在上覆于框架30的涂布材料内或在这种涂布材料外部。类似地,在其它实施例中,可将所述阻力组件提供为框架30的一部分,例如经配置以(在未由添加的阻力组件扩增的情况下)抵制在稳定配置之间的转变的铰链部分52。同样地,如下文所论述,所述阻力组件可以是或可包括安置于框架30上的弹性体涂布材料。在这种实施例中,所述涂布材料可基于所述涂布材料自身的弹性或其它物理特性提供阻力。另一选择为,由所述涂层提供的阻力可以是基于弹性及/或硬度不同的涂层的区域,借此在所述涂层内形成阻力结构或区域。
如上文所提及,在本技术的某些实施例中,框架30(例如,骨干、内部框架)经涂布以形成整体或一体式感测器组合件,如图6-10中所描绘。这种经包覆模制的实施例可产生其中完全地或大致涂布内部框架30的感测器组合件。在其中将内部框架30形成或模制为相对打开或扁平结构的实施例中,可在将内部框架30弯曲为所述闭合配置之前或之后实施所述包覆模制或涂布过程。
举例来说,可通过注射模制过程形成双稳态感测器10。在这种过程的一个实例中,可将具有或不具有附接的弹性带50的内部框架30定位于具有双稳态感测器10的所需形状的模具或塑模内。然后,将熔融或以其它方式未凝固的材料注射到所述模具或塑模内。举例来说,在一个实施方案中,在约400°F到约450°F之间将熔融热塑性弹性体注射到所述塑模内。然后,可通过冷却一分钟或一分钟以上或通过化学处理将所述包覆模制材料凝固,以形成围绕内部框架30及(若存在)弹性带50的感测器主体。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)附接或插入到其各自的外壳内或定位于所述包覆模制的感测器主体上。
另一选择为,可在包覆模制之前将所述光学组件(例如发射器22及检测器24)及/或传导结构(例如导线或挠性电路)置于内部框架30上。然后,可将内部框架30及相关联组件定位于模具或塑模内且如先前所述包覆模制。为保护发射器22、检测器24及或其它电组件,可采用保护这些组件免于高温的常规技术。举例来说,发射器22及/或检测器24可包括相关联透明窗口(例如,塑料或晶体窗口),所述窗口与所述塑模接触以防止将涂层施加于所述窗口上。在一个实施例中,与这种窗口接触的材料可由防止所述注射模制过程的热通过所述窗口传递到所述光学组件的材料(例如铍铜)组成。举例来说,在一个实施例中,最初在约40°F下将铍铜材料与和发射器22及/或检测器24相关联的窗口接触以防止涂布所述窗口及热传递到各自的光学组件。如所属技术领域的技术人员应了解,本文所述的注射模制过程仅是一种借以涂布具有或不具有相关联感测组件的框架30以形成感测器主体的技术。其它可采用的技术包括但不限于:将框架30浸渍于熔融或以其它方式未凝固的涂布材料内以涂布框架30或向框架30喷涂熔融或以其它方式未凝固的涂布材料以涂布框架30。在这种实施方案中,随后可通过(例如)冷却或化学手段凝固所述涂布材料以形成所述涂层。如上文所论述,就这种替代技术可牵涉的高温来说,其可包括通过(例如)使用铍铜或其它合适的材料热保护任何存在的光学组件以防止通过与所述光学组件相关联的窗口的热传递。
通过这种技术,可将框架30以及所述光学组件及其中所需的相关联电路系统装入涂布材料60内以形成不具有框架30的暴露或外部移动部分的一体式或整体组合件。举例来说,如图6及7中所描绘,双稳态感测器10包括现在完全或部分地包覆模制的下伏内部框架30的特征,例如包覆模制的发射器外壳62及检测器外壳64。另外,包覆模制的双稳态感测器10包括包覆模制的上部70及下部72,在双稳态感测器10呈闭合配置时所述上部及下部可配合到患者的手指、脚趾、耳朵或其它附肢。
在一个实施方案中,包覆模制或涂层60是热塑性弹性体或其它适合的涂层或材料。在这种实施例中,所述热塑性弹性体可包括诸如热塑性聚烯烃、热塑性硫化橡胶合金、硅酮、热塑性聚氨酯等合成物。如所属技术领域的技术人员应了解,所述包覆模制合成物可依据一致性、耐用性、可湿性、弹性或所需的其它物理及/或化学特性的程度变化而变化。
此外,如图6及7中所描绘,涂布材料60可经选择或配置以提供对双稳态感测器10在打开及闭合配置之间转变的一些或所有阻力。举例来说,现在参照图6及7,可将涂布材料60安置为围绕所述双稳态感测器的铰链区域的厚区域74或层(通常对应于框架30的经包覆模制的铰链区域52)。以此方式,厚区域74的厚度及涂布材料60的弹性可提供由力箭头F指示的阻力,所述阻力阻碍在双稳态感测器10的不同配置之间的转变。举例来说,如图7中所描绘,在打开配置中,厚区域74的涂布材料所提供的阻力用以将感测器主体10的上部70及下部72偏置开。然而,足够的反作用或闭合力可克服由厚区域74的涂布材料所提供的阻力以将感测器主体10转变为如图6中所描绘的闭合配置。一旦处于所述闭合配置,则如图6中由力箭头F所指示,厚区域74的涂布材料抵制转变到所述打开配置。如所属技术领域的技术人员应了解,在所述闭合配置中,可部分地分离上部70及下部72而不完全地克服转变阻力(即,不“打开”感测器10),从而允许将感测器10舒适且适合地配合到患者手指76(如图8中所描绘)或配合到患者的脚趾、耳朵等等(在其它实施例中)。
因此,所描绘的感测器10具有两个机械稳定配置,即其是双稳态的,其中在没有足以克服由所述感测器自身提供的阻力的情况下每一稳定配置阻止改变。如所属技术领域的技术人员应了解,稳定配置之间的转变阻力可取决于各种因素,例如由本文实例所述的因素。举例来说,如图6及7中所描绘,就至少部分由厚区域74的涂布材料提供的阻力来说,所述阻力可以是厚区域74的厚度、涂布材料60的弹性及/或硬度及在厚区域74内或周围存在额外阻力结构的函数。举例来说,厚区域74可由具有均匀组成、弹性、硬度等等的涂布材料60组成。另一选择为,厚区域74可以是由多于一种类型的涂布材料60组成,其中不同的涂布材料具有不同的弹性、硬度或其它影响感测器10的稳定配置之间的转变阻力的机械特性。此外,厚区域74的涂布材料可上覆、并入或支撑额外阻力结构,例如围绕所述框架的铰链区域52而安置的弹性带50。因此,如所属技术领域的技术人员应了解,阻碍感测器10的稳定配置之间转变的阻力可由各种因素确定,例如围绕感测器10的铰链的涂布材料60的厚度、围绕感测器10的铰链的涂布材料60的组成、配置及/或均匀性、围绕感测器10的铰链的额外阻力结构的构造或包括、以及其它可能的因素。
虽然涂布材料60的选择可以是基于上文所提及的阻力考虑,但还可基于对内部框架30与涂布材料60之间的化学键的需要选择涂布材料60。这种化学键可以是所得包覆模制的双稳态感测器10的耐用性所需。举例来说,为防止涂层60从内部框架30分离,用于形成涂层60的材料可经选择以便在所述包覆模制过程期间涂层60与一些或所有内部框剪30键合。在这种实施例中,涂层60与涂层60所键合的内部框架30部分是不可分离的,即其形成一个连续且大体不可分离的结构。
此外,在其中所采用的涂层60是不透液体或流体的实施例中,这种双稳态感测器10可易于通过将所述感测器浸渍如消毒剂或清洁溶液或在(例如)流水下冲洗感测器10进行维护、清洁及/或消毒。举例来说,如图7中所描绘在感测器10的打开配置中,可用水或消毒剂溶液浸渍或冲洗感测器10以进行简易清洁。当然,可以所述闭合或打开配置清洁双稳态感测器10。特定来说,包覆模制的双稳态感测器10可通常或大致没有通常允许生物碎屑或渣滓积聚的缺口、缝隙、接头或其它通常与多部分构造相关联的表面不规则性。这种无缺口或其它不规则性可进一步便于感测器10的清洁及护理。
现在转向图9及10,其描绘通过分别地由图6的剖面线8及9表示的横向光学平面所截取呈闭合配置的经涂布双稳态感测器10的剖面图。处双稳态感测器10的其它方面以外,图8及9描绘包覆模制材料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,以及相应发射器22、检测器24及信号传输结构(例如,布线82或用于传导电或光信号的其它结构)。在所描绘的实施例中,如可适于脉搏血氧测定应用,可大致与双稳态感测器10的患者面向表面齐平地提供发射器22及检测器24。对于其它生理监视应用(例如测量组织水份或其它身体流体相关度量的应用)来说,可需要其配置。举例来说,在这种流体测量应用中,可需要相对于双稳态感测器10的患者面向表面凹陷地提供发射器22及检测器24中的一者或两者。这种修改可通过正确配置或设计包覆模制内部框架30中所使用的塑模或模具及/或通过正确设计内部框架30的发射器外壳38或检测器外壳40实现。
另外,如图9及10中所描绘,在某些实施例中,涂布材料60的部分86可以是挠性,例如安置于骨干框架的支撑结构34之间的涂布材料60的薄或隔膜区域。这种挠性区域86允许针对感测器10的既定保持或夹持力适应更大范围的手指或脚趾大小。举例来说,在其中将各个外壳38及40挠性附接到框架30的剩余部分的实施例中挠性区域86可允许发射器22及/或检测器24挠曲或沿光轴彼此展开。以此方式,感测器10可容纳不同大小的手指或脚趾。举例来说,对于相对小的手指或脚趾来说,挠性区域86大致未变形或垂直移位,且因此发射器22及/或检测器24均大致为移位。然而,对于较大手指或脚趾来说,挠性区域86可经变形或移位呈更大范围以容纳所述手指或脚趾,借此移位发射器11及/或检测器24。另外,对于中大型手指或脚趾来说,挠性区域86还可通过增加施加保持力的表面面积来增加感测器10在所述手指或脚趾上的保持力。
此外,随着挠性区域86变形,施加于所述手指或脚趾的力扩展于由于挠性区域86的变形所致的所述手指或脚趾上的更大面积上。以此方式,可在既定垂直力的情况下提供对所有大小的手指或脚趾的较低压力。因此,可在其中发射器22及侦测器24维持与所述手指或脚趾的接触而无需施加集中及/或不合需要量的力的情况下获得合适的贴合配合,借此提高通过所述手指或脚趾的血液流量。
在图6-10中所描绘的实例中,其描绘双稳态感测器10的侧边上的涂布材料60的襟翼或侧延伸部88,所述襟翼或侧延伸部便于将环境或室内光排除在双稳态感测器60的内部之外。这种延伸部帮助防止或降低检测来自外侧环境的光,所述光可被感测器10不适当地检测为相关的SaO2。因而,所述脉搏血氧测定感测器可检测与下伏SaO2水平无关的信号调制差异。因而,这可影响所检测的红色比红外调制比例及(因此)所测量的血氧饱和度(SaO2)值。因此,感测器10的贴合的贴合性及侧延伸部88的使用可帮助防止或降低这种误差。
虽然本文所论述的实例性双稳态感测器10是包覆模制的或经涂布的医疗装置的一些实例,但还可预期其它这种装置且其在本揭示内容的范围内。举例来说,可有利地使用本文所论述的双稳态感测器主体应用其它医疗感测器及/或外部施加于患者的接触。这种感测器或接触的实例可包括葡萄糖监视器或其它感测器,或通常邻近患者皮肤固持以便需要舒适且贴合配合的接触。同样地,且如上文所提及,用于测量组织水份或其它身体流体相关度量的装置可利用如本文所述的感测器。同样地,其它其中将探头附接到患者的分光光度测定应用可利用如本文所述的感测器。
另外,目前还可预期供以侵入方式使用(即在患者体内)的包覆模制的双稳态医疗装置。举例来说,可将以侵入方式使用的夹子或其它医疗装置设计为双稳态装置(即,具有打开及闭合位置),其中使用充分力完成配置之间的转变,借此防止打开与闭合配置之间的偶然或意外转变。此外,包覆模制或其它涂层可提供于这种装置上,例如其中需要与身体流体或组织的无反应性或其中通常需要提供具有极少或无暴露裂缝或缺口的侵入式装置或其中通常需要涂布装置的内部框架或骨干。
尽管易于对本发明作出各种修改及替代形式,但其特定实施例以实例方式显示于所述图示中并详细阐述于本文中。然而,应理解,并不希望将本发明限定于所揭示的特定形式。相反,本发明将涵盖属于随附权利要求书所界定的本发明的精神及范围内的所有修改、等效形式及替代方案。实际上,本技术不仅可应用于供脉搏血氧测定法中使用的透射型感测器,且还可应用于反射型以及其它感测器设计。同样地,本技术不仅限于用于手指及脚趾上,且也可用于置于其它身体部分上,例如在一些实施例中经配置以用于耳朵或鼻子上。
Claims (20)
1、一种感测器组合件,其包含:
框架,其包含两个或更多个结构支撑;
涂层,其提供于所述框架上,其中所述涂层包含安置于所述两个或两个以上结构支撑之间的至少一个可变形区域;及
至少一个光学组件,其安置于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移动。
2、如权利要求1所述的感测器组合件,其中所述至少一个光学组件包含发光二极管或光电检测器中的至少一者。
3、如权利要求1所述的感测器组合件,其中所述涂层包含安置于第一与第二结构支撑之间的第一可变形区域及安置于第三与第四结构支撑之间的第二可变形区域。
4、如权利要求3所述的感测器组合件,其中所述至少一个光学组件包含:发光二极管,其安置于所述第一可变形区域内且能够相对于所述第一及第二结构支撑移动;及光电检测器,其安置于所述第二可变形区域内且能够相对于所述第三及第四结构支撑移动。
5、如权利要求1所述的感测器组合件,其包含连接到所述至少一个光学组件的一个或多个信号传输结构。
6、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含脉搏血氧测定感测器、用于测量水份的感测器、或用于测量脉搏血氧及水份数据的组合感测器中的至少一者。
7、如权利要求1所述的感测器组合件,其中所述框架包含单一模制部分。
8、如权利要求1所述的感测器组合件,其中所述框架包含经结合以形成所述框架的两个或两个以上部分。
9、如权利要求1所述的感测器组合件,其中所述涂层包含热塑性弹性体。
10、如权利要求9所述的感测器组合件,其中所述热塑性弹性体包含热塑性聚烯烃、热塑性硫化橡胶合金、热塑性聚氨酯、硅酮或其组合中的至少一者。
11、如权利要求1所述的感测器组合件,其中所述涂层包含适合的材料。
12、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分不从所述涂层暴露出。
13、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经配置以在至少两个机械稳定配置之间移动。
14、一种感测器组合件,其包含:
框架,其包含通过铰链连接的第一部分及第二部分;
发射器,其安置于所述框架上;
检测器,其安置于所述框架上;
涂层,其提供于所述框架、所述发射器及所述检测器上以形成整体感测器组合件;及
阻力提供组件,其大体上围绕所述铰链而安置。
15、一种感测器组合件,其包含:
框架;
附接到所述框架的至少一个感测器组件;及
涂层,其提供于所述框架及所述至少一个感测器组件上,以形成具有至少两个机械稳定配置的感测器组合件。
16、一种制造感测器的方法;其包含:
将发射器及检测器定位于骨干框架上;及
用涂布材料涂布所述骨干框架以形成具有至少两个机械稳定配置的感测器组合件。
17、一种用于获取生理数据的方法,其包含:
从具有至少两个机械稳定配置的感测器组合件的发射器发射两个或两个以上波长的光;
使用所述感测器组合件的光电检测器来检测透射或反射的光;及
基于所述检测的光确定生理参数。
18、一种制造双稳态感测器主体的方法,其包含:
用涂布材料涂布骨干框架以形成具有至少两个稳定配置的感测器主体。
19、一种感测器主体,其包含:
框架;
涂层,其提供于所述框架上以形成感测器主体;及
阻力提供组件,其经配置以抵制在所述感测器主体的第一稳定配置与第二稳定配置之间的转变。
20、一种感测器的骨干框架,其包含:
两个或两个以上结构支撑部件,其具有位于所述两个或两个以上结构支撑部件之间的一个或多个空间,其中所述两个或两个以上结构支撑部件经配置以对存在时的上覆涂层提供支撑;
铰链,其连接一些或所有所述两个或抵制结构支撑部件;及
阻力提供组件,其大体上围绕所述铰链而安置,使得所述骨干框架具有两个或抵制机械稳定配置。
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Cited By (4)
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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 |
CN110944583A (zh) * | 2017-07-26 | 2020-03-31 | 皇家飞利浦有限公司 | 测量人体肢体的生理参数的装置和制造这种装置的方法 |
CN110944583B (zh) * | 2017-07-26 | 2023-02-28 | 皇家飞利浦有限公司 | 测量人体肢体的生理参数的装置和制造这种装置的方法 |
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EP1926428A1 (en) | 2008-06-04 |
JP2009504253A (ja) | 2009-02-05 |
US9216528B2 (en) | 2015-12-22 |
US8528185B2 (en) | 2013-09-10 |
US7590439B2 (en) | 2009-09-15 |
CA2618601A1 (en) | 2007-02-15 |
US20090308531A1 (en) | 2009-12-17 |
US20130330465A1 (en) | 2013-12-12 |
US20070032716A1 (en) | 2007-02-08 |
US7657296B2 (en) | 2010-02-02 |
US20070032712A1 (en) | 2007-02-08 |
US7693559B2 (en) | 2010-04-06 |
AU2006278399A1 (en) | 2007-02-15 |
WO2007019419A1 (en) | 2007-02-15 |
US20070032710A1 (en) | 2007-02-08 |
TW200722052A (en) | 2007-06-16 |
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