CN103491860A - 用于测量生理特性的光学传感器 - Google Patents
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Abstract
本发明提供了一种生理探针,其舒适地附接至患者的拇指的根部,从而空出患者的手指用于医院中的常规活动,如阅读和进食。所述探针包括分开的托架模块和传感器模块,所述探针紧固至所述拇指并且测量对应于在660nm和905nm附近操作的LED的依赖时间的信号。所述托架模块含有易于配戴的元件,所述托架模块优选地提供为一次性单元。
Description
相关申请
本申请要求2011年2月18日提交的美国临时申请号61/444,320的优先权的权益,所述美国临时申请在此以引用的方式并入本文,其中包括附图。
发明背景
以下发明背景论述仅提供来帮助读者理解本发明,且并非承认描述或构成本发明的现有技术。
血液中的周边血氧饱和度(SpO2)有时被称为‘第五生命体征(fifth vital sign)’。医学专业人员能够通过监测患者的SpO2来检测低氧血症,即,缺氧。约95%与约100%之间的值被视为正常的;低于这个值的那些值指示低氧血症,并且将通常在医院机构中触发警报。
称为脉搏血氧定量法的技术测量SpO2。技术上,这个参数是自患者的动脉血氧饱和度或SaO2来测定的,所述动脉血氧饱和度是存在于患者的血液中的氧合动脉血红蛋白的百分比。功能性血红蛋白分子可与高达四个氧分子结合得到‘氧合’血红蛋白(HbO2)。结合至小于四个氧分子的血红蛋白分子被归类为‘还原’血红蛋白(Hb)。常规的脉搏血氧定量计的特征为以下算法:其假定仅HbO2和Hb存在在于血液中,并且根据方程式(1)自氧合血红蛋白与血红蛋白(氧合血红蛋白和还原血红蛋白两者)的总量的比率来测量SpO2:
HbO2和Hb的特征为在可见区和红外区中的不同吸收光谱,并且因此可用光学方法予以测量。常规的脉搏血氧定量计的特征因此通常为在红(接近660nm)光谱区和红外(通常在900nm与950nm之间)光谱区中辐射的光源(最通常为发光二极管或LED)。光检测器测量通过患者的脉动血液传送但是并未被吸收的每一波长下的辐射的一部分。在660nm处,例如,Hb吸收的辐射为HbO2的约十倍多,而在905nm处,HbO2吸收的辐射为Hb的约两倍多。对在这些波长下传播的辐射的检测得到两个依赖时间的波形,其中各自被称为体积描记图(PPG),血氧定量计分析所述波形来求出如以上方程式(1)中所定义的SpO2。
具体来说,血氧定量计处理用红(RED(PPG))波长和红外(IR(PPG))波长测量的PPG波形以确定依赖时间的AC信号和DC信号。如本文中所使用,术语‘AC’信号是指随时间相对迅速变化的PPG波形的一部分,例如由患者血液中的博动所调变的信号的部分。相反,‘DC’信号为随时间相对不变的PPG的部分,例如源自如骨骼、皮肤的组分和患者血液的非脉动组分散射开的信号的部分。
更具体来说,AC信号是由存在于这两个波形中的心跳诱发的脉搏所调变的。脉搏表示由心脏发动的压力波,所述压力波通过患者的脉管系统传播并且在动脉和毛细血管两者中产生容积的依赖时间的增加。当压力脉搏到达由血氧定量计的光学系统所照射的脉管系统时,根据比尔-朗伯定律(Beer-Lambert Law),临时容积增加导致相对较大的光学吸收。通常,仅约0.5%至约1%的由光检测器所测量的总信号是源自AC信号,而其余信号是源自DC信号。AC信号与DC信号的分离通常使用本领域中熟知的模拟和数字滤波技术来完成。
在脉搏血氧定量法期间,通常使用以下方程式(2)自AC信号和DC信号来计算归一化的‘r’值:
r表示Hb与HbO2的比率,它有时被称为‘比值比率(RoR)’。r使介于0O2至100%O2之间的实际SpO2值与类似非线性方程的经验关系等同。高于约70%O2时,这个方程式通常得到精确到百分之几的值。低于这个值的测量值虽然未必精确,但是仍然指示需要医疗照顾的缺氧患者。
像SpO2一样,连续无创血压(“cNIBP”)监测依赖于自脉搏血氧定量计获得的PPG波形和ACC波形,以及心电图波形(ECG)的精确测量。cNIBP通常使用‘复合技术’予以测量,所述‘复合技术’在标题名为:VITAL SIGN MONITOR FOR MEASURING BLOOD PRESSURE USING OPTICAL,ELECTRICAL,AND PRESSURE WAVEFORMS(U.S.S.N12/138,194;2008年6月12日提交并且公开为20090018453A1)和BODY-WORN SYSTEM FOR MEASURING CONTINUOUS NON-INVASIVE BLOOD PRESSURE(cNIBP)(U.S.S.N12/650,354,2009年11月15日提交并且公开为20100168589A1)的共同待决专利申请中予以详细描述,上述专利申请的内容以引用的方式全部并入本文中。
如上述专利申请中所描述,复合技术(或替代地,在其中被称为‘混合技术’)通常使用来自SpO2测量的单个PPG波形(通常为IR(PPG)波形,因为这个波形的信噪比通常比RED(PPG)波形好),以及ECG波形,来计算称为‘脉搏传导时间(PTT)’的参数,所述脉搏传导时间与血压强烈地相关联。具体来说,ECG波形的特征为指示心脏左心室的去极化的尖峰QRS波群,并且非正式地提供心跳的依赖时间的标记。PTT为分隔QRS波群的峰与RED/IR(PPG)波形的起始或‘底部’的时间;其通常为几百毫秒。QRS波群以及RED/IR(PPG)中的每个脉搏的底部可用来使用以下详细描述的数学技术更精确地提取AC信号。在某些实施方案中,RED/IR(PPG)波形两者可被集体处理来提高cNIBP测量的精确度。
典型的脉搏血氧定量计的特征为探针和光检测器,所述探针被包 围在衣夹形外罩中,所述衣夹形外罩包括红LED和红外LED两者,所述光检测器在来自LED的辐射穿过患者躯体的一部分之后检测所述辐射。探针通常夹在患者的食指上。大多数探针以传送模式的光学几何结构来操作,并且将由LED和光检测器测量的模拟波形转送至外部处理单元。因为脉搏血氧定量法是基于光学测量,所以脉搏血氧定量法可能对于患者的运动极其敏感。如行走、手指轻敲、跌倒和抽搐的活动可产生使以血氧定量计的光学系统来测量的波形的AC分量和DC分量两者变形的许多伪影。运动有关的活动例如可使血氧定量计探针相对于患者的手指移动,改变照射光检测器的环境光的量,并且扰乱由光学系统所测量的脉管系统中的动脉血流和静脉血流两者。这些事件中的每一个都可生成伪影,所述伪影在一些情况下类似于PPG波形内的AC信号和DC信号。最终,这会使脉搏血氧定量计产生不精确的值和假警报。
在此以引用的方式整体并入本文中的国际专利申请号PCT/US2010/039000描述一种生理探针,其被舒适地夹在患者拇指的根部,从而空出患者的手指用于医院中的常规活动,如阅读和进食。探针使用例如易用的维可牢(Velcro)带、一次性绑带或类似闭合件可翻转地紧固至拇指,或可以在拇指上滑动的闭环形式被提供。探针测量对应于通常在接近660nm和905nm处操作的LED的依赖时间的波形(RED/IR(PPG))。在患者的拇指根部进行的临床上精确的脉搏血氧定量法测量需要将r(来自方程式2)与SpO2联系起来的一组系数,所述系数通常使用一组经验试验(例如‘吹气(breathe down)’研究,以下所述)予以确定。这些系数由于拇指的根部与食指的尖端中脉管系统之间的差异而不同于在常规血氧定量法测量中使用的那些系数。通常,拇指的根部的特征为相对较少的毛细血管床,并且因此优选相应地调整系数。
将理解,本发明在其应用中不限于构造的细节和以下描述中所阐述或在附图中示出的组件的布置。本发明能够进行除描述的那些之外的实施方案,并且能够以多种方式实践和实行。另外,将理解,本文 中使用的用语和术语,以及抽象概念是出于描述目的,并且不应被视为限制。
这样,本领域技术人员将了解,可容易地将本公开所基于的概念用作用于实行本发明的若干目的的其它结构、方法和系统的设计基础。因此,重要的是,在这类等同构造不脱离本发明的精神和范围的限度内,权利要求书被认为是包括所述等同构造的。
发明概述
本发明的一个目标在于提供一种生理探针,其具有至少一个发射器和关联检测器,所述关联检测器被构造来附接至组织部位,其中所述检测器被构造来在其已与组织部位交互之后测量响应于来自发射器的能量强度的检测器信号。非常适于充当如下文中所述的脉搏血氧定量计探针的这些生理探针被构造用于紧固至受试者的手指,并且最优选地在近节指骨的水平处紧固至受试者的拇指。
具体来说,本发明的生理探针包括传感器模块和托架模块。在各方面,本发明涉及探针的个别组件,涉及探针本身,并且涉及探针的制造和使用方法。
所述传感器模块包括:(a)电子电路,其在某些实施方案中采取柔性电路板的形式,所述电子电路包括(i)电磁辐射的一个或多个并且优选至少两个源,和(ii)光检测器,其被构造来检测已穿过受试者的组织或已由所述受试者的组织所反射的来自所述一个或多个源的辐射,从而获得至少与所述受试者的血氧饱和水平有关的数据,其中所述光检测器可操作地连接至用于将光检测器信号递送至外部处理单元的连接电缆;以及(b)柔性外壳,其为所述电路板提供封盖,其中所述柔性外壳包括(i)至少一个孔口,所述一个或多个源通过所述至少一个孔口发射辐射用于照射所述受试者的组织,(ii)至少一个孔口,所述光检测器通过所述至少一个孔口接收已与所述受试者的组织交互(例如,穿过所述受试者的组织和/或由所述受试者的组织所反射)的辐射, 和(iii)孔口,所述连接电缆穿过所述孔口。
所述托架模块包括:至少第一刚性外罩构件和第二刚性外罩构件,所述至少第一刚性外罩构件和第二刚性外罩构件经由铰链区彼此配合来形成近似半圆形环,所述近似半圆形环被构造来可翻转地接收所述传感器模块;也就是说,在使用中所述传感器模块是可释放地附接至所述托架模块。
任选地,本发明的生理探针进一步包括固位器,其附接至所述托架模块并且被构造来例如通过环绕受试者的手指的整个圆周将所述生理探针可翻转地附接至手指。
如本文中所使用,术语“可释放地附接”是指在正常使用过程中可彼此啮合并且彼此脱离的两个分开的模块。在某些实施方案中,铰链区被构造来提供环的直径的一系列调整,同时物理上将在所述源与所述光检测器之间测量的夹角约束在预定范围内。如本文中所使用,术语“半圆形环”并非意味着是指形成延伸180度的固定半径的圆弧的几何形状。而是所述术语是指如例如图4中所描绘围绕手指的一部分而非全部圆周沿圆周配合的形状。
如所述,铰链区提供对由托架所形成的半圆形环的直径的一系列调整,从而允许生理探针适应一系列不同的手指围长。在旨在与人类拇指相容的某些实施方案中,成人尺寸的托架的铰链优选被设计来适应介于约6.2cm与约7.4cm之间的围长,并且使得小儿尺寸或用于其它(较小)手指的尺寸适当较小。同时,对于适当功能重要的是将辐射源和光检测器的几何结构维持在用于传感器的适当功能的可接受范围内。
在一个实施例中,铰链区可为枢转接头,其中一个刚性外罩构件上的销钉配合至另一个刚性外罩构件上的对应孔洞中。或者,铰链区可简单地为柔性区,所述柔性区跨接两个刚性外罩构件。熟练的业内人士将显而易知其它类型的铰链布置。需要时,可通过在第一刚性外 罩构件和第二刚性外罩构件中的一个或两个中提供“挡块”来实现角度约束,所述挡块防止铰链敞开或闭合越过预定范围。优选地,在源与光检测器之间测量的夹角的预定范围小于或等于约60°,并且更优选地介于约60°与约30°之间,并且最优选地介于约55°与约35°之间。本专利申请的上下文中的术语“约”是指给定测量值的+/-10%。
所述托架模块优选地被设计为一次性组件,其接纳优选地被设计用于多次使用的传感器模块。如本文中所使用,关于托架的术语“一次性的”是指以下特征:在正常使用过程中可由生理探针的使用者使托架模块自传感器模块上脱离,使得传感器模块可容易地与托架分离,并且不需要与托架一起丢弃。这可用来将对配戴和可清洗性问题最敏感的生理探针的装置组件放置在一次性单元上,而将更昂贵的电子组件保持在易于可清洁和可重复使用的单元上。在某些实施方案中,铰链被构造成使得可施加力来移动铰链越过它的“挡块”中的一个或多个,从而将第一刚性外罩构件与第二刚性外罩构件分开并且防止不恰当的重复使用。这还可以有助于传感器模块的移除以便其重复使用。在某些实施方案中,可通过密封最邻近一个或多个辐射源进行定位的孔口和具有提供对在装置中使用的适当波长有充分透射性的材料的检测器,来使传感器模块为可清洁的以便重复使用。
当传感器模块配合至托架时,传感器模块大体上符合由托架产生的半圆形环形状。如本文中所使用,术语“大体上符合”是指模块以一种方式配合至另一模块的设计形状中从而允许两个模块以预期样式充当一个单元。为促进这个适形配合,传感器模块可包括一个或多个柔性铰链区(例如,塑模至柔性外壳中的一个或多个活动铰链)。
在某些实施方案中,在两个模块配合时变得接触的传感器模块的表面和托架模块的表面包括对应的对准结构,例如,在一个模块上的脊结构,所述脊结构插入另一模块上的对应的凹坑结构中;在一个模块上的舌片,所述舌片配合至另一模块上的对应的凹槽中。如本文中所使用的术语“对准”是指调整或对齐彼此有关的装置部分的行为。这 些对应的对准结构可有助于确保传感器模块至托架模块中的恰当放置。刚性托架外罩与组件的精细对准的组合有助于维持探针中的光学组件的一致定向,并且改进穿过动脉和毛细血管组织的光学路径的一致性,同时通过在传感器模块上使用相对较软的和柔性材料来维持舒适性。
在优选实施方案中,所述传感器模块包括至少两个柔性铰链点,使得所述传感器模块至所述托架的配合生成三个大体上平坦的传感器模块表面。第一平坦表面包括辐射源;中间平坦表面提供平坦的基部表面来啮合受试者的拇指组织;并且第三平坦表面包括光检测器。这些大体上平坦的表面可用来改进对下层动脉的压力施加,从而有助于增加信号振幅并且维持一致的光路径。
在某些实施方案中,托架模块的长度小于所需的近节指骨的平均长度。在成人尺寸的拇指的情况下,托架的长度可为约1cm至1.5cm,并且使得儿科尺寸适当较小。在本上下文中的术语“约”是指给定测量值的+/-10%。
辐射源优选地以约660nm波长和约905nm波长发射辐射。优选地,辐射源彼此邻近,并且最优选地包含在同一电子封装内。在恰当使用中,将生理探针放置在手指(优选拇指)的手掌方面。本发明可提供来自辐射源的一致光学路径,其穿过近节指骨下的拇主要动脉和软组织,并且随后到达光检测器。
其它实施方案见于以下发明详述中,并且见于权利要求书中。
附图简述
图1示出作为本发明的生理探针的组件使用的示例性托架模块的三维机械图,所述生理探针被设计来充当脉搏血氧定量计探针。
图2示出作为本发明的生理探针的组件使用的示例性传感器模块的三维机械图,所述生理探针被设计来充当脉搏血氧定量计探针。
图3示出图2的传感器模块的远端的照片,所述远端包括一对光源和光检测器。
图4A至图4B示出附接至柔性材料的图1的托架模块的三维机械图,所述托架模块被构造来包裹环绕患者的拇指并且容纳图2的传感器模块。
图4C示出容纳图2的传感器模块的图1的托架模块的二维机械图。
图5是描绘图2的传感器模块如何插入图1的托架模块中来形成示例性生理探针的一系列机械图。
图6示出描绘自医学教科书中的理论模型进行的、自患者的食指的尖端进行的以及自患者的拇指的根部进行的测量的SpO2与‘比值比率’(RoR)之间的关系的图。
发明详述
图1至图4描绘半圆形生理探针100的组件,所述探针包括分开的传感器模块101和托架模块102,这两个模块彼此配合。探针被设计成舒适地配戴较长一段时间(例如若干天),同时空出患者的手指用于在例如医院中平常的活动如阅读和进食。虽然详细地描述为脉搏血氧定量计探针,但是本发明的生理探针可应用于任何类似装置,所述装置具有至少一个发射器和关联检测器,所述关联检测器被构造来附接至组织部位。
托架模块102被定形为半圆形环,所述半圆形环包裹环绕患者手指的根部以测量依赖时间的波形(PPG),所述波形可用于例如SpO2和cNIBP的测定中。托架模块102由两个大体上刚性的构件103、104构成,这些构件由铰链105连接。刚性构件103、104可由本领域中已知的许多材料制成,如塑料、金属等;例如,聚丙烯、丙烯酸酯(PMMA、SMMA等)、苯乙烯(SAN、PS、ASA、ABS等)、聚碳酸酯、 共聚物、离聚物树脂(沙林树脂(Surlyn))、聚酰胺、聚酯、热塑性弹性体、铝、黄铜、镍等。优选实例为Eastman TritanTM共聚酯。托架模块的长度小于近节指骨的平均长度,以便不干扰手指在关节处的弯曲。用于被构造成附接至拇指的成人尺寸的托架的最佳长度在1cm至1.5cm的范围内。
每一刚性构件的一部分通过提供两个刚性构件之间的干扰物理接触点而处于铰链位置之下,所述接触点充当挡块来将铰链的敞开和闭合约束在预定范围内。这达到了两个目的。第一,铰链105提供配合在手指上的半圆形环中的开口的直径的一系列调整,从而允许生理探针适应一系列不同的手指尺寸。在某些实施方案中,成人尺寸的托架的铰链优选地被设计成适应约1.8cm至2.3cm的拇指直径,或介于约6.2cm与约7.4cm之间的围长。第二,为增加辐射穿过组织中的动脉和毛细血管的量,并且从而最优化信号品质,托架发挥作用以将LED106、107和光电二极管108维持在近似35度至55度的夹角(θ)处。如图4C中所示,‘夹角θ’是指平行于包括辐射源的平坦表面绘制的第一线与平行于包括光检测器的平坦表面绘制的第二线之间形成的角。在这个角处分开的光学组件倾向于增加来自动脉的信号的相对贡献;最终这改进了cNIBP测量的精确度,因为由动脉组分测量的PTT值比由毛细血管组分测量的那些PTT值更好地与血压相关联。
探针用分别在660nm和905nm处操作的一对嵌入式LED106、107,和在波长穿过处于LED之下的脉管系统及其它组织之后检测这些波长的单个光检测器108,来沿手指的内部进行传输模式的光学测量。优选地,LED和光检测器两者被定位来测量拇主要动脉的部分中的的血液脉动,所述拇主要动脉是拇指的主要动脉并且起源于桡动脉。测量在这个动脉中流动的血液提高血压的基于PTT的测量的精确度,如在以下专利申请中更详细地描述:VITAL SIGN MONITOR FOR MEASURING BLOOD PRESSURE USING OPTICAL,ELECTRICAL,AND PRESSURE WAVEFORMS(U.S.S.N12/138, 194;2008年6月12日提交并且公开为20090018453A1)和BODY-WORN SYSTEM FOR MEASURING CONTINUOUS NON-INVASIVE BLOOD PRESSURE(cNIBP)(U.S.S.N12/650,354,2009年11月15日提交并且公开为20100168589A1),上述专利申请的内容先前已以引用的方式并入本文中。
提供LED和光检测器的电子电路可以传感器模块中的小柔性电路板109的形式来提供,所述电子电路可另外包括例如用于放大来自光检测器的光电流并且将所述光电流转换为对应的电压的跨阻放大器。电子电路还可以包括电阻器,所述电阻器标识由LED发射的特定波长;这些波长又影响将RoR与SpO2联系起来的相关系数的值,如以下所述。在其它实施方案中,柔性电路板109可用一系列绝缘线来代替,所述绝缘线连接LED、光检测器、跨阻放大器及其它组件来形成电路。
柔性外罩110封盖并保护柔性电路板109。柔性外罩110可优选地由任何耐水且耐酒精材料形成,其中材料的硬度(A)在25至60的范围内(例如,HTV弹性体、RTV弹性体或LSR弹性体等),所述材料提供舒适和充分的耐压强度的最优组合以允许探针将压力施加至下层动脉。尤其优选的材料的硬度(A)为约40,如Nusil MED-4044硅树脂弹性体。出于制造的目的,可经由顶部的缝隙状开口115将电路板插入外罩中,然后可例如使用液体硅树脂弹性体材料密封缝隙状开口。连接电缆116延伸穿过外罩底部处的开口117。
外罩的特征为矩形开口111和112,经由所述矩形开口LED发射辐射并且光检测器接收辐射。在某些实施方案中,滤波器可提供在光检测器之上以密封孔口和滤波器不需要的环境光频率两者。在发射侧上,可使用硅树脂材料密封开口11,所述硅树脂材料在发射波长下是充分可透射的。以白色形成外罩允许外罩材料将来自源的更多散射辐射反射至检测器,从而改良传感器效率。开口111和112的尺寸也影响传感器的效率,其中最佳尺寸为稍微大于活动组件区域的窗 口。优选窗口尺寸为约3mm至5mm,并且可具有任何形状,包括正方形、矩形或圆形。
外罩的特征还包括两个切口部分113、114或‘活动铰链’,所述切口部分使外罩可弯曲并且能够适应托架模块的形状。这些活动铰链用来将托架细分为三个大体上平坦的传感器模块表面。第一平坦表面包括辐射源;中间平坦表面提供平坦的基部表面来啮合受试者的拇指组织;并且第三平坦表面包括光检测器。如图4中所示,当将外罩配合至托架时,外罩大体上符合托架的形状,同时提供三个相对平坦的表面,所述三个相对平坦的表面接触组织。这些表面提供对下层动脉的更均匀的压力施加,从而有助于增加信号振幅并且维持一致的光路径。这还用来改良传感器效率。
为确保传感器模块在托架模块内的恰当对准,在配合时变得接触的每一表面包括对应的对准结构,例如,传感器模块上的脊结构,所述脊结构插入托架模块上的对应的凹坑或开口118、119中。对准结构可采取安置在传感器模块外罩的表面上的凸脊的形式,所述凸脊与开口111、112相对。当恰当地定位传感器模块时,所述脊插入托架模块中的开口118、119中来提供两个模块的完全对准。熟练的业内人士将理解,可提供对准结构的其它布置。例如,可将凸脊安置在托架模块的表面上,并且可将对应的凹坑安置在传感器模块上。传感器模块的远侧部也可插入托架模块中的对准凹槽121、122中,从而进一步确保传感器模块在这个组件内的恰当定位。
使用可重新闭合的固位器将探针围绕手指的根部固持在适当位置,所述可重新闭合的固定器如柔性尼龙带120。所述带可以本领域中已知的许多方法附接至托架,如穿过位于托架远端的两个开口;或如图4中所描绘通过经由粘合剂、热熔或超声波焊接将托架粘结至带上。所述带的一部分的特征为维可牢贴片(含有例如‘钩’),所述维可牢贴片粘附至带的主要部分上的配合贴片(含有例如‘圈’);当将探针放置在患者的手指上时,所述贴片可逆性地彼此粘附,并且易于分离, 以便可移除所述带。所述带允许探针被牢固地紧固,这也最小化相对于测量部位的运动。
柔性电缆116用来将血氧定量计探针的电子设备连接至用于处理确定SpO2和/或血压测量所必需的信号的外部处理器。电缆可将I/O信号传送至根据时序图驱动LED的探针电子设备,并且将由光检测器测量的模拟信号传送至放大/滤波电路。电缆优选地包括远侧连接器123,所述远侧连接器将插头插入外部处理模块中,来可操作地将探针连接至外部处理器。在那里,模拟信号被放大、过滤、数字化并且被处理,来测量SpO2和/或血压(例如cNIBP)值,如以下详细地描述。
用于将要并入血氧定量计探针中的电路,和血氧定量计探针至手腕配戴式外部处理模块的互连的优选实施方案的详细描述可见于标题名为BODY-WORN PULSE OXIMETER的国际专利申请号PCT/US2010/039000中,所述国际专利申请在此以引用的方式整体并入本文中。
图5以示意形式描绘在使用之前插入托架模块中的传感器模块的一个实施例。为了插入,在活动铰链处折曲传感器模块,以便传感器模块可接近托架模块的半圆形形状。如以上关于图2所述,传感器模块含有生理探针的电子组件,并且被构造用于多种用途。相反,如图1中所描绘,托架缺乏电子组件,并且旨在一次性使用,因为所述托架含有可能更难以适当地清洁的部件。由于托架模块的刚性结构和受约束的铰链,所以传感器模块至托架模块中的插入用来相对于光检测器恰当地定位LED以用于精确的脉搏血氧定量法测量。
在脉搏血氧定量法测量期间,LED依照大致500Hz在660nm和905nm下间歇地发射辐射光束。一旦发射,光束便进入下层组织中并且迅速地发散以散射离开组织如组织外表面附近的皮肤、骨骼和毛细血管。在拇指的情况下,在辐射照亮光检测器之前也由辐射抽样拇 主要动脉的一部分。毛细血管和动脉两者均载运血液,所述血液随着每一次心跳脉动并且吸收由LED发射的辐射。这产生了分离的依赖时间的光学波形(即RED/IR(PPG)),所述波形由660nm和905nm辐射生成。两个波形的特征为对应于依赖时间的脉动血液的AC信号和对应于不依赖时间的散射离开皮肤、骨骼和毛细血管与动脉的非脉动组分的DC信号。在任何过滤之前,AC分量通常表示总信号的约0.5%至1%。
集中处理RED/IR(PPG)波形的AC信号和DC信号两者得到SpO2值。外部处理器可使用许多信号处理方法来计算这些分量,所述信号处理方法另外对于确定基于PTT的cNIBP是重要的。最终,AC分量和DC分量得到RoR,然后使用一系列凭经验确定的系数将RoR与SpO2联系起来。在一个实施方案中,例如,RoR是通过首先测量RED/IR(PPG)波形,然后使所述波形通过特征为20Hz截止的低通滤波器来确定。每一波形的平均基线分量被抽样并存储在存储器中,且表示RED/IR(DC)。两个波形然后另外使用具有0.1Hz截止频率的高通滤波器来过滤,所述过滤通常使用有限脉冲响应函数来实行,并且所述波形最终使用可变增益放大器来放大。这些步骤可使用模拟电子滤波器或数字软件滤波器来完成。一旦确定,便处理AC信号和DC信号来得到RoR值,在方程式(3)中描述,所述RoR值与SpO2相关:
图6示出对于用血氧定量计探针在拇指的根部处进行的测量的介于RoR与SpO2之间的经验关系,以及对于用现成的血氧定量计探针在食指的尖端处进行的测量的类似关系(小破折号),和对于由食指的尖端进行的测量的理论曲线(大破折号)。对应于由食指和拇指进行的测量的曲线是根据在类似条件下测量的一组患者凭经验确定的。如从图中清楚地看出,RoR与SpO2之间的关系是类似的,但是由于测 量部位的差异而稍有偏差。在不受任何理论束缚的情况下,这些差异可起因于与食指的尖端中的毛细血管床相比拇指的根部附近的毛细血管床的密度相对较低。图6中的所有曲线的关系均是非线性的,尤其是在约70%至100%范围内的SpO2值。低于70%的值可使用不同的非线性模型来解释,所述非线性模型如基于二阶多项式的非线性模型。用于这个模型的系数a、b和c是通过将经验数据拟合至像以下方程式(4)中示出的二阶多项式的对应的数学函数来确定的:
SpO2=(a+b*RoR+c*RoR2)x100 (4)
对应于在拇指的根部处进行的测量的a、b和c系数的最优化值在以下表1中示出:
参数 | 值 |
A | 107.3 |
B | -3.0 |
C | -20.0 |
表1-用于将对于在拇指的根部处进行的测量的RoR与SpO2联系起来的方程式4的系数
在表1中示出的参数的精确值将取决于在脉搏血氧定量计探针中使用的LED的特定波长。这是因为SpO2测量基本上由红光谱区和红外光谱区中的Hb和HbO2的相对光学吸收率来确定,并且吸收率又将取决于由LED发射的波长。Hb和HbO2的吸收光谱在红外光谱区中相对平坦,但是在红光谱区中强烈分叉。表1中示出的系数因此对于红LED的精确波长相对敏感。为此,在制造之前需要使用特征为围绕红发射波长(例如600nm至610nm)而波长变化的LED的脉搏血氧定量计探针来执行一系列经验研究。这样的研究通常被分类为‘吹气’研究,因为其涉及降低在医疗监督下的一系列患者(通常约10至15个)的SpO2值。SpO2通常通过减少每位患者经由专用呼吸器面罩吸入的氧的量来降低;这经常在具有降低温度的房间中进行。来自患者的血液是自动脉线抽取的,并且使用血液气体分析器来分析以确 定其氧含量。同时,具有已知LED波长的脉搏血氧定量计探针附接至每位患者(在这种情况下,在拇指的根部处)并且用来测量方程式(3)中描述的RoR。如使用血液气体分析器测量的这个实验的SpO2值通常在70%至100%范围内。同时研究通常使用具有含不同红发射光谱的LED的脉搏血氧定量计探针来进行。在研究完成之后,使RoR的依赖波长的值与如由血液气体分析器测定的SpO2联系起来,以计算如表1中所描述的系数a、b、c。一般来说,不同集合的系数将针对不同的LED波长。这些系数和其相对应的光学波长,以及以下所描述的电阻器值被存储在手腕配戴式收发器上的存储器中的数据库中。
在拇指的根部处进行的测量提供对SpO2值的测量的改进,因为在这个位置处的循环解剖结构得到更可预测的动脉信号;这个位置还通过空出手指的尖端供使用来增加患者的舒适性。自这个部位测量的IR(PPG)在结合ECG波形处理时得到可使用复合技术来处理以得到精确cNIBP测量的PTT值。如上所述,主要自拇主要动脉测量的IR(PPG)波形提高cNIBP测量的精确度。在基于初始压力的校准下,可使用以上提到的专利申请中描述的算法对于每一次心跳明确地确定收缩期(SYS)和舒张期(DIA)血压,所述专利申请的内容先前已以引用的方式并入本文。通常,使用统计滤波将PTT值处理20秒至40秒的时间(经常以‘移动平均’来实行)以改进精确度。为较好地定义PPG波形的起始,并且因此改进确定SYS和DIA的精确度,通常将对应于RED(底部)和IR(底部)的时间在一起平均。当与在使用股骨动脉线的临床条件下测量的SYS值和DIA值相比时,自这个特殊位置进行的cNIBP测量很好地在用于精确度(+/-5mmHg)和标准偏差(8mmHg)的FDA标准内。出于这个原因和其它原因,拇指的根部似乎为用于测量SpO2和cNIBP两者的独特良好位置。
本领域技术人员易于了解,本发明充分适于执行目标并且获得所提到的以及其中固有的结果和优点。本文中提供的实施例代表优选实施方案,为示例性的,并且并非旨在作为本发明的范围的限制。
本领域技术人员将易于显而易见的是,在不脱离本发明的范围和精神的情况下可对本文中所公开的发明进行可变的替换和修改。
说明书中提到的所有专利和公布指示本发明所属领域中的普通技术人员的水平。所有专利和公布在本文中以引用的方式并入,其程度与仿佛每一单独公布特定且个别地指示为以引用的方式并入相同。
本文中适当地说明性地描述的发明可在缺少在本文中并未具体公开的任何一个或多个元件、一个或多个限制的情况下实践。因此,例如,在本文中的每一个例子中,术语“包括”、“主要由……组成”和“由……组成”中的任何术语可由其它两个术语中的任何一个代替。已使用的术语和措辞是用作描述而非限制的术语,并且在使用这类术语和措辞时并非旨在排除所示出和描述的特征或其部分的任何等同物,但是应认识到,各种修改在本发明要求的范围内是可能的。因此,应理解,尽管本发明已由优选实施方案和任选特征具体公开,但是本领域技术人员可采用本文中公开的概念的修改和变化,并且应理解,所述修改和变化被视为是在如由所附权利要求书定义的本发明的范围内。
在以上权利要求书内阐述其它实施方案。
Claims (26)
1.一种生理探针,其被构造用于紧固至受试者的手指,所述生理探针包括:
传感器模块,其包括
(a)电子电路,其包括(i)电磁辐射的至少一个源,和(ii)光检测器,所述光检测器被构造来在其已与所述受试者的组织交互之后检测来自所述电磁辐射的至少一个源的辐射,从而获得与所述受试者的至少一个生理特性有关的数据,其中所述光检测器是可操作地连接至用于将光检测器信号递送至外部处理单元的连接电缆,以及
(b)柔性外壳,其为所述电子电路提供封盖,其中所述柔性外壳包括(i)至少一个孔口,所述电磁辐射的至少一个源通过所述至少一个孔口发射辐射用于照射所述受试者的组织,(ii)至少一个孔口,所述光检测器在其已与所述受试者的组织交互之后通过所述至少一个孔口接收辐射,和(iii)孔口,所述连接电缆穿过所述孔口;以及
托架模块,其包括
(a)至少第一刚性外罩构件和第二刚性外罩构件,所述至少第一刚性外罩构件和第二刚性外罩构件经由铰链区彼此配合以形成近似半圆形环,所述近似半圆形环被构造来可释放地接收所述传感器模块,其中所述铰链区被构造来提供所述环的直径的一系列调整,同时物理上将在所述电磁辐射的至少一个源与所述光检测器之间测量的夹角约束在预定范围内。
2.根据权利要求1所述的生理探针,其中为了获得与受试者的至少一个生理特性有关的数据,所述铰链被构造来在近节指骨的水平处适应所述受试者的拇指。
3.根据权利要求1所述的生理探针,其中所述铰链被构造来适应介于约6.2cm与约7.4cm之间的围长。
4.根据权利要求1所述的生理探针,其中所述铰链区为通过配合所述第一刚性外罩构件和所述第二刚性外罩构件而形成的枢转铰链,并且其中所述第一刚性外罩构件和所述第二刚性外罩构件的结构在经由所述枢转铰链彼此配合时约束所述铰链的敞开或关闭超过所述预定范围。
5.根据权利要求1所述的生理探针,其中在所述电磁辐射的一个或多个源与所述光检测器之间测量的所述夹角的所述预定范围小于或等于约60°。
6.根据权利要求5所述的生理探针,其中在所述电磁辐射的一个或多个源与所述光检测器之间测量的所述夹角的所述预定范围介于约60°与约30°之间。
7.根据权利要求6所述的生理探针,其中在所述电磁辐射的一个或多个源与所述光检测器之间测量的所述夹角的所述预定范围介于约55°与约35°之间。
8.根据权利要求4所述的生理探针,其中,所述铰链被构造使得施加来移动所述铰链超过所述预定范围的力使所述第一刚性外罩构件与所述第二刚性外罩构件分开。
9.根据权利要求1所述的生理探针,其中所述传感器模块包括所述柔性外壳中的一个或多个铰链点。
10.根据权利要求9所述的生理探针,其中所述传感器模块包括所述柔性外壳中的至少两个铰链点,当所述传感器模块配合至所述托架模块时,所述至少两个铰链点被构造来提供三个大体上平坦的传感器模块表面。
11.根据权利要求1所述的生理探针,其中当所述两个模块配合时变得接触的所述传感器模块的表面和所述托架模块的表面包括对应的对准结构,所述对应的对准结构被构造来对准所述传感器模块在所述托架模块中的位置。
12.根据权利要求1所述的生理探针,其中所述托架模块的长度介于约1cm与约1.5cm之间。
13.根据权利要求1所述的生理探针,其中所述托架模块是一次性的。
14.一种自受试者获得脉搏血氧定量法信号的方法,其包括:
在近节指骨的水平处将根据权利要求1的生理探针贴附至所述受试者的手指的手掌方面,其中所述探针定位在所述受试者的手指上使得所述电磁辐射的一个或多个源在激发时通过所述手指的毛细血管、动脉和软组织提供对所述受试者的组织的照射,并且随后提供至光检测器;
激发所述源来照射所述受试者的所述组织;以及
在经由所述连接电缆可操作地连接的外部处理单元处检测光检测器信号。
15.根据权利要求14所述的方法,其进一步包括使用所述光检测器信号来计算所述受试者的血压值、SpO2值、脉搏率、呼吸周期以及光体积描记器波形中的一个或多个。
16.根据权利要求14所述的方法,其包括使用所述光检测器信号来测定所述受试者的血压值。
17.一种适配用于在生理探针中使用的托架模块,其包括:
至少第一刚性外罩构件和第二刚性外罩构件,所述至少第一刚性外罩构件和第二刚性外罩构件经由枢转铰链彼此配合来形成近似半圆形环,所述近似半圆形环被构造来可释放地附接至传感器模块,所述传感器模块包括(i)电磁辐射的一个或多个源,和(ii)光检测器,所述光检测器被构造来检测已穿过受试者的组织或已由所述受试者的组织所反射的来自所述源的辐射,
其中所述铰链被构造来提供所述环的直径的一系列调整,同时物理上将在所述电磁辐射的一个或多个源与所述光检测器之间测量的夹角约束在预定范围内。
18.根据权利要求17所述的托架模块,其中为了获得与受试者的至少一个生理特性有关的数据,所述铰链被构造来在近节指骨的水平处适应所述受试者的拇指。
19.根据权利要求17所述的托架模块,其中所述铰链被构造来适应介于约6.2cm与约7.4cm之间的围长。
20.根据权利要求17所述的托架模块,其中所述铰链区为通过配合所述第一刚性外罩构件和所述第二刚性外罩构件而形成的枢转铰链,并且其中所述第一刚性外罩构件和所述第二刚性外罩构件在经由所述枢转铰链彼此配合时约束所述铰链的敞开或关闭超过所述预定范围。
21.根据权利要求17所述的托架模块,其中在所述源与所述光检测器之间测量的所述夹角的所述预定范围小于或等于约60°。
22.根据权利要求21所述的托架模块,其中在所述源与所述光检测器之间测量的所述夹角的所述预定范围介于约60°与约30°之间。
23.根据权利要求22所述的托架模块,其中在所述源与所述光检测器之间测量的所述夹角的所述预定范围介于约55°与约35°之间。
24.根据权利要求17所述的托架模块,其中,所述铰链被构造使得施加来移动所述铰链超过所述预定范围的力使所述第一刚性外罩构件与所述第二刚性外罩构件分开。
25.根据权利要求17所述的托架模块,其中在所述两个模块配合时变得与所述传感器模块接触的所述托架模块的表面包括对准结构,所述对准结构被构造来对准所述传感器模块在所述托架模块中的位置。
26.根据权利要求17所述的托架模块,其中所述托架模块的长度介于约1cm与约1.5cm之间。
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EP2675346A1 (en) | 2013-12-25 |
EP2675346B1 (en) | 2024-04-10 |
US10357187B2 (en) | 2019-07-23 |
US20200008724A1 (en) | 2020-01-09 |
WO2012112885A1 (en) | 2012-08-23 |
SG10201601161YA (en) | 2016-03-30 |
US20130046159A1 (en) | 2013-02-21 |
EP2675346A4 (en) | 2018-01-10 |
SG192835A1 (en) | 2013-09-30 |
EP2675346C0 (en) | 2024-04-10 |
CN103491860B (zh) | 2016-10-19 |
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