CN1418072A - 非侵入式测量血液参数的探针 - Google Patents

非侵入式测量血液参数的探针 Download PDF

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CN1418072A
CN1418072A CN01806533A CN01806533A CN1418072A CN 1418072 A CN1418072 A CN 1418072A CN 01806533 A CN01806533 A CN 01806533A CN 01806533 A CN01806533 A CN 01806533A CN 1418072 A CN1418072 A CN 1418072A
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伊利亚·法恩
亚历山大·费纳罗夫
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    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
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    • A61B5/022Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A61B5/0225Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds
    • A61B5/02255Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors
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    • A61B5/0048Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0053Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
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    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring 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
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    • AHUMAN NECESSITIES
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    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6843Monitoring or controlling sensor contact pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1491Heated applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6824Arm or wrist

Abstract

一种探针装置,用于非侵入地光学测量病人的至少一个血液参数。该探针装置包括:一个手指夹具,其形式为夹子构件(16),它使手指尖固定在该构件的夹脚(16A、16B)之间。探针装置支承着一个测量器(20),用于对手指上的测量部位进行光学测量,并载有加压组件(24),该加压组件可操作地把可控的、可变动的基本上为低心脏收缩压力施加于测量部位附近处的手指上。在测量部位上,以入射光的至少两个不同的波长运行许多测量时段,以检测介质的光反应,并产生指示光反应的测得数据,且施加于测量部位附近的压力,在测量期间同时变动着。对应于入射光的不同波长和不同压力值的压力,被加以分析,且确定最佳压力值,从而,利用介质的对应光反应,从中推导出至少一个血液参数。

Description

非侵入式测量血液参数的探针
技术领域
本发明通常涉及非侵入式光学测量技术领域,该技术用于测量血液参数,并涉及应用于病人手指上的探针。
背景技术
测量各种血液参数,例如测量血氧饱和度和包含在血液中的物质(血色素、葡萄糖及其他物质)浓度的非侵入式技术,已经很普及,因为这种技术不需要从病人体内采集血样。特殊类型的光学测量技术,通常利用所测量的病人身体部位所发射或反射的光来进行探测,且以分光光度计测量法为根据,该测量法能根据已知的血液成分的光谱性状,显示各种各样血液成分的存在。大多数此种技术,都是利用光学测量装置或探测器,该装置或探测器设计成附着在病人的手指上,它们包括光学组件,该组件用光来照射手指,并探测手指对光的反应。
美国专利第5810723号公开了一种设备,该设备用于非侵入地监测病人的碳氧血红蛋白水平。病人吸入的氧,在探测之前,就使其血液的血色素饱和了。该设备利用带臂的夹子固定在病人手指上:一只臂支承着光发射源,另一只臂支承着探测器。一个微处理器控制着所探测信号的量度与过程。
美国专利第5638816号及其后续件美国专利第5860919号,公开了一种设备,该设备把压力施加于病人手指上,非侵入地监测血液参数,因此,就在其中引发活动脉冲。所引发的血液体积的变化,就能获得较好的信噪比。
美国专利第5782757号公开了一种一次性测量装置,它埋置着带有折叠了的粘贴式光学传感器。探针被设计得可以舒适地装配在病人的手指尖上。
所有的专用类型常规装置,均旨在测量由于含有介质(手指)的血液体积所引起的增强光学脉冲信号。目前已知,规则的光学脉冲信号通常为总发射量的2%至3%。上述装置能够获得达到总的光发射强度8%至10%的增强脉冲信号。自然脉冲信号的这种增强,是所有的专用类型常规技术的边界。
在一个PCT专利申请,即指派给本申请的代理人的国际公开件WO99/65384号中,公开了一种不同的技术。这是一种以闭塞为依据的技术,以该技术所测量到的信号不是脉冲信号。按照该技术,血液停滞的状态,是在受测量的介质中形成的,且在此种状态下来采纳量度。这样,比起前面所述那种涉及脉冲信号的技术来,就能获得很好的对介质的增强了的光反应。为了形成这种血液停滞状态,就需要把超心脏收缩压力(over-systolic pressure),对应于正常的血液流动方向而言,施加于所测量区域上游的病人手指部位上。一旦血液流动停滞状态形成了,光学特性就急剧变化,使得该特性与正常血液流动的多肉介质(fleshy medium)的特性,不同之处约达25%至45%,有时甚至达到60%。至少两个及时分开的测量时段(measurement sessions)被运行,每个都包括带有不同入射辐射(incident radiation)波长的至少两个量度。没有哪种探针适合于达到这样的目的。形式为手指夹具的探针,适合于把超心脏收缩压力施加在病人手指的第一部位上,且把光学量度施加在第一部位下游处的第二部位上,这种探针,在指派给本申请的代理人的待批准的(co-pending)美国专利申请系列第09/407390号中公开了。
发明内容
需要通过提供一种新颖的探测装置,应用于非侵入式光学测量中,来进一步改进对血液参数的非侵入式测量,该新颖的测量能在病人器官(即其手指)的测量部位附近,应用可变的受控压力。
本发明的主要目的是,提供一种装置,它使手指组织和血液体积最佳,从而,为最精确的测量提供条件。
发明人业已发现,被测量信号的精确性,通过在测量部位附近的区域,施加某种低心脏收缩压力(under-systolic pressure)(0至250mmHg),就能大为改进。此种压力,是明显地提高测量精确性所要求的,它可以依不同的病人而有所不同,尤其是依据特定病人的内部血压,还有手指尺寸、形状的单个特性,以及生理情况而定。这种最佳压力的值,还要依据探针装置本身构造的刚性而定。所以,应该提供装置,使得可控地使所施加压力的量级能够变化。
一般而言,本发明提供一种活性的感应装置,它能为特定病人选择最佳压力,从而,使此种压力的施加,为得自该压力的最佳光学测量信号提供正确的参数值,以便测量。换言之,本发明能把病人器官上测量部位的条件,调节成最佳信号测定的。
因此,按照本发明的一个广泛方面,提供一种方法,非侵入地测量病人血液的最少一个参数,该方法包括下列步骤:
(a)把探针装置施加于病人充血的多肉介质上,其中,探针装置负载着光学测量器及加压组件,它们可操作地把可控的、变动着的基本为低心脏收缩压力,施加在该介质的测量部位上;
(b)在上述介质的测量部位上运行许多测量时段,以便探测介质的光反应,并产生该反应所指示的测得数据,且同时变动施加于该测量部位附近的压力,其中,每个测量时段都利用入射光的至少两个不同波长;
(c)分析对应于不同入射光的波长以及不同压力值的介质光反应,并确定最佳压力值,以便利用对应的介质光反应,推导出上述至少一个血液参数。
符合本发明的方法,最好还包括把超心脏收缩压力,施加在测量部位上游的部位上,该上游是相对于介质中血液流动方向而言的,以便形成血液流动停滞状态。在此情况下,就在此种状态期间进行测量。多个分开时间的测量时段,可在单个血液停滞状态期间运行,或在后续的血液停滞状态期间运行。后者那样的运行模式,事实上就是所谓“多次闭塞”,它是连续施加及释放超心脏收缩压力而获得的。
能被测量的参数,包括血液中的血氧饱和度和物质例如血色素、葡萄糖等等的浓度。本发明可以利用校准阶段(calibration stage),在该阶段期间,各种各样的病人经过测量后,把对应于不同血液参数的校准曲线(calibration curves),作为所施加的低心脏收缩压力的函数来标示。
入射光的波长,选择得与要测量的参数相一致。最好连续应用几种不同的波长,以便在相同的测量时段内获得数据,而不同的血液参数就是从该数据推导出的。
符合本发明的探针装置,使用载有测量器的手指夹具,以及加压组件,它们均由控制系统操作。测量器通常包括照明系统和检测系统,视情况而定,测量器被布置得检测被反射或被传送的光。加压组件被设计得便于把可变的受控压力,施加于测量部位附近的组织。
一般而言,探针装置可与任何其他适合的病人器官,例如病人的手或手腕,结合起来用。如果考虑用在病人的手上,那么,就用刚性连接件与病人的手臂配合,以防止该连接件在肘关节处折叠。然而,更为实用的是,把该装置用在病人的手指上。
手指夹具为夹子形式的,它把指尖固定在夹具的夹脚之间,并载有测量器。夹子可形成得带有一对或两对脚。四脚设计则能便利地为手指提供四侧支撑,从而,就防止夹具在末梢指骨处折叠。当该装置被操作时,就使用一对操纵臂打开及关闭夹子。在两脚设计的情况下,脚的扩张起到了操纵臂的作用。在四脚设计的情况下,操纵臂通过任何适当的机构与夹脚相连接,这就能使所有的夹脚都枢转移动。
加压组件是气动类型的。按照本发明的一个实施例,加压组件包括风箱状箍带,它以自己相反的末端被互连在操纵臂之间,且它连接着被控制系统操作的驱动器。因此,袖子的扩张和挤压就操作了操纵臂的枢转移动,从而,减弱或增强了夹脚的夹持效果。按照本发明的另一个实施例,加压组件包括气球状平坦的衬垫,该衬垫连接着夹子的上部夹脚与挠性衬垫状构件之间的夹子内侧,该构件与病人手指接触,从而,在夹子下方的手指部分上施压。在此情况下,配置一个锁闭装置,以防止夹子敞开。按照本发明的又一个实施例,加压组件包括环状衬垫,当探针装置被操作时,该衬垫连接着夹子内侧,以便包裹手指。控制系统操作衬垫的扩张与挤压。
因此,根据本发明的另一个方面,提供一种探针装置,以便用于非侵入地光学测量病人的血液参数,该探针装置包括手指夹具,该夹具带有夹子构件,使手指被固定在该构件的夹脚之间,其中,手指夹具支承着对手指上的测量部位进行光学测量的测量器,且夹具载有加压组件,该组件可被操作得把可控变动的、基本上是低心脏收缩压力,施加于手指的上述测量部位附近处。
探针装置可以带有氧浓度计一起用,其中,施加可控变动的低心脏收缩压力,就能使该探针装置从测量到的信号中,推导出更多的信息。这种信息包含脉冲信号和/或交流/直流比的最大幅度。
因此,根据本发明的又一个方面,配置利用上述探针装置的脉冲-氧浓度计,并配置一个控制系统,该系统操作加压组件和测量器,并产生可指示测得参数的数据。
探针装置最好还包括另一个加压组件,该组件也可以是气动类型的,且由与上述加压组件所用者同样的驱动装置所操作。这另一个加压组件的目的,是为了施加超心脏收缩压力,以便引起血流停滞状态,并能做闭塞依据式(occlusion-based)测量。超心脏收缩压力被施加于测量部位上游的部位上,该上游是相对于正常血液流动方向而言的。
另一个加压组件最好通过一个基本为刚性的连接件,连接着夹子,该连接件沿着中间指骨及最接近的指节间(intephalangeal)关节而接触手指。这与这样的事实有关,即闭塞依据式测量并非为测定体积的,且被测量着的手指部分的血液的体积不符合此种测量的要求。然而,受压(超心脏收缩压力)的手指有一种自然趋向,就是在最接近的指节间(intephalangeal)关节处折叠,从而导致不符合要求的血液体积变化。在测量期间,为中间指骨区域处的手指提供基本上为刚性的支承,就能避免此种不符合要求的折叠。
本发明还提供光学测量装置,用于非侵入地测量病人的血液参数,该装置包括:
—一个手指夹具,它附着在病人手指上,其中,手指夹具为夹子构件形式的,该构件把手指尖固定在构件的夹脚之间,并支承着测量器,使得可以在手指的测量部位上进行光学测量;
—第一加压组件,该组件可操作地把超心脏收缩压力施加在相对于正常血液流动方向的上述测量部位上游的病人手指部位上,以便在上述测量部位处形成血液流动停滞状态;
—第二加压组件,该组件与手指夹具结合,并可操作地把合乎要求的压力,施加于上述测量部位附近处的手指上;以及
—控制系统,它选择性地操作第一和第二加压组件,并选择性地操作测量器,该控制系统具有处理器,用于接受对于来自测量器的测得信号加以指示的数据,并分析该数据。
附图说明
为了理解本发明并明白它可以怎样实施,下面,参照附图,仅以非限定性举例的方式,来说明推荐实施例,在这些附图中:
图1是符合本发明一个实施例的探针装置的示意略图;
图2是符合本发明另一个实施例的探针装置的示意略图;
图3是符合本发明又一个实施例的探针装置的示意略图;
图4a至4d以图解所显示的试验结果,是以符合本发明探针装置的不同操作方式而获得的。
具体实施方式
参看图1,图中显示了探针装置,它统一被标示为10,该装置应用于病人手指F上,对病人的血液参数,例如血氧饱和度、血压,或者各种物质例如血色素、葡萄糖、胆固醇的浓度以及其他被分析物的浓度,进行非侵入式测量。探针10的形式为手指夹具12,它安装在病人手指F上,并与控制系统14相连接。
手指夹具12的形式为夹子构件16,该构件具有夹脚,在本例中为两只夹脚16A与16B,它们以轴17为枢轴,用于把病人手指F固定在它们之间。一对操纵臂18A与18B,使夹脚做枢转移动,以便把探针装置附着在病人手指上。夹子构件16载有安装在其内侧上的测量器20,以便对病人手指上的测量部位L1做光学测量。在探针装置10中还配置了加压组件24,该组件与手指夹具12相结合。在本例中,探针装置10用来做闭塞依据式测量。为达到此目的,还配置了另一个加压组件22,它用来把超心脏收缩压力施加在它下方的充血的多肉介质上。当进行血氧定量法式测量时,加压组件22的配置可以省略。
加压组件(第一组件)22由空气箍带25和气压驱动器26组成,空气箍带的形式为包裹着病人手指F的环,而气压驱动器通过管子27连接着箍带25。那个环在相对于正常血液流动方向而言的测量部位L1上游的部位L2处,包裹着手指F。当加压组件22被启动时,就被操作得把超心脏收缩压力,例如220至300mmHg的压力(通常而言,对于每个特定病人是可以调节的),施加在部位L2处,从而,在测量部位L1处产生血流停滞状态。箍带25由一个基本上是刚性的连接件28,连接着夹子构件16。刚性的板状连接件28沿着中间的指骨而与手指配合,以防止折叠在远处的指节间(intephalangeal)关节上,从而避免了不合要求的血液体积变化。连接件28的形状为板状的,且它被设计得能使箍带25沿着连接件28的轴线,相对于夹具16做往复滑动移动。这样,就能把整个手指夹具12的长度,调节为每个特定病人的手指长度。例如,尽管没有专门显示,但也可知道,板状连接件能形成得带有长槽,而箍带环则形成得带有一个突出部,在该突出部中装有该槽,用以使连接件沿着自己的轴线做往复滑动移动。
在图1所示的本例中,另一个(第二个)加压组件24由风箱状空气箍带29组成,该箍带通过管子31而连接着气压驱动器30。通过适当地扩张或挤压箍带29,夹脚的夹持效果就被调节得便于把合乎要求的压力,施加在病人手指的测量部位L1附近处。然而,应当注意,普通的气压驱动器也能操作箍带25和29这两者。
再如图1所示,一对挠性热电偶衬垫32(或内置加热器的衬垫),例如由橡胶或硅树脂所制的衬垫,配置在夹脚16A和16B的内表面上。衬垫32连接着被对应的控制系统14所操作的电源(未显示),该电源把适当的、基本上是低电压(例如范围在1V至24V)送给衬垫32,使它能在测量部位处把手指加热到36度至38度。探针装置的加热能力,增加了非侵入式探测所得血液参数的准确性。一方面,加热所需的基本上为低的电压供应,对于医疗装置而言是能接受的,另一方面,可以使用电池,从而,便于携带整个装置。
测量器20并不形成为本发明的一部分,因此,无需专门显示和说明,但要注意,它包括统一标示为34之处的主要构造部分例如照明组件和检测组件,且它产生指示手指的光反应的数据。一般而言,当以反射模式操作时,照明组件和检测组件不能容纳在手指那一侧,而当以发射模式操作时,则不能容纳于对着手指的那一侧。这些反射出或发射出的信号,把手指的光反应显示为发射辐射。根据上述PCT申请所公开的闭塞依据式技术,测量器为手指的照明,提供了至少两种不同的波长,且检测经该波长而发射的光。
照明器最好包括多个光源(例如发光二极管),用于在接近红外光谱处,以多个不同的波长,照明测量部位。这样,就能同时确定不同的血液参数。波长是根据所确定的参数而选择的。例如,假如要确定血色素的浓度,所选择的波长的范围,在此范围下血色素和血浆的吸收特性表达得更为清晰,即,在600至1000nm和1100-1400nm的范围内。假如要确定血氧饱和度,所选择的波长,其范围,使血色素(Hb)与氧基血红素(HbO2)之间的差异表达得比较清晰,该范围是600至780nm(在此范围内,血色素与氧基血红素的灵敏度的差异最大)和820至980nm(参考范围)。当涉及到葡萄糖浓度时,可以把1500至1600nm的光谱范围,添加给上述600至1300nm的范围,以便选择波长。
所产生的指示了被检测的光(被照明介质的光反应)的数据,被传送给控制系统14,以便处理和分析。为达到此目的,控制系统14包括由适当的软件操作的处理器36,以便分析检测到的信号,并确定合乎要求的病人血液参数,如下文要参照图4a至4d所进一步专门说明的那样。
因此,第一和第二加压组件22和24的每个驱动器26和30,当由对应地利用控制系统14而启动时,就分别操作得把所要求的压力,施加在部位L1和L2的手指部分上。加压组件24首先被启动,且当某个低心脏收缩压力被施加在测量部位L1附近时,控制系统14就启动加压组件22,以便向部位L2施加超心脏收缩压力。当血液流动停滞状态形成时,控制系统14就操作测量器20,以不同的波长照射测量部位,并检测光反应。超心脏收缩压力的施加(在部位L2处)保持一段时间,以便不致引起手指不可回撤的变化,接着,控制系统操作驱动器26而释放该压力。加压组件24施加不同值的低心脏收缩压力,加压组件22被操作得运行另一段闭塞-释放时段。在每段此种闭塞-释放时段中,测量部位的光反应,被作为时间的函数而确定。有效率的测量值,即必须加以分析的结果,是在血流停滞状态下所取得的。
装置10的操作模式,可以是让控制系统14启动测量器20,以便在开始施加超心脏收缩压力之前进行持续的测量。在此情况下,只有那些信号,即与血液停滞有关的信号,才被加以考虑。在这种状态形成之前的时期中所采取的测量,应当不予考虑,因为运动的和/或其他的人造物品不可避免的影响,使光的发射出现非单调的波动。按照装置10的一个可选操作模式,控制系统14在施加超心脏收缩压力之后的短时间里,启动测量器20。在与血液停滞的状态存在所对应的时期中,有相对的光发射,它达到最大值,且通常延续一秒钟到几分钟。
为了获得显著结果,要么两个及时分离的测量时段应当加以考虑,要么在血液停滞期间至少考虑它们当中的一个,或者从血液停滞状态形成之后,就要考虑开始单一的长的持续测量时段。在第一测量时段中,控制系统14操作得把箍带25和衬垫29保持在它们受挤压的位置上,且把加热元件32操作得加热测量部位附近的手指。然后,控制系统14操作气压驱动器26和30,使它们释放压力。箍带25的挤压作用停止了,在由控制器中相应的软件预设的短时延迟之后,血液流量明显增大,直至其达到新的备用状态为止。接着,控制系统14在过渡的血液流动状态下,启动第二测量时段。照明组件继续照射手指,但挤压却暂停了。检测组件,它由控制系统14同步操作,此时就检测手指的光反应。换言之,控制系统14选择性地操作测量器20及加压组件22和24,并分析来自测量器的数据,如下文要说明的那样。
参见图2,该图显示符合本发明另一个实施例的探针装置100。为了便于理解,同样的标号被用来表示在装置10和100中共同的部件。装置100的构造大体上相似于装置10,但手指夹具112的设计略微不同。在此装置中,加压组件124使用了一个箍带状的衬垫129,它通过管子31连接着气压驱动器30。换言之,第二加压组件124的构造大体上相似于第一组件22,但它是与测量部位L1结合而在该部位施加低心脏收缩压力。加热元件32可以连接着与手指皮肤接触的衬垫129的表面。装置100的操作,相似于装置10的操作。然而应当注意,加压组件124可以与组件24(见图1)结合使用,而不是代替它。
图3显示了探针装置200,该装置设计得与前面说明的例子略微有些差别。在此装置中,加压组件224,它是用来把超心脏收缩压力施加于测量部位L1的,包括气球状的平坦衬垫229,该衬垫被容纳在挠性衬垫32与夹脚16B的内表面之间,或容纳在衬垫32之内,且通过管子31连接着驱动器30。为了防止夹子构件敞开,当该构件处于衬垫229的扩张位置上时,就适当地配置一个锁闭机构230。
应当注意,尽管没有专门显示,但夹子构件可为设计为四脚的,在此种情况下,一对夹脚配合在手指尖和手指根上,且另一对夹脚与手指的相反一侧配合。此种对手指尖的四侧支撑,防止了该构件折叠在末梢指骨上,从而,就防止了不合乎要求的血液体积变化。
还应当注意,刚性连接件28可以位于病人手指的任何一侧上。可选的是,一对此种可用的连接件,位于手指相反的两侧上。另外,处理器可以容纳在箍带25之内,如果有电线连接着处理器与测量器20的输出电路的话,那么,该电线可以穿过刚性连接件。
现在来看图4a至4d,本发明的优良性能,在这些图中以图表显示了。图4a和4b分别显示了图线G1和G2,它们代表以探针装置10的两种不同模式所获得的试验结果,这两种模式就是当加压组件24处于其主动(操作的)与被动(非操作的)状态下的模式。每条图线G1与G2,对应于血色素浓度,该浓度是以测量器20所获得的测量数据而推导出的,这些图线是一种常规技术(侵入式)所获血色素浓度的函数。为了标示每条图线,采用了10个测量点。结果显示,以加压组件的主动模式,当合乎要求时,最佳的低心脏收缩压力被施加于测量部位,以不同技术所获得的浓度值之间的测得的相关性,约为0.91,且标准误差为0.9。而以加压组件的被动模式来看,这些参数分别为0.79与1.3。
图4c和4d的例子,显示的是本发明的技术,该技术能把测定为合乎要求的、最佳的压力,用加压组件24,施加于特定的病人。图4c显示了4条图线H1、H2、H3和H4。图线H1和H2对应于参数斜度(parametric slope),该参数斜度是组件24所施加之压力的函数,其中,参数斜度是由两对不同波长获得的,分别为:(1)λ1=660和λ2=940nm以及(2)λ1=1300和λ2=940nm。
测定血液的物质浓度的斜度依据式(slope-based)技术,公开在了分派给本申请代理人的上述PCT申请中。参数斜度被确定为在某个时间间歇(例如长的闭塞)或在及时分开的闭塞阶段(即多个闭塞-释放时段),光波λ2的发射对数(transmission logarithm)即Log(λ2)与光波λ1的对数Log(λ1)。应当明白,斜坡依据式技术也可以与脉冲-血氧定量法合用。在此情况下,斜度对应于能使血液参数确定的交流/直流比。换言之,参数斜度是Log(λ2)与Log(λ1)的线性函数,其斜度例如可用已知的线性回归算法来确定。
图线H3和H4分别对应于作为上述参数斜度所用的压力函数的斜度错误(即标准误差)。为了确定斜度错误,就以相同的光波对子来取用许多测量时段,对应于所计算的参数斜度,且确定标准误差的值。如图中清楚显示的那样,图线H1中斜度的最大值(0.55),它代表用于测定血氧饱和度的某种结果标准,对应于图线H3中压力值约为100mmHg的相应斜度错误的最小值(0.04)。相似地,图线H2中斜度的最小值(0.35),它代表另一个结果标准,对应于图线H4中压力值约为100mmHg的相应斜度错误的最小值(0.04)。因此,此压力就是对于此特定病人的最佳压力,且应当在光学测量期间施加于该人手指上测量部位附近处。
图4d显示了测得信号的幅度,它是所施加压力的函数。如图所示,在某种压力值(约为120mmHg)下,该幅度达到其最大值。
所以,试验结果显示出,病人血液的光学参数,例如光反应的斜度及幅度,是随压力变动而变化的。这样,就能选择最佳的压力值(或范围),以便增强测量的准确性,且获得更好的结果。一般来说,最佳压力值的确定,是以某种光学标准为基础的,例如以最小标准误差、测得光学信号的最大幅度、交流/直流比、参数斜度等等为基础的。应当明白,上述例子中的压力值,仅仅是与试验中所用探针的特定设计相关的,且对于不同的病人和不同的探针构形,则可以有所不同。如上所述,探针的构造零件,其刚性会影响用于优化测量结果的最佳压力。
专业人员都清楚,可以对以上所述的本发明的推荐实施例,加以各种变动和修改,只要不背离随附的权利要求书中各个权项限定的范围就行。

Claims (17)

1.一种方法,它用于非侵入地光学测量病人血液的至少一个参数,该方法包括下列步骤:
(a)把探针装置施加于病人充血的多肉介质上,其中,探针装置负载着光学测量器及加压组件,它们可操作地把可控的、变动着的基本为低心脏收缩压力,施加在该介质的测量部位上;
(b)在上述介质的测量部位上运行许多测量时段,以便探测介质的光反应,并产生该反应所指示的测得数据,且同时变动施加于该测量部位附近的压力,其中,每个测量时段都利用入射光的至少两个不同波长;
(c)分析对应于入射光的不同波长及不同压力值的介质光反应,并确定最佳压力值,以便利用对应的介质光反应,推导出上述至少一个血液参数。
2.根据权利要求1所述的方法,其特征在于:上述最佳压力值,被确定为对应于某种光学标准之结果的压力值。
3.根据权利要求2所述的方法,其特征在于:标准结果至少利用一个下列参数:最小标准误差、最大光反应幅度、交流/直流比、参数斜度。
4.一种探针装置,用于非侵入地光学测量病人的血液参数,该探针装置包括:一个手指夹具,该夹具带有夹子构件,使手指被固定在该构件的夹脚之间,其中,手指夹具支承着对手指上的测量部位进行光学测量的测量器,且夹具载有加压组件,该组件可被操作得把可控变动的、基本上是低心脏收缩压力,施加于手指的上述测量部位附近处。
5.根据权利要求4所述的探针,还包括另一个加压组件,它可操作地把超心脏收缩压力,施加于测量部位上游的病人手指的一个部位上,该上游是相对于正常血液流动方向而言的,以便在上述测量部位上引起血流停滞状态。
6.根据权利要求4所述的探针,其特征在于:上述加压组件与夹子构件的操纵臂结合,以便可控地变动固定在夹脚之间的手指尖上的夹脚的压力。
7.根据权利要求4所述的探针,其特征在于:上述加压组件包括风箱状箍带,它以自己相反的末端被互连在操纵臂之间,且它连接着被控制系统操作的气压驱动器,该驱动器选择性地可操作得供应可控的可变动压力。
8.根据权利要求4所述的探针,其特征在于:上述加压组件与测量部位结合,且被容纳在夹子构件的内侧上。
9.根据权利要求8所述的探针,其特征在于:上述第二个加压组件包括连接着气压驱动器的箍带状衬垫,该驱动器选择性地可操作得供应可控的可变动压力。
10.根据权利要求4所述的探针,其特征在于:上述加压组件包括基本上平坦的气球状的衬垫,该衬垫连接着气压驱动器,气球状平坦的衬垫,被容纳在上部夹脚的内表面与基本上是挠性的衬垫之间,该挠性衬垫与病人的手指相接触。
11.根据权利要求4所述的探针,其特征在于:上述另一个加压组件,包括空气衬垫箍带环,它包裹着上述测量部位上游的那个部位,且气压驱动器连接着箍带环,以便把上述超心脏收缩压力施加于那个上游部位。
12.根据权利要求11所述的探针,还包括基本上为刚性的连接件,该连接件位于夹子构件与另一个加压组件的一个零件之间,该加压组件位于手指的上述那个上游部位上,且该连接件适合于沿着手指的中间指骨及最接近的intephalangeal关节而接触手指,从而防止该连接件在测量期间折叠。
13.根据权利要求12所述的探针,其特征在于:上述连接件可使另一个加压组件的上述零件,沿着手指,相对于夹子构件做往复移动。
14.根据权利要求4所述的探针,其特征在于:上述夹子构件的内表面上配置了挠性构件,用于包裹手指的测量部位,该挠性构件是由热电偶材料制成的,用于把上述测量部位加热到合乎要求的温度。
15.根据权利要求5所述的探针,其特征在于:上述测量器,以及加压组件,由控制系统操作,该系统具有处理器,该处理器用于接受和分析来自测量器并指示测得的手指光反应的数据。
16.一种脉冲-氧浓度计,用于非侵入地测量病人的血液参数,该脉冲-氧浓度计包括权利要求4所述的探针装置,以及一个控制系统,该控制系统操作加压组件和测量器,并产生指示测得参数的数据。
17.一种光学测量装置,用于非侵入地测量病人的血液参数,该装置包括:
—一个手指夹具,它附着在病人手指上,其中,手指夹具为夹子构件形式的,该构件把手指尖固定在构件的夹脚之间,并支承着测量器,使得可以在手指的测量部位上进行光学测量;
—第一加压组件,该组件可操作地把超心脏收缩压力施加在相对于正常血液流动方向的上述测量部位上游的病人手指部位上,以便在上述测量部位处形成血液流动停滞状态;
—第二加压组件,该组件与手指夹具结合,并可操作地把合乎要求的压力,施加于上述测量部位附近处的手指上;以及
—控制系统,它选择性地操作第一和第二加压组件,并选择性地操作测量器,该控制系统具有处理器,用于接受对于来自测量器的测得信号加以指示的数据,并分析该数据。
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