CN1100514C - 适用于低饱和度的脉冲血氧计传感器及血氧饱和度的测量方法 - Google Patents
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Abstract
一种脉冲血氧计传感器(410),其中包括对于低氧饱和度最优化以最大程度地减少人为扰动影响的光源。可取的是,采用一个红光光源(112)和红外光源(114),其中红光光源(112)的平均波长在700-790nm之间。红外光源(114)可以具有与用于具有高饱和度的病人的已有技术相同的平均波长。本发明的传感器还通过设置发光管(112、114)与光探测器(116)之间的间隔以使测量对于人为扰动的敏感性最小而实现最优化。本发明将所选择的波长最优化以使红光光源和红外光源的吸收系数与散射系数的乘积更接近一致。这种最优化处理使得当有扰动现象,诸如力的变化、组织成分变化和氧饱和度本身变化存在时测量值更加确定。
Description
发明背景技术
脉冲血氧计用于在手术室、观察室、特护病房连续监测成人、儿童和新生儿的动脉血氧饱和度,在普通病房中的应用也在不断增加。此外还需要产房中用脉冲血氧计在分娩过程中监测胎儿的供氧状态,以及用于监测心脏病人的血氧状态。
脉冲血氧计通常用于其动脉血氧饱和度大于90%,即动脉血液中功能血红蛋白的90%以上是氧合血红蛋白,不到10%的血红蛋白是还原血红蛋白的患者。这类患者的氧饱和度很少低于70%。如果氧饱和度降低到这样低的一个值,就会表现出不健康的临床症状,通常需要手术。在这种情况下,高度准确地测定血氧饱和度与临床的关系,不象确定其随时间变化的趋势与临床的关系密切。
常规的两波长脉冲血氧计从两个发光二极管(LEDs)向搏动组织床发射光,并周位于相对表面的(透射型脉冲血氧计),或位于相邻表面的(反射型脉冲血氧计)一个光电二极管收集透射光或散射光。发光二极管和光电探测器封装在一个可重复使用的或一次性使用的传感器中,该传感器与脉冲血氧计的电路部分和显示部分相连。脉冲血氧计中的“脉冲”来自于在心脏血液循环过程中组织中动脉血液的时间变化量,由于循环重复的光衰减,光探测器输出的信号经过处理后生成所熟知的体积描记图波形。为了测量氧饱和度,两个发光二极管中至少有一个的主要波长必须选择在电磁光谱中氧合血红蛋白(HbO2)的吸收与还原血红蛋白(Hb)的吸收不同的某个点处。两个发光二极管中的第二个的波长必须选择在该光谱的一个不同点上,此外,这一点上Hb与HbO2之间的吸收率差别与第一波长处是不同的。市售的脉冲血氧计利用了可见光谱中660nm附近的近红波段的一个波长,和可见光谱中880-940nm范围内的近红外波段的另一个波长(见图1)。如在本申请中所使用的含义,“红”波长或“红”波谱是指电磁波谱中600-800nm的部分;“近红”是指600-700nm的部分;“远红”是指700-800nm的部分;“红外”或“近红外”是指800-1000nm的部分。
检测和处理光探测器中产生的光电流以测量红光和近红光信号的调制比。如图2所示,可以看到这个调制比与动脉氧饱和度的相关性很好。可以通过在一组病人、健康的志愿者或动物的活体内测量动脉氧饱和度(SaO2),再测定与该测量范围相应的调制比来实验标定脉冲血氧计和脉冲血氧计传感器。所观测到的相关性则反过来用于在实时测量的调制比值的基础上测算氧饱和度(SpO2)。(如本申请中所用的含义,SaO2表示在活体内测得的官能饱和度,而SpO2表示利用脉冲血氧计测量的官能饱和度。)
常规脉冲血氧计所使用的发光管波长的选择基于以下几个因素,但是并不局限于这些,即信号穿过充血组织的最佳透射性、对于动脉血氧饱和度变化的敏感度、和市售发光二极管在所需波长的发光强度和有效性。通常,两个波长之一选自HbO2的消光系数与Hb的消光系数明显不同的吸收光谱区域(图1)。这个接近660nm的区域中还原血红蛋白对光的吸收率与氧合血红蛋白对光的吸收率之比最大。660nm波段的高强度发光二极管也容易购得。为了数值上的便利,红外波长通常选择在接近805nm的区域(等吸光点),或选择在880-940nm波段内,在这一波段由于Hb和HbO2成反比的吸收关系可以得到增强的灵敏度。不过,使用波长在660nm波段和900nm波段的一对发光二极管的脉冲血氧计在低血氧饱和度情况下都表现出准确度下降。
EP-0522674讨论了发光频率范围为500-1000nm的一种卤光源,利用一个光栅分光谱仪对所说光谱进行分频。采用利用3个或更多变量的多变量算法计算30%-100%范围内的血氧饱和度值。
发明概述
根据本发明,通过使第一和第二光源的波长谱最优化实现了利用脉冲血氧计对于低动脉氧饱和度的更加准确的测量,从而与采用常规的第一和第二波长谱相比改善了对于低饱和度值的饱和度测量,而同时却使对于高饱和度值的饱和度测量受到的不利影向减到最小程度。已经发现如果第一波光谱的预期的或预计的吸收率和散射率比选择常用的波长光谱时,例如采用中心在660nm的第一波长和中心在880-940nm范围内任何一点的第二波长时更加接近,最好是等于第二波长光谱的吸收率和散射率,则可以明显提高在低饱和度下的计算准确性。
本发明解决了一个长期的需求,即对可以在低氧饱和度情况,即饱和度等于或小于80%、75%、70%、65%、或60%时比现有技术中的脉冲血氧计能够更加准确地测量动脉血氧饱和度的脉冲血氧计传感器和系统的需求。这种传感器和系统对于测量分娩过程中的活胎儿的动脉血氧饱和度是十分有用的,在这种情况下最重要和有意义的饱和度范围通常是15%到65%;对于测量活着的心脏病人的动脉血氧饱和度也是特另有用的,这种病人的静脉血液会在心脏中明显地分流到他们的动脉中,所以对于他们十分重要和有意义的饱和度范围大约是在50%到80%之间。相对照而言,一个通常的健康人的饱和度大于90%。当一个活体,人或动物的饱和度处于较低范围时本发明是有用的。
除了在低饱和度时可以更准确地测量动脉血氧饱和度,当存在人为的扰动并且发生在所监视的对象上时,本发明的传感器、监视器和系统还可以更好和更加准确地测量氧饱和度。
当利用该第一和第二波长谱测得的组织的吸收率和散射率与具有特殊意义的饱和度值接近时,就会改善利用第一和第二波长实际测得的组织饱和度的对应性和一致性,于是有力地减小了由于人为扰动导致的误差。例如,当一个波长的光被吸收的比率明显高于其它波长的光时,其它波长的光会更显著地穿透到组织中。当被检测的组织特别不均匀时,光穿透深度的差别对于动脉血氧饱和度测量的准确性具有明显的相反的影响。
人为扰动包括,但是不限于,任何对于被检测的介质的相对的光学特性的测量具有影响的人为效应。人为扰动包括,但是不限于,以下所列:
(1)利用传感器检测的组织成分随着测试对象的不同而不同,即,其中脂肪、骨质、脑髓、皮肤、肌肉、动脉、静脉等等的相对含量的变化;
(2)被检测的组织中血红蛋白浓度的变化,例如由脉管扩张或脉管收缩,和任何其它影响血液在被检测组织中的灌注的物理原因所引起的变化;
(3)施加在传感器和被检测的组织之间的力量的变化,于是影响到附近组织中存在的血量。
在一个实施例中,本发明提供一种具有适合于胎儿血氧饱和度范围的光源,并且能够最大程度地免除人为扰动的胎儿脉冲血氧计传感器。可取的是使用一种远红和红外光源,其中远红光源的平均波长为700-790nm。红外光源可以具有与已有技术中用于高饱和度患者的装置相同的平均波长,即800-1000nm之间。在本申请中所使用的“高饱和度”的意思是指动脉血氧饱和度大于70%,最好大于75%,或者大于80%,也可以大于90%。
本发明的胎儿传感器还特别适于调整发射光进入组织的位置与被探测光从组织中出射的位置之间的间距以使对人为扰动的敏感降到最低。
根据一个优选实施例,光电传感器(例如,LEDs和光电探测器)位于光进出组织的部位。根据另一个实施例,光电传感器远离组织,例如在血氧计监视器中,一些光纤将传感器与用光纤末端照射的组织相连,被组织散射的光由一根光纤的末端采集。最好是采用多根光纤或光纤束。
本发明人认识到胎儿典型的血氧饱和度范围为5-65%,通常为15-65%,相比之下,一个典型的具有正常(高)饱和度的病人的饱和度为90%以上。此外,胎儿传感器受到增加的人为扰动的影响。胎儿血氧计的另一个独特的特点是传感器一般从阴道插入,它停留的准确位置预先是不知道的。
本发明认识到所有这些对于胎儿血氧计或低饱和度病人用的血氧计独有的特征,并提供了一种最适于免除人为扰动影响的传感器。这种适宜性是通过牺牲对于饱和度值变化的灵敏度而实现的。这种折衷的结果是可以更加可靠地计算饱和度,而这对于使用已有技术方法的人来说不是显而易见的,因为已有技术方法的目的是使对饱和度值的变化的灵敏度最大。为实现这些适宜性所作的改进对于反射型和透射型脉冲血氧计传感器都是可以应用的。在美国专利申请No.07/752168中记载了一种可用于本发明的胎儿透射型脉冲血氧计结构的实例,该申请已转让给本发明的受让人,其公开内容在本申请中引用作为参照内容。在美国专利US-4830014中记载了一种可应用于本发明的非胎儿用透射型脉冲血氧计结构,其公开内容在本申请中引用作为参照内容。
附图简介
图1为氧合血红蛋白(HbO2)和还原血红蛋白(Hb)相对于表示现有技术中近红和红外LED波长的波长的吸收特征谱图;
图2为红/红外调制比相对于血氧饱和度的关系图;
图3为表示光透过组织的处在不同深度的不同层的示意图;
图4A表示对于不同的饱和度值在一定范围波长内衰减系数和散射系数变化的曲线图;
图4B为图4A中各种值的列表;
图5为表示一个传感器在胎儿上放置的示意图;
图6为本发明的LED的光谱图;
图7-18表示对于不同的红光和红外光波长组合的调制比和作为饱和度函数的饱和度误差的实验模式;
图19-23表示在羊身上所作的实验中对于发光管波长和发光管探测器间隔的不同组合,饱和度和由于施加力产生的误差的实验数据图;
图24和图25为表示本发明传感器结构的示意图;
图26A-B为用于本发明的单封装、双发光管封装的示意图;
图27为本发明的脉冲血氧计的方框图。
对于优选实施例的详细描述
对于本发明的胎儿传感器设计的理解需要对传感器工作环境有所了解。图3表示可以放置一个传感器的典型的胎儿位置处的组织层面。一般来说,有第一层皮肤12,其下也许是一层脂肪14、一层肌肉16和一层骨骼18。这仅仅是为了说明目的画出的一个简单的示意图。不同位置处的轮廓和层次可以有所变化。例如,在前额处骨头更接近表面,相反,在颈部肌肉更接近表面。这种随位置不同而产生的变化可以产生在由于组织成分变化产生的效应概述中所说的第一种类型的人为扰动。
从发光管20到光探测器22的基本光路用箭头24和26表示。箭头24表示几乎直接从发光管20进入探测器22的光,基本上是经过含有很少血液的组织,从一个分流到另一个之中。另一方面,箭头26表示另一条光路中光的较深穿透。穿透的深度受到光波长和饱和度的影响。例如,在低饱和度情况下,红外光比近红光穿透得更深。由于红外光信号穿过更多不同的层次,较深的穿透会产生红外光和红光信号之间的不希望产生的变化。
图3中还表示使用发光管28的效果,发光管28在组织上与探测器30的距离比上述的第一对20、22之间的距离更大。如所看到的,这种更大的间距导致在组织中的穿透深度更大,如箭头32和34所示。因此,虽然由于有更多的光被组织吸收和更长的光传播距离而使光更大地衰减,从而降低了在探测器中接收到的信号的强度,但是较大的间距也增加了穿透的深度。
在概要中所述的第二种扰动是在不同病人的组织之间或者随着时间变化血液浓度的变化。较低的浓度会导致较低的吸收率,使穿透深度增加。本发明人计算出光子在组织中的平均穿透深度与吸收率和散射系数的乘积相关,这个计算结果与Weiss等人的发现是一致的,参见“从被照射的组织中再发射的光子穿透深度的统计”一文,该文章发表在现代光学杂志1989年第36卷第3期349-359,354页,该篇文献在本申请中作为参考文献。
电磁波谱中可见光和近红外光在组织中的吸收是由血红蛋白的吸收特征所决定的。血红蛋白的吸收系数在一些文献中可以找到,例如Zijistra等人在临床化学37/9,1633-1638,1991中发表的“胎儿和成人的氧合血红蛋白、脱氧血红蛋白、碳氧血红蛋白和正铁血红蛋白的吸收光谱”一文(此文在本申请中作为参考文献)。虽然普遍认为对于波长的相对灵敏度与所用测量方法无关,但是所测量的组织的散射系数受到测量方法和处理数据的数学模型的影响。本发明人所采用的组织散射系数是根据漫散射理论得出的,取自Schmitt的“脉冲血氧计中多种散射效应的简单光子漫散射分析”,生物医学工程IEEE学报,Vol.38,No.12,1991年12月,此文在本申请中作为参考文献。
图4A为表示0%、40%、85%和100%血氧饱和度情况下对于600nm-1000nm波长范围内光波的吸收和散射系数乘积的曲线图。对于85-100%组织血氧饱和度,如曲线101上A点和B点所示对于通常所选择的一对波长(即660nm和892nm),吸收系数散射系数的乘积具有良好的平衡或相关性。
对于较低的组织血氧饱和度,曲线102上的C点和D点表明660nm的近红光和892nm的红外光的吸收系数和散射系数的乘积之间存在明显的不协调,对于近红光的吸收和散射更强。这种吸收和散射的明显不匹配导致用近红光和红外光检测组织的结果差别极大,因而明显地降低了动脉氧饱和度计算的准确性。此外,当需要准确计算较大范围的低动脉血氧饱和度时,例如在监测一个处于分娩过程中的胎儿时,其动脉血氧饱和度可以从15%扩展到65%,从图4A中可以明显地看出不仅近红光和红外光的吸收率和散射率之间存在明显的不匹配,而且不匹配量随着动脉血氧饱和度的变化而非常显著地改变,因此造成对动脉血氧饱和度计算随着动脉血氧饱和度的变化而具有不同的准确性。
另一方面,图4A中曲线102上的D点和E点表明了本发明的一个优选实施例所选择的第一和第二波长,即732nm和892nm的优点,这两个波长在40%的组织氧饱和度情况下比现有技术中的一对波长660nm和892nm具有更接近平衡的吸收和散射特性。可以理解,由于该732nm波长光的消光和散射系数与该892nm波长光的消光和散射系数更加接近地一致,所以用这两个波长的光对组织的检测结果的重合会得到改善。此外,732nm波长光与660nm相比,其作为氧饱和度函数的消光和散射系数的变化较小,因此能够在较宽的饱和度范围内更好和更准确地计算氧饱和度。图4A中所示的氧饱和度值与动脉血氧饱和度值更加相关。一般来说,一个给定的组织氧饱和度对应于一个较高的动脉氧饱和度值。例如,发明人计算出85%的组织氧饱和度对应于大约100%的动脉氧饱和度。
本发明的一个优选实施例是使用于测算分娩过程中的胎儿动脉氧饱和度的传感器的波长最优化,在所说分娩过程中所检测的饱和度通常低于70%,典型的监测范围在15%-65%之间。由于人为扰动在数量和幅度上都很强,所以努力使胎儿传感器所使用的两个波长的吸收率和散射率一致或平衡是十分有用的。例如,对于一个表面反射型传感器,采用已有技术很难知道传感器会放置到胎儿的什么部位。例如,有时它会放置在头部,而有时则会放置在面颊部。因而,组织成分会随着每次的使用而不同。此外,由于在分娩过程中作用在传感器上的力是变化的,所以又会产生其它的人为扰动。
本发明的另一个实施例是将本发明的传感器用于饱和度在50%-80%之间的心脏病患者,对于他们来说计算的准确性是十分重要的。
图5表示一个传感器410在一个胎儿412上的放置状态。该传感器通过一根缆线414与一个位于外部的脉冲血氧计监视器相连。如从图中所见,传感器410嵌入阴道壁416与胎儿412之间。在这个实施例中,传感器位于胎儿头部的侧面。传感器的嵌入在直接位于传感器下面的皮肤上施加了一个力,这减少了光信号从中通过部分的血液量,从而增加了得到准确的血氧饱和度读数的难度。
在选择一个最佳的LED波长时,必须牢记LED有一定频宽,并不象激光器那样是一个单一窄波段波长的器件。图6表示本发明的传感器所用的一个优选波长的频谱分布,如图所示远红波长735nm为峰值波长。但是,箭头510表示在强度近似为峰值波长的50%时的波长分布大约为25nm宽。此外,在制造LED的过程中,很难严密地控制平均波长。例如订货商指定了一个特定的波长,诸如在本发明的一个实施例中为735nm,而应当预料到所接收的LED的实际的平均波长可能偏离指定波长10、20或更多纳米。通过检测和挑选一般可以达到较窄的离散范围。
图27是实施本发明的一个脉冲血氧计的方框图。从光源210发出的光进入病人组织212,发生散射并被光探测器214所探测。一个包含光源和光探测器的传感器200还可以包含一个编码器216,该编码器提供光源210的指示信号以使血氧计可以选择用于计算氧饱和度的适宜的标定系数。编码器216可以,例如,是一个电阻器。
传感器200与一个脉冲血氧计220相连。血氧计包括一个与一条内部总线224相连的微处理器222。与该总线相连的还包括一个RAM存储器226和一个显示器228。一个时间处理单元(TPU)230向光驱动电路232提供定时控制信号,该光驱动电路控制什么时间光源210照明,如果使用了多个光源,则对于不同的光源使用复路定时信号控制。TPU230还控制信号从光电探测器214通过一个放大器233和一个开关电路234的选通。如果使用了多个光源,则根据多个光源中哪一个处于照明状态,在适当的时间对这些信号进行采样。接收到的信号经过一个放大器236、一个低通滤波器238、和一个模数转换器240。然后将数字数据存储在一个串行模块(QSM)242中,以便在以后当QSM242充满后卸载到RAM26中。在一个实施例中,对于所接收的多个光波长或波谱可以有独立的滤波器和A/D转换器的多个平行电路。
一个探测器和解码器模块242确定编码器216中光源的波长。实现这个目的的电路的一个实施例记载在一同转让的US-4770179中,该专利说明书在本申请中引用作为参考文献。
在与光电探测器214所接收的光相应的所接收信号值基础上,微处理器222采用已知的算法计算氧饱和度。这些算法需要一些与例如所使用的光波长对应的系数,这些系数可以通过实验确定。它们存储在一个存储器ROM246中。对于任何一对波长所选择的一组特定的系数是根据由对应于在某一传感器200中的某一光源的编码器216所指示的值确定的。在一个实施例中,可以设计多个电阻器值以选择不同组的系数。在另一个实施例中,同样的电阻器被用于从适合于与一个近红光源或远红光源配对的一个红外光源的系数中进行选择。可以利用控制输入装置254的控制输入信号来确定是选择近红组还是远红组。控制输入装置254可以是,例如脉冲血氧计上的一个开关,一个键盘,或是一个输入来自远处的主计算机的指令的端口。
本发明的发明人采用数学模型和实验样机两种方式来使所提出的传感器实现最优化。存在许多用于描述组织中的光散射的数学模型。发明人所采用的数学模型假定在均匀的组织床中的散射是各向同性的。尽管这是组织中光散射的真实性质的一种简化(组织是不均匀的,光是基本向前方散射的),但是这些模型对于描述脉冲血氧计的操作,和对于许多设计参数的灵敏度是有用的。
利用这样一个模型,可以实现不同波长的LED选择组合。将组织特性数字化定义,对于所考虑的每对波长计算出SaO2和调制率之间的基本(标定)相关性。生理条件的变化可以通过修正一个或多个数字化定义的物理参数来模拟。再利用所得到的调制比计算出SpO2,将其中误差最小的饱和度范围标记出来。对于80%以上的动脉饱和度,已有技术选择的660nm和890nm这一对波长具有最佳性能,而对于低于70%的动脉饱和度,735nm配以890nm波段的发光器件则具有更高的可靠性。
图7至图18表示相对于各种红光和红外光LED波长对,将组织血液体积量改变到基本值的四分之一时的预期误差。A图(如图7A)表示调制比与SaO2的关系图。B图(如图7B)表示饱和度误差与SaO2的关系图。这种扰动模拟在病人群体内血量变化、组织中贫血、局部缺血、或局部放血的效果。
在下面的图表中表示了相对于几对红光和红外光波长,对组织中血液浓度变化标定的灵敏度。在每种情况中,LED没有次级辐射,扰动范围为组织中标称血液浓度2%到0.5%。
红外光LED | |||
红光LED | 805nm | 890nm | 940nm |
660nm | 7 | 8 | 9 |
700nm | 10 | ||
730nm | 11 | 12 | 13 |
760nm | 14 | 15 | 16 |
790nm | 17 | 18 |
图7-9表示在常规脉冲血氧计中存在的特性的类型。图10-18表示当LED波长选择在700-900nm频谱范围时最佳特性区域从饱和度在80%以上变化到较低饱和度时的偏移。光散射受到氧合作用变化的影响最小,但是当组织中的还原血红蛋白转变为氧合血红蛋白时或者当相反过程发生时光吸收受到明显的影响。当两个频道在充血组织中的散射和吸收特性达到平衡时就会形成脉冲血氧计的最佳特性区域。当由两个频道所测得的组织量具有很好的重叠性时平衡就达到了,这要求两个波长的光的穿透深度一致。在较高饱和度的情况下,当一对波长中红光发光管波长在660nm波段时达到最佳平衡,而在较低饱和度情况下,由于使用了730nm波段的红光发光管而改善了平衡。红外光LED波长从805nm变化到940nm对于特性没有明显的影响。
当脉冲血氧计采用接近730nm和890nm的一对LED时,调制比相对于氧饱和度变化的灵敏度(即,例如图1中曲线的斜率)与使用660nm和890nm波长的LED时相比降低了,但是对于除氧饱和度以外的组织特性的测量值变得更加确定了。调制比测量值中由于诸如仪器电子噪声、数字化、或环境光影响等因素产生的噪声变得更加重要,但是通常可以通过很好地设计仪器和适当的信号处理而加以克服。但是当发光管波长是在主要关注的饱和度范围基础上进行选择时,由于组织光学特性产生的偏移和偏差对于这些波长的选择的意义不大了。
本发明人利用样机在羊身上进行了实验。实验观测支持在脉冲血氧计设计中采用735nm波段的红光LED,它在较低饱和度范围内对于人为扰动具有更好的适应能力。反射型脉冲血氧计传感器是采用常规的660nm-890nmLED对,和735nm-890nmLED对制造的。
图19-23表示沿X轴表示的氧饱和度从大约100%到小于10%范围内的测量结果。这些曲线图表示相对于每个实际的饱和度值(SaO2)计算出来的饱和度值(SpO2)。同时还从放置在左股骨动脉中的动脉导管中抽取血样测定实际的饱和度。SaO2利用实验室等价血氧计(仪器标号IL282或辐射计OSM-3)测得。这些值就是在这些图中的X轴上采用的值。
如所看到的,图19、20和22中的对角线表示当计算值等于从动脉血管中测得的实际值时所需要的结果。图19、20和22中所示的检测是将传感器抵住皮肤并施加大约50克的标称力而进行的。
采用660nm的传感器,使发光管/探测器在组织上中心与中心之间相隔14mm,如19表示传感器标定对于所探测组织类型是非常敏感的。在头部和在颈部上标定结果是非常不同的。
采用735nm的传感器,使发光管/探测器在组织上中心与中心之间相隔5.8mm,如图20所示头部与颈部之间的偏差大大减小了。但是对于表面贫血实质上仍然是敏感的。这在图21中表现得很清楚,该图表示了人为扰动(在传感器上施加力)的影响。
图22表示当发光管/探测器中心与中心之间相隔14mm采用735nm传感器时对位置的不敏感性。图23表示这个传感器对于施加到该传感器上的力(人为的扰动)也是不敏感的。
实验证明对于735nm/890nm的LED波长,将发光管/探测器中心与中心之间间隔从5.8mm增大会使对人为扰动的敏感程度降低,当发光管/探测器间隔等于或大于10mm时可以实现优良的特性。
模拟计算和实际实验都表明通过使红光波长在700-790nm的最佳范围内可以改善饱和度测量的可靠性。此外,通过增加发光管与探测器之间的间隔可以使当有力作用时饱和度测量误差减小。
作用在传感器上的力引起表面组织的贫血,进一步增大了由于组织的不均匀性造成的差异,或造成发光管与探测器之间光的分流,从而造成饱和度计算的误差。通过加宽发光管/探测器之间的间隔可以对此加以补偿,这使得从红光和红外光LED中发出的光在组织中穿透得更深,从而一般来说增加了它们穿透具有相同组成的组织结构的可能性,如图3所示。
图24为本发明的一个实施例中的一个传感器的俯视图。传感器表面110上安装有一个远红光LED112和一个红外光LED114。它们与一个探测器116的中心距为14mm。可取的是,远红光和红外光LED的中心之间间距不超过0.5mm。传感器表面通过一根电缆118与一个用于连接到脉冲血氧计的连接器120相连。图25为图24中传感器的侧视图,表示传感器的可转动部分122和传感器背面132。当将传感器放进子宫时,子宫将会在传感器背面132施加一个力,并使转轴122变形。如所看到的,这个技术导致有一个力作用在该传感器上,从而使得传感器-胎儿之间有良好的接触,但是有可能造成组织中局部贫血。应当记住任何传感器实施例都有可能造成局部贫血。
模拟计算和实验测量表明脉冲血氧计中调制比与饱和度的相关性与组织的光学性质有关,通过选择发光管波长可以对变化的人为扰动的灵敏度产生影响。对于高氧饱和度,选择660nm和890nm波段发光管适合于稳定的脉冲血氧计计算,而在低饱和度情况下,700-790nm和890nm波段的发光管性能更好。利用与上述相同的分析,其它波长组合可以从光谱中可见光及近红外光部分中选择。但是,目前,从仪器的总体设计考虑(例如电子信噪比和在反射型探头中采用窄间距部件时可能造成的光的分流),更愿意采用所讨论的波长。利用所述分析,还可能实现脉冲血氧计的其它改进。图19-23表示利用一些传感器样机所作检测的结果。
图26A和图26B为包含图24和25中所示发光管112和114的一体化封装结构的前视图和侧视图。两个发光管都封装在一个半导体管中,以使封装更加紧凑,从而实现最小化,这对于胎儿传感器应用是十分有利的。在图26A所示的实施例中,发光管模112利用导电环氧树脂胶130粘结到基板132上。基板132采用金属板,其外面部分134构成该封装的外部导线。发光管114安装在金属板136的顶部,其外面部分138形成第二导线。
发光管114的电子连接是通过导线138向上穿过导电环氧树脂胶的一端和在导线焊点140上的另一端构成的,所说焊点与另一导线134相连。同样,导线134通过导电环氧树脂胶130与第二发光管112相连,发光管112的另一端通过导线焊点142与导线138相连。所以,如所看到的,在两根导线134和138上施加具有第一极性的电压将使其中一个发光管发光,而关闭另一个,而翻转极性则使发光和关闭的发光管颠倒过来。这些发光管和它们相应的基板都封装在一个外壳144中,该外壳可能是例如塑料制成的。
图26B为侧视图,从侧面表示封装外壳144,表示从发光管112、114中发出的光146。图26A-26B中所示结构是紧凑的,适用于胎儿传感器的用途。可取的是,两个发光管112中心之间的距离小于2mm。这种外壳布线的方式使得该外壳具有两根导线,与四根导线不同,后者需要使用两个分开的发光管外壳。
另一种方案是采用一个远红光和一个红外LED,选择两个不同波长光谱的其它方法也是可以采用的。例如,可以使用激光元件而不是LED。或者,可以使用白光或其它光源同时使其波长对探测器而言是最优化的。这可以通过在光源或者探测器的前面使用适合的滤色器,或者通过使用一个对波长敏感的探测器而实现。如果使用了几个滤色片,可以将它们放置在探测器或者发光管前面,或者可以使滤光片在一个发光管或探测器前面交替地活化。
在宽饱和度范围内使用的脉冲血氧计可以利用多个波长对(例如与一个900nm发光管配对的660nm和730nm波段的发光管两种组合),选择用于在所测算的氧饱和度值的基础上计算SpO2的适合的发光管对。
这样一种脉冲血氧计可以用两个或多个红光LED来实现,或者采用一个光源和多个滤光片,或多个波长敏感的探测器来实现。根据病人的饱和度范围,可以使用不同的红光波谱。
如那些本领域技术人员所理解的,在不脱离本发明的基本特征的前提下可以采用其它具体方式实现本发明。根据本发明波长是可以变化的而仍然保持最优化。而且,根据本发明的构思还可以使用光波导管、光纤、多个滤光片、或多个探测器。可以使用与图25所示的转轴结构不同的传感器,例如球胆结构以使传感器可以浮起和保持在胎儿身上。所以,本发明的范围取决于所附的权利要求书。
Claims (8)
1、一种胎儿脉冲血氧计传感器(200),其特征在于:
具有至少一个光源(210)和至少一个光探测器(214)的外壳,所述光源和探测器以将探测器与光源分隔开并能检测由组织散射后的来自光源的光的方式安装在外壳中,其中光源只提供具有第1光谱和第2光谱的光信号,第1光谱具有在惯常用以量度高血饱和度病人的氧饱和度的从805至940nm的红外范围内的平均波长,而第2光谱具有从700-790nm的平均波长。
2.如权利要求1所述的血氧计传感器,其特征在于:上述光源(210)包括至少第1和第2LED(112,114)。
3.如权利要求1所述的血氧计,其特征在于,上述光源包括发射在805至940nm和700至790nm波长范围的光,并与上述探测器分隔开至少10mm,最好是至少14mm。
4.如权利要求1所述的血氧计传感器,其特征在于:上述光探测器探测有限光谱的光。
5.如权利要求1所述的血氧计传感器,其特征在于:包括有一个放置于光源和光探测器之间的滤光器,用以通过有限光谱的光。
6.如权利要求1至5的任一项所述的血氧计传感器,其特征在于:上述光探测器是个反射探测器。
7.如权利要求1至5的任一项所述的血氧计传感器,其特征在于:上述光探测器是个透射传感器。
8.一种用于测量血氧饱和度的方法,其特征在于,包括以下步骤:
选择远红色和红外光源以及光探测器;
在上述光探测器探测包括对测量高饱和度病人中的氧饱和度有用的红外波长谱的光,探测到的光包括具有平均波长在700-790nm的远红光波长谱;
在上述光探测器测量由组织散射后的来自上述光源的光的强度;
只使用上述红外波长谱和上述远红光波长谱的上述强度决定上述血氧饱和度。
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US08/221,911 US5421329A (en) | 1994-04-01 | 1994-04-01 | Pulse oximeter sensor optimized for low saturation |
US08/221,911 | 1994-04-01 |
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