CN1882277A - 监测葡萄糖水平的方法 - Google Patents
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Abstract
监测或测量人体或动物血液中葡萄糖浓度的方法使用无创伤技术和包括测量血液中的声速、血液的传导性和血液的热容,或通过无创伤测量任何其它能用来计算葡萄糖水平的参数。其后,计算对于这三个测量中每一个的葡萄糖水平(102、108、114),最终的葡萄糖值由这三个计算的葡萄糖值的加权平均来确定(126)。
Description
技术领域
本发明涉及针对特定疾病的药物和治疗,具体地说,涉及使用无创伤技术监测人体和动物血液中葡萄糖水平的方法。
背景技术
正如在医疗领域中公知的那样,为诊断目的测量的重要血液组分之一是葡萄糖,特别是对于糖尿病患者。测定血糖浓度的公知和典型方法是确保血样安全并将该血样应用于酶促加药的比色纸或电化学探针。通常,这通过手指针实现。对于需要每天多次测量血糖的糖尿病患者来说,这种方法带来极大的不适、皮肤特别是被扎手指的剧烈疼痛以及感染。
多年来,已经有很多用于监测和测量人体和动物中葡萄糖水平的方法。然而,这些方法通常包括创伤技术(invasive technique),因此对患者来说具有一定的风险,或者至少会带来不适。近来,一些无创伤技术已经得到发展,但他们仍然不能稳定地提供血糖的最佳测量。目前还没有实践上确认的解决方案。
Thomas(US专利5,119,819)教导了一种监测血糖的无创伤方法,但它只基于以超声波脉冲的两端传播时间为基础的声速测量。
Gozani(US专利5,771,891)公开了一种用于血液分析物测量的无创伤方法。首先,电刺激内源性组织,然后检测对于刺激形成的电响应。一个实施方案显示电刺激缺氧性末梢神经,然后检测沿该神经形成的复合动作电位。
Cho(US专利5,795,305和5,924,996)使用联合温度测量红外辐射或热传导来测定葡萄糖浓度。
Chou(US专利5,941,821和6,049,728)通过光声测量测定血糖,其中声脉冲是通过用电磁辐射加热患者皮肤产生的。
在每种现有技术中,只测量了一个(或在一种情况下两个)参数。因而,误差的可能性增加。本发明使用三个不同参数的测量方法测定血糖浓度,从而实质上提高了测量的准确度。此外,现有技术中没有使用任何导电性和热容的测量,而这是本发明测量的两个参数。
因此,需要更准确的测量葡萄糖水平的无创伤方法,通过检测多个参数实现。
发明内容
本发明的这个和其他目的通过使用无创伤技术监测或测量人体和动物血液中葡萄糖浓度的方法而实现,该方法包括使用两种、三种或更多不同技术的同时测量以得到更准确可靠的结果,其中这些技术彼此互利。
该方法使用如下所述三种技术的任意联合:
测量体内血液中的声速,
测量血液的传导性,利用电磁感应,
测量血液的热容,通过改变所测批量的温度。
优选的,这些测量可通过例如耳垂进行。
通过测定患者血液的三个物理性质,可推断出血液中血糖的浓度。需要测量的特定物理性质是声速、导电性和热容。
该方法可用于:
1.单一试验,使用两种或三种技术,或者
2.连续试验,使用一种、两种或三种技术,或者
3.上述(1)和(2)的联合技术。
附图说明
图1-4是显示用每个参数的单一测量测定葡萄糖水平的方法的流程图。
图5是显示用单一参数的连续测量测定葡萄糖水平趋势的方法的流程图。
具体实施方式
该测量概念基于三种技术:血液中的声速、血液的传导性和血液的热容。具体地说,该方法使用这三种技术中任意一种的联合,同时或顺序进行。
首先,要测定:
体内血液中的声速,
血液的传导性,利用电磁感应,
血液的热容,通过改变所测批量的温度。
优选的,这些测量可通过例如耳垂进行。因而,基于这样得到的参数可计算出葡萄糖水平。
在单一测量模式(SM)中,使用这三种方法,设备开始测量程序。如下所述,将不同结果进行分析和对比,从而概括数据并显示组合结果。
在连续测量模式(CM)中,使用这三种方法,设备如在SM中一样开始。如下例行测量基于单一方法,并以预定间隔重复进行。每进行一些测量,或进行一定时间后,该设备根据全部三种测量自动进行一次详细测量,并进行自身校正。该方法也用于校正下述结果。
不同参数的结果通过预定的容差窗口(tolerance window)进行检验,其检验组合结果的可靠性。一旦不同结果满足该容差,该最终结果即是所有单一测量的加权平均。当一个或多个测量结果的偏差超出该容差窗口,则该方法首先根据选择树检验该偏差是否能接受,如果能,则给出最后结果。如果该偏差不能接受,则该方法指令开始新一轮测量。如果全部结果超出容差,则也会发生这种情况。
在连续测量模式中,当使用单一技术时,以一定的预定时间间隔自动进行联合测量,从而补偿漂移并重新校正结果。
血液中的声速与血液中葡萄糖浓度有关。例如超声波信号通过耳垂传输,击中另一侧的声短路并返回到接收元件。基于该测量,则葡萄糖水平可通过已知方式进行计算。
此外,传导性水平是血液中葡萄糖水平的函数。例如,在耳垂处引起具有已知参数的电磁信号,而由感应引起的电流水平取决于葡萄糖水平。测量并分析电流振幅从而得到葡萄糖水平。
溶液,这里指血液,的热容是其成分的函数。例如,将已知量的能量施加于耳垂,并引起其温度的改变。该梯度的强度是葡萄糖水平的函数,由于其是控制变化成分。测量该强度是为了将其与葡萄糖水平关联。
一旦测定了速度、传导性和热容,就可根据这三种参数中每一个的测量结果计算出葡萄糖水平。然后,评价这三个葡萄糖值从而判断全部三个值在规定的容差水平内是否相同。如果它们相同,则根据这三个葡萄糖水平的加权平均确定葡萄糖水平。如果一个结果超出容差,则利用更严的容差检验其它两个;如果它们都满足要求,则计算最后结果。
还应当指出,本发明的优点通过测量三个参数实现,而非现有技术中常用的仅仅一个,然后检验以判断这些测量是否在特定容差内,接着计算加权平均。具体参数,如声速、传导性和热容仅用于说明目的。如果使用其它参数的无创伤测量并检验结果以保证它们在可接受的容差范围内,接着计算加权平均,这也将落入本发明的范围内。这样的话,本发明的方法的作用将会完全一样。可以无创伤方式测量的其它参数有:声阻抗、电/磁系数、热传导、弹性、血密度、比重、偏振系数、光散射、核磁共振、分析物、血液和人体温度、热波效应、从身体自然发射的红外辐射、组织对刺激的响应以及电性能例如电动势或电流。因而,本发明不仅仅使用声速、传导性和热容的测量,而且包括使用这些参数中的一个或两个与一个或两个其它参数的测量,或者甚至是全部使用三个其它参数。本发明的精髓是三个参数的无创伤测量,而使用什么参数并不重要,只要它们是可以测定葡萄糖水平的参数。
该方法有两种操作模式:单一和连续测量。在单一模式中,采用单一测量(对于全部三种方法)。如果结果在预定容差窗口内,则结束测量,否则,重复该方法。在连续模式中,通过使用全部三种方法进行第一测量,然后,重复地,只使用单一技术(例如,只用声),从而根据第一(联合)测量作为参考测量趋势。进度由用户预先确定(如果他需要不同于默认的时段),可预定在例如大约10分钟至2小时的范围。在连续模式中,每一持续时段(大概在两小时量级左右),或在进行预定数量的测量后,通过(自动)使用全部三种技术进行自身校正过程,并将结果校正的更准确。
可通过两种方式之一测定容差。一种方式是对比不同测量的结果并检验它们之间的偏差,限定在一定的比例内(大概在10%或15%量级左右)。第二种方式是检验每个结果和前一结果之间的偏差。在这种情况下,偏差水平是测量间隔时间的函数。此处的量级可在大约20%(对于短时段)至大约50%(甚至更大)(对于长时段)之间变化。
对于单一测量,该方法要求该3种不同参数的单独测量。每个结果乘以其相关校正因子(离线计算),从而将所有结果转化成相同测量单位(即:mg/dl)。然后,对比这些结果。如果全部三个结果是相似的,在特定容差窗口内(例如:结果1=结果±10%,且结果2=结果3±10%,且结果1=结果3±10%),则加权平均最后结果将会如下进行计算:最后结果=(结果1×相对重量1)+(结果2×相对重量2)+(结果3×相对重量3)。如果只有2个测量给出相似的结果,而第三个超出容差窗口,则该算法检验这两个相似结果是否在较窄的容差窗口(例如5%)内。如果是,则最后结果是这两个结果的加权平均,而计数器(涉及第三方法)将会使其状态加一。当该计数器达到一定限制,其会向用户显示警报,通知该具体方法中的问题,并要求用户重新校正。在三种方法给出不同读书的情况(全部三个超出宽容差窗口,或一个超出宽窗口而两个超出窄窗口)下,该方法自动(无需用户的任何干预)重复该测量。如果该问题重复超过一定次数,例行程序警告测量无效,并要求用户重新校正。
每个测量的权重取决于具体测量方法的可靠性。这些数值通常将会在临床试验中测定。在其中这3中测量方法都同等可靠的情形中,加权因子是相同的,等于1/3(0.333…)。使用“相对重量”变量的目的是考虑到一种事实情况,即在某些情形中,由于所用具体测量方法的原因,一个测量可能比另一个更准确。例如,如果一个测量比其他的更可靠,可赋予它更高的权重(例如,0.5),而其他的将会得到(例如)0.2和0.3(权重的总和应当为1或100%)。通过实施例,假定所有方法给出相同读书(比如,95mg/dl),因此,最后结果将是:0.5×95+0.2×95+0.3×95=95。
只要存在合理结果,该方法在当前用户的目录下记录该结果,以及该结果的日期和时间,并在用户的屏幕上显示该结果。
对于连续测量,用户规定自动校正之间的测量数,且测量是使用单一(持续)方法以预定进度重复进行的。每次测量数通过预定数值时,如在单一测量情况下一样,使用全部三种方法进行完整测量。记录和显示结果的相同方法用于该过程。
在图1-4中,流程图解释单一测量程序。首先(参看图1),进行这些测量之一102,例如测量声速,但它可以是在无创伤方式中测量的任何参数。然后,将其乘以任何必要的校正因子104,接着以某种方式记下葡萄糖水平的该值106。重复该程序以进行其他测量,例如导电性和热容或者可通过无创伤方式测量的任何其他选择参数,这样,对于这三个参数的每一个都有一个值(步骤108-112和114-118)。
在这一点上,例行程序检验以确定第一参数葡萄糖测量是否在第二参数葡萄糖测量的可接受偏差范围内120。如果是,则检验以确定第一参数葡萄糖测量是否在第三参数葡萄糖测量的可接受偏差范围内122。在这两个值也足够接近时,则例行程序检验以确定第二参数葡萄糖测量是否在第三参数葡萄糖测量的可接受偏差范围内124。
(下面,为了方便使用描述流程图的术语,在使用术语“第一测量”时是指“第一参数葡萄糖测量”,并且同样适用于第二和第三测量。)
确定全部三个测量在彼此的可接受偏差范围内后,计算加权平均126。这为用户提供了葡萄糖水平的最后结果,然后其可以任何适当方式记下来以备将来参考128。这将结束单一测量程序。
在例行程序检验并确定第一测量不在第二测量的可接受偏差范围内时200,则(参见图2)例行程序检验以判断第一测量是否在第三测量的可接受更严偏差范围内202。如果不在,则对比第二和第三测量以确定第二测量是否在第三测量的可接受更严偏差范围内204。在这两个测量也不在可接受限制内时,则有这样的情形,其中三个测量中没有一个在其它两个测量的可接受偏差范围内,则这些测量不能用。计数器加一以记下不成功程序206。如果还没有达到不成功例行程序的预定数208,则例行程序返回到开始(A)并重复整个程序。如果计数器显示不成功例行程序的预定数,则相反,该例行程序停止210,单一测量例行程序结束212。然后,给用户产生一个信号以重新校正整个例行程序的测量程序。
在例行程序确定第一测量不在第二测量的可接受偏差范围内,但(参见图2)该例行程序接着确定第一测量在第三测量的可接受更严偏差范围内时,将第二测量的权重设为0而将其它两个测量的权重分别增加,计算加权平均(步骤214)。将计数器增量以显示第二测量偏离其它测量太多216。这为用户提供了葡萄糖水平的最后结果,然后其可以任何适当方式记下来以备将来参考218。这将结束单一测量程序。在计数器显示第二参数的很多测量偏离太多时220,给用户产生一个信号以重新校正第二参数的测量程序222。
在例行程序确定第一测量不在第二测量的可接受偏差范围内并且第一测量不在第三测量的可接受更严偏差范围内,但(参见图2)该例行程序接着确定第二测量在第三测量的可接受更严偏差范围内时,将第一测量的权重设为0而将其它两个测量的权重分别增加,计算加权平均(步骤224)。将计数器增量以显示第一测量偏离其它测量太多226。这为用户提供了葡萄糖水平的最后结果,然后其可以任何适当方式记下来以备将来参考228。这将结束单一测量程序。在计数器显示第一参数的很多测量偏离太多时230,给用户产生一个信号以重新校正第一参数的测量程序232。
在例行程序确定第一测量在第二测量的可接受偏差范围内,但该例行程序接着确定第一测量不在第三测量的可接受偏差范围内时300,则(图3)该例行程序检验确定第二测量是否在第三测量的可接受更严偏差范围内302。在这两个测量也不在可接受限制内时,则也会有这样的情形,其中三个测量中没有一个在其它两个测量的可接受偏差范围内,则这些测量不能用。计数器加一以记下不成功程序304。如果还没有达到不成功例行程序的预定数306,则例行程序返回到开始(A)并重复整个程序。如果计数器显示不成功例行程序的预定数308,则相反,该例行程序停止,单一测量例行程序结束。然后,给用户产生一个信号以重新校正整个例行程序的测量程序。
在例行程序确定第一测量在第二测量的可接受偏差范围内,但确定第一测量不在第三测量的可接受偏差范围内,接着确定第二测量在第三测量的可接受更严偏差范围内时,将第一测量的权重设为0而将其它两个测量的权重分别增加,计算加权平均(步骤310)。将计数器增量以显示第一测量偏离其它测量太多312。这为用户提供了葡萄糖水平的最后结果,然后其可以任何适当方式记下来以备将来参考314。这将结束单一测量程序。在计数器显示第一参数的很多测量偏离太多时316,给用户产生一个信号以重新校正第一参数的测量程序318。
在例行程序确定第一测量在第二和第三测量的可接受偏差范围内,但确定第二测量不在第三测量的可接受偏差范围内时400,该例行程序(图4)检验以确定第一测量是否在第三测量的可接受更严偏差范围内402。如果不在,则对比第一和第二测量以确定第一测量是否在第二测量的可接受更严偏差范围内404。在这两个测量也不在可接受限制内时,则有这样的情形,其中三个测量中没有一个在其它两个测量的可接受偏差范围内,则这些测量不能用。计数器加一以记下不成功程序406。如果还没有达到不成功例行程序的预定数408,则例行程序返回到开始(A)并重复整个程序。如果计数器显示不成功例行程序的预定数410,则相反,该例行程序停止,单一测量例行程序结束。然后,给用户产生一个信号以重新校正整个例行程序的测量程序。
在例行程序确定第一测量在第三测量的可接受更严偏差范围内时,将第二测量的权重设为0而将其它两个测量的权重分别增加,计算加权平均(步骤412)。将计数器增量以显示第二测量偏离其它测量太多414。这为用户提供了葡萄糖水平的最后结果,然后其可以任何适当方式记下来以备将来参考416。这将结束单一测量程序。在计数器显示第二参数的很多测量偏离太多时418,给用户产生一个信号以重新校正第二参数的测量程序420。
另一方面,如果第一测量不在第三测量的可接受更严偏差范围内时,则将第一测量与第二测量进行对比,从而判断它们是否在可接受更严偏差范围内404。如果在,将第三测量的权重设为0而将其它两个测量的权重分别增加,计算加权平均(步骤422)。将计数器增量以显示第三测量偏离其它测量太多424。这为用户提供了葡萄糖水平的最后结果,然后其可以任何适当方式记下来以备将来参考426。这将结束单一测量程序。在计数器显示第三参数的很多测量偏离太多时428,给用户产生一个信号以重新校正第三参数的测量程序430。
图5解释连续测量程序。首先,使用单一测试程序,对于三个参数中每一个得到一个值。接着,用户必须设定自动校正前的测量数和测量之间的间隔(除非用户决定使用在前的数)502。
现在,计数器自动加一504。如果现在计数器达到了自动校正前的测量数506,连续测量例行程序的当前部分结束,并且该例行程序回到单一测量程序,这样对于三个参数中每一个得到新值,并可开始新的连续测量部分。
如果不是进行自动校正的时间,则测量选择参数(例如,速度的第一参数)508。将其乘以校正因子510并以任何适当方式记下得到的葡萄糖值512。在这点上,例行程序计数时间。当合适时间间隔发生时514,该例行程序回到开始(步骤504)并重复该过程。
虽然参考具体实施方式详细描述了本发明,但应当理解为其它各种变型也可实现,且也在本发明的精神和范围内。
Claims (19)
1.一种确定患者血液中葡萄糖水平的无创伤方法,包括以下步骤:
a.无创伤测量患者血液中的声速;
b.无创伤测量患者血液的导电性;
c.无创伤测量患者血液的热容;
d.对于声速、血液的导电性和血液的热容测量中的每一个计算相应的葡萄糖水平;
e.对比这三个计算的葡萄糖水平;和
f.1.如果全部三个计算的葡萄糖水平在预定容差水平范围内是相似的,则通过确定这三个计算的葡萄糖水平的加权平均来计算最后葡萄糖水平;或
2.如果这三个计算水平中只有两个在预定容差水平范围内是相似的,则通过确定所述这两个相似的计算的葡萄糖水平的加权平均来计算最后葡萄糖水平。
2.如权利要求1所述的无创伤方法,还包括以下步骤:
g.根据所述步骤a-c中任意一个重复测量所述的速度、传导性或热容参数中之一;
h.对于所述步骤g中的参数测量计算相应的葡萄糖水平;和
i.定时重复所述步骤a-f以确保葡萄糖计算的准确性。
3.如权利要求1所述的无创伤方法,其中声速是通过测量在体内传输的超声波信号而确定的。
4.如权利要求1所述的无创伤方法,其中血液的导电性是通过电磁感应确定的。
5.如权利要求1所述的方法,其中血液的热容是通过改变所测批量的温度而确定的。
6.一种确定患者血液中葡萄糖水平的无创伤方法,包括以下步骤:
a.无创伤测量能用于计算葡萄糖水平的身体的三个不同参数;
b.对于这三个测量的每一个计算相应的葡萄糖水平;
c.对比这三个计算的葡萄糖水平;和
d.1.如果全部三个计算的葡萄糖水平在预定容差水平范围内是相似的,则通过确定这三个计算的葡萄糖水平的加权平均来计算最后葡萄糖水平;或
2.如果这三个计算水平中只有两个在预定容差水平范围内是相似的,则通过确定所述这两个相似的计算的葡萄糖水平的加权平均来计算最后葡萄糖水平。
7.如权利要求6所述的无创伤方法,还包括以下步骤:
e.重复测量所述参数中之一;
f.对于所述步骤e中的参数测量计算相应的葡萄糖水平;和
g.定时重复所述步骤a-d以确保葡萄糖计算的准确性。
8.如权利要求6所述的方法,其中所述的能用于计算葡萄糖水平的身体的三个不同参数选自体内的声速、传导性、血液的热容、声阻抗、电/磁系数、热传导、弹性、血密度、比重、偏振系数、光散射、核磁共振、分析物、血液温度、人体温度、热波效应、从身体自然发射的红外辐射、组织对刺激的响应、电性能、电动势和电流。
9.如权利要求1的无创伤方法,其中对于每个计算的葡萄糖水平的权重是基于相应参数测量的可靠性的。
10.如权利要求6所述的方法,其中对于每个计算的葡萄糖水平的权重是基于相应参数测量的可靠性的。
11.如权利要求2所述的方法,其中在预定量的时段后重复步骤a-f。
12.如权利要求2所述的方法,其中在预定数的测量后重复步骤a-f。
13.如权利要求7所述的方法,其中在预定量的时段后重复步骤a-d。
14.如权利要求7所述的方法,其中在预定数的测量后重复步骤a-d。
15.如权利要求1所述的方法,其中如果计算的葡萄糖水平之一不在预定容差水平范围内,则检验剩下两个计算的葡萄糖水平以确保它们在更严容差范围内,并且接着通过确定所述这两个相似的计算的葡萄糖水平的加权平均来计算最后葡萄糖水平。
16.如权利要求6所述的方法,其中如果计算的葡萄糖水平之一不在预定容差水平范围内,则检验剩下两个计算的葡萄糖水平以确保它们在更严容差范围内,并且接着通过确定所述这两个相似的计算的葡萄糖水平的加权平均来计算最后葡萄糖水平。
17.如权利要求1所述的方法,包括以下额外步骤:每次计算的葡萄糖水平之一不在容差水平范围内时给计数器增量;和当该计数器显示计算的葡萄糖水平不在该容差水平范围内的预定次数时重新校正测量程序。
18.如权利要求6所述的方法,包括以下额外步骤:每次计算的葡萄糖水平之一不在容差水平范围内时给计数器增量;和当该计数器显示计算的葡萄糖水平不在该容差水平范围内的预定次数时重新校正测量程序。
19.一种确定患者血液中葡萄糖水平的无创伤方法,包括以下步骤:
a.无创伤测量能用于计算葡萄糖水平的身体的三个不同参数;
b.对于这三个测量的每一个计算相应的葡萄糖水平;
c.通过确定这三个计算的葡萄糖水平的加权平均来计算葡萄糖水平;
d.重复测量所述参数中之一;
e.对于所述步骤d中的参数测量计算相应的葡萄糖水平;和
g.定时重复所述步骤a-c以确保葡萄糖计算的准确性。
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TR200600651T2 (tr) | 2007-01-22 |
ZA200600989B (en) | 2007-05-30 |
EP1656065B1 (en) | 2011-07-06 |
ATE515230T1 (de) | 2011-07-15 |
ES2367023T3 (es) | 2011-10-27 |
JP2007521098A (ja) | 2007-08-02 |
JP4538691B2 (ja) | 2010-09-08 |
IL173695A0 (en) | 2006-07-05 |
CA2536133C (en) | 2010-12-14 |
KR20060061838A (ko) | 2006-06-08 |
IL173695A (en) | 2010-11-30 |
RU2006104991A (ru) | 2006-07-27 |
BRPI0413762B1 (pt) | 2020-12-01 |
US6954662B2 (en) | 2005-10-11 |
CN100546535C (zh) | 2009-10-07 |
EP1656065A2 (en) | 2006-05-17 |
AU2004264570A1 (en) | 2005-02-24 |
EP1656065A4 (en) | 2010-03-03 |
US20050043602A1 (en) | 2005-02-24 |
AU2004264570B2 (en) | 2009-04-23 |
KR100926155B1 (ko) | 2009-11-10 |
WO2005017642A3 (en) | 2005-08-04 |
BRPI0413762B8 (pt) | 2021-06-22 |
WO2005017642A2 (en) | 2005-02-24 |
MXPA06001917A (es) | 2006-05-17 |
CA2536133A1 (en) | 2005-02-24 |
BRPI0413762A (pt) | 2006-11-14 |
RU2376927C2 (ru) | 2009-12-27 |
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