Method and device for the noninvasive determination of hemoglobin and hematocrit
First Claim
1. A method for the non-invasive determination of hemoglobin concentration and hematocrit value in human tissue, said method comprising the steps of:
- (a) setting the temperature of an area of skin of a body part to a first temperature, said first temperature being below the core temperature of the body, (b) performing an optical measurement in which at least one light introduction site on the surface of said skin is illuminated by a light beam at a plurality of wavelengths and the light re-emitted from the underlying dermal layers is collected at at least one light collection site, the at least one light introduction site and the at least one light collection site being separated by at least one sampling distance, the at least one sampling distance between said at least one light introduction site and said at least one collection site being selected to restrict the sampling depth of said body part to within the epidermis layer and dermis layer only, whereby contributions from light re-emitted from adipose tissue and muscle tissue are minimized and contributions from light re-emitted from the epidermis and dermis layers are collected, said temperature being maintained at a constant value during said optical measurement, (c) setting the temperature of said area of said skin of said body part to at least a second temperature that is within the physiological temperature range, (d) repeating step (b) at said at least second temperature, (e) determining a plurality of optical parameters at each temperature and determining the dependence of at least one of said aforementioned optical parameters on temperature, (f) establishing a calibration relationship that relates (1) at least one of said plurality of optical parameters at a given temperature and (2) the dependence of at least one of said plurality of optical parameters on temperature with the concentration of hemoglobin or the hematocrit value measured independently, and (g) determining the concentration of hemoglobin or the hematocrit value by means of a subsequent determination of the plurality of optical parameters at a given temperature and the dependence of the at least one of said aforementioned optical parameters on temperature and the calibration relationship established in step (f), wherein said biological sample comprises intake human tissue.
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Abstract
A method for the determination of hemoglobin and hematocrit by means of an apparatus that is capable of controlling the temperature of a defined subcutaneous volume of human skin. The method involves a calculation of hemoglobin concentration and hematocrit value that takes into consideration the values of optical parameters of the sample at various pre-set temperatures. The apparatus and method employ steady state optical measurements of samples, such as, for example, human tissue, by means of a reflectance tissue photometer and localized control of the temperature of the sample. According to the method of this invention, an optical signal from a defined subcutaneous volume of human skin is measured as the temperature of this volume is controlled. The method and apparatus of this invention allow determination of hemoglobin concentration and hematocrit value non-invasively in a population of subjects having different skin colors by means of steady state reflectance measurements. The method of this invention for determination of hemoglobin concentration and hematocrit value is useful for monitoring patients, testing at the point of care, and screening for anemia. In contrast to other attempts in the prior art that rely on signals of cardiac pulses, the method of this invention has the advantage for the determination of analytes in weak cardiac pulse situations, such as, for example, in elderly patients.
140 Citations
23 Claims
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1. A method for the non-invasive determination of hemoglobin concentration and hematocrit value in human tissue, said method comprising the steps of:
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(a) setting the temperature of an area of skin of a body part to a first temperature, said first temperature being below the core temperature of the body, (b) performing an optical measurement in which at least one light introduction site on the surface of said skin is illuminated by a light beam at a plurality of wavelengths and the light re-emitted from the underlying dermal layers is collected at at least one light collection site, the at least one light introduction site and the at least one light collection site being separated by at least one sampling distance, the at least one sampling distance between said at least one light introduction site and said at least one collection site being selected to restrict the sampling depth of said body part to within the epidermis layer and dermis layer only, whereby contributions from light re-emitted from adipose tissue and muscle tissue are minimized and contributions from light re-emitted from the epidermis and dermis layers are collected, said temperature being maintained at a constant value during said optical measurement, (c) setting the temperature of said area of said skin of said body part to at least a second temperature that is within the physiological temperature range, (d) repeating step (b) at said at least second temperature, (e) determining a plurality of optical parameters at each temperature and determining the dependence of at least one of said aforementioned optical parameters on temperature, (f) establishing a calibration relationship that relates (1) at least one of said plurality of optical parameters at a given temperature and (2) the dependence of at least one of said plurality of optical parameters on temperature with the concentration of hemoglobin or the hematocrit value measured independently, and (g) determining the concentration of hemoglobin or the hematocrit value by means of a subsequent determination of the plurality of optical parameters at a given temperature and the dependence of the at least one of said aforementioned optical parameters on temperature and the calibration relationship established in step (f), wherein said biological sample comprises intake human tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for the determination of hemoglobin and hematocrit in human body, said method comprising the steps of:
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(a) setting the temperature of an area of skin of a body part to a given temperature, the given temperature being below the core temperature of the body, (b) performing an optical measurement in which at least one light introduction site on the surface of the skin is illuminated by a light beam at a plurality of wavelengths and the light re-emitted from the underlying dermal layers is collected at at least one light collection site, the at least one light introduction site and the at least one collection site being separated by at least one sampling distance, the at least one sampling distance between the at least one light introduction site and the at least one light collection site being selected to restrict the sampling depth of the body part to within the epidermis layer and dermis layer only, whereby contributions from light re-emitted from adipose tissue and muscle tissue are minimized and contributions from light re-emitted from the epidermis and dermis avers are collected, the given temperature being maintained at a constant value during the optical measurement, whereby the optical measurement generates a measurable signal corresponding to at least one optical parameter, (c) correlating the measurable signal of step (b) with hemoglobin concentration or hematocrit value determined by an independent method to establish a calibration relationship, and (d) determining the concentration of hemoglobin or the hematocrit value from a signal from a subsequent optical measurement and the calibration relationship of step (c), wherein said biological sample comprises intact human tissue. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification