System for noninvasive hematocrit monitoring
First Claim
1. A system for determining the hematocrit of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient or in an extracorporeal passageway in communication with the circulatory system of the patient so as to be subjectable to transcutaneous examination in the body part or to noninvasive examination in the extracorporeal passageway, the body part and the extracorporeal passageway defining a blood conduit and the system comprising:
- (a) a blood conduit receiving means for receiving a blood conduit containing the flowing blood of the patient;
(b) emission means for directing radiation into the flowing blood within the blood conduit, said emission means being situated within said blood conduit receiving means, said radiation defining a directed radiation comprising;
(i) a first quantity of a radiation at a first radiation wavelength which, when directed into the flowing blood in the blood conduit,(A) has a first extinguishment value which varies with the hematocrit in the flowing blood and(B) has a second extinguishment value which varies with the plasma in the flowing blood, which second extinguishment value is at least ten times smaller than said first extinguishment value; and
(ii) a first quantity of radiation at a second radiation wavelength, distinct from said first wavelength, which, when directed into the flowing blood within the blood conduit,(A) has a third extinguishment value which for varying hematocrit in the flowing blood is a non-fixed multiple of said first extinguishment value; and
(B) has a fourth extinguishment value which varies with the plasma in the flowing blood, which fourth extinguishment value is at least ten times greater than said second extinguishment value;
(c) detection means for detecting the portion of said directed radiation which passes through both the blood conduit and the flowing blood therein, said detection means being situated within said blood conduit receiving means, said detected portion of said directed radiation comprising;
(i) a second quantity of a radiation at the first radiation wavelength, and(ii) a second quantity of a radiation at the second radiation wavelength;
(d) calculation means for determining the hematocrit of the patient by operating exclusively on the second quantities of the first and second radiation wavelengths.
8 Assignments
0 Petitions
Accused Products
Abstract
A system for determining the hematocrit transcutaneously and noninvasively. Disclosed are a finger clip assembly and an earlobe clip assembly, each including at least a pair of emitters and a photodiode in appropriate alignment to enable operation in either a transmissive mode or a reflectance mode. At least two, and preferably three, predetermined wavelengths of light are passed onto or through body tissues such as the finger, earlobe, or scalp, etc. and the extinction of each wavelength is detected. Mathematical manipulation of the detected values compensates for the effects of body tissue and fluid and determines the hematocrit value. If a fourth wavelength of light is used which is extinguished substantially differently by oxyhemoglobin and reduced hemoglobin and which is not substantially extinguished by plasma, then the blood oxygen saturation value, independent of hematocrit, may be determined.
It is also disclosed how to detect and analyze multiple wavelengths using a logarithmic DC analysis technique. Then a pulse wave is not required. So this method may be utilized in states of low blood pressure or low blood flow.
246 Citations
53 Claims
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1. A system for determining the hematocrit of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient or in an extracorporeal passageway in communication with the circulatory system of the patient so as to be subjectable to transcutaneous examination in the body part or to noninvasive examination in the extracorporeal passageway, the body part and the extracorporeal passageway defining a blood conduit and the system comprising:
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(a) a blood conduit receiving means for receiving a blood conduit containing the flowing blood of the patient; (b) emission means for directing radiation into the flowing blood within the blood conduit, said emission means being situated within said blood conduit receiving means, said radiation defining a directed radiation comprising; (i) a first quantity of a radiation at a first radiation wavelength which, when directed into the flowing blood in the blood conduit, (A) has a first extinguishment value which varies with the hematocrit in the flowing blood and (B) has a second extinguishment value which varies with the plasma in the flowing blood, which second extinguishment value is at least ten times smaller than said first extinguishment value; and (ii) a first quantity of radiation at a second radiation wavelength, distinct from said first wavelength, which, when directed into the flowing blood within the blood conduit, (A) has a third extinguishment value which for varying hematocrit in the flowing blood is a non-fixed multiple of said first extinguishment value; and (B) has a fourth extinguishment value which varies with the plasma in the flowing blood, which fourth extinguishment value is at least ten times greater than said second extinguishment value; (c) detection means for detecting the portion of said directed radiation which passes through both the blood conduit and the flowing blood therein, said detection means being situated within said blood conduit receiving means, said detected portion of said directed radiation comprising; (i) a second quantity of a radiation at the first radiation wavelength, and (ii) a second quantity of a radiation at the second radiation wavelength; (d) calculation means for determining the hematocrit of the patient by operating exclusively on the second quantities of the first and second radiation wavelengths. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A system for determining the hematocrit of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient or in an extracorporeal passageway in communication with the circulatory system of the patient so as to be subjectable to transcutaneous examination in the body part or to noninvasive examination in the extracorporeal passageway, the body part and the extracorporeal passageway defining a blood conduit, the system comprising:
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(a) a blood conduit receiving means for receiving a blood conduit containing the flowing blood of the patient; (b) first optical emitter means for directing radiation into the flowing blood within the blood conduit, said first optical emitter means being situated within said blood conduit receiving means, said radiation defining a first directed radiation comprising a first quantity of a radiation at a first radiation wavelength which, when directed into the flowing blood in the blood conduit is posessed of the following properties; (i) a frequency that is near isobestic for oxyhemoglobin and reduced hemoglobin in the flowing blood; (ii) a first extinguishment value which varies with the hematocrit in the flowing blood; and (iii) a second extinguishment value which varies with the plasma in the flowing blood, which second extinguishment value is at least ten times smaller than said first extinguishment value; (c) second optical emitter means for directing radiation into the flowing blood within the blood conduit, said second optical emitter emission means being situated within said blood conduit receiving means, said radiation defining a second directed radiation comprising a first quantity of radiation at a second radiation wavelength, distinct from said first wavelength, which, when directed into the flowing blood within the blood conduit is posessed of the following properties; (i) a third extinguishment value which for varying hematocrit in the flowing blood is a non-fixed multiple of said first extinguishment value; and (ii) a fourth extinguishment value which varies with the plasma in the flowing blood, which fourth extinguishment value is at least ten times greater than said second extinguishment value; (d) third optical emitter means for directing radiation into the flowing blood within the blood conduit, said third optical emitter emission means being situated within said blood conduit receiving means, said radiation defining a third directed radiation comprising a first quantity of a radiation at a third radiation wavelength distinct from said first and second radiation wavelengths and which, in combination with one of the first or second radiation wavelengths, is independent of hematocrit, and which, when directed into the flowing blood in the blood conduit is posessed the following properties; (i) a fifth extinguishment value which varies with the competing biologic constituent concentration in the flowing blood, said fifth extinguishment value being at least five times greater than said second extinguishment value; and (ii) a sixth extinguishment value which varies with the concentration of components other than the competing biologic constituent concentration in the flowing blood; (e) photodetection means for detecting the portion of said first, second and third directed radiation which passes through both the blood conduit and the flowing blood therein, said photodetection means being situated within said blood conduit receiving means, said detected portions comprising; (i) a second quantity of a radiation at the first radiation wavelength, (ii) a second quantity of a radiation at the second radiation wavelength, (iii) a second quantity of a radiation at the third radiation wavelength; and (f) positioning means for holding the first optical emitter means, the second optical emitter means, the third optical emitter means, and the photodetection means such that the radiation path from the first, second, and third optical emitter means to the photodetection means are approximately equal; (g) calculation means for the following; (i) mathematically operating on the second quantities to the first, second, and third radiation wavelengths such that the spatial, geometric, and tissue variations are eliminated in each wavelength (ii) mathematically operating on the second quantities of the first, second, and third radiation wavelengths to compensate for the effect of the competing blood constituent, and (iii) determining the hematocrit of the patient; and (h) display means for providing a visually perceptible indication of the hematocrit. - View Dependent Claims (27, 28, 29)
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30. A system for determining the desired biologic constituent concentration of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient or in an extracorporeal passageway in communication with the circulatory system of the patient so as to be subjectable to transcutaneous examination in the body part or to noninvasive examination in the extracorporeal passageway, the body part and the extracorporeal passageway defining a blood conduit, the system comprising:
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(a) a blood conduit receiving means for receiving a blood conduit containing the flowing blood of the patient; (b) emission means for directing radiation into the flowing blood within the blood conduit, said emission means being situated within said blood conduit receiving means, said radiation defining a directed radiation comprising; (i) a first quantity of a radiation at a first radiation wavelength which, when directed into the flowing blood within the blood conduit, (A) has a first extinguishment value which varies with the desired biologic constituent concentration in the flowing blood and (B) has a second extinguishment value which varies with the concentration of components other than the desired biologic constituent in the flowing blood, which second extinguishment value is at least ten times smaller than said first extinguishment value; and (ii) a first quantity of a radiation at a second radiation wavelength, distinct from said first wavelength, which, when directed into the flowing blood within the blood conduit, (A) has a third extinguishment value which for varying concentrations in the flowing blood of the desired blood constituent is a non-fixed multiple of said first extinguishment value and (B) has a fourth extinguishment value which varies with the concentration of components other than the desired biologic constituent in the flowing blood, which fourth extinguishment value is at least ten times greater than said second extinguishment value; (c) detection means for detecting the portion of said directed radiation which passes through both the blood conduit and the flowing blood therein, said detection means being situated within said blood conduit receiving means, said detected portion of said directed radiation comprising; (i) a second quantity of a radiation at the first radiation wavelength, and (ii) a second quantity of a radiation at the second radiation wavelength; and (d) calculation means for determining the desired biologic constituent concentration by operating exclusively on the second quantities of the first and second radiation wavelengths. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
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52. A method for determining the hematocrit of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient or in an extracorporeal passageway in communication with the circulatory system of the patient so as to be subjectable to transcutaneous examination in the body part or to noninvasive examination in the extracorporeal passageway, the body part and the extracorporeal passageway defining a blood conduit and the method comprising the steps of:
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(a) placing the blood conduit within a blood conduit receiving means with the flowing blood in the blood conduit; (b) directing radiation into the flowing blood within the blood conduit using a radiation generation means situated within the blood conduit receiving means, said radiation defining a directed radiation comprising; (i) a first quantity of a radiation at a first radiation wavelength which, when directed into the flowing blood within the blood conduit, (A) is extinguished substantially the same amount by oxyhemoglobin and reduced hemoglobin in the flowing blood and (B) is extinguished by the plasma in the flowing blood in a first manner; and (ii) a first quantity of radiation at a second radiation wavelength which, when directed into the flowing blood within the blood conduit, (A) is extinguished substantially the same amount by oxyhemoglobin and reduced hemoglobin in the flowing blood and (B) is extinguished by the plasma in the flowing blood in a second manner substantially different from said first manner; (c) detecting the portion of said directed radiation which passes through both the blood conduit and the flowing blood therein with a radiation detection means situated within said conduit receiving means, said detected portion of said directed radiation comprising; (i) a second quantity of a radiation at the first radiation wavelength being detected by steps comprising; (A) determining the extinguishment of the total first radiation wavelength; (B) determining a first radiation wavelength pulsatile value representing the difference between the maximum and the minimum extinguishment of a pulsatile component of the first radiation wavelength; (C) determining the ratio between the first radiation wavelength pulsatile value and the extinguishment of the total first radiation wavelength over a period of time; and (D) determining a first mean ratio value over a period of time of the ratio between the first radiation wavelength pulsatile component and the average extinguishment of the first radiation wavelength, and (ii) a second quantity of a radiation at the second radiation wavelength; and (d) operating on the second quantities of the radiations at the first and second radiation wavelengths to determine the hematocrit of the patient.
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53. A system for determining the hematocrit of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient or in an extracorporeal passageway in communication with the circulatory system of the patient so as to be subjectable to transcutaneous examination in the body part or to noninvasive examination in the extracorporeal passageway, the body part and the extracorporeal passageway defining a blood conduit and the system comprising:
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(a) a blood conduit receiving means for receiving a blood conduit containing the flowing blood of the patient; (b) emission means for directing radiation into the flowing blood within the blood conduit, said emission means being situated within said blood conduit receiving means, said radiation defining a directed radiation comprising; (i) a first quantity of a radiation at a first radiation wavelength which, when directed into the flowing blood in the blood conduit, (A) is extinguished substantially the same amount by oxyhemoglobin and reduced hemoglobin in the flowing blood and (B) is extinguished by the plasma in the flowing blood in a first manner; and (ii) a first quantity of a radiation at a second radiation wavelength which, when directed into the blood flowing within the blood conduit, (A) is extinguished substantially the same amount by oxyhemoglobin and reduced hemoglobin in the flowing blood and (B) is extinguished by the plasma in the flowing blood in a second manner substantially different from said first manner; (c) detection means for detecting the portion of said directed radiation which passes through both the blood conduit and the flowing blood therein, said detection means being situated within said blood conduit receiving means, said detected portion of said directed radiation comprising; (i) a second quantity of a radiation at the first radiation wavelength, and (ii) a second quantity of a radiation at the second radiation wavelength; (d) calculation means for determining the hematocrit of the patient by operating on the second quantities of the first and second wavelengths, wherein the calculation means includes means for determining the logarithmic intensity ratio of the second quantities of the first and second radiation wavelengths.
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Specification