IP Library Granted Patent US 10,898,082
Granted Patent B2
US 10,898,082 · App. 16/198,834 · Granted Jan 26, 2021

Method and apparatus for non-invasively detecting blood volume imbalances in a mammalian subject

Inventor: Thomas Sandgaard (Castle Rock, CO)
Assignee: Zynex Monitoring Solutions Inc.
A61B5/02042A61B5/02055A61B5/4848A61B5/6826A61B5/6829A61B5/746A61B5/7425A61B5/026A61B5/0531A61B5/443A61B5/7435A61B2505/05A61B2562/029
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Quick Facts
Patent No.
US 10,898,082
App. No.
16/198,834
Granted
Jan 26, 2021
Kind
B2
Abstract

Noninvasive methods and apparatus for detecting blood volume imbalances in a mammalian subject are disclosed. The method includes obtaining baseline measurements of at least three physiological parameters from a subject wherein the parameters are selected from the group consisting of heart rate, electrical body impedance, skin temperature, perfusion index, peripheral blood flow and skin humidity. Measurements of electrical body impedance, skin temperature, perfusion index, peripheral blood flow and skin humidity are taken at one or more extremities of the subject such as the calf, ankle, forearm, thigh, fingers and toes. The physiological parameters for which baseline measurements were obtained are then monitored to detect changes from the baseline measurements that indicate blood volume imbalances. A preferred embodiment comprises computing a baseline blood volume index from the baseline value measurements of each parameter to be monitored and then carrying out the step of monitoring by obtaining real time (current) value measurements of these parameters which are inputted into an algorithm which computes a real time (current) blood volume index based upon the differences between the baseline and real time (current) value measurements.

Claims (38)

1. A noninvasive method for detecting blood volume imbalances in a mammalian subject comprising:

providing an apparatus including a number of noninvasive sensors, communicable with the subject to obtain baseline and real time (current) physiologic value measurements from the subject; and at least one integrated circuit, operably connected with the sensors and configured to:

i) compute a real time (current) blood volume index from the physiologic value measurements wherein the blood volume index is derived from at least three physiological parameters selected from the group including heart rate, electrical body impedance, skin temperature, peripheral blood flow and skin humidity and wherein measurements of electrical body impedance, skin temperature, peripheral blood flow and skin humidity are taken at one or more extremities of the subject, and wherein the parameters are monitored by obtaining real time (current) value measurements for the parameters which are inputted into an algorithm which computes the real time (current) blood volume index based upon the differences between corresponding baseline and real time (current) value measurements, and wherein the algorithm includes coefficients for accurately weighting each parameter used in computing the real time blood volume index, and

ii) display the real time (current) blood volume index on a display of the apparatus, wherein the display is initially set to display a starting value blood volume index which indicates 100% of the subject's normal total blood volume and wherein the displayed real time (current) blood volume index is capable of indicating a blood volume change in the subject of as low as 10% of the subject's total blood volume;

using the noninvasive sensors, obtaining baseline and real time (current) physiologic value measurements of at least three of said physiological parameters from the subject;

using the algorithm of the at least one integrated circuit, computing the real time (current) blood volume index from the physiologic value measurements,

displaying the real time (current) blood volume index on the display of the apparatus; and,

monitoring the physiological parameters for which said baseline physiologic value measurements were obtained to detect changes from the baseline measurements that indicate blood volume imbalances as low as 10% of the subject's total blood volume.

2. The method of claim 1 wherein baseline measurements of at least four physiological parameters from the group consisting of heart rate, electrical body impedance, skin temperature, peripheral blood flow and skin humidity are obtained.

3. The method of claim 1 wherein baseline measurements of at least five physiological parameters from the group consisting of heart rate, electrical body impedance, skin temperature, peripheral blood flow and skin humidity are obtained.

4. The method of claim 1 further comprising monitoring changes from the baseline measurements to determine whether a predetermined change threshold is reached.

5. The method of claim 4 further comprising sounding or signaling an alarm when the threshold is reached.

6. The method of claim 1 wherein the blood volume index=(100*(1−(((BI Normalized −BI Baseline )/BI Baseline )*BI Coefficient )−(((HR Realtime −HR Baseline )/HR Baseline *HR Coefficient )+(((PBF Realtime −PBF Baseline )/PBF Baseline *PBF Coefficient )−(((GSR Realtime −GSR Baseline )/GSR Baseline *GSR Coefficient )+(((STemp Realtime −STemp Baseline )/STemp Baseline *STemp Coefficient ))) wherein BI is electrical body impedance, HR is heart rate, PBF is peripheral blood flow, GSR is galvanic skin response which measures skin humidity and STemp is skin temperature and wherein the subject's starting value blood volume index is adjusted to display a reading of 100 which indicates 100% of the subject's normal total blood volume.

7. The method of claim 6 wherein the real time blood volume index has an active range between 110 and 60 and wherein a reading of 85 indicates potential blood loss of about 15% in an adult human subject and a reading of 110 indicates an increase of about 10% in the subject's intravascular fluids.

8. The method of claim 6 wherein the real time blood volume index has an active range between 140 and 45 and wherein a reading of 45 indicates potential blood loss of about 55% in an adult human subject and a reading of 140 indicates an increase of about 40% in the subject's intravascular fluid levels.

9. The method of claim 6 further comprising monitoring the real time blood volume index to determine whether a predetermined blood volume index threshold is reached.

10. The method of claim 1 wherein the extremities of the subject at which measurements are taken include one or more of the subject's thigh, forearm, ankle, calf, fingers and toes.

11. An apparatus for noninvasively detecting blood volume changes in a mammalian subject, the apparatus comprising:

a number of noninvasive sensors, communicable with the subject to obtain baseline and real time (current) physiologic value measurements from the subject; and

at least one integrated circuit, operably connected with the sensors and configured to:

i) compute a real time (current) blood volume index from the physiologic value measurements wherein the blood volume index is derived from at least three physiological parameters selected from the group including heart rate, electrical body impedance, skin temperature, peripheral blood flow and skin humidity and wherein measurements of electrical body impedance, skin temperature, peripheral blood flow and skin humidity are taken at one or more extremities of the subject, and wherein the parameters are monitored by obtaining real time (current) value measurements for the parameters which are inputted into an algorithm which computes the real time (current) blood volume index based upon the differences between corresponding baseline and real time (current) value measurements and wherein the algorithm includes coefficients for accurately weighting each parameter used in computing the real time blood volume index, and

ii) display the real time (current) blood volume index on a display of the apparatus, wherein the display is initially set to display a starting value blood volume index which indicates 100% of the subject's normal total blood volume, and wherein the displayed real time (current) blood volume index is capable of indicating a blood volume change in the subject as low as 10% of the subject's total blood volume.

12. The apparatus of claim 11 , wherein the sensors comprise a plurality of electrodes disposed on a thigh band, an ankle band or an arm band.

13. The apparatus of claim 11 , wherein the sensors comprise a plurality of electrodes disposed in a blood pressure cuff.

14. The apparatus of claim 11 , wherein the sensors comprise a plurality of independently positionable electrodes.

15. The apparatus of claim 11 wherein the algorithm for computing the blood volume index=(100*(1−(((BI Normalized −BI Baseline )/BI Baseline )*BI Coefficient )−(((HR Realtime −HR Baseline )/HR Baseline *HR Coefficient )+(((PBF Realtime −PBF Baseline )/PBF Baseline *PBF Coefficient )−(((GSR Realtime −GSR Baseline )/GSR Baseline *GSR Coefficient )+(((STemp Realtime −STemp Baseline )/STemp Baseline *STemp Coefficient ))) wherein BI is electrical body impedance, HR is heart rate, PBF is peripheral blood flow, GSR is galvanic skin response which measures skin humidity and STemp is skin temperature and wherein the subject's starting value blood volume index is adjusted to display a reading of 100 which indicates 100% of the subject's normal total blood volume.

16. A noninvasive method for detecting blood volume imbalances in a mammalian subject comprising:

providing an apparatus including a number of noninvasive sensors, communicable with the subject to obtain baseline and real time (current) physiologic value measurements from the subject; and at least one integrated circuit, operably connected with the sensors and configured to:

i) compute a real time (current) blood volume index from the physiologic value measurements wherein the blood volume index is derived from at least three physiological parameters selected from the group including heart rate, electrical body impedance, skin temperature, perfusion index, peripheral blood flow and skin humidity and wherein measurements of electrical body impedance, skin temperature, perfusion index, peripheral blood flow and skin humidity are taken at one or more extremities of the subject, and wherein the parameters are monitored by obtaining real time (current) value measurements for the parameters which are inputted into an algorithm which computes the real time (current) blood volume index based upon the differences between corresponding baseline and real time (current) value measurements, and wherein the algorithm includes coefficients for accurately weighting each parameter used in computing the real time blood volume index, and

ii) display the real time (current) blood volume index on a display of the apparatus, wherein the display is initially set to display a starting value blood volume index which indicates 100% of the subject's normal total blood volume and wherein the displayed real time (current) blood volume index is capable of indicating a blood volume change in the subject of as low as 10% of the subject's total blood volume;

using the noninvasive sensors, obtaining baseline and real time (current) physiologic value measurements of at least three of said physiological parameters from the subject;

using the algorithm of the at least one integrated circuit, computing the real time (current) blood volume index from the physiologic value measurements,

displaying the real time (current) blood volume index on the display of the apparatus; and,

monitoring the physiological parameters for which said baseline physiologic value measurements were obtained to detect changes from the baseline measurements that indicate blood volume imbalances as low as 10% of the subject's total blood volume.

17. The method of claim 16 wherein baseline measurements of at least four physiological parameters from the group consisting of heart rate, electrical body impedance, skin temperature, perfusion index, peripheral blood flow and skin humidity are obtained.

18. The method of claim 16 wherein baseline measurements of at least five physiological parameters from the group consisting of heart rate, electrical body impedance, skin temperature, perfusion index, peripheral blood flow and skin humidity are obtained.

19. The method of claim 16 further comprising monitoring the real time blood volume index to determine whether a predetermined blood volume index threshold is reached.

20. The method of claim 19 further comprising sounding or signaling an alarm when the threshold is reached.

Assignments (1)
SECURITY INTEREST Recorded Mar 26, 2026
From: ZYNEX MONITORING SOLUTIONS, INC.; KESTREL LABS, INC.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS AGENT
Reel/Frame 074194/0170 →
Continuity (3)
Continuation 14160545 · Jan 21, 2014
Provisional Application 61754912 · Jan 21, 2013
Related Publication 20190150761A1 · May 23, 2019
Cited By (24)
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