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

• US 10,136,822 B1
• Filed: 01/21/2014
• Issued: 11/27/2018
• Est. Priority Date: 01/21/2013
• Status: Active Grant

• Current Assignee: Zynex Monitoring Solutions Inc.
• Original Assignee: Zynex Monitoring Solutions Inc.
• Inventors: Sandgaard, Thomas
• Primary Examiner(s): BERHANU, ETSUB D
• Application Number:
  US14/160,545
• Time in Patent Office: 1,771 Days
• Field of Search: None
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/029 Humidity sensors
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/443 Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/7425 Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image geometric transforms for image registration G06T3/14; enhancement using image fusion G06T5/50; algorithms for registration of images G06T7/30
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

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

1. 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 the baseline and real time (current) value measurements and wherein the algorithm includes coefficients for accurately weighting each parameter in the real time blood volume index, and wherein said algorithm for computing the real time (current) 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_Normalized is peripheral bioimpedance normalized by removing known physiological drift, BI_Coefficient=0.725, HR_Coefficient=0.145, PBF_Coefficient=0.043, GSR_Coefficient=0.014, and _{StempCoefficient}=0.072, 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 of 100 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.

2. The apparatus of claim 1, wherein the sensors comprise a plurality of electrodes disposed on a thigh band, an ankle band or an arm band.

3. The apparatus of claim 1, wherein the sensors comprise a plurality of electrodes disposed in a blood pressure cuff.

4. The apparatus of claim 1, wherein the sensors comprise a plurality of independently positionable electrodes.