IP Library Granted Patent US 12,251,239
Granted Patent B2
US 12,251,239 · App. 18/385,294 · Granted Mar 18, 2025

System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated EKG and PPG sensors

Inventors: Eric Raman (Seattle, WA); Kevin Peterson (Mountain View, CA); Iain Hueton (Salt Lake City, UT)
Assignee: HEMOCEPT INC.
A61B5/7285A61B5/0006A61B5/0036A61B5/004A61B5/0205A61B5/024A61B5/14A61B5/14552A61B5/282A61B5/349A61B5/366A61B5/4839A61B5/6823A61B5/6831A61B5/6833G16H40/63A61B5/02427A61B5/0245A61B2560/0223A61B2562/146
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Quick Facts
Patent No.
US 12,251,239
App. No.
18/385,294
Filed
Oct 30, 2023
Granted
Mar 18, 2025
Kind
B2
Art Unit
3796
USPC
600/301
Abstract

A system using combined electrocardiography (EKG) and photoplethysmography (PPG) sensing to assess intra-arterial fluid volume is described. The system uses averaging of similar pulses based on prior (n−1; n minus 1) R-to-R pulse wave duration, and prior-prior (n−2; n minus 2) R-to-R pulse wave duration, to determine a patient's fluid status and whether it is below or above optimal intravascular hydration.

Claims (48)

1. A computer logic system for and analyzing a PPG signal and an EKG signal, wherein the computer logic system is configured to:

obtain (a) the PPG signal from a device that includes at least on PPG sensor mounted thereon for measuring the person's PPG signal at multiple wavelengths of light, and (b) the EKG signal from a plurality of electrodes configured to be attached to the person;

segment the PPG signal into a series of PPG signal segments based upon features in the identified cardiac cycles,

sort the PPG signal segments into a plurality of bins, wherein a first set of PPG signal segments are sorted into a first plurality of bins based upon a similarity in durations of prior R-to-R cardiac cycles, and a second set of PPG signal segments are sorted into a second plurality of bins based upon a similarity in durations of prior-prior R-to-R cardiac cycles,

generate a composite signal for each of the first and second pluralities of bins comprising a system for summing or averaging the PPG signal segments in the bin,

generate a composite Signal Prime Over Signal (SPOS) for each of the composite signals comprising a system for calculating a derivative of the composite signal and normalizing the derivative of the composite signal by the composite signal itself,

measure a person's relative hydration level by detecting a change in the shape of at least one of the composite SPOS generated from the first plurality of bins and the composite SPOS generated from the second plurality of bins; and

output to a display device a treatment recommendation based on the person's relative hydration level, wherein the treatment recommendation is at least of a positional change, giving further fluid, holding fluid, removing fluid, or giving diuretics.

2. The system of claim 1 , wherein comparing the composite signals generated from bins on the basis of the prior R-to-R cardiac cycles against the composite signals generated from bins the basis of the prior-prior R-to-R cardiac cycles comprises:

plotting a first line representing left ventricular output with arterial pulse shape as a function of prior R-to-R, the first line being based upon values of the composite signals generated from prior R-to-R cardiac cycles,

plotting a second line representing venous return with arterial hemoglobin oxygen saturation as a function of prior-prior R-to-R, the second line being based upon the composite signals generated from prior-prior R-to-R cardiac cycles, and

determining an intersection point of the first and second lines as a metric of a person's relative hydration level.

3. The system of claim 1 , wherein comparing the composite signals generated from bins on the basis of the prior R-to-R cardiac cycles against the composite signals generated from bins the basis of the prior-prior R-to-R cardiac cycles comprises:

calculating a first relationship representing left ventricular output with arterial pulse shape as a function of prior R-to-R, the first relationship being based upon values of the composite signals generated from prior R-to-R cardiac cycles,

calculating a second relationship representing venous return with arterial hemoglobin oxygen saturation as a function of prior-prior R-to-R, the second relationship being based upon the composite signals generated from prior-prior R-to-R cardiac cycles, and

comparing the first and second relationships as a metric of a person's relative hydration level.

4. The system of claim 1 , wherein measuring a person's hydration level detects changes in the shape of a composite signal measured at an infrared wavelength of light.

5. The system of claim 4 , wherein detecting changes in the shape of a composite signal measured at an infrared wavelength of light comprises correlating intra-arterial fluid volume to an area under the curve of the composite signal measured at an infrared wavelength of light.

6. The system of claim 1 , wherein the computer logic system is further configured to:

determine Pulse Wave Transit Time by determining a time interval between an onset of an R-wave complex in the cardiac cycle and the occurrence of a shape feature in the composite SPOS.

7. The system of claim 6 , wherein the shape feature in the composite SPOS is a minimum of the composite SPOS.

8. The system of claim 1 , wherein the device is a hand-held device with the at least one PPG sensor mounted thereon and a plurality of electrode wires extending therefrom.

9. The system of claim 8 , wherein the device is a hand-held device with the at least one PPG sensor mounted thereon and at least one of the plurality of electrodes mounted thereon.

10. The system of claim 8 , wherein an optical waveguide is interposed between the at least one PPG sensor on the device and the person's skin.

11. The system of claim 1 , wherein the device is positioned within a strap or band disposed around the person's chest or limb such that the at least one PPG sensor and the plurality of electrodes are disposed within the strap or band disposed around the person's chest or limb.

12. The system of claim 1 , wherein the device is a patch with the at least one PPG sensor and at least one of the plurality of electrodes positioned therein.

13. The system of claim 1 , wherein the computer logic system is positioned within the device such that the composite signals are generated within the device, and wherein the computer logic system comprises:

a data transmission system for transmitting one or both of:

the composite signals to a remote computer system for analysis, or

measured PPG and EKG signals to a remote computer system for analysis.

14. The system of claim 1 , wherein generating a composite signal for each of the plurality of bins comprises a system for removing aberrant PPG signal segments from the calculation of the composite signal.

15. The system of claim 1 , wherein generating a composite signal for each of the sets comprises a system for iteratively re-calculating the composite signal, by:

comparing a SPOS of each of the PPG signal segments used to calculate the composite signal against the composite SPOS of the calculated composite signal,

removing outlier PPG signal segments,

re-calculating the composite signal with the outlier PPG signal segments removed, and

repeating the iteration until there are no more outlier PPG signal segments.

16. The system of claim 15 , wherein outlier PPG signal segments are identified by comparing PPG signal segments measured at different wavelengths of light against the calculated composite signal.

17. The system of claim 1 , wherein the computer logic system is further configured to:

calculate arterial hemoglobin oxygen saturation by comparing composite SPOS signals measured at different wavelengths of light.

18. A method for receiving and analyzing a PPG signal and an EKG signal, the method comprising:

obtaining, via a computer logic system, (a) the PPG signal from a device that includes at least on PPG sensor mounted thereon for measuring the person's PPG signal at multiple wavelengths of light, and (b) the EKG signal from a plurality of electrodes coupled to the person;

identifying, via the computer logic system, cardiac cycles in the EKG signal;

segmenting, via the computer logic system, the PPG signal into a series of PPG signal segments based upon features in the identified cardiac cycles,

sorting, via the computer logic system, the PPG signal segments into a plurality of bins, wherein a first set of PPG signal segments are sorted into a first plurality of bins based upon a similarity in durations of prior R-to-R cardiac cycles, and a second set of PPG signal segments are sorted into a second plurality of bins based upon a similarity in durations of prior-prior R-to-R cardiac cycles,

generating, via the computer logic system, a composite signal for each of the first and second pluralities of bins by summing or averaging the PPG signal segments in the bin,

generating, via the computer logic system, a composite Signal Prime Over Signal (SPOS) for each of the composite signals by calculating a derivative of the composite signal and normalizing the derivative of the composite signal by the composite signal itself,

measuring, via the computer logic system, a person's relative hydration level by detecting a change in the shape of at least one of the composite SPOS generated from the first plurality of bins and the composite SPOS generated from the second plurality of bins; and

outputting, to a display device, a treatment recommendation based on the person's relative hydration level, wherein the treatment recommendation is at least of a positional change, giving further fluid, holding fluid, removing fluid, or giving diuretics.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2023
From: RUBYELF, LLC
To: HEMOCEPT INC.
Reel/Frame 065490/0783 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2023
From: RAMAN, ERIC; PETERSON, KEVIN; HUETON, IAIN
To: RUBYELF LLC
Reel/Frame 065460/0062 →
Continuity (6)
Continuation 17229741 · Apr 13, 2021
Continuation 17135936 · Dec 28, 2020
Provisional Application 63067147 · Aug 18, 2020
Provisional Application 63009470 · Apr 14, 2020
Related Publication 20240130692A1 · Apr 25, 2024
Related Publication 20240225562A9 · Jul 11, 2024
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