System and method for characterizing circulatory blood flow

• US 9,173,579 B2
• Filed: 07/08/2011
• Issued: 11/03/2015
• Est. Priority Date: 07/08/2010
• Status: Active Grant

• Current Assignee: Intelomed, Inc.
• Original Assignee: Intelomed, Inc.
• Inventors: Berkow, Jan
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US13/178,966
• Publication Number:
  US 20120029374A1
• Time in Patent Office: 1,579 Days
• Field of Search: 600/526
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02116 of pulse wave amplitude A61B5/02225 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00

Abstract

A computer-implemented method for characterizing circulatory blood volume is disclosed. The method has the steps of acquiring a biological signal that emulates the arterial pulse wave from a sensor. Two derived parameters, circulatory stress, which reflects a harmonic of heart rate, and circulatory blood flow, which reflects the amplitude of the unprocessed biological signal, are extrapolated from the biological signal, and are each compared to a threshold value and assessed to determine an adequacy of circulatory blood volume. In embodiments, the assessment of circulatory blood volume is used to manage a patient'"'"'s cardiovascular autoregulatory function or the adequacy of transfer of fluids to and from the circulatory system, with the ultimate goal of achieving a circulatory blood volume that adequately supplies the demands of the patient'"'"'s tissues and organs.

Claims

1. A method for characterizing a circulatory blood flow, the method comprising:

receiving, by a computing device, a biological signal emulating an arterial pulse wave from a sensor associated with a human body;

calculating, by the computing device, a fundamental frequency and a plurality of integer harmonics of a heart rate from the biological signal, wherein each of the fundamental frequency and the plurality of integer harmonics is characterized by a frequency amplitude;

calculating, by the computing device, at least one normalized parameter based on at least one pre-determined parameter baseline and at least one of the plurality of frequency amplitudes;

comparing, by the computing device, the at least one normalized parameter to a pre-determined threshold value;

characterizing the circulatory blood flow from the comparison of the at least one normalized parameter to the predetermined threshold value; and

providing an output of the characterization of the circulatory blood flow to a clinician monitoring the human body.

2. The method of claim 1, wherein the sensor comprises one or more of the following:

a transmissive photo-optic sensor;

a reflective photo-optic sensor;

a pressure transducer;

a tonometry device;

a strain gauge;

an ultrasound device;

an electrical impedance device; and

a radar device.

3. The method of claim 1, wherein calculating, by the computing device, a fundamental frequency and a plurality of integer harmonics of a heart rate from the biological signal comprises calculating the fundamental frequency and the plurality of integer harmonics of the heart rate from a conditioned biological signal.

4. The method of claim 3, wherein the conditioned biological signal comprises an amplified or an inverted biological signal.

5. The method of claim 1, wherein calculating a fundamental frequency and a plurality of integer harmonics of a heart rate from the biological signal comprises:

sampling, by the computing device, the biological signal into a plurality of discrete data within a time window, to form windowed discrete signal data; and

calculating, by the computing device, a spectrum analysis of the windowed discrete signal data.

6. The method of claim 5, wherein calculating a spectrum analysis of the windowed signal data comprises calculating a Fast-Fourier Transform of the windowed signal data.

7. The method of claim 5, wherein calculating a spectrum analysis of the windowed signal data comprises calculating a wavelet transformation of the windowed signal data.

8. The method of claim 1, wherein calculating at least one normalized parameter comprises calculating a percent change of at least one of the plurality of frequency amplitudes.

9. The method of claim 8, wherein calculating a percent change of at least one of the plurality of frequency amplitudes comprises dividing at least one of the plurality of frequency amplitudes by the at least one predetermined parameter baseline.

10. The method of claim 1, wherein the pre-determined threshold value is a clinically validated value from a specific patient population.

11. The method of claim 1, where the pre-determined threshold value is associated with a pre-symptomatic circulatory blood volume inadequacy condition.

12. The method of claim 1, where the pre-determined threshold value is associated with a symptomatic circulatory blood volume inadequacy condition.

13. The method of claim 1, further comprising applying, by the computing device, a continuous-time filter to at least one of the plurality of frequency amplitudes over time.

14. The method of claim 13, wherein the continuous-time filter comprises one or more of the following:

a Butterworth filter;

a Chebyshev filter;

a Bessel filter;

an elliptical filter;

a custom low pass filter; and

a filter based on determining a moving average.

15. The method of claim 1, further comprising comparing a pattern of at least one of the fundamental frequency and the plurality of integer harmonics over time to a library of patterns of the fundamental frequency and the plurality of integer harmonics over time.

16. The method of claim 1, wherein at least one of the fundamental frequency and the plurality of integer harmonics is associated with a circulatory stress.

17. The method of claim 16, wherein at least one of the fundamental frequency and the plurality of integer harmonics is at least a second integer harmonic.

18. The method of claim 1, wherein at least of the fundamental frequency and plurality of integer harmonics is associated with a circulatory blood flow.

19. The method of claim 16, wherein at least one of the fundamental frequency and the plurality of integer harmonics is selected according to one or more of a patient age, a sensor resolution, and a type of stress applied to a patient.

22. The method of claim 1, further comprising calculating, by the computing device, the at least one parameter baseline from a variance of at least one of the plurality of frequency amplitudes.

24. The method of claim 1, further comprising:

receiving, by the computing device, a second biological signal emulating an arterial pulse wave from the sensor associated with the human body;

calculating, by the computing device, at least one second normalized parameter based on at least one second pre-determined parameter baseline and the second biological signal; and

comparing, by the computing device, the at least one second normalized parameter to a pre-determined second threshold value,

wherein, characterizing the circulatory blood flow comprises a comparison of the at least one normalized parameter to the predetermined threshold value and a comparison of the at least one second normalized parameter to the predetermined second threshold value.

20. A method for characterizing a circulatory blood flow in a human body in a response to a stress, the method comprising:

calculating a measure of a steady-state circulatory blood volume by;

receiving, by a computing device, a first biological signal emulating an arterial pulse wave from a sensor associated with the human body,

calculating, by the computing device, a first fundamental frequency and a first plurality of integer harmonics of a heart rate from the first biological signal, wherein each of the first fundamental frequency and the first plurality of integer harmonics is characterized by a first frequency amplitude;

calculating, by the computing device, at least one first normalized parameter based on at least one predetermined first parameter baseline and at least one of the first plurality of frequency amplitudes, and

calculating the measure of the steady-state circulating blood flow based on the at least one first normalized parameter;

applying at least one stress to the human body;

calculating a measure of stressed circulatory blood flow by;

receiving, by the computing device, a second biological signal emulating an arterial pulse wave from a sensor associated with the human body,

calculating, by the computing device, a second fundamental frequency and a second plurality of integer harmonics of a heart rate from the second biological signal, wherein each of the second fundamental frequency and the second plurality of integer harmonics is characterized by a second frequency amplitude;

calculating, by the computing device, at least one second normalized parameter based on at least one predetermined second parameter baseline and at least one of the second plurality of frequency amplitudes, and

calculating the measure of stressed circulatory blood flow based on the at least one second normalized parameter;

calculating a comparison of the measure of the steady-state circulatory blood flow to the measure of stressed circulatory blood flow; and

providing an output of the comparison to a clinician monitoring the human body.

21. The method of claim 20, wherein applying a stress comprises reducing a patient'"'"'s circulatory volume during dialysis.

23. The method of claim 20, further comprising:

calculating, by the computing device, the at least one first parameter baseline from a variance of at least one of the first plurality of frequency amplitudes; and

calculating, by the computing device, the at least one second parameter baseline from a variance of at least one of the second plurality of frequency amplitudes.