Method and device for detecting and assessing reactive hyperemia using segmental plethysmography

• US 9,788,733 B2
• Filed: 03/11/2014
• Issued: 10/17/2017
• Est. Priority Date: 06/02/2009
• Status: Active Grant

• Current Assignee: Cordex Systems, Inc.
• Original Assignee: Cordex Systems, Inc.
• Inventors: Whitt, Michael David, Magliato, Kathy Elizabeth, Ritterbush, Stephen
• Primary Examiner(s): WEARE, MEREDITH H
• Application Number:
  US14/204,736
• Publication Number:
  US 20140276144A1
• Time in Patent Office: 1,316 Days
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/02255 the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A method for measuring reactive hyperemia in a subject is disclosed. The method includes performing a first segmental cuff plethysmography to generate a baseline arterial compliance curve and/or a baseline pressure-area (P-A) curve, performing a second segmental cuff plethysmography to generate a hyperemic arterial compliance curve and/or a hyperemic P-A curve, and calculating an area between the baseline and the hyperemic curves. The size of the area can be used as an indication of endothelial dysfunction (ED) and ED-related diseases.

Claims

1. A method for measuring reactive hyperemia in a subject, comprising:

performing a first segmental cuff plethysmography having an inflation phase and a deflation phase and generating a first cuff compliance curve based only on data collected during the deflation phase of the first segmental cuff plethysmography;

generating a baseline arterial compliance curve and/or a baseline pressure-area (P-A) curve on a portion of the body of the subject, wherein the cuff pressure is increased to a first peak cuff pressure during the inflation phase and immediately reduced from the first peak cuff pressure during the deflation phase;

performing a second segmental cuff plethysmography having an inflation phase, a holding phase, and a deflation phase and generating a second cuff compliance curve based only on data collected during the deflation phase of the first segmental cuff plethysmography;

generating a hyperemic arterial compliance curve and/or a hyperemic P-A curve, wherein the cuff pressure is increased to a second peak level during the inflation phase, maintained at the second peak cuff pressure for a predetermined period of time during the holding phase, and then reduced from the second peak cuff pressure during the deflation phase;

calculating the difference between the baseline arterial compliance curve and the hyperemic arterial compliance curve as an area between the arterial compliance curves, and/or the difference between the baseline P-A curve and the hyperemic P-A curve as an area between the P-A curves; and

measuring a level of reactive hyperemia based on the area between the arterial compliance curves and/or the area between the P-A curves,

wherein said first and second cuff compliance curves are generated using a flowmeter that directly measures the volume change in the cuff during the deflation phase.

2. The method of claim 1, wherein said cuff is inflated during the first and second segmental cuff plethysmography using a low-frequency pump.

3. The method of claim 2, wherein said low-frequency pump has an operation frequency of 10 Hertz or lower.

4. The method of claim 2, wherein said low-frequency pump has an operation frequency of 2 Hertz or lower.

5. The method of claim 1, further comprising:

determining a level of endothelial dysfunction (ED) in the subject based on the result of the measuring step.

6. The method of claim 1, further comprising:

determining a risk of an ED-related disease based on the result of the measuring step.

7. The method of claim 6, wherein the ED related disease is selected from the group consisting of hypertension, atherosclerosis, cardiovascular disease, stroke, atrial fibrillation, congestive heart failure, peripheral vascular disease, septic shock, hypercholesterolemia, type I and II diabetes, erectile dysfunction, rheumatic arthritis, HIV, liver diseases and pre-eclampsia.

8. The method of claim 1, wherein the first peak cuff pressure and the second peak cuff pressure are in the range of 150-180 mmHg.

9. The method of claim 1, wherein the predetermined period of time is 2-10 minutes.

10. The method of claim 1, wherein the calculating step calculates the difference between the baseline arterial compliance curve and the hyperemic arterial compliance curve as an area between the arterial compliance curves within a transmural pressure range of 0-100 mmHg, and wherein the calculating step calculates the difference between the baseline P-A curve and the hyperemic P-A curve as an area between the P-A curves within a transmural pressure range of 0-100 mmHg.

11. The method of claim 10, wherein the calculating step calculates the difference between the baseline arterial compliance curve and the hyperemic arterial compliance curve as an area between the arterial compliance curves within a transmural pressure range of 20-80 mmHg, and wherein the calculating step calculates the difference between the baseline P-A curve and the hyperemic P-A curve as an area between the P-A curves within a transmural pressure range of 20-80 mmHg.

12. The method of claim 1, wherein the generation of said baseline arterial compliance curve and/or a baseline pressure-area (P-A) curve comprising applying a band pass filter of 0.5-5.0 Hertz to cuff pressure data collected during the deflation phase of said first segmental cuff plethysmography and wherein the generation of said hyperemia arterial compliance curve and/or hyperemia pressure-area (P-A) curve comprising applying a band pass filter of 0.5-5.0 Hertz to cuff pressure data collected during the deflation phase of said second segmental cuff plethysmography.

13. The method of claim 12, further comprising the step of applying an additional DC low pass filter (0-0.5 Hz) to data generated by the pressure transducer during the deflation phase of said first and second segmental cuff plethysmography.

14. A method for determining endothelial dysfunction (ED) in a subject, comprising:

(a) inflating a cuff around a portion of the body of the subject and immediately deflating the cuff after reaching a first cuff pressure and measuring the volume and pressure changes in the cuff during the deflation process;

(b) generating a first curve based on the measurements in step (a);

(c) inflating the cuff around the portion of the body of the subject for the second time, maintaining the inflation at a second cuff pressure for a predetermined period of time, deflating the cuff, and measuring the volume and pressure changes in the cuff during the deflation process;

(d) generating a second curve based on the measurements in step (c);

(e) determining a difference between areas under the first curve and the second curve, wherein the first curve and the second curve are arterial compliance curves or pressure-area (P-A) curves; and

(f) determining a level of endothelial dysfunction based on the difference determined in step (e),

wherein step (a) further comprises generating a first cuff compliance curve and step (c) further comprises generating a second cuff compliance curve, wherein each of the first and second cuff compliance curves are generated using a flowmeter to directly measure the volume change in the cuff during each respective deflation process, and a pressure sensor to measure pressure change for each known volume change during each respective deflation process,

wherein the first curve is generated further based on the first cuff compliance curve, and wherein the second curve is generated further based on the second cuff compliance.

15. The method of claim 14, wherein the cuff is inflated with a low-frequency pump operating at a frequency of 10 Hertz or lower.

16. The method of claim 14, further comprising:

determining a risk of an ED-related disease based on the result of step (e).

17. The method of claim 14, wherein the difference between areas under the first curve and the second curve in step (e) is determined within a transmural pressure range of 0-100 mmHg.

18. An apparatus comprising:

an inflatable cuff having an inlet and an outlet;

a pump connected to said inlet of said cuff for inflating the cuff;

a flowmeter connected to said outlet of said cuff;

a pressure transducer for measuring the pressure inside the cuff; and

a computer configured to;

generate a cuff compliance curve by directly measuring volume change in said cuff with said flowmeter and pressure change inside the cuff with said pressure transducer during a deflation process of the cuff;

calculate an arterial compliance curve and a P-A curve during the deflation process of the cuff; and

calculate difference between areas under a first arterial compliance curve and a second arterial compliance curve and difference between areas under a first pressure-area (P-A) curve and a second P-A curve.

19. The apparatus of claim 18, wherein said pump is a low-frequency pump operating at a frequency of 10 Hertz or lower.