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

• US 8,708,921 B2
• Filed: 06/02/2010
• Issued: 04/29/2014
• Est. Priority Date: 06/02/2009
• Status: Active Grant

• Current Assignee: Cordex Systems, Inc.
• Original Assignee: Cordex Systems, LLC
• Inventors: Whitt, Michael David, Magliato, Kathy Elizabeth, Ritterbush, Stephen
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): WEARE, MEREDITH H
• Application Number:
  US12/792,504
• Publication Number:
  US 20100305459A1
• Time in Patent Office: 1,427 Days
• Field of Search: 600481-507
• US Class Current: 600/490
• 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

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;

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 and immediately reduced from the first peak cuff pressure;

performing a second 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, maintained at the second peak cuff pressure for a predetermined period of time, and then reduced from the second peak cuff pressure;

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 a first cuff compliance curve is generated during the first segmental cuff plethysmography and a second cuff compliance curve is generated during the second segmental cuff plethysmography, wherein said first and second cuff compliance curves are generated using a metering pump to measure the volume change in a cuff, and a pressure sensor to measure pressure change for each known volume change, and wherein the metering pump is a low-frequency pump operating at a frequency that is not higher than the arterial cycle frequency.

2. 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.

3. The method of claim 1, further comprising:

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

4. The method of claim 3, 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.

5. The method of claim 1, wherein the first peak cuff pressure is in the range of 150-180 mmHg.

6. The method of claim 1, wherein the second peak cuff pressure is a pressure that is above the systolic pressure of the subject.

7. The method of claim 6, wherein the second peak cuff pressure is in the range of 150-180 mmHg.

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

9. The method of claim 8, wherein the predetermined period of time is about 5 minutes.

10. The method of claim 1, wherein the systolic blood pressure of the subject is determined during the first segmental cuff plethysmography.

11. A method for monitoring the efficacy of a medical procedure in a subject, comprising:

performing a first measurement of reactive hyperemia in the subject using the method of claim 1;

performing a second measurement of reactive hyperemia in the subject using the method of claim 1; and

comparing the results of the first measurement and the second measurement.

12. The method of claim 11, wherein the first measurement is performed prior to the initiation of the medical treatment.

13. The method of claim 11, wherein the medical procedure is a treatment procedure for an ED-related disease.

14. The method of claim 11, wherein the medical procedure is statin treatment.

15. The method of claim 11, wherein the medical procedure is an anesthetic procedure.

16. The method of claim 1, wherein the first and the second segmental cuff plethysmography each comprises a cuff inflation phase and a cuff deflation phase, wherein data is obtained during both the cuff inflation phase and the cuff deflation phase, and wherein band pass filtering method is used to obtain systolic blood pressure, diastolic blood pressure and mean arterial blood pressure.

17. 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 inflation process and 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 inflation process and 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 a first cuff compliance curve is generated during step (a) and a second cuff compliance curve is generated during step (c) using a metering pump to directly measure the volume change in a cuff, and a pressure sensor to measure pressure change for each known volume change, and wherein the metering pump is a low-frequency pump operating at a frequency that is not higher than the arterial cycle frequency, wherein the first curve is generated based the first cuff compliance curve, and wherein the second curve is generated based the second cuff compliance curve.

18. The method of claim 17, further comprising:

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

19. The method of claim 18, 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.

20. The method of claim 17, wherein the first cuff pressure in step (a) is in the range of 150-180 mmHg.

21. The method of claim 17, wherein the second cuff pressure in step (c) is in the range of 150-180 mmHg.

22. The method of claim 17, wherein predetermined period of time in step (c) is about 2-10 minutes.

23. An apparatus comprising:

an inflatable cuff;

a metering pump for inflating and deflating the 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 metering pump and pressure change inside the cuff with said pressure transducer;

calculate an arterial compliance curve and a P-A curve during the inflation and 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,

wherein the metering pump is a low-frequency pump operating at a frequency that is not higher than the arterial cycle frequency.

24. The apparatus of claim 23, further comprising an amplifier.

25. The apparatus of claim 23, further comprising means for band pass filtering data.