Method for non-evasively determining an endothelial function and a device for carrying out said method

• US 10,238,306 B2
• Filed: 04/03/2006
• Issued: 03/26/2019
• Est. Priority Date: 02/20/2006
• Status: Active Grant

• Current Assignee: Everist Genomics, Inc.
• Original Assignee: Everist Genomics, Inc.
• Inventors: Parfyonov, Alexander Sergeevich, Parfyonova, Maria Alexandrovna
• Primary Examiner(s): Agahi, Puya
• Application Number:
  US12/279,939
• Publication Number:
  US 20100298717A1
• Time in Patent Office: 4,740 Days
• Field of Search: 600301, 600483, 600490-492, 600494-500, 600504, 600323, 600324, 600465, 600479-481, 600485
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02116 of pulse wave amplitude A61B5/02225 takes precedence
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02422 within occluders
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• 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 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

The invention relates to medicine. The inventive method for non-evasively determining an endothelial function consists in reducing a transmural pressure in a limb, recording the amplitude of plethysmographic signals at different pressures, determining the pressure of a maximum plethysmographic signal amplitude, reducing the pressure to a value corresponding to the specified percentage of the maximum amplitude, carrying out an occlusion sample in the course of which a pressure higher by at least 50 mm Hg than the systolic pressure of a tested patient is produced in a cuff arranged proximally to the located limb area, wherein the occlusion is carried out during at least 5 minutes. The inventive device for carrying out said method comprises a sensory unit, a pressure producing unit, an electronic unit constructed in such a way that it makes it possible to measure the cuff pressure corresponding to the maximum plethysmographic signal amplitude and a unit for controlling the pressure producing unit in such a way that the cuff pressure corresponding to the amplitude of a plethysmographic signal, which represents a specified percentage of the maximum amplitude, is attained. The sensory unit is connected to the electronic unit to the output of which the pressure producing unit is connected.

Claims

1. A method for noninvasive assessment of endothelial function in a patient, which method comprises:

a. lowering a transmural pressure in an artery in an extremity by means of a pressure generating cuff;

b. measuring, via a monitoring channel, an amplitude of a plethysmographic signal at various transmural pressures generated in step (a);

c. determining a pressure in the pressure generating cuff at which the amplitude of the plethysmographic signal is maximal;

d. lowering the pressure in the pressure generating cuff to 50% of the pressure at which said maximal amplitude occurs;

e. when the pressure in the pressure generating cuff is 50% of the pressure at which said maximal amplitude occurs, running an occlusion test;

wherein running an occlusion test comprises generating a pressure in the pressure generating cuff on an observed region of the extremity which exceeds a measured systolic pressure by at least 50 mmHg for at least 5 minutes;

f. lowering the pressure in the pressure generating cuff to zero;

g. measuring an amplitude of the plethysmographic signal for at least 3 minutes and simultaneously measuring, via a reference channel, an amplitude of a plethysmographic signal detected from an artery in a second extremity where the occlusion test has not been performed;

h. using amplitudal and timely analyses to compare data collected through the reference and monitoring channels; and

i. providing an assessment of the patient'"'"'s endothelial function based on the amplitudal and timely analyses.

2. The method according to claim 1, wherein pressure applied to the extremity is increased gradually, with each step being 5 mmHg and lasting 5-10 seconds, at the same time recording the amplitude of the plethysmographic output.

3. The method according to claim 1, wherein (i) during the amplitudal analysis data from the reference channel are compared to those collected from the monitoring channel;

(ii) a rate of the increase of the amplitude in the monitoring channel is analyzed;

(iii) a relationship of an amplitude of a maximum plethysmographic signal recorded during various transmural pressures is compared to a maximal amplitude of a plethysmographic signal recorded after the running of the occlusion test; and

/or (iv) during the temporal analysis, plethysmographic waveforms collected through the reference and monitoring channels are compared, the plethysmographic waveforms are then normalized and a time delay or phase change is determined.

4. An apparatus for noninvasive assessment of endothelial function comprising a double-channeled sensor unit, capable of detecting pulse wave signals from peripheral arteries, a pneumatic unit capable of creating gradually increasing pressure in a pressure generating cuff, a pressure sensor configured to detect a blood pressure of a patient;

and an electronic block configured to perform at least the following steps;

a. lowering a transmural pressure in an artery in an extremity by means of a pressure generating cuff;

b. measuring, via a monitoring channel, an amplitude of a plethysmographic signal at various transmural pressures generated in step (a);

c. determining a pressure in the pressure generating cuff at which the amplitude of the plethysmographic signal is maximal;

d. lowering the pressure in the pressure generating cuff to 50% of the pressure at which said maximal amplitude occurs;

e. when the pressure in the pressure generating cuff is 50% of the pressure at which said maximal amplitude occurs, running an occlusion test wherein running an occlusion test comprises generating a pressure in the pressure generating cuff on an observed region of the extremity which exceeds a measured systolic pressure by at least 50 mmHg for at least 5 minutes;

f. lowering the pressure in the pressure generating cuff to zero;

g. measuring an amplitude of the plethysmographic signal for at least 3 minutes and simultaneously measuring, via a reference channel, an amplitude of a plethysmographic signal detected from an artery in a second extremity where the occlusion test has not been performed; and

h. using amplitudal and timely analyses to compare data collected through the reference and monitoring channels;

wherein the double-channeled sensor unit is connected to the electronic block, which is in turn linked through an outlet to the pneumatic unit.

5. The apparatus according to claim 4, wherein the pneumatic unit is capable of generating pressure in the pressure generating cuff which is increased gradually by increments of 5 mmHg with time increments of five to ten seconds.

6. The apparatus according to claim 4, wherein each channel of the double-channeled sensor unit comprises an infrared diode and a photoreceptor, both configured to record a light signal passing through an observed field.

7. The apparatus according to claim 4, wherein each of the channels of the double-channeled sensor unit comprises an infrared light diode and a photoreceptor, both configured to record a diffused light signal reflected off an observed field.

8. The apparatus according to claim 4, wherein (i) the double-channeled sensor unit comprises impedancemetric electrodes, or Hall sensors, or an elastic tube filled with electro-conductive material;

or (ii) it additionally comprises orthogonally-placed polarized filters protecting the photoreceptor from extraneous exposure to light.

9. The apparatus according to claim 6, wherein the photoreceptor is connected to a filter configured to filter pulse wave components out of a general signal.

10. The apparatus according to claim 4, further comprising a liquid-crystal screen for displaying results of endothelial tissue assessment, and/or an interface system connected to the electronic block for transferring collected data to a computer.

11. The apparatus according to claim 4, wherein lowering the pressure in the pressure generating cuff to 50% of the pressure at which said maximal amplitude occurs comprises providing optimal arterial compliance.