Method and apparatus for patient skin color monitoring and drug efficacy measurement

• US 10,154,813 B1
• Filed: 06/21/2018
• Issued: 12/18/2018
• Est. Priority Date: 07/03/2017
• Status: Active Grant

• Current Assignee: Spyros Kokolis
• Original Assignee: Spyros Kokolis
• Inventors: Kokolis, Spyros
• Primary Examiner(s): Fernandez, Katherine
• Assistant Examiner(s): KELLOGG, MICHAEL S
• Application Number:
  US16/015,057
• Publication Number:
  US 20190000379A1
• Time in Patent Office: 180 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/1032 Determining colour for diagnostic purposes measuring colour in general G01J3/46
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: A61K 49/0006 Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)

Abstract

Methods and apparatus for determining the efficacy of a drug by diagnosing cardiovascular health in a patient by monitoring changes in skin redness levels, which is associated with perfusion and ability of circulatory system to adapt to physical exertion. Color detectors including colorimeters and spectrophotometers may be used to monitor and quantify skin color. Wet run solutions such as acetylcholine solutions may be applied to the skin area being monitored. Skin redness can be monitored during the course of exercise or a stress test, as well as during recovery. Wearable color detector devices can be worn by patients during exercise.

Claims

1. A method for determining an efficacy of a medication for a patient, the method comprising:

(A) administering to the patient the medication selected from the group consisting of a statin, an angiotensin enzyme inhibitor, an angiotensin receptor blocker, an antibiotic, an anti-clotting medication, ranolazine, clopidogrel, ticagrelor, prasugrel, aspirin, evolocumab, alirocumab, trastuzumab, adalimumab and etanercept;

(B) applying a wet run solution to a testing area of a skin surface of the patient, wherein the wet run solution comprises a chemical selected from the group consisting of acetylcholine, bradykinin, adenosine, vasopressin, nitroglycerin, sildenafil, serotonin, and thrombin;

(C) positioning a color detector on the patient after the application of wet run solution, wherein the color detector is configured for detecting at least a red wavelength light and comprises an input for receiving light, and wherein the input is positioned to receive light from the testing area;

(D) making and saving a baseline color measurement of the testing area using the color detector, the baseline color measurement comprising a baseline skin redness level of the testing area with the patient resting;

(E) initiating an exercise protocol after the baseline color measurement, wherein the exercise protocol comprises the patient engaging in a physical exercise;

(F) making and saving a plurality of exercise color measurements of the testing area at different times during the exercise protocol, the exercise color measurements each comprising skin redness levels measured by the color detector;

(G) ending the exercise protocol by the patient ending the physical exercise;

(H) after the exercise protocol ends, beginning a recovery phase, with the patient resting during the recovery phase;

(I) making and saving a plurality of recovery color measurements of the testing area at different times during the recovery phase, the recovery color measurements each comprising skin redness levels;

(J) calculating the red shift for the patient, the red shift being calculated by comparing the baseline skin redness level and one of a maximum skin redness level and a minimum skin redness level, the maximum skin redness level or minimum skin redness level being selected from the exercise color measurements and the recovery color measurements; and

(K) determining that the medication is not efficacious when a negative red shift value is calculated by comparing the baseline skin redness level with the minimum skin redness level to determine that the negative red shift value has occurred.

2. The method of claim 1, wherein the statin is selected from the group consisting of atorvastatin, rosuvastatin, simvastatin, and pravastatin, wherein the angiotensin enzyme inhibitor is selected from the group consisting of ramipril, fosinopril, and lisinopril, wherein the angiotensin receptor blocker is selected from the group consisting of valsartan, candesartan, and losartan, wherein the antibiotic is selected from the group consisting of adriamycin and bleomycin, and wherein the anti-clotting medication is selected from the group consisting of warfarin, dabigatran, rivaroxaban, apixaban, calgrelor, and cilostazol.

3. The method of claim 1, further comprising displaying on a display a graph plotting skin redness levels over a period of time, the graph comprising the baseline color measurement, at least one exercise color measurement of the plurality of exercise color measurements, and at least one recovery color measurement of the plurality of recovery color measurements.

4. The method of claim 1, wherein the exercise color measurements and the recovery color measurements are made at evenly spaced time intervals, the time intervals being between 10 seconds and five minutes;

and

wherein the exercise protocol comprises increasing at least one of a speed and a resistance of the physical exercise one or more times.

5. The method of claim 1, wherein the color detector is selected from a colorimeter and a spectrophotometer.

6. The method of claim 1, wherein the wet run solution comprises acetylcholine and at least one of alcohol and water.

7. The method of claim 1, wherein the wet run solution comprises acetylcholine and at least one of petroleum jelly and an oil.

8. The method of claim 1, wherein the exercise protocol comprises the patient using at least one exercise machine selected from a treadmill, a stationary bicycle, an elliptical trainer, and an arm ergometer.

12. The method of claim 2, wherein the exercise color measurements and the recovery color measurements are made at evenly spaced time intervals, the time intervals being between 10 seconds and five minutes;

and

wherein the exercise protocol comprises increasing at least one of a speed and a resistance of the physical exercise one or more times.

9. A method for determining an efficacy of a medication for a patient, the method comprising:

(A) administering to the patient the medication selected from the group consisting of a statin, an angiotensin enzyme inhibitor, an angiotensin receptor blocker, an antibiotic, an anti-clotting medication, ranolazine, clopidogrel, ticagrelor, prasugrel, aspirin, evolocumab, alirocumab, trastuzumab, adalimumab and etanercept;

(B) applying a wet run solution to a testing area of a skin surface of the patient, wherein the wet run solution comprises a chemical selected from the group consisting of acetylcholine, bradykinin, adenosine, vasopressin, nitroglycerin, sildenafil, serotonin, and thrombin;

(C) positioning a color detector on the patient after the application of wet run solution, wherein the color detector is configured for detecting at least a red wavelength light and comprises an input for receiving light, and wherein the input is positioned to receive light from the testing area;

(D) making and saving a baseline color measurement of the testing area using the color detector, the baseline color measurement comprising a baseline skin redness level of the testing area with the patient resting;

(E) initiating an exercise protocol after the baseline color measurement, wherein the exercise protocol comprises the patient engaging in a physical exercise;

(F) making and saving a plurality of exercise color measurements of the testing area at different times during the exercise protocol, the exercise color measurements each comprising skin redness levels measured by the color detector;

(G) ending the exercise protocol by the patient ending the physical exercise;

(H) after the exercise protocol ends, beginning a recovery phase, with the patient resting during the recovery phase;

(I) making and saving a plurality of recovery color measurements of the testing area at different times during the recovery phase, the recovery color measurements each comprising skin redness levels;

(J) calculating the red shift for the patient, the red shift being calculated by comparing the baseline skin redness level and one of a maximum skin redness level and a minimum skin redness level, the maximum skin redness level or minimum skin redness level being selected from the exercise color measurements and the recovery color measurements; and

,

(K) determining that the medication is efficacious when a positive red shift value of at least +10% is calculated by comparing the baseline skin redness level with the maximum skin redness level to determine that the positive red shift value of at least +10% has occurred.

10. The method of claim 9, wherein the statin is selected from the group consisting of atorvastatin, rosuvastatin, simvastatin, and pravastatin, wherein the angiotensin enzyme inhibitor is selected from the group consisting of ramipril, fosinopril, and lisinopril, wherein the angiotensin receptor blocker is selected from the group consisting of valsartan, candesartan, and losartan, wherein the antibiotic is selected from the group consisting of adriamycin and bleomycin, and wherein the anti-clotting medication is selected from the group consisting of warfarin, dabigatran, rivaroxaban, apixaban, calgrelor, and cilostazol.

11. The method of claim 9, further comprising displaying on a display a graph plotting skin redness levels over a period of time, the graph comprising the baseline color measurement, at least one exercise color measurement of the plurality of exercise color measurements, and at least one recovery color measurement of the plurality of recovery color measurements.

13. The method of claim 9, wherein the color detector is selected from a colorimeter and a spectrophotometer.

14. The method of claim 9, wherein the wet run solution comprises acetylcholine and at least one of alcohol and water.

15. The method of claim 9, wherein the wet run solution comprises acetylcholine and at least one of petroleum jelly and an oil.

16. The method of claim 9, wherein the exercise protocol comprises the patient using at least one exercise machine selected from a treadmill, a stationary bicycle, an elliptical trainer, and an arm ergometer.