Claims for Patent: 10,154,813

Summary for Patent: 10,154,813

Title:	Method and apparatus for patient skin color monitoring and drug efficacy measurement
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.
Inventor(s):	Kokolis; Spyros (Brooklyn, NY)
Assignee:
Application Number:	16/015,057
Patent 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. 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. 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. 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.

Details for Patent 10,154,813

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2037-07-03
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2037-07-03
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2037-07-03
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2037-07-03
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2037-07-03
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2037-07-03