Methods and apparatus for repeated ischemic conditioning treatment of hypertension and other medical conditions

• US 8,986,342 B2
• Filed: 11/25/2008
• Issued: 03/24/2015
• Est. Priority Date: 11/25/2007
• Status: Active Grant

• Current Assignee: American Heart Technologies, LLC
• Original Assignee: IC Therapeutics, Inc.
• Inventors: Naghavi, Morteza, Yen, Albert Andrew, Hassan, Haider, Panthagani, David
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/323,392
• Publication Number:
  US 20090137884A1
• Time in Patent Office: 2,310 Days
• Field of Search: 606/202, 606/203, 600490-499
• US Class Current: 606/201
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/417 the bone marrow

Abstract

Methods for ischemic conditioning treatments of a chronic medical condition are provided. Baseline disease-related parameters of a patient with a chronic medical condition are measured. Ischemia is induced in the patient by occluding and releasing arterial flow in one or more extremities of the patient. Post-ischemia parameters in the patient are measured. The baseline and post-ischemia parameters are compared to provide an assessment of an ischemic conditioning treatment of a chronic medical condition. The repeated, scheduled delivery of ischemic conditioning provides a beneficial, therapeutic effect on the chronic medical condition. Also provided is a device for pulse oximetry during periods of absent or low pulsatile blood flow including an artificial pulse generator as well as the use of said device in assessment of ischemic conditioning.

Claims

1. A method for treatment of a chronic disease by administering personalized chronic ischemic conditioning treatments causing repeated ischemia by interrupting blood flow to a tissue using a non-invasive occluding device adapted to occlude a blood vessel and cause ischemia comprising:

a) measuring baseline vascular function;

programming the duration of the ischemia;

c) interrupting blood flow to a tissue using a non-invasive blood flow occluding device adapted to cause ischemia according to the program;

d) restoring blood flow to the tissue according to the program;

e) Repeating steps (c) and (d) at least 3 times per treatment session;

f) Repeating steps (c) to (e) at least 2 times per week;

g) Measuring vascular function to monitor the effect of treatment at least once every 4 weeks.

2. The method of claim 1, comprising a program including a repeated schedule of personalized ischemic conditioning for lowering blood pressure.

3. The method of claim 1, wherein the treated individual has one or more vascular conditions belonging to the group consisting of:

hypertension, endothelial dysfunction, Raynaud'"'"'s syndrome, coronary heart disease (CHD), coronary artery disease (CAD), heart failure, peripheral arterial disease (PAD), diabetes, diabetic neuropathy, pulmonary hypertension (PH), and connective tissue disorders.

4. The method of claim 1, wherein the ischemic conditioning treatments are applied to one or more extremities using an external pressure system for arterial occlusion.

5. The method of claim 4, wherein the ischemic conditioning treatments are applied to the skin at one or more extremities using external pressure to the skin using a pressurizable garment.

6. The method of claim 4, wherein the ischemic conditioning treatments are applied to one or more extremities using external cuff to the skin for ischemic conditioning of the skin of the extremities.

7. The method of claim 1, further comprising measurement of blood oxygen saturation during ischemia using artificial pulse together with oximetry.

8. The method of claim 7, wherein the artificial pulse is generated by mechanical actuation.

9. The method of claim 8, wherein the mechanical actuation is effected by pulsating fluid pressure in a cuff to cause mechanical disturbance of arterial blood, repetitive, external electromechanical actuation, or repetitive, self-induced physical motion.

10. The method of claim 7, wherein the artificial pulse is generated by external non-mechanical optical illumination utilized to imitate an absorption pattern of a pulsatile blood flow signal by oscillating an intensity of a light source of either a single or multiple wavelength.

11. The method of claim 1 further comprising applying heat sufficient to induce vasodilation before, during, or after each ischemic conditioning treatment.

12. The method of claim 1 further comprising a scheduled performance of hand and/or foot exercises by the individual.

13. The method of claim 1 further comprising pharmacotherapy by administration with one or more of the group of anti-hypertensive agent, vasodilators, anti-oxidants, anti-inflammatory and anesthetic compounds and nitric oxide (NO) donors, precursors and agonists.

14. The method of claim 1 wherein vascular function is measured based on one or more of inherent skin temperature, clearance of induced skin temperature, tonometry, Doppler ultrasound, laser Doppler flowmetry, plethysmography, iontoporesis, capillometry, and/or changes in magnetic or electromagnetic properties of the tissue.

15. The method of claim 1 further comprising using one or more noninvasive electric, magnetic, or electromagnetic neuromodulating devices to increase local autonomic nervous system activity.

25. The method of claim 1 further comprising a scheduled performance of hand and/or foot exercises by the individual.

16. A method for treatment of a chronic medical condition by administering personalized chronic ischemic conditioning treatments causing repeated ischemia by interrupting blood flow to a tissue using a non-invasive occluding device adapted to occlude a blood vessel and cause ischemia comprising:

a) measuring baseline vascular function

b) programing the duration of the ischemia;

c) interrupting blood flow to a tissue using a non-invasive blood flow occluding device adapted to cause ischemia according to the program;

d) concurrently monitoring tissue ischemia and adjusting the duration of the ischemia based on monitored parameters;

e) restoring blood flow to the tissue according to the program;

f) repeating steps (c) to (e) at least 3 times per treatment session;

g) repeating steps (c) to (f) at least 2 times per week;

h) measuring vascular function to monitor the effects of treatment at least once every 4 weeks.

17. The method of claim 16, comprising a program including a repeated schedule of personalized ischemic conditioning for lowering blood pressure.

18. The method of claim 16, wherein the treated individual has one or more vascular conditions belonging to the group consisting of:

hypertension, endothelial dysfunction, Raynaud'"'"'s syndrome, coronary heart disease (CHD), coronary artery disease (CAD), heart failure, peripheral arterial disease (PAD), diabetes, diabetic neuropathy, pulmonary hypertension (PH), and connective tissue disorders.

19. The method of claim 16, wherein the ischemic conditioning treatments are applied to one or more extremities using an external pressure system for arterial occlusion.

20. The method of claim 19, wherein the ischemic conditioning treatments to the skin are applied to one or more extremities using external pressure to the skin using a pressurizable garment.

21. The method of claim 16, wherein monitoring of tissue ischemia comprises measurement of blood oxygen saturation during ischemia using artificial pulse together with oximetry.

22. The method of claim 21, wherein the artificial pulse is generated by mechanical actuation.

23. The method of claim 22, wherein the mechanical actuation is effected by pulsating fluid pressure in a cuff to cause mechanical disturbance of arterial blood, repetitive, external electromechanical actuation, or repetitive, self-induced physical motion.

24. The method of claim 21, wherein the artificial pulse is generated by external non-mechanical optical illumination utilized to imitate an absorption pattern of a pulsatile blood flow signal by oscillating an intensity of a light source of either a single or multiple wavelength.

26. The method of claim 16 further comprising pharmacotherapy by administration with one or more of the group of anti-hypertensive agent, vasodilators, anti-oxidants, anti-inflammatory and anesthetic compounds and nitric oxide (NO) donors, precursors and agonists.

27. The method of claim 16 wherein vascular function is measured based on one or more of inherent skin temperature, clearance of induced skin temperature, tonometry, Doppler ultrasound, laser Doppler flowmetry, plethysmography, iontoporesis, capillometry, and/or changes in magnetic or electromagnetic properties of the tissue.

28. The method of claim 16 further comprising using one or more noninvasive electric, magnetic, or electromagnetic neuromodulating devices to increase local autonomic nervous system activity.