METHODS AND DEVICES FOR REMOTE ISCHEMIC CONDITIONING VIA PARTIAL LIMB OCCLUSION

• US 20150190301A1
• Filed: 03/18/2015
• Published: 07/09/2015
• Est. Priority Date: 06/23/2009
• Status: Active Grant

• Current Assignee: Infarct Reduction Technologies, Inc.
• Original Assignee: Infarct Reduction Technologies, Inc.
• Inventors: Leschinsky, Boris
• Granted Patent: US 9,801,780 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 5/02208 using the Korotkoff method
• CPC Class Codes: A61B 5/02225 using the oscillometric method
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5071 Pressure sensors
• CPC Class Codes: A61H 2205/06 Arms
• CPC Class Codes: A61H 2205/10 Leg
• CPC Class Codes: A61H 2230/30 Blood pressure A61H2230/04 takes precedence
• CPC Class Codes: A61H 9/0092 Cuffs therefor

Abstract

Single- or dual-bladder devices for automated delivery of remote ischemic conditioning treatment via partial limb occlusion involve various methods of operating the cuff in which partial or full limb occlusion is achieved during the periods of cuff inflation. Achieving clinical benefits of remote ischemic conditioning without extended cessation of limb blood flow are advantageous due to lower required cuff pressure and reduced risk of clot formation in the limb vasculature.

Claims

1. A device for delivery of remote ischemic conditioning treatment to a subject, said device comprising:

a cuff configured for placement over a limb of the subject, said cuff is further configured to at least partially reduce blood flow in said limb upon inflation thereof;

a controller operably connected to said cuff, said controller is configured upon activation to deliver said remote ischemic conditioning treatment by performing a plurality of remote ischemic conditioning treatment cycles, each treatment cycle comprising;

a period of cuff inflation when said controller is causing said cuff to be inflated to and maintained at or above a pressure sufficient to cause at least a partial reduction of blood flow in said limb to produce an ischemic stress therein for at least about one minute, and

a period of cuff deflation when said controller is causing said cuff to deflate so as to increase blood flow in said limb and relieve said ischemic stress,

wherein said ischemic stress is sufficient to cause said remote ischemic conditioning treatment, said controller is further configured to avoid complete occlusion of said limb by said cuff lasting more than about one minute during at least one of said treatment cycles.

2. The device as in claim 1, wherein said controller is further configured to inflate said cuff during at least a portion of said period of cuff inflation to a pressure at or below a lesser pressure of either a systolic blood pressure of said subject or a limb occlusion pressure of said subject.

3. The device as in claim 2, wherein said controller is further configured during said entire period of cuff inflation to inflate said cuff at or above a pressure sufficient to cause about ninety percent reduction of unrestricted blood flow in said limb.

4. A device for delivery of remote ischemic conditioning treatment to a subject, said device comprising:

a cuff configured for placement over a limb of the subject, said cuff is further configured to at least partially reduce blood flow in said limb upon inflation thereof;

a controller operably connected to said cuff, said controller is configured upon activation to deliver said remote ischemic conditioning treatment by performing a plurality of remote ischemic conditioning treatment cycles, each treatment cycle comprising;

a period of cuff inflation when said controller is causing said cuff to inflate to a pressure sufficient to at least partially reduce blood flow in said limb and produce an ischemic stress therein causing said remote ischemic conditioning, said period of cuff inflation lasting at least about one minute, and

a period of cuff deflation when said controller is causing said cuff to deflate and increase blood flow in said limb to relieve said ischemic stress,

wherein during at least one of said periods of cuff inflation said controller is further configured to vary pressure in said cuff so as to increase or decrease said ischemic stress in said limb.

5. The device as in claim 4, wherein said controller is further configured to vary said pressure in said cuff to cause at least one period of complete occlusion and at least one period of partial occlusion of blood flow in said limb during at least one period of cuff inflation of said treatment cycles.

6. The device as in claim 5, wherein said controller is further configured to periodically vary said cuff pressure so as to alternate complete limb occlusion with partial limb occlusion during at least one period of cuff inflation of said treatment cycles.

7. A device for delivery of remote ischemic conditioning treatment to a subject, said device comprising:

a cuff configured for placement over a limb of the subject, said cuff is further configured upon inflation to compress said limb to at least partially reduce blood flow therein;

a controller operably connected to said cuff, said controller is configured upon activation to inflate and deflate said cuff to deliver said remote ischemic conditioning treatment via performing a plurality of remote ischemic conditioning treatment cycles, each treatment cycle comprising;

a cuff inflation period wherein said cuff is inflated to a pressure sufficient to reduce blood flow in said limb and cause an ischemic stress therein to reach or exceed a predetermined ischemic stress threshold, said cuff inflation period lasting at least about one minute, and

a cuff deflation period wherein said cuff is deflated to increase blood flow in said limb and relieve said ischemic stress therein,

wherein said controller is further configured to avoid complete occlusion of blood flow in said limb by said cuff lasting more than about one minute during at least one of said treatment cycles.

8. The device as in claim 7, wherein said predetermined ischemic stress threshold is achieved by reducing blood flow in said limb below a predetermined blood flow reduction threshold.

9. The device as in claim 8, wherein said predetermined blood flow reduction threshold is about 10 percent of unrestricted blood flow in said limb.

10. The device as in claim 8, wherein said predetermined blood flow reduction threshold is about 30 ml/min.

11. The device as in claim 8, wherein said predetermined blood flow reduction threshold is about 10 ml/min per 1,000 grams of limb tissue weight.

12. The device as in claim 7, wherein said predetermined blood flow reduction is achieved by reducing cumulative limb oxygenation over the period of cuff inflation below a predetermined cumulative tissue oxygenation reduction threshold.

13. The device as in claim 12, wherein said cumulative limb oxygenation reduction threshold is about 40% of unrestricted limb oxygenation defined by unrestricted blood flow therein.

14. The device as in claim 7, wherein during at least a portion of said period of cuff inflation said cuff is inflated to at least a mean arterial pressure of said subject.

15. The device as in claim 14, wherein during at least a portion of said period of cuff inflation said cuff is inflated to a pressure exceeding said mean arterial pressure of said subject by a predetermined mean arterial pressure offset.

16. The device as in claim 7, wherein during at least a portion of said period of cuff inflation said cuff is inflated to a pressure at or below a lesser of a systolic blood pressure of said subject or a limb occlusion pressure of said subject.

17. The device as in claim 16, wherein during at least a portion of said period of cuff inflation said cuff is inflated to a pressure below said systolic blood pressure of said subject by a predetermined first systolic pressure offset.

18. The device as in claim 17, wherein said first systolic pressure offset is about 10 mmHg.

19. The device as in claim 7, wherein during said cuff deflation period, said cuff is deflated to increase blood flow above a predetermined reperfusion threshold.

20. The device as in claim 19, wherein said controller is further configured to vary cuff pressure during said period of cuff deflation so as to increase or decrease said blood flow in said limb during at least one of said treatment cycles.

21. The device as in claim 19, wherein said reperfusion threshold is defined as about 70 percent of unrestricted perfusion in said limb.