MULTI-MODE INFLATABLE LIMB OCCLUSION DEVICE

• US 20130211269A1
• Filed: 03/15/2013
• Published: 08/15/2013
• 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 8,974,491 B2
• Time in Patent Office: Days
• US Class Current: 600/499
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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: A61B 5/0225 the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS

Abstract

Methods for adaptive cuff inflation for the purposes of occluding a limb of a subject include inflating a cuff to a pressure at or above limb occlusion pressure and periodically deflating the cuff to detect amplitude of oscillometric oscillations reaching or exceeding a predetermined threshold, whereby indicating that the cuff pressure has reached an updated systolic blood pressure. Selecting the cuff to be wide enough to define limb occlusion pressure at or below the systolic blood pressure assures that this maneuver does not compromise cessation of blood flow to the limb. Devices are disclosed configured to operate in at least two of the following three operating modes: a tourniquet mode, a remote conditioning mode and a blood pressure monitoring mode.

Claims

1. A multi-mode inflatable limb occlusion device comprising a controller configured to inflate a cuff placed about a limb of a subject to at least a limb occlusion pressure, whereby causing cessation of blood flow through the limb, said controller is configured to operate in at least two of the following three modes of operation:

a remote conditioning mode of operation, wherein said controller is configured to inflate and deflate the cuff according to a remote conditioning treatment protocol, said treatment protocol including a plurality of treatment cycles, each treatment cycle comprising;

a period of cuff inflation, during which the cuff is inflated and maintained at a pressure at or above said limb occlusion pressure for at least about one minute, and

a period of cuff deflation, during which the cuff is deflated below the limb occlusion pressure, whereby at least partially restoring blood flow through the limb,

a tourniquet mode of operation, wherein said controller is configured to inflate the cuff to at least said limb occlusion pressure for a predetermined or manually set period of cuff inflation lasting at least one minute, and

a blood pressure monitoring mode of operation, wherein said controller is configured to detect blood pressure of the subject.

2. The multi-mode inflatable limb occlusion device as in claim 1, wherein said controller is further configured to detect systolic blood pressure of the subject at least once during said period of cuff inflation.

3. The multi-mode inflatable limb occlusion device as in claim 2, wherein said controller is further configured to detect amplitude of oscillometric oscillations in the cuff, said systolic pressure is determined when said amplitude exceeds a predetermined threshold.

4. The multi-mode inflatable limb occlusion device as in claim 1, wherein said controller is further configured to detect blood pressure of the subject at least once when said controller is operated in said remote conditioning mode of operation or said tourniquet mode of operation.

5. The multi-mode inflatable limb occlusion device as in claim 1, wherein while said controller is operated in either said remote conditioning mode of operation or said tourniquet mode of operation, said controller is configured to simultaneously operate in said blood pressure monitoring mode of operation.

6. The multi-mode inflatable limb occlusion device as in claim 1, wherein said controller is further configured to inflate the cuff to a pressure at or above said limb occlusion pressure but at or below said systolic blood pressure of the subject at least once during said period of cuff inflation.

7. The multi-mode inflatable limb occlusion device as in claim 1, wherein during said period of cuff inflation said controller is further configured to at least once or periodically dither pressure in the cuff in a range between said limb occlusion pressure and a holding pressure exceeding said limb occlusion pressure by a predetermined safety margin.

8. The multi-mode inflatable limb occlusion device as in claim 1, wherein said cuff is configured to define said limb occlusion pressure as equal to or less than said systolic blood pressure of the subject.

9. The multi-mode inflatable limb occlusion device as in claim 1, wherein said controller is configured to operate in said remote conditioning mode of operation preceding said controller operating in said tourniquet mode of operation.

10. The multi-mode inflatable limb occlusion device as in claim 1, wherein said controller is further configured to operate in said blood pressure monitoring mode of operation prior to, during, or following said controller operating in either said remote conditioning mode of operation or said tourniquet mode of operation.

11. A multi-mode inflatable limb occlusion device comprising a controller configured to deliver remote conditioning by periodically:

inflating a first cuff sized to fit about a first limb of a subject to a pressure at or above a limb occlusion pressure of the subject and maintaining the first cuff at or above said limb occlusion pressure for at least one minute, whereby causing cessation of blood flow through the first limb;

deflating the first cuff to at least partially restore blood flow through the first limb;

said controller is further configured during or after completion of remote conditioning to inflate and maintain the first cuff or a second cuff in a tourniquet mode of operation to at least said limb occlusion pressure, said second cuff sized to fit about a second limb of the subject, said tourniquet mode lasting for a predetermined or manually set period of cuff inflation of at least one minute, whereby inflation of the first cuff or the second cuff causing cessation of blood flow to respectively the first limb or the second limb of the subject.

12. The multi-mode inflatable limb occlusion device as in claim 11, wherein said predetermined or manually set period of cuff inflation in the tourniquet mode of operation lasting between about 30 minutes and about 3 hours.

13. The multi-mode inflatable limb occlusion device as in claim 11, wherein said controller is further configured to detect blood pressure of the subject at least once during delivery of remote conditioning or operating in the tourniquet mode of operation.

14. A comprehensive monitor of physiologic parameters of a subject including at least blood pressure monitoring and automatic delivery of remote conditioning, the monitor comprising a cuff sized to fit about a limb of the subject and a controller connected to the cuff and configured to monitor the blood pressure before, during, or after delivery of remote conditioning, said remote conditioning is delivered by said controller by periodically:

inflating the cuff to a pressure at or above a limb occlusion pressure of the subject defining an inflated state and maintaining the cuff in the inflated state for at least one minute, and

deflating the cuff to restore blood flow to the limb.

15. The comprehensive monitor as in claim 14, wherein systolic blood pressure of the subject is determined at least once during delivery of remote conditioning by inflating said cuff to a pressure when amplitude of oscillometric oscillations in the cuff reaches a predetermined threshold.

16. A method for adaptive limb occlusion of a subject, the method comprising the steps of:

(a) providing a cuff sized to be placed about a limb of the subject, said cuff is configured to define a limb occlusion pressure to be equal to or below a systolic blood pressure of the subject;

(b) determining the systolic blood pressure of a subject by inflating the cuff placed about the limb of the subject;

(c) inflating the cuff to a pressure sufficient to cause cessation of blood flow through the limb, said pressure being below, at or above the systolic blood pressure calculated in step (b) for a period of cuff inflation, said period of cuff inflation lasting at least about one minute;

(d) at least once during the period of cuff inflation, decreasing cuff pressure sufficiently to determine an updated systolic blood pressure of the subject but without compromising cessation of blood flow through the limb; and

(e) inflating the cuff to a pressure below, at or above the updated systolic blood pressure calculated in step (d), said pressure being sufficient to continue causing cessation of blood flow through the limb.

17. The method as in claim 16, wherein the cuff is inflated in steps (c) and (e) to the pressure at or above a limb occlusion pressure.

18. The method as in claim 16, wherein said step (d) further including a step of decreasing cuff pressure until an amplitude of detected oscillometric oscillations increases to a predetermined threshold indicating the cuff pressure to be equal to or below the updated systolic blood pressure but at least equal to or above the corresponding limb occlusion pressure of the subject, whereby the updated systolic blood pressure is determined without compromising cessation of blood flow through the limb.

19. The method as in claim 16, wherein said steps (d) and (e) are repeated on a scheduled basis throughout the period of cuff inflation.

20. The method as in claim 16, wherein said steps (c) and (e) are conducted by inflating the cuff to a pressure exceeding the systolic blood pressure by a predetermined safety margin.