Methods and devices for remote ischemic preconditioning and near-continuous blood pressure monitoring
First Claim
1. A device for remote ischemic preconditioning, the device comprising:
- a cuff sized to fit about a limb of a subject in a deflated state, the cuff configured to be inflated from the deflated state to an inflated state to at least substantially reduce a blood flow through the limb, said cuff is configured to assure a limb occlusion pressure equal or less than a systolic blood pressure of said subject,a controller connected to said cuff, said controller including a cuff inflation assembly configured to inflate and deflate said cuff according to a preconditioning treatment protocol, said treatment protocol includes a plurality of treatment cycles, each cycle comprising the intervals of;
cuff inflation, during which said cuff inflation assembly inflates said cuff to at least said limb occlusion pressure,an ischemic duration, during which said controller maintains said cuff at or above said limb occlusion pressure but at or below the systolic blood pressure of the subject for at least a portion of said ischemic duration, the ischemic duration lasting for at least about a minute,cuff deflation, during which said controller deflates said cuff to said deflated state, anda reperfusion duration.
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Accused Products
Abstract
Single- or dual-bladder devices for remote ischemic preconditioning and blood pressure monitoring are disclosed along with various oscillometry-based and other methods for detecting systolic and diastolic blood pressure while the ischemic preconditioning treatment is in progress. The devices and methods of the invention provide for delivery of ischemic preconditioning at the lowest effective cuff pressure while closely monitoring patient'"'"'s hemodynamics. Advantageously, the device of the invention allows both ischemic preconditioning and blood pressure monitoring to be done on the same limb. Disposable battery-powered version of the device of the present invention is especially useful for emergency use with patients suffering from acute myocardial infarction, acute stroke, or acute trauma. Additional device configurations are described for use in a percutaneous intervention and vascular sealing settings.
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Citations
30 Claims
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1. A device for remote ischemic preconditioning, the device comprising:
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a cuff sized to fit about a limb of a subject in a deflated state, the cuff configured to be inflated from the deflated state to an inflated state to at least substantially reduce a blood flow through the limb, said cuff is configured to assure a limb occlusion pressure equal or less than a systolic blood pressure of said subject, a controller connected to said cuff, said controller including a cuff inflation assembly configured to inflate and deflate said cuff according to a preconditioning treatment protocol, said treatment protocol includes a plurality of treatment cycles, each cycle comprising the intervals of; cuff inflation, during which said cuff inflation assembly inflates said cuff to at least said limb occlusion pressure, an ischemic duration, during which said controller maintains said cuff at or above said limb occlusion pressure but at or below the systolic blood pressure of the subject for at least a portion of said ischemic duration, the ischemic duration lasting for at least about a minute, cuff deflation, during which said controller deflates said cuff to said deflated state, and a reperfusion duration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A device for remote ischemic preconditioning and blood pressure monitoring, the device comprising:
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a cuff configured to retract about a limb of a subject, said cuff including at least two bladders, a controller connected to said bladders, said controller including a cuff inflation assembly configured to individually inflate and deflate said bladders according to a preconditioning treatment protocol, said treatment protocol includes a plurality of treatment cycles, each cycle comprising the intervals of; cuff inflation, during which said cuff inflation assembly inflates said bladders to at least a limb occlusion pressure, an ischemic duration, during which said controller maintains said bladders about or above said limb occlusion pressure, the ischemic duration lasting for at least about a minute, cuff deflation, during which said controller deflates said bladders, and a reperfusion duration during which both said bladders remain at least partially deflated to allow for reperfusion of said limb. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A device for remote ischemic preconditioning, the device comprising:
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a cuff configured to retract about a limb of a subject, said cuff including a proximal bladder and a distal bladder, a controller connected to said proximal and distal bladders, said controller configured to detect pressure pulsations in said distal bladder, said controller including a cuff inflation assembly configured to inflate and deflate said proximal and distal bladders according to a preconditioning treatment protocol, said treatment protocol includes a plurality of treatment cycles, each cycle comprising the intervals of; cuff inflation, during which said cuff inflation assembly inflates said opposing proximal and distal bladders together or individually to a first pressure when said pressure pulsations are detected by said controller in said distal bladder, said controller configured to cause said cuff inflation assembly to continue inflating said bladders together or individually staring with said proximal bladder to a second pressure characterized by a rapid decrease in amplitude of pressure pulsations in said distal bladder, an ischemic duration, during which said controller maintains said bladders at or above said second pressure, the ischemic duration lasting for at least about a minute, cuff deflation, during which said controller deflates said bladders to allow at least partial reperfusion of said limb, and a reperfusion duration.
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28. A device for remote ischemic preconditioning, the device comprising:
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a cuff sized to fit about a limb of a subject in a deflated state, a controller connected to said cuff, said controller configured to inflate and deflate said cuff according to a remote ischemic preconditioning treatment protocol, said treatment protocol includes a plurality of treatment cycles, each of said cycles comprising; inflating said cuff to a cuff pressure at or above a limb occlusion pressure of the subject, maintaining said cuff pressure at or above said limb occlusion pressure for a period of at least about one minute, and deflating said cuff to said deflated state, wherein said controller is further configured to inflate said cuff pressure at or below a systolic blood pressure of the subject for at least a portion of said period during at least one of said cycles.
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29. A device for remote ischemic preconditioning, the device comprising a controller configured to periodically:
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inflate a cuff sized to fit about a limb of a subject to a cuff pressure at or above a limb occlusion pressure of the subject, maintain said cuff pressure at or above said limb occlusion pressure for a period of at least about one minute while inflating said cuff pressure at or below a systolic blood pressure of the subject for at least a portion of said period, and deflate said cuff to said deflated state.
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30. A method of inflating and deflating a cuff placed about a limb of a subject to deliver a remote ischemic preconditioning therapy to said subject, said therapy including a plurality of treatment cycles, each of said treatment cycles comprising:
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inflating said cuff to at least a limb occlusion pressure of said subject, maintaining said cuff at or above said limb occlusion pressure for a period of at least about one minute, and deflating said cuff, said method further including inflating said cuff to a pressure at or below a systolic blood pressure of the subject for at least a portion of said period during at least one of said cycles.
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Specification