Automatic devices for remote ischemic preconditioning
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Publication Number
US-9610213-B2
Publication Date
2017-04-04
Expiration Date
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.
Core Innovation
The invention provides an automatic device for remote ischemic preconditioning treatment that uses a disposable cuff configured to retract about a limb of a subject. A reusable battery-operated rechargeable controller is detachably retained on the cuff and includes a pressure sensor configured to detect cuff pressure within the cuff. The controller periodically inflates the cuff to a cuff pressure at or above a limb occlusion pressure and maintains the cuff pressure at or above the limb occlusion pressure for a period of at least about one minute, then deflates the cuff.
The controller determines the target cuff pressure using cuff pressure reading from the pressure sensor, either by inflating until a set cuff pressure level is reached based solely on the cuff pressure reading or by automatically determining the cuff pressure based solely on the cuff pressure reading. The device delivers the remote ischemic preconditioning therapy as one unit retained about the limb of the subject, and the controller is configured to complete the treatment automatically after initial activation by a user.
The treatment is performed at least twice and sequentially by inflating to a target cuff inflation pressure, maintaining cuff pressure at or above the limb occlusion pressure for a period of at least about one minute, and deflating for at least about one minute to restore blood flow in the limb. A described configuration supports an emergency device and near-continuous hemodynamic surveillance on the same limb during ischemia/reperfusion without fully deflating the cuff, using oscillometry-based estimation of systolic and diastolic blood pressure from oscillometric envelope segments and related detection approaches.
Claims Coverage
The provided set includes three independent claims, each centered on an automatic remote ischemic preconditioning device and its automated delivery sequence. Across the independent claims, there are four main inventive feature themes: a disposable retractable cuff with a detachably retained reusable rechargeable controller and pressure sensor, pressure-sensor-only determination of cuff inflation targets at or above limb occlusion pressure, automated sequential inflation/maintenance/deflation with specified minimum intervals, and automatic completion of the treatment after initial user activation.
Disposable retractable cuff with detachably retained rechargeable pressure-sensing controller
An automatic device for remote ischemic preconditioning treatment comprising a disposable cuff configured to retract about a limb of a subject, and a reusable battery-operated rechargeable controller detachably retained on the disposable cuff, the controller comprising a pressure sensor configured to detect a cuff pressure in the cuff, where the cuff and the controller are retained about the limb and deliver the remote ischemic preconditioning therapy as one unit.
Pressure-sensor-only cuff inflation target at or above limb occlusion pressure
The controller is configured to periodically either inflate the cuff until a set cuff pressure level is reached based solely on said cuff pressure reading from said pressure sensor, or automatically determine said cuff pressure based solely on said cuff pressure reading from said pressure sensor, wherein the inflation target is at or above a limb occlusion pressure of the subject.
At-least-once minimum occlusion maintenance with inflation and deflation cycle
The controller inflates the cuff to said cuff pressure at or above said limb occlusion pressure for a period of at least about one minute, and then deflates the cuff.
Sequential at least twice inflation/maintenance/restore blood flow cycles with autonomous completion
After initial activation by a user, the controller is configured to at least twice and sequentially perform inflating the cuff to said target cuff inflation pressure, maintaining the cuff pressure at or above the limb occlusion pressure for a period of at least about one minute, and deflating the cuff for at least about one minute to restore blood flow in said limb, and complete the entire treatment without further user input.
Method delivering remote ischemic preconditioning as one unit with detaching/discarding cuff
A method for delivery of remote ischemic preconditioning treatment including providing an automatic device with a disposable retractable cuff and a reusable battery-operated rechargeable controller detachably retainable on the disposable cuff, positioning and retaining the controller and cuff as one unit about a limb, activating the controller, delivering the remote ischemic preconditioning treatment automatically, performing at least twice and sequentially the inflating/maintaining/deflating procedure to restore blood flow, and upon completion detaching the reusable controller and discarding the disposable cuff.
The independent claims collectively define an automatic remote ischemic preconditioning system in which a disposable retractable cuff with a pressure-sensing, rechargeable controller delivers therapy as one retained unit, uses cuff pressure readings to set or determine a cuff pressure at or above limb occlusion pressure, performs sequential at least twice inflation/maintenance/deflation cycles with minimum intervals, and completes treatment without further user input.
Stated Advantages
Automatic delivery of remote ischemic preconditioning treatment.
Inflation and target pressure determination based solely on cuff pressure readings from the pressure sensor.
Completion of the entire treatment without further user input after initial activation by a user.
After completion, detaching the reusable controller and discarding the disposable cuff.
Documented Applications
Remote ischemic preconditioning treatment for a subject's limb using an automatic device that delivers therapy as one unit and performs sequential inflation/maintaining/deflation cycles.
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