Neurostimulation and recording of physiological response for the treatment of chronic cardiac dysfunction
AssigneesCyberonics, Inc., East Tennessee State University
InventorsImad Libbus, Badri Amurthur, Bruce H. KenKnight, Jeffrey L. Ardell
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Abstract
Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A neural fulcrum zone is identified and ongoing neurostimulation therapy is delivered within the neural fulcrum zone. The implanted stimulation device includes a physiological sensor for recording the patient's response to the neurostimulation therapy on an ambulatory basis over extended periods of time.
Claims26
An implantable medical device (IMD), comprising:
- an electrode assembly;
- a neurostimulator coupled to the electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient in the patient's neural fulcrum zone, said stimulation signal comprising an ON time and an OFF time;
- a heart rate sensor configured to acquire a heart rate signal from the patient;
- a non-volatile memory;
- a control system coupled to the neurostimulator, the physiological sensor, and the non-volatile memory, said control system being programmed to:
- monitor a baseline signal acquired by the heart rate sensor, wherein the baseline signal comprises a baseline heart rate during the OFF time periods of the stimulation signal;
- monitor a response signal acquired by the heart rate sensor, wherein the response signal comprises a heart rate response during the ON time periods of the stimulation signal;
- and
- record in the non-volatile memory the baseline signals and the response signals on an ambulatory basis;
- wherein the neural fulcrum zone corresponds to a stimulation intensity during which a transition heart rate response is detected, said transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change of between 0% and 5%.
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A method of operating an implantable medical device (IMD) comprising a non-volatile memory, a heart rate sensor configured to acquire a heart rate signal from the patient, and a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient, the method comprising:
- activating the neurostimulator to deliver a stimulation signal in a patient's neural fulcrum zone, said stimulation signal comprising an ON time and an OFF time;
- monitoring a baseline signal acquired by the heart rate sensor, wherein the monitoring the baseline signal comprises monitoring a baseline heart rate during the OFF time periods of the stimulation signal;
- monitoring a response signal acquired by the heart rate sensor, wherein the monitoring the response signal comprises monitoring a heart rate response during the ON time periods of the stimulation signal;
- and
- recording in the non-volatile memory the baseline signals and the response signals on an ambulatory basis;
- wherein the neural fulcrum zone corresponds to a stimulation intensity during which a transition heart rate response is detected, said transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change of between 0% and 5%.
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Dependencies are inferred from the claim text.