Computer-implemented system and method for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction
First Claim
1. A computer-implemented system for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, comprising:
- an external programmer, comprising;
a programming computer configured to execute using a processor program code that is stored in a recordable memory, comprising;
a plurality of therapy profiles stored in the recordable memory that each comprise different sets of stimulation parameters that cooperatively define alternating cycles of stimuli application and stimuli inhibition for a neurostimulator that are tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle in a range between 5% and 30%, at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers comprising a cervical vagus nerve of a patient to both efferently activate the heart'"'"'s intrinsic nervous system and afferently activate the patient'"'"'s central reflexes; and
a user interface comprising input controls and a visual display and configured to display the therapy profiles to the patient and to select the set of stimulation parameters in the therapy profile chosen by the patient;
a programming wand interfaced to the programming computer and configured to provide the selected set of stimulation parameters to the neurostimulator through wireless telemetry; and
an implantable neurostimulator comprising a cervical vagus nerve stimulation therapy lead terminated by a pair of helical electrodes and electrically coupled to the neurostimulator, which is configured to therapeutically stimulate the patient'"'"'s cervical vagus nerve through the helical electrodes by creating and propagating the action potentials with a pulse generator as specified by the selected set of stimulation parameters stored in the recordable memory.
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Accused Products
Abstract
A computer-implemented system and method for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction is provided. An external programmer includes a plurality of therapy profiles stored in memory. The therapy profiles include different sets of stimulation parameters that cooperatively define alternating cycles of stimuli application and stimuli inhibition for a neurostimulator that are tuned to both efferently activate the heart'"'"'s intrinsic nervous system and afferently activate the patient'"'"'s central reflexes. A programming wand is configured to provide the set of stimulation parameters chosen by the user to the neurostimulator through wireless telemetry. Finally, an implantable neurostimulator device includes a stimulation therapy lead terminated by helical electrodes and electrically coupled to the neurostimulator. The implantable neurostimulator is configured to therapeutically stimulate the cervical vagus nerve through the helical electrodes by triggering bi-directional action potentials as specified by the selected set of stimulation parameters.
221 Citations
20 Claims
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1. A computer-implemented system for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, comprising:
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an external programmer, comprising; a programming computer configured to execute using a processor program code that is stored in a recordable memory, comprising; a plurality of therapy profiles stored in the recordable memory that each comprise different sets of stimulation parameters that cooperatively define alternating cycles of stimuli application and stimuli inhibition for a neurostimulator that are tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle in a range between 5% and 30%, at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers comprising a cervical vagus nerve of a patient to both efferently activate the heart'"'"'s intrinsic nervous system and afferently activate the patient'"'"'s central reflexes; and a user interface comprising input controls and a visual display and configured to display the therapy profiles to the patient and to select the set of stimulation parameters in the therapy profile chosen by the patient; a programming wand interfaced to the programming computer and configured to provide the selected set of stimulation parameters to the neurostimulator through wireless telemetry; and an implantable neurostimulator comprising a cervical vagus nerve stimulation therapy lead terminated by a pair of helical electrodes and electrically coupled to the neurostimulator, which is configured to therapeutically stimulate the patient'"'"'s cervical vagus nerve through the helical electrodes by creating and propagating the action potentials with a pulse generator as specified by the selected set of stimulation parameters stored in the recordable memory. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A computer-implemented method for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, comprising:
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storing a plurality of therapy profiles in a recordable memory of a programming computer, each therapy profile comprising different sets of stimulation parameters that cooperatively define alternating cycles of stimuli application and stimuli inhibition for a neurostimulator that are tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle in a range between 5% and 30%, at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers in both afferent and efferent directions of a cervical vagus nerve to both efferently activate the heart'"'"'s intrinsic nervous method and afferently activate the patient'"'"'s central reflexes; displaying the therapy profiles to the patient and retrieving the set of stimulation parameters in the therapy profile selected by the patient; and providing the selected set of stimulation parameters to the neurostimulator through wireless telemetry, wherein the neurostimulator is configured to therapeutically stimulate a cervical vagus nerve of the patient through a pair of helical electrodes by creating and propagating the action potentials with the pulse generator as specified by the selected set of stimulation parameters stored in the recordable memory. - View Dependent Claims (8, 9, 10, 11, 12)
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13. An implantable device for treatment of chronic cardiac dysfunction using select therapy profiles, comprising:
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a cervical vagus nerve stimulation therapy lead, comprising; a pair of helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath of a patient; and a set of connector pins electrically connected to the helical electrodes by an insulated electrical lead body; and a neurostimulator powered by a primary battery and enclosed in a hermetically sealed housing, further comprising; an electrical receptacle comprised on an outer surface of the housing into which the connector pins are securely and electrically coupled; a recordable memory into which a therapy profile has been stored by an external programmer, the therapy profile comprising a set of stimulation parameters that cooperatively define alternating cycles of stimuli application and stimuli inhibition that are tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at a periodic duty cycle in a range between 5% and 30%, at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers comprising a cervical vagus nerve to both efferently activate the heart'"'"'s intrinsic nervous method and afferently activate the patient'"'"'s central reflexes; and a pulse generator configured to therapeutically stimulate the patient'"'"'s cervical vagus nerve through the helical electrodes based on the set of stimulation parameters in the therapy profile stored in the recordable memory. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20)
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Specification