Implantable Device For Providing Electrical Stimulation Of Cervical Vagus Nerves For Treatment Of Chronic Cardiac Dysfunction With Bounded Titration

An implantable device for treating chronic cardiac dysfunction with bounded titration, comprising:

• an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation 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 in continuous alternating cycles of stimuli application and stimuli inhibition;
• a cervical vagus nerve stimulation therapy lead electrically coupled to the pulse generator and terminated by a pair of helical electrodes through which the therapeutic electrical stimulation is delivered to the patient's cervical vagus nerve;
• and
• an integrated leadless heart rate sensor configured to sense and record a patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator is further configured to alter the therapeutic electrical stimulation in response to the sensed heart rate, as sensed by the leadless heart rate sensors, falling outside of a predetermined range of acceptable heart rates stored in a recordable memory in the pulse generator.

An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration, comprising:

• 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 pulse generator configured to therapeutically stimulate the cervical vagus nerve through the helical electrodes in 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 the vagus nerve to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by creating and propagating the action potentials;
• and
• an integrated leadless heart rate sensor configured to sense and record a patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator is further configured to sense the patient's heart rate, wherein the pulse generator is configured to alter the creation and propagation of the action potentials in response to the sensed heart rate, as sensed by the leadless heart rate sensors, falling outside of a predetermined range of the acceptable heart rates.

A vagus nerve neurostimulator for treating chronic cardiac dysfunction with autonomous titration, comprising:

• an implantable neurostimulator comprising:
• a pulse generator configured to deliver electrical therapeutic stimulation 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 through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead;
• and
• a leadless heart rate sensor configured to sense and record a patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator is further configured to trigger automatic titration of the electrical therapeutic stimulation into a stored set of stimulation parameters progressively over a fixed period of time.

An implantable device for treating chronic cardiac dysfunction with autonomous titration, comprising:

• an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation 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 in continuous alternating cycles of stimuli application and stimuli inhibition;
• a cervical vagus nerve stimulation therapy lead electrically coupled to the pulse generator and terminated by a pair of helical electrodes through which the therapeutic electrical stimulation is delivered to the patient's cervical vagus nerve;
• and
• a leadless heart rate sensor configured to sense and record the patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator is further configured to trigger automatic titration of the therapeutic electrical stimulation into a set of stimulation parameters stored in a recordable memory in the pulse generator progressively over a fixed period of time.

An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with autonomous titration, comprising:

• 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 pulse generator configured to therapeutically stimulate the cervical vagus nerve through the helical electrodes in 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 the vagus nerve to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by creating and propagating the action potentials;
• and
• an integrated leadless heart rate sensor configured to sense and record the patient's heart rate in response to the electrical therapeutic stimulation, wherein the pulse generator is further configured to trigger automatic titration of the action potentials into a predetermined set of stimulation parameters progressively over a fixed period of time.