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.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A computer-implemented control system is operated to automatically identify a neural fulcrum zone based on a monitored patient physiological response. Ongoing neurostimulation therapy is delivered within the neural fulcrum zone.

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. This neural fulcrum zone may be identified by monitoring a patient's response to incrementally increased intensity settings at a first frequency. If the incremental intensity increases do not result in the identification of the neural fulcrum zone, the frequency may be changed to provide finer resolution identification of the neural fulcrum zone.

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. This neural fulcrum zone corresponds to a combination of stimulation parameters at which autonomic engagement is achieved, while the tachycardia-inducing stimulation effects are offset by the bradycardia-inducing effects, thereby minimizing side effects such as significant heart rate changes while providing a therapeutic level of stimulation.

Abstract: An implantable device (11) for evaluating autonomic cardiovascular drive in a patient (10) suffering from chronic cardiac dysfunction is provided. A stimulation therapy lead (13) includes helical electrodes (14) configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins (28) electrically connected to the helical electrodes (14). A neurostimulator (12) includes an electrical receptacle (25) into which the connector pins (28) are securely and electrically coupled. The neurostimulator (12) also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes (14) in alternating cycles of stimuli application and stimuli inhibition (90) that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. The neurostimulator (12) includes a recordable memory (29) storing a baseline heart rate.

Abstract: A method for managing hypertension through renal nerve denervation and vagus nerve stimulation is provided. Renal nerves are disrupted to inhibit a sympathetic nervous system. Thereafter, an implantable neurostimulator, including a pulse generator, is configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers of a patient's cervical vagus nerve. A maintenance dose of the electrical therapeutic stimulation is delivered to the vagus nerve via the pulse generator to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses.

Abstract: Multi-modal stimulation therapy may be utilized in which two or more stimulation therapies having different stimulation parameters may be delivered to a single patient. This can preferentially stimulate different nerve fiber types and drive different functional responses in the target organs. The stimulation parameters that may vary between the different stimulation therapies include, for example, pulse frequency, pulse width, pulse amplitude, and duty cycle.

Abstract: A system for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration is provided. The system includes a patient-operable external controller to transmit a plurality of unique signals. The system further includes an implantable neurostimulator, which includes a pulse generator to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses that result in creation and propagation (in both afferent and efferent directions) of action potentials within the cervical vagus nerve of a patient through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead.

Abstract: An implantable device (11) for evaluating autonomic cardiovascular drive in a patient (10) suffering from chronic cardiac dysfunction is provided. A stimulation therapy lead (13) includes helical electrodes (14) configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins (28) electrically connected to the helical electrodes (14). A neurostimulator (12) includes an electrical receptacle (25) into which the connector pins (28) are securely and electrically coupled. The neurostimulator (12) also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes (14) in alternating cycles of stimuli application and stimuli inhibition (90) that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. The neurostimulator (12) includes a recordable memory (29) storing a baseline heart rate.

Abstract: An implantable neurostimulator-implemented method for managing tachyarrhythmias upon a patient's awakening from sleep through vagus nerve stimulation is provided. An implantable neurostimulator, including a pulse generator, is configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers comprising the cervical vagus nerve of a patient. Operating modes of the pulse generator are stored. An enhanced dose of the electrical therapeutic stimulation is parametrically defined and tuned to prevent initiation of or disrupt tachyarrhythmia upon the patient's awakening from a sleep state through at least one of continuously-cycling, intermittent and periodic ON-OFF cycles of electrical pulses. Other operating modes, including a maintenance dose and a restorative dose are defined.

Abstract: A system for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration is provided. The system includes a patient-operable external controller to transmit a plurality of unique signals. The system further includes an implantable neurostimulator, which includes a pulse generator to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses that result in creation and propagation (in both afferent and efferent directions) of action potentials within the cervical vagus nerve of a patient through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. The neurostimulator includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. The neurostimulator includes an integrated leadless heart rate sensor configured to sense heart rate and to record the sensed heart rate as data into a memory.

Abstract: An implantable neurostimulator-implemented method for managing tachyarrhythmias upon a patient's awakening from sleep through vagus nerve stimulation is provided. An implantable neurostimulator, including a pulse generator, is configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers comprising the cervical vagus nerve of a patient. Operating modes of the pulse generator are stored. An enhanced dose of the electrical therapeutic stimulation is parametrically defined and tuned to prevent initiation of or disrupt tachyarrhythmia upon the patient's awakening from a sleep state through at least one of continuously-cycling, intermittent and periodic ON-OFF cycles of electrical pulses. Other operating modes, including a maintenance dose and a restorative dose are defined.

Abstract: An implantable device for evaluating autonomic cardiovascular drive in a patient suffering from chronic cardiac dysfunction is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. The neurostimulator includes a recordable memory storing a baseline heart rate.

Abstract: A sleep quality assessment approach involves collecting data based on detected physiological or non-physiological patient conditions. At least one of detecting patient conditions and collecting data is performed using an implantable device. Sleep quality may be evaluated using the collected data by an implantable or patient-external sleep quality processor. One approach to sleep quality evaluation involves computing one or more summary metrics based on occurrences of movement disorders or breathing disorders during sleep.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials.

Abstract: A patient suffering from congestive heart failure is at increased risk of cardiac arrhythmogenesis during sleep, particularly if experiencing central sleep apnea as a co-morbidity. Low intensity peripheral neurostimulation therapies that target imbalance of the autonomic nervous system have been shown to improve clinical outcomes. Thus, bi-directional autonomic regulation therapy is delivered to the cervical vagus nerve at an intensity that is insufficient to elicit pathological or acute physiological side effects and without the requirement of an enabling physiological feature or triggering physiological marker. The patient's physiology is monitored to identify periods of sleep. In one embodiment, upon sensing a condition indicative of tachyarrhythmia following a period of bradycardia, as naturally occurs during sleep, an enhanced “boost” dose of bi-directional neural stimulation intended to “break” the tachyarrhythmic condition is delivered.

Abstract: A method and device for delivering ventricular resynchronization pacing therapy in conjunction with electrical stimulation of nerves which alter the activity of the autonomic nervous system is disclosed. Such therapies may be delivered by an implantable device and are useful in preventing the deleterious ventricular remodeling which occurs as a result of a heart attack or heart failure. The device may perform an assessment of cardiac function in order to individually modulate the delivery of the two types of therapy.

Abstract: A method for monitoring a biological cardiac pacemaker is provided. The method may include stimulating a heart at a region selected for implantation of a biological pacemaker and sensing at least one electrical signal indicative of a cardiac depolarization originating in the region selected for implantation of the biological pacemaker. The method may further include sensing at least one subsequent electrical signal produced by the heart and determining if the subsequent electrical signal originated in the region selected for the biological pacemaker or another region of the heart. In an alternative embodiment, the method may include determining a template time difference between two points on cardiac complexes sensed in two or more different cardiac locations during normal sinus rhythm. The method may further include determining a time difference between two points on a subsequent cardiac complex sensed in two or more different cardiac locations.

Abstract: A system for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration is provided. The system includes a patient-operable external controller to transmit a plurality of unique signals. The system further includes an implantable neurostimulator, which includes a pulse generator to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses that result in creation and propagation (in both afferent and efferent directions) of action potentials within the cervical vagus nerve of a patient through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead.