Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. This titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Abstract: A system includes one or more memory devices having instructions stored thereon that, when executed by one or more processors, cause the one or more processors to perform operations including calculating a depression detection value based in part on a first depression-indicative value based on a first body parameter value, a second depression-indicative value based on a second body parameter value, and a weighting applied to at least one of the first depression-indicative value and the second depression-indicative value, comparing the depression detection value to a first threshold and a second threshold that is different from the first threshold to detect an onset of a depression episode, and initiating neurostimulation therapy by one or more electrodes responsive to detecting the onset of the depression episode.

Abstract: Systems and methods for customizable titration of an implantable neurostimulator are provided. A method of titrating a neurostimulation signal delivered to a patient from an implantable pulse generator includes delivering a first neurostimulation signal with a first set of parameters, increasing a first value of the first neurostimulation signal at a first rate for a first period of time while delivering the first neurostimulation signal, ceasing delivery of the first neurostimulation signal when the first value reaches a first target value, delivering a second neurostimulation signal with a second set of parameters, and increasing the second neurostimulation signal at a second rate for a second period of time while delivering the second neurostimulation signal.

Abstract: A method of neurostimulation titration. The method includes setting titration parameters for an electrical signal delivered by an implantable medical device, initiating titration with the titration parameters and an aggressiveness profile, performing titration by increasing at least one of a current amplitude, a frequency, a pulse width or a duty cycle of the electrical signal until a threshold is reached or a side effect is detected, pausing the titration while waiting for commands from the patient or caregiver, and resuming the titration in response to receiving authorization from an external device.

Abstract: A method of detecting a seizure status of a subject includes collecting first data from a first accelerometer positioned on a first limb of the subject and a second data from a second accelerometer positioned on a torso of the subject, determining that one of the first accelerometer or the second accelerometer provides a better indication (e.g., greater level of sensitivity or a lesser level of a false positive rate) by comparing the first data and the second data, detecting an indication of the seizure status of the subject using at least one of the first data and the second data, and generating an alert in response to the detection of the indication of the seizure status of the subject.

Abstract: A method for managing bradycardia through vagus nerve stimulation is provided. An implantable neurostimulator configured to deliver electrical therapeutic stimulation in both afferent and efferent directions of a patient's cervical vagus nerve is provided. An operating mode is stored, which includes parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses. The maintenance dose is delivered via a pulse generator through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead independent of cardiac cycle. The patient's physiology is monitored, and upon sensing a condition indicative of bradycardia, the delivery of the maintenance dose is suspended.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of 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.

Abstract: An assessment system is provided for vagus nerve stimulation treatment with a neurostimulator configured to deliver a stimulation signal having a plurality of ON-periods and OFF-periods. The assessment system includes a wand assembly configured to generate a delivery detection signal indicating delivery of the stimulation signal, a lead assembly configured to acquire an ECG signal, and a data acquisition system configured to capture the delivery detection and ECG signals. The assessment system further includes a processor and a non-transitory computer-readable memory storing instructions that, when executed by the processor, cause the assessment system to record the ECG signal over at least one successive pair of ON- and OFF-periods, determine a heart rate dynamic response from the ECG signal, and determine an instantaneous heart rate for each determined R-R interval to determine heart rate dynamics for assessment of autonomic engagement in response to the vagus nerve stimulation treatment.

Abstract: A method includes receiving sensor data at a processor from sensors of an external medical device. The sensor data corresponds to at least a first body parameter value for a patient and a second body parameter value for the patient. The method includes determining a first depression-indicative value based on the first body parameter value, a second depression-indicative value based on the second body parameter value, a depression detection value as a function of a first weight applied to the first depression-indicative value and a second weight applied to the second depression-indicative value, and a depression state based at least in part on a comparison of the depression detection value to one or more threshold values.

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: Embodiments include a screening method for evaluating patient suitability for an implanted hypoglossal nerve stimulation (HGNS) device. The screening method evaluates blood oxygen data relating to respiratory events, with the blood oxygen data providing mean blood oxygen desaturation values for comparison to severity thresholds to identify patients who are likely or unlikely to benefit from the implantation of the HGNS device.

Abstract: An assessment system is provided for vagus nerve stimulation therapy treatment for congestive heart failure in a subject. The assessment system includes a first interface configured to communicate with a device that delivers a stimulation signal to a vagus nerve of the subject, a second interface configured to capture heart electrical activity of the subject in response to the stimulation signal, and a processor and a non-transitory computer readable memory storing instructions that, when executed by the processor, cause the assessment system to determine and display heart rate dynamics and display a digital ECG signal in real-time in response to the stimulation signal.

Abstract: A system includes a vagus nerve stimulation (VNS) device configured to deliver a vagus nerve stimulation signal having an ON-period status and an OFF-period status, and a processor and a non-transitory computer readable memory. The memory stores instructions that, when executed by the processor, cause the system to synchronously record a first ECG profile of during the ON-period status and a second ECG profile during the OFF-period status, determine heart rate dynamics from the first and second ECG profiles, the heart rate dynamics including a plurality of R-R intervals in each ECG profile, generate display data configured to be displayed on a display, and transmit the display data to the display. The display data includes the R-R intervals for each of the first and second ECG profiles. The display data further includes a Poincaré plot.

Abstract: An assessment system is provided for a subject patient implanted with a neurostimulator configured to deliver a stimulation signal having a plurality of ON-periods and OFF-periods. The assessment system includes a wand assembly configured to generate a delivery detection signal indicating delivery of an initiating pulse. The assessment system also includes a processor and a memory associated with the wand. The memory stores instructions that, when executed by the processor, cause the assessment system to record an ECG signal over at least one successive pair of ON- and OFF-periods and determine changes in heart rate dynamics to indicate autonomic response to the stimulation. The wand assembly includes a programming device configured to wirelessly communicate with the neurostimulator and a cable connector configured to form a surface contact with the programming device. The cable connector includes a detection circuit configured to indirectly detect a time of the initiating pulse.

Abstract: A method includes applying, by an implantable medical device (IMD), stimulation to a cranial nerve of a patient responsive to a determination that a level of synchrony between neural activity of one or more regions of an autonomic nervous system of the patient and one or more regions of a central nervous system of the patient falls below a first threshold and discontinuing the application of stimulation by the IMD when the level of synchrony exceeds a second threshold.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients. Stimulation from an implantable medical device (IMD) may be suspended in response to detecting a patient discomfort event, such as a cough, throat irritation, or voice alteration. The suspension period may be based on at least one of a severity level of the patient discomfort event and a patient physical state, such as being asleep or lying down. Detection of a patient discomfort event may be calibrated.

Abstract: Systems and methods are provided for delivering vagus nerve stimulation and cardioversion/defibrillation therapies to patients for treating chronic heart failure. The vagus nerve stimulation and cardioversion/defibrillation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies to provide an acute vagus nerve stimulation therapy in advance of delivering cardioversion-defibrillation energy.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level until a target T-wave alternans change from a baseline T-wave alternans is achieved.

Abstract: A method of detecting a subject's physiological status, seizure state, or seizure type with limb-based accelerometers identifying a favored accelerometer or limb that provides a better sensitivity or false positive rate as compared to other accelerometers or limbs. The detection method may include determining whether the seizure conforms with an anticipated seizure type, and determining whether to base a seizure detection on data from the favored or un-favored accelerometers or limbs. The method may also include applying a weighing factor to base the detection on data obtained primarily from the favored accelerometer or limb or to not rely on data obtained primarily from un-favored accelerometers or limbs. The method may also include comparing data obtained from a favored accelerometer or limb with data obtained from other accelerometers or limbs or obtained from detection devices using ECG or EEG. An alert may be generated based on the detection of a seizure.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of 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.