Cardiac Pacemakers, Inc.

Livanova Usa, Inc.

Cyberonics, Inc.

Scott R Stubbs

Imad Libbus

Bruce H KenKnight

Badri Amurthur

Scott Thomas Mazar

James O Gilkerson

William J Linder

Hiten J Doshi

Jeffrey E Stahmann

Kenneth Paul Hoyme

Douglas J Lang

Vickie L Conley

Conrad L Sowder

Lynn H Elliott

Arthur J Foster

Diane Schuster

Keith R Maile

Joseph M Bocek

Kevin G Wika

Jacob M Ludwig

Yingbo Li

Nicholas J Stessman

Thomas J Harris

Christopher R Perrey

Ronald W Kunkel

Douglas J Gifford

Douglas J Brandner

Bruce H Kenknight

Douglas Michael Hannan

Lynn S Elliott

Christopher Perrey

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.

Customizable titration for an implantable neurostimulator

Systems and methods for a user interface for titration of an implantable neurostimulator are provided. A method of managing titration using a management device for a patient implanted with a neurostimulator includes receiving, from the neurostimulator, data for the patient relating to stimulation being provided to the patient by the neurostimulator while the neurostimulator is in communication with the management device, displaying a user interface on a display of the management device, the user interface including at least a portion of the data displayed within a graph, the user interface allowing a user to modify a parameter of the titration, receiving a selection of the parameter, based on the selection, determining a titration schedule for the patient, and transmitting the titration schedule to the neurostimulator.

User interface for titration assist

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.

Stimulation suspension in response to patient discomfort or state

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. Between titration sessions one or more parameters, such as, for example, an acclimation interval, may be adjusted based on the patient's response to the stimulation. This personalized titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Neurostimulation titration process via adaptive parametric modification

A method of neurostimulation titration includes titrating a neurostimulation signal from a first set of parameters toward a target set of parameters according to a titration aggressiveness profile having a titration hold point. The method further includes receiving a hold indicator indicating that the titration has reached the titration hold point. The method further includes initiating an intermediate hold of the titrating of the neurostimulation signal in response to receiving the hold indicator. The method further includes receiving an indication of a titration resumption that discontinues the intermediate hold.

Neurostimulator with titration assist

Systems and methods of managing a plurality of patients undergoing titration using a management device. The method includes receiving, via a processor of a management device, a plurality of patient information from the plurality of patients, evaluating, via the processor of the management device, each patient based on patient information, determining, via the processor of the management device, a status of each patient, where the status is based on a progression of the titration based on titration assist parameters and determining, via the processor of the management device, a priority of each patient based on patient status. In some embodiments the method includes sorting that patients based on user input. In some embodiments, the plurality of patient information is received via remote communication with at least one of a programming device, an implantable medical device, or a home management device.

Titration assist management dashboard

A programmer configured to collect data from an implantable pulse generator about ongoing neurostimulation being applied during a stimulation titration process by the implantable pulse generator while in communication with the communication circuitry; display, via a user interface, an indication relating to a timing of neurostimulation bursts applied by the implantable pulse generator while in communication with the communication circuitry based on the collected data, the indication being displayed according to a time delay that accounts for a transport delay between the implantable pulse generator and the programmer such that the indication displayed coincides with an actual application of each stimulation burst by the implantable pulse generator; and adjust at least one stimulation parameter applied during the stimulation titration process by the implantable pulse generator.

A neurostimulation system comprises a control system configured to monitor a patient receiving neurostimulation therapy. The neurostimulation therapy has a stimulation cycle comprising a stimulation ON period, in which the patient is receiving neurostimulation, and a stimulation OFF period, in which the patient is not receiving neurostimulation. The control system is programmed to receive electrocardiogram (ECG) data from the patient receiving the neurostimulation therapy. The control system is further programmed to monitor a heart rate of the patient based on the ECG data over at least one stimulation cycle of the neurostimulation therapy. The control system is further programmed to generate an indication of signal stability to be displayed to a user based on the received ECG data.

User interface for a titration assist system

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 Poincar&#xe9; plot.

Poincare display to assess autonomic engagement responsive to vagus nerve stimulation

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.

Assessment system with wand detection cable synchronizing ECG recording

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.

R-R interval analysis for ECG waveforms to assess autonomic response to vagus nerve stimulation

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.

Display signal to assess autonomic response to vagus nerve stimulation treatment

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.

A neurostimulation system comprises a sensor and a control system. The sensor is configured to detect a cardiac physiological measure of a patient. The control system is programmed to monitor, via the sensor, the cardiac physiological measure during the treatment. The control system is further programmed to detect a change in the cardiac physiological measure during the treatment. The control system is further programmed to determine, based on the detected change in the cardiac physiological measure, a first transition time in a duty cycle of a neurostimulation signal delivered to the patient where the neurostimulation signal transitions between a stimulation OFF period and a stimulation ON period.

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Maple Grove, MN, United States of America

Scott R Stubbs