Cardiac Pacemakers, Inc.

Livanova Usa, Inc.

Cyberonics, Inc.

East Tennessee State University

The Uab Research Foundation

Cardiac Intelligence Corporation

Livanova Us, Inc.

Bruce H KenKnight

Imad Libbus

Badri Amurthur

Scott Thomas Mazar

Scott R Stubbs

Jeffrey L Ardell

Qingsheng Zhu

Yatheendhar D Manicka

Julio Cesar Spinelli

Rodney W Salo

Roger W Dahl

Steven D Girouard

Robert J Sweeney

Weimin Sun

Raymond E Ideker

William Hsu

Jiang Ding

Douglas R Daum

Jay A Warren

Stephen John Hahn

Eric G Lovett

David K Swanson

Andrew P Kramer

Ronald W Heil, Jr

Julia Moffitt

Robert G Hauser

Jeffrey A Hall

Yinghong Yu

Joseph M Pastore

Martin Tze

Yayun Lin

Richard S Sanders

Janice Jones

Jeffrey E Stahmann

Veerichetty A Kadhiresan

Mohan Krishnan

Milton M Morris

Gregory P Walcott

Peter T Kelley

Jeffrey T Bartig

David S Wood

Mudit Jain

Scott M Partridge

Robert S Booker, Iii

Allan Charles Shuros

Quan Ni

John D Hatlestad

Gerrard Merrill Carlson

Jesse W Hartley

Kent Lee

Shantha Arcot-Krishnamurthy

Wade A Bowe

Richard Fogoros

Richard L Verrier

Bruce D Nearing

G Neal Kay

Robert W Wickham, Jr

Sophia H Wang

Michael J Pederson

Gregory A Ordway

Gust H Bardy

Yi Zhang

Randy W Westlund

Bruce Alan Tockman

Julie A Thompson

Abhilash Patangay

Tamara Colette Baynham

Douglas J Lang

Adam W Cates

Geng Zhang

Amir J Tehrani

Christine Henry

Richard V Calfee

Stuart R Chastain

Brian Brandell

William J Eastman

Robert W Wickham, Jr, Deceased

Nipon Chattipakorn

Wickham, Jr Robert W

By Duane Quiggle, Legal Administrator

Jian Huang

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

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. A progressively increasing amount of time is spent waiting via a controller and, upon sensing a condition indicative of an absence or termination of the bradycardia, a progressively increasing partial maintenance dose is delivered via the pulse generator.

Implantable neurostimulator-implemented method for managing bradycardia through vagus nerve stimulation

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 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 monitoring the patient's response to the neurostimulation therapy on an ambulatory basis over extended periods of time and a control system for adjusting stimulation parameters to maintain stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation.

Responsive neurostimulation for the treatment of chronic cardiac dysfunction

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.

Neurostimulation titration utilizing T-wave alternans

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.

Customizable titration for an implantable neurostimulator

An implantable vagus nerve stimulation (VNS) system includes a sensor configured to measure ECG data for a patient, a stimulation subsystem configured to deliver VNS to the patient, and a control system configured to perform a heart rate variability analysis with the ECG data. In some aspects, performing the heart rate variability analysis includes measuring R-R intervals between successive R-waves for the ECG data measured during a stimulation period of VNS therapy and a baseline period of the VNS therapy, wherein the stimulation period comprises at least a portion of the ON period and the baseline period comprises at least a portion of the OFF period immediately preceding the ON period, and generating a plot of each R-R interval against an immediately successive R-R interval for each of the stimulation period and the baseline period configured to be displayed on a display.

Evaluation of vagus nerve stimulation using heart rate variability analysis

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

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.

Neurostimulation titration process

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.

Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction

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

Growing community of inventors

Maple Grove, MN, United States of America

Bruce H KenKnight