Cardiac Pacemakers, Inc.

Livanova Usa, Inc.

Cyberonics, Inc.

East Tennessee State University

Corventis, Inc.

Medtronic Monitoring, Inc.

Cardiac Research, Inc.

Imad Libbus

Badri Amurthur

Bruce H KenKnight

Andrew P Kramer

Scott Thomas Mazar

Jeffrey E Stahmann

Anthony V Caparso

Scott R Stubbs

William J Linder

Yatheendhar D Manicka

Julio Cesar Spinelli

Kent Lee

Paul Allan Haefner

Krzysztof Z Siejko

Robert J Sweeney

Marina V Brockway

Rodolphe Katra

Yi Zhang

Avram Scheiner

Aaron R McCabe

Joseph M Pastore

Ronald W Heil, Jr

Quan Ni

Randy W Westlund

Qingsheng Zhu

David J Ternes

John D Hatlestad

Stephen B Ruble

Steven D Girouard

Jiang Ding

Rodney W Salo

Gerrard Merrill Carlson

Julia Moffitt

Kristofer J James

Jeffrey L Ardell

Mark J Bly

Jonathan T Kwok

Yachuan Pu

Jerry S Wang

M Jason Brooke

Niranjan Chakravarthy

Alok S Sathaye

Sophia H Wang

Scot C Boon

Bruce H Kenknight

Scott R Vanderlinde

Weiying Zhao

Aaron Lewicke

Richard L Verrier

Ankur Garg

Bruce D Nearing

Brett A Landrum

Stefan Nikles

Rich Fogoros

Gregory A Ordway

Dan Li

Barun Maskara

Eric G Lovett

Tamara Colette Baynham

Christine Henry

Jeffrey Ross

Joseph Walker

Shivkumar Sabesan

Matt Merkert

David J Smith

Benjamin Ettori

Scott Stubbs

Eugene Yu-Chun Wu

Scott Mazar

Scot Boon

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

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.

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

Systems and methods are provided for delivering vagus nerve stimulation and carotid baroreceptor stimulation to patients for treating chronic heart failure and hypertension. The vagus nerve stimulation and carotid baroreceptor stimulation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies.

Vagus nerve and carotid baroreceptor stimulation system

Various aspects of the present subject matter relate to an implantable device. Various device embodiments comprise at least one port to connect to at least one lead with at least electrode, stimulation circuitry connected to the at least one port and adapted to provide at least one neural stimulation therapy to at least one neural stimulation target using the at least one electrode, sensing circuitry connected to the at least one port and adapted to provide a sensed signal, and a controller connected to the stimulation circuitry to provide the at least one neural stimulation therapy and to the sensing circuitry to receive the sensed signal. In response to a triggering event, the controller is adapted to switch between at least two modes. Other aspects and embodiments are provided herein.

Implantable neural stimulator with mode switching

Growing community of inventors

Saint Paul, MN, United States of America

Imad Libbus