Advanced Bionics Corporation

Setpoint Medical Corporation

Advanced Bionics Ag

The Johns Hopkins University

Massachusetts Institute of Technology

Alfred E. Mann Foundation for Scientific Research

The Feinstein Institute for Medical Research

The Feinstein Institutes for Medical Research

Michael Allen Faltys

Jacob Arial Levine

Jesse M Simon

Gerald E Loeb

Edward Holman Overstreet

William Vanbrooks Harrison

Ralph J Zitnik

Yiming Liu

Glen A Griffith

Roy Christian Martin

Steven E Scott

Abhijit Kulkarni

Janusz A Kuzma

Lee F Hartley

Philip A Segel

Joseph H Schulman

Kevin J Tracey

Alfred E Mann

Lakshmi Narayan Mishra

John Charles Gord

Timothy J Starkweather

Michael Steven Colvin

Scott A Crawford

Charles Coleman Della Santina

Anthony K Arnold

Jian Xie

Lakshimi Narayan Mishra

Leonid Michael Litvak

Todd K Whitehurst

Carla Mann Woods

James P McGivern

Rahul Sarpeshkar

Logan P Palmer

Carla M Mann

James H Wolfe

Andrew W Voelkel

Jared M Huston

Thomas H R Lenarz

Robert Dan Dell

Howland Shaw Warren

Christopher J Czura

Carol Ann Amella

Ji-Jon Sit

Chris J Hetlinger

Richard A Block

Mauricio Rosas-Ballina

Francis J R Richmond

Carol Murad

Kitti McMeel

Andy Voelkel

Leadless, implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the microstimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature.

Implantable neurostimulator having power control and thermal regulation and methods of use

Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the microstimulator is configured to operate using closed-loop feedback. The feedback for the microstimulator can be electrical activity of the vagus nerve and/or heart sensed by the microstimulator. The feedback can be used to modulate the stimulation duration, intensity, frequency, on-time and off-time.

Closed-loop vagus nerve stimulation

Described herein are methods and systems for using EEG recordings to improve vagus nerve stimulation (VNS) therapy. In particular, described herein are methods and systems for using EEG recordings to detect P300 and/or activation of the nucleus basalis and/or the locus coeruleus to determine the efficacy of VNS. The EEG recordings can be used to provide feedback control to help optimize stimulation parameters and to screen for patients that respond well to VNS therapy.

Systems and methods for stimulating and/or monitoring loci in the brain to treat inflammation and to enhance vagus nerve stimulation

Described herein are systems and methods for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation using feedback to adjust the off times between stimulations. In particular, the feedback include an assessment of the level of inflammation by the patient or the healthcare provider, or by measure the level of an inflammatory analyte or biomarker, or by detecting nerve activity correlated with inflammation.

Extremely low duty-cycle activation of the cholinergic anti-inflammatory pathway to treat chronic inflammation

Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be leadless and batteryless.

Batteryless implantable microstimulators

A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.

Neural stimulation devices and systems for treatment of chronic inflammation

An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.

Nerve cuff with pocket for leadless stimulator

Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.

Control of vagal stimulation

An implanted stimulator can deliver a patient-detectable electrical stimulation to remind or prompt a patient to interact with an implanted therapeutic device (e.g., neurostimulator) when a prompting event occurs. For example, the apparatuses and methods described herein may be configured to apply a prompting patient-detectable electrical vagus nerve stimulation to remind a patient that it is time to administer a therapeutic dose. When the therapeutic device is operated in an automatic fashion, the apparatus can also deliver a patient-detectable warning stimulation prior to the therapeutic stimulation to let the patient know that a therapeutic stimulation will be delivered soon thereafter.

Apparatus and method for reminding, prompting, or alerting a patient with an implanted stimulator

Leadless, implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the micro stimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature.

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Valencia, CA, United States of America

Michael Allen Faltys