Medtronic, Inc.

Kristin N Hageman

Hank Bink

David A Dinsmoor

Christopher L Pulliam

Jiashu Li

Duane L Bourget

Leonid Michael Litvak

Avram Scheiner

Scott R Stanslaski

Robert A Corey

James B Hissong

Kanthaiah Koka

Sean Patrick Skubitz

Thomas I Miller

Joel A Anderson

Todd V Smith

Andrew L Schmeling

Adam J Rivard

David J Miller

Reid K Bornhoft

Erik J Peterson

Thomas Adamski

Robert T Sandgren

David Simons

Rebecca A Miron

Heba Tareq Omar

Laura Ann Skarie

Abigail Lauren Skerker

Christopher Edwards

Nikita Tandon

Ricardo Vallejo

Techniques are disclosed for implementing the use of electrically evoked compound action potentials (ECAPs) to adaptively adjust parameters of high frequency electrical stimulation. In one example, a medical device delivers electrical stimulation therapy comprising a train of electrical stimulation pulses to a patient, wherein the train of electrical stimulation pulses comprises a pulse frequency greater than or equal to 500 Hertz. After delivering the train of electrical stimulation pulses, the medical device ceases delivery of the high frequency electrical stimulation therapy for a predetermined period of time. During the predetermined period of time, the medical device senses an ECAP from the patient and determines, based on the sensed ECAP, a value of a parameter at least partially defining the train of electrical stimulation pulses. Responsive to the predetermined period of time elapsing, the medical device resumes delivery of the high frequency electrical stimulation according to the determined parameter.

ECAP sensing for high frequency neurostimulation

Systems, devices, and techniques for adjusting electrical stimulation are described. For example, processing circuitry is configured to receive, via a sensing electrode located at a target region of a patient, a plurality of evoked compound action potential (ECAP) signals elicited from respective electrical stimuli delivered to the patient; determine, based on the plurality of ECAP signals, an aggressor category for at least some ECAP signals of the plurality of ECAP signals, the aggressor category determined from a plurality of aggressor categories; determine, based on the aggressor category, a set of control policy parameters that at least partially define closed-loop control of stimulation therapy; and controlling delivery of the stimulation therapy according to at least the set of control policy parameters and one or more subsequent ECAP signals.

Hybrid control policy for ECAP-servoed neuromodulation

Systems, devices, and techniques are described for calibrating a medical device that senses ECAP signals from a patient's nerve tissue. For example a method includes instructing, with processing circuitry, stimulation circuitry of a medical device to deliver, on stimulation electrodes of the medical device, an electrical stimulation signal having an amplitude substantially equal to zero to a patient, entering, with the processing circuitry subsequent to instructing the stimulation circuitry to deliver the electrical stimulation signal, a passive recharge state on stimulation electrode circuitry, and auto-zeroing, with the processing circuitry, inputs to an operational amplifier of sensing circuitry electrically coupled to sensing electrodes of the medical device while the stimulation electrode circuitry is in the passive recharge state.

Calibration for ECAP sensing

Systems, devices, methods, and techniques are described for using evoked compound action potential (ECAP) signals to monitor lead position and/or detect lead migration. An example system includes sensing circuitry configured to sense an ECAP signal, and processing circuitry. The processing circuitry controls the sensing circuitry to detect, after delivery of an electrical stimulation pulse, a current ECAP signal, and determines one or more characteristics of the current ECAP signal. The processing circuitry also compares the one or more characteristics of the current ECAP signal to corresponding one or more characteristics of a baseline ECAP signal, and determines, based on the comparison, a migration state of the electrodes delivering the electrical stimulation pulse. Additionally, the processing circuitry outputs, based on the migration state, an alert indicative of migration of the electrodes.

Implantable lead migration monitoring using ECAP

A medical system for obstructive sleep apnea (OSA) treatment includes therapy delivery circuitry configured to output one or more electrical stimulation signals to a tongue of a patient; sensing circuitry configured to sense one or more compound muscle action potential (CMAP) signals, wherein the one or more CMAP signals are generated in response to the delivery of the one or more electrical stimulation signals; and processing circuitry configured to: cause the therapy delivery circuitry to output the one or more electrical stimulation signals to the tongue; receive information indicative of the one or more CMAP signals from the sensing circuitry; determine, based on the one or more CMAP signals, one or more therapeutic stimulation parameters for the OSA treatment; and cause the therapy delivery circuitry to deliver therapeutic electrical stimulation signals according to at least the determined one or more therapeutic stimulation parameters.

Stimulation therapy for treating obstructive sleep apnea (OSA) based on compound muscle action potential (CMAP)

Systems, devices, and techniques are described for adjusting electrical stimulation based on detected ECAPs. In one example, a medical device includes processing circuitry configured to control stimulation circuitry to deliver a first electrical stimulation pulse and sensing circuitry to detect, after delivery of the first electrical stimulation pulse, an ECAP signal. The processing circuitry may be configured to determine a characteristic value of the ECAP signal, determine an ECAP differential value that indicates whether the characteristic value of the ECAP signal is one of greater than a selected ECAP characteristic value or less than the selected ECAP characteristic value, determine, based on the ECAP differential value, a gain value, determine, based on the gain value, a parameter value that at least partially defines a second electrical stimulation pulse, and control the stimulation circuitry to deliver the second electrical stimulation pulse according to the parameter value.

Hysteresis compensation for detection of ECAPs

Devices, systems, and techniques are described for selecting an evoked compound action potential (ECAP) growth curve based on a posture of a patient. The ECAP growth curve defines a relationship between a parameter defining delivery of stimulation pulses delivered to the patient and a parameter of an ECAP signal of a nerve of a patient elicited by a stimulation pulse. In one example, a medical device detects a posture of a patient and selects an ECAP growth curve corresponding to the detected posture. The medical device selects, based on the ECAP growth curve corresponding to the detected posture and a characteristic of a detected ECAP signal, a value for a parameter for defining delivery of the stimulation pulses to the patient and controls delivery of the stimulation pulses according to the selected value for the parameter.

Posture-based control of electrical stimulation therapy

Systems, devices, and techniques are described for determining a posture state of a patient based on detected evoked compound action potentials (ECAPs). In one example, a medical device includes stimulation circuitry configured to deliver electrical stimulation and sensing circuitry configured to sense a plurality of evoked compound action potential (ECAP) signals. The medical device also includes processing circuitry configured to control the stimulation circuitry to deliver a plurality of electrical stimulation pulses having different amplitude values, control the sensing circuitry to detect, after delivery of each electrical stimulation pulse of the plurality of electrical stimulation pulses, a respective ECAP signal of the plurality of ECAP signals, and determine, based on the plurality of ECAP signals, a posture state of the patient.

Determining posture state from ECAPs

This disclosure is directed to devices, systems, and techniques for controlling electrical stimulation. In some examples, a system includes a user interface and processing circuitry. The processing circuitry is configured to output, for display by the user interface, a message requesting the patient perform a set of actions, receive, from the user interface, user input indicative of a patient response associated with the set of actions, and determine, based on the user input, one or more adjustments to a control policy which controls electrical stimulation delivered by a medical device based on a plurality of evoked compound action potentials (ECAPs) sensed by the medical device.

Control policy settings for electrical stimulation therapy

Systems, devices, and techniques for adjusting electrical stimulation based on a posture state of a patient are described. For example, a system may include sensing circuitry configured to sense an ECAP signal and processing circuitry configured to control delivery of the electrical stimulation to a patient according to a first value of a stimulation parameter and determine a characteristic value of the ECAP signal. The processing circuitry may also be configured to receive, from a sensor, a posture state signal representing a posture state of the patient, determine, based on the posture state signal, a gain value for the stimulation parameter, adjust, based on the characteristic value of the ECAP signal and the gain value, the first value of the stimulation parameter to a second value of the stimulation parameter, and control delivery of the electrical stimulation according to the second value of the stimulation parameter.

ECAP and posture state control of electrical stimulation

In one example, the disclosure describes a method comprising receiving, by processing circuitry, information indicative of one or more evoked compound action potential (ECAP) signals. The one or more ECAP signals are sensed by at least one electrode carried by a medical lead. The processing circuitry determining that at least one characteristic value of the one or more ECAP signals is outside of an expected range. Responsive to determining that the at least one characteristic value of the one or more ECAP signals is outside of the expected range, the processing circuitry performs a lead integrity test for the medical lead.

Lead integrity and closed-loop algorithm diagnostic

Systems, devices, and techniques include analyzing evoked compound action potentials (ECAP) signals to assess the effect of a delivered electrical stimulation signal. In one example, a system includes processing circuitry configured to receive ECAP information representative of an ECAP signal sensed by sensing circuitry, and determine, based on the ECAP information, that the ECAP signal includes at least one of an N2 peak, P3 peak, or N3 peak. The processing circuitry may then control delivery of electrical stimulation based on at least one of the N2 peak, P3 peak, or N3 peak.

Analyzing ECAP signals

Devices, systems, and techniques for controlling electrical stimulation therapy are described. In one example, a system may be configured to deliver electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a plurality of therapy pulses at a predetermined pulse frequency over a period of tune and deliver, over the period of time, a plurality of control pulses interleaved with at least some therapy pulses of the plurality of therapy pulses. The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses, a respective evoked compound action potential (ECAP), adjust, based on at least one respective ECAP, one or more parameter values that at least partially defines the plurality of therapy pulses, and deliver the electrical stimulation therapy to the patient according to the adjusted one or more parameter values.

ECAP based control of electrical stimulation therapy

Systems, devices, and techniques for adjusting electrical stimulation based on a posture state of a patient are described. For example, processing circuitry is configured to control delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, control delivery of a control stimulation pulse to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter, determine a characteristic value of the ECAP signal elicited from the control stimulation pulse, receive, from a sensor, a posture state signal representing a posture state of the patient, and adjust, based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter.

Control pulses and posture for ECAPs

Systems, devices, and techniques are described for analyzing evoked compound action potentials (ECAP) signals to assess the effect of a delivered electrical stimulation signal. In one example, a system includes a stimulation generator configured to deliver a stimulation pulse to a patient, sensing circuitry configured to sense an evoked compound action potential (ECAP) signal evoked from the stimulation pulse, and processing circuitry. The processing circuitry may be configured to determine a maximum value of a derivative of the ECAP signal, determine a minimum value of the derivative of the ECAP signal, determine, based on the maximum value of the derivative and the minimum value of the derivative, a characteristic value of the ECAP signal, and determine, based on the characteristic value of the ECAP signal, at least one parameter value at least partially defining electrical stimulation therapy to be delivered to the patient.

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Dayton, MN, United States of America

Kristin N Hageman