IP Library › Granted Patent US 12,370,366
Granted Patent B2
US 12,370,366 · App. 18/151,873 · Granted Jul 29, 2025

ECAP sensing for high frequency neurostimulation

Inventors: David A. Dinsmoor (North Oaks, MN); Christopher L. Pulliam (Plymouth, MN); Hank T. Bink (Golden Valley, MN); Kristin N. Hageman (Dayton, MN)
Assignee: Medtronic, Inc.
A61N1/36157A61N1/36062A61N1/36067A61N1/36071A61N1/36139A61N1/36164A61N1/36175A61N1/36178A61N1/36171
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Quick Facts
Patent No.
US 12,370,366
App. No.
18/151,873
Granted
Jul 29, 2025
Kind
B2
Abstract

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.

Claims (90)

1. A method comprising:

delivering, by a medical device, electrical stimulation therapy comprising a first train of electrical stimulation pulses and a second train of electrical stimulation pulses to a patient, wherein the first train of electrical stimulation pulses comprises a first pulse frequency, and wherein the first train of electrical stimulation pulses is separated from the second train of electrical stimulation pulses by a predetermined period of time;

after delivering the first train of electrical stimulation pulses, ceasing, by the medical device, the delivery of the electrical stimulation therapy for the predetermined period of time;

during the predetermined period of time, sensing, by the medical device, an evoked compound action potential (ECAP) signal from a tissue of the patient;

determining, by the medical device and based on a characteristic value of the ECAP signal, a value of at least one parameter at least partially defining a second train of electrical stimulation pulses, wherein the second train of electrical stimulation pulses comprises a second pulse frequency; and

responsive to the predetermined period of time elapsing, delivering the second train of electrical stimulation pulses according to the value of the at least one parameter at least partially defining the second train of electrical stimulation pulses.

2. The method of claim 1 ,

wherein the ECAP signal comprises a first ECAP signal, and

wherein the method further comprises:

after delivering the second train of electrical stimulation pulses, ceasing, by the medical device, the delivery of the electrical stimulation therapy for the predetermined period of time;

during the predetermined period of time, sensing, by the medical device, a second ECAP signal from the tissue of the patient;

determining, by the medical device and based on a characteristic value of the second ECAP signal, a value of at least one parameter at least partially defining a third train of electrical stimulation pulses, wherein the third train of electrical stimulation pulses comprises a third pulse frequency; and

responsive to the predetermined period of time elapsing, delivering the third train of electrical stimulation pulses according to the value of the at least one parameter at least partially defining the second train of electrical stimulation set of pulses.

3. The method of claim 1 , wherein:

the first train of electrical stimulation pulses comprises a plurality of primary electrical stimulation pulses followed by a master electrical stimulation pulse,

the plurality of primary electrical stimulation pulses are defined by a primary set of parameters and configured to contribute to therapy of the patient, and

the master electrical stimulation pulse is defined by a master set of parameters and configured to evoke the ECAP signal from the tissue of the patient, wherein a value of the master set of parameters is different than a value of the primary set of parameters.

4. The method of claim 3 , wherein the master electrical stimulation pulse of the first train comprises a current amplitude greater than a pulse amplitude of the plurality of primary electrical stimulation pulses of the first train.

5. The method of claim 3 ,

wherein the plurality of primary electrical stimulation pulses of the first train is a first primary current amplitude,

wherein the master electrical stimulation pulse of the first train comprises a first master current amplitude,

wherein the plurality of primary electrical stimulation pulses of the second train comprises a second primary current amplitude,

wherein the master electrical stimulation pulse of the second train comprises a second master current amplitude, and

wherein determining the value of the at least one parameter defining the second train of electrical stimulation pulses comprises:

determining a value of the second primary current amplitude that is different from a value of the first primary current amplitude;

determining a value of the second master current amplitude that is different from a value of the first master current amplitude,

wherein a ratio of the second primary current amplitude to the second master current amplitude is the same as a ratio of the first primary current amplitude to the first master current amplitude.

6. The method of claim 5 ,

wherein the value of the second primary current amplitude is greater than the value of the first primary current amplitude,

wherein the value of the second master current amplitude is greater than the value of the first master current amplitude, and

wherein the ratio of the second primary current amplitude to the second master current amplitude is the same as the ratio of the first primary current amplitude to the first master current amplitude.

7. The method of claim 5 ,

wherein the value of the second primary current amplitude is less than the value of the first primary current amplitude,

wherein the value of the second master current amplitude is less than the value of the first master current amplitude, and

wherein the ratio of the second primary current amplitude to the second master current amplitude is the same as the ratio of the first primary current amplitude to the first master current amplitude.

8. The method of claim 1 , wherein the method further comprises:

during the predetermined period of time, delivering, by the medical device, electrical stimulation therapy comprising a third train of electrical stimulation pulses to the patient, wherein the third train of electrical stimulation pulses comprises a third pulse frequency less than 500 Hertz; and

responsive to the predetermined period of time elapsing, ceasing the delivery of the electrical stimulation therapy comprising the third train of electrical stimulation pulses.

9. The method of claim 1 , further comprising:

delivering electrical stimulation therapy comprising a plurality of primary electrical stimulation pulses to the patient;

detecting, by the medical device, a change in posture of the patient, wherein:

delivering the electrical stimulation therapy comprising the first train of electrical stimulation pulses to the patient comprises delivering, in response to the detected change in posture of the patient, the first train of electrical stimulation pulses comprising the plurality of primary electrical stimulation pulses followed by a master electrical stimulation pulse to the patient,

the plurality of primary electrical stimulation pulses are configured to provide therapy to the patient, and

the master electrical stimulation pulse is configured to evoke the ECAP signal from the tissue of the patient.

10. The method of claim 1 , wherein the electrical stimulation therapy comprises a burst frequency greater than or equal 1 Hertz and less than or equal to 200 Hertz, wherein the burst frequency comprises a frequency at which the first train of electrical stimulation pulses and the second train of electrical stimulation pulses are delivered to the patient.

11. The method of claim 1 , wherein the medical device is an implantable medical device.

12. A medical device configured to:

deliver electrical stimulation therapy comprising a first train of electrical stimulation pulses and a second train of electrical stimulation pulses to a patient, wherein the first train of electrical stimulation pulses comprises a first pulse frequency, and wherein the first train of electrical stimulation pulses is separated from the second train of electrical stimulation pulses by a predetermined period of time;

after delivering the first train of electrical stimulation pulses, cease the delivery of the electrical stimulation therapy for the predetermined period of time;

during the predetermined period of time, sense an evoked compound action potential (ECAP) signal from a tissue of the patient;

determine, based on a characteristic value of the ECAP signal, a value of at least one parameter at least partially defining a second train of electrical stimulation pulses, wherein the second train of electrical stimulation pulses comprises a second pulse frequency; and

responsive to the predetermined period of time elapsing, deliver the second train of electrical stimulation pulses according to the value of the at least one parameter at least partially defining the second train of electrical stimulation pulses.

13. The medical device of claim 12 ,

wherein the ECAP signal comprises a first ECAP signal, and

wherein the medical device is further configured to:

after delivering the second train of electrical stimulation pulses, cease the delivery of the electrical stimulation therapy for the predetermined period of time;

during the predetermined period of time, sense a second ECAP signal from the tissue of the patient;

determine, based on a characteristic value of the second ECAP signal, a value of at least one parameter at least partially defining a third train of electrical stimulation pulses, wherein the third train of electrical stimulation pulses comprises a pulse frequency; and

responsive to the predetermined period of time elapsing, deliver the third train of electrical stimulation pulses according to the value of the at least one parameter at least partially defining the second train of electrical stimulation pulses.

14. The medical device of claim 12 , wherein:

the first train of electrical stimulation pulses comprises a plurality of primary electrical stimulation pulses followed by a master electrical stimulation pulse,

the plurality of primary electrical stimulation pulses are defined by a primary set of parameters and configured to contribute to therapy of the patient, and

the master electrical stimulation pulse is defined by a master set of parameters and configured to evoke the ECAP signal from the tissue of the patient, wherein a value of the master set of parameters is different than a value of the primary set of parameters.

15. The medical device of claim 14 , wherein the master electrical stimulation pulse of the first train comprises a current amplitude greater than a pulse amplitude of the plurality of primary electrical stimulation pulses of the first train.

16. The medical device of claim 14 ,

wherein the plurality of primary electrical stimulation pulses of the first train is a first primary current amplitude,

wherein the master electrical stimulation pulse of the first train comprises a first master current amplitude,

wherein the plurality of primary electrical stimulation pulses of the second train comprises a second primary current amplitude,

wherein the master electrical stimulation pulse of the second train comprises a second master current amplitude, and

wherein to determine the value of the at least one parameter defining the second train of electrical stimulation pulses, the medical device is configured to:

determine a value of the second primary current amplitude that is different from a value of the first primary current amplitude; and

determine a value of the second master current amplitude that is different from a value of the first master current amplitude,

wherein a ratio of the second primary current amplitude to the second master current amplitude is the same as a ratio of the first primary current amplitude to the first master current amplitude.

17. The medical device of claim 16 ,

wherein the value of the second primary current amplitude is greater than the value of the first primary current amplitude,

wherein the value of the second master current amplitude is greater than the value of the first master current amplitude, and

wherein the ratio of the second primary current amplitude to the second master current amplitude is the same as the ratio of the first primary current amplitude to the first master current amplitude.

18. The medical device of claim 16 ,

wherein the value of the second primary current amplitude is less than the value of the first primary current amplitude,

wherein the value of the second master current amplitude is less than the value of the first master current amplitude, and

wherein the ratio of the second primary current amplitude to the second master current amplitude is the same as the ratio of the first primary current amplitude to the first master current amplitude.

19. The medical device of claim 12 , wherein the medical device is further configured to:

during the predetermined period of time, deliver electrical stimulation therapy comprising a third train of electrical stimulation pulses to the patient, wherein the third train of electrical stimulation pulses comprises a third pulse frequency less than 500 Hertz; and

responsive to the predetermined period of time elapsing, cease the delivery of the electrical stimulation therapy comprising the third train of electrical stimulation pulses.

20. A non-transitory, computer-readable medium comprising instructions that, when executed, are configured to cause processing circuitry of an implantable medical device to:

control a stimulation generator of the implantable medical device to deliver electrical stimulation therapy comprising a first train of electrical stimulation pulses and a second train of electrical stimulation pulses to a patient, wherein the first train of electrical stimulation pulses comprises a first pulse frequency, and wherein the first train of electrical stimulation pulses is separated from the second train of electrical stimulation pulses by a predetermined period of time;

after delivering the first train of electrical stimulation pulses, control the stimulation generator to cease the delivery of the electrical stimulation therapy for the predetermined period of time;

during the predetermined period of time, sense an evoked compound action potential (ECAP) signal from a tissue of the patient;

determine, based on a characteristic value of the ECAP signal, a value of at least one parameter at least partially defining the second train of electrical stimulation pulses, wherein the second train of electrical stimulation pulses comprises a second pulse frequency; and

responsive to the predetermined period of time elapsing, control the stimulation generator to deliver the second train of electrical stimulation pulses according to the value of the at least one parameter at least partially defining the second train of electrical stimulation pulses.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 9, 2023
From: DINSMOOR, DAVID A.; PULLIAM, CHRISTOPHER L.; BINK, HANK; HAGEMAN, KRISTEN N.
To: MEDTRONIC, INC.
Reel/Frame 062315/0602 →
Continuity (3)
Continuation 17065282 · Oct 7, 2020
Provisional Application 62926164 · Oct 25, 2019
Related Publication 20230142761A1 · May 11, 2023
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Maeda et al., “Low frequencies, but not high frequencies of bi-polar spinal cord stimulation reduce cutaneous and muscle hyperalgesia induced by nerve injury,” Pain; Feb. 2008; 138(1): pp. 143-152. [cited by applicant]
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Prosecution History from U.S. Appl. No. 17/065,282, now issued U.S. Pat. No. 11,547,855, dated Mar. 29, 2022 through Sep. 8, 2022, 33 pp. [cited by applicant]
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Sluka, et al., “High-frequency, but not low-frequency, transcutaneous electrical nerve stimulation reduces aspartate and glutamate release in the spinal cord dorsal horn,” J Neurochem. Oct. 17, 2005; 95(6); pp. 1794-180… [cited by applicant]
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Song Md Phd. et al., “Efficacy of kilohertz-frequency and conventional spinal cord stimulation in rat models of different pain conditions,” Neuromodulation Jan. 2014; 17(3): pp. 226-234. [cited by applicant]
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U.S. Appl. No. 17/065,383, by Medtronic, Inc. (Inventors: Dinsmoor et al.), filed Oct. 7, 2020. [cited by applicant]
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Wille Md et al., “Altering Conventional to High Density Spinal Cord Stimulation: An Energy Dose-Response Relationship in Neuropathic Pain Therapy,” Neuromodulation 2016, Aug. 2016, 9 pp. [cited by applicant]
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Youn et al., “The Effect of High Frequency Stimulation on Sensory Thresholds in Chronic Pain Patients,” North American Neuromodulation Society. 2014, 1 pp. Applicant points out in accordance with MPEP 609.04(a) that the… [cited by applicant]
Youn et al., The Effect of High-Frequency Stimulation on Sensory Thresholds in Chronic Pain Patients, Stereotact Funct Neurosurg, Oct. 8, 2015, pp. 355-359. [cited by applicant]
First Examination Report from counterpart Australian Application No. 2020369477 dated Mar. 5, 2025, 3 pp. [cited by applicant]