IP Library Granted Patent US 12,390,642
Granted Patent B2
US 12,390,642 · App. 18/423,717 · Granted Aug 19, 2025

Stimulation suspension in response to patient discomfort or state

Inventors: Imad Libbus (St. Paul, MN); Scott R. Stubbs (Maple Grove, MN); Bruce H. Kenknight (Maple Grove, MN)
Assignee: LivaNova USA, Inc.
A61N1/36053A61N1/36114A61N1/36132A61N1/36139A61N1/3614A61N1/36167A61B5/0823A61B5/086A61B5/1135
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Quick Facts
Patent No.
US 12,390,642
App. No.
18/423,717
Granted
Aug 19, 2025
Kind
B2
Abstract

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.

Claims (42)

1. A method of suspending stimulation from an implantable medical device (IMD) in response to detecting a patient discomfort event, the method comprising:

detecting the patient discomfort event, the patient discomfort event comprising at least one of a first cough, a first throat irritation, or a first voice alteration;

in response to detecting the patient discomfort event, suspending the stimulation from the IMD for a suspension period;

subsequent to the suspension period, detecting a subsequent patient discomfort event, the subsequent patient discomfort event comprising at least one of a second cough, a second throat irritation, or a second voice alteration;

determining an elapsed time between an end of the suspension period and the subsequent patient discomfort event; and

adjusting a duration of the suspension period based on the elapsed time between the end of the suspension period and the subsequent patient discomfort event.

2. The method of claim 1 , wherein the patient discomfort event is detected during an ON cycle of the IMD and suspending the stimulation from the IMD comprises transitioning the IMD to an OFF cycle.

3. The method of claim 1 , wherein the patient discomfort event is detected during an OFF cycle of the IMD and suspending the stimulation from the IMD comprises delaying initiation of an ON cycle of the IMD.

4. The method of claim 1 , wherein the patient discomfort event is detected via at least one of: an accelerometer, an acoustic sensor, an impedance sensor, a piezoelectric sensor, or a transthoracic impedance sensor.

5. The method of claim 1 , wherein suspending the stimulation from the IMD comprises transitioning the IMD to an OFF cycle for the duration of the suspension period and transitioning the IMD to an ON cycle after the suspension period.

6. The method of claim 1 , further comprising setting the suspension period based on a proximity of one or more parameters of the stimulation to one or more corresponding target stimulation parameters during a titration process.

7. The method of claim 1 , wherein the elapsed time between the end of the suspension period and the subsequent patient discomfort event is a patient discomfort event response level, and adjusting the duration of the suspension period comprises:

comparing the patient discomfort event response level to a patient discomfort event response threshold; and

adjusting the duration of the suspension period based on the comparison between the patient discomfort event response level and the patient discomfort event response threshold.

8. The method of claim 7 , wherein the duration of the suspension period is decreased in response to determining that the patient discomfort event response level is higher than the patient discomfort event response threshold.

9. The method of claim 7 , wherein the duration of the suspension period is increased in response to determining that the patient discomfort event response level is lower than the patient discomfort event response threshold.

10. The method of claim 7 , wherein determining the patient discomfort event response level comprises detecting one or more additional patient discomfort events.

11. The method of claim 1 , wherein adjusting the duration of the suspension period comprises nonlinearly increasing or decreasing the duration of the suspension period.

12. An implantable medical device (IMD) comprising:

a sensor;

a processor coupled to the sensor; and

a memory operably coupled to the processor and comprising instructions that, when executed by the processor, cause the processor to:

detect a patient discomfort event via the sensor, the patient discomfort event comprising at least one of a first cough, a first throat irritation, or a first voice alteration;

in response to detecting the patient discomfort event, suspend stimulation from the IMD for a suspension period;

subsequent to the suspension period, detecting a subsequent patient discomfort event, the subsequent patient discomfort event comprising at least one of a second cough, a second throat irritation, or a second voice alteration;

determine an elapsed time between an end of the suspension period and the subsequent patient discomfort event; and

adjust a duration of the suspension period based on the elapsed time between the end of the suspension period and the subsequent patient discomfort event.

13. The IMD of claim 12 , wherein the sensor is at least one of: an accelerometer, an acoustic sensor, an impedance sensor, a piezoelectric sensor, or a transthoracic impedance sensor.

14. The IMD of claim 12 , wherein suspending the stimulation from the IMD for the suspension period is further performed in response to determining that a severity of the patient discomfort event exceeds a patient discomfort event threshold.

15. A method comprising:

delivering stimulation to a subject via an implantable medical device (IMD);

detecting a patient discomfort event, the patient discomfort event comprising at least one of a first cough, a first throat irritation, or a first voice alteration;

determining a severity of the patient discomfort event;

in response to detecting the patient discomfort event, suspending the stimulation from the IMD for a suspension period, wherein the stimulation is suspended after a response time corresponding to the severity of the patient discomfort event;

subsequent to the suspension period, detecting a subsequent patient discomfort event, the subsequent patient discomfort event comprising at least one of a second cough, a second throat irritation, or a second voice alteration;

determining an elapsed time between an end of the suspension period and the subsequent patient discomfort event; and

adjusting a duration of the suspension period based on the elapsed time between the end of the suspension period and the subsequent patient discomfort event.

16. The method of claim 15 , wherein the response time for suspending stimulation is shorter when a patient discomfort event is more severe, and the response time for suspending stimulation is longer when a patient discomfort event is less severe.

17. The method of claim 15 , wherein the response time for suspension of stimulation is determined automatically based on the severity of the patient discomfort event.

18. The method of claim 15 , wherein the elapsed time between the end of the suspension period and the subsequent patient discomfort event is a patient discomfort event response level, and adjusting the duration of the suspension period comprises:

comparing the patient discomfort event response level to a patient discomfort event response threshold; and

adjusting the duration of the suspension period based on the comparison between the patient discomfort event response level and the patient discomfort event response threshold.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2025
From: LIBBUS, IMAD; STUBBS, SCOTT R.; KENKNIGHT, BRUCE H.
To: CYBERONICS, INC.
Reel/Frame 071851/0346 →
CHANGE OF NAME Recorded Jul 28, 2025
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 072280/0679 →
Continuity (4)
Continuation 17144692 · Jan 8, 2021
Continuation 15285337 · Oct 4, 2016
Provisional Application 62237078 · Oct 5, 2015
Related Publication 20240245916A1 · Jul 25, 2024
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