IP Library Granted Patent US 10,898,714
Granted Patent B2
US 10,898,714 · App. 15/285,337 · Granted Jan 26, 2021

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.
A61N1/36053A61N1/3614A61N1/36114A61N1/36132A61N1/36139A61N1/36167A61B5/0809A61B5/0823A61B5/1135
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Quick Facts
Patent No.
US 10,898,714
App. No.
15/285,337
Granted
Jan 26, 2021
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 (52)

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

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

determining a severity of the patient discomfort event, wherein determining the severity of the patient discomfort event comprises differentiating between the at least one of the cough, the throat irritation, or the voice alteration having a first intensity corresponding to a first severity value or a second intensity corresponding to a second severity value;

determining a suspension period based on the severity of the patient discomfort event; and

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

2. The method according to claim 1 , wherein:

the detecting the patient discomfort event further comprises detecting the patient discomfort event during an ON cycle of the IMD; and

the suspending the stimulation from the IMD comprises transitioning the IMD to an OFF cycle.

3. The method according to claim 1 , wherein:

the detecting the patient discomfort event further comprises detecting the patient discomfort event during an OFF cycle of the IMD; and

the suspending the stimulation from the IMD comprises delaying initiation of an ON cycle of the IMD.

4. The method according to claim 1 , wherein:

the detecting the patient discomfort event comprises detecting the patient discomfort event 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 , 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.

6. The method of claim 1 , wherein:

the suspension period is based on a patient physical state.

7. The method of claim 6 , wherein:

the patient physical state is selected from at least one of: sleeping, lying down, awake, sitting, standing, or moving.

8. The method according to claim 1 , further comprising:

determining a patient discomfort event response level based on a response of a patient to the suspension period; and

adjusting the suspension period based on comparing the patient discomfort event response level to a patient discomfort event response threshold.

9. The method according to claim 8 , wherein:

the determining the patient discomfort event response level comprises detecting one or more additional patient discomfort events.

10. The method according to claim 8 , wherein:

the adjusting the suspension period comprises nonlinearly increasing or decreasing the suspension period.

11. The method according to claim 1 , wherein the patient reaction having the first intensity is a clearing of a throat of the patient or a low intensity cough and the patient reaction having the second intensity is a hard cough or a hacking cough.

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 cough, a throat irritation, or a voice alteration;

determine a severity of the patient discomfort event, wherein determining the severity of the patient discomfort event comprises differentiating, using data received by the processor from the sensor, between the at least one of the cough, the throat irritation, or the voice alteration having a first intensity corresponding to a first severity value or a second intensity corresponding to a second severity value;

determine a suspension period based on the severity of the patient discomfort event; and

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

13. The device according to 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 device according to claim 12 , wherein the processor is further configured to:

determine a patient discomfort event response level based on a response of a patient to the suspension period; and

adjust the suspension period based on comparing the patient discomfort event response level to a patient discomfort event response threshold.

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

detecting the patient discomfort event via a sensor in the IMD, wherein the patient discomfort event comprises at least one of a cough, a throat irritation, or a voice alteration and detecting the patient discomfort event comprises differentiating between the at least one of the cough, the throat irritation, or the voice alteration corresponding to a first discomfort event value or a second discomfort event value;

assessing a severity level of the patient discomfort event based on the patient discomfort event value received from the sensor;

in response to detecting the patient discomfort event, suspending the stimulation from the IMD by:

transitioning the IMD to an OFF cycle for the duration of a suspension period; and

transitioning the IMD to an ON cycle after the suspension period; and

wherein the suspension period is based on the severity level of the patient discomfort event and a patient physical state.

16. The method according to claim 15 , wherein:

the sensor is selected from the group consisting of: an accelerometer, an acoustic sensor, an impedance sensor, a piezoelectric sensor, or a transthoracic impedance sensor.

17. The method according to claim 15 , wherein:

the patient physical state is at least one of: sleeping, lying down, awake, sitting, standing, or moving.

18. The method according to claim 15 , wherein:

the suspension period is longer based on the patient physical state being at least one of sleeping or lying down as compared to the physical state being at least one of awake, sitting, or standing.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: LIVANOVA USA, INC.
Reel/Frame 057552/0378 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: LIVANOVA USA, INC.
Reel/Frame 057189/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: LIVANOVA USA, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0784 →
CHANGE OF NAME Recorded Jun 29, 2020
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 053306/0229 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 6, 2016
From: LIBBUS, IMAD; STUBBS, SCOTT R.; KENKNIGHT, BRUCE H.
To: CYBERONICS, INC.
Reel/Frame 039960/0867 →