IP Library Granted Patent US 8,849,409
Granted Patent B2
US 8,849,409 · App. 13/783,393 · Granted Sep 30, 2014

Dynamic cranial nerve stimulation based on brain state determination from cardiac data

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Quick Facts
Patent No.
US 8,849,409
App. No.
13/783,393
Granted
Sep 30, 2014
Kind
B2
Abstract

A method of treating a medical condition in a patient using an implantable medical device, comprising providing an electrical signal generator; providing at least a first electrode operatively coupled to the electrical signal generator and to a vagus nerve of the patient; sensing cardiac data of the patient; determining at least a first cardiac parameter based upon said cardiac data; setting at least a first value; declaring an unstable brain state of a patient from said at least a first cardiac parameter and said at least a first value; and adjusting the at least a first value. Also, a computer readable program storage device encoded with instructions that, when executed by a computer, performs the method. In addition, the implantable medical device used in the method.

Claims (78)

1. An medical device comprising:

a cardiac data sensing module operable to sense cardiac data;

a value setting module operable to set a first cardiac threshold value and dynamically adjust the first cardiac threshold value based upon sensed cardiac data from the cardiac sensing module;

a cardiac module operable to determine a first cardiac parameter based upon sensed cardiac data from the cardiac sensing module;

an unstable brain state declaration module operable to declare a seizure when the first cardiac parameter exceeds the first cardiac threshold value.

2. The medical device of claim 1 , wherein:

the value setting module is operable to set a second cardiac threshold value and dynamically adjust the second cardiac threshold value based upon sensed cardiac data from the cardiac data sensing module;

the cardiac module is operable to determine a second cardiac parameter based upon sensed cardiac data; and

the unstable brain state declaration module is further operable to declare a seizure when the second cardiac parameter exceeds the second cardiac threshold value.

3. The medical device of claim 1 , further comprising:

a non-cardiac data sensing module operable to sense non-cardiac data;

the value setting module operable to set a first non-cardiac threshold value and dynamically adjust the first non-cardiac threshold value based upon sensed non-cardiac data from the non-cardiac sensing module;

a non-cardiac module operable to determine a first non-cardiac parameter based upon sensed non-cardiac data from the non-cardiac data sensing module; and

the unstable brain state declaration module operable to declare an a seizure when the first non-cardiac parameter exceeds the first non-cardiac threshold value.

4. The medical device of claim 3 , wherein:

the value setting module is further operable to apply a weighting factor to the first cardiac threshold value and the first non-cardiac threshold value; and

the unstable brain state declaration module is operable to utilize the weighted first cardiac threshold value and the first non-cardiac threshold value in declaring a seizure.

5. The medical device of claim 3 , wherein the first non-cardiac parameter is selected from the group comprising:

an activity level;

an output of an accelerometer;

a catamenial cycle;

a time of day;

an indicator of a sleep state;

an inclination of a body;

a pupil dilation;

a body temperature;

a blood pressure; and

an electroencephalogram (EEG).

6. The medical device of claim 1 , wherein the value setting module sets the first cardiac threshold value in response to a user request to set the first cardiac threshold value.

7. The medical device of claim 1 , wherein the value setting module adjusts the first cardiac threshold value in response to a user request to adjust the first cardiac threshold value.

8. The medical device of claim 1 , wherein the value setting module is operable to adjust the first cardiac threshold value to render the unstable brain state declaration module more likely to declare a seizure.

9. The medical device of claim 1 , wherein the value setting module is operable to adjust the first cardiac threshold value to render the unstable brain state declaration module less likely to declare a seizure.

10. The medical device of claim 1 , wherein the first cardiac parameter is selected from the group comprising:

an instantaneous heart rate;

a moving average heart rate over a predetermined time period;

a ratio of a first moving average heart rate over a first predetermined time period and a second moving average heart rate over a second predetermined time period;

a rate of change of a heart rate;

an elevation of an instantaneous heart rate above a baseline heart rate;

a duration of an elevation of a heart rate above a baseline heart rate;

a depression of a heart rate below a baseline heart;

a duration of an elevation of a first moving average heart rate over a second moving average heart rate;

an R-R interval;

a PR segment interval;

a PQ segment interval;

a QRS interval;

an ST segment interval;

a statistical analysis heart parameter;

a spectral analysis heart parameter;

a fractal analysis heart parameter;

an interbeat interval;

an amplitude or a magnitude of a P wave, Q wave, R wave, S wave, T wave, U wave;

a change in amplitude or a magnitude of a P wave, Q wave, R wave, S wave, T wave, U wave; and

a rate of change an amplitude or magnitude of a P wave, Q wave, R wave, S wave, T wave, U wave.

11. The medical device of claim 1 , further comprising a memory that stores a timestamp associated with a declaration of a seizure.

12. The medical device of claim 11 , wherein the value setting module is further configured to adjust a threshold value based upon the timestamp at which a seizure is declared.

13. The medical device of claim 11 , wherein the value setting module is further configured to:

perform an analysis of a log of times at which a seizure was declared to determine a first period when an increased frequency of seizure declarations are likely to occur; and

adjust the first cardiac threshold value to render the unstable brain state declaration module more likely to declare a seizure during the first period.

14. The medical device of claim 1 , wherein the medical device comprises an implantable medical device (IMD).

15. A method of declaring a seizure using a medical device, comprising:

sensing cardiac data;

setting a first cardiac threshold value based upon the sensed cardiac data;

dynamically adjusting the first cardiac threshold value based upon the sensed cardiac data;

determining a first cardiac parameter based upon the sensed cardiac data; and

declaring a seizure in response to the first cardiac parameter exceeding the first cardiac threshold value.

16. The method of claim 15 , further comprising:

setting a second cardiac threshold value based upon the sensed cardiac data;

dynamically adjusting the second cardiac threshold value based upon the sensed cardiac data;

determining a second cardiac parameter based upon the sensed cardiac data; and

declaring a seizure in response to the second cardiac parameter satisfying the second cardiac threshold value.

17. The method of claim 16 , further comprising:

applying a weighting factor to the first cardiac threshold value and the second cardiac threshold value; and

utilizing the weighted first cardiac threshold value and the weighted second cardiac threshold value in declaring seizure.

18. The method of claim 15 , further comprising storing a timestamp associated with declaring a seizure.

19. The method of claim 18 , further comprising adjusting a threshold value based upon the timestamp at which a seizure is declared.

20. The method of claim 18 , further comprising:

performing an analysis of a log of times at which a seizure was declared to determine a first period when an increased frequency of seizure declarations are likely to occur; and

adjusting the first cardiac threshold value to render the unstable brain state declaration module more likely to declare a seizure during the first period.

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 →
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 Dec 11, 2013
From: COLBORN, JOHN C.
To: CYBERONICS, INC.
Reel/Frame 031763/0669 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2013
From: FREI, MARK G.; OSORIO, IVAN
To: FLINT HILLS SCIENTIFIC, LLC
Reel/Frame 031763/0687 →