IP Library Granted Patent US 11,963,779
Granted Patent B2
US 11,963,779 · App. 16/905,644 · Granted Apr 23, 2024

Neurological event detection tools for implantable medical devices

Inventor: Rosana Esteller (Marietta, GA)
Assignee: NeuroPace, Inc.
A61B5/291A61B5/24A61B5/4064A61B5/4094A61B5/6868A61B5/7282A61B5/0006
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Quick Facts
Patent No.
US 11,963,779
App. No.
16/905,644
Granted
Apr 23, 2024
Kind
B2
Abstract

An implantable device includes one or more electrodes to sense an electrical signal from a brain and a waveform analyzer to identify a half wave in the electrical signal; determine an amplitude and a duration of the half wave; determine if the amplitude satisfies a half wave amplitude criterion defined by a set of amplitude parameters comprising a minimum half wave amplitude and a maximum half wave amplitude; determine if the duration satisfies a half wave duration criterion defined by a set of duration parameters comprising a minimum half wave duration and a maximum half wave duration; and identify the half wave as a qualified half wave when the half wave amplitude criterion and the half wave duration criterion is satisfied. A neurological event may be detected based on one or more qualified half waves and electrical stimulation therapy may be delivered to the brain in response to the detection.

Claims (47)

1. An implantable medical device, comprising:

one or more electrodes configured to be implanted on or in a brain; and

a waveform analyzer configured to:

identify a half wave in an electrical signal sensed by the one or more electrodes;

determine an amplitude of the half wave and a duration of the half wave;

determine whether the identified half wave has a positive slope or a negative slope;

in a case of a positive-slope half wave, determine if the amplitude satisfies a positive-slope half wave amplitude criterion defined by a first set of amplitude parameters comprising a minimum amplitude and a maximum amplitude, and if the duration satisfies a positive-slope half wave duration criterion defined by a first set of duration parameters comprising a minimum duration and a maximum duration;

in a case of a negative-slope half wave, determine if the amplitude satisfies a negative-slope half wave amplitude criterion defined by a second set of amplitude parameters comprising a minimum amplitude and a maximum amplitude that is different from the first set of amplitude parameters, and if the duration satisfies a negative-slope half wave duration criterion defined by a second set of duration parameters comprising a minimum duration and a maximum duration that is different from the first set of duration parameters;

identify the half wave as a qualified half wave when each of the half wave amplitude criterion and the half wave duration criterion is satisfied;

determine, based on a count of a number of qualified half waves occurring within a time window and a half wave count criterion, whether the electrical signal includes electrographic activity indicative of epileptiform activity; and

output an event detection upon determining the electrical signal includes electrographic activity indicative of epileptiform activity; and

a stimulation subsystem coupled to the one or more electrodes and configured to receive the event detection from the waveform analyzer and to output an electrical stimulation to the one or more electrodes in response to the event detection.

2. The implantable medical device of claim 1 , wherein the half wave amplitude criterion is satisfied when the amplitude of the half wave is between the minimum half wave amplitude and the maximum half wave amplitude.

3. The implantable medical device of claim 1 , wherein the half wave duration criterion is satisfied when the duration of the half wave is between the minimum half wave duration and the maximum half wave duration.

4. The implantable medical device of claim 1 , wherein the processor is configured to:

determine the count of the number of qualified half waves occurring within the time window;

compare the count to the half wave count criterion; and

determine the electrical signal includes electrographic activity indicative of epileptiform activity when the count exceeds the half wave count criterion.

5. The implantable medical device of claim 1 , wherein the epileptiform activity corresponds to one of an epileptic seizure or a seizure onset.

6. The implantable medical device of claim 1 , wherein:

the first set of amplitude parameters includes a positive-slope minimum half wave amplitude of between 0 and 1022 units of amplitude, and a positive-slope maximum half wave amplitude of between 1 and 1023 units of amplitude; and

the first set of duration parameters includes a positive-slope minimum half wave duration of between 0 and 386 ms, and a positive-slope maximum half wave duration of between 4 and 400 ms.

7. The implantable medical device of claim 1 , wherein

the second set of amplitude parameters is a negative-slope minimum half wave amplitude of between 0 and 1022 units of amplitude, and a negative-slope maximum half wave amplitude of between 1 and 1023 units of amplitude; and

the second set of duration parameters comprises a negative-slope minimum half wave duration of between 0 and 386 ms, and a negative-slope maximum half wave duration of between 4 and 400 ms.

8. A method of an implanted medical device, the method comprising:

identifying a half wave in an electrical signal sensed from a brain;

determining an amplitude of the half wave and a duration of the half wave;

determining whether the identified half wave has a positive slope or a negative slope;

in a case of a positive-slope half wave, determining if the amplitude satisfies a positive-slope half wave amplitude criterion defined by a first set of amplitude parameters comprising a minimum amplitude and a maximum amplitude, and if the duration satisfies a positive-slope half wave duration criterion defined by a first set of duration parameters comprising a minimum duration and a maximum duration;

in a case of a negative-slope half wave, determining if the amplitude satisfies a negative-slope half wave amplitude criterion defined by a second set of amplitude parameters comprising a minimum amplitude and a maximum amplitude that is different from the first set of amplitude parameters, and if the duration satisfies a negative-slope half wave duration criterion defined by a second set of duration parameters comprising a minimum duration and a maximum duration that is different from the first set of duration parameters;

identifying the half wave as a qualified half wave when each of the half wave amplitude criterion and the half wave duration criterion is satisfied; and

determining, based on a count of a number of qualified half waves occurring within a time window and a half wave count criterion, whether the electrical signal includes electrographic activity indicative of epileptiform activity;

outputting an electrical stimulation to one or more electrodes upon determining the electrical signal includes electrographic activity indicative of epileptiform activity.

9. The method of claim 8 , wherein the half wave amplitude criterion is satisfied when the amplitude of the half wave is between the minimum half wave amplitude and the maximum half wave amplitude.

10. The method of claim 8 , wherein the half wave duration criterion is satisfied when the duration of the half wave is between the minimum half wave duration and the maximum half wave duration.

11. The method of claim 8 , further comprising:

determining the count of the number of qualified half waves occurring within the time window;

comparing the count to the half wave count criterion; and

determining the electrical signal includes electrographic activity indicative of epileptiform activity when the count exceeds the half wave count criterion.

12. The method of claim 8 , wherein the epileptiform activity corresponds to one of an epileptic seizure or a seizure onset.

13. The method of claim 8 , wherein:

the first set of amplitude parameters includes a positive-slope minimum half wave amplitude of between 0 and 1022 units of amplitude, and a positive-slope maximum half wave amplitude of between 1 and 1023 units of amplitude; and

the first set of duration parameters includes a positive-slope minimum half wave duration of between 0 and 386 ms, and a positive-slope maximum half wave duration of between 4 and 400 ms.

14. The method of claim 8 , wherein

the second set of amplitude parameters is a negative-slope minimum half wave amplitude of between 0 and 1022 units of amplitude, and a negative-slope maximum half wave amplitude of between 1 and 1023 units of amplitude; and

the second set of duration parameters comprises a negative-slope minimum half wave duration of between 0 and 386 ms, and a negative-slope maximum half wave duration of between 4 and 400 ms.

Assignments (4)
SECURITY INTEREST Recorded Jun 25, 2025
From: NEUROPACE, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 071712/0422 →
RELEASE OF SECURITY INTEREST Recorded Jun 4, 2025
From: CRG SERVICING LLC AS SUCCESSOR TO CAPITAL ROYALTY PARTNERS II L.P., CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P., AND PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
To: NEUROPACE INC.
Reel/Frame 071495/0800 →
SECURITY INTEREST Recorded Sep 25, 2020
From: NEUROPACE, INC.
To: CRG SERVICING LLC
Reel/Frame 053885/0932 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2020
From: ESTELLER, ROSANA
To: NEUROPACE, INC.
Reel/Frame 052991/0500 →