Method and system for logging quantitative seizure information and assessing efficacy of therapy using cardiac signals

• US 9,050,469 B1
• Filed: 11/24/2004
• Issued: 06/09/2015
• Est. Priority Date: 11/26/2003
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark G.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US10/997,540
• Time in Patent Office: 3,849 Days
• Field of Search: 607/4, 607/6, 607/14, 607/17, 607/24, 607/45, 600/483, 600/485, 600/544
• US Class Current: 1/1
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A system and method for analyzing and logging changes in brain state of a subject for administering therapy to the subject based on the at least one cardiac signal wherein the system and method comprises the steps of receiving at least one cardiac signal of the subject into a processor, analyzing the cardiac signal to detect at least one cardiac signal change indicative of a brain state change, and logging at least one characteristic of the detected signal change or the brain state change.

Claims

1. A method for assessing efficacy of an administered therapy for brain state changes of a subject via an implantable medical device, the method comprising:

(a) receiving at least one cardiac signal of the subject via the implantable medical device;

(b) detecting a change in a brain state of the subject based on a detected first cardiac signal feature value of the cardiac signal, the change in the brain state indicative of a seizure;

(c) determining at least one characteristic of the detected brain state change based on the cardiac signal, the characteristic including at least one of an onset time of a detected brain state change, an end time of the detected brain state change, a duration of the detected brain state change, an intensity of the detected brain state change, and a severity of the detected brain state change;

(d) logging the at least one characteristic of the detected brain state change at a memory;

(e) administering a therapy for treating the detected brain state change of the subject;

(f) logging data associated with the administered therapy, wherein the data includes at least one of a dose, an administration site, and a timing of an administration;

(g) assessing the efficacy of the administered therapy based on the logged data and the at least one logged characteristic; and

(h) generating therapy efficacy information based on the logged data;

wherein the intensity of the detected brain state change is determined by at least one of;

(a) a maximal deviation of a second cardiac signal feature value occurring after an indication of the detected brain state change event, the maximal deviation being measured from a baseline for the first signal characteristic prior to the indication;

(b) a first time from the indication to the maximal deviation;

(c) a second time from the maximal deviation to a recovery to the baseline;

(d) a third time from the indication to the recovery to the baseline;

(e) conformance of a third cardiac signal feature value to a stereotypical pattern for the third cardiac signal feature value during the third time between the indication and the recovery to the baseline; and

(f) a change in morphology of a cardiac signal.

2. The method as described in claim 1, wherein the administered therapy includes electrical stimulation of a brain.

3. The method as described in claim 1, wherein the administered therapy includes electrical stimulation of a vagus nerve of the subject.

4. The method as described in claim 1, wherein the cardiac signal is a phonocardiogram signal.

5. The method as described in claim 1, wherein the cardiac signal is an electrocardiogram signal.

6. The method as described in claim 1, wherein the cardiac signal is obtained from a combination of a phonocardiogram signal and an electrocardiogram signal.

7. The method as described in claim 1, wherein the timing of the administration of the administered therapy is dependent upon a timing of a detection of the detected brain state change.

8. The method as described in claim 1, wherein the timing of the administration of the administered therapy is independent of a timing of a detection of the detected brain state change.

9. The method as described in claim 1, wherein the baseline for the second cardiac signal feature value is measured during a period without brain state change events.

10. A method for assessing efficacy of a therapy for a brain state change of a subject via an implantable medical device, the method comprising:

(a) receiving one or more cardiac signals of the subject via the implantable medical device;

(b) determining a first cardiac signal feature value based on the received one or more cardiac signals;

(c) detecting an underlying brain state change event based on the detected first cardiac signal feature value, the underlying brain state change event indicative of an epileptic seizure;

(d) administering therapy for treating the underlying brain state change event;

(e) determining a second cardiac signal feature value of the subject after the detection of the underlying brain state change event and an administration of therapy based on the received one or more cardiac signals;

(f) determining a characteristic of the underlying brain state change event based on a comparison of the first cardiac signal feature value and the second cardiac signal feature value;

(g) logging into a memory the characteristic;

(h) assessing the efficacy of the administered therapy based on the detection of the underlying brain state change event and the logged characteristic;

(i) logging at least one feature indicative of the administered therapy into the memory; and

(j) transmitting the logged information corresponding to the efficacy of the administered therapy to a device external to the implantable medical device.

11. The method of claim 10, further comprising logging the comparison into the memory.

12. The method of claim 10, wherein the first cardiac signal feature value is heart rate and the second cardiac signal feature value is heart rate variability.

13. The method of claim 10, wherein the first cardiac signal feature value is an amplitude of an R wave and the second cardiac signal feature value is an S-T segment.