Automatic activation of a neurostimulator device using a detection algorithm based on cardiac activity

• US 5,928,272 A
• Filed: 05/02/1998
• Issued: 07/27/1999
• Est. Priority Date: 05/02/1998
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: O'Donovan, Cormac A., Terry, Reese S. Jr., Adkins, Robert A.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/071,856
• Time in Patent Office: 451 Days
• Field of Search: 607/45
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

A device and method of controlling seizures in an epileptic patient, in which the device is implanted in the patient for selective activation to generate an electrical waveform constituting a pre-programmed therapy regimen for application to the patient'"'"'s vagus nerve to modulate the electrical activity thereof in a manner to inhibit, abort, or reduce the severity and duration of the seizure. The device is activated to generate the waveform upon detecting a time rate of change in the patient'"'"'s heart rate relative to a predetermined threshold time rate of change which is sufficiently abrupt and of sufficient magnitude to be inconsistent with normal physical activity, as being indicative of an imminent epileptic seizure. Sustained cardiac activity at the highest heart rate detected in the change in heart rate is used as a confirmation of imminent seizure. The electrical waveform is generated a burst of pulses, with a minimum time interval between consecutive pulse bursts selected to avoid overstimulation of the nerve. Cardiac activity of the patient is detected using electrodes which include the conductive housing for the device and a stimulating electrode to be mounted on the nerve for large signal detection, or which are integral with the device housing itself so that no electrical leads are required to be implanted for such detection and the electrodes are arranged to detect the cardiac activity with a sensitivity that is substantially independent of orientation of the device as implanted in the patient.

Claims

1. A medical device for treating an epileptic patient, comprising:

implantable electronic means housed in a case substantially impervious to body fluids and tissue and operative when activated for generating selected ones of electrical waveforms representing preprogrammed therapy regimens to control epileptic seizures;

implantable lead means adapted for electrical connection to the electronic means via an electrical connector mounted on the case thereof, for delivering selected ones of said therapy regimens to a preselected cranial nerve of the patient to electrically stimulate and thereby modulate electrical activity of the selected nerve in a manner which is predetermined to control seizures;

said electronic means including means for detecting time rate of change of the patient'"'"'s heart rate from cardiac activity, and activation means responsive to detection of a sudden time rate of change of heart rate which is inconsistent with normal physical activity of the patient, as being indicative of an impending seizure, for automatically activating the electronic means to generate a selected one of the therapy regimens for application to said lead means, whereby to deliver a desired stimulus to the selected cranial nerve.

2. The medical device of claim 1, wherein:

said detection means includes means for assessing the time rate of change of detected cardiac activity relative to a preset threshold slope indicative of an impending seizure.

3. The medical device of claim 2, wherein:

said detection means comprises a microprocessor.

4. The medical device of claim 1, wherein:

said detection means includes means for analyzing the high frequency portion of the spectrum of detected cardiac activity for indication of an impending seizure.

5. The medical device of claim 1, wherein:

the detection means includes electrode means integral with and electrically insulated from said case, including first and second electrodes spaced apart on the case and electrically connected in parallel to detect cardiac activity independent of the orientation of the case as implanted in the patient.

6. The medical device of claim 5, wherein:

the case is electrically conductive for use as an additional electrode to detect cardiac activity of the patient.

7. The medical device of claim 5, wherein:

one of said first and second electrodes is located on the case at an electrically insulative header in which the electrical connector for the electronic means is mounted.

8. The medical device of claim 1, wherein:

the lead means has a proximal end and a distal end, the proximal end including an electrical connector for mating with the electrical connector on the case, and the distal end including a nerve electrode constructed and adapted to be implanted on the patient'"'"'s vagus nerve for stimulation thereof as the selected cranial nerve.

9. The medical device of claim 8, wherein:

said electrode means includes the nerve stimulating electrode.

10. An electrical stimulus generator adapted for implantation in a patient suffering from epilepsy, to provide electrical stimuli for application to a selected cranial nerve as a therapy to alleviate a seizure, the stimulus generator comprising:

electronics effective when energized for generating said electrical stimuli;

an electrically conductive case housing said electronics; and

electrode means electrically connected to said electronics for sensing cardiac activity of the patient,

said electronics including means responsive to sudden time rate of change of the patient'"'"'s heart rate in the sensed cardiac activity for distinguishing a change which is a precursor of an imminent epileptic seizure from a change attributable to normal physical exercise, to energize the electronics to generate said electrical stimuli upon the seizure-indicative change.

11. The stimulus generator of claim 10, wherein:

said distinguishing means comprises a microprocessor.

12. The stimulus generator of claim 10, wherein:

said distinguishing means comprises means for identifying a seizure-indicative change from its slope relative to a threshold slope representative of a reference time rate of change.

13. The stimulus generator of claim 10, wherein:

said distinguishing means comprises spectrum analyzer means for distinguishing a seizure-indicative change from an exercise-indicative change by the direction of a change in high frequency peak of the high frequency portion of the spectrum of cardiac activity.

14. The stimulus generator of claim 10, wherein:

said electrode means includes first and second electrodes mounted on and electrically insulated from said case;

said first and second electrodes being electrically connected in parallel and adapted to cooperate with said case as an additional electrode with sufficient sensitivity to detect the patient'"'"'s cardiac activity independently of the orientation of the implanted stimulus generator.

15. The stimulus generator of claim 10, wherein:

said electrode means includes said case, and further includes a nerve electrode mounted on said selected cranial nerve for application of the electrical stimuli generated by said electronics to the selected cranial nerve.

16. The stimulus generator of claim 10, wherein:

said distinguishing means includes means for identifying a seizure-indicative time rate of change by detecting when a predetermined threshold slope of time rate of change in heart rate is exceeded.

17. A device-implemented method of controlling seizures in an epileptic patient, comprising the steps of:

implanting into the patient a medical device adapted to be selectively activated to generate an electrical waveform constituting a pre-programmed therapy regimen to control epileptic seizures by application of the waveform to modulate electrical activity of the patient'"'"'s vagus nerve;

detecting time rate of change of cardiac activity of the patient indicative of an imminent epileptic seizure; and

responding to the detection of such time rate of change of cardiac activity to automatically activate the device and thereby generate said electrical waveform for application as an electrical stimulus to the vagus nerve.

18. The method of claim 17, including:

detecting a time rate of change of the patient'"'"'s heart rate relative to a predetermined threshold time rate of change to distinguish seizure-indicative change from physical activity-indicative change.

19. The method of claim 18, wherein:

an imminent seizure is indicated when the time rate of change of the patient'"'"'s heart rate exceeds said predetermined threshold time rate of change.

20. The method of claim 17, including:

detecting a time rate of change of the patient'"'"'s heart rate indicative of an imminent seizure by a spectral analysis of cardiac activity.

21. The method of claim 20, wherein:

a time rate of change of the patient'"'"'s heart rate indicative of an imminent seizure is detected by a spectral analysis of cardiac activity exhibiting an increasing peak in the high frequency portion of the spectrum.

22. The method of claim 17, including:

detecting sustained cardiac activity at the highest heart rate detected in said

change as a confirmation of imminent seizure.

23. The method of claim 22, including:

generating a pulse burst as said electrical waveform.

24. The method of claim 23, including:

programming a minimum time interval between consecutive ones of said pulse bursts to avoid overstimulation of the nerve.

25. The method of claim 17, including:

detecting cardiac activity of the patient with electrodes integral with the device having sensitivity substantially independent of orientation of the implanted device in the patient.

26. The method of claim 17, including:

detecting cardiac activity of the patient with electrodes including an electrode for use in applying said waveform as an electrical stimulus to the vagus nerve.

27. The method of claim 26, including:

electrically insulating part of the device housing to preclude muscle stimulation.