US5928272A
Expired / Lapsed
US
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Automatic activation of a neurostimulator device using a detection algorithm based on cardiac activity
Assignee: Livanova USA Inc
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Filing: 1998-05-02
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Granted: 1999-07-27
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Expires: 2018-05-02
Abstract
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.
Inventors
- 👤 Robert A. Adkins
- 👤 Cormac A. O'Donovan
- 👤 Reese S. Terry, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 04:24
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/18; A61N1/32; A61N1/36; A61N1/3605; A61N1/36128; A61N1/36135; A61N1/3606; A61N1/36064; A61N1/36053
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
183 words
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.
Claim 2
Dependent Claim
183 words
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.
Claim 3
Dependent Claim
34 words
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.
Claim 4
Dependent Claim
13 words
The medical device of claim 2, wherein: said detection means comprises a microprocessor.
Claim 5
Dependent Claim
31 words
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.
Claim 6
Dependent Claim
52 words
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.
Claim 7
Dependent Claim
25 words
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.
Claim 8
Dependent Claim
35 words
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.
Claim 9
Dependent Claim
61 words
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.
Claim 10
Dependent Claim
15 words
The medical device of claim 8, wherein: said electrode means includes the nerve stimulating electrode.
Claim 11
Dependent Claim
121 words
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.
Claim 12
Dependent Claim
121 words
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.
Claim 13
Dependent Claim
13 words
The stimulus generator of claim 10, wherein: said distinguishing means comprises a microprocessor.
Claim 14
Dependent Claim
33 words
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.
Claim 15
Dependent Claim
44 words
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.
Claim 16
Dependent Claim
62 words
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.
Claim 17
Dependent Claim
40 words
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.
Claim 18
Dependent Claim
37 words
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.
Claim 19
Independent Claim
106 words
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.
Claim 20
Independent Claim
106 words
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.
Claim 21
Dependent Claim
34 words
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.
Claim 22
Dependent Claim
30 words
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.
Claim 23
Dependent Claim
29 words
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.
Claim 24
Dependent Claim
42 words
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.
Claim 25
Dependent Claim
25 words
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.
Claim 26
Dependent Claim
14 words
The method of claim 22, including: generating a pulse burst as said electrical waveform.
Claim 27
Dependent Claim
24 words
The method of claim 23, including: programming a minimum time interval between consecutive ones of said pulse bursts to avoid overstimulation of the nerve.
Claim 28
Dependent Claim
31 words
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.
Claim 29
Dependent Claim
31 words
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.
Claim 30
Dependent Claim
17 words
The method of claim 26, including: electrically insulating part of the device housing to preclude muscle stimulation.
References Cited (Backward Citations)
US4702254A
Cited
US5269302A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-07-26 | 2003-01-25 | 2003-07-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-07-26 | 2007-01-25 | 2007-07-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-07-26 | 2011-01-25 | 2011-07-27 | $7700.00 | Window Closed / Lapsed |