CA2331020A1 - Cardiac activity algorithm activation of a neurostimulator - Google Patents

Cardiac activity algorithm activation of a neurostimulator Download PDF

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Publication number
CA2331020A1
CA2331020A1 CA002331020A CA2331020A CA2331020A1 CA 2331020 A1 CA2331020 A1 CA 2331020A1 CA 002331020 A CA002331020 A CA 002331020A CA 2331020 A CA2331020 A CA 2331020A CA 2331020 A1 CA2331020 A1 CA 2331020A1
Authority
CA
Canada
Prior art keywords
change
patient
cardiac activity
seizure
electrical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002331020A
Other languages
French (fr)
Other versions
CA2331020C (en
Inventor
Robert A. Adkins
Cormac A. O'donovan
Reese S. Terry, Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Livanova USA Inc
Original Assignee
Cyberonics, Inc.
Robert A. Adkins
Cormac A. O'donovan
Reese S. Terry, Jr.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cyberonics, Inc., Robert A. Adkins, Cormac A. O'donovan, Reese S. Terry, Jr. filed Critical Cyberonics, Inc.
Publication of CA2331020A1 publication Critical patent/CA2331020A1/en
Application granted granted Critical
Publication of CA2331020C publication Critical patent/CA2331020C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064—Epilepsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36053—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation

Abstract

Cardiac activity indicative of an imminent epileptic seizure is sensed (45), and timed (65) to deliver a status signal to a logic and control circuit (35 ) which contains a microprocessor (36) and a random access memory (66) to analyze the input data, and set the stimulus parameters for delivery by the output section (42) through electrodes (43) to treat the imminent epilepsy.< /SDOAB>

Claims (27)

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 mews 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 ins 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 tune 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 meahod 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 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.
CA2331020A 1998-05-02 1999-04-30 Cardiac activity algorithm activation of a neurostimulator Expired - Lifetime CA2331020C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/071,856 US5928272A (en) 1998-05-02 1998-05-02 Automatic activation of a neurostimulator device using a detection algorithm based on cardiac activity
US09/071,856 1998-05-02
PCT/US1999/009372 WO1999056822A1 (en) 1998-05-02 1999-04-30 Cardiac activity algorithm activation of a neurostimulator

Publications (2)

Publication Number Publication Date
CA2331020A1 true CA2331020A1 (en) 1999-11-11
CA2331020C CA2331020C (en) 2012-01-17

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2331020A Expired - Lifetime CA2331020C (en) 1998-05-02 1999-04-30 Cardiac activity algorithm activation of a neurostimulator

Country Status (8)

Country Link
US (1) US5928272A (en)
EP (2) EP2258444B1 (en)
JP (1) JP3571651B2 (en)
AU (1) AU752688B2 (en)
CA (1) CA2331020C (en)
DK (1) DK1087815T3 (en)
ES (1) ES2402991T3 (en)
WO (1) WO1999056822A1 (en)

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