Activation techniques for implantable medical device

• US 5,304,206 A
• Filed: 11/18/1991
• Issued: 04/19/1994
• Est. Priority Date: 11/18/1991
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Baker, Ross G. Jr., Terry, Reese S. Jr., Adkins, Alan
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/793,842
• Time in Patent Office: 883 Days
• Field of Search: 128/419 R, 128/419 C, 128/420.5, 128/903, 128/423
• US Class Current: 607/2
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

Improvements are disclosed in apparatus and techniques for activating an implantable medical device, such as a neurostimulator adapted to treat and control a disorder of a patient where the disorder is susceptible to relief in response to predetermined modulation of the electrical activity of a selected nerve or group of nerves of the patient. The neurostimulator includes a stimulus generator responsive, when activated, to generate a programmable electrical waveform, and an electrode array electrically connected to the stimulus generator for delivering the waveform to a selected nerve of the patient, such as the vagus nerve. The neurostimulator is also adapted to be programmed to provide the waveform with parameter values selected to stimulate the selected nerve to produce the predetermined modulation of the nerve'"'"'s electrical activity. The neurostimulator is implemented to respond to a patient initiated signal which may be derived either manually or automatically to selectively activate the stimulus generator. Response to a manually derived signal produces a signal to trigger activation of the stimulus generator. Response to an automatically derived signal indicative of a manifestation of the disorder being treated will separately trigger activation of the stimulus generator.

Claims

1. A medical device for treating a disorder of a patient, comprising:

implantable electronic means operative when activated for developing a predetermined therapy to treat the disorder,

implantable delivery means connectable to the electronic means for delivering said therapy to a selected region of the patient'"'"'s body, and

activation means responsive to a signal initiated by the patient for activating the electronic means to cause the delivery of the therapy by the delivery means, when connected to the electronic means, to the selected body region and thereby to treat the disorder, the activation means including

detection means responsive to tapping by the patient in at least one coded sequence of taps on the skin adjacent the implanted electronic means for manual activation thereof, and

adjustment means for varying a preselected parameter of the therapy in response to another coded sequence of taps.

2. A medical device for treating a disorder of a patient, comprising:

implantable electronic means operative when activated for developing a predetermined therapy to treat the disorder,

implantable delivery means connectable to the electronic means for delivering said therapy to a selected region of the patient'"'"'s body, and

activation means responsive to a signal initiated by the patient for activating the electronic means to cause the delivery of the therapy by the delivery means, when connected to the electronic means, to the selected body region and thereby to treat the disorder, the activation means including

detection means responsive to tapping by the patient in at least one coded sequence of taps on the skin adjacent the implanted electronic means for manual activation thereof, and

deactivating means responsive to another coded sequence of taps while the electronic means is activated for deactivating the electronic means.

3. A medical device for treating a disorder of a patient, comprising:

implantable electronic means operative when activated for developing a predetermined therapy to treat the disorder,

implantable delivery means connectable to the electronic means for delivering said therapy to a selected region of the patient'"'"'s body, and

activation means responsive to a signal initiated by the patient for activating the electronic means after a predetermined delay interval to cause the delivery of the therapy by the delivery means, when connected to the electronic means, to the selected body region and thereby to treat the disorder.

4. A neurostimulator for treating a disorder of a patient manifested by seizures characterized by violent disorganized movements of the patient, comprising:

implantable electronic means operative when activated for developing a predetermined therapy to treat the disorder, including signal generator means for generating a programmed electrical stimulus comprising the therapy,

implantable delivery means connectable to the generator means adapted to deliver said stimulus to a preselected nerve of the patient, and

activation means including

motion sensor means responsive to said movements by the patient for automatically activating the electronic means to cause delivery of said stimulus by the delivery means to said preselected nerve when the delivery means is connected to the generator means, whereby to treat the disorder, and

selection means for precluding activation of the electronic means in response to detection of movements by the patient which are characteristic of normal physical activity by the patient and not of the violent disorganized type associated with a seizure.

5. The invention of claim 4, wherein

the selection means includes sensitivity means for determining the violence of the movements.

6. The invention of claim 5, wherein

the motion sensor means produces an electrical signal indicative of frequency of movements by the patient, and the sensitivity means includes an electrical signal filter for limiting the electrical signal to a predetermined frequency band.

7. The invention of claim 5, wherein

the motion sensor means produces an electrical signal indicative of the frequency of making and breaking of electrical contacts in response to movements by the patient, and the sensitivity means includes a counter to ascertain the number of contacts made during a predetermined interval of the movements.

8. The invention of claim 4, wherein

the implantable electronic means has a housing, and

the activation means is located within the housing.

9. A medical device for treating a disorder of a patient, comprising:

implantable electronic means operative when activated for developing a predetermined therapy to treat the disorder,

implantable delivery means connectable to the electronic means for delivering said therapy to a selected region of the patient'"'"'s body, and

activation means responsive to a signal initiated by the patient for activating the electronic means to cause the delivery of the therapy by the delivery means to the selected body region when the delivery means is connected to the electronic means, whereby to treat the disorder, the activation means comprising a bracelet including manual signalling means for producing a signal in the range of one of audio and ultrasonic frequencies.

10. The invention of claim 9, wherein

the bracelet further includes sensing means responsive to a physiological manifestation of the disorder being treated for producing a signal to automatically activate the electronic means.

11. The invention of claim 10, wherein

the implantable electronic means has a housing, and

the activation means further includes receiving means located within the housing and responsive to the signal produced by the sensing means for ascertaining whether the signal is indicative of a physiological manifestation of the disorder being treated in contrast to a similar physiological manifestation of a normal reaction, and limiting activation of the electronic means only in response to the former physiological manifestation.

12. The invention of claim 11, further including

means external to the patient for selectively adjusting the sensitivity of the receiving means to the signal produced by the sensing means.

13. Neurostimulator apparatus for treating and controlling a disorder of a patient susceptible to relief in response to predetermined modulation of the electrical activity of a selected nerve or group of nerves of the patient, including

a stimulus generator adapted for implantation and responsive, when activated, to generate a programmable electrical waveform,

an electrode array adapted for implantation and electrical connection to the stimulus generator for delivering the waveform to a selected nerve of the patient,

said stimulus generator being programmable to provide the waveform with parameter values selected to stimulate the selected nerve to modulate the electrical activity thereof according to said predetermined modulation, and

activation means responsive to a patient initiated signal which may be derived both manually and automatically for selectively activating the stimulus generator, the activation means including

means responsive to a manually derived signal for producing a signal to trigger activation of the stimulus generator, and

means responsive to an automatically derived signal for verifying that the automatically derived signal is indicative of a manifestation of the disorder being treated before activating the stimulus generator.