Method and system for providing therapy for migraine/chronic headache by providing electrical pulses to vagus nerve(s)

• US 20050216070A1
• Filed: 05/10/2005
• Published: 09/29/2005
• Est. Priority Date: 05/09/2002
• Status: Abandoned Application

• Current Assignee: Angely Widhany, Birinder R. Boveja
• Original Assignee: Angely Widhany, Birinder R. Boveja
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Application Number:
  US11/126,746
• Publication Number:
  US 20050216070A1
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A method and system for providing predetermined electrical pulses for neuromodulating vagus nerve(s) or its branches to provide therapy for migraine/chronic headache, comprises implantable and external components. The electrical pulses to vagus nerve(s) may be stimulating and/or blocking. The pulsed electrical stimulation/blocking to vagus nerve(s) may be provided using one of the following stimulation systems, such as: a) an implanted stimulus-receiver with an external stimulator; b) an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator; c) a programmer-less implantable pulse generator (IPG) which is operable with a magnet; d) a microstimulator; e) a programmable implantable pulse generator; f) a combination implantable device comprising both a stimulus-receiver and a programmable implantable pulse generator (IPG); and g) an implantable pulse generator (IPG) comprising a rechargeable battery. The pulse generator system comprises predetermined/pre-packaged programs. In one embodiment, the external components such as the programmer or external stimulator may comprise a telemetry means for networking. The telemetry means therefore allows for interrogation or programming of implanted device, from a remote location over a wide area network.

Claims

1. A method of treating or alleviating the symptoms of migraine/chronic headache by stimulating and/or blocking vagus nerve(s) or its branches or parts thereof with pre-determined electric pulses, which comprises:

a) selecting a migraine/chronic headache patient;

b) providing a pulse generator means capable of providing both stimulating and blocking electrical pulses for treating or alleviating the symptoms of migraine/chronic headache;

c) implanting at least one lead adapted to be in electrical connection with said pulse generator means; and

d) providing at least one electrode at the distal end of said at least one lead, wherein said at least one electrode is adapted to be in contact with said vagus nerve(s) or its branches or part thereof, to deliver said pre-determined electric pulses.

2. The method of claim 1, wherein said nerve blocking comprises at least one from a group consisting of:

DC or anodal block, Wedenski block, and Collision block.

3. The method of claim 1, wherein said stimulating and/or blocking pre-determined electric pulses are provided for a therapy that has cumulative effect.

4. The method of claim 1, wherein said treating or alleviating the symptoms of migraine/chronic headache is based on selective stimulation of left vagus nerve without the effect of EEG desynchroniztion.

5. The method of claim 1, wherein said stimulation and/or blocking employs an open-loop method, without feed-back control.

6. The method of claim 1, wherein said pulse generator means for providing said pre-determined electric pulses for treating or alleviating the symptoms of migraine/chronic headache, further comprises an external stimulator used in conjunction with an implanted stimulus-receiver comprising a high value capacitor for storing electric charge.

7. The method of claim 1, wherein said pulse generator means for providing said pre-determined electric pulses for treating or alleviating the symptoms of migraine/chronic headache, further comprises a microstimulator.

8. The method of claim 1, wherein said pulse generator means for providing said pre-determined electric pulses for treating or alleviating the symptoms of migraine/chronic headache further comprises a programmable implantable pulse generator (IPG).

9. The method of claim 1, wherein said pulse generator means for providing electric pulses for treating or alleviating the symptoms of migraine/chronic headache, further comprises a combination implantable device comprising both a programmable implantable pulse generator (IPG) and a stimulus-receiver.

10. The method of claim 1, wherein said pulse generator means for providing said predetermined electric pulses for treating or alleviating the symptoms of migraine/chronic headache, further comprises a programmable implantable pulse generator (IPG) having a rechargeable battery.

11. The method of claim 1, wherein said pre-determined electric pulses can be provided anywhere along the length of said vagus nerve(s) or its branches, at one or multiple sites.

12. The method of claim 1, wherein said pulse generator means further comprises at least two predetermined/pre-packaged programs stored in said memory, wherein said predetermined/pre-packaged programs define parameters of pulse amplitude, pulse width, pulse frequency, on-time and off-time sequences.

13. The method of claim 1, wherein said predetermined electrical pulses can be modified.

14. The method of claim 1, wherein said pulse generator means further comprises a telemetry means for remote device interrogation and programming, over a wide area network.

15. The method of claim 1, wherein said at least one electrode is from a group consisting of spiral electrodes, cuff electrodes, steroid eluting electrodes, wrap-around electrodes, and hydrogel electrodes.

16. The method of claim 1, wherein said electric pulses further comprise pulse amplitude between 0.1 volt-15 volts;

pulse width between 20 micro-seconds-5 milli-seconds;

stimulation frequency between 5 Hz and 200 Hz, and blocking frequency between 0 and 750 Hz.

17. A method of treating or alleviating the symptoms of migraine/chronic headache by stimulating and/or blocking vagus nerve(s) or its branches or parts thereof with pre-determined electric pulses, which comprises:

a) providing a pulse generator means to provide said pre-determined electrical pulses, wherein said pulse generator means comprises microprocessor, circuitry, and memory;

b) providing at least two predetermined/pre-packaged programs stored in said memory, wherein said predetermined/pre-packaged programs define parameters of pulse amplitude, pulse width, pulse frequency, on-time and off-time sequences;

c) providing a means for activating and/or adjusting parameters of said predetermined/pre-packaged programs; and

d) providing at least one implantable lead adapted to be in electrical connection with said pulse generator means, and having at least one electrode at the distal end of said at least one lead adapted to be in contact with said vagus nerve(s) or its branches or part thereof, to deliver said pre-determined electric pulses.

18. The method of claim 17, wherein said pulse generator means further comprises a telemetry means for remote device interrogation and programming, over a wide area network.

19. A method of providing stimulating and/or blocking electric pulses to a vagus nerve(s) with external or implanted pulse generator means for providing cumulative therapy for migraine/chronic headache, comprising the steps of:

a) selecting a patient for said therapy;

b) selecting a pulse generation means for said therapy from a group consisting of i) an external stimulator used in conjunction with an implanted stimulus-receiver comprising a high value capacitor for storing electric charge;

ii) a microstimulator;

iii) a programmable implantable pulse generator (IPG);

iv) a combination implantable device comprising both a programmable implantable pulse generator (IPG) and a stimulus-receiver;

v) a programmable implantable pulse generator (IPG) having a rechargeable battery;

c) providing an implanted lead adapted to be in electrical connection with said pulse generator means for providing said cumulative therapy; and

d) providing at least one electrode at the distal end of said lead, wherein said at least one electrode is adapted to be in contact with said vagus nerve(s) or its branches or part thereof, to deliver said pre-determined electric pulses.

20. The method of claim 19, wherein said pulse generator means further comprises at least two predetermined/pre-packaged programs stored in said memory, wherein said predetermined/pre-packaged programs define parameters of pulse amplitude, pulse width, pulse frequency, on-time and off-time.