Method and system for modulating the vagus nerve (10th cranial nerve) with electrical pulses using implanted and external componants, to provide therapy for neurological and neuropsychiatric disorders

• US 20050004621A1
• Filed: 05/08/2004
• Published: 01/06/2005
• Est. Priority Date: 05/09/2002
• Status: Active Grant

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Granted Patent: US 7,076,307 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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 neuromodulating vagus nerve(s) to provide therapy for neurological and neuropsychiatric disorders comprises implantable and external components. The pulsed electrical stimulation to vagus nerve(s) is used for disorders such as epilepsy, depression, anxiety disorders, neurogenic pain, compulsive eating disorders, obesity, dementia including Alzheimer'"'"'s disease, and migraines. The pulsed electrical stimulation 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 programmable implantable pulse generator; e) a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and f) an IPG comprising a rechargeable battery. 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 providing electrical pulses to a vagus nerve(s) of a patient for treating or alleviating the symptoms of at least one of neurological, neuropsychiatric, and obesity disorders, comprising the steps of:

a) providing a microprocessor based pulse generator;

wherein said pulse generator comprises at least one predetermined program to deliver said electrical pulses;

b) providing a lead in electrical contact with said pulse generator;

wherein said lead comprising at least one electrode adapted to be in contact with said vagus nerve(s);

c) providing means for programming said pulse generator; and

d) activating said at least one predetermined program to emit said predetermined pulses to said vagus nerve(s).

2. The method of claim 1, wherein said electric pulses are provided to said vagus nerve(s) to provide neuromodulation therapy for at least one of epilepsy, involuntary movement disorders including Parkinson'"'"'s disease, depression, anxiety disorders, neurogenic/psychogenic pain, obsessive compulsive disorders, obesity, dementia including Alzheimer'"'"'s disease, and migraines.

3. The method of claim 1, wherein said vagus nerve(s) further comprises at least one of the left vagus nerve, right vagus nerve, and branches of said left vagus nerve and right vagus nerve.

4. The method of claim 1, wherein said electric pulses are supplied to said vagus nerve(s) at any point along the length of said vagus nerve(s).

5. The method of claim 1, wherein said at least one predetermined program can be modified.

6. The method of claim 1, wherein said pulse generator may further comprise a telemetry means for remote device interrogation and programming.

7. The method of claim 1, wherein said at least one predetermined program:

a) comprises at least one variable components from a group consisting of pulse amplitude, pulse width, pulse frequency, ON-time, and OFF-time sequences, and

b) controls said variable component of said electric pulses.

8. The method of claim 1 wherein, said pulse generator may be external to the body.

9. The method of claim 1 wherein, said pulse generator may be implanted in the patient.

10. The method of claim 9 wherein, wherein said pulse generator implanted in the patient is programmed with an external programmer.

11. The method of claim 9, wherein said pulse generator implanted in the patient may comprises rechargeable power source.

12. The method of claim 1, wherein said lead comprises a lead body with insulation selected from the group consisting of polyurethane, silicone, and silicone with polytetrafluoroethylene.

13. The method of claim 1, wherein said at least one electrode comprises a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride, and carbon.

14. 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.

15. A method of neuromodulating the vagus nerve(s) or its branches for controlling or alleviating the symptoms of at least one of neurological, neuropsychiatric, and obesity disorders, comprising the steps of:

a) providing a pulse generator to supply electric pulses, wherein said pulse generator consists of one from a group comprising of;

an implanted stimulus-receiver with an external stimulator;

an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator;

a programmer-less implantable pulse generator (IPG) which is operable with a magnet;

a programmable implantable pulse generator;

a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and

an IPG comprising a rechargeable battery.

b) providing at least one predetermined program control the output of said pulse generator;

c) providing a lead in electrical contact with said at least one pulse generator;

d) activating said at least one predetermined program to emit said electrical pulses to said vagus nerve(s);

e) providing at least one electrode connected to said lead wherein said at least one electrode is adapted to be in contact with said vagus nerve(s);

whereby, neuromodulation of said vagus nerve(s) is provided according to said at least one predetermined program.

16. The method of claim 15, wherein said electric pulses are provided to said vagus nerve(s) to provide neuromodulation therapy for at least one of epilepsy, involuntary movement disorders including Parkinson'"'"'s disease, depression, anxiety disorders, neurogenic/psychogenic pain, obsessive compulsive disorders, obesity, dementia including Alzheimer'"'"'s disease, and migraines.

17. The method of claim 15, wherein said pulse generator may further comprise a telemetry means for remote device interrogation and programming.

18. The method of claim 15, wherein said at least one predetermined program:

a) comprises at least one variable components from a group consisting of pulse amplitude, pulse width, pulse frequency, ON-time, and OFF-time sequences, and

b) controls said variable component of said electric pulses.

19. A method for providing predetermined electrical pulses to a vagus nerve(s) comprising implanted and external components, to provide therapy for at least one of epilepsy, depression, anxiety disorders, neurogenic pain, compulsive eating disorders, obesity, dementia including Alzheimer'"'"'s disease, and migrane, comprising the steps of:

a) providing a programmable implanted pulse generator to provide said electrical pulses;

b) providing an implantable lead in electrical contact with said pulse generator, and at least one electrode adapted to be in contact with said vagus nerve(s);

c) providing an external programmer; and

d) programming said implanted pulse generator with said external programmer to deliver predetermined electrical pulses for providing said therapy.

20. A Method of claim 19, wherein said implanted pulse generator comprises means to remotely control said electrical pulses generated by said implanted pulse generator.

21. A system of providing electrical pulses to a vagus nerve(s) of a patient for treating or alleviating the symptoms of at least one of neurological, neuropsychiatric, and obesity disorders, comprising:

a) a microprocessor based pulse generator;

wherein said pulse generator comprises at least one predetermined program to deliver said electrical pulses;

b) a lead in electrical contact with said pulse generator;

wherein said lead comprising at least one electrode adapted to be in contact with said vagus nerve(s);

c) means for programming said pulse generator; and

d) activating said at least one predetermined program to emit said predetermined pulses to said vagus nerve(s).

22. The system of claim 21, wherein said vagus nerve(s) further comprises at least one of a left vagus nerve, right vagus nerve, and branches of said left vagus nerve and right vagus nerve.

23. The system of claim 21, wherein said electric pulses are supplied to said vagus nerve(s) anywhere along the length of said vagus nerve(s).

24. The system of claim 21, wherein said pulse generator may further comprise a telemetry means to remotely control said predetermined program(s).

25. The system of claim 21, wherein said at least one predetermined program:

a) comprises at least one variable components from a group consisting of pulse amplitude, pulse width, pulse frequency, ON-time, and OFF-time sequences, and

b) controls said variable component of said electric pulses.

26. The system of claim 21 wherein, said pulse generator may be external to the body.

27. The system of claim 21, wherein said pulse generator may be implanted in the patient.

28. The system of claim 27, wherein said pulse generator implanted in the patient is programmed with an external programmer.

29. The system of claim 27, wherein said pulse generator comprises rechargeable power source.

30. The system of claim 21, wherein said lead comprises a lead body with insulation selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

31. The system of claim 21, wherein said at least one electrode comprises a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride, and carbon.

32. The system of claim 21, wherein said at least one electrode consists from a group comprising, spiral electrodes, cuff electrodes, steroid eluting electrodes, wrap-around electrodes, and hydrogel electrodes.

33. The system of claim 21, wherein said electric pulses are provided to said vagus nerve(s) to provide neuromodulation therapy for at least one of epilepsy, involuntary movement disorders including Parkinson'"'"'s disease, depression, anxiety disorders, neurogenic/psychogenic pain, obsessive compulsive disorders, obesity, dementia including Alzheimer'"'"'s disease, and migraines.