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

• US 7,076,307 B2
• Filed: 05/08/2004
• Issued: 07/11/2006
• Est. Priority Date: 05/09/2002
• Status: Expired due to Term

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Boveja, Birinder R., Widhany, Angely
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US10/841,995
• Publication Number:
  US 20050004621A1
• Time in Patent Office: 794 Days
• Field of Search: 607/2, 607 9- 10, 607/40, 607 45- 48, 607/30, 607 32- 33
• 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.

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:

providing a microprocessor based implanted pulse generator, wherein said pulse generator comprises microprocessor, circuitry, memory, and power source;

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

providing an implanted lead in electrical contact with said implanted pulse generator;

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

providing programmer means for activating and/or programming said implanted pulse generator, wherein bi-directional inductive telemetry is used to exchange data with said implanted pulse generator; and

selectively choosing between at least two predetermined/pre-packaged program and activating said selected program.

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 two predetermined/pre-packaged programs can be modified.

6. The method of claim 1, wherein said implanted pulse generator may further comprise a telemetry means for remote device interrogation and/or programming over a wide area network.

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 implanted pulse generator is activated or programmed with an external programmer.

9. The method of claim 1, wherein said implanted pulse generator comprises rechargeable power source wherein said power source is recharged via an external system with inductively coupled energy transfer.

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

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

12. 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.

13. 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:

providing an implanted pulse generator to supply electrical pulses, wherein said implanted pulse generator consists of one from a group comprising of;

a combination implantable device wherein said implantable device comprises both a stimulus-receiver module and a programmable implanted pulse generator module IPG, an implantable pulse generator (IPG) comprising a rechargeable battery, or a programmable implanted pulse generator (IPG).

providing at least one predetermined/pre-packaged program to control the output of said implanted pulse generator, wherein said predetermined/pre-packaged programs define neuromodulation parameters of pulse amplitude, pulse-width, pulse frequency, on-time and off-time;

providing an implanted lead in electrical contact with said implanted pulse generator;

providing means for activating and/or programming said implantable pulse generator, wherein bi-directional inductive telemetry is used to exchange data with said implanted pulse generator;

activating said at least one predetermined/pre-packaged program to emit said electrical pulses to said vagus nerve(s);

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); and

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

14. The method of claim 13, wherein said electric pulses are provided to said vagus nerve(s) to provide neuromodulation therapy for at least one of epilepsy, Parkinson'"'"'s disease, depression, anxiety disorders, neurogenic/psychogenic pain, obsessive compulsive disorders, obesity, dementia including Alzheimer'"'"'s disease, and migraines.

15. The method of claim 13, wherein said pulse generator may further comprise a telemetry means for remote device interrogation and/or programming over a wide area network.

16. The method of claim 13, 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.

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

providing a programmable implanted pulse generator to provide said electrical pulses comprising microprocessor, electrical circuitry, memory, and power source;

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

providing an external programmer comprising circuitry for programming said implantable pulse generator using inductively coupled means for bi-direction data exchange, and further comprising telemetry means for remote communication using a wide area network;

programming said implanted pulse generator with said external programmer to deliver predetermined electrical pulses for providing said therapy; and

remotely communicating with said external programmer for data exchange over a wide area network.

18. A system for 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:

an implantable pulse generator comprising microprocessor, circuitry, memory, and power source;

at least two predetermined/pre-packaged programs of stimulation therapy stored in said memory to control said electrical pulses emitted by said implantable pulse generator, wherein said predetermined/pre-packaged programs define neuromodulation parameters of pulse amplitude, pulse-width, pulse frequency, on-time and off-time;

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

means for activating and/or programming said implantable pulse generator, wherein bi-directional inductive telemetry is used to exchange data with said implantable pulse generator.

19. The system of claim 18, 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.

20. The system of claim 18, wherein said electric pulses are supplied to said vagus nerve(s) anywhere along the length of said vagus nerve(s).

21. The system of claim 18, wherein said pulse generator may further comprise a telemetry means to remotely control said predetermined program(s).

22. The system of claim 18, 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.

23. The system of claim 18, wherein said pulse generator implanted in the patient is programmed with an external programmer.

24. The system of claim 18, wherein said implantable pulse generator comprises rechargeable power source wherein said power source is recharged via an external system with inductively coupled energy transfer.

25. The system of claim 18, wherein said implanted lead comprises a lead body with insulation selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

26. The system of claim 18, 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.

27. The system of claim 18, wherein said at least one electrode consists from a group comprising, spiral electrodes, cuff electrodes, steroid eluting electrodes, wrap-around electrodes, and hydrogel electrodes.

28. The system of claim 18, wherein said electric pulses are provided to said vagus nerve(s) to provide neuromodulation therapy for at least one of epilepsy, Parkinson'"'"'s disease, depression, anxiety disorders, neurogenic/psychogenic pain, obsessive compulsive disorders, obesity, dementia including Alzheimer'"'"'s disease, and migraines.