System and method for providing electrical pulses to the vagus nerve(s) to provide therapy for obesity, eating disorders, neurological and neuropsychiatric disorders with a stimulator, comprising bi-directional communication and network capabilities

• US 7,263,405 B2
• Filed: 08/27/2003
• Issued: 08/28/2007
• Est. Priority Date: 08/27/2003
• Status: Expired due to Fees

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Widhany, Angely R., Boveja, Birinder R.
• Primary Examiner(s): Layno; Carl
• Assistant Examiner(s): Bertram; Eric D.
• Application Number:
  US10/649,077
• Publication Number:
  US 20050049655A1
• Time in Patent Office: 1,462 Days
• Field of Search: 607/46, 607 58- 61, 607/118, 607/40, 607/45
• US Class Current: 607/60
• 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

Abstract

A system and method for providing pulsed electrical stimulation to one or both vagus nerve(s) of a patient to provide therapy for obesity, eating disorders, neurological and neuropsychiatric disorders. The electrical pulses can be provided either unilaterally or bilaterally (left and right vagus nerves) and can be supra-diaphramatic or be sub-diaphramatic. The system comprising implantable stimulator, lead(s), an external stimulator, and a programmer. The implantable stimulator, comprising a pulse generator module, and a stimulus-receiver module which is used in conjunction with an external stimulator. Control circuitry ensures selective operation of one of the modules of the implanted stimulator, at a time. Further, the external stimulator comprises a telemetry module for remotely activating (or de-activating) programs over the internet, to arrive at the optimal program for each patient. Once the optimal “dose” is titrated using the external stimulator, the implanted pulse generator can then be programmed to similar parameters. The external stimulator in conjunction with the implanted stimulus-receiver can override the implanted pulse generator module, to provide extra dose of therapy, and also to conserve the implanted battery. The external stimulator is networked to other computers. Using the networking, a physician situated remotely can monitor and program the devices, as well as, automatically generate invoicing. In one embodiment, the external stimulator also comprises GPS circuitry for locating patient.

Claims

1. A method to provide electrical pulses to one or both vagus nerve(s) and/or its branches of a patient to provide therapy for at least one of obesity, eating disorders, comprising the steps of:

providing at least one implanted stimulator to provide electrical pulses, wherein said implanted stimulator comprises a pulse generator module and a stimulus-receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator adapted to be inductively coupled to said stimulus-receiver module; and

providing at least one implanted lead in electrical contact with said implanted stimulator, and at least one electrode adapted to be in contact with said vagus nerve(s) and/or its branches,

whereby electrical pulses are provided to one or both vagus nerve(s) and/or its branches.

2. Method of claim 1, wherein said implanted stimulator further comprises control circuitry for selectively operating one of said implanted pulse generator module and said implanted stimulus-receiver module.

3. Method of claim 1, wherein said electrical pulses are provided at any level along the length of said vagus nerve(s) and its branches.

4. Method of claim 1, wherein said electrical pulses are provided to said vagus nerve(s) at a level above the diaphragmatic level in a patient.

5. Method of claim 1, wherein said electrical pulses are provided to said vagus nerve(s) at a level below the diaphragmatic level in a patient.

6. Method of claim 1, wherein said electrical pulses are provided with two separate said implanted stimulators to said both (left and right) vagus nerve(s).

7. Method of claim 1, wherein said electrical pulses are-provided with one said implanted stimulator to said both (left and right) vagus nerve(s).

8. Method of claim 1, wherein said electrical pulses further comprises at least one variable component selected from the group consisting of the current output, pulse width, pulse frequency, pulse amplitude, and on-off timing sequence.

9. Method of claim 1, wherein an external programmer programs said implanted stimulator.

10. Method of claim 1, wherein a magnet programs said implanted stimulator.

11. Method of claim 1, wherein said external stimulator further comprises a telemetry unit for bi-directional communications.

12. Method of claim 11, wherein said telemetry unit further provides bi-directional communications for at least one of patient billing and invoicing, patient monitoring and management, communicating with other computers.

13. Method of claim 1, wherein said external stimulator further comprises telemetry unit for remotely controlling said electrical pulses provided by said external stimulator to a patient.

14. Method of claim 1, wherein said implanted stimulator further comprises rechargeable power source.

15. A method of providing pulsed electrical stimulation to one or both vagus nerve(s) and/or its branches in a patient, for providing therapy for at least one of neurological disorders, neuropsychiatric disorders, obesity and eating disorders, comprising the steps of:

providing at least one implanted stimulator, wherein said implanted stimulator comprises a pulse generator module and a stimulus-receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator for inductively coupling to said implanted stimulus-receiver module;

providing control circuitry for selectively operating one of said pulse generator module or said implanted stimulus-receiver module;

providing at least one implanted lead in electrical contact with said implanted stimulator, and at least one electrode in contact with said vagus nerve(s) for providing therapy for at least one of neurological disorders, neuropsychiatric disorders, obesity and eating disorders; and

providing electrical pulses from either said implanted pulse generator module or external stimulator to said at least one electrode in contact with said vagus nerve(s) and/or its branches,

whereby pulsed electrical stimulation to one or both vagus nerve(s) and/or its branches is provided.

16. Method of claim 15, wherein further said neurological disorders and neuropsychiatric disorders comprises at least one of partial complex epilepsy, generalized epilepsy, involuntary movement disorders caused by Parkinson'"'"'s disease, migraines, neurogenic pain, depression, Alzheimer'"'"'s disease, anxiety disorders, obsessive compulsive disorders.

17. Method of claim 15, wherein said external stimulator is further used for optimizing doage of said electrical pulses provided to a patient.

18. Method of claim 15, wherein said electrical pulses further comprises at least one variable component selected from the group consisting of current output, pulse width, pulse frequency, pulse amplitude and on-off timing sequence.

19. Method of claim 15, wherein an external programmer programs said implanted stimulator.

20. Method of claim 15, wherein a magnet programs said implanted stimulator.

21. Method of claim 15, wherein said external stimulator further comprises a telemetry unit for bi-directional communications.

22. Method of claim 21, wherein said telemetry unit further provides bi-directional communications for at least one of patient billing and invoicing, patient monitoring and management, communicating with other computers.

23. Method of claim 15, wherein said external stimulator further comprises telemetry unit for remotely controlling said electrical pulses provided by said external stimulator to a patient.

24. Method of claim 15, wherein said implanted stimulator further comprises rechargeable power source.

25. Method of providing electrical pulses to one or both vagus nerve(s) and/or its branches in a patient, comprising the steps of:

providing an implantable stimulator, wherein said implantable stimulator comprises a pulse generator module and a stimulus-receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator for inductively coupling to said stimulus-receiver and further comprising a network telemetry unit for bi-directional communications for at least one of patient billing and invoicing, patient management and monitoring, communicating with other computers, remotely controlling said electrical pulses delivered by said external stimulator to a patient, global positioning for patient location;

providing control circuitry to selectively operate one of said pulse generator module and said stimulus-receiver module;

providing at least one implantable lead with at least one electrode in contact with said vagus nerve(s); and

providing electrical pulses from either said implanted pulse generator module or external stimulator to said at least one electrode in contact with said vagus nerve(s) and/or its branches.

26. Method of claim 25 wherein said electric pulses are provided to said vagus nerve(s) and/or its branches for therapy for at least one of neurological disorders, neuropsychiatric disorders, obesity and eating disorders.