Method and system for providing pulsed electrical stimulation to a craniel nerve of a patient to provide therapy for neurological and neuropsychiatric disorders

• US 7,191,012 B2
• Filed: 05/11/2003
• Issued: 03/13/2007
• Est. Priority Date: 05/11/2003
• Status: Expired due to Fees

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Primary Examiner(s): Bockelman; Mark
• Application Number:
  US10/436,017
• Publication Number:
  US 20050143786A1
• Time in Patent Office: 1,402 Days
• Field of Search: 607/30, 607/33, 607/45, 607/32, 607/60, 607/61
• US Class Current: 607/60
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• 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 1/37223 Circuits for electromagnetic coupling

Abstract

A method and system for providing electrical pulses for neuromodulating a cranial nerve of a patient utilizing an implantable stimulator. The implantable stimulator comprising a pulse generator module and a stimulus receiver module for coupling with an external stimulator. Control circuitry ensures selective operation of one pulse generator module. 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 such parameters. The external stimulator in conjunction with the implanted stimulus receiver can override the implanted pulse generator, to provide extra dose of therapy or to conserve the implanted battery. The external stimulator is also networked to other computers. The external programmer may also comprise a global positioning system (GPS) module for determining patient location.

Claims

1. A method to provide electrical pulses to a vagus nerve(s) of a patient for providing therapy for at least one of neurological and neuropsychiatric disorders, comprising the steps of:

providing an implanted stimulator, wherein said implanted stimulator comprises a microprocessor based programmable 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 programmer for programming said implanted stimulator;

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

providing control circuitry that selectively operating one of said implanted pulse generator module and said stimulus receiver module; and

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

whereby electric pulses are provided to said vagus nerve(s).

2. The method of claim 1, wherein said electrical pulses are provided anywhere along the length of said vagus nerve(s).

3. Method of claim 1, wherein said neurological and neuropsychiatric disorders further comprises 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, and the like.

4. The method of claim 1, wherein said vagus nerve(s) comprises at least one of left vagus nerve, right vagus nerve, or both vagus nerve(s).

5. Method of claim 1, wherein said external stimulator comprising telemetry means for remotely controlling said external stimulator.

6. Method of claim 1, wherein said external stimulator comprises means for networking with remote computers.

7. Method of claim 1, wherein said external stimulator further comprises a global positioning system (GPS) module for determining patient location.

8. Method of claim 1, wherein said external stimulator can be utilized to determine dose of electrical stimulation provided to said vagus nerve(s).

9. Method of claim 1, wherein said implanted pulse stimulator generator further comprises rechargeable power source, and is capable of being recharged via an external power source.

10. A method to provide therapy for central nervous system disorders using pulsed electrical stimulation to a vagus nerve(s) of a patient, comprising the steps of:

providing an 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 pulsed electrical stimulation independently of said pulse generator module;

providing an external stimulator with adjustable programs of stimulation, for inductively coupling to said implanted stimulus receiver;

providing a lead in electrical contact with said implantable stimulator, and at least one electrode adapted to be in contact with said vagus nerve;

determining suitable stimulation program for said patient, using said external stimulator; and

programming said implanted stimulator with said suitable stimulation program using an external programming means,

whereby said pulsed electrical stimulation is delivered to said vagus nerve(s).

11. Method of claim 10, wherein said implanted pulse generator module further comprises rechargeable power source.

12. Method of claim 10, wherein said implanted stimulator further comprises a circuitry means for selectively operating one of said stimulus receiver module and said pulse generator module.

13. Method of claim 10, wherein said external stimulator comprising telemetry means for remotely controlling said external stimulator.

14. Method of claim 10, wherein said external stimulator is networked with remote computers.

15. Method of claim 10, wherein said external programming means comprises a global positioning system (GPS) means for determining patient location.

16. A system comprising implantable and external components for providing pulsed electrical stimulation to a vagus nerve(s) of a patient, to provide therapy for one of neurological, neuropsychiatric disorders, comprising:

an implantable stimulator, wherein said implantable stimulator comprising a pulse generator module and a stimulus receiver module that receives external stimulus signals and is capable of applying said pulsed electrical stimulation independently of said pulse generator module;

an external stimulator for inductively coupling to said stimulus receiver;

an external programmer for programming said implanted stimulator;

control circuitry incorporated within said implanted stimulator; and

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

whereby said pulsed electrical stimulation is provided to said vagus nerve(s).

17. The method of claim 16, wherein said electrical pulses are provided anywhere along the length of said vagus nerve(s).

18. The method of claim 16, wherein said vagus nerve(s) comprises at least one of left vagus nerve, right vagus nerve, or both vagus nerve(s).

19. System of claim 16, wherein said neurological and neuropsychiatric disorders further comprises partial complex epilepsy, generalized epilepsy, involuntary movement disorders caused by Parkinson'"'"'s disease, or like, migraines, neurogenic pain, depression, Alzheimer'"'"'s disease, anxiety disorders, obsessive compulsive disorders, and the like.

20. System of claim 16, wherein said external stimulator comprises telemetry module for remotely controlling said external stimulator.

21. System of claim 20, wherein said remote control is over the internet.

22. System of claim 16, wherein said external stimulator is networked with remote computers.

23. System of claim 16, wherein said external stimulator comprises a global positioning system (GPS) module for patient location.

24. A system for neuromodulation of a vagus nerve(s) of a patient for providing therapy for one of neurological and neuropsychiatric disorders, comprising:

an implantable stimulator, wherein said implantable stimulator comprising a stimulus receiver module, and a pulse generator module programmable with a magnet;

an external stimulator for inductively coupling to said stimulus receiver;

circuitry means to selectively operate one of said pulse generator module and said stimulus receiver module; and

an implantable lead with at least one electrode adopted to be in contact with said vagus nerve(s),

whereby said pulsed electrical stimulation is provided to said vagus nerve(s) selectively by either external stimulator/stimulus receiver module or implanted pulse generator module.

25. System of claim 24, wherein said external stimulator comprises a global positioning system (GPS) module for determining patient location.

26. System of claim 24, wherein said neurological and neuropsychiatric disorders further comprises from a group consisting 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, and the like.

27. System of claim 24, wherein said external stimulator comprises telemetry module for remotely controlling said external stimulator.

28. System of claim 24, wherein said external stimulator is networked with remote computers.

29. A system for providing electrical stimulation to a vagus nerve(s) for providing therapy for one of partial complex epilepsy, generalized epilepsy, involuntary movement disorders caused by Parkinson'"'"'s disease, migraines, depression, Alzheimer'"'"'s disease, anxiety disorders, obsessive compulsive disorders, and the like, comprising:

an implantable stimulator comprising a pulse generation module and a stimulus receiver module, that receives external signals and is capable of applying said electrical stimulation independently of said pulse generation module wherein said implantable stimulator is adapted to be rechargeable with an external power source;

an external power source to recharge said implantable stimulator; and

an implantable lead adapted to connected to said implantable stimulator with at least one electrode adapted to be in contact with said vagus nerve(s),

whereby said therapy is provided using said rechargeable system.

30. The method of claim 29, wherein said vagus nerve(s) comprises at least one of left vagus nerve, right vagus nerve, or both vagus nerve(s).