APPARATUS AND METHOD FOR ADJUNCT (ADD-ON) THERAPY FOR DEPRESSION, MIGRAINE, NEUROPSYCHIATRIC DISORDERS, PARTIAL COMPLEX EPILEPSY, GENERALIZED EPILEPSY AND INVOLUNTARY MOVEMENT DISORDERS UTILIZING AN EXTERNAL STIMULATOR

• US 6,356,788 B2
• Filed: 11/30/2000
• Issued: 03/12/2002
• Est. Priority Date: 10/26/1998
• Status: Expired due to Fees

• Current Assignee: Birinder Bob Boveja
• Original Assignee: Birinder Bob Boveja
• Inventors: Boveja, Birinder Bob
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/727,570
• Publication Number:
  US 20010003799A1
• Time in Patent Office: 467 Days
• Field of Search: 607/45
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• 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 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

An apparatus and method for adjunct (add-on) therapy of depression, migraine, neuropsychiatric disorders, partial complex epilepsy, generalized epilepsy and involuntary movement disorders comprises an implantable lead-receiver, and an external stimulator having controlling circuitry, a power source, and a coil to inductively couple the stimulator to the lead-receiver. The external stimulator emits electrical pulses to stimulate a cranial nerve such as the left vagus nerve according to a predetermined program. In a second mode of operation, an operator may manually override the predetermined sequence of stimulation.

Claims

1. An apparatus for electrical stimulation therapy for treatment of at least one of depression, migraine and neuropsychiatric disorders comprising:

a) an implantable lead-receiver comprising a secondary coil and at least one electrode capable of stimulating a cranial nerve;

b) an external stimulator comprising a power source, circuitry to emit electrical signals, at least two predetermined programs to control said electrical signals, and a primary coil;

c) said primary coil of said external stimulator and said secondary coil of said implantable lead-receiver being capable of forming an electrical connection by inductive coupling,

whereby said external stimulator is capable of controlling the stimulation of said cranial nerve.

2. The apparatus of claim 1 wherein said neuropsychiatric disorder comprises obsessive compulsive disorders.

3. The apparatus of claim 1, wherein said cranial nerve is the left vagus nerve.

4. The apparatus of claim 1, wherein said external stimulator comprises a patient override mechanism to manually activate said external stimulator.

5. The apparatus of claim 1, wherein said predetermined programs are capable of being modified to modify said electrical signals.

6. The apparatus of claim 1, further comprising a program selection mechanism wherein said at least two predetermined programs may be selectively operated.

7. The apparatus of claim 1, wherein said primary coil of said external stimulator is adapted to be in contact with the skin of the patient.

8. The apparatus of claim 1, wherein said lead-receiver comprises a lead body with at least one lumen, a lead body insulation, a conductor, at least one electrode and a coil.

9. The apparatus of claim 8, wherein said at least one lumen is selected from the group consisting of single, double, triple and coaxial lumens.

10. The apparatus of claim 8 wherein said lead body insulation is selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

11. The apparatus of claim 8 wherein said lead body further comprises a coating selected from the group consisting of lubricious PVP, antimicrobial and anti-inflammatory coatings.

12. The apparatus of claim 8 wherein said electrode comprises a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride and carbon.

13. The apparatus of claim 8 wherein said electrode is selected from the group consisting of standard ball electrodes, hydrogel electrodes, spiral electrodes, steroid eluting electrodes, and fiber electrodes.

14. The apparatus of claim 1, wherein said electrical signals comprise at least one variable component selected from the group consisting of the current amplitude, pulse width, frequency and on-off timing sequence, and said at least two predetermined programs controls said variable component of said electrical signals.

15. A method to provide therapy for at least one of depression, migraine and neuropsychiatric disorders, comprising;

a) providing an implantable lead-receiver comprising a secondary coil and at least one electrode to stimulate a cranial nerve;

b) providing an external stimulator comprising circuitry to emit electrical signals, at least two programs to control said electrical signals, an external coil and a power supply;

c) activating one of said at least two programs of said external stimulator to emit said electrical signals to said external coil;

d) inductively transferring said electrical signals from said external coil of said external stimulator to said secondary coil of said lead-receiver;

whereby said electrical signals stimulate said cranial nerve according to at least one of said at least two predetermined programs.

16. The method of claim 15, wherein said cranial nerve is the left vagus nerve.

17. The method of claim 15, wherein said cranial nerve is stimulated by bipolar stimulation.

18. The method of claim 15, wherein said cranial nerve is stimulated by unipolar stimulation.

19. The method of claim 15, wherein the step of activating one of said at least two predetermined programs is manually performed.

20. The method of claim 15, further comprising manually controlling said electrical signals to stimulate said cranial nerve.

21. The method of claim 15, wherein:

a) said electrical signals comprise at least one variable component selected from the group consisting of the current amplitude, pulse width, frequency, and on-off timing sequence; and

b) said at least two predetermined programs controls said variable component of said electrical signals.

22. The method of claim 15, further comprising manually disengaging said at least two predetermined programs.

23. A method for treating symptoms of depression, migraine or neuropsychiatric disorders comprising:

a) selecting a predetermined program to control the output of an external stimulator;

b) activating said external stimulator to emit electrical signals in accordance with said predetermined program; and

c) inductively coupling said external stimulator with an implantable lead-receiver to stimulate a cranial nerve.

24. A method for treating symptoms of depression, migraine or neuropsychiatric disorders comprising:

a) selecting one of at least two predetermined programs to control the output of an external stimulator;

b) activating said external stimulator to emit electrical signals in accordance with said one of at least two predetermined programs; and

c) inductively coupling said external stimulator with an implantable lead-receiver to stimulate a cranial nerve.

25. The method of claim 24, further comprising implanting beneath the skin of a patent said lead-receiver in direct electrical contact with said cranial nerve.