Apparatus and method for adjunct (add-on) treatment of coma and traumatic brain injury with neuromodulation using an external stimulator

• US 6,564,102 B1
• Filed: 04/19/2001
• Issued: 05/13/2003
• Est. Priority Date: 10/26/1998
• Status: Expired due to Fees

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Birinder R. Boveja
• Inventors: Boveja, Birinder R.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/837,662
• Time in Patent Office: 754 Days
• Field of Search: 128/897-898, 607/1-2, 607/33, 607/45, 607/59-62, 607/65-66
• 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 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

A system and method of neuromodulation adjunct (add-on) therapy for coma and traumatic brain injury, comprises an implantable lead-receiver and an external stimulator. Neuromodulation is performed using a pulsed electrical stimulation. The external stimulator contains a power source, controlling circuitry, a primary coil, and predetermined programs. The primary coil of the external stimulator inductively transfers electrical signals to the lead-receiver, which is also in electrical contact with a vagus nerve. The external stimulator emits electrical pulses to stimulate the vagus nerve according to a predetermined program. The predetermined programs have different levels of control, which is password protected. The external stimulator may also be equipped with a telecommunications module to control the predetermined programs remotely.

Claims

1. An adjunct (add-on) coma and traumatic brain injury therapy apparatus using neuromodulation of a cranial nerve, comprising;

a) an implantable lead-receiver comprising circuitry, a secondary coil and at least one electrode adapted for stimulating a cranial nerve;

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

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

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

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

3. The apparatus of claim 1, wherein said external stimulator comprises an override mechanism to manually activate said external stimulator.

4. The apparatus of claim 1, wherein said predetermined programs comprising means for modifying the predetermined programs controlling the electrical signals.

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

6. The apparatus of claim 1, wherein a proximity sensing mechanism provides means for optimally positioning the primary coil.

7. The apparatus of claim 1, wherein said external stimulator has wireless communication means to control the predetermined programs from a remote location.

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, circuitry 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-receiver 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, spiral electrodes, hydrogel electrodes, steroid eluting electrodes, and standard ball 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. The apparatus of claim 1, wherein said apparatus comprises means for bipolar stimulation.

16. The apparatus of claim 1, wherein said apparatus comprises means for unipolar stimulation.

17. The apparatus of claim 1, wherein said apparatus comprises means for locking out at least one of the predetermined programs using password protection.

18. A method of neuromodulating a cranial nerve for treatment of coma and traumatic brain injury, comprising;

a) selecting a predetermined program from 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 predetermined program; and

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

19. The method of claim 18, further comprising implanting beneath the skin of a patient said stimulus receiver in direct electrical contact with said cranial nerve.

20. The method of claim 18 wherein the cranial nerve is the vagus nerve.

21. A method for adjunct (add-on) therapy for coma and traumatic brain injury using neuromodulation of a cranial nerve, comprising;

a) providing an implantable lead-receiver comprising circuitry, 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 predetermined programs to control said electrical signals, a primary coil coil and a power supply;

c) activating one of said at least two programs of said external stimulator;

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

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

22. The method of claim 21, wherein said cranial nerve is the vagus nerve.

23. The method of claim 21, wherein said predetermined programs are capable of being modified to modify said electrical signals.

24. The method of claim 21, wherein a proximity sensing means is used for optimally positioning the primary coil.

25. The method of claim 21, wherein said external stimulator has wireless communication means to control the predetermined programs from a remote location.

26. The method of claim 21, wherein said cranial nerve is stimulated by bipolar stimulation.

27. The method of claim 21, wherein said cranial nerve is stimulated by unipolar stimulation.

28. The method of claim 21, wherein the step of activating one of said at least two predetermined programs is manually performed.

29. The method of claim 21, further comprising manually controlling said electrical signals to stimulate said cranial nerve.

30. The method of claim 21, 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.

31. The method of claim 21, further comprising manually disengaging said at least two predetermined programs.

32. The method of claim 21, wherein said method comprises means for locking out at least one of the predetermined programs using password protection.