Apparatus and method for adjunct (add-on) therapy for pain syndromes utilizing an implantable lead and an external stimulator

• US 6,208,902 B1
• Filed: 10/26/1998
• Issued: 03/27/2001
• 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:
  US09/178,058
• Time in Patent Office: 883 Days
• Field of Search: 607/45, 607/46, 607/58, 607/59, 607/63, 607/72, 607/116, 607/61, 607/118
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

An apparatus and method for adjunct (add-on) therapy of painful syndromes comprises an implantable lead-receiver, an external stimulator having controlling circuitry and a power source, and an coil to inductively couple the stimulator to the lead-receiver. The external patch contains means for compensating for the change in axis of external transmitting and internal receiving coils. The external stimulator emits electrical pulses to stimulate a cranial nerve such as the left vagus nerve according to a predetermined program. The pre-determined programs include both short term and long term stimulation.

Claims

1. An apparatus for treatment of painful syndromes which may be neuropathic and/or psychogenic, comprising:

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

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 vagus nerve.

2. The apparatus of claim 1, wherein said at least two predetermined programs are capable of being modified to modify said electrical signals.

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

4. 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.

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

6. The apparatus of claim 5, wherein said at least one lumen is selected from the group consisting of single, double, triple and coaxial lumens.

7. The apparatus of claim 5 wherein said lead body insulation is selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

8. The apparatus of claim 5 wherein said lead body further comprises a coating selected from the group consisting of lubricious PVP, antimicrobial and anti-inflammatory coatings.

9. The apparatus of claim 1 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.

10. The apparatus of claim 1 wherein said electrode is selected from the group consisting of standard ball electrodes, hydrogel electrodes, spiral electrodes, steroid eluting electrodes, and fiber electrodes.

11. 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.

12. A method to provide therapy for painful syndromes comprising:

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

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

c) activating one of said at least two predetermined programs 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 left vagus nerve according to at least one of said at least two predetermined programs.

13. The method of claim 12, further comprising implanting said lead-receiver beneath the skin of a patient with said at least one electrode in direct electrical contact with said left vagus nerve.

14. The method of claim 12, wherein said external stimulator comprises at least six predetermined programs to control said electrical signals.

15. The method of claim 12, wherein the step of activating one of said at least two predetermined programs is manually performed.

16. The method of claim 12, further comprising manually controlling said electrical signals to stimulate said cranial nerve.

17. The method of claim 12, 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) at least one of said at least two predetermined programs controls said at least one variable component of said electrical signals.

18. The method of claim 12, further comprising manually disengaging said at least two predetermined programs.

19. A method for providing therapy for the treatment of neuropathic and/or psychogenic pain comprising:

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

b) activating said external stimulator to emit a 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.

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