Apparatus and method for electrical stimulation adjunct (add-on) therapy of atrial fibrillation, inappropriate sinus tachycardia, and refractory hypertension with an external stimulator

• US 6,668,191 B1
• Filed: 04/19/2001
• Issued: 12/23/2003
• 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:
  US09/837,512
• Time in Patent Office: 978 Days
• Field of Search: 607/1-2, 607/4-5, 607/9-10, 607/14, 607/23, 607/33, 607/44, 607/46, 607/59-62, 607/65-66, 607/118, 128/897-899
• US Class Current: 607/2
• 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 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• 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 atrial fibrillation, refractory hypertension, and inappropriate sinus tachycardia comprises an implantable lead-receiver and an external stimulator. Neuromodulation is performed using 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 implanted 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. In a second mode of operation, an operator may manually override the predetermined sequence of stimulation. The external stimulator may also be equipped with a telecommunications module to control the predetermined programs remotely.

Claims

1. A method for providing adjunct (add-on) neuromodulation therapy for at least one of atrial fibrillation, refractory hypertension, and inappropriate sinus tachycardia, comprising the steps of:

a) providing an implantable lead-receiver comprising circuitry, a secondary coil, and at least one electrode adapted to be in contact with a vagus nerve of a patient;

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

c) providing a proximity sensing means for optimally positioning said primary coil in relation to said secondary coil;

d) activating one of said more than two predetermined programs of said external stimulator to emit said electrical signals;

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

whereby said electrical signals neuromodulate said vagus nerve according to at least one of said more than two predetermined programs to provide adjunct therapy for at least one of atrial fibrillation, refractory hypertension, and inappropriate sinus tachycardia.

2. The method of claim 1, wherein said vagus nerve is left vagus nerve.

3. The method of claim 1, wherein said vagus nerve is right vagus nerve.

4. The method of claim 1, wherein said vagus nerve is neuromodulated by means for bipolar stimulation.

5. The method of claim 1, wherein said vagus nerve is neuromodulated by means for unipolar stimulation.

6. The method of claim 1, wherein said external stimulator further comprises a means for patient override mechanism to manually activate said external stimulator.

7. The method of claim 1, wherein said external stimulator further comprising means to manually control said electrical signals to neuromodulate said vagus nerve.

8. The method of claim 1, 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 more than two predetermined programs controls said variable component of said electrical signals.

9. The method of claim 1, wherein said external stimulator further comprises means to modify said more than two predetermined programs to modify said electrical signals.

10. The method of claim 1, wherein said external stimulator further comprises means to lock out at least one of said more than two predetermined programs to the patient.

11. The method of claim 1, wherein a feedback regulation means is used for regulating said electrical signals delivered to said vagus nerve.

12. The method of claim 1, wherein said external stimulator further comprises means for wireless communication over the internet to remotely control said more than two predetermined programs.

13. The method of claim 1, wherein said lead-receiver further comprises a lead body with at least one lumen, a lead body insulation, a conductor.

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

15. A method for providing adjunct (add-on) neuromodulation therapy for at least one of atrial fibrillation, refractory hypertension, and inappropriate sinus tachycardia, comprising the steps of:

a) providing an implantable lead-receiver comprising a secondary coil, and at least one electrode adapted to be in contact with a patient'"'"'s vagus nerve;

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

c) locking out at least one of said more than two predetermined programs to the patient;

d) activating one of said more than two predetermined programs of said external stimulator to emit said electrical signals;

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

whereby said therapy is provided by neuromodulating said vagus nerve.

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

17. The method of claim 15, wherein said vagus nerve is right vagus nerve.

18. The method of claim 15, wherein said vagus nerve is neuromodulated by means for bipolar stimulation.

19. The method of claim 15, wherein said vagus nerve is neuromodulated by means for unipolar stimulation.

20. The method of claim 15, wherein said external stimulator further comprises a means for patient override mechanism to manually activate said external stimulator.

21. The method of claim 15, further comprising means to manually control said electrical signals to neuromodulate said vagus nerve.

22. 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 more than two predetermined programs controls said variable component of said electrical signals.

23. The method of claim 15, wherein said external stimulator further comprises means to modify said more than two predetermined programs to modify said electrical signals.

24. The method of claim 15, further comprises a proximity sensing a means for optimally positioning said primary coil in relation to said secondary coil.

25. The method of claim 15, wherein a feedback regulation means is used for regulating said electrical signals delivered to said vagus nerve.

26. The method of claim 15, wherein said external stimulator further comprises means for wireless communication over the internet to remotely control said more than two predetermined programs.

27. The method of claim 15, wherein said lead-receiver further comprises a lead body with at least one lumen, a lead body insulation, a conductor.

28. A method of providing pulsed electrical stimulation to a cranial nerve of a patient for cardiovascular disorders, comprising the steps of:

a) providing an external stimulator with more than two predetermined programs to control the output of said external srimulator;

b) activating one of said more than two predetermined programs said external stimulator;

c) positioning said primary coil in relation to said secondary with a means for proximity sensing;

d) inductively transferring said electrical signals to an implanted lead-receiver adapted to be in contact with said cranial nerve of a patient,

whereby said pulsed electrical stimulation therapy is provided to a patient.

29. The method of claim 28, further comprising implanting beneath the skin of a patient said lead-receiver in direct electrical contact with said cranial nerve.

30. The method of claim 28, wherein said cranial nerve is vagus nerve.

31. An apparatus for pulsed electrical stimulation therapy for at least one of atrial fibrillation, refractory hypertension, and inappropriate sinus tachycardia comprising:

a) an implantable lead-receiver comprising circuitry, a secondary coil, and at least one electrode adapted to be in contact with a vagus nerve of a patient;

b) an external stimulator comprising a power source, circuitry to emit electrical signals, a computer readable medium encoded with more than two predetermined programs to control said electrical signals, and a primary coil;

c) a proximity sensing mechanism which provides means for optimally positioning said primary coil in relation to said secondary;

d) 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 apparatus provides said pulsed electrical stimulation therapy to a patient.

32. The apparatus of claim 31, wherein said vagus nerve comprises a left vagus nerve.

33. The apparatus of claim 31, wherein said vagus nerve comprises a right vagus nerve.

34. The apparatus of claim 31, said external stimulator further comprising a means for selective operation, whereby said more than two predetermined programs may be selectively operated.

35. The apparatus of claim 31, wherein said external stimulator further comprises means to modify said more than two predetermined programs to modify said electrical signals.

36. The apparatus of claim 31, wherein said apparatus further comprises means to manually activate said more than two predetermined programs.

37. The apparatus of claim 31, wherein said apparatus further comprises a means to provide feedback regulation of said electric signals delivered to said vagus nerve.

38. The apparatus of claim 31, wherein said electrical signals comprises at least one variable component selected from the group consisting of the current amplitude, pulse width, frequency and on-off timing sequence, and said more than two predetermined programs controls said variable component of said electrical signals.

39. The apparatus of claim 31, wherein said vagus nerve is stimulated by means for bipolar stimulation.

40. The apparatus of claim 31, wherein said vagus nerve is stimulated by means for unipolar stimulation.

41. The apparatus of claim 31, further comprises means to lock out at least one of said more than two predetermined to the patient.

42. The apparatus of claim 31, wherein said external stimulator further comprises means for wireless communication over the internet to remotely control said more than two predetermined programs.

43. The apparatus of claim 31, wherein said lead-receiver further comprises a lead body with at least one lumen, a lead body insulation, a conductor.

44. The apparatus of claim 31, wherein said at least one lumen is selected from the group consisting of single, double, triple and coaxial lumens.

45. The apparatus of claim 31, wherein said lead body insulation is selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

46. The apparatus of claim 31, wherein said lead body further comprises a coating selected from the group consisting of lubricious PVP, antimicrobial and anti-inflammatory coatings.

47. The apparatus of claim 31, 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.

48. The apparatus of claim 31, wherein said electrode is selected from the group consisting of spiral electrodes, hydrogel electrodes, steroid eluting electrodes, and standard ball electrodes.

49. An apparatus for providing adjunct (add-on) therapy for at least one of atrial fibrillation, refractory hypertension, and inappropriate sinus tachycardia comprising:

a) an implantable lead-receiver comprising circuitry, a secondary coil, and at least one electrode adapted to be in contact with a vagus nerve of a patient;

b) an external stimulator comprising a power source, circuitry to emit electrical signals, a computer readable medium encoded with more than two predetermined programs to control said electrical signals, and a primary coil;

c) means to lockout at least one of said more than two predetermined programs to the patient;

d) 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 apparatus provides said therapy to a patient.

50. The apparatus of claim 49, wherein said vagus nerve comprises a left vagus nerve.

51. The apparatus of claim 49, wherein said vagus nerve comprises a right vagus nerve.

52. The apparatus of claim 49, wherein said external stimulator further comprises a means for selective operation of said more than two predetermined programs.

53. The apparatus of claim 49, wherein said external stimulator further comprises means to modify said more than two predetermined programs to modify said electrical signals.

54. The apparatus of claim 49, wherein said apparatus further comprises means to manually activate said more than two predetermined programs.

55. The apparatus of claim 49, further comprises a feedback regulation means to regulate said electric signals delivered to said vagus nerve.

56. The apparatus of claim 49, 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 more than two predetermined programs controls said variable component of said electrical signals.

57. The apparatus of claim 49, wherein said vagus nerve is stimulated by means for bipolar stimulation.

58. The apparatus of claim 49, wherein said vagus nerve is stimulated by means for unipolar stimulation.

59. The apparatus of claim 49, wherein said external stimulator further comprises means for wireless communication over the internet to remotely control said more than two predetermined programs.

60. The apparatus of claim 49, wherein said lead-receiver further comprises a lead body with at least one lumen, a lead body insulation, a conductor.

61. The apparatus of claim 49, wherein said at least one lumen is selected from the group consisting of single, double, triple and coaxial lumens.

62. The apparatus of claim 49, wherein said lead body insulation is selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

63. The apparatus of claim 49, wherein said lead body further comprises a coating selected from the group consisting of lubricious PVP, antimicrobial and anti-inflammatory coatings.

64. The apparatus of claim 49, 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.