Enhancing intrinsic neural activity using a medical device to treat a patient

• US 20070025608A1
• Filed: 07/29/2005
• Published: 02/01/2007
• Est. Priority Date: 07/29/2005
• Status: Abandoned Application

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph
• Application Number:
  US11/193,520
• Publication Number:
  US 20070025608A1
• Time in Patent Office: Days
• US Class Current: 382/132
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A method, system, and an apparatus are provided for providing an electrical neurostimulation therapy to a patient. The method comprises generating an electrical biasing signal defined by a plurality of parameters, at least one of which comprises a random value within a defined range, and applying the electrical biasing signal to a neural structure to bias an intrinsic neural signal on the structure. Neurostimulators and neurostimulation systems are provided for generating such a biasing signal and applying the signal to the neural structure, and include a stimulus generator for generating the signal, one or more electrodes for delivering the signal to a neural structure, and a controller for applying the signal to the electrodes.

Claims

1. A method for providing a neurostimulation therapy to a patient, comprising:

generating an electrical biasing signal comprising a pulsed electrical signal defined by a plurality of parameters including at least one parameter selected from the group consisting of a voltage magnitude, a current magnitude, a pulse width, a pulse period, an on-time and an off-time, and wherein at least one of said voltage magnitude, said current magnitude, said pulse width, said pulse period, said on-time and said off-time comprises a random value that varies within a defined range; and

applying said electrical biasing signal to a neural structure of the patient.

2. The method of claim 1 wherein at least one of said voltage magnitude, said current magnitude, said pulse width, said pulse period, said on-time and said off-time vary randomly within a defined range for each of said parameters, and wherein said defined range for said voltage magnitude comprises a programmed range within the range of −

15.0 volts to 15.0 volts, said defined range for said current magnitude comprises a programmed range within the range of from −

8.0 to 8.0 milliamps, said defined range for said pulse width comprises a programmed range within the range of from 1 microsecond to 1 second, said defined range for said pulse period comprises a programmed range within the range of from 1 microsecond to 1 second, said defined range for said on-time comprises a programmed range within the range of from 1 second to 24 hours, and said defined range for said off-time comprises a programmed range within the range of from 1 second to 24 hours.

3. The method of claim 1, wherein said neural structure of said patient comprises an intrinsic neural signal and said pulsed electrical signal operates either to attenuate an intrinsic neural signal or to amplify an intrinsic neural signal.

4. The method of claim 1, wherein said neural structure of said patient comprises an intrinsic neural signal, said method further comprising:

changing a threshold of interpretation for said intrinsic neural signal to enable the brain of the patient to interpret the intrinsic neural signal in a desired manner, wherein changing a threshold comprises a change selected from the group consisting of raising said threshold of interpretation and lowering said threshold of interpretation.

5. The method of claim 3, wherein said neural structure of said patient comprises an intrinsic neural signal, said method further comprising:

modulating the intrinsic neural signal with said pulsed electrical signal to block transmission of the intrinsic neural signal along said neural structure.

6. The method of claim 3 further comprising, prior to said step of applying said electrical biasing signal to said neural structure:

detecting an intrinsic neural signal on said neural structure.

7. The method of claim 6, further comprising:

comparing said detected intrinsic neural signal to a threshold of intrinsic neural activity, and wherein the electrical biasing signal that is generated depends upon the outcome of said comparing step.

8. The method of claim 1 wherein said defined range for said at least one parameter comprises an upper limit and a lower limit, and wherein at least one of said upper limit and said lower limit is defined based upon a pain threshold of the patient.

9. The method of claim 1 wherein the electrical biasing signal biases an intrinsic neural signal selected from the group consisting of a sub-threshold intrinsic neural signal and a supra-threshold intrinsic neural signal sufficiently to allow said intrinsic neural signal to cross a threshold of interpretation for the brain of the patient.

10. The method of claim 1 further comprising generating a plurality of afferent action potentials on said neural structure to enhance interpretation of the intrinsic neural signal by the brain of the patient.

11. The method of claim 1, wherein said at least one parameter comprises a current magnitude and wherein said current magnitude of said pulses is random and varies within a range within the range of from −

8.0 milliamps to 8.0 milliamps.

12. The method of claim 11, wherein said current magnitude of said pulses is random and varies within a range within the range of from −

3.0 milliamps to 3.0 milliamps.

13. The method of claim 1, wherein said at least one parameter comprises a pulse width and wherein said pulse width of said pulses is random and varies within a range within the range of from 1 microsecond to 1 second.

14. The method of claim 1, wherein said neural structure comprises a cranial nerve of the patient.

15. The method of claim 14, wherein said cranial nerve comprises a vagus nerve.

16. The method of claim 1 wherein said at least one parameter comprises a current magnitude and a pulse width, and wherein said current magnitude comprises a random value that varies within a first defined range and said pulse width comprises a random value that varies within a second defined range.

17. The method of claim 1, wherein said electrical biasing signal comprises a pulsed noise signal.

18. The method of claim 1, wherein said at least one parameter comprises a pulse period and wherein said pulse period of said pulses is random and varies within a range within the range of from 1 microsecond to 1 second.

19. The method of claim 1, wherein said at least one parameter comprises a voltage magnitude and wherein said voltage magnitude of said pulses is random and varies within a range within the range of from −

15.0 volts to 15.0 volts.

20. The method of claim 1, wherein the neural structure comprises a structure within the patient'"'"'s brain.

21. The method of claim 1, wherein the neural structure comprises a spinal cord structure of the patient.

22. The method of claim 1, wherein the neural structure comprises a sympathetic nerve of the patient.

23. The method of claim 1, wherein said at least one parameter comprises an on-time and an off-time, and wherein at least one of said on-time and said off-time comprises a random value that varies within a defined range.

24. The method of claim 23, wherein said on-time is random and varies within a range within the range of from 1 second to 24 hours, and said off-time is random and varies within a range within the range of from 1 second to 24 hours.

25. The method of claim 1 further comprising:

providing at least one electrode;

coupling said at least one electrode to said neural structure;

providing an electrical signal generator;

coupling said electrical signal generator to said at least one electrode;

generating said electrical biasing signal using said electrical signal generator; and

applying said electrical biasing signal to said at least one electrode.

26. The method of claim 1 further comprising a first time interval wherein at least one of said voltage magnitude, said current magnitude, said pulse width, said pulse period, said on-time and said off-time comprises a random value that varies within a defined range, and a second time interval wherein said at least one parameter comprising a random value in said first time interval comprises a non-random value.

27. The method of claim 1 wherein said random value varies within a defined range on a pulse-to-pulse basis.

28. The method of claim 1 wherein said random value varies within a defined range on a burst-to-burst basis.

29. A method of providing a neurostimulation therapy to a patient, comprising:

generating an electrical biasing signal comprising a pulsed electrical signal defined by a plurality of parameters comprising at least a current magnitude, a pulse width, and a pulse period, wherein said pulse period comprises a random value that varies within a defined range; and

applying said electrical biasing signal to a neural structure of the patient.

30. The method of claim 29, further comprising a first time interval wherein said pulse period comprises a random value that varies within a defined range, and a second time interval wherein said pulse period comprises a non-random value.

31. The method of claim 29 wherein said pulse period comprises a random value that varies within a defined range on a pulse-to-pulse basis.

32. The method of claim 29 wherein said current magnitude comprises a constant magnitude.

33. The method of claim 29 wherein said current magnitude comprises a random value that varies within a defined range.

34. The method of claim 29 wherein said pulse width comprises a random value that varies within a defined range.

35. The method of claim 29, wherein said electrical biasing signal comprises a continuous electrical signal.

36. The method of claim 29, wherein said pulsed electrical signal further comprises an on-time and an off-time, and wherein said on-time and said off-time may comprise a random value or a constant value.

37. The method of claim 29 wherein said neural structure comprises an intrinsic neural signal and wherein said method further comprises detecting said intrinsic neural signal on said neural structure.

38. The method of claim 37, further comprising:

comparing said detected intrinsic neural signal to a threshold of intrinsic neural activity;

wherein said pulsed electrical signal further comprises an on-time and an off-time, said on-time and said off-time each comprising one of a random value that varies within a defined range and a constant value;

and wherein at least one of said on-time and said off-time depends upon the outcome of said comparing step.

39. A method of providing a neurostimulation therapy to a patient, comprising:

generating an electrical biasing signal comprising a pulsed electrical signal defined by a plurality of parameters comprising a constant current magnitude, a constant pulse width, an on-time and an off-time, wherein at least one of said on-time and said off-time comprises a random value that varies within a defined range; and

applying said electrical biasing signal to a neural structure of a patient.

40. The method of claim 39, further comprising a first time interval wherein at least one of said on-time and said off-time comprises a random value that varies within a defined range, and a second time interval wherein said on-time and said off-time comprises a non-random value.

41. The method of claim 39 wherein said on-time comprises a random value that varies within a first defined range, and said off-time comprises a random value that varies within a second defined range.

42. The method of claim 39, wherein said plurality of parameters further comprises a frequency selected from the group consisting of a controlled frequency, a random frequency within a defined frequency range, or a swept frequency within a defined range.

43. The method of claim 39, wherein said plurality of parameters further comprises a pulse period selected from the group consisting of a controlled pulse period and a random pulse period that varies within a defined range.

44. A method of providing a neurostimulation therapy to a patient, comprising:

generating an electrical biasing signal comprising an electrical signal defined by a plurality of parameters comprising a current magnitude and at least one of an on-time and an off-time, wherein at least one of said current magnitude, said on-time and said off-time comprises a random value that varies within a defined range; and

applying said electrical biasing signal to a neural structure of the patient.

45. The method of claim 44 further comprising a first time interval wherein at least one of said current magnitude, said on-time and said off-time comprises a random value that varies within a defined range, and a second time interval wherein said at least one parameter comprising a random value in said first time interval comprises a non-random value.

46. The method of claim 44, wherein said electrical signal comprises a non-pulsed electrical signal.

47. The method of claim 44, wherein said electrical signal comprises a charge-balanced electrical signal.

48. The method of claim 44, wherein said electrical biasing signal comprises a noise signal having a random current magnitude that varies within a range within the range of from −

8.0 to 8.0 milliamps.

49. The method of claim 44, wherein said on-time is random and varies within a range within the range of from 1 second to 24 hours, and wherein said off-time is random and varies within a range within the range of from 1 second to 24 hours.

50. A method of providing a neurostimulation therapy to a patient, comprising:

generating an electrical biasing signal comprising a non-pulsed, continuous electrical signal defined by at least a current magnitude, wherein said current magnitude is random and varies within a range within the range of from −

8.0 to 8.0 milliamps; and

applying said electrical biasing signal to a neural structure of the patient.

51. A method of providing a neurostimulation therapy to a patient, comprising:

generating an electrical biasing signal comprising an electrical noise signal; and

applying said electrical biasing signal to a neural structure of the patient selected from the group consisting of a cranial nerve, a brain structure, a spinal cord structure, and a sympathetic nerve structure.

52. The method of claim 51, wherein said electrical noise signal comprises a noise signal selected from the group consisting of a zero-mean, pseudo-random, or Gaussian noise signal.