SPINAL CORD MODULATION FOR INDUCING PARESTHETIC AND ANESTHETIC EFFECTS, AND ASSOCIATED SYSTEMS AND METHODS

• US 20100274312A1
• Filed: 04/22/2010
• Published: 10/28/2010
• Est. Priority Date: 04/22/2009
• Status: Abandoned Application

• Current Assignee: Nevro Corporation
• Original Assignee: Crg Servicing LLC
• Inventors: Parker, Jon, Walker, Andre B., Alataris, Konstantinos
• Application Number:
  US12/765,685
• Publication Number:
  US 20100274312A1
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods are disclosed. A representative method in accordance with an embodiment of the disclosure includes creating a therapeutic effect and a sensation in a patient by delivering to the patient first pulses having a first set of first signal delivery parameters and second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set, and wherein the first pulses, the second pulses or both the first and second pulses are delivered to the patient'"'"'s spinal cord.

Claims

1. A method for treating a patient, comprising:

creating a therapeutic effect and a sensation in a patient by delivering to the patient first pulses having a first set of first signal delivery parameters and second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set, and wherein the first pulses, the second pulses or both the first and second pulses are delivered to the patient'"'"'s spinal cord.

2. The method of claim 1 wherein delivering the first pulses includes delivering bursts of first pulses, and wherein delivering the second pulses includes delivering a single second pulse during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, wherein the first pulses have a first pulse width and the second pulses have a second pulse width greater than the first pulse width.

3. The method of claim 1 wherein delivering the first and second pulses includes delivering the first and second pulses to the same electrode implanted in electrical communication with a target neural population at the patient'"'"'s spinal cord, and wherein delivering the first pulses includes delivering intermittent bursts of first pulses, and wherein delivering the second pulses includes delivering a single second pulse during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, wherein the first pulses have a first pulse width and the second pulses have a second pulse width greater than the first pulse width.

4. The method of claim 1 wherein delivering the first pulses includes delivering bursts of first pulses, and wherein delivering the second pulses includes delivering a burst of second pulses during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, wherein the first pulses have a first pulse width and the second pulses have a second pulse width greater than the first pulse width.

5. The method of claim 1 wherein the first parameter is a first signal frequency and the second parameter is a second signal frequency and wherein the first signal frequency is higher than the second signal frequency.

6. The method of claim 1 wherein the first parameter is a first signal frequency and the second parameter is a second signal frequency and wherein the first signal frequency is in the range of from about 1.5 kHz to about 50 kHz, and the second signal frequency is in the range of from about 2 Hz to about 1.2 kHz.

7. The method of claim 1 wherein creating a therapeutic effect includes creating an anesthetic, non-paresthetic effect, and wherein creating a sensation includes creating a paresthetic effect.

8. A method for treating a patient, comprising:

creating a therapeutic, non-paresthetic effect in a patient by delivering, to a target neural population at the patient'"'"'s spinal cord, first pulses having a first set of first signal delivery parameters; and

creating a sensation in the patient by delivering, to the spinal cord, second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set.

9. The method of claim 8 wherein creating a therapeutic effect includes creating an anesthetic effect.

10. The method of claim 8 wherein creating a sensation includes creating a paresthetic effect.

11. The method of claim 8 wherein delivering the second pulses includes delivering the second pulses to the target neural population.

12. The method of claim 8 wherein delivering the first pulses includes delivering bursts of first pulses, and wherein delivering the second pulses includes delivering a single second pulse during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, wherein the first pulses have a first pulse width and the second pulses have a second pulse width greater than the first pulse width.

13. The method of claim 8 wherein delivering the first and second pulses includes delivering the first and second pulses to the same electrode implanted in electrical communication with the target neural population, and wherein delivering the first pulses includes delivering intermittent bursts of first pulses, and wherein delivering the second pulses includes delivering a single second pulse during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, wherein the first pulses have a first pulse width and the second pulses have a second pulse width greater than the first pulse width.

14. The method of claim 8 wherein delivering the first pulses includes delivering bursts of first pulses, and wherein delivering the second pulses includes delivering a burst of second pulses during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, wherein the first pulses have a first pulse width and the second pulses have a second pulse width greater than the first pulse width.

15. The method of claim 8 wherein the first parameter is a first signal frequency and the second parameter is a second signal frequency and wherein the first signal frequency is higher than the second signal frequency.

16. The method of claim 8 wherein the first parameter is a first signal frequency and the second parameter is a second signal frequency and wherein the first signal frequency is in the range of from about 1.5 kHz to about 50 kHz, and the second signal frequency is in the range of from about 2 Hz to about 1.2 kHz.

17. The method of claim 8 wherein the first parameter is a first pulse width and the second parameter is a second pulse width and wherein the first pulse width is less than the second pulse width.

18. The method of claim 8, further comprising:

fixing an amplitude of the first pulses and preventing the patient from changing the amplitude of the first pulses; and

allowing the patient to change an amplitude of the second pulses.

19. The method of claim 8, further comprising:

increasing an amplitude of the first pulses without creating a patient-detectable sensation;

creating a patient sensation by increasing an amplitude of the second pulses as the amplitude of the first pulses is increased; and

based on patient feedback to the second pulses, changing the first signal delivery parameters.

20. A method for treating a patient, comprising:

creating an anesthetic, non-paresthetic effect in a patient by delivering, to a target neural population at the patient'"'"'s spinal cord, first pulses having a first set of first signal delivery parameters, wherein the anesthetic effect of the first pulses is undetected by the patient and/or produces a reduction or elimination of pain in the patient;

creating a patient-detectable paresthetic effect in the patient concurrent with the anesthetic, non-paresthetic effect by delivering, to the patient'"'"'s spinal cord, second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set; and

based on patient feedback to the second pulses, changing the first signal delivery parameters.

21. The method of claim 20 wherein creating a patient-detectable paresthetic effect includes creating a patient-detectable paresthetic effect with an external trial modulator placed external to the patient, and wherein the method further comprises:

implanting a modulator in the patient; and

programming the implanted modulator to create an anesthetic, non-paresthetic effect in the patient by delivering the first pulses in accordance with the changed first signal delivery parameters.

22. The method of claim 20 wherein delivering the second pulses includes delivering the second pulses to the same target neural population as receives the first pulses.

23. The method of claim 20 wherein the target neural population is a first target neural population and wherein delivering the second pulses includes delivering the second pulses to a second target neural population different than the first target neural population.

24. The method of claim 20 wherein changing the first signal delivery parameters includes changing an amplitude of the first pulses.

25. The method of claim 20 wherein changing the first signal delivery parameters includes changing a position of an electrode delivering the first pulses.

26. The method of claim 20 wherein delivering first pulses includes delivering first pulses from a first electrode of an implanted electrode device, and wherein changing the first signal delivery parameters includes delivering the first pulses from a second electrode spaced apart from the first electrode.

27. The method of claim 20, further comprising identifying the patient as one who receives the anesthetic, non-paresthetic effect when in at least one body position, but not when in at least another body position.

28. The method of claim 20, further comprising obtaining patient feedback as a result of changing strengths of the first and second pulses in a parallel manner.

29. A method for treating a patient, comprising:

creating an anesthetic, non-paresthetic effect in a patient by delivering, to a target neural population at the patient'"'"'s spinal cord, first pulses having a first set of first signal delivery parameters, wherein the anesthetic effect of the first pulses is undetected by the patient and/or produces a reduction or elimination of pain in the patient;

providing an indication of a strength of the first pulses by creating a patient-detectable paresthetic effect in the patient, wherein creating the paresthetic effect includes delivering, to the patient'"'"'s spinal cord, second pulses having a second set of second signal delivery parameters, and wherein a strength of the second pulses is correlated with a strength of the first pulses, and wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set; and

changing the strengths of the first and second pulses in a parallel manner.

30. The method of claim 29 wherein changing the strengths of the pulses includes changing the amplitudes of the pulses.

31. The method of claim 29 wherein changing the strengths of the first and second pulses in a parallel manner includes (a) increasing the strengths concurrently, (b) decreasing the strengths concurrently, or both (a) and (b).

32. The method of claim 29 wherein changing the strengths of the pulses includes changing the strengths of the first and second pulses by the same amount.

33. The method of claim 29 wherein the strengths of the pulses are offset, and wherein changing the strengths of the pulses includes changing the strengths of the pulses by different amounts.

34. The method of claim 29 wherein delivering the first and second pulses includes delivering the first and second pulses to the same target neural population.

35. The method of claim 29 wherein changing the strengths of the first and second pulses includes increasing the strength of the second signal as the strength of the first signal increases, in a concurrent or sequential manner.

36. The method of claim 29 wherein changing the strengths of the pulses includes changing the strengths of the pulses in response to a patient request.

37. A method for treating a patient, comprising:

creating an anesthetic, non-paresthetic effect in a patient by delivering, to a target neural population at the patient'"'"'s spinal cord, first pulses having a first set of first signal delivery parameters, wherein the anesthetic effect of the first pulses is undetected by the patient and/or produces a reduction or elimination of pain in the patient;

creating a patient-detectable paresthetic effect in the patient by delivering, to the patient'"'"'s spinal cord, second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set;

changing amplitudes of the first and second pulses in parallel; and

identifying a fault with the delivery of the first pulses based in least in part on the presence or absence of patient response to the changing amplitude of the second pulses.

38. The method of claim 37 wherein changing the amplitudes of the first and second signals includes changing the amplitudes concurrently.

39. The method of claim 37 wherein identifying a fault is based at least in part on an absence of a patient response.

40. The method of claim 37 wherein identifying a fault is based at least in part on the presence of a patient response.

41. The method of claim 37 wherein changing amplitudes includes increasing amplitudes.

42. The method of claim 37 wherein changing amplitudes includes decreasing amplitudes.

43. The method of claim 37 wherein identifying a fault includes identifying an electrical discontinuity in an electrical path between a pulse generator and a signal delivery electrode.

44. The method of claim 37 wherein identifying a fault includes identifying a signal delivery system as being in an off state.

45. A method for treating a patient, comprising:

creating an anesthetic, non-paresthetic effect in a patient by delivering, to a target neural population at the patient'"'"'s spinal cord, first pulses having a first set of first signal delivery parameters; and

based on a request from the patient, supplementing the anesthetic, non-paresthetic effect in the patient with a patient-detectable paresthetic effect by delivering, to the patient'"'"'s spinal cord, second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set.

46. The method of claim 45 wherein the patient previously received paresthesia-inducing pulses from a first implanted spinal cord modulator, and wherein delivering the first pulses includes delivering the first pulses from a second implanted spinal cord modulator, and wherein supplementing the anesthetic, non-paresthetic effect in the patient with a patient-detectable paresthetic effect includes emulating an effect of the paresthesia-inducing pulses by delivering the second pulses from the second implanted spinal cord modulator.

47. The method of claim 45, further comprising:

fixing an amplitude of the first pulses and preventing the patient from changing the amplitude of the first pulses; and

allowing the patient to change an amplitude of the second pulses.

48. The method of claim 45 wherein providing the first and second pulses includes providing the first and second pulses to the same target neural population.

49. The method of claim 45 wherein providing the first and second pulses includes providing the first and second pulses to different target neural populations.

50. A method for treating a patient, comprising:

in a patient who previously received paresthesia-inducing pulses from a first implanted spinal cord modulator, implanting a second spinal cord modulator; and

using the second spinal cord modulator to;

create an anesthetic, non-paresthetic effect in the patient by delivering first pulses having a first set of first signal delivery parameters to a target neural population at the patient'"'"'s spinal cord; and

create a patient-detectable paresthetic effect in the patient by delivering, to the patient'"'"'s spinal cord, second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set, and wherein the paresthetic effect emulates the paresthesia-inducing pulses from the first implanted spinal cord modulator.

51. The method of claim 50, further comprising removing the first implanted spinal cord modulator from the patient and replacing the first implanted spinal cord modulator with the second spinal cord modulator.

52. The method of claim 50, further comprising:

fixing an amplitude of the first pulses and preventing the patient from changing the amplitude of the first pulses; and

allowing the patient to change an amplitude of the second pulses.

53. A patient treatment system, comprising:

a signal delivery device having a plurality of electrodes configured to be implanted within a patient, proximate to one or more target neural populations at the patient'"'"'s spinal cord;

an implantable pulse generator having a controller programmed with instructions for;

directing first pulses to the signal delivery device to create an anesthetic, non-paresthetic effect in the patient, the first pulses having a first set of first signal delivery parameters; and

directing second pulses to the signal delivery device to create a paresthetic effect in the patient, the second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set.

54. The system of claim 53, further comprising:

an external physician programmer programmed with instructions for adjusting an amplitude of the first pulses; and

an external patient controller programmed with instructions for adjusting an amplitude of the second pulses, and programmed with instructions preventing adjustment of the amplitude of the first pulses.

55. The system of claim 53 wherein the implantable pulse generator further includes instructions for receiving updates to the first signal delivery parameters, independent of updates to the second signal delivery parameters.

56. The system of claim 53 wherein the implantable pulse generator includes instruction for interleaving one or more second pulses between sequential bursts of the first pulses.

57. The system of claim 53 wherein the implantable pulse generator includes instructions for directing the first pulses to a first electrode of the signal delivery device and directing the second pulses to a second electrode of the signal delivery device different that the first electrode.

58. The system of claim 53 wherein the first pulses have a frequency of from about 3 kHz to about 10 kHz, and the second pulses have a frequency of from about 20 Hz to about 1.2 kHz.

59. The system of claim 53 wherein the implantable pulse generator is programmed with instructions for directing the first and second pulses sequentially to the same electrode of the signal delivery device.

60. The system of claim 53 wherein the implantable pulse generator is programmed with instructions for directing the first and second pulses to the same electrode of the signal delivery device, with a single second pulse directed during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, and with the first pulses having a first pulse width and the second pulses having a second pulse width less than the first pulse width, the first pulses being directed at a first frequency, the second pulses being directed at a second frequency less than the first frequency.