Spinal cord modulation for inhibiting pain via short pulse width waveforms, and associated systems and methods

• US 10,149,978 B1
• Filed: 11/06/2014
• Issued: 12/11/2018
• Est. Priority Date: 11/07/2013
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Park, Sangsoo Wesley
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US14/534,769
• Time in Patent Office: 1,496 Days
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

Short pulse width spinal cord modulation for inhibiting pain with reduced side effects and associated systems and methods are disclosed. In particular embodiments, modulation signal has pulse widths in the range of from about 10 microseconds to about 50 microseconds may be applied to the patient'"'"'s spinal cord region to address chronic pain without using paresthesia or tingling to mask or cover the patient'"'"'s sensation of pain. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications.

Claims

1. A spinal cord stimulation system for reducing or eliminating pain in a patient, the system comprising:

an implantable signal generator having a computer-readable medium with instructions to generate and transmit a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 1,200 Hz, with a pulse width in a pulse width range from 30 microseconds to 35 microseconds, and a current amplitude in a current amplitude range from 1 to 5 mA; and

a signal delivery device electrically coupled to the implantable signal generator and designed to be implanted in the patient'"'"'s epidural space to deliver the therapy signal to the dorsal column of the patient'"'"'s spinal cord.

2. The system of claim 1, wherein the implantable signal generator generates the therapy signal at a duty cycle.

3. The system of claim 2, wherein the duty cycle is 100%.

4. The system of claim 2, wherein the duty cycle is 50-100%.

5. The system of claim 2, wherein the frequency is applied throughout the length of an on period in the duty cycle.

6. The system of claim 2, wherein the frequency is applied during a portion of an on period in the duty cycle.

7. The system of claim 1, wherein the therapy signal is delivered at a current amplitude of about 2.5 mA.

8. The system of claim 1, wherein at least a portion of the therapy signal is a square-wave signal.

9. The system of claim 1, wherein the signal delivery device is a percutaneous lead.

10. The system of claim 1, wherein the signal delivery device is a paddle lead.

11. The system of claim 1, wherein the signal delivery device is an elongated lead having one or more electrodes.

12. The system of claim 1, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.

13. A spinal cord stimulation system for reducing or eliminating pain in a patient, the system comprising:

an implantable signal generator programmed to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 1,200 Hz, with a pulse width in a pulse width range from 10 microseconds to 50 microseconds, and a current amplitude in a current amplitude range from 0.1 mA to 3 mA; and

a signal delivery device electrically coupled to the implantable signal generator to deliver the therapy signal to the dorsal column of the patient'"'"'s spinal cord.

14. The system of claim 13, wherein the implantable signal generator generates the therapy signal at a duty cycle.

15. The system of claim 14, wherein the duty cycle is 100%.

16. The system of claim 14, wherein the duty cycle is 50-100%.

17. The system of claim 14, wherein the frequency is applied throughout the length of an on period in the duty cycle.

18. The system of claim 14, wherein the frequency is applied during a portion of an on period in the duty cycle.

19. The system of claim 13, wherein the therapy signal is delivered at a current amplitude of 2.5 mA.

20. The system of claim 13, wherein at least a portion of the therapy signal is a square-wave signal.

21. The system of claim 13, wherein the signal delivery device is a percutaneous lead.

22. The system of claim 13, wherein the signal delivery device is a paddle lead.

23. The system of claim 13, wherein the signal delivery device is an elongated lead having one or more electrodes.

24. The system of claim 13, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.

25. A spinal cord stimulation system for reducing or eliminating pain in a patient, the system comprising:

an implantable signal generator programmed to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 1,200 Hz, with a pulse width in a pulse width range from 10 microseconds to 50 microseconds, and a current amplitude in a current amplitude range from 0.5 mA to 7 mA; and

a signal delivery device electrically coupled to the implantable signal generator to deliver the therapy signal to the dorsal column of the patient'"'"'s spinal cord.

26. The system of claim 25, wherein the implantable signal generator generates the therapy signal at a duty cycle.

27. The system of claim 26, wherein the duty cycle is 100%.

28. The system of claim 26, wherein the duty cycle is 50-100%.

29. The system of claim 26, wherein the frequency is applied throughout the length of an on period in the duty cycle.

30. The system of claim 26, wherein the frequency is applied during a portion of an on period in the duty cycle.

31. The system of claim 25, wherein the therapy signal is delivered at a current amplitude of 2.5 mA.

32. The system of claim 25, wherein at least a portion of the therapy signal is a square-wave signal.

33. The system of claim 25, wherein the signal delivery device is a percutaneous lead.

34. The system of claim 25, wherein the signal delivery device is a paddle lead.

35. The system of claim 25, wherein the signal delivery device is an elongated lead having one or more electrodes.

36. The system of claim 25, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.

37. A method for reducing or eliminating pain in a patient, without causing paresthesia in the patient, the method comprising:

programming a computer-readable medium of an implanted signal generator to;

generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 1,200 Hz, with a pulse width in a pulse width range from 30 microseconds to 35 microseconds, and a current amplitude in a current amplitude range from 1 to 5 mA; and

transmit the therapy signal to the dorsal column of the patient'"'"'s spinal cord via a signal delivery device implanted in the patient'"'"'s epidural space and electrically coupled to the implanted signal generator.

38. The method of claim 37, wherein generating the therapy signal includes generating the therapy signal at a duty cycle.

39. The method of claim 38, wherein the duty cycle is 100%.

40. The method of claim 38, wherein the duty cycle is 50-100%.

41. The method of claim 38, wherein the frequency is applied throughout the length of an on period in the duty cycle.

42. The method of claim 38, wherein the frequency is applied during a portion of an on period in the duty cycle.

43. The method of claim 37, wherein the therapy signal is generated at a current amplitude of about 2.5 mA.

44. The method of claim 37, wherein at least a portion of the therapy signal is a square-wave signal.

45. The method of claim 37, wherein the signal delivery device is a percutaneous lead.

46. The method of claim 37, wherein the signal delivery device is a paddle lead.

47. The method of claim 37, wherein the signal delivery device is an elongated lead having one or more electrodes.

48. The method of claim 37, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.