Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods

• US 10,245,433 B2
• Filed: 08/07/2015
• Issued: 04/02/2019
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Alataris, Konstantinos, Walker, Andre B., Parker, Jon, Chitre, Yougandh, Park, Sangsoo Wesley, Thacker, James R.
• Primary Examiner(s): Wu, Eugene T
• Application Number:
  US14/821,405
• Publication Number:
  US 20150343220A1
• Time in Patent Office: 1,334 Days
• Field of Search: 607 2, 607 46, 607115-117, 607154
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36089 Addiction or withdrawal from substance abuse such as alcohol or drugs
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 : providing test stimulations
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: G01R 21/133 : by using digital technique

Abstract

A spinal cord modulation system is disclosed. While in one embodiment the system is used for the treatment of pain, other embodiments are also provided. In particular embodiments, the spinal cord modulation system generates and delivers an electrical therapy signal at a frequency in the range of from about 1.5 kHz to about 100 kHz to address pain without creating unwanted sensory and/or motor side effects. The system may further include various signal delivery devices to deliver the therapy signal to a patient'"'"'s spinal cord region.

Claims

1. A spinal cord modulation system, comprising:

an implantable signal generator having a machine-readable medium containing instructions that, when executed, generate a therapy signal having a frequency between 1.5 kHz and 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 30 microseconds and 35 microseconds; and

an implantable signal delivery device coupleable to the implantable signal generator and designed to be implanted within a patient'"'"'s epidural space to deliver the therapy signal from the implantable signal generator to the patient'"'"'s spinal cord.

2. The system of claim 1, wherein the current amplitude is 2.5 mA.

3. The system of claim 1, wherein the frequency is between 3 kHz and 10 kHz.

4. The system of claim 1, wherein the frequency is 8 kHz.

5. The system of claim 1, wherein the frequency is 9 kHz.

6. The system of claim 1, wherein the frequency is 10 kHz.

7. The system of claim 1, wherein the therapy signal includes a plurality of biphasic pulses.

8. The system of claim 1, wherein the machine-readable medium contains instructions that, when executed, deliver the therapy signal at a duty cycle.

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

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

11. A spinal cord modulation system, comprising:

an implanted signal generator programmed to generate a therapy signal having a plurality of biphasic pulses with a frequency between 1.5 kHz and 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 30 microseconds and 35 microseconds; and

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

12. The system of claim 11, wherein the amplitude is between 2 mA and 3.5 mA.

13. The system of claim 11, wherein the frequency is between 3 kHz and 10 kHz.

14. The system of claim 11, wherein the frequency is 8 kHz.

15. The system of claim 11, wherein the frequency is 9 kHz.

16. The system of claim 11, wherein the frequency is 10 kHz.

17. The system of claim 11, further comprising:

a physician'"'"'s programmer in wireless communication with the signal generator and having a machine-readable medium containing instructions that, when executed, select the amplitude of the therapy signal.

18. The system of claim 11, wherein the implantable signal delivery device is a percutaneous lead.

19. The system of claim 11, wherein the implantable signal delivery device is a paddle lead.

20. A spinal cord modulation system, comprising:

an implantable signal generator having a signal generator machine-readable medium containing instructions to generate a therapy signal with at least three signal parameter, including;

(i) a frequency between 1.5 kHz and 10 kHz,

(ii) pulse widths between 30 microseconds and 35 microseconds, and

(iii) a current amplitude between 0.5 mA and 4 mA;

an implantable signal delivery device coupleable to the signal generator and designed to be implanted in the patient'"'"'s epidural space to deliver the therapy signal from the implantable signal generator to the patient'"'"'s spinal cord; and

a programmer wirelessly coupleable to the implantable signal generator and having a programmer machine-readable medium containing instructions that, when executed, program at least one of the signal parameters.

21. The system of claim 20, wherein the current amplitude is between 2 mA and 3.5 mA.

22. The system of claim 20, wherein the frequency is between 3 kHz and 10 kHz.

23. The system of claim 20, wherein the frequency is 8 kHz.

24. The system of claim 20, wherein the frequency is 9 kHz.

25. The system of claim 20, wherein the frequency is 10 kHz.

26. A spinal cord modulation system, comprising:

an implantable signal generator programmable to generate a therapy signal in accordance with one or more therapy signal parameters;

an implantable signal delivery device electrically coupleable to the implantable signal generator and designed to be implanted in a patient'"'"'s epidural space to deliver the therapy signal to the patient'"'"'s spinal cord; and

a programmer wirelessly coupleable to the implantable signal generator and having a programmer machine-readable medium containing instructions to program the one or more therapy signal parameters in the implantable signal generator,

wherein the one or more therapy signal parameters include

(i) a frequency in a frequency range from 1.5 kHz to 10 kHz,

(ii) an amplitude between 0.5 mA and 4 mA, and

(iii) pulse widths between 30 microseconds and 35 microseconds.

27. The system of claim 26, wherein the amplitude is between 2 mA and 3.5 mA.

28. The system of claim 26, wherein the pulse widths are 30 microseconds.

29. The system of claim 26, wherein the frequency range is from 3 kHz to 10 kHz.

30. The system of claim 26, wherein the frequency is 8 kHz.

31. The system of claim 26, wherein the frequency is 9 kHz.

32. The system of claim 26, wherein the frequency is 10 kHz.

33. The system of claim 26, wherein the implantable signal generator includes a signal generator machine-readable medium with instructions that, when executed, (i) generate the therapy signal in accordance with instructions received from the programmer, and (ii) deliver the therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device.

34. A spinal cord modulation system, comprising:

a signal generator programmed to generate a therapy signal having a frequency of 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulses having a pulse width between 30 microseconds and 35 microseconds; and

a signal delivery device electrically coupled to the signal generator and designed to deliver the therapy signal from the signal generator to a patient'"'"'s spinal cord when implanted in the patient'"'"'s epidural space.

35. The system of claim 34, wherein the therapy signal includes a plurality of biphasic pulses.

36. The system of claim 34, further comprising:

a physician'"'"'s programmer in wireless communication with the signal generator and having a machine-readable medium containing instructions that, when executed, select the amplitude of the therapy signal.

37. The system of claim 34, wherein the signal delivery device is a percutaneous lead.

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

39. A spinal cord modulation system, comprising:

an implantable signal generator having a machine-readable medium containing instructions that, when executed, generate and deliver a therapy signal with a frequency of 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 30 microseconds and 35 microseconds; and

an implantable signal delivery device coupleable to the implantable signal generator and designed to be implanted within a patient'"'"'s epidural space to deliver the therapy signal from the implantable signal generator to the patient'"'"'s spinal cord.

40. The system of claim 39, wherein the therapy signal includes a plurality of biphasic pulses.

41. The system of claim 39, wherein the machine-readable medium contains instructions that, when executed, deliver the therapy signal at a duty cycle.

42. The system of claim 39, wherein the implantable signal delivery device is a percutaneous lead.

43. The system of claim 39, wherein the implantable signal delivery device is a paddle lead.

44. A spinal cord modulation system, comprising:

an implantable signal generator having a machine-readable medium containing instructions that, when executed, generate and deliver a therapy signal with a frequency of 10 kHz, pulses with pulse widths between 30 microseconds and 35 microseconds, and a current amplitude between 0.5 mA and 4 mA;

an implantable signal delivery device coupleable to the implantable signal generator and designed to be implanted in the patient'"'"'s epidural space to deliver the therapy signal from the implantable signal generator to the patient'"'"'s spinal cord; and

a programmer designed to wirelessly communicate with the implantable signal generator to select at least the amplitude of the therapy signal.

45. The system of claim 44, wherein the current amplitude is between 2 mA and 3.5 mA.

46. A spinal cord modulation system, comprising:

an implantable signal generator programmed to generate a therapy signal having a plurality of biphasic pulses with pulse widths between 30 microseconds and 35 microseconds and a frequency of 10 kHz;

an implantable signal delivery device electrically coupleable to the implantable signal generator and designed to be implanted in a patient'"'"'s epidural space to deliver the therapy signal from the implantable signal generator to the patient'"'"'s spinal cord; and

a programmer wirelessly coupleable to the implantable signal generator and having a machine-readable medium containing instructions that, when executed, select an amplitude of the therapy signal between 0.5 mA and 4 mA to program into the implantable signal generator, and communicate the selected amplitude to the implantable signal generator.

47. The system of claim 46, wherein the amplitude is between 2 mA and 3.5 mA.