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

• US 10,463,857 B2
• Filed: 10/23/2014
• Issued: 11/05/2019
• 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:
  US14/522,500
• Publication Number:
  US 20150051664A1
• Time in Patent Office: 1,839 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 5 kHz to about 15 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:

at least one machine-readable memory containing therapy signal parameters, including;

(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;

a signal generator for generating a therapy signal in accordance with the therapy signal parameters; and

an implantable signal delivery device implantable in a patient'"'"'s epidural space and operatively coupleable to the signal generator to deliver the therapy signal from the signal generator to the patient'"'"'s spinal cord.

2. The system of claim 1, wherein the amplitude is between 2 mA and 3.5 mA.

3. The system of claim 1, wherein the pulses are square wave pulses.

4. The system of claim 1, wherein the therapy signal parameters include a duty cycle.

5. The system of claim 4, wherein the duty cycle is from 50% to 100%.

6. The system of claim 4, wherein the duty cycle is 70%.

7. The system of claim 4, wherein the duty cycle is other than 50% to 100%.

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

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

10. The system of claim 1, further comprising:

a programmer in wireless communication with the signal generator and having a programmer machine-readable memory containing instructions that, when executed, allow a practitioner and/or a patient to select the amplitude of the therapy signal.

11. A spinal cord modulation system, comprising:

a machine-readable memory containing therapy signal parameters, including;

(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;

an implantable signal generator for generating a therapy signal in accordance with the therapy signal parameters; and

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

12. The system of claim 11, wherein the current amplitude is 2.5 mA.

13. The system of claim 11, wherein the therapy signal includes a plurality of biphasic pulses.

14. The system of claim 13, wherein the pulses are square wave pulses.

15. The system of claim 11, wherein the therapy signal parameters include a duty cycle.

16. The system of claim 15, wherein the duty cycle is from 50% to 100%.

17. The system of claim 15, wherein the duty cycle is 70%.

18. The system of claim 15, wherein the duty cycle is other than 50% to 100%.

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

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

21. A spinal cord modulation system, comprising:

a machine-readable memory containing therapy signal parameters, including;

(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;

a signal generator for generating a therapy signal in accordance with the therapy signal parameters;

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

a programmer wirelessly coupleable to the signal generator to communicate instructions to the signal generator.

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

23. The system of claim 21, wherein the machine-readable memory is carried by the signal generator and includes instructions that, when executed, (i) generate the therapy signal in accordance with input received from the programmer, and (ii) deliver the therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device.

24. A spinal cord modulation system, comprising:

a machine-readable memory containing therapy signal parameters, including;

(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;

an implantable signal generator for generating a therapy signal in accordance with the therapy signal parameters;

an implantable signal delivery device implantable in a patient'"'"'s epidural space and coupleable to the implantable signal generator 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.

25. The system of claim 24, wherein the current amplitude is between 2 mA and 3.5 mA.

26. A spinal cord modulation system, comprising:

a machine-readable memory containing therapy signal parameters, including;

(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;

a signal generator for generating a therapy signal having a plurality of biphasic pulses in accordance with the therapy signal parameters; and

an implantable delivery device implantable in a patient'"'"'s epidural space and operatively coupleable to the signal generator to deliver the therapy signal from the signal generator to the patient'"'"'s spinal cord.

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 implantable signal delivery device is a percutaneous lead.

29. The system of claim 26, wherein the implantable signal delivery device is a paddle lead.

30. The system of claim 26, further comprising:

a programmer in wireless communication with the signal generator and having a programmer machine-readable memory containing instructions that, when executed, allow a practitioner and/or a patient to select the amplitude of the therapy signal.