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

• US 10,220,209 B2
• Filed: 04/05/2016
• Issued: 03/05/2019
• 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:
  US15/091,527
• Publication Number:
  US 20160287888A1
• Time in Patent Office: 1,064 Days
• 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

Selective high-frequency spinal cord modulation for inhibiting pain with reduced side effects and associated systems and methods are disclosed. In particular embodiments, a programmer has a computer-readable medium containing executable instructions in memory to, in response to an input, select between at least two therapy programs: a first having a frequency of less than 1,500 Hz, and a paresthesia-inducing amplitude between 3 mA and 10 mA; and a second having a frequency between 5 kHz and 15 kHz, and a non-paresthesia-inducing amplitude between 0.5 mA and 10 mA.

Claims

1. A programmer for use in a spinal cord stimulation system, wherein the spinal cord stimulation system includes a signal generator programmable to generate an electrical therapy signal, and an implantable signal delivery device electrically coupleable to the signal generator to receive the electrical therapy signal from the signal generator and deliver the electrical therapy signal to the patient'"'"'s spinal cord, the programmer comprising:

a computer-readable memory having executable instructions to;

(i) in response to an input, select between at least two therapy programs,

wherein therapy signal parameters for a first of the therapy programs include a frequency of less than 1,500 Hz, and a paresthesia-inducing first amplitude between 3 mA and 10 mA, and

wherein therapy signal parameters for a second of the therapy programs include a frequency in a frequency range from 5 kHz to 15 kHz, a pulse width in a pulse width range from 10 microseconds to 333 microseconds, and a non-paresthesia-inducing second amplitude in an amplitude range from 0.5 mA to 10 mA; and

(ii) direct the signal generator to generate and deliver a therapy signal in accordance with the selected therapy program to a target location in a patient'"'"'s spinal cord via at least one electrode of the implantable signal delivery device.

2. The programmer of claim 1, wherein:

the input is a first input;

in response to the first input, the executable instructions select the first therapy program;

in response to a second input, the executable instructions select the second therapy program; and

signals delivered in accordance with the first and second programs do not overlap temporally with each other.

3. The programmer of claim 1, wherein the therapy signal parameters for the first therapy program include a first electrode having a position stored in memory as corresponding to a first target location for the paresthesia-inducing electrical therapy signal, and the therapy signal parameters for the second therapy program include a second electrode having a position stored in memory as corresponding to a second target location for the non-paresthesia-inducing electrical therapy signal.

4. The programmer of claim 3, wherein the first electrode and the second electrode are the same.

5. The programmer of claim 1, wherein the at least one electrode has a position stored in memory as corresponding to a thoracic vertebral level in the patient.

6. The programmer of claim 5, wherein the at least one electrode has a position stored in memory as corresponding to a thoracic vertebral level between T9 and T12, inclusively.

7. The programmer of claim 1, wherein the second amplitude is in an amplitude range from 1 mA to 6 mA.

8. The programmer of claim 1, wherein the second amplitude is in an amplitude range from 0.5 mA to 4 mA.

9. The programmer of claim 1, wherein the second amplitude is in an amplitude range from 1 mA to 4 mA.

10. The programmer of claim 1, wherein the second amplitude is in an amplitude range from 2 mA to 3.5 mA.

11. The programmer of claim 1, wherein the pulse width is in a pulse width range from 25 microseconds to 166 microseconds.

12. The programmer of claim 1, wherein the pulse width is in a pulse width range from 30 microseconds to 35 microseconds.

13. The programmer of claim 1, further comprising the signal generator, and wherein the signal generator is implantable.

14. A programmer for use in a spinal cord stimulation system, wherein the spinal cord stimulation system includes a signal generator programmable to generate an electrical therapy signal, and an implantable signal delivery device electrically coupleable to the signal generator to receive the electrical therapy signal from the signal generator and deliver the electrical therapy signal to the patient'"'"'s spinal cord, the programmer comprising:

a computer-readable memory having executable instructions to;

(i) in response to an input, select between at least two therapy programs;

wherein therapy signal parameters for a first of the therapy programs include a first frequency of less than 1,500 Hz, and a paresthesia-inducing first amplitude between 3 mA and 10 mA, and

wherein therapy signal parameters for a second of the therapy programs include a second frequency of 10 kHz, a pulse width in a pulse width range from 10 microseconds to 333 microseconds, and a non-paresthesia-inducing second amplitude in an amplitude range from 0.5 mA to 10 mA; and

(ii) direct the signal generator to generate and deliver a therapy signal in accordance with the selected therapy program to a target location in a patient'"'"'s spinal cord via at least one electrode of the implantable signal delivery device.

15. The programmer of claim 14, wherein:

the input is a first input;

in response to the first input, the executable instructions select the first therapy program;

in response to a second input, the executable instructions select the second therapy program; and

signals delivered in accordance with the first and second programs do not overlap temporally with each other.

16. The programmer of claim 14, wherein the therapy signal parameters for the first therapy program include a first electrode having a position stored in memory as corresponding to a first target location for the paresthesia-inducing electrical therapy signal, and the therapy signal parameters for the second therapy program include a second electrode having a position stored in memory as corresponding to a second target location for the non-paresthesia-inducing electrical therapy signal.

17. The programmer of claim 16, wherein the first electrode and the second electrode are the same.

18. The programmer of claim 14, wherein the at least one electrode has a position stored in memory as corresponding to a thoracic vertebral level in the patient.

19. The programmer of claim 18, wherein the at least one electrode has a position stored in memory as corresponding to a thoracic vertebral level between T9 and T12, inclusively.

20. The programmer of claim 14, wherein the first amplitude is in an amplitude range from 3 mA to 10 mA.

21. The programmer of claim 14, wherein the second amplitude is in an amplitude range from 1 mA to 6 mA.

22. The programmer of claim 14, wherein the second amplitude is in an amplitude range from 0.5 mA to 4 mA.

23. The programmer of claim 14, wherein the second amplitude is in an amplitude range from 1 mA to 4 mA.

24. The programmer of claim 14, wherein the second amplitude is in an amplitude range from 2 mA to 3.5 mA.

25. The programmer of claim 14, wherein the pulse width is in a pulse width range from 25 microseconds to 166 microseconds.

26. The programmer of claim 14, wherein the pulse width is in a pulse width range from 30 microseconds to 35 microseconds.

27. The programmer of claim 14, further comprising the signal generator, and wherein the signal generator is implantable.