SELECTIVE HIGH FREQUENCY SPINAL CORD MODULATION FOR INHIBITING PAIN WITH REDUCED SIDE EFFECTS, AND ASSOCIATED SYSTEMS AND METHODS

• US 20130204321A1
• Filed: 03/14/2013
• Published: 08/08/2013
• 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.
• Granted Patent: US 8,874,221 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• 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 chord modulation for inhibiting pain with reduced side affects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient'"'"'s spinal chord region to address low back pain without creating unwanted sensory and/or motor side affects. 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 method for treating a patient with a spinal modulation system, wherein the spinal modulation system includes a pulse generator and a signal delivery element coupleable to the pulse generator, the method comprising:

subcutaneously implanting the spinal modulation system such that the signal delivery element is positioned to apply to the patient'"'"'s spinal cord region a therapy signal that is generated by the pulse generator;

electrically coupling the signal delivery element to the pulse generator; and

configuring the pulse generator to generate the therapy signal, wherein at least a portion of the therapy signal is

a bi-phasic square-wave having

a frequency in a frequency range of from about 3 kHz to about 20 kHz,

a current amplitude in an amplitude range of from about 0.5 mA to about 4 mA,

a pulse width between about 25 microseconds and about 166 microseconds, and

does not induce paresthesia in the patient.

2. The method of claim 1, wherein the therapy signal is applied to the patient'"'"'s spinal cord region to at least partially reduce the patient'"'"'s sensation of pain.

3. The method of claim 2, wherein the signal deliver element is positioned proximate to the vertebral level between about T9 and about T12.

4. The method of claim 3, wherein at least a portion of the therapy signal is at a frequency of about 10 kHz.

5. The method of claim 4, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle.

6. The method of claim 5, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle from 50%-100%.

7. The method of claim 1, wherein the therapy signal is applied to the patient'"'"'s spinal cord region to at least partially reduce the patient'"'"'s sensation of pain without affecting other neural transmissions.

8. The method of claim 1 wherein electrical contacts carried by the signal delivery element are positioned at an epidural location.

9. A method for treating a patient with a spinal modulation system, wherein the spinal modulation system includes a pulse generator and a signal delivery element coupleable to the pulse generator, the method comprising:

subcutaneously implanting the spinal modulation system such that the signal delivery element is positioned to apply to the patient'"'"'s spinal cord region a therapy signal that is generated by the pulse generator;

electrically coupling the signal delivery element to the pulse generator; and

configuring the pulse generator to generate the therapy signal, wherein at least a portion of the therapy signal is at

a frequency in a frequency range of from about 1.5 kHz to about 100 kHz,

a current amplitude in an amplitude range of from about 0.1 mA to about 6 mA,

a pulse width between about 10 microseconds and about 333 microseconds, and

at least partially reduces the patient'"'"'s sensation of pain without affecting neural transmissions of touch or heat.

10. The method of claim 9, wherein the signal deliver element is located proximate to a vertebral level between about T9 and about T12, and the therapy signal is applied to at least partially reduce the patient'"'"'s sensation of pain.

11. The method of claim 9, wherein the therapy signal is applied without inducing the sensation of paresthesia.

12. The method of claim 9, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle.

13. The method of claim 12, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle from 50%-100%.

14. The method of claim 9, wherein the frequency range is from about 3 kHz to about 20 kHz.

15. The method of claim 9, wherein the frequency range is from about 5 kHz to about 15 kHz.

16. The method of claim 9, wherein at least a portion of the therapy signal is at a frequency of about 10 kHz.

17. The method of claim 16, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle, wherein the therapy signal is at a frequency of about 10 kHz during an on period of the duty cycle.

18. A method for treating a patient with a spinal modulation system, wherein the spinal modulation system includes a pulse generator and a signal delivery element coupleable to the pulse generator, the method comprising:

subcutaneously implanting the spinal modulation system such that the signal delivery element is positioned to apply to the patient'"'"'s spinal cord region a therapy signal that is generated by the pulse generator;

electrically coupling the signal delivery element to the pulse generator; and

configuring the pulse generator to generate the therapy signal,

wherein at least a portion of the therapy signal is at a supratheshold current amplitude and does not induce paresthesia in the patient.

19. The method of claim 18, wherein the therapy signal is applied to the patient'"'"'s spinal cord region to at least partially reduce the patient'"'"'s sensation of pain.

20. The method of claim 19, further comprising:

programming the pulse generator to generate the therapy signal with at least a portion of the therapy signal having a frequency in a frequency range of from about 3 kHz to about 20 kHz.

21. The method of claim 18, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle.

22. The method of claim 18, further comprising:

programming the pulse generator to generate the therapy signal at a duty cycle from 50%-100%.

23. The method of claim 18, wherein the therapy signal is applied to the patient'"'"'s spinal cord region to at least partially reduce the patient'"'"'s sensation of pain without affecting other neural transmissions.

24. A method for treating a patient with a spinal modulation system, wherein the spinal modulation system includes a pulse generator and a signal delivery element coupleable to the pulse generator, the method comprising:

subcutaneously implanting the spinal modulation system such that the signal delivery element is positioned to apply to the patient'"'"'s spinal cord region a non-paresthesia-producing therapy signal that is generated by the pulse generator;

electrically coupling the signal delivery element to the pulse generator; and

configuring the pulse generator to generate the therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range of from about 1.5 kHz to about 100 kHz.

25. The method of claim 24 wherein electrical contacts carried by the signal delivery element are positioned at an epidural location.