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

• US 8,880,177 B2
• Filed: 01/24/2014
• Issued: 11/04/2014
• 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): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US14/164,057
• Publication Number:
  US 20140142656A1
• Time in Patent Office: 284 Days
• Field of Search: 607/2, 607/46, 607115-117
• 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 cord modulation for inhibiting pain with reduced side effects 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 cord region to address low back pain without creating unwanted sensory and/or motor side effects. 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 configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord, to at least partially alleviate a patient'"'"'s sensation of pain, without using paresthesia or tingling to mask the patient'"'"'s sensation of pain, wherein the spinal cord modulation system includes

an implantable signal delivery device for implantation proximate to a vertebral level in a range of from T9 to T12, inclusive and

a therapy signal generator electrically coupleable to the implantable signal delivery device and programmable to generate and deliver a therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device,

the method comprising:

programming the therapy signal generator to generate a non-paresthesia-producing therapy signal, wherein the therapy signal is a bi-phasic square-wave having

(i) pulses with pulse widths between 25 microseconds and 166 microseconds, and

(ii) a current amplitude in an amplitude range of from 0.5 mA to 10 mA.

2. The method of claim 1, wherein the pulse widths are between 30 microseconds and 35 microseconds.

3. The method of claim 1, further comprising:

programming the therapy signal generator to deliver the therapy signal to the patient'"'"'s spinal cord at a vertebral level between T9 and T10, inclusive.

4. The method of claim 3, further comprising:

programming the therapy signal generator to generate the therapy signal with a frequency in a frequency range from 3 kHz to 20 kHz.

5. The method of claim 4, further comprising:

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

6. The method of claim 1, wherein the therapy signal is at a current amplitude that at least partially reduces the patient'"'"'s sensation of pain without affecting neural transmissions of touch or heat.

7. The method of claim 1, wherein the therapy signal is at a frequency of 10 kHz.

8. A method for configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord, to at least partially alleviate a patient'"'"'s sensation of pain, without using a paresthesia mapping procedure to mask the patient'"'"'s sensation of pain, wherein the spinal cord modulation system includes

an implantable signal delivery device for implantation proximate to the patient'"'"'s spinal cord, wherein the implantable signal delivery device includes a plurality of electrical contacts, and

a signal generator adapted to be electrically coupled to the implantable signal delivery device, to generate a therapy signal, and to deliver the therapy signal to the patient'"'"'s spinal cord via at least two of the plurality of electrical contacts, the method comprising:

programming the signal generator to

(a) generate a non-paresthesia-producing therapy signal, wherein the therapy signal is a bi-phasic square wave and

(i) has a current amplitude in an amplitude range of from 0.5 mA to 10 mA,

(ii) includes pulses with pulse widths between 25 microseconds and 166 microseconds, and

(iii) at least partially reduces a sensation of pain in the patient, and

(b) deliver the therapy signal via at least two electrical contacts of the implantable signal delivery device without generating the sensation of paresthesia in the patient.

9. The method of claim 8, wherein the pulse widths are between 30 microseconds and 35 microseconds.

10. The method of claim 8, wherein the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz.

11. The method of claim 8, wherein the therapy signal is delivered to a target location of the patient'"'"'s spinal cord at a vertebral level between T9 and T10, inclusive, and the therapy signal at least partially reduces a sensation of pain in the patient'"'"'s lower back and/or leg.

12. The method of claim 8, wherein the therapy signal is delivered to a target location of the patient'"'"'s spinal cord at a thoracic vertebral level, and the therapy signal at least partially reduces a sensation of pain in the patient associated with shingles.

13. The method of claim 8, wherein the therapy signal is delivered to a target location in the patient'"'"'s spinal cord at a vertebral level between C3 and C7, inclusive, and the therapy signal at least partially reduces a sensation of pain in the patient associated with chronic regional pain syndrome.

14. The method of claim 8, wherein the therapy signal is at a frequency of 10 kHz.

15. The method of claim 8, wherein the current amplitude range is between 0.5 mA and 4 mA.

16. A method for configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord without using paresthesia or tingling to mask the patient'"'"'s sensation of pain, and/or without performing a paresthesia mapping procedure to mask the patient'"'"'s sensation of pain, wherein the spinal cord modulation system includes

an implantable signal delivery device, and

a signal generator electrically coupled to the implantable signal delivery device, the method comprising:

programming the signal generator to

(a) generate a therapy signal, wherein the therapy signal is a bi-phasic square wave having pulses with pulse widths between 25 microseconds and 166 microseconds, and a current amplitude that at least partially reduces a sensation of pain in the patient without generating paresthesia, and

(b) deliver the therapy signal to a location in the patient'"'"'s spinal cord, via the implantable signal delivery device.

17. The method of claim 16, wherein the implantable signal delivery device is percutaneously implanted proximate to the patient'"'"'s spinal cord.

18. The method of claim 16, wherein the programming is performed without the patient reporting whether or not

(1) pain reduction is achieved while in an operating room, or

(2) a sensation of paresthesia at least partially masks the sensation of pair, or

(3) both (1) and (2).

19. The method of claim 16, wherein the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz.

20. The method of claim 16, further comprising:

programming the signal generator to generate the therapy signal with a frequency of 10 kHz.

21. The method of claim 20, further comprising:

programming the signal generator to apply the therapy signal at a duty cycle.

22. A method for configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord for reducing or eliminating pain in the patient without using paresthesia or tingling to mask the patient'"'"'s sensation of pain, wherein the spinal cord modulation system includes

an implantable signal delivery device, and

a signal generator electrically coupled to the implantable signal delivery device,

the method comprising:

programming the signal generator to

(a) generate a non-paresthesia-producing therapy signal, wherein the therapy signal is a biphasic square wave having pulses with pulse widths between 25 microseconds and 166 microseconds, and

(b) deliver the therapy signal to a location in the patient'"'"'s spinal cord, via the implantable signal delivery device, without using paresthesia mapping to identify said location.

23. The method of claim 22, wherein the programming is performed without the patient reporting whether or not

(1) pain reduction is achieved while in an operating room, or

(2) a sensation of paresthesia at least partially masks the sensation of pain, or

(3) both (1) and (2).

24. The method of claim 22, wherein the therapy signal is delivered at an amplitude that at least partially reduces a sensation of lower back and/or leg pain in the patient without generating the sensation of paresthesia.

25. The method of claim 24, further comprising:

programming the signal generator to generate the therapy signal with a frequency in a frequency range of from 1.5 kHz to 50 kHz.

26. The method of claim 24, further comprising:

programming the signal generator to generate the therapy signal with a frequency of 10 kHz.

27. The method of claim 22, further comprising:

programming the signal generator to generate the therapy signal with pulses having pulse widths between 30 microseconds and 35 microseconds.