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

• US 8,874,217 B2
• Filed: 03/14/2013
• Issued: 10/28/2014
• 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): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US13/830,992
• Publication Number:
  US 20130204338A1
• Time in Patent Office: 593 Days
• Field of Search: 607/2, 607/16, 607/41, 607/46, 607/59, 607115-117
• US Class Current: 607/41
• 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 of treating urinary incontinence, comprising:

implanting one or more signal delivery devices proximate to at least one sacral nerve in a patient'"'"'s sacral region; and

applying an electrical therapy signal to the at least one sacral nerve via the one or more signal delivery devices to treat urinary incontinence without generating paresthesia in the patient,

wherein at least a portion of the electrical therapy signal is at a frequency in a frequency range of from about 1.5 kHz to about 100 kHz and a pulse width in a pulse width range of from about 10 microseconds to about 333 microseconds.

2. The method of claim 1, wherein the frequency range is from about 3 kHz to about 20 kHz.

3. The method of claim 1, wherein the frequency range is from about 5 kHz to about 15 kHz.

4. The method of claim 1, further comprising:

coupling the one or more implanted signal delivery devices to an implanted signal generator,

wherein the signal generator is configured to treat urinary incontinence by generating and delivering the electrical therapy signal to the sacral nerve.

5. The method of claim 1, wherein the one or more signal delivery devices include a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

6. The method of claim 1, wherein the electrical therapy signal includes one or more pulses with a pulse width between about 25 microseconds and about 166 microseconds.

7. A method of treating urinary incontinence with a spinal cord modulation system, comprising:

implanting one or more signal delivery devices proximate to a target location in a patient'"'"'s spinal cord region, wherein the target location is a sacral nerve in the patient'"'"'s sacral region;

coupling the one or more signal delivery devices to a signal generator; and

configuring the signal generator to generate and deliver a urinary incontinence therapy signal to the target location, via the one or more implanted signal delivery devices, without generating paresthesia;

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.

8. The method of claim 7, wherein the frequency range is from about 3 kHz to about 20 kHz.

9. The method of claim 7, wherein the frequency range is from about 5 kHz to about 15 kHz.

10. The method of claim 7, wherein the one or more signal delivery devices include a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

11. The method of claim 7, further comprising:

configuring the signal generator to generate the therapy signal with one or more pulses having a pulse width between about 10 microseconds and about 333 microseconds.

12. The method of claim 7, further comprising:

configuring the signal generator to generate the therapy signal with one or more pulses having a pulse width between about 25 microseconds and about 166 microseconds.

13. A urinary incontinence treatment system, comprising:

a spinal cord modulation system having

at least one signal delivery device configured to be implanted proximate to a sacral nerve in a patient'"'"'s sacral region, and

a signal generator configured to treat urinary incontinence by generating and delivering a non-paresthesia-generating electrical therapy signal to the sacral nerve, via the at least one signal delivery device,

wherein at least a portion of the electrical therapy signal is at a frequency in a frequency range of from about 1.5 kHz to about 100 kHz and a pulse width in a pulse width range of from about 10 microseconds to about 333 microseconds.

14. The system of claim 13, wherein the frequency range is from about 3 kHz to about 20 kHz.

15. The system of claim 13, wherein the frequency range is from about 5 kHz to about 15 kHz.

16. The system of claim 13, wherein the at least one signal delivery device includes a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

17. The system of claim 13, wherein the electrical therapy signal includes one or more pulses with a pulse width between about 25 microseconds and about 166 microseconds.