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

• US 9,333,360 B2
• Filed: 10/10/2014
• Issued: 05/10/2016
• 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
• Application Number:
  US14/512,325
• Publication Number:
  US 20150032182A1
• Time in Patent Office: 578 Days
• US Class Current: 1/1
• 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 100 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. Particular embodiments include applying a paresthesia-inducing signal with a frequency of less than 1.2 kHz.

Claims

1. A programmer for use in a spinal cord stimulation system for providing pain relief to a patient, wherein the spinal cord stimulation system includes a pulse generator configured to generate an electrical signal, and a signal delivery device configured to receive the electrical signal from the pulse generator and deliver the electrical signal to the patient'"'"'s spinal cord region, the physician programmer comprising:

a computer-readable medium programmed with executable instructions to select signal parameters from two sets of signal parameters,

wherein the first set of signal parameters generates a paresthesia-inducing electrical signal with a frequency of less than 1.2 kHz, and wherein the second set of signal parameters generates a non-paresthesia-inducing therapy signal with a frequency between 1.5 kHz and 100 kHz.

2. The programmer claim 1, wherein the two sets of signal parameters include a first target location for the paresthesia-inducing electrical signal and a second target location for the non-paresthesia-inducing therapy signal.

3. The programmer of claim 2, wherein the first target location and the second target location are the same.

4. The programmer of claim 2, wherein the second target location is a vertebral level between T9 and T12, inclusively.

5. The programmer of claim 2, wherein the second target location is lateral from a midline of the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

6. The programmer of claim 1, wherein at least one of the first and second set of signal parameters includes a target location lateral from a midline of the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

7. The programmer of claim 1, wherein the computer-readable medium is programmed with executable instructions for delivering the paresthesia-inducing electrical signal and the non-paresthesia-inducing therapy signal so as to not overlap temporally with each other.

8. The programmer of claim 1, wherein the second set of signal parameters generates the non-paresthesia-inducing therapy signal at a frequency of 10 kHz.

9. The programmer of claim 1, wherein the second set of signal parameters generates the non-paresthesia-inducing therapy signal at a frequency between 3 kHz and 20 kHz.

10. The programmer of claim 1, wherein the second set of signal parameters generates the non-paresthesia-inducing therapy signal at a frequency between 1.5 kHz and 50 kHz.

11. The programmer of claim 1, wherein the second set of signal parameters include a non-paresthesia-inducing amplitude between 0.5 mA and 4 mA.

12. The programmer of claim 1, wherein the second set of signal parameters includes an amplitude in an amplitude range between 0.5 mA and 10 mA.

13. The of claim 1, wherein the second set of signal parameters includes an amplitude in an amplitude range between 0.1 mA and 20 mA.

14. The programmer of claim 1, further comprising a wireless communication system.

15. The programmer claim 14, wherein the wireless communication system is in wireless communication with an implantable pulse generator.