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

• US 20160303374A1
• Filed: 04/20/2016
• Published: 10/20/2016
• Est. Priority Date: 04/22/2009
• Status: Abandoned Application

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Alataris, Konstantinos, Walker, Andre B., Parker, Jon, Chitre, Yougandh, Park, Sangsoo Wesley, Thacker, James R.
• Application Number:
  US15/134,285
• Publication Number:
  US 20160303374A1
• Time in Patent Office: 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 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

1-137. -137. (canceled)

138. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:

a signal generator configured to generate a therapy signal producing no sensory effect other than to reduce or eliminate pain, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz; and

an implantable signal delivery device electrically coupleable to the signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord region.

139. The system of claim 138 wherein the signal delivery device is a paddle lead configured to be implanted in a target location.

140. The system of claim 138 wherein the signal delivery device is an elongated lead having one or more electrodes configured to direct the therapy signal to a target location.

141. The system of claim 138 wherein the signal generator is an implantable signal generator.

142. The system of claim 138 wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 10 microseconds to 333 microseconds.

143. The system of claim 138 wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

144. The system of claim 138 wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

145. The system of claim 138 wherein the frequency range is from 1.5 kHz to 50 kHz.

146. The system of claim 138 wherein the frequency range is from 3 kHz to 20 kHz.

147. The system of claim 138 wherein at least a portion of the therapy signal has a current amplitude in a current amplitude range from 0.5 to 10 mA.

148. The system of claim 138 wherein the frequency range is from 3 to 20 kHz, and wherein a pulse width of the therapy signal is in a pulse width range from 10 to 333 microseconds, and wherein a current amplitude of the therapy signal is in a current amplitude range from 0.5 mA to 10 mA.

149. The system of claim 138 wherein the signal generator is programmed with instructions for generating the therapy signal.

150. The system of claim 138 wherein at least a portion of the therapy signal is a square-wave signal.

151. The system of claim 138 wherein the signal generator generates the therapy signal at a duty cycle of less than 100%.

152. A spinal cord modulation system for reducing or eliminating pain in a patient without creating a sensory effect other than reducing or eliminating pain in the patient, the system comprising:

an implantable signal generator configured to generate a therapy signal producing no sensory effect other than to reduce or eliminate pain in the patient, wherein at least a portion of the therapy signal is a biphasic square-wave signal, at a frequency in a frequency range from 1.5 kHz to 100 kHz, and at a current amplitude of less than about 20 mA; and

a signal delivery device electrically coupleable to the implantable signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord region.

153. The system of claim 152 wherein the signal delivery device is an implantable signal delivery device.

154. The system of claim 152 wherein the signal delivery device is a paddle lead configured to be implanted in a target location.

155. The system of claim 152 wherein the signal delivery device is an elongated lead having one or more electrodes configured to direct the therapy signal to a target location.

156. The system of claim 152 wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 10 microseconds to 333 microseconds.

157. The system of claim 152 wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

158. The system of claim 152 wherein the frequency range is from 3 kHz to 20 kHz.

159. The system of claim 152 wherein the therapy signal has a current amplitude in a current amplitude range from 0.5 to 10 mA.

160. The system of claim 152 wherein the frequency range is from 3 to 20 kHz, and wherein a pulse width of the therapy signal is in a pulse width range from 10 to 333 microseconds, and wherein a current amplitude of the therapy signal is in a current amplitude range from 0.5 mA to 10 mA.

161. A method for configuring a spinal cord stimulation system to deliver a therapy signal to a patient'"'"'s spinal cord, the method comprising:

programming the spinal cord stimulation system to

(1) generate a therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range from 1.5 kHz to 100 kHz and does not create a sensory effect other than to reduce or eliminate pain in the patient; and

(2) deliver the therapy signal to the patient'"'"'s spinal cord via an implantable signal delivery device.

162. The method of claim 161, further comprising programming the spinal cord stimulation system to deliver the therapy signal to a vertebral level between T9 and T12, inclusively.

163. The method of claim 161, further comprising programming the spinal cord stimulation system to deliver the therapy signal to a thoracic vertebral level.

164. The method of claim 161, further comprising programming the spinal cord stimulation system to deliver the therapy signal to a vertebral level between C3 and C7, inclusively.

165. The method of claim 161 wherein the frequency range is between 3 kHz and 20 kHz.

166. The method of claim 161 wherein the frequency range is between 5 kHz and 15 kHz.

167. The method of claim 161 wherein the frequency is 10 kHz.

168. The method of claim 161 wherein the frequency range is from 3 kHz and 20 kHz, and wherein a pulse width of the therapy signal is in a pulse width range from 10 to 333 microseconds, and wherein a current amplitude of the therapy signal is in a current amplitude range from 0.5 mA to 10 mA.

169. A method for treating a patient, comprising:

delivering an electrical therapy signal to the patient'"'"'s spinal cord via at least one implanted signal delivery device to reduce or eliminate pain in the patient without producing a sensory effect other than to reduce or eliminate the pain, the signal having a frequency in a frequency range from 1.5 kHz to 100 kHz.

170. The method of claim 169, further comprising:

placing or instructing placement of the at least one signal delivery device at a position along the spinal cord as at least part of a placement process, without using patient feedback during the placement process to at least assist in selecting the position.

171. The method of claim 169 the electrical therapy signal reduces or eliminates both low-back pain and leg pain.

172. The method of claim 169 wherein the frequency range is from 3 kHz to 20 kHz.

173. The method of claim 169 wherein the frequency range is from 5 kHz to 15 kHz.

174. The method of claim 169 wherein the frequency range is from 3 kHz to 20 kHz, and wherein a pulse width of the therapy signal is in a pulse width range from 10 to 333 microseconds, and wherein a current amplitude of the therapy signal is in a current amplitude range from 0.5 mA to 10 mA.

175. A method for treating a patient, comprising:

delivering or instructing delivery of an electrical signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device; and

wherein the electrical signal has a frequency in a frequency range from 1.5 kHz to 100 kHz and does not create a sensory effect other than to reduce or eliminate pain in the patient.

176. The method of claim 175 wherein the frequency range is between 3 kHz and 20 kHz.

177. The method of claim 175 wherein the frequency range is between 5 kHz and 15 kHz.

178. The method of claim 175 wherein the frequency is 10 kHz.

179. The method of claim 175 wherein the frequency range is from 3 kHz and 20 kHz, and wherein a pulse width of the therapy signal is in a pulse width range from 10 to 333 microseconds, and wherein a current amplitude of the therapy signal is in a current amplitude range from 0.5 mA to 10 mA.