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

• US 20160287888A1
• Filed: 04/05/2016
• Published: 10/06/2016
• 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.
• Granted Patent: US 10,220,209 B2
• 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 programmer for use in a spinal cord stimulation system for providing pain relief to a patient, wherein the spinal cord stimulation system includes a signal generator configured to generate an electrical therapy signal, and a signal delivery device configured to receive the electrical therapy signal from the signal generator and deliver the electrical therapy signal to the patient'"'"'s spinal cord, the programmer comprising:

a computer-readable medium programmed with executable instructions to

(i) select therapy signal parameters for generating one of at least two types of pain alleviating therapies, the first type of therapy being a paresthesia-inducing electrical therapy signal, and the second type of therapy being a non-paresthesia-inducing electrical therapy signal,

wherein the therapy signal parameters for the first type of therapy include a paresthesia-inducing frequency of less than 1,500 Hz, and a paresthesia-inducing amplitude between 3 mA and 10 mA, and

wherein the therapy signal parameters for the second type of therapy include a non-paresthesia-inducing frequency between 5 kHz and 15 kHz, and a non-paresthesia-inducing amplitude between 0.5 mA and 10 mA; and

(ii) direct the signal generator to generate and deliver one of the at least two types of pain alleviating therapies to a target location in a patient'"'"'s spinal cord.

140. The programmer of claim 138, wherein the signal generator is configured to generate and deliver the paresthesia-inducing electrical therapy signal or the non-paresthesia-inducing electrical therapy signal to a thoracic vertebral level in the patient via the signal delivery device.

141. The programmer of claim 140, wherein the thoracic vertebral level is between T9 and T12, inclusively.

142. The programmer of claim 138, wherein delivery of the paresthesia-inducing electrical therapy signal and the non-paresthesia-inducing electrical therapy signal do not overlap temporally with each other.

143. The programmer of claim 138, wherein the signal generator is implantable.

144. The programmer of claim 143, wherein the programmer is in wireless communication with the implantable signal generator.

145. The programmer of claim 138, wherein the signal generator includes a processor with instructions for generating the electrical therapy signal in response to input received from the programmer.

146. The programmer of claim 138, further comprising:

a connection element between the signal delivery device and the signal generator.

147. The programmer of claim 138, wherein the therapy signal parameters for the second type of therapy include an amplitude in an amplitude range from 0.5 mA to 4 mA.

148. The programmer of claim 138, wherein the therapy signal parameters for the second type of therapy include an amplitude in an amplitude range from 1 mA to 4 mA.

149. The programmer of claim 138, wherein the therapy signal parameters for the second type of therapy include an amplitude in an amplitude range from less than 1 mA to 8 mA.

150. The programmer of claim 138, wherein the therapy signal for the second type of therapy include includes an amplitude in an amplitude range from less than 1 mA to 6 mA.

151. The programmer of claim 138, wherein the therapy signal for the second type of therapy include includes an amplitude in an amplitude range from 1 mA to 6 mA.

152. The programmer of claim 138, wherein the non-paresthesia-inducing frequency is 10 kHz.

153. The programmer of claim 138, wherein the therapy signal parameters for the second type of therapy include a pulse width in a pulse width range from 10 microseconds to 133 microseconds.

154. The programmer of claim 138, wherein the therapy signal parameters for the second type of therapy include a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

155. The programmer of claim 138, wherein the therapy signal parameters for the second type of therapy include a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

156. The programmer of claim 138, wherein the therapy signal parameters for the first type of therapy include an amplitude in an amplitude range from 3 mA to 10 mA.

157. The programmer of claim 138, wherein the therapy signal parameters for the first type of therapy include a first target location for the paresthesia-inducing electrical therapy signal, and the therapy signal parameters for the second type of therapy include a second target location for the non-paresthesia-inducing electrical therapy signal.

158. The programmer of claim 157, wherein the first target location and the second target location are the same.

139. 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 signal generator configured to generate an electrical therapy signal, and a signal delivery device configured to receive the electrical therapy signal from the signal generator and deliver the electrical therapy signal to the patient'"'"'s spinal cord, the programmer comprising:

a computer-readable medium programmed with executable instructions to

(i) select therapy signal parameters for generating one of at least two types of pain alleviating therapies, the first type of therapy being a paresthesia-inducing electrical therapy signal, and the second type of therapy being a non-paresthesia-inducing electrical therapy signal,

wherein the therapy signal parameters for the first type of therapy include a first frequency of less than 1,500 Hz, and a first amplitude between 3 mA and 10 mA, and

wherein the therapy signal parameters for the second type of therapy include a second frequency of 10 kHz, and a second amplitude between 0.5 mA and 10 mA; and

(ii) direct the signal generator to generate and deliver one of the at least two types of pain alleviating therapies to a target location in a patient'"'"'s spinal cord.

159. The programmer of claim 139, wherein the signal generator is configured to generate and deliver the paresthesia-inducing electrical therapy signal or the non-paresthesia-inducing electrical therapy signal to a thoracic vertebral level in the patient via the signal delivery device.

160. The programmer of claim 159, wherein the thoracic vertebral level is between T9 and T12, inclusively.

161. The programmer of claim 139, wherein delivery of the paresthesia-inducing electrical therapy signal and the non-paresthesia-inducing electrical therapy signal do not overlap temporally with each other.

162. The programmer of claim 139, wherein the signal generator is implantable.

163. The programmer of claim 162, wherein the programmer is in wireless communication with the implantable signal generator.

164. The programmer of claim 139, wherein the signal generator includes a processor with instructions for generating the electrical therapy signal in response to input received from the programmer.

165. The programmer of claim 139, further comprising:

a connection element between the signal delivery device and the signal generator.

166. The programmer of claim 139, wherein the therapy signal parameters for the second type of therapy include an amplitude in an amplitude range from 0.5 mA to 4 mA.

167. The programmer of claim 139, wherein the therapy signal parameters for the second type of therapy include an amplitude in an amplitude range from 1 mA to 4 mA.

168. The programmer of claim 139, wherein the therapy signal parameters for the second type of therapy include an amplitude in an amplitude range from less than 1 mA to 8 mA.

169. The programmer of claim 139, wherein the therapy signal for the second type of therapy include includes an amplitude in an amplitude range from less than 1 mA to 6 mA.

170. The programmer of claim 139, wherein the therapy signal for the second type of therapy include includes an amplitude in an amplitude range from 1 mA to 6 mA.

171. The programmer of claim 139, wherein the therapy signal parameters for the second type of therapy include a pulse width in a pulse width range from 10 microseconds to 133 microseconds.

172. The programmer of claim 139, wherein the therapy signal parameters for the second type of therapy include a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

173. The programmer of claim 139, wherein the therapy signal parameters for the second type of therapy include a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

174. The programmer of claim 139, wherein the therapy signal parameters for the first type of therapy include an amplitude in an amplitude range from 3 mA to 10 mA.

175. The programmer of claim 139, wherein the therapy signal parameters for the first type of therapy include a first target location for the paresthesia-inducing electrical therapy signal, and the therapy signal parameters for the second type of therapy include a second target location for the non-paresthesia-inducing electrical therapy signal.

176. The programmer of claim 175, wherein the first target location and the second target location are the same.