# US 8,209,021 B2 · Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,209,021 B2 - Document ID: US8209021B2 - Status: Granted - Kind: B2 - Application number: 13/245,471 - Filed: 2011-09-26 - Published: 2012-01-19 - Granted: 2012-06-26 - Earliest claimed: 2009-04-22 - Assignees: Nevro Corporation - Inventors: Konstantinos Alataris; Andre B. Walker; Jon Parker; Yougandh Chitre; Sangsoo Wesley Park; James R. Thacker - Web page: https://patentgrep.com/patent/US8209021B2 ## CPC - A61N 1/36071: {Pain} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/0553: {Paddle shaped electrodes, e.g. for laminotomy} - A61N 1/06: for high-frequency therapy - A61N 1/323: {Interference currents, i.e. treatment by several currents summed in the body} - A61N 1/326: {for promoting growth of cells, e.g. bone cells} - A61N 1/36021: {for treatment of pain} - A61N 1/36062: {Spinal stimulation} - A61N 1/36089: {Addiction or withdrawal from substance abuse such as alcohol or drugs} - A61N 1/36128: {Control systems} - A61N 1/36132: {using patient feedback} - A61N 1/36157: {Current (A61N1/3616 takes precedence)} - A61N 1/3616: {Voltage density or current density} - A61N 1/36164: {Sub-threshold or non-excitatory signals (non-excitatory signals to the heart A61N1/3628)} - A61N 1/36167: {Timing, e.g. stimulation onset} - A61N 1/36171: {Frequency} - A61N 1/36175: {Pulse width or duty cycle} - A61N 1/36178: {Burst or pulse train parameters} - A61N 1/36182: {Direction of the electrical field, e.g. with sleeve around stimulating electrode} - A61N 1/37235: {Aspects of the external programmer} - A61N 1/37241: {providing test stimulations} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - A61N 1/37264: {Changing the program; Upgrading firmware} - A61N 1/3787: {from an external energy source} - G01R 21/133: by using digital technique - A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12) ## Abstract Selective high-frequency spinal chord modulation for inhibiting pain with reduced side affects 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 chord region to address low back pain without creating unwanted sensory and/or motor side affects. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications. ## Claims ### Claim 1 A patient treatment device, comprising: an implantable pulse generator programmed to direct a pulsed electrical signal at a frequency of from about 1.5 kHz to about 50 kHz, the implantable pulse generator having a first connector positioned to couple to at least one implantable electrical lead; and at least one implantable, elongated electrical lead having a proximal portion and a distal potion, the proximal portion having a second connector positioned to be coupled with the first connector of the implantable pulse generator, the distal portion having multiple electrical contacts for delivering the pulsed electrical signal to one or more epidural locations along a patient's spinal cord to reduce or inhibit at least one of chronic low-back pain and leg pain in the patient through application of the pulsed electrical signal, the implantable pulse generator being configured to direct the pulsed electrical signal without the electrical signal creating paresthesia. ### Claim 2 (depends on 1) The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal with charge-balanced, biphasic, square-wave pulses, and wherein individual phases of the pulses are applied at approximately equal and opposite current amplitudes. ### Claim 3 (depends on 1) The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of from about 5 kHz to about 15 kHz. ### Claim 4 (depends on 1) The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of about 10 kHz. ### Claim 5 (depends on 1) The device of claim 1 wherein immediately neighboring electrical contacts are spaced apart from each other by a distance of from about 8 millimeters to about 64 millimeters. ### Claim 6 (depends on 1) The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of from about 3 kHz to about 20 kHz. ### Claim 7 (depends on 1) The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of from about 3 kHz to about 15 kHz. ### Claim 8 (depends on 1) The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of from about 3 kHz to about 10 kHz. ### Claim 9 (depends on 1) The device of claim 1 wherein the implantable pulse generator is configured to reduce or inhibit at least one of chronic low-back pain and leg pain without the electrical signal creating at least one of: (a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than low-back pain and leg pain signals; and (b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord. ### Claim 10 (depends on 1) The device of claim 1 wherein the implantable pulse generator is configured to direct the pulsed electrical signal to reduce or inhibit both chronic low-back pain and leg pain without the electrical signal creating either of: (a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than low-back pain and leg pain signals; and (b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord. ### Claim 11 A patient treatment device, comprising: at least one implantable lead having a proximal portion and a distal potion, the proximal portion having a lead connector, the distal portion having multiple electrical contacts for delivering a pulsed electrical signal to one or more epidural locations along a patient's spinal cord; and a pulse generator having a pulse generator connector positioned to releasably couple to the at least one implantable electrical lead, the pulse generator having instructions for directing a pulsed electrical signal at a frequency of from about 1.5 kHz to about 20 kHz, to reduce or inhibit at least one of chronic low-back pain and leg pain in the patient, the pulse generator being configured to direct the pulsed electrical signal without the electrical signal creating paresthesia. ### Claim 12 (depends on 11) The device of claim 11 wherein the pulse generator is an implantable pulse generator. ### Claim 13 (depends on 11) The device of claim 11 wherein the pulse generator is an external pulse generator. ### Claim 14 (depends on 11) The device of claim 11 wherein the pulse generator is programmed to direct the electrical signal at a frequency of from about 5 kHz to about 15 kHz. ### Claim 15 (depends on 11) The device of claim 11 wherein the pulse generator is programmed to direct the electrical signal at a frequency of about 10 kHz. ### Claim 16 (depends on 11) The device of claim 11 wherein immediately neighboring electrical contacts are spaced apart from each other by a distance of from about 8 millimeters to about 64 millimeters. ### Claim 17 (depends on 11) The device of claim 11 wherein the pulse generator is programmed to direct the electrical signal at a frequency of from about 3 kHz to about 20 kHz. ### Claim 18 (depends on 11) The device of claim 11 wherein the pulse generator is programmed to direct the electrical signal at a frequency of from about 3 kHz to about 15 kHz. ### Claim 19 (depends on 11) The device of claim 11 wherein the pulse generator is programmed to direct the electrical signal at a frequency of from about 3 kHz to about 10 kHz. ### Claim 20 (depends on 11) The device of claim 11 wherein the pulse generator is configured to reduce or inhibit at least one of chronic low-back pain and leg pain without the electrical signal creating at least one of: (a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than low-back pain and leg pain signals; and (b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord. ### Claim 21 (depends on 11) The device of claim 11 wherein the pulse generator is configured to direct the pulsed electrical signal to reduce or inhibit both chronic low-back pain and leg pain without the electrical signal creating either of: (a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than low-back pain and leg pain signals; and (b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord. ### Claim 22 A patient treatment device, comprising: at least one implantable electrical lead having a proximal portion and a distal potion, the lead being elongated along a lead axis between the proximal portion and the distal portion, the proximal portion having at least one lead connector, the distal portion having multiple electrical contacts arranged along the distal portion of the lead for delivering a pulsed electrical signal to one or more epidural locations along a patient's spinal cord; and an implantable pulse generator having a pulse generator connector positioned to releasably couple to the lead connector of the at least one implantable electrical lead, the implantable pulse generator including a computer-readable medium programmed with instructions that, when executed, direct the pulsed electrical signal at a frequency of from about 5 kHz to about 15 kHz, to reduce or inhibit at least one of chronic low-back pain and leg pain in the patient, the implantable pulse generator being configured to direct the pulsed electrical signal without the electrical signal creating paresthesia. ### Claim 23 (depends on 22) The device of claim 22 wherein the instructions, when executed, direct the pulsed electrical signal at a frequency of about 10 kHz. ### Claim 24 (depends on 22) The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by from about 8 millimeters to about 64 millimeters. ### Claim 25 (depends on 22) The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by at least 16 millimeters. ### Claim 26 (depends on 22) The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by at least 32 millimeters. ### Claim 27 (depends on 22) The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by approximately 64 millimeters. ### Claim 28 (depends on 22) The device of claim 22 wherein the lead body includes a variable-length portion. ### Claim 29 (depends on 28) The device of claim 28 wherein the variable-length portion has a helical shape. ### Claim 30 (depends on 22) The device of claim 22 wherein the implantable pulse generator is configured to reduce or inhibit at least one of chronic low-back pain and leg pain without the electrical signal creating at least one of: (a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than low-back pain and leg pain signals; and (b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord. ### Claim 31 (depends on 22) The device of claim 22 wherein the implantable pulse generator is configured to direct the pulsed electrical signal to reduce or inhibit both chronic low-back pain and leg pain without the electrical signal creating either of: (a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than low-back pain and leg pain signals; and (b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord.