# US 10,245,433 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 10,245,433 B2 - Document ID: US10245433B2 - Status: Granted - Kind: B2 - Application number: 14/821,405 - Filed: 2015-08-07 - Published: 2015-12-03 - Granted: 2019-04-02 - Earliest claimed: 2009-04-22 - Assignees: Nevro Corporation - Applicants: Nevro Corp. - Inventors: Konstantinos Alataris; Andre B. Walker; Jon Parker; Yougandh Chitre; Sangsoo Wesley Park; James R. Thacker - Web page: https://patentgrep.com/patent/US10245433B2 ## 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 A spinal cord modulation system is disclosed. While in one embodiment the system is used for the treatment of pain, other embodiments are also provided. In particular embodiments, the spinal cord modulation system generates and delivers an electrical therapy signal at a frequency in the range of from about 1.5 kHz to about 100 kHz to address pain without creating unwanted sensory and/or motor side effects. The system may further include various signal delivery devices to deliver the therapy signal to a patient's spinal cord region. ## Claims ### Claim 1 A spinal cord modulation system, comprising: an implantable signal generator having a machine-readable medium containing instructions that, when executed, generate a therapy signal having a frequency between 1.5 kHz and 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 30 microseconds and 35 microseconds; and an implantable signal delivery device coupleable to the implantable signal generator and designed to be implanted within a patient's epidural space to deliver the therapy signal from the implantable signal generator to the patient's spinal cord. ### Claim 2 (depends on 1) The system of claim 1, wherein the current amplitude is 2.5 mA. ### Claim 3 (depends on 1) The system of claim 1, wherein the frequency is between 3 kHz and 10 kHz. ### Claim 4 (depends on 1) The system of claim 1, wherein the frequency is 8 kHz. ### Claim 5 (depends on 1) The system of claim 1, wherein the frequency is 9 kHz. ### Claim 6 (depends on 1) The system of claim 1, wherein the frequency is 10 kHz. ### Claim 7 (depends on 1) The system of claim 1, wherein the therapy signal includes a plurality of biphasic pulses. ### Claim 8 (depends on 1) The system of claim 1, wherein the machine-readable medium contains instructions that, when executed, deliver the therapy signal at a duty cycle. ### Claim 9 (depends on 1) The system of claim 1, wherein the implantable signal delivery device is a percutaneous lead. ### Claim 10 (depends on 1) The system of claim 1, wherein the implantable signal delivery device is a paddle lead. ### Claim 11 A spinal cord modulation system, comprising: an implanted signal generator programmed to generate a therapy signal having a plurality of biphasic pulses with a frequency between 1.5 kHz and 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 30 microseconds and 35 microseconds; and a signal delivery device designed to be implanted in a patient's epidural space, electrically coupled to the signal generator, and designed to deliver the therapy signal from the signal generator to the patient's spinal cord. ### Claim 12 (depends on 11) The system of claim 11, wherein the amplitude is between 2 mA and 3.5 mA. ### Claim 13 (depends on 11) The system of claim 11, wherein the frequency is between 3 kHz and 10 kHz. ### Claim 14 (depends on 11) The system of claim 11, wherein the frequency is 8 kHz. ### Claim 15 (depends on 11) The system of claim 11, wherein the frequency is 9 kHz. ### Claim 16 (depends on 11) The system of claim 11, wherein the frequency is 10 kHz. ### Claim 17 (depends on 11) The system of claim 11, further comprising: a physician's programmer in wireless communication with the signal generator and having a machine-readable medium containing instructions that, when executed, select the amplitude of the therapy signal. ### Claim 18 (depends on 11) The system of claim 11, wherein the implantable signal delivery device is a percutaneous lead. ### Claim 19 (depends on 11) The system of claim 11, wherein the implantable signal delivery device is a paddle lead. ### Claim 20 A spinal cord modulation system, comprising: an implantable signal generator having a signal generator machine-readable medium containing instructions to generate a therapy signal with at least three signal parameter, including: (i) a frequency between 1.5 kHz and 10 kHz, (ii) pulse widths between 30 microseconds and 35 microseconds, and (iii) a current amplitude between 0.5 mA and 4 mA; an implantable signal delivery device coupleable to the signal generator and designed to be implanted in the patient's epidural space to deliver the therapy signal from the implantable signal generator to the patient's spinal cord; and a programmer wirelessly coupleable to the implantable signal generator and having a programmer machine-readable medium containing instructions that, when executed, program at least one of the signal parameters. ### Claim 21 (depends on 20) The system of claim 20, wherein the current amplitude is between 2 mA and 3.5 mA. ### Claim 22 (depends on 20) The system of claim 20, wherein the frequency is between 3 kHz and 10 kHz. ### Claim 23 (depends on 20) The system of claim 20, wherein the frequency is 8 kHz. ### Claim 24 (depends on 20) The system of claim 20, wherein the frequency is 9 kHz. ### Claim 25 (depends on 20) The system of claim 20, wherein the frequency is 10 kHz. ### Claim 26 A spinal cord modulation system, comprising: an implantable signal generator programmable to generate a therapy signal in accordance with one or more therapy signal parameters; an implantable signal delivery device electrically coupleable to the implantable signal generator and designed to be implanted in a patient's epidural space to deliver the therapy signal to the patient's spinal cord; and a programmer wirelessly coupleable to the implantable signal generator and having a programmer machine-readable medium containing instructions to program the one or more therapy signal parameters in the implantable signal generator, wherein the one or more therapy signal parameters include (i) a frequency in a frequency range from 1.5 kHz to 10 kHz, (ii) an amplitude between 0.5 mA and 4 mA, and (iii) pulse widths between 30 microseconds and 35 microseconds. ### Claim 27 (depends on 26) The system of claim 26, wherein the amplitude is between 2 mA and 3.5 mA. ### Claim 28 (depends on 26) The system of claim 26, wherein the pulse widths are 30 microseconds. ### Claim 29 (depends on 26) The system of claim 26, wherein the frequency range is from 3 kHz to 10 kHz. ### Claim 30 (depends on 26) The system of claim 26, wherein the frequency is 8 kHz. ### Claim 31 (depends on 26) The system of claim 26, wherein the frequency is 9 kHz. ### Claim 32 (depends on 26) The system of claim 26, wherein the frequency is 10 kHz. ### Claim 33 (depends on 26) The system of claim 26, wherein the implantable signal generator includes a signal generator machine-readable medium with instructions that, when executed, (i) generate the therapy signal in accordance with instructions received from the programmer, and (ii) deliver the therapy signal to the patient's spinal cord via the implantable signal delivery device. ### Claim 34 A spinal cord modulation system, comprising: a signal generator programmed to generate a therapy signal having a frequency of 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulses having a pulse width between 30 microseconds and 35 microseconds; and a signal delivery device electrically coupled to the signal generator and designed to deliver the therapy signal from the signal generator to a patient's spinal cord when implanted in the patient's epidural space. ### Claim 35 (depends on 34) The system of claim 34, wherein the therapy signal includes a plurality of biphasic pulses. ### Claim 36 (depends on 34) The system of claim 34, further comprising: a physician's programmer in wireless communication with the signal generator and having a machine-readable medium containing instructions that, when executed, select the amplitude of the therapy signal. ### Claim 37 (depends on 34) The system of claim 34, wherein the signal delivery device is a percutaneous lead. ### Claim 38 (depends on 34) The system of claim 34, wherein the signal delivery device is a paddle lead. ### Claim 39 A spinal cord modulation system, comprising: an implantable signal generator having a machine-readable medium containing instructions that, when executed, generate and deliver a therapy signal with a frequency of 10 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 30 microseconds and 35 microseconds; and an implantable signal delivery device coupleable to the implantable signal generator and designed to be implanted within a patient's epidural space to deliver the therapy signal from the implantable signal generator to the patient's spinal cord. ### Claim 40 (depends on 39) The system of claim 39, wherein the therapy signal includes a plurality of biphasic pulses. ### Claim 41 (depends on 39) The system of claim 39, wherein the machine-readable medium contains instructions that, when executed, deliver the therapy signal at a duty cycle. ### Claim 42 (depends on 39) The system of claim 39, wherein the implantable signal delivery device is a percutaneous lead. ### Claim 43 (depends on 39) The system of claim 39, wherein the implantable signal delivery device is a paddle lead. ### Claim 44 A spinal cord modulation system, comprising: an implantable signal generator having a machine-readable medium containing instructions that, when executed, generate and deliver a therapy signal with a frequency of 10 kHz, pulses with pulse widths between 30 microseconds and 35 microseconds, and a current amplitude between 0.5 mA and 4 mA; an implantable signal delivery device coupleable to the implantable signal generator and designed to be implanted in the patient's epidural space to deliver the therapy signal from the implantable signal generator to the patient's spinal cord; and a programmer designed to wirelessly communicate with the implantable signal generator to select at least the amplitude of the therapy signal. ### Claim 45 (depends on 44) The system of claim 44, wherein the current amplitude is between 2 mA and 3.5 mA. ### Claim 46 A spinal cord modulation system, comprising: an implantable signal generator programmed to generate a therapy signal having a plurality of biphasic pulses with pulse widths between 30 microseconds and 35 microseconds and a frequency of 10 kHz; an implantable signal delivery device electrically coupleable to the implantable signal generator and designed to be implanted in a patient's epidural space to deliver the therapy signal from the implantable signal generator to the patient's spinal cord; and a programmer wirelessly coupleable to the implantable signal generator and having a machine-readable medium containing instructions that, when executed, select an amplitude of the therapy signal between 0.5 mA and 4 mA to program into the implantable signal generator, and communicate the selected amplitude to the implantable signal generator. ### Claim 47 (depends on 46) The system of claim 46, wherein the amplitude is between 2 mA and 3.5 mA.