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

• US 20120016438A1
• Filed: 09/26/2011
• Published: 01/19/2012
• 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 8,209,021 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• 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 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

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 20 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 connected to 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, without the electrical signal creating at least one of;

(a) paresthesia;

(b) 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

(c) disruptions that are detectable by the patient in motor signals along the spinal cord.

2. 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.

3. 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.

4. The device of claim 1 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of about 10 kHz.

5. 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.

6. 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, without the electrical signal creating at least one of;

(a) paresthesia;

(b) 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

(c) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord.

7. The device of claim 6 wherein the pulse generator is an implantable pulse generator.

8. The device of claim 6 wherein the pulse generator is an external pulse generator.

9. The device of claim 6 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of from about 5 kHz to about 15 kHz.

10. The device of claim 6 wherein the implantable pulse generator is programmed to direct the electrical signal at a frequency of about 10 kHz.

11. The device of claim 6 wherein immediately neighboring electrical contacts are spaced apart from each other by a distance of from about 8 millimeters to about 64 millimeters.

12. 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, without the electrical signal creating;

(a) paresthesia; and

(b) 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

(c) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord.

13. The device of claim 12 wherein the instructions, when executed, direct the pulsed electrical signal at a frequency of about 10 kHz.

14. The device of claim 12 wherein immediately neighboring contacts are spaced apart from each other by from about 8 millimeters to about 64 millimeters.

15. The device of claim 12 wherein immediately neighboring contacts are spaced apart from each other by at least 16 millimeters.

16. The device of claim 12 wherein immediately neighboring contacts are spaced apart from each other by at least 32 millimeters.

17. The device of claim 12 wherein immediately neighboring contacts are spaced apart from each other by approximately 64 millimeters.

18. The device of claim 12 wherein the lead body includes a variable-length portion.

19. The device of claim 18 wherein the variable-length portion has a helical shape.