IP Library Granted Patent US 8,209,021
Granted Patent B2
US 8,209,021 · App. 13/245,471 · Granted Jun 26, 2012

Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods

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Quick Facts
Patent No.
US 8,209,021
App. No.
13/245,471
Granted
Jun 26, 2012
Kind
B2
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 (49)

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.

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. 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.

7. 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.

8. 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.

9. 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.

10. 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.

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.

12. The device of claim 11 wherein the pulse generator is an implantable pulse generator.

13. The device of claim 11 wherein the pulse generator is an external pulse generator.

14. 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.

15. The device of claim 11 wherein the pulse generator is programmed to direct the electrical signal at a frequency of about 10 kHz.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

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.

23. The device of claim 22 wherein the instructions, when executed, direct the pulsed electrical signal at a frequency of about 10 kHz.

24. The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by from about 8 millimeters to about 64 millimeters.

25. The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by at least 16 millimeters.

26. The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by at least 32 millimeters.

27. The device of claim 22 wherein immediately neighboring contacts are spaced apart from each other by approximately 64 millimeters.

28. The device of claim 22 wherein the lead body includes a variable-length portion.

29. The device of claim 28 wherein the variable-length portion has a helical shape.

30. 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.

31. 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.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Apr 4, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS AGENT
To: NEVRO CORP.
Reel/Frame 070743/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 1, 2023
From: NEVRO CORP.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS AGENT
Reel/Frame 065744/0302 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY DATA NAME PREVIOUSLY RECORDED AT REEL: 030718 FRAME: 0543. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Nov 21, 2016
From: ALATARIS, KONSTANTINOS; WALKER, ANDRE B.; PARKER, JON; CHITRE, YOUGANDH; PARK, SANGSOO WESLEY; THACKER, JAMES R.
To: NEVRO CORP.
Reel/Frame 040653/0230 →
RELEASE OF SECURITY INTEREST Recorded Jun 27, 2016
From: CRG SERVICING LLC
To: NEVRO CORP.
Reel/Frame 039168/0890 →
ASSIGNMENT AGREEMENT (REAFFIRMATION) Recorded Jun 13, 2016
From: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
To: CRG SERVICING LLC,
Reel/Frame 038984/0865 →
SECURITY INTEREST Recorded Dec 12, 2014
From: NEVRO CORP.
To: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Reel/Frame 034619/0546 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 1, 2013
From: ALATARIS, KONSTANTINOS; WALKER, ANDRE B.; PARKER, JON; CHITRE, YOUGANDH; PARK, SANGSOO WESLEY; THACKER, JAMES R.
To: NEVRO CORPORATION
Reel/Frame 030718/0543 →