IP Library Granted Patent US 9,333,357
Granted Patent B2
US 9,333,357 · App. 14/503,259 · Granted May 10, 2016

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

Inventors: Konstantinos Alataris (Belmont, CA); Andre B. Walker (Monte Sereno, CA); Jon Parker (San Jose, CA); Yougandh Chitre (Santa Clara, CA); Sangsoo Wesley Park (San Jose, CA); James R. Thacker (Homer, AK)
Assignee: Nevro Corporation
A61N1/36171A61N1/0551A61N1/0553A61N1/06A61N1/36021A61N1/36071A61N1/36157A61N1/36164A61N1/36175A61N1/36182A61N1/3787A61N1/37235A61N1/37247A61N1/37264A61N1/3605
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Quick Facts
Patent No.
US 9,333,357
App. No.
14/503,259
Granted
May 10, 2016
Kind
B2
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 (78)

1. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord via one or more implantable signal delivery devices, the system comprising:

a signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord from an epidural location via the one or more signal delivery devices,

wherein the electrical therapy signal has

a plurality of sequential bi-phasic pulses having a pulse width between 10 microseconds and 333 microseconds, and

an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia.

2. The system of claim 1 , wherein the pulse width is between 25 microseconds and 166 microseconds.

3. The system of claim 1 , wherein the signal generator generates the therapy signal at a frequency in a frequency range between 1.5 kHz and 50 kHz.

4. The system of claim 1 , wherein the signal generator generates the therapy signal at a frequency in a frequency range between 5 kHz and 15 kHz.

5. The system of claim 1 , wherein the therapy signal has a frequency of 10 kHz, and wherein the pulses have a pulse width between 30 microseconds and 35 microseconds.

6. The system of claim 1 , wherein the executable instructions deliver the therapy signal to a vertebral level between T9 and T12, inclusive.

7. The system of claim 1 , wherein the executable instructions deliver the therapy signal at a duty cycle.

8. The system of claim 1 , wherein the signal generator is implantable.

9. The system of claim 1 wherein the signal generator is coupled to the one or more signal delivery devices.

10. The system of claim 1 wherein the signal generator is directly coupled to the one or more signal delivery devices.

11. A spinal cord modulation system for delivering a therapy signal to a patient's spinal cord via at least one implantable signal delivery device, the system comprising:

an implantable pulse generator coupleable to the at least one signal delivery device and configured to generate and deliver an electrical therapy signal to the patient's spinal cord from an epidural location via the at least one signal delivery device,

wherein the electrical therapy signal has a plurality of sequential bi-phasic pulses having

a pulse width between 25 microseconds and 166 microseconds, and

an amplitude between 0.5 mA and 10 mA, which at least partially reduces a patient's sensation of pain without generating paresthesia.

12. The system of claim 11 , wherein the pulse width is between 33 microseconds and 100 microseconds.

13. The system of claim 11 , wherein the pulse width is between 50 microseconds and 166 microseconds.

14. The system of claim 11 , wherein the pulse width is between 30 microseconds and 35 microseconds.

15. The system of claim 11 , wherein the amplitude is in an amplitude range between 0.5 mA and 4 mA.

16. The system of claim 11 , wherein the therapy signal has a frequency of 10 kHz.

17. The system of claim 11 , wherein the pulse generator is configured to deliver the therapy signal at a duty cycle.

18. The system of claim 11 , wherein the pulse generator is configured to deliver the therapy signal to a vertebral level between T9 and T12, inclusive.

19. The system of claim 11 wherein the implantable pulse generator is coupled to the at least one signal delivery device.

20. The system of claim 11 wherein the implantable pulse generator is directly coupled to the at least one signal delivery device.

21. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord, to at least partially alleviate a patient's sensation of pain without using paresthesia or tingling to mask the patient's sensation of pain, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord via one or more implantable signal delivery devices, the system comprising:

an implantable signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord from an epidural location via the one or more signal delivery devices,

wherein the electrical therapy signal has a plurality of sequential bi-phasic pulses having

a pulse width between 33 microseconds and 100 microseconds, and

an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia.

22. The system of claim 21 , wherein the therapy signal has an amplitude in an amplitude range between 0.5 mA and 4 mA.

23. The system of claim 21 , wherein the therapy signal has an amplitude in an amplitude range between 0.5 mA and 2.5 mA.

24. The system of claim 21 , wherein the therapy signal has a frequency in a frequency range between 1.5 kHz and 100 kHz.

25. The system of claim 21 , wherein the therapy signal has a frequency in a frequency range between 3 kHz and 20 kHz.

26. The system of claim 21 , wherein the executable instructions deliver the therapy signal at a duty cycle.

27. The system of claim 21 , wherein the executable instructions deliver the therapy signal to a vertebral level between T9 and T12, inclusive.

28. The system of claim 21 , wherein the executable instructions deliver the therapy signal to a vertebral level between T9 and T10, inclusive.

29. The system of claim 21 wherein the implantable signal generator is coupled to the one or more signal delivery devices.

30. The system of claim 21 wherein the implantable signal generator is directly coupled to the one or more signal delivery devices.

31. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord region, to at least partially alleviate a patient's sensation of pain without using paresthesia or tingling to mask the patient's sensation of pain, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord region via one or more implantable signal delivery devices, the system comprising:

an implantable signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord region via the one or more signal delivery devices,

wherein the electrical therapy signal is a bi-phasic signal having a plurality of pulses having

a pulse width between 33 microseconds and 100 microseconds,

an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia, and

a frequency in a frequency range between 1.5 kHz and 100 kHz.

32. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord region, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord region via one or more implantable signal delivery devices, the system comprising:

a signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord region via the one or more signal delivery devices,

wherein the electrical therapy signal is

a bi-phasic signal having a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds,

at an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia, and

a frequency range between 1.5 kHz and 50 kHz.

33. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord region, to at least partially alleviate a patient's sensation of pain without using paresthesia or tingling to mask the patient's sensation of pain, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord region via one or more implantable signal delivery devices, the system comprising:

an implantable signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord region via the one or more signal delivery devices,

wherein the electrical therapy signal is a bi-phasic signal having a plurality of pulses having

a pulse width between 33 microseconds and 100 microseconds,

an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia, and

a frequency in a frequency range between 3 kHz and 20 kHz.

34. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord region, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord region via one or more implantable signal delivery devices, the system comprising:

a signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord region via the one or more signal delivery devices,

wherein the electrical therapy signal is

a bi-phasic signal having a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds,

at an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia, and

a frequency range between 5 kHz and 15 kHz.

35. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord region via at least one implantable signal delivery device, the system comprising:

an implantable pulse generator coupleable to the at least one signal delivery device and configured to generate and deliver the electrical therapy signal to the patient's spinal cord region via the at least one signal delivery device,

wherein the electrical therapy signal is a bi-phasic signal having a plurality of pulses having

a pulse width between 25 microseconds and 166 microseconds,

an amplitude between 0.5 mA and 10 mA, which at least partially reduces a patient's sensation of pain without generating paresthesia, and

a frequency of 10 kHz.

36. A spinal cord modulation system for delivering an electrical therapy signal to a patient's spinal cord region, wherein the system is configured to deliver the electrical therapy signal to the patient's spinal cord region via one or more implantable signal delivery devices, the system comprising:

a signal generator coupleable to the one or more signal delivery devices and having executable instructions to generate and deliver the electrical therapy signal to the patient's spinal cord region via the one or more signal delivery devices,

wherein the electrical therapy signal is

a bi-phasic signal having a plurality of pulses having a pulse width between 30 microseconds and 35 microseconds,

at an amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient's sensation of pain without generating paresthesia, and

a frequency of 10 kHz.

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'S NAME PREVIOUSLY RECORDED AT REEL: 033857 FRAME: 0937. 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 040661/0611 →
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 Sep 30, 2014
From: ALATARIS, KONSTANTINOS; WALKER, ANDRE B.; PARKER, JON; CHITRE, YOUGANDH; PARK, SANGSOO WESLEY
To: NEVRO CORPORATION
Reel/Frame 033857/0937 →
Continuity (5)
Continuation 14164044 · Jan 24, 2014
Continuation 12765747 · Apr 22, 2010
Provisional Application 61176868 · May 8, 2009
Provisional Application 61171790 · Apr 22, 2009
Related Publication 20150039049A1 · Feb 5, 2015