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

DC CAFC

US 9,333,357 B2
Filed: 09/30/2014
Issued: 05/10/2016
Est. Priority Date: 04/22/2009
Status: Active Grant

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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 hasa plurality of sequential bi-phasic pulses having a pulse width between 10 microseconds and 333 microseconds, andan amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.

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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.

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36 Claims

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 hasa plurality of sequential bi-phasic pulses having a pulse width between 10 microseconds and 333 microseconds, andan amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- - 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 havinga pulse width between 25 microseconds and 166 microseconds, andan amplitude between 0.5 mA and 10 mA, which at least partially reduces a patient'"'"'s sensation of pain without generating paresthesia.
- View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
- - 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 havinga pulse width between 33 microseconds and 100 microseconds, andan amplitude between 0.5 mA and 10 mA, which at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.
- View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30)
- - 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 havinga 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, anda 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 isa 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, anda 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 havinga 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, anda 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 isa 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, anda 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 havinga 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, anda 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 isa 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, anda frequency of 10 kHz.

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Current Assignee
Nevro Corporation
Original Assignee
Nevro Corporation
Inventors
Alataris, Konstantinos, Walker, Andre B., Parker, Jon, Chitre, Yougandh, Park, Sangsoo Wesley, Thacker, James R.
Primary Examiner(s)
Wu, Eugene

Application Number

US14/503,259
Publication Number

US 20150039049A1
Time in Patent Office

588 Days
Field of Search

607/2, 607/46, 607115-117, 607/154
US Class Current

1/1
CPC Class Codes

A61N 1/0551   Spinal or peripheral nerve ...

A61N 1/0553   Paddle shaped electrodes, e...

A61N 1/06   for high-frequency therapy

A61N 1/323   Interference currents, i.e....

A61N 1/36021   for treatment of pain

A61N 1/3605   Implantable neurostimulator...

A61N 1/36062   Spinal stimulation

A61N 1/36071   Pain

A61N 1/36089   Addiction or withdrawal fro...

A61N 1/36128   Control systems

A61N 1/36132   using patient feedback

A61N 1/36157   Current A61N1/3616 takes pr...

A61N 1/3616   Voltage density or current ...

A61N 1/36164   Sub-threshold or non-excita...

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 parame...

A61N 1/36182   Direction of the electrical...

A61N 1/37235   Aspects of the external pro...

A61N 1/37241 : providing test stimulations

A61N 1/37247 : User interfaces, e.g. input...

A61N 1/37264 : Changing the program; Upgra...

A61N 1/3787 : from an external energy source

G01R 21/133 : by using digital technique

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

First Claim

6 Assignments

Litigations

1 Petition

Accused Products

Abstract

328 Citations

36 Claims

Specification

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

First Claim

6 Assignments

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Litigations

1 Petition

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Accused Products

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Abstract

328 Citations

36 Claims

Specification

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Solutions

Use Cases

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