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

DC CAFC

US 9,327,125 B2
Filed: 04/24/2014
Issued: 05/03/2016
Est. Priority Date: 04/22/2009
Status: Active Grant

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1. A method for treating a patient, comprising:

a step for communicating with a signal generator, including establishing a wireless link with the signal generator; and

a step for configuring the signal generator, including programming the signal generator to generate and deliver a paresthesia-free therapy signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, wherein the therapy signal has (a) a frequency in a frequency range from 1.5 kHz to 100 kHz, (b) a plurality of bi-phasic pulses having a pulse width in a pulse width range from 10 microseconds to 333 microseconds, and (c) is at an amplitude that is therapeutic but does not generate paresthesia in the patient.

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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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68 Claims

1. A method for treating a patient, comprising:
- a step for communicating with a signal generator, including establishing a wireless link with the signal generator; and
  
  a step for configuring the signal generator, including programming the signal generator to generate and deliver a paresthesia-free therapy signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, wherein the therapy signal has (a) a frequency in a frequency range from 1.5 kHz to 100 kHz, (b) a plurality of bi-phasic pulses having a pulse width in a pulse width range from 10 microseconds to 333 microseconds, and (c) is at an amplitude that is therapeutic but does not generate paresthesia in the patient.
- View Dependent Claims (2, 3, 4, 5)
- - 2. The method of claim 1 wherein the step for configuring the signal generator is a first step for configuring the signal generator, and wherein the method further comprises a second step for configuring the signal generator, including programming the signal generator to deliver the therapy signal at a duty cycle of less than 100%.
  - 3. The method of claim 1, wherein the step for configuring the signal generator does not include the use of paresthesia-mapping to identify a target location for delivering the therapy signal to the patient'"'"'s spinal cord.
  - 4. The method of claim 1 wherein the frequency range is from 3 kHz to 20 kHz.
  - 5. The method of claim 1 wherein the pulse width range is from 30 microseconds to 35 microseconds.

6. A method for treating a patient, comprising:
- a step for communicating with a signal generator, including establishing a wireless link with the signal generator;
  
  a first step for configuring the signal generator, including programming the signal generator to generate and deliver a paresthesia-free therapy signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, wherein the therapy signal has (a) a frequency in a frequency range from 1.5 kHz to 100 kHz, (b) a plurality of bi-phasic pulses having a pulse width in a pulse width range from 10 microseconds to 333 microseconds, and (c) an amplitude that is therapeutic but does not generate paresthesia in the patient; and
  
  a second step for configuring the signal generator, including programming the signal generator to deliver the therapy signal to a vertebral level between T9 and T12, inclusive, via the at least one implantable signal delivery device.
- View Dependent Claims (7, 8)
- - 7. The method of claim 6 wherein the frequency range is from 3 kHz to 20 kHz.
  - 8. The method of claim 6 wherein the pulse width range is from 30 microseconds to 35 microseconds.

9. A method for treating a patient, comprising:
- a step for communicating with a signal generator, including establishing a wireless link with the signal generator;
  
  a first step for configuring the signal generator, including programming the signal generator to generate and deliver a paresthesia-free therapy signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, wherein the therapy signal has (a) a frequency in a frequency range from 1.5 kHz to 100 kHz, (b) a plurality of bi-phasic pulses having a pulse width in a pulse width range from 10 microseconds to 333 microseconds, and (c) an amplitude that is therapeutic but does not generate paresthesia in the patient; and
  
  a second step for configuring the signal generator, including programming the signal generator to deliver the therapy signal to a vertebral level between T9 and T10, inclusive, via the at least one implantable signal delivery device.
- View Dependent Claims (10, 11)
- - 10. The method of claim 9 wherein the frequency range is from 3 kHz to 20 kHz.
  - 11. The method of claim 9 wherein the pulse width range is from 30 microseconds to 35 microseconds.

12. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a paresthesia-free therapy signal with a signal frequency in a frequency range from 1.5 kHz to 100 kHz; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord, wherein the means for delivering the therapy signal is at least partially implantable.
- View Dependent Claims (13, 14, 15, 16, 17)
- - 13. The system of claim 12 wherein the means for generating includes an implantable pulse generator.
  - 14. The system of claim 12 wherein the means for generating includes an external pulse generator.
  - 15. The system of claim 12 wherein the means for delivering includes a percutaneous lead.
  - 16. The system of claim 12 wherein the signal frequency is between 3 kHz and 20 kHz.
  - 17. The system of claim 12 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 10 microseconds to 333 microseconds.

18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a paresthesia-free therapy signal with a signal frequency in a frequency range from 1.5 kHz to 100 kHz; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord at a vertebral level of from T9 to T12, wherein the means for delivering the therapy signal is at least partially implantable.
- View Dependent Claims (19, 20, 21, 22, 23)
- - 19. The system of claim 18 wherein the frequency range is from 3 kHz to 20 kHz.
  - 20. The system of claim 18 wherein a pulse width of the therapy signal is in a pulse width range of from 10 microseconds to 333 microseconds.
  - 21. The system of claim 18 wherein a pulse width of the therapy signal is in a pulse width range of from 25 microseconds to 166 microseconds.
  - 22. The system of claim 18 wherein a pulse width of the therapy signal is in a pulse width range of from 30 microseconds to 35 microseconds.
  - 23. The system of claim 18 wherein an amplitude of the therapy signal is in an amplitude range of from 0.5 milliamps to 10 milliamps.

24. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a paresthesia-free therapy signal with a signal frequency in a frequency range from 1.5 kHz to 100 kHz and pulses having a pulse width in a pulse width range from 25 microseconds to 166 microseconds; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord, wherein the means for delivering the therapy signal is at least partially implantable.
- View Dependent Claims (25, 26, 27, 28, 29)
- - 25. The system of claim 24 wherein the means for generating includes an implantable pulse generator.
  - 26. The system of claim 24 wherein the means for generating includes an external pulse generator.
  - 27. The system of claim 24 wherein the means for delivering includes an elongated flexible lead.
  - 28. The system of claim 24 wherein the frequency range is from 3 kHz to 20 kHz.
  - 29. The system of claim 24 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

30. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a paresthesia-free therapy signal wherein;
  
  the signal has a signal frequency in a frequency range from 3 kHz and 20 kHz;
  
  the therapy signal includes pulses having a pulse width between 25 microseconds and 166 microseconds, inclusive; and
  
  the therapy signal includes a current amplitude between 0.5 milliamps and 10 milliamps, inclusive; and
  
  wherein the system further comprises;
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord, wherein the means for delivering the therapy signal is at least partially implantable.
- View Dependent Claims (31, 32, 33)
- - 31. The system of claim 30 wherein the means for generating includes an implantable pulse generator.
  - 32. The system of claim 30 wherein the means for generating includes an external pulse generator.
  - 33. The system of claim 30 wherein the means for delivering includes an elongated flexible lead.

34. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a paresthesia-free therapy signal with a signal frequency of 10 kHz; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord, wherein the means for delivering the therapy signal is at least partially implantable.
- View Dependent Claims (35, 36, 37, 38)
- - 35. The system of claim 34 wherein the means for generating includes an implantable pulse generator.
  - 36. The system of claim 34 wherein the means for generating includes an external pulse generator.
  - 37. The system of claim 34 wherein the means for delivering includes an elongated flexible lead.
  - 38. The system of claim 34 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

39. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a paresthesia-free therapy signal wherein the therapy signal has a signal frequency of 10 kHz, includes pulses having a pulse width between 30 microseconds and 35 microseconds, inclusive, and includes a current amplitude between 0.5 milliamps and 10 milliamps, inclusive; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord, wherein the means for delivering the therapy signal is at least partially implantable.
- View Dependent Claims (40, 41, 42)
- - 40. The system of claim 39 wherein the means for generating includes an implantable pulse generator.
  - 41. The system of claim 39 wherein the means for generating includes an external pulse generator.
  - 42. The system of claim 39 wherein the means for delivering includes an elongated flexible lead.

43. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord region, wherein the means for delivering the therapy signal is configured to be implanted in the patient'"'"'s epidural space.
- View Dependent Claims (44, 45, 46, 47, 48)
- - 44. The system of claim 43 wherein the means for generating includes an implantable pulse generator.
  - 45. The system of claim 43 wherein the means for generating includes an external pulse generator.
  - 46. The system of claim 43 wherein the means for delivering includes an elongated flexible lead.
  - 47. The system of claim 43 wherein the frequency range is from 3 kHz to 20 kHz.
  - 48. The system of claim 43 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 10 microseconds to 333 microseconds.

49. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz and wherein the therapy signal includes pulses having a pulse width in a pulse width range from 25 microseconds to 166 microseconds; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord region, wherein the means for delivering the therapy signal is configured to be implanted in the patient'"'"'s epidural space.
- View Dependent Claims (50, 51, 52, 53, 54)
- - 50. The system of claim 49 wherein the means for generating includes an implantable pulse generator.
  - 51. The system of claim 49 wherein the means for generating includes an external pulse generator.
  - 52. The system of claim 49 wherein the means for delivering includes an elongated flexible lead.
  - 53. The system of claim 49 wherein the frequency range is from 3 kHz to 20 kHz.
  - 54. The system of claim 49 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

55. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a non-paresthesia-producing therapy signal, wherein;
  
  at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz;
  
  the therapy signal includes pulses having a pulse width in a pulse width range from 25 microseconds to 166 microseconds; and
  
  the therapy signal includes a current amplitude in a current amplitude range from 0.5 milliamps to 10 milliamps; and
  
  wherein the system further comprises;
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord region, wherein the means for delivering the therapy signal is configured to be implanted in the patient'"'"'s epidural space.
- View Dependent Claims (56, 57, 58, 59)
- - 56. The system of claim 55 wherein the means for generating includes an implantable pulse generator.
  - 57. The system of claim 55 wherein the means for generating includes an external pulse generator.
  - 58. The system of claim 55 wherein the means for delivering includes an elongated flexible lead.
  - 59. The system of claim 55 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

60. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 10 kHz; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord region, wherein the means for delivering the therapy signal is configured to be implanted in the patient'"'"'s epidural space.
- View Dependent Claims (61, 62, 63, 64)
- - 61. The system of claim 60 wherein the means for generating includes an implantable pulse generator.
  - 62. The system of claim 60 wherein the means for generating includes an external pulse generator.
  - 63. The system of claim 60 wherein the means for delivering includes an elongated flexible lead.
  - 64. The system of claim 60 wherein the therapy signal includes pulses having a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

65. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
- means for generating a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 10 kHz, includes pulses having a pulse width in a pulse width range from 30 microseconds to 35 microseconds, and includes a current amplitude in a current amplitude range from 0.5 milliamps to 10 milliamps; and
  
  means for delivering the therapy signal to the patient'"'"'s spinal cord region wherein the means for delivering the therapy signal is configured to be implanted in the patient'"'"'s epidural space.
- View Dependent Claims (66, 67, 68)
- - 66. The system of claim 65 wherein the means for generating includes an implantable pulse generator.
  - 67. The system of claim 65 wherein the means for generating includes an external pulse generator.
  - 68. The system of claim 65 wherein the means for delivering includes an elongated flexible lead.

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Litigation Data

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

US14/261,369
Publication Number

US 20140343622A1
Time in Patent Office

740 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

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Accused Products

Abstract

327 Citations

68 Claims

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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

0 Petitions

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Accused Products

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Abstract

327 Citations

68 Claims

Specification

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