Systems and methods for deploying patient therapy devices

• US 9,895,538 B1
• Filed: 01/22/2014
• Issued: 02/20/2018
• Est. Priority Date: 01/22/2013
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Thacker, James R., Walker, Andre B., Parker, Jon, Gliner, Bradford Evan, Moeri, Heinz
• Primary Examiner(s): Evanisko, George
• Application Number:
  US14/161,592
• Time in Patent Office: 1,490 Days
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Methods for identifying responders to paresthesia-free stimulation therapy, and associated systems are disclosed. A representative method comprises implanting a pair of spinal cord signal delivery devices and connecting an external signal generator thereto. A plurality of the electrical contacts are simultaneously activated with a high frequency signal without causing paresthesia in the patient, wherein the electrical contacts would cause paresthesia in the patient if activated with a low frequency signal. The high frequency signal is in a range of from about 3 kHz to about 20 kHz and an amplitude of less than 4 mA. If the patient responds favorably, a signal generator is implanted in the patient. A second high frequency signal is then applied to fewer than the plurality of electrical contacts.

Claims

1. A method of identifying patient responders to a paresthesia-free spinal cord stimulation therapy, the method comprising:

implanting in a patient a pair of spinal cord signal delivery devices, each having at least eight electrical contacts;

connecting an external signal generator to the spinal cord signal delivery devices;

initially simultaneously activating at least twelve of the electrical contacts with a therapy signal from the external signal generator without causing paresthesia in the patient while delivering the therapy;

implanting a signal generator in the patient if the patient responds favorably to the simultaneous activation of the at least twelve electrical contacts; and

after implanting the signal generator, applying the therapy signal to the patient via fewer than the at least twelve electrical contacts.

2. The method of claim 1, wherein at least a portion of the therapy signal is at a frequency in a frequency range between 1.5 kHz and 100 kHz.

3. The method of claim 2, wherein the amplitude of the therapy signal is between 0.5 mA and 20 mA.

4. The method of claim 1, wherein after implanting the signal generator, the therapy signal is applied via two of the plurality of electrical contacts.

5. The method of claim 1, wherein after implanting the signal generator, the therapy signal is applied at a duty cycle of less than about 17%.

6. The method of claim 1, wherein after implanting the signal generator, the therapy signal is applied at a duty cycle of less than about 10%.

7. The method of claim 1, further comprising monitoring the impedance of each of the fewer than the at least twelve electrical contacts and grouping the fewer than the at least twelve electrical contacts into a first group and a second group based on the impedance of the individual contacts and simultaneously activating the contacts of the first group of contacts using a first current source and the contacts of the second group of contacts using a second current source.

8. The method of claim 7, further comprising removing a selected contact from the first group if the selected contact'"'"'s impedance is outside a selected range and including the selected contact in the second group.

9. The method of claim 1, further comprising simultaneously activating the at least twelve of the electrical contacts for a duration of approximately 20 minutes or more.

10. A method for deploying a patient therapy system, comprising:

implanting in a patient at least one spinal cord signal delivery device having at least 8 electrical contacts;

connecting an external signal generator to the at least one spinal cord signal delivery device;

determining whether the patient responds favorably to a paresthesia-free therapy signal from the external signal generator by initially simultaneously applying the signal to at least 75% of any of the electrical contacts;

implanting a signal generator into the patient when the patient responds favorably; and

after implanting the signal generator, applying the paresthesia-free therapy signal to a plurality of the electrical contacts fewer than the at least 75% of the electrical contacts via the implanted signal generator.

11. The method of claim 10, wherein at least a portion of the therapy signal is at a frequency in a frequency range from about 1.5 kHz to about 100 kHz.

12. The method of claim 10, wherein the therapy signal is at a frequency in a frequency range from about 3 kHz to about 50 kHz.

13. The method of claim 12, wherein the therapy signal is at a frequency in a frequency range from about 5 kHz to about 15 kHz.

14. The method of claim 10, wherein the therapy signal has an amplitude of less than 2.5 mA.

15. The method of claim 10, wherein the at least 75% of the electrical contacts includes twelve electrical contacts.

16. The method of claim 15, wherein the at least 75% of the electrical contacts includes all of the electrical contacts.

17. The method of claim 10, further comprising two spinal cord signal delivery devices, each having multiple electrical contacts.

18. The method of claim 10, further comprising monitoring the impedance of each of the fewer than the at least 75% of electrical contacts and grouping the fewer than the at least 75% of electrical contacts into a first group and a second group based on the impedance of the individual contacts and simultaneously activating the contacts of the first group of contacts using a first current source and the contacts of the second group of contacts using a second current source.

19. The method of claim 18, further comprising removing a selected contact from the first group if the selected contact'"'"'s impedance is outside a selected range and including the selected contact in the second group.

20. The method of claim 10, further comprising simultaneously applying the signal to the at least 75% of the electrical contacts for a duration of approximately 20 minutes or more.