Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions

• US 8,849,410 B2
• Filed: 04/05/2013
• Issued: 09/30/2014
• Est. Priority Date: 01/29/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Walker, Andre B., Fang, Zi-Ping, Caparso, Anthony V.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/857,960
• Publication Number:
  US 20140180359A1
• Time in Patent Office: 543 Days
• Field of Search: 607/46
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions are disclosed. A method in accordance with a particular embodiment includes selecting a target stimulation frequency that is above a threshold frequency, with the threshold frequency corresponding to a refractory period for neurons of a target sensory neural population. The method can further include producing a patient sensation of paresthesia by directing an electrical signal to multiple sensory neurons of the target sensory neural population at the stimulation frequency, with individual neurons of the sensory neural population completing corresponding individual refractory periods at different times, resulting in an asynchronous sensory neuron response to the electrical signal.

Claims

1. A therapy system for treating a patient'"'"'s pain, comprising:

a pulse generator coupled to a signal delivery element to transmit multiple electrical stimulation signals to the signal delivery element, the signal delivery element comprising a lead body including one or more electrodes; and

a machine-readable medium within the pulse generator, the machine-readable medium containing instructions that, when executed, cause the pulse generator to transmit the multiple electrical stimulation signals to multiple neurons of a target sensory neural population via the signal delivery element, wherein the multiple electrical stimulation signals have a target stimulation frequency that is in a range from 3.0 kHz to 10 kHz, and wherein the multiple electrical stimulation signals produce an asynchronous sensory neuron response.

2. The therapy system of claim 1, wherein the target stimulation frequency is above a threshold frequency that corresponds to a refractory period for individual neurons of the target sensory neural population.

3. The therapy system of claim 2 wherein the multiple electrical stimulation signals have a frequency at least an order of magnitude greater than the threshold frequency.

4. The therapy system of claim 2 wherein the multiple electrical stimulation signals have a frequency at least twice the threshold frequency.

5. The therapy system of claim 1 wherein the multiple electrical stimulation signals delivered to the patient include a continuous string of bi-phasic, charge-balanced, paired pulses.

6. The therapy system of claim 5, wherein the pulses are delivered at a frequency greater than a threshold frequency, which corresponds to a refractory period for individual neurons of the target sensory neural population, during a first period of time to initiate the asynchronous sensory neuron response.

7. The therapy system of claim 6 further comprising:

machine-readable medium within the pulse generator, the machine-readable medium containing instructions that, when executed, cause the pulse generator to deliver first and second electrical signals during a second period of time to extend the duration of the asynchronous sensory response, wherein pulses of the first and second signals are interleaved.

8. The therapy system of claim 6 wherein the multiple electrical stimulation signals delivered to the patient include:

a generally constant stream of pulses delivered at a frequency greater than a threshold frequency, which corresponds to a refractory period for individual neurons of the target sensory neural population, during a first period of time to initiate the asynchronous sensory neuron response; and

additional pulses delivered during a second period of time to extend the duration of the asynchronous sensory response, the additional pulses being spaced apart from each other by a quiescent period that is less than the refractory period.

9. The therapy system of claim 6 wherein the multiple electrical stimulation signals have a single, generally unvarying frequency.

10. The therapy system of claim 1 wherein the electrical stimulation signals include a first electrical signal having a first frequency and a second electrical signal having a second frequency, the pulses of the second electrical signal being spaced apart from the neighboring pulses of the first electrical signal.

11. The therapy system of claim 10 wherein the pulses of the second electrical signal are spaced apart from neighboring pulses of the first signal by less than a refractory period for individual neurons of the target sensory neural population.

12. The therapy system of claim 10 wherein the second frequency is the same as the first frequency.

13. The therapy system of claim 10 wherein the first electrical signal has a first intensity level and the second electrical signal has a second intensity level greater than the first intensity level.

14. The therapy system of claim 10 wherein the first electrical signal includes pulses spaced apart at constant inter-pulse intervals, and wherein the second electrical signal include pulses that are delayed relative to the neighboring pulses of the first electrical signal by a varying value.

15. The therapy system of claim 14 wherein the instructions automatically:

adjust the frequency in a stepwise fashion; and

identify the asynchronous sensory neuron response based at least in part on a drop in a level of the neural response detected by the patient sensor.

16. The therapy system of claim 1, further comprising a patient sensor positionable relative to the patient to detect a patient neural response to the multiple electrical stimulation signals, and wherein the machine-readable medium further contains instructions that, when executed, adjust the frequency of the multiple electrical stimulation signals and determine when the multiple electrical stimulation signals produce the asynchronous sensory neuron response.

17. A method for configuring a spinal cord stimulation device for treating a patient'"'"'s pain, the method comprising:

selecting a target stimulation frequency that is above a threshold frequency corresponding to a refractory period for neurons of a target sensory neural population, wherein the target stimulation frequency is in a range from 3.0 kHz to 10 kHz; and

programming the device to deliver multiple electrical stimulation signals, wherein the multiple electrical stimulation signals together produce the target stimulation frequency and an asynchronous sensory neuron response in the target sensory neural population.

18. The method of claim 17 wherein selecting a target frequency includes selecting a target frequency to be at least an order of magnitude greater than the threshold frequency.

19. The method of claim 17, further comprising programming the device to direct the multiple electrical stimulation signals to multiple sensory neurons of the target sensory neural population, via at least one signal delivery element, without blocking afferent sensory signals from the target sensory neural population.

20. The method of claim 17 wherein directing the multiple electrical stimulation signals includes directing the multiple electrical stimulation signals without triggering a muscle response.

21. A therapy system for delivering multiple electrical stimulation signals to a patient'"'"'s spinal cord region, the system comprising:

an implantable lead having a plurality of electrodes, wherein the lead is positionable to deliver the multiple electrical stimulation signals to a target neural population of the patient;

an implantable pulse generator coupleable to the implantable lead to transmit the multiple electrical stimulation signals to the implantable lead; and

a machine-readable medium containing instructions that, when executed, cause the implantable pulse generator to transmit the multiple electrical stimulation signals to the patient'"'"'s spinal cord region via the implantable lead, wherein the multiple electrical stimulation signals have a target stimulation frequency that is in a range from 3.0 kHz to 10 kHz, and wherein the multiple electrical stimulation signals produce an asynchronous sensory neuron response.

22. The system of claim 21, wherein the target stimulation frequency is above a threshold frequency that corresponds to a refractory period for individual neurons in the patient'"'"'s spinal cord region.

23. The therapy system of claim 21, further comprising a patient sensor positionable relative to the patient to detect a patient neural response to the multiple electrical stimulation signals delivered by the implantable lead.

24. The therapy system of claim 23 wherein the machine-readable medium further contains instructions that, when executed, adjust the frequency of the multiple electrical stimulation signals and determine when the multiple electrical stimulation signals produce the asynchronous sensory neuron response.