Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods

• US 10,328,256 B1
• Filed: 11/09/2017
• Issued: 06/25/2019
• Est. Priority Date: 06/22/2012
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Gliner, Bradford Evan
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/808,591
• Time in Patent Office: 593 Days
• Field of Search: 607117, 607 64
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods. A method for treating a patient in accordance with a particular embodiment includes selecting a neural modulation site to include a neural population of the patient'"'"'s spinal cord, and selecting parameters of a neural modulation signal to at least reduce an autonomic system deficit in the patient.

Claims

1. A method for treating a patient, comprising:

reducing or modifying an organ dysfunction of an identified organ in the patient by applying or directing application of an electrical signal to WDR neurons of the patient'"'"'s spinal cord via an implanted signal delivery device, at a vertebral level corresponding to the identified organ, the electrical signal having a frequency of from about 1.5 kHz to about 100 kHz.

2. The method of claim 1 wherein reducing or modifying the organ dysfunction includes reducing or modifying an imbalance between an effect of the patient'"'"'s sympathetic system and an effect of the patient'"'"'s parasympathetic system.

3. The method of claim 1 wherein reducing or modifying the organ dysfunction includes normalizing a combined effect of the patient'"'"'s sympathetic and parasympathetic systems.

4. The method of claim 1 wherein the electrical signal has a frequency in a range of from about 3 kHz to about 20 kHz.

5. The method of claim 1 wherein the electrical signal is directed to the patient'"'"'s dorsal horn.

6. A method for evaluating a patient'"'"'s pain, comprising:

directing an electrical therapy signal via an implanted signal delivery device to reduce or inhibit pain in the patient, the electrical therapy signal having a frequency of from about 1.5 kHz to about 100 kHz;

receiving feedback corresponding to an autonomic system response of the patient to the electrical therapy signal, wherein the autonomic system response is a reduction or modification of an organ dysfunction achieved by normalizing a combined effect of the patient'"'"'s sympathetic and parasympathetic systems; and

based at least in part on the feedback, identifying a characteristic of a pain response of the patient to the electrical therapy signal.

7. The method of claim 6, further comprising adjusting at least one signal delivery parameter in accordance with which the electrical therapy signal is directed to the patient'"'"'s spinal cord, based at least in part on the feedback.

8. The method of claim 7 wherein adjusting at least one signal delivery parameter improves an effect of the electrical therapy signal.

9. The method of claim 6 wherein receiving feedback includes directly observing changes in the characteristic of the patient'"'"'s pain response.

10. The method of claim 9 wherein the autonomic system response is a heart condition, a diabetic response, a pulmonary function, or a sexual function.

11. The method of claim 6 wherein receiving feedback includes directly observing a function of the patient controlled by the autonomic nervous system.

12. The method of claim 6 wherein receiving feedback includes directly observing a function of the patient controlled by an organ identified as having the organ dysfunction.

13. The method of claim 6, further comprising correlating the patient'"'"'s autonomic system response to the electrical therapy signal with the characteristic of the patient'"'"'s pain response.

14. The method of claim 13 wherein the patient'"'"'s autonomic system response to the electrical therapy signal indicates the patient'"'"'s pain response.

15. The method of claim 6 wherein directing application of the electrical signal includes directing application of the electrical signal to WDR neurons of the patient'"'"'s spinal cord.

16. The method of claim 6 wherein directing application of the electrical signal includes directing application of the electrical signal at a vertebral level corresponding to an organ having the organ dysfunction.

17. The method of claim 16 wherein the vertebral level of the patient'"'"'s spinal cord is an upper thoracic vertebral level.

18. The method of claim 16 wherein the vertebral level of the patient'"'"'s spinal cord is a cervical level of the spinal cord.

19. The method of claim 6 wherein the autonomic system response affects a target organ of the patient'"'"'s cardiovascular system.

20. The method of claim 6 wherein the autonomic system response affects a target organ of the patient'"'"'s gastrointestinal system.

21. The method of claim 6 wherein directing the electrical therapy signal includes directing the electrical therapy signal without the electrical therapy signal causing paresthesia in the patient.

22. The method of claim 6 wherein receiving feedback includes monitoring the patient'"'"'s autonomic system with a medical device.

23. A method for evaluating a patient'"'"'s pain, comprising:

directing an electrical therapy signal to the patient'"'"'s spinal cord via an implanted signal delivery device to reduce or inhibit pain in the patient, the electrical therapy signal having a frequency of from about 1.5 kHz to about 100 kHz;

receiving feedback corresponding to the patient'"'"'s autonomic system response to the electrical therapy signal by monitoring an input from a sensor with a control algorithm embedded within the implanted signal delivery device; and

based at least in part on the feedback, identifying a characteristic of the patient'"'"'s pain response to the electrical therapy signal.

24. The method of claim 23 wherein the sensor is an accelerometer, a gyroscope, a blood pressure sensor, an impedance sensor, a thoracic impedance sensor, a heart rate monitor, a respiration rate monitor, or a temperature sensor.

25. The method of claim 23, further comprising;

initializing the sensor with a value;

setting a delta change threshold for the sensor; and

setting a confidence interval for the control algorithm.

26. The method of claim 25, further comprising determining a value range based on the confidence interval of the control algorithm.

27. The method of claim 25 wherein the delta change threshold indicates if the sensor input is outside of an expected sensor input range.

28. The method of claim 27, further comprising programming the implanted signal delivery device to, monitor the sensor input and, if the monitored sensor input is outside of the expected sensor input range, change a stimulation program or a stimulation parameter.

29. The method of claim 28 wherein the implanted signal delivery device emits an alert if the implanted signal delivery device changed the stimulation program or the stimulation parameter.