Systems and devices to identify and limit nerve conduction

• US 9,693,817 B2
• Filed: 08/24/2015
• Issued: 07/04/2017
• Est. Priority Date: 01/21/2015
• Status: Active Grant

• Current Assignee: Serene Medical, Inc.
• Original Assignee: Serene Medical, Inc.
• Inventors: Mehta, Bankim H., McCall, Mark, McGill, Scott A.
• Primary Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US14/834,298
• Publication Number:
  US 20160206363A1
• Time in Patent Office: 680 Days
• Field of Search: 600554, 606 28, 606 34, 606 41, 607 48, 607 99, 607113, 607115, 607116, 607118
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00321 Head or parts thereof
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/0047 Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00958 for switching between different working modes of the main function
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

Methods and devices for improved precision in finding one or more nerves and then interrupting the transmission of neural signals through the target nerve. The treated nerve can be rendered incapable of transmitting neural signals for a select duration of time, where such a duration can be on a temporarily basis (e.g., hours, days or weeks) or a longer term/permanent basis (e.g., months or years). One embodiment of the apparatus includes a precise energy source system which features energy transfer elements that are capable of creating areas of nerve destruction, inhibition and ablation with precision.

Claims

1. A method of treating a nerve in a tissue region, the method comprising:

positioning a working end of a device into the tissue region;

where the device includes a stimulation mode and an energy delivery mode, the stimulation mode comprises at least a first parameter setting that stimulates the nerve at a first distance from the working end, and a second parameter setting that stimulates the nerve at a second distance from the working end, where the first distance is greater than the second distance, and where the device is configured to prevent activation of the energy delivery mode when the stimulation mode is in the first parameter setting;

activating the device in the stimulation mode at the first parameter setting while observing for stimulation of the nerve;

repositioning the working end of the device in the tissue region to move the working end closer to the nerve;

re-activating the device in the stimulation mode at the second parameter setting while observing for stimulation of the nerve such that observing stimulation of the nerve using the second parameter setting confirms positioning of the working end of the device closer to the nerve; and

activating the device in the energy delivery mode to create a first treatment zone on the nerve, where activating the device in the energy delivery mode causes the device to reset to the first parameter setting.

2. The method of claim 1, further comprising moving the working end in a direction relative to the nerve to create multiple treatment zones along the nerve.

3. The method of claim 2, where moving the working end of the device in the direction relative to the nerve comprises moving the working end of the device in a forward direction distally to a first treatment zone along the nerve such that a muscle associated with the nerve can be stimulated during stimulation of the nerve.

4. The method of claim 1, where positioning the working end of the device and repositioning the working end of the device occurs without removing the device from a puncture site.

5. The method of claim 4, further comprising performing moving the device in a plurality of directions without removing the device from the tissue region to increase an area for observing stimulation of the nerve.

6. The method of claim 1, further comprising injecting an anesthetic at or near the first treatment zone prior to activating the device in the energy delivery mode.

7. The method of claim 1, further comprising reducing a temperature of a surface of the tissue region prior to delivering energy and during the energy delivery.

8. The method of claim 1, further comprising the use of an external nerve stimulator to map a nerve anatomy on a surface of the tissue region, prior to inserting the device, and using the map as a guide to identify target treatment locations.

9. The method of claim 1, where the first parameter setting comprises a first current setting and the second parameter setting comprises a second current setting, where the second current setting is less than the first current setting.

10. The method of claim 1, where the first parameter setting is fixed.

11. The method of claim 10, where the second parameter setting is adjustable.

12. The method of claim 1, where activating the device in the stimulation mode at the first parameter setting while observing for stimulation of the nerve comprises observing movement of a surface of the tissue region.

13. The method of claim 1, where activating the device in the stimulation mode at the first parameter setting while observing for stimulation of the nerve comprises performing electromyography on at least one muscle associated with the nerve.

14. The method of claim 1, where activating the device in the stimulation mode at the first parameter setting while observing for stimulation of the nerve comprises measuring an electrical impulse in at least one muscle associated with the nerve using a measuring electrode.

15. The method of claim 1, where creating the first treatment zone on the nerve comprises using a pre-determined temperature.

16. The method of claim 1, where the device includes a controller configured to power the device between the stimulation mode and the energy delivery mode.

17. The method of claim 1, where the device is capable of being manually overridden to the energy delivery mode when the stimulation mode is in the first parameter setting.

18. A method of treating a nerve in a tissue region, the method comprising:

positioning a device into the tissue region at a first location;

applying energy to the tissue region through the device at the first location using a first setting configured to stimulate the nerve within a first distance from a working end of the device;

observing for stimulation of the nerve;

re-applying energy to the tissue region through the device at a second location using a second setting configured to stimulate the nerve within a second distance from the working end of the device, where the second distance is less than the first distance;

re-assessing whether the nerve is stimulated at the second setting to determine if the second location is closer to the nerve than the first location;

activating the device to apply therapeutic energy to the nerve to affect the ability of the nerve to transmit a neural signal upon observing stimulation of the nerve when using the second setting.

20. The method of claim 18, where re-applying energy to the tissue region through the device at the second location comprises moving the device in a direction relative to the nerve to create multiple treatment zones along the nerve.

21. The method of claim 20, where moving the device in the direction relative to the nerve comprises moving the device in a forward direction distally to the first location along the nerve such that a muscle associated with the nerve can be stimulated during stimulation of the nerve.

22. The method of claim 20, where positioning the device at the first location and the second location occurs without removing the device from a puncture site.

23. The method of claim 18, further comprising moving the device in a plurality of directions without removing the device from the tissue region prior to re-applying energy at the second location.

24. The method of claim 18, further comprising injecting an anesthetic at or near the tissue region at the first location site prior to applying energy to the tissue region.

25. The method of claim 18, further comprising reducing a temperature of a surface of the tissue region prior to applying energy to the nerve and during the energy delivery.

26. The method of claim 18, further comprising using an external nerve stimulator to map a nerve anatomy, prior to inserting the device, and using the map as a guide to identify target treatment locations.

27. The method of claim 18, where the first setting comprises a first current setting and the second setting comprises a second current setting, where the second current setting is less than the first current setting.

28. The method of claim 18, where observing stimulation of the nerve comprises observing for movement of a surface of the tissue region.

29. The method of claim 18, where observing stimulation of the nerve comprises performing electromyography on at least one muscle associated with the nerve.

30. The method of claim 18, where observing stimulation of the nerve comprises measuring an electrical impulse in at least one muscle associated with the nerve using a measuring electrode.

19. The method of 18, wherein the device resets to the first setting after applying energy to the nerve, the method further comprising re-adjusting the device to the second setting and subsequently re-applying energy to the tissue region through the device at a subsequent location using the second setting configured to stimulate the nerve within the second distance from the working end of the device.