DEVICES, METHODS AND SYSTEMS FOR NEURAL LOCALIZATION

• US 20090171381A1
• Filed: 01/12/2009
• Published: 07/02/2009
• Est. Priority Date: 12/28/2007
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Wallace, Michael P., Schmitz, Gregory P., Miller, Eric C.
• Application Number:
  US12/352,385
• Publication Number:
  US 20090171381A1
• Time in Patent Office: Days
• US Class Current: 606/167
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1611 the two jaw elements being integral with respective elongate shaft elements
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts

Abstract

Described herein are tissue manipulation devices having a tight bipole network. In particular, described herein are smart tools such as rongeurs configured to sense the presence of a nerve or portion of nerve. Tissue may be cut (or otherwise manipulated) by using a tool having a tight bipolar network to sense when a nerve or portion of a nerve is in the tool prior to cutting.

Also described are systems for determining if a nerve is nearby an insertable tool. These systems typically include a tool with a neurostimulation electrode, an accelerometer configured to detect muscle twitch, and a feedback controller to provide feedback indicating if the tool is near a nerve. Methods of controlling insertion of a tool using feedback from such a system are also described.

Claims

1. A tissue manipulation device that can detect the presence of a nerve in a tissue to be manipulated by the device, the device comprising:

a tissue receiving portion including a first tissue receiving surface and a second tissue receiving surface, wherein the first tissue receiving surface is configured to move relative to the second tissue receiving surface to engage tissue within the tissue receiving portion; and

a tight bipole network in communication with the tissue receiving portion, wherein the tight bipole network is configured to emit a broadcast field that is limited to the tissue receiving portion and sufficient to stimulate a nerve within the tissue receiving portion.

2. The tissue manipulation device of claim 1 further comprising a handle proximal to the tissue receiving portion.

3. The tissue manipulation device of claim 2, wherein the handle comprises a control for moving the first tissue receiving surface.

4. The tissue manipulation device of claim 1 further comprising an elongate body extending proximally to the tissue receiving portion.

5. The tissue manipulation device of claim 1, wherein the tissue receiving portion comprises a jaw.

6. The tissue manipulation device of claim 1, wherein the second tissue receiving surface is not movable.

7. The tissue manipulation device of claim 1, wherein the tight bipole network comprises a bipole pair.

8. The tissue manipulation device of claim 1, wherein the tight bipole network comprises a plurality of anodes and cathodes arranged within the tissue receiving portion.

9. The tissue manipulation device of claim 1, wherein the tight bipole network comprises a plurality of anodes and cathodes configured to form an effectively continuous bipole field within the tissue receiving portion.

10. The tissue manipulation device of claim 1, wherein the tissue manipulation device is configured as a rongeur and the first tissue receiving surface is configured to move relative to the second tissue receiving surface to cut tissue within the tissue receiving portion.

11. A rongeur device for cutting tissue that can detect the presence of a nerve in the tissue to be cut, the rongeur device comprising:

a jaw having a tissue receiving portion, the tissue receiving portion including a first tissue receiving surface and a second tissue receiving surface, wherein the first tissue receiving surface is configured to move towards the second tissue receiving surface to cut tissue within the tissue receiving portion; and

a tight bipole network on the jaw configured to emit a broadcast field that is limited to the tissue receiving portion and sufficient to stimulate a nerve within the tissue receiving portion.

12. The rongeur device of claim 11 further comprising a handle.

13. The rongeur device of claim 11 further comprising an elongate body, wherein the jaw is located at the distal region of the elongate body.

14. The rongeur device of claim 11, wherein the second tissue receiving surface is not movable.

15. The rongeur device of claim 11, wherein the tight bipole network comprises a bipole pair.

16. The rongeur device of claim 11, wherein the tight bipole network comprises a plurality of anodes and cathodes arranged within the tissue receiving portion.

17. The rongeur device of claim 11, wherein the tight bipole network comprises a plurality of anodes and cathodes configured to form an effectively continuous bipole field within the tissue receiving portion.

18. A rongeur device for cutting tissue that can detect the presence of a nerve in the tissue to be cut, the rongeur device comprising:

a handle;

an elongate body extending distally from the handle along a longitudinal axis;

a tissue receiving portion near the distal end of the elongate body, the tissue receiving portion including a first tissue receiving surface and a second tissue receiving surface, wherein the first tissue receiving surface is configured to move longitudinally towards the second tissue receiving surface to cut tissue within the tissue receiving portion; and

a tight bipole network in communication with the tissue receiving portion wherein the tight bipole network is configured to emit a broadcast field that is limited to the tissue receiving portion and sufficient to stimulate a nerve within the tissue receiving portion.

19. The rongeur device of claim 18, wherein the second tissue receiving surface is not movable.

20. The rongeur device of claim 18, wherein the tight bipole network comprises a bipole pair.

21. The rongeur device of claim 18, wherein the tight bipole network comprises a plurality of anodes and cathodes arranged within the tissue receiving portion.

22. The rongeur device of claim 18, wherein the tight bipole network comprises a plurality of anodes and cathodes configured to form an effectively continuous bipole field within the tissue receiving portion.

23. A method of cutting tissue using a rongeur device capable of determining if a nerve is present in the tissue to be cut, the method comprising

placing tissue within a tissue receiving portion of the rongeur device;

energizing a tight bipole network to emit a broadcast field that is substantially limited to the tissue receiving portion;

determining if a nerve or a portion of a nerve is present in the tissue receiving portion of the rongeur device; and

cutting the tissue within the tissue receiving portion of the rongeur device.

24. The method of claim 23, wherein the step of energizing the tight bipole network comprises applying energy to a plurality of bipole pairs in communication with the tissue receiving portion of the rongeur device.

25. The method of claim 23, wherein the step of energizing the tight bipole network comprises emitting an effectively continuous bipole field within the tissue receiving portion of the rongeur device.

26. The method of claim 23, wherein the step of determining if a nerve or portion of a nerve is present comprises observing an EMG.

27. The method of claim 23, wherein the step of determining if a nerve or portion of a nerve is present comprises monitoring muscle twitch.

28. The method of claim 23, wherein the step of cutting comprises actuating the handle of the rongeur device to move a first tissue receiving surface of the tissue receiving portion of the rongeur device towards a second tissue receiving surface.

29. The method of claim 23, wherein the step of cutting comprises cutting the tissue within the tissue receiving portion of the rongeur device if a nerve or portion of a nerve is not present in the tissue receiving portion of the rongeur device.

30. A system for determining if a nerve is nearby an insertable tool, the system comprising:

an insertable tool having a first surface comprising a neurostimulation electrode configured to detect proximity to a nerve;

an accelerometer to detect muscle movement upon stimulation of a nerve by the neurostimulation electrode; and

a feedback controller configured to receive input from the accelerometer and determine activation of a nerve by the neurostimulation electrode, wherein the feedback controller is further configured to provide feedback to tool to control operation of the tool.

31. The system of claim 30, wherein the tool is selected from the group consisting of:

a probe, a pedicle screw, and an implant.

32. The system of claim 30, further comprising a power source for applying power to the neurostimulation electrode.

33. The system of claim 30, wherein the neurostimulation electrode comprises a bipole pair.

34. The system of claim 30, wherein the neurostimulation electrode comprises a tight bipole network configured to emit an effectively continuous bipole field.

35. The system of claim 30, wherein the accelerometer comprises a multiple axis accelerometer.

36. The system of claim 30, wherein the accelerometer is a disposable accelerometer.

37. The system of claim 30, further comprising an output configured to indicate when the accelerometer detects a nerve in proximity to the tool.

38. The system of claim 30, wherein the feedback controller is configured to provide feedback to the tool indicating detection of a nerve.

39. A system for determining if a nerve is nearby an insertable tool, the system comprising:

an insertable tool having a first surface comprising a tight bipole network configured to emit an effectively continuous bipole field;

an accelerometer to detect muscle movement upon stimulation of a nerve by the tight bipole network; and

a feedback controller configured to receive input from the accelerometer and determine activation of a nerve by the neurostimulation electrode.

40. A method of controlling a tool insertable into a human body, the method comprising:

securing an accelerometer to a patient'"'"'s body;

inserting a tool into the patient'"'"'s body;

applying energy to a neurostimulation electrode on the surface of the tool; and

monitoring the accelerometer to determine muscle twitch resulting from the application of energy to the neurostimulation electrode.

41. The method of claim 40, further comprising providing feedback to the tool based on the output of the accelerometer.

42. The method of claim 40, wherein the step of monitoring the accelerometer further comprises filtering the output of the accelerometer to remove artifact.

43. The method of claim 40, wherein the step of monitoring the accelerometer further comprises synchronizing the monitoring of the accelerometer with the application of energy to the neurostimulation electrode.

44. The method of claim 40, wherein the step of applying energy to a neurostimulation electrode comprises applying energy to a tight bipole network to emit an effectively continuous bipole field.

45. The method of claim 40, wherein the step of applying an accelerometer to the surface of a patient'"'"'s body comprises applying a plurality of accelerometers to the surface of the patient'"'"'s body.

46. The method of claim 40, wherein the step of securing an accelerometer to a patient'"'"'s body comprises securing a disposable accelerometer to the surface of the patient'"'"'s body.

47. A method of controlling a tool insertable into a human body, the method comprising:

securing an accelerometer to a patient'"'"'s body;

inserting a tool into the patient'"'"'s body;

applying energy to a tight bipole network to emit an effectively continuous bipole field on the surface of the tool; and

monitoring the accelerometer to determine muscle twitch resulting from the application of energy to the tight bipole network.

48. The method of claim 47, further comprising providing feedback to the tool based on the output of the accelerometer.

49. The method of claim 47, wherein the step of monitoring the accelerometer further comprises filtering the output of the accelerometer to remove artifact.

50. The method of claim 47, wherein the step of monitoring the accelerometer further comprises synchronizing the monitoring of the accelerometer with the application of energy to the neurostimulation electrode.