Systems and methods for intra-operative regional neural stimulation

• US 20110060243A1
• Filed: 08/19/2010
• Published: 03/10/2011
• Est. Priority Date: 03/01/2005
• Status: Abandoned Application

• Current Assignee: Checkpoint Surgical, LLC
• Original Assignee: Checkpoint Surgical, LLC
• Inventors: Hausman, Michael R., Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Application Number:
  US12/806,698
• Publication Number:
  US 20110060243A1
• Time in Patent Office: Days
• US Class Current: 600/554
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/1412 Blade
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4523 Tendons
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 90/04 Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]

Abstract

Systems and methods according to the present invention provide a means for determining, as an example, the health or location of nerves. Generally, embodiments according to the present invention may be used to verify the absence of nerve tissue along a prospective incision location to avoid damage caused by such incision. Alternatively or additionally, embodiments according to the present invention may be used to locate and/or hone in on a more precise location of one or more nerves. Electrical stimulation may be applied to tissue in an iterative fashion in one or more desired patterns and at one or more stimulation intensities to determine one or more regional neural responses and one or more focused neural responses.

Claims

1. A method of avoiding nerve tissue in a surgical procedure, the method comprising the steps of:

identifying a first potential incision location and a first potential incision length;

in a first application step, applying a first electrical stimulation, with an electrode, to a first tissue region along the first potential incision length;

during the first application step, observing a neural response to the first stimulation;

identifying a second incision location and a second potential incision length;

in a second application step, applying a second electrical stimulation, with the electrode, to a second tissue region along the second potential incision length;

during the second application step, observing no neural response to the second stimulation; and

after observing no neural response to the second stimulation, performing a surgical procedure through the second tissue region.

2. A method according to claim 1, wherein the step of performing a surgical procedure comprises the step of incising a portion of the second tissue region along a portion of the second potential incision length.

3. A method according to claim 1, further comprising, after observing the neural response to the first stimulation, the steps of:

adjusting a parameter of the first electrical stimulation; and

in a third application step, applying a third electrical stimulation, with an electrode, to the first tissue region along the first potential incision length.

4. A method according to claim 3, wherein the adjusting step comprises the step of decreasing stimulation intensity of the first electrical stimulation by reducing one of electrical stimulation pulse duration and electrical stimulation amplitude.

5. A method according to claim 1, further comprising, after observing no neural response to the second stimulation, the steps of:

adjusting a parameter of the second electrical stimulation; and

in a third application step, applying a third electrical stimulation, with an electrode, to the second tissue region along the second potential incision length.

6. A method according to claim 5, wherein the adjusting step comprises the step of increasing stimulation intensity of the second electrical stimulation by increasing one of electrical stimulation pulse duration and electrical stimulation amplitude.

14. A method according to claim 1, wherein the electrode is coupled to a first device and a second device is used for the surgical procedure.

15. A method according to claim 14, wherein the second device is a scalpel.

36. A method according to claim 1, wherein the tissue region comprises subcutaneous tissue.

7. A method of locating nerve tissue to perform a surgical procedure, the method comprising the steps of:

identifying a first potential incision location and a first potential incision length;

in a first application step, applying a first electrical stimulation, with an electrode, to a tissue region along the first potential incision length;

during the first application step, observing no desired neural response to the first stimulation;

altering a parameter of the electrical stimulation;

in a second application step, applying a second stimulation to the tissue region;

during the second application step, observing a desired neural response to the second stimulation;

after the first and second application steps, making an incision along the first potential incision length;

performing a surgical procedure through the incision;

in a third application step, applying the first stimulation to the tissue region, observing the desired neural response during the third application step.

8. A method according to claim 7, wherein the first application step is performed before the altering step and the second application step is performed after the altering step.

9. A method according to claim 7, wherein the altering step comprises the step of increasing electrical stimulation intensity.

10. A method according to claim 9, wherein the step of increasing electrical stimulation intensity comprises the step of increasing at least one of electrical stimulation amplitude and electrical stimulation pulse duration.

11. A method according to claim 7, wherein the first application step further comprises the step of translating the electrode along at least a portion of the first incision length while the electrode is in contact with the tissue.

12. A method according to claim 11, wherein the first electrical stimulation is applied during the translating step.

13. A method according to claim 7, wherein the surgical procedure comprises the step of removing scar tissue through the incision.

37. A method according to claim 7, wherein the tissue region comprises subcutaneous tissue.

16. A method for honing in on nerve fibers disposed below or innervating animal tissue, the method comprising the steps of:

at a first stimulation intensity, applying a first electrical stimulation to animal tissue within an identified stimulation region, the first electrical stimulation being applied with an electrode in contact with the tissue;

in a first identifying step, identifying a plurality of first active stimulation locations within the stimulation region at which one or more neural response is generated in response to the first electrical stimulation, the first active stimulation locations being disposed about a perimeter of a focused stimulation region;

at a reduced stimulation intensity, applying a second electrical stimulation within the focused stimulation region; and

in a second identifying step, identifying a second active stimulation location within the focused stimulation region at which one or more neural response is generated in response to the second electrical stimulation.

17. A method according to claim 16, wherein the first identifying step comprises the step of translating the electrode across the tissue while applying the first electrical stimulation.

18. A method according to claim 17, wherein the translating step comprises the step of translating the electrode in a desired pattern.

19. A method according to claim 18, wherein the pattern comprises a star pattern.

20. A method according to claim 18, wherein the pattern comprises a spiral pattern.

21. A method according to claim 16, wherein the second identifying step comprises the step of translating the electrode across the tissue while applying the second electrical stimulation.

22. A method according to claim 21, wherein the translating step comprises the step of translating the electrode in a desired pattern.

23. A method according to claim 22, wherein the pattern comprises a star pattern.

24. A method according to claim 22, wherein the pattern comprises a spiral pattern.

25. A method according to claim 16, wherein the reduced stimulation intensity is generated by a step of altering an electrical stimulation parameter of the first electrical stimulation.

26. A method according to claim 25, wherein the step of altering comprises reducing one of electrical pulse stimulation pulse duration and electrical stimulation amplitude.

38. A method according to claim 18, wherein the animal tissue comprises subcutaneous tissue.

27. A method of seeking a neural response to electrical stimulation, the method comprising the steps of:

identifying a prospecting location on animal tissue;

applying electrical stimulation to the tissue at the prospecting location with an electrode to determine whether a neural response is generated;

observing no neural response to the electrical stimulation, translating the electrode in contact with the tissue radially outward from the prospecting location in a first direction for a first honing distance;

observing no neural response to the electrical stimulation, translating the electrode in a second direction back to the prospecting location;

translating the electrode radially outward from the prospecting location in a third direction for a second honing distance; and

observing a neural response to the electrical stimulation.

28. A method according to claim 27, wherein the step of translating in the first direction is performed while applying the electrical stimulation to the tissue.

29. A method according to claim 27, wherein the second direction is opposite the first direction.

30. A method according to claim 27, wherein the first honing distance is substantially the same as the second honing distance

31. A method according to claim 27, wherein the second direction is substantially the same as the third direction.

32. A method according to claim 27, wherein the step of translating in the second direction is performed while the electrode is in contact with the tissue.

33. A method according to claim 27, wherein the step of translating in the third direction is performed while the electrode is in contact with the tissue.

34. A method according to claim 27, further comprising the step of identifying an active stimulation location on the tissue.

35. A method according to claim 27, further comprising the step of repeating at least once each of the steps of:

identifying a prospecting location;

applying electrical stimulation to the tissue at the prospecting location with an electrode to determine whether a neural response is generated; and

identifying an active stimulation location on the tissue.

39. A method according to claim 29, wherein the animal tissue comprises subcutaneous tissue.