Systems and methods for Intra-operative semi-quantitative threshold neural response testing related applications

• US 20110054346A1
• Filed: 08/19/2010
• Published: 03/03/2011
• Est. Priority Date: 03/01/2005
• Status: Active Application

• Current Assignee: Checkpoint Surgical, Inc.
• Original Assignee: Checkpoint Surgical, LLC
• Inventors: Hausman, Michael R., Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Application Number:
  US12/806,705
• Publication Number:
  US 20110054346A1
• 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 5/4893 Nerves
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• 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

Abstract

Systems and methods according to the present invention provide a means for determining, as an example, the health or location of nerves. A determination according to the present invention may include semi-quantitative threshold testing using intra-operative electrical stimulation to determine whether one or more nerves are functioning as expected. A determination according to the present invention may also be utilized to determine or predict the success of a surgical procedure that may affect the functioning of one or more nerves. Semi-quantitative analysis may be performed by comparing electrical stimulation intensity, or an approximation thereof, at which a threshold neural response is observed to an expected or previously applied electrical stimulation intensity, or an approximation thereof.

Claims

1. A method for semi-quantitative threshold nerve response testing, the method comprising the steps of:

in a first application step, applying a first electrical stimulation to a first targeted tissue region;

during the application of the first electrical stimulation, observing no desired neural response caused by the first electrical stimulation;

in a second application step, applying a second electrical stimulation to the first targeted tissue region; and

during the application of the second electrical stimulation, observing a desired neural response caused by the second electrical stimulation.

2. A method according to claim 1, wherein the first electrical stimulation and the second electrical stimulation each has parameters of electrical current amplitude and pulse duration.

3. A method according to claim 2, further comprising the step of changing at least one of the parameters.

4. A method according to claim 3, wherein the changing step occurs between the first and second stimulation.

5. A method according to claim 2, wherein the amplitude of the first electrical stimulation is different than the amplitude of the second electrical stimulation.

6. A method according to claim 5, wherein the amplitude of the second electrical stimulation is greater than the amplitude of the first electrical stimulation.

7. A method according to claim 5, wherein the pulse duration of the first electrical stimulation is different than the pulse duration of the second electrical stimulation.

8. A method according to claim 7, wherein the pulse duration of the second electrical stimulation is greater than the pulse duration of the first electrical stimulation.

9. A method according to claim 2, wherein the pulse duration of the first electrical stimulation is different than the pulse duration of the second electrical stimulation.

10. A method according to claim 9, wherein the pulse duration of the second electrical stimulation is greater than the pulse duration of the first electrical stimulation

11. A method according to claim 1, wherein the second electrical stimulation is applied after the first electrical stimulation.

12. A method according to claim 1, wherein the first electrical stimulation is applied after the second electrical stimulation.

13. A method according to claim 1, wherein the targeted tissue region comprises at least one of muscle tissue and nerve fibers.

14. A method according to claim 1, further comprising the step of providing a device, and using the device in performing the first application step and the second application step, the device comprising:

a housing extending along a housing longitudinal axis between a housing proximal end and a housing distal end;

electrical stimulation generation circuitry at least substantially contained within the housing;

an operative element extending from the housing proximal end, the operative element comprising an electrode operatively coupled to the electrical stimulation generation circuitry; and

a power supply disposed at least substantially within the housing, the power supply being electrically coupled to the electrical stimulation generation circuitry.

15. A method according to claim 14, the device further comprising an electronic visual indicator operatively coupled to the stimulation circuitry.

16. A method according to claim 15, further comprising a step of observing a first visual indication provided by the visual indicator, the first visual indication being indicative of electrical stimulation flowing at least partially through the targeted tissue region.

17. A method according to claim 16, further comprising a step of observing a second visual indication provided by the visual indicator, the second visual indication being indicative of electrical power supplied to the stimulation circuitry by the power supply.

18. A method according to claim 17, wherein the first visual indication is an illumination of a first color and the second visual indication is an illumination of a second color, the second color being different from the first color.

19. A method according to claim 17, wherein the visual indicator is an illumination device that is radially visible from 360 degrees around the longitudinal axis of the handle.

20. A method according to claim 14, further comprising the step of carrying the device by a single human hand.

21. A method according to claim 20, further including the step of manipulating, with the single human hand, the device to change an electrical stimulation parameter.

22. A method according to claim 21, wherein the manipulating step occurs between the first and second stimulation.

23. A method according to claim 1, further comprising the step of performing a surgical procedure on the first targeted tissue region.

24. A method according to claim 23, wherein the surgical procedure is performed after the first application step, and the second application step is performed after the surgical procedure.

25. A method according to claim 23, further comprising the step of:

in a third application step, applying a third electrical stimulation to the first targeted tissue region; and

during the application of the third electrical stimulation, observing a desired neural response caused by the third electrical stimulation.

26. A method according to claim 25, wherein the second electrical stimulation and the third electrical stimulation each has parameters of electrical current amplitude and pulse duration, the method further comprising the steps of:

recording a threshold stimulation parameter; and

recording a post-surgery threshold stimulation parameter.

27. A method according to claim 26, further comprising the steps of:

comparing the post-surgery threshold stimulation parameter to the threshold stimulation parameter; and

grading the surgical procedure.

28. A method according to claim 26, wherein the surgical procedure is performed after the first application step and before the second application step.

29. A method according to claim 26, wherein the surgical procedure is performed after the second application step and before the third application step.