Systems and methods for intra-operative physiological functional stimulation

• US 20110060238A1
• 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., THROPE, GEOFFREY B., MRVA, JOSEPH J., STROTHER, ROBERT B.
• Application Number:
  US12/806,691
• Publication Number:
  US 20110060238A1
• Time in Patent Office: Days
• US Class Current: 600/544
• 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 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

Improved assemblies, systems, and methods provide safeguarding against tissue injury during surgical procedures and/or identify nerve damage occurring prior to surgery and/or verify range of motion or attributes of muscle contraction during reconstructive surgery. Embodiments of methods according to the present invention provide the ability to intra-operatively simulate post-operative physiologic function of a body part. Such methods may be used during various surgical procedures, including tendon transfer procedures. Included are one or more steps of confirming paralysis or a weakened condition of a body part, confirming responsivity or operability of transfer tissue to supplement the functionality of the paralyzed or weakened part, and intra-operatively simulating post-operative functionality of the transfer tissue to enhance and/or predict the outcome of the surgical procedure.

Claims

1. In a surgical procedure affecting functional change of muscle tissue innervated by working nerve tissue, a method of physiologic functional simulation comprising the steps of:

relocating first tendon tissue to an unnatural position;

in a first application step, applying a first electrical stimulation to first muscle tissue into which the first tendon tissue is naturally inserted; and

in a first observation step, observing a neural response to the first electrical stimulation.

2. A method according to claim 1, wherein the first tendon tissue comprises a first tendon having two ends, wherein a first end is inserted into the first muscle tissue and a second end is coupled to a first bone, the method further comprising the steps of:

incising all or part of the first tendon at or near the first bone to form a tendon free end; and

coupling the tendon free end to a second body part.

3. A method according to claim 2, wherein the second body part is a second bone.

4. A method according to claim 3, wherein the tendon spans a joint between the second bone and a third bone.

5. A method according to claim 2, wherein the relocating step is performed before the first application step.

6. A method according to claim 5, wherein the neural response is a movement of the second body part through a predetermined range of motion.

7. A method according to claim 2, wherein the incising step comprises the step of severing the first tendon.

8. A method according to claim 7, wherein the coupling step comprises the step of stitching the first tendon to one of a second tendon, a second muscle, and a periosteum of the second bone.

9. A method according to claim 1, the method further comprising the steps of:

providing a 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; and

wherein the first application step comprises the step of applying the first electrical stimulation from the electrode to the first muscle tissue.

10. A method according to claim 9, wherein the device is at least substantially sterile.

11. A method according to claim 9, wherein the stimulation circuitry is contained entirely within the housing.

12. A method according to claim 9, wherein the device is capable of delivering, through the electrode sufficient electrical stimulation to activate the first muscle tissue when the electrode is in physical contact therewith.

13. A method according to claim 9, wherein the power supply is contained entirely within the housing.

14. A method according to claim 9, further comprising the step of carrying the device by a single human hand.

15. A method according to claim 14, further including the step of manipulating, with the single human hand, the device to change an electrical stimulation parameter.

16. A method according to claim 9, the device further comprising an electronic visual indicator operatively coupled to the stimulation circuitry.

17. A method according to claim 16, 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.

18. A method according to claim 17, 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.

19. A method according to claim 18, 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.

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

21. A method according to claim 15, wherein the manipulating step occurs during the first application step.

22. A method according to claim 1, wherein the neural response is at least a twitch of the first muscle.

23. A method according to claim 1, wherein the first application step and the first observation step are performed before the relocating step, further comprising, after the relocating step, the steps of:

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

in a second observation step, observing a second neural response to the second electrical stimulation.

24. A method according to claim 1, further comprising the step of, prior to the relocating step, confirming a paralysis of a second muscle, the function of which will be supplemented by the first muscle tissue.

25. A method according to claim 24, wherein the confirming step is performed, in a confirmation step, by applying a second electrical stimulation to the second muscle, the electrical stimulation having an amplitude of about twenty milliamps.

26. A method according to claim 25, wherein the first application step and the first observation step are performed before the relocating step, further comprising, after the relocating step, the steps of:

applying a third electrical stimulation to the first muscle tissue; and

observing a second neural response to the third electrical stimulation.