Systems and methods for intra-operative stimulation

• US 20060200207A1
• Filed: 04/06/2005
• Published: 09/07/2006
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Checkpoint Surgical, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Granted Patent: US 7,896,815 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00734 battery operated
• 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
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

Improved assemblies, systems, and methods provide safeguarding against nerve 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. A stimulation control device may incorporate a range of low and high intensity stimulation to provide a stimulation and evaluation of both nerves and muscles. A stimulation control device is removably coupled to a surgical device or is imbedded within the medical device to provide a stimulation and treatment medical device.

Claims

1. A tissue stimulation system comprising:

a housing having a proximal end and a distal end,

an operative element having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, the operative element extending from the distal end of the housing, and wherein the electrical stimulation is in the form of a signal having an amplitude and a duration for providing a first indication,

a stimulation control device electrically coupled to the operative element, the stimulation control device comprising stimulation signal generating circuitry,

the housing including a first control device for turning the stimulation signal to the operative element on and off and for providing adjustment of the stimulation signal amplitude, the first control device being electrically coupled to the stimulation control device, and

the housing including a second control device for providing adjustment of the stimulation signal duration, the second control device being electrically coupled to the stimulation control device.

2. A tissue stimulation system according to claim 1

wherein the stimulation signal amplitude ranges between about zero milliamps and about 20 milliamps, allowing for selective stimulation of a muscle or a nerve.

3. A tissue stimulation system according to claim 1

wherein the stimulation signal duration ranges between about zero microseconds and about 200-microseconds.

4. A tissue stimulation system according to claim 1

wherein the first indication comprises an indication of close proximity of the operative element to the targeted tissue region.

5. A tissue stimulation system according to claim 1

wherein the first indication comprises an indication of close proximity of the operative element to a nerve or to identify nerve tissue.

6. A tissue stimulation system according to claim 1

wherein the first indication comprises an indication of an intact nerve to determine if a repair is needed.

7. A tissue stimulation system according to claim 1

wherein the first indication comprises an indication of a muscle condition to identify whether the muscle is innervated or whether the muscle is intact or whether the muscle is severed.

8. A tissue stimulation system according to claim 1

wherein the first indication comprises an indication of muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure.

9. A tissue stimulation system according to claim 1

wherein the first indication includes a visual or audio indication.

10. A tissue stimulation system according to claim 1

wherein the tissue stimulation system is sterilized and prepackaged for single use.

11. A tissue stimulation system according to claim 1

wherein the operative element comprises a probe and the electrically conductive surface of the probe comprises between about 1 millimeter and about 10 millimeters of the distal end of the probe.

12. A tissue stimulation system according to claim 1

wherein the operative element comprises a probe, the probe having a diameter between about 0.5 millimeters and about 1.0 millimeters.

13. A tissue stimulation system according to claim 1

further including a return electrode electrically coupled to the stimulation control device.

14. A tissue stimulation system according to claim 1

wherein the operative element is non-linear in shape.

15. A tissue stimulation system according to claim 1

wherein the housing is tubular shaped.

16. A tissue stimulation system according to claim 1

further including a second indication means to provide confirmation of power on to the device and delivery of a stimulation signal to the electrically conductive surface.

17. A tissue stimulation system according to claim 16

wherein the second indication means is located on the housing.

18. A tissue stimulation system comprising:

a housing having a proximal end and a distal end, the housing sized and configured to be held by a user,

a probe having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, the probe extending from the distal end of the housing, and wherein the electrical stimulation is in the form of a signal having an amplitude and a duration for providing a physical motor response,

a stimulation control device electrically coupled to the probe and sized and configured to be positioned within the housing, the stimulation control device comprising stimulation signal generating circuitry,

the housing including a first control device for turning the stimulation signal to the probe on and off and for providing adjustment of the stimulation signal amplitude, the first control device being electrically coupled to the stimulation control device, and

the housing including a second control device for providing adjustment of the stimulation signal duration, the second control device being electrically coupled to the stimulation control device.

19. A tissue stimulation system according to claim 18

wherein the stimulation signal amplitude ranges between about zero milliamps and about 20 milliamps, allowing for selective stimulation of a muscle or a nerve.

20. A tissue stimulation system according to claim 18

wherein the stimulation signal duration ranges between about zero microseconds and about 200 microseconds.

21. A tissue stimulation system according to claim 18

wherein the physical motor response includes an indication of close proximity of the operative element to a nerve or to identify nerve tissue.

22. A tissue stimulation system according to claim 18

wherein the physical motor response includes an indication of an intact nerve to determine if a repair is needed.

23. A tissue stimulation system according to claim 18

wherein the physical motor response includes an indication of a muscle condition to identify whether the muscle is innervated or whether the muscle is intact or whether the muscle is severed.

24. A tissue stimulation system according to claim 18

wherein the physical motor response includes an indication of muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure.

25. A tissue stimulation system according to claim 18

further comprising a first indication which includes a visual or audio indication.

26. A tissue stimulation system according to claim 18

wherein the tissue stimulation system is sterilized and prepackaged for single use.

27. A tissue stimulation system according to claim 18

wherein the electrically conductive surface of the probe comprises between about 1 millimeter and about 10 millimeters of the distal end of the probe.

28. A tissue stimulation system according to claim 18

wherein the probe comprises a diameter between about 0.5 millimeters and about 1.0 millimeters.

29. A tissue stimulation system according to claim 18

further including a return electrode electrically coupled to the stimulation control device.

30. A tissue stimulation system according to claim 18

wherein the probe is non-linear in shape.

31. A tissue stimulation system according to claim 18

wherein the housing is tubular shaped.

32. A tissue stimulation system according to claim 18

further including a second indication means to provide confirmation of power on to the device and delivery of a stimulation signal to the electrically conductive surface.

33. A tissue stimulation system according to claim 32

wherein the second indication means is located on the housing.

34. A method of testing a tissue region of a patient comprising:

providing a tissue stimulation system having an operative element,

engaging the patient with the operative element at a targeted tissue region,

moving a first control device to an activation position causing a stimulation signal to be generated by the stimulation system and transmitted to the operative element, and

observing the targeted tissue region for a first indication.

35. A method according to claim 34 further comprising

moving a second control device to adjust the stimulation signal.

36. A method according to claim 34 further comprising

engaging the patient with a second electrode which is electrically coupled to the stimulation system, the second electrode allowing the stimulation signal to flow from the operative element, through the patient'"'"'s body to the second electrode, and back to the stimulation system.

37. A method according to claim 34

wherein observing includes evaluating close proximity of the operative element to the targeted tissue region.

38. A method according to claim 34

wherein observing includes evaluating close proximity of the operative element to a nerve or to identify nerve tissue.

39. A method according to claim 34

wherein observing includes evaluating if a nerve is intact to determine if a repair is needed.

40. A method according to claim 34

wherein observing includes evaluating a muscle condition to identify whether the muscle is innervated or whether the muscle is intact or whether the muscle is severed.

41. A method according to claim 34

wherein observing includes evaluating muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure.