Systems and methods for intra-operative stimulation

• US 20070191915A1
• Filed: 01/09/2007
• Published: 08/16/2007
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Checkpoint Surgical, Inc.
• Original Assignee: NDI Medical, Inc. (Medtronic Plc)
• Inventors: Coburn, James, Thrope, Geoffrey, Strother, Robert, Pack, Danny, Galecki, Steven, Mrva, Joseph, Thierfelder, Christopher
• Granted Patent: US 7,878,981 B2
• Time in Patent Office: Days
• US Class Current: 607/63
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00424 ergonomic, e.g. fitting in fist
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• 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. 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. A disposable hand held stimulation system includes an operative element extending from the housing, the housing includes an operative element adjustment portion and a visual indication to provide feedback or status to the user.

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 proximal end of the housing,

the housing proximal end comprising an operative element adjustment portion to allow movement of the operative element,

the electrical stimulation being in the form of a stimulation signal having an amplitude and a duration for providing a first indication, and

a stimulation control device electrically coupled to the operative element, the stimulation control device comprising a power source and stimulation signal generating circuitry.

2. A tissue stimulation system according to claim 1

wherein the stimulation control device is positioned within the housing.

3. A tissue stimulation system according to claim 1

wherein the tissue stimulation system conforms to the IPX1 water ingress standard.

4. A tissue stimulation system according to claim 1

wherein the housing comprises a gripping base portion and the operative element adjustment portion.

5. A tissue stimulation system according to claim 1

wherein the operative element adjustment portion comprises a flexible nose cone.

6. A tissue stimulation system according to claim 1

the housing further 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 further 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.

7. A tissue stimulation system according to claim 1

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

8. A tissue stimulation system according to claim 1

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

9. A tissue stimulation system according to claim 1

wherein the operative element is non-linear in shape.

10. 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 proximal end of the probe.

11. 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 1.5 millimeters.

12. A tissue stimulation system according to claim 1

wherein the first indication provides confirmation of power on to the device and delivery of a stimulation signal to the electrically conductive surface.

13. A tissue stimulation system according to claim 1

wherein the first indication comprises a visual indication located on the housing.

14. A tissue stimulation system according to claim 13

the visual indication further including a reflective element.

15. A tissue stimulation system according to claim 13

wherein the housing is tubular shaped.

16. A tissue stimulation system according to claim 15

wherein the visual indication comprises an illuminating circumferential ring indicator, the illuminating circumferential ring indicator being visible around the circumference of the tubular housing.

17. 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 proximal 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,

the housing proximal end comprising a probe adjustment portion to allow movement of the probe,

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.

18. A tissue stimulation system according to claim 17

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

19. A tissue stimulation system according to claim 17

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

20. A tissue stimulation system according to claim 17

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.

21. A tissue stimulation system according to claim 17

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.

22. A tissue stimulation system according to claim 17

wherein the probe is non-linear in shape.

23. A tissue stimulation system according to claim 17

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.

24. A tissue stimulation system according to claim 23

wherein the second indication means is located on the housing.

25. A tissue stimulation system according to claim 24

wherein the second indication means comprises an illuminating circumferential ring indicator, the illuminating circumferential ring indicator being visible around the circumference of the housing.

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

providing a tissue stimulation system having an operative element extending from a proximal end of a housing,

the housing proximal end comprising an operative element adjustment portion to allow movement of the operative element,

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,

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

observing the targeted tissue region for a first indication.

27. A method according to claim 26 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.

28. A hand held tissue stimulation apparatus comprising:

a tubular shaped housing comprising a gripping base portion and an operative element adjustment portion,

the gripping base portion comprising a first housing element and a second housing element,

a stimulation control device positioned within the gripping base portion,

a battery positioned within the gripping base portion and coupled to the stimulation control device to provide power to the stimulation control device,

a visual indication coupled to a proximal end of the gripping base portion, the visual indication comprising an illuminating circumferential ring indicator, the illuminating circumferential ring indicator being visible around the circumference of the tubular housing, and

an operative element having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, the operative element being coupled to the stimulation control device and extending from the proximal end of the operative element adjustment portion.

29. An apparatus according to claim 28

wherein the operative element adjustment portion comprises a flexible nose cone sized and configured to allow movement of the operative element.

30. An apparatus according to claim 28

the visual indication further including a reflector element.

31. An apparatus according to claim 28

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

32. A kit of devices to provide tissue stimulation to a targeted tissue region, the kit comprising,

a hand held stimulation probe including a housing sized and configured to be held with either a left or right hand, the stimulation probe being sterilized and disposable, and including an operative element extending from a proximal end of the housing,

the housing proximal end comprising an operative element adjustment portion to allow movement of the operative element,

a lead including a return electrode coupled to the stimulation probe, and

instructions for use describing the unpacking and tissue contact procedure for the stimulation probe.