Surgical access system and related methods

• US 7,207,949 B2
• Filed: 05/25/2005
• Issued: 04/24/2007
• Est. Priority Date: 09/25/2003
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Martinelli, Scot, Finley, Eric, Miles, Patrick
• Primary Examiner(s): Bockelman; Mark
• Application Number:
  US11/137,169
• Publication Number:
  US 20060069315A1
• Time in Patent Office: 699 Days
• Field of Search: 607/2, 600/201, 600/214, 600/226, 600/554, 600/546, 600/117
• US Class Current: 600/554
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• 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 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: Y10S 606/909 Bone

Abstract

A surgical access system including a tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures before, during, and after the establishment of an operative corridor to a surgical target site.

Claims

1. A system for accessing a surgical target site, comprising:

a tubular distraction member capable of being advanced to said surgical target site;

an elongated inner member dimensioned to be received within said tubular distraction member and advanced to said surgical target site, said elongated inner member having a stimulation electrode;

a retractor assembly having a plurality of blades capable of being advanced to said surgical target site while in a closed position and thereafter opened to create an operative corridor to said surgical target site; and

a monitoring system capable of electrically stimulating said stimulation electrode, monitoring electromyographic activity in muscle myotomes associated with nerves in the vicinity of said surgical target site, and alerting a user of the presence of a nerve near said elongated inner element if said electrical stimulation results in electromyographic activity in at least one of said muscle myotomes.

2. The system of claim 1, including at least one secondary tubular distraction member dimensioned to be advanced over said tubular distraction member to create a distraction corridor to said surgical target site prior to advancing said retractor blades to said surgical target site.

3. The system of claim 1, wherein said elongated inner element has a distal region and said stimulation electrode is located on said distal region.

4. The system of claim 3, wherein said elongated inner element has a substantially smaller diameter than a diameter of said tubular distraction member.

5. The system of claim 4, wherein said elongated inner element is a K-wire.

6. The system of claim 5, wherein said stimulation electrode is an un-insulated region at said distal region of said K-wire.

7. The system of claim 1, wherein said monitoring system includes an electrode configured to sense electromyographic activity of a muscle myotome coupled to said nerve.

8. The system of claim 1, wherein said retractor assembly is dimensioned to be advanced over said tubular distraction member after said tubular distraction member has been advanced to said surgical target site.

9. The system of claim 1, wherein said system for establishing an operative corridor to a surgical target site is configured to access a spinal target site.

10. The system of claim 9, wherein said system for establishing an operative corridor to a surgical target site is configured to establish said operative corridor to said spinal target site via a lateral, trans-psoas approach.

11. The system of claim 1, wherein said monitoring system includes an electrical connection to said elongated inner member for communicating said electrical stimulation to said stimulation electrode.

12. The system of claim 1, wherein the monitoring system includes a display operable to display at least one of an electromyographic (EMG) response of said muscle myotome associated with said nerve and a stimulation threshold required to obtain said electromyographic activity from said muscle myotome.

13. The system of claim 12, wherein said display is a touch-screen display operable to receive commands from a user.

14. The system of claim 1, wherein said retractor assembly includes at least one of a light source for illuminating said surgical target site and a fixation element to affix at least one of said plurality of blades adjacent to said surgical target site.

15. The system of claim 1, wherein at least one of said plurality of retractor blades has a stimulation electrode.

16. A method of accessing a spinal target site, comprising the steps of:

creating an initial distraction corridor to a spinal target site using a tubular distraction member;

disposing an elongated inner member within said tubular distraction member at least one of during and after the creation of said initial distraction corridor, said elongated inner member having a stimulation electrode;

electrically stimulating said stimulation electrode at least one of during and after the creation of said initial distraction corridor;

monitoring electromyographic activity in muscle myotomes associated with nerves in the vicinity of said spinal target site at least one of during and after the creation of said initial distraction corridor;

alerting a user to at least one of the presence and absence of a nerve near said elongated inner element based on said monitored electromyographic activity at least one of during and after the creation of said initial distraction corridor;

introducing a plurality of retractor blades to said spinal target site while in a generally closed position in the event of an absence of said nerve near said elongated inner element; and

moving said retractor blades to create an operative corridor to said spinal target site.

17. The method of claim 16, further comprising the step of slidably passing at least one secondary tubular distraction member over said tubular distraction member prior to the introduction of said plurality of retractor blades to said spinal target site.

18. The method of claim 17, wherein the steps of electrically stimulating, monitoring electromyographic activity, and alerting said user are additionally performed after the introduction said plurality of blades to said spinal target site but prior to moving said plurality of retractor blades to create said operative corridor.

19. The method of claim 17, wherein said step of slidably passing at least one secondary tubular distraction member is accomplished via sequential dilation using successively larger cannulae.

20. The method of claim 16, further comprising the step of determining at least one of a direction and approximate distance from said elongated inner element to said nerve based upon the monitored electromyographic activity.

21. The method of claim 16, wherein said elongated inner element has a distal region and said stimulation electrode is located on said distal region.

22. The method of claim 21, wherein said elongated inner element has a substantially smaller diameter than a diameter of said tubular distraction member.

23. The method of claim 22, wherein said elongated inner element is a K-wire.

24. The method of claim 23, wherein said stimulation electrode is an un-insulated region at said distal region of said K-wire.

25. The method of claim 16, wherein said monitoring is accomplished by coupling at least one electrode configured to sense electromyographic activity to said muscle myotomes.

26. The method of claim 16, wherein the step of introducing said plurality of retractor blades are simultaneously advanced over said tubular distraction member.

27. The method of claim 16, wherein said spinal target site is located in the lumbar spine.

28. The method of claim 16, wherein said an operative corridor to a spinal target site is established via a lateral, trans-psoas approach.

29. The method of claim 16, further comprising the steps of communicating said electrical stimulation from said monitoring system to said stimulation electrode of said elongated inner member.

30. The method of claim 29, wherein said monitoring system is coupled to said elongated inner element to establish electrical communication between said monitoring system and said stimulation electrode.

31. The method of claim 16, comprising the step of displaying to said user at least one of an electromyographic (EMG) response of said muscle myotome associated with said nerve and a stimulation threshold required to obtain said electromyographic activity from said muscle myotome.

32. The method of claim 31, comprising the step of providing a display capable of communicating at least one of alpha-numeric and graphical indicia to said user.

33. The method of claim 32, wherein said display is a touch-screen display operable to receive commands from a user.

34. The method of claim 16, further comprising the step of providing at least one of said plurality of retractor blades with a light source for illuminating the spinal target site.

35. The method of claim 34, wherein said light source is coupled to at least one of said plurality of retractor blades.

36. The method of claim 16, further comprising affixing at least one of said plurality of blades adjacent to said surgical target site via at least one fixation element.

37. The method of claim 36, wherein said fixation element comprises a shim having a generally pointed distal end.

38. The method of claim 16, comprising the step of equipping at least one of said plurality of retractor blades with a stimulation electrode.