Surgical access system and related methods

• US 8,137,284 B2
• Filed: 10/08/2003
• Issued: 03/20/2012
• Est. Priority Date: 10/08/2002
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Miles, Patrick, Martinelli, Scott, Finley, Eric, Gharib, James, Farquhar, Allen, Kaula, Norbert, Blewett, Jeffrey
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US10/682,568
• Publication Number:
  US 20080058606A1
• Time in Patent Office: 3,086 Days
• Field of Search: 600/201, 600/211, 600/214, 600/546, 600/554, 600/184, 600/227, 600/231, 600/232, 600/202, 606/86, 606/90, 606/105, 606/32, 606/41, 606/108
• US Class Current: 600/554
• 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 17/0218 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 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00261 Discectomy
• 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 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A system for accessing a surgical target site and related methods, involving an initial distraction system for creating an initial distraction corridor, and an assembly capable of distracting from the initial distraction corridor to a secondary distraction corridor and thereafter sequentially receiving a plurality of retractor blades for retracting from the secondary distraction corridor to thereby create an operative corridor to the surgical target site, 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 method of accessing a spinal target site via a lateral, trans-psoas surgical approach, comprising the steps of:

establishing a distraction corridor via a lateral, trans-psoas surgical approach to said spinal target site with a distraction assembly prior to the introduction of a first retractor blade;

affixing said first retractor blade introduced to said spinal target site via said lateral, trans-psoas approach such that said first retractor blade forms a posterior border of an operative corridor along said lateral, trans-psoas surgical approach to said spinal target site and is fixed relative to said spinal target site, wherein affixing said first retractor blade is accomplished with a fixation element removably engaged with said first retractor blade after said first retractor blade is introduced to said spinal target site and such that a distal tip of said fixation element extends past said first retractor blade and penetrates into the spinal target site; and

moving a second retractor blade introduced to said spinal target site via said lateral, trans-psoas approach relative to said affixed first retractor blade such that said operative corridor is established between said first and second retractor blades to said spinal target site.

2. The method of claim 1, wherein said first retractor blade is introduced to said spinal target site before said second retractor blade is introduced to said spinal target site.

3. The method of claim 1, wherein said step of moving said second retractor blade relative to said affixed first retractor blade is accomplished by using a distraction system.

4. The method of claim 3, wherein said distraction system comprises a sequential dilation system disposed in between said first and second retractor blades to sequentially move said first and second retractor blades apart from one another.

5. The method of claim 1, wherein said distraction assembly includes a plurality of dilators and a K-wire, wherein said plurality of dilators are capable of being passed over said K-wire.

6. The method of claim 5, wherein said plurality of dilators of said distraction assembly includes a dilating cannula and at least two dilator members disposed within said dilating cannula, wherein said at least two dilator members and said dilating cannula are capable of being slideably passed over said K-wire.

7. The method of claim 1, further comprising the step of performing neuromonitoring during at least one of establishing said distraction corridor and establishing said operative corridor to the spinal target site.

8. The method of claim 7, wherein said step of performing neuromonitoring comprises activating a control unit that:

stimulates a stimulation electrode on at least one of the distraction assembly and said first retractor blade, senses a response of a nerve depolarized by said stimulation, determines at least one of nerve proximity and nerve direction based on said sensed response, and communicates said at least one of nerve proximity and nerve direction to a surgeon performing said surgery.

9. The method of claim 8, wherein said sensing of said depolarized nerve is accomplished through the use of a recording electrode configured to sense a neuromuscular response of a muscle coupled to said depolarized nerve, the recording electrode being communicatively linked to the control unit.

10. The method of claim 8, wherein said communication of said at least one of nerve proximity and nerve direction is accomplished through the use of a display communicatively linked to said control unit and operable to display an electromyographic (EMG) response of a muscle coupled to said nerve depolarized by said stimulation.

11. The method of claim 10, wherein said display comprises a touch-screen display operable to receive commands from a user.

12. The method of claim 8, wherein said stimulation electrode is positioned on a posteriorly facing surface of said first retractor blade and said electrode is stimulated as first retractor blade is introduced to said spinal target site.

13. The method of claim 8, wherein said step of determining at least one of nerve proximity and nerve direction includes determining a threshold stimulation level required to evoke said neuromuscular response and wherein said step of determining a threshold stimulation level includes establishing first a bracket containing said threshold stimulation level and bisecting said bracket to form a smaller second bracket containing said threshold stimulation level.

14. The method of claim 1, wherein said step of affixing the fixation element is a shim element that removably engages with an inward facing surface of said first retractor blade such that a distal tip of said shim element extends past said first retractor blade and penetrates into a lumbar intevertebral disc comprising the spinal target site.

15. The method of claim 14, wherein said shim element engages a groove formed in the inward facing surface of said first retractor blade after said first retractor blade is introduced to said surgical target site.

16. The method of claim 1, wherein said second retractor blade is affixed to said spinal target site after being moved relative to said first retractor blade.

17. A method of accessing a spinal target site via a lateral, trans-psoas surgical approach, comprising the steps of:

introducing a first retractor blade and a second retractor blade to said spinal target site via a lateral, trans-psoas surgical approach such that said first retractor blade is positioned along a posterior aspect of a lumbar intervertebral disc comprising said spinal target site and comprises a posterior border of an operative corridor along said lateral, trans-psoas surgical approach to said spinal target site;

penetrating the intervertebral disc with a shim element removeably engaged to said first retractor blade after introducing said first retractor blade to said spinal target site and extending from a distal end of the first retractor blade so as to affix said first retractor blade relative to said spinal target site;

moving said second retractor blade relative to said affixed first retractor blade to establish said operative corridor along said lateral, trans-psoas surgical approach between said first and second retractor blades to said spinal target site; and

passing an implant toward said spinal target site through said operative corridor established between said first retractor blade and said second retractor blade.

18. The method of claim 17, wherein said first retractor blade is introduced to said spinal target site before said second retractor blade is introduced to said spinal target site.

19. The method of claim 17, wherein said step of moving said second retractor blade relative to said affixed first retractor blade is accomplished by using a distraction system.

20. The method of claim 19, wherein said distraction system comprises a sequential dilation system disposed in between said first and second retractor blades to sequentially move said first and second retractor blades apart from one another.

21. The method of claim 17, further comprising the step of establishing an initial distraction corridor through the use of an initial distraction assembly via said lateral, trans-psoas surgical approach to said spinal target site prior to the introduction of said first retractor blade.

22. The method of claim 21, further comprising the step of performing neuromonitoring during at least one of establishing said distraction corridor and establishing said operative corridor to the spinal target site.

23. The method of claim 22, wherein said step of performing neuromonitoring comprises activating a control unit that:

stimulates a stimulation electrode on said first retractor blade, senses a response of a nerve depolarized by said stimulation, determines at least one of nerve proximity and nerve direction based on said sensed response, and communicates said at least one of nerve proximity and nerve direction to a surgeon performing said surgery.

24. The method of claim 23, wherein said stimulation electrode is positioned on a posteriorly facing surface of said first retractor blade and said electrode is stimulated as first retractor blade is introduced to said spinal target site.

25. The method of claim 22, wherein said step of performing neuromonitoring comprises activating a control unit that:

stimulates a stimulation electrode on the distraction assembly, senses a response of a nerve depolarized by said stimulation, determines at least one of nerve proximity and nerve direction based on said sensed response, and communicates said at least one of nerve proximity and nerve direction to a surgeon performing said surgery.

26. The method of claim 25, wherein said sensing of said depolarized nerve is accomplished through the use of a recording electrode configured to sense a neuromuscular response of a muscle coupled to said depolarized nerve, the recording electrode being communicatively linked to the control unit.

27. The method of claim 25, wherein said communication of said at least one of nerve proximity and nerve direction is accomplished through the use of a display communicatively linked to said control unit and operable to display an electromyographic (EMG) response of a muscle coupled to said nerve depolarized by said stimulation.

28. The method of claim 27, wherein said display comprises a touch-screen display operable to receive commands from a user.

29. The method of claim 25, wherein said step of determining at least one of nerve proximity and nerve direction includes determining a threshold stimulation level required to evoke said neuromuscular response and wherein said step of determining a threshold stimulation level includes establishing first a bracket containing said threshold stimulation level and bisecting said bracket to form a smaller second bracket containing said threshold stimulation level.

30. The method of claim 21, wherein said initial distraction assembly includes:

a plurality of dilators having one or more stimulation electrodes, and a K-wire, wherein said plurality of dilators are capable of being passed over said K-wire.

31. The method of claim 17, wherein said shim element slidably engages with a groove formed in a surface of said first retractor blade facing toward said operative corridor after said first blade is introduced to said spinal target site.

32. The method of claim 17, wherein after said second retractor blade is moved relative to said first retractor blade, said second retractor blade is affixed to said spinal target site.

33. A method of accessing a targeted site on the spine of a patient via a lateral, trans-psoas surgical approach, comprising the steps of:

establishing an initial distraction corridor through the use of an initial distraction assembly via a lateral, trans-psoas surgical approach to a targeted site on said spine while performing neuromonitoring during insertion of said initial distraction assembly via said lateral, trans-psoas surgical approach to the targeted site, wherein at least a component of the initial distraction assembly penetrates into an intervertebral disc of said spine;

after establishing said initial distraction corridor, introducing a first retractor blade to said targeted site on said spine via a lateral, trans-psoas surgical approach such that said first retractor blade is positioned in a first position along said spine;

after said first retractor blade is positioned in said first position along said spine, removably engaging an extension element to said first retractor blade such that the extension element extends from said first retractor blade into said spine to affix said first retractor blade relative to said spine;

moving a second retractor blade away from said affixed first retractor blade such that an operative corridor is established between said first and second retractor blades to said targeted site on said spine.

34. The method of claim 33, wherein said first retractor blade is introduced to said spinal target site before said second retractor blade is introduced to said spinal target site.

35. The method of claim 33, wherein said step of moving said second retractor blade relative to said affixed first retractor blade is accomplished by using a distraction system.

36. The method of claim 35, wherein said distraction system comprises a sequential dilation system disposed in between said first and second retractor blades to sequentially move said first and second retractor blades apart from one another.

37. The method of claim 33, wherein said initial distraction assembly includes:

a plurality of dilators having one or more stimulation electrodes, and a K-wire, wherein said plurality of dilators are capable of being passed over said K-wire.

38. The method of claim 33, wherein said first extension element comprises a shim member slidably engaged to said first retractor blade and said second extension element comprises a shim member slidably engaged to said second retractor blade.

39. The method of claim 33, wherein said step of performing neuromonitoring during insertion of said initial distraction assembly includes activating a control system that:

stimulates at least one stimulation electrode on said initial distraction assembly, senses a response of a nerve depolarized by said stimulation, determines at least one of nerve proximity and nerve direction based on said sensed response, and communicates said at least one nerve proximity and nerve direction to a surgeon performing said surgery.

40. The method of claim 39, wherein said communication of said at least one of nerve proximity and nerve direction is accomplished through the use of a display communicatively linked to said control unit and operable to display an electromyographic (EMG) response of a muscle coupled to said nerve depolarized by said stimulation.

41. The method of claim 40, wherein said display comprises a touch-screen display operable to receive commands from a user.

42. The method of claim 33, further comprising performing neuromonitoring during introduction of said first retractor blade by using a neuromonitoring system including a control unit capable of stimulating at least one stimulation electrode arranged on said first retractor blade, sensing a response of a nerve depolarized by said stimulation, determining at least one of nerve proximity and nerve direction based on said sensed response, and communicating said at least one nerve proximity and nerve direction to a surgeon performing said surgery.

43. The method of claim 42, wherein said sensing of said depolarized nerve is accomplished through the use of a recording electrode configured to sense a neuromuscular response of a muscle coupled to said depolarized nerve, the recording electrode being communicatively linked to the control unit.

44. The method of claim 42, wherein said at least one stimulation electrode is positioned on a posteriorly facing surface of said first retractor blade.

45. The method of claim 42, wherein said step of determining at least one of nerve proximity and nerve direction includes determining a threshold stimulation level required to evoke said neuromuscular response and wherein said step of determining a threshold stimulation level includes establishing first a bracket containing said threshold stimulation level and bisecting said bracket to form a smaller second bracket containing said threshold stimulation level.

46. The method of claim 42, wherein said first position along said spine is a posterior region of an intervertebral disc of said spine.

47. The method of claim 46, wherein said second position along said spine is an anterior region of said intervertebral disc of said spine.

48. The method of claim 33, wherein said second retractor blade is positioned angularly relative to said first retractor blade before being affixed to said spinal target site.