Surgical access system and related methods

• US 9,622,732 B2
• Filed: 10/11/2005
• Issued: 04/18/2017
• Est. Priority Date: 10/08/2004
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Martinelli, Scot, Arambula, Jared, Finley, Eric, Miles, Patrick
• Primary Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US11/665,039
• Publication Number:
  US 20090018399A1
• Time in Patent Office: 4,207 Days
• Field of Search: 606104, 600201-210, 600213-217, 600221-226, 600228- 23, 600 5, 600228-235
• 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 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00407 Ratchet means
• 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 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 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/4619 for extraction
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

A surgical access system including a tissue distraction assembly 40 and a tissue retraction assembly 10, both of which may be equipped with one or more electrodes 23 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 15 to a surgical target site. The tissue retraction assembly 10 has a plurality of blades 12, 16, 18 which may be introduced while in a closed configuration, after which point they may be opened to create an operation corridor 15 to the surgical target site, including pivoting at least one blade 12, 16, 18 to expand the operative corridor 15 adjacent to the operative site.

Claims

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

a retractor assembly having first, second, and third blades and a blade holder assembly, the first, second, and third blades being advanceable to said surgical target site while in a first position in which the first blade is immediately adjacent the second and third blades, the second blade is immediately adjacent the first and third blades, and the third blade is immediately adjacent the first and second blades, and adjustable to a second position in which the first, second, and third blades are separated relative to said first position, said blade holder assembly including first arm having a first longitudinal axis and a second arm having a second longitudinal axis, the first and second arms being coupled about a pivot, said first retractor blade being coupled to said first arm distally to said pivot and said second retractor blade being coupled to said second arm distally to said pivot, wherein adjustment from the first position to the second position includes pivoting movement of the first and second arms about said pivot such that said first longitudinal axis and said second longitudinal axis move away from each other distal of said pivot, said first arm having a first rotatable arm section situated distally to a first static arm section, the first retractor blade being rigidly secured to the first rotatable arm section, said first rotatable arm section rotatable relative to said first static arm section and about said first longitudinal axis to translocate a distal end of said first blade relative to a proximal end of the first blade, said second arm having a second rotatable arm section situated distally to a second static arm section, the second retractor blade being rigidly secured to the second rotatable arm section, said second rotatable arm section rotatable relative to said second static arm section and about said second longitudinal axis to translocate a distal end of said second blade relative to a proximal end of the second blade.

2. The system of claim 1, including a distraction assembly for creating a distraction corridor to said surgical target site prior to advancing said first, second and third blades to said surgical target site.

3. The system of claim 2, wherein said distraction assembly includes a first dilator having a stimulation electrode on a distal end portion thereof.

4. The system of claim 3, including a secondary distraction assembly including a plurality of sequentially larger diameter dilators that advance along the first dilator for distracting said initial distraction corridor to a secondary distraction corridor, said first, second and third blades being advanced through said secondary distraction corridor to said surgical target site.

5. The system of claim 4, wherein each dilator of the plurality of sequentially larger diameter dilators includes a stimulation electrode on a distal end portion.

6. The system of claim 5, wherein another stimulation electrode is positioned near a distal end of the third retractor blade.

7. The system of claim 3, further comprising a control unit configured to electrically stimulate said stimulation electrode, sense a response of a nerve depolarized by said stimulation, determine a relative proximity from said first dilator to the nerve based upon the sensed response, and communicate said direction to a user.

8. The system of claim 7, further comprising an electrode configured to sense a neuromuscular response of a muscle coupled to said depolarized nerve, the electrode being operable to send the response to the control unit.

9. The system of claim 8, wherein the control unit comprises a display operable to display an electromyographic (EMG) response of the muscle.

10. The system of claim 7, further comprising a coupling device that provides an electrical connection to said first dilator for delivering an electrical stimulation signal to the first dilator at the direction of said control unit.

11. The system of claim 7, wherein the control unit comprises a touch-screen display operable to receive commands from a user.

12. The system of claim 3, wherein said distraction assembly also includes a K-wire configured for disposal within the first dilator.

13. The system of claim 1, wherein said third retractor blade includes a stimulation electrode.

14. The system of claim 13, wherein the stimulation electrode is positioned near a distal end of said third blade.

15. The system of claim 13, further comprising a control unit capable of electrically stimulating said stimulation electrode, sensing a response of a nerve depolarized by said stimulation, determining a relative proximity from said distraction assembly to the nerve based upon the sensed response, and communicating said relative proximity to a user.

16. The system of claim 15, further comprising an electrode configured to sense a neuromuscular response of a muscle coupled to the depolarized nerve, the electrode being operable to send the response to the control unit.

17. The system of claim 16, wherein the control unit comprises a display operable to display an electromyographic (EMG) response of the muscle.

18. The system of claim 15, further comprising a coupling device that provides an electrical connection between said stimulation electrode and said control unit.

19. The system of claim 15, wherein the control unit comprises a touch-screen display operable to receive commands from a user.

20. The system of claim 1, wherein said system for accessing a spinal surgical target site is configured to provide said access to the spinal surgical target site via a lateral, trans-psoas approach.

21. The system of claim 1, wherein at least one of the first, second, and third blades is constructed from a material that is at least partially radiolucent.

22. The system of claim 1, wherein said first rotatable arm section and said second rotatable arm section are each equipped with a locking mechanism to selectively lock the first and second blades in a selected position.

23. The system of claim 22, wherein the locking mechanism allows the first and second blades to be locked in any of a variety of predetermined angles.

24. The system of claim 23, wherein the locking mechanism includes a plurality of pre-selected stops corresponding to said predetermined angles.

25. The system of claim 23, wherein the predetermined angles include the range of 0 to 20 degrees relative to when the first and second blades are in the first position.

26. The system of claim 1, further comprising at least one tool for moving the distal ends of the first and second blades relative to the proximal ends thereof, wherein the at least one tool comprises at least one of a wrench and a blade expander.

27. The system of claim 1, further comprising at least one of a blade extender and a blade shim configured to be releasably coupled to at least one of the three retractor blades.

28. The system of claim 27, wherein at least one of the blade extender and the blade shim include a lateral extension to increase the width of the blade extender and blade shim.

29. The system of claim 27, wherein at least one of the blade extender and the blade shim include a distal extension to increase the length of the blade extender and blade shim.

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

a retractor assembly having first, second, and third blades and a blade holder assembly, the first, second, and third blades being advanceable to said surgical target site while in a first position in which the first blade is immediately adjacent the second and third blades, the second blade is immediately adjacent the first and third blades, and the third blade is immediately adjacent the first and second blades, and adjustable to a second position in which the first, second, and third blades are separated relative to said first position, said blade holder assembly including first arm having a first longitudinal axis and a second arm having a second longitudinal axis, the first and second arms being coupled about a pivot, said first retractor blade being coupled to said first arm distally to said pivot and said second retractor blade being coupled to said second arm distally to said pivot, said blade holder assembly also including a third translating arm coupled to said third retractor blade, wherein adjustment from the first position to the second position includes both pivoting movement of the first and second arms about said pivot such that said first longitudinal axis and said second longitudinal axis move away from each other distal of said pivot and linearly moving said third retractor blade relative to said first and second retractor blades, said first arm having a first rotatable arm section situated distally to a first static arm section, said first rotatable arm section rotatable relative to said first static arm section and about said first longitudinal axis to translocate a distal end of said first blade relative to a proximal end of the first blade, said second arm having a second rotatable arm section situated distally to a second static arm section, said second rotatable arm section rotatable relative to said second static arm section and about said second longitudinal axis to translocate a distal end of said second blade relative to a proximal end of the second blade.

31. A method of accessing a surgical target site, comprising the steps of:

introducing a retractor assembly including first, second, and third retractor blades coupled to a blade holder assembly to a surgical target site while the three retractor blades are in a first position with the first blade being immediately adjacent the second and third blades, the second blade being immediately adjacent the first and third blades, and the third blade being immediately adjacent the first and second blades, said blade holder assembly having a first arm having a first longitudinal axis and second arm having a second longitudinal axis, the first and second arms being coupled about a pivot, the first arm having a first rotating arm section situated distal to a first static arm section, said first rotating arm section being rotatable relative to said first static arm section and around said first longitudinal axis, the second arm having a second rotating arm section situated distal to a second static arm section, the second rotatable arm section being rotatable relative to said second static arm section and around said second longitudinal axis, said blade holder assembly further having a third arm that translates linearly relative to the pivot, wherein the first retractor blade is coupled to the first arm, the second retractor blade is coupled to the second arm, and the third retractor blade is coupled to said third arm; and

pivoting said first arm and said second arm around said pivot such that said first said longitudinal axis and said second longitudinal axis move away from each other distal of said pivot and said first retractor blade and said second retractor move away from each other to create an operative corridor to said surgical target site, and further expanding a distal dimension of the operative corridor adjacent the surgical target site by rotating said first rotating arm section to translocate a distal end of said first retractor blade outward relative to a proximal end of the first retractor blade and rotating said second rotating arm section to translocate a distal end of said second retractor blade outward relative to a proximal end of the second retractor blade.

32. The method of claim 31, further comprising moving the third retractor blade linearly relative to the first and second retractor blades to enlarge the operative corridor.

33. The method of claim 31, further comprising the step of advancing a sequential dilation system including a plurality of dilators of increasing diameter to the surgical target site, the first, second, and third retractor blades thereafter being slidably advanced along the sequential dilation system to the surgical target site.

34. The method of claim 33, wherein at least one of said dilators of said sequential dilation system includes a stimulation electrode situated on a distal end portion for transmitting an electrical stimulation signal.

35. The method of claim 34, further comprising electrically coupling a control unit capable of directing the electrical stimulation signal to said at least one stimulation electrode, sensing a response of a nerve depolarized by said stimulation, determining a relative proximity of the at least on dilator to the nerve based upon the sensed response, and communicating said relative proximity to a user.

36. The method of claim 31, wherein said first rotating arm section and said second rotating arm section are each equipped with a locking mechanism to selectively lock the first and second blades in a selected position.

37. The method of claim 36, wherein the locking mechanism allows the first and second blades to be locked in any of a variety of predetermined angles.

38. The method of claim 37, wherein the locking mechanism includes a plurality of pre-selected stops corresponding to said predetermined angles.

39. The method of claim 38, wherein the predetermined angles include the range of 0 to 20 degrees relative to when the first and second blades are in the first position.

40. The method of claim 38, further comprising the step of providing at least one tool for rotating the first and second rotating arm sections, wherein the at least one tool comprises at least one of a wrench and a blade expander.

41. The method of claim 31, including the step of providing at least one of a blade extender and a blade shim configured to be releasably coupled to at least one of the three retractor blades.

42. The method of claim 41, wherein at least one of the blade extender and the blade shim include a lateral extension to increase the width of the blade extender and blade shim.

43. The method of claim 41, wherein at least one of the blade extender and the blade shim include a distal extension to increase the length of the blade extender and blade shim.