Surgical access system and related methods

• US 9,974,531 B2
• Filed: 10/17/2017
• Issued: 05/22/2018
• Est. Priority Date: 09/25/2003
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Miles, Patrick, Martinelli, Scot, Finley, Eric
• Primary Examiner(s): BOLES, SAMEH RAAFAT
• Application Number:
  US15/786,594
• Publication Number:
  US 20180035991A1
• Time in Patent Office: 217 Days
• 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 forming an operating corridor along a lateral, trans-psoas path to a lumbar spine, comprising:

plurality of dilators of increasing diameters to create a tissue distraction corridor along the selected path through the bodily tissue toward the targeted intervertebral disc of the lumbar spine, the plurality of dilators including at least a first dilator and a second dilator that slidably advances over an exterior of the first dilator and engages the lumbar spine;

a three-bladed retractor slidable along a dilator of the plurality of dilators toward the lumbar spine to enlarge the tissue distraction corridor and thereby form an operative corridor along the selected lateral, trans-psoas path through the bodily tissue toward the targeted intervertebral disc of the lumbar spine, the three-bladed retractor tool including;

a blade holder coupled to first, second, and third retractor blades, wherein the three-bladed retractor is adjustable from a closed position in which the first, second, and third retractor blades are adjacent to one another and slidable over the outer dilator of the plurality of sequential dilators to an opened position in which the first, second, and third retractor blades are spaced apart from one another to thereby form the operative corridor along the selected path through the bodily tissue toward the targeted intervertebral disc of the lumbar spine,

wherein the blade holder includes a first arm with a first connector for coupling the first retractor blade, a second arm with a second connector for coupling the second retractor blade, and a third arm with a third connector for coupling the third retractor blade, wherein the first arm pivots relative to the second arm and the third arm to move the first retractor blade away from the second and third retractor blades, the second arm pivots relative to the first arm and the third arm to move the second retractor blade away from the first and third retractor blades, and the third arm linearly translates relative to the first arm and second arm to move the third retractor blade relative to the first and second retractor blades, wherein the blade holder includes a rotatable actuator that controls translation of the third arm independent of the pivoting of the first arm and the pivoting of the second arm,

a first arm extender that releasably couples to the first arm opposite the first connector and a second arm extender that releasably couples to the second arm opposite the second connector,

wherein when the three-bladed retractor is adjusted to the opened position to form the operative corridor along the selected path through the bodily tissue toward the targeted intervertebral disc of the lumbar spine, the operative corridor is dimensioned so as to pass an implant through the operative corridor along the selected lateral, trans-psoas path toward the targeted intervertebral disc of the lumbar spine.

2. The system of claim 1, wherein the first dilator has a length that is greater than the length of the second dilator.

3. The system of claim 2, wherein the first dilator includes a stimulation electrode situated at a distal end region of the first dilator that is electrically connectable to a nerve surveillance system for detecting nerves situated in the tissue along the lateral, trans-psoas path to the lumbar spine.

4. The system of claim 2, wherein the second dilator includes a stimulation electrode situated at a distal end region of the second dilator that is electrically connectable to a nerve surveillance system for detecting nerves situated in the tissue along the lateral, trans-psoas path to the lumbar spine.

5. The surgical access system of claim 4, further including a connector that releasably couples to a proximal connecting region of the first and second dilators for establishing electrical connection with a nerve surveillance system.

6. The surgical access system of claim 5, wherein the spinal fusion implant comprises bone products or bone morphogenetic protein.

7. The system of claim 1, further including a K-wire configured to extend through the first dilator and penetrate into the targeted intervertebral disc.

8. The system of claim 1, wherein the first, second, and third retractor blades are adjacent to one another in the closed position the first, second, and third retractor blades abut one another.

9. The surgical access system of claim 8, wherein the first, second, and third retractor blades define a distraction corridor between them that is circular in cross-sectional shape when in the closed position.

10. The surgical access system of claim 9, wherein the first, second, and third retractor blades define a distraction corridor that is non-circular in cross-sectional shape when opened.

11. The surgical access system of claim 1, wherein the first arm extender includes a post extending from a distal end of the first arm extender that is received within an opening in a proximal end of the first arm.

12. The surgical access system of claim 11, wherein the second arm extender includes a post extending from a distal end of the second arm extender that is received within an opening in a proximal end of the second arm.

13. The surgical access system of claim 1, wherein moving the first arm extender towards the second arm extender pivots the first arm to move the first blade away from the second and third blades.

14. The surgical access system of claim 13, wherein moving the second arm extender towards the first arm extender pivots the second arm to move the second blade away from the first and third blades.

15. The surgical access system of claim 14, wherein the first arm extender and the second arm extender are squeezed together simultaneously to move the first blade away from the second and third blades simultaneously with moving the second blade away from the first and third blades.

16. The surgical access system of claim 1, wherein the third blade extends from a proximal end having a mounting structure for connecting to the third connector to a distal end spaced longitudinally from the proximal end.

17. The surgical access system of claim 16, wherein the third blade includes an exterior face and an interior face, the interior face including a track extending longitudinally along at least a portion of the interior face of the third blade for receiving a connectable element.

18. The surgical access system of claim 17, wherein the interior face further includes a plurality of horizontally oriented grooves spaced longitudinally along at least a portion of the interior face.

19. The surgical access system of claim 18, wherein the track comprises a first longitudinally extending receptacle adjacent a first edge of the third blade and a second longitudinally extending receptacle adjacent a second edge of the third blade.

20. The surgical access system of claim 19, wherein the plurality of horizontally oriented grooves lie between the first longitudinally extending receptacle and the second longitudinally extending receptacle.

21. The surgical access system of claim 20, wherein the first retractor blade extends from a proximal end having a mounting structure for connecting to the first connector to a distal end spaced longitudinally from the proximal end, the interior face including a track extending longitudinally along at least a portion of the interior face of the third blade.

22. The surgical access system of claim 21, wherein the track along the interior face of the first blade comprises a first longitudinally extending receptacle adjacent a first edge of the first blade and a second longitudinally extending receptacle adjacent a second edge of the first blade.

23. The surgical access system of claim 22, wherein the second retractor blade extends from a proximal end having a mounting structure for connecting to the second connector to a distal end spaced longitudinally from the proximal end, the interior face including a track extending longitudinally along at least a portion of the interior face of the second blade.

24. The surgical access system of claim 23, wherein the track along the interior face of the second blade comprises a first longitudinally extending receptacle adjacent a first edge of the second blade and a second longitudinally extending receptacle adjacent a second edge of the second blade.

25. The surgical access system of claim 23, further comprising a light emitting element connectable to at least one of the first, second, and third blades.

26. The surgical access system of claim 20, wherein the connectable element comprises an intradiscal shim.

27. The surgical access system of claim 26, wherein the intradiscal shim includes a proximal portion that slidably engages with the track along the interior face of the third blade and a distal extension configured to extend distally beyond the distal end of the third retractor blade and penetrate into the targeted intervertebral disc when the proximal portion is advanced to a distal position along the third retractor blade.

28. The surgical access system of claim 27, wherein the proximal portion includes a first longitudinally extending engagement element that is received in the first longitudinally extending receptacle and a second longitudinally extending engagement element that is received in the second longitudinally extending receptacle.

29. The surgical access system of claim 28, wherein the proximal portion further includes a tooth situated between the first longitudinally extending engagement element and second longitudinally extending engagement element that engages with the horizontally extending grooves.

30. The surgical access system of claim 29, wherein the tooth is situated on a flexible tab.

31. The surgical access system of claim 30, wherein the distal extension has a maximum lateral width that is less than a minimum lateral width of the proximal portion and a tapered distal end.

32. The system of claim 31, further including a k-wire configured to extend through the first dilator and penetrate into the targeted intervertebral disc, and wherein the first dilator has a length that is greater than the length of the second dilator, the first dilator including a first stimulation electrode situated at a distal end region of the first dilator and the second dilator including a second stimulation electrode situated at a distal end of the second dilator, the first stimulation electrode and second stimulation electrode being electrically connectable to a nerve surveillance system for detecting nerves situated in the tissue along the lateral, trans-psoas path to the lumbar spine.

33. The system of claim 32, wherein when the first, second, and third retractor blades are adjacent to one another in the closed position the first, second, and third retractor blades abut one another and define a distraction corridor between them that is circular in cross-sectional shape, and wherein the first, second, and third retractor blades define a distraction corridor that is non-circular in cross-sectional shape when opened.

34. The surgical access system of claim 32, wherein the first arm extender includes a post extending from a distal end of the first arm extender that is received within an opening in a proximal end of the first arm and the second arm extender includes a post extending from a distal end of the second arm extender that is received within an opening in a proximal end of the second arm, and wherein moving the first arm extender towards the second arm extender pivots the first arm to move the first blade away from the second and third blades, and moving the second arm extender towards the first arm extender pivots the second arm to move the second blade away from the first and third blades.

35. The surgical access system of claim 34, wherein the first retractor blade extends from a proximal end having a mounting structure for connecting to the first connector to a distal end spaced longitudinally from the proximal end, the interior face including a track extending longitudinally along at least a portion of the interior face of the third blade, the track comprising a first longitudinally extending receptacle adjacent a first edge of the first blade and a second longitudinally extending receptacle adjacent a second edge of the first blade.

36. The surgical access system of claim 35, wherein the second retractor blade extends from a proximal end having a mounting structure for connecting to the second connector to a distal end spaced longitudinally from the proximal end, the interior face including a track extending longitudinally along at least a portion of the interior face of the second blade, wherein the track along the interior face of the second blade comprises a first longitudinally extending receptacle adjacent a first edge of the second blade and a second longitudinally extending receptacle adjacent a second edge of the second blade.

37. The surgical access system of claim 36, further comprising a light emitting element connectable to at least one of the first, second, and third blades.

38. The surgical access system of claim 36, further including a spinal fusion implant sized and shaped to insert through the operative corridor formed between the first, second and third retractor blades along the lateral, transpsoas path.

39. The surgical access system of claim 1, further including a spinal fusion implant sized and shaped to insert through the operative corridor formed between the first, second and third retractor blades along the lateral, transpsoas path.