Surgical access system and related methods

• US 8,016,767 B2
• Filed: 04/23/2007
• Issued: 09/13/2011
• 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:
  US11/789,284
• Publication Number:
  US 20070198062A1
• Time in Patent Office: 1,604 Days
• Field of Search: 607/2, 600/117, 600/201, 600/214, 600/226, 600/546, 600/554, 600/202, 600/215, 600/245, 606/99
• 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 method of accessing a surgical target site, comprising:

forming an initial distraction corridor using an elongate stimulation instrument that is delivered to a lateral aspect of a targeted spinal disc along a lateral, trans-psoas path to the lumbar spine while a stimulation electrode of the elongate stimulation instrument outputs an electrical stimulation signal from a distal tip portion for nerve monitoring during delivery of the elongate stimulation instrument along the lateral, trans-psoas path to the lumbar spine;

activating a nerve monitoring system that controls the electrical stimulation signal output from the stimulation electrode of the elongate stimulation instrument during delivery of the elongate stimulation instrument along the lateral, trans-psoas path to the lumbar spine, the nerve monitoring system detecting electromyographic (EMG) activity via a set of EMG sensor electrodes in communication with muscle myotomes associated with nerves in the vicinity of the targeted spinal disc;

receiving nerve monitoring information from a video display device of the nerve monitoring system that contemporaneously displays;

a numeric stimulation threshold required to obtain the EMG activity in at least one of said leg muscle myotomes, and a graphical representation of a patient, wherein the video display device is operable to alert a user to at least one of a presence and absence of a nerve near the elongate stimulation instrument;

positioning an inner wire member in a disc annulus at the lateral aspect of the targeted spinal disc, the inner wire member being slidably disposed within a tubular distraction member of the elongate stimulation instrument such that a distal tip of the inner wire member is inserted along the lateral, trans-psoas path and penetrates into the disc annulus at the lateral aspect of the targeted spinal disc;

after forming the initial distraction corridor using the elongate stimulation instrument, advancing a plurality of sequential dilators to further dilate tissue along the lateral, trans-psoas path to the lumbar spine while the inner wire member remains engaged with the disc annulus at the lateral aspect of the targeted spinal disc;

slidably advancing a plurality of retractor blades of a retractor assembly simultaneously over an outer dilator of the plurality of sequential dilators and toward the targeted spinal disc along the lateral, trans-psoas path to the lumbar spine, the retractor assembly including the plurality of retractor blades and a handle assembly having pivotable arm portions that extend generally perpendicularly relative to the plurality of retractor blades, wherein the plurality of retractor blades are simultaneously advanced over the outer dilator while in a closed position, wherein the retractor blades are operable to adjust to an opened position by rotation of a rotatable knob element of the handle assembly that mates with teeth of a rack member so as to move a first retractor blade relative to a second retractor blade of the plurality of retractor blades, wherein each of the pivotable arm portions is arranged between the plurality of retractor blades and the rotatable knob element and is pivotable so as to reposition one arm portion relative to another;

removing the plurality of sequential dilators away from the retractor assembly so that the plurality of retractor blades form a lateral operative corridor to the lateral aspect of the targeted spinal disc along the lateral, trans-psoas path to the lumbar spine, and

removably engaging a fixation element with the first retractor blade of the plurality of retractor blades so that a distal portion of the fixation element extends from a distal end of the first retractor blade and secures into a portion of the lumbar spine; and

inserting an implant through the lateral operative corridor formed by the plurality of retractor blades along the lateral, trans-psoas path to the lumbar spine.

2. The method of claim 1, wherein after the step of removably engaging the fixation element, the distal portion of the fixation element is positioned in the lumbar spine to secure the first retractor blade in fixed relation relative the targeted spinal disc.

3. The method of claim 2, wherein the fixation element comprises a shim for insertion into the lumbar spine.

4. The method of claim 1, wherein the step of positioning the inner wire member in the disc annulus at the lateral aspect of the targeted spinal disc is performed such that the distal tip of the inner wire member resides within a disc space of the targeted spinal disc.

5. The method of claim 1, wherein the plurality of retractor blades form the lateral operative corridor by adjusting said retractor blades to the opened position.

6. The method of claim 5, wherein the step of adjusting said retractor blades to the opened position comprises rotating of the rotatable knob element of the handle assembly after said retractor blades are simultaneously advanced over the outer dilator while in the closed position.

7. The method of claim 6, wherein the step of adjusting said retractor blades to the opened position further comprises pivoting the pivotable arm portions of the handle assembly after said retractor blades are simultaneously advanced over the outer dilator while in the closed position.

8. The method of claim 7, wherein after the plurality of retractor blades are adjusted to the opened position to form the lateral operative corridor, the lateral operative corridor is dimensioned so as to pass the implant through the lateral operative corridor and into the lumbar spinal target site.

10. The method of claim 1, further comprising coupling one or more light emitting devices to at least some of the plurality of retractor blades so as to direct light through the lateral operative corridor toward the targeted spinal disc.

11. The method of claim 1, wherein when the plurality of retractor blades form the lateral operative corridor, the plurality of retractor blades are spaced apart.

12. The method of claim 11, wherein when the plurality of retractor blades form the lateral operative corridor, the plurality of blades are maintained generally parallel to one another and each of the plurality of retractor blades is separated by a gap from a respective adjacent retractor blade of the plurality of retractor blades.

13. The method of claim 11, wherein when the plurality of retractor blades are simultaneously advanced over the outer dilator while in the closed position, each of the plurality of retractor blades is in abutting relation with a respective adjacent refractor blade of the plurality of retractor blades.

14. The method of claim 11, wherein when the plurality of retractor blades form the lateral operative corridor, the plurality of retractor blades are spaced apart to define a cross-sectional shape of the lateral operative corridor that is one of generally ellipsoidal and oval.

15. The method of claim 1, further comprising attaching the handle assembly to an articulating arm mounted to an operating table.

16. The method of claim 1, wherein each of the plurality of sequential dilators includes a distal region and a stimulation electrode at the distal region that outputs electrical stimulation for nerve monitoring during delivery of each of the plurality of sequential dilators along the lateral, trans-psoas path to the lumbar spine.

17. The method of claim 1, wherein the nerve monitoring system comprises a control unit having said video display device, a patient module connected to the control unit via a data cable, and an EMG sensor harness connected to the patient module, the EMG sensor harness having said set of EMG sensor electrodes.

18. The method of claim 17, wherein the nerve monitoring system further comprises an electrical connection between the patient module and the elongate stimulation instrument for communicating said electrical stimulation signal to said stimulation electrode of the elongate stimulation instrument.

19. The method of claim 1, wherein at least one of the plurality of retractor blades comprises a stimulation electrode that outputs electrical stimulation for nerve monitoring during advancement of the plurality of retractor blades along the lateral, trans-psoas path to the lumbar spine.

20. The method of claim 1, wherein the retractor assembly comprises a three-bladed retractor assembly.

9. The method of clam 1, wherein the plurality of retractor blades comprises the first retractor blade, the second retractor blade, and a third retractor blade, wherein the first retractor blade is adjustable relative to the second retractor blade by rotation of the knob element that engages teeth along the rack member, and wherein the second and third retractor blades are pivotable relative to one another by movement of the pivotable arm portions of the handle assembly.