Surgical access system and related methods

• US 9,265,493 B2
• Filed: 01/16/2015
• Issued: 02/23/2016
• 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
• Application Number:
  US14/599,313
• Publication Number:
  US 20150126811A1
• Time in Patent Office: 403 Days
• US Class Current: 1/1
• 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 refraction 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, the system comprising:

a trans-psoas dilator system, which includes at least a first dilator cannula, to create a tissue distraction corridor along the lateral, trans-psoas path through bodily tissue to the targeted intervertebral disc of the lumbar spine;

a three-bladed tissue retraction assembly to maintain the tissue distraction corridor along the lateral, trans-psoas path through bodily tissue to the targeted intervertebral disc of the lumbar spine, the three-bladed retractor comprising;

a caudal-most retractor blade connectable at a proximal end of the caudal-most retractor blade;

a cephalad-most retractor blade connectable at a proximal end of the cephalad-most retractor blade;

a posterior-most retractor blade connectable at a proximal end of the posterior-most retractor blade;

a first retractor arm having a first length extending between a first proximal end and a first distal end, the first retractor arm comprising a first blade connecting portion connectable to the proximal end of the caudal-most retractor blade;

a second retractor arm having a second length extending between a second proximal end and a second distal end, the second retractor arm comprising a second blade connecting portion connectable to the proximal end of the cephalad-most retractor blade;

a translating member having a third length extending between a third proximal end and a third distal end, the translating member being translatable in response to rotation of an actuating member and the translating member comprising a third blade connecting portion connectable to the proximal end of the posterior-most retractor blade; and

a coupling mechanism hingedly connecting the first pivot portion of the first retractor arm and the second pivot portion of the second retractor arm such that the first retractor arm is pivotable with respect to the second retractor arm about an axis that extends through the translating member; and

a spinal fusion implant sized and shaped to insert between the retractor blades along the trans-psoas path and into the targeted intervertebral disc of the lumbar spine while the retractor blades maintain the tissue-distraction corridor along the trans-psoas path.

2. The system of claim 1, wherein the translating member moves linearly along a line that intersects with the axis.

3. The system of claim 2, wherein the translating member moves linearly along a line that is perpendicular to the axis.

4. The system of claim 1, wherein the first and second retractor arms are slidably connected to a translation slot of the translating member via the coupling mechanism.

5. The system of claim 1, further comprising one or more light emitting devices to couple with one or more of the caudal-most retractor blade and the cephalad-most retractor blade and emit light toward the targeted intervertebral disc of the lumbar spine when the three-bladed tissue retraction assembly maintains the tissue distraction corridor.

6. The system of claim 1, wherein the three-bladed tissue retraction assembly further includes a spine penetration element that releasably engages with the posterior-most retractor blade so that a distal portion of the spine penetration element extends distally from the posterior-most retractor blade to anchor the posterior-most retractor blade in fixed relation relative the lumbar spine.

7. The system of claim 6, wherein the spine penetration element includes a tapered tip for penetrating the lumbar spine and includes a proximal connection portion to mate with the posterior-most retractor blade.

8. The system of claim 1, wherein when the three-bladed tissue retraction assembly is in a closed position, the distal-most retractor blade, the caudal-most retractor blade and the cephalad-most retractor blade abut one another.

9. The system of claim 1, wherein the caudal-most retractor blade, the cephalad-most retractor blade and the posterior-most retractor blade define a tissue-distracting corridor having a cross-sectional shape that is not circular.

10. The system of claim 1, wherein the spinal fusion implant further comprises bone products or bone morphogenic protein.

11. The system of claim 1, wherein the trans-psoas dilator system comprises:

an initial dilator and at least one supplemental dilator that slidably advances over an exterior of the initial dilator and engages the lumbar spine.

12. The system of claim 1, and further comprising:

a nerve surveillance system electrically connectable to each of the first dilator cannula and the three-bladed tissue retraction assembly and configured to stimulate the first dilator cannula and the three-bladed tissue retraction assembly when inserted into tissue proximate nerves.

13. The system of claim 12, wherein the nerve surveillance system comprises:

an EMG (electromyography) harness having a plurality of recording electrodes positioned along branches of the EMG harness in pairs, wherein each branch of the EMG harness has a plurality of pairs of recording electrodes; and

a control unit operably connectable to the stimulation electrodes to activate the stimulation electrodes and to the recording electrodes on the EMG harness to receive EMG response signals from the recording electrodes.

14. A method of accessing a surgical target site using the system of claim 1, the method comprising:

forming the tissue distraction corridor using the trans-psoas dilator system along the lateral, trans-psoas path to the lumbar spine;

slidably advancing the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade of the three-bladed tissue retraction assembly over the trans-psoas dilator system along the lateral, trans-psoas path to the lumbar spine; and

inserting the spinal fusion implant through the tissue distraction corridor formed by the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade along the lateral, trans-psoas path to the lumbar spine.

15. The method of claim 14, and further comprising:

performing surgeon-driven EMG (electromyography) monitoring while traversing the lateral, trans-psoas path to the lumbar spine.

16. A method of accessing a surgical target site using the system of claim 1, the method comprising:

actuating a nerve surveillance system when electrically connected to each of the first dilator cannula and the three-bladed tissue retraction assembly when positioned along the lateral, trans-psoas path to the lumbar spine.

17. A method of accessing a surgical target site using the system of claim 1, the method 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 of the trans-psoas dilator system 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 the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade of the three-bladed tissue retraction 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 three-bladed tissue retraction assembly including a handle assembly having pivotable arm portions that extend generally perpendicularly relative to the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade, wherein the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade are simultaneously advanced over the outer dilator while in a closed position, wherein the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade 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 the posterior-most retractor blade relative to the cephalad-most retractor blade and the caudal-most retractor blade, wherein each of the pivotable arm portions is arranged between the caudal-most retractor blade and the cephalad-most retractor blade 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 three-bladed tissue retraction assembly so that the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade 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 posterior-most retractor blade so that a distal portion of the fixation element extends from a distal end of the posterior-most retractor blade and secures into a portion of the lumbar spine; and

inserting an implant through the lateral operative corridor formed by the caudal-most retractor blade, the cephalad-most retractor blade, and the posterior-most retractor blade along the lateral, trans-psoas path to the lumbar spine.