Surgical access system and related methods

• US 10,357,238 B2
• Filed: 10/24/2017
• Issued: 07/23/2019
• Est. Priority Date: 01/16/2003
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Miles, Patrick, Martinelli, Scot, Finley, Eric, Gharib, James E., Farquhar, Allen, Kaula, Norbert F., Blewett, Jeffrey J.
• Primary Examiner(s): Hammond, Ellen C
• Application Number:
  US15/792,652
• Publication Number:
  US 20180042594A1
• Time in Patent Office: 637 Days
• 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 17/0206 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 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 5/4893 Nerves

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 forming an operating corridor to a lumbar spine of a patient, the patient having an anterior aspect, a posterior aspect and two lateral aspects, the method comprising:

inserting a first sequential dilator of a plurality of sequential dilators into the patient at an insertion position on one of the two lateral aspects of the patient and advancing the first sequential dilator to a lateral aspect of a target intervertebral disc of the lumbar spine, a lateral, trans-psoas path having a path axis that extends from the insertion position on the one of the two lateral aspects to the other of the two lateral aspects of the patient, wherein a first stimulation electrode at a distal region of the first sequential dilator is configured to deliver electrical stimulation for nerve monitoring, the first sequential dilator comprising a first proximal connector portion for electrical connection with a nerve monitoring system;

delivering electrical stimulation signals from the first stimulation electrode while the first sequential dilator is advanced along the lateral, trans-psoas path to detect and avoid directly contacting the nerves in the psoas muscle, advancing an elongate penetration member extending through the first sequential dilator into the target intervertebral disc, advancing a second sequential dilator of the plurality of sequential dilators over the first sequential dilator along the lateral, trans-psoas path to the targeted intervertebral disc of the lumbar spine;

simultaneously delivering three retractor blades of a retractor assembly over an outermost dilator of the plurality of sequential dilators along the lateral, trans-psoas path, wherein the three retractor blades slide over the outermost dilator of the plurality of dilators in a closed position in which the three retractor blades are adjacent one another to form an enclosed corridor along the lateral trans-psoas path to the target intervertebral disc;

positioning the retractor assembly such that the three retractor blades comprise a posterior retractor blade, a caudal retractor blade, and a cephalad retractor blade;

removing the plurality of sequential dilators from the lateral aspect of the target intervertebral disc of the lumbar spine after the three retractor blades are positioned along the lateral, trans-psoas path;

advancing a shim device along the posterior retractor blade to a position in which a portion of the shim device extends from the posterior retractor blade and into the target intervertebral disc; and

adjusting the retractor assembly to move the caudal retractor blade and the cephalad retractor blade away from the posterior retractor blade to an open position such that the three retractor blades form a non-enclosed operating corridor to the target intervertebral disc of the lumbar spine that is dimensioned to pass an implant; and

after adjusting the retractor assembly to form the operating corridor, passing an implant through the operative corridor along the lateral, trans-psoas path to the targeted intervertebral disc of the lumbar spine.

2. The method of claim 1, further comprising actuating a blade holder assembly of the retractor assembly to adjust the retractor assembly from the closed position to the open position.

3. The method of claim 2, wherein the three retractor blades extend generally perpendicularly relative to arm portions of the blade holder assembly.

4. The method of claim 1, wherein the elongate penetration member is delivered together with the first sequential dilator along the lateral, trans-psoas path.

5. The method of claim 4, wherein the elongate penetration member comprises a K-wire.

6. The method of claim 1, comprising the additional step of delivering a fourth retractor blade along the lateral, trans-psoas path after adjusting the retractor assembly to the open position and coupling the fourth retractor blade to the retractor assembly.

7. The method of claim 6, wherein the fourth retractor blade is positioned to be an anterior retractor blade along the lateral, trans-psoas path.

8. The method of claim 1, wherein the shim device includes a proximal portion configured to releasably attach to the posterior blade and a distal extension configured to extend distally of the posterior blade and penetrate into the target intervertebral disc space.

9. The method of claim 8, wherein the proximal portion includes a rearwardly extending ridge structure to releasably engage with a corresponding groove along an interior face of the posterior retractor blade when the shim device is advanced along the posterior retractor blade.

10. The method of claim 1, wherein the shim device has a maximum longitudinal length extending from a proximal-most end of the proximal portion to a distal-most end of the distal extension and extending parallel to a longitudinal axis of the shim device, wherein the maximum longitudinal length of the shim device is less than a maximum longitudinal length of the posterior retractor blade.

11. The method of claim 10, wherein the distal extension includes a maximum lateral width located proximally away from a distal-most end of the distal extension, the proximal portion having a proximal lateral width that is greater than the maximum lateral width of the distal extension.

12. The method of claim 11, wherein the distal-most end of the distal extension includes a tapered tip region.

13. The method of claim 1, wherein adjusting the retractor assembly includes pivoting a first pivot arm coupled to the cephalad retractor blade and pivoting a second pivot arm coupled to the caudal retractor blade.

14. The method of claim 1, comprising the additional step of delivering electrical stimulation signals from a second stimulation electrode at a distal region of the second sequential dilator while the second sequential dilator is advanced along the lateral, trans-psoas path to detect and avoid directly contacting the nerves in the psoas muscle, the second sequential dilator comprising a second proximal connector portion for electrical connection with a nerve monitoring system.

15. The method of claim 1, further comprising:

electrically connecting a cable of the nerve monitoring system to the first proximal connector portion of the first sequential dilator, wherein the nerve monitoring system delivers an electrical stimulation signal to the first stimulation electrode of the first sequential dilator during advancement of the first sequential dilator along the lateral, trans-psoas path to the targeted intervertebral disc of the lumbar spine, the nerve monitoring system monitoring muscle activity detected by a set of sensor electrodes in communication with leg muscles associated with the nerves in the psoas muscle, and the nerve monitoring system displaying to a user a numeric stimulation current threshold required to obtain the detected muscle activity in at least one of said leg muscles during advancement of the first sequential dilator.

16. The method of claim 15, wherein the muscle activity is detected with electromyography (EMG) sensors.