Surgical access system and related methods

• US 9,204,871 B2
• Filed: 01/16/2015
• Issued: 12/08/2015
• Est. Priority Date: 10/08/2002
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Miles, Patrick, Martinelli, Scot, Finley, Eric, Gharib, James, Farquhar, Allen, Kaula, Norbert F., Blewett, Jeffrey J.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/599,237
• Publication Number:
  US 20150133735A1
• Time in Patent Office: 326 Days
• Field of Search: 600/201, 600/202, 600/211, 600/546
• US Class Current: 1/1
• 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 17/0218 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 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00261 Discectomy
• 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 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 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A system for accessing a surgical target site and related methods, involving an initial distraction system for creating an initial distraction corridor, and an assembly capable of distracting from the initial distraction corridor to a secondary distraction corridor and thereafter sequentially receiving a plurality of retractor blades for retracting from the secondary distraction corridor to thereby create an operative corridor to the surgical target site, 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 retractor assembly comprising;

a first retractor blade having a first proximal end and a first distal end;

a second retractor blade having a second proximal end and a second distal end;

a third retractor blade having a third proximal end and a third distal end;

a fourth retractor blade having a fourth proximal end and a fourth distal end; and

a blade holder apparatus comprising a mounting structure comprising first, second, third, and fourth support portions, wherein the first support portion is connected to ends of the second and fourth support portions, wherein the second support portion is connected to ends of the first and third support portions, wherein the third support portion is connected to ends of the second and fourth support portions, and wherein the fourth support portion is connected to ends of the third and first support portions such that the first, second, third, and fourth support portions define a mounting structure hole,

wherein each of the first, second, third, and fourth retractor blades are connectable to the mounting structure at the first, second, third, and fourth proximal ends, respectively, such that the first, second, third, and fourth proximal ends are positioned at least partially in the mounting structure hole and the first, second, third, and fourth distal ends extend distally away from the mounting structure so as to define an operative corridor between the first, second, third, and fourth retractor blades that aligns with the mounting structure hole,

wherein at least two of the first, second, third, and fourth retractor blades are hingedly connected to the blade holder apparatus such that at least two of the first, second, third, and fourth distal ends can be independently angled outward with respect to the operative corridor, and

wherein all of the first, second, third, and fourth retractor blades are slidably connected to the blade holder apparatus such that the first, second, third, and fourth distal ends can be independently slid inward and/or outward with respect to the operative corridor;

wherein the mounting structure has a substantially square shape, with the first support portion being positioned opposite and substantially parallel to the third support portion and with the second support portion being positioned opposite and substantially parallel to the fourth support portion.

2. The system of claim 1, wherein the first retractor blades is hingedly connected to the blade holder apparatus so as to pivot about an axis that is parallel to a plane defined by the first, second, third, and fourth support portions.

3. The system of claim 1, wherein the blade holder apparatus further comprises means for connecting the first, second, third, and fourth retractor blades to the mounting structure.

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

an initial dilator configured to advance to a targeted spinal disc along a lateral, trans-psoas path to the lumbar spine, an elongate inner member advanceable through an inner lumen of the initial dilator and being configured to penetrate into a lateral aspect of a targeted spinal disc along the lateral, trans-psoas path to the lumbar spine, and a plurality of sequential dilators of sequentially larger diameter deliverable to the targeted spinal disc along the lateral, trans-psoas path to the lumbar spine, wherein at least one instrument from a group consisting of the initial dilator, the elongate inner member, and the sequential dilators includes a stimulation electrode at a distal tip region to deliver electrical stimulation for nerve monitoring when the stimulation electrode is positioned in the lateral, trans-psoas path, wherein the elongate inner member has a longitudinal length that is greater than a longitudinal length of the initial dilator, and wherein one or more dilators of the plurality of sequential dilators have an outer diameter that is greater than an outer diameter of the initial dilator,

wherein the first, second, third, and fourth retractor blades of are releasably attachable to the blade holder apparatus,

wherein the first, second, third, and fourth retractor blades are configured to maintain the operative corridor along the lateral, trans-psoas path to the lumbar spine after advancement of the plurality of sequential dilators along the lateral, trans-psoas path to the lumbar spine, and

wherein the blade holder apparatus is configured to retain the plurality of retractor blades in a selected position so that the trans-psoas operative corridor is so dimensioned to pass an implant through the trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine.

5. The system of claim 4, and further comprising a monitoring system configured to deliver an electrical stimulation signal to the stimulation electrode of said at least one instrument, configured to monitor electromyographic activity detected by a set of sensor electrodes in muscle myotomes associated with nerves in the vicinity of the spinal disc, and configured to display a numeric stimulation threshold in units of milliAmps indicating an electrical current magnitude required to obtain the electromyographic activity in at least one of said muscle myotomes.

6. The system of claim 1, wherein the retractor assembly further comprises a fixation element that is releasably attachable to the first refractor blade such that a distal penetration portion of the fixation element extends distally of the first distal end of the first retractor blade and is configured to penetrate into the lumbar spine for affixing the first retractor blade to the lumbar spine.

7. The system of claim 6, wherein the fixation element is slidably engageable with the first retractor blade and the fixation element includes a proximal portion having a width that is greater than a maximum width of the distal penetration portion of the fixation element.

8. The system of claim 6, wherein the fixation element configured to be releasably attached to only the first and third retractor blades.

9. The system of claim 1, and further comprising means for surgeon-driven EMG (electromyography) monitoring for traversing a lateral, trans-psoas path to the lumbar spine.

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

a nerve surveillance system electrically connectable to at least one of the first, second, third, and fourth retractor blades and configured to stimulate an electrode on at least one of the first, second, third, and fourth retractor blades when inserted into tissue proximate nerves.

11. The system of claim 10, 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.

12. The system of claim 1, wherein the first, second, third, and fourth support portions comprise first, second, third, and fourth elongated struts.

13. The system of claim 12, wherein the first, second, third, and fourth elongated struts are movably connected.

14. The system of claim 12, wherein the first strut is hingedly connected to the second and fourth elongated struts and where the third strut is hingedly connected to the second and fourth elongated struts.

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

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

maintaining the operative corridor using the retractor assembly along the lateral, trans-psoas path to the lumbar spine; and

inserting a spinal fusion implant through the operative corridor maintained by the first, second, third, and fourth refractor blades along the lateral, trans-psoas path to the lumbar spine.

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

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

17. The method of claim 15, wherein the first retractor blade is a posterior-most retractor blade, the second retractor blade is an anterior-most retractor blade, the third retractor blade is a caudal-most retractor blade, and the fourth retractor blade is a cephalad-most retractor blade.

18. The method of claim 17, wherein at least the posterior-most retractor blade and the anterior-most retractor blade are hingedly connected to the blade holder apparatus.

19. The method of claim 18, and further comprising:

advancing a fixation element into the working corridor so as to be attached to the posterior-most retractor blade and advanced into the disc space so as to distract adjacent vertebral bodies.