Surgical access system and related methods

• US 9,750,490 B2
• Filed: 04/28/2014
• Issued: 09/05/2017
• Est. Priority Date: 06/26/2002
• Status: Active Grant

• 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): BECCIA, CHRISTOPHER J
• Application Number:
  US14/263,797
• Publication Number:
  US 20140235950A1
• Time in Patent Office: 1,226 Days
• Field of Search: 600102
• 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 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• 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 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

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 trans-psoas surgical access system for accessing a spinal disc of a lumbar spine, comprising:

a distraction assembly to create a trans-psoas distraction corridor to a lumbar spine, wherein said distraction assembly comprises;

an elongate inner member configured to be delivered toward a spinal disc along a lateral, trans-psoas path to the lumbar spine, and a first dilator configured to be delivered to the spinal disc along the lateral, trans-psoas path to the lumbar spine, the first dilator having a passage configured to slidably receive the elongate inner member, wherein at least one instrument from the group consisting of the elongate inner member and the first dilator has a stimulation electrode situated at a distal end region thereof to deliver electrical stimulation for nerve monitoring when said stimulation electrode is positioned in the lateral, trans-psoas path to the lumbar spine; and

a trans-psoas retraction assembly comprising;

a blade holder apparatus, and a plurality of retractor blades configured to enlarge the trans-psoas distraction corridor and configured to maintain a trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine when the plurality of retractor blades are delivered to the lumbar spine, wherein the blade holder apparatus that is configured to retain the first and second retractor blades in an orientation in which the first retractor blade is spaced apart from the second retractor blade by a gap therebetween, wherein the plurality of retractor blades are sized and shaped to maintain the trans-psoas operative corridor that is so dimensioned to pass a spinal implant through the trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine, and wherein with a first retractor blade of the plurality of retractor blades defines a first channel that is fixedly positioned relative to a proximal end of the respective retractor blade and that is configured to slidably engage a first fixation member for anchoring to the lumbar spine, the first fixation member having a proximal portion with a proximal end, a distal portion extending from the proximal portion to a distal end, a length between the proximal end and distal end, a corridor facing surface and a blade facing surface, a thickness defined between the corridor facing surface and the blade facing surface, and a width, wherein the width is greater than the thickness, the fixation member being slidably advanceable along the channel to a position wherein the distal end extends distally from the retractor blade to anchor into the lumbar spine.

2. The system of claim 1, wherein when the plurality of retractor blades are delivered to the lumbar spine, the distal portion of the first fixation member is adapted to anchor into the spinal disc between adjacent vertebral bodies and secures the first retractor blade relative to the adjacent vertebral bodies.

3. The system of claim 1, wherein the retractor assembly further comprises a plurality of light emitting devices to direct light through the operative corridor toward the spinal disc, the plurality of light emitting devices being coupled to the plurality of retractor blades.

4. The system of claim 1, wherein the plurality of retractor blades comprises the first retractor blade and a second retractor blade that is spaced apart from the first retractor blade when the plurality of retractor blades enlarge the tissue distraction corridor to form the trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine.

5. The system of claim 4, wherein the first retractor blade is a posterior-most retractor blade when the plurality of retractor blades are delivered to the lumbar spine, wherein the first fixation member is configured to slidably engage with the posterior-most blade and to anchor into the lumbar spine when the posterior-most blade is delivered to the lumbar spine.

6. The system of claim 1, wherein the stimulation electrode of said at least one instrument comprises an exposed electrode surface positioned on a tapered distal tip portion of said at least one instrument.

7. The system of claim 6, wherein the distraction assembly further comprises a second dilator having a larger diameter than the first dilator, the second dilator being advanceable over the first supplemental dilator along the lateral, trans-psoas path to the lumbar spine.

8. The system of claim 7, wherein each of the elongate inner member, the first dilator, and the second dilator comprises a corresponding stimulation electrode positioned on a respective tapered distal tip portion of the respective one of the elongate inner member, the first dilator, and the second dilator.

9. The system of claim 1, wherein the distraction assembly further comprises a secondary distraction assembly.

10. The system of claim 9, wherein the secondary distraction assembly comprises a speculum instrument to prepare the trans-psoas distraction corridor for receipt of the plurality of retractor blades.

11. The system of claim 1, wherein each retractor blade of the plurality of retractor blades is sequentially advanced along the lateral, trans-psoas path to the targeted spinal site.

12. The system of claim 1, wherein each retractor blade of the plurality of retractor blades comprises a stimulation electrode to deliver electrical stimulation for nerve monitoring.

13. The system of claim 1, further comprising a monitoring system that delivers an electrical stimulation signal to the stimulation electrode of said at least one instrument, monitors electromyographic activity detected by a set of sensor electrodes in muscle myotomes associated with nerves in the vicinity of the spinal disc, and displays a numeric stimulation threshold value in units of milliAmps which varies in response to the electromyographic activity detected by the set of sensor electrodes.

14. The system of claim 13, wherein the monitoring system displays to the user the numeric stimulation threshold value in units of milliAmps while also contemporaneously displaying myotome levels being monitored, the numeric stimulation threshold being an electrical current value required to obtain a threshold level of electromyographic activity in at least one of said muscle myotomes.

15. The system of claim 13, wherein the monitoring system comprises a control unit having a video display device, a patient module connected to the control unit via a data cable, an EMG sensor harness having the set of sensor electrodes connected to the patient module, and wherein the control unit receives signals from the patient module and processes EMG responses output from the sensor electrodes to extract characteristic information for each of said muscle myotomes.

16. The system of claim 1, wherein the elongate inner member has a first length, and the first dilator has a second length less than the first length of the elongate inner member.

17. The system of claim 1, wherein the elongate inner member comprises a guide wire instrument.

18. The system of claim 1, wherein the plurality of retractor blades includes first and second retractor blades that each have a proximal connector region for mounting to the blade holder apparatus and an elongate blade body extending distally from the proximal connector region, wherein the elongate blade body of the first retractor blade has the same shape and maximum width as the elongate blade body of the second retractor blade.

19. The system of claim 1, wherein the elongate inner member is configured to be simultaneously delivered with the first dilator toward the spinal disc along the lateral, trans-psoas path to the lumbar spine.