SURGICAL ACCESS SYSTEM AND RELATED METHODS

• US 20140180016A1
• Filed: 03/03/2014
• Published: 06/26/2014
• Est. Priority Date: 10/08/2002
• 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.
• Granted Patent: US 8,956,283 B2
• Time in Patent Office: Days
• US Class Current: 600/214
• 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. (canceled)

2. A surgical system for providing a lateral, trans-psoas operative corridor to a lumbar spine, comprising:

an first cannula 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 first cannula and having a tip configured to engage with 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 first cannula, and the elongate inner member, and the sequential dilators includes a stimulation electrode at 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 first cannula, 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 first cannula; and

a trans-psoas retractor assembly comprising a blade holder apparatus and a plurality of retractor blades configured to mate with and mount onto said blade holder apparatus, wherein the plurality of retractor blades of the trans-psoas retractor assembly are configured to maintain a trans-psoas 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, wherein at least two retractor blades of the plurality of retractor blades are mountable to the blade holder apparatus so as to be caudal-most and cephalad-most retractor blades when the plurality of retractor blades maintain a trans-psoas operative corridor along the lateral, trans-psoas path, 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.

3. The system of claim 2, wherein the trans-psoas retractor assembly further comprises a fixation element that is releasably attachable to a first refractor blade of the plurality of retractor blades such that a distal penetration portion of said fixation element extends distally of a distal end of the said first retractor blade and is configured to penetrate into the lumbar spine for affixing the first retractor blade to the lumbar spine, wherein said fixation element includes a proximal portion having a width that is greater than a maximum width of said distal penetration portion of said fixation element.

4. The system of claim 3, wherein a second retractor blade of the plurality of retractor blades is movable away from the first retractor blade.

5. The system of claim 3, wherein said fixation element of the trans-psoas retractor assembly is slidably engageable with said first retractor blade.

6. The system of claim 2, further comprising a monitoring system configured to deliver an electrical stimulation signal to the stimulation electrodes of said at least one instrument and said sequential dilators, 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 that changes in response to the electromyographic activity in at least one of said muscle myotomes.

7. The system of claim 6, 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, and an EMG sensor harness having the set of sensor electrodes positioned along branches of the EMG sensor harness in pairs, wherein each branch of the EMG sensor harness has a plurality of pairs of sensor electrodes connected to the patient module.

8. The system of claim 7, wherein the control unit receives signals from the patient module and processes EMG response output from the sensor electrodes to extract characteristic information for each of said muscle myotomes.

9. The system of claim 6, wherein said at least one instrument is connected to said monitoring system via a removable connector that establishes electrical communication between the monitoring system and the stimulation electrode at the distal tip region of said at least one instrument.

10. The system of claim 2, wherein an angular orientation of each of the two retractor blades of the plurality of retractor blades is independently adjustable relative to said blade holder apparatus.

11. The system of claim 10, wherein the angular orientation of each of the two retractor blades of the plurality of retractor blades is independently adjustable such that the distal ends of the two retractor blades are adjustable to extend toward each other.

12. The system of claim 10, wherein the angular orientation of each of the two retractor blades of the plurality of retractor blades is independently adjustable such that the distal ends of the two retractor blades are adjustable to extend away from each other.

13. The system of claim 2, wherein a first retractor blade of the plurality of retractor blades is configured to be delivered along the lateral, trans-psoas path before a second retractor blade of the plurality of retractor blades is delivered along the lateral, trans-psoas path.

14. The system of claim 2, wherein a first retractor blade of the plurality of retractor blades is configured to away from a second retractor blade of the plurality of retractor blades under force from at least one of said plurality of sequential dilators.

15. The system of claim 2, wherein said plurality of sequential dilators are configured to be delivered along the lateral, trans-psoas path after removal of the first cannula.

16. The system of claim 2, wherein the elongate inner member comprises a k-wire.

17. The system of claim 2, wherein said plurality of retractor blades comprises four retractor blades.

18. The system of claim 17, wherein when the plurality of retractor blades comprises four retractor blades are delivered along the lateral, trans-psoas path, the first retractor blade of the four retractor blades is a posterior-most retractor blade, the second retractor blade of the four retractor blades is an anterior-most retractor blade, a third retractor blade of the four retractor blades is a caudal-most retractor blade, and a fourth refractor blade of the four retractor blades is a cephalad-most retractor blade.

19. A surgical system for providing a lateral, trans-psoas operative corridor to a lumbar spine, comprising:

an first cannula 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 first cannula 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 first cannula and the elongate inner member includes a stimulation electrode at distal tip region to deliver electrical stimulation for nerve monitoring when the stimulation electrode is positioned in the lateral, trans-psoas path, wherein each of the sequential dilators includes one or more stimulation electrodes at distal tip regions to deliver electrical stimulation for nerve monitoring when the stimulation electrodes are 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 first cannula, 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 first cannula; and

a trans-psoas retractor assembly comprising a blade holder apparatus and a plurality of retractor blades coupled to said blade holder apparatus, wherein at least two retractor blades of the plurality of retractor blades are releasably attachable to said blade holder apparatus, wherein the plurality of retractor blades of the trans-psoas retractor assembly are configured to maintain a trans-psoas 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, wherein a first retractor blade of the plurality of retractor blades is movable away from a second retractor blade of the plurality of retractor blades while in the lateral, trans-psoas path, 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.

20. The system of claim 19, further comprising a monitoring system configured to deliver an electrical stimulation signal to the stimulation electrodes of said at least one instrument and said sequential dilators, 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 that changes in response to the electromyographic activity in at least one of said muscle myotomes, 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, and an EMG sensor harness having the set of sensor electrodes positioned along branches of the EMG sensor harness in pairs, wherein each branch of the EMG sensor harness has a plurality of pairs of sensor electrodes connected to the patient module.

21. A surgical system for providing a lateral, trans-psoas operative corridor to a lumbar spine, comprising:

an first cannula 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 first cannula and being configured to is 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 first cannula and the elongate inner member includes a stimulation electrode at distal tip region to deliver electrical stimulation for nerve monitoring when the stimulation electrode is positioned in the lateral, trans-psoas path, wherein each of the sequential dilators includes one or more stimulation electrodes at distal tip regions to deliver electrical stimulation for nerve monitoring when the stimulation electrodes are 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 first cannula, 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 first cannula; and

a trans-psoas retractor assembly comprising a blade holder apparatus and a plurality of retractor blades configured to releasably lock onto said blade holder apparatus, wherein all of the retractor blades of the trans-psoas retractor assembly have a distal portion shaped to safely advanced along the lateral, trans-psoas path to the lumbar spine, wherein a first retractor blade of the plurality of retractor blades is movable away from a second retractor blade of the plurality of retractor blades while in the lateral, trans-psoas path, wherein the plurality of retractor blades of the trans-psoas retractor assembly are shaped and operable to safely maintain a trans-psoas 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.