Surgical access system and related methods

• US 8,945,004 B2
• Filed: 08/01/2014
• Issued: 02/03/2015
• 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 RAAFAT
• Application Number:
  US14/449,313
• Publication Number:
  US 20140343363A1
• Time in Patent Office: 186 Days
• Field of Search: 600201-210, 600213-217, 600221-226, 600228-235
• US Class Current: 600/224
• 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 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 system for inserting an implant through a trans-psoas operative corridor to a lumbar spine, comprising:

means for creating a trans-psoas operative corridor along a trans-psoas path through a psoas muscle toward a targeted intervertebral disc of a lumbar spine by at least simultaneously advancing a plurality of retractor blades slidably along the trans-psoas path, wherein the plurality of retractor blades each have an outwardly facing convex surface region configured to engage the psoas muscle and that each have an inwardly facing concave surface region configured to engage a cylindrical exterior surface region of a trans-psoas dilator, the plurality of retractor blades including at least a caudal-most retractor blade and a cephalad-most retractor blade when the means for creating the trans-psoas operative corridor creates the operative corridor along the trans-psoas path, wherein the means for creating an operative corridor further comprises a first means for pivotably adjusting the cephalad-most retractor blade relative to the caudal-most retractor blade and a second means for pivotably adjusting the caudal-most retractor blade relative to cephalad-most retractor blade, wherein the means for creating the trans-psoas operative corridor is configured to adjust from a first position in which the plurality of retractor blades are positioned to simultaneously advance along the trans-psoas path to a second position in which the caudal-most retractor blade and the cephalad-most retractor blade are spaced apart from one another, the means for creating the trans-psoas operative corridor comprising means for actuating independent linear movement of a position of one retractor blade of the plurality of retractor blades relative to another retractor blade of the plurality of retractor blades in response to rotation of the actuating means;

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

nerve monitoring means for delivering an electrical stimulation signal to a stimulation electrode positioned within the psoas muscle, for monitoring electromyographic activity detected in leg muscle myotomes associated with nerves in the vicinity of the spinal disc, and for displaying;

a numeric stimulation threshold that changes in response to the electromyographic activity detected in said leg muscle myotomes, a graphical representation of a patient, and myotomes levels being monitored.

2. The system of claim 1, wherein the plurality of retractor blades includes a posterior-most retractor blade when the means for creating the trans-psoas operative corridor creates the operative corridor along the trans-psoas path.

3. The system of claim 2, wherein the position of the posterior-most retractor blade is linearly adjustable relative in response to rotation of the actuating means.

4. The system of claim 1, further comprising a trans-psoas dilator system to create a tissue distraction corridor along the trans-psoas path through bodily tissue toward the targeted intervertebral disc of the lumbar spine, wherein an outermost dilator of the dilator system is said trans-psoas dilator having said cylindrical exterior surface region configured to be engaged by the plurality of retractor blades of the trans-psoas retractor tool.

5. The system of claim 4, wherein the trans-psoas dilator system comprises:

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

6. The system of claim 5, further comprising an elongate inner member slidable in a lumen of the initial dilator of the dilator system, wherein at least one instrument selected from the group consisting of said elongate inner member, the initial dilator, the supplemental dilator, and the trans-psoas dilator includes the stimulation electrode that outputs said electrical stimulation signal of the nerve monitoring means.

7. The system of claim 6, wherein the elongate inner member is configured to be advanced along the trans-psoas path together with the initial dilator.

8. The system of claim 1, wherein the nerve monitoring means 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.

9. The system of claim 1, further comprising a spine penetration element removably attachable with a corresponding one of the plurality of retractor blades so that a distal portion of the spine penetration element extends distally from said corresponding one of the plurality of retractor blades to anchor said corresponding one of the plurality of retractor blades in fixed relation relative the lumbar spine.

10. The system of claim 9, wherein the spine penetration element includes a tapered tip for penetrating the lumbar spine and includes a proximal connection portion to mate with said corresponding one of the plurality of retractor blades.

11. The system of claim 1, wherein the means for creating the trans-psoas operative corridor comprises a trans-psoas retractor tool that is sized and shaped to create the trans-psoas operative corridor through the psoas muscle.

12. The system of claim 1, wherein when the means for creating the trans-psoas operative corridor is in the first position, the caudal-most retractor blade and the cephalad-most retractor blade abut one another.

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

14. The system of claim 1, further comprising means for emitting light toward the targeted intervertebral disc of the lumbar spine, the means for emitting light being attachable to the means for creating the trans-psoas operative corridor.

15. The system of claim 14, wherein the means for emitting light comprises one or more light emitting devices coupled with one or more of the caudal-most retractor blade and the cephalad-most retractor blade when the means for creating the trans-psoas operative corridor forms the operative corridor.

16. The system of claim 1, wherein the first means for pivotably adjusting the cephalad-most retractor blade comprises a first adjustable arm portion of the means for creating the trans-psoas operative corridor.

17. The system of claim 16, wherein the second means for pivotably adjusting the caudal-most retractor blade comprises a second adjustable arm portion of the means for creating the trans-psoas operative corridor.

18. The system of claim 1, wherein the means for actuating independent linear movement comprises a rotatable knob of the means for creating the trans-psoas operative corridor.