Surgical access system and related methods

• US 8,628,469 B2
• Filed: 07/30/2013
• Issued: 01/14/2014
• 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:
  US13/954,550
• Publication Number:
  US 20130317304A1
• Time in Patent Office: 168 Days
• Field of Search: 600201-210, 600213-217, 600221-226, 600228-235, 606/104
• 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 refraction 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 forming a trans-psoas operative corridor to a lumbar spine, comprising:

a trans-psoas dilator system to create a tissue distraction corridor along a lateral, trans-psoas path through bodily tissue toward a targeted intervertebral disc of the lumbar spine, the trans-psoas dilator system including an outer dilator having a cylindrical exterior surface region configured to engage a psoas muscle; and

a multi-bladed psoas retractor tool to create an operative corridor along a lateral, trans-psoas path through bodily tissue toward a targeted intervertebral disc of a lumbar spine, the multi-bladed psoas retractor tool including;

a plurality of retractor blades that each have an outwardly facing convex surface region configured to engage the psoas muscle and that each have an inwardly facing concave surface region to engage the cylindrical exterior surface region of the outer dilator of the trans-psoas dilator system, the plurality of retractor blades including a caudal-most retractor blade when the multi-bladed psoas retractor tool creates the operative corridor along the lateral, trans-psoas path, and the plurality of retractor blades including a cephalad-most retractor blade when the multi-bladed psoas retractor tool creates the operative corridor along the lateral, trans-psoas path; and

a blade holder assembly comprising adjustable arm portions, wherein the plurality of retractor blades extend generally perpendicularly relative to the arm portions of the blade holder assembly, wherein a first pivotable arm portion of the adjustable arm portions is configured to pivotably adjust the cephalad-most retractor blade relative to the caudal-most retractor blade, wherein the multi-bladed psoas retractor tool is adjustable from a first position in which the plurality of retractor blades are positioned to simultaneously advance along the lateral, trans-psoas path to a second position in which the caudal-most retractor blade and the cephalad-most retractor blade are spaced further apart from one another, the blade holder assembly comprising a rotatable actuator that causes 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 rotatable actuator,

wherein when at least the caudal-most retractor blade and the cephalad-most retractor blade of the multi-bladed psoas retractor tool maintain the operative corridor along the lateral, trans-psoas path through the bodily tissue toward the targeted intervertebral disc of the lumbar spine, the operative corridor is dimensioned so as to pass an implant through the operative corridor along the lateral, trans-psoas path toward the targeted intervertebral disc of the lumbar spine.

2. The system of claim 1, wherein when the multi-bladed psoas retractor tool is in the first position, the caudal-most refractor blade and the cephalad-most retractor blade are positioned to simultaneously slide over the outer dilator of the trans-psoas dilator system toward the lumbar spine to enlarge the tissue distraction corridor.

3. The system of claim 1, wherein the plurality of retractor blades includes a posterior-most retractor blade when the multi-bladed psoas retractor tool creates the operative corridor along the lateral, trans-psoas path.

4. The system of claim 3, wherein the position of the posterior-most retractor blade is linearly adjustable relative in response to rotation of the rotatable actuator.

5. The system of claim 4, wherein the position of the posterior-most retractor blade is linearly adjustable relative to the caudal-most retractor blade and the cephalad-most retractor blade while the caudal-most retractor blade and the cephalad-most retractor blade remain generally stationary relative to the blade holder assembly.

6. The system of claim 3, wherein the rotatable actuator of the blade holder assembly linearly adjusts a translating arm portion of the adjustable arm portions of the blade holder assembly that is coupled to the posterior-most retractor blade.

7. The system of claim 6, wherein the rotatable actuator of the blade holder assembly interacts with teeth on a rack of the translating arm portion to linearly adjust the position of the posterior-most retractor blade relative to the caudal-most retractor blade and the cephalad-most retractor blade.

8. The system of claim 1, wherein a second pivotable arm portion of the adjustable arm portions is configured to pivotably adjust the caudal-most retractor blade relative to the cephalad-most retractor blade.

9. The system of claim 1, wherein the trans-psoas dilator system comprises:

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

10. The system of claim 9, further comprising an elongate inner member being positionable in a lumen of the initial dilator of the trans-psoas 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 outer dilator includes a stimulation electrode that outputs electrical stimulation for nerve monitoring when the instrument is positioned in the lateral, trans-psoas path.

11. The system of claim 10, further comprising a monitoring system that delivers an electrical stimulation sign to the stimulation electrode of the at least one instrument selected from the group consisting of said elongate inner member, the initial dilator, the supplemental dilator, and the outer dilator, that monitors electromyographic activity detected by a set of sensor electrodes in leg muscle myotomes associated with nerves in the vicinity of the spinal disc, and that displays to a user:

a numeric stimulation threshold required to obtain the electromyographic activity in said leg muscle myotomes, a graphical representation of a patient, and myotomes levels being monitored.

12. The system of claim 11, 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.

13. The system of claim 10, wherein the elongate inner member is advanceable together with the initial dilator along the lateral, trans-psoas path.

14. The system of claim 1, further comprising one or more light emitting devices to couple with one or more of the caudal-most retractor blade and the cephalad-most retractor blade and emit light toward the targeted intervertebral disc of the lumbar spine when the multi-bladed psoas retractor tool forms the operative corridor.

15. The system of claim 1, wherein the multi-bladed psoas retractor tool further includes a spine penetration element that releasably engages 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.

16. The system of claim 15, 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.

17. The system of claim 1, wherein when the multi-bladed psoas retractor tool is in the first position, the caudal-most retractor blade and the cephalad-most retractor blade abut one another.

18. The system of claim 1, wherein when the plurality of retractor blades maintain the operative corridor along the lateral, trans-psoas path, the operative corridor is dimensioned so as to pass the implant through the operative corridor along the lateral, trans-psoas path, the implant comprising a lateral approach fusion implant carrying bone products or bone morphogenic protein.