Surgical access system and related methods

• US 8,355,780 B2
• Filed: 11/20/2009
• Issued: 01/15/2013
• 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): BOCKELMAN, MARK
• Application Number:
  US12/623,016
• Publication Number:
  US 20100069783A1
• Time in Patent Office: 1,152 Days
• Field of Search: 607/2, 600/117, 600201-202, 600214-215, 600/226, 600/245, 600/546, 600/554, 606/99
• US Class Current: 607/2
• 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 an operating corridor to a lumbar spine, comprising:

an elongate member deliverable to a spinal disc along a lateral, trans-psoas path to the lumbar spine such that a distal tip region of the elongate member penetrates into an annulus of the spinal disc, the distal tip region of the elongate member including a stimulation electrode to deliver electrical stimulation for nerve monitoring when the stimulation electrode is positioned along the lateral, trans-psoas path to the lumbar spine;

a dilator system to create a distraction corridor along the lateral, trans-psoas path to the lumbar spine, the dilator system comprising at least one dilator cannula that slidably engages an exterior of the elongate member, the at least one dilator being deliverable to the spinal disc along the lateral, trans-psoas path to the lumbar spine;

a three-bladed retractor assembly slidable over the dilator system toward the spinal disc along the lateral, trans-psoas path, the three-bladed retractor assembly including;

a blade holder assembly and first, second, and third retractor blades that extend generally perpendicularly relative to arm members of the blade holder assembly,

wherein the three-bladed retractor assembly is adjustable from a first position in which the first, second, and third retractor blades are adjacent to one another and slidable over the dilator system to a second position in which the second and third retractor blades are moved away from the first retractor blade to enlarge the distraction corridor and thereby form an operative corridor along the lateral, trans-psoas path to the lumbar spine,

wherein the first retractor blade is linearly movable relative to the second and third retractor blades in response to rotation of a knob element on the blade holder assembly, and

wherein the second and third retractor blades are movable relative to the first blade in response to pivoting movement of two of the arm members of the blade holder assembly; and

wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor along the lateral, trans-psoas path to the lumbar spine, the first retractor blade is a posterior-most retractor blade of the first, second, and third retractor blades and the operative corridor is dimensioned so as to pass an implant through the operative corridor and into the lumbar spine.

2. The system of claim 1, wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor, the first retractor blade is the posterior-most retractor blade, the second blade is a cephalad-most retractor blade, and the third blade is a caudal-most retractor blade.

3. The system of claim 2, wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor, the cephalad-most retractor blade and the caudal-most retractor blade are moved away from one another to define a cross-sectional shape of the operative corridor that is one of generally ellipsoidal and oval.

4. The system of claim 2, wherein the three-bladed retractor assembly includes a plurality of light emitting devices to direct light through the operative corridor toward the spinal disc, the plurality of light emitting devices including a first light emitting device that coupled to the cephalad-most retractor blade and a second light emitting device coupled to the caudal-most retractor blade.

5. The system of claim 1, wherein the two arm members of the blade holder assembly comprise a first pivotable arm member coupled to the second refractor blade and a second pivotable arm member coupled to the third retractor blade.

6. The system of claim 5, wherein the blade holder assembly further comprises a translating arm member coupled to the first retractor blade.

7. The system of claim 6, wherein the rotation of the knob element of the blade holder assembly causes the translating arm member to linearly adjust a position of the first retractor blade relative to the second and third retractor blades, and wherein at least a portion of each of the first and second pivotable arm members is arranged between the rotatable knob element and the first, second, and third retractor blades.

13. The system of claim 1, wherein the blade holder assembly further comprises handle extenders coupled to the two arm members, the second and third refractor blades simultaneously moving in response to movement of the handle extenders.

14. The system of claim 1, wherein the elongated member is advanced together with the at least one dilator cannula along the lateral, trans-psoas path to the lumbar spine.

15. The system of claim 1, wherein when the three-bladed retractor assembly is adjusted to create the operative corridor, the first, second, and third retractor blades are spaced apart and maintained generally parallel to one another.

16. The system of claim 1, wherein when the three-bladed retractor assembly is in the first position, the first, second, and third retractor blades are in generally abutting relation with one another.

17. The system of claim 1, wherein the dilator system comprises a plurality of supplemental dilators for sequential insertion along the lateral, trans-psoas path to the lumbar spine.

18. The system of claim 1, wherein the elongate member comprises a K-wire.

19. The system of claim 1, further comprising a monitoring system that delivers an electrical stimulation sign to the stimulation electrode of the elongate member, 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 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.

20. The system of claim 18, 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.

8. The system of clam 1, wherein the three-bladed retractor assembly includes a shim element removably engageable with the first refractor blade so that a distal portion of the shim element extends from a distal end of the first retractor blade.

9. The system of claim 8, wherein when the three-bladed retractor assembly is advanced toward the spinal disc along the lateral, trans-psoas path, the distal portion of the shim element is positioned in the spinal disc to secure the first retractor blade in fixed relation relative the lumbar spine.

10. The system of clam 9, wherein the shim element is removably engageable with grooves along an inner-facing of the first retractor blade.

11. The system of clam 10, wherein the three-bladed retractor assembly includes a first retractor extension member that is removably engageable with the second retractor blade and a second refractor extension member that is removably engageable with the third retractor blade.

12. The system of clam 11, wherein the first retractor extension member is removably engageable with grooves along an inner-facing of the second retractor blade, and the second retractor extension member is removably engageable with grooves along an inner-facing of the third retractor blade.

21. A system for forming an operating corridor to a lumbar spine, comprising:

a dilator system to create a distraction corridor along a lateral, trans-psoas path to the lumbar spine, wherein said dilator system comprises at least two dilators of sequentially larger widths deliverable to a spinal disc along the lateral, trans-psoas path to the lumbar spine, a second dilator of said at least two dilators being slidably engageable with an exterior of a first of said at least two dilators, at least one of the first and second dilators including a stimulation electrode to deliver electrical stimulation for nerve monitoring when the stimulation electrode is positioned along the lateral, trans-psoas path to the lumbar spine;

a three-bladed retractor assembly slidable over the dilator system toward the spinal disc along the lateral, trans-psoas path, the three-bladed retractor assembly including;

a blade holder assembly and first, second, and third retractor blades that extend generally perpendicularly relative to arm members of the blade holder assembly,

wherein the three-bladed retractor assembly is adjustable from a first position in which the first, second, and third retractor blades are adjacent to one another and slidable over the dilator system to a second position in which the second and third retractor blades are moved away from the first retractor blade to enlarge the distraction corridor and thereby form an operative corridor along the lateral, trans-psoas path to the lumbar spine,

wherein the first retractor blade is linearly movable relative to the second and third retractor blades in response to rotation of a knob element on the blade holder assembly,

wherein the second refractor blade is movable relative to the first blade in response to pivoting movement of a first pivotable arm member of said arm members which is coupled to the second retractor blade, and wherein the third retractor blade is movable relative to the first blade in response to pivoting movement of a second pivotable arm member of said arm members which is coupled to the third refractor blade; and

wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor along the lateral, trans-psoas path to the lumbar spine, the first retractor blade is a posterior-most retractor blade of the first, second, and third retractor blades and the operative corridor is dimensioned so as to pass an implant through the operative corridor and into the lumbar spine.

22. The system of claim 21, wherein when the three-bladed retractor assembly is adjusted to the second position to form the operative corridor, the first retractor blade is the posterior-most retractor blade, the second blade is a cephalad-most retractor blade, and the third blade is a caudal-most refractor blade.

23. The system of claim 22, wherein the three-bladed retractor assembly includes a plurality of light emitting devices to direct light through the operative corridor toward the spinal disc, the plurality of light emitting devices including a first light emitting device that coupled to the cephalad-most retractor blade and a second light emitting device coupled to the caudal-most retractor blade.

24. The system of claim 21, wherein said arm members of the blade holder assembly further comprise a translating arm member coupled to the first retractor blade, wherein the rotation of the knob element of the blade holder assembly causes the translating arm member to linearly adjust a position of the first retractor blade relative to the second and third retractor blades.

26. The system of claim 21, wherein the second and third retractor blades are configured to simultaneously move in response to movement of the first and second pivotable arm members.

27. The system of claim 21, further comprising an elongate member deliverable to a spinal disc along a lateral, trans-psoas path to the lumbar spine such that a distal tip region of the elongate member is configured to penetrate into an annulus of the spinal disc, said first dilator being configured to slidably engage an exterior of the elongate member.

28. The system of claim 21, wherein when the three-bladed retractor assembly is in the first position, the first, second, and third retractor blades are in generally abutting relation with one another.

29. The system of claim 21, further comprising a monitoring system that delivers an electrical stimulation sign to the stimulation electrode, 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 displays to a user a numeric stimulation threshold required to obtain the electromyographic activity in said leg 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, an EMG sensor harness having the set of sensor electrodes connected to the patient module.

25. The system of clam 21, wherein the three-bladed retractor assembly includes an intradiscal shim element having a proximal portion removably engageable with the first retractor blade so that a distal portion of the shim element extends from a distal end of the first retractor blade and is configured to penetrate into the spinal disc, wherein the proximal portion of the shim element is slidably engageable with grooves defined along the first retractor blade.