Surgical access system and related methods

• US 9,795,367 B1
• Filed: 03/29/2012
• Issued: 10/24/2017
• Est. Priority Date: 10/17/2003
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Lee, James Coleman, Scholl, Thomas, Gharib, James, Pimenta, Luiz
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): McCrosky, David J
• Application Number:
  US13/434,845
• Time in Patent Office: 2,035 Days
• Field of Search: 600546, 600547, 600210, 600215, 600217, 600201, 600202, 600205, 600219, 600221, 600227, 600235, 606 86 A
• 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 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00048 Spectral analysis
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 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 2090/065 for measuring contact or contact pressure

Abstract

A surgical access system comprising a tissue dilation 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 and one or more pressure sensors for determining and monitoring pressure on neural structures near the tissue dilation assembly or the tissue retraction assembly.

Claims

1. A system for creating an operative corridor to a spinal surgical target site, comprising:

a retractor assembly including a retractor body and a plurality of retractor blades extending generally perpendicularly to the retractor body, the retractor body being operable to separate the plurality of retractor blades relative to each other to retract tissue away from an interior of the retractor blades when the retractor is advanced to the surgical site and the retractor blades are separated to thereby form an operative corridor to the surgical site, wherein a center retractor blade of the plurality of retractor blades is a pressure sensing blade and wherein the pressure sensing blade has a distal end; and

a disposable insert including a proximal end, the proximal end configured to insert into the distal end of the pressure sensing blade, the disposable insert configured to be removably secured in the pressure sensing blade, and wherein the insert includes a pressure sensing member configured to measure the pressure exerted on tissue adjacent the pressure sensing blade.

2. The system of claim 1, wherein the pressure sensing blade comprises an elongate interior slot extending longitudinally therethrough.

3. The system of claim 2, wherein the pressure sensing blade further comprises an aperture connecting to the elongate slot near the distal end of the pressure sensing blade.

4. The system of claim 3, wherein a distal area of the pressure sensing member is configured to align with the distal aperture of the pressure sensing blade.

5. The system of claim 1, wherein the pressure sensing member is in communication with a processing unit configured to process said pressure measurements.

6. The system of claim 1, wherein said pressure measurements comprise at least one of amount and duration of pressure exerted.

7. The system of claim 1, wherein the disposable insert is constructed from a generally stiff and elastic material.

8. The system of claim 7, wherein the disposable insert also includes a stimulation electrode configured to transmit an electrical stimulation signal to tissue adjacent the pressure sensing blade.

9. The system of claim 8, wherein the stimulation electrode comprises a conductive trace extending along the disposable insert between a proximal exposed area and a distal exposed area.

10. The system of claim 9, wherein the proximal exposed area is configured for attachment to a neurophysiology monitoring system.

11. The system of claim 10, wherein the conductive trace element is insulated with a dielectric coating to prevent current shunting along its length between the proximal and distal exposed areas.

12. A method of accessing a surgical target site on the lumbar spine, comprising the steps of:

advancing an elongate dilator along a retroperitoneal path toward a psoas muscle, the distal end of the elongate dilator being guided to the psoas muscle with a finger inserted through an incision into the retroperitoneal space;

advancing at least one additional dilator of larger diameter over the elongate dilator along the lateral trans-psoas path to the surgical target site on the lumbar spine;

advancing a plurality of retractor blades over an outermost of the at least one additional dilator along the trans-psoas path to the surgical target site on the lumbar spine, wherein a center retractor blade of the plurality of retractor blades is a pressure sensing blade including a distal end;

moving at least one of said plurality of retractor blades away from at least one other of said plurality of retractor blades to retract body tissue away from the lateral trans-psoas path and create an operative corridor along the lateral trans-psoas path to said surgical target site on the lumbar spine;

maintaining the operative corridor along the lateral trans-psoas path to said surgical target site on the lumbar spine with said plurality of retractor blades;

measuring a pressure exerted upon the retracted body tissue adjacent the operative corridor along the trans-psoas path, the pressure being measured with a pressure sensor situated on a disposable insert inserted into said pressure sensing blade, the disposable insert configured to be removably secured in the pressure sensing blade, and wherein said disposable insert includes a proximal end, the proximal end configured to insert into the distal end of the pressure sensing blade; and

selectively controlling the amount of stress applied to the retracted body tissue adjacent the operative corridor along the trans-psoas path by altering the degree of retraction until a desired balance between access and tissue stress is achieved.

13. The method of claim 12, wherein the pressure sensor measures pressure based on at least one of piezoelectric-based pressure sensing, capacitive-based pressure sensing, strain gauge-based pressure sensing, and ink-based pressure sensing.

14. The method of claim 12, wherein the step of advancing at least one additional dilator of larger diameter over the elongate dilator comprises sequentially advancing a plurality of sequentially larger diameter dilators along the lateral trans-psoas path to the surgical target site on the lumbar spine.

15. The method of claim 14, further comprising advancing a k-wire along said lateral trans-psoas path to the surgical target site and into an intervertebral disc of the lumbar spine, the k-wire configured to be slidably received within the elongate dilator.

16. The method of claim 14, wherein said dilator comprises a stimulation electrode along a distal region and wherein an electrical stimulation is delivered to the stimulation electrode while the initial dilator is positioned in the lateral trans-psoas path to detect the proximity of one or more nerves relative to the stimulation electrode.

17. The method of claim 12, wherein the disposable insert is constructed from a generally stiff and elastic material.

18. The method of claim 17, wherein the pressure sensing blade is a posterior most retractor blade in relation to the plurality of retractor blades.

19. The method of claim 17, wherein said plurality of retractor blades are constructed from a metallic material and said insert is constructed from a plastic material.

20. The method of claim 19, further comprising advancing a shim into an intervertebral disc at the surgical target site on the lumbar spine, said shim slidably engageable with a posterior most retractor blade of said plurality of retractor blades.

21. The method of claim 19, wherein said pressure sensing blade comprises an elongate interior slot extending longitudinally through the pressure sensing blade.

22. The method of claim 12, further comprising the step of delivering an electrical stimulation to a stimulation electrode situated on a distal region of the pressure sensing blade during at least one of the steps of advancing said plurality of retractor blades over an outermost of the at least one additional dilator along the lateral, trans-psoas path to the surgical target site, moving at least one of said plurality of retractor blades away from at least one other of said plurality of retractor blades to retract body tissue away from the lateral trans-psoas path and create an operative corridor along the lateral trans-psoas path to said surgical target site on the lumbar spine, and maintaining the operative corridor along the lateral trans-psoas path to said surgical target site on the lumbar spine with said plurality of retractor blades.

23. The method of claim 22, wherein said stimulation electrode is situated on the disposable insert and wherein the pressure sensing blade is the posterior most retractor blade in relation to the plurality of retractor blades.

24. The method of claim 12, wherein said step of measuring the pressure exerted upon the retracted body tissue adjacent the operative corridor along the trans-psoas path is performed during at least one of the steps of moving at least one of said plurality of retractor blades away from at least one other of said plurality of retractor blades to retract body tissue away from the lateral trans-psoas path and create an operative corridor along the lateral trans-psoas path to said surgical target site on the lumbar spine, and maintaining the operative corridor along the lateral trans-psoas path to said surgical target site on the lumbar spine with said plurality of retractor blades.