System and method for performing percutaneous spinal interbody fusion

• US 9,387,088 B2
• Filed: 12/08/2014
• Issued: 07/12/2016
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: Spineology Incorporated
• Original Assignee: Spineology Incorporated
• Inventors: Roche, Karen, Boylan, Clint, McPhillips, Dan, Walnofer, Tim, Gleason, Joseph
• Primary Examiner(s): Sevilla, Christian
• Application Number:
  US14/563,987
• Publication Number:
  US 20150094811A1
• Time in Patent Office: 582 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442

Abstract

A method of performing percutaneous interbody spinal fusion on adjacent vertebrae in a patient including the steps of: creating a percutaneous access opening on the patient, using indirect visualization to establish a surgical path through the access opening via neural monitoring, creating a cavity in a disc space between the adjacent vertebra, without retraction, evaluating the created cavity, inserting a container sized and configured to fit through the access opening into the cavity and filling the container with fill material.

Claims

1. A method of performing percutaneous interbody spinal fusion on adjacent vertebrae of a patient, the method comprising:

creating a percutaneous access opening into the patient;

using indirect visualization, without retraction, to establish a surgical path to an intervertebral disc through the percutaneous access opening;

after establishing the surgical path to the intervertebral disc through the percutaneous access opening, creating a cavity in the intervertebral disc by inserting an instrument through the surgical path, without retraction of the percutaneous access opening;

evaluating the cavity created in the intervertebral disc without retraction of the percutaneous access opening;

inserting an implantable device into the created cavity through the surgical path in an undeployed state, wherein the device in the undeployed state is sized to fit through the percutaneous access opening without retraction of the percutaneous access opening; and

after inserting the implantable device into the cavity, filling the device with fill material through the surgical path via the percutaneous access opening, without retraction of the percutaneous access opening, wherein the fill material promotes bony fusion and stabilization of the adjacent vertebrae.

2. The method of claim 1, further comprising the step of sequential dilation of the surgical path prior to the step of creating the cavity in the intervertebral disc space.

3. The method of claim 1, further comprising the step of filling the device sufficiently to distract the adjacent vertebrae.

4. The method of claim 1, wherein all instrumentation for accessing the intervertebral disc space is introduced through the same surgical path.

5. The method of claim 1 further including sequentially dilating the surgical path prior to forming the cavity in the disc, comprising the steps of:

inserting a first dilator through the surgical path, the first dilator including a tapered tip, wherein the first dilator is inserted until the tapered tip penetrates into the vertebral disc to deflect neural structures outward to a major diameter of the first dilator;

inserting a second dilator through the surgical path and over the first

dilator, the second dilator having a larger outer diameter than the first dilator, the second dilator including having a tapered tip configured to further deflect the neural structures outward to a major diameter of the second dilator.

18. The method of claim 1, wherein the step of evaluating the cavity created in the intervertebral disc includes inserting a discectomy evaluation device through the percutaneous surgical path.

6. A method for performing percutaneous interbody spinal fusion on adjacent vertebrae of a patient, the method comprising:

providing imaging equipment adapted to provide indirect visualization of the patient during the percutaneous interbody spinal fusion procedure and present images of the patient'"'"'s internal anatomy on a viewing screen visible to a surgeon performing the percutaneous interbody spinal fusion procedure;

forming a percutaneous surgical path to an intervertebral disc between the adjacent vertebrae;

inserting at least one disc cavity creation tool through the percutaneous surgical path;

creating the cavity in an intervertebral disc space of the adjacent vertebrae with the at least one disc cavity creation tool;

evaluating the cavity created in the intervertebral disc;

inserting through the percutaneous surgical path an expandable implant in an undeployed state;

filling the collapsed expandable implant through the percutaneous surgical path with fill material to expand the expandable implant within the cavity in the intervertebral disc space to promote bony fusion of the adjacent vertebrae to stabilize a spinal motion segment; and

providing instructions for use of the expandable implant to perform the percutaneous interbody spinal fusion procedure.

7. The method of claim 6, further comprising the step of inserting sequential dilators through the percutaneous surgical path.

8. The method of claim 6, further comprising providing markings to the implant for x-ray visualization.

9. The method of claim 6, further comprising sequentially dilating the percutaneous surgical path prior to forming the cavity in the disc, comprising the steps of:

inserting a first dilator through the percutaneous surgical path, the first dilator including a tapered tip, wherein the first dilator is inserted until the tapered tip penetrates into the intervertebral disc to deflect neural structures outward to a major diameter of the first dilator; and

inserting a second dilator through the percutaneous surgical path and over the first dilator, the second dilator having a larger outer diameter than the first dilator, the second dilator including a tapered tip configured to further deflect the neural structures outward to a major diameter of the second dilator.

10. The method of claim 6, further comprising filling the expandable implant through the percutaneous surgical path sufficiently to distract the adjacent vertebrae.

19. The method of claim 6, wherein the step of evaluating the cavity created in the intervertebral disc includes inserting a discectomy evaluation device through the percutaneous surgical path.

11. A method of performing percutaneous interbody spinal fusion on adjacent vertebrae of a patient, the method comprising:

creating a percutaneous access opening in the patient;

establishing a percutaneous surgical path through the percutaneous access opening, without retraction of the percutaneous access opening and without directly viewing the surgical path, to a vertebral disc of the patient between the adjacent vertebrae to be fused;

inserting at least one disc cavity creation tool through the percutaneous surgical path and creating a cavity in an intervertebral disc space of the adjacent vertebrae;

evaluating the cavity created in the intervertebral disc space;

after evaluating the cavity in the intervertebral disc space, inserting an expandable device sized and configured to fit through the access opening, without retraction of the percutaneous surgical path, into the cavity; and

filling the expandable device, after insertion into the cavity, with fill material via the surgical path, wherein the fill material promotes bony fusion to stabilize a spinal motion segment.

12. The method of claim 11, wherein all instrumentation for accessing the intervertebral disc space is introduced through the same percutaneous surgical path.

13. The method of claim 11, further comprising providing markings to the device for x-ray visualization.

14. The method of claim 11, further comprising the step of sequential dilation of the percutaneous surgical path prior to forming the cavity in the intervertebral disc space, the sequential dilation step comprising:

inserting a first dilator through the percutaneous surgical path, the first dilator including a tapered tip, wherein the first dilator is inserted until the tapered tip penetrates into the vertebral disc to deflect neural structures outward to a major diameter of the first dilator; and

inserting a second dilator through the percutaneous surgical path and over the first dilator, the second dilator having a larger outer diameter than the first dilator, the second dilator including having a tapered tip configured to further deflect the neural structures outward to a major diameter of the second dilator.

15. The method of claim 11, further including the step of filling the expandable device through the percutaneous surgical path sufficiently to distract the adjacent vertebrae.

16. The method of claim 11, further comprising providing imaging equipment adapted to provide indirect visualization of the patient during the percutaneous interbody spinal fusion procedure and present images of the patient'"'"'s internal anatomy on a viewing screen visible to a surgeon performing the percutaneous interbody spinal fusion procedure.

17. The method of claim 11, wherein the step of establishing a surgical path through the percutaneous access opening includes using indirect visualization, without retraction, to place a neural monitoring probe into the percutaneous access opening to establish the surgical path to an intervertebral disc via neural monitoring.

20. The method of claim 11, wherein the step of evaluating the cavity created in the intervertebral disc space includes inserting a discectomy evaluation device through the percutaneous surgical path.