System and method for performing percutaneous spinal interbody fusion

• US 8,906,094 B2
• Filed: 12/31/2009
• Issued: 12/09/2014
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: Spineology Incorporated
• Original Assignee: Spineology Incorporated
• Inventors: Roche, Karen, McPhillips, Dan, Gleason, Joseph, Boylan, Clint, Walnofer, Tim
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US12/650,889
• Publication Number:
  US 20100318134A1
• Time in Patent Office: 1,804 Days
• Field of Search: 623/17.12, 606/279, 607/117
• US Class Current: 623/17.12
• 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 an access opening on the patient, the access opening being less than 10 mm wide, using indirect visualization: establishing a surgical path through the access opening via neural monitoring, creating a cavity in a disc space between the adjacent vertebra, evaluating the created cavity, inserting a container sized and configured to fit through the less than 10 mm 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 comprising the steps of:

creating a percutaneous access opening into the patient, the access opening being less than 10 mm wide; and

using indirect visualization, without retraction, to place a neural monitoring probe into the percutaneous access opening to establish a surgical path to an intervertebral disc via neural monitoring through the percutaneous access opening;

after establishing the surgical path via neural monitoring, creating a cavity in an intervertebral disc space of the adjacent vertebrae by inserting an instrument through the surgical path, without retraction;

after creating the cavity, evaluating the created cavity;

inserting an expandable container into the created cavity through the surgical path in a collapsed state, wherein the container in the collapsed state is sized to fit through the less than 10 mm wide percutaneous access opening without retraction of the access opening; and

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

2. The method of claim 1, further including 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 including the step of filling the container sufficiently to distract the adjacent vertebrae.

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

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

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;

inserting a neural stimulating component into the patient'"'"'s tissues to aid the surgeon in creating a percutaneous surgical path through a less than 10 mm percutaneous access opening to a disc between the adjacent vertebrae;

forming the less than 10 mm percutaneous access opening to a disc between the adjacent vertebrae;

inserting at least one disc cavity creation tool through the percutaneous surgical path, the tool configured to create a cavity in an intervertebral disc space of the adjacent vertebrae;

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

inserting a discectomy evaluation device through the percutaneous surgical path;

inserting through the percutaneous surgical path an expandable container sized and in a collapsed state to fit through the less than 10 mm percutaneous access opening;

filling the collapsed container intervertebral disc space through the percutaneous surgical path with fill material to expand the container and promote bony fusion to stabilize a spinal motion segment; and

providing instructions for use of the container to perform percutaneous interbody spinal fusion on adjacent vertebrae of a patient.

5. The method of claim 4 further including the step of inserting sequential dilators through the percutaneous surgical path.

16. The method of claim 4, further comprising providing markings to the container for x-ray visualization.

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

creating a percutaneous access opening in the patient, the access opening being less than 10 mm wide;

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

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

after creating the cavity in the intervertebral disc space, inserting an expandable container sized and configured to fit through the less than 10 mm access opening, without retraction, into the cavity; and

filling the container after insertion into the cavity with fill material via the surgical path to promote bony fusion to stabilize a spinal motion segment.

7. The method of claim 6 further including the step of sequential dilation of 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.

8. The method of claim 6, further including the step of filling the container through the surgical path sufficiently to distract the adjacent vertebrae.

17. The method of claim 6, wherein all instrumentation for accessing the an intervertebral disc space is introduced through the same surgical path.

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

providing imaging equipment adapted to provide indirect visualization of the patient during the percutaneous interbody spinal fusion procedure;

providing at least one tool configured to establish a percutaneous surgical path to the adjacent vertebrae of the patient through a less than 10 mm access opening;

providing at least one disc cavity creation tool configured to be inserted through the percutaneous surgical path and to create a cavity in an intervertebral disc space of the adjacent vertebrae while inserted through the percutaneous surgical path;

providing an expandable container sized and configured to fit through the less than 10 mm access opening, without retraction of the surgical path, and expand within the cavity in the intervertebral disc space upon the introduction of fill material to the container;

providing fill material adapted for filling the expandable container through the surgical path, without retraction, while the container is disposed in the intervertebral disc space; and

providing instructions for use of the expandable container.

10. The method of claim 9, further including the step of providing sequential dilators configured to be inserted through the surgical path prior to insertion of the at least one disc cavity creation tool.

11. The method of claim 9, further including the step of providing a neural stimulating component to allow the surgeon to create the surgical path to the intervertebral disc without retraction of a patient'"'"'s tissues.

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

creating a percutaneous access opening into the patient, the access opening being less than 10 mm wide;

establishing a surgical path through a patient'"'"'s tissues from the access opening to a disc located between the adjacent vertebrae of the patient using indirect visualization without retraction of the patient'"'"'s tissues;

creating a cavity in an intervertebral disc space of the adjacent vertebrae via at least one disc cavity creation tool inserted through the surgical path without retracting the patient'"'"'s tissues;

inserting an expandable container through the less than 10 mm percutaneous access opening, through the surgical path and into the cavity without retracting the patient'"'"'s tissues; and

filling the container with fill material through the surgical path sufficient to indirectly decompress foramenal nerve root and promote bony fusion to stabilize a spinal motion segment.

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

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

creating a percutaneous access opening into the patient, the access opening being less than 10 mm wide;

establishing a surgical path through a patient'"'"'s tissues from the access opening to a disc located between the adjacent vertebrae of the patient using indirect visualization without retraction of the patient'"'"'s tissues;

creating a cavity in an intervertebral disc space of the adjacent vertebrae via at least one disc cavity creation tool inserted through the surgical path without retracting the patient'"'"'s tissues;

inserting an expandable container through the less than 10 mm percutaneous access opening, through the surgical path and into the cavity without retracting the patient'"'"'s tissues; and

filling the container with fill material through the surgical path to promote bony fusion to stabilize a spinal motion segment.

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

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

using a posterolateral approach to access the spine for performing percutaneous interbody spinal fusion on the adjacent vertebrae of the patient,

creating a percutaneous access opening into the patient, the access opening being less than 10 mm wide;

establishing a surgical path through tissue of the patient from the access opening to a disc located between the adjacent vertebrae using indirect visualization without retraction of the patient'"'"'s tissues;

creating a cavity in an intervertebral disc space of the adjacent vertebrae via at least one disc cavity creation tool inserted through the surgical path without retracting the patient'"'"'s tissues;

inserting an expandable container through the less than 10 mm percutaneous access opening, through the surgical path and into the cavity without retracting the patient'"'"'s tissues; and

filling the container with fill material through the surgical path to promote bony fusion to stabilize a spinal motion segment.

20. The method of claim 14, wherein all instrumentation for accessing the an intervertebral disc space is introduced through the same surgical path.