This chapter is designed to provide you with a pre-operative and intra-operative overview of key surgical considerations for clinical treatment using the Barricaid®. Please refer to the Barricaid® Instructions For Use as well as the Surgeon Technique Manual for a complete description of indications for use, precautions, warnings, contra indications and surgical technique for the instrument setup and implantation procedure.
The Barricaid® surgical procedure is an adjunct to a limited lumbar discectomy procedure to replace missing or damaged section of the anulus identified at the time of surgery.
The Barricaid® Prosthesis for Partial Anulus Replacement is an implantable device designed to help reduce the risk of reherniation through the anular defect following limited discectomy. The Barricaid® is available in three widths of mesh (8mm, 10mm and 12mm), and is delivered pre-loaded on a disposable delivery tool.
Fluoroscopy set up
Intra-operative imaging using a fluoroscope or X-ray is essential to ensure proper alignment and use of measurement devices and proper alignment and placement of the Barricaid®.
Anular Defect Location and Size
The Barricaid® is intended to partially replace missing or damaged section of anulus in the posterior lumbar intervertebral disc.
- An anular defect or weakness must be present to implant the Barricaid®. If possible, the Barricaid® should be inserted through the pre-existing or naturally occurring defect.
- Posterior disc height must be at least 3mm, equal to the thickness of any of the defect measurement tools.
- The anular defect should be no taller than 6mm and should be no wider than the mesh being inserted (e.g., for an 8mm-wide mesh, the anular defect should be no wider than 8mm; for a 10mm-wide mesh, the anular defect should be no wider than 10mm; for a 12mm-wide mesh, the anular defect should be no wider than 12mm). There is no limit on disc height, only the defect height.
- Measure defect height and width by inserting different sized Defect Measurement Tools into the anulotomy, in both orientations.
- The Barricaid® can be implanted into either the inferior or superior vertebral body.
- The defect must be confirmed to be a full-thickness defect by inserting a defect measurement tool into the central region of the disc space.
Confirm Access and Angle
Barricaid® implantation requires that you gain adequate access to the implantation site to permit the Barricaid® and implantation tools to pass through the lamina to the intervertebral disc and anulus. Make sure that the initial skin incision is made so that you will have the appropriate angle and approach to the defect and the target vertebral body. Depending on the location of the anular defect, removal of bone from the lamina may be required to allow adequate access.
- Insert the distal end of the Sizing Trial Tool through the anulotomy. Keep the endplate guide along the surface of the endplate of the vertebral body to be implanted and ensure the distal end of the Sizing Trial Tool is against the posterior wall of the vertebra. Confirm proper position using fluoro. If access is blocked by the lamina, gradually remove bone from the lamina until access is gained.
- Angle the Sizing Trial Tool to determine the optimal angle for implantation. Note the angle, which should be replicated during implantation. Obtaining the appropriate angle should require little or no force. If force is required, remove additional bone from the lamina or consider the opposite endplate for implantation.
- Insert the distal end (including implant) of the Delivery Tool through the anulotomy. Keep the endplate guides along the endplate of the vertebral body to be implanted.
- Angle the Delivery Tool to the correct implantation angle, as determined by the Sizing Trial. The alignment rod at the proximal end of the Delivery Tool should be parallel to the disc plane to ensure proper rotation. Using fluoro, confirm that the endplate guides are against the endplate and are not rotated, but in plane with each other.
- Maintaining a steady hand position with the distal end of the Barricaid® Delivery Tool against the posterior wall of the target vertebra, tap the Strike Cap with the supplied hammer at the proximal end of the Delivery Tool until the deployment depth indicator on the tool indicates the proper depth. Use small, steady forces when tapping the Strike Cap. This will help maintain the proper angle and reduce the risk of damage to the vertebral body from misalignment. When deployed, the Barricaid® will be countersunk in the bone by ~2mm.