Luminary ALIF. Disc preparation and implant insertion instruments.

Transcription

1 Luminary ALIF. Disc preparation and implant insertion instruments. Technique Guide Instruments and implants approved by the AO Foundation

2 Table of Contents Introduction Luminary ALIF 2 AO Principles 4 Surgical Technique Preparation 5 Straight Anterior Approach 6 Anterolateral Approach (30º Offset) 16 Product Information Instruments 18 Set Lists 21 Image intensifier control Synthes Spine

3 Luminary ALIF Anterior Approach The Luminary ALIF instruments can be used in an anterior lumbar interbody fusion procedure using a straight anterior approach to the lumbar spine. The illustration depicts a Luminary CC-ALIF Spacer being implanted at the L5 S1 level. ALIF Synthes Quick Inserter/Distractor (SQUID) Provides distraction of disc space, insertion of implant and ejection of instrument in one simple procedure No assembly required Easy to use, integrated adjustable countersink, 3 mm and 6 mm depths from the outer wall of the implant to the outer wall of the vertebral body Shaft can be released for quick set-up and can be engaged for controlled insertion Spring ramps firmly hold implant during procedure Impact-free insertion 26 mm depth 30 mm width 2 Synthes Spine Luminary ALIF

4 Anterolateral Approach The Luminary ALIF instruments can also be used in an anterior lumbar interbody fusion procedure using an anterolateral approach, or 30 offset from straight anterior. This approach preserves the anterior longitudinal ligament and avoids patient vasculature. The illustration depicts a Luminary CC-ALIF Spacer being implanted at the L4 L5 level. 3 mm 6 mm Synthes Spine 3

5 AO Principles In 1958, the AO formulated four basic principles, 1 which have become the guidelines for internal fixation. They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural elements. 2 AO Principles as Applied to the Spine 3 Anatomic alignment Restoration of normal spinal alignment to improve the biomechanics of the spine. Stable internal fixation Stabilization of the spinal segment to promote bony fusion. Preservation of blood supply Creation of an optimal environment for fusion. Early, active mobilization Minimization of damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient. 1. M.E. Müller, M. Allgöwer, R. Schneider, H. Willenegger: AO Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag Ibid. 3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin: Springer-Verlag Synthes Spine Luminary ALIF

6 mm Inches 24 mm GP1739-A 3/01 J3554 Preparation 1 Preoperative planning Determine surgical approach (anterior or anterolateral). The surgical approach, based on surgeon preference, determines the implant type. 2 Determine implant height Instrument ANTERIOR HEIGHT SYNTHES Spine 1690 Russell Road, Paoli, PA To order: ALIF SPACER PREOPERATIVE PLANNER Actual Size Lateral view 9 mm 11 mm 13 mm 15 mm 8052* ALIF Preoperative Planner ANTERIOR HEIGHT 17 mm 19 mm 21 mm 30 mm Preoperative planning is recommended for precise selection of a Luminary CC-ALIF spacer. Determine the implant height by comparing a lateral view on the ALIF preoperative planner with adjacent intervertebral discs on a lateral radiograph. 100 % actual size NOTE: All ALIF Spacers are 24 mm in anterior-posterior direction and 30 mm in lateral width. ALIF Preoperative Planner (8052) The implant must be firmly seated with a secure fit between the endplates when the segment is fully distracted. It is essential to use the tallest possible implant, as determined by the preoperative planning, to maximize segmental stability. Due to variations in radiographic magnification, the templates only provide an estimate of the ideal implant size. Templates represent 40% 80% (in 5% increments) and 100% actual size for use with MRI and CT scans. 10% and 15% magnification templates are available for x-ray use. * Also available Synthes Spine 5

7 Straight Anterior Approach Optional sets ProPrep Disc Preparation Set Anterior Instrument Set The ProPrep instrument set is a comprehensive collection of traditional disc preparation instruments to facilitate a complete discectomy Expose the disc Expose the midline of the intervertebral disc. 6 Synthes Spine Luminary ALIF

8 2 Perform discectomy Instrument Scalpel Handle* Using a scalpel, cut a window in the annulus, centered on the vertebral midline to prepare the position for the implant. For the quickest and most effective removal of a disc, separate the disc from the endplate with an endplate elevator. Endplate elevators for ALIF surgery are available in the optional sets and individually through the Synthes catalog. *Note: Blades are not included in the set. Synthes Spine 7

9 Straight Anterior Approach continued 2 Perform discectomy continued Instruments Disc Excisor Rongeur, 9 mm height Disc Excisor Rongeur, 11 mm height Disc Excisor Rongeur, 13 mm height Remove disc material from the intervertebral disc space using any combination of the following options: disc excisor rongeur, side-biting rongeur, or disc shaver/excisor. Note: Removing the superficial layers of the cartilaginous endplates exposes bleeding bone. Adequate preparation of the endplates is important to facilitate vascular supply to the bone graft. Excessive cleaning, however, may weaken the endplate due to removal of bone underlying the cartilaginous layers. Use the disc excisor rongeur to begin removing the disc. The disc excisor rongeurs are also effective to remove disc in the posterolateral disc space (Figure 1). Figure 1 8 Synthes Spine Luminary ALIF

10 Instruments Bone Rongeur, side-biting, 9 mm height Bone Rongeur, side-biting, 11 mm height Bone Rongeur, side-biting, 13 mm height ALIF Spreaders, 9 mm 21 mm Disc Shavers/Excisors, 9 mm 21 mm Use the side-biting rongeurs to remove disc material and cartilaginous tissue from the superior and inferior surfaces of the vertebral endplates. The double-sided cutting edges allow both surfaces to be cleaned simultaneously. Use the ALIF disc shavers/excisors for thorough removal of disc material and cartilaginous tissue from the intervertebral disc space. Multiple flutes maximize scraping and collection of disc material. The ALIF spreaders can be used to distract the disc space while allowing room to work contralaterally. The disc shavers/excisors can be used in a controlled manner to clean the lateral disc space. Synthes Spine 9

11 Straight Anterior Approach continued 3 Prepare endplates Instrument ALIF Trial Spacer Rasp, with handle, 7 mm height After the discectomy is complete, use the double-sided rasp to remove the superficial cartilaginous layers of the endplates and expose bleeding bone. Note: Excessive removal of the subchondral bone may weaken the vertebral endplate. If the entire endplate is removed, subsidence and loss of segmental stability may result. 4 Determine implant size Instruments ALIF Trial Spacer Rasps, quick release, mm 21 mm ALIF Trial Spacers, quick release, mm 21 mm Quick Release T-Handle The trial spacer rasps can be used to simultaneously trial the disc space for the implant while exposing bleeding bone. For final size determination, connect the appropriately sized trial spacer or trial spacer rasp to the desired length quick release T-handle. Insert the trial spacer into the intervertebral disc space using gentle impaction. Fluoroscopy can assist in confirming the fit and geometry of the trial spacer. 10 Synthes Spine Luminary ALIF

12 If the trial spacer appears too small or too tight, try the next larger or smaller size until the most secure fit is achieved. It is essential to use the tallest clinically reasonable implant to maximize segment stability. Optional instruments Quick Release T-Handle, 185 mm PDL102 Slotted Mallet The slotted mallet can be used to facilitate the insertion or removal of the trial spacers and trial spacer rasps. Synthes Spine 11

13 Straight Anterior Approach continued 5 Insert implant T-handle Option 1: Using SQUID Instruments ALIF Synthes Quick Inserter/Distractor (SQUID) Screw shaft * Autoclavable Oil Release the main thread by pushing the release button on the grip and slide the ejector fully back. Set the countersink depth 3 mm or 6 mm by turning the ejector in either direction with your fingers. The number closer to the tips of the instrument is the current setting. Note: Ejector can only be turned when in the keyhole. Engage/ release button SQUID Care Instructions To ensure maximum longevity of SQUID, complete these four steps after each use: Keyhole Ejector 1. Wash and disinfect instrument after surgery. 2. Apply autoclavable oil over entire length of the screw shaft. Spring ramp guides 3. Spread autoclavable oil over entire thread length by engaging the button and screwing the T-handle all the way down and back. 4. Sterilize SQUID before use (see package insert). Pusher Tips *Also available 12 Synthes Spine Luminary ALIF

14 Once the countersink depth is set, place the instrument flat on the table to load the implant. Pack bone graft material into the center of the implant as appropriate. Place the implant onto the bottom spring ramp. Holding both sides of the implant, engage the grooves with the spring ramp guides and gently slide the implant forward until the implant is held without sliding back. Note: The tips of the inserter will be inserted into the disc space up to the depth stops on the spring ramps; to allow full insertion, the tips must not be spread apart. Slide the pusher up to the implant and engage the main thread by pressing the engage button. The implant is now held securely. Depth stops Main thread Synthes Spine 13

15 Straight Anterior Approach continued 5 Insert implant continued Option 1: Using SQUID continued Place the tips of the instrument into the disc space so the depth stops on the spring ramps touch the anterior rim of the vertebral body. The tips of the instrument are 26 mm deep and 30 mm wide. Note: It is important to remember that the pusher will be moving toward the vertebral body and the ejector is proud above the spring ramps and stops. Be aware of soft tissue and blood vessels that may be in the path of the pusher and ejector as they move toward and push against the vertebral bodies. With the main thread engaged, turn the T-handle on the SQUID to advance the implant down the spring ramps and into the disc space. The force required to turn the T-handle will increase as the implant advances down the spring ramps and the instrument distracts the disc space. Continue turning the T-handle until the instrument is fully ejected and released. An audible click as the spring ramps spring back to meet each other confirms that the implant is seated and the instrument is fully ejected and released. 14 Synthes Spine Luminary ALIF

16 Option 2: Using implant holder and impactor Instruments ALIF Implant Holder ALIF Impactor, crescent Insert the implant using the ALIF implant holder, ensuring that the tallest side of the implant lies against the holder. The implant holder aligns with the preformed grooves or slot on the implant for easy insertion. Ensure that the implant is held flush against the holder. Tighten the locking screw on the implant holder to firmly secure the instrument jaws against the implant. Introduce the spacer into the intervertebral disc space until the implant is flush or slightly recessed. Slight impaction on the implant holder may be necessary. Release the implant holder by loosening the locking screw and use the impactor to fully seat the implant. Important: Before use, ensure that the impactor fits flush against the implant. Do not forcibly strike the impactor when tapping the implant into position. Synthes Spine 15

17 Anterolateral Approach (30 Offset) 1 Expose and remove disc and prepare endplate For anterolateral insertion, the center of the implant will sit 30 offset to the anterior vertebral midline. Remove the disc and prepare the endplates according to Steps 2 and 3 of the straight anterior approach (pages 7 10). 2 Distract and size Instruments ALIF Trial Spacer Rasp with handle, 7 mm ALIF Trial Spacer Rasps, quick release, mm 21 mm ALIF Trial Spacers, quick release, mm 21 mm Determine the correct implant size using the ALIF trial spacers or trial spacer rasps. The same trial spacers and trial spacer rasps can be used for anterior or anterolateral approaches. The desired approach can be changed by unscrewing the sleeve, aligning the head in the correct position and reattaching the sleeve. Insert the trial spacer and determine the correct implant size as described in Step 4 of the anterior approach (page 10). 16 Synthes Spine Luminary ALIF

18 3 Insert the implant Insert the implant according to Step 5 of the straight anterior approach (pages 12 15). Synthes Spine 17

19 Instruments Scalpel Handle Quick Release T-Handle, 185 mm Disc Excisor Rongeurs, 9 mm 13 mm height Bone Rongeurs, side-biting, mm 13 mm height ALIF Spreaders, 9 mm 21 mm height Synthes Spine Luminary ALIF

20 Disc Shavers/Excisors, 9 mm 21 mm height ALIF Trial Spacer Rasp, with handle, 7 mm height ALIF Trial Spacer Rasps, quick release, 9 mm 21 mm height ALIF Trial Spacers, quick release, mm 21 mm height ALIF Synthes Quick Inserter/Distractor (SQUID) Synthes Spine 19

21 Instruments continued ALIF Implant Holder, with grooves ALIF Impactor, crescent Quick Release T-Handle PDL102 Slotted Mallet 20 Synthes Spine Luminary ALIF

22 Luminary ALIF Disc Preparation Instrument Set ( ) Graphic Case Graphic Case, for Luminary ALIF Disc Preparation Instrument Set Instruments Scalpel Handle* Quick Release T-Handle, 185 mm Quick Release T-Handle, 2 ea. Disc Excisor Rongeurs mm height mm height mm height Bone Rongeurs, side-biting mm height mm height mm height ALIF Spreaders mm height mm height mm height mm height mm height mm height mm height Disc Shavers/Excisors mm height mm height mm height mm height mm height mm height mm height * Blades not included Note: For additional information, please refer to package insert. Synthes Spine 21

23 Luminary ALIF Insertion Instrument Set ( ) Graphic Case Graphic Case for Luminary ALIF Insertion Instrument Set Instruments Quick Release T-handle, 185 mm ALIF Trial Spacer Rasp, with handle, 7 mm height ALIF Synthes Quick Inserter/Distractor (SQUID) ALIF Implant Holder, with grooves ALIF Impactor, crescent Quick Release T-handle, 2 ea. PDL102 Slotted Mallet ALIF Trial Spacer Rasps, quick release mm height mm height mm height mm height mm height mm height mm height ALIF Trial Spacers, quick release mm height mm height mm height mm height mm height mm height mm height 22 Synthes Spine Luminary ALIF

24 Also Available Optional Sets ProPrep Disc Preparation Set Anterior Instrument Set Instruments Disc Excisor Rongeurs mm height mm height mm height mm height mm height Bone Rongeurs, side-biting mm height mm height mm height mm height 8052 ALIF Preoperative Planner Synthes Spine 23

25 Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. ProPrep and Synthes are trademarks of Synthes, Inc or its affiliates. Printed in U.S.A. 8/08 J6782-B