Transforaminal Lumbar Interbody Fusion age (TLIF) 990100010 DOULE ENGINE MEDIL MTERIL O., LTD. No. 218 Houxiang Road, Haicang District, Xiamen 361022, P.R.hina Tel: +86 592 6087101 Fax: +86 592 6587078 E-mail: info@double-engine.com Website: www.double-engine.com
1 2 INDEX Indications ontraindications Preoperative Planning Surgical Technique - Step 1 Patient Position - Step 2 Surgical pproach and Exposure - Step 3 Discectomy - Step 4 Preparation for Disc Space - Step 5 Trial for Implant Size - Step 6 Implant Preparation Warning This publication describes the recommended procedures for using Double Engine devices and instruments. It offers guidance that you should pay attention to. ut as with any such technical guide, the guide alone does not provide sufficient background for direct use of the instrument set, each surgeon should also consider the particular needs of each patient and make appropriate adjustments when required. Instruction by experienced surgeon is still highly recommended. ll non-sterile devices must be cleaned and sterilized before use. Multi-component instruments must be disassembled for cleaning. Please follow the instructions provided in our Reprocessing, are and Maintenance Guide (RMG-2012). Please refer to Package Insert for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary. - Step 7 TLIF Implant Insertion - Step 8 Posterior Support - Step 9 Implant Removal aution The implants are designed for temporary fixation of fractured bone fragments until the bone heals. Therefore, if bone does not heal or bone consolidation is delayed or not sufficient, the system may break. Post-operative care under the guidance of the surgeon is also very important and it must be done to ensure the promotion of bone consolidation.
3 4 Surgical Technique Indications The TLIF implant is intended to replace lumbar intervertebral discs and to fuse the adjacent vertebral bodies together at vertebral levels L1 S1. The TLIF implant is designed for a transforaminal approach. Indications are lumbar and lubosacral pathologies in which segmental spondylodesis is indicated, for example: - Degenerative disc diseases and spinal instabilities - Revision procedures for post-discectomy syndrome - Pseudarthrosis or failed spondylodesis - Degenerative spondylolisthesis - Isthmic spondylolisthesis ontraindications - Vertebral body fractures - Spinal tumours - Major spinal instabilities - Primary spinal deformities - Osteoporosis STEP 1 PTIENT POSITION The patient should be positioned in a restored physiological lordosis and decompressed the abdomen to minimize venous stasis. STEP 2 SURGIL PPROH ND EXPOSURE 2.1 pproach 111782000 Lamina Spreader Use the rm to locate the correct operative level. Make a standard open incision and retract the muscle layer to view the desired segment. Position the lamina spreader for TLIF at the base of the spinous process. With the help of necessary Instrument of lamina spreader, distract carefully until required distraction is achieved. Note: For decompression and delivery of the implant, distraction can help to open the posterior disc space and promote exposure. Preoperative Planning It s necessary to have all necessary imaging studies readily available to prepare the placement of TLIF implant and visualize individual patient anatomy. Have all sets of instrument set and complete set of implants readily available prior to surgery. 2.2 Preparing Transforaminal Window 111781700 Rongeur, straight, 4.0 mm 111781800 Rongeur, curved, 4.0 mm 111781900 Laminectomy Punch, 4.0 mm In order to prepare a window for the transforaminal, it s recommended to use the osteotome to remove the inferior facet of the cranial vertebra and the superior facet of the caudal vertebra. The additional bone or osteophytes can be remove by using the laminectomy punch and rongeur. STEP 3 DISETOMY 111780900 Osteotome, straight 111781200 Ring urette, straight, bayoneted 111781300 urette, rectangular, bayoneted 111781400 urette, rectangular, angled, left, bayoneted 111781500 urette, rectangular, angled, right, bayoneted 111781700 Rongeur, straight, 4.0 mm 111781800 Rongeur, curved, 4.0 mm 111781900 Laminectomy Punch, 4.0 mm 111782500-111782900 Shaver for Intervertebral Discs, 7mm-15mm
5 Through an incision above the pedicle, access the foramen and remove disc material, with the help of the following instruments: rectangular and ring curette, rongeur, laminectomy punch and the shavers. It s recommended to preserve the annulus to provide additional support for the TLIF implant and prevent migration of the bone graft or bone graft substitute into the spinal canal. Use the shavers ream out disc space material or for final removal of the disc space material and cartilaginous tissue. In order remove the tissue in the far lateral disc space, use the left or right angled curettes and the curved rongeur. Important: Enough lateral exposure to the disc can minimize dural retraction. STEP 4 PREPRTION FOR DIS SPE 111781000 111781100 111781600 Rasp, bayoneted Rasp, angled, bayoneted Impactor, curved, bayoneted fter completing the discectomy, use the rasp to remove superficial cartilaginous layers of the endplates until exposing the bleeding bone. Don t excessively remove the subchondral bone, which may weaken the vertebral endplate. The subsidence and a loss of segmental stability may happen if the entire endplate is removed. Insert the applicator inner shaft into the applicator outer shaft making sure that the arrow on the outer shaft is aligned with the distal opening of the inner shaft (). The applicator inner shaft should now be trapped inside the outer shaft (). 5.2 onnecting Trial Implant to the pplicator For disassembly pull the security ring down, turn the applicator knob counterclockwise until it stops. Push the small button on the applicator knob and simultaneously pull the inner shaft out of the outer shaft. Turn the applicator knob clockwise. onnect an appropriately sized trial implant to the applicator. Pull the security ring down and simultaneously turn the knob at the proximal end of the applicator counterclockwise. The applicator jaws open (). 111783000 111783400 Trial Implant, 7mm, 0-15mm, 5 STEP 5 The anterior and far lateral disc space should be filled with bone graft or bone graft substitute before the TLIF age is implanted. TRIL FOR IMPLNT SIZE 5.1 ssemble pplicator and onnect Trial Implant 111780100 111780200 111780300 pplicator Outer Shaft pplicator Inner Shaft pplicator Knob efore insertion of the trial implant, the applicator must be assembled. ttach the applicator knob to the proximal end of the applicator outer shaft by turning the knob counterclockwise until it stops (). Place the jaws over the proximal end of the trial implant making sure to align the arrows on the end of the applicator with those on the trial implant (). 5.3 Inserting Trial Implant Turn the applicator knob clockwise to close the jaws. During this closing procedure the security ring moves upwards, so that the green color band is visible (). ontinue to turn the knob until it is tightened (). Recheck and make sure the trial implant is firmly connected to applicator, which can be checked manually by applying pressure on the lateral side of the trial implant with the thumb to make sure that the trial implant cannot pivot. Note: The trial implant cannot pivot or detach when the applicator knob remains tightened status. 111780800 ombined Hammer 6
7 Insert the trial implant to the disc space while the orientation of the trial implant is correct. The trial implant tip should be orientated medial. Maintain between the applicator handle and the sagittal plane during trial implant insertion (). If necessary, advance the trial implant into the intervertebral disc space with controlled and light hammering on the applicator. It s important to check the position and fit of the trial implant by using fluoroscopy. The tip should be placed near the anterior edge of the adjacent vertebral bodies (). 5.4 Positioning Trial Implant Turn the applicator knob counterclockwise until it stops (). Ensure applicator knob is turned counterclockwise until it stops to avoid trial or applicator outer shaft deformation. If necessary, pivot the trial implant into final position with controlled and light hammering on the applicator. Use fluoroscopy when pivoting the trial implant and confirm fit and position of the trial implant. If necessary, the combination hammer may also be used to help to remove the trial implant. Remove the slide hammer from the handle by pushing on the end of the slide hammer. In order to disassemble the trial implant from the applicator, pull the security ring down and simultaneously turn the knob counterclockwise until it stops (D). D E F Push the small button on the applicator knob and remove the trial implant (E). Insert the applicator inner shaft into the applicator outer shaft making sure that the arrow on the outer shaft is aligned with the distal opening of the inner shaft (F). The applicator inner shaft should now be trapped inside the outer shaft. The applicator is knew ready to accept the implant. The trial implant tip indicates approximate final anterior position of trial implant (). STEP 6 Each trial has a medial or lateral and an anterior or posterior opening for position control. If the trial implant appears too small or too tight, try the next larger or smaller size height until the most secure fit is achieved. Make sure that the trial implant is positioned where the TLIF implant will be positioned. Optional: Position Trial Implant In case of that trial implant does not pivot automatically, turn the applicator handle medially to initiate pivoting upon impaction (). fter the pivoting is initiated, the applicator handle must be turned back to an angle of from the sagittal plane to pivot the trial implant into the final appropriate position (). 5.5 Removing Trial Implant IMPLNT PREPRTION 6.2 Packing Implant 111780700 111780800 6.1 TLIF Implant Selection 111780500 111780600 Turn the packing block on its side and use the cancellous bone impactor to firmly pack the bone graft into the implant cavities (). Slide Hammer ombined Hammer Ensure that the applicator is in the pivoting position to remove the trial implant (). ttach the slide hammer onto the end of the applicator knob with quick coupling (). While holding the handle with one hand, apply an upward force to the slide hammer with the other hand. Repeat this procedure until the trial implant is removed (). Packing lock Select the TLIF implant which corresponds to the height and size measured using the trial implant in the previous steps. Insert the selected implant into the appropriate packing block place. ancellous one Impactor 8
9 10 STEP 7 Ensure that the implant is well placed in the packing block to avoid implant damage while filling bone graft (). It is important to fill the implant until the filling material protrudes from its perforations in order to ensure optimal contact with the vertebral endplates (). TLIF IMPLNT INSERTION 7.1 Inserting Implant 111780800 ombined Hammer heck again the firm connection of implant to applicator. Insert the implant into the disc space, ensuring that the orientation of the implant is correct. The implant tip should be orientated medial. Maintain 10 15 between the applicator handle and the sagittal plane during implant insertion (). If necessary, apply controlled and light hammers on the applicator to advance the implant into the intervertebral disc space. Use fluoroscopy to confirm position and fit of the implant. The tip should be positioned near the anterior edge of the adjacent vertebral bodies (). The implant tip marker pin indicates approximate final anterior position of implant (). 6.3 onnecting Implant to the pplicator 111780100 111780200 111780300 pplicator Outer Shaft pplicator Inner Shaft pplicator Knob In order to connect the implant to the applicator, turn the packing block upwards again. Pull the security ring down and simultaneously turn the knob at the proximal end of the applicator counterclockwise. The applicator jaws open (). Place the jaws over the proximal end of the implant making sure to align the arrows on the end of the applicator with those on the implant (). Turn the applicator knob clockwise to close the jaws. During this closing procedure the security ring moves upwards, so that the green color band is visible. ontinue to turn the knob until it is tightened (). 7.2 Positioning TLIF Implant 111780600 Packing lock Turn the applicator knob counterclockwise until it stops (). If necessary, apply controlled and light hammers on the applicator to pivot the implant into final position (). Use fluoroscopy during the pivoting procedure and confirm fit and position of the implant. With a medial/lateral fluoroscopic image of the cage in the final position, the two anterior pins of the implant should appear as one line. In an anterior/posterior fluoroscopic image, the two anterior pins should be equidistant to the pedicles. The tip pin indicates the lateral edge of the implant.
11 12 STEP 9 Optional: Position Implant 8.2 Packing Disc Space IMPLNT REMOVL If implant does not pivot automatically, turn the applicator handle medially to initiate pivoting upon impaction (). fter pivoting is initiated the applicator handle must be turned back to an angle of 10 15 from the sagittal plane to pivot the implant into final position (). The TLIF implant is intended to be used with Double Medical supplemental posterior fixation, e.g. Universal Spine System. Option 1: Implant Removal with the pplicator 111780100 111780200 111780300 pplicator Outer Shaft pplicator Inner Shaft pplicator Knob Ensure that the applicator is in the fully open position. Locate the implant and close the applicator by turning the knob clockwise until the security ring is moving upwards. There should be no gap between the applicator knob and the security ring. To ensure that the knob is in contact with the security ring, turn the knob counterclockwise until it stops, in this position the implant can pivot but not detach from the applicator. The implant can now be removed. If necessary, apply hammers to facilitate removal. STEP 8 7.3 Detaching TLIF Implant POSTERIOR SUPPORT Option 2: Implant Removal with the Removal Forceps To detach the implant, pull the security ring down and simultaneously turn the applicator knob counterclockwise until it stops. The applicator can now be removed from the implant. 8.1 Packing Disc Space 111780400 111781600 Use fluoroscopy to verify final position of the implant. With a medial/lateral fluoroscopic image, the two anterior pins of the implant should appear as one line and the tip marker as a dot. fter the TLIF implant is implanted, fill the posterior disc space and the lateral disc space with bone graft or bone graft substitute to create optimal conditions for fusion. Ensure that the removal forceps for TLIF is in the fully open position. Locate the implant and squeeze the handle firmly. dvance the speed nut to lock the handle. The implant can now be removed. If necessary, apply hammers to facilitate removal. Impactor, curved, bayoneted Removal Forceps
13 Instruments 110380000 111780100 pplicator Outer Shaft 111780200 pplicator Inner Shaft 111780300 111780400 111780500 111780900 Osteotome, straight 111781000 Rasp, bayoneted 111781100 Rasp, angled, bayoneted 111781200 Ring urette, straight, bayoneted 111781300 urette, rectangular, bayoneted 111781400 urette, rectangular, angled, left, bayoneted 111781500 urette, rectangular, angled, right, bayoneted 111781600 Impactor, curved, bayoneted pplicator Knob Removal Forceps ancellous one Impactor 111780600 Packing lock 111780700 Slide Hammer 111780800 ombined Hammer 14
15 111781700 111781800 111781900 111782000 111782100 Rongeur, straight, 4.0 mm 111782200 Soft Tissue Retractor, width 8mm 111782300 Soft Tissue Retractor, width 10mm 111782400 T-Handle With Quick oupling 111782500 Shaver for Intervertebral Discs, 7mm 111782600 Shaver for Intervertebral Discs, 9mm 111782700 Shaver for Intervertebral Discs, 11mm 111782800 Shaver for Intervertebral Discs, 13mm 111782900 Shaver for Intervertebral Discs, 15mm Rongeur, curved, 4.0 mm Laminectomy Punch, 4.0 mm Lamina Spreader Soft Tissue Retractor, width 6mm 16
17 111783000 Trial Implant, 7mm, 0 111783100 Trial Implant, 9mm, 5 111783200 Trial Implant, 11mm, 5 111783300 Trial Implant, 13mm, 5 111783400 Trial Implant, 15mm, 5 111785000 TLIF Instrument ase 18