surgical technique iliadtm - piemca · iliad screw is drawn toward the provisionally-tightened...
TRANSCRIPT
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ILIADTM
Spinal Fixation System
U.S.FDAAPPROVED
Surgical Technique
Surgical Technique
Contents
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Surgical Technique | 2•3
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Introduction
TMILIAD Spinal FixationSystem
ILIADTM Spinal Fixation System provides simple andcomprehensive stabilization solutions for spinal fixation.The Patented Reverse DOVETAIL Locking System with LINEARSLOT is a foundation of the ILIADTM system. This unique threaddesign practically eliminates cross threading, prevents splaying ofthe screw head and increase the holding moment up to 30Nm.
Outside Head Diameter : 13.80mmReverse Dove Tail ThreadLinear Slot in the middle of Set ScrewTop-Loading, Top-Tightening, Self-Tapping Screws Oscillation Angle up to 60。Anodized Color-coding of Polyaxial Pedicle Screws by Diameter Accomodate Both 6.0 and 6.35 Rods. Material : Ti6Al-4V ELI per ASTM F136
Indications
ILIADTMSpinal Fixation System is used for lumbar andlumbosacral degenerative pathologies for which segmentalspondylodesis is indicated.
Degenerative Disc Diseases and Instabilities Degenerative SpondylolisthesisIsthmic Spondylolisthesis Pseudoarthrosis or Failed Spondylodesis
Severe OsteoporosisUnstable Burst Fractures and Compression FracturesDestructive TumorsAcute Infections Extensive Peridural Scarring
Contraindications
STEP 1 PATIENT POSITIONING
The patient is positioned on the operating table in theprone position. There are numerous frames that can beused including, but not limited to The Wilson Frame, ChestRolls, Relton Hall Frame, Hasting Frame, HeffingtonFrame, and the Andrews Frame. Intra-abdominalpressure must be minimized to avoid venous congestionand excess intra-operative bleeding, while allowingadequate ventilation of the anesthetized patient. Thepatient°Øs hips should be extended to preserve lumbarlordosis for fusion and instrumentation of thelumbosacral junction.
STEP 2 INCISION AND EXPOSURE
The surgical approach is carried out through a standardmidline incision to the spinal column over the anatomicposition of the spinous process. The exposure of thespinous process should extend to an additional level. Thespinal column is then exposed in routine fashion by thesurgeon and decompression is carried out as needed.
Note :Decortication and placement of bone grafts are usuallydone after pedicle screw preparation just priorto insertion of the pedicle screw. Meticulous fusiontechniques are critical for success of the procedure.
Surgical Technique
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PEDICLE PREPARATIONENTRY POINT, DECORTICATION AND AWL STEP 3
The pedicle entry point is intersected by the vertical linethat connects the lateral edges of bony crest extension ofthe pars inter-articularis, and the horizontal line thatbisects the middle of the transverse process. Anatomicalvariation in individual patients may cause slightdifferences in the entry site. There differences should beconsidered carefully and noted on the pre-operative x-rays. A small rounger or a burr may be used todecorticate the pedicle entry point. The awl is used tomake an entry hole through the cortex at the pedicleentry point.
STEP 4 PEDICLE PREPARATION - PROBE
After confirmation of the position of the guide pinsrelative to the pedicle canal, the probe is inserted throughthe entry hole and gently pressed through the pediclecanal. The probe is passed through the pedicle canal untilthe anterior cortex of the vertebral body is reached.Caution should be taken not to violate the anterior wall ofthe vertebral body or cortical walls. The probe can bemeasured at 10mm intervals (30, 40, 50mm) and theCurved Probe is also available.
Surgical Technique | 4•5
AWL CURVED PEDICLE PROBE
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STEP 5 PEDICLE SCREW PREPARATION - GUIDE PIN
After making the pedicle entry point through the cortexof the pedicle, guide pins are inserted into the pediclecanal. Ensure all liked shaped guide pins are inserted onthe same side of the spinal column for identificationpurposes on the x-ray. After all guide pins have beeninserted, intra-operative x-rays should be taken to verifythe position of the guide pins relative to the pedicle canal.The different shaped pins can distinguish the right andthe left.
STEP 6 PEDICLE PREPARATION - TESTER
After use of the probe and guide pins, the Tester is usedto confirm continuity of the cortical walls of the pedicle.The Tester can also be used to palpate the inner surfaceof the pedicle canal to check for defects or punctures inthe cortical walls.
GUIDE PINS BALL TIP PROBE (TESTER)
Surgical Technique
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After all of the pedicle screw preparation steps (step 3 ~step 7) are completed, the ILIAD pedicle screws areinserted via the ILIADO screw driver. The screw driversand screw can be assembled together by taking screwhead into the Screw Driver tip and then turning the ScrewDriver Nut closed, in the clockwise direction, to attach thescrew securely. The pedicle screws should be insertedinto the vertebral body until to the desired height. Thescrew driver is disengaged from the ILIAD housing byturning the screw driver shaft counterclockwise whilestabilizing the ILIAD housing with the screw driver sleeve.The pedicle screw should parallel the endplates andextend 50% to 80% into the vertebral body when fullyseated.
STEP 7 PEDICLE SCREW PREPARATION - TAP
After the step 6 is fully verified, a Tap (size collates to thesize of screw to be used) is used to thread thepediclecanal so that the pedicle screw can be easily driven intothe pedicle canal. 11 different sizes of Taps can be used forthis step which corresponds to the outside diameter ofthe pedicle screw to be used.
FIXED TAP
POLYAXIAL SCREWDRIVER
PEDICLE PREPARATION SCREW DRIVER ASSEMBLYSTEP 8
TMILIAD Spinal FixationSystem
Surgical Technique | 6•7
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Surgical Technique | 6•7
PEDICLE SCREW IMPLANTATION SCREW PLACEMENTSTEP 9
After the step 8, the screw is inserted and driven into thepedicle canal in the clockwise direction to the determineddepth. After the screw is securely fastened inside thevertebral body, remove the screw driver by turning theScrewdriver shaft in the Counter-clockwise direction.
STEP 10 ROD SELECTION AND INSERTION
After the pedicle screws have been placed in the pedicles,the correct length of rod is selected. The rods areprovided pre-cut in lengths ranging from 40mm to500mm. The rod should extend approximately 5millimeters beyond the superior and inferior pediclescrews. After the appropriate length of rod has beenselected, lordosis may be bent into the rod via the rodbender. The polyaxial adjustability of the systemeliminates the need for precision bending of the rod. Asimple lordodic bend is sufficient and the amount oflordosis is based on the patient°Øs anatomy and theamount of reduction to be achieved; the rod is thenloaded onto the pedicle screw heads with the Rod Holder.
ROD HOLDER
Surgical Technique
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1. Available Screw Diameter 4.0 / 4.5 / 5.0 / 5.5 / 6.0 / 6.5 / 7.0 / 7.5 / 8.0 / 8.5mm
2. Available Screw TypeMono - & Poly AxialReduction Mono - & Poly AxialCannulated Mono - & Poly Axial
3. Oscillation Angle up to 60。4. Accomodate both 6.0 and 6.35 Rods.
ILIADTM Pedicle Screws
1. Titanium Alloy Rods / CoCr Rods Available2. 6.0mm & 6.35mm Rod Diameter3. Available in Pre-contoured and Straight Rod Configuration4. Longest Available Size 500mm
ILIADTM Rods
Straight Rods Pre-contoured Rods
STEP 11
TMILIAD Spinal FixationSystem
Surgical Technique | 8•9
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1. Linear Slot Design built into the threads allowsfor increase holding force during final tightening.The design acts like a vice grip reducing thechance of the set screw back out after finaltightening.
2. Unique Dovetail Thread Design allows easy insertionwhile reducing the chance of cross threading.
Linear Slot Effect
Provisional tightenedset screw
Final tightened set screwwith linear slot compressed
STEP 12 DEROTATION, COMPRESSION, AND DISTRACTION
After all of the set screw assemblies have been loosely inserted onto the ILIAD screw housing, the derotator is used torotate the contoured rod into lordosis. The proper position of the rod is confirmed by ensuring that the centerline lasermarked on the rod is visible from the top and parallel to the floor. While the rod is held into place with the derotator, thesetscrew of the of the most superior ILIAD housing is provisionally tightened via the T-Wrench. The remaining ILIAD setscrews are left loose so compression and distraction can be accomplished. After the construct has been properlyassembled, segmental compression and distraction is accomplished as needed to adjust frontal or sagital plane deformities.Compression is accomplished via the compressor. The compressor fits onto the rod on the outside of the provisionally-tightened ILIAD set screw assembly and the ILIAD screw to be compressed. As the compressor handle is closed, the looseILIAD screw is drawn toward the provisionally-tightened ILIAD set screw/housing assembly accomplishing compression ofthe desired segment. When the desired amount of compression has been achieved, the setscrew of the loose set screw istightened via the set-screw T-Wrench while being held into place with the compressor.
Note :Caution should be taken not to over tighten the setscrew without use of the Power Holder as loosening or the pediclescrews may result. Distraction is accomplished via the spreader. The spreader fits onto the rod on the inside of theprovisionally-tightened ILIAD set screw/housing assembly and the ILIAD screw to be distracted. As the spreader handle isclosed, the loose ILIAD screw is pushed away from the provisionally-tightened ILIAD set screw/housing assemblyaccomplishing distraction of the desired segment. When the desired amount of distraction has been achieved, the setscrewof the loose set screw is tightened via the set-screw T-Wrench while being held into place with the spreader.
Note :Caution should be taken not to over tighten the setscrew without use of the Power Holder as loosening or the pediclescrews may result.
COMPRESSIONDISTRACTION
Surgical Technique
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STEP13 FINAL LOCKING
After compression and distraction has beenaccomplished and the set-screws are provisionallytightened, the power holder is used to stabilize theassemblied construct durring final tightening the ILIADset screw/housing assembly. The Torque Wrench isinserted into the cannulated hole of the power holder andengaged into the ILIAD set-screw. The power holder isthen inserted over the ILIAD screw housing and engagedonto the rod. A window has been cut into one side of theanti-torque holder in case the ILIAD screws are too closetogether to fully insert the power holder over the ILIADscrew housing. Each ILIAD set screw/housing assembly issequentially tightened using the torque wrench whilebeing stabilized via the power holder.
STEP 14 TRANSVERSE LINK SELECTION AND INSERTION
After final tightening of the ILIAD set screw/housingassembly, the transverse link is installed, if desired. Thetransverse link assembly consists of two transverse barand two transverse hooks. Once the desired location ofthe transverse link has been determined, the appropriatetransverse link size is selected. The transverse is placedover the rods via the transverse hook. The secondtransverse hook is then placed into position on theopposite rod. The compressor may be used to adjust andposition the transverse link on the rods. The cross-linkscrew driver is used to tighten each transverse hook ontothe rods as well as the tightening the center screw todetermine the final length of the transverse link. Thepower holder should be used to secure the constructduring the tighteningTORQUE DRIVER
ANTI-TORQUE WRENCH
TMILIAD Spinal FixationSystem
Surgical Technique | 10•11
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1. ILIADTM has 6 different sizes of Cross Links. 2. Available Cross Link Size
41 / 46 / 51 / 56 / 61 / 66mm3. Cross Links are designed to accomodate either 6.0mm or 6.35mm
rods in order to stablize a spinal construct. 4. One step tightening with a single instrument.
ILIADTM Cross Links
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ILIAD TM Instrument List
Screw Lever NCSL-002
Set Screw Starter Single-endedTwisted Tip NNSS-T03Straight Tip NNSS-001
Straight Pedicle ProbeBlunt Narrow NCPN-S11Blunt Wide NCPW-S11
TesterDouble-ended NCTD-101Single-ended NCTS-101
Inserter NNIR-002
Set Screw Starter Double-endedTwisted Tip NNSO-T03Straight Tip NNSO-001
Torque Wrench(Final Tightener)Twisted Tip NNTW-T03Straight Tip NNTW-S03
Pedicle MarkerTip Type NCGT-002Non-tip Type NCGN-002
Curved Pedicle ProbeThoracic NCPK-C11
Fixed Tap 4.5mm NCTT-0455.5mm NCTT-0556.5mm NCTT-065
Available Sizes : 4.0~8.5mm / Cannulated Taps are available from 5.5mm.
Modular Tap4.5mm NCTM-1455.5mm NCTM-1556.5mm NCTM-165
Available Sizes : 4.0~8.5mm / Cannulated Taps are available from 5.5mm.
Rod Bender NNRB-101
Anti Torque WrenchNNAT-202
Set Screw Driver (T-wrench)Straight Tip NNSD-S03Twisted Tip NNSD-T03
Thoracic Type and Lumbar Cann. Type are available.
Awl-Lumbar5mm NCAW-L0510mm NCAW-L1015mm NCAW-L1520mm NCAW-L2025mm NCAW-L25
Rod Holder NNRH-002
Cross Link DriverT-handle NNCT-101I-handle NNCD-002
Rod Derotator NNRD-002 Head Adjuster NNFD-002
Rod Fork NNRF-002
Rod RotatorHexagon NCRH-001Hole NCRO-001
Persuader NNPS-002
Rod Pusher 6.0mm Rod NNRP-0026.35mm Rod NLRP-002
Reduction Tab Remover NNRR-001
Ratchet T-HandleNNRT-201
CompressorStandard NNCO-101Parallel NNCO-002Large NNCO-201
Ratchet Straight-HandleNNRI-201
DistractorStandard NNDR-101Parallel NNDR-002Large NNDR-201
ILIAD Screw Drivers
Polyaxial Screw Driver Standard NNPD-101Short NNPD-401Cannulated NNCP-101
Monoaxial Screw Driver Standard NNMD-101Short NNMD-401Cannulated NNCM-101
Modular Monoaxial Screw Driver Standard NNMD-211Short NNMD-311Cannulated NNCM-211
Modular Polyaxial Screw DriverStandard NNPD-211Short NNPD-311Cannulated NNCP-211
Global HeadquartersMedyssey Co., Ltd.
148, Sandan-ro 68beon-gil, Uijeongbu-si, Gyeonggi-do, 480-859 Rep. of KOREA
Tel : +82. 31. 879. 0414Fax : +82. 31. 879. 0415
Web : www.medyssey.co.kr
U.S. HeadquartersMedyssey Co., Ltd.
1550 E. Higgins Rd., Ste # 123, Elk Grove Village, IL 60007, USA
Tel : +1.847.427.0200 / 0201Fax : +1. 888. 846. 1037
Web : www.medyssey.com
At the Helm of Medical TechnologyTM
ⓒ2012 All rights reserved by Medyssey Co., Ltd.Products shown are protected by Korea Patent Numbers : 20-0399039, 20-0410476, 10-2007-0011197, 20-0299664, 20-0208706
by U.S. Patent Numbers : US6.723.128.B2by Japan Patent Numbers : 3148465
as well as other pending U.S. and foreign patent applications.