Normalize ( Brochure Erisma ) - Implant Service · Spinal stenosis Lumbar deformities Trauma Tumor...

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Surgical technique

Inspired by the spine

Inspired for the spine

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Erisma LP brochure EN_Mise en page 1 31/05/11 13:40 Page1

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Designed by a team with extensive expertise in the development of spinalinstrumentation, Erisma–LP is the result of optimized development based on an analysisof existing technologies.

The Erisma–LP spinal instrumentation is apedicle screw based fixation. The designteam focused on creating a top loadingsystem that incorporates reduced implantvolume and ergonomically designedinstrumentation. Erisma–LP was developedto meet the spine surgeon’s needs forreliability, security and ease of use duringday-to-day surgical practice. Erisma–LP is a

comprehensive system of implants andinstruments designed to address pathologiesof the spine in the thoraco-lumbar region.Composed of polyaxial screws, monoaxialscrews, crosslinks, rods and set screws,Erisma–LP integrates a wide selection ofsizes and diameters, allowing the surgeon toperform posterior fixation of the spine forvarious pathologies.

Introduction 3Features & benefits 4Surgical technique 6Product catalog 14Instructions for use 18

Indications:Disc Degenerative diseaseSpondylolisthesisSpinal stenosisLumbar deformitiesTraumaTumorPseudarthrosisFailed previous fusion

Introduction

Contents


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Features & benefits

Optimized volumeand profile

Limited interference with

anatomical features

Tapered thread Enhanced strength under

bending moments

Self-tapping blunt tip Easy, smooth and non-

aggressive screw insertion

Color-codedscrews and taps

Quick screw selection

SCREWS

SET SCREW

Buttress thread

Optimized thread entry

No splaying of the screw head

Optimized performance of

the screw/rod connection

Prevents cross-threading

30°


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INSTRU

MEN

TATION

CROS

SLINK

Shortpre-bent rods

Straight rods withguiding line

Quick rod preparation

Facilitate bending of the

rod within one plane

Facilitate rod positioning

Fully adjustablecrosslink

Easy implantation in all

configurations

User-friendly

Quick connect andmodular handles

Precise, quick and efficient

maneuvers

Adaptability to the

surgeon’s habits

Ergonomic design Complete instrumentation,

compact instrument set

RODS


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Pedicle preparation1

After adequate exposure, theappropriate pedicle entrypoint is located and theentrance to the pedicle canalis perforated using the squareawl.

Surgical Technique

1 Pedicle preparation2 Pedicle drilling and screw selection3 Tapping4 Pedicle screw insertion5 Rod preparation6 Rod insertion

7 Set screw positioning8 Correction maneuvers9 Final tightening10 Crosslink placement11 Removal

Following all necessary safety protocols, the patient is positioned on theoperating table in the prone position. The surgical approach is performedaccording to the known and validated techniques routinely used by surgeons.

99702000 SQUARE AWL


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99731000 PEDICLE PROBE

997010** TAP

99730000 PEDICLE SOUNDER

Pedicle drilling and screw selection2

A pathway in theintrapedicular cancellousbone is then opened up usingthe pedicle probe at theappropriate angle and depth.The pedicle probe isgraduated with 10mmintervals to determine thedepth measurement, as wellas to determine the properscrew length.

The integrity of the pedicularhole’s walls is then checkedwith the pedicle sounder.

Tapping3

The Erisma–LP screws areself-tapping and do notrequire tapping. For thesurgeon’s convenience,optional tapping can beperformed using the tapsprovided in all diameters. Thescrew diameter is determinedby the color-code indicatedon the tap.


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Pedicle screw insertion4

The appropriate screwdiameter and length aredetermined.

The proper screw length may bechecked using the screw gaugeplaced on the instrument tray.

To implant the screw, fullyengage the tip of the holdingscrewdriver in the head of thescrew and turn the lockingknob clockwise . Then,make sure that the screw isstraight and secured .

The screw is inserted in thepedicle hole and the holdingscrewdriver is disengaged byturning the locking knobcounterclockwise. Repeat foreach screw.

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3

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18710002HOLDING SCREWDRIVER

HANDLES

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2

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99733*** ROD TEMPLATE

99750001 FRENCH BENDER

99715003NARROW NOSE ROD HOLDER

99715002ANGLED ROD HOLDING FORCEPS

99743000 ROD PUSHER

Rod preparation5

Once the screws have beeninserted and their positionshave been verified by X-ray,the appropriate rod length isselected using the rodtemplate. If necessary, bendthe rod using the Frenchbender to set the appropriatespinal contours.

The rod is inserted in thescrew heads using the angledrod holding forceps. TheErisma–LP system offers twooptions for linking the rod tothe screw heads:

Rod PusherWhen the rod is slightlyabove the screw head, therod pusher may be used topush the rod into position.

Rod insertion6


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Set screw positioning 7

The set screws are fitted onthe tip of the set screwholder and sequentiallythreaded on the implant. Onlya few threads are necessaryto secure the rod in theimplants. Repeat for each setscrew.

It is recommended to use thepersuader to guarantee that therod is perfectly in position andtherefore, avoid possible cross-threading.

PersuaderThe persuader is used ifadditional force is needed tobring the rod to the implant.The persuader is connectedto the head of the screw. Thetrigger is then pressed andthe tube slid down.

Once the lever is pusheddown, the rod is fully seatedin the implant. When theintroduction lever is tippeddown, the persuader stays inposition.

The lever can be pushed downonly when the persuader is well-positioned on the implant andthe tube slid down.

When finished, press the triggeragain, slide the tube up and pullthe lever up. The persuader canbe removed and is ready to useagain.

01714001 SET SCREW HOLDER

18742002 PERSUADER


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99740001 COMPRESSOR

99741001 DISTRACTOR

Correction maneuvers8

Before final tightening of theconstruct, rod rotation,compression or distractionmay be achieved.

Rod rotationTo achieve the final rodpositionning, the rod can beturned using the narrow noserod holder.

Distraction andcompressionSegmental distraction orcompression may be carriedout using the compressor orthe distractor.

99715003NARROW NOSE ROD HOLDER


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18733001 CROSSLINK TEMPLATE

01721003 COUNTER TORQUE

99781200TORQUE LIMITED T HANDLE

01720003TIGHTENING WRENCH T30

Final tightening9

Crosslink placement10

To complete the construct, acrosslink may be added toprovide increased stability.The appropriate size of thecrosslink (S, M, L, XL, XXL) isdetermined using thecrosslink template.

The set screw is tightened using the tightening wrench T30attached to the torque limited T-handle. The counter torque ispositioned over the screw head and the wrench is insertedthrough the tube of the counter-torque. Tighten until the torquelimited T-handle triggers once. Repeat for each screw.


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18713001 CROSSLINK HOLDER

01720001TIGHTENING WRENCH T20

Once the crosslink size isdetermined and its unlockedposition is checked, thecrosslink holder is used toposition the crosslink. Thefirst transverse connector ispositioned and its set screwis tightened using thetightening wrench . Theoperation is repeated for thesecond connector . Whenlateral set screws are secured,the center set screw istightened .

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Removal11

The set screws can be removed using the counter torque and thetightening wrench to turn the set screws counterclockwise. Whenthe set screws are removed, the rod can be easily extracted usingthe angled rod holding forceps. The holding screwdriver is usedto remove the screws.


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Product catalog

SQUARE AWL 99702000 PEDICLE SOUNDER 99730000 PEDICLE PROBE 99731000

ANGLED ROD HOLDING FORCEPS 99715002

T T

TAP ø4.5mm 99701045ø5.5mm 99701055ø6.5mm 99701065ø7.5mm 99701075ø8.5mm 99701085

HOLDING SCREWDRIVER 18710002 FIXED PALM HANDLE 99780000NON RATCHETING T-HANDLE 99781000RATCHETING HANDLE 99781100TORQUE LIMITED T-HANDLE 99781200

FRENCH BENDER 99750001 NARROW NOSE ROD HOLDER 99715003


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ROD PUSHER 99743000 PERSUADER 18742002 SET SCREW HOLDER 01714001

DISTRACTOR 99741001 COMPRESSOR 99740001 COUNTER TORQUE 01721003

TIGHTENING WRENCH T30 01720003TIGHTENING WRENCH T20 01720001

CROSSLINK TEMPLATE 18733001


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CROSSLINK HOLDER 18713001

SET SCREW 18620009

CROSSLINK S (27-31 mm) 18442731M (30-37 mm) 18443037L (35-47 mm) 18443547XL (45-67 mm) 18444567XXL (58-93 mm) 18445893

BENT ROD length 30 mm 18415503length 40 mm 18415504length 50 mm 18415505length 60 mm 18415506length 70 mm 18415507length 80 mm 18415508length 90 mm 18415509length 100 mm 18415510

ROD length 120 mm 18455512length 140 mm 18455514length 160 mm 18455516length 180 mm 18455518length 200 mm 18455520length 220 mm 18455522length 240 mm 18455524

ROD TEMPLATE length 100 mm 99733100length 250 mm 99733250

IMPLANTS TRAY 18790001 INSTRUMENTS TRAY 18790002

Product catalog


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MONOAXIAL SCREWLength (mm) ø4.5 ø5.5 ø6.5 ø7.5 ø8.5

25 * * — — —30 * 18015530 18016530 — —35 * 18015535 18016535 18017535 *40 * 18015540 18016540 18017540 *45 — 18015545 18016545 18017545 *50 — * 18016550 18017550 *

* Available upon request

POLYAXIAL SCREWLength (mm) ø4.5 ø5.5 ø6.5 ø7.5 ø8.5

25 * * — — —30 * 18045530 18046530 — —35 * 18045535 18046535 18037535 *40 * 18045540 18046540 18037540 *45 — 18045545 18046545 18037545 *50 — * 18046550 18037550 *

* Available upon request


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Notice d’instructionsL’instrumentation Erisma–LP est destinée autraitement chirurgical des pathologiesrachidiennes. Ce traitement consiste à fusionnerun segment de deux ou plusieurs vertèbres avecou sans geste chirurgical endocanalaire associé,pour lui donner une stabilité. Pour optimiser lerésultat, un diagnostic préopératoire détaillé, unetechnique chirurgicale méticuleuse ainsi que dessoins postopératoires adaptés sontindispensables. Il est important que le patient etle chirurgien soient pleinement conscients desrisques et complications inhérents à ce type dechirurgie. Cette technique exige que le chirurgiensoit expérimenté dans le placement des vispédiculaires dans des vertèbres. Nousconseillons au chirurgien de suivre une formationauprès d’un chirurgien déjà expérimenté avantde démarrer l’utilisation de cette technique.

1|DESCRIPTIONL’instrumentation Erisma–LP est composée detiges fixées sur la colonne vertébrale à l’aide devis pédiculaires. En outre, elle comporte uneliaison transverse qui relie deux tiges entre elles.Les implants de l’instrumentation Erisma–LP sontréalisés en alliage de titane selon la norme ISO5832-3 ou ASTM F136 rappelé par le symbole .Il est impératif d’utiliser les implants Erisma–LPavec le matériel ancillaire conçu à cet effet. Pourobtenir un descriptif plus détaillé du matériel, ilest nécessaire de se référer à la documentationtechnique. Le matériel Erisma–LP doit êtreassemblé avec des éléments neufs définiscomme étant compatibles entre eux.

2|INDICATIONSLes critères et principes généraux pour poser lesindications en matière de chirurgie rachidiennes’appliquent.- Pathologies dégénératives- Déformation rachidienne- Traumatologie- Pathologie tumorale

3|CONTRE INDICATIONS- Grossesse- Infection- Allergie reconnue au matériau

4|EFFETS SECONDAIRES, COMPLICATIONSPOSSIBLES- Pseudarthrose- Démontage ou rupture d’implant- Infection, Allergie au matériau

5|PRECAUTIONS D’EMPLOINe jamais réutiliser un implant même en parfaitétat. Tout implant ayant été utilisé, déformé,tordu, courbé, implanté puis retiré, même s’ilapparaît intact doit être éliminé. Ceci est rappelésur l’étiquette par le symbole . Utilisersystématiquement des implants neufs. Ne pasmélanger des matériaux différents.

• Préopératoire : Le chirurgien doit maîtriserparfaitement tous les aspects de la techniquechirurgicale, connaître les indications et contre-indications. Le chirurgien doit vérifier qu’aucunfacteur d’origine biologique, biomécanique ouautre ne viendra affecter le bon déroulementde l’intervention et de ses suites. Un éventailadéquat des tailles doit être disponible lors del’intervention.

• Per-opératoire : La sélection correcte du typeet de la taille des implants adaptés au patient,ainsi que son positionnement sontextrêmement importants.

• Postopératoire : Les patients doivent êtreinformés des précautions à prendre dans leurvie quotidienne afin de garantir la durée de viemaximale des implants. Il est recommandéd’effectuer un contrôle postopératoire régulierqui permet de mettre en évidence des signesprécoces de faillite du matériel. Les implantspeuvent être retirés après la consolidationosseuse. La dégradation du dispositif aprèsconsolidation osseuse ne peut être considérée

comme un dysfonctionnement ou unealtération des caractéristiques du matériel. Unprogramme de rééducation adapté doit êtreétabli et mis en œuvre.

6|MANIPULATION / STOCKAGELa manipulation du matériel Erisma–LP doit êtreeffectuée aussi peu souvent que possible et avecprécautions. Le stockage des implants Erisma–LP(dans leur conditionnement d’origine) doit êtreréalisé avec soin dans un environnement propre etsec. Ne pas exposer les implants Erisma–LP à desrayonnements ou à des températures extrêmes. Lenon-respect de ces prescriptions peut provoquerune baisse des caractéristiques mécaniquespouvant conduire dans certains cas, à leur rupture.Les instruments chirurgicaux spécifiques àl’instrumentation Erisma–LP devront être vérifiéssur le plan fonctionnel avant toute intervention.

7|PRÉ-TRAITEMENT / NETTOYAGE /STERILISATION :Les opérations de nettoyage, décontamination etstérilisation sont impératives pour les implantset les instruments avant et après utilisation. Lesimplants et les instruments en sachet doiventêtre sortis de leur emballage d’origine pour lesopérations de prétraitement, de nettoyage et destérilisation qui seront mises en œuvre suivantles recommandations de bonnes pratiques envigueur. Les implants doivent être stérilisés avantemploi. Il est recommandé de stériliser lesimplants dans un autoclave à vapeur selon laméthode employée dans les hôpitaux et lescliniques (valeurs recommandées ci-dessous).

Méthode de stérilisation : AutoclaveCycle PrionTempérature 134°CDurée d’exposition 18 min (minimum)

Cependant nous conseillons aux utilisateurs quine suivent pas la méthode recommandée devalider leur méthode en faisant appel à destechniques de laboratoire appropriées.

FR

Instructions for useThe Erisma–LP instrumentation is designed forthe surgical treatment of spinal pathologies. Thetreatment consists of the fusion of two or severalvertebrae in order to restore spinal stability, withor without any other endocanalar concomitantsurgical procedure. For optimal results, adetailed preoperative evaluation, a meticuloussurgical technique and adequate post-operativecare are mandatory. It is important that both thepatient and surgeon are fully aware of the risksand possible complications associated with thistype of surgery. This technique requires that thesurgeon be experienced in the placement of thepedicle screws in vertebrae. Before attemptingthis technique, surgeons are advised to attend atraining course with a surgeon alreadyexperienced with the use of the device.

1|DESCRIPTIONThe Erisma–LP system is composed of rods fixedon the spine with pedicle screws. Moreover, thisinstrumentation includes transverse link whichconnects two rods altogether. The implants usedin the Erisma–LP system are made of titaniumalloy ISO 5832-3 or ASTM F136 as indicated bythe symbol . It is essential to insert implantswith instrumentation specifically designed for

this purpose. For more description of theinstrumentation it is necessary to read thetechnical documentation associated to theErisma–LP product. The Erisma–LP implants mustbe assembled with new Erisma–LP componentsdefined as being compatible with one another.

2|INDICATIONSGeneral criteria and principles related toinstrumented spinal surgery are applied here :- Degenerative pathologies- Spinal deformity- Traumatology- Tumor pathology

3|CONTRA-INDICATIONS- Pregnancy- Infection- Recognized allergies to titanium or titaniumalloys

4|SECONDARY AND POSSIBLE SIDE EFFECTS- Pseudarthrosis- Implant disassembly or implant failure- Infection- Allergy to materials used

5|CAUTIONS OF USENever reuse an implant, even in perfect state.Any implant which has been used, twisted, bent,implanted and then removed, even if appearsintact, must be discarded. Use new implantsroutinely. This is indicated on the labeling of theimplant package by the next symbol . Do notmix dissimilar materials.

• Preoperative : The surgeon must be fullyconversant with all aspects of the surgicaltechnique and know the indications andcontra-indications of this type of implant. Thesurgeon must have acquainted himself beforethe operation with the specific technique forinsertion of the product which is available fromthe manufacturer. As part of the pre-operativeexamination, the surgeon must check that nobiological, biomechanical or other factors willaffect the correct conduct of the operation andthe post-operative period. An appropriaterange of sizes must be available at the time ofthe operation.

• Intraoperative : The correct selection of thetype of size of implant appropriate to thepatient and the positioning of the implant areextremely important.

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• Postoperative : Patients must be informed ofthe precautions to be taken in their everydaylife to guarantee a maximum implant servicelife. It is recommended that a regularpostoperative follow-up be undertaken todetect early signs of failure of the implants andto consider the action to be taken.Deterioration of the device after boneconsolidation cannot be considered toconstitute a dysfunction or degradation in thecharacteristics of the implant. The implant canbe removed after the consolidation of the bonegraft. A suitable rehabilitation program must bedesigned and implemented.

6|HANDLING AND STORAGEThe handling of the Erisma–LP material must bedone as seldom as possible and always with the

utmost care. The Erisma–LP implants (in theiroriginal packaging) must be stored with care in aclean and dry place. Do not expose the Erisma–LP implants to radiations or extremetemperatures. Should these requirements not befollowed, reduced mechanical properties mayoccur which could lead to implant failure in somecases. Proper function of the surgical instrumentsspecific to the Erisma–LP instrumentation shouldbe verified prior to every surgical procedure.

7|CLEANING / DECONTAMINATION /STERILISATIONThe operations of cleaning, decontamination andsterilization must be realized for the implantsand the instruments before and after use. Allpackaging must be removed before theoperations of pre treatment, cleaning and

sterilization which will be implemented accordingto the recommendations good practices in force.The implants must be sterilized before use. It isadvisable to sterilize the implants in a steamautoclave according to the method used inhospitals and clinics (recommended valuesbelow).

Sterilization method AutoclaveCycle Porous load (prion)Temperature 134°CExposure time 18 Min (Minimum)

However we advise the users not following therecommended method to validate their methodsby means of appropriate laboratory technique.

Manual de instruccionesLa instrumentación Erisma–LP está destinada altratamiento quirúrgico de las patologías raquídeas.Este tratamiento consiste en fusionar un segmentode dos o varias vértebras con o sin actuaciónquirúrgica endocanalar asociada, para darleestabilidad. Para optimizar el resultado, sonindispensables un diagnóstico preoperatoriodetallado, una técnica quirúrgica meticulosa ycuidados postoperatorios adaptados. Es importanteque el paciente y el cirujano sean plenamenteconscientes de los riesgos y complicacionesinherentes a este tipo de cirugía. Esta técnica exigeque el cirujano tenga experiencia en la colocaciónde los tornillos pediculares en vértebras.Recomendamos que, antes de utilizarla, el cirujanosiga una formación con un cirujano experimentado.

1|DESCRIPCIÓNLa instrumentación Erisma–LP está compuestapor barras fijadas en la columna vertebralmediante tornillos pediculares. Además, incluyeuna conexión transversal que une las dos barrasentre ellas. Los implantes de la instrumentaciónErisma–LP son en aleación de titanio según lanorma ISO 5832-3, ASTM F136 señalada con elsímbolo . Es imperativo utilizar los implantesErisma–LP con los instrumentos diseñados a talefecto. Para obtener una descripción másdetallada del material, referirse a ladocumentación técnica. El material Erisma–LPdebe ensamblarse con elementos nuevosdefinidos como compatibles entre ellos.

2|INDICACIONESSe aplican los criterios y principios generalespara las indicaciones en materia de cirugíaraquídea.- Patología degenerativa- Deformación raquídea- Traumatología- Patología tumoral

3|CONTRAINDICACIONES- Embarazo- Infección- Alergia reconocida al titanio y aleaciones deTitanio

4|EFECTOS SECUNDARIOS, COMPLICACIONESPOSIBLES- Pseudarthrosis- Desmontaje o ruptura del implante- Infección- Alergia al material

5|PRECAUCIONES DE EMPLEONo reutilizar nunca un implante, incluso si está enperfecto estado. Todo implante que haya sidoutilizado, deformado, torcido, curvado, implantadoy después retirado, incluso si parece intacto, debeser desechado. Està recordado en la etiqueta conel símbolo . No mezclar materiales diferentes.Utilizar sistemáticamente implantes nuevos.

• Preoperatorio : El cirujano debe dominarperfectamente todos los aspectos de la técnicaquirúrgica, y conocer las indicaciones ycontraindicaciones. También debe verificar queningún factor de origen biológica, biomecánicau otra pueda afectar al correcto desarrollo dela intervención y de sus consecuencias.Durante la intervención se deberá disponer deuna gama adecuada de tamaños de implantes.

• Peroperatorio : La correcta selección del tipo ytamaño de los implantes adaptados alpaciente, así como su posición, sonsumamente importantes.

• Postoperatorio : Los pacientes deben serinformados de las precauciones que debentomar en su vida diaria para garantizar laduración de vida máxima de los implantes. Seaconseja efectuar un control postoperatorioregular que permita poner en evidencia signosprecoces de quiebra del material. Losimplantes pueden ser retirados después de laconsolidación ósea. El deterioro del dispositivodespués de la consolidación ósea no puedeser considerado como un disfuncionamiento ouna alteración de las características delmaterial. Se deberá establecer y aplicar unprograma de reeducación adaptado.

6|MANIPULACIÓN, ALMACENAMIENTOLa manipulación del material Erisma–LP debeefectuarse lo más raramente que posible y conprecauciones. El almacenamiento de losimplantes Erisma–LP (en su envase original)tiene que ser realizado con cuidado en unambiente limpio y seco. No exponer losimplantes Erisma–LP a radiaciones otemperaturas extremas. El incumplimiento deesas condiciones puede provocar unadisminución de las características mecánicas quepueden conducir en algunos casos, a su ruptura.Los instrumentos quirúrgicos específicos de lainstrumentación Erisma–LP tendrán que sercomprobados al nivel funcional antes de todaintervención.

7|LIMPIEZA / DESCONTAMINACIÓN /ESTERILISACIONLas operaciones de limpieza, dedescontaminación y de esterilización sonimperativas por los implantes y los instrumentesantes y después el uso. Los implantes y losinstrumentes deben extraerse de su embalaje deorigen para las operaciones de limpieza,descontaminación y esterilización. Lasoperaciones de limpieza, de descontaminación yde esterilización deben respectar lasrecomendaciones en uso. Los implantes debenesterilizarse antes del empleo. Se recomiendaesterilizar los implantes en un autoclave a vaporsegún el método empleado en los hospitales ylas clínicas (valores recomendados abajo).

Método de esterilización AutoclaveCiclo PriónTemperatura 134°CDuración de exposición 18 Min (Mínimo)

Sin embargo aconsejamos a los usuarios que nosiguen el método recomendado validar sumétodo recurriendo a técnicas de laboratorioadaptadas.

ES

CLARIANCE17 rue James WATT — ZAF-62000 Dainville, FRANCETL +33 (0)3 21 16 12 15FX +33 (0)3 21 15 50 73 0434


17, rue James Watt, ZA

F-62000 Dainville, FRANCE

TL +33 (0)3 2116 1215

FX +33 (0)3 2115 5073

[email protected]

innovation for spine surgeryinnovation for spine surgerywww.clariance-spine.com

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