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On-X Chord-X Series, Инструкция по эксплуатации

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5

2. INDICATIONS

Chord-X

™

 Pre-Measured Loops and Chord-X

™

 Suture System for Mitral 

Chordal Replacement are indicated for the repair or replacement of chordae 

tendinae.

3. CONTRAINDICATIONS

This device is contraindicated for use in ophthalmic surgery, microsurgery, 

and peripheral neural tissue.

4. WARNINGS 

The replacement of chordae tendinae requires accurate sizing to ensure 

satisfactory functioning of the valve mechanism post repair or replacement. 

Chordae tendinae replaced with sutures that are either too long or too short 

can result in failure to correct valvular incompetence. See the 

Recommended 

Techniques

 section for determining correct length.

Caution and surgical judgment is necessary when considering the use of 
this product in the setting of infectious endocarditis. The surgeon must 
be aware that prosthetic material may become infected in the presence 
of infectious endocarditis. Use in the presence of infectious endocarditis 
can result in failure of the valve repair.

 

The prosthesis has been sterilized using ethylene oxide. Do not re-
sterilize.

Potential tissue in-growth of the Chord-X

™

 Pre-Measured Loops or the 

Chord-X

™

 Suture System for Mitral Chordal Replacement made of ePTFE 

Nonabsorbable Monofilament suture and/or the pledgets made of PTFE 

felt may result in the attachment of the suture to the tissue it penetrates. 

Such attachment could make removal of the Chord-X

™

 Pre-Measured 

Loops or Chord-X

™

 Suture System sutures made of ePTFE Nonabsorbable 

Monofilament suture difficult.

5. PRECAUTIONS

Successful use of this device requires appropriate training and experience in 

cardiac surgical techniques including mitral valve repair.

Содержание Chord-X Series

Страница 1: ...Monofilament Suture U S P with PTFE Pledgets Mode d emploi Fran ais FIL DE SUTURE en ePTFE Chord X Gebrauchsanleitung Deutsch Chord X ePTFE NAHTMATERIAL Instrucciones de uso Espa ol SUTURA DE ePTFE Ch...

Страница 2: ......

Страница 3: ...5 6 RECOMMENDED TECHNIQUES 7 6 1 Determine Loop Length 7 6 2 Unpack Chord X Prostheses from the Base Plate 7 6 3 Removing Extra Loops 7 6 4 Papillary Suture Placement 8 6 5 Leaflet Loop Placement 8 6...

Страница 4: ...offered 1 configured with pre measured pre knotted ePTFE suture loops See Figure 1 and 2 configured with ePTFE suture strands with no pre tied knots allowing the surgeon to adjust and create artificia...

Страница 5: ...f this product in the setting of infectious endocarditis The surgeon must be aware that prosthetic material may become infected in the presence of infectious endocarditis Use in the presence of infect...

Страница 6: ...placement made of ePTFE suture Additional throws may be necessary depending on surgical circumstances When tying knots with the Chord X Pre Measured Loops or the Chord X Suture System prostheses made...

Страница 7: ...wer chordal sutures are desired excess segments can be removed without jeopardizing the rest of the prosthesis 1 Remove foam base plates from case 2 Unwrap the papillary suture with attached pledget f...

Страница 8: ...edget is provided in the case The papillary suture is then tied using at least seven 7 flat square throws Additional throws may be necessary depending on surgical circumstances See Figure 5 6 5 Leafle...

Страница 9: ...ving antegrade cardioplegia or performing both maneuvers With such testing if residual regurgitant jets are identified the surgeon may adjust the length of the Chord X Suture System suture strands Kno...

Страница 10: ...CTIONS Potential adverse effects associated with the use of any suture include wound dehiscence infection and localized transitory inflammatory tissue reaction Loop Length 3 8 Circle 1 2 Circle 3 8 Ci...

Страница 11: ...h 3 8 Circle 1 2 Circle 3 8 Circle 1 2 Circle Adjustable CXL 30 2238 0 CXL 30 2212 0 CXL 30 1838 0 CXL 30 1812 0 12mm CXL 30 2238 12 CXL 30 2212 12 CXL 30 1838 12 CXL 30 1812 12 16mm CXL 30 2238 16 CX...

Страница 12: ...ed Using Ethylene Oxide Quantity Taper Point Needle Manufacturer Date of Manufacture Double Armed Needle Use By Consult Instructions For Use Do Not Reuse Catalogue Number Batch Code Authorized Represe...

Страница 13: ...termination de la longueur des boucles 17 6 2 Retrait des proth ses Chord X de la plaque de support 17 6 3 limination des boucles inutiles 18 6 4 Mise en place du fil de suture papillaire 18 6 5 Mise...

Страница 14: ...es de la valve mitrale se d clinent en plusieurs configurations c est dire en diff rentes configurations de diam tre de fil de suture de longueur de boucle et d aiguille voir la section Conditionnemen...

Страница 15: ...ie ophtalmique microchirurgie et pour les tissus nerveux p riph riques 4 AVERTISSEMENTS Le remplacement des cordages tendineux exige de d terminer une longueur pr cise afin de garantir le bon fonction...

Страница 16: ...de suture avec des instruments chirurgicaux ou de l exposer des bords coupants au risque de compromettre sa r sistance la traction viter d utiliser des pousse n uds dot s d imperfections telles que d...

Страница 17: ...UES RECOMMAND ES 6 1 D termination de la longueur des boucles pr mesur es Chord X artificielles ou des boucles ajustables du syst me de fil de suture Chord X La technique choisie par le chirurgien doi...

Страница 18: ...l de suture papillaire puis le mettre au rebut voir la figure 3 Attention le fait de couper 2 brins laissera un morceau de fil de suture libre qui devra tre r cup r 2 limination des brins de suture su...

Страница 19: ...e ajustable du syst me de suture Chord X dans le feuillet et r alisation des n uds Lorsque le fil de suture est ancr au muscle papillaire passer tous les fils de suture de cordage requis travers le bo...

Страница 20: ...ets et le succ s de la r paration de la valve Lorsque le patient n est plus sous circulation extracorporelle proc der une chocardiographie trans sophagienne afin de confirmer les r sultats des tests h...

Страница 21: ...ND SIRABLES Les effets ind sirables potentiels associ s l utilisation de tout fil de suture sont notamment d hiscence de la plaie infection et r action inflammatoire transitoire localis e des tissus L...

Страница 22: ...suture Chord X pour le remplacement des cordages de la valve mitrale sont fournis ST RILES sauf si l int grit de l emballage a t compromise Ne pas utiliser ce dispositif si l emballage a t endommag C...

Страница 23: ...27 6 1 Schlingenl nge bestimmen 27 6 2 Chord X Set von der Basisplatte entfernen 27 6 3 brige Schlingen entfernen 28 6 4 Nahtplatzierung am Papillarmuskel 28 6 5 Schlingenplatzierung am Klappensegel 2...

Страница 24: ...l ngen und Nadelkonfigurationen siehe Lieferform Die Chord X Schlingen in vorgeschnittenen L ngen und das Chord X Nahtmaterialsystem werden folgenderma en angeboten 1 konfiguriert mit vorgeknoteten eP...

Страница 25: ...iezufriedenstellendeFunktiondesHerzklappenmechanismus nach der Rekonstruktion oder dem Ersatz sicherzustellen Der Ersatz von Chordae tendineae durch zu lange oder zu kurze Nahtmaterialf den kann zum F...

Страница 26: ...bei jedem Nahtmaterial ist Vorsicht geboten um Besch digungen bei der Handhabung zu vermeiden Das Nahtmaterial darf nicht durch chirurgische Instrumente gequetscht oder geknickt und keinen scharfen K...

Страница 27: ...odukts f hren Eine Wiederverwendung kann zu Infektionen schweren Verletzungen oder dem Tod des Patienten f hren 6 EMPFOHLENE TECHNIKEN 6 1 Bestimmen Sie die anpassbare Schlingenl nge der k nstlichen C...

Страница 28: ...ngen entfernen Entfernen Sie nicht ben tigte Schlingen indem Sie einen Einzelfaden des Nahtmaterials zwischen dem Knoten und dem Nahtmaterialfaden f r den Papillarmuskel abschneiden und entsorgen sie...

Страница 29: ...appensegels gef hrt und anschlie end festgezogen Verknoten Sie die Enden der Chord X Schlingen in vorgeschnittenen L ngen mit mindestens sieben 7 flachen Knoten Fahren Sie mit der Platzierung der brig...

Страница 30: ...Chord X Nahtmaterialsystems je nach Bedarf fort um den k nstlichen Ersatz der Chordae tendineae fertigzustellen und verknoten Sie die einzelnen F den wie beschrieben Eine Verk rzung der k nstlichen Se...

Страница 31: ...x ist ein eingetragenes Warenzeichen von W L Gore Associates Inc Flagstaff AZ 86004 6 7 Referenzen David TE Artificial Chordae Seminars in Thoracic and Cardiovascular Surgery Vol 16 No 2 Summer 2004 p...

Страница 32: ...1838 12 CXL 30 1812 12 16 mm CXL 30 2238 16 CXL 30 2212 16 CXL 30 1838 16 CXL 30 1812 16 20 mm CXL 30 2238 20 CXL 30 2212 20 CXL 30 1838 20 CXL 30 1812 20 24 mm CXL 30 2238 24 CXL 30 2212 24 CXL 30 18...

Страница 33: ...Determinar la longitud de bucle 37 6 2 Desembalaje de la pr tesis Chord X de la placa base 37 6 3 Eliminaci n de bucles adicionales 37 6 4 Colocaci n de la sutura papilar 38 6 5 Colocaci n del bucle...

Страница 34: ...pr tesis configuradas con 1 bucles de sutura de ePTFE premedidos y preanudados Consulte la Figura 1 y 2 hilos de sutura de ePTFE sin nudos previos para que el cirujano pueda ajustar y crear bucles art...

Страница 35: ...s para determinar la longitud correcta Es necesario actuar con cautela y criterio quir rgico si se utiliza este producto en caso de endocarditis infecciosa El cirujano debe ser consciente de que el ma...

Страница 36: ...onseja efectuar al menos siete 7 lazadas cuadradas planas equitensadas al atar los bucles premedidos Chord X o el sistema de sutura Chord X para reemplazo cordal mitral de sutura de ePTFE Puede que se...

Страница 37: ...uerdas artificiales elija la pr tesis con bucles premedidos Chord X o el sistema de sutura Chord X que corresponda Abra el envase utilizando una t cnica est ril Cada pr tesis est situada sobre una ser...

Страница 38: ...os Chord X o del sistema de sutura Chord X pasando la aguja a trav s del m sculo papilar de modo que se sit e un parche a cada lado del m sculo La pr tesis contiene un parche preinstalado El segundo p...

Страница 39: ...ener las superficies de coaptaci n de las dos v lvulas al mismo nivel en el ventr culo Consulte la Figura 7 Los cirujanos pueden emplear una serie de pruebas intraoperatorias para evaluar la longitud...

Страница 40: ...eemplazo cordal acabado Consulte la Figura 8 6 7 Bibliograf a David TE Artificial Chordae Seminars in Thoracic and Cardiovascular Surgery Vol 16 No 2 Summer 2004 pp 161 168 Frater RWM Gabbay S Shore D...

Страница 41: ...ES ADVERSAS Los efectos adversos potenciales asociados con el uso de cualquier sutura incluyen dehiscencia e infecci n de heridas y reacci n inflamatoria tisular transitoria localizada Longitud de buc...

Страница 42: ...hord X para reemplazo cordal mitral se suministran EST RILES a menos que se haya da ado la integridad del envase No utilice el dispositivo si el envase est da ado o abierto El dispositivo est dise ado...

Страница 43: ...Determinazione della lunghezza del cappio 47 6 2 Rimozione delle protesi Chord X dalla piastra base 47 6 3 Rimozione dei cappi superflui 48 6 4 Posizionamento delle suture papillari 48 6 5 Posizioname...

Страница 44: ...al tipo di ago vedere la sezione Come si presenta Le protesi costituite dai cappi premisurati Chord X e dal sistema di sutura Chord X sono disponibili nelle seguenti configurazioni 1 con cappi di sutu...

Страница 45: ...de tendinee vengono sostituite con fili da sutura troppo lunghi o troppo corti la buona riuscita della correzione dell insufficienza valvolare pu essere compromessa Per determinare la lunghezza corret...

Страница 46: ...danneggiare la sutura Evitare di sciogliere i nodi di sutura preannodati su ciascun cappio premisurato Sono necessari almeno sette 7 intrecci piani e quadrati tesi in modo uguale per annodare in mani...

Страница 47: ...egolabili del sistema di sutura Chord X mediante la tecnica preferita dal chirurgo in modo da mantenere le superfici attigue dei due lembi allo stesso livello nel ventricolo 6 2 Rimuovere le protesi c...

Страница 48: ...durr un segmento di filo libero da recuperare 2 Rimozione dei fili da sutura superflui dalla versione di protesi costituita dal sistema di sutura regolabile Chord X Rimuovere il filo da sutura superfl...

Страница 49: ...lembo e legatura dei nodi con la versione di protesi costituita dal sistema di sutura regolabile Chord X Dopo aver ancorato la sutura al muscolo papillare far passare i fili da sutura cordale necessa...

Страница 50: ...eferito o di una tecnica di imaging Dopo aver rimosso il bypass cardiopolmonare dal paziente necessario eseguire un ecocardiografia transesofagea allo scopo di confermare i risultati dei test idrodina...

Страница 51: ...effetti avversi associati all uso di suture di qualsiasi genere comprendono fra gli altri deiscenza della ferita infezione e reazione infiammatoria transitoria localizzata dei tessuti Lunghezza del c...

Страница 52: ...itraliche sono forniti STERILI a condizione che l integrit della confezione non sia compromessa Non usare il dispositivo se la confezione stata compromessa Il dispositivo esclusivamente monouso 9 DEFI...

Страница 53: ...57 6 1 Determinar o comprimento da la ada 57 6 2 Retirar as Pr teses Chord X da placa de base 57 6 3 Remover la adas adicionais 58 6 4 Coloca o da sutura papilar 58 6 5 Coloca o da la ada do folheto...

Страница 54: ...oduto constitu das por diferentes configura es de di metro de sutura comprimento de la ada e agulha Consultar Modo de fornecimento As pr teses La adas Pr Medidas Chord X e Sistema de Sutura Chord X s...

Страница 55: ...mo da v lvula no per odo p s repara o ou substitui o Cordas tendinosas substitu das com suturas demasiado longas ou demasiado curtas podem determinar uma fal ncia na corre o da incompet ncia valvular...

Страница 56: ...ite utilizar empurradores de n s com imperfei es tais como rebarbas ou arestas que possam danificar a sutura Evite desatar os n s de sutura previamente atados em cada la ada pr medida S o necess rias...

Страница 57: ...vel das pr teses La adas Pr Medidas Chord X ou Sistema de Sutura Chord X utilizando a t cnica da sua prefer ncia para manter as superf cies de ajuste dos dois folhetos ao mesmo n vel no ventr culo 6...

Страница 58: ...mova um fio de sutura indesejado cortando um nico fio de sutura para cordas tendinosas e deite fora Consultar a Figura 4 Aten o Tenha em aten o que se forem cortados 2 fios ficar um peda o de sutura s...

Страница 59: ...o individualmente posicionadas e atadas O cirurgi o dever estabelecer o comprimento de cada sutura de substitui o da corda tendinosa utilizando o m todo da sua prefer ncia A sutura definida para mant...

Страница 60: ...tados do teste hidrodin mico e avaliar a repara o da v lvula Substitui o das cordas tendinosas conclu da Consultar a Figura 8 6 7 Bibliografia David TE Artificial Chordae Seminars in Thoracic and Card...

Страница 61: ...Os potenciais efeitos adversos associados com a utiliza o de qualquer sutura incluem deisc ncia da ferida infe o e rea o inflamat ria tecidual tempor ria e localizada Comprimento da la ada 3 8 c rculo...

Страница 62: ...a substitui o das cordas tendinosas da v lvula mitral s o fornecidas EST REIS exceto se a integridade da embalagem tiver sido comprometida N o utilize o dispositivo se a embalagem tiver sido compromet...

Страница 63: ...CHNIEKEN 67 6 1 Luslengte bepalen 67 6 2 Chord X prothesen losmaken van de basisplaat 67 6 3 Extra lussen verwijderen 68 6 4 Plaatsing van papillaire hechtingen 68 6 5 Plaatsing van lussen in het klep...

Страница 64: ...bestaande uit verschillende configuraties van hechtdraaddiameters luslengten en naalden zie Wijze van levering De Chord X voorgemeten lussen en het Chord X hechtdraadsysteem zijn als volgt verkrijgba...

Страница 65: ...n na reparatie of vervanging Als chordae tendinae worden vervangen door hechtdraden die te lang of te kort zijn kan dit ertoe leiden dat de klepfunctie niet goed wordt hersteld Zie het hoofdstuk Aanbe...

Страница 66: ...het gebruik van knoopaandrukkers met imperfecties zoals boorgaten of bramen waardoor de hechtdraad beschadigd kan worden Maak de op elke voorgemeten lus vooraf aangebrachte knopen niet los Er zijn ten...

Страница 67: ...lus van het Chord X hechtdraadsysteem via de voorkeurstechniek van de chirurg zodanig dat de samenkomende oppervlakken van de twee klepbladen op hetzelfde niveau in het ventrikel gehouden worden 6 2 D...

Страница 68: ...tdraad door n chordale hechtdraad door te knippen en weg te gooien zie afbeelding 4 Let op Als u 2 draden doorknipt dan blijft er een los stuk hechtdraad over dat weggehaald moet worden 6 4 Plaatsing...

Страница 69: ...ussen afzonderlijk worden gepositioneerd en vastgeknoopt Bepaal de lengte van elke chorda vervangende hechtdraad met de voorkeursmethode van de chirurg De hechtdraad wordt zo geplaatst dat de samenkom...

Страница 70: ...hydrodynamische tests te controleren en de klepreparatie te evalueren Voltooide chorda vervanging Zie figuur 8 6 7 Referenties David TE Artificial Chordae Seminars in Thoracic and Cardiovascular Surge...

Страница 71: ...EN Mogelijke ongewenste neveneffecten die samenhangen met het gebruik van elke hechtdraad zijn wonddehiscentie infectie en gelokaliseerde voorbijgaande ontstekingsreactie van weefsel Luslengte 3 8 cir...

Страница 72: ...ging worden gegarandeerd STERIEL geleverd tenzij de verpakking beschadigd is Gebruik het hulpmiddel dus niet als de verpakking beschadigd is Het hulpmiddel is uitsluitend bedoeld voor eenmalig gebruik...

Страница 73: ...73 1 74 2 74 3 75 4 75 5 75 6 76 6 1 76 6 2 Chord X 76 6 3 77 6 4 77 6 5 77 6 6 78 6 7 79 7 79 8 80 9 80 81...

Страница 74: ...74 On X Chord X On X Chord X ePTFE USP PTFE 1 Chord X Chord X ePTFE ePTFE 50 Chord X Chord X Chord X Chord X 1 ePTFE 1 2 ePTFE 2 Chord X Chord X PTFE Chord X Chord X 2 Chord X Chord X...

Страница 75: ...75 3 4 ePTFE PTFE Chord X Chord X ePTFE Chord X Chord X 5...

Страница 76: ...76 ePTFE Chord X Chord X ePTFE Chord X Chord X Chord X Chord X Chord X Chord X 6 6 1 Chord X Chord X Chord X Chord X 6 2 Chord X Chord X Chord X Chord X 1...

Страница 77: ...77 2 3 3 4 PTFE 6 3 Chord X Chord X 1 Chord X 3 2 Chord X 4 6 4 Chord X Chord X 5 6 5 1 Chord X Chord X...

Страница 78: ...78 Chord X Chord X Chord X 6 2 Chord X Chord X 7 Chord X Chord X Chord X 6 6 8...

Страница 79: ...Valve Surgery Austin R G Lades Company 1994 159 Zussa Claudio Different Applications of ePTFE Valve Chordae Surgical Techniques J Heart Valve Disease 1996 5 356 361 7 3 8 1 2 3 8 1 2 CXL 20 2238 0 CX...

Страница 80: ...0 2238 16 CXL 30 2212 16 CXL 30 1838 16 CXL 30 1812 16 20mm CXL 30 2238 20 CXL 30 2212 20 CXL 30 1838 20 CXL 30 1812 20 24mm CXL 30 2238 24 CXL 30 2212 24 CXL 30 1838 24 CXL 30 1812 24 1 5 22mm 18mm 3...

Страница 81: ...hord X Suture System prosthesis version 2 Close up illustration of Chord X Pre Measured Loops prosthesis version with attached pledget and pre measured and pre tied loops 2 Close up illustration of Ch...

Страница 82: ...move undesired prosthetic loops by cutting a single strand of suture between the knot and the papillary suture strand 2 Discard the undesired loop by removing the single strand in entirety Caution Be...

Страница 83: ...just able prosthesis version Remove undesired suture strand by cutting a single chordal suture strand 2 Discard the undesired strand by removing the strand in entirety Caution Be aware if 2 strands ar...

Страница 84: ...Figures 84 Figure 5 Papillary suture placement 2 1 3...

Страница 85: ...Figures 85 Figure 6 Chord X Pre Measured Loops leaflet placement and knot tying Figure 7 Chord X Suture System Adjustable prosthesis version leaflet placement and knot tying 1 1 2 2...

Страница 86: ...Figures 86 Figure 8 Final Chordal Replacement...

Страница 87: ......

Страница 88: ...ding B Austin Texas 78752 U S A Telephone 512 339 8000 Facsimile 512 339 3636 www onxlti com onx onxlti com CryoLife Europa Ltd Bramley House The Guildway Old Portsmouth Road Guildford Surrey GU3 1LR...

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