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Caution: Be aware if 2 strands are cut, there will be a free-floating piece 
of suture that will need to be retrieved.

 

2.  

Removing extra suture strands from the Chord-X

 Suture System 

Adjustable prosthesis version: 

Remove undesired suture strand by cutting a single chordal suture strand 

and discard. (

See Figure 4

)

 

Caution: Be aware if 2 strands are cut, there will be a free-floating piece 
of suture that will need to be retrieved. 

6.4. Papillary Suture Placement:

Place the Chord-X

 Pre-Measured Loops or the Chord-X

 Suture System 

prosthesis papillary suture with attached needle through the papillary 

muscle, with a pledget placed on each side of the muscle. One pledget is 

pre-attached to the prosthesis. The second pledget 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. Leaflet Loop Placement:
1.   Chord-X

 Pre-Measured Loops prosthesis version leaflet placement 

and knot tying: 

Once the suture has been anchored to the papillary muscle, pass each 

required chordal pre-measured suture loop through the free edge of the 

prolapsed leaflet, taking care to not entrap native chordae as the Chord-X

 

Pre-Measured Loops are individually positioned and tied. 

The two suture strands of each Chord-X

 chordal Loops are run through the 

free margin of the leaflet, then tied. 

Tie the Chord-X

 Pre-Measured Loop ends using at least seven (7) flat square 

throws. Continue placement of the remaining Chord-X

 Pre-Measured 

Loops as needed to complete artificial chordal replacement, tying each one 

as described. (

See Figure 6

)

Summary of Contents for Chord-X Series

Page 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...

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

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

Page 87: ......

Page 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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