3 F.Galli - Fondazione Maugeri Pavia MATERIAL USEDTeflon (PTFE) –PoliethylenePVCPolyurethane ( there are 3 different generations)SiliconF.Galli - Fondazione Maugeri Pavia12
4 Material Years Time of placement Kind of cath Teflon/PVC 80’s 3 days – 1 weekShort timePolyurethane 1° generation85’s1 week-2 weeksPolyurethane termosensible 2° generation90’s1 week-3 weeksSilicon1 week – 2 yearsMedium long termNew generation of polyurethane 3° generationEnd 90’s1 week- years
5 FUTURE “ENRICHED” POLYURETHANE Less adherence of plateletsLess adherence of bacteriaHigher mechanic adherence
6 BIOSTABILITY POLYURETHANE MATERIALSBIOSTABILITY POLYURETHANEIMPROVES Less THROMBOGENICITYPERFORMANCESH2Oes:heparinDECREASESPLATELETS ADHERENCECOAGULATION
8 IF MATERIAL SURFACE IS ONDULATED INCREASE OF BACTERIA ADHERENCEINCREASE OF THROMBOGENICITYGROWTH OF BACTERIA COLONY
9 section Side by side “ D “ COAxIALE Single lumen SMILE PERM-CATH COOK-ULDALLTESIO5
10 SECTIONS AND SIDE HOLES GEOMETRY GEOMETRIESSECTIONS AND SIDE HOLES GEOMETRYDOUBLE D SECTION HAS:LITTLE “WHIP” EFFECT BUT LESS TRAUMATIC EFFECT FOR THE VESSEL VS. COAXIAL CONFIGURATIONVADOUBLE D COAXIAL
11 POLYURETHANE “ MODIFIED TIP” GEOMETRIESThe shape of the tipTipPOLYURETHANE “ MODIFIED TIP”Less trauma both in the vessel and in the inletSilicon Tip
12 Anatomy of a CVC permanent catheter LengthmaterialTesioFixed Cufftip3
13 TUNNEL ANCHORING SYSTEMS MATERIALSTUNNEL ANCHORING SYSTEMSFIXED MOBILEMaterialsSILICONEDACRONMIXED
19 INCLUDED IN THE KIT COMPONENTS: Introducer needle 18 GaX7 cm Guide wire with dispenser 0,98mmX70cmDilator (12 Fr ONLY for double lumen catheter)Injection caps (2 for double and 1 for single lumen)Y Extension line ( ONLY for single lumen)Sterile drapeNot return valveInstruction for use (1 for box)
20 PROMOTION SALES & MKTG 1. KNOWLEDGE OF THIS MARKET ( Ask your customers about it……)2. PRESENTATION TO THE MAIN CUSTOMER(Opinion leader and user)3. USE AND CONFIDETIALITY WITH THIS PRODUCT( present new ideas)
21 Most important questions to make to the customers: N° of patients in dialysisN° of catheters implantedImplant made by:NephrologistIntensive careVascular surgeonOther……………..Kinds of vessel used:Femoral vein %………Jugular vein %………Subclavian vein %………Permanence on site:Short %………..Medium %………..Long %………..Short= 2-4 weeks Medium=4weeks-6 months Long= more than 6 months
22 Most important questions to make to the customers: Materials:Teflon %…………..Polyurethane rigid %…………..Polyurethane flexible %…………..Silicone %…………..Catheter’s model:Straight single lumen %…………..Straight coaxial double lumen %…………..Straight 2D double lumen %…………..Pre-curved single lumen %…………..Pre-curved double lumen %…………..Pre-curved extension single lumen %…………..Pre-curved extension double lumen %…………..
23 Most important questions to make to the customers: Disinfecting Agents:AlcoholIodineAmuchinaEthereWound dressing frequency:DailyAt every dialysis sessionWeeklyOtherUseful instructions written on the package ( P ) and/or on catheter ( C ):Priming Volume P CDiameter P CLength P CProduct code P CDescription P CProduction information P C
24 WITH REGARDS TO PRICE HOW TO APPROACH KNOWLEDGE OF THIS MARKET STANDARD PRODUCT FOR CHEAPER MARKETINNOVATIVE PRODUCT FOR COMPETITIVE MARKETEXCLUSIVE PRODUCT FOR TOP LEVEL MARKET
26 TrombogenicityWhen the catheter is not used, it is filled with heparin solution. The distal level of the solution generally does not pass the first proximal hole.Inside the Catheter "at rest" between the proximal distal hole and the holes the blood tend to recirculate (Venturi effect)Thus on the tip of the catheter there are spaces, not protected by 'anticoagulant, where the risk of thrombosis is higherThe catheter without side holes at the tip is less prone to thrombosis although it is not fully protected against this risk!?3
27 Kind of polyurethane Tecoflex 8 items Tecothane 6 items Carbothane 5 items1st polyurethane was used on the cath production on the 1983These three classes of resins have been well studied for biocompatibility and biostability using standard biological toxicity tests, in addition to long-time plant. The biocompatibility tests were performed using procedures recommended by the Commission for medical devices for blood and tissue contact. The biostability of all resins were evaluated by measurements of physical properties and SEM observations of the materials before and after implantation in living tissue. The materials were examined only after ETO sterilization.
29 CarbothaneFamily of polyurethanes based on aliphatic polycarbonate type available in different hardnesses, colors and opacities. This type of polyurethane resulted in an excellent oxidation stability, properties that can be adapted to a long-term stability. This family is easily processable and will not “turn yellow” over time easily.
30 Carbothane® The Carbothane is a Polyurethane: Extremely smooth surface = less adhesion to the wall;Same softness as silicon;Greater mechanical strength than silicon;High tensile strength and restistance to chemical agents;At the same external diameter we have higher internal diameter. The polyurethane catheter has a smaller wall thickness, giving then an increased flow with same French sizeIl carbothane è facilmente lavorabile e ha grazie alla sua natura ha una maggiore resistenza meccanica rispetto al silicone che consente di avere un maggiore diametro interno a parità di diametro esterno.
31 single lumen with soft extension and clips for curved system Carbothane temporary catheteres, available with the following features:single lumen with soft extension and clips for curved systemdouble lumen with soft extensions, clips for curved system and soft atraumatic tipprecurved double lumen with soft extensions, clips for curved system and smooth atraumautic tipGeometrie presetntazione stato dell’arteLength:8 Fr single lumen : 16, 21, 26 cm11,5 Fr double lumen : 16, 21, 26 cm11,5 Fr precurved double lumen : 21, 26 cm
32 kit containing a single arterial or venous catheter Carbothane permanent catheters with dacron cuff, available with the following features:kit containing a single arterial or venous catheterkit containing both arterial and venous catheterkit containing a single femoral catheterLenght:10 Fr artherial catheter : 19, 22, 27 cm10 Fr venous catheter : 22, 25, 30 cm10 Fr femoral catheter : 45 cmDiapo immagine
33 G ® System is made up by a curved tunneler and its counter-tunneler. CUFF TUNNELER(counter-tunneler)G ® System is made up by a curved tunneler and its counter-tunneler.The curved tunneler allows an easier handling of the tunneling procedures and, when used with the counter-tunneler, permits to enlarge the subcutaneous tunnel enough to perfectly place the dacron cuff: it is not necessary to pull the catheter under the skin in order to create the proper place.CUFF TUNNELER(counter-tunneler)CUFF
34 Completely different from all others internal stylets “ MAC ® ““ MAC ® Stylet“Completely different from all others internal styletsThe Mac ® stylet, placed inside a smooth catheter, allows an easier insertion catheter by making the catheter stiffer.It’s striped surface slides frictionless inside the catheter: the stylet removal, once the catheter inserted, is quick and simple.
37 The new permanent and temporary catheters range, ideal for a high-flux use
38 Carbothane double lumen catheters (not precurved) completely smooth, available with the following features:temporary catheterpermanent catheter with dacron cuffLength:13,5 Fr temporary double lumen catheter : 16, 21, 26 cm13,5 Fr permanent double lumen catheter : 29, 33, 37 cm
39 Priming volume shown on clamps Length shown on canulaDiameter measure displayed (13,5 Fr)Antikinking smooth materialPuntaCone-shaped tip with single hole to the sideMateriali presentazione storicaSmooth fixing wings
40 Reduction of the whip effect, the two flows are independent; Dualys is a permanent catheter with split ends. The body includes two catheters with separate tips. The result? Many advantagesReduction of the whip effect, the two flows are independent;Reduced risk of occlusion;Increased blood flow;Single Introduction and single tunneling.Length:14 Fr Long term double lumen catheter: 15, 25, 30 cm
41 Titanium ring with removable extensions Ends separatedTitanium ring with removable extensionsBody measuring rodEnlightenment with indications of length and volume of primingDacron Anchoring
42 Priming volume on clamps Cannula diameter on Y GEOMETRIESDimensionPriming volume on clampsCannula diameter on YLenght printed along tube
43 Curved system for jugular GEOMETRIESCurved system for jugularBetter confort for the patientCurving the extensions
44 Polyurethane with soft tip GEOMETRIESTip modelPolyurethane with soft tiptipless traumatic action on the vassel
45 Better blood flow Vs pressure GEOMETRIESHoles and sectionVALess “WHIP” effectLess vessel traumaBetter blood flow Vs pressure
46 Soft & flexible Not trauma Less adhesion to vessel wall GEOMETRIESFlexible materialsSoft & flexibleNot traumaLess adhesion to vesselwall
47 FIXED MOBILE Cuff system Tunnell down skin Silicon/polyurethane MATERIALICuff systemTunnell down skinFIXED MOBILESilicon/polyurethaneOnly dacronMix
50 High tensile strength (4000-10000 psi) Therefore in general there are many differences between the medical grade polyurethanes that involve the following chemical, mechanical and biological properties:High tensile strength ( psi)High elongation capacity ( %)Variety of hardness (72-84 degrees shore)Good biocompatibilityHigh abrasion resistanceGood hydrolytic stabilityAbility to Eto and Gamma SterilisationKeep of elastomeric properties at low temperaturesGood mixing for extrusion and injection molding process
51 Tecoflex Tecothane Carbothane Tecophilic Tecoplast Alifatico Aromatico Tecoflex(base polietere)TecothaneCarbothane(base policarbonato)TecophilicTecoplastAliphatic o AromaticAlifaticoAromaticoHarness Shore72A-83D75A-77D73A-75D83A-72D82A-84DRadiopacityBarium sulfate, Salts of Bismuth TungstenBarium sulfate, Salts of TungstenNot ApplicableRange of colorYesLimitedsolvent SolubleNo*Injection and/or mouldingBothOnly injectionExtrusion temperature150°-90°C200°-220°C190°-220°C145°-190°C215°-230°CDegradation and biostabilityGoodAverageExcellentNot determined
52 Tecoflex Polyurethanes family based on aliphatic polyether-type available in different hardnesses, colors and opacities. These resins are easily processed and do not turn yellow easily. They are intended to replace the latex. Caution should be used especially in low degrees of hardness, for long term implan as there is a potential strength of the material under stress .TecothanePolyurethanes family based on aromatic polyether available in different hardnesses, colors and opacities. An interesting aspect is the increased resistance to solvents and Tecoflex biostability when compared to the same hardness. As aromatic polyurethanes tend to yellowing, especially when subjected to radiation.
53 ProprietàTecothaneTecoflexCarbothaneTecophilicYellowingConsiderableNot significantSolvents resistanceExcellentLow hardness polyurethanes are affected to swelling and edoding when exposed to prolonged contact with polar organic solventsMorbidity at body temperatureYesYes only up a certain temperatureMDA FormationPossible if not properly processedNot possibleProcess TemperatureHigh TemperaturesLow TemperaturesLow temperatures