MATERIAL USED Teflon (PTFE) – Poliethylene PVC Polyurethane ( there are 3 different generations) Silicon F.Galli - Fondazione Maugeri Pavia
MaterialYearsTime of placement Kind of cath Teflon/PVC80’s3 days – 1 week Short time Polyurethane 1° generation 85’s1 week-2 weeks Short time Polyurethane termosensible 2° generation 90’s1 week-3 weeks Short time Silicon90’s1 week – 2 years Medium long term New generation of polyurethane 3° generation End 90’s 1 week- years Medium long term
FUTURE “ENRICHED” POLYURETHANE Less adherence of platelets Less adherence of bacteria Higher mechanic adherence
COMPONENTS: u Introducer needle 18 GaX7 cm u Guide wire with dispenser 0,98mmX70cm u Dilator (12 Fr ONLY for double lumen catheter) u Injection caps (2 for double and 1 for single lumen) u Y Extension line ( ONLY for single lumen) u Sterile drape u Not return valve u Instruction for use (1 for box) INCLUDED IN THE KIT
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) PROMOTION SALES & MKTG
Most important questions to make to the customers: N° of patients in dialysis N° of catheters implanted Implant made by: Nephrologist Intensive care Vascular surgeon Other…………….. 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
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%…………..
Most important questions to make to the customers: Disinfecting Agents: Alcohol Iodine Amuchina Ethere Wound dressing frequency: Daily At every dialysis session Weekly Other Useful instructions written on the package ( P ) and/or on catheter ( C ): Priming VolumePC DiameterPC LengthPC Product codePC DescriptionPC Production informationPC
KNOWLEDGE OF THIS MARKET STANDARD PRODUCT FOR CHEAPER MARKET INNOVATIVE PRODUCT FOR COMPETITIVE MARKET EXCLUSIVE PRODUCT FOR TOP LEVEL MARKET WITH REGARDS TO PRICE HOW TO APPROACH
When 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 higher The catheter without side holes at the tip is less prone to thrombosis..... although it is not fully protected against this risk!? Trombogenicity
Kind of polyurethane –Tecoflex8 items –Tecothane6 items –Carbothane5 items 1st polyurethane was used on the cath production on the 1983 These 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.
Carbothane Family 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.
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 size
Carbothane temporary catheteres, available with the following features: single lumen with soft extension and clips for curved system double lumen with soft extensions, clips for curved system and soft atraumatic tip precurved double lumen with soft extensions, clips for curved system and smooth atraumautic tip Length: 8 Fr single lumen : 16, 21, 26 cm 11,5 Fr double lumen : 16, 21, 26 cm 11,5 Fr precurved double lumen : 21, 26 cm
Carbothane permanent catheters with dacron cuff, available with the following features: kit containing a single arterial or venous catheter kit containing both arterial and venous catheter kit containing a single femoral catheter Lenght: 10 Fr artherial catheter : 19, 22, 27 cm 10 Fr venous catheter : 22, 25, 30 cm 10 Fr femoral catheter : 45 cm
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. G ® SYSTEM CUFF TUNNELER (counter-tunneler) CUFF CUFF TUNNELER (counter-tunneler) CURVED TUNNELER
“ MAC ® Stylet“ Completely different from all others internal stylets “ MAC ® “ The 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.
CVC Metallic guidewire MAC ® Plain stylet Striped MAC ® stylet
The new permanent and temporary catheters range, ideal for a high-flux use
Carbothane double lumen catheters (not precurved) completely smooth, available with the following features: temporary catheter permanent catheter with dacron cuff Length: 13,5 Fr temporary double lumen catheter : 16, 21, 26 cm 13,5 Fr permanent double lumen catheter : 29, 33, 37 cm
Priming volume shown on clamps Length shown on canula Smooth fixing wings Diameter measure displayed (13,5 Fr) Punta Cone-shaped tip with single hole to the side Antikinking smooth material
Dualys is a permanent catheter with split ends. The body includes two catheters with separate tips. The result? Many advantages 1.Reduction of the whip effect, the two flows are independent; 2.Reduced risk of occlusion; 3.Increased blood flow; 4. Single Introduction and single tunneling. Length: 14 Fr Long term double lumen catheter: 15, 25, 30 cm
Ends separated Titanium ring with removable extensions Body measuring rod Dacron Anchoring Enlightenment with indications of length and volume of priming
GEOMETRIES Dimension Priming volume on clamps Cannula diameter on Y Lenght printed along tube
GEOMETRIES Curved system for jugular Better confort for the patient Curving the extensions
GEOMETRIES Tip model Polyurethane with soft tip tip less traumatic action on the vassel
GEOMETRIES Holes and section V AV Less “WHIP” effect Less vessel trauma Better blood flow Vs pressure
GEOMETRIES Flexible materials Soft & flexible Not trauma Less adhesion to vessel wall
Cuff system FIXED MOBILE MATERIALI Silicon/polyurethane Only dacron Mix Tunnell down skin
High tensile strength (4000-10000 psi) High elongation capacity (250-700%) Variety of hardness (72-84 degrees shore) Good biocompatibility High abrasion resistance Good hydrolytic stability Ability to Eto and Gamma Sterilisation Keep of elastomeric properties at low temperatures Good mixing for extrusion and injection molding process Therefore in general there are many differences between the medical grade polyurethanes that involve the following chemical, mechanical and biological properties:
Tecoflex (base polietere) Tecothane (base polietere) Carbothane (base policarbonato) Tecophilic (base polietere) Tecoplast (base polietere) Aliphatic o Aromatic AlifaticoAromaticoAlifatico Harness Shore 72A-83D75A-77D73A-75D83A-72D82A-84D RadiopacityBarium sulfate, Salts of Bismuth Tungsten Barium sulfate, Salts of Tungsten Barium sulfate, Salts of Bismuth Tungsten Not Applicable Range of color Yes LimitedYes solvent Soluble YesNo* YesNo* Injection and/or moulding Both Only injection Extrusion temperature 150°-90°C200°-220°C190°-220°C145°-190°C215°-230°C Degradation and biostability GoodAverageExcellentNot determined
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. Tecothane Polyurethanes 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.
Propriet à TecothaneTecoflexCarbothaneTecophilic YellowingConsiderableNot significant Solvents resistance ExcellentLow hardness polyurethanes are affected to swelling and edoding when exposed to prolonged contact with polar organic solvents Morbidity at body temperature YesYes only up a certain temperature Yes MDA Formation Possible if not properly processed Not possible Process Temperature High Temperatures Low Temperatures Low temperatures