Venous Central Catheter

F.Galli - Fondazione Maugeri Pavia FOCUS POINT: - MATERIAL - SECTION - SURFACE F.Galli - Fondazione Maugeri Pavia 13

F.Galli - Fondazione Maugeri Pavia MATERIAL USED Teflon (PTFE) – Poliethylene PVC Polyurethane ( there are 3 different generations) Silicon F.Galli - Fondazione Maugeri Pavia 12

Material Years Time of placement Kind of cath Teflon/PVC 80’s 3 days – 1 week Short time Polyurethane 1° generation 85’s 1 week-2 weeks Polyurethane termosensible 2° generation 90’s 1 week-3 weeks Silicon 1 week – 2 years Medium long term New generation of polyurethane 3° generation End 90’s 1 week- years

FUTURE “ENRICHED” POLYURETHANE Less adherence of platelets Less adherence of bacteria Higher mechanic adherence

BIOSTABILITY POLYURETHANE MATERIALS BIOSTABILITY POLYURETHANE  IMPROVES Less THROMBOGENICITY PERFORMANCES H2O es:heparin DECREASES PLATELETS ADHERENCE COAGULATION

BIOSTABILITY POLYURETHANE MATERIALS BIOSTABILITY POLYURETHANE  BACTERIOSTATIC ACTION ANTIBACTERIC ACTION i.e. silver antibiotics

IF MATERIAL SURFACE IS ONDULATED INCREASE OF BACTERIA ADHERENCE INCREASE OF THROMBOGENICITY GROWTH OF BACTERIA COLONY

section Side by side “ D “ COAxIALE Single lumen SMILE PERM-CATH COOK-ULDALL TESIO 5

SECTIONS AND SIDE HOLES GEOMETRY GEOMETRIES SECTIONS AND SIDE HOLES GEOMETRY DOUBLE D SECTION HAS: LITTLE “WHIP” EFFECT BUT LESS TRAUMATIC EFFECT FOR THE VESSEL VS. COAXIAL CONFIGURATION V A DOUBLE D COAXIAL

POLYURETHANE “ MODIFIED TIP” GEOMETRIES The shape of the tip Tip POLYURETHANE “ MODIFIED TIP” Less trauma both in the vessel and in the inlet Silicon Tip

Anatomy of a CVC permanent catheter Length material Tesio Fixed Cuff tip 3

TUNNEL ANCHORING SYSTEMS MATERIALS TUNNEL ANCHORING SYSTEMS FIXED MOBILE Materials SILICONE DACRON MIXED

4 1 5 2 3 “Uldall” Cook “Tesio” Medcomp “Permanent” Kimal Permanent “Permcath” Quinton Permanent GamCath “Uldall” Cook “Permanent” Kimal 4

PORT NEW SYSTEMS BIOLINK VASCA LIFE

OUR CHOICE LAST GENERATION OF POLYURETHANE SMOOTH SURFACE GOOD PORE SIZE QUALITY

DOUBLE LUMEN CATH GOOD QUALITY OF THE CENTRAL SECTION FLEXIBLE EXTENSION ( PRECURVABLE) NON-TRAUMATIC TIP GOOD PORE SIZE QUALITY PRIMING VOLUME ON THE CLAMPS SCALE OF LENGHT ON THE CATHETER

INCLUDED IN THE KIT COMPONENTS: Introducer needle 18 GaX7 cm Guide wire with dispenser 0,98mmX70cm Dilator (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 drape Not return valve Instruction for use (1 for box)

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)

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 Volume P C Diameter P C Length P C Product code P C Description P C Production information P C

WITH REGARDS TO PRICE HOW TO APPROACH KNOWLEDGE OF THIS MARKET STANDARD PRODUCT FOR CHEAPER MARKET INNOVATIVE PRODUCT FOR COMPETITIVE MARKET EXCLUSIVE PRODUCT FOR TOP LEVEL MARKET

Infection sources skin vein Hands saline Endogenous Infections catetere Fibrin sleeve by cutaneous Thrombus Lumen saline Hands contaminated disinfectant Microflora Endogenous Infections Blood 4

Trombogenicity 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!? 3

Kind of polyurethane Tecoflex 8 items Tecothane 6 items Carbothane 5 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.

Classification of polyurethane HMDI HydrogenatedMethylene Diisocyanates MDI MetilDianilina methylene diisocyanates Tecoflex (based on polyethere) Carbothane (based on polycarbonate) Tecothane (based on polyethere) Aromatic Aliphatic © pmghezzi 2004

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 Il 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.

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 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 Geometrie presetntazione stato dell’arte 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

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 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 Diapo immagine

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

Completely different from all others internal stylets “ MAC ® “ “ MAC ® Stylet“ Completely different from all others internal stylets 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 CVC MAC® Plain stylet Striped MAC® stylet

“ MAC ® “

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 Diameter measure displayed (13,5 Fr) Antikinking smooth material Punta Cone-shaped tip with single hole to the side Materiali presentazione storica Smooth fixing wings

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 advantages Reduction 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

Titanium ring with removable extensions Ends separated Titanium ring with removable extensions Body measuring rod Enlightenment with indications of length and volume of priming Dacron Anchoring

Priming volume on clamps Cannula diameter on Y GEOMETRIES Dimension Priming volume on clamps Cannula diameter on Y Lenght printed along tube

Curved system for jugular GEOMETRIES Curved system for jugular Better confort for the patient Curving the extensions

Polyurethane with soft tip GEOMETRIES Tip model Polyurethane with soft tip tip less traumatic action on the vassel

Better blood flow Vs pressure GEOMETRIES Holes and section V A Less “WHIP” effect Less vessel trauma Better blood flow Vs pressure

 Soft & flexible Not trauma Less adhesion to vessel wall GEOMETRIES Flexible materials  Soft & flexible Not trauma Less adhesion to vessel wall

FIXED MOBILE Cuff system Tunnell down skin Silicon/polyurethane MATERIALI Cuff system Tunnell down skin FIXED MOBILE Silicon/polyurethane Only dacron Mix

GEOMETRIE Ancillaries 1 2 3

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 (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

Tecoflex Tecothane Carbothane Tecophilic Tecoplast Alifatico Aromatico     Tecoflex (base polietere) Tecothane Carbothane (base policarbonato) Tecophilic Tecoplast Aliphatic o Aromatic Alifatico Aromatico Harness Shore 72A-83D 75A-77D 73A-75D 83A-72D 82A-84D Radiopacity Barium sulfate, Salts of Bismuth Tungsten Barium sulfate, Salts of Tungsten Not Applicable Range of color Yes Limited solvent Soluble No* Injection and/or moulding Both Only injection Extrusion temperature 150°-90°C 200°-220°C 190°-220°C 145°-190°C 215°-230°C Degradation and biostability Good Average Excellent Not 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.

Proprietà Tecothane Tecoflex Carbothane Tecophilic Yellowing Considerable Not significant Solvents resistance Excellent Low hardness polyurethanes are affected to swelling and edoding when exposed to prolonged contact with polar organic solvents Morbidity at body temperature Yes Yes only up a certain temperature MDA Formation Possible if not properly processed Not possible Process Temperature High Temperatures Low Temperatures Low temperatures

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