1. Venous Central Catheter

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

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

4. 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

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

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

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

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

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

10. 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

11. 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

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

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

14. 4 1 5 2 3 “Uldall” Cook “Tesio” Medcomp “Permanent” Kimal Permanent
“Permcath”
Quinton
Permanent
GamCath
“Uldall”
Cook
“Permanent”
Kimal 4

15. PORT NEW SYSTEMS
BIOLINK VASCA LIFE

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

17. 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

19. 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)

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 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

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:
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

24. 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

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

26. 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

27. 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.

28. 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

29. 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.

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 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.

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 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

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 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

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 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.

35. CVC
Metallic guidewire
CVC
MAC®
Plain stylet
Striped MAC® stylet

36. “ MAC ® “

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 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

39. 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

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 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

41. 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

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

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

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

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

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

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

48. GEOMETRIE
Ancillaries 1 2 3

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 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

51. 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

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 .
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.

53. 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

54. Thanks !