venous central catheter f.galli - fondazione maugeri pavia focus point: - material - section -...
TRANSCRIPT
Venous Central Catheter
F.Galli - Fondazione Maugeri Pavia
FOCUS POINT:
- MATERIAL
- SECTION
- SURFACE
MATERIAL USED
Teflon (PTFE) –
Poliethylene
PVC
Polyurethane ( there are 3 different generations)
Silicon
F.Galli - Fondazione Maugeri Pavia
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
Short time
Polyurethane termosensible 2° generation
90’s 1 week-3 weeks
Short time
Silicon 90’s 1 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
BIOSTABILITY POLYURETHANE
• IMPROVES Less THROMBOGENICITY
PERFORMANCES
MATERIALS
• DECREASES
PLATELETS ADHERENCE
COAGULATION
H2OH2O H2O
es:heparin
BIOSTABILITY POLYURETHANE
• BACTERIOSTATIC
ACTION
• ANTIBACTERIC ACTION
i.e. silverantibiotics
MATERIALS
IF MATERIAL SURFACEIS ONDULATED
• INCREASE OF BACTERIA ADHERENCE
• INCREASE OF THROMBOGENICITY• GROWTH OF BACTERIA COLONY
Single lumen Side by side “ D “ COAxIALESMILE
PERM-CATH COOK-ULDALL TESIO
section
DOUBLE D SECTION HAS:• LITTLE “WHIP” EFFECT BUT LESS TRAUMATIC EFFECT FOR THE
VESSEL VS. COAXIAL CONFIGURATION
V AAA
V
DOUBLE D COAXIAL
GEOMETRIES
SECTIONS AND SIDE HOLES GEOMETRY
POLYURETHANE “ MODIFIED TIP”
• Less trauma both in the vessel and in the inlet
Silicon Tip
GEOMETRIES
Tip
The shape of the tip
Lengthmaterial
Tesio
Anatomy of a CVC permanent catheter
tip
Fixed Cuff
F.Galli - Fondazione Maugeri Pavia
TUNNELANCHORING SYSTEMS
FIXED MOBILEMaterials
• SILICONE• DACRON• MIXED
MATERIALS
4
5
1
2 3
“Tesio”Medcomp
“Permcath”Quinton
PermanentGamCath
1
2
3
“Uldall”Cook
“Permanent”Kimal
4
5
F.Galli - Fondazione Maugeri Pavia
PORT NEW SYSTEMSBIOLINK VASCA LIFE
• 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
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)
INCLUDED IN THE KIT
• 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.
HMDI Hydrogenated
Methylene Diisocyanates
Tecoflex (based on polyethere)Carbothane (based on polycarbonate)
Tecothane (based on polyethere)
MDI MetilDianilina methylene
diisocyanates
Aromatic Aliphatic© pmghezzi 2004
Classification of polyurethane
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
C A T H E T E R A D V A N C E D T E C H N O L O G Y
em nCarbothane 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
CVC
Metallic guidewire
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
Smooth fixing wings
Diameter measure displayed (13,5 Fr)
PuntaCone-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
GEOMETRIE
Ancillaries
1
2
3
• 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
Alifatico Aromatico Alifatico Alifatico Alifatico
Harness Shore 72A-83D 75A-77D 73A-75D 83A-72D 82A-84D
Radiopacity Barium sulfate,Salts of Bismuth Tungsten
Barium sulfate,Salts of Tungsten
Barium sulfate,Salts of Tungsten
Barium sulfate,Salts of Bismuth Tungsten
Not Applicable
Range of color Yes Yes Yes Limited Yes
solvent Soluble Yes No* No* Yes No*
Injection and/or moulding
Both Both Both 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
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 Not significant Not significant
Solvents resistance
Excellent Low hardness polyurethanes are affected to swelling and edoding when exposed to prolonged contact with polar organic solvents
Low hardness polyurethanes are affected to swelling and edoding when exposed to prolonged contact with polar organic solvents
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
Yes Yes
MDA Formation
Possible if not properly processed
Not possible Not possible Not possible
Process Temperature
High Temperatures
Low Temperatures
Low Temperatures
Low temperatures
Thanks !