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 !