INDICATIONS

The TITAN-PORT D allows repeated vascular access for veno-venous dialysis in dialysis-dependent kidney failure

• either primary
• or as an alternative to failed long-term access such as e.g. Cimino shunts, Sheldon catheters, Gortex catheters etc.
• On each occasion before treatment, ensure the correct position of the port chamber by palpation and check that there is no wound or infection present.

KONTRAINDIKATION

TITAN-PORT D Systeme dürfen nicht eingesetzt werden bei:

• einer sehr seltenen aber möglichen Unverträglichkeit von Titan, Polyurethan oder Silikon
• Verdacht auf Bakteriämie / Sepsis
• Disseminierter intravasaler Gerinnung (DIC)

COMPLICATIONS and possible side effects

The following are examples of general complications and possible side effects:

• surgical complications
• implant intolerance
• localized erythema / edema / hematoma
• infections
• disconnection and dislocation
• thrombosis / embolism
• membrane and catheter luxation
• paravascular deposits due to improper handling
• damage to surrounding tissue
• leakage from chamber, septum or connection sites
• Air embolism
• Cardiac arrhythmia

APPLICATION NOTES: PORT IMPLANTATION

Warning: It is essential to ensure aseptic conditions during implantation!
Selection, decision-making and technique are the responsibility of the physician performing implantation.
Implantation is normally performed under insufflation anesthesia.
The internal jugular vein is the typical site for implantation with alternative locations also possible.
The following represents an example of the possible or standard surgical implantation technique.

PREPARATION

• Before implantation, fill the catheter with 0.9% saline solution and use enclosed clamp for closure.
• Also fill and vent the port chamber while holding the outlet tube of the port upwards, so that the remaining air can escape. For this purpose, use the puncture needle provided

1. Expose the internal jugular vein
   (supraclavicular incision)
2. Apply distal and proximal loop ligatures
3. Subclavicular incision
4. Subcutaneous tunnel between the two incisions
5. Subcutaneous preparation of a recess
6. Move the catheter tip from the sub-clavicular incision to the supraclavicular incision via the subcutaneous tunnel.
7. Small phlebotomy (caution air embolism!). Insert catheter tip 15-20 cm up to the superior vena cava or atrium (positional check by intraatrial ECG tracing or by x-ray fluoroscopy)
8. Pursestring suture at the phlebotomy.
9. Connect catheter end to the port.
10. Slide the catheter end onto the port outlet tube and secure by squeezing the cuff.
11. Position the port chamber subcutaneously as far as possible from the cutaneous incision, and secure if necessary.
12. Cutaneous suture
13. With optimum implantation, the system can be used immediately.

CARE OF THE SYSTEM / SPECIAL APPLICATION NOTES

- On each occasion before treatment, ensure the correct position of the port chamber by palpation and check that there is no wound or infection present.

USER INSTRUCTIONS

• Skin disinfection
• Trendelenburg position
• Puncture the port septum with a special puncture needle with a mandrin (supplied)
• Check for occlusion with saline solution and connect up the dialysis system.
• At the end of dialysis, fill the port chambers with saline solution (or with heparin, tauroline or citrate respectively)
• Remove the puncture needle using gentle positive pressure
• Disinfect the skin; apply dry dressing

Caution:

• Puncture the port chambers only with the special puncture needles provided (flow rate approx. 300 ml/ min)
• Always insert the needle into the silicone membrane carefully and per-pendicular to the base plate with the mandrin accurately positioned.
• Catheter or port thrombotic occlusions can generally be resolved with fibrinolytic agents such as streptokinase / urokinase (e.g. inject 5000 IE/ml 0.9% saline solution and small solution amounts at intervals). Allow time for resolution and check for occlusion.

Causes for abnormally high puncture resistance can include:

• Incorrect placement of the tip of the needle in the portal cavity
• Fibrin deposits or a thrombotic occlusion of catheter or port
• Kinked catheter
• If blood aspiration is unsuccessful, first flush the port chamber and then change the position of the patient slightly.

(The stated concentrations are recommendations and must always be adapted to individual patient requirements and are the responsibility of the therapist. Medication and solutions employed are basically subject to the directions provided by the pharmaceutical manufacturers. Attention must be given to the specific requirements of the dialysis. The port systems provide only an access route for veno-venous dialysis and have no influence on the function itself).

INDICATIONS FOR EXPLANTATION

• When dialysis no longer necessary
• Irreversible occlusion of the system
• Membrane or catheter leaks
• Thrombosis (v. jugularis, v. subclavia, v. cava)
• Infection

WARNING NOTES

• Secure the port in the subcutaneous tissue with single sutures or place it in the smallest possible subcutaneous recess to prevent migration.
• Secure the catheter to the vein with an adequately tight but not strangulating suture
• Ensure that the catheter is firmly connected to the port chamber

After a lengthy implantation period or system use, check the membrane for leakage resulting from frequent punctures.
Where there are no complications, a puncture frequency of up to approx. 1000 punctures using a special needle allows a corresponding implantation time depending on the frequency of dialysis.

PRECAUTIONS

Meticulous hygiene and sterile handling technique are mandatory for this system, e.g.

• Implantation under sterile surgical conditions
• Disinfect hands and skin
• Only sterile products to be used

MONITORING

Regular usage followed by system care and maintenance provide continuous monitoring.

The system should not be used by physicians / medical staff who are not familiar with the product and/or possible complications. These can occur at any time during or after the intervention.

Prior to use, the packaged product should be stored in dry conditions as far as possible at temperatures of 5° - 35° C and should be protected from direct sunlight.
Do not use products from damaged packaging.