TITAN-PORT APH (extracorporeale apheresis) is a fully implantable port catheter system providing an access facility for performing extracorporeal apheresis. The set contains a titanium port chamber with a self-sealing silicone membrane and a single-lumen polyurethane catheter for connection to the port chamber and fixing to the outlet tube with a screw. Each system also includes a special puncture needle SFN 1835 B, an introducer set, a tunnelizer, a vein lifter, a rinsing needle, a port cannulae SFN 0930 G, user instructions and patient ID card.

The port chamber is made of hypoallergenic, biocompatible titanium. The material is non-magnetic. The chamber dimensions are: width 20.6 mm, height 16.7 mm, length 25.5 mm, weight ca. 15 g, priming volume 1.4 ml. The base plate has suture openings for securing the system to the fascia. Port chamber and catheter can be disconnected and are connected via a screw with the outlet tube.

The silicone membrane in the port (118 mm2 puncture area) can be punctured frequently with a suitable non-coring puncture needle. The membrane is highly resistant to pressure and holds the inserted needle reliably in place.

The single-lumen polyurethane catheter 10 F, with an outer diameter 3.35 mm, an inner diameter 2.0 mm, total length 70 cm and internal volume of 0.31 mL per 10 cm, has at the distal end a special catheter tip (fishmouth tip) and if necessary the catheter can be shortened at the proximal end. After implantation, the distal tip reduces adsorption at the vessel wall, thereby also improving the flow rate. The catheter is marked, every centimeter, with length marker until 40 cm (lines means 1 cm, points means 5 cm) and radiopaque.

Only the special puncture needles for dialysis ports provided must be used for puncturing the membranes.

Depending on indication and flow rate different special puncture needles can be used. These may be the DPK 2035, SFN 1835 B and SFN 1535 B as well as the smaller SFN® port needles in various sizes, e. g. SFN 0930 G. The needles exhibit a unique bevel and angle at the tip. This prevents punch defects at the membrane when the needle is inserted. Each system contains a suitable needle. Appropriate accessories can be ordered separately if
required.
The gravity flow rate is 175 mL/min if punctured with DPK 2035. The flow rate depends on the kind of use, the equipment used and the applied cannulae.

The patient ID card is filled out by the physician who performs the implantation, and is handed to the patients who should always carry this document with them.
These instructions for use should also be available to nurses and doctors for follow-up care.

TITAN-PORTcatheter systems are MR-conditioned-safe. On request, we will be happy to provide you with further information.

INDICATIONS

• long-term, high-volume venous access to central vascular system
• apheresis

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CONTRAINDICATIONENS
TITAN-PORT APH systems are contraindicated in:

• patients with very rare but possible intolerance to titanium or silicone
• suspected bacteremia / sepsis
• disseminated intravascular coagulation (DIC)

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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
• internal damage of the cardiac wall

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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.

Possible implantation sites are the V. jugularis interna, externa or subclavia with alternative locations also possible. Implantation can be performed in local anesthesia.
The following represents an example of the possible / standard surgical implantation technique. Other surgical procedures, alternatives are possible. Postoperative X-Ray control is indispensable.

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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 subclavicular incision to the supraclavicular incision via the subcutaneous tunnel.
7. Small phlebotomy (caution air embolism!). Insert catheter tip into the right atrium.(positional check by intraatrial ECG tracing or by x-ray fluoroscopy)
8. Purse-string suture at the phlebotomy.
9. Length of catheter can be shortened as required
10. Connect catheter end to the port.
11. Slide the catheter end onto the port outlet tube and secure with the screw
12. Position the port chamber subcutaneously as far as possible from the cutaneous incision, and secure if necessary.
13. Cutaneous suture

Alternative: Seldinger technique
The system could be used immediately, but recommended after complete healing of wound (approx. one week).

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CARE OF THE SYSTEM/SPECIAL APPLICATION NOTE

• 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.

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USER INSTRUCTIONS

1. Skin disinfection, sterile gloves, mask (patient and operator)
2. Trendelenburg position
3. Puncture the port membrane only with a special puncture needle (supplied) until the tip of the needle touches the bottom plate, caution air embolism!
4. Unblocking the system
5. Check for occlusion with saline solution and connect up the apheresis system.
6. At the end of apheresis, flushing the system with NaCl 0.9 %
7. block the system with e.g. heparin, taurolidine-citrat 4% or citrate 30%*
8. Remove the puncture needle using gentle positive pressure
9. Disinfect the skin; apply dry dressing

Caution:

• Puncture the port chamber only with the special puncture needles provided!
• 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 in small solution amounts at intervals) *. Allow time for resolution and check for occlusion

Potential reasons for insufficient or failing flow rate:

• Incorrect placement of the tip of the needle in the portal cavity
• Fibrin deposits or a thrombotic occlusion of catheter or port
• Catheter was twisted or bent
• Position of catheter not correctly in right atrium
• If blood aspiration is unsuccessful, first flush the port chamber and then change the position of the patient slightly

^{* The stated concentrations and the complete procedure 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 apheresis The port systems provide only an access route and have no influence on the function itself.}

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INDICATIONS FOR EXPLANTATION

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

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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. When there are no complications, a puncture frequency of up to approx. 1000 punctures (DPK 1835) - 500 punctures with DPK 2035 using a special needle allows a corresponding implantation time. It is possible to exchange the port chamber in the event of silicone membrane leakage also under local anesthesia.

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PRECAUTIONS

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

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

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MONITORING

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

The system may 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.

Special puncture needles are mandatory.

e.g.
DPK 1835 (PZN 05108104)
DPK 2035 (PZN 02429581)
SFN 1535 G (PZN 10216563)
SFN 1320 S (PZN 07746257)

Unit: 25 pcs/package
Please pay attention to the separate instructions for use!

Product description Port Needles

Puncture of portchamber only with special port needles is mandatory!

1. Needle with mandrin and needle free adapter for puncture of implanted dialysis portsystems or peritoneal portsystems- if a sufficient inner diameter is required for necessary flow. Non coring due to a special tip and mandrin

2. Special non coring puncture needle with side hole

Art. No.	Cannulas								PZN
	Ø	Lenght	Gauge	Volume	Flow	Puncture frequency	Unit	Extras
SFN 1320 S	1,3 mm	20 mm	18	0,31 ml	72 ml/min	~ 3000	25 pcs	curved, with tubing and clamp/Luer Lock	07746257
SFN 1325 S	1,3 mm	25 mm	18	0,31 ml	72 ml/min	~ 3000	25 pcs	curved, with tubing and clamp/Luer Lock	11094033
SFN 1535 B	1,5 mm	35 mm	17	0,5 ml	while hemodialysis 200 ml/min, in gravity 150 ml/min	~ 1500	25 pcs	straight, with Luer Lock-Adapter, with tubing	12363624
SFN 1835 B	1,8 mm	35 mm	15	0,5 ml	while hemodialysis 300 ml/min, in gravity 225 ml/min	~ 1000	25 pcs	straight, with Luer Lock-Adapter, with tubing	12363630
DPK 2035	2,0 mm	35 mm	14	0,3 ml	while hemodialysis 500 ml/min, in gravity 300 ml/min	~ 500	25 pcs	with mandarin + needle free adapter	02429581

   

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Recommendation to frequent questions according use of portsystems for
APHERESIS (e.g. Portsystem code no. 111255 Dor 111260 APH):

• The portcathetersystem can be implanted with Seldinger technique via V. Jugluaris interna, externa or subclavia into the right atrium (length of catheter can be shortened as required)
• The system could be used immediately, but recommend after complete healing of wound (approx.
  one week)
• Use only with sterile gloves, mask (patient and operator), sterile coverage
• Before each use the block liquid must be extracted
• After each application the system must be flushed with 30 ml saline 0,9%, the needle should be withdrawn under positive pressure
• Afterwards filling with a blocking solution
  • for portchamber 0,6 ml
  • for catheter for each 10 cm 0,5 ml
  • for needles 1,0 ml (DPK 1835) or 0,27 ml (DPK 2035)

Recommended as blocking solution: e.g. Citrat 30%, Taurolodin·Citrat 4%, Heparin
(Dilutions of heparine are not reasonable due to short half life time)

• In permanent problems of flow lysis of the complete portsystem might be necessary (previously xray
  control recommended)
• Special non coring portneedles for punct ure are mandatory
  such as DPK 1835, DPK 2035, SFN 1535 G, SFN 1320 S 
• In periods of long intervals or at end of treatment the system should be flushed with saline 0,9%
  and blocked as mentioned
• In special risk of thrombosis particular prophylaxis is recommended

Potential reasons for insufficient or failing flow rate

• Position of needle not correctly in portchamber -> needle must be advanced up to the base
  
• Suspected thrombosis? -> Lysis necessary
• Catheter was twisted or bent during implantation -> correction necessary
• Position of catheter not correctly in right atrium -> revision and replacement of catheter

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