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TITAN-PORTS PC (PERITONEAL CHEMOTHERAPY)

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TITAN PORTS PC (Peritoneal Chemotherapy) is a fully implantable, titanium PORT system providing an access facility for performing peritoneal chemotherapy. The set contains a port chamber with a self-sealing silicone membrane, and a single-lumen polyurethane catheter with a cuff for connection to the port chamber and for fixing the catheter to the outlet tube. Above all, each system also includes a special puncture needle, user instructions and patient ID documentation.

Titan ports PC (peritoneal chemotherapy) is a fully implantable, titanium PORT system providing an access facility for performing peritoneal chemotherapy. The set contains a port chamber with a self-sealing silicone membrane and a single-lumen polyurethane catheter with a cuff for connection to the port chamber and for fixing the catheter to the outlet tube. Each system also includes a special puncture needle, user instructions and patient ID documentation.

Port Chamber

The port chamber consists of hypoallergenic, biocompatible titanium. Also, this material is non-magnetic.
The chamber dimensions are: bottom diameter 30 mm, top diameter 21 mm, height 16 mm, weight 30 g and an outlet tube of 3.5 mm diameter in the lower part. The base plate has 3 suture openings for securing the system to the fascia. Port chamber and catheter can be disconnected and are interconnected via a squeezing mechanism with a catheter cuff via the outlet tube.

Silicone Membrane

The silicone membrane in the port (18mm diameter, height 8mm) can be punctured (up to 1000 times) with a suitable non-coring puncture needle. However, the membrane possesses high pressure stability and holds the needle securely in position.

The polyurethane catheter 13.5 F, 2.3 x 4.7 mm has 16 lateral holes at the distal end, a round tip, an overall length of 55cm, and if necessary can also be shortened at the proximal (unperforated) end and must connect  via a cuff to the outlet tube of the port chamber (see illustration).

Only the special puncture needles provided must be used for puncturing the membrane (small lumen special port needles can also be used depending on indication and flow rate e.g. various size SFN port needles). However, in order to achieve high flow rates, appropriately large lumen needles are required (e.g. DPK 1630 or DPK 1625 with external diameter 1.6 mm, internal diameter 1.4 mm). These are provided with an internal mandrin, and are specially bevelled to prevent fragmentation of silicone particles and puncture defects of the membrane. Each system includes an appropriate cannula. These are available separately for further applications.

The patient ID documentation included is filled out fully by the physician who performed the implantation, and is handed to the patient who should always carry this document with him.

These user instructions should also be available to nursing staff and physicians responsible for further care.

The contents of the set are stated on the label of the double sterile blister packaging.

TITAN PORTS PC (PERITONEAL-CHEMOTHERAPY + PERITONEAL-THERAPY)

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INTRODUCER SETS

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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

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INDICATIONS

The TITAN PORTS PC allows repeated access to the peritoneal cavity as necessary while minimizing the justifiably feared rate of infection with external peritoneal catheters.
The main indication is intraabdominal chemotherapy. The advantage is the direct administration of a high concentration of the applied substances with a low risk of infection, simplified access and considerably improved quality of life for the patient as provided by the closed system.


CONTRAINDICATIONS

TITAN PORTS PC systems are contraindicated in:

  • patients with very rare but possible intolerance to titanium, polyurethane or silicone
  • suspected bacteremia / sepsis
  • disseminated intravascular coagulation (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
  • membrane and catheter luxation
  • paravascular deposits due to improper handling
  • damage to surrounding tissue
  • leakage from chamber, septum or connection sites
  • injuries to abdominal organs

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.
Possible implantation sites are the right or left abdominal wall according to the preferred puncture procedure (particularly with self-puncture).
Implantation is performed similar to that used with the Tenckhoff catheter. Various implantation techniques can be employed.

After successful placing of the catheter in the abdominal cavity, it is particularly important to provide a water-tight pursestring suture at the entry point of the catheter into the peritoneum!

Tunneling to the port in a port recess in the abdominal wall.
Shorten the catheter as required and secure it close to the skin with the cuff by squeezing at the port
Cutaneous sutures
With optimum implantation, the system can be used after approx. 3 days if the peritoneum is tightly closed at the catheter entrance.


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, sterile gloves
  • Use only the special port needles which are suitable for puncture.
  • For example puncture the port septum with special puncture needle with mandrin (as provided) (until the tip of the needle touches the base plate)
  • Remove the mandrin, test for occlusion with saline solution and check in particular for paravascular deposits.
  • At the end of treatment, gently withdraw the puncture needle (exerting opposite pressure at the port).
  • Disinfect the skin; apply dry dressing
Caution:
  • When using the relevant special puncture needle with mandrin (flow rate approx. 2000 ml in 12 min), always insert the needle gently and perpendicular to the base plate along with accurate positioning of the mandrin in the silicone membrane.
Causes for abnormally high puncture resistance can include:
  • Incorrect placement of the tip of the needle in the portal cavity
  • Fibrin deposits blocking catheter or port.
(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 peritoneal dialysis. The port systems provide only an access route for peritoneal dialysis and have no influence on the function itself).