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Arterieller Katheter 1 PakuMed Port Groß GW 5303  PakuMed Umverpackung GW 5932 PakuMedSML01

Arterieller Katheter 1 PakuMed Port Groß GW 5303  PakuMed Umverpackung GW 5932 PakuMedSML01

PRODUKTBESCHREIBUNG

 

Intraarterial Portsystem for Regional Intraarterial Chemotherapy

TITAN-PORT Systems are totally implantable port catheter systems consisting of an injection chamber (port), a screw closure machanism, a self-sealing silicone membrane and a catheter. Each system includes a special access needle, a dilatator, catheter introducer, these instructions for use and a patient ID-card. Some sets contain introduction instruments and tunnelizers.

The portal chamber is made of hypoallergenic biocompatible titanium. This material is MR-conditional (report available) . The base plate has
holes for securing the system to the fascia with sutures.The portal chamber and the catheter can be disconnected.

The silicone membrane can be punctured frequently (up to 3000 times) with a suitable special needle, e.g. the enclosed SFN non-coring access needle. The membrane is highly resistant to pressure and holds the inserted needle reliably in place.

The catheter can be shortened proximally to the individual length required. It bears calibration markings at 5 cm length intervals and is conically tapered at the tip. It has an additional opening at the side (especially to facilitate blood sampling). The arterial catheter has two additional distal fixation rings.

Introduction instruments include a puncture needle, a guide wire, and a dilatator which facilitate introduction of catheters into the blod vessels via Seldinger's technique. The tunnelizer aids in passing the catheter through the subcutaneous tissues.

Only special non-coring portal access needles (e.g. SFN portneedles) should be used to puncture the port membrane. The needles exhibit a unique bevel and angle at the tip. This prevents punch defects of the membrane when the needle is inserted. Different lengths and diameters are available. 22 G or 20 G is recommended for standard use. Each system contains a suitable needle.

The patient ID-card is filled out by the doctor who performed the implantation and is given to the patients who should always carry this document with them. 

The instructions for use should also be available to nurses and doctors responsible for follow-up care.

TITAN-PORT Systems are MR conditional.

MR Symbol

Technical data

 

CompletE sets
Art. No. Port Catheter PZN
  Material Base Height Septum Ø Weight Reservoir Material OD ID Lenght French  
111251 A (arterial) Titanium 21 mm 9,8 mm 8 mm <10g 0,4 ml Polyurethane** 1,7 mm 0,9 mm 700 mm 5,15 01673793

Gebrauchsinformationen

INDICATIONS

The TITAN-PORT Systems ensure repeated access to the vascular system for example for the following indications:

regional intraarterial chemotherapy of hepatic metastases of gastrointestinal neoplasmsregional intraarterial chemotherapy of hepatic metastases of gastrointestinal neoplasmsmalignant primary liver tumors- pancreatic carcinoma- head and neck tumors

TITAN-PORT A (arterial): for direct perfusion of organs, for inoperable hepatic metastases via the gastroduodenal artery, via the coeliac trunk for pancreatic and via the aorta and internal iliac arteries for pelvic neoplasms


CONTRAINDICATIONS
The TITAN-PORT systems should not be used in:

  • extremely rare but possible hypersensitivity to silicone, polyurethane or titanium
  • suspected bacteremia or sepsis
  • disseminated intravascular coagulation (DIC)

COMPLICATIONS and potential ADVERSE REACTIONS
The following complications or adverse reactions can occur:

  • technical intraoperative complications
  • tissue incompatibility
  • local reactions (inflammation, edema, hematoma)
  • infection
  • disconnection or dislocation
  • thrombosis / thromboembolism
  • breakage of the catheter between the clavicle and first rib
  • breakage of catheter or damage to catheter
  • torsion of chamber or catheter
  • perforation of catheter
  • drug extravasation due to improper handling of the system
  • damage to neighboring tissue by the pharmaceutical agents (in the event of leakage of portal components)

Implantation Techniques:

  • Using sterile technique the port chamber is punctured using non-coring SFN.needles
  • The port system is flushed with heparinized physiologic saline solution.
  • Commence chemotherapy by connecting to a perfusor suitable for intraarterialapplications.
  • Upon completion of chemotherapy, remove needle after heparin block. Band-aiddressing.
  • Continuous treatment with thrombocyte aggregation inhibitors (100 mg ofacetylsalicylic acid) to prevent catheter thrombosis
  • an arterial implantation requires flushing with 20 ml 0,9% saline solution once every 2 weeks

Specifics: The port system must be checked with contrast media (port angiography) before everycycle of chemotherapy to exclude extravasation or arterial dissection.

Problems:

  • blood drawing from port not possible
  • danger of septic complications when port system infected (hepatic abscess)
  • possible gastric ulceration if port circulation includes gastric perfusion areas (when necessary vessel ligation or embolization, gastric medications)
  • bile duct/arterial fistula formation
  • in arterial portal systems, by the administration of a platelet aggregation inhibitor (e.g. acetylsalicylic acid).

Further notes: Download Flyer

 

Causes of abnormally high resistance to access needle may include

  • incorrect placement of the access needle in the portal chamber
  • bending and kinking of the catheter
  • fibrin deposition or thrombotic occlusion of catheter or port.

CAUTION: When blood aspiration is not successful, the port should be flushed and the patient's position changed.

Blood deposits in the system generally indicate one of the following causes:

  • leakage of the system
  • defective septum
  • faulty handling

 

 

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