Tel./Phone:  +49 201 43 70 97 0

GW PakuMed 97 98 PakuMed 084 GW PakuMed DPK2035 GW 5240 PakuMed Drainage 

GW PakuMed 97 98 PakuMed 084 GW PakuMed DPK2035 GW 5240 PakuMed Drainage 

Product description

Titan-Port DR (Drainage)  is a totally implantable, titanium PORT system providing an access facility to the pleura cavity. The set contains a port chamber with a self-sealing silicone membrane, a single-lumen polyurethane catheter and a screw for fixing the catheter to the outlet tube. Each system also includes a port cannulae, a special puncture needle SFN 1835 B, introducer set, a tunnelizer, a rinsing needle, user instructions and patient ID-card.

The port chamber is made of hypoallergenic, biocompatible titanium. This material is non-magnetic. The chamber dimensions are: width 20.6 mm, height 16.7 mm, length 25.5 mm, weight approx. 15 g priming volume 1.4 ml. The base 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 3.4 mm, an inner diameter 2.0 mm, total length 72 cm and internal volume of 0.31 mL per 10 cm, has at the distal end a fishmouth tip and ten sideholes. If necessary the catheter can be shortened at the proximal end. The catheter is marked, every centimeter, with length marker until 40 cm (lines means 1 cm, points means 5 cm) and radiopaque.

Only special non-coring portal access needles should be used to puncture the port membrane.

Depending on indication different special puncture needles can be used. These may be the large-lumen cannulaes DPK 2035, SFN 1835 B and SFN 1535 B as well as the thinner SFN® port needles, e.g. SFN 0930 B. The needles exhibit a unique bevel and angle at the tip. This prevents punch defects in 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 application method, the equipment used and the applied cannula.

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.

instruction for use

INDICATIONS
The TITAN-PORT DR allows repeated access to the pleura cavity if necessary especially for drainage of blood, secretions and gases within the following indications

  • Pleural effusion
  • Pleural empyema
  • Chylothorax
  • Hemothorax
  • Postoperative care after thoracotomy, sternotomy and thoracoscopy

The advantage is a low risk of infection, simplified access and considerably improved quality of life for the patient as provided by the closed system.


CONTRAINDICATIONENS
Relative contraindications are: coagulation disorders, lung emphysema, skin infections or adhesions of the lung with the thoracic wall after surgery.
TITAN-PORT DR systems are contraindicated in:

  • patients with very rare but possible intolerance to titanium 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, breakage
  • paravascular deposits due to improper handling
  • damage to surrounding tissue
  • leakage from chamber, septum or connection sites

APPLICATION NOTES: PORT IMPLANTATION

Warning! It is essential to ensure aseptic conditions during implantation! 
Implantation should only be performed by experienced medical professionals.
Selection, decision-making and technique are the responsibility of the physician performing implantation.


PREPARATION

Implantation is normally performed under insufflation anesthesia according to seldinger technique.
Possible implantation sites are according to the preferred puncture procedure. Various implantation techniques can be employed.

Example:

  • Placement of the catheter in the desired position
  • Tunneling to the port chamber in a port recess
  • Shorten the catheter as required and secure it to the portchamber with the screw
  • Cutaneous sutures
  • Control of the catheter position by X-ray, CT or ultrasound is indispensable.

With optimum implantation, the system can be used directly


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.

USER INSTRUCTIONS

  1. Skin desinfection, sterile gloves, mask (patient and operator)
  2. Puncture the port septum with a special puncture needle (until the tip of the needle touches the base plate)
  3. Check for occlusion with physiological saline solution and especially pay attention to possible extravasation.
  4. At end of treatment, gently withdraw the puncture needle (exerting opposite pressure at the port).
  5. Disinfect the skin; apply dry dressing

Caution:

  • Puncture of port chamber only with the special puncture needle (e.g. SFN 1835 B)
    For lower flow-rates other recommended SFN® port needles may be sufficient.

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 and procedures are recommendations and must always be adapted to individual patient requirements and are the responsibility of the therapist. Attention must be given to the specific requirements of the pleura application. The port systems provide only an access route to the pleura cavity and have no influence on the function itself.


INDICATIONS FOR EXPLANTATION

  • When therapy no longer necessary
  • Irreversible occlusion of the system
  • Membrane or catheter leaks
  • 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.
  • 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 (with SFN 1835 B) 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.

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 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 available
For example:

  • DPK 2035 (PZN 02429581)
  • SFN 1835 B (PZN 12363630)
  • SFN 1535 B (PZN 12363624)

SFN® port needles with different sizes and lengths
For example:

  • SFN 0930 B (PZN 13837567)
  • SFN 0930 G (PZN 01060286)

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

Technical data

 Art.Nr. Port Catheter PZN
  Material Width Lenght
Height
Septum  Weight
Volume
Material AD ID French Volume  
111262 DR*
drainage
Titanium 20,6 mm 25,5 mm 16,7 mm 118 mm2 15 g 1,4 ml Polyurethane 3,35 mm 2,0 mm 10 with fish mouth tip, 10 side holes 72 cm: 2,3 ml 13837550

*including introducer set and tunnelizer

Port Needles

Product description Port Needles

Puncture of portchamber only with special port needles is mandatory!

Art. No. Cannulas PZN
  Ø Length 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 1,0 ml  in gravity 150 ml/min ~ 1500 25 pcs straight, with Luer Lock-Adapter, with Z-10 tubing 12363624
SFN 1835 B 1,8 mm 35 mm 15  0,5 ml 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 in gravity 300 ml/min ~ 500 25 pcs with mandarin + needle free adapter 02429581

*Puncture cannula with mandrine and Needle Free Adapter for use on the implanted port system - with large diameter to achieve the necessary flow rate for the application - punch-free due to special grinding with inner mandrine


PakuMed 91 Web
 PakuMed kanuele PakuMed 01 Web SafeKanueleVorgang2 Ret 

Order Forms

» order here «

Recommendation

Recommendations on common questions concerning the use of the port system for DRAINAGE (port system art. 111262 DR)

PM-96

  • Theoretically, the system can be used immediately, but it is recommended to use it after the wound has healed after about one week
  • Use only with sterile gloves, face mask (patient and user), sterile cover
  • Rinse with 30 ml NaCI 0.9% after each treatment, pull the needle under positive pressure
  • Block the system according to the instructions of the attending physician
  • It is mandatory to use only punch-free port cannulas e.g: DPK 1835, DPK 2035 or also SFN 1320 S or SFN 1535 G

Possible causes of insufficient or no flow

  • Cannula is not seated properly in the port chamber -> push the cannula in until it reaches the base plate
    rightwrong
  • Catheter was twisted or kinked during implantation -> correction necessary

Video

We are serious in data and privacy protection. Therefore the following
information is available for registered users only.

Please register or enter in the login-area and follow the instructions
to have further access to downloads.

loginpic

Thank you for understanding!

PakuMed medical products gmbh © 2020