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PakuMed Port D ein doppel GW 5976 PakuMed 103 GW PakuMed 143 GW PakuMed DialysePort RZ 2   

PakuMed Port D ein doppel GW 5976 PakuMed 103 GW PakuMed 143 GW PakuMed DialysePort RZ 2   

Product description

TITAN-PORT D (dialysis) is a fully implantable, titanium PORT system providing an access facility for per-forming veno-venous dialysis. The set contains two identical port chambers with a self-sealing silicone membrane and a double lumen polyurethane cathe-ter each case with one inlet and one outlet connec-tion to a Port chamber, and two srews for fixation of catheter to port outlets. Each system also includes two special puncture needles, introducer set, tunnel-izer, user instructions and patient ID documentation.

The port chamber consists of hypoallergenic, bio-compatible titanium. This material is non-magnetic. The chamber has the following dimensions: width 24 mm, length 36 mm, height 17.5 mm, weight 25g, internal volume 0.6ml, outlet pipe diameter 3.5 mm. The base has 2 suture openings for securing the system to the fascia. Port chamber and catheter can be disconnected and are interconected via a srew twist mechanism that is connected with a sleeve to the outlet pipe.

The silicone membrane in the port can be punctured up to 1000 times with a suitable noncoring puncture needle. The membrane possesses high pressure stability and holds the needle securely in position.

There are 2 different systems available – with double-lumen PUcatheter 14 F and single-lumen silicone catheter 12 F

The doublelumen polyurethane catheter 14 F has two openings at the distal end corresponding to the doublelumen construction, recognizable also by the markings on the connecting piece. The longer seg-ment is for afferent blood flow, the posterior opening with two additional lateral openings are for efferent blood flow (see illustration). The internal volume of the longer catheter portion is 2.3 ml, the shorter one is 2.2 ml. Mixture of the blood is minimized and insignificant for the blood washing effect by the mandatory separation of the openings and the natural direction of blood flow of venous blood to the central vessels. The efferent and afferent sections of the catheter are connected to the two implanted ports. These may be shortened as required.

The single-lumen silicone catheter 12 F, with an outer diameter 4.0 mm, an inner diameter 2.5 mm, total length 40 cm and internal volume 1,6 ml, has 6 lateral holes at the distal end a round tip and if necessary the catheter can be shortened at the proximal (unperforated) end. After implantation, the distal round tip prevents flotation of the catheter tip at the implantation site, e.g. due to suction or pulsation in the blood vessel and reduces adsorption at the vessel wall, thereby also improving the flow rate.

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

In order to achieve the blood flow rate needed for dialysis, appropriately large lumen needles are required e.g. DPK 1835 and DPK 2035. These are specially bevelled to prevent fragmentation of sili-cone particles and puncture defects of the mem-brane. Each system includes two appropriate can-nulae. These are available separately for further applications.

The patient ID documentation included is filled out fully by the physician who performed the implanta-tion, 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.

Technical data

 Art.Nr. Port Catheter PZN
  Material Wight
Lenght
Height
Septum Ø Weight
Volume Material French Volume   
111252 D-PU
hemodialysis
Titanium 24 mm 36 mm 19,9 mm 11,5 mm 22 g 0,8 ml Polyurethane
double-lumen
14 long portion: 2,3 ml
short portion: 2,2 ml
01674462
111255 D
hemodialysis
Titanium 24 mm 36 mm 19,9 mm 11,5 mm 22 g 0,8 ml Silicone
single-lumen
12 catheter 60cm: 2,9 ml 01674166

including Introducer set and tunnelizer

Introducer sets

Introducer sets
Art.-Nr. Description PZN
ITS 432013 13 F Introducer 13 F, peel-away 02260805
ITS 432015 15 F Introducer 15 F, peel-away 08439480


info ports5 big PM-126 verlauf gr rl

Port Needles

Product description Port Needles

Puncture of portchamber only with special port needles is mandatory!

  1. DPK 1835, dialysis port needle with special bevel at the tip
  2. DPK 2035, dialysis port needle with mandrin and needle free adapter for puncturing implantable port catheter systems for venous-venous hemodialysis and peritoneal dialysis- with large diameter to ensure an adequate flow rate for dialysis – guaranteed no punch defects because of unique bevel with mandrin
Art.-Nr. Canulae PZN
  Ø mm Lenght mm Gauge Volumen ml VE Extra  
DPK 1835 1,8 35 15 1,0 25 St. with tubing 05108104
SFN 1835 G 1,8 35 15 1,0 25 St. straight with Luer-Lock
(optional with tubing)
10838997
SFN 1835 B 1,8 35 15 1,0 25 St. with tubing 12363630
DPK 2035 2,0 35 14 0,27 25 St. with mandrin + needle free adapter 02429581


PM-15
 PM-80 verlauf gr rl


order forms

» order here «

instruction for use

portd schraeg gross portd2 new gross PM-31 verlauf gr rl

INDICATIONS

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

  • Venous access in kidney failure
  • large lumen venous access primary

The advantage lies in the use of a closed system with a low infection rate and longer implantation time. In particular, this also considerably improves the quality of life of the patient.


CONTRAINDICATIONS

TITAN-PORT D systems is 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
  • 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

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.
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. Other surgical procedures, alternatives are possible. Postoperative X-Ray control is indispensable.


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

Alternative :Seldinger technique

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


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

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

Caution:

  • Puncture the port chambers only with the special puncture needles provided (flow rate approx. 300 ml/ min)
  • 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 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 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 with DPK 1835 or 500 punctures with DPK 2035 using a special needle allows a corresponding implantation time depending on the frequency of dialysis. 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 dialysis port needles are mandatory. e. g.

  • DPK 1835 PZN 5108104
  • DPK 2035 PZN 2429581

Unit: 25 pcs
See separate instruction for use.

PM-136 portd2 new gross PM-31 verlauf gr rl

INDICATIONS

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

  • Venous access in kidney failure
  • large lumen venous access primary

The advantage lies in the use of a closed system with a low infection rate and longer implantation time. In particular, this also considerably improves the quality of life of the patient.


CONTRAINDICATIONS

TITAN-PORT D systems is 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 sideeffects:

  • surgical complications
  • implant intolerance
  • localized erythema / edema / hematoma
  • infections
  • disconnection and dislocation
  • thrombosis / embolism
  • membrane and catheter luxation, catheter fragmentation
  • 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

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

Alternative: Seldinger technique


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

  1. Skin disinfection, sterile gloves, mask ( patient and user)
  2. Trendelenburg position
  3. Puncture the port membrane with a special puncture needle (supplied), caution air embolism!
  4. Unblock the system
  5. Check for occlusion with saline solution and connect to the relevant inlet and outlet parts of the dialysis machine.

 

Warning! To avoid confusion, always check the inlet and outlet directions against the illustration!

  1. At the end of dialysis, flush the port chambers with sufficient saline solution 0.9%
  2. block the system with e.g. heparin, taurolidine or citrate respectively
  3. Remove the puncture needle using gentle positive pressure
  4. Disinfect the skin; apply dry dressing

 

Caution:
  • Puncture the port chambers only with the special puncture needles provided (flow rate approx. 300 ml/ min)
  • 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

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 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 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
  • Pay particular attention concerning localization to the inlet and outlet ends of the double catheter when making connection to the port chambers in order to ensure the necessary effect at the outlet end!
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 ( DPK 1835) or 500 punctures ( DPK 2035) allocated on the entire membrane using a special needle allows a corresponding implantation time depending on the frequency of dialysis. 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, sterile gloves
  • 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.

Special dialysis port needles are available separately.
e. g.
  • DPK 1835 ( 15 Gauge) 0PZN 5108104
  • DPK 2035 ( 14 Gauge ) 0PZN 2429581

Unit: 25 pcs

 

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