MEDIONICS INTERNATIONAL INC.

Pleural Effusion & Ascites Drainage Catheter Sets

The Drainage Catheter Sets enable recurrent pleural effusions and malignant ascites to be drained on an outpatient basis.

The Drainage Catheter Set is indicated for intermittent, long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. It is indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion).

The Drainage Catheter Set is also indicated for periodic drainage of recurrent and symptomatic malignant ascites. It is intended for long term access of the peritoneal cavity in order to relieve symptoms such as dyspnea.

The Drainage Catheter Set comprises an implant grade 15.5 French silicone catheter and accessories used for the tunneled insertion of drainage catheter using Seldinger technique.

The accessories are:

1 - J-Tip Guidewire, Graduated
1 - 16FR Peel-Away Introducer
1 - 10cc Syringe L.L.
1 - 20cc Syringe L.L.
6 - Gauze Pad 4"x4"
1 - Fenestrated Drape 60"x43" w/10"x6" fenestration
1 - 5-IN-1 Drainage Line Adapter
1 - Drainage Line

1 - Introducer Needle, 18 Ga
1 - Tunneler
1 - Safety Scalpel, #11
1 - Dilator 12 FR x 8"
1 - Safety Needle 18GA x 1.5"
1 - Safety Needle 22GA x 1.5"
1 - Split Foam Dressing, 4" x 4"
1 - Self Adhesive Dressing, Transparent Film, 6" x 8"
1 - Catheter Insertion Stylet

The silicone catheter can be thought of as containing three zones: the fenestrated zone, which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone, which includes a luer activated swabable valve that remains closed, except when purposely accessed for a drainage procedure. The cuff is intended to decrease migration of the catheter, and the valve prevents leakage from the catheter as well as entry of air into the pleural or peritoneal space. A radiopaque stripe runs the entire length of the catheter.

DCS-100 (for pleural effusion): X = 26 cm, Y = 13 cm, Z = 26 cm, Total Length = 66 cm
DCS-101 (for ascites): X = 26 cm, Y = 15 cm, Z = 30 cm, Total Length = 72 cm

The drainage valve is a luer activated swabable valve that remains closed, except when purposely accessed for a drainage procedure. The valve prevents leakage from the catheter as well as entry of air into the pleural or peritoneal space. No end caps are required.

The polyester cuff is positioned in the tunnel subcutaneously. It is intended to decrease migration of the catheter.

The Drainage Catheter Set includes a Drainage Line which is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. Drainage is almost painless, when compared with other forms of treatment.

Recurring pleural effusions or malignant ascites can be treated on an outpatient basis.