Integra OSV II Mode D'emploi page 7

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Connect a syringe with the provided Luer connector to the ventricular catheter and aspirate 2 to 3 ml of CSF to eliminate
possible debris from the CSF.
Note: If desired, sample CSF for analysis or inject antibiotics at this time.
5.
Place the RAG into the burr hole. The channel should point in the direction of the valve. Bend the exposed catheter into the
channel of the RAG until the catheter snaps in place.
Note: The use of the RAG in premature infants or neonates is at the discretion of the surgeon. If the RAG is not used, the surgeon
should trim the rim of the burr hole where the catheter emerges to provide a smooth angular transition for the catheter.
Trim the ventricular catheter to length (approximately 2 cm from the burr hole).
6.
Fill the valve system with a sterile apyrogenic saline solution by gentle aspiration through the distal catheter, or using the
provided tubing and luer connector for models without distal catheters. Carefully insert the integral inlet straight connec-
tor of the valve into the ventricular catheter. Do not dislodge the catheter. Tie the catheter onto the connector and to the
underlying fascia, using appropriate sutures.
Note: For configurations with burr hole cap, attach the cap to the reservoir.
7.
Connect a syringe with the provided Luer connector to the drainage catheter and rinse the system by gently aspirating 2
to 3 ml of CSF to eliminate possible debris and purge air.
8.
If desired, trim the drainage catheter.
9.
Introduce the drainage catheter in the peritoneal cavity using a trocar or standard laparotomy technique consistent with
the surgeon's experience.
10. Caution: Prior to the introduction of the drainage catheter into the abdominal cavity, it is advisable to confirm the patency
of the system by observing the formation of CSF droplets at the end of the drainage catheter.
Notes: • The CSF droplets formation rate may be lower than that observed with conventional DP shunts because of the
flow restriction mode of the OSV II Valve System.
• In children, insert sufficient drainage catheter length into the abdominal cavity to allow for growth.
11.
Close incisions.
Note: X-ray the complete system just after implantation for future reference to determine whether system components
have shifted.
Introduction of Integral Ventricular Catheter (Alternative for Steps 4-5)
If the RAG is used, slide the catheter through the center hole of the RAG. Position the RAG as far along the catheter as possible.
Lock the stylet of the ventricular catheter introducer into its cannula as shown in Figure 4. Insert the tip of the introducer into
the hole nearest the tip of the ventricular catheter. Align the catheter with the introducer cannula and snap it into the adjustable
plastic collar.
Caution: To avoid improper placement, do not overstretch the ventricular catheter when positioning it on the introducer. Punc-
ture the ventricle with this assembly. Carefully withdraw the stylet from the introducer cannula, causing the ventricular catheter
tip to disengage from the stylet.
Note: Sample CSF at this time if desired by withdrawing fluid from the cannula.
Disengage the catheter from the collar on the cannula, ensuring that the catheter's position is maintained. Remove the intro-
ducer cannula from the burr hole. For instructions on the use of the RAG, refer to Steps 4 and 5 of the «Ventriculoperitoneal
Approach» procedure.
Ventriculoatrial Approach
Caution: The procedure is based on the use of a separate ventricular catheter. If a valve with an integral ventricular catheter is
used, follow the procedure «Introduction of Integral Ventricular Catheter».
1.
Position the patient and open the skull as described in Steps 1 and 2 of the «Ventriculoperitoneal Approach» procedure above.
Using blunt dissection, create a small pocket under the skin to avoid unnecessary pull strength on the drainage catheter
when positioning the shunt.
2.
Make a neck incision over the point where the angle of the mandible crosses the anterior edge of the sternocleidomastoid
muscle. If the internal jugular vein is used, facilitate entry by mobilizing the common facial vein at its junction with the
internal jugular vein.
3.
Tunnel the drainage catheter from the skull subcutaneous pocket to the neck incision. Position the valve under the skin.
4.
Insert the ventricular catheter following the Steps 4, 5, and 6 of the «Ventriculoperitoneal Approach» procedure.
5.
Trim the drainage catheter at the neck incision. Fill the distal part with sterile apyrogenic saline solution. Clamp the proxi-
mal end. Introduce the drainage catheter into the vein. Position the distal end of the drainage catheter in the heart's right
atrium at the level of the 6th or 7th thoracic vertebra. Determine the exact location of the catheter by X-ray, radioscopy,
ECG, pressure analysis or echography.
Note: To enhance X-ray visualization, the atrial catheter may be filled with contrast.
6.
Carefully maintaining the catheter in place, trim its proximal part, and the valve outlet tubing to length. Connect the two
together using a straight connector. Tie securely using appropriate sutures.
7.
Close incisions.
Note - X-ray the complete system just after implantation for future reference to determine whether system components
have shifted.
Valve Pumping after Implantation
Percutaneous depression of the antechamber with the finger will force CSF out of the valve in both the proximal and distal direc-
tions. Occlude either the distal or proximal side of the antechamber by finger pressure (according to Figure 5), then depress the
antechamber. This will push the fluid in the direction opposite to the occlusion.
Warning : Shunt obstruction may occur in any component of a shunt system and should be diagnosed by clinical symptoms and
X-rays. Valve pumping testing may not be adequate to diagnose occlusion of catheters.
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