Integra OSV II Lumbar Valve Systems Mode D'emploi page 6

Placement of the lumbar catheter
Caution: Do not use bacitracin solution to flush the catheter and guidewire as it may impair the insertion and removal of the
guidewire. Use only sterile saline solution to flush the catheter and guidewire.
1. At the physician's option, make a 2 cm incision prior to Tuohy needle insertion.
2. Connect a syringe to the Luer-lock hub of the guidewire dispenser and flush the guidewire with sterile saline solution.
3. Insert the Luer connector into the catheter. Connect a syringe to the adapter and flush the catheter with sterile saline solution.
4. Insert the guidewire, PTFE-coated tip first, into the catheter.
5. Insert the Tuohy needle, with obturator in place, into the subarachnoid space. Insert the needle bevel up for cephalad place-
ment of the catheter; bevel down for caudad placement.
6. To verify that the lumen of the needle has entered subarachnoid space, withdraw the obturator slowly until CSF appears. If
it does not, reinsert the obturator and reposition the needle.
7. Verify that the needle is correctly positioned. Then, remove the obturator and insert the catheter and guidewire through the
needle to the desired lumbar level.
8. Remove the Luer connector and withdraw the needle over the end of the catheter.
Caution: To avoid damage to the catheter, do not withdraw the catheter after it has been inserted into the needle. If the
catheter must be removed, withdraw the needle and catheter simultaneously.
9. Remove the guidewire. Caution: To avoid damage to the catheter, do not withdraw the guidewire without first removing the
Tuohy needle.
10. Connect a syringe with the provided Luer connector to the lumbar catheter and aspirate 2 to 3 ml of CSF to eliminate pos-
sible debris from the CSF.
11. Clamp the lumbar catheter at incision level.
12. Anchor the lumbar catheter to fascia using the suture clamp.
13. Using a tunneler or other suitable instrument, pass the lumbar catheter subcutaneously from the back to the previous inci-
sion. Do not reduce catheter length at this time.
Placement of the valve
1. Fill the valve system with a sterile apyrogenic saline solution by gentle aspiration through the distal catheter.
2. Using blunt dissection, create a small pocket under the skin to avoid unnecessary pull strength on the drainage catheter
when positioning the shunt.
3. Trim the free (output) end of the lumbar catheter to the desired length. Connect the lumbar catheter to the tubing of the
valve using the stepdown connector, place the small end in lumbar catheter. For easy connection, insert the guidewire
through the stepdown connector and a short distance into the distal end of the catheter. Slide the catheter onto the con-
nector and remove the guidewire.
4. Secure all connections with non absorbable sutures, and tie catheter to underlying fascia.
5. To check valve patency, release the clamp on the lumbar catheter and remove air from the system by allowing CSF to flow
through the catheter.
6. 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 Lumbar Valve System.
• In children, insert sufficient drainage catheter length into the abdominal cavity to allow for growth.
7. Introduce the drainage catheter in the peritoneal cavity using a trocar or standard laparotomy technique consistent with the
surgeon's experience.
8. Close the superficial fascia and skin in a routine manner.
Note - X-ray the complete system just after implantation for future reference to determine whether system components have shifted.
Caution: When sampling or infusing solution using the antechamber, a 25G or smaller beveled needles should be used. Care
must be taken during insertion and removal of the needle to avoid tearing the silicone material. It is also advised to avoid punc-
turing several times at the same place. Taking into account the above recommendations, the antechamber is qualified to sustain
up to 40 punctures without leaking.
Caution: Do not overpressurize the valve system. Excessive flushing pressures may lead to valve damage.
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