Surgical Procedure; Preoperative Valve Test; Re-Implantation - B.Braun Aesculap MIETHKE paediGAV Mode D'emploi

| INSTRUCTIONS FOR USE
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SURGICAL PROCEDURE

Positioning the ventricular catheter
Several surgical techniques are available for po-
sitioning the ventricular catheter. The necessary
skin incision should be carried out, preferably,
in the shape of a lobule pedicled towards the
draining catheter or as a straight skin incision.
To avoid CSF leakage, care should be taken
that the dura opening is kept as small as pos-
sible after applying the burrhole. The ventricular
catheter is stiffened by the introducing stylet
supplied with the product.
The paediGAV is available in different shunt vari-
ants: When using a paediGAV SHUNTSYSTEM
with Burrhole reservoir, the ventricular catheter is
implanted first. Once the introducing stylet has
been removed, the patency of the ventricular ca-
theter can be tested by checking if CSF is drip-
ping out. The catheter is shortened and the Burr-
hole reservoir is connected, with the connection
secured with a ligature. The skin incision should
not be located directly above the reservoir.
The paediGAV SHUNTSYSTEM with precham-
ber comes with a deflector. This deflector is
used for adjusting the position of deflection be-
fore implantation of the ventricular catheter. The
catheter is deflected; the prechamber is put into
place. The position of the ventricular catheter
should be inspected again by postoperative CT
or MR imaging.
Positioning the valve:
The paediGAV operates in different modes
depending on the patient's position. Hence
it is important that the valve is implanted par-
allel to the body axis. A suitable implant site
is behind the ear. Following the skin incision
and the tunneling through the skin, the cathe-
ter is pushed forward to the implantation site
chosen for the valve. If necessary, the cathe-
ter is shortened and fastened at the paedi-
GAV by means of a ligature, taking care that
the valve does not lie directly under the skin
incision. The valve is marked with an arrow
pointing towards the feet of the patient (towards
the distal end or downwards respectively).
Positioning the peritoneal catheter
The access site for the peritoneal catheter is left
to the surgeon's discretion. It can be applied
e. g. para-umbilically in a horizontal direction
18
or transrectally at the height of the epigastrium.
Likewise, various surgical techniques are
available for positioning the peritoneal catheter.
We recommend pulling through the peritoneal
catheter, using a subcutaneous tunneling tool
and perhaps with an auxiliary incision, from the
shunt to intended position of the catheter. The
peritoneal catheter, which is usually securely
attached to the paediGAV, has an open distal
end, but no wall slits. Following the exposure
of, and the entry into, the peritoneum by means
of a trocar, the peritoneal catheter (shortened,
if necessary) is pushed forward into the open
space in the abdominal cavity.

PREOPERATIVE VALVE TEST

Isotonic sterile sodium chloride solution
Fig. 6: Patency test
The paediGAV can be filled most gently by aspi-
ration through a sterile, single-use syringe atta-
ched to the distal end of the catheter. The pro-
ximal end of the valve is immersed in a sterile,
physiological saline solution. The valve is patent
if fluid can be extracted in this way (see fig. 6).
Caution: Pressure admission through the
single-use syringe should be avoided, both
at the proximal and the distal end.
Contaminations in the solution used for the
test can impair the product's performance.

RE-IMPLANTATION

Under no circumstances should products that
have had previously been implanted in a pati-
ent be subsequently reimplanted in another,
because a successfull decontamination of the
device cannot be reached without functional
degradation.
paediGAV