Tube Systems; Implantation - MIETHKE proGAV 2.0 Instrucciones De Manejo

GB | INSTRUCTIONS FOR USE
WARNING
Frequent pumping can result in excessive
drainage and thus lead to pressure condi-
tions outside the normal physiological range.
The patient should be properly informed
about this risk.
Burrhole Deflector
Because of the tight fit on the ventricular
catheter, the Burrhole Deflector makes it pos-
sible to choose the length of catheter pen-
etrating into the skull prior to implantation.
The ventricular catheter is deflected at a right
angle in the burrhole (see chapter "Implanta-
tion").

TUBE SYSTEMS

The proGAV 2.0 can be ordered as an individ-
ual valve unit or as a shunt system with inte-
grated catheters (interior diameter 1.2 mm,
exterior diameter 2.5 mm). The supplied
catheters do not fundamentally change the
pressure-flow characteristics. If catheters by
other manufacturers are used, a tight fit must
be ensured. In any case, catheters have to
be carefully fixed with a ligature to the valve's
Titanium Connectors.

IMPLANTATION

Positioning the ventricular catheter
Several surgical techniques are available
for positioning the ventricular catheter. The
required skin incision should be made in form
of a lobule pedicled towards the draining
catheter. If a Burrhole Deflector is used, the
skin incision should not be located right above
the reservoir. To avoid CSF leakage, care
should be taken that the dura opening is kept
as small as possible after applying the bur-
rhole.
The proGAV 2.0 is available in a range of dif-
ferent configurations: If a Burrhole Reservoir
is used, the ventricular catheter is implanted
first. Once the introducing stylet has been
removed, the patency of the ventricular
catheter can be tested by checking if cere-
brospinal fluid is dripping out. The catheter
is shortened and the Burrhole Reservoir con-
nected, with the connection secured with a lig-
ature. A shunt system with prechamber comes
with a Burrhole Deflector.
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The deflector is used for adjusting the length
of catheter to be implanted and for its posi-
tioning inside the ventricle. The ventricular
catheter is deflected and the prechamber is
put into place. The position of the ventricular
catheter should be checked after implantation
by imaging (such as CT or MRI).
Positioning the valve
The proGAV 2.0 operates depending on its
position. You must therefore ensure that
the gravitational unit is implanted parallel to
the body axis. Therefore, if a shunt sys-
tem in which the valve has been pre-fitted
with a Burrhole Reservoir, only the occipital
access should be used. A location behind the
ear is suitable as an implantation position,
whereby the implantation height has no influ-
ence on the valve function. The adjustable
differential pressure unit should be contact-
ing the bone or the periosteum since pres-
sure must be exerted on the valve during
any later adjustment. A large arch-shaped
or a smaller straight skin incision should
be made, which is then provided with two
pockets (proximal from the incision for the
adjustable differential pressure unit and distal
from the incision for the gravitational unit). The
catheter is then pushed forward from the bur-
rhole to the selected valve implantation loca-
tion, shortened if necessary, and secured to
the proGAV 2.0 with a ligature. Neither the
adjustable differential pressure unit nor the
gravitational unit should be located directly
under the skin incision. Both valve units have
been provided with an arrow in the flow direc-
tion (arrow towards distal or downwards).
WARNING
The adjustable differential pressure unit
should not be implanted in an area which
makes the detection or palpation of the valve
difficult (e.g. underneath heavily scarred tis-
sue).
WARNING
The catheters should only be blocked with a
sheathed clamp and not directly behind the
valve as they might be damaged otherwise.
proGAV 2.0