Stryker Target Gebrauchsanweisung Seite 7

2. Open the RHV on the microcatheter and insert the tapered distal end of the
introducer sheath through the RHV and into the hub of the 2-tip infusion
microcatheter until the sheath is firmly seated. A slight buckling of the
introducer sheath indicates proper positioning. Tighten the RHV around the
introducer sheath to prevent the back flow of blood, but not so tight as to
damage the coil during its introduction into the catheter.
3. Transfer the Target Detachable Coil into the catheter by advancing the
®
coil delivery wire in a smooth, continuous motion. This procedure is best
accomplished by two people, one to maintain the introducer sheath inside the
RHV and 2-tip infusion catheter hub and one to hold the sheath straight and
advance the coil.
4. Insert the delivery wire until the proximal end of the delivery wire is 2 inches
away from the proximal end of the introducer sheath.
5. Loosen the RHV, hold the delivery wire in place and remove the introducer
sheath over the delivery wire's proximal end making sure the coil does not
come out with the sheath.
Caution: Failure to remove the introducer sheath after inserting the delivery
wire into the RHV of the microcatheter will interrupt normal infusion of flush
solution and allow back flow of blood into the microcatheter.
6. Once completed, tighten the RHV around the delivery wire. Do not discard the
introducer sheath until after the Target Detachable Coil has been positioned
and detached.
7. Visually verify that the flush solution is infusing normally. Once confirmed,
loosen the RHV enough to advance the delivery wire, but not so much as to
compromise the continuous infusion.
8. Locate the fluoro-saver marker on the delivery wire.
warning: The fluoro-saver marker is designed for use with a Rotating
Hemostatic Valve (RHV). If used without an RHV, the distal end of the coil may
be beyond the alignment marker when the fluoro-saver marker reaches the
microcatheter hub.
Caution: Some low level overhead light near or adjacent to the patient is
required to visualize the fluoro-saver marker; monitor light alone will not allow
sufficient visualization of the fluoro-saver marker.
warning: If the fluoro-saver marker is not visible, do not advance the coil
without fluoroscopy.
9. Advance the coil through the microcatheter until the distal end of the fluoro-
saver is flush with the proximal end of the RHV and turn on fluoroscopy.
figure 3. fluoro-saver marker
10. Advance the Target Detachable Coil under fluoroscopy and position carefully
at the desired site. If the Target Detachable Coil placement is unsatisfactory,
slowly withdraw by pulling on the delivery wire, and then slowly advance again
to reposition the coil. If the coil size is inappropriate, remove and replace with
appropriately sized coil (Section 7.3.1 Coil Size & Microcatheter Selection).
Caution: Advance and retract the Target Detachable Coil carefully and
smoothly without excessive force. If unusual friction is noticed, slowly
withdraw the Target Detachable Coil and examine for damage. If damage
is present, remove and use a new Target Detachable Coil. If friction or
resistance is still noted, carefully remove the Target Detachable Coil and
microcatheter and examine the microcatheter for damage.
Caution: If it is necessary to reposition the Target Detachable Coil, verify
under fluoroscopy that the coil moves with a one-to-one motion. If the coil
does not move with a one-to-one motion or movement is difficult, the coil may
have stretched and could possibly migrate or break. Gently remove both the
coil and microcatheter and replace with new devices.
warning: Do not rotate the delivery wire during or after delivery of the coil into
the aneurysm. Rotating the Target Detachable Coil delivery wire may result in
a stretched coil or premature detachment of the coil from the delivery wire,
which could result in coil migration.
11. Continue to advance the Target Detachable Coil until the radiopaque proximal
marker on the delivery wire is exactly distal to the proximal marker on the 2-tip
microcatheter (see Figure 4 below). Tighten the RHV to prevent movement of
the delivery wire.
Caution: Increased detachment times may occur when delivery wire and
microcatheter markers are not properly aligned.
Proximal Marker of the
Delivery Wire just beyond
Proximal Marker of the
Detachment
2-Tip Microcatheter
Zone
Target
Detachable
Coil
Distal and Proximal Markers
of the 2-Tip Microcatheter
figure 4. optimal alignment of radiopaque Markers
warning: Verify repeatedly that the distal shaft of the catheter is not under
stress before detaching the Target Detachable Coil. Axial compression or
tension forces could be stored in the 2-tip microcatheter causing the tip
to move during coil delivery. Microcatheter tip movement could cause the
aneurysm or vessel to rupture.
7
2-Tip Microcatheter
Delivery Wire
Black (K) ∆E ≤5.0