4. Estimate stricture length by one of several methods (e.g.
withdrawal of catheter with radiopaque marker at its tip or
withdrawal of marked guidewire).
5. Allowing for possible further tumor development and post
implant stent shortening (due to continued expansion),
determine the length and number of stents necessary to
cross the stricture. (Note: The fully expanded stent length
should be at least 4 cm longer than the length of the
stricture.) Should multiple stents be required, the leading
stent should be placed first followed by the trailing stent,
allowing for adequate overlapping.
If the obstruction happens to fall near a bend, it is recommended
that the stent(s) total length should be such that the two free
ends fall beyond the bend and open freely into the lumen.
6. Carefully remove the delivery system from its protective
packaging.
Caution: Visually inspect the entire system for damage.
Visually check that the exterior tube covers the leading end
of the stent. Ensure that the delivery system does not have
any kinked sections.
7. Pass the WallFlex™ Duodenal Stent System with Anchor
Lock Delivery System over the guidewire, through the
endoscope working channel and to the site of the stricture.
8. Advance the stent across the stricture until the Post
Deployment Marker Band is at the outermost point of the
proximal end of the stricture. (See Figure B)
note: Accounting for maximum shortening, the Post
Deployment Marker Band identifies the approximate furthest
position of the proximal end of the deployed stent. Because
shortening will vary based on anatomy, the Post Deployment
Marker Band should only be used to approximate the final
proximal end of the stent. The Exterior Tube Marker Band
should be at least 4 cm beyond the distal end of the stricture
(See Figure B). If the Exterior Tube Marker Band is not at
least 4 cm beyond the distal end of the stricture, a longer
stent may be required or a second overlapping stent may be
used to cross the stricture adequately.
Exterior Tube
Marker Band
4 cm
Distal End of Stricture
Figure B
9. To begin stent deployment, immobilize the hub handle in one
hand and grasp the exterior tube handle with the other hand.
Gently slide the exterior tube handle back along the stainless
steel tube towards the hub handle. At the same time and
the same rate, the endoscopist should gently withdraw the
exterior tube to prevent inadvertent stent advancement.
note: The stent can be reconstrained at any time up
to when the Exterior Tube Marker Band reaches the
Deployment Limit Marker band. (See Figure C).
Figure C
Post-deployment marker band
Deployment limit marker band
Proximal End of Stricture
Exterior tube marker band
Deployment limit marker band
5
Black (K) ∆E ≤5.0