COOK Medical Biodesign Mode D'emploi page 5

Superficial Button Placement
9. Use the tether to pull the plug into the internal opening and through the
fistula tract. Ensure the plug is drawn completely into the tract. Do not
use the entire plug unless the tract is the full length of the plug.
IMPORTANT: The internal opening is the high-pressure zone of the fistula.
The button end of the plug must be securely fastened to the internal
opening or fully implanted below the mucosa to prevent ingress of fecal
debris. The higher pressures within the rectum and anal canal assist in
maintaining the plug in the fistula tract.
10. Once the plug is properly positioned, gently pull the tether to hold the
plug in place during fixation on the internal side.
11. Using a 2-0 PDO, PDS, coated PGA or comparable suture, secure the
button to the adjacent tissue by suturing through the center portion of
the button and directly through the rectal wall and mucosa. Obtain an
adequate bite of sphincter muscle and secure the button to the tissue by
tying the two suture ends together. Equally space four interrupted sutures
around the button to evenly distribute force.
Submucosal Button Placement
12. Create a mucosal flap of sufficient size to accommodate the 16 mm
diameter button.
13. Use the tether to pull the plug into the internal opening and through the
fistula tract. Ensure the plug is drawn completely into the tract and that
the button is positioned within the mucosal flap.
14. Suture the plug according to PROCEDURE STEP 11.
15. Reapproximate the mucosal flap and securely suture the tissue over the
button.
16. Trim the excess external plug flush with the skin. Do not suture the
plug to the external opening. The external opening may be enlarged to
facilitate drainage.
NOTE: Complete obstruction of the external opening may result in
accumulation of fluid, infection, or abscess.
5