COOK Medical Biodesign Instrucciones De Uso página 5

8. Attach the tether connected to the Fistula Plug to the end of the Cook
Fistula Brush located at the primary opening.
IMPORTANT: The button of the Fistula Plug should closely approximate
the rectal wall or be fully implanted below the mucosa in order to
minimize contact of the Fistula Plug material with bowel contents.
IMPORTANT: The rectal opening is the high-pressure zone of the
fistula, as well as the site of ingress of fecal debris. The button end of
the plug must therefore be securely snug against the rectal opening or
fully implanted below the mucosa to prevent ingress of fecal debris. In
addition, the higher pressures within the rectum and anal canal assist in
maintaining the plug in the fistula tract by simple mechanical force.
Superficial Button Placement
9. Draw the tether attached to the Fistula Plug into the rectal (primary)
opening and through the fistula tract until the Fistula Plug is drawn
completely into the fistula tract and the Biodesign button is against the
rectal wall.
Fistula
Vagina
Recto-vaginal fistula repair
10. When the Fistula Plug is properly positioned, grip the tether used to draw
the Fistula Plug into the fistula tract and apply gentle tension to it. This
will hold the Fistula Plug in place during fixation of the device on the
rectal side. Refer to the illustration below.
11. Using a 2-0 PDO, PDS, coated PGA or comparable suture, secure the
button to adjacent tissue by stitching through the center portion of
the button and directly through the rectal wall and mucosa. Obtain
an adequate bite of sphincter muscle with the suture and secure the
button to the tissue by tying the two suture ends together. This should
be repeated four times and the sutures should be equally spaced around
the button.
Rectum
Superficial Button Placement
5
Anorectal fistula repair