COOK Medical Biodesign Instrucciones De Uso página 5

10. Keep the flap in the raised position and, using the ruler on the template,
measure the length from the base of the flap to the base of the C-cap on
the flap as shown in Figure 1B.
(A)
11. Close the donor site using non-resorbing or slow resorbing suture, as
shown in Figures 2A and 2B.
(A)
12. Two methods can be used to prepare the nipple flap and place the
cylinder. One method is to suture the flap to create a silo, followed by
placement of the prepared cylinder within the silo. The other method is
to first prepare the cylinder and then to wrap the flap around the cylinder
and suture it in place.
Method 1: Silo Prepared Prior to Cylinder Placement (Steps 13-15)
13. Suture the flap into an appropriately sized silo using non-resorbing or
slow resorbing suture, as shown in Figure 3. Avoid stretching the skin flap
or placing tension on the skin flap while suturing.
14. Prepare the cylinder for placement.
NOTE: The cylinder provided can be trimmed to length for the desired
final appearance. It is not recommended to trim the device less than 1.0
cm due to risk of projection loss after post-operative contraction.
a. Using sterile forceps and gloved hands, aseptically remove the cylinder
from the tray. Discard the cylinder if it falls out of the sterile field or its
sterility is compromised.
b. Trim the cylinder length with a fresh sterile scalpel or sterile scissors to
desired height. Use the measurement taken in Step 10 to determine the
necessary cylinder length. Repeat sizing with ruler if needed.
c. Place the cylinder into a sterile dish in the sterile field.
d. Add sterile saline or sterile lactated Ringer's solution to the sterile dish.
e. Allow the cylinder to rehydrate, fully submerged, for less than or equal
to 10 seconds. IMPORTANT: Cylinder rigidity is lost as the rehydration
time is increased. Minimize manipulation of the cylinder during
rehydration to avoid delamination.
15. Place the cylinder into the prepared skin flap silo, maximizing contact
with well-vascularized tissue. Avoid applying excessive pressure during
implantation.
Method 2: Wrap the Flaps Around the Prepared Cylinder (Steps 16-17)
16. Prepare the cylinder for placement.
NOTE: The cylinder provided can be trimmed to length for the desired
final appearance. It is not recommended to trim the device less than 1.0
cm due to risk of projection loss after post-operative contraction.
a. Using sterile forceps and gloved hands, aseptically remove the cylinder
from the tray. Discard the cylinder if it falls out of the sterile field or its
sterility is compromised.
b. Trim the cylinder length with a fresh sterile scalpel or sterile scissors to
desired height. Use the measurement taken in Step 10 to determine the
necessary cylinder length.
c. Place the cylinder into a sterile dish in the sterile field.
d. Add sterile saline or sterile lactated Ringer's solution to the sterile dish.
e. Allow the cylinder to rehydrate, fully submerged, for less than or equal
to 10 seconds. IMPORTANT: Cylinder rigidity is lost as the rehydration
time is increased. Minimize manipulation of the cylinder during
rehydration to avoid delamination.
Figure 1
Figure 2
Figure 3
5
(B)
(B)