Implantation of the
ActiconŽ Neosphincter typically takes about two hours. Following is a
brief summary of the surgical procedure.
Caution: This
information is for educational purposes only. See the operating room
manuals and videos for more detailed instructions on this surgical
procedure.
Step 1: Incisions
The patient
should be prepped, placed in a lithotomy position and draped for both a
perianal and a suprapubic incision. To begin the procedure, make a
perianal incision and dissect around the anal canal.
You may choose to use a single anterior transverse incision, pre-and retroanal incisions or bilateral vertical incisions.
Step 2: Measurement
Use
the cuff sizer provided to determine the approximate circumference and
length of the anal canal at the site where the occlusive cuff is to be
implanted. This sizer is for reference only and your own judgment should
determine the appropriate cuff size.
Step 3: Cuff Placement
To
implant the prepared cuff, pass the cuff—tab first—around the anal
canal with the pillow facing toward the canal. To avoid damage to the
cuff, grasp the cuff tab with a silicone-shod hemostat. Thread the cuff
tubing through the adapter hole and close the cuff by pulling the
adapter hole over the cuff button.
Step 4: Balloon Implantation
To
implant the pressure regulating balloon, make a suprapubic incision,
divide the rectus fascia transversely, and use a spreading motion to
separate the linea alba to reach the prevesical space. Use blunt
dissection to create a space big enough for the inflated balloon.
Position the prepared balloon in the prevesical space, and fill it with
55cc of the recommended filling solution.
Step 5: Cuff Pressurization
Next,
the cuff must be pressurized. Temporarily connect the cuff and balloon
tubing using a straight connector. Remove the tubing clamps and wait 60
seconds for the cuff to pressurize. After pressurization you may insert a
finger into the anus to determine if adequate anal canal compression is
achieved. This also should help you determine if the correct cuff size
was implanted.
Step 6: Aspirate and Refill Balloon
Clamp
the cuff tubing and balloon tubing with silicone-shod mosquito
hemostats and remove the temporary straight connector. Use a syringe and
a 15-gauge blunt needle to aspirate all of the remaining fluid from the
balloon. Refill it with 40cc of filling solution and reclamp the tubing
with a silicon-shod mosquito hemostat.
Route the balloon tubing
through the rectus muscle and fascia to the abdominal incision. Then
route the cuff tubing to this area using the Acticon Tubing Passer.
Step 7: Control Pump Implantation
Create
a dependent, subdartos pouch in the scrotum or soft tissue of the
labium for the control pump using blunt dissection. Place the pump in
the pouch, making sure that the deactivation button faces outward and is
palpable.
Step 8: Connecting and Closing
All
components are connected and incisions are closed. The device is
deactivated for 6 to 8 weeks to allow operative edema to subside.
A reference copy of the Operating Room Manual is provided below.
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