Implantation of the Acticon® 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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