Promedon ANCORIS POP Instructions D'utilisation page 6

Posterior Approach:
The description of the technique is summarized in the following steps:
a. Patient should be in dorsal lithotomy position with legs raised and
bent, under spinal, local or general anesthesia. The administration of
prophylactic therapy with antibiotics should be considered, according to
hospital procedures.
b. Insert a size 12 or 14 Foley catheter in the urethra.
c. Make a lengthwise incision along the posterior vaginal wall, beginning 2
cm below the vaginal apex.
d. Perform a lateral blunt dissection towards the ischial spine, then identify
the ischial spine, the coccygeal muscle and the sacrospinous ligament on
the right side. The same procedure is performed on the left side.
e. Identify the right ischial spine as a point of reference and determine the
position, size and thickness of the sacrospinous ligament.
f. To prime the ANCORIS POP Repair System, the tip of the RIG needs to
be moved out by pressing the trigger on the handle down and shoving
it forward.
g. Then, the TAS has to be attached to the retractable insertion guide (Ref.:
DPN-MNL). The TAS Anchors have a hole that can be placed on the
tip of the RIG. Ensure that the switch on the RIG's handle (1) has been
pushed into the upper position to extend the RIG's tip before putting
on the TAS Anchor. Pick up a TAS from the Dispenser Unit and place
the anchor on the extended RIG tip. Once there is a "click", the anchor
is attached to the RIG. The TAS can now be safely removed from the
Dispenser Unit. Place the suture ends around the fixation point (2) on
the handle. The protective tube (3) is pulled over the RIG until there is a
"click". The protective tube is now securely attached to the RIG. Ensure
that the suture ends are passed through the slot (5) on the bottom of the
protective tube. Refer to figure 1.
NOTE: The protection tube closes with the tip of the Retractable
Insertion Guide to prevent it from becoming stuck or injuring
surrounding tissue due to the spikes of the anchor.
h. Carefully guide the TAS with the RIG downwards to the sacrospinous
ligament by guidance of the index finger.
i. Insert the TAS to the top side of the sacrospinous ligament 2 to 2.5 cm
medial from the ischial spine. The surgeon should use the index finger
to touch and identify the ligament and to guide the retractable insertion
guide to its correct implant location. The TAS should be placed bilaterally,
one in each sacrospinous ligament.
Hold the RIG firmly and straight when pushing the RIG on the
sacrospinous ligament at its final position. Then, the protective tube must
be released by pushing the protective tube lock and release mechanism
(4) in its unlocked position. Subsequently, the TAS can be inserted into
the sacrospinous ligament using firm pressure. Release the anchor by
shifting the switch on the handle (1) downwards. The RIG can then be
safely removed.
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3
4
5
2
1
Figure 1
1. Retractable
mechanism (switch
of the handle)
2. Suture fixation
point
3. Protective tube
4. Protective tube
lock and release
mechanism
5. Slot