Promedon Splentis Gebrauchsanweisung Seite 5

• Serial and lot number or unique device identifier as appropriate
• Manufacture's name, address and website
• Name of the patient or patient ID;
• Name and address of the healthcare institution which performed the
implantation
• Date of implantation/explantation
• Warnings, precautions or measures to be taken by the patient
• Expected lifetime of the device and mandatory follow-ups
• Any other information to ensure safe use of the device by the patient.
The implant card is NOT included in the Splentis kit and must be created by
the physician.
SURGICAL PROCEDURE
Prepare the patient for surgery according local standard procedures and
requirements for transvaginal POP repair. Splentis is implanted under general
or regional anesthesia. The description of the technique is summarized in the
following steps:
NOTE: Remove a vaginal pessary four weeks prior to the operation
to avoid preoperative injuries of the vaginal epithelium, such as
erosions or ulcerations.
Positioning
Use standard or high lithotomy position according to the surgeon's standard
procedure. Ensure the bladder is empty prior to starting the operation. Use a
urinary catheter as appropriate.
NOTE: Lower extremity nerve injury and compartment syndrome
may occur with lithotomy positioning of the patient. Limit the risk by
avoiding excessive hip flexion and hip abduction and reducing the
operation time.
Surgical Steps
1. Full thickness vaginal wall dissection
Place two Allis clamps vertically on the vaginal wall for the midline incision.
Milk the bladder away from the vaginal wall with the thumb and index
finger to develop the vesicovaginal space. Perform a hydrodissection with
injectable saline prior to fist incision to create a space between the vaginal
wall and the underlying structures. Perform a midline anterior colpotomy
and subsequently full thickness vaginal wall dissection for entry of the
vesicovaginal space by sharp and blunt preparation.
NOTE: Limit the use of electrocautery to prevent the disruption of
blood flow.
NOTE: A partial-thickness dissection may disrupt the blood supply to
the vaginal mucosa and increases the risk of mesh exposure.
2. Mesh implantation
Develop the vesico- and rectovaginal space by sharp and blunt dissection
as appropriate. Subsequently, enter the pararectal space using blunt finger
dissection to identify the ischial spine with the index finger. The ischial spine
and sacrospinous ligament are identified by palpation. The surrounding tissue
of the sacrospinous ligament is wiped away carefully from the ischial spine
along the ligament using the index finger. Perform this step bilaterally.
NOTE: The final position of the anchor is recommended to be approx.
2 cm medially from the ischial spine in the sacrospinous ligament.
Surrounding tissue should be minimised at the intended position of
the anchor.
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 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 (DU) 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 on the handle. The protective tube 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 on the
bottom of the protective tube.
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 anchor's barbed hooks.
The TAS is fixed to the right sacrospinous ligament by the left hand. Firstly,
the right index finger identifies the sacrospinous spine and ligament. The
rectum is gently pulled medially. The right hand remains in this position in
order to guide the TAS to the sacrospinous ligament. The RIG is subsequently
pushed forward with the left hand along the right hand for guidance to
the sacrospinous ligament. The final position for the TAS should be located
approximately 2 cm medially from the ischial spine on the 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
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 downwards. The RIG can then be safely removed.
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