TiLOOP® Total 6

Implantation

• Recommended implantation procedure for cystoceles (adapt accordingly for rectoceles). In the operating theatre, prepare the patient under strict sterile conditions in accordance with clinical standards.

Step1: Patient preparation

• The transobtural prolapse repair using a TiLOOP® mesh implant for pelvic floor reconstruction is performed under local or general anaesthetic.
• In the operating theatre, the patient is placed in the dorsal lithotomy position, with legs flexed at the hips and strapped in supports and buttock moved to the edge of the operating table or a bit beyond.
• The bladder is to be emptied prior to the procedure. The use of a urinary catheter is recommended. It is up to the surgeon to decide whether to use a suprapubic or a transurethral catheter.

Step 2: Preparation of the TiLOOP® mesh

• Check that the sterile barrier is undamaged before removing the TiLOOP® mesh from its package.
• Open the package of the TiLOOP® mesh itself in a sterile environment.
• Check that all contents are complete and undamaged. If contents are incomplete or damaged in any way, use a different package.

Step3: Dissection of the vagina, the endopelvic fascia and the sciatic spine

• Performance of an anterior median colpotomy up to approx. 3 cm from the external urethral orifice.  
• The bladder is exposed, while ensuring that circulation to the vagina is retained be leaving it in its entire thickness.
• The dissection is large enough if the exposure extends laterally to the tendinous arch.
• Then sciatic spine is exposed.
• This process is repeated on the opposite site while carefully controlling the bleeding.
• From this position, the sacrospinous ligament is prepared medially and dorsally.
• This process is repeated on the opposite site while carefully controlling the bleeding.  

Step 4: Preparation for the passage of instruments

• Mark the site of the skin incisions for the passage of instruments (needle applicators, tunnelling needles).
• The first incision should be made at the genitofemoral fold along the lateral edge of the descending pubic ramus on the level of the clitoris.
• The second incision is made 1–2 cm laterally and 2–3 cm caudally of the first.
• This process is repeated on the opposite side.
• A third incision is made 3 cm laterally and dorsally of the anus.
• This process is repeated on the opposite side.  

Step 5: Insertion of instruments and TiLOOP® mesh arms

• The helical tunnelling needle is inserted through the anterior incision, passing closely by the descending pubic ramus. The tip of the instruments is enclosed by the surgeon's fingers in order to avoid injury to the bladder.
• The front arm of the TiLOOP® mesh is hooked to the eyelet of the helical tunnelling needle (the actual mechanism for attaching the mesh may differ depending on the instrument used).  
• This process is repeated on the opposite side.
• The curved tunnelling needle is inserted through the second incision and passes the obturator foramen in the dorsocaudal corner.
• The instrument is passed along the pubic bone to the sciatic spine behind the obturator internus muscle until the tip of the needle emerges laterocranially at the level of the incision at the sciatic spine.
• In addition to this process, the central arm of the TiLOOP® Total 6 mesh implant is hooked to the eyelets of the tunnelling needle (the actual mechanism for attaching the mesh may differ depending on the instrument used).
• This process is repeated on the opposite side.
• The curved tunnelling needle is inserted 3 cm laterally and dorsally of the anus, then passed through the ischioanal fossa, and the sacrospinous ligament is pierced from the back dorsally 25 mm medial of the spine.
• The dorsal arm of the TiLOOP® Total 6 mesh implant is hooked to the eyelets of the tunnelling needle (the actual mechanism for attaching the mesh may differ depending on the instrument used) and the mesh arm carefully extracted.
• The process is repeated on the opposite side.
• The mesh arm can also be put in place using a different process.
• Instead of attaching the mesh arms directly and guiding them using the attached instruments, it may be indicated to use a nonabsorbable suture to guide the mesh arms.

Step 6: Fixation of the TiLOOP® mesh implant

• Ensure that the mesh is extended level and tension-free.
• The mesh is fixed in this position on both sides at the vesicoureteral junction using a nonabsorbable suture.
• If the uterus remains unaffected, the craniodorsale part of the mesh is fixed to the cervix. After a preceding or simultaneous hysterectomy, the mesh is fixed on both sides of the vaginal apex.

Step 7: Suture

• To finish, the vaginal wound is fully closed after débridement of the wound using an absorbable surgical suture.
• After the operation, a vaginal pack is inserted.

Titanisation

Chemical vapour deposition (CVD) is a process for the metallisation of complex components while at the same time achieving strong bonds. However, as this process involves temperatures in excess of 150°C, it is not an option for many prosthetic materials which would not be shape retentive at such temperatures (e.g. polypropylene).

For that reason, the titanisation of plastic implants takes place at low temperatures using a special plasma-coating process known as PACVD (plasma-activated chemical vapour deposition).

Plasma is the term used for an excited (ionised) gas. In that stage, atoms/molecules are highly energetic. However, plasma is not hot. In everyday life, we are familiar with plasma in fluorescent tubes. The electrically charged gas components emit light as the result of their highly energetic state, but the fluorescent tube remains cold.

In the titanisation process, gaseous titanium is introduced into the coating chamber as a precursor. By adding energy in form of plasma, the precursor is split into individual ionised atoms. These ionised titanium atoms have free electrons at their surfaces.

In addition to the precursor, the plasma also excites the surfaces of the plastic implants with the result that their surfaces also have free electrons. The ionised titanium atoms come into contact with the ionised surface of the implant resulting in the formation of covalent bonds with the free electrons. Covalent bonds are seen as the strongest of chemical bonds; the titanium is thus almost permanently bonded to the plastic.

This process creates a composite material whose surface is coated with an ultra-thin, approx. 30–50 nm (1 nanometre = 1 millionth of a millimetre), highly biocompatible layer of titanium. The coating is so thin that it appears to be transparent and is also highly flexible.

Because the titanium precursor is introduced in gaseous form, it reaches all parts of the plastic implant. As the result, the entire surface, including gaps in between complex shapes, is completely and evenly titanised.