TiLOOP® Fix


The TiLOOP® Fix mesh implant is used to correct the position of the vaginal stump in defect-specific pelvic floor reconstruction. Thanks to its outstanding biocompatibility, it enables a better quality of life and shorter convalescence.


Benefits

Outstanding biocompatibility  The mesh implant is titanised, very lightweight and hydrophilic and thus outstandingly biocompatible.

Excellent quality of life combined with shorter convalescence  Outstanding biocompatibility keeps inflammation rates, shrinkage and migration to a minimum and ensures shorter convalescence. The implant is not recognized as a foreign body, and postoperative pain is prevented.

Globally unique technology  The nanotechnological finishing process for the covalent bonding of polypropylene and the titanium-dioxide surface is patented and thus completely unique.

Details

  • Laser-cut edges
  • Large-pore structure
  • Monofilament fabric

Tech. Data

  • Tension-free titanised polypropylene mesh implant for defect-specific pelvic floor reconstruction (surgical treatment/corrective positioning of the vaginal stump); cardinal ligament (tissue anchor)
  • Material: polypropylene with covalently bonded titanised surface
  • Thickness of titanisation layer: approx. 30–50 nm
  • Fabric: knitted monofilament fibres
  • Edging: laser cut, rounded
Characteristics

lightstrong
Weight35 g/m65 g/m2
Thickness (DIN EN ISO 5084)0,30 mm0,45 mm
Pore size> 1 mm> 1 mm
Fibre diameter58 dtex (90 µm)103 dtex (120 µm)
Porosity , 2D61 %53 %
Porosity , 3D87 %82 %
Physiological elasticity at 16 N20 %8 %
Tensile strength (grab test)61 N142 N
Sizes (mm)
abc
1541530

Practice

Implantation

The shape of the TiLOOP® Fix (for fixation of connective tissue structures in the true pelvis) is modelled on the anatomic structures in order to compensate for static pelvic floor defects. This makes single or multiple applications during surgery possible.

The round anchor is fixed using suture material at the base of the reconstruction area, and the ligament is then guided using the special needle in the desired direction through the true pelvis. The choice of access (inside-out or outside-in technique) is left to the experienced surgeon to decide the best option for an individual patient. Care must be taken in the correct choice of these static points (reference points: sciatic spine or obturator foramen).

The outstanding effectiveness of titanised polypropylene in surgery has been demonstrated in more than 175,000 hernia operations worldwide.

Knowledge

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.

Application Range

Indication

TiLOOP® mesh implants were developed for a variety of indications in urological, gynaecological and surgical patient treatment within the broad range of procedures that use surgical mesh implants.

TiLOOP® mesh implants are particularly used for supporting and strengthening of connective tissue structures and ligaments.

The tension-free TiLOOP® Fix pelvic floor mesh – a cardinal ligament (tissue anchor) – is ideally suited for the surgical treatment / corrective positioning of the vaginal stump in the individual reconstruction of the ligaments in the true pelvis.

Manufacturer

pfm medical titanium gmbh

Südwestpark 42

90449 Nürnberg, Germany

Ordering Information

TiLOOP® Fix
REFDescriptionWeightSizeMaterialPU
6000521w/o sleeve35 g/m2, light41,5 x 1,5 cmtitanized polypropylene3
6000522w/o sleeve65 g/m2 (strong)41,5 x 1,5 cmtitanized polypropylene3