TiSURE®


The TiSURE® mesh implant is used in hernia surgery for the treatment of diaphragm defects around the oesophagus. 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

  • Titanised soft tissue reinforcement implant for the medical treatment of hiatal hernias
  • Material: polypropylene with covalently bonded titanised surface
  • Thickness of titanisation layer: approx. 30–50 nm
  • Fabric: knitted monofilament fibres
  • Edges: laser cut, rounded
Eigenschaften
  light strong
Weight 35 g/m2 65 g/m2
Strength (DIN EN ISO 5084) 0,30 mm 0,45 mm
Pore size ≥ 1 mm ≥ 1 mm
Fibre diameter 58 dtex (90 µm) 103 dtex (120 µm)
Sizes (mm)
a b c d e
70 100 35 50 22

Practice

Implantation

TiSURE® is used to strengthen the diaphragm in the case of existing defects around the oesophageal hiatus. To start with, the hernia opening is carefully prepared and then, if possible, narrowed with sutures to the diaphragmatic crura. For reinforcement, TiSURE® is placed around the oesophagus and can be secured there with sutures or glue.

The use of staples for securing the mesh is strongly discouraged due to reports of complications associated with their use.

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

Surgical mesh implants from titanised polypropylene fabric are used for the treatment of soft tissue defects. TiSURE® is used for repairs to the diaphragm around the oesophagus.

Manufacturer

pfm medical titanium gmbh

Südwestpark 42

90449 Nürnberg, Germany

Ordering Information

TiSURE®
REFWeightSizePU
600043835 g/m²7 cm x 10 cm3