TiLOOP® Male

Area of application

Male stress urinary incontinence (SUI) °I/II (depending on diagnostic findings) after radical prostatectomy, TURP, laser treatment and enucleation of an adenoma

Implantation

Position the patient in a moderate lithotomy position with hip and knee joints flexed no more than 90°–110°. Insert a transurethral indwelling catheter. Mark the two exit points of the tape about 2 cm below and 1 cm lateral of the attachment point of the ligament of the adductor longus muscle; medially, the medial limit of the obdurator foramen should be palpable. Make a median incision about 3 cm below the scrotum. Split the bulbourethral muscle and expose the bulbus urethra to each side up to the inferior pubic ramus. Using helical needles, the tape can be inserted inside-out or outside-in; in each case, a strong vicryl suture is put in place to insert the tape. Secure the tape on the bulbus urethralis using 4 vicryl sutures. Tension the tape and visually check the relocation of the bulbus. Perform cystoscopy for safety. Secure the tape subcutaneously by suture attachment. Alternatively, perform angled subcutaneous tunnelling approx. 4 cm to dorsal, allowing the tape to be incorporated under slight tension. Trim the edges of the tape just below the skin. Close the wound. Empty the patient’s bladder.

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.