We care for Precision
As a specialist in implantable textiles, Cousin Surgery has developed its expertise in a wide variety of materials. This industrial and technological experience opens up a wide range of innovation opportunities for implant designers.
Manufacturing entirely takes place in clean rooms, in a controlled environment, on more than 1200 m2 (ISO Class 8 to 6), from braiding to packaging.
The processes are all validated according to the strictest norms in terms of qualification. The references used are ISO 13485 and 21 CFR Part 820 (FDA).
Cousin Surgery’s production capabilities allow it to manufacture implants made of a wide variety of materials and to benefit from a unique expertise in implantable textile solutions.
- Mono and multi filaments textiles from polymer based extrusion process (polyethylene terephthalate, polyethylene, polyetheretherketone, poly-L-Lactic Acid,…) or from spinning process (nitinol, stainless steel)
- Absorbing and elastomer materials (silicone)
- Hard materials: titanium, stainless steel, polymers, etc.
Cousin Surgery masters a wide range of manufacturing techniques, particularly in textiles:
- Braiding (mono or multifilaments, with or without core, round braids, flat, tubular, tri-axial,…)
- Rewinding threads
- Assembly of different raw materials
- Functionalization ( Biocompatible dies, printing with silk-screening or marker pen, coating, covering with glue, collagene, PLLA, silicone, ePTFE, Cyclodextrine)
This unique know-how is complemented by a great mastery of other processing techniques for plastics and metals: moulding, injection and manufacturing.
Shaping enables to obtain the final device, thanks to the mastery of numerous manufacturing processes mainly manual.
- Laser cutting (2D programming machine)
- Thermal cutting (hot pen, heatead bled)
- Ultrasound cutting
- Cold cutting, manual or machinal
- Semi-automatic or automatic sewing
- Manual sewing
- Ultrasound welding
- Thermal welding
- High frequency welding
- Glueing (silicone glue or cyanoacrylate)
- Splicing to assemble braids
- Mechanical embroidery
- Thermal shaping
- Chemical treatments (steriliser or high temperature oven)
Depending on the materials, cleaning is done by ether or with the innovative process supercritical carbon dioxide.
Controls are carried out in all the manufacturing stages. The final control of the aspect, presence of particles, and dimensional, is carried out in constant luminosity.
Packaging and labeling
Products are packaged in a white room in a double packaging (Tyvek pouches or blisters), before going to final packaging, which includes box, labels and IFU.
Cousin Surgery carries out the sterilisation of the devices by gamma irradiation or ethylene oxide.