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Biocompatible ceramic brings clinical benefits

04 May 2011

Morgan Technical Ceramic’s biocompatible Zyranox zirconia ceramic is being used to develop a pioneering ceramic speech valve that results in less trauma for throat cancer patients and cost savings for health service providers.

Morgan Technical Ceramics (MTC) is working with University of Hull spin out company, Avoco Medical, on a pioneering speech-restoration project for patients with throat cancer. The company is taking to market a new speech valve comprising zirconia ceramic components that extend valve life and thus remove the need for frequent valve changes. This clearly improves quality of life for patients and reduces costs for healthcare providers.

Up to fifteen per cent of patients diagnosed with throat cancer every year require a laryngectomy (removal of the larynx) which results in speech loss. Some speech and vocal function can be restored through the use of valves which reconnect the trachea (wind pipe) and oesophagus (food pipe). Current valve designs consist of a tube (stent) and incorporate a flap which opens as air is forced through. 

Traditionally the valve is made from silicone rubber, but as the material is exposed to a hostile and non-sterile environment a biofilm develops on the surface, causing the performance of the valve to deteriorate. Replacement then becomes necessary - typically on a three monthly cycle - which is a distressing procedure for the patient and costly to the health service.

Ceramic is a more attractive material because of its stability, biocompatibility and compliance. It has a hard, impervious surface which makes it more resistant to the adverse effects described above. Indeed, laboratory tests have shown that ceramic valves should last more than two years - at least eight times longer than those made from silicone, as MTC's Yannick Galais explains:

“We started this project with Avoco Medical two years ago and are pleased that our Zyranox zirconia ceramic has proven to be highly resistant to biofilm during extensive laboratory testing. This longer valve lifetime generates less trauma for the patient as the device does not have to be changed so often and it also delivers cost saving for all medical parties.” Professor Michael Fagan, Avoco Medical's technical director, explains why his team chose MTC as the manufacturing partner in this project:

“We approached Morgan Technical Ceramics for their ceramics expertise and manufacturing excellence. The Kingston speech valve includes three ceramic components which need to be precision manufactured so they work together properly. The company has the ability to manufacture the parts to tight tolerances and complex geometries, which is essential to providing high quality and reliable valves.”

Morgan Technical Ceramics offers bespoke components in Zyranox, which is biocompatible and complies with ISO13356 certification for ‘implants for surgery using nonmetallic materials’. Custom design implantable components are also available in Vitox alumina and Vitox AMC (Alumina Matrix Composite) materials, both complying with the ISO 6474 standards. Applications include reconstructive joints, neurostimulation housings for cochlear implants, Vergus Nerve Stimulation (VNS) and Implantable Pulse Generators (IPG).

The company’s site in Rugby is also ISO13485:2003 certified which means it can provide medical devices and related services that consistently meet customer and regulatory requirements.

The speech valve design, which is protected by a worldwide patent, will be supplied with a specially designed multi-function insertion tool.

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