Leading manufacturer of ceramic components Morgan Advanced Materials is working with University of Hull spin out company, Avoco Medical Ltd, on a pioneering speech-restoration project for patients with throat cancer.
The company is taking to market a new patent- protected speech valve that uses zirconia ceramic components which enable valve life to increase, resulting in less frequent valve changes for patients. This improves quality of life for patients and reduces cost to healthcare providers.
Up to 15 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. As a result, the performance of the valve deteriorates so that it has to be replaced, typically every three months, 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 hostile environment. Laboratory tests have shown that ceramic valves should last more than two years - at least eight times longer than silicone ones.
"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," says Yannick Galais, Morgan Advanced Materials. "This longer lifetime of the valve 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."
"We approached Morgan Advanced Materials for their ceramics expertise and manufacturing excellence," says Professor Michael Fagan, Technical Director, Avoco Medical. "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 Advanced Materials 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 VitoxTM alumina and VitoxTM 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 the company provides 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.