R&D of RoHS compliant lead (Pb) free piezoelectric materials in active medical needle devices

"Active Needle Technology Limited ""ANT"" are the developers of a specialised high frequency vibrating needle that aims to reduce needle placement errors associated with ultrasound guided interventional procedures. This will save time, lower the cost burden on the NHS and other healthcare providers and reduce the need for the patient to return because their medical procedures (biopsy or epidural) failed. The ANT team has progressed to stage of having a pre-production prototype of this vibrating needle. ANT's development pathway is blocked by a near term environmental and regulatory roadblock. In order to work, the needle must vibrate rapidly, and these vibrations are provided by a special ceramic material (piezomaterials) that contains high quantities of lead. This large lead content creates hazards during processing, limits applications (e.g., _in vivo_), and is environmentally toxic during disposal. As response, regulatory agencies world-wide, including the EU (RoSH Directive), have begun restricting its use, which has triggered a strong desire to identify new lead-free alternatives with comparable properties to those currently used. While the medical device industry is currently exempt from such restrictions (until 2019), ANT aims to be ahead of the game by developing lead-free piezomaterials in its needle guidance technology. A particular market of focus for ANT is Germany, hence having a lead-free product is consider to be a major market advantage.

The challenge for ANT, and project motivation, is to identify and characterise the most suitable lead-free piezomaterials for ANT's needle. In particular, a major aspect of ANT's in-house development is the use of computer modelling to ensure the needle actuator delivers the required performance. Current computer models can't deal with lead-free piezoceramic. The innovation takes a number of forms:

1 - ANT's active needle approach is innovative in terms of clinical practice;

2 - to date nobody has used lead free piezomaterials in a medical device and;

3 - The refinement of current computer models so that lead-free piezomaterials can be designed and manufactured."