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

“Active Needle Technology Limited”“Ant”是一种专门的高频振动针的开发商，旨在减少与超声引导介入手术相关的针头放置错误。这将节省时间，降低NHS和其他医疗保健提供者的成本负担，并减少患者因医疗程序(活检或硬膜外)失败而返回的需要。蚂蚁团队已经进入了这种振动针的预生产原型阶段。蚂蚁的发展道路因近期的环境和监管障碍而受阻。为了工作，针必须快速振动，而这些振动是由一种特殊的陶瓷材料(压电材料)提供的，这种陶瓷材料含有大量的铅。这种大量的铅含量在加工过程中会造成危险，限制了应用(例如，体内)，并且在处置过程中对环境有害。作为回应，世界各地的监管机构，包括欧盟(Rosh Directive)，已经开始限制其使用，这引发了人们强烈的愿望，即寻找性能与当前使用的产品类似的新的无铅替代品。虽然医疗器械行业目前不受此类限制(到2019年)，但蚂蚁金服的目标是在其针导引技术中开发无铅压电材料，从而走在游戏的前列。蚂蚁特别关注的一个市场是德国，因此拥有无铅产品被认为是一个主要的市场优势。蚂蚁面临的挑战和项目动机是确定和表征最适合蚂蚁针的无铅压电材料。特别是，蚂蚁内部开发的一个主要方面是使用计算机建模来确保针执行器提供所需的性能。目前的计算机模型不能处理无铅压电陶瓷。这项创新有许多形式：1-蚂蚁的主动针方法在临床实践方面是创新的；2-到目前为止还没有人在医疗设备中使用无铅压电材料；3-改进现有的计算机模型，以便可以设计和制造无铅压电材料。

"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."