Public Funding for Industrial Design Consultancy Limited

Severe Dry Eyes affects over 2 million people in the EU and 2 million in the US. Current treatments are generally below what is required for patient's condition. The aim of this project to create a prototype micropipette device to allow trials of a new, innovative and uniquely effective treatment for Severe Dry Eyes. The programme will research and define the core requirement and then develop a micropipette device to allow trials by a much wider patient population.

The optimum range of a \`balanced' soft tissue tension within the hip joint is not simple to determine and subjective amongst surgical professionals during hip replacement surgery. It forms the basis for intraoperative evaluation of impingement, subluxation, dislocation and prediction of postoperative functional outcome. The current approach involves a sequence of dislocating the hip joint whilst applying axial traction to gauge the tightness of the reduction. This "shuck" test is subjective and reliant upon surgeon skill and expertise requiring support from back-table surgical personnel to manually exchange multiple femoral neck and head implant trials of different sizes. This increases the opportunity for dropped tools, loss of sterility and interference with surgeon concentration during joint manipulation. Therefore, successful soft-tissue balancing contributes towards accurate leg-length and offset reducing the need for a walking aid and/or unnecessary restrictions in daily activities during recovery. Our CoxAdjust is an autoclavable easy-to-clean femoral implant trial that uses a pair of leadscrews and sixteen adjustable segments to automatically and independently adjust length, offset and head diameter respectively during soft tissue balancing. The adjustment range is comparable with existing manual trials, however, it does not require multiple exchanges to achieve a stable and balanced hip. CoxAdjust also measures the forces exerted through the joint during trial adjustment to help achieve a balance between stability and mobility for a given range of motion. Our project team brings together a large (Smith+Nephew) and a small company (Industrial Design Consultancy) with combined expertise in medical device design, manufacture and micro-actuators. Collaboration with sub-contractor(s) Strain Measurement Devices and South Tees Hospital provides access to thin-film strain gauges and clinical governance respectively. Access to SMART funding will advance CoxAdjust from a lab-demonstrator to a device tested in cadavers. A successful outcome will propel CoxAdjust for internal funding and Class IIa and 510(k) registration.

Periodontal diseases are inflammatory conditions that affect the supporting tissues of teeth and can lead to destruction of the bone support and ultimately tooth loss if untreated. The condition is treated locally by scaling and root planing. Progression of periodontitis is usually site specific but is not uniform, and currently there are no accurate clinical methods for distinguishing sites where there is active disease progression from sites that are quiescent. This results in a significant number of, unnecessary and costly treatments of non progressing periodontal sites, which potentially cause additional damage to the tooth attachment. In this project, a generic low cost non-invasive sensor system capable of more accurately identifying periods of active inflammation at point of care, has been developed. The work has resulted in a disposable sensor strip and a prototype meter capable of measuring, within a few minutes, the activity of four newly identified host and bacterial biomarkers of active inflammation in a fluid volume of 1.5 ul. The biosensor developed in this project is designed to significantly improve the efficiency of periodontitis targeted treatment options.