Title: Anti-bacterial 'Fill & Flush' Urinary Catheter Development
Funder: Department of Health and Social Care

Abstract: The main objective is to deliver maximum Patient Benefit in the shortest time. The developments to date are ultrasonic cutting, an anti-bacterial, embedded nano-silver polymer and a simple valve. 'Evaluation demonstrated this valve prevented any intraluminal migration of Proteus mirabilis for >14 days, demonstrating its inclusion could reduce bladder infections >50%. Tests on the eyelets and nano-silver polymer produced equally impressive results - Dr Nicola Morris, Research Manager, BUI. Of these, the valve element should provide the most immediate benefit of - reduced infections. - reduced loss of bladder control (incontinence). As the valve is external to the body it is classified under MHRA a Class 2 device requiring less stringent testing saving time and money and is safer for Patients. Testing of the valve currently manufactured (without any anti-bacterial embedded nano-silver) will be the highest priority. Once completed this can be a separate device, easily manufactured and distributed. Following full development and testing of the valve, the ultrasonic cutting and the anti-bacterial polymer elements will be combined with the valve and then into the remaining elements of the standard Foley type catheter e.g. eyelets, lumen etc. It is important to note that other devices, developments and patents typically only produce benefit for a small portion of all potential Patients 'groups'. Due to the flexibility of the range of pressures the valve can be manufactured to, it shows potential to provide benefit across a much wider range of Patients (6,7,8) e.g. - in-patient or home based. - conscious or un-conscious. - child, adult or elderly. - a wide range of bladder dysfunction. - ambulatory or wheel-chair users. It is not within the scope of this research plan to develop products for all these potential Users. The early results of the 'First in Human' trials development will, however, determine which 'groups' should be addressed and in which order to balance.. - maximised Patient benefit per 'group'. with - maximum potential commercial benefits in order to attract commercial manufacturers and distributors. The eventual aim is to provide the smallest range of 'standard' valves covering the maximum number of Patients for the most effective cost / benefit ratio. Further commercially led research will determine costs associated with providing valves for more 'specialised groups'. Outline Project Plan & Milestones Trials Planning and Scoping - IRAS Ethics Committee Application. - MHRA Class 2 Device Application. - Identify overall scales and Patient groups. - Map groups to valve specifications. - Order/produce additional valves if required. - Produce valve components. First in Human Trials - Initial limited trial to identify potential valve problems. - Analyse results and adjust valve accordingly. - Full Patient Trials. - Analysis of results. - Cost / Benefits analysis. Ultrasonic cutting and welding - Valve - Study of LMS Aptar experience. - Valve - Rainbow to conduct trials, review & implement results. - Holder &ndash; Development of cutting and welding tools. - Holder- Testing samples. - Assembly &ndash; Laboratory testing for bacterial encrustation by BUI. Nano-silver polymer (silicone) - Study of previous QMUL development in silicone. - Refinement of QMUL process. - Develop samples for testing by Raumedic AG. - Analysis of results. - Scalability of results. - Scaled production by Raumedic AG. - Laboratory testing for bacterial encrustation by BUI. Combination of Elements - Sample assemblies of ultrasonically cut nano-silver embedded silicone valve and holder. - Laboratory testing for bacterial encrustation by BUI. Commercialisation - Cost of manufacture / Sale price etc. - Route(s) to market. - IP Protection - Assessment of competition at that stage. - Choice of manufacturer(s). - Licensing agreement(s). - Establishment of UK company for marketing / sales.

Lay abstract: Infections from indwelling urinary catheters are the second greatest cause of hospital acquired infection leading, each year, in the UK to 3000 deaths, 250,000 serious infections and healthcare costs of &pound;500m. A similar scale of problem exists among those 90,000 long-term catheter users in Care Homes or based at home. The Team has developed three discreet, but combinable, elements to significantly reduce infections and prevent loss of bladder control. These have been tested in laboratory conditions which show that .. Specialised cutting of the catheter eyelets stops bacteria building-up for more than three days. An new anti-bacterial plastic used for the catheter tube, stops bacteria for more than seven days. A simple valve allowing the bladder to naturally fill and flush stops bacteria for more than fourteen days. These developments now need to be tested in humans under hospital conditions to ensure they are safe and to provide data to measure the human and financial benefits from introducing them into the NHS. This research focuses on testing the valve, which should produce the quickest and the majority of the benefits. The valve is placed outside of the body, either without a drainage bag, or between the catheter tube and the drainage bag by standard twist connectors. This placement ensures simplest Device Approval under Medical & Healthcare Products Regulatory Authority (MHRA). It requires the least amount of human testing, saving time and money, allowing it to be introduced quickly maximising the patient and financial benefits. Patients that can benefit are in hospital recovering from surgery or medical conditions such as stroke. They may be conscious or un-conscious and all ages and sizes. Patients who are in Care Homes or based at home will also be represented in the trials. Patient and Public Involvement (PPI) is a priority throughout the research.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INFECTION