Title: TURBOCARDIA: mechanical circulatory support installed via minimally invasive surgery
Funder: Department of Health (England)

Abstract: Milestones M ; deliverables D We will design, troubleshoot, successively modify to improve, and test in-vitro TC devices, aiming to develop a final specification and in-vitro testing of a novel MCS device ready for more animal and formal human trials (with initial compassionate use), suitable for US and UK/EU approval, and prepare for commercialisation via spin out or licensing. The design will be based on formal turbomachinery, mechanical, electrical and control-system design principles and procedures. Each successive modification of the prototype will be guided by the outputs of in-vitro testing and computations of the previous prototype. We will collect AND use research data consistent with US and EU regulatory approval processes, and assess commercialization routes. The work will be conducted by two research assistants (RA1, RA2) and a PhD student (PhD), under the supervision of the PI and co-investigators, in consultation with the Advisory Committee (AC). Over the first two years a series of 4 increasingly-optimized prototypes (four deliverables, Dx4) will be constructed and tested in vitro. The optimization stages will be guided by the results of computational and experimental in-vitro work, aiming to detailed specification of the device at the end of year 2. Mx4: each of four stages, proceed if the prototype is promising and meets performance requirements. During the 3rd year we will make final modifications and optimization to the finished prototype (D), and the then test the finished prototype in-vitro, initially a few hours at a time, then in increasing intervals of time, and finally aiming to week-long and possibly month-long durability tests. M: in-vitro tested device ready for follow-on animal tests. For the design/optimization phases during the first two years we will use prior specialty design techniques and computer programs developed by members of the proposing team, and commercially-available software. During these two years in each of four consecutive rounds of improvement (six months each) there will be a period of design/construction, followed by a period of testing and critical evaluation of improvements that must be made. Improvements of prototypes will be guided by the in-vitro results and the computations. During the third year we will embark on a final stage of miniaturization, design for installation with minimally invasive surgery (D), and in-vitro testing of the final optimized prototype. Concurrently we will be documenting the design steps, computational and experimental results, preparing a dossier for the UK/EU and USA regulatory approval processes (D), and applying for patents as described below (D). The work will be divided as follows Research assistant 1: Hydrodynamic and magnetic bearings (design, performance analysis, and prototype construction of the two types of bearings, each optimized for TC. Choice of the preferred bearing type for the final prototype) Turbomachinery components (design and construction of centrifugal impeller, including magnetic inserts at the hub, the pumping element and motor rotor) Biocompatible components (analytic reports, design specification, and interface with all components of the prototypes) Research assistant 2: motor stator (design, performance analysis, and construction of prototype) controller (design, performance analysis, integration with motor and turbomachine) transcutaneous energy transmission (TET, construction based on existing technology) PhD student Test the prototypes in our mock circulation rig, simulating the diseased native heart operating in unison with the prototype TC. Compare with computational results. At the beginning of year 3 apply for separate funding for in-vivo porcine tests from other sources. We will pursue forming a spin-out company or license the technology, and also pursue follow-on funding. We are in the process of applying for a UK patent based on stage-1 feasibility results (see invoice in the Appendix) and additional patents and dissemination will be pursued.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR