Development of a novel sensor for the real-time measurement of mitral coaptation force

Project Summary The proposed project will develop a breakthrough endovascular sensor technology to allow for real-time quantification of the mitral coaptation force (MCF) of the mitral valve during both open and percutaneous mitral valve repair (MVR). Mitral regurgitation (MR) is the most common heart valve disorder in the U.S. population, with over 2 million individuals affected. Current methods to assess MVR completion during surgery are lacking, resulting in up to 25% of patients developing recurrent MR following surgery. New technologies must be developed to allow surgeons to assess MCF during surgery in order to improve MVR and long term outcomes. The proposed device, MitralPrint, is an endovascular guidewire with printed piezoelectric sensors on its distal tip. It is designed to be inserted within the leaflets of the mitral valve to measure MCF in real-time. This innovative device will allow surgeons to identify repair issues and confirm the successful completion of MVR, which ultimately improves long term outcomes for patients by reducing MR recurrence. This device builds upon a substantial amount of work already conducted by the MitralPrint team, including a USPTO/PCT provisional patent, and ex vivo testing within a porcine heart. The project will involve iterative prototype development, ultimately leading to an engineering freeze of the device design, throughout the timeline of the proposal. This process will be informed through 1) benchtop testing to validate sensor function and device useability, 2) ex vivo testing in a heart simulator to assess the feasibility of acquiring MCF data in a porcine mitral valve and using this data to judge MR status, and 3) in vivo safety and feasibility testing in a live animal porcine model, including determining the range of “healthy” MCF. This project represents an innovative solution to a clear clinical need. The team represents all key aspects required to ensure success of the project: medical device development, sensor engineering proficiency, and cardiovascular surgical expertise. The approach is feasible within the anticipated timeline and budget, and is de- risked through prior work and seasoned advisors.