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

项目摘要 拟议的项目将开发一种突破性的血管内传感器技术， 在开放和经皮二尖瓣成形术期间，二尖瓣的二尖瓣对合力（MCF）的量化 瓣膜修复术（MVR）。二尖瓣返流（MR）是美国人群中最常见的心脏瓣膜疾病， 超过两百万人受到影响目前缺乏在手术期间评估MVR完成的方法， 导致高达25%的患者在手术后复发MR。新技术必须 开发用于允许外科医生在手术期间评估MCF，以改善MVR和长期结局。 申报器械MitralPrint是一种远端带有印刷压电传感器的血管内导丝 tip.其设计用于插入二尖瓣瓣叶内，以实时测量MCF。这一创新 器械将允许外科医生识别修复问题并确认MVR的成功完成， 通过减少MR复发，最终改善患者的长期结局。该设备建立在 MitralPrint团队已经进行了大量工作，包括USPTO/PCT临时工作 专利，以及猪心脏内的离体测试。 该项目将涉及迭代原型开发，最终导致该设备的工程冻结 设计，贯穿于提案的整个时间轴。该过程将通过1）台架测试进行通知， 确认传感器功能和器械可用性，2）在心脏模拟器中进行体外测试，以评估 采集猪二尖瓣中的MCF数据并使用该数据判断MR状态，以及3）体内安全性， 在活体动物猪模型中进行可行性测试，包括确定"健康" MCF的范围。 该项目代表了一个明确的临床需求的创新解决方案。该团队代表了所有关键方面 确保项目成功所需的：医疗器械开发，传感器工程熟练程度，以及 心血管外科专业知识。该方法在预期的时间轴和预算范围内是可行的，并且是可持续的。 通过之前的工作和经验丰富的顾问冒险。

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.