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项突破性的血管内传感器技术，以允许实时 二尖瓣开放和经皮二尖瓣关闭时二尖瓣粘附力的定量研究 瓣膜修复(MVR)。二尖瓣返流(MR)是美国人群中最常见的心脏瓣膜疾病， 有200多万人受到影响。目前缺乏在手术期间评估MVR完成情况的方法， 导致多达25%的患者在手术后出现复发的MR。新技术必须是 开发的目的是允许外科医生在手术中评估MCF，以改善MVR和长期结果。 建议的装置MitralPrint是一种血管内导丝，其远端带有印刷的压电传感器 小费。它被设计成插入二尖瓣的瓣叶内，以实时测量MCF。这是一项创新 该设备将允许外科医生识别修复问题并确认成功完成MVR，这 最终通过减少MR复发来改善患者的长期结果。该设备建立在 MitralPrint团队已经进行了大量工作，包括USPTO/PCT临时 专利，以及在猪心内进行体外试验。 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，贯穿提案的整个时间线。此流程将通过1)台式测试告知 验证传感器功能和设备可用性，2)在心脏模拟器中进行体外测试，以评估 获取猪二尖瓣的MCF数据，并使用该数据来判断MR状态，以及3)活体安全性和 在活体动物猪模型中进行可行性测试，包括确定“健康的”母婴传播函数的范围。 该项目代表了一种创新的解决方案，满足了明确的临床需求。该团队代表了所有关键方面 确保项目成功所需的条件：医疗设备开发、传感器工程熟练程度以及 心血管外科专业知识。该办法在预期的时间表和预算内是可行的，而且是不可行的。 冒着风险通过先前的工作和经验丰富的顾问。

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.