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

开发一种实时测量二尖瓣接合力的新型传感器

• 批准号: 10601890
• 负责人: Daniel Grinberg
• 金额: $ 29.96万
• 依托单位: MITRALPRINT INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10601890
• 关键词: Adoption; Adverse event; Affect; Animals; Anterior; Area; Budgets; Cardiac Surgery procedures; Cardiovascular Surgical Procedures; Cessation of life; Clinical; Data; Detection; Development; Device Designs; Device or Instrument Development; Devices; Diagnostic; Distal; Echocardiography; Engineering; Ensure; Exclusion; Family suidae; Freezing; Future; Goals; Heart; Heart Valve Diseases; Heart failure; Individual; Interruption; Intervention; Legal patent; Measurement; Measures; Medical Device; Methodology; Methods; Mitral Valve; Mitral Valve Insufficiency; Modeling; Morphology; Normal Range; Operative Surgical Procedures; Outcome; Pathologic; Patient-Focused Outcomes; Patients; Phase; Population; Prevalence; Printing; Process; Ptosis; Recording of previous events; Recurrence; Risk; Seasons; Serious Adverse Event; Surface; Surgeon; Techniques; Technology; Testing; Time; Work; comorbidity; data acquisition; design; experience; experimental study; falls; feasibility testing; flexibility; force sensor; improved; in vivo; in vivo evaluation; innovation; mortality; multidisciplinary; new technology; novel; operation; patient population; porcine model; pressure; pressure sensor; prevent; procedure safety; prototype; repaired; safety and feasibility; sensor; sensor technology; success; temporal measurement; timeline; valve replacement

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.

项目概要 拟议的项目将开发突破性的血管内传感器技术，以实现实时 开放和经皮二尖瓣手术期间二尖瓣接合力 (MCF) 的量化 瓣膜修复（MVR）。二尖瓣反流（MR）是美国人群中最常见的心脏瓣膜疾病， 目前有超过 200 万人受到影响，目前缺乏评估手术期间 MVR 完成情况的方法， 导致高达 25% 的患者在手术后出现复发性 MR。必须采用新技术。 开发的目的是让外科医生在手术期间评估 MCF，以改善 MVR 和长期结果。 所提出的设备 MitralPrint 是一种血管内导丝，其远端带有印刷压电传感器 它设计用于插入二尖瓣小叶内以实时测量 MCF。 设备将使外科医生能够识别修复问题并确认 MVR 成功完成，这 该设备以减少 MR 复发为基础，最终改善患者的长期预后。 MitralPrint 团队已经开展了大量工作，包括 USPTO/PCT 临时文件 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，最终导致设备的工程冻结 设计，整个提案的时间表将通过 1) 台式测试来通知。 验证传感器功能和设备可用性，2) 在心脏模拟器中进行离体测试以评估可行性 获取猪二尖瓣的 MCF 数据并使用该数据判断 MR 状态，以及 3) 体内安全性和 在活体猪模型中进行可行性测试，包括确定“健康”MCF 的范围。 该项目代表了针对明确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能力：医疗设备开发、传感器工程熟练程度，以及 该方法在预期的时间和预算内是可行的，并且是可行的。 通过之前的工作和经验丰富的顾问承担风险。