Development of a pediatric transcatheter pulmonary valve system

儿科经导管肺动脉瓣系统的开发

• 批准号: 9141781
• 负责人: Thuy M Pham
• 金额: $ 19.97万
• 依托单位: SUTRA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-15 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9141781
• 关键词: Accounting; Achievement; Acute; Address; Adult; Anatomy; Animal Experiments; Animals; Biomechanics; Biotechnology; Blood flow; Cadaver; Caliber; Cardiac Surgery procedures; Catheters; Cattle; Child; Childhood; Chronic; Clinical; Congenital Heart Defects; Connecticut; Data; Development; Device Designs; Devices; Disease; Dura Mater; Failure; Family suidae; Fatigue; Fracture; Functional disorder; Goals; Guidelines; Heart; Heart Abnormalities; Heart Valves; Hospitals; Human; Implant; Investments; Label; Lung; Manufacturer Name; Marketing; Mechanics; Medical Device Designs; Methods; Modeling; Obstruction; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Positioning Attribute; Psychological reinforcement; Pulmonary Valve Insufficiency; Pulmonary valve structure; Reporting; Safety; Series; Small Business Innovation Research Grant; Specific qualifier value; Stents; Stress; Structure; Structure of jugular vein; Suspension substance; Suspensions; System; Technology; Testing; Thick; Toxicology; Ventricular; Work; biomaterial compatibility; clinical application; design; experience; implantation; improved; in vitro testing; in vivo; innovation; meetings; novel; patient population; pediatric patients; prototype; public health relevance; pulmonary valve replacement; verification and validation

 DESCRIPTION (provided by applicant): Approximately 40,000 babies in the US and over 1 million babies worldwide each year are born with congenital heart defect (CHD). It is estimated that 20% of CHD children have specific heart defects that involve the right ventricular outflow tract (RVOT) and pulmonary valve. These pediatric patients are typically subjected to multiple invasive open-heart surgeries throughout their lifetime in order to reestablish normal blood flow from the heart to the lungs. Transcatheter pulmonary valve replacement (TPVR) is emerging as a safe, less invasive alternative to surgical procedure. However, the only available TPVR device in the market, the Melody valve from Medtronic, has several limitations: it can only be used for patients who have a pulmonary diameter less than 24.5 mm and does not have a larger size valve; the device is a bulky device with a 22 Fr delivery system, which cannot be used for small pediatric patients; and its stent fracture has been extensively reported. Thus, there is a clear unmet market need for a TPVR device with smaller crimped profile, larger size and good durability. Building upon extensive academic, clinical and industrial experiences on heart valve biomechanics and medical device designs, the team at Dura Biotech has invented Dura Valve Leaflet Technology (DVLT) for developing low profile TPVRs that could fit within the various anatomic configurations across a range of pulmonic diameters that extended from young child to full adult size. The novel DVLT design-adding the reinforcement suspension structures on the valve leaflets-can elegantly reduce leaflet thickness without increasing leaflet peak stress concentration, which is a key factor influencing mechanical damage leading to valve leaflet failure. With the DVLT design, TPVR device can be smaller with thinner leaflets while maintaining durability. The goal of this SBIR Fast-Track project is to develop and commercialize this paradigm- changing Dura TPVR device. In phase 1 of the project, we proposed to finalize the valve and stent designs of the TPVR device through a series of computational and experimental tests to meet customer requirements as well as all criteria specified by the Federal Drug Administration (FDA). In phase 2, the entire finalized TPVR system will be subjected to verification-and-validation tests and then evaluated for feasibility and safety through an animal study. Lastly, Dura Biotech will develop a strategy for quality system initiation and prepare for regulatory submission to FDA. Successful completion of this project will yield an innovative TPVR device to treat an untapped population of patients with RVOT and PV diseases and improve patient outcomes.

 描述（由申请人提供）：美国每年约有 40,000 名婴儿，全世界有超过 100 万婴儿出生时患有先天性心脏病 (CHD)。据估计，20% 的先心病儿童患有特定的心脏缺陷，涉及右心室流出道 (RVOT) 和肺动脉瓣。这些儿科患者通常在一生中接受多次侵入性心脏直视手术，以重建从心脏到肺部的正常血流。 经导管肺动脉瓣置换术 (TPVR) 正在成为一种安全、侵入性较小的外科手术替代方案。然而，市场上唯一可用的TPVR设备，即美敦力公司的Melody瓣膜，有几个局限性：它只能用于肺直径小于24.5毫米且没有更大尺寸瓣膜的患者；该设备体积庞大，配有 22 Fr 输送系统，无法用于小型儿科患者；其支架断裂已被广泛报道。因此，对于具有更小压接轮廓、更大尺寸和良好耐用性的TPVR装置，显然存在未满足的市场需求。基于心脏瓣膜生物力学和医疗设备设计方面的丰富学术、临床和工业经验，Dura Biotech 团队发明了 Dura 瓣膜小叶技术 (DVLT)，用于开发薄型 TPVR，该 TPVR 可以适应从幼儿到成人大小的各种肺直径范围内的各种解剖结构。新颖的DVLT设计——在瓣叶上添加加强悬挂结构——可以在不增加瓣叶峰值应力集中的情况下优雅地减小瓣叶厚度，而峰值应力集中是影响导致瓣叶失效的机械损伤的关键因素。通过 DVLT 设计，TPVR 装置可以更小、瓣叶更薄，同时保持耐用性。 该 SBIR Fast-Track 项目的目标是开发这种改变范式的 Dura TPVR 设备并将其商业化。在项目的第一阶段，我们建议通过一系列计算和实验测试来最终确定 TPVR 装置的瓣膜和支架设计，以满足客户的要求以及美国联邦药物管理局 (FDA) 规定的所有标准。在第二阶段，整个最终确定的 TPVR 系统将接受验证和确认测试，然后通过动物研究评估可行性和安全性。最后，Dura Biotech 将制定质量体系启动战略，并准备向 FDA 提交监管报告。该项目的成功完成将产生一种创新的 TPVR 设备，用于治疗尚未开发的 RVOT 和 PV 疾病患者群体，并改善患者的治疗效果。