DEVELOPMENT OF A PULMONARY FLOW RESTRICTOR FOR HYPOPLASTIC LEFT HEART SYNDROME

用于左心发育不全综合征的肺流量限制器的开发

• 批准号: 10383607
• 负责人: Beverly Tang
• 金额: $ 44.8万
• 依托单位: STARLIGHT CARDIOVASCULAR, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-15 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383607
• 关键词: Address; American; Anatomic Models; Anatomy; Animal Testing; Animals; Biomechanics; Birth; Blood Circulation; Blood flow; Boston; Brain; Cardiopulmonary Bypass; Cardiovascular system; Catheters; Chest; Childhood; Clinical; Clinical Research; Clinical Trials; Computer Models; Congenital Heart Defects; Device Designs; Device or Instrument Development; Devices; Distal; Ductus Arteriosus; Environment; Evaluation; FDA approved; Femoral vein; Future; Grant; Growth; Hospital Costs; Hybrids; Hypoplastic Left Heart Syndrome; Implant; Intervention; Left; Left ventricular structure; Length; Length of Stay; Life; Liquid substance; Lung; Mechanics; Medical Device; Modeling; Morbidity - disease rate; Newborn Infant; Operative Surgical Procedures; Oxygen; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Phase; Procedures; Pulmonary Artery Branch; Pulmonary artery structure; Reconstructive Surgical Procedures; Research Design; Risk; Safety; Small Business Innovation Research Grant; Stents; Surgical sutures; System; Testing; Thinness; Thrombosis; Universities; Venous; Work; artery stenosis; base; clinically relevant; commercialization; cost; design; hemodynamics; implant design; improved; in silico; in vivo; innovation; lung pressure; model development; mortality; neonate; palliation; prevent; prototype; pulmonary arterial pressure; reconstruction; verification and validation

ABSTRACT Starlight Cardiovascular is developing what will be the first FDA approved percutaneous flow restrictor to replace surgical banding in congenital heart defects (CHD), including Hypoplastic Left Heart Syndrome (HLHS). The potential worldwide market for the Starlight Flow Restrictor is over $200M. Approximately 1,000 Americans are born each year with Hypoplastic Left Heart Syndrome (HLHS), a condition where the left ventricle is severely underdeveloped or barely present. Babies born with HLHS require palliation surgery, commonly a Norwood procedure, within days after birth to survive, subjecting the neonate to cardiopulmonary bypass and a costly, invasive surgery. A hybrid (half surgical and half percutaneous) palliation procedure exists as an alternative, however a limitation of the hybrid procedure is reliable branch pulmonary artery banding. Branch pulmonary artery banding requires an open surgery and can interfere with pulmonary artery growth, necessitating pulmonary artery reconstruction surgery. Attempts at modifying existing devices to create percutaneous flow restrictors to replace surgical banding produced some promising clinical results. However use of these modified devices is limited by technical challenges such as large and stiff delivery systems, long implant lengths, lack of adjustability and reliability, and designs that increase thrombosis risk. Starlight Cardiovascular is developing a percutaneous and adjustable branch pulmonary artery blood flow restrictor to replace surgical banding. Our device addresses the shortcomings from previous attempts at a percutaneous flow restrictor, by providing safe venous implant delivery, reliable flow reduction, percutaneous adjustability, beneficial hemodynamics, and a short and well anchored implant design that is removable. These pulmonary flow restrictors designed for HLHS can be modified to also replace main pulmonary artery banding, more than doubling the number of patients who could benefit. This Phase I SBIR grant will consist of computational fluid dynamics modeling and testing to inform device design, benchtop model development, and final device design selection through end-user benchtop testing by pediatric interventional cardiologists. Successful completion of this project will produce a final device design that is ready for animal testing, design refinement, and Verification and Validation testing in Phase II, which will prepare the flow restrictor device for a clinical trial, FDA Humanitarian Device Exemption approval, and commercialization.

抽象的 星光心血管公司正在开发第一个 FDA 批准的经皮限流器来替代 先天性心脏缺陷 (CHD) 的外科束带治疗，包括左心发育不全综合征 (HLHS)。这 Starlight 限流器的全球潜在市场超过 2 亿美元。 每年大约有 1,000 名美国人出生时患有左心发育不良综合症 (HLHS) 左心室严重发育不全或几乎不存在。出生时患有 HLHS 的婴儿需要姑息治疗 手术，通常是诺伍德手术，在出生后几天内进行，以保证新生儿存活 体外循环和昂贵的侵入性手术。混合（半手术和半经皮）姑息治疗 手术作为一种替代方案存在，但是混合手术的局限性是可靠的分支肺 动脉束带。肺动脉分支束带术需要开放手术，并且会干扰肺动脉 动脉生长，需要进行肺动脉重建手术。尝试修改现有设备 创建经皮限流器来取代手术束带产生了一些有希望的临床结果。 然而，这些改进设备的使用受到技术挑战的限制，例如大而僵硬的输送系统、 种植体长度长、缺乏可调节性和可靠性以及增加血栓形成风险的设计。 星光心血管正在开发经皮可调节分支肺动脉血流 限制器取代手术带。我们的设备解决了以前尝试的缺点 经皮限流器，通过提供安全的静脉植入物输送、可靠的流量减少、经皮 可调节性、有益的血流动力学以及可拆卸的短且锚定良好的植入物设计。这些 专为 HLHS 设计的肺流量限制器可以进行修改，以取代主肺动脉束带， 受益的患者数量增加了一倍以上。 第一阶段 SBIR 资助将包括计算流体动力学建模和测试，以告知设备 设计、台式模型开发以及通过最终用户台式测试进行的最终器件设计选择 儿科介入心脏病专家。该项目的成功完成将产生最终的设备设计 已准备好进行第二阶段的动物测试、设计改进以及验证和确认测试，这将 准备用于临床试验的限流装置、FDA 人道主义装置豁免批准，以及 商业化。