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 星光心血管正在开发第一个FDA批准的经皮流量限制器来替换 先天性心脏缺陷（CHD）中的手术带，包括左心脏综合征（HLHS）。这 星光流量限制仪的潜在全球市场超过2亿美元。 每年大约有1,000名美国人出生，患有左心脏综合征（HLHS），这种情况 左心室严重发育不足或几乎没有存在的地方。患有HLHS的婴儿需要抚慰 外科手术，通常是诺伍德手术，在生存后的几天之内 心肺旁路和昂贵的侵入性手术。杂交（半手术和半经皮）palliation 程序是作为替代方案而存在的，但是杂交程序的局限性是可靠的分支肺部 动脉带。分支肺动脉带需要开放手术，并且会干扰肺部 动脉生长，需要进行肺动脉重建手术。尝试将现有设备修改为 创建经皮流量限制器来替代手术带可产生一些有希望的临床结果。 但是，这些修改设备的使用受到技术挑战的限制，例如大而僵硬的交付系统， 植入长度长，缺乏可调节性和可靠性，以及增加血栓形成风险的设计。 星光心血管正在发展经皮且可调的分支肺动脉流动 限制器以替换手术带。我们的设备解决了以前尝试的缺点 经皮流量限制仪，通过提供安全的静脉植入物输送，可靠的流量，经皮。 可调性，有益的血液动力学以及可移动的短而锚定的植入物设计。这些 为HLHS设计的肺流量限制器可以修改以替代主肺动脉带， 可以使受益的患者人数增加一倍以上。 此阶段I SBIR赠款将包括计算流体动力学建模和测试以告知设备 设计，台式模型开发和最终设备设计选择，通过最终用户台式测试 小儿介入心脏病学家。该项目的成功完成将产生最终的设备设计 准备进行动物测试，设计精致，验证和验证测试，这将 为临床试验，FDA人道主义设备豁免批准和 商业化。