PFI-TT: Three-Dimensional Printing and Magnetic Assembly for Minimally Invasive Cardiac Surgery

这项创新技术转化伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是一种微创、基于导管的心脏瓣膜修复方法。目前，瓣膜修复的标准手术是心内直视手术，这只适用于接受手术的患者。心内直视手术有很大的风险和康复要求。拟议的原型集成了三维打印和磁性组装，使植入物通过被称为导管的细管部署成为可能，这种导管可以将替代瓣膜放置在心脏中，解决了心内直视手术的需求，并有可能提供更有效的治疗血液回流到心脏。这种新方法将扩大心脏瓣膜修复的机会，特别是二尖瓣修复，对于那些接受心脏直视手术风险太高的患者来说。心脏瓣膜置换术的需求正在增长，这种新方法将通过解决未满足的需求进一步增加市场。三维打印可以为患者提供不同尺寸的植入物，而患者体内的磁性组装是一个尚未开发的概念，具有更广泛的外科和介入性应用潜力。拟议的项目将产生一种新型环形成形术环的原型，该环形成形术环通过三维打印制造，包括磁铁，允许在二尖瓣内进行磁力引导组装。环形成形术环是设计用于经皮输送通过导管和导管为基础的工具操作。装配后，将环固定在二尖瓣的环空上，并采用内部机制减小环的直径，从而改善小叶的配合，治疗二尖瓣反流。当心脏跳动时，可调节的直径缩小的能力是标准的心内直视手术的独特优势。磁性组装和直径减小的机制将通过设计、制造和测试组织幻影和猪心脏的结构来研究。由材料研究人员、临床医生和企业家组成的跨学科团队进行该项目的设计将同时满足制造和材料特性的要求，具有通过导管输送的紧凑设计，并且易于翻译。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project is a minimally invasive, catheter-based approach for repairing heart valves. Currently, the standard surgery for valve repairs is an open-heart surgery, which is only available to patients who are acceptable surgical candidates. Open-heart surgery has significant risk and recovery requirements. The proposed prototype integrates three-dimensional printing and magnetic assembly to make possible deployment of implants through thin tubes known as catheters that can place the replacement valve in the heart, addressing the need for open-heart surgery and potentially providing more effective treatment of blood back flow into the heart. This new approach will expand access to heart valve repairs, specifically the mitral valve, to patients for whom the risk of open-heart surgery is too high. The need for heart valve replacement is growing, and this new approach will further increase the market by addressing unmet needs. Three-dimensional printing can provide implants with different sizes for custom fits to individual patients, and magnetic assembly inside patients is an under-explored concept that has potential for wider surgical and interventional applications.The proposed project will result in a prototype for a novel annuloplasty ring that is fabricated through three-dimensional printing and includes magnets, allowing for magnetically guided assembly within the mitral valve. The annuloplasty ring is designed for percutaneous delivery through a catheter and manipulation with catheter-based tools. Following assembly, the ring will be anchored to the annulus of the mitral valve, and an internal mechanism will be engaged to reduce the diameter of the ring, thus improving coaptation of the leaflets and treating mitral valve regurgitation. The capability for tunable diameter reduction, while the heart is beating, is a unique advantage over the standard open-heart surgery. Mechanisms for magnetic assembly and diameter reduction will be investigated by designing, fabricating, and testing structures on tissue phantoms and pig hearts. The interdisciplinary team of materials researchers, clinicians, and entrepreneurs conducting this project will choose designs that simultaneously meet requirements for manufacturing and material properties, have a compact design for delivery through catheters, and are straightforward to translate.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.