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

这一创新技术转化伙伴关系(PFI-TT)项目的更广泛影响/商业潜力是一种基于导管的微创心脏瓣膜修复方法。目前，瓣膜修复的标准手术是心内直视手术，只有可以接受手术的患者才能接受。心内直视手术有很大的风险和恢复要求。拟议中的原型集成了三维打印和磁性组装，使植入物能够通过被称为导管的细管部署，可以将替换的瓣膜放置在心脏中，满足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。这一新方法将扩大心脏瓣膜修复的机会，特别是二尖瓣，扩大到心脏直视手术风险太高的患者。心脏瓣膜置换术的需求正在增长，这种新的方法将通过解决未得到满足的需求来进一步增加市场。三维打印可以提供不同尺寸的植入物，以适应不同的患者，而患者体内的磁性组件是一个未被探索的概念，具有更广泛的外科和介入应用的潜力。拟议的项目将导致一种新型的瓣环成形环的原型，该环通过三维打印制造并包括磁体，允许在二尖瓣内进行磁引导组装。环状成形术环设计用于通过导管进行经皮给药和使用基于导管的工具进行操作。组装后，环将固定在二尖瓣环上，内部机构将接合以减小环的直径，从而改善瓣叶的粘合和治疗二尖瓣返流。心脏跳动时可调直径缩小的能力，是标准心脏直视手术的独特优势。将通过设计、制造和测试组织模体和猪心的结构来研究磁性组装和减小直径的机制。进行该项目的材料研究人员、临床医生和企业家组成的跨学科团队将选择同时满足制造和材料特性要求的设计，具有通过导管传递的紧凑设计，并且易于翻译。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.