I-Corps: Minimally-invasive Patient-specific Intracardiac Implants

I-Corps项目更广泛的影响/商业潜力是开发一个经导管制造平台。大量生产的、现成的医疗植入物往往不能与人体解剖结构的几何、机械和生物学特征相匹配。传统的制造技术通常涉及硬材料，并且仅限于在有限的尺寸和形状范围内生产预先定义的设备。然而，人体解剖结构是由柔软而精致的组织组成的，其大小和形状几乎是无限的，具有复杂的凸、凹、叶和小梁。这种严重的患者-器械不匹配导致植入物贴合不良，治疗效果不佳，局部组织损伤，愈合反应受损，手术前工作流程冗长，手术前后并发症风险增加。这一愿景的成功实现将代表医疗制造技术的范式转变，并为患者、提供者和整个医疗保健系统带来更好的结果。这个I-Corps项目的基础是开发一种制造技术，用于直接在人体内制造即时护理、微创、针对患者的植入物。设想的工具包利用了材料科学、增材制造、导管技术和植入式设备方面的技术和概念进步。提出的解决方案将允许临床医生在目标组织部位提供，组装和稳定软生物材料。致密压实的生物聚合物构建块流化并通过导管输送到可膨胀的生物聚合物包封层中。在目标组织中，软构建块被加层成用户定义的3D形状，可以自愈以匹配宿主解剖结构的大小和形状。最后，外层封装网提供了额外的稳定性，以支持长期的结构完整性和快速的组织愈合和生物整合。总之，该系统可以在深层解剖位置实现自底向上的无伤大雅、个性化3D医疗植入物的制造，而无需进行侵入性手术或术前计划和设备选择。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 I-Corps project is the development of a transcatheter manufacturing platform. Mass-produced, off-the-shelf medical implants often fail to match the geometric, mechanical, and biological characteristics of human anatomy. Traditional manufacturing techniques typically involve hard materials and are restricted to producing pre-defined devices in a limited range of sizes and shapes. However, human anatomy is composed of soft and delicate tissues displaying a virtually-limitless range of sizes and shapes with complex convexities, concavities, lobes, and trabeculations. This profound patient-device mismatch leads to poorly-fitting implants, sub-optimal treatment outcomes, local tissue damage, impaired healing responses, lengthy pre-procedural workflows, and elevated risk for peri- and post-procedural complications. Successful realization of this vision would represent a paradigm shift in medical manufacturing technology and open the door for better outcomes for patients, providers, and the overall healthcare system. This I-Corps project is based on the development of a manufacturing technology for point-of-care, minimally-invasive, patient-specific implant generation directly inside the human body. The envisioned toolkit leverages technical and conceptual advancements in materials science, additive manufacturing, catheter-based technologies, and implantable devices. The proposed solution will allow clinicians to deliver, assemble, and stabilize soft biomaterials at the target tissue site. Densely-compacted biopolymeric building blocks are fluidized and delivered via catheter into a distensible biopolymeric encapsulation layer. At the target tissue, the soft building blocks are additively-layered into user-defined 3D shapes that self-heal to match the size and shape of the host anatomy. Finally, the outer encapsulation mesh provides additional stability to support long-term structural integrity and rapid tissue healing and bio-integration. Together, this system could enable bottom-up fabrication of atraumatic, personalized 3D medical implants in deep anatomic locations without any need for invasive surgery or pre-procedural planning and device selection.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.