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

这个i-Corps项目的更广泛的影响/商业潜力是开发一个经导管制造平台。批量生产的现成医用植入物往往无法与人体解剖学的几何、机械和生物学特征相匹配。传统的制造技术通常涉及硬质材料，并被限制在生产有限尺寸和形状的预定义设备。然而，人体解剖学是由柔软和精致的组织组成的，显示出几乎无限的大小和形状，具有复杂的凸起、凹陷、叶和小梁。这种严重的患者-设备不匹配导致植入物不合适、治疗结果不佳、局部组织损伤、愈合反应受损、冗长的术前工作流程以及术前和术后并发症的风险增加。这一愿景的成功实现将代表着医疗制造技术的范式转变，并为患者、提供者和整个医疗系统打开更好的结果之门。这个i-Corps项目是基于一种制造技术的开发，该技术用于直接在人体内产生护理点、微创、针对患者的植入物。设想的工具包利用了材料科学、添加剂制造、基于导管的技术和可植入设备方面的技术和概念上的进步。建议的解决方案将允许临床医生在目标组织部位交付、组装和稳定软生物材料。密实的生物聚合物构建块被流态化，并通过导管输送到可膨胀的生物聚合物封装层。在目标组织处，软构建块被添加到用户定义的3D形状中，该3D形状可以自我修复以匹配宿主解剖的大小和形状。最后，外包裹网状物提供额外的稳定性，以支持长期的结构完整性以及快速的组织愈合和生物整合。总而言之，该系统可以在深解剖位置自下而上地制造无创、个性化的3D医疗植入物，而不需要任何侵入性手术或术前规划和设备选择。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 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.