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

该I-Corps项目更广泛的影响/商业潜力是开发经导管制造平台。大规模生产的现成医疗植入物通常无法匹配人体解剖结构的几何、机械和生物特征。传统的制造技术通常涉及硬质材料，并且限于生产尺寸和形状范围有限的预定义设备。然而，人体解剖结构是由柔软而精致的组织组成的，这些组织显示出几乎无限的尺寸和形状范围，具有复杂的凸面、凹面、叶和小梁。这种严重的患者-器械不匹配导致植入物适配不良、次优治疗结局、局部组织损伤、愈合反应受损、冗长的术前工作流程以及术中和术后并发症风险升高。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，供应商和整个医疗保健系统提供更好的结果。这个I-Corps项目是基于直接在人体内生产即时、微创、患者特定植入物的制造技术的开发。设想的工具包利用材料科学、增材制造、基于导管的技术和植入式设备的技术和概念进步。 所提出的解决方案将允许临床医生在靶组织部位输送、组装和稳定软生物材料。将致密的生物聚合物结构单元流化并通过导管递送到可膨胀的生物聚合物包封层中。在目标组织处，软构建块被附加地分层成用户定义的3D形状，其自我愈合以匹配宿主解剖结构的大小和形状。最后，外部封装网提供额外的稳定性，以支持长期结构完整性和快速组织愈合和生物整合。总之，该系统可以实现自下而上的无创伤制造，个性化的3D医疗植入物在深解剖位置，而无需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，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.