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

I-Corps：微创患者专用心内植入物

• 批准号: 2402654
• 负责人: Ellen Roche
• 金额: $ 5万
• 依托单位: Massachusetts Institute of Technology
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-01-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2402654&HistoricalAwards=false
• 关键词: Corps; Minimally; invasive; Patient; specific

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.

该I-Corps项目的更广泛的影响/商业潜力是开发经导管制造平台。批量生产，现成的医疗植入物通常无法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，并且仅限于在有限尺寸和形状范围内生产预定义的设备。但是，人体解剖结构由柔软而细腻的组织组成，这些组织几乎没有限制的尺寸和形状，并具有复杂的凸，凹陷，叶和小径。这种严重的患者设备不匹配导致植入植入物不佳，最佳治疗结果，局部组织损伤，愈合受损反应，冗长的术前工作流程以及升高的风险升高。该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，提供者和整体医疗保健系统的更好结果打开大门。这个I-Corps项目基于制造技术的开发，用于直接在人体内部的护理，微创，特定于患者的植入物产生。设想的工具包利用材料科学，添加剂制造，基于导管的技术和可植入设备的技术和概念进步。 该提出的解决方案将使临床医生能够在目标组织部位运送，组装和稳定软性生物材料。密集压缩的生物聚合物构建块被流化，并通过导管传递到可扩大的生物聚合封装层中。在目标组织下，软构件在用户定义的3D形状中添加层状，以符合宿主解剖结构的大小和形状。最后，外封装网格提供了支持长期结构完整性和快速组织愈合和生物整合的额外稳定性。该系统共同可以在深层解剖位置上自下而上的个性化的3D医疗植入物，而无需进行入侵性手术或术前计划和设备选择。这项奖项反映了NSF的法定任务，并已通过评估该基金会的智力优点和广泛的影响来评估NSF的法定任务。