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

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.