I-Corps: Fabrication of accurate and realistic anatomical models for medical education, training, and medical device development

The University Of Central Florida Board Of Trustees, Orlando FL

Investigators

Abstract

The broader impact and commercial potential of this I-Corps project encompasses all human tissue models currently manufactured for medical education, training, surgical planning, and medical device development. Medical students, residents, surgical fellows, and physicians rely on human simulators and part-task trainers made out of silicones, rubbers, common plastics, and foams. Trainers are used for suturing, intubation, laparoscopic surgery, among others. The disparity between simulator materials and human tissues has been known to induce negative training. To satisfy this need, medical professionals and medical device engineers rely on animal and cadaveric models. These models are expensive, unreliable, and require additional protocols for handling and disposal. The lack of a solution that consolidates anatomical and physical realism leads physicians and engineers to draw conclusions by interpolating findings from several, unrealistic experiments. This I-Corps project seeks to consolidate and satisfy these needs through the development and printing of patient- or case-specific, high fidelity human tissue models. These models could disrupt the medical simulation and medical device development markets ($1.36 billion and >$300 billion respectively). 3D modeling and 3D printing manufacturers have recently received FDA 510(k) clearance for patient data modeling and fabrication, indicative of a growing medical demand. This I-Corps project is based on the premise that heterogeneous, composite structures give rise to particular physical properties in nature. In order to replicate the non-linear mechanics of human tissues for instance, composites that resemble the microstructure of tissues must be designed. The I-Corps team has developed and patented a method for the automated design and fabrication of composites with tunable physical properties (U.S. Patent No. 10,073,440). The team's patent portfolio includes three continuations to the base patent. The method shifts the paradigm of additive manufacturing from replicating form to recreating function, physical behavior. The most advanced additive manufacturing systems feature multiple materials, with varying color and compliance, and micrometer resolution. Relying on a library of geometries with known characteristics, the method can approximate the physical response of an input or target material by re-iterating through design parameters and material combination. The method builds upon itself, as each iteration expands the libraries of solutions for future targets. The resulting composite structures cannot be fabricated using traditional methods. 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.