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

这个i-Corps项目的更广泛的影响和商业潜力涵盖了目前为医学教育、培训、手术规划和医疗器械开发而制造的所有人体组织模型。医学生、住院医生、外科研究员和医生依靠由硅胶、橡胶、普通塑料和泡沫制成的人体模拟器和兼职训练器。训练器用于缝合、插管、腹腔镜手术等。众所周知，模拟器材料和人体组织之间的差异会导致消极训练。为了满足这一需求，医疗专业人员和医疗器械工程师依赖于动物和身体模型。这些型号昂贵、不可靠，并且需要额外的处理和处置协议。缺乏整合解剖学和物理现实主义的解决方案，导致医生和工程师通过插入几个不切实际的实验的结果来得出结论。这个i-Corps项目寻求通过开发和打印针对患者或病例的高保真人体组织模型来巩固和满足这些需求。这些模式可能会扰乱医疗模拟和医疗器械开发市场(分别为13.6亿美元和3000亿美元)。3D建模和3D打印制造商最近获得了FDA 510(K)对患者数据建模和制造的许可，这表明医疗需求不断增长。这个i-Corps项目基于这样的前提，即异质、复合结构在自然界中会产生特定的物理特性。例如，为了复制人体组织的非线性力学，必须设计出类似于组织微结构的复合材料。I-Corps团队开发了一种用于自动设计和制造具有可调物理性能的复合材料的方法并获得了专利(美国专利号10073,440)。该团队的专利组合包括三项基础专利的续展。该方法将加法制造的范式从复制形式转变为重新创造功能和物理行为。最先进的添加剂制造系统具有多种材料，具有不同的颜色和顺应性，以及微米分辨率。该方法依赖于具有已知特征的几何库，通过反复迭代设计参数和材料组合来近似输入或目标材料的物理响应。该方法建立在自身的基础上，因为每次迭代都会为未来的目标扩展解决方案库。这一奖项反映了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 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.