I-Corps: Next Generation Composite-based Interbody Cages for Spinal Fusion

这个i-Corps项目的更广泛的影响/商业潜力是开发一种具有多功能特征的新型脊柱间融合器。具体地说，这种医疗设备旨在促进椎间隙中的新骨形成，并抑制感染。这两种植入能力都是至关重要的，因为它们将加速接受脊柱融合手术的患者的康复。拟议的技术还可以降低患者的总治疗成本，因为笼子有可能消除额外蛋白质和植入涂层的使用，以及减少抗生素的使用。预计未来脊柱融合设备市场将大幅增长，拟议的技术可能会通过推出一种产品来填补一个关键空白，该产品可以以比当前疗法更低的成本提高退行性脊柱问题患者的恢复率。这个I-Corps项目基于一种医疗设备的开发，该设备使用多功能聚合物-生物陶瓷复合材料来创建脊柱椎体间融合器。先前的基础研究表明，该复合配方可以解决目前使用的聚醚醚酮(PEEK)聚合物保持架的局限性。具体地说，所提出的支架组合物可以有效地与邻近的骨结合，也可以迅速促进新骨的形成，如体外和体内模型所示。基于这些结果，提出的植入物可能会挑战传统PEEK融合器的使用，并确立PEEK-生物陶瓷复合材料融合器在脊柱融合中的优势。此外，生物陶瓷磷酸镁作为生物活性成分的加入可能会挑战其著名的对应物磷酸钙的使用。建议的植入物也可以支持聚合物-磷酸镁复合材料配方的开发，不仅用于椎间融合器，而且用于其他骨科植入物和植入物附件。如果成功，建议的技术可以确认可行性，并产生使用熔丝制造技术设计复合材料椎间保持架作为其他制造方法的替代方案所需的知识。植入物的生物力学测试可能提供设计适应市场的椎间融合器所需的必要知识。该奖项反映了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/commercial potential of this I-Corps project is the development of a new class of spinal interbody fusion cages with multi-functional features. Specifically, the medical device is designed to promote new bone formation in the intervertebral space and also inhibit infections. Both of these implant capabilities are critical as they will result in the expedited recovery of patients undergoing spinal fusion surgery. The proposed technology also may reduce the total treatment cost for patients as the cage holds the potential to eliminate the use of additional proteins and implant coatings as well as reduce the use of antibiotics. The spinal fusion device market is projected to increase substantially in the future, and the proposed technology may fill a key gap by introducing a product that may enhance the recovery rate in patients with degenerative spinal problems at a lower cost than current therapeutics.This I-Corps project is based on the development of a medical device that uses a multi-functional, polymer-bioceramic composite to create a spinal interbody fusion cage. Previous fundamental research indicated that the composite formulation may address the limitations related to the currently used polyether etherketone (PEEK) polymer cages. Specifically, the proposed cage composition may bind to neighboring bone effectively and also promote new bone formation promptly as shown using in vitro and in vivo models. Based on these results, the proposed implant may challenge the usage of traditional PEEK cages and establish the advantages of utilizing PEEK-bioceramic composite cages in spinal fusion. In addition, the inclusion of the bioceramic, magnesium phosphate, as the bioactive component may challenge the usage of its well-known counterpart, calcium phosphate. The proposed implant also may support the development of polymer-magnesium phosphate composite formulations not only for interbody cages but for other orthopedic implants and implant accessories. If successful, the proposed technology may confirm the feasibility and generate the knowledge required to use the Fused Filament Fabrication technique to design composite interbody cages as an alternative to other manufacturing methods. Biomechanical testing of the implants may provide the necessary knowledge required to design market-ready interbody cages.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.