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

I-Corps项目更广泛的影响/商业潜力是开发一种具有多功能特征的新型脊柱椎间融合器。具体来说，该医疗装置旨在促进椎间隙的新骨形成，并抑制感染。这两种植入物的功能都是至关重要的，因为它们将加速脊柱融合手术患者的恢复。提出的技术还可以降低患者的总治疗成本，因为笼具有消除使用额外蛋白质和植入物涂层以及减少抗生素使用的潜力。脊柱融合装置市场预计将在未来大幅增长，拟议的技术可能会填补一个关键的空白，通过引入一种产品，可以提高退行性脊柱问题患者的康复率，比目前的治疗方法成本更低。这个I-Corps项目是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制造脊柱椎间融合器。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）聚合物笼的局限性。具体而言，所提出的笼式组合物可以有效地与邻近骨结合，并迅速促进新骨形成，如体外和体内模型所示。基于这些结果，所提出的植入物可能会挑战传统PEEK保持器的使用，并确立PEEK-生物陶瓷复合保持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包含可能会挑战其众所周知的对应物，磷酸钙的使用。所建议的植入物也可以支持聚合物-磷酸镁复合制剂的发展，不仅用于体间保持器，而且用于其他骨科植入物和植入物附件。如果成功，所提出的技术可能会证实可行性，并产生使用熔融长丝制造技术来设计复合体间保持架所需的知识，作为其他制造方法的替代方案。植入物的生物力学测试可以为设计市场就绪的椎间固定器提供必要的知识。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.