SBIR Phase I: Development of Production-Ready 3D Printable Cartilage Repair Device for Clinical Use

这个SBIR一期项目将研究一种用于膝关节软骨修复的新型植入式医疗器械的安全性和有效性。植入物是基于一种类似软骨的新型材料，以及3D打印设计。目前，金属关节置换是治疗膝关节软骨损伤最有效的方法。然而，符合条件的患者年龄为55岁或以上。有几种植入物适用于更年轻、更活跃的患者群体，但它们都有很大的局限性，比如成功率低、所治疗的损伤大小、恢复时间长或成本高。该项目将开发出一种能够支撑体重并促进新骨和软骨形成的植入式装置。该设备也是由高性能低成本的材料制成的，3D打印可以创建定制和定制设备，从而提高效率并进一步降低成本。一种低成本的设备，可以减少恢复时间，提高临床成功率，将大大改善年轻患者的治疗，并预防更严重的关节疾病。该项目支持NSF？通过增加骨科生物重要材料的制造和临床应用方面的知识，来完成美国的使命。这个项目将开发一个？在需求?该装置能够充分填充和支撑临界尺寸的软骨缺损，同时快速地移植到下方的软骨下骨，从而为全层软骨组织损伤的治疗提供了新的解决方案。全层软骨病变通常与低成功率和高患者发病率（意味着60%的治疗失败）相关，因为软骨下骨需要足够的血管并且与软骨移植物融合。研究人员已经使用复杂的仿生纳米材料和3D打印来创建关节修复策略。这些材料在受控的实验室环境下工作良好，但只能使用沉积或挤压的3D打印技术进行打印。与商用激光系统相比，这种类型的增材制造受到分辨率和打印速度/体积的限制。该项目的意义在于改善临床结果，使植入物在机械和生物学上更加稳定，同时也解决了这些制造和成本问题。因此，该项目将验证可植入软骨修复装置的有效性，该装置由新的组织生长材料和与选择性激光烧结兼容的设计制成，并为骨科治疗的功能性医学植入物提供关键的科学验证。

This SBIR Phase I project will investigate the safety and efficacy of a new type of implantable medical device for cartilage repair in the knee. The implant is based on a novel material that is cartilage-like, as well 3D printed designs. Currently, cartilage damage in the knee is most effectively treated by a metallic joint replacement. However, qualifying patient age is 55 or older. There are several implants available to a younger and more active patient population, but they all suffer from major limitations such as low success rate, the size of the damage they treat, long recovery time or high cost. This project will mature an implantable device that can support weight and encouraging new bone and cartilage formation. The device is also made from a high performance yet low cost material, and 3D printing can create custom made and made to order devices that increase efficiency and further reduce cost. A low-cost device which can decrease recovery time and increase clinical success would greatly improve treatment of young patients, and prevent more advanced joint disease. The project supports the NSF?s mission by increasing knowledge surrounding the manufacturing and clinical use of biologically significant materials for orthopedics. This project will develop an ?on demand? device to adequately fill and support a critical-sized cartilage defect while quickly grafting to underlying subchondral bone, thus providing a new solution to the treatment of full-thickness cartilage tissue injury. Full-thickness cartilage lesions often are associated with a low rate of success and high patient morbidity (meaning 60% treatment failure) due to the need for adequate vasculature in the subchondral bone and integration with the cartilage graft. Researchers have used complex biomimetic nanomaterials and 3D printing to create strategies for joint repair. These materials work well in a controlled laboratory setting, but as is can only be printed using deposition or extrusion-based 3D printing techniques. This type of additive manufacturing is limited by resolution and print speed / volume when compared to commercial laser-based systems. The significance of this project is tied into improving clinical outcomes, with a more mechanically and biologically stable implant, while also addressing these manufacturing and cost issues. Thus, this project will validate the efficacy of an implantable cartilage repair device, made from new tissue growth materials and designs compatible with selective laser sintering, and provide critical scientific validation of a functional medical implant for orthopedic treatment.