SBIR Phase I: Nanotechnology-Enabled Implant for Controlling Intraocular Pressure

这个SBIR第一阶段项目旨在通过开发和测试世界上最薄的眼球植入物来改善开角型青光眼(OAG)患者的手术治疗。OAG是最常见的青光眼形式，是世界上导致不可逆转失明的主要原因。到2020年，美国将有340万人患有青光眼，全球将有8000万人患有青光眼。在美国，青光眼每年造成超过40亿美元的医疗和社会成本。对于青光眼患者，升高的眼压必须降低，以保护视神经免受损害。然而，传统的外科植入物治疗方法体积大、侵入性强，并会引起慢性不适。虽然较新、较小的设备侵入性较小，但它们存在长期疗效问题，因为它们在疤痕形成时不足以维持较低的眼压。该项目将开发一种比人类头发细许多倍的植入物，以安全地减少眼压，同时将患者不适和疤痕造成的失败风险降至最低。这种由纳米技术驱动的设备将通过机械和材料工程的组合来设计，以促进生物兼容性、患者舒适度和医生插入。除了在青光眼中的应用，开发的技术将在未来永久有效的眼科植入物--一种快速增长的视力护理组成部分--方面发挥关键作用。这项创新涉及对用于治疗青光眼的超薄植入物的材料成分和微结构的精心设计。具体地说，该项目将优化一种新型的波纹微结构，以实现机械和流体流动特性的独特组合。特殊的波纹将提供医生处理所需的僵硬，以及与软眼组织相适应的灵活性。来自波纹的微通道也将被设计成图案，以提供足够的流量来降低眼压，同时提供足够的阻力来防止过低的压力。微尺度的建筑和材料将首先通过拉伸刚度、弯曲刚度、剪切强度、水稳定性和压力流动特性的实验测试来设计。具有最佳材料微结构的植入物随后将在活体眼球模型中进行研究。这项研究将监测眼压、瘢痕组织形成、炎症水平、不良事件和植入物的稳定性。试验台和临床前测试将一起为进一步改进这种植入物提供关键数据，并促进实现最佳防盲措施的进展。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。

This SBIR Phase I project aims to improve the surgical treatment used for patients suffering from open angle glaucoma (OAG), through the development and testing of the world's thinnest ocular implant. OAG is the most common form of glaucoma, the leading cause of irreversible blindness in the world. By 2020, glaucoma will affect 3.4 million people in the U.S. and 80 million people globally. In the U.S., glaucoma incurs over $4 billion in medical and societal costs per year. For patients with glaucoma, elevated eye pressure must be lowered to protect the optic nerve from damage. However, conventional surgical implant treatments are bulky, highly invasive, and cause chronic discomfort. While newer, smaller devices are less invasive, they present issues with long-term efficacy as they inadequately sustain lower eye pressure when scarring occurs. This project will develop an implant many times thinner than a human hair to safely reduce eye pressure while minimizing the risk of patient discomfort and failure from scarring. The nanotechnology-enabled device will be designed to facilitate biocompatibility, patient comfort, and physician insertion through a combination of mechanical and materials engineering. Beyond the application in glaucoma, the technology developed will play a key role in future permanent and efficacious ocular implants - a rapidly growing component of vision care.This innovation involves careful engineering of the materials composition and microarchitecture of an ultrathin implant to treat glaucoma. Specifically, the project will optimize a novel corrugated microstructure for a unique combination of mechanical and fluid flow properties. Specific corrugations will provide the stiffness required for handling by physicians, as well as the flexibility to conform to soft eye tissues. Microchannels from the corrugations will also be patterned to provide adequate flow for reducing intraocular pressure, while providing enough resistance to prevent overly low pressure. Microscale architecture and materials will first be engineered through experimental testing of tensile stiffness, bending stiffness, shear strength, aqueous stability, and pressure flow characteristics. The implant with the optimal materials microarchitecture will subsequently be studied in an in vivo leporine eye model. This study will monitor intraocular pressure, scar tissue formation, levels of inflammation, adverse events, and implant stability. Together, the bench and pre-clinical tests will provide critical data for further refinement of this implant and facilitate progress towards realizing an optimal defense against blindness.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.