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

SBIR第一阶段项目旨在通过开发和测试世界上最薄的眼部植入物，改善开角型青光眼（OAG）患者的手术治疗。OAG是青光眼最常见的形式，是世界上不可逆失明的主要原因。到2020年，青光眼将影响美国340万人和全球8000万人。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，必须降低升高的眼压以保护视神经免受损害。然而，传统的外科植入物治疗是庞大的，高度侵入性的，并导致慢性不适。虽然较新、较小的设备侵入性较低，但它们存在长期有效性的问题，因为当疤痕发生时，它们不能充分维持较低的眼压。该项目将开发一种比人类头发细许多倍的植入物，以安全地降低眼压，同时最大限度地减少患者不适和疤痕失败的风险。纳米技术使能器械的设计将通过机械和材料工程的组合来促进生物相容性、患者舒适度和医生插入。除了在青光眼中的应用外，该技术还将在未来永久有效的眼部植入物中发挥关键作用-这是一种快速增长的视力保健组成部分。这项创新涉及精心设计用于治疗青光眼的植入物的材料成分和微结构。具体而言，该项目将优化一种新型波纹微结构，以实现机械和流体流动特性的独特组合。特定的波纹将提供医生处理所需的刚度，以及适应软眼组织的柔性。来自波纹的微通道也将被图案化以提供用于降低眼内压的足够的流动，同时提供足够的阻力以防止过低的压力。微尺度结构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体内兔眼模型中进行研究。本研究将监测眼内压、瘢痕组织形成、炎症水平、不良事件和植入物稳定性。实验室试验和临床前试验将为进一步完善该植入物提供关键数据，并促进实现最佳防盲效果的进展。该奖项反映了NSF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。

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.