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

这个小企业创新研究（SBIR）二期项目的更广泛影响是改善青光眼患者的治疗方法。青光眼是导致不可逆失明的主要原因，影响着340万美国人和全世界8000万人。到2024年，全球青光眼手术器械市场规模将达到17.4亿美元，年复合增长率为20%。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防止视神经损伤。然而，传统的手术植入治疗是庞大的，高度侵入性的，并引起慢性不适。较新的，较小的设备侵入性较小，但影响长期疗效，因为它们不能在瘢痕形成时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的不适和疤痕造成的失败。该装置将通过机械和材料工程的结合，提高患者的舒适度和手术的便利性。除了青光眼，这项技术将在未来永久有效的眼部植入物中发挥关键作用——这是视力保健中一个快速增长的组成部分。这个小企业创新研究（SBIR）二期项目继续开发治疗青光眼的超薄植入物。具体来说，该项目将优化一种具有独特机械和流体流动特性组合的新型波纹微结构。这些特性为植入物提供了操作所需的刚度、适应眼软组织的灵活性以及控制眼内压的流动特性。器件将使用改进的微机电系统（MEMS）方法制造，并在设计用于评估流动阻力的新仪器上进行验证。该项目将进行生物相容性、毒理学和性能研究，监测眼压、炎症水平、不良事件和植入物稳定性。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 of this Small Business Innovation Research (SBIR) Phase II Project is an improved treatment for patients suffering from glaucoma. Glaucoma is the leading cause of irreversible blindness, affecting 3.4 million Americans and 80 million people worldwide. The global glaucoma surgery devices market will reach $1.74 billion by 2024, increasing at a compound annual growth rate of 20%. In the U.S., glaucoma incurs over $4 billion in medical and societal costs annually. For patients with glaucoma, elevated eye pressure must be lowered to prevent optic nerve damage. However, conventional surgical implant treatments are bulky, highly invasive, and cause chronic discomfort. Newer, smaller devices are less invasive but affect 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 patient discomfort and failure from scarring. The device will facilitate patient comfort and surgical ease through a combination of mechanical and materials engineering. Beyond glaucoma, the technology will play a key role in future permanent and efficacious ocular implants - a rapidly growing component of vision care.This Small Business Innovation Research (SBIR) Phase II project continues development of an ultrathin implant to treat glaucoma. Specifically, this project will optimize a novel corrugated microstructure with a unique combination of mechanical and fluid flow properties. These characteristics provide the implant with stiffness required for handling, flexibility to conform to soft eye tissues, and flow properties for controlling intraocular pressure. Devices will be fabricated using improved micro-electromechanical systems (MEMS) methods and validated on a new instrument designed to evaluate flow resistance. This project will conduct biocompatibility, toxicology, and performance studies, monitoring intraocular pressure, levels of inflammation, adverse events, and implant stability.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.