SBIR Phase II: A novel, microfluidic device to improve collection and analysis of biopsy samples from ocular paracentesis

这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力是通过提供一种新的眼液活组织检查工具来改变目前的眼睛护理。眼睛中的液体通过血-眼屏障与身体的其他部分隔绝，因此获取血液工作对诊断大多数眼部问题没有帮助。眼液检测已被证明可以降低眼部感染病例的盲目率。然而，由于目前收集流体的方法存在缺陷，这一程序没有得到充分利用。正因为如此，眼部感染可能会被误诊和治疗不足，这可能会导致视力丧失的比率增加。此外，眼液是新兴生物标志物的未开发储存库，这创造了对收集这种液体的更好工具的未得到满足的需求。该项目将产生一种新产品，可用于收集眼液进行分析，以指导一些最常见的威胁视力的疾病的治疗，包括黄斑变性、青光眼和糖尿病。这项技术将开辟眼科诊断的新前沿，并改善患者的视力结果。这个小型企业创新研究(SBIR)第二阶段项目专注于制造一种用于眼液活组织检查的新型医疗设备。这个项目将创造一种专门设计的仪器，用于从眼睛前面收集液体。这项研究将包括优化针头以降低入射力。这一新工具将加强外科医生在手术过程中的控制，并降低受伤风险。这项研究还将结合微流体室和专为处理小体积液体而设计的专门收集系统来研究收集的流体动力学。当前方法的一个重要局限性是收集的液体体积很小，并且当前方法导致液体损失和结果不准确。其他开发将评估先进的工程功能，以连接该设备进行药物输送。这项研究的预期结果是一种创新的手术工具，将使眼科医生能够更可靠地进行眼液活检，并取得更好的结果。该奖项反映了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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to transform current eye care by providing a novel tool for ocular fluid biopsies. The fluid in the eye is isolated from the rest of the body by a blood-ocular barrier, so obtaining blood work does not help for diagnosing most ocular problems. Testing of ocular fluid has been shown to decrease rates of blindness in cases of ocular infections. However, this procedure is under-utilized due to the flaws with the current method for collecting fluid. Because of this, ocular infections can be misdiagnosed and undertreated, which can lead to increased rates of vision loss. Additionally, ocular fluid is an untapped reservoir for emerging biomarkers which has created an unmet need for better tools to collect this fluid. This project will result in a new product that can be used to collect ocular fluid for analyses that will guide treatment of some of the most common sight-threatening conditions including macular degeneration, glaucoma, and diabetes. This technology will open a new frontier in ocular diagnosis and improve vision outcomes for patients. This Small Business Innovation Research (SBIR) Phase II project is focused on fabricating a new medical device for ocular fluid biopsies. This project will create an instrument that is specifically designed to collect of fluid from the front of the eye. The research will include optimization of the needle to decrease the force of entry. This new tool will enhance the surgeon’s control during the procedure and decrease risk of injury. This research will also investigate the fluid dynamics of collection with the integration of a microfluidic chamber and specialized collection system that is designed to handle small fluid volumes. A significant limitation of the current procedure is that the fluid volumes collected are small and the current method leads to fluid loss and inaccurate results. Additional development will evaluate advanced engineering features to connect the device for drug delivery. The expected outcome of this research is an innovative surgical tool that will enable ophthalmologists to perform ocular fluid biopsies more reliably and achieve better results.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.