Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases

项目摘要 尽管眼科疾病的治疗取得了进展，但威胁视力的疾病或眼损伤仍然是前10名 成年人的残疾。这些眼部疾病中的一些需要前房穿刺术（ACP）。 ACP在临床上适用于降低急性升高的眼内压（IOP），以避免永久性视力的风险 损失，并对用于疾病诊断和监测的房水进行采样。需要降低IOP的疾病 包括急性闭角型青光眼、治疗视网膜脱离充气视网膜固定术和医源性IOP 与玻璃体内注射抗血管内皮生长因子（抗VEGF）药物相关的升高， 治疗新生血管性年龄相关性黄斑变性、糖尿病视网膜病变和视网膜静脉等疾病 闭塞。需要房水取样的情况包括葡萄膜炎、视网膜母细胞瘤和淋巴瘤，以及 水性生物标志物越来越多地指导治疗选择和药物监测，例如，与抗vegf 剂.不幸的是，没有专门为ACP设计的仪器，而是结核菌素注射器 使用标准的过长的针。这需要一个稳定的外科医生的手和稳定的病人的眼睛 而患者位于裂隙灯生物显微镜中。因此，ACP手术可能导致严重的 由于眼内结构的意外创伤引起的并发症如前房出血和白内障（例如，角膜， 睫状体、虹膜和透镜），并且抽吸速率和房水体积难以控制和不可预测。 因此，机场核心计划的安全性和效率在过去世纪并无改善。克服 与现有过时技术相关的局限性，F Square Medical正在开发， 将首款专为ACP手术设计的器械商业化。Parasafe仪器是 一种无菌、一次性、重量轻且重要的是安全的用于快速和可重复ACP的仪器。在这个阶段 I SBIR建议我们将：1）与经验丰富的美国合同工程和原型公司合作， Gilero，完善设计和制造Parasafe原型，2）进行总结性评估人类 因素的研究，和3）评估的Parasafe与执业眼科医生和离体的功能 猪模型拟议目标的完成将导致对一项文书的核查和确认， 将显著降低与ACP相关的损伤风险，同时优化手术功能， 将这一变革工具推进到商业化的下一阶段。

PROJECT SUMMARY Despite advances in the treatment of ocular diseases, vision threatening disease or eye injury remain the top 10 disabilities among adults. Several of these ocular conditions require an anterior chamber paracentesis (ACP). ACP is clinically indicated to reduce acutely elevated intraocular pressure (IOP) to avoid risk of permanent vision loss and to sample aqueous humor for disease diagnostics and monitoring. Conditions requiring IOP reduction include acute angle closure glaucoma, pneumatic retinopexy to treat retinal detachments, and iatrogenic IOP elevations associated with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents to treat diseases such as neovascular age-related macular degeneration, diabetic retinopathy and retinal vein occlusions. Conditions requiring aqueous humor sampling include uveitis, retinoblastoma and lymphoma, and aqueous biomarkers increasingly are guiding treatment selection and drug monitoring, e.g., with anti-VEGF agents. Unfortunately, there exists no instrument specifically designed for ACP, and instead tuberculin syringes with standard excessively long needles are used. This requires a steady surgeon hand and steady patient eye while the patient is positioned in the slit lamp biomicroscope. As a result, the ACP procedure may lead to serious complications such as hyphema and cataract due to inadvertent trauma to intraocular structures (e.g., cornea, ciliary body, iris and lens), and the aspiration rate and aqueous volume is difficult to control and unpredictable. As a result, there have been no improvements in the safety or efficiency of ACP in the past century. To overcome the limitations associated with existing antiquated techniques, F Square Medical is developing and commercializing the first-ever instrument designed specifically for ACP procedures. The Parasafe instrument is a sterile, disposable, light-weight and importantly, safe instrument for rapid and reproducible ACP. In this Phase I SBIR proposal we will: 1) work with an experienced USA-based contract engineering and prototyping firm, Gilero, to refine the design and manufacture a Parasafe prototype, 2) conduct summative evaluation human factors studies, and 3) assess the functionality of the Parasafe with practicing ophthalmologists and an ex vivo porcine model. The completion of the proposed aims will result in verification and validation of an instrument that will significantly reduce the risk of injury associated with ACP while optimizing functionality of the procedure and advancing this transformational instrument to the next phase of commercialization.