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

开发首个安全有效的前房穿刺器械来治疗和诊断眼部疾病

• 批准号: 10325880
• 负责人: samer farah
• 金额: $ 29.36万
• 依托单位: F SQUARE MEDICAL LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325880
• 关键词: 3-Dimensional; 3D Print; Acute; Address; Adult; Age related macular degeneration; American; Angle-Closure Glaucoma; Aqueous Humor; Aspirate substance; Biological Markers; Blindness; Cataract; Chronic; Ciliary Body; Clinic; Clinical; Collaborations; Contracts; Cornea; Corneal Endothelium; Development; Device or Instrument Development; Devices; Diabetic Retinopathy; Diagnosis; Diagnostic; Disease; Drug Monitoring; Dyes; Economic Burden; Engineering; Ensure; Environment; Evaluation; Exudative age-related macular degeneration; Eye; Eye Injuries; Face; Family suidae; Foundations; Future; Glaucoma; Goals; Hand; Human; Hyphema; Iatrogenesis; Infection; Inflammation; Injections; Injury; Intervention; Iris; Lead; Liquid substance; Lubrication; Lymphoma; Malignant Neoplasms; Measures; Mechanics; Medical; Medicine; Methods; Modeling; Modernization; Molds; Monitor; Needles; Ocular orbit; Ophthalmologist; Ophthalmology; Paracentesis; Patient-Focused Outcomes; Patients; Pattern; Performance; Pharmaceutical Preparations; Phase; Physiologic Intraocular Pressure; Positioning Attribute; Procedures; Reproducibility; Retinal Detachment; Retinal Vein Occlusion; Retinoblastoma; Risk; Running; Safety; Sampling; Selection for Treatments; Series; Small Business Innovation Research Grant; Sterility; Structure; Surgeon; Syringes; Techniques; Testing; Time; Trauma; Tuberculin; Uveitis; Vascular Endothelial Growth Factors; Vision; Visualization; Work; anterior chamber; aqueous; base; bevacizumab; clinically relevant; college; commercialization; design; diagnostic biomarker; disability; experience; human model; improved; individualized medicine; innovation; instrument; intravitreal injection; lens; light weight; porcine model; portability; predictive marker; preference; prototype; research clinical testing; standard of care; success; usability; verification and validation

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.

项目总结 尽管眼科疾病的治疗取得了进展，但威胁视力的疾病或眼睛损伤仍位居前十 成年人中的残疾。其中一些眼部疾病需要前房穿刺术(ACP)。 ACP的临床应用表明可以降低急性升高的眼压，以避免永久视力的风险。 并采集房水样本，用于疾病诊断和监测。需要降低眼压的情况 包括急性闭角型青光眼、气动视网膜固定术治疗视网膜脱离以及医源性眼压 玻璃体内注射抗血管内皮生长因子(抗血管内皮生长因子)药物引起的眼球抬高 治疗新生血管性老年性黄斑变性、糖尿病视网膜病变和视网膜静脉疾病 闭塞。需要进行房水采样的情况包括葡萄膜炎、视网膜母细胞瘤和淋巴瘤，以及 水性生物标记物越来越多地指导治疗选择和药物监测，例如使用抗血管内皮生长因子 探员们。不幸的是，没有专门为ACP设计的仪器，而是结核菌素注射器 在标准情况下，使用过长的针。这需要一只稳定的外科医生手和一双稳定的耐心的眼睛 当病人被放置在裂隙灯生物显微镜中时。因此，机场核心计划程序可能会导致严重的 由于眼内结构(例如，角膜， 睫状体、虹膜和晶状体)，吸入率和房水体积难以控制和不可预测。 因此，在过去的一个世纪里，机场核心工程的安全性或效率没有任何改善。要克服 与现有过时技术相关的限制，F Square Medical正在开发和 将第一台专门为ACP程序设计的仪器商业化。Parasafe乐器是 一种无菌的、一次性的、重量轻的、重要的是安全的快速和可重复的ACP仪器。在此阶段 I SBIR建议我们将：1)与一家经验丰富的美国合同工程和原型公司合作， 吉列罗，改进Parasafe样机的设计和制造，2)进行总结性评估人类 因素研究，以及3)与执业眼科医生和体外实验评估Parasafe的功能 猪模。拟议目标的完成将导致对符合以下条件的文书进行核查和确认 将显著降低与ACP相关的受伤风险，同时优化程序的功能和 将这一变革性工具推进到下一阶段的商业化。