A Real Time Monitoring System to Measure IOP in Glaucoma

测量青光眼眼压的实时监测系统

• 批准号: 7053206
• 负责人: Doug J Jackson
• 金额: $ 37.5万
• 依托单位: ASSENTI, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-01 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7053206
• 关键词: assistive device /technology; bioengineering /biomedical engineering; biomedical equipment development; glaucoma; intraocular pressure; laboratory rabbit; microprocessor /microchip; miniature biomedical equipment; optic nerve disorder; patient monitoring device; telemetry

DESCRIPTION (provided by applicant): Assenti LLC is a 10-person start-up company formed out of collaborative research teams from the University of Louisville's Speed School of Engineering and the Department of Ophthalmology & Visual Sciences along with key industry partners. Assenti's enclosed SBIR Phase II application will allow us to continue our significant progress and momentum towards becoming the first company to bring a MEMS (Micro-Electrical-Mechanical Systems) based device to market for treating glaucoma patients. This revolutionary technology has the potential to eliminate the root cause of blindness for patients with glaucoma by providing continuous, non-invasive monitoring of Intra-Ocular Pressure (IOP). Our near term goal for commercialization is to develop our Gen I "Smart IOP" monitor that will strictly monitor IOP, so patients can self-administer eye drops to reduce pressure, which will lead to the elimination of optic nerve damage and hence prevention of blindness from glaucoma. However, our eventual longer term goal is to develop a self contained system that will either release hypotensive medication to reduce IOP or use a switch controlled MEMS valve, to create a totally autonomous system requiring no patient intervention. Recent studies have shown that applying topical ocular hypotensive medication was effective in delaying or preventing the onset of primary open-angle glaucoma [1,2]. Assenti has met or exceeded all three specific aims from our funded SBIR Phase I and we anxiously look forward to build upon this progress in Phase II. We have identified the following three specific aims to accomplish for Phase II: 1. Develop a reliable, production ready, battery-free IOP monitoring system using an ultra-miniature MEMS pressure sensor as well as a telemetry 1C, whose combined size measures less than 2mm x 2mm x 0.5mm (75% volume reduction from the phase I device) for FDA animal and eventual human trials. 2.Implementation of our strategic FDA test plan developed by Arkios LLC to obtain our IDE and lead Assenti towards a PMA of our Smart IOP monitor. S.Research into our longer term goal of combining Assenti's Smart IOP monitor with an invivo IOP reducing mechanism that can lead to autonomous control of the entire system and completely eliminate patient intervention.

简介（由申请人提供）：Assenti LLC是一家10人的初创公司，由路易斯维尔大学斯比德工程学院和眼科与视觉科学系的合作研究团队以及主要行业合作伙伴组成。Assenti的SBIR二期申请将使我们继续取得重大进展，并成为第一家将基于MEMS（微电子机械系统）的设备推向市场治疗青光眼患者的公司。这项革命性的技术有可能通过提供持续的、无创的眼压监测来消除青光眼患者失明的根本原因。我们的近期商业化目标是开发我们的第一代“智能IOP”监测器，严格监测IOP，因此患者可以自行使用眼药水来降低眼压，从而消除视神经损伤，从而预防青光眼失明。然而，我们最终的长期目标是开发一个独立的系统，该系统可以释放降压药物来降低IOP，或者使用开关控制的MEMS阀，从而创建一个完全自主的系统，无需患者干预。近期研究表明，局部应用降眼压药物可有效延缓或预防原发性开角型青光眼的发病[1,2]。Assenti已经达到或超过了我们资助的SBIR第一阶段的所有三个具体目标，我们热切期待在第二阶段取得这一进展。我们为第二阶段确定了以下三个具体目标：使用超小型MEMS压力传感器和遥测1C开发可靠的，可生产的，无电池的IOP监测系统，其组合尺寸小于2mm x 2mm x 0.5mm（比第一阶段设备体积减少75%），用于FDA动物和最终的人体试验。2.实施我们由Arkios LLC开发的战略FDA测试计划，以获得我们的IDE并带领Assenti走向我们的智能IOP监视器的PMA。研究我们的长期目标，将Assenti的智能IOP监测器与体内IOP降低机制相结合，从而实现整个系统的自主控制，完全消除患者干预。