Micro-technology Enhanced Pediatric & Adult Lens Capsulotomy Device

描述（由申请人提供）：本项目旨在开发一种创新的微技术增强型手术器械并获得监管批准，该器械可解决儿童和成人透镜白内障治疗中的重大治疗瓶颈。作为儿童失明的主要原因，透镜白内障干扰眼睛的光学性能，如果不治疗，可导致终身视觉缺陷或失明。成人白内障手术每年有300多万例，是美国最常见的外科手术，随着人口老龄化，将继续增加我们的医疗负担。儿童和成人白内障手术的第一步在技术上是最具挑战性的，并且涉及在薄透镜囊中创建孔（囊切开术），以提供用于随后移除患病的透镜的通路，并且如果需要，植入人工眼内透镜。由于未成熟的透镜囊的独特生物力学性质，如果应用于婴儿和幼儿，用于创建囊切开术开口的当前成人程序仅具有20%的成功机会。因此，儿科白内障外科医生必须使用最初设计用于非白内障手术用途的具有组织切割功能的装置，从而导致次优的晶状体囊切开术。在成人中，囊切开术并发症表现为每年约24，000例囊撕裂，这要求改变手术计划并产生不理想的视力矫正。最近的研究表明，飞秒激光产生的完美尺寸和圆形囊切开术可能会导致更好的临床和视力结果。然而，飞秒激光器对于医生来说极其昂贵，并且使个体患者额外花费1，500美元的自付费用，从而将该技术的益处限制在300万白内障手术的一小部分。 患者每年该项目的总体目标是为医生提供一种低成本的设备，该设备可以自动为所有接受白内障手术的儿童和成人患者提供尺寸完美的晶状体囊切开术。 在第一和第二阶段，我们开发了一种易于使用的一次性晶状体囊切开术器械，该器械使用新型微尺度组织切割技术，在各种手术技能中提供快速、一致的晶状体囊切开术。该设备是基于一个微型切割环元件容纳在一个可折叠的弹性外壳，以产生精确的囊切开毫秒的时间尺度。我们的设备通过标准的2.5 mm角膜切口插入，并重新扩张以产生直径为5-6 mm的所需囊切开术。在IIB阶段，我们将执行FDA强制要求的认证和器械监管批准所需的测试。特别是，我们寻求支持，将这种创新的微技术增强型晶状体囊切开术器械的制造转移到FDA认证的生产环境中，并完成临床前和临床研究，以满足FDA的监管要求。

DESCRIPTION (provided by applicant): This project seeks to develop and obtain regulatory approval for an innovative microtechnology- enhanced surgical device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children and adults. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, can result in lifelong deficits in visual perception or blindness. Cataract surgey in adults, with 3 million plus cases per year, is the most common surgical procedure in the United States that, with the aging demographics, will continue to add to our healthcare burden. The first step in pediatric and adult cataract surgery is technically the most challenging and involves the creation of a hole in the thin lens capsule (capsulotomy) to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial intraocular lens. Due to the unique biomechanical properties of the immature lens capsule, current adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. As a result, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non-cataract surgical uses, resulting in suboptimal capsulotomies. In adults, capsulotomy complications manifest as approximately 24,000 cases of capsule tears each year, which mandate alterations in the surgical plan and produce less than ideal vision correction. Recent studies show that perfectly sized and circular capsulotomies produced by femtosecond lasers potentially lead to better clinical and visual outcomes. However femtolasers are extremely expensive for physicians to acquire and cost individual patients an additional $1,500 out of pocket expense, thus limiting the benefits of this technology to a small fraction of the 3 million cataract surgery patients each year. The overall goal of this project is to provide physicians with a low cost device that automatically delivers dimensionally perfect capsuotomies for all pediatric and adult patients undergoing cataract surgery. In Phase I & II, we developed an easy to use disposable capsulotomy device that uses a novel microscale tissue cutting technology to provide quick, consistent capsulotomies across a range of surgical skills. The device is based on a microfabricated cutting ring element housed within a collapsible elastomeric housing to produce precise capsulotomies on a millisecond time scale. Our device is inserted through the standard 2.5 mm corneal incision and re-expands to produce a desired capsulotomy 5-6 mm in diameter. Under Phase IIB, we will perform the FDA mandated certifications and testing required for device regulatory approval. In particular, we seek support for transferring the manufacturing of this innovative microtechnology- enhanced capsulotomy device into a FDA certified production environment and the completion of pre-clinical and clinical studies to meet FDA regulatory requirements.