Micro-technology Enhanced Pediatric & Adult Lens Capsulotomy Device

描述（由申请人提供）：本项目旨在开发并获得监管部门批准的一种创新的微技术增强手术装置，以解决儿童和成人晶状体白内障治疗的重大治疗瓶颈。作为儿童失明的主要原因，晶状体白内障会干扰眼睛的视觉功能，如果不治疗，可能导致终身视力缺陷或失明。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，包括在薄晶状体囊上开一个洞（囊囊切除术），为随后取出病变晶状体提供通道，如果需要，还可以植入人工晶状体。由于未成熟晶状体囊独特的生物力学特性，目前的成人手术如果用于婴儿和幼儿，只有20%的成功率。因此，儿童白内障外科医生必须使用原本为非白内障手术设计的具有组织切割功能的设备，从而导致囊膜切开术不理想。在成人中，每年约有24000例囊膜撕裂并发症，这就要求改变手术计划，并不能达到理想的视力矫正效果。最近的研究表明，由飞秒激光产生的完全大小和圆形的包膜切开术可能会带来更好的临床和视觉效果。然而，对于医生来说，获得飞激光是非常昂贵的，而且每个患者还要额外支付1500美元的自付费用，因此，这项技术的好处限制了300万白内障手术的一小部分

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.