Micro-technology Enhanced Pediatric & Adult Lens Capsulotomy Device

描述(由申请人提供)：该项目寻求开发一种创新的微技术增强型手术设备，并获得监管部门的批准，以解决儿童和成人晶状体白内障治疗中的一个重大治疗瓶颈。作为儿童失明的主要原因，晶状体白内障会干扰眼睛的光学性能，如果不治疗，可能会导致终身视觉障碍或失明。成人白内障手术每年有300多万例，是美国最常见的手术方式，随着人口老龄化，这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(囊膜切开术)，为随后取出患病晶状体提供通道，如果需要，还需要植入人工晶状体。由于未成熟晶状体囊独特的生物力学特性，目前成人创造囊膜切开口的手术，如果应用于婴幼儿，成功率只有20%。因此，儿科白内障外科医生只能凑合使用最初设计用于非白内障手术的具有组织切割功能的设备，导致次优的囊膜切除。在成人中，囊膜切开并发症表现为每年约24,000例囊膜撕裂，这要求手术计划发生变化，产生不太理想的视力矫正。最近的研究表明，由飞秒激光产生的完全大小和圆形的囊膜切开术可能会带来更好的临床和视觉结果。然而，对于医生来说，购买飞秒激光极其昂贵，而且每个患者还需要自掏腰包支付1500美元的额外费用，因此这项技术的好处仅限于300万例白内障手术中的一小部分 每年都有病人。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上完美的囊袋切开术。在第一阶段和第二阶段，我们开发了一种简单易用的一次性囊膜切开术，它使用了一种新的微型组织切割技术，通过一系列手术技能提供快速、一致的囊膜切开术。该装置基于可折叠弹性体壳内的微型制造切割环元件，以在毫秒级的时间尺度上产生精确的囊膜切除。我们的设备通过标准的2.5 mm角膜切口处插入，并重新扩张，以产生所需的直径5-6 mm的囊膜切开术。在第二阶段，我们将执行FDA规定的认证和测试，以获得设备监管部门的批准。特别是，我们寻求支持将这种创新的微技术增强型囊膜切开装置的制造转移到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.