Micro-technology Enhanced Pediatric Lens Capsulotomy Device

描述(申请人提供)：我们提出了一种创新的微技术增强的手术装置，解决了儿童晶状体白内障治疗中的一个重要治疗瓶颈。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，会导致终生视觉障碍。儿童白内障手术的第一步在技术上是最具挑战性的，需要在薄薄且高度弹性的晶状体囊上开一个洞，以便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，成人手术创造囊膜切开，如果应用于婴幼儿，成功率只有20%。晶状体囊膜撕裂阻碍晶状体取出，影响人工晶状体植入物的机械稳定性和性能。目前，儿童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，导致儿童晶状体囊膜切开术效果不佳。为了简化和自动化儿科晶状体囊膜切开术，从而增强对年轻患者的视力护理，我们提出了一种一次性微技术增强型晶状体囊膜切开术装置，以在一系列外科技术中实现一致的结果。该装置是基于一种专有的组织切割方法 微细加工的切割环容纳在可折叠的弹性体壳内，以在亚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2.8 mm角膜切口处插入，并重新扩张，以产生所需的直径为5 mm的囊膜切开术。在第一阶段，我们通过开发在眼内使用、可压缩性和囊膜切割方面符合规格的设备原型，成功地证明了项目的可行性。在拟议的第二阶段研究中，我们将开发商业版本的囊膜切开器，进行工程台架测试，并在公认的兔模型上进行手术验证，目标是实现产品设计冻结。同时，作为第二个目标，我们还将开发一个紧凑的桌面控制台，为开腹手术设备提供电力、定时电路、真空、诊断和安全警报。这项第二阶段工作的结果将使我们能够根据临床试验启动和FDA最终批准所需的良好实验室规范(GLP)认可的设施推进设备认证。

DESCRIPTION (provided by applicant): We propose an innovative microtechnology-enhanced surgical device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, results in lifelong deficits in visual perception. The first step in pediatric cataract surgery is technically the most challenging and involves the creation of a hole in the thin and highly elastic lens capsule to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial lens. Due to the unique biomechanical properties of the immature lens capsule, adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. Capsule tears hinder lens removal and affect the mechanical stability and performance of artificial lens implants. Currently, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non- cataract surgical uses, resulting in suboptimal pediatric lens capsulotomies. In order to simplify and automate pediatric lens capsulotomies and thus enhance the delivery of vision care to young patients, we propose a disposable microtechnology-enhanced capsulotomy device to achieve consistent results across a range of surgical skills. The device is based on a proprietary method of tissue cutting in which a microfabricated cutting ring is housed within a collapsible elastomeric housing to produce precise capsulotomies on a sub-millisecond time scale. Our device is inserted through the standard 2.8 mm corneal incision and re-expands to produce a desired capsulotomy of 5 mm in diameter. In Phase I, we sucessfully demonstrated project feasibility by developing device protoypes that met specifications in terms of dimensions for intraocular use, compressibility, and capsule cutting. In the proposed Phase II studies, we will develop a commercial version of the capsulotomy device, conduct engineering bench testing, and undertake surgical validation in an accepted rabbit model, with the goal of achieving product design freeze. In parallel, as a second aim, we will also develop a compact table-top console to provide power, timing circuits, vacuum, diagnostics, and safety alerts for the casulotomy device. Results from this Phase II work will allow us to advance to device certification by good laboratory practice (GLP) accredited facilities as required for clinical trial initiation and ultimte FDA approval.