Micro-technology Enhanced Pediatric Lens Capsulotomy Device

描述（由申请人提供）：我们提出了一种创新的微技术增强的手术装置，其解决了儿童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，会导致终身的视觉缺陷。小儿白内障手术的第一步在技术上是最具挑战性的，并且涉及在薄且高弹性的透镜囊中创建孔，以提供用于随后移除患病的透镜的通路，并且如果需要，植入人工透镜。由于未成熟的透镜囊的独特生物力学性质，用于创建囊切开术开口的成人手术，如果应用于婴儿和幼儿，只有20%的成功机会。囊膜撕裂阻碍透镜的取出并影响人工透镜植入物的机械稳定性和性能。目前，小儿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碎功能的装置，导致次优的小儿透镜囊切开术。为了简化和自动化的儿科透镜囊切开术，从而提高视力护理的年轻患者的交付，我们提出了一个一次性的微技术增强囊切开术设备，以实现一致的结果，在一系列的手术技巧。该器械基于一种专有的组织切割方法， 其中微制造的切割环容纳在可收缩的弹性体壳体内以在亚毫秒时间尺度上产生精确的囊切开术。我们的装置通过标准的2.8 mm角膜切口插入，并重新扩张以产生直径为5 mm的所需囊切开术。在第一阶段，我们成功地证明了项目的可行性，通过开发设备原型，满足规格方面的眼内使用，压缩性和胶囊切割。在拟定的II期研究中，我们将开发囊切开术器械的商业版本，进行工程台架测试，并在可接受的家兔模型中进行手术确认，目标是实现产品设计冻结。与此同时，作为第二个目标，我们还将开发一个紧凑的台式控制台，为子宫切除术设备提供电源、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按照临床试验启动和最终FDA批准的要求，通过良好实验室规范（GLP）认证机构进行器械认证。

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.