Microtechnology-Enhanced Surgical Device For Pediatric Lens Capsulotomy And Treat

描述（申请人提供）：我们提出了一种新的介入装置，解决了儿童晶状体白内障治疗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视觉功能，如果不治疗，会导致终生的视觉缺陷。儿童白内障手术的第一步在技术上是最具挑战性的，包括在薄而高弹性的晶状体囊上开一个洞，为随后取出病变晶状体提供通道，如果需要的话，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，如果应用于婴儿和幼儿，成人程序创建囊切开开口只有20%的成功机会。晶状体囊撕裂阻碍晶状体摘除，影响人工晶状体植入物的力学稳定性和性能。目前，儿童白内障手术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，导致儿童晶状体囊切开术不理想。为了简化和自动化儿童晶状体囊状体切开术，从而提高对年轻患者的视力护理，我们提出了一种微纳米技术增强的囊状体切开术设备，以实现一系列手术技能的一致结果。该设备基于一种专有的组织切割方法，其中一个微制造的切割环被安置在一个可折叠的弹性体外壳内，以在微秒的时间尺度上进行精确的包膜切割。我们的设备通过标准的2.75毫米角膜切口插入，并重新扩张以产生5.5毫米直径的理想囊切开术。在前期工作中，我们已经获得了包括胶囊切割和设备可压缩性在内的重要设备功能的原理证明。在拟议的研究中，我们将优化器件组件设计，材料选择，并进行工程应力测试。设备的功能也将通过离体眼模型进行测试，并在小型手术系列中对兔子进行测试，这些兔子的晶状体囊模仿儿童晶状体的弹性囊。第一阶段研究的目标是生产和功能验证一种自动晶状体囊切开术设备，适用于第二阶段广泛的设备安全性和性能试验。

DESCRIPTION (provided by applicant): We propose a new interventional 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 micro and nanotechnology-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 microsecond time scale. Our device is inserted through the standard 2.75 mm corneal incision and re-expands to produce a desired capsulotomy of 5.5 mm in diameter. In preliminary work, we have obtained proof of principle for important device functions including capsule cutting and device compressibility. In the proposed studies, we will optimize device component designs, choice of materials, and conduct engineering stress tests. Device function will also be tested using both ex vivo eye models and in a small surgical series in rabbits whose lens capsule mimics the elastic capsule of the pediatric lens. The goal of this Phase I study is the production and functional validation of an automated lens capsulotomy device suitable for extensive device safety and performance trials in Phase II. PUBLIC HEALTH RELEVANCE: This work seeks to develop a microtechnology and nanotechnology-enhanced surgical instrument to aid in the treatment of childhood blindness due to lens cataract. Lens cataract is the leading cause of pediatric visual disabilities, and cataract removal restores sight and improves the quality of life for both patients and their families. The proposed device simplifies and automates a technically challenging surgical task in cataract surgery.