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，我们提出了一种微米和纳米技术增强的囊膜切开术装置，以在一系列外科技术中实现一致的结果。该设备基于一种专有的组织切割方法，在这种方法中，微型制造的切割环被安置在可折叠的弹性体壳内，以在微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2.75 mm角膜切口处插入，并重新扩张，以产生所需的5.5 mm直径的囊膜切开术。在前期工作中，我们已经获得了包括胶囊切割和装置可压缩性在内的重要装置功能的原理证明。在拟议的研究中，我们将优化器件部件设计、材料选择和进行工程应力测试。该装置的功能也将使用体外眼模型和小手术系列在兔身上进行测试，其晶状体囊模仿儿科晶状体的弹性囊。这项第一阶段研究的目标是生产一种自动晶状体囊膜切开术装置并进行功能验证，该装置适用于第二阶段广泛的装置安全性和性能试验。 公共卫生相关性：这项工作旨在开发一种微技术和纳米技术增强的手术器械，以帮助治疗因晶状体白内障而致盲的儿童。晶状体白内障是导致儿童视力障碍的主要原因，白内障摘除可以恢复视力，提高患者及其家人的生活质量。拟议的设备简化并自动化了白内障手术中一项具有技术挑战性的手术任务。

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.