Micro-technology Enhanced Pediatric Lens Capsulotomy Device

微技术增强型小儿晶状体囊切开术装置

• 批准号: 8913399
• 负责人: Christopher Keller
• 金额: $ 2.5万
• 依托单位: MYNOSYS CELLULAR DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8913399
• 关键词: Adult; Affect; Animal Testing; Animals; Anterior; Biomechanics; Blindness; Caliber; Calorimetry; Caring; Cataract; Cataract Extraction; Cell Survival; Certification; Child; Childhood; Clinical Engineering; Clinical Trials; Consult; Cornea; Corneal Endothelium; Data; Development; Development Plans; Device Designs; Devices; Diagnostic; Dimensions; Disease; Effectiveness; Elasticity; Endothelial Cells; Engineering; Equipment; Evaluation; Excision; Eye; Failure; Family; Freezing; Goals; Health; Housing; Human; Implant; In Vitro; Infant; Intraocular lens implant device; Life; Manuals; Measurement; Measures; Mechanics; Membrane; Methods; Metric; Modeling; Only Child; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Patients; Performance; Phase; Procedures; Production; Property; Quality of life; Resort; Safety; Series; Side; Signal Transduction; Simulate; Specimen; Staging; Stress Tests; Surgeon; Surgical Instruments; Surgical incisions; System; Technology; Temperature; Testing; Therapeutic; Therapeutic Intervention; Time; Tissues; Vacuum; Vacuum Pumps; Validation; Vision; Visual; Visual Perception; Work; base; capsule; commercialization; cost; design; device Artificial lens; disability; elastomeric; eye chamber; foot; good laboratory practice; implantation; improved; innovation; lens; lens capsule; meetings; millisecond; novel; performance tests; phase 2 study; pre-clinical; prototype; safety testing; skills; success; usability; voltage

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.

描述（由申请人提供）：我们提出了一种创新的微技术增强手术装置，解决了儿童晶状体白内障治疗的重大治疗瓶颈。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，儿童白内障外科医生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，我们提出了一种一次性微技术增强囊状体切开术设备，以实现一系列手术技能的一致结果。该装置基于一种专有的组织切割方法