Micro-technology Enhanced Pediatric & Adult Lens Capsulotomy Device

微技术增强儿科

• 批准号: 8991490
• 负责人: John N Hendrick
• 金额: $ 84.15万
• 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 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8991490
• 关键词: Adoption; Adult; Anatomy; Automation; Biomechanics; Blindness; Cadaver; Caliber; Cataract; Cataract Extraction; Certification; Child; Childhood; Cities; Clinical; Clinical Data; Clinical Research; Contracts; Cornea; Data; Demographic Aging; Device Approval; Device Safety; Devices; Elasticity; Elements; Ensure; Environment; Equipment; Excision; Eye; Family; Food and Drug Administration Device Approval; Goals; Health; Healthcare; Housing; Human; Infant; Infection Control; Institutional Review Boards; Intraocular lens implant device; Knowledge; Laboratories; Lasers; Lead; Manuals; Manufacturer Name; Medical; Methods; Modeling; Only Child; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outcome; Patients; Performance; Phase; Physicians; Pre-Clinical Model; Procedures; Production; Property; Protocols documentation; Quality of life; Resort; Safety; Speed; Staging; Sterility; Sterilization; Surgeon; Surgical Instruments; Surgical incisions; System; Technology; Testing; Therapeutic; Time; Tissues; Uninsured Medical Expense; United States; Validation; Variant; Vision; Visual; Visual Perception; Wireless Technology; anterior chamber; base; biomaterial compatibility; capsule; cost; cytotoxicity; design; disability; efficacy trial; elastomeric; human study; human subject; implantation; improved; individual patient; innovation; innovative technologies; irritation; lens; lens capsule; manufacturing process; meetings; millisecond; novel; pediatric patients; performance tests; pre-clinical; preclinical study; research and development; safety testing; skills; success; tool

DESCRIPTION (provided by applicant): This project seeks to develop and obtain regulatory approval for an innovative microtechnology- enhanced surgical device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children and adults. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, can result in lifelong deficits in visual perception or blindness. Cataract surgey in adults, with 3 million plus cases per year, is the most common surgical procedure in the United States that, with the aging demographics, will continue to add to our healthcare burden. The first step in pediatric and adult cataract surgery is technically the most challenging and involves the creation of a hole in the thin lens capsule (capsulotomy) to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial intraocular lens. Due to the unique biomechanical properties of the immature lens capsule, current adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. As a result, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non-cataract surgical uses, resulting in suboptimal capsulotomies. In adults, capsulotomy complications manifest as approximately 24,000 cases of capsule tears each year, which mandate alterations in the surgical plan and produce less than ideal vision correction. Recent studies show that perfectly sized and circular capsulotomies produced by femtosecond lasers potentially lead to better clinical and visual outcomes. However femtolasers are extremely expensive for physicians to acquire and cost individual patients an additional $1,500 out of pocket expense, thus limiting the benefits of this technology to a small fraction of the 3 million cataract surgery patients each year. The overall goal of this project is to provide physicians with a low cost device that automatically delivers dimensionally perfect capsuotomies for all pediatric and adult patients undergoing cataract surgery. In Phase I & II, we developed an easy to use disposable capsulotomy device that uses a novel microscale tissue cutting technology to provide quick, consistent capsulotomies across a range of surgical skills. The device is based on a microfabricated cutting ring element housed within a collapsible elastomeric housing to produce precise capsulotomies on a millisecond time scale. Our device is inserted through the standard 2.5 mm corneal incision and re-expands to produce a desired capsulotomy 5-6 mm in diameter. Under Phase IIB, we will perform the FDA mandated certifications and testing required for device regulatory approval. In particular, we seek support for transferring the manufacturing of this innovative microtechnology- enhanced capsulotomy device into a FDA certified production environment and the completion of pre-clinical and clinical studies to meet FDA regulatory requirements.

描述（由申请人提供）：该项目旨在开发一种创新的微技术增强型手术设备并获得监管部门的批准，该设备可解决儿童和成人晶状体白内障治疗中的重大治疗瓶颈。作为儿童失明的主要原因，晶状体白内障会干扰眼睛的光学性能，如果不及时治疗，可能会导致终生视觉感知缺陷或失明。成人白内障手术每年有超过 300 万例，是美国最常见的外科手术，随着人口老龄化，它将继续增加我们的医疗负担。儿科和成人白内障手术的第一步在技术上最具挑战性，涉及在薄晶状体囊上开一个孔（囊切开术），以便为随后移除患病晶状体以及在需要时植入人工晶状体提供通道。由于未成熟的晶状体囊具有独特的生物力学特性，目前用于创建囊切开开口的成人手术如果应用于婴儿和幼儿，成功的机会只有 20%。因此，小儿白内障外科医生必须使用最初为非白内障手术设计的具有组织切割功能的设备，从而导致囊膜切开术效果不佳。在成人中，囊切开术并发症表现为每年约 24,000 例囊膜撕裂，这需要改变手术计划并产生不理想的视力矫正效果。最近的研究表明，飞秒激光产生的完美尺寸和圆形囊切开术可能会带来更好的临床和视觉效果。然而，对于医生来说，购买飞秒激光器极其昂贵，并且个别患者需要额外支付 1,500 美元的自付费用，因此该技术的优势仅限于 300 万例白内障手术中的一小部分。 每年都有患者。该项目的总体目标是为医生提供一种低成本设备，自动为所有接受白内障手术的儿童和成人患者提供尺寸完美的囊膜切开术。 在第一阶段和第二阶段，我们开发了一种易于使用的一次性囊切开术装置，该装置采用新颖的微型组织切割技术，可在一系列手术技能中提供快速、一致的囊切开术。该设备基于安装在可折叠弹性体外壳内的微加工切割环元件，可在毫秒时间内进行精确的囊切开术。我们的设备通过标准 2.5 毫米角膜切口插入并重新扩张以产生所需的直径 5-6 毫米的囊切开术。在 IIB 阶段，我们将执行 FDA 规定的设备监管批准所需的认证和测试。我们特别寻求支持，将这种创新的微技术增强型囊切开术装置的制造转移到 FDA 认证的生产环境中，并完成临床前和临床研究，以满足 FDA 的监管要求。