Minimally Invasive Glaucoma Surgical Instrument

微创青光眼手术器械

• 批准号: 6689039
• 负责人: SOHEILA MIRHASHEMI
• 金额: $ 14.8万
• 依托单位: NEOMEDIX CORPORATION
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6689039
• 关键词: biomedical device power system; biomedical equipment development; computer system design /evaluation; cornea; cost effectiveness; digital imaging; glaucoma; glaucoma surgery; health care cost /financing; human tissue; portable biomedical equipment; technology /technique development; trabecular meshwork

DESCRIPTION (provided by applicant): Glaucoma remains a major public health problem in America and worldwide. It is estimated that about 3 million Americans and over 67 million people in foreign countries suffer from this debilitating disease. Blindness from glaucoma and treatment of glaucoma impose significant annual costs to the United States Government in Medicare, Medicaid, Social Security, and other healthcare expenditures. Current approaches to glaucoma management include pharmaceuticals, surgical methodologies, and surgical drainage implants. Although each of these treatment approaches provides some positive results among certain subsets of patients, there exists a need for a treatment approach that is more universally efficacious and cost-effective. NeoMedix Corporation is developing an innovative, proprietary Atraumatic Goniectomy System (AGS) technology as a surgical treatment for glaucoma. AGS is the first technology to offer the potential for a cost-effective, user-friendly, ab interno surgical procedure to effectively and permanently reduce IOP in glaucoma patients by atraumatically removing a 90x sector of trabecular meshwork overlaying Schlemm's canal in order to re-establish outflow of aqueous humor through the collective channels. Preliminary studies with an early AGS prototype system have demonstrated that sectors of the trabecular meshwork can be rapidly and readily removed without trauma to the underlying tissues of Schlemm's canal. The specific aims of this proposed research for advancing AGS toward commercialization are as follows: 1) design and build an advanced instrument prototype, 2) perform experimental studies to select and optimize design and operating parameters, and 3) evaluate the basic safety and effectiveness of the AGS technology in the freshly harvested human cornea model.

描述（由申请人提供）：青光眼仍然是美国和世界范围内的主要公共卫生问题。据估计，大约有300万美国人和6700多万外国人患有这种使人衰弱的疾病。青光眼致盲和青光眼治疗给美国政府带来了医疗保险、医疗补助、社会保障和其他医疗保健支出方面的巨大年度成本。目前青光眼治疗的方法包括药物、手术方法和手术引流植入物。尽管这些治疗方法中的每一种在某些患者亚群中提供了一些积极的结果，但仍然需要一种更普遍有效和成本有效的治疗方法。NeoMeetion公司正在开发一种创新的、专有的非创伤性前房角切除术系统（AGS）技术，作为青光眼的手术治疗。AGS是第一项技术，它提供了一种具有成本效益、用户友好的内部外科手术的潜力，通过无创地去除覆盖施莱姆氏管的90倍小梁网扇区，以重建通过集合通道的房水流出，从而有效和永久地降低青光眼患者的IOP。早期AGS原型系统的初步研究表明，部分小梁网可以快速，容易地删除，而不会对施累姆氏管的下层组织的创伤。本研究旨在推进AGS商业化，具体目标如下：1）设计和构建先进的仪器原型，2）进行实验研究以选择和优化设计和操作参数，3）评估AGS技术在新鲜采集的人角膜模型中的基本安全性和有效性。