Laser Activated Collagen Solder for Ophthalmic Surgery

用于眼科手术的激光激活胶原焊料

• 批准号: 6934023
• 负责人: BARBARA Ann SOLTZ
• 金额: $ 12.3万
• 依托单位: CONVERSION ENERGY ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-01 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934023
• 关键词: biomaterials; collagen; eye laser surgery; keratoplasty; lasers; surgery material /equipment; surgical wound; technology /technique development; wound healing

DESCRIPTION (provided by applicant): The significance of this study is the development of a laser tissue welding technique for cornea surgery, provide a foundation for innovative treatment of eye disease and demonstrate the unique properties of laser activated collagen adhesives to repair ophthalmic tissue with high strength and biostability. At least four million ophthalmic procedures are performed annually in the US, many incorporating sutures to close and seal wounds. Yet this method can cause severe complications, can weaken the integrity of the eye and may pose a risk for ocular rupture in case of blunt trauma. Ophthalmic adhesives have been studied as a substitute for sutures but frequently the outcome is less than satisfactory. Laser assisted tissue welding using concentrated collagen derivatives may be an innovative solution to these problems. The goal of Phase I is to demonstrate the feasibility of unique, light activated, collagen solders to seal and close corneal wounds and provide a baseline for survivor subjects in Phase II. Collagen was selected due to its long history as a safe, biocompatible material with the ability to be functionalized into formulations that exhibit remarkable strengths. During Phase I solder compositions will be modified to enhance chemical crosslinks to ocular tissue. Operating parameters will be optimized for a laser that is integrated with a temperature feedback control system to prevent peripheral tissue damage. The adhesive strength of the solder and maximum leak pressure of corneal repairs will be measured. A model will be developed to predict solder biostability in a simulated physiological environment. In vitro studies will be performed using human donor corneas, not suitable for transplantation, to compare CEE's method with suture and cyanoacrylate glue repairs. Endpoints include visual examination, time to complete the procedure, bond integrity and histology.

描述（申请人提供）：本研究的意义在于开发了用于角膜手术的激光组织焊接技术，为眼部疾病的创新治疗提供了基础，并展示了激光活化胶原粘合剂修复眼组织的高强度和生物稳定性的独特性能。美国每年至少进行 400 万例眼科手术，其中许多采用缝合来闭合和密封伤口。然而，这种方法可能会导致严重的并发症，会削弱眼睛的完整性，并且在钝性外伤的情况下可能会造成眼部破裂的风险。人们已经对眼科粘合剂作为缝线的替代品进行了研究，但结果常常不尽如人意。使用浓缩胶原蛋白衍生物的激光辅助组织焊接可能是解决这些问题的创新解决方案。第一阶段的目标是证明独特的光激活胶原焊料密封和闭合角膜伤口的可行性，并为第二阶段的幸存者受试者提供基线。之所以选择胶原蛋白，是因为它作为一种安全、生物相容性材料的悠久历史，能够功能化成具有显着优势的配方。在第一阶段，焊料成分将被修改，以增强与眼组织的化学交联。将对与温度反馈控制系统集成的激光器的操作参数进行优化，以防止周围组织损伤。将测量焊料的粘合强度和角膜修复的最大泄漏压力。将开发一个模型来预测模拟生理环境中焊料的生物稳定性。将使用不适合移植的人类供体角膜进行体外研究，以将 CEE 的方法与缝合和氰基丙烯酸酯胶修复进行比较。终点包括目视检查、完成手术的时间、粘合完整性和组织学。