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用于角膜手术的激光组织焊接技术，为眼病的创新治疗提供基础，并展示激光激活胶原胶粘剂的独特性能，以高强度和生物稳定性修复眼组织。在美国，每年至少进行400万例眼科手术，其中许多手术采用缝合线来闭合和封闭伤口。然而，这种方法可能会导致严重的并发症，削弱眼睛的完整性，并可能在钝性创伤的情况下造成眼破裂的风险。眼用粘合剂已被研究作为缝线的替代品，但结果往往不太令人满意。使用浓缩胶原衍生物的激光辅助组织焊接可能是解决这些问题的一种创新方案。第一阶段的目标是展示独特的、光激活的胶原蛋白焊料用于封闭和闭合角膜伤口的可行性，并为第二阶段的幸存者提供一个基准。选择胶原蛋白是因为它作为一种安全、生物兼容的材料有很长的历史，能够被功能化成表现出非凡强度的配方。在第一阶段，将对焊料成分进行修改，以增强与眼组织的化学交联性。将优化激光器的运行参数，将其与温度反馈控制系统集成在一起，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焊料在模拟生理环境中的生物稳定性。体外研究将使用不适合移植的人类供体角膜，将CEE的方法与缝合和氰基丙烯酸酯胶修补术进行比较。终点包括肉眼检查、完成手术的时间、粘接完整性和组织学。