Laser Activated Ophthalmic Adhesive

激光激活眼科粘合剂

• 批准号: 7352743
• 负责人: BARBARA Ann SOLTZ
• 金额: $ 36.52万
• 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 2010-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7352743
• 关键词: Adhesions; Adhesives; Anastomosis - action; Animal Experiments; Animal Model; Animals; Area; Biocompatible Materials; Biodegradation; Biological; Blindness; Blood Vessels; Blunt Trauma; Bulla; Cataract; Cataract Extraction; Chemistry; Clinical; Clinical Trials; Closure; Collagen; Conjunctival Pterygium; Cornea; Corneal Injury; Corneal Ulcer; Cross-Linking Reagents; Cyanoacrylates; Data; Development; Doctor of Philosophy; Drug Formulations; End Point; Ensure; Excision; Extracapsular; Eye; Eye diseases; Film; Foundations; Funding; Glaucoma; Glues; Goals; Grant; Hand; Human; Impairment; In Situ; In Vitro; Institutes; Investigation; Keratitis; Keratoplasty; Laboratory Research; Laceration; Lamellar Keratoplasty; Laser In Situ Keratomileusis; Lasers; Lead; Measures; Mechanics; Medical Electronics; Membrane; Methods; Modeling; National Eye Institute; Object Attachment; Operative Surgical Procedures; Outcome; Patients; Penetrating Keratoplasty; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Physiologic Intraocular Pressure; Postoperative Period; Preparation; Principal Investigator; Procedures; Process; Property; Proteins; Psychological reinforcement; Radial Keratotomy; Rate; Reaction; Reagent; Research; Research Personnel; Retinal; Risk; Rupture; Sampling; Secure; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solutions; Standards of Weights and Measures; Sterility; Sterilization for infection control; Strabismus; Surgical Flaps; Surgical Models; Surgical incisions; Surgical sutures; Survivors; System; Techniques; Technology; Temperature; Tensile Strength; Testing; Thick; Time; Tissue Adhesives; Tissues; Trauma; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; Vision; Visual Discomfort; Welding; Work; anterior chamber; articular cartilage; base; biomaterial compatibility; cell injury; commercialization; conjunctiva; corneal surgery; design; experience; improved; in vitro Model; in vivo; innovation; pre-clinical; pressure; protein crosslink; reconstruction; repaired; research study; response; seal; sensor; skills; tissue glueing; tissue soldering; tissue welding; wound

DESCRIPTION (provided by applicant): The significance of this project is the development of a laser assisted tissue welding technique to close corneal wounds, provide a foundation for innovative treatment of eye disease and demonstrate the unique properties of a laser cured collagen adhesive to repair ophthalmic tissue with superior strength and stability. Millions of ophthalmic procedures are performed annually, most 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 the case of blunt trauma. Other techniques to close wounds, including the use of tissue glues or grafting, can be even more problematic. Phase I studies were conducted to measure the biostability of solder formulations, evaluate tissue bonding strategies and compare wound stability as a function of intrachamber pressure in four in vitro models of clinical corneal surgery: radial keratotomy, LASIK flaps, penetrating keratoplasty and cataract excision. The results confirmed that the laser solder approach is superior to standard sutures with no evidence of tissue shrinkage. The strength of the soldered repair was dependent upon reaching a precise temperature set by choice of laser, solder composition and film thickness. Solder biostability is increased by reaction with a standard cross linking reagent. The specific aim for Phase II is to optimize solder processing, laser techniques and surgical outcome in survivor animal surgical models. Task descriptions include preparation of sterile solder under stringent process controls, design and assembly of a compact preclinical laser systems, optimization of a laser hand piece and perform ex vivo and in vivo experiments on a lapine model. Surgical endpoints will include the quality of the wound seal, the extent, if any, of collateral thermal tissue damage, solder stability and biocompatibility. The current methods for closing ocular incisions, similar to other body tissue, require placing sutures to bring tissue edges in apposition. The presence of sutures in the cornea leads to patient discomfort, visual distortions, risk for bacterial proliferation and keratitis. The use of a biological tissue adhesive, with sufficient sealing properties to resist sudden changes in intraocular pressure for a prolonged time, may be of great benefit for the synthesis of corneal wounds, caused either by trauma or induced by surgery.

描述（申请人提供）：该项目的意义在于开发激光辅助组织焊接技术来闭合角膜伤口，为眼部疾病的创新治疗提供基础，并展示激光固化胶原粘合剂修复眼组织的独特性能，具有卓越的强度和稳定性。每年进行数百万例眼科手术，其中大多数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。其他闭合伤口的技术，包括使用组织胶或移植，可能会产生更大的问题。进行第一阶段研究的目的是测量焊料配方的生物稳定性，评估组织粘合策略，并比较四种体外临床角膜手术模型（放射状角膜切开术、LASIK 皮瓣、穿透性角膜移植术和白内障切除术）中伤口稳定性与室内压力的函数关系。结果证实，激光焊接方法优于标准缝合，且没有组织收缩的证据。焊接修复的强度取决于通过选择激光、焊料成分和薄膜厚度达到精确设定的温度。通过与标准交联剂反应可提高焊料的生物稳定性。第二阶段的具体目标是优化幸存者动物手术模型中的焊料加工、激光技术和手术结果。任务描述包括在严格的过程控制下制备无菌焊料、紧凑型临床前激光系统的设计和组装、激光手持件的优化以及在兔子模型上进行离体和体内实验。手术终点将包括伤口密封的质量、附带热组织损伤的程度（如果有）、焊接稳定性和生物相容性。目前用于闭合眼部切口的方法与其他身体组织类似，需要放置缝合线以使组织边缘并置。角膜中缝线的存在会导致患者不适、视觉扭曲、细菌增殖和角膜炎的风险。使用具有足够密封性能以长时间抵抗眼内压突然变化的生物组织粘合剂，可能对于由外伤或手术引起的角膜伤口的合成有很大好处。