BIOELASTIC MATERIAL TO PREVENT POST-LAMINECTOMY ADHESION

防止椎板切除术后粘连的生物弹性材料

• 批准号: 6387840
• 负责人: JIE XU
• 金额: $ 37.69万
• 依托单位: BIOELASTICS RESEARCH, LTD
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6387840
• 关键词: adhesions; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biotherapeutic agent; elasticity; gel; histology; laminectomy; peptide structure; polymers; postoperative complications; protein purification; sheep; spinal disk injury

Using two biocompatible elastic protein-based polymers (in viscolelastic gel and elastic sheet forms), the Phase I study demonstrated both materials to be highly effective in preventing adhesions to the spinal dura in the rabbit laminectomy model. The specific aims of Phase II are: 1) to identify the preferred membrane and/or gel configuration(s) of two biocompatible and resorbable polymer compositions for prevention of adhesions in a large animal laminectomy model, 2) to develop sensitive double radio-label standards for purification and a quality control protocol, 3) to utilize an adult sheep lumbar spine model with laminectomies performed at two non-contiguous levels (L3-L4 and L5-L6) allowing for a randomization of the polymer placement to surgical site, 4) to develop a mechanical test method for assessing the interface between the dura mater and the tested polymer and the epidural fibrotic tissue at the control site, and 5) to complete biocompatibility testing and prepare an IDE application for the preferred polymer(s) and state(s). The physical disability resulting from intervertebral disc herniation constitutes the third most common condition for worker disability in the U.S. An improved outcome of intervertebral disc laminectomy would improve the quality of life and restore function for many millions of disabled Americans. PROPOSED COMMERCIAL APPLICATION: Low back pain, for which intervertebral disc pathology is the major cause, is second only to the common cold for work absenteeism in the United States; it is reported to result in more productivity loss than any other medical condition and in an annual health care cost of $33 billion. Over four million cases of prolapsed intervertebral discs are reported annually in the U.S. Development of materials that would improve the outcome of intervertebral disc laminectomy would clearly be of commercial significance while impacting favorably on medical care costs.

I期研究使用两种生物相容性弹性蛋白聚合物（在粘弹性凝胶和弹性片形式中），证明两种材料在防止兔椎板切除术模型中对脊髓硬脑膜的粘附非常有效。第二阶段的具体目的是：1）确定两个生物相容性和可吸收的聚合物组成的首选膜和/或凝胶构型（S），以预防大型动物层状切除术模型中的粘附模型，2）以开发敏感的双向射击标准，以净化敏感的双标准和质量控制协议，3）使用质量控制协议3）非连续水平（L3-L4和L5-L6）允许将聚合物放置到手术部位，4）开发一种机械测试方法，以评估硬脑膜和测试的聚合物与测试的聚合物之间的界面以及在对照部位上的硬膜膜纤维化组织，以及5）以完成生物相相测试和plosems（s）的extrym and Repperress（S）（S）。椎间盘疝引起的身体残疾构成了美国工人残疾的第三大常见状况，改善了椎间盘椎间盘切除术的结果将改善数百万美国人的生活质量并恢复生活质量和恢复功能。拟议的商业应用：椎间盘病理学是主要原因的下背痛，仅次于美国的缺勤症的普通感冒。据报道，这会导致比任何其他医疗状况的生产率损失更高，并且每年的医疗保健费用为330亿美元。每年在美国开发将改善椎间盘层状切除术结果的材料中，每年都有超过400万例脱垂的椎间盘均具有商业意义，同时对医疗费用有利。