BIOELASTIC MATERIAL TO PREVENT POST-LAMINECTOMY ADHESION

使用两种生物相容的弹性蛋白聚合物(粘弹性凝胶和弹性片状)，I期研究证明这两种材料在兔椎板切除模型中都能高效地防止粘连到脊髓硬脑膜。第二阶段的具体目标是：1)确定用于在大型动物椎板切除模型中防止粘连的两种生物相容和可吸收聚合物组合物的优选膜和/或凝胶构型(S)，2)开发用于纯化的灵敏的双放射标记标准和质量控制方案，3)利用在两个不连续的节段(L3-L4和L5-L6)进行椎板切除的成年绵羊腰椎模型，允许将聚合物随机放置到手术部位，4)开发一种机械测试方法，用于评估硬脑膜和被测试的聚合物与对照部位的硬膜外纤维组织之间的界面，5)完成生物相容性测试，准备首选聚合物(S)和状态(S)的集成开发环境应用程序。在美国，腰椎间盘突出导致的身体残疾是工人残疾的第三大常见状况。椎间盘椎板切除术的改善结果将改善数百万美国残疾人的生活质量和恢复功能。拟议的商业应用：在美国，腰痛是仅次于因旷工而导致的普通感冒的第二大原因，腰椎病变是其主要原因；据报道，它导致的生产力损失比任何其他医疗疾病都要严重，每年的医疗费用为330亿美元。据报道，美国每年有超过400万例腰椎间盘突出症。开发能够改善椎间盘椎板切除术结果的材料显然具有商业意义，同时也会对医疗成本产生有利影响。

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.