BIOELASTIC MATERIALS FOR INTERVERTEBRAL DISC RESTORATION

这项应用的广泛和长期目标是为椎间盘病理引起的腰痛提供一种明显更便宜的微创治疗。具体施舍有：1)设计具有压力活性和生物相容性的粘弹性蛋白基聚合物i)在髓核植入过程中实现适当的椎间盘内压力发展，以机械恢复压缩椎间盘的正确尺寸和内部压力ii)刺激组织重建，使椎间盘结构恢复到更自然的状态。2)评估人体尸体腰椎的病变状态，选择合适的病变状态进行生物弹性聚合物的植入；3)对选定的腰椎节段（L1-L5）进行力学研究，评估植入的粘弹性蛋白基聚合物在恢复病变椎间盘适当力学性能方面的功效；4)对四种专门设计的生物弹性聚合物进行基因工程，用于微生物生物合成生产。5)计划在II期使用所设计的四种生物弹性聚合物进行体内动物模型研究，研究所设计的生物弹性聚合物对损伤椎间盘恢复正常状态的功效。仅在美国，每年的成功就可以使数百万人重返工作岗位，并减少数百亿美元的医疗成本。建议的商业应用：腰痛，椎间盘病变是主要原因，在美国是仅次于普通感冒的缺勤原因；据报道，它造成的生产力损失比任何其他疾病都要大，每年的保健费用为330亿美元。在美国，每年报告的椎间盘脱垂病例超过400万例。开发修复病变椎间盘的材料将具有商业意义，并将对医疗费用产生有利影响。

The broad, long term objective of this application is to provide a markedly less expensive, minimally invasive treatment for low back pain arising from intervertebral disc pathology. The specific alms are: 1) to design pressure-active and biocompatible viscoelastic protein-based polymers i) to effect proper intra-disc pressure development on implantation in the nucleus pulposus for mechanical restoration of the compressed disc to its correct dimensions and internal pressure and ii) to stimulate tissue reconstruction for structural restoration of the intervertebral disc to its more natural state, 2) to evaluate the diseased state of human cadaver lumbar spines and to select appropriate diseased states for implantation of bioelastic polymers, 3) to perform mechanical studies on the selected lumbar spine segments (L1-L5) to assess efficacy of implanted viscoelastic protein-based polymers in restoring proper mechanical properties to diseased intervertebral discs, 4) to genetically engineer four specially designed bioelastic polymers for production by microbial biosynthesis, and 5) to plan in vivo animal model studies using the four designed bioelastic polymers in Phase II wherein injured intervertebral discs could be studied for efficacy of designed bioelastic polymers to restore the normal state. Success could, annually in the U.S. alone, return millions to work and reduce health care costs by tens of billions of dollars. PROPOSED COMMERCIAL APPLICATIONS: 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 a health care cost of $33 billion dollars/year. Over 4 million cases of prolapsed intervertebral discs are reported annually in the U.S. Development of materials to restore diseased intervertebral discs would be of commercial significance and would impact favorably on medical care costs.