BIOELASTIC MATERIALS FOR INTERVERTEBRAL DISC RESTORATION

本申请的广泛的长期目标是提供一种明显更便宜的微创治疗由椎间盘病变引起的腰痛。具体的施舍是：1）设计压力活性和生物相容性粘弹性蛋白质基聚合物，i）在植入髓核中时实现适当的椎间盘内压力发展，用于将压缩的椎间盘机械恢复到其正确的尺寸和内部压力，和ii）刺激组织重建，用于将椎间盘结构恢复到其更自然的状态，2）评估人尸体腰椎的病变状态并选择合适的病变状态用于植入生物弹性聚合物，3）对选定的腰椎节段（L1-L5）进行力学研究，以评估植入的粘弹性蛋白质的有效性。在恢复患病椎间盘的适当机械性能方面，4）对四种特别设计的生物弹性聚合物进行基因工程改造，以通过微生物生物合成来生产，和5）计划在第II阶段中使用四种设计的生物弹性聚合物进行体内动物模型研究，其中可以研究损伤的椎间盘的功效，设计了生物弹性聚合物来恢复正常状态。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费用。拟议的商业应用：在美国，腰痛是仅次于普通感冒的主要原因，椎间盘病变是腰痛的主要原因;据报道，腰痛导致的生产力损失比任何其他医疗状况都多，每年的医疗保健费用为330亿美元。 在美国，每年报告超过400万例椎间盘脱出病例。开发用于恢复患病椎间盘的材料将具有商业意义，并将对医疗保健成本产生有利影响。

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.