I-Corps: Hydrogels for Intervertebral Disc Repair

I-Corps项目更广泛的影响/商业潜力是为接受脊柱手术的椎间盘突出症患者提供可靠的治疗方法。每年大约有50万人接受椎间盘切除术，每次手术的费用估计在1.5万到5万美元之间。医疗经济学研究发现，每100名接受手术的患者中，由于初次手术失败（再疝），大约要花费30万美元用于翻修手术。因此，在每年接受椎间盘切除术的总人数中，如果能够预防椎间盘再突出，每年有可能通过预防翻修手术节省14亿美元。此外，使用这种水凝胶技术将其他修复植入物定位在椎间盘内，将使更多的治疗方法有可能获得监管部门的批准，并提高脊柱修复的质量。水凝胶技术的商业化将允许各种生物和机械植入物用于脊柱修复的开发和临床应用。这个I-Corps项目进一步开发了可注射的生物材料，用于在微创手术中密封缺陷和固定植入装置，重点是脊柱应用。椎间盘是脊柱中的软骨组织，连接相邻的椎体，吸收震动，并在运动时保持灵活性。在椎间盘退变中，坚硬的外部组织的病变使凝胶状的内部组织突出并压迫周围的神经。椎间盘切除术是目前治疗椎间盘退变的标准干预措施，它能缓解疼痛，但不能有效治愈病变组织。临床研究发现椎间盘切除术后显著的再突出率，尝试使用各种修复植入物来防止再突出和恢复丢失的椎间盘组织。这些植入材料和装置在椎间盘内的固定不牢固，因此目前的策略经常因植入物周围的再突出或植入物本身的移动而存在缺陷。本项目正在开发可注射水凝胶，用于固定椎间盘修复植入物，有效防止植入物移位和椎间盘材料突出。在临床前研究中，水凝胶与其他装置一起使用可以防止椎间盘突出，并在很大程度上恢复椎间盘的力学性能。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is to provide a reliable treatment method for patients with intervertebral disc herniations undergoing spine surgery. There are approximately half a million individuals who undergo a discectomy procedure each year, where each procedure costs an estimated $15,000-$50,000. Studies on healthcare economics found that for every 100 patients undergoing the procedure, approximately $300,000 is spent on revision surgeries due to the failure of the initial surgery (reherniation). Therefore, of the total population undergoing discectomy each year, there is the potential to save $1.4 billion annually through prevention of revision surgeries if reherniation can be prevented. Additionally, using this hydrogel technology to localize other reparative implants inside the intervertebral disc would enable more therapies to potentially obtain regulatory approval and improve the quality of spine repair. Commercialization of the hydrogel technology will allow the development and clinical use of a variety of biologic and mechanical implants for spine repair.This I-Corps project further develops injectable biomaterials for sealing defects and securing implant devices in minimally invasive procedures with emphasis on spinal applications. Intervertebral discs are cartilaginous tissues in the spine that connect adjacent vertebra, absorb shock and allow flexibility during motion. In intervertebral disc degeneration, lesions in the stiff outer tissue allow the gelatinous inner tissue to herniate and compress surrounding nerves. Discectomy, the current standard intervention for intervertebral disc degeneration, relieves pain but does not actively heal the diseased tissue. Clinical research has found significant reherniation rates following discectomy procedures with various efforts attempted to use repair implants that prevent reherniation and restore lost disc tissue. These implant materials and devices are not tightly secured within the disc, and thus current strategies are often flawed by reherniation around the implant or migration of the implant itself. This project is developing injectable hydrogels to secure disc repair implants, effectively preventing migration of the implants and herniation of disc material. In pre-clinical studies, hydrogels used with other devices prevented herniation and largely restored native intervertebral disc mechanical properties.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.