I-Corps: Hydrogels for Intervertebral Disc Repair

该I-Corps项目的更广泛影响/商业潜力是为接受脊柱手术的椎间盘突出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，其中每个手术的费用估计为15，000 - 50，000美元。对医疗保健经济学的研究发现，每100名接受该手术的患者，由于初次手术失败（再疝），大约花费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口中，如果可以预防再突出，通过预防翻修手术每年可以节省14亿美元。此外，使用这种水凝胶技术将其他修复性植入物定位在椎间盘内，将使更多的治疗方法能够获得监管机构的批准，并提高脊柱修复的质量。 水凝胶技术的商业化将允许开发和临床使用各种生物和机械植入物用于脊柱修复。这个I-Corps项目进一步开发可注射生物材料，用于密封缺陷和固定植入器械，重点是脊柱微创手术。椎间盘是脊柱中的软骨组织，其连接相邻椎骨，吸收冲击并在运动期间允许灵活性。在椎间盘退变中，坚硬的外部组织的损伤使得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椎间盘退变的标准干预措施，可以缓解疼痛，但不能主动治愈病变组织。临床研究发现，椎间盘切除术后的再突出率很高，各种尝试使用修复植入物来防止再突出和恢复丢失的椎间盘组织。这些植入物材料和装置没有紧密地固定在椎间盘内，因此当前的策略通常由于植入物周围的再疝形成或植入物本身的移位而存在缺陷。该项目正在开发可注射水凝胶，以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，水凝胶与其他器械一起使用可预防突出，并在很大程度上恢复了天然椎间盘的机械性能。该奖项反映了NSF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.