SBIR Phase II: Development of a novel, highly efficient Descemet's Membrane Endothelial Keratoplasty preparation device expands the donor pool

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力涉及超过2500万等待角膜移植以恢复视力的人的重大的、未满足的临床和商业需求。角膜失明导致身体伤害、精神障碍、社会孤立和认知能力下降的风险增加，导致预期寿命减少15年以上。幸运的是，95%的角膜疾病可以通过移植来治疗。部分厚度角膜移植是一种创新的手术，为90%以上的角膜疾病患者提供了最佳的临床结果；然而，安全有效地分离角膜层以制备角膜移植物和进行移植的困难导致这些手术的利用不足。该项目旨在将用于角膜移植准备和角膜移植手术中组织分离的一次性辅助设备商业化，从而有可能提高眼库和眼科医生的效率，增加角膜移植的可及性，并改善这些手术的结果。这些设备具有时间和资本效率，可以改善患者的治疗效果，并进入每年3.4亿美元的全球市场。这个小企业创新研究（SBIR）二期项目涉及开发新型的、一流的移植物制备和辅助手术设备，以标准化、去技能化和提高角膜移植中液体泡（LBT）和大泡技术（BBT）的可行性。LBT是一种移植准备技术，可以在几分钟内从所有供体眼睛准备移植物；然而，这种方法比较困难，很少被眼库使用。BBT是一种外科技术，可以为移植患者提供有效、精确的角膜层分离；然而，它极具挑战性，导致组织穿孔率很高，即使是经验丰富的外科医生也报告了5-39%的失败率。该项目利用一种控制组织层分离的技术，克服了LBT和BBT的主要障碍，并使部分厚度角膜移植手术得以采用。该提案将测试该技术可以提供符合现有临床工作流程的高质量移植物的假设，并且可以实现安全，有效和标准化的角膜层分离，而不会出现并发症。这些研究与领先的眼库/角膜专家合作，将推进设备设计，以确保人类供体眼睛的功能性、可用性、可制造性和有效性。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 Small Business Innovation Research (SBIR) Phase II project relates to the significant, unmet clinical and commercial need of more than 25 million individuals waiting for a corneal transplant to restore their vision. Corneal blindness leads to an increased risk of physical harm, mental disorders, social isolation, and cognitive decline, resulting in an over 15-year reduction in life expectancy. Fortunately, 95% of corneal diseases can be treated via a transplant. Partial thickness corneal transplants are innovative procedures that provide the best clinical outcomes for over 90% of patients with corneal disorders; however, the difficulty of safely and efficiently separating the layers of the cornea to prepare corneal grafts and perform transplants has led to under-utilization of these procedures. This project seeks to commercialize single-use, assistive devices for tissue separation in corneal graft preparation and corneal transplant surgery with the potential to improve the efficiency of eye banks and ophthalmologists, increase access to corneal transplants, and improve the outcomes of these procedures. These devices have a time- and capital-efficient path to improving patient outcomes and entering the $340 million global market, annually. This Small Business Innovation Research (SBIR) Phase II project involves development of novel, first-in-class graft preparation and assistive surgical devices that standardize, de-skill, and improve the viability of the liquid bubble (LBT) and big bubble techniques (BBT) in corneal transplantation. LBT is a graft preparation technique shown to prepare grafts in minutes from all donor eyes; however, it is more difficult and rarely used by eye banks. BBT is a surgical technique shown to provide efficient, precise separation of layers of the cornea in transplant patients; however, it is extremely challenging and leads to high rates of tissue perforation, with even experienced surgeons reporting 5–39% failure rates. This project leverages a technology for controlled separation of tissue layers to overcome the major barriers of LBT and BBT and enable adoption of partial thickness corneal transplant procedures. This proposal will test the hypotheses that this technology can provide high quality grafts that fit into existing clinical workflows and can enable safe, efficient, and standardized separation of corneal layers without complications. These studies, in collaboration with leading eye banks/corneal specialists, will advance device designs to ensure functionality, usability, manufacturability, and efficacy in human donor eyes.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.