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

该SBIR一期项目的更广泛/商业影响将研究和改进眼库中的角膜移植物制备过程，用于恢复视力的移植手术，以治疗角膜疾病，影响美国超过400万人。内皮膜角膜移植术（DMEK）是一种涉及角膜薄层移植的先进手术，具有出色的临床效果。然而，这给眼库带来了巨大的负担，因为他们使用了一个困难的、时间和成本密集的过程来分离供体角膜的薄层（DMEK移植物），然后提供给外科医生进行移植。这项拟议的研究将有助于开发和评估一种新型的DMEK移植物，以降低制备DMEK移植物的难度，减少所需的时间，并扩大合格的供体池。改进移植准备过程将提高眼库的经济效率，并有助于使美国个人更容易获得恢复视力的DMEK手术。该项目旨在开发和评估一种新型的，一流的移植物制备设备，该设备标准化，去技能，并提高液体气泡技术（LBT）用于DMEK移植物制备的可行性。该装置克服了采用LBT的主要障碍：(1)针头始终插入正确的组织平面；(2)由于角膜高压导致的内皮细胞丢失（ECL）。它通过一个稳定的角膜基础和一个针插入系统来实现，允许在5分钟内进行简单、标准化的DMEK准备，在适当的移植物存活率下，即使在糖尿病和肥胖的供体角膜中，失败率也低于5%。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/commercial impact of this SBIR Phase I project will study and improve the process of corneal graft preparation in eye banks for use in vision-restoring transplant procedures to treat corneal diseases, affect more than over 4 million people in the United States. Descemets membrane endothelial keratoplasty (DMEK) is an advanced procedure involving transplantation of a thin layer of the cornea with outstanding clinical outcomes. However, this places a significant burden on eye banks as they use a difficult, time- and cost-intensive process to isolate the thin layer of the donor cornea (DMEK graft), subsequently provided to a surgeon for transplantation. The proposed research will enable development and evaluation of a novel to decrease the difficulty of DMEK graft preparation, reduce the time required, and expand the eligible donor pool. Improving the graft preparation process will result in increased economic efficiency within eye banks, and help enable greater access to vision-restoring DMEK procedures to individuals in the United States. This project seeks to develop and evaluate a novel, first-in-class graft preparation device that standardizes, de-skills, and improves the viability of the liquid bubble technique (LBT) for DMEK graft preparation. The proposed device overcomes the major barriers to LBT adoption: (1) consistent needle insertion into the correct tissue plane and (2) endothelial cell loss (ECL) due to high pressure in the cornea. It does so via a stabilizing corneal base in conjunction with a needle insertion system to allow for simple, standardized DMEK preparation in under 5 minutes with less than 5% failure rates at appropriate graft viability, even in diabetic and obese donor corneas.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.