CORD BLOOD COLLECTION DEVICE

我们建议开发一种脐带血采集器，以更好地支持脐带血造血干/祖细胞在移植中的广泛使用。拟议中的设备将使脐带与环境中的污染物隔离，并将保护医务人员免受尖锐的针头和刀片的影响。该设备的设计是在程序允许的情况下，在最新鲜的状态下收集最大数量的脐带血。无论是在胎盘分娩之前还是之后，它都是可行的。这项第一阶段提案的具体目标是优化脐带周围无菌密封的设计，优化切割机构的设计，并在胎盘分娩后对脐带样本进行测试和验证。第二阶段的目标是提供一个原型设备，用于在交付套件中进行测试。该项目的成功将带来一种可供商业评估和测试的设备。一旦商业化，该设备将为医学界提供一种手段，以高度可靠和安全的方式收集有价值的胎儿血细胞来源，能够支持癌症和遗传性致命血液疾病患者的造血系统恢复。在出生时收集这些细胞并随后进行冷冻保存将允许在个体一生中的任何时间进行自体移植。此外，未来的进展可能允许在基因转移治疗中使用这些相同的细胞。拟议的商业应用：目前还没有提供在分娩套件内或外部安全、高效和有效地收集脐带血的设备。该设备将为脐带血库的操作员、产科医生和脐带血移植的接受者提供显著的好处。目前正在分销血库用品和设备或产科用品和设备的公司将对该设备的普及感兴趣。

We propose to develop a cord blood collection device to better support the wide spread use of cord blood hematopoeitic stem and progenitor cells in transplantation. The proposed device will isolate the umbilical cord from contaminants in the environment and will protect medical staff from exposure to sharp needles and blades. The device is designed to collect the maximal amount of cord blood in as fresh a state as procedures permit. It will opemte either preor post-placental delivery. The specific aims of this Phase I proposal are to optimize the design of the aseptic seal around the cord, to optimize the design of the cutting mechanism, and to test and validate the device on a sampling of umbilical cords post-placenta delivery. The aims of Phase II will be to provide a prototype device for testing in the delivery suite. Success in this project will result in the availability of a device ready for commercial evaluation and testing. Once commercialized the device will offer to the medical community a means to collect with high reliability and safety a valuable source of fetal blood cells capable of supporting restoration of the hematopoietic system in individuals with cancer and inherited fatal blood conditions. Collection of these cells at birth and subsequent cryopreservation will allow autologous transplantation at any time in an individuals lifetime. In addition, future advances may allow the use of these same cells in gene transfer therapies. PROPOSED COMMERCIAL APPLICATION: There are no devices currently available which provide for the safe, efficient, and effective collection of cord blood in the delivery suite or outside. This device will offer significant benefits to operators of cord blood banks, obstetricians, and recipients of cord blood transplants. Companies currently distributing blood banking supplies and equipment or obstetrical supplies and equipment will be interested in the commemialization of this device.