CORD BLOOD COLLECTION DEVICE

我们建议开发一种脐带血采集装置，以更好地支持脐带血造血干细胞和祖细胞在移植中的广泛应用。拟议的设备将隔离脐带与环境中的污染物，并将保护医务人员免受锋利的针头和刀片。该设备旨在收集尽可能多的新鲜状态的脐带血。它将在胎盘分娩前或胎盘分娩后运行。该I期提案的具体目标是优化脐带周围无菌密封的设计，优化切割机制的设计，并在胎盘分娩后的脐带样本上测试和验证该器械。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。该项目的成功将导致设备的可用性，可用于商业评估和测试。一旦商业化，该设备将为医学界提供一种以高可靠性和安全性收集胎儿血细胞的有价值来源的手段，该胎儿血细胞能够支持患有癌症和遗传性致命血液病的个体的造血系统的恢复。在出生时收集这些细胞并随后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疗法中使用这些相同的细胞。拟定商业应用：目前还没有任何设备可以在分娩室或分娩室外安全、高效和有效地采集脐带血。该设备将为脐带血库的操作者、产科医生和脐带血移植的接受者提供显著的益处。目前经销血库用品和设备或产科用品和设备的公司将对纪念这一装置感兴趣。

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.