SBIR Phase I: Suction Retention Smart Variable Geometry Sockets (SVGS) for Transtibial Prostheses

该小型企业创新研究I期项目将证明经胫骨（TT）假体吸力保持的重大改进。 真实TT吸力保持（即，火箭内压力低于环境压力）是罕见的，因为密封困难。 拟合是艰巨和昂贵的;残端体积变化每日，在疾病和月经期间。 一个TT插座，持有吸力穿上，可能会失去它在白天。 随着Synergy的智能可变几何插座（SVGS）的出现，现在可以自动保持TT树桩上的吸力密封。 SVGS简单，坚固，相对便宜;它可以增强血液循环，自动防止缺血，保护神经功能障碍的残端免于坏死。 项目成果包括大大提高舒适性、稳定性、安全感和组织健康。 该项目是必要的，因为TT体重支撑不同于TF支撑，并且需要近端周向承窝密封。 动态的火箭内压力，截肢工作，耐力，速度和稳定性，以及截肢者的安全感将被测量。 第二阶段将包括广泛的临床试验。 美国大约有165，000名经胫骨（TT）截肢者，每年有45，000例TT截肢。 随着该项目的成功，TT假体的吸力保持应该会变得流行。 我们预计SVGS/TT插座内衬套件的全球销售额为1000万美元/年。

This Small Business Innovation Research Phase I project will demonstrate major improvement in suction retention for transtibial (TT) prostheses. True TT suction retention (i.e., intrasocket pressure below ambient) is rare because of sealing difficulty. Fitting is arduous and expensive; stump volume changes diurnally, during illness and menstruation. A TT socket that holds suction on donning, may lose it during the day. The advent of Synergy's Smart Variable Geometry Socket (SVGS), now makes possible maintaining, automatically, a suction seal on the TT stump. SVGS is simple, robust and relatively inexpensive; it enhances blood circulation and automatically prevents ischemia, protecting a stump with dysfunctional nerves from necrosis. Project outcomes include greatly improved comfort, stability, sense of security and tissue health. This project is necessary because TT body weight support is different from TF support, and a proximal, circumferential socket seal is needed. Dynamic intrasocket pressures, ambulation work, endurance, speed and stability, and the amputee's sense of security will be measured. Phase II will include broad clinical trials. There are approximately 165,000 U.S. transtibial (TT) amputees, with 45,000 TT amputations annually. Suction retention of TT prostheses should become popular with success of this project. We project $10s millions/year worldwide sales of SVGS/TT socket-liners kits.