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

这个小企业创新研究第一阶段项目将展示跨胫（TT）假体吸力保持的重大改进。由于密封困难，真正的TT吸力滞留（即，套内压力低于环境压力）是罕见的。装配既费力又昂贵；残肢体积每天变化，在疾病和月经期间。戴上吸力的TT插座，白天可能会丢失。Synergy的智能可变几何套接字（SVGS）的出现，现在可以自动维护TT残端上的吸力密封。SVGS简单、坚固且相对便宜；它能促进血液循环，自动防止缺血，保护神经功能失调的残肢免于坏死。项目成果包括大大提高舒适度、稳定性、安全感和组织健康。这个项目是必要的，因为TT车身重量支撑不同于TF支撑，并且需要近端、周向的插座密封。将测量动态套内压力、行走功、耐力、速度和稳定性以及截肢者的安全感。第二阶段将包括广泛的临床试验。美国大约有165,000例跨胫截肢患者，每年有45,000例跨胫截肢。随着该项目的成功，TT假体的吸力保留应该会得到普及。我们预计SVGS/TT插座衬垫套件的全球年销售额为1000万美元。

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.