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

SBIR 第一阶段：用于小腿假体的吸力保持智能可变几何插座 (SVGS)

• 批准号: 9960955
• 负责人: Robert Dean, Jr.
• 金额: $ 10万
• 依托单位: SYNERGY INNOVATIONS INC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-01-01 至 2000-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=9960955&HistoricalAwards=false
• 关键词: SBIR; Phase; Suction; Retention; Smart

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.

这个小型企业创新研究第一阶段项目将展示经胫骨(TT)假体在吸力保持方面的重大改进。由于密封困难，真正的TT吸力保持(即低于环境的腔内压力)很少见。试穿既费力又昂贵；在生病和月经期间，残肢体积每天都会发生变化。在穿上时保持吸力的TT插座可能会在白天失去吸力。Synergy的智能可变几何插座(SVGS)的出现，现在使自动维护TT残端上的吸气密封成为可能。SVGS简单、坚固且相对便宜；它增强血液循环并自动防止缺血，保护功能失调的神经残端免受坏死。项目成果包括极大地改善舒适性、稳定性、安全感和组织健康。这个项目是必要的，因为TT体重支持不同于TF支持，并且需要近端周向插座密封。将测量动态袋内压力、步行功、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名胫骨(TT)截肢者，每年有45,000名TT截肢者。随着这个项目的成功，TT假体的吸力保持应该会流行起来。我们预计SVGS/TT插座衬垫套件的全球年销售额为1000多万美元。