SBIR Phase I: Safety Syringe Needle for Prevention of Unintended/Accidental Puncture (Needlestick Injury)

SBIR 第一阶段：用于预防意外/意外穿刺（针刺伤）的安全注射针头

• 批准号: 2219892
• 负责人: Steven Opolski
• 金额: $ 24.94万
• 依托单位: GNU COMPANY, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2219892&HistoricalAwards=false
• 关键词: SBIR; Phase; Safety; Syringe; Needle

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel medical device for intramuscular injections that will reduce needlestick injury. Unintended or accidental puncture is the second most common occupational hazard for healthcare staff. An estimated 385,000 needlestick injuries occur in the United States each year impacting 5.6 million healthcare workers. Needlestick injury represents one of the largest risks, both financially ($258 million annually) and medically (e.g., bloodborne pathogen exposure), to healthcare providers. This project aims to develop a novel, flexible hypodermic needle with a safety syringe that enables rapid injections while replacing sharp needles and significantly reducing risks of unintended health care provider injury.This Small Business Innovation Research Phase I project provides a novel, flexible, polymer needle-based safety syringe for health care providers to perform intramuscular injections in patients. A novel and variable stiffness shaft is integrated with an external safety lumen mechanism to create an integrated delivery system with the same delivery reliability and repeatability as standard needlesticks. The design will be prototyped and evaluated under a variety of human factors considerations. The device will be required to pass several mechanical tests for puncture, insertion, and lumen integrity in a consistent manner, as anticipated during routine clinical use.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是一种用于肌肉注射的新型医疗设备，将减少针刺伤害。意外或意外穿刺是卫生保健人员第二大最常见的职业危害。据估计，美国每年发生38.5万起针刺伤事件，影响560万医护人员。针刺伤害是医疗保健提供者面临的最大风险之一，无论是经济风险（每年2.58亿美元）还是医疗风险（例如血源性病原体暴露）。该项目旨在开发一种具有安全注射器的新型柔性皮下注射针头，在替代尖锐针头的同时实现快速注射，并显著降低医疗保健提供者意外受伤的风险。这个小企业创新研究第一阶段项目为医疗保健提供者提供了一种新型的、灵活的、基于聚合物针头的安全注射器，用于对患者进行肌肉注射。一种新颖的可变刚度轴与外部安全腔机构集成在一起，形成一个集成的输送系统，具有与标准针头相同的输送可靠性和可重复性。该设计将在各种人为因素的考虑下进行原型设计和评估。如常规临床使用中预期的那样，该装置需要以一致的方式通过穿刺、插入和管腔完整性的几项机械测试。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。