SBIR Phase II: Active Device for Reliable Cleaning of Feeding Tubes

该奖项是根据2009年《美国复苏和再投资法案》(Public Law 111-5)资助的。这个小企业创新研究第二阶段项目将继续开发Tube-Clear(TM)设备，以清理堵塞和迟缓的喂养管，满足关键的医疗需求，并进入可行的商业市场。当受损的患者无法吞咽食物或药物时，喂养管被用来管理药物和营养。木塞会让患者几个小时甚至几天没有药物或营养，对患者和照顾者都是非常令人沮丧的。美国每年大约放置410,000根聚乙二醇管(长期)和500万根NG(短期)管。每种类型的管子都给进料、堵塞和清洁带来了特殊的挑战。Tube-Clear(TM)PEG原型在不到一分钟的时间内清除了食物和地面药物的堵塞，而使用任何其他可用的方法都无法轻松清除这些堵塞。在四个焦点小组向来自不同临床环境的20多名护士展示了聚乙二醇阿尔法原型，产生了对该设备的压倒性积极反应。第二阶段(在IB阶段之后)将进一步将聚乙二醇管和NG管清洁器开发为Beta原型，将这些设备用于临床试验，并建立制造方案，所有这些都将在符合食品和药物管理局的质量体系下进行。Tube-Clear将减轻护理人员和患者处理堵塞和迟缓的喂养管的压力。利用SBIR(第一阶段、IB阶段、第二阶段和IIB阶段)、宾夕法尼亚州、商业合作伙伴和股权投资的资金，制定了一项结构化的财务和技术计划，以在2.5年期间达到具体的里程碑。NSF第一阶段项目以一个非常成功的聚乙二醇管的Alpha原型开始了这一开发工作，该原型在一系列护理焦点小组中进行了测试，获得了非常积极的评价。用于聚乙二醇管清洗的Tube-Clear预计将于2010年上市，随后将于2011年推出NG管清洗设备市场。到2013年，Piezo Resonance Innovation(PRI)预计Tube-Clear(TM)的收入将达到2500万至5000万美元。在肠内喂养市场有业务的三家商业合作伙伴对该设备表现出了浓厚的兴趣，并将提供进入市场的途径、营销人员和设备开发专业知识。他们还表示愿意提供资金，可能是作为第二阶段B的合作伙伴。Prii的工作人员还将在宾夕法尼亚州立护理学院教授医疗器械设计的客座讲座。

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).This Small Business Innovation Research Phase II project will continue development of the Tube-Clear(TM) device to clear clogged and sluggish feeding tubes, satisfying a critical medical need and reaching a viable commercial market. When compromised patients are unable to swallow food or medication, feeding tubes are used to administer medication and nutrition. A clog leaves the patient without medication or nutrition for hours, or even days, and is extremely frustrating to both patient and caregiver. Approximately 410,000 PEG (long-term) tubes and 5 million NG (short-term) tubes are placed each year in the U.S. Each type of tube presents specific challenges for feeding, clogging and cleaning. The Tube-Clear(TM) PEG prototype cleaned a clog of food and ground medication, in less than one minute, that could not be easily removed using any other available approach. Demonstration of the PEG alpha-prototype at four focus groups, for over 20 nurses from a variety of clinical settings, produced an overwhelmingly positive response toward the device. Phase II (following on Phase IB) will further develop both the PEG tube and NG tube cleaners to beta-prototypes, take the devices through clinical trials, and establish manufacturing protocols, all under a Food and Drug Administration compliant quality system.The Tube-Clear will ease the burden on nursing staff and patients dealing with the frustration of clogged and sluggish feeding tubes. A structured financial and technical plan has been put in place using a combination of funds from SBIR (Phase I, IB, II and IIB), the State of Pennsylvania, Commercial Partners, and equity investment to reach specific milestones over a 2.5 year period. The NSF Phase I project kicked off this development effort with a highly successfully Alpha prototype for PEG tubes, which was tested in a series of nursing focus groups, resulting in extremely positive reviews. The Tube-Clear for PEG cleaning has an anticipated market launch date in 2010, followed by a NG tube cleaning device market launch in 2011. By 2013, Piezo Resonance Innovations (PRII) anticipates revenue for the Tube-Clear (TM) of $25-50 Million. Three commercial partners, with presence in the enteral feeding market, have indicated strong interest in the device and would provide access to their paths to market, marketing staff, and device development expertise. They have also expressed willingness to contribute financially, potentially as Phase IIB partners. PRII staff will also teach guest lectures on medical device design in the Penn State School of Nursing.