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（公法111-5）资助的。这个小企业创新研究二期项目将继续开发Tube-Clear（TM）设备，以清除堵塞和迟钝的饲管，满足关键的医疗需求，并达到可行的商业市场。当受损患者无法吞咽食物或药物时，喂食管用于给药和营养。堵塞会使患者数小时甚至数天没有药物或营养，这对患者和护理人员来说都是非常令人沮丧的。在美国，每年大约有41万根PEG（长期）管和500万根NG（短期）管被放置，每种类型的管在进料、堵塞和清洁方面都面临着特定的挑战。Tube-Clear(TM) PEG原型机在不到一分钟的时间内清洁了一团食物和地面药物，这是其他任何可用方法都无法轻易清除的。PEG α -原型在四个焦点小组的演示中，来自不同临床环境的20多名护士对该设备产生了压倒性的积极反应。第二阶段（继IB阶段之后）将进一步开发PEG管和NG管清洁剂的beta原型，使设备通过临床试验，并建立制造方案，所有这些都在食品和药物管理局合规的质量体系下进行。管清将减轻护理人员和病人的负担，处理堵塞和缓慢的喂食管。利用SBIR（第一阶段、第二阶段和第三阶段）、宾夕法尼亚州、商业合作伙伴和股权投资的资金组合，已经制定了一项结构化的财务和技术计划，以在2.5年的时间内达到特定的里程碑。NSF第一阶段项目以一个非常成功的PEG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，得到了非常积极的评价。用于PEG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。压电共振创新公司（PRII）预计，到2013年，Tube-Clear （TM）的收入将达到2500万至5000万美元。三家在肠内喂养市场有业务的商业合作伙伴对该设备表示了浓厚的兴趣，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，可能作为IIB阶段的合作伙伴。PRII的工作人员还将在宾夕法尼亚州立护理学院教授关于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.