Novel Technology for Reprocessing Flexible Endoscopes

描述(申请人提供)：清洗狭窄的内部通道 在低流速下使用液体的柔性内窥镜是不够的 因为流体动力学的基本限制。要实现高效 必须将清洁、足够的湍流和高剪应力应用于 渠道表面。Novaflux发明的湍流两相流方法 满足不同直径通道的这些条件。在第一阶段， 一个自动可编程的设备被设计和建造来提供 一种新的用于内流道系统“整个”表面的两相流 流动路径回路。枯草芽孢杆菌芽胞减少率为6~8log10 用两阶段法一致地实现了内部通道。这个 清洁效率是用放射性核素法独立验证的 使用Tc99。溪流和弥散流态占主导地位。 风水流道的风速清洗&30m/S：两相清洗 似乎是由于液滴撞击(高剪应力)对土壤的侵蚀而发生的 通过“高效”漂洗来清除清洗过程中产生的泥土碎片。这个 第二阶段的具体目标是：1)设计、建造和测试修订后的 以及完整的内窥镜再处理装置，以执行有效的清洁和 基于湍动两相清洗技术的消毒方案。2) 要使用两阶段方法验证内部通道清理，请使用 预测性评估方法包括：放射性核素和目视检查， 以及微生物回收方法。3)研究和验证清洁工作 挠性内窥镜内部通道参数。4)学习和学习 验证消毒周期以实现高级别消毒(HLD)或 可能在两阶段清洗过程中进行灭菌。5) 进行全面的体外模拟研究，模拟病人的土壤和 多种微生物验证将用于临床的方案 学习。6)进行多中心临床研究，以评估和验证 一种不同厂家生产的内窥镜的后处理方法及装置 制造商。 拟议的商业应用：在美国，每年进行的胃肠道内窥镜手术超过1000万例，这一数字以每年7.5%的速度增长。目前商用自动内窥镜再处理器(AER)最大的问题是它们无法从内部通道中去除土壤和生物，因为这种再处理设备没有设计成执行有效的清洁周期。此外，戊二醛是一种已知的致癌物质，许多人对其有强烈的过敏反应。替代液体杀菌剂是Steris使用的过氧乙酸；它也具有腐蚀性，会对内窥镜组件造成损害。 商业AER的售价在1万美元到3万美元之间，具体取决于它们同时重新处理一个以上内窥镜的能力以及自动记录系统等其他技术功能。一种一次只能处理一个内窥镜的设备现在售价在1万美元左右。这些设备的使用寿命在五到七年之间。国内年总销量估计约相当于每年2500个内窥镜的容量，另外还有5000个内窥镜销往国外。因此，每年的全球市场规模在1.5亿美元左右。其他收入来自辅助设备销售、部件更换、培训课程和维护合同。 Novaflux相信，通过将技术授权给现有的市场领先者或提供新产品，它可以迅速获得收入。使用这项技术给医疗行业带来的好处是： 1.减少内窥镜检查导致患者感染的风险：据估计，去年治疗140万住院患者的医院感染花费了近65亿美元。尽管官方提到的内窥镜检查感染风险很低，但大多数专家承认，大多数感染都没有被发现，或者导致了不危及生命的反应。 2.更短的再处理时间和更低的人工成本：大多数内窥镜再处理方案目前需要30到60分钟的时间，其中一部分需要人工清洁。用自动Novaflux设备取代大部分清洁周期，每次处理将节省10至15分钟，从而大大节省工作人员的人力。根据最近的估计，人工占内窥镜清洁和消毒程序总成本的44%，所引用的每次清洁成本在30美元左右。因此，在美国，每个手术每年可节省约4美元或高达4,000万美元的劳动力。 3.降低维护成本和延长设备寿命：内窥镜维护也是重新处理总成本的主要因素。Shields的研究推断，出于维护考虑，需要大量的内窥镜库存，以应对后处理对手术调度的影响。Urayama等人最近的一项调查。表明内窥镜的平均寿命在4.6到6.9年之间，具体取决于仪器的类型。考虑到仪器成本高达30,000美元，最大限度地减少对仪器的损害和可能延长设备使用寿命的再处理程序为医疗保健提供者提供了显着的成本效益。总而言之，这些好处的承诺应该会对内窥镜再处理中采用两阶段清洁技术提供巨大的激励。

DESCRIPTION (Provided by applicant): The cleaning of narrow internal channels of flexible endoscopes with liquids at low flow velocities is inadequate because of a fundamental limitation of fluid dynamics. To achieve efficient cleaning, sufficient turbulence and high shear stresses must be applied to the channel surface. The turbulent two-phase flow method invented by Novaflux satisfies these conditions for channels with different diameters. In Phase I, an automated-programmable device was designed and constructed to deliver two-phase flow to the "entire" surface of internal-channel system using a new flow paths circuit. 6 to 8 log 10 reduction of Bacillus subtilis spores from internal channels were consistently achieved with the two-phase method. The efficiency of cleaning was independently verified with the radionuclide method using Tc99. Rivulet and dispersed flow patterns were found to predominate the cleaning of air-water channel at velocities> 30 m/s. The two-phase cleaning appears to occur by erosion of soil by droplet impact (high shear stresses) and by "efficient" rinsing to remove soil fragments produced during cleaning. The Specific Aims of the Phase II are: 1) To design, construct and test a revised and complete endoscope-reprocessing device to perform a validated cleaning and disinfecting protocol based on the turbulent two-phase cleaning technology. 2) To validate internal channel cleaning with the two-phase method using predictive evaluation methods including: radionuclide and visual inspection, and microbial recovery methods. 3) To study and validate the cleaning parameters for internal channels of flexible endoscopes. 4) To study and validate a disinfecting cycle to achieve high-level disinfection (HLD) or possibly sterilization in conjunction with the two-phase cleaning process. 5) To conduct comprehensive in-vitro simulation studies mimicking patient soil and diverse microorganisms to validate a protocol to be used in the clinical studies. 6) To conduct multi-center clinical studies to evaluate and validate the reprocessing method and device for endoscopes made by different manufacturers. PROPOSED COMMERCIAL APPLICATION: More than 10 million gastrointestinal endoscopic procedures are performed each year in the United States with the number growing at a rate of 7.5% per year. The most significant problem with current commercial automated endoscope reprocessors (AERs) is their inability to remove soil and organisms from internal channels since such reprocessing devices are not designed to perform a validated cleaning cycle. In addition, glutaraldehyde is a known carcinogen to which many people have strong allergic reactions. The alternative liquid germicide is peracetic acid as used by Steris; it is also corrosive and results in damage to endoscope components. Commercial AERs sell in the range of $10,000 to $30,000 depending on their capacity to simultaneously reprocess more than one endoscope at a time and on other technology features such as automatic record keeping systems. A device capable of processing only one endoscope at a time now sells in the $10,000 range. These devices have lifetimes in the five to seven years range. Total domestic yearly sales are estimated to be approximately the equivalent of 2500 single endoscope capacity units per year with an additional 5000 units sold abroad. Thus the annual worldwide market is in the 150 million dollars range. Other revenues are derived from ancillary equipment sales, parts replacement, training sessions and maintenance contracts. Novaflux believes that it can rapidly capture revenues by licensing the technology to existing market leaders or by offering a new product. The benefits to the health care industry derived from using the technology are: 1. Reduced risk of patient infection from endoscopy procedures: Treatment of nosocomial infections in 1.4 million hospital patients is estimated to have cost nearly $6.5 billion last year. Although the official cited risk of infection is low for endoscopy procedures, most experts concede the majority of infections go undetected or result in non-life threatening reactions. 2. Shorter reprocessing time and reduced labor costs: Most endoscope reprocessing protocols currently require between 30 to 60 minutes of time with a part of it consisting of manual cleaning. Substituting most of the cleaning cycle by the automated Novaflux device would save between 10 and 15 minutes per processing and would thus offer a significant savings in staff labor. According to recent estimates, labor accounts for 44% of total cost of an endoscope cleaning and disinfection procedure and the cited cost per cleaning was in the $30 range. Thus labor savings of approximately $4 per procedure or up to 40 million dollars would be saved annually in the US. 3. Reduced maintenance costs and longer equipment lifetime: Endoscope maintenance is also a major factor in the overall cost of reprocessing. The Shields study infers that maintenance concerns result in the need for a large inventory of endoscopes to counter the effects of reprocessing on procedure scheduling. A recent survey by Urayama et al. indicates that the average lifetime of an endoscope is between 4.6 and 6.9 years depending on the type of instrument. Given instrument costs as high as $30,000 a reprocessing procedure that minimizes damage to the instrument and possible equipment service life extension offers a significant cost benefit to the health care provider. In summary the promise of these benefits should offer a significant incentive to the adoption of the two-phase cleaning technology in endoscope reprocessing.