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

这个小型企业创新研究第一阶段项目将开发Tube-Clear设备，以清除饲管中的凝块。在美国，每年有超过41.1万人接受喂食管。当重症和受损患者失去吞咽能力，但仍然需要营养或药物时，饲管成为必需品。阻塞是治疗这些患者的一个重要问题，导致没有营养或药物的时间。虽然有几种方法可以去除凝块，但没有一种是100%成功的，当它们失败时，需要一个不舒服和昂贵的过程来更换管。用于清洁饲管的现有过程可能是耗时的，即使它们成功。随着人口老龄化，更可靠的血栓清除设备变得至关重要。SBIR第一阶段计划将开发Tube-Clear，一种激活设备，用于进入饲管并快速可靠地破碎食物凝块，而不会移除或损坏饲管。Tube-Clear将减轻护理人员和患者处理饲管堵塞的挫折感的负担。预计售价为35美元，可重复使用的控制单元售价为300美元。预计数量为每年2 000个。第二阶段将更详细地研究定价对市场接受程度的影响。除了清洁饲管的市场，PRII相信我们的技术可以扩展到其他医疗设备和管道的清洁，如微创手术（MIS）的导管和内窥镜以及引流管。这些设备的市场每年有数十万至数百万台。护理专家表示，Tube-Clear设备将是处理喂养管堵塞的一个重大进步。

This Small Business Innovation Research Phase I project will develop the Tube-Clear device to remove clots from feeding tubes. In excess of 411,000 people receive feeding tubes annually in the United States. Feeding tubes become a requirement when critically ill and compromised patients lose the ability to swallow, but still need nutrients or medication. Clogging is a significant problem in the treatment of these patients, leading to time without nutrients or medication. While several approaches exist for clot removal, none are 100% successful, and when they fail, an uncomfortable and expensive process is required to replace the tube. Existing processes for cleaning feeding tubes can be time consuming, even when they succeed. With the aging population, a more reliable device to remove clots becomes critical. This SBIR Phase I program will develop the Tube-Clear, an activated device, to pass into a feeding tube and break up food clots, quickly and reliably, without removing or damaging the feeding tube. The Tube-Clear will ease the burden on nursing staff and patients dealing with the frustration of clogged feeding tubes. The anticipated selling price would be $35 with a reusable control unit selling for $300. Anticipated volume would be 2,000 per year. The effect of pricing on market acceptance will be studied in more detail in Phase II. In addition to the market for cleaning feeding tubes, PRII believes our technology can be extended to cleaning of other medical devices and tubes, such as catheters and endoscopes for Minimally Invasive Surgery (MIS) and drain tubes. Markets for these devices are in the hundreds of thousands to millions of units per year. Nursing experts have expressed that the Tube-Clear device would be a significant advance in dealing with clogged feeding tubes.