Advanced Manufacturing, Electronics and Microsystems: TechConnect Briefs 2016Advanced Manufacturing, Electronics and Microsystems TechConnect Briefs 2016

MEMS & NEMS Devices, Modeling & Applications Chapter 3

The TubeClear® System – On the Market for Clearing Clogged Feeding Tubes – and Evaluating Increasingly Challenging Tubes in the Body: NSF SBIR Funded Medical Device Platform

R.B. Bagwell, S.M. Aippersbach, N.C. Becker, D.R. Dillon, M.L. Mulvihill
Actuated Medical Inc, United States

pp. 102 - 106

Keywords: ICU, feeding tubes, critical care, nutrition, clog

Feeding tubes deliver critical nutrition and medications to patients that are unable to swallow. Unfortunately, these tubes often clog. Clogged feeding tubes can cause patients to go extended periods without food and medication. Traditional methods to clear these tubes are often unsuccessful, strain nursing resources, and potentially lead to tube replacement - and patient risk and discomfort. Actuated Medical, Inc (AMI). (Bellefonte, PA) has used NSF SBIR, equity investment and other funds to develop the TubeClear System. The system is a patented, FDA-cleared and CE-marked medical device that clears clogged feeding tubes at bedside - while the tube remains in the patient. The system comprises a reusable Control Box that actuates a single-use Clearing Stem. The Clearing Stem is inserted into the feeding tube and the gentle backward and forward motion of the Clearing Stem Tip mechanically disrupts and clears clogged materials. The first case was a 27 year old soldier at Walter Reed National Military Medical Center – an emotional day for a small company. Our device improved a patient’s outcome, and helped someone injured fighting for our country. An adult case study has also been completed, documenting twelve cases in which the TubeClear System was used to clear clogged nasoenteral (NE) feeding tubes. All documented cases were successful, completed by a single healthcare practitioner, without any issues reported by the practitioner or patients. The next steps are to 1) expand awareness and sales of the device on the market and 2) push the platform technology into additional clinical uses. Partners and investors are being engaged to meet Goal 1. For Goal 2, AMI is using a National Institutes of Health/National Institute of Child Health and Human Development (NIH/NICHD) Phase II SBIR to develop a TubeClear model for pediatrics. In 2015, the device received a Non-significant Risk (NSR) determination from the FDA, followed by IRB approval for a clinical study at the Children’s Hospital of Philadelphia (CHOP). The CHOP clinical study is scheduled for March 2016. Further expansion of the technology includes a) lower-stress suctioning of endotracheal tubes (particularly for tiny, fragile neonatal patients), b) removing blood clots from the stomach that are preventing access to dangerous gastrointestinal bleeds, and c) other critical tubing such as chest tubes and venous access lines. Clearing clogged feeding tubes, in patient, saves healthcare resources, and eases the burden on patients and staff. Pushing the technology platform into additional clinical indications will further expand the market and value of the technology. AMI has 7 issued US patents, and additional pending, for clearing tubes in the body. AMI’s goal is to de-risk medical technologies. Sales, marketing, and distribution are transferred to a larger OEM, while we move onto a new innovation. Strategic partners are extremely hesitant to adopt new technology packages until a) in-patient use, b) regulatory & reimbursement approvals, c) patents, d) manufacturing scale-up and e) initial targeted sales have occurred. These 5 activities are integral to AMI’s product development process.