Feeding Tube Insertion at the Bedside

Making a Procedure More Accessible to Patients

We worked with Dr. Steven Tropello, an Emergency and Critical Care Physician at the University of Maryland School of Medicine, to develop a novel method of Coaptive Ultrasound Gastrostomy to insert a feeding tube under ultrasound guidance.

This method simplifies the procedure so non-surgical providers can perform it outside the hospital setting with inexpensive equipment while reducing the rate of complication. Most of the development was supported by TEDCO and funded through Maryland Innovation Initiative (MII) grants.

Assessing Potential, Reducing the Risk<br /> Pairing experience and expertise to make confident decisions

Medical Device Design: From Concept to FDA Approval

Concept Design

We supported the project from the earliest concept phase, which you can see in an example concept drawing to the left.

Then, we helped transition into the next phase of work by fabricating custom, low-cost prototypes. The point of these low-fidelity prototypes is to demonstrate feasibility and to perform initial testing – in this case, on human cadavers.

Having shown favorable results, we refined the design through several stages of prototyping and cadaver studies toward a sterilized, medical-grade product. The preliminary data and 4th-generation prototypes were well-received by the FDA in a pre-submission presentation.

The project has spun out of the University of Maryland to form Coaptech, LLC under an exclusive licensing agreement. We also continued to work with the company to take the device into manufacturing and through the regulatory approval process.

Keep up with CoapTech

This project in the news:

Highlights

Fabrication

  • Dip Molding Balloons
  • Magnets!
  • Material Selection
  • Tubing

TESTING

  • Benchtop Fixtures
  • Cadaver Studies
  • Large Animals

Our Impact

  • Demonstrate feasibility
  • Support trial studies
  • Design for manufacturing

CUSTOMER

Gallery

dip molding balloon
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