Pediatric ECMO Catheters

Period of Performance: 08/15/2004 - 01/14/2005

$125K

Phase 1 SBIR

Recipient Firm

Origen Biomedical, Inc.
Austin, TX 78703
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): This proposal is for the development of specialty catheters designed to make single catheter ECMO (Extracorporeal Membrane Oxygenation) available to pediatric patients over 14 kg. Single catheter ECMO has become the standard of care for neonatal respiratory problems unresponsive to other forms of treatment. Two catheters in 22 French and 26 French sizes will be designed, produced and tested in-vitro. These products are not available and would make a beneficial treatment available to the pediatric population. The study will use a scale-up of a neonatal ECMO catheter as a starting point. We will perform computer-aided flow studies at LSU on this design to develop a performance baseline. The internal geometry of the catheter will then be varied and the flow studies re-run. When an optimum flow condition is achieved, prototypes will be built to that design. Custom extrusions will be made and tipped, a transition hub molded on, and connection lines attached. At the same time, two methods of reinforcing the section of the catheter that protrudes from the skin will be investigated. Catheters will be produced with no reinforcement, with a flattened metal spiral reinforcement, and with braided fabric reinforcement. These prototypes will be subjected to flow testing at the University of Michigan to confirm performance expectations and study hemolysis in-vitro. The reinforcing methods will be destructively tested and also evaluated by potential users. The end point of the project will be two finished catheters ready to proceed to clinical testing.