Electromagnetic Bougienage for Esophageal Atresia

DESCRIPTION (provided by applicant): In esophageal atresia (EA) the esophagus is malformed so that its distal and proximal segments each end in a pouch and fail to bridge the connection from the mouth to the stomach. It is characterized by incomplete formation of the tubular esophagus and/or an abnormal connection between the esophagus and trachea. EA is the most common congenital malformation of the esophagus (one per 3000 births; approx. incidence of 1300/yr in the United States). When the two esophageal segments are sufficiently close they can be joined by anastomosis without tension (90% of cases). However, for approximately 100 babies/yr in the United States (7.5% of cases] the two ends of the esophagus are too widely separated for this remedy. If the ends were to be joined they would be under too much tension to endure. For these cases the most common procedure is to interpose a segment of colon to bridge the distance. This is an extremely arduous procedure for the child and has significant continuing care consequences. Hendren and Hale in 1975 described a procedure based on electromagnetic bougienage (stretching) to lengthen the esophageal segments. Ferromagnetic metal bougies were placed in the two ends of the esophagus. An electromagnetic field was placed over the chest of the infant. Then alternating applications of current through the electromagnetic device was used to magnetize and draw the bougies together over a 30-day period. In the four trial cases the ends of the esophagus were seen to become elongated and thickened allowing successful primary repair. Nursing resistance to the protracted immobilization of the infants in the crude equipment discouraged further development at that time, but in 2004 is strongly supported by nursing. We propose a next generation device for electromagnetic bougienage that will meet modern hospital standards for safety and ease of use. In the proposed device the progress of the tissue stretch will be monitored by ultrasound imaging systems. The specific aims of this Phase I proposal: (1) to fabricate an operational prototype Electro-Magnetic Bougienage Nursing Station (EMBNS), (2) to demonstrate safety criteria appropriate to in-hospital use and (3) to carry out clinical trials on two or more infants. A Phase II proposal will be submitted to develop "smart" bougie bullets that will continuously monitor the distance between the bullets, to continue clinical trials and to explore additional related application of the EM bougienage technique. Our overall goal is a treatment that will result in shorter hospitalization, better clinical outcomes and a higher quality of life for the patient.