The procedure involves a catheter inserted via a vein in the neck or the groin. With the catheter in place, the physician places two positioning balloons–one in the front end of the catheter passing through the hole and the other on the side of the heart wall. The patch is placed on the heart and then the catheter’s UV light is activated. The light reflects of the shiny balloon interior, which activates the adhesive coating on the biodegradable patch. As the glue cures, the balloons provide pressure on either side to hold the patch in place. Finally, the balloons are deflated and the catheter withdrawn.
Normal tissue growth is intended to resume subsequently with heart tissue growing over the patch, which dissolves when it’s no longer necessary. “This really is a completely new platform for closing wounds or holes anywhere in the body,” Conor Walsh, Wyss Institute Core Faculty member, Assistant Professor of Mechanical and Biomedical Engineering at the School of Engineering and Applied Sciences, founder of the Harvard Biodesign Lab, and author on the paper, said in a statement. He added, “The device is a minimally invasive way to deliver a patch and then activate it using UV light, all within a matter of five minutes and in an atraumatic way that doesn’t require a separate incision.”
The catheter was developed jointly by researchers from Boston Children’s Hospital, the Wyss Institute for Biologically Inspired Engineering at Harvard University, Harvard’s Paulson School of Engineering and Applied Sciences and the Karp Lab at Brigham and Women’s Hospital.
The catheter-patch-glue combo was first tested in rat tissue, then in the beating hearts of pigs to address a septal defect. It has also been used to seal porcine stomach ulcers and abdominal hernias ex vivo.
The glue was developed by Jeff Karp, a bioengineer at Brigham and Women’s Hospital and a co-founder of Gecko Biomedical. Gecko will be testing the glue in humans later this year.
“In addition to avoiding open heart surgery, this method avoids suturing into the heart tissue, because we’re just gluing something to it,” said Dr. Pedro delNido, chief of cardiac surgery at Boston Children’s and a contributing author of the study, in a statement. “The way the glue works in the face of blood is revolutionary. We don’t have to stop the heart,” he added. “This will enable a wide range of cardiac procedures in the future.”
REFERENCE: Fierce Medical Devices; 05 OCT 2015; Stacy Lawrence