Children between the ages of three and five often have recurrent ear infections, which produce excessive fluid in the inner ear. The condition frequently requires a surgical procedure.
Each year, approximately one million children have metal, plastic, or latex tubes surgically inserted into their ear drum. The tubes drain the fluid, preventing long-term problems with hearing and cognitive development.
The procedure, although common, has two drawbacks: The tubes are made of a permanent material, and the procedure calls for the additional requirement of daily, stinging antibiotics.
In November of 2016, the medical device company PAVmed Inc., announced a licensing agreement with Tufts University and two Harvard Medical School teaching hospitals – Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital – to develop and commercialize a potentially better option: antibiotic-eluting resorbable ear tubes. The dissolvable cylinders, based on a proprietary aqueous silk technology, can be loaded with antibiotics.
The ear tubes eliminate the need for a second general anesthesia procedure to remove retained or dislodged tubes in most patients. In addition, having the antibiotics eluted from the device eliminates the difficult-to-administer post-procedure antibiotic ear drop regimen.
Tech Briefs spoke with Dr. Lishan Aklog, M.D., Chairman and CEO of PAVmed, about the tube technology.
Tech Briefs: What is the problem with current ear tubes?
Dr. Lishan Aklog: They are made from a permanent material. Those tubes need to stay in for at least a year. They can fall out, or get caught up in wax and buildup in the ear canal, making it very difficult for the pediatricians to monitor a child for recurring ear infections. Occasionally, the tubes can fail to fall out.
Another challenge: The standard treatment, after the inner tube is placed in, is to give the kids at least a week of ear drops, twice a day. This burns, and it can be difficult for parents to have to hold their children in place.
Tech Briefs: What is the value of an “antibiotic-eluting resorbable ear tube?”
Dr. Lishan Aklog: Because the tube goes away in the body, the prospect of having the tube fall out, or get stuck in the wax in the ear, is eliminated. The tube will eventually dissolve on its own, in its location. Probably the more important benefit, certainly from the parents’ and pediatrician’s point of view, is the fact that while the tube is in, it will deliver the antibiotic locally to the ear and eliminate the need for antibiotic eardrops, which can be expensive and quite challenging [to administer].
Tech Briefs: How did you acquire the technology?
Dr. Lishan Aklog: We acquired the technology from a group of academic centers in Boston. Dr. Christopher Hartnick at Mass Eye and Ear Infirmary and Harvard Medical School became aware of a technology that came out of Tufts University: A professor of biological engineering, David Kaplan, came up with a chemical processing technique to take actual silk from silkworms and process it in such a way that it became aqueous, and could be used and molded. Dr. Hartnick had became aware of this and thought it would be a great technology to use to create ear tubes that were a) resolvable over time and b) were able to elute, or deliver, the antibiotic locally as well. We’ve licensed the technology from them for those two applications.
Tech Briefs: What is most exciting to you about this kind of technology?
Dr. Lishan Aklog: I was a heart surgeon, with 10 years of training and 15 years of practice. I got my gratification in that phase of my career through direct interaction with patients. What we’re doing here is not 1-on-1 patient interaction, but we’re trying to develop technologies that ultimately improve patients’ lives, mitigate their suffering, and allow them to be treated less invasively and with few complications.
- Learn more about the PAVmed resorbable ear tubes.
- A new device improves diagnosis of ear infections.
- Read more Medical Design Briefs.
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