Middle ear infection is the most common childhood disease worldwide. To relieve the infection, ventilation tubes are inserted into the eardrum to drain fluid from the infection and allow direct access of topical antibiotics. This tube insertion procedure is the most common surgical procedure performed on pediatric patients, affecting over 1 million US children each year. Of these surgeries, about 170,000 patients will develop a permanent eardrum perforation, which left untreated can lead to additional ear infections, hearing loss, and potentially nerve and brain damage. This is particularly detrimental for children as early-life hearing loss from recurrent ear infection has been linked to behavioral and communication disorders.
The surgical repair procedure for eardrums, called tympanoplasty, can cost up to $18,000 per surgery. This highly invasive surgery requires the otolaryngologist to make an incision around the base of the ear so that the entire ear can be retracted to provide access to the eardrum. The margins of the perforation are abraded to induce an inflammatory response before the hand-trimmed graft (autologous or synthetic) is applied to the perforation. Scarring, surgical site infection, facial nerve damage and graft failure are the most common morbidities associated with tympanoplasty, combined with respiratory distress and peripheral nerve damage as the most common anesthesia-related complications for pediatric patients.
Autologous cartilage and fascia are the most common grafts used during tympanoplasty, though these grafts are non-resorbable and imperfect transducers of sound to the cochlea. Some synthetic grafts of hyaluronic acid and gelatin have been developed, but still require the same invasive surgery to apply and are not able to restore the native, three-layer architecture of the eardrum. Though the search for the perfect regenerative material for eardrum repair continues today, current surgical techniques for tympanoplasty have changed little since the 1960s. Our highly innovative technology will replace surgical tympanoplasty with a short office visit while regenerating high-quality eardrum tissue, thereby eliminating a common surgery and its complications for thousands of children each year.
This device is a light-curable gel patch called Perf-Fix. It was designed to replace traditional tympanoplasty with an office procedure. The gel patch acts as a scaffold that allows cells to grow across the perforation while resorbing the material. At the same time, it is pliable enough to move with the vibrations of the eardrum without dislodging from the perforation site. Major significances that are implicated with the device include benefits for both patients and medical professionals. For patients, all surgical and anesthesia complications are eliminated, which makes the procedure less painful for the patients; while, for otolaryngologists, the process of conducting this procedure is more efficient and allows them to treat more patients per hour.
APDC's funds will be used to narrow down the design requisites for the delivery system and develop initial prototypes.