Tympanic Membrane Prosthesis with Mechanical Fixation

Perforations of the tympanic membrane result from many different processes such as infections of the middle ear, direct trauma to the eardrum, or poor post-operative healing. They usually do not present an immediate danger to the patient?s hearing apparatus, but they can lead to symptoms of decreased hearing, autophony (hearing an echo of one?s own speech), or pain secondary to infection. They can be sub-categorized based on the duration of the perforation (acute vs. chronic) and the presence of drainage (dry vs. wet). These categories have some effect on the prognosis of a given perforation. For example, acute, dry perforations (such as those seen with direct trauma to the eardrum from a sharp object) usually heal spontaneously. On the other hand, people with acute or chronic otitis media can develop chronic perforations (duration longer than 2 months) that can remain unhealed for periods longer than a decade. The relatively common use of P-E (pressure equalization) tubes in children with recurrent otitis media has also resulted in an increase in chronic perforations in these young patients. In response to this pervasive problem, many techniques have been developed for the closure of TM perforations. Myringoplasty is a procedure where the ear drum is patched with a graft material such as muscle fascia. It has a success rate that often exceeds 95% but involves the use of an operating room, anesthesia and an incision to harvest the graft material. These factors not only expose the patient to risks (infection, bleeding, death from anesthesia, loss of hearing, etc.) but also result in high medical costs. Non-surgical techniques, on the other hand, can provide the benefit of decreased risk and discomfort for the patient as well as decreased cost to the medical system. Many non-surgical approaches to the healing of tympanic membrane perforations have been developed including rice-paper patches and growth stimulants applied to the perforation borders. These techniques have met with only limited success and studies of their efficacy have been conducted mostly in animal models or in small numbers of human patients in uncontrolled studies in Europe. The current idea involves mechanical fixation of a synthetic prosthesis to the tympanic membrane to act as a substrate or stimulant of cell growth and healing. In its current form, the three components of this system can be separated into (1) an artificial membrane material which provides a substrate for (or stimulates and supports) endothelial cell growth; (2) stainless steel fixation tacks; and (3) a tack insertion device mounted on an operable hand instrument. The fixation tacks and insertion device are similar to the parts shown in Figure 1 which is a scanning electron micrograph of the iris tack system produce by Grieshaber. This assemblage is very similar to the tack/insertion device system described here. This system should provide a non-surgical, low cost solution to the problem of acute or chronic tympanic membrane perforations. Description (Set) Proposed Use (Set) This system should provide a non-surgical, low cost solution to the problem of acute or chronic tympanic membrane perforations Patent (Set) 6,309,419

US 6,309,419

Type of Offer: Licensing

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