Construction of Ear Frameworks For Microtia Repair Using AuryzoN™, A Novel Investigational Medical Device.
Angelo A. Leto Barone, MD, Michael Grzelak, BS, Regina Cho, BS, MSE, Amy Q. Quan, MD, George Kokosis, MD, Georges Samaha, MD, Patrick Byrne, MD, Anirudh Arun, MD, Richard Redett, III, MD.
Johns Hopkins University, Baltimore, MD, USA.
Microtia is a congenital deformity characterized by an abnormally shaped or absent ear that affects 3 in 10,000 live births in the general population. Autologous reconstruction, currently the gold standard for surgical ear reconstruction in microtia patients, is a time-consuming and skill-dependent process. Hand carving the cartilage for ear reconstruction often results in suboptimal outcomes. Furthermore, the costs of these procedures are relatively expensive and, at times, prohibitive for patients. Alloplastic implants are an alternative option, although themselves costly and burdened by frequent complications. We present a novel medical device that allows for the development of anatomically accurate, safe, precise, and consistent ear frameworks for microtia repair.
The AuryzoN™ system consists of two components. A thickness cutter, named DimensioN, allows the user to slice cartilage or other synthetic implantable materials to achieve a desired thickness. The second device, AuryzoN™, is essentially a press, and utilizes steel blades shaped in specific ear cartilage configurations. The desired blade tray is inserted into the press device and the cartilage placed on the base of the device, allowing for precise cutting. The individual components can then be assembled to form the final construct, which can be subsequently implanted under a skin flap. Biologic and non-biologic materials were used in our preliminary tests as a substrate to test framework production. Individuals from different professional backgrounds (including people not in the medical field, as well as medical students and plastic surgery residents) were recruited. Testers were asked to carve an ear framework by hand with the aid of clinically used paper templates and afterwards using AuryzoN™. Time to framework completion was recorded and ease of use of the device was assessed. Overall quality of the construct was scored by plastic surgeons who were blinded to operator technique and the operator's level of skill.
N=10 ear frameworks were obtained either by traditional hand carving techniques or with the AuryzoN™ device using non-animal substrates. Individual components of the ear framework were obtained in an average of 4.82 minutes in all instances with AuryzoN (range: 4.2-5.5 minutes) versus an average of 37.52 minutes (range: 19.9-46.6 minutes) when the substrate was cut by hand using a provided template. Cartilage framework production using AuryzoN™ was accurate regardless of operator skill level or professional background (Fig.1). Significantly higher quality scores were reported in all constructs obtained with the AuryzoN device.
Our preliminary data shows that AuryzoN™ allows users to reliably obtain a cartilaginous ear framework with high fidelity, in a user-friendly system within several minutes. A clinical trial for the use of our device has just started at our institution. Due to the portable and analog nature of the device, we seek to enhance ear reconstruction both in the U.S. and in resource-poor countries.
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