Novel Tracheostoma Device

ABSTRACT Surgical removal of the larynx profoundly affects a patient’s quality of life, particularly in the loss of normal vocalization, physical change in appearance, and emotional challenges to adapt to living a normal life. Post operatively, a laryngectomy requires a patient’s stoma to be protected utilizing various heat moister exchange (HME) filters, which attach with devices either (i) extraluminal using adhesives and straps around the stoma or (ii) intraluminal using a tracheostomal button (“TE Button”) inserted into the stoma. Utilization of either device is challenging for the patient, extraluminal adhesive-based devices require change several times per week, causing tissue irritation and injury, social and emotional stress, frustration, and device failure. The existing products for laryngectomy patients have been void of meaningful innovation for over 20 years, utilizing antiquated materials while ignoring the vast number of innovations in biocompatible materials and technology that could address most patient issues. TE Button failure is easily identifiable and the byproduct of TE Buttons’ circular and rigid design which unevenly displaces pressure due to lack of uniformity unique to each laryngectomy regarding tracheostomal anatomy. This results in poor tolerability and retention due to dermal irritation, tissue erosion, and random dislodging from the stoma caused by the device’s movement within the tracheal lumen during normal daily activities, speech, and respiration. Most laryngectomy patients have undergone months or years of traumatic surgeries, chemotherapy, and radiation then attempt to reenter society with significant changes in physical appearance, social anxieties, emotional stress, and frustration as they adapt to their ‘new’ normal quality of life. TE Button failures limit a patient’s ability to successfully utilize various intraluminal attachments such as a Tracheoesophageal (TE) voice restoration devices for hands-free TE speech production. These TE Button failures reduce quality of life, impeding the ability to return to normal daily routines and activities after total removal of their larynx. This Phase I proposal aims to develop a TE Button capable of improved stability, durability, reduced pistoning and relative motion because it adapts to various stomal geometries and configurations. This project will provide an alternative for hands-free speech production to patients who are unable to use currently available intraluminal devices. We aim to utilize the advances in material sciences that have occurred since the original tracheostoma buttons were invented. These include high elongation, high tear strength, low durometer silicone elastomers and the lower cost of Nitinol wire and composites of wire such as braids and stents.