Project Description:

Transesophageal Echocardiography (TEE) is an ultrasound imaging technique used intraoperatively during structural heart procedures. While TEE has traditionally been associated with relatively low risk complications when used for quick preoperative or diagnostic imaging, these minimally invasive procedures require the probe to remain in the esophagus for 2-6 hours with frequent and sometimes aggressive manipulation to get many complex views during the case. This prolonged procedure time combined with repeated flexion and sustained pressure of the probe against the esophagus, substantially increases the risk of mechanical injuries (mucosal tears, perforations, etc.) and thermal injuries related to constant ultrasound heating and inadequate cooling. These risks are especially concerning in older and comorbid populations. This prolonged TEE probe use can cause significant esophageal injury with reported complication rates as high as 86%. Physicians performing TEE during structural heart procedures need a solution to reduce thermal and mechanical complications to decrease injury prevalence and improve patient recovery processes. The problem to be solved and the purpose of the invention is to enable safer prolonged TEE use by reducing mechanical and thermal injury to the esophagus without compromising the continuous, high-resolution images needed to guide transcatheter structural heart procedures. SafeScope has developed the first gel administration and saline-inflated balloon device, which provides controlled delivery of cooling ultrasound gel to limit thermal injury and reduce friction while the balloon protects the esophagus from mechanical injury and improves acoustic properties. The device is designed to be used with existing TEE probes without altering probe performance or inhibiting physician productivity. By reducing esophageal injury risk and potential procedure delays, this device has both clinical safety and operational value, minimizing procedure-related complications. The device is a novel integration of lubrication and thermal buffering not currently present in the existing TEE market.