Project Description:

Annually, 180,000 thoracenteses are performed. Considering the cost of each procedure, this lends to a serviceable market of over 400 million dollars. 20,000 of those thoracentesis patients experience pneumothorax as a complication of the procedure due to lung puncture, the incidence rate of which is around 11%. This is because physicians have no confident way of knowing the depth of their needle which can lead to lung puncture. To solve this, we present EffusionEaseTM, a dual layered needle system with a pleural space indicator. A spring loaded blunt outer cover retracts to allow the inner needle to pierce the body layers and extends upon pleural entry to block lung puncture and alert the operator. The design verification has demonstrated a minimal force increase (< 3N) to successfully operate the proposed needle, greater 20 mm of compressibility for sensitive articulation in response to the needle environment, and extension within less than 5mm of fluid space entry ensuring accurate and rapid response for lung protection. This design is novel as it combines three unique components – internal retraction, a dual-layer embedded needle, and force sensitive automatic retraction. It is also appealing to our users as it makes the thoracentesis procedure easier, especially for physicians who are new to the procedure, by adding a mechanism that can make them more confident in their ability to avoid pneumothorax. It also provides minimal change to the workflow by eliminating notable changes to the ergonomic and force components of the typical thoracentesis needle. Looking to the future, next steps include taking the necessary pathways to get EffusionEase to market and scaling up to mass production.