4TECH Cardio is a medical device company dedicated to the development of Transcatheter Technologies for the treatment of Tricuspid Regurgitation. The company required an accurate bench top test model to allow the company to accelerate its research and development activities. No beating heart model existed for replicating tricuspid regurgitation and preclinical models were inadequate as they are anatomically different to the disease in the human anatomy.
A project plan was proposed to develop a state of art cardiac model that could be used to improve the efficacy of the delivery systems for 4TECH technology. In order to develop an anatomically accurate bench top model of the right heart, CT scans of 13 Tricuspid Regurgitation (TR) patients were acquired and analysed. Based on a Radiological Measurement Protocol, CT scans for 3 TR patients were determined as suitable representations for Mild, Moderate and Severe cases of TR anatomies. The material used for fabrication of the models was a biomechanically compliant elastomer reproducing the acoustic properties of cardiac tissue and the Tricuspid Valve Annulus and Leaflets. A bench top testing rig was generated to house the model, with anatomically accurate positioning of structures including the oesophagus, Inferior and Superior Vena Cava (IVC, SVC) determined from CT scan measurement. Realistic movement of the tricuspid leaflets was replicated and models were interchanged to allow for Mild, Moderate and Severe case replication.
The final model was shown to accurately represent the anatomy of right heart and tricuspid valve and provided a suitable simulator for replication of the physiological and biomechanical conditions of TR. Since completion of the innovation partnership, MET has maintained a high level of interaction with the company and in addition to the company availing of the medical imaging technologies the Centre has generated several patient specific models with varying disease characteristics. This case study is an example of the proposed technology offering in theme 1 and 2.
This project was co-funded by the European Regional Development Fund and Enterprise Ireland under the Border, Midland and Western Regional Operational Programme 2014-2020.