The development of a transcatheter tricuspid valve
prosthesis for the treatment of
tricuspid regurgitation (TR) is presented. The design process involves an iterative development method based on computed tomography data and different steps of finite
element analysis (FEA). The enhanced design consists of two self-expandable
stents, one is placed inside the superior vena cava (SVC) for primary device anchoring, the second lies inside the tricuspid valve annulus (TVA). Both
stents are connected by flexible connecting struts (CS) to anchor the TVA-
stent in the orthotopic position. The iterative development method includes the expansion and crimping of the
stents and CS with FEA. Leaflet performance and leaflet-
stent interaction were studied by applying the physiologic pressure cycle of the right heart onto the leaflet surfaces. A previously implemented
nitinol material model and a new porcine pericardium material model derived from uniaxial tensile tests were used. Maximum strains/stresses were approx. 6.8% for the
nitinol parts and 2.9 MPa for the leaflets.
Stent displacement because of leaflet movement was ≤1.8 mm at the commissures and the coaptation height was 1.6-3 mm. This led to an overall good performance of the
prosthesis. An anatomic study showed a good anatomic fit of the device inside the human right heart.