Relationship between Some Design Characteristics and Wear in the Bicarbon Heart Valve Prosthesis

Abstract

The hinge design of a new bileaflet valve (Bicarbon) is presented in relation to the long-term durability characteristics. Theoretical considerations supported by experimental findings, lead to the identification of two different wear mechanisms acting in bileaflet valves, i.e. impact and friction wear. Impact wear, caused by the collision between the hinge stops and inflow surface of the leaflet pivots, is the predominant phenomenon; it is mostly influenced by the design of the coupling elements. The wear due friction is significantly less important, given a proper kinematic coupling and a thorough washout. These different mechanisms can significantly affect the wear resistance and long-term reliability of bileaflet valves; therefore, they have been properly taken into account in designing the new valve model. The safety of the overall material and design solutions adopted in the Bicarbon valve has been confirmed by extensive accelerated durability tests resulting in no mechanical failure or loss of functionality.

Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up

“…The leaflets, which open up to 80 from a 20 horizontal axis, move through an innovative rolling hinge mechanism, which provides low turbulence, partitioning of the flow into 3 equivalent bloodstreams, and a full washing effect through the cardiac cycle. 12,13 Patient Characteristics A total of 507 patients were reviewed (Table 1). There were 306 men (60%) and 201 women (40%); the mean age was 62 AE 10 years (range, 21-86 years).…”

The Sorin Bicarbon over 15 years clinical outcomes: multicentre experience in 1704 patients☆

“…The leaflets, included in a titanium alloy housing coated with a thin layer of carbon (Carbofilm TM ), move through a rolling hinge mechanism. The housing is rotatable within the sewing ring, which is also coated with Carbofilm TM [6,7].…”

Experience of the Small Size (25 mm) Sorin Bicarbon Bileaflet Prosthetic Valve in Patients with Small Mitral Annuli

“…Bileaflet mechanical heart valves have already been proved to ensure excellent hemodynamic performance, with low complication rates and low prosthetic failure or dysfunction 5 . Curved leaflets and a new pivot design were proposed in the Bicarbon (Sorin Biomedica, Sauggia, Italy) mechanical prosthetic heart valve 5–7 in order to further reduce complications and enhance the hydrodynamic performance. Its design is based on two pyrolytic carbon leaflets hinged on a titanium alloy housing coated with a thin carbon layer (Carbofilm™) 1 …”