Edwards Lifesciences Corporation

Jeff Dove

Darin P Dobler

Jim Davidson

Jaime E Siman

Darin Dobler

A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification is disclosed. The method includes preconditioning, pre-stressing, or pre-damaging fixed bioprosthetic tissue in a manner that mimics the damage associated with post-implant use, while, and/or subsequently applying a calcification mitigant such as a capping agent or a linking agent to the damaged tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the damage process (service stress) and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. The linking agent will act as an elastic reinforcement or shock-absorbing spring element in the tissue structure at the site of damage from the pre-stressing. In one method, tissue leaflets in assembled bioprosthetic heart valves are preconditioned by simulating actual flow conditions for a predetermined number of cycles, during or after which the valve is exposed to the capping agent.

Methods for pre-stressing and capping bioprosthetic tissue

An enhanced antimicrobial antithrombogenic medical device is formed by using an oligodynamic metal and a noble metal with a polymer, and forming the mixture into a device. By using low concentrations of conductive polymers or ionophoric compounds, non-conductive, or highly plasticized polymers can be likewise blended into an iontophoretic-capable composition. The surface of the device may be treated with a solvent to remove the top surface of the polymer and create surface voids in the composition in order to expose previously encapsulated iontophoretic materials. This surface treatment results in a larger reaction area of the iontophoretic capable composition that produces larger yields of bacteriostatic oligodynamic ions for a longer duration thereby increasing the antimicrobial effectiveness of the composition. The surface of the antimicrobial composition may be treated with an anticoagulant such as heparin or heparin complexed with a quaternary ammonium salt for an added bacteriostatic effect.

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Santa Ana, CA, United States of America

Jeff Dove