Minnesota Patent of the Month – July 2023

Native heart valves occasionally need replacing. This is a common treatment option when a patient experiences congenital heart defects or disease. Replacing the heart valve improves blood flow and addresses obstruction from plaque and the like. This procedure is traditionally done either by surgical repair or by deploying a valve with a transcatheter.

Anteris Technologies Corporation, a leading medical technology company, is working to revolutionize the heart valve replacement industry with their biomimetic TAVR valve technology. This system introduces a novel approach to valve replacement, aiming to improve patient outcomes and enhance maneuverability during the delivery process.

The core limitation found with standard valve replacements is the external diameter of the catheter tube which is consistently large and limits mobility. Anteris Technologies’ system reduces this sizing, improving maneuverability and outcomes. Their design includes an inverted heart valve which, along with the reduced external diameter, results in improved sealing of the valve against the native wall.

To facilitate delivery, a retractable sheath is incorporated into the system’s design. The valve assembly is stored within this sheath in a delivery position. When the procedure begins, the retractable sheath is retracted, revealing the valve assembly ready for deployment. It is this innovative feature which reduces the size of the external diameter of the catheter required for delivery, improving maneuverability and minimizing the invasiveness of the procedure.

During deployment, the valve assembly is expanded from its delivery position into an expanded position. At this stage, cable wires attached to the distal end of the valve come into play. These cable wires enable precise control and manipulation of the valve’s position. By pulling the distal end of the valve through the valve lumen and partially through the stent lumen, the valve is transposed from its inverted orientation to a deployed position.

Ensuring secure attachment, the expandable stent incorporates locking features near its distal end. These features engage with the valve when it reaches the deployed position, providing stability and preventing dislodgement. Once the locking feature is engaged, the cable wires are safely disconnected from the valve, allowing for seamless functionality.

The system also includes gripping fingers located at the proximal end of the expandable stent. These fingers, positioned between the retractable sheath and the delivery catheter’s inner shaft, facilitate repositioning of the valve assembly if necessary. By applying a retrieving force in a proximal direction, the valve assembly can be easily pulled back into the retractable sheath, offering flexibility during the procedure.

Anteris Technologies has prioritized patient safety by incorporating a sterilized packaging system into the design. The valve assembly is stored in a fluid chamber within the packaging system, ensuring optimal conditions and maintaining sterility. The valve remains wet and operably connected to the delivery catheter until it is loaded into the retractable sheath, streamlining the workflow and minimizing the risk of contamination.

By revolutionizing transcatheter heart valve repair procedures, Anteris Technologies has set a new standard in endovascular interventions. This innovative system offers enhanced maneuverability, reduced invasiveness, and improved patient outcomes.

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