Kentucky Patent of the Month – October 2022

Previously, aortic valve replacement required a major procedure including stopping the heart, cutting out the diseased valve, and then suturing a prosthetic implantation in its place. Not only was this a challenging procedure, it was hard on patients which limited who could benefit from it. A revolution in the medical field was seen when it was discovered the old, diseased valve could be left in place while a prosthetic could be simply implanted within the existing valve. This method requires just a simple catheter procedure. This means no cardiopulmonary bypass, no heart stopping, and no suturing a valve into position.

Since this discovery, innovation has focused on perfecting the implant. Unfortunately, many prosthetic valves have led to heart blockages – a dangerous condition. With new knowledge, today’s doctors make every effort possible to ensure the lowest point of an implant is positioned less than 4 mm below the lowest point of the aortic valve leaflets. This positions the valve optimally by the septum – a membrane which separates the ventricles of the aorta. Any lower than 4-5mm below this position, and rate of heart block is seen to increase.

HBX, Inc. has developed a methodology for the precise delivery of a prosthetic valve to ensure it meets this 4 mm cut off every time. The methods include a prosthetic valve which has a stent frame with a single cutout configured to align with the conduction tissue below the native aortic valve. This ensures the lower edge of the stent prevents contact of the structural elements of the stent frame with this tissue. This placement and careful alignment creates a dual benefit of adequate sealing and preventing the disruption of signals that could lead to complete heart block.

To properly deliver this prosthetic, the delivery sheath and prosthetic are aligned so that a radiopaque (i.e. opaque and cannot be seen through on an X-ray) marks the desired contact point. The native aortic valve is marked with a fluoroscope so that the radiopaque mark and fluoroscope mark can be aligned, ensuring the proper orientation of the prosthetic. Between the stent’s contact point and the alignment tools, the prosthetic valve is positioned carefully within a safe range to prevent heart block.

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