Packaging for dry tissue prosthetic heart valve

Abstract

The present invention provides 'dry' packaging in which a prosthetic heart valve is packaged within a container with hydrogel (116) that can be provided in many forms. Certain embodiments include hydrogel (116) that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel (116) is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Description

[0001] Cross References to Related Applications [0002] This non-provisional patent application claims the benefit of the filing date of U.S. Provisional Patent Application Serial No. 62 / 500,046, filed May 2, 2017, the entire teachings of which are incorporated herein by reference. Background technique [0003] The disclosed embodiments relate to packaging for a "dry" tissue prosthetic heart valve with or without a portion of a delivery device. Also disclosed are methods of packaging a transcatheter heart valve with or without a portion of a delivery device. [0004] The human heart consists of four heart valves that determine the path of blood flow through the heart: the mitral, tricuspid, aortic, and pulmonary valves. The mitral and tricuspid valves are atrioventricular valves located between the atria and ventricles, while the aortic and pulmonary valves are semilunar valves located in the arteries leaving the heart. Ideally, the native leaflets of a heart valve move awa...

AI Technical Summary

Problems solved by technology

Possible problems with the valve include: stenosis, where the valve does not open properly; and / or incompetence or regurgitation, where the valve does not close properly

In other valve prosthesis packaging, the valve prosthesis is packaged in a dry compartment, however, it has been found that shipping, storage, and ethylene oxide (EtO) sterilization may dry out the valve prosthesis tissue under these conditions

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