Dry Packaging for Prosthetic Heart Valve Using Hydrogel Humidity Regulation
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Solution Overview
Problem
Transportation, storage, and ethylene oxide (EtO) sterilization can dry out tissue of a prosthetic heart valve stored in 'dry' packaging, which does not submerge the valve in a preserving and/or sterilizing solution.
Innovation Solution
The use of a container with a first compartment for the prosthetic heart valve and a second compartment housing hydrogel, separated by a semi-permeable membrane, where the hydrogel maintains hydration through humidity regulation, optionally preloaded with glycerol or similar hydrators to prevent tissue drying.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If dry packaging is used for the prosthetic heart valve, then the packaging simplicity and ease of sterilization are improved, but the tissue of the valve dries out during transportation, storage, and sterilization
Solution Approach 1:
The packaging container is divided into two separate compartments: a first compartment for housing the prosthetic heart valve and a second compartment for housing the hydrogel. This segmentation allows the valve to be packaged in a dry environment for ease of sterilization while the hydrogel in the separate compartment maintains humidity through the semi-permeable membrane, preventing tissue drying without complicating the overall packaging structure.
Solution Approach 2:
A semi-permeable membrane is introduced as an intermediary between the valve compartment and the hydrogel compartment. This membrane allows water vapor to pass through from the hydrogel compartment to the valve compartment, maintaining tissue hydration without requiring direct contact between the valve and hydrogel, thus preserving packaging simplicity while ensuring tissue reliability.
2Ease of manufacture
If the prosthetic heart valve is stored in dry packaging without submersion in preserving solution, then the packaging and storage process is simplified, but the tissue loses moisture during sterilization and storage
Solution Approach 1:
The hydrogel is pre-loaded into the second compartment of the packaging container before the valve is placed in the first compartment. This preliminary action ensures that the hydrogel is already in position to regulate humidity when the valve is packaged, maintaining tissue moisture content without requiring complex wet packaging procedures or post-packaging moisture addition steps.
Solution Approach 2:
The hydrogel automatically regulates humidity within the packaging container through equilibration between the humidity inside the container and the hydrogel's water-holding capacity. This self-service mechanism maintains tissue moisture content without requiring external intervention, complex monitoring systems, or additional preserving solutions, thus preserving ease of manufacture while ensuring composition stability.
3Reliability
If ethylene oxide sterilization is performed on dry-packaged valves, then sterilization effectiveness is improved, but the valve tissue becomes dehydrated
Solution Approach 1:
The semi-permeable membrane acts as a protective intermediary during ethylene oxide sterilization. It allows the sterilization agent to reach the valve tissue for effective sterilization while simultaneously allowing water vapor to pass from the hydrogel compartment to replace any moisture lost during sterilization, preventing tissue dehydration while maintaining sterilization effectiveness.
Solution Approach 2:
The packaging system combines two functional materials: a semi-permeable membrane that selectively allows vapor transmission and hydrogel that provides sustained moisture release. This composite material system enables simultaneous achievement of sterilization effectiveness and tissue water content preservation during the sterilization process.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Prevents tissue drying by maintaining humidity levels within the packaging, ensuring the prosthetic heart valve remains hydrated during sterilization and storage, thereby extending its shelf life and maintaining its functionality.
Implementation Method 1
a container including a first compartment housing the prosthetic heart valve and a second compartment housing hydrogel; wherein a semi-permeable membrane separates the first and second compartments
Implementation Method 2
the hydrogel regulates the humidity within the container through the equilibration between humidity within the container and the hydrogel's ability to hold water
Implementation Method 3
a second compartment housing hydrogel; wherein a semi-permeable membrane separates the first and second compartments
Implementation Method 4
Optionally, the hydrogel, valve tissue and/or container are preloaded with glycerol or similar hydrator that maintains the hydration of the valve tissue
Data Source
AI summary
A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel 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 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.