Refrigerated Skin Equivalent Storage Packaging

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Solution Overview

Problem

Current methods for storing and shipping engineered tissues are inefficient due to the need for controlled conditions, leading to high production costs and inventory losses, as these tissues are sensitive and often require specialized storage and handling, such as liquid nitrogen for cryopreservation, which is expensive and not universally available.

Innovation Solution

Developing a method to package organotypically cultured skin equivalents with a gel support in a sterile package, allowing storage and shipping at 2-8°C, maintaining sterility and integrity for up to 15 days, eliminating the need for complex revival processes and specialized handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If cryopreservation is used to store engineered tissues, then long-term storage is achieved, but storage cost and complexity increase due to liquid nitrogen requirements

Engineering Contradiction:
Improvestorage durationVSAvoidstorage system complexity
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The patent changes the storage temperature parameter from cryogenic temperatures (liquid nitrogen, -196°C) to refrigerated temperatures (2-8°C). This parameter change allows the skin equivalent to be stored without ice formation while maintaining viability for extended periods (at least 15 days), thereby reducing storage system complexity and cost while achieving sufficient storage duration for clinical use.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If engineered tissues are stored under controlled conditions, then tissue viability is maintained, but production costs increase and inventory losses occur due to limited storage time

Engineering Contradiction:
Improvetissue viabilityVSAvoidmanufacturing efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent applies preliminary action by pre-packaging the skin equivalent in a sterile container with gel support and pre-cooling it to 2-8°C before shipment. This preliminary preparation ensures the tissue remains viable during transport and storage without requiring continuous active maintenance, thereby extending usable inventory time and reducing manufacturing pressure while maintaining tissue reliability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The gel support acts as an intermediary between the skin equivalent and the storage environment. It provides structural support, maintains moisture, and facilitates even temperature distribution during refrigerated storage, thereby preserving tissue viability without requiring complex controlled condition systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If skin equivalents are shipped at refrigerated temperatures, then specialized storage infrastructure is reduced, but maintaining sterility and integrity during shipping becomes challenging

Engineering Contradiction:
Improvestorage infrastructureVSAvoidsterility maintenance
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent uses a nested packaging structure where the skin equivalent is first placed in a sterile container with gel support, then this container is nested within an insulated shipping box with cold packs. This nested design maintains sterility at the inner level while providing thermal control at the outer level, reducing infrastructure requirements without compromising reliability.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The sterile container uses flexible, sterile barriers that maintain sterility while allowing thermal transfer. These flexible shells protect the skin equivalent during shipping and can be sealed to maintain sterility, yet permit the refrigerated temperature regime to effectively preserve the tissue.

Inventive Principle:
Principle #30Flexible shells and thin films

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

This approach enables the storage and shipping of skin equivalents under routine refrigeration conditions, reducing costs and increasing availability, as the skin equivalents remain viable and functional for extended periods without the need for specialized storage or handling.

Implementation Method 1

a sterile package comprising a gel support; packaging the skin equivalent in a sterile package under sterile conditions so that the skin equivalent contacts the gel support

Methodology Applied
Scientific EffectGel: Gel

Implementation Method 2

lowering the temperature of the sterile package to 2-8 degrees Celsius; storing the sterile package at the site of use at 2-8 degrees Celsius

Methodology Applied
Scientific EffectRefrigeration: Cooling

Data Source

PatentUS10743533B2Cold storage of organotypically cultured skin equivalents for clinical applications
Publication Date: 2020.08.18 STRATATECH CORP
  • US10743533B2 patent drawing
  • US10743533B2 patent drawing
  • US10743533B2 patent drawing

AI summary

The present invention relates generally to systems and methods for storing, shipping and using skin equivalents made by organotypic culture. In particular, the present invention relates to systems and methods for producing, transporting, storing and using skin equivalents produced by organotypic culture at reduced temperatures, preferably from 2-8 degrees Celsius. The methods include sterile packaging of the grafts so that the sterility and integrity of the package is maintained until the time of use for grafting purposes.