Bi-Component Medical Device Package With Mechanical Interlock
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Solution Overview
Problem
Current medical device packaging lacks enhanced integrity and functionality, often leading to spills, bio-burden from adhesives, and difficulty in accessing medical devices without risking damage or drops, especially for larger formats which require excessive paperboard and are challenging to open.
Innovation Solution
A bi-component package with a hydrophobic outer component made of synthetic materials like Tyvek and a hydrophilic inner component of cellulose, mechanically interlocked with slits and tabs for secure locking and easy access, using Tyvek for sterilization compatibility and paper for moisture removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If adhesive materials are used to secure packaging components together, then the packaging structure is strengthened, but bio-burden increases and adhesive may leach into the medical device
Solution Approach 1:
The patent replaces adhesive bonding with a mechanical interlocking system consisting of a locking tab on the inner component that engages with a locking slot on the outer component. This mechanical connection achieves structural strength without introducing adhesive materials that create bio-burden or leaching risks.
Solution Approach 2:
The locking tab acts as an intermediary mechanical element that transfers and secures the connection between inner and outer packaging components without requiring adhesive substances. The tab physically bridges the gap between components through geometric interlocking rather than chemical bonding.
2Reliability
If the package is designed to securely lock medical devices, then spill prevention is improved, but device access becomes more difficult
Solution Approach 1:
The packaging system transitions from a static sealed structure to a dynamic system where the outer component can be peeled away from the inner component. The medical device remains securely held by the inner component's locking mechanism during transport, but the outer layer can be dynamically removed at the point of use for easy device access.
Solution Approach 2:
The packaging is divided into separable segments: an outer protective component and an inner holding component. This segmentation allows the outer layer to provide secure locking and spill prevention while being removable, and the inner layer to maintain device security during use.
3Strength
If large amounts of paperboard are used in packaging, then structural support is improved, but the package becomes difficult to open and requires excessive material for large format devices
Solution Approach 1:
The outer component utilizes a flexible peel-away structure that can be easily separated from the inner component. This flexible design provides sufficient structural support during transport while allowing simple manual opening by peeling the outer layer away, avoiding the need for excessive rigid paperboard.
4Reliability
If the package protects the medical device until immediately prior to use, then sterility is maintained, but access and dispensing becomes more difficult
Solution Approach 1:
The packaging system separates the sterility maintenance function (inner component with locking tab) from the access function (outer peel-away component). The outer layer can be removed to expose the inner sterile package, allowing easy access while maintaining sterility until the moment of use.
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
The package securely locks medical devices, prevents spills, reduces bio-burden, and allows easy access while maintaining sterility, with the cellulose component acting as a desiccant to manage moisture and provide structural support.
Implementation Method 1
the inner component is more hydrophilic than the outer component and the inner component is adapted to remove moisture present in the medical implant and inside the package
Implementation Method 2
the cellulose component acting as a desiccant to manage moisture
Implementation Method 3
The combination of materials of the top and bottom sheets prevents or impedes the transmission of moisture therethrough
Data Source
Figure 1
Figure 2A
Figure 2B
AI summary
A package for a flat medical implant (190) includes a flexible outer component (50), such as Tyvek®, including a first panel (52) and a second panel (94) foldable over said first panel for closing the package, and an inner component (120), such as paper, mechanically interlocked with the flexible outer component. A flat medical implant is held by the inner component. While the outer and inner components remains mechanically interconnected to one another, the upper ends of the first and second panels of the outer component are peelable away from one another for opening the package and accessing the flat medical implant at an upper end of the package.