Sterilization Packaging Seal and Drape Layout for Tear-Free Handling
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Solution Overview
Problem
Existing sterilization methods for surgical instruments and medical devices face inefficiencies such as the need for multiple packaging materials, potential tearing or puncturing of wraps, requirement for separate packaging of components, and the use of bulky and expensive rigid containers that complicate handling and storage.
Innovation Solution
A sterilization packaging system comprising a base with a support surface and a wrap that forms a sealed volume using a sealing device, allowing for efficient sterilization of multiple items without the need for additional draping and reducing the complexity of handling and storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional wrapping methods are used for sterilization, then instruments can be sterilized, but the packaging material may tear or puncture requiring repetition of the sterilization process
Solution Approach 1:
The patent combines multiple functions into a single integrated system: the rigid container provides both structural support and sterilization barrier, while the integrated seal mechanism combines sealing and filtering functions. This eliminates the need for separate wraps that could tear, as the rigid container maintains its integrity throughout the sterilization process.
Solution Approach 2:
The rigid container structure provides pre-established protection against tearing and puncturing that pliable wraps experience. The container is designed beforehand to withstand sterilization conditions without compromising its barrier integrity, preventing the need to repeat sterilization due to wrap failure.
2Reliability
If multiple packaging materials are used for sterilization, then sterility can be maintained, but the complexity of handling and storage increases
Solution Approach 1:
The patent merges multiple packaging functions into a single rigid container system. The container itself serves as both the packaging and the sterilization barrier, with an integrated seal mechanism that combines sealing and filtering capabilities. This eliminates the need for separate wraps, drapes, and filters, simplifying the overall packaging system while maintaining sterility.
Solution Approach 2:
The rigid container is designed to perform multiple functions simultaneously: it provides structural support, acts as a sterilization barrier, incorporates an integrated seal mechanism, and includes a filter for sterilizing agent venting. This multi-functional design reduces the number of separate components needed, simplifying handling and storage.
3Reliability
If rigid containers are used for sterilization, then sterility can be maintained, but the containers are bulky and expensive increasing storage and handling costs
Solution Approach 1:
The rigid container system is designed with modular components that can be configured based on the specific sterilization needs. The container can be segmented into sections for different instruments, and the seal mechanism can be applied only where needed. This reduces the overall material usage and weight compared to using a single large rigid container for all instruments.
Solution Approach 2:
While maintaining the structural integrity of a rigid container, the patent incorporates thin film sealing mechanisms and flexible seal components that reduce the overall bulk. The seal mechanism uses thin sealing surfaces rather than thick rigid barriers, reducing weight and storage space while maintaining sterility assurance.
4Object-affected harmful factors
If filters are placed over vents for sterilization, then particles can be blocked, but the filter must be removed and inspected requiring additional time and complexity
Solution Approach 1:
The patent integrates the filter directly into the seal mechanism, combining the sealing function with the particle blocking function. The seal mechanism itself acts as the barrier, eliminating the need for a separate removable filter component. This integration reduces the inspection process to verifying the seal integrity, which is already part of the sterilization validation.
Solution Approach 2:
The integrated seal mechanism performs the filtering function automatically as part of the sealing process. The seal structure itself provides the particle barrier, and its integrity can be verified through the same means used to verify proper sealing, eliminating the need for separate filter inspection procedures.
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 system provides a more efficient and cost-effective sterilization process by minimizing the need for multiple packaging materials, reducing the risk of tears, and simplifying the handling and storage of sterilized instruments, while ensuring a sterile field is maintained.
Implementation Method 1
a seal mechanism configured to seal the wrap to the base
Implementation Method 2
A filter is typically placed over the vent to keep particles or extraneous materials from entering the cabinet before, during or after the sterilizing process
Data Source
AI summary
A sterilization packaging system for an object requiring sterilization in a sterilizer, the sterilization packaging system comprising a base having a support surface and a plurality of sides, the support surface configured to support an object requiring sterilization, a wrap sized to overlie the sides of the base and the object requiring sterilization, the wrap having a main body portion and a lower portion, a sealing interface between the lower portion of the wrap and the base, the sealing interface configured to form a continuous seal between the lower portion of the wrap and a first sealing surface, and a first drape moveable between an unfolded position and a folded position, wherein the first drape is sized to overlie at least a first portion of a support surface of the base in the folded position.