Sterilized Catheter Packaging System for Immediate Use
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Solution Overview
Problem
Current packaging systems for catheters require significant pre-operation time and resources for sterilization and preparation, as they need to be rinsed and loaded with deployable medical devices, which can be time-consuming and inefficient.
Innovation Solution
A packaging system that maintains a terminally sterile environment using a tray within a sealable container, where the catheter and deployable medical device are immersed in a sterilizing fluid, such as propylene oxide, allowing the device to remain wet and sterile until use, reducing the need for additional preparation steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the catheter and deployable medical device are packaged separately with the catheter in a dry compartment and the device in a wet compartment, then sterilization is achieved, but the system requires rinsing steps to remove storage solution and additional preparation time
Solution Approach 1:
The patent merges the catheter and deployable medical device into a single sterile packaging environment, eliminating the separation into dry and wet compartments. Both components are packaged together in fluid communication, allowing the sterilizing fluid to contact both items simultaneously, thus achieving sterilization without requiring separate rinsing steps for each component.
Solution Approach 2:
The catheter and deployable medical device are pre-assembled in the loaded configuration before packaging. This preliminary assembly is performed in a sterile environment, so that when the package is opened, the device is ready for immediate use without requiring additional assembly or preparation steps in the operating room.
2Stability of the object's composition
If the catheter is packaged in a dry environment, then storage stability is maintained, but the catheter requires rinsing and additional preparation steps before use
Solution Approach 1:
The patent changes the storage environment from dry to wet by introducing a sterilizing fluid into the packaging. The fluid is selected to be non-toxic and compatible with the catheter and device materials, allowing stable storage in a wet environment without degradation. This parameter change eliminates the need for rinsing before use, as the storage fluid is already suitable for contact with the medical device.
3Ease of manufacture
If the catheter and deployable medical device are assembled in a non-sterile environment, then manufacturing is simpler, but sterilization time and resources increase
Solution Approach 1:
The catheter and deployable medical device are assembled in the loaded configuration before packaging, performing the assembly action in advance. This preliminary assembly is done in a controlled environment, and the entire assembled unit is then packaged together in a sterile container, allowing the sterilization process to act on the complete assembly rather than requiring separate sterilization of each component.
Solution Approach 2:
The patent combines the catheter and deployable medical device into a single packaged unit for sterilization purposes. By merging these components into one sterile package, the sterilization process can be applied simultaneously to both items, reducing the total sterilization time and resources compared to separate sterilization processes.
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 solution significantly reduces pre-operation preparation time by keeping the catheter and medical device in a sterile environment, eliminating the need for rinsing and minimizing resource usage, allowing for immediate use with minimal additional steps.
Implementation Method 1
At least the one chamber for the deployable medical device may contain a fluid that is a component of and a final product of a sterilization process, such as, but not limited to, the methods and processes described in U.S. application Ser. No. 15/150,025, entitled 'Sterilization Process'
Implementation Method 2
A vacuum pressure may then be applied to remove at least some of the excess air and/or fluid from the chambers of the tray, allowing the deployable medical device and catheter to remain sufficiently wet and therefore in contact with the sterilizing fluid until opened by an end user.
Data Source
AI summary
A packaging system for storing a deployable medical device within a sterilized environment includes a sealed container; a tray disposed within the sealed container; a catheter assembly comprising at least one sheath; a deployable medical device engaged with the catheter assembly; and a sterilizing fluid. The tray comprises a first chamber; a second chamber in fluid communication therewith; and at least a third chamber between the first and second chambers, and in fluid communication with at least the first chamber. The deployable medical device is disposed within the tray in a storage configuration, in which the deployable medical device is disposed within the first chamber in a partially deployed state distally from a distal end of the catheter and the catheter assembly spans between the first chamber and the second chamber. The sterilizing fluid contacts at least a part of the deployable medical device in the storage configuration.