Hinged Long Sealed Tray for Aseptic Catheter Removal
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Solution Overview
Problem
Long catheter delivery systems face challenges in sterile removal and aseptic presentation from their delivery system packages, as they must be removed without contacting non-sterile surfaces, which complicates the process.
Innovation Solution
A packaging assembly featuring an outer tray with a hinged portion and a lid that creates a sterile cavity, allowing the inner tray to be aseptically presented for removal by bending the proximal portion downward, thereby exposing the inner tray for sterile extraction without contacting non-sterile surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the delivery system is packaged in a sealed container, then sterility is maintained, but removal without contacting non-sterile surfaces becomes difficult
Solution Approach 1:
The packaging assembly is divided into separate segments: an outer tray with a hinged proximal portion, an inner tray, and a lid. The hinged portion acts as a flexible barrier that segments the sterile and non-sterile zones, allowing the inner tray to be removed while maintaining sterility by keeping the hinge folded over the sterile field.
Solution Approach 2:
The proximal portion of the outer tray is designed with a hinge that allows it to be dynamically folded backward during removal. This dynamic movement creates a flexible barrier that moves with the inner tray, maintaining the sterile boundary while enabling easy removal without contacting non-sterile surfaces.
2Reliability
If a rigid sealed package is used, then sterility is ensured, but manipulation and presentation for removal becomes complex
Solution Approach 1:
The proximal portion of the outer tray incorporates a hinge that transforms the rigid package into a dynamic structure. During removal, the hinged portion is folded backward to follow the inner tray, maintaining the sterile barrier while simplifying manipulation. This dynamic feature reduces the complexity of aseptic presentation compared to fully rigid packages.
Solution Approach 2:
The hinged proximal portion acts as a flexible barrier that can be folded and manipulated. This flexible element maintains the sterile field while allowing easy manipulation and presentation of the inner tray for removal, reducing the complexity of the overall process.
3Ease of operation
If the entire outer tray is removed, then the inner tray is exposed, but non-sterile surfaces are contacted
Solution Approach 1:
The outer tray is segmented into a proximal portion with a hinge and a distal portion. During removal, only the necessary portion of the outer tray is manipulated while the hinged proximal portion remains folded over the sterile field, preventing contact with non-sterile surfaces while exposing the inner tray for removal.
Solution Approach 2:
The hinged proximal portion dynamically folds backward during the removal process, maintaining the sterile barrier while allowing the inner tray to be exposed and removed. This dynamic movement ensures that the sterile field is maintained even as the package is opened for removal.
Data Source
AI summary
A packaging assembly comprising an outer tray and a lid coupled to the outer tray. The lid and the outer tray define a sterile cavity therein. The packaging assembly further includes an inner tray housing a delivery system within the sterile cavity. The outer tray includes a proximal portion, a distal portion, and a hinged portion coupling the proximal portion to the distal portion. To aseptically present the inner tray for removal from the outer tray, the lid is partially or completely removed. The proximal portion is then bent downward to expose the inner tray for removal.