Flip-Cap Catheter Package With Sterile Snap-Fit Closure
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Solution Overview
Problem
Existing catheter packages are wasteful, difficult to open, prone to premature opening, and do not maintain sterility under user handling, especially for users with limited dexterity, and require improved sealing mechanisms to withstand compression and radial forces.
Innovation Solution
A catheter package with a hinge-connected cap that allows selectable movement between open and closed positions, featuring a seal that can be repeatedly engaged to maintain sterility, and a design that includes a case insert with an O-ring and latches to resist lateral forces, ensuring secure closure and easy access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional molded container or bag is used to package the catheter, then the catheter is protected during transport and storage, but the package is difficult to open, may break open prematurely, and is wasteful of material
Solution Approach 1:
The package is divided into a case and a separate cap that can be removed and replaced. The cap acts as an independent sealing element that can be securely attached to the case, providing reliable sealing while allowing easy removal and replacement without damaging the overall package structure.
Solution Approach 2:
The cap is designed to be movable between attached and detached states, enabling easy opening and reclosing of the package. This dynamic element allows users to access the catheter when needed and reclose the package for disposal, eliminating the need to break open traditional rigid containers.
2Reliability
If a secure cap closure is used to maintain sterility, then the catheter remains sterile under compression and handling, but the package becomes difficult to open and reclose
Solution Approach 1:
The cap is pre-formed with a frangible wall that is designed to break at a predetermined location during initial opening, but the cap itself remains intact and can be reclosed. This preliminary breaking action facilitates easy opening while the remaining cap structure maintains secure closure capability for sterility protection.
Solution Approach 2:
The cap is designed to be discarded after use, but before disposal it can be reclosed to contain the used catheter. The cap's frangible wall breaks during opening, but the rest of the cap structure is recovered and reused to securely contain the used catheter until disposal, maintaining hygiene and sterility throughout the process.
3Volume of moving object
If a compact package design is used for discreet carrying, then the catheter package fits in purses and pouches, but the package may be subjected to compression and radial forces that compromise sealing
Solution Approach 1:
The cap is designed with a substantially spherical shape, which distributes compression and radial forces evenly across its surface. This spherical geometry provides structural strength to withstand forces encountered during carrying in purses or pouches, while maintaining a compact size that fits discreetly in personal items.
Solution Approach 2:
The cap is formed from a resilient material that combines flexibility with strength, allowing it to withstand compression and radial forces while maintaining its sealing function. The material properties enable the cap to deform slightly under pressure and return to its original shape, preserving the seal integrity.
4Ease of operation
If a frangible wall is used for easy opening, then the package opens easily with minimal force, but the opening mechanism may not provide sufficient sealing strength
Solution Approach 1:
The opening mechanism is segmented into two functional parts: a frangible wall that breaks easily to initiate opening, and a cap body that remains intact and provides the sealing function. The frangible wall is designed to break at a predetermined location with minimal force, while the cap body maintains sufficient sealing strength through its resilient material and spherical geometry.
Solution Approach 2:
The cap transitions from a fully intact sealed state to a partially broken state after opening, with the frangible wall breaking but the cap body remaining functional. This dynamic transformation allows easy opening through frangible wall failure while preserving sealing capability through the intact cap structure that can be reclosed to maintain sterility.
Data Source
AI summary
A package for a medical device such as an intermittent catheter has a case which is closed at one end and open at the other end. A cap is connected to the case by a hinge to permit selectable movement of the cap between an open position, wherein access is provided to the open end of the case, and a closed position, wherein the cap prevents access to the open end of the case. A seal is connected to one of the cap and case. The seal is engageable with the other of the cap and case when the cap is closed to form a barrier that maintains a sterile environment inside the package. The seal can be repeatedly made and broken whenever the user closes or opens the cap, respectively. The case includes a pair of slots at the open end. A pair of latches are formed in the cap. The latches fit into the slots to prevent lateral forces from distorting the cap when the cap is closed.