Medical Device Packaging with Detachable Tips for Shape Memory Devices
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Solution Overview
Problem
Existing medical device packaging methods, such as those described in U.S. Pat. No. 5,765,682, are not well-suited for certain types of medical devices and device delivery strategies, particularly those made from shape memory materials, as they do not effectively maintain the device in a state suitable for loading and can lead to difficulties in removing the device from the package and ensuring sterility during long-term storage and deployment.
Innovation Solution
A medical device package featuring an elongate tubular holder with detachable tips that opposes the self-shaping bias of the device, allowing it to be loaded and stored in a controlled environment, ensuring containment and easy removal while maintaining sterility, and a method involving positioning the device within the holder, applying a load to counteract its self-shaping bias, and using snap-off tips to deploy the device into a patient's body lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional sheath with tear-away or peel-away feature is used to package a medical device, then easy access to the device is achieved, but the device cannot be effectively maintained in a state suitable for loading and removal difficulties occur
Solution Approach 1:
The holder is segmented into a body and detachable tips (first and second tips) that can be removed independently. This segmentation allows the device to be securely contained during storage while enabling easy access during deployment by simply detaching the tips, resolving the contradiction between secure containment and easy access.
Solution Approach 2:
The medical device is pre-loaded into the holder in a compressed or constrained state before use. The holder maintains the device in this loaded state during storage and transport, and the tips are designed to be detached at the appropriate time to allow device deployment,从而实现 preliminary preparation without compromising device integrity.
2Device complexity
If shape memory medical devices are packaged in traditional containers, then packaging simplicity is maintained, but the devices cannot be kept in the required loaded state for delivery
Solution Approach 1:
Different parts of the packaging system have different functions: the holder body provides structural support and maintains the loaded state, while the detachable tips provide access control. This local differentiation of qualities allows the packaging to maintain device stability without excessive overall complexity.
Solution Approach 2:
The packaging transitions from a static closed state (tips attached, device contained) to a dynamic open state (tips detached, device accessible). This dynamic design allows the same packaging structure to serve both storage and deployment functions, maintaining device state stability while enabling easy access when needed.
3Manufacturing precision
If the medical device is loaded in opposition to its self-shaping bias, then the device can be contained in a delivery-ready state, but difficult removal from the package occurs
Solution Approach 1:
The tips are extracted or removed from the holder body to release the constrained device. This extraction mechanism allows the device to be easily removed from the loaded state by simply detaching the tips, resolving the contradiction between precise loading control and easy removal.
Solution Approach 2:
The tips extend beyond the holder body in a longitudinal dimension, providing leverage and mechanical advantage for device removal. This dimensional extension allows the operator to apply force at a distance from the device, making removal easier despite the device being loaded in opposition to its self-shaping bias.
4Ease of operation
If detachable tips are used to contain the medical device, then easy device removal is enabled, but package complexity increases
Solution Approach 1:
The detachable tips are nested within or integrated with the holder body structure. This nesting design allows the tips to be easily attached and detached without requiring separate complex packaging components, thus enabling easy device removal while minimizing overall package complexity.
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 ensures that medical devices, like embolization coils, are securely contained and easily deployable, preventing accidental exposure or loss, and maintains sterility throughout the packaging and deployment process, addressing the limitations of previous packaging methods.
Implementation Method 1
a medical device positioned within the cavity, the medical device having a self-shaping bias and being loaded in opposition to the self-shaping bias
Data Source
AI summary
A medical device package includes an elongate tubular holder having a first and a second detachable tip, and a medical device positioned within a cavity and contained within the holder via the first and second detachable tips. The medical device has a self-shaping bias and is loaded in opposition to the bias via contact with an inner surface of the holder defining the cavity. The first and second detachable tips may include snap-off tips, such that upon detachment the cavity is opened for removing the medical device. Related methodology is disclosed.