Hydrated Storage Container for Implantable Medical Device Loading
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Solution Overview
Problem
There is a need for efficient storage and loading systems for implantable medical devices, particularly those that require hydrating conditions or have concerns about long-term memory effects from reduced-diameter storage, to simplify and standardize the loading procedures for clinicians.
Innovation Solution
A storage and loading system comprising a container with a funnel-shaped neck and a delivery system with a sheath and grasper, allowing for the transfer of implantable medical devices from a hydrating fluid environment to a device holding chamber, ensuring the device remains in a hydrated state and minimizing damage during loading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the implantable medical device is stored in a delivery system during manufacturing, then the loading process is simplified, but the device may suffer from extended storage effects such as dehydration or memory effects
Solution Approach 1:
The system separates the storage function (container with hydrating fluid) from the delivery function (delivery system), allowing the device to be stored separately in optimal conditions and loaded only when needed, thus avoiding extended storage in the delivery system while maintaining manufacturing efficiency
Solution Approach 2:
A container with hydrating fluid acts as an intermediary between manufacturing and implantation, providing temporary storage that maintains device hydration and prevents memory effects while allowing delayed loading into the delivery system
2Reliability
If the implantable medical device is stored separately from the delivery system, then device performance is maintained through proper hydrating conditions, but the loading procedure becomes more complex
Solution Approach 1:
The loading procedure merges multiple steps into a single integrated process: the grasper retrieves the device from the storage container and simultaneously loads it into the delivery system, reducing procedural complexity while maintaining device performance
Solution Approach 2:
The grasper automatically engages with the device in the storage container and facilitates its own transfer to the delivery system through a single retraction motion, simplifying the loading procedure without requiring additional manual manipulation
3Productivity
If the implantable medical device is loaded directly into the delivery system without separate storage, then the implantation process is faster, but the device may be damaged during extended storage in the delivery system
Solution Approach 1:
The device is prepared and stored in optimal hydrating conditions in advance in a separate container, ensuring it is ready for immediate loading into the delivery system right before implantation, thus achieving fast implantation without extended storage damage
Solution Approach 2:
The storage container with hydrating fluid provides protective conditions before the device enters the delivery system, cushioning against dehydration and memory effects that would otherwise occur during extended storage, enabling rapid implantation with protected device integrity
Data Source
AI summary
Storage and loading systems for expandable intraluminal medical devices are described. The systems include a container that defines an opening that tapers from a relatively large first diameter to a relatively small second diameter. A neck region includes structure adapted to engage an outer sheath of a delivery system such that an intraluminal medical device within the chamber of the container can be advanced through the tapered opening to effect compression of the intraluminal medical device and, ultimately, loading of the device into the delivery system. Methods of preparing and intraluminal medical device for implantation in a patient and kits useful in such methods are also described.