Heart Valve Storage Container With Integrated Crimping Mechanism
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Solution Overview
Problem
There is a need for a storage and preparation system for transcatheter heart valves that prevents damage during storage and enables easy and safe removal, preparation, and crimping of the valves prior to implantation, as existing methods leave the valves susceptible to damage during manipulation.
Innovation Solution
A storage container with a crimping mechanism that allows the heart valve to be stored in its expanded configuration and easily converted to a crimped configuration upon removal, featuring a container housing and a crimping mechanism with a tapered channel and rotatable top cover to facilitate the transition from expanded to crimped state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the heart valve is stored in a jar filled with sterilant and preservative solution, then the valve is stabilized and protected from damage during storage, but the valve requires washing and handling that increases susceptibility to damage prior to implantation
Solution Approach 1:
The patent combines the storage jar and crimping mechanism into a single integrated system. The jar that stores the valve in preservative solution also contains the crimping mechanism, allowing the valve to be crimped without removal from the protective solution environment. This merging eliminates the harmful intermediate handling step where the valve is most susceptible to damage.
Solution Approach 2:
The crimping mechanism is prepared in advance within the jar, with the tapered crimping surface and compression elements positioned ready to receive the valve. The valve remains in the protective solution throughout the crimping process, with preservative solution drainage features allowing fluid removal during crimping without requiring valve removal from the jar.
2Ease of operation
If the heart valve is removed from the storage jar for washing and crimping, then the valve can be prepared for implantation, but the valve becomes susceptible to damage during manipulation
Solution Approach 1:
The storage and preparation functions are merged into a single jar assembly that includes both the storage container and the crimping mechanism. This allows washing, crimping, and storage to occur in one location without transferring the valve between containers or removing it from the protective solution environment.
Solution Approach 2:
The preservative solution acts as an intermediary medium that protects the valve throughout the preparation process. Drainage features in the jar allow the solution to be removed during crimping, and the solution can be replenished afterward, maintaining protection without requiring direct contact between the delicate valve tissue and external handling surfaces.
3Productivity
If the heart valve is crimped after removal from the storage solution, then the valve can be delivered via catheter, but the valve is exposed to damage risk during the crimping process
Solution Approach 1:
The crimping mechanism is pre-positioned within the jar with the tapered compression surface and compression elements ready to receive the valve. The valve is crimped while still in the protective solution, which cushions and protects it during the compression process. The mechanism requires only axial movement of the jar or compression elements to initiate crimping.
Solution Approach 2:
The preservative solution provides beforehand cushioning during the crimping process. The valve remains immersed in the solution during compression, which protects the delicate tissue from direct contact with hard surfaces and distributes the compression forces more evenly. The solution can be drained during crimping to allow better contact between the valve and crimping surfaces while maintaining protection.
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
The system effectively protects the valve during storage, minimizes the risk of damage, and allows for efficient crimping and preparation for implantation, enhancing the safety and ease of transcatheter heart valve delivery.
Implementation Method 1
a crimping mechanism with a tapered channel and rotatable top cover to facilitate the transition from expanded to crimped state
Data Source
AI summary
Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.