Cuff Management Device for Prosthetic Heart Valve Loading
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Solution Overview
Problem
Current devices and methods require high forces to load collapsible prosthetic heart valves into delivery devices due to the larger collapsed size of the valves, and the outer cuff tends to catch on edges, making the process inefficient and prone to snagging.
Innovation Solution
A cuff management device with a ring body and protrusions is used to manage the cuff during loading, reducing the loading forces and preventing snagging by controlling the placement of the cuff and other features, such as the outer cuff, within the stent, utilizing active and passive compliance mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the stented valve is compressed to a reduced diameter for loading into the delivery device, then the valve can be delivered less invasively, but high forces are required and the outer cuff tends to catch on edges
Solution Approach 1:
The cuff management device is divided into multiple functional segments: a body portion for engagement, multiple legs that can be independently positioned, and segments with protrusions for specific interactions. This segmentation allows each component to perform its specific function in managing the outer cuff during compression and loading, reducing the overall force required while maintaining control.
Solution Approach 2:
The cuff management device acts as an intermediary tool between the operator and the stented valve. It provides controlled interaction points through its legs and protrusions, allowing precise manipulation of the outer cuff during the loading process. This intermediary mechanism distributes and controls the forces applied, preventing the outer cuff from catching on edges while enabling effective compression.
2Productivity
If the outer cuff is compressed along with the stent, then the valve assembly can be loaded into the delivery device, but the outer cuff has a tendency to catch on the edge of the delivery device
Solution Approach 1:
The cuff management device performs preliminary actions on the outer cuff before the actual loading into the delivery device. The legs and protrusions pre-position and pre-compress the outer cuff in a controlled manner, ensuring it is properly configured and less likely to catch on edges during subsequent loading. This preliminary management of the cuff geometry prevents snagging issues that would otherwise occur during the loading process.
Solution Approach 2:
The device applies different local qualities to different parts of the outer cuff through its multiple legs and segments with protrusions. Each leg can be positioned to apply specific local compression or support to critical areas of the cuff, ensuring that high-stress regions are properly managed. This localized control prevents the outer cuff from catching on edges while maintaining overall compression efficiency.
Data Source
AI summary
A cuff management device for use when loading a prosthetic heart valve includes a body extending between a first end and a second end, a plurality of legs disposed at the first end, and one or more segments disposed at the second end, the one or more segments having one or more protrusion on an interior surface thereof.