Prosthetic Heart Valve Packaging With Slotted Funnel Compression
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Solution Overview
Problem
The process of packaging and collapsing a replacement heart valve for minimally invasive procedures is complex, requiring skilled practitioners and multiple tools, which can lead to human error and increased operational complexity.
Innovation Solution
A packaging assembly comprising a funnel with a varying interior diameter and longitudinal slots, a valve support, and a retention mechanism, which securely holds the heart valve in place and allows for easy transition from an expanded to a collapsed configuration for delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate tools and devices are used to collapse the valve into the delivery system, then the valve can be properly prepared for implantation, but the operational complexity increases and more tools are required
Solution Approach 1:
The packaging assembly merges multiple functions (storage, collapse, and delivery) into a single integrated system. The jar serves as both the storage container and the collapse tool, eliminating the need for separate crimping devices and funnels, thereby reducing operational complexity while maintaining valve preparation reliability
Solution Approach 2:
The packaging assembly is designed to perform multiple functions: it stores the valve in an expanded state, provides the collapsing mechanism through its structural design, and serves as the delivery system. This multi-functionality eliminates the need for multiple specialized tools, directly addressing the contradiction between reliability and device complexity
2Reliability
If skilled practitioners perform rinsing and assembling manually, then the valve can be properly prepared, but the process requires more time and skill
Solution Approach 1:
The valve is pre-assembled and pre-sterilized within the packaging assembly during manufacturing. The packaging itself is designed to facilitate the collapsing action without requiring manual manipulation, thereby reducing the time and skill required during the procedural while maintaining assembly accuracy
Solution Approach 2:
The packaging assembly is designed to enable the practitioner to perform the collapsing action through a simple pulling motion without requiring complex manual manipulation or specialized skills. The system serves itself by providing all necessary functions (storage, collapse, delivery) through its design, reducing both time and skill requirements
3Reliability
If the valve is held stationary in liquid-filled jars during packaging, then damage to the valve is prevented, but additional steps are required to remove and prepare the valve for delivery
Solution Approach 1:
The packaging assembly merges the protective storage function with the collapse and delivery functions into a single system. The valve remains protected within the jar during shipment, and the same jar structure provides the collapse mechanism, eliminating the need for separate preparation steps and tools while maintaining valve protection
Solution Approach 2:
The packaging assembly serves multiple purposes: it protects the valve during shipment, provides the collapse mechanism through its structural design, and serves as the delivery system. This multi-functionality eliminates additional preparation steps while maintaining valve protection, directly addressing the contradiction between reliability and device complexity
Data Source
AI summary
A system for heart valve replacement includes a collapsible and expandable replacement heart valve and a packaging assembly for storing the replacement heart valve. The packaging assembly includes a funnel extending from a first end to a second end. The funnel has a first interior diameter at the first end and a second interior diameter, the second interior diameter smaller than the first interior diameter. The funnel defines an internal lumen extending between the first and second ends. The funnel defines a plurality of longitudinal slots extending along an interior surface of the funnel between the first and second ends.