Integrated Valve Packaging Sleeve for Heart Valve Handling

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Solution Overview

Problem

Current packaging systems for prosthetic heart valves are complex and time-consuming to assemble and disassemble, and they are limited by the respective jar orientations for mitral and aortic valves, making it difficult for medical practitioners to easily and safely remove the valves and attach surgical handles.

Innovation Solution

A packaging sleeve with a single piece clip/sleeve hybrid that securely retains the valve within a jar, allowing the valve holder to be oriented towards the bottom, facilitating quick and easy removal and attachment of a surgical handle, and reducing overall complexity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If conventional packaging systems with separate clip and tubular sleeve structures are used, then the valve is stabilized during storage and transit, but the assembly and disassembly processes become complex and time-consuming

Engineering Contradiction:
Improvevalve stabilityVSAvoidpackaging structure complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent combines the previously separate clip and tubular sleeve structures into a single integrated packaging component. This unified structure maintains the valve stabilization function while eliminating the complexity of assembling and disassembling multiple separate parts, directly resolving the contradiction between stability and device complexity

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If conventional packaging with separate clip and sleeve components is used, then the valve is protected from damage, but the time required for assembly and disassembly increases

Engineering Contradiction:
Improvevalve protectionVSAvoidassembly and disassembly time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

By merging the clip and sleeve into a single integrated component, the patent enables the valve to remain protected during storage and transit while allowing for rapid assembly and disassembly. The unified structure eliminates the time-consuming steps of assembling multiple separate components, directly addressing the contradiction between reliability and time loss

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If conventional packaging systems are used, then the valve is securely retained in the jar, but the process of removing and attaching surgical handles becomes difficult and time-consuming

Engineering Contradiction:
Improvevalve retentionVSAvoidvalve removal and handle attachment ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The integrated packaging structure provides secure valve retention during storage while facilitating easy removal and handle attachment during surgery. The unified design eliminates the complexity of manipulating multiple separate components, directly improving ease of operation without compromising retention reliability

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS11311378B2Prosthetic heart valve packaging and deployment systems
Publication Date: 2022.04.26 EDWARDS LIFESCIENCES CORP
  • US11311378B2 patent drawing
  • US11311378B2 patent drawing
  • US11311378B2 patent drawing

AI summary

Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.