Expandable Prosthetic Valve Leaflets for Growth-Driven Diameter Changes
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Solution Overview
Problem
Prosthetic valves face challenges in accommodating changes in diameter over time, such as patient growth, requiring adjustments from a smaller to a larger inner diameter without complications or risks associated with removal and reimplantation.
Innovation Solution
A prosthetic valve design featuring primary and auxiliary leaflets, where the auxiliary leaflets are stored in an inactive state and transition to an active state upon diametric expansion, secured by folds, coatings, adhesives, or mechanical fasteners, allowing the valve to adjust from a first operative diameter to a larger second diameter while maintaining functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the prosthetic valve is designed with a fixed inner diameter, then the manufacturing and initial implantation are simple, but the valve cannot accommodate patient growth or diameter changes over time
Solution Approach 1:
The valve is segmented into primary leaflets and auxiliary leaflets that can be independently activated. The auxiliary leaflets are initially stored in an inactive state within folds of the primary leaflets and can be deployed to change the effective valve diameter, allowing the valve to adapt to different diameter requirements without replacing the entire device.
Solution Approach 2:
The auxiliary leaflets are nested within the folds of the primary leaflets in their inactive state. This nesting allows the auxiliary components to be stored compactly within the existing valve structure, adding diameter adaptability without significantly increasing the overall device size or complexity.
2Volume of moving object
If the auxiliary leaflets are stored in an inactive state using folds and securing mechanisms, then the valve maintains a compact initial size, but the mechanism to secure and release the folds adds structural complexity
Solution Approach 1:
The valve utilizes flexible leaflet material that can be folded and secured. The folds are created by manipulating the flexible leaflet material itself, and securing mechanisms such as coatings, adhesives, or mechanical fasteners are applied to maintain the folded configuration. This approach allows compact storage of auxiliary leaflets using the leaflet material's inherent flexibility rather than requiring rigid containment structures.
3Length of stationary object
If the prosthetic valve allows diametric expansion, then the valve can accommodate growth and provide larger inner diameter, but the expansion process and mechanism increase device complexity
Solution Approach 1:
The valve transitions from a static fixed-diameter structure to a dynamic adjustable-diameter structure. The auxiliary leaflets can be activated to change the effective valve diameter, allowing the valve to adapt dynamically to different size requirements. This dynamic capability is achieved through the deployable auxiliary leaflet mechanism rather than requiring a complex active expansion system.
Data Source
AI summary
Various features and associated advantages are described for diametrically adjustable support structures, adjustable valve structures, removable/replaceable valve structures, and associated systems and methods. Although some examples are directed toward prosthetic valve that is a conduit having a valve structure, or a “valved conduit” (e.g., used to replace a pulmonary valve and a portion of the corresponding pulmonary artery or an aortic valve and the aortic root), and other examples are directed toward prosthetic valves implanted native valve orifices (e.g., to replace an aortic or mitral valve), the features and advantages of the structures associated with those examples are interchangeable regardless of a particular application for which the examples are described.