Expandable Prosthetic Valve Leaflets for Patient Growth
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Solution Overview
Problem
Prosthetic valves face challenges in accommodating changes in diameter over time, such as patient growth, requiring adjustments that can be complicated and risky, especially in pediatric applications where initial smaller diameters need to be expanded to larger sizes without causing complications.
Innovation Solution
The development of prosthetic valves with primary and auxiliary leaflets that are initially stored in an inactive state, secured by folds or a support structure, which can be released to an active state upon diametric expansion, allowing the valve to transition from a smaller to a larger operative diameter, ensuring proper function and minimizing complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a prosthetic valve is implanted with a smaller inner diameter to accommodate initial patient size, then the valve can be initially installed successfully, but the valve cannot accommodate patient growth requiring complex and risky removal and re-implantation procedures
Solution Approach 1:
The prosthetic valve incorporates an expandable frame structure that can dynamically change its inner diameter from an initial compressed state to an expanded state. The frame includes expandable elements such as balloons or self-expanding mechanisms that allow the valve to grow with the patient, eliminating the need for complex removal and re-implantation procedures while maintaining adaptability to patient growth.
Solution Approach 2:
The prosthetic valve design includes nested components where auxiliary leaflets are stored within the primary valve structure in a compressed state. When expansion is needed, these nested components are deployed outward, allowing the valve to increase in diameter without requiring complete removal. This nested configuration enables growth accommodation while simplifying the expansion process.
2Ease of operation
If auxiliary leaflets are stored in an inactive state within the primary leaflets, then the valve structure remains compact for implantation, but the folds must be reliably secured to prevent premature activation
Solution Approach 1:
The auxiliary leaflets are pre-positioned and folded within the primary leaflet structure during manufacturing, with securing mechanisms such as adhesives or mechanical fasteners already in place. This preliminary configuration ensures the valve remains compact for implantation while maintaining reliable securing of the folded state, preventing premature activation until intentional expansion occurs.
3Adaptability or versatility
If the prosthetic valve is expanded diametrically to a larger size, then the valve can accommodate patient growth and provide larger flow diameter, but the expansion process may cause complications and risks
Solution Approach 1:
The expansion mechanism utilizes controlled parameter changes, such as gradual inflation pressure or staged self-expansion, to transition the valve from a compressed to an expanded state. This controlled parameter change allows the valve to accommodate patient growth and provide larger flow diameter while minimizing expansion-related complications through progressive, manageable expansion steps.
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.