Expandable Prosthetic Valve Leaflets for Patient Growth
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Solution Overview
Problem
Prosthetic valves face challenges in adapting to changes in diameter over time, such as patient growth, requiring complex and risky procedures for replacement or adjustment, which can lead to complications.
Innovation Solution
A prosthetic valve design featuring primary and auxiliary leaflets that are initially folded and secured, allowing for diametric expansion to transition from a smaller to a larger diameter, with the auxiliary leaflets becoming active to enhance flow regulation, using mechanisms like folds, coatings, and selective expansion features.
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 is appropriate for pediatric patients at that time, but following growth of the patient, the valve becomes too small and requires removal and replacement
Solution Approach 1:
The prosthetic valve is designed with dynamic expandability, allowing it to transition from a compressed delivery state to an expanded functional state. The valve includes expansion features such as radially expandable frames, elongatable leaflets, and adjustable components that enable the valve diameter to be increased after implantation, adapting to patient growth without requiring removal and replacement
Solution Approach 2:
The prosthetic valve is designed with nested components where auxiliary leaflets are stored within or alongside primary leaflets in a compressed configuration during delivery. After implantation, these nested components are deployed to increase the valve diameter, allowing the valve to grow with the patient while maintaining a single-implant structure
2Adaptability or versatility
If valve removal and replacement procedures are performed to accommodate patient growth, then a larger flow diameter can be achieved, but various complications and concomitant risks arise
Solution Approach 1:
The prosthetic valve is pre-configured with auxiliary leaflets and expansion mechanisms that are prepared in advance for deployment. These components are stored in a compact, deliverable state but are ready to be activated to increase valve diameter, eliminating the need for subsequent surgical intervention and associated risks
Solution Approach 2:
The prosthetic valve includes self-contained expansion mechanisms that can be activated through minimally invasive procedures. The valve structure itself contains the means for its own enlargement, with auxiliary leaflets that can be deployed from within the valve assembly to increase flow diameter without requiring removal of the original valve
3Ease of operation
If auxiliary leaflets are stored in an inactive state within the prosthetic valve, then the valve can be delivered in a compact size, but the auxiliary leaflets must be reliably released and activated upon diametric expansion
Solution Approach 1:
The prosthetic valve is segmented into primary functional components and auxiliary expandable components. The auxiliary leaflets are separated from the main valve structure but integrated through connection mechanisms that allow controlled deployment. This segmentation enables independent delivery of compact components with reliable activation capability
Solution Approach 2:
Connection mechanisms serve as intermediaries between the primary valve structure and auxiliary leaflets. These intermediaries maintain the auxiliary leaflets in a stored, inactive state during delivery but can be activated to deploy the auxiliary components when diametric expansion is required, providing reliable transition between states
Data Source
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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.