Prosthetic Valve Expansion With Auxiliary 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 are complicated and risky, involving the removal and reimplantation of valves with different diameters.
Innovation Solution
A prosthetic valve design with primary and auxiliary leaflets that are initially stored in an inactive state, secured by folds or a support structure, which transition to an active state upon diametric expansion, allowing the valve to adjust from a smaller to a larger diameter without the need for removal or reimplantation.
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 fits the patient's current anatomy, but the valve cannot accommodate patient growth and requires removal and reimplantation of a larger valve
Solution Approach 1:
The prosthetic valve incorporates an expandable frame structure that can dynamically change its inner diameter from an initial smaller diameter to a larger diameter. 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 removal and reimplantation while maintaining continuous valve functionality.
Solution Approach 2:
The prosthetic valve design includes nested components where an inner valve structure is contained within an outer expandable frame. The inner valve provides initial functionality at a smaller diameter, while the outer frame can be expanded to increase the inner diameter, allowing the valve to accommodate growth without removal. This nested configuration enables seamless diameter transition.
2Adaptability or versatility
If the prosthetic valve is designed with a fixed inner diameter, then the manufacturing and implantation process is simpler, but the valve cannot be adjusted to accommodate changes in patient size over time
Solution Approach 1:
The prosthetic valve frame is divided into multiple expandable segments or struts that can be independently actuated to increase the inner diameter. Each segment contains expansion mechanisms such as balloons or self-expanding elements. This segmentation allows for controlled diameter adjustment while maintaining a manageable structural complexity through modular design.
Solution Approach 2:
The valve incorporates materials and structures with specific mechanical properties that enable diameter change. The frame uses shape memory alloys or elastomeric materials that can transition between different diameter states in response to thermal, mechanical, or chemical stimuli. This parameter change capability allows diameter adjustment without proportionally increasing overall device complexity.
3Adaptability or versatility
If the prosthetic valve uses auxiliary leaflets stored in an inactive state, then the valve maintains a smaller effective diameter initially, but the auxiliary leaflets can be deployed to increase the diameter and enhance flow regulation
Solution Approach 1:
The auxiliary leaflets are pre-positioned and stored in an inactive state within the valve structure during manufacturing. These leaflets are prepared in advance to be deployed when diameter expansion occurs. The preliminary positioning ensures that when the valve expands, the auxiliary leaflets are already in place to immediately enhance flow regulation capability without requiring additional complex deployment mechanisms.
Solution Approach 2:
The auxiliary leaflets are integrated with the primary valve structure, combining multiple functions into a unified design. The auxiliary leaflets merge with the primary leaflets to form a complete valve system that provides both initial flow regulation at smaller diameter and enhanced flow regulation at expanded diameter. This merging reduces overall device complexity by eliminating separate valve systems.
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.