Modular Prosthetic Heart Valve Adaptability
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Solution Overview
Problem
Current transcatheter and endovascular aortic valve designs are limited in their adaptability to different patient anatomies and conditions, such as bicuspid aortic valves, degenerated bioprosthetic valves, and aortic aneurysms, leading to hemodynamic complications and reduced effectiveness in valve-in-valve implantations.
Innovation Solution
The development of a two-part modular prosthetic aortic valve design, comprising a separate lower base portion and upper valve portion, allows for adaptable implantation within the valve annulus or above it, accommodating various patient anatomies and conditions, and enabling repositioning and potential replacement of the upper valve portion over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single integrated transcatheter valve design is used, then the device complexity is reduced and ease of manufacture is improved, but the adaptability to different patient anatomies and conditions deteriorates
Solution Approach 1:
The valve is divided into separate modular components including a delivery catheter, a compression device, and the valve itself, allowing each component to be optimized independently for specific functions while maintaining overall system adaptability
Solution Approach 2:
The valve incorporates expandable and compressible elements that allow dynamic adjustment during delivery and implantation, enabling adaptation to various anatomical configurations while maintaining a relatively simple base structure
2Ease of operation
If the valve is delivered in a compressed configuration stowed in access catheters, then the ease of operation and minimally invasive approach are improved, but the adaptability to different anatomies deteriorates
Solution Approach 1:
The valve is designed to be nested within the delivery catheter in a compressed configuration during delivery, then expanded at the implantation site to its full operational size, allowing minimally invasive access while achieving anatomical adaptability
Solution Approach 2:
The valve incorporates expandable elements that change their physical parameters (diameter, volume) from a compressed delivery state to an expanded implantation state, enabling adaptation to various anatomical sizes through a single delivery platform
3Ease of operation
If present transcatheter valve designs are used, then the ease of operation and minimally invasive approach are improved, but the adaptability to complex conditions like bicuspid aortic valves and aortic aneurysms deteriorates
Solution Approach 1:
The valve system is designed with universal features that allow it to address multiple valve pathologies including bicuspid aortic valves, aortic aneurysms, and degenerated bioprosthetic valves through a single transcatheter delivery platform
Solution Approach 2:
The valve incorporates dynamic expandable elements that can adapt their geometry and size during implantation to accommodate complex anatomical variations while maintaining the minimally invasive transcatheter delivery approach
4Adaptability or versatility
If valve-in-valve implantation is performed within small bioprosthetic valves, then the adaptability to replace degenerated valves is improved, but hemodynamic performance deteriorates due to reduced valve area
Solution Approach 1:
The replacement valve is nested within the degenerated bioprosthetic valve while incorporating an expandable framework that extends beyond the original valve boundaries, allowing valve-in-valve implantation while restoring adequate valve area for hemodynamic performance
Solution Approach 2:
The valve design incorporates an axial component that extends in the longitudinal dimension beyond the original valve, creating additional flow area while maintaining radial fit within the degenerated valve structure
Data Source
AI summary
A prosthetic aortic valve intended for native or valve-in-valve within bioprostheses includes an expandable support scaffold and valve leaflets disposed within an upper leaflet portion of the support scaffold. The valve leaflets within the upper portion may be located within the annulus (intravalvular), above the annulus, or above the native or prosthetic leaflets (supravalvular). The valve within a previously implanted degenerated heart valve such that a base or lower portion of the replacement valve is within the previously implanted valve and the upper portion is expanded within the aorta, the internal area of the valve can be increased and the hemodynamics of the valve improved. Alternatively, the valve may include separate upper and lower portions allowing the portions to be implanted sequentially and the length and other characteristics of the valve to be adjusted based on patient anatomy and condition.