Prosthetic Heart Valve Leaflet Geometry to Reduce Pinching
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Solution Overview
Problem
There is a need for improved transcatheter prosthetic valves that can be efficiently delivered and deployed in the human body to replace malfunctioning heart valves, addressing the limitations of existing percutaneous valve technology.
Innovation Solution
A radially expandable and compressible prosthetic heart valve with a frame and leaflet assembly, featuring commissure tabs and coaptation edge regions, allowing for controlled movement between open and closed states, and a delivery apparatus for precise implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a percutaneous delivery approach is used to implant prosthetic heart valves, then minimally invasive surgery is achieved, but the risk of leaflet pinching and delivery complexity increase
Solution Approach 1:
The prosthetic valve is nested within a delivery catheter in a compressed state, allowing percutaneous delivery through the vasculature to the implantation site. The valve is then expanded from the compressed state to its functional size at the target location, resolving the contradiction by enabling minimally invasive access while managing delivery complexity through the nesting mechanism.
Solution Approach 2:
The prosthetic valve transitions from a static compressed state during delivery to a dynamic expanded state at implantation. This dynamic transformation allows the valve to adapt to the implantation site while being delivered through a minimally invasive percutaneous approach, addressing both the ease of operation and device complexity concerns.
2Ease of manufacture
If the prosthetic valve uses a traditional leaflet attachment method, then manufacturing is simpler, but the risk of leaflet pinching increases
Solution Approach 1:
The leaflet attachment structure incorporates commissure tabs and coaptation edge regions with specific local geometric features. These localized structural modifications create clearance spaces that prevent pinching at critical areas while maintaining overall manufacturing feasibility, thus resolving the contradiction between manufacturing simplicity and reliability.
3Volume of moving object
If the coaptation edge regions are positioned close to the frame inner surface, then the valve structure is more compact, but leaflet pinching risk increases
Solution Approach 1:
The design introduces a radial dimension clearance between the coaptation edge regions and the frame inner surface. By positioning the coaptation edges at a controlled radial distance from the frame, the design prevents pinching while maintaining compact overall valve dimensions, resolving the contradiction between compactness and harmful factor reduction.
4Ease of operation
If the prosthetic valve is designed for self-expansion, then deployment is simpler, but control precision during implantation decreases
Solution Approach 1:
The delivery catheter serves as an intermediary mechanism that provides controlled expansion of the prosthetic valve. The catheter system allows the operator to control the timing and extent of valve expansion, combining the simplicity of a self-expanding design with precise implantation control, thus resolving the contradiction between deployment simplicity and implantation precision.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The prosthetic valve provides effective blood flow management and durability, with reduced risk of leaflet pinching and enhanced stress distribution, facilitating safe and efficient implantation in the heart.
Implementation Method 1
the coaptation edge regions can pivot relative to the commissure tabs at respective pivot axes intersecting the cut-out regions to move the leaflet assembly from a closed state to a partially opened state
Implementation Method 2
a radially expandable and compressible frame comprising an inflow end and an outflow end
Data Source
AI summary
A prosthetic valve includes a frame and a leaflet assembly having a plurality of leaflets coupled to the frame. The leaflet assembly is movable between an open state and a closed state to allow unidirectional blood flow through the prosthetic valve. Each leaflet includes an outflow edge, a cusp edge, and a pair of commissure tabs extending from opposite sides of the leaflet and between the outflow edge and the cusp edge. Each commissure tab is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly. The outflow edge of each leaflet includes a coaptation edge region and cut-out regions between opposite ends of the coaptation edge region and the commissure tabs. When the leaflet assembly moves between the open and closed states, the coaptation edge regions pivot relative to the commissure tabs at respective pivot axes intersecting the cut-out regions.