Prosthetic Heart Valve Leaflets with Rigid Support Skeleton
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves suffer from leaflet erosion or tearing over extended patient lifespans, leading to potential surgical interventions or additional valve replacements.
Innovation Solution
The prosthetic heart valve design incorporates an expandable stent with leaflets attached to a cuff or the stent, featuring a primary leaflet material and a support skeleton with a rigid reinforcing material to enhance durability and reduce stress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If biological tissue leaflets are used in conventional collapsible prosthetic heart valves, then the valve can be made collapsible for minimally invasive delivery, but the leaflets may erode or tear over extended patient lifespans
Solution Approach 1:
The patent uses composite materials by combining biological tissue leaflets with a support skeleton made of rigid reinforcing material. This composite structure allows the valve to maintain collapsibility for minimally invasive delivery while the support skeleton prevents erosion and tearing of the biological leaflets over extended periods, thereby resolving the contradiction between ease of delivery and long-term reliability.
2Device complexity
If biological leaflets are used, then the valve structure can be simplified, but the leaflets wear on edges where they contact and coapt with one another and where they attach to the frame
Solution Approach 1:
The support skeleton is strategically positioned at specific locations within the leaflet structure, particularly at the edges where coaptation occurs and where the leaflets attach to the frame. This local reinforcement approach maintains overall valve structure simplicity while providing targeted strength enhancement at critical wear-prone areas, resolving the contradiction between device complexity and leaflet edge strength.
3Ease of manufacture
If non-uniform or unbalanced leaflet coaptation occurs, then the valve may be easier to manufacture, but stresses in the tissue leaflets cause functional failures through tears or hole formation
Solution Approach 1:
The support skeleton modifies the mechanical parameters of the leaflet structure by providing rigid reinforcement that influences coaptation dynamics. This reinforcement ensures uniform and balanced coaptation across all leaflets, distributing stresses more evenly and preventing the formation of tears or holes that would compromise valve function, thereby resolving the contradiction between ease of manufacture and valve reliability.
Data Source
AI summary
A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a primary leaflet material, as well as features that reinforce specific regions of the leaflet.