Prosthetic Heart Valve Commissure Assembly for Outflow Orifice Expansion
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Solution Overview
Problem
Existing prosthetic heart valves have valvular structures that position the outflow edges of leaflets radially inward of the frame, leading to a narrower effective outflow orifice and high pressure gradients, which can cause cavitation and other clinical risks.
Innovation Solution
The prosthetic heart valves are designed with commissure configurations that position the bending axis of the leaflets radially inwardly from the frame, using sutures and reinforcing members to prevent leaflet contact with the frame, thereby maximizing the outflow orifice and minimizing damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the outflow edges of leaflets are positioned radially inward of the frame, then leaflet abrasion is prevented, but the effective outflow orifice becomes narrower and pressure gradient increases
Solution Approach 1:
The patent introduces a new spatial dimension by positioning the bending axis radially inward of the frame rather than at the frame interface. This dimensional repositioning allows the leaflet main body to clear the frame during opening while maintaining a larger outflow orifice, as the leaflet arcs along a bending axis that is offset from the frame's radial position.
Solution Approach 2:
The commissure structure acts as an intermediary element that mediates between the frame and the leaflet. By positioning the bending axis through the commissure assembly rather than directly at the frame-leaflet interface, the design allows the leaflet to open without contacting the frame while maintaining optimal outflow geometry.
2Reliability
If the outflow edges of leaflets are positioned radially inward of the frame, then leaflet contact with frame is avoided, but high pressure gradients occur leading to cavitation
Solution Approach 1:
By repositioning the bending axis to a different radial dimension (inward of the frame), the patent enables the leaflet to achieve sufficient clearance from the frame during opening without requiring the outflow edges to be positioned radially inward. This maintains a larger outflow orifice area, reducing pressure gradients and eliminating cavitation risk.
3Area of stationary object
If commissures are configured to position bending axis radially inwardly from the frame, then outflow orifice is maximized, but device complexity increases
Solution Approach 1:
The commissure assembly serves multiple functions simultaneously: it anchors the leaflet to the frame, defines the bending axis position, and contributes to the outflow orifice geometry. By integrating these functions into a single structural element rather than separate components, the patent achieves the desired bending axis positioning without proportionally increasing device complexity.
Data Source
AI summary
An implantable prosthetic device can include a radially expandable and compressible annular frame comprising an inflow end portion and an outflow end portion, and a plurality of leaflets arranged within the frame. Each leaflet can include one or more commissure tabs. The commissure tabs of two adjacent leaflets coupled to a commissure attachment member to form a commissure. The commissure can be secured to the frame via first and second sutures, each suture extending through a respective commissure tab, through the commissure attachment member, crossing over the other suture and being secured to the frame. The commissure can define a bending axis disposed radially inwardly of the frame such that a main body of each leaflet is prevented from contacting the frame when the valvular structure is in an open configuration.