Wedge-Stabilized Prosthetic Heart Valve Leaflet Assemblies

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Solution Overview

Problem

Existing prosthetic heart valves face challenges in assembling commissure tab assemblies, which are complex, time-consuming, and prone to wear and displacement during handling and expansion, leading to instability.

Innovation Solution

A method for assembling prosthetic heart valves by inserting wedge members into commissure tab assemblies between adjacent tabs to restrain radial motion, simplifying the assembly process and reducing the need for sutures, thereby enhancing stability and reducing the risk of leaflet tearing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If commissure tab assemblies are attached using numerous stitches to commissure posts, then the leaflet assembly can be mounted to the frame, but the assembly process becomes complex and time-consuming

Engineering Contradiction:

Improveassembly process simplicityVSAvoidassembly time

Core Design Contradiction:

Ease of manufactureVSLoss of time

Solution Approach 1:

The commissure tab assembly is divided into separate components: the tab itself and the reinforcement element. This segmentation allows for simplified attachment methods where the reinforcement element can be inserted through the tab and secured with minimal stitching, rather than requiring numerous stitches to attach the entire assembly

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The reinforcement element is pre-positioned within the commissure tab assembly during manufacturing, allowing the assembly to be prepared in advance. This preliminary action enables faster final assembly since the reinforcement is already in place and only requires minimal stitching to secure the tab to the commissure post

Inventive Principle:

Principle #10Preliminary action

2Reliability

If numerous stitches are used to attach commissure tab assembly to commissure post, then the attachment can be secured, but wear occurs along the stitches leading to potential failure

Engineering Contradiction:

Improveattachment stabilityVSAvoidstitch wear

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A reinforcement element acts as an intermediary component between the commissure tab and the commissure post. This intermediary distributes the mechanical stresses and forces across a larger area, reducing the concentration of stress on individual stitches and thereby minimizing wear on the suture material

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The commissure tab assembly uses composite construction combining the tab material with a reinforcement element made of different material properties. This composite structure provides both flexibility for stitching and strength for load-bearing, creating a more durable attachment that resists wear better than single-material constructions

Inventive Principle:

Principle #40Composite materials

3Ease of manufacture

If commissure tab assembly is attached to commissure post, then the leaflet assembly is mounted to the frame, but displacement occurs during handling and expansion causing instability

Engineering Contradiction:

Improvemounting capabilityVSAvoidassembly stability

Core Design Contradiction:

Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The reinforcement element provides localized structural enhancement at the commissure tab assembly. This local quality improvement creates a stiffer, more stable region that resists displacement during handling and expansion, while the rest of the leaflet assembly maintains its required flexibility

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The reinforcement element is configured with a curved or tapered geometry that complements the natural curvature of the commissure post and tab assembly. This curved design allows the reinforcement to conform to the anatomical shapes, providing stable attachment while accommodating the dynamic movements during valve expansion and contraction

Inventive Principle:

Principle #14Spheroidality (Curvature)

Data Source

PatentUS20250281282A1Prosthetic heart valve leaflet assemblies and methods

Publication Date: 2025.09.11 EDWARDS LIFESCIENCES CORP

AI summary

Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.