Prosthetic Valve Leaflets with Mechanical Projections

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Solution Overview

Problem

Conventional methods for securing leaflets to prosthetic valve frames, such as sewing or adhesive/thermal bonding, are labor-intensive and prone to integrity issues in aqueous environments, leading to potential leaflet failure due to peak stress at the commissure area under fluid backpressure.

Innovation Solution

A prosthetic valve design featuring leaflets coupled to a frame via leaflet frame projections, where the leaflets wrap around and engage with projections, distributing stress and minimizing the risk of detachment, using a flexible polymer jacket for additional support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sewing or adhesive/thermal bonding is used to attach leaflets to the leaflet frame, then the leaflets can be secured to the support structure, but the integrity of the bond deteriorates in aqueous environments over time and the process is labor-intensive

Engineering Contradiction:
Improvebond integrityVSAvoidservice life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent replaces chemical bonding methods (sewing and adhesive/thermal bonding) with a purely mechanical attachment system. The leaflet frame projections mechanically engage with slots in the leaflet attachment region, creating a physical interlocking mechanism that does not rely on chemical bonds vulnerable to degradation in aqueous environments. This mechanical substitution eliminates the reliability issues associated with sewing and adhesive bonding over the long term.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces an intermediary mechanical connection system consisting of projections and slots. Instead of directly bonding the leaflet to the frame using vulnerable chemical methods, the projections extend through the slots to create a mediated mechanical connection. This intermediary structure distributes stresses and provides a reliable attachment that maintains integrity in aqueous environments throughout the prosthetic valve's service life.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If leaflet thickness is increased to increase tear resistance, then the ultimate tensile strength increases, but the bending stiffness increases and overall prosthetic valve performance decreases

Engineering Contradiction:
Improvetear resistanceVSAvoidvalve performance
Core Design Contradiction:
StrengthVSUse of energy by moving object

Solution Approach 1:

The patent applies local quality by concentrating structural reinforcement at specific locations rather than uniformly increasing leaflet thickness. The leaflet frame projections are strategically positioned at the attachment regions and commissure areas where stress concentration occurs. This localized mechanical support provides enhanced tear resistance at critical points without increasing the overall leaflet thickness, thereby maintaining the leaflet's flexibility and bending characteristics for optimal valve performance.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent implements preliminary action by providing pre-configured mechanical support structures (projections and slots) that are built into the leaflet frame before the leaflet is subjected to operational stresses. These projections are designed with specific geometries and positioning to preemptively counteract stress concentrations and potential tear points. This preliminary structural reinforcement enables the use of thinner, more flexible leaflet material while maintaining adequate tear resistance through the engineered mechanical support system.

Inventive Principle:
Principle #10Preliminary action

3Strength

If commissure post height is increased to distribute load over greater length, then tear resistance improves, but prosthetic valve profile increases and interaction with native anatomy worsens

Engineering Contradiction:
Improveload distributionVSAvoidvalve profile
Core Design Contradiction:
StrengthVSLength of moving object

Solution Approach 1:

The patent applies segmentation by dividing the load-bearing function into multiple discrete projection elements rather than relying on a single tall commissure post. The leaflet frame includes multiple projections distributed along the attachment region, with each projection engaging through its own slot. This segmentation distributes the mechanical load across multiple contact points and structural elements, achieving effective load distribution without requiring increased overall commissure post height, thereby maintaining a compact valve profile suitable for transcatheter applications.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a vertical load distribution approach (taller commissure posts) to a distributed multi-point approach. Instead of extending the commissure post height in the vertical dimension, the patent distributes load-bearing projections along the attachment region in a different spatial arrangement. The projections extend through slots at various positions, creating a distributed load path that achieves load distribution effectiveness without increasing the vertical profile of the prosthetic valve, thus avoiding adverse interactions with native anatomy.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Data Source

PatentUS20240252314A1Prosthetic valves with mechanically coupled leaflets
Publication Date: 2024.08.01 EDWARDS LIFESCIENCES CORP
  • US20240252314A1 patent drawing
  • US20240252314A1 patent drawing
  • US20240252314A1 patent drawing

AI summary

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with a leaflet attachment region of a leaflet. Some embodiments include a leaflet retention feature that engages the leaflet frame projections and operates to secure the leaflet to the leaflet frame. Methods of making and using such prosthetic valve devices are also described.