Prosthetic Heart Valve Leaflet Cuff Attachment

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Solution Overview

Problem

Current collapsible prosthetic heart valves face challenges with anatomical variations leading to inadequate leaflet coaptation, increased stress, and potential valve failure, due to conventional attachment methods that do not allow for sufficient operability and flexibility during deployment.

Innovation Solution

The proposed solution involves a prosthetic heart valve design where leaflets are predominantly attached to a cuff rather than the stent, using a unique suturing pattern and an underwire for reinforcement, allowing for better adjustment to anatomical variations and reduced stress distribution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If leaflets are attached to the stent using conventional methods, then the valve structure is stable, but anatomical variations cause inadequate leaflet coaptation and increased stress leading to valve failure

Engineering Contradiction:
Improvevalve durabilityVSAvoidadjustment to anatomical variations
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The cuff acts as an intermediary element between the stent and the leaflets. Instead of directly attaching leaflets to the stent, the cuff provides a flexible intermediate layer that can adapt to anatomical variations while maintaining the structural support from the stent. This mediator allows for better coaptation and stress distribution.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The cuff is designed to be flexible and dynamic rather than rigid, allowing it to conform to different anatomical configurations. This flexibility enables the valve to adapt to anatomical variations between patients while maintaining stable attachment points through the underwire reinforcement.

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If conventional attachment methods are used, then the valve structure is simple, but insufficient operability during partial deployment occurs

Engineering Contradiction:
Improveoperability during deploymentVSAvoidattachment structure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The attachment structure is segmented into distinct functional components: the cuff for flexible attachment, the underwire for reinforcement, and the stent for structural support. This segmentation allows each component to perform its specific function optimally during deployment and operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The attachment structure uses composite construction combining different materials and properties: flexible cuff material, reinforcing underwire (potentially shape-memory alloy), and rigid stent structure. This composite approach provides both flexibility for operation and structural integrity.

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If the valve is designed for collapsibility to enable minimally invasive delivery, then delivery via catheter is possible, but adequate leaflet coaptation becomes difficult to achieve

Engineering Contradiction:
Improveminimally invasive deliveryVSAvoidleaflet coaptation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The valve assembly is nested within the delivery catheter during minimally invasive delivery, allowing the valve to be collapsed and delivered through small vessels. After deployment, the valve expands and the cuff opens to engage with the annulus, enabling adequate coaptation while maintaining the benefits of minimally invasive delivery.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The valve transitions between different parameter states: collapsed diameter for delivery through catheters, then expanded diameter for operation. The cuff also changes from a compressed state during delivery to an expanded state during operation, allowing it to engage properly with the patient's annulus and achieve adequate coaptation.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4154849A1Valve cuff support
Publication Date: 2023.03.29 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP4154849A1 patent drawingFigure 1A~1B
  • EP4154849A1 patent drawingFigure 2A~2B
  • EP4154849A1 patent drawingFigure 3~4

AI summary

A prosthetic heart valve (1000) includes a stent having a collapsed condition and an expanded condition. The stent has a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts. A valve assembly is secured to the stent and includes a cuff (1006) and a plurality of leaflets (1008). The cuff being coupled to an underwire (1030) and the plurality of leaflets. Each of the plurality of leaflets is folded over itself at a proximal end (1052) to form a belly flap (1056) oriented toward the cuff and an inner layer. The underwire is coupled to the cuff and each of the plurality of leaflets by at least one stitch.