Heart Valve Leaflet Assembly With Minimal Suturing

Solution Overview

Problem

The time-consuming and labor-intensive process of attaching leaflets to a stent in transcatheter valve replacement devices is a significant challenge, often requiring hundreds of sutures, which increases manufacturing costs and time.

Innovation Solution

A heart valve replacement device with a stent and a valve formed from a single sheet of tissue, attached with fewer than forty sutures, utilizing a mold to shape the tissue and potentially cross-linking processes to secure the valve to the stent.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional transcatheter valve replacement devices use hundreds of sutures to attach leaflets to the stent, then the attachment security is improved, but the manufacturing time and labor cost increase significantly

Engineering Contradiction:

Improveattachment securityVSAvoidmanufacturing time

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent merges the leaflets into a single integrated sheet structure that is molded directly onto the stent framework. This consolidation eliminates the need for hundreds of individual suture attachments, reducing manufacturing steps while maintaining secure attachment through the unified molded structure.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces the mechanical suture-based attachment system with a molded integration system where the leaflet sheet is thermally or chemically bonded to the stent framework. This substitution eliminates manual sewing operations while providing secure attachment through material bonding.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If traditional transcatheter valve replacement devices use hundreds of sutures to attach leaflets to the stent, then the attachment security is improved, but the labor cost increases significantly

Engineering Contradiction:

Improveattachment securityVSAvoidlabor cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent merges the leaflets into a single integrated sheet structure that is molded directly onto the stent framework. This consolidation eliminates the need for hundreds of individual suture attachments, reducing manufacturing steps while maintaining secure attachment through the unified molded structure.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces the mechanical suture-based attachment system with a molded integration system where the leaflet sheet is thermally or chemically bonded to the stent framework. This substitution eliminates manual sewing operations while providing secure attachment through material bonding.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Device complexity

If a single sheet of tissue is used to form the valve, then the manufacturing complexity is reduced, but the attachment security may be compromised

Engineering Contradiction:

Improvemanufacturing complexityVSAvoidattachment security

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent merges the leaflets into a single integrated sheet structure that is molded directly onto the stent framework. This consolidation eliminates the need for hundreds of individual suture attachments, reducing manufacturing steps while maintaining secure attachment through the unified molded structure.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces the mechanical suture-based attachment system with a molded integration system where the leaflet sheet is thermally or chemically bonded to the stent framework. This substitution eliminates manual sewing operations while providing secure attachment through material bonding.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Reduces the number of sutures required for attachment, thereby decreasing manufacturing time and cost while maintaining the integrity and functionality of the valve.

Implementation Method 1

forming a valve from a single sheet of tissue material... utilizing a mold to shape the tissue

Methodology Applied

Scientific EffectDeformation: Deformation

Implementation Method 2

potentially cross-linking processes to secure the valve to the stent

Methodology Applied

Scientific EffectCross-linking: Chemical Bonding

Data Source

PatentUS12521238B2Replacement heart valve with reduced suturing

Publication Date: 2026.01.13 ANTERIS TECHNOLOGIES CORP

AI summary

A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.