Kidney Capsule Leaflet Material for Prosthetic Heart Valves

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Solution Overview

Problem

Current prosthetic heart valves made from bovine or porcine pericardial tissue have limitations in terms of thickness and mechanical properties, such as ultimate tensile strength and elasticity, which can affect their performance and profile in implantation.

Innovation Solution

The use of cross-linked kidney capsule tissue as leaflets for prosthetic heart valves, which is bi-axially oriented and treated with glutaraldehyde to enhance mechanical properties like tensile strength and elasticity, allowing for a thinner profile while maintaining sufficient structural integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If bovine or porcine pericardial tissue is used for prosthetic heart valve leaflets, then the structural integrity and strength are maintained, but the wall thickness is excessive and the profile is bulky

Engineering Contradiction:
Improvewall thicknessVSAvoidstructural integrity
Core Design Contradiction:
Length of moving objectVSStrength

Solution Approach 1:

The patent applies parameter changes by treating kidney capsule tissue with glutaraldehyde to achieve cross-linking, which fundamentally alters the material's physical and mechanical properties. This chemical treatment enables the tissue to achieve superior strength characteristics while maintaining a thinner profile compared to traditional pericardial tissue

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite material system by combining kidney capsule tissue with glutaraldehyde cross-linking agents. This composite approach produces a material that exhibits enhanced mechanical properties including improved strength-to-thickness ratio, allowing for thinner valve leaflets with adequate structural integrity

Inventive Principle:
Principle #40Composite materials

2Strength

If traditional pericardial tissue is used, then adequate strength is achieved, but the elasticity and mechanical performance are insufficient

Engineering Contradiction:
Improveultimate tensile strengthVSAvoidelasticity
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The patent utilizes parameter changes through controlled chemical cross-linking with glutaraldehyde, which modifies the tissue's molecular structure to simultaneously enhance both strength and elasticity. The cross-linking process creates a network structure that provides both tensile strength and elastic recovery, improving overall mechanical performance

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the natural mechanical properties of pericardial tissue with chemically enhanced properties through glutaraldehyde treatment. This substitution transforms the material from relying on native tissue mechanics to utilizing chemically-induced cross-linking for achieving superior elastic and strength characteristics

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

3Length of moving object

If kidney capsule tissue is used with thinner profile, then the wall thickness is reduced, but the mechanical properties may be compromised

Engineering Contradiction:
Improvewall thicknessVSAvoidmechanical properties
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The patent applies parameter changes by controlling the cross-linking process variables including glutaraldehyde concentration, treatment time, and tissue preparation conditions. These parameter optimizations ensure that thin kidney capsule tissue achieves the necessary mechanical reliability through controlled cross-linking density and distribution

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs preliminary action by pre-treating the kidney capsule tissue with glutaraldehyde before valve fabrication. This preliminary cross-linking ensures that the tissue achieves optimal mechanical properties before being formed into the final valve structure, guaranteeing reliability even in thin-walled configurations

Inventive Principle:
Principle #10Preliminary action

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

The cross-linked kidney capsule tissue provides a thinner wall thickness with improved mechanical properties, including increased elasticity and reduced profile, making it a more effective and suitable material for prosthetic heart valves compared to traditional materials.

Implementation Method 1

the tissue is cross-linked by submerging the kidney capsule tissue in a solution of between 0.1 and 1.5 wt% glutaraldehyde for at least 10 minutes

Methodology Applied
Scientific EffectCross-linking: Chemical Bonding

Implementation Method 2

the kidney capsule tissue is bi-axially oriented

Methodology Applied
Scientific EffectBi-axial orientation:

Data Source

PatentEP3373860B1Kidney capsule leaflet material
Publication Date: 2024.10.02 BOSTON SCIENTIFIC SCIMED INC
  • EP3373860B1 patent drawingFigure 1A~1B
  • EP3373860B1 patent drawingFigure 2
  • EP3373860B1 patent drawingFigure 3

AI summary

A prosthetic heart valve provided herein can include a kidney capsule tissue leaflet. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member. The kidney capsule tissue can be obtained from a farm animal, such as a cow, pig, horse, goat, or sheep. In some cases, the kidney capsule tissue can be tensioned (e.g., bi-axially tensioned) and/or chemically cross-linked.