Polyisobutylene-Fiber Valve Leaflets for Durable Anticoagulant-Free Use

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Solution Overview

Problem

Animal-derived heart valve leaflets suffer from poor durability and require re-operation, while mechanical valves necessitate lifelong anticoagulant therapy.

Innovation Solution

A biocompatible composite material comprising a network of electrospun fibers embedded in a non-porous polyisobutylene matrix, which can be oriented and cross-linked to form a prosthetic heart valve leaflet with improved durability and biocompatibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If animal-derived tissue valves are used, then avoidance of lifelong anticoagulant therapy is achieved, but durability is poor requiring re-operation in 10 to 20 years

Engineering Contradiction:
ImprovedurabilityVSAvoidservice life of valve
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent employs a composite material system consisting of polyisobutylene polymer matrix combined with fibrous reinforcement (electrospun fibers). This composite structure provides both the biocompatibility needed to avoid anticoagulant therapy and the mechanical strength required for long-term durability, resolving the contradiction between reliability and service life.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes cross-linking of the polyisobutylene polymer to fundamentally change the material properties, transforming it from a simple polymer to a thermoset network with enhanced mechanical strength, elasticity, and durability. This parameter change enables the material to withstand long-term physiological stresses without degradation.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If mechanical valves are used, then durability is improved, but lifelong anticoagulant therapy is required

Engineering Contradiction:
ImprovedurabilityVSAvoidneed for anticoagulant therapy
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the surface properties and bulk characteristics of the polyisobutylene polymer through cross-linking and fiber reinforcement, creating a material that is both mechanically durable like mechanical valves and biocompatible like tissue valves, thereby eliminating the need for anticoagulant therapy while maintaining durability.

Inventive Principle:
Principle #35Parameter changes

3Strength

If electrospun fibers are embedded in polyisobutylene matrix, then mechanical properties are enhanced, but manufacturing complexity increases

Engineering Contradiction:
Improvemechanical strengthVSAvoidmanufacturing process complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent creates the fibrous reinforcement structure first through electrospinning, then subsequently impregnates the fibers with polyisobutylene and applies cross-linking. This preliminary action of forming the fiber network before polymer integration simplifies the overall manufacturing process while achieving the desired composite structure with enhanced mechanical properties.

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 composite material offers high durability, reduced calcification, and tunable mechanical properties, eliminating the need for re-operation and anticoagulant therapy, and is suitable for various medical device applications.

Implementation Method 1

adsorbing to the surface of the network of electrospun fibers a cross-linkable polyisobutylene composition

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

initiating cross-linking of the polyisobutylene polymer to create a continuous, interpenetrating thermoset polyisobutylene matrix

Methodology Applied
Scientific EffectPhotopolymerization: Photopolymerisation

Data Source

PatentEP3615097B1Biocompatible polyisobutylene-fiber composite materials and methods
Publication Date: 2026.03.11 BOSTON SCIENTIFIC SCIMED INC
  • EP3615097B1 patent drawingFigure 1
  • EP3615097B1 patent drawingFigure 2~4
  • EP3615097B1 patent drawingFigure 5~6

AI summary

Aspects herein relate to biocompatible polyisobutylene-fiber composite materials and related methods. In one aspect a biocompatible composite material is included. The biocompatible composite material can include a network of fibers comprising one or more polymers to form a substrate and a continuous, interpenetrating polyisobutylene matrix that is non-porous and completely surrounds the electrospun fibers. Other aspects are included herein.