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
Engineering 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
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.
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.
2Reliability
If mechanical valves are used, then durability is improved, but lifelong anticoagulant therapy is required
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.
3Strength
If electrospun fibers are embedded in polyisobutylene matrix, then mechanical properties are enhanced, but manufacturing complexity increases
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.
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
Implementation Method 2
initiating cross-linking of the polyisobutylene polymer to create a continuous, interpenetrating thermoset polyisobutylene matrix
Data Source
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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.