Bioabsorbable Elastomeric Networks for Implant Fixation

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Solution Overview

Problem

There is a need for new polymer blends that can form non-biodegradable or biodegradable interpenetrating networks suitable for elastomeric implantable devices, particularly for tissue, tooth, and bone replacement, as existing materials lack the necessary elasticity and toughness for dynamic stress environments without causing tissue irritation or mechanical breakdown.

Innovation Solution

The development of semi-interpenetrating networks using bioabsorbable α-amino acid-based linear polymers and di- or poly-functional cross-linkers with hydrolytically degradable functional groups that polymerize upon exposure to an active species, providing increased elasticity and toughness, allowing for in vivo or ex vivo cross-linking to create implantable fixation devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bioabsorbable linear polymers are used to form implantable devices, then biocompatibility and biodegradation are improved, but elasticity and toughness are insufficient for dynamic stress environments

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidelasticity and toughness
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent creates a semi-interpenetrating network composite by combining bioabsorbable linear polymers (PEA, PEUR, or PEU) with cross-linkers containing polymerizable groups. The cross-linkers form a three-dimensional network within the linear polymer matrix, creating a composite material that exhibits both biocompatibility from the linear polymer and enhanced elasticity/toughness from the cross-linked network structure.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical and chemical parameters of the linear polymer by introducing cross-linking. The cross-linking degree, cross-linker concentration, and polymerization conditions are adjusted to optimize the balance between elasticity and biodegradation rate, allowing the material to meet specific mechanical requirements while maintaining biocompatibility.

Inventive Principle:
Principle #35Parameter changes

2Strength

If cross-linkers are added to increase elasticity and toughness, then mechanical strength is improved, but complexity of polymer composition increases

Engineering Contradiction:
Improveelasticity and toughnessVSAvoidpolymer composition complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent uses adjustable parameters such as cross-linker concentration (0.1-10 wt%), polymerization time, and initiator type to control the degree of cross-linking. This allows optimization of mechanical properties while keeping the composition relatively simple and the processing conditions controllable.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces polymerization initiators as intermediaries that trigger the cross-linking reaction. These initiators (photoinitiators, redox initiators, or thermal initiators) enable controlled cross-linking without requiring complex processing equipment, simplifying the overall manufacturing process while achieving the desired mechanical enhancement.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Strength

If cross-linking is performed to create elastomeric network, then elasticity is improved, but manufacturing process complexity increases

Engineering Contradiction:
ImproveelasticityVSAvoidmanufacturing process simplicity
Core Design Contradiction:
StrengthVSEase of manufacture

Solution Approach 1:

The patent employs photoinitiators that enable cross-linking upon light exposure, allowing for simple and controlled manufacturing. The light-curing process can be performed in situ or during device fabrication without requiring complex equipment, making the manufacturing process straightforward while achieving the desired elastomeric properties.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces traditional thermal or chemical cross-linking methods with photo-initiated cross-linking. This substitution eliminates the need for complex heating equipment or prolonged chemical treatment, simplifying the manufacturing process while effectively creating the elastomeric network structure.

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

4Duration of action of stationary object

If bioabsorbable polymers are used for implantable devices, then biodegradation is improved, but mechanical breakdown resistance is insufficient under dynamic stress

Engineering Contradiction:
Improvebiodegradation controlVSAvoidmechanical breakdown resistance
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent creates a semi-interpenetrating network composite by combining bioabsorbable linear polymers (PEA, PEUR, or PEU) with cross-linkers containing polymerizable groups. The cross-linking provides increased elasticity to the composition by imparting a plasticizing effect. After cross-linkers are polymerized, the composition also possesses increased toughness, enabling the material to withstand dynamic stress without mechanical breakdown while maintaining controlled biodegradation.

Inventive Principle:
Principle #40Composite materials

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 resulting polymer compositions offer enhanced elasticity and toughness, enabling their use in implantable devices such as bioabsorbable stents and internal fixation devices that can withstand dynamic stress while minimizing tissue irritation and mechanical breakdown, with the option for controlled bio-degradation.

Implementation Method 1

cross-linkers that contain one or more hydrolyzable functional groups and that polymerize upon exposure to an active species

Methodology Applied
Scientific EffectPhotopolymerization: Photopolymerisation

Implementation Method 2

cross-linkers that contain one or more hydrolyzable functional groups

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS7649022B2Bioabsorbable elastomeric polymer networks, cross-linkers and methods of use
Publication Date: 2010.01.19 MEDIVAS LLC
  • US7649022B2 patent drawing
  • US7649022B2 patent drawing
  • US7649022B2 patent drawing

AI summary

The invention provides elastomeric polymer networks and semi-interpenetrating networks in which a linear PEA, PEUR or PEU polymer is crosslinked by ester or alpha-amino-acid containing cross-linkers that polymerize upon exposure to active species. Bioabsorbable elastomeric internal fixation devices fabricated using such polymer networks and semi-interpenetrating networks are useful for in vivo implant and delivery of a variety of different types of molecules in a time release fashion. Alpha-amino-acid containing ester amide cross-linkers are also provided by the invention.