Elastomeric Bone Filler for Early Osteoid Phase Healing

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Solution Overview

Problem

Current bone filler technologies using hard, brittle calcium and phosphate salts overlook the early osteoid phase of bone healing, failing to promote the expression of appropriate cell types during the initial stages of bone regeneration, and often include animal-based carriers, lack moldability, and antimicrobial properties.

Innovation Solution

A bone filling composite comprising microparticles of poly(glycerol sebacate)-based thermoset elastomeric material, doped with filler and carrier dopants, mixed with a poly(glycerol sebacate) resin, which is conformable, moldable, and provides antimicrobial properties, simulating the mechanical forces of early bone growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If hard, brittle calcium and phosphate salts are used to simulate mature cortical bone mechanical properties, then the mechanical strength is improved, but the ability to promote early osteoid phase cell expression deteriorates

Engineering Contradiction:
Improvemechanical strengthVSAvoidability to promote early osteoid phase cell expression
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent changes the mechanical parameter of the bone filler from hard and brittle (simulating mature cortical bone) to soft and elastomeric (simulating early osteoid tissue). This parameter change allows the material to provide appropriate mechano-biologic cues for early-stage bone healing while maintaining structural integrity through the elastomeric properties of poly(glycerol sebacate).

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite material system combining poly(glycerol sebacate) elastomeric matrix with bone-forming cells and growth factors. This composite approach allows the material to simultaneously provide mechanical support and biological activity, resolving the contradiction between mechanical strength and biological efficacy by integrating both functions into a single system.

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If conventional putty formulations use animal-based carrier materials, then the carrier matrix is provided, but the antimicrobial properties and resistance to irrigation deteriorate

Engineering Contradiction:
Improvecarrier matrix provisionVSAvoidantimicrobial properties
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material composition parameter from animal-based carriers to synthetic poly(glycerol sebacate) resin. This synthetic material inherently provides resistance to irrigation and can be formulated with antimicrobial properties, eliminating the harmful effects associated with animal-based materials while maintaining carrier matrix functionality.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If plastic materials are included in commercial filler, then the binding matrix is provided, but the stress transmission capability deteriorates

Engineering Contradiction:
Improvebinding matrixVSAvoidstress transmission
Core Design Contradiction:
Ease of manufactureVSForce

Solution Approach 1:

The patent uses the elastomeric properties of poly(glycerol sebacate) to create a flexible binding matrix that can transmit stress dynamically. The elastomeric nature allows the material to deform and transmit mechanical forces to surrounding tissues, unlike rigid plastic materials that shield or block stress transmission.

Inventive Principle:
Principle #30Flexible shells and thin films

4Reliability

If the filler requires mixing with blood to achieve appropriate consistency, then the osteoconductive properties are improved, but the ease of operation and single-step application deteriorate

Engineering Contradiction:
Improveosteoconductive propertiesVSAvoidease of application
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent incorporates osteoconductive calcium salts pre-mixed within the poly(glycerol sebacate) resin matrix before implantation. This preliminary incorporation eliminates the need for intraoperative mixing with blood, allowing direct application while maintaining osteoconductive properties. The material is ready-to-use in a single step, resolving the contradiction between biological efficacy and operational simplicity.

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 solution effectively initiates the osteoid phase of bone healing, promoting early collagen deposition and bone growth by mimicking the mechano-biologic cues of early bone regeneration, while being non-animal-based and resistant to irrigation.

Implementation Method 1

microparticles of poly(glycerol sebacate)-based thermoset elastomeric material... simulating the mechanical forces of early bone growth

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3746140B1Osteostimulating elastomeric bone filling compositions
Publication Date: 2023.07.12 SECANT GROUP LLC
  • EP3746140B1 patent drawingFigure 1~2
  • EP3746140B1 patent drawingFigure 3~4
  • EP3746140B1 patent drawingFigure 5~6

AI summary

A bone filling composition includes a bone filler. The bone filler includes microparticles of at least one elastomeric material. The at least one elastomeric material includes a poly(glycerol sebacate)-based thermoset. The poly(glycerol sebacate)-based thermoset may be porous thermoset poly(glycerol sebacate) flour, thermoset poly(glycerol sebacate) microspheres, or a combination thereof. In some embodiments, the bone filling composition is a bone filling composite that further includes a carrier material including a poly(glycerol sebacate) resin. A method of forming a bone filling composite includes selecting a bone filler and mixing the bone filler with a carrier material to form the bone filling composite. A method of treating a bony defect includes molding a bone filling composite and placing the bone filling composite in the bony defect. The bone filling composite includes a bone filler mixed with a carrier material.