Fibrin-Calcium Phosphate Composite for Bone Regeneration

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Solution Overview

Problem

Current bone regeneration methods, such as autologous and allogenic bone grafting, face limitations including limited bone supply, donor site morbidity, disease transmission, and fracture non-union, prompting the need for effective bone graft substitutes.

Innovation Solution

An extracellular matrix material comprising fibrin or fibrinogen combined with a ceramic, such as calcium phosphate, and optionally a bulking agent, which is cross-linked to enhance mechanical and biodegradable properties, promoting bone regeneration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fibrin is used as a bone regeneration material, then biocompatibility and pro-angiogenesis are improved, but mechanical strength and biodegradable properties deteriorate

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidmechanical strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent combines fibrin with biodegradable polymers (such as poly(DL-lactide-co-glycolide) or poly(propylene fumarate)) to create a composite material that maintains the biocompatibility and pro-angiogenic properties of fibrin while gaining improved mechanical strength and controlled biodegradability from the polymer component

Inventive Principle:
Principle #40Composite materials

2Reliability

If fibrin is used as a bone regeneration material, then biocompatibility and pro-angiogenesis are improved, but mechanical strength and biodegradable properties deteriorate

Engineering Contradiction:
ImprovebiocompatibilityVSAvoiddegradation rate
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The composite structure allows the biodegradation rate to be tuned by the polymer component, which degrades more slowly than fibrin alone, providing sustained structural support while maintaining the bioactive benefits of fibrin

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the degradation characteristics by changing the molecular weight, composition ratio, and cross-linking degree of the polymer-fibrin composite, thereby controlling the duration of action to match bone regeneration timelines

Inventive Principle:
Principle #35Parameter changes

3Strength

If cross-linking is applied to fibrin, then mechanical strength is improved, but biodegradability deteriorates

Engineering Contradiction:
Improvemechanical strengthVSAvoidbiodegradation time
Core Design Contradiction:
StrengthVSDuration of action of stationary object

Solution Approach 1:

The patent optimizes cross-linking parameters including cross-linking agent concentration (such as glutaraldehyde or genipin), cross-linking time, and temperature to achieve the desired balance between mechanical reinforcement and controlled biodegradation, preventing excessive cross-linking that would cause permanent structural rigidity

Inventive Principle:
Principle #35Parameter changes

4Reliability

If bone grafting is performed using autologous bone, then bone regeneration efficacy is improved, but donor site morbidity and limited bone supply worsen

Engineering Contradiction:
Improvebone regeneration efficacyVSAvoidbone supply
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent creates a synthetic bone graft substitute that eliminates the need to harvest autologous bone, using readily available materials (fibrin from blood and biodegradable polymers) that can be prepared locally, thus avoiding donor site morbidity and unlimited by bone supply constraints while maintaining regeneration efficacy

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

5Quantity of substance

If bone grafting is performed using allogenic bone, then bone supply is improved, but disease transmission and fracture non-union worsen

Engineering Contradiction:
Improvebone supplyVSAvoidsafety
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent uses a synthetic, acellular composite material that eliminates the risks associated with allogenic bone grafts, including disease transmission and immunogenicity, while providing sufficient bone substitute material for any defect size through scalable manufacturing

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 extracellular matrix material demonstrates improved mechanical strength, reduced degradation rate, and maintained porosity, allowing for effective cell migration and bone formation, while maintaining the pro-angiogenic and bioactive properties of fibrin.

Implementation Method 1

The fibrin or fibrinogen, and optionally the bulking agent, may be cross-linked. Cross-linking may be achieved using methods described herein.

Methodology Applied
Scientific EffectCross-linking: Chemical Bonding

Implementation Method 2

a ceramic deposited on the scaffold

Methodology Applied
Scientific EffectDeposition: Deposition (physical)

Implementation Method 3

Biomaterials incorporating CaP may be osteoconductive, meaning that they promote direct bonding with bone tissue on the biomaterial surface

Methodology Applied
Scientific EffectOsteoconduction: Adsorption

Implementation Method 4

may be osteoinductive, which means that they induce the local stem cells to differentiate into bone cells

Methodology Applied
Scientific EffectOsteoinduction: Adsorption

Data Source

PatentUS12280174B2Extracellular matrix material
Publication Date: 2025.04.22 RAFT ENTERPRISES LTD
  • US12280174B2 patent drawing
  • US12280174B2 patent drawing
  • US12280174B2 patent drawing

AI summary

An extracellular matrix material is described. The material has a cross-linked scaffold comprising fibrin or fibrinogen, and a bulking agent. Deposited on the scaffold is a calcium phosphate mineral phase. Also described are methods for forming such materials.