Injectable Fibrin Bone Void Filler with Micro-Porous Particles

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Solution Overview

Problem

Current bone void fillers face issues such as donor tissue limitations, risk of disease transmission, immunogenicity, cytotoxicity, exothermicity, and leakage, which limit their effectiveness and safety for treating osseous defects.

Innovation Solution

A micro-porous, fully resorbable fibrin-based composition is developed, comprising fibrinogen, thrombin, a plasticizer, and particles with diameters of 200 μm or less, which can be fine-tuned for mechanical properties and rheology to facilitate injection and biodegradability, incorporating osteoinductive agents and mineral additives.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If bone graft substitutes or bone cement are used to fill bone voids, then mechanical strength and structural support are improved, but cytotoxicity and immunogenicity risks increase

Engineering Contradiction:

Improvemechanical strengthVSAvoidcytotoxicity and immunogenicity

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material composition parameters by using fibrinogen (natural protein) instead of synthetic polymers or calcium phosphates, fundamentally altering the biocompatibility parameter while maintaining mechanical strength through the natural properties of fibrin and controlled particle integration

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite material system combining fibrinogen (biopolymer matrix) with particles (calcium phosphate, hydroxyapatite, or other bone substitutes), integrating the mechanical strength of particles with the biocompatibility and degradability of natural fibrin, achieving both structural support and biological safety

Inventive Principle:

Principle #40Composite materials

2Stability of the object's composition

If PMMA bone cement is used for filling bone voids, then structural stability is improved, but exothermicity and leakage risks increase

Engineering Contradiction:

Improvestructural stabilityVSAvoidexothermicity and leakage

Core Design Contradiction:

Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The patent employs a biodegradable fibrin-based material that is intentionally designed to be temporary and self-resorbing, replacing permanent synthetic cements with a natural material that performs its function and then safely degrades, eliminating long-term structural stability concerns while avoiding exothermic polymerization and leakage issues

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The invention changes the material state from solid polymer cement to liquid injectable fibrinogen suspension, fundamentally altering the delivery mechanism and eliminating the exothermic polymerization reaction and leakage problems associated with PMMA, while maintaining structural stability through controlled fibrin gelation and particle support

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If injectable calcium salt void fillers are used, then ease of injection is improved, but setting time and leakage risks worsen

Engineering Contradiction:

Improveease of injectionVSAvoidsetting time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The patent incorporates particles and adjuvants into the fibrinogen suspension before injection, pre-establishing the structural framework and setting triggers within the material itself, so that upon injection and activation, the material rapidly forms its structural integrity without requiring prolonged setting time or external chemical triggers

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The invention uses fibrinogen as an intermediary carrier material that can be injected in a liquid state and then rapidly transforms into a gel-like structure through thrombin activation or other triggers, providing a controllable setting mechanism that balances ease of injection with rapid structural formation, while particles serve as structural intermediaries that prevent leakage

Inventive Principle:

Principle #24Intermediary (Mediator)

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 fibrin-based composition provides mechanical stability and biocompatibility, reduces leakage risk, and is fully resorbed during healing, offering a safer and more effective alternative for filling bone voids without exothermicity or toxicity concerns.

Implementation Method 1

component (a) comprising fibrin; component (b) comprising thrombin

Methodology Applied

Scientific EffectCoagulation: Coagulation

Implementation Method 2

component (c) comprising at least one plasticizer... the rheology must be such that it permits injection

Methodology Applied

Scientific EffectRheology modification:

Implementation Method 3

component (d) comprising particles having a diameter of about 200 μm or less... mechanical stability

Methodology Applied

Scientific EffectParticle reinforcement:

Data Source

PatentUS9248215B2Injectable bone void filler

Publication Date: 2016.02.02 BAXTER INT INC

AI summary

The present invention relates to a biodegradable fibrin based composition for injection into osseous defects or voids, which can be the result of osteoporosis, surgery, bone cysts, tumor removal or traumatic bone injury.