Binder-Free Lyophilized Bone Graft Materials

Solution Overview

Problem

Current bone grafting procedures face challenges with demineralized bone matrix (DBM) fibers that lack cohesiveness, requiring binders to maintain structure, which increases manufacturing costs and complicates regulatory approvals.

Innovation Solution

A lyophilized coherent mass of milled and demineralized bone fibers, without any binder, is developed. These fibers are ribbon-shaped, corkscrew-shaped, or helical, with a length ranging from 0.5 cm to 10 cm, allowing for hydration with a liquid to form a moldable putty.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If binders are added to DBM fibers to maintain cohesiveness, then structural stability is improved, but manufacturing cost and regulatory complexity increase

Engineering Contradiction:

ImprovecohesivenessVSAvoidregulatory complexity

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The invention extracts and removes the binder component from the DBM fiber composition entirely. By using naturally cohesive DBM fibers obtained through specific processing methods (freeze-drying, controlled demineralization), the patent eliminates the need for added binders, thereby reducing manufacturing complexity and regulatory burden while maintaining structural stability.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The DBM fibers are processed to exhibit self-cohesiveness through their natural properties. The freeze-drying and demineralization processes create a fiber matrix that maintains its own structural integrity without requiring external binding agents, allowing the material to serve itself structurally.

Inventive Principle:

Principle #25Self-service

2Stability of the object's composition

If binders are added to DBM fibers to maintain cohesiveness, then structural stability is improved, but manufacturing cost increases

Engineering Contradiction:

ImprovecohesivenessVSAvoidmanufacturing cost

Core Design Contradiction:

Stability of the object's compositionVSEase of manufacture

Solution Approach 1:

The invention extracts and removes the binder component from the DBM fiber composition entirely. By using naturally cohesive DBM fibers obtained through specific processing methods (freeze-drying, controlled demineralization), the patent eliminates the need for added binders, thereby reducing manufacturing complexity and regulatory burden while maintaining structural stability.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the physical and chemical parameters of the DBM fibers through controlled demineralization and freeze-drying processes. These parameter changes enhance the natural cohesiveness of the fibers themselves, eliminating the need for additional binder materials and reducing manufacturing costs.

Inventive Principle:

Principle #35Parameter changes

3Device complexity

If DBM fibers are made without binders, then manufacturing cost and regulatory complexity decrease, but cohesiveness and structural stability worsen

Engineering Contradiction:

Improveregulatory complexityVSAvoidcohesiveness

Core Design Contradiction:

Device complexityVSStability of the object's composition

Solution Approach 1:

The patent changes the physical and chemical parameters of the DBM fibers through controlled demineralization and freeze-drying processes. These parameter changes enhance the natural cohesiveness of the fibers themselves, eliminating the need for additional binder materials and reducing manufacturing costs.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The freeze-drying process creates a porous structure within the DBM fibers that enhances their mechanical properties and cohesiveness. This porous architecture allows the fibers to interlock and maintain structural stability without requiring external binders.

Inventive Principle:

Principle #31Porous 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 binder-free DBM compositions facilitate osteogenesis, osteoinduction, and osteoconduction, enhancing bone regeneration while eliminating the need for costly binders and simplifying regulatory processes.

Implementation Method 1

contacting the bone material with the liquid, the bone material comprising the coherent mass of milled, lyophilized and demineralized bone fibers; molding the bone material into a shape

Methodology Applied

Scientific EffectHydration: Mineral Hydration

Implementation Method 2

a lyophilized coherent mass of milled and demineralized bone fibers

Methodology Applied

Scientific EffectLyophilization: Freeze Drying

Data Source

PatentEP3217925B1Bone graft materials, devices and methods of use

Publication Date: 2025.04.02 WARSAW ORTHOPEDIC INC

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AI summary

A device for mixing a bone material with a liquid is provided. The device comprises a chamber having a proximal end and a distal end, and the bone material disposed within the chamber, the bone material comprising a coherent mass of milled and lyophilized demineralized bone fibers; and a plunger having at least a portion slidably disposed within the proximal end of the chamber and configured to dispense the bone material mixed with liquid from the distal end of the chamber, when the plunger is in an extended position.