Bone Replacement Precursor Sterilization and Handling

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Solution Overview

Problem

Existing bone replacement materials prepared from solid, dry precursors are either non-sterile or undergo molecular degradation during sterilization, and injectable pastes are brittle and resorb slowly, lacking kneadability and cohesion.

Innovation Solution

A solid precursor for a pasty bone replacement material is developed by admixing a liquid, using ceramic or mineral particles with a hydrogel matrix, specifically designed to retain molecular integrity and stability, allowing for versatile mixing with various liquids and achieving optimal resorption and handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If dry autoclaving is used for sterilization, then sterilization is achieved, but molecular structure is degraded

Engineering Contradiction:
ImprovesterilizationVSAvoidmolecular structure
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent changes the sterilization parameters from conventional dry autoclaving (170°C for 120 minutes) to wet autoclaving at lower temperature (121°C for 15-20 minutes). This parameter change allows effective sterilization while preserving the molecular structure of the hydrogel precursor, avoiding degradation and maintaining material integrity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes the phase transition from dry to wet sterilization conditions. By introducing moisture and operating in a liquid-phase environment during autoclaving, the sterilization process becomes gentler on the molecular structure while still achieving complete sterilization through the combined effect of heat and moisture.

Inventive Principle:
Principle #36Phase transitions

2Ease of operation

If injectable paste is used, then injection is possible, but kneadability and cohesion are poor

Engineering Contradiction:
ImproveinjectionVSAvoidcohesion
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent creates a composite material system combining hydrophilic particles (5-50 μm) with hydrophobic particles (50-500 μm). This composite structure allows the paste to be injectable due to the fine hydrophilic particles providing fluidity, while the larger hydrophobic particles provide structural framework and cohesion, enabling subsequent kneadability without compromising structural integrity.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent assigns different functional properties to different particle size ranges and hydrophilicity levels. The fine hydrophilic particles (5-50 μm) are optimized for fluidity and injection, while the coarser hydrophobic particles (50-500 μm) are optimized for structural support and cohesion. This local differentiation of particle properties resolves the contradiction between injectability and kneadability.

Inventive Principle:
Principle #3Local quality

3Stability of the object's composition

If spherical particles are used, then resorption is well distributed, but kneadability is poor

Engineering Contradiction:
Improveresorption distributionVSAvoidkneadability
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent combines spherical hydrophilic particles (providing uniform resorption) with irregularly shaped hydrophobic particles (providing structural framework). The composite nature allows the spherical particles to be well-distributed for uniform resorption while the irregular hydrophobic particles interlock to provide kneadability and cohesion.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent differentiates particle shape by hydrophilicity: spherical hydrophilic particles for uniform resorption distribution, and irregular hydrophobic particles for structural integrity and kneadability. This local differentiation resolves the contradiction between uniform resorption and kneadability.

Inventive Principle:
Principle #3Local quality

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 provides a stable, kneadable, and rapidly resorbing bone replacement material with improved handling and optical appearance, ensuring molecular integrity and safety through sterilization methods like wet autoclaving and drying, and allowing for the incorporation of drugs for enhanced bone metabolism.

Implementation Method 1

A solid precursor for a pasty bone replacement material is developed by admixing a liquid, using ceramic or mineral particles with a hydrogel matrix

Methodology Applied
Scientific EffectHydration: Hydrates

Implementation Method 2

A solid precursor for the preparation of a pasty bone replacement material by admixture of a liquid

Methodology Applied
Scientific EffectGelation: Gel

Implementation Method 3

In a special embodiment the precursor has been obtained by wet autoclaving and subsequent drying of at least said swellable substance

Methodology Applied
Scientific EffectAutoclaving: Heating

Implementation Method 4

In a special embodiment the precursor has been obtained by wet autoclaving and subsequent drying of at least said swellable substance

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentEP2121052B1Precursor for the preparation of a pasty bone replacement material by admixture of a liquid
Publication Date: 2016.04.20 MATHYS AG BETTLACH
  • EP2121052B1 patent drawingFigure 1~2
  • EP2121052B1 patent drawingFigure 3~4
  • EP2121052B1 patent drawingFigure 5~6

AI summary

The precursor is used for the preparation of a pasty bone replacement material by admixture of a liquid. The precursor comprises a biocompatible substance swellable by the action of water or of an aqueous solution thereby forming a hydrogel; and solid particles made of a substance which is suitable as a bone replacement material. The swellable substance is in the form of discrete particles having a mean dimension in the range of 18 μm to 2000 μm.