Bone Cement Composition Using Water-Soluble Polyether

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Solution Overview

Problem

Existing bone replacement materials that react with water or aqueous solutions to form solid bodies often experience volume expansion, leading to tissue damage and reduced strength, and may contain surfactants that are harmful to the body or have poor storage stability.

Innovation Solution

A composition comprising a water-soluble polyether, a particulate calcium-containing salt, a catalyst, and an optional pharmaceutical active ingredient, which reacts to form a solid body without significant volume increase, is stable in storage, and sets upon contact with water or body fluids without mechanical mixing, using polyethylene glycol as the polyether and calcium sulfate hemihydrate as the calcium-containing salt.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If non-water-soluble carrier liquids are used in bone replacement materials, then the composition can be formed into a paste, but the water absorbed during curing causes volume expansion that damages surrounding bone tissue

Engineering Contradiction:
Improvepaste formationVSAvoidvolume stability
Core Design Contradiction:
Ease of manufactureVSVolume of moving object

Solution Approach 1:

The patent changes the key parameter from using non-water-soluble carrier liquids to using water-soluble carrier liquids. This fundamental parameter change eliminates the volume expansion problem because water-soluble liquids are completely replaced by water during curing, preventing the harmful volume increase that damages bone tissue while still allowing paste formation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the previously harmful effect of water absorption (which caused volume expansion with non-water-soluble liquids) into a beneficial effect. By using water-soluble carrier liquids, the same water absorption process now leads to complete replacement without volume expansion, turning a source of harm into a controlled curing mechanism.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

2Volume of moving object

If surfactants are added to non-water-soluble carrier liquids to reduce volume increase, then volume stability improves, but the surfactants have potentially membrane-damaging effects on the body

Engineering Contradiction:
Improvevolume stabilityVSAvoidbiocompatibility
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the harmful surfactant component from the formulation entirely. By switching to water-soluble carrier liquids, the invention eliminates the need for surfactants completely, thereby removing the membrane-damaging effects while maintaining volume stability through the complete replacement mechanism.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses simple, biocompatible water-soluble carrier liquids that are completely replaced during curing, rather than relying on harmful surfactants. This approach uses safe, temporary components that serve their purpose during mixing and then are fully displaced by water, leaving no harmful residues.

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

3Speed

If the composition sets rapidly to form a solid body, then the bone replacement material provides immediate structural support, but the setting reaction may cause excessive heat generation

Engineering Contradiction:
Improvesetting speedVSAvoidheat generation
Core Design Contradiction:
SpeedVSTemperature

Solution Approach 1:

The patent modifies the chemical composition parameters by using specific water-soluble carrier liquids and calcium-containing salts that undergo curing with controlled heat generation. This parameter change allows the composition to set rapidly enough to provide structural support while limiting excessive heat buildup that could damage surrounding tissue.

Inventive Principle:
Principle #35Parameter changes

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 composition forms a dimensionally stable solid body that can be shaped and introduced into bone cavities without expanding, maintaining viscosity until set, and releases pharmaceutical active ingredients locally, while being biocompatible and free of surfactants, ensuring stability and effectiveness as a bone replacement material.

Implementation Method 1

The setting reaction usually consists in dissolving water-soluble powder components

Methodology Applied
Scientific EffectDissolution: Solvation

Implementation Method 2

composition reacts with water or an aqueous solution in a cementitious setting reaction and forms a solid body

Methodology Applied
Scientific EffectCementitious setting reaction: Chemical Bonding

Implementation Method 3

subsequently precipitating a more stable or heavy soluble phase or salt form

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Implementation Method 4

in recrystallizing metastable powder components into a modification that is thermodynamically stable under the conditions of use

Methodology Applied
Scientific EffectRecrystallization: Crystallisation

Data Source

PatentUS20240091416A1Composition for producing a bone replacement material, method for producing a pharmaceutical excipient, pharmaceutical excipient, and use thereof
Publication Date: 2024.03.21 HERAEUS MEDICAL GMBH

AI summary

A composition for producing a bone replacement material, which composition reacts with water or an aqueous solution in a cementitious setting reaction and forms a solid body. Additionally disclosed is a method for producing a pharmaceutical excipient having the aforementioned composition, the pharmaceutical excipient produced in this way, and the use of such a composition or such a pharmaceutical excipient for the local release of at least one pharmaceutical active ingredient.