Calcium Sulfate Bone Substitute with Gentamicin for Infection Control

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Solution Overview

Problem

Current bone replacement materials face challenges with microbial infections during surgical procedures, as they can be contaminated, and existing solutions lack effective antimicrobial properties to prevent post-operative infections.

Innovation Solution

A composition comprising calcium sulfate, alkaline earth carbonate, a binder, and gentamicin sulfate, which is mixed with viable cells and formed into granules for delayed antibiotic release, providing antimicrobial protection and promoting bone healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If artificial bone substitute materials are used, then bone cavities can be filled effectively, but microbial infections may occur during surgical procedures

Engineering Contradiction:
Improvebone substitute material volumeVSAvoidmicrobial infection risk
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent combines calcium sulfate as the bone substitute material with gentamicin sulfate as an antimicrobial agent to create a composite material. This composite structure allows the material to fulfill both bone filling function and infection prevention function simultaneously, resolving the contradiction between providing sufficient bone substitute volume and preventing microbial infections.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent extracts the antimicrobial function from separate preventive measures and incorporates it directly into the bone substitute material composition. By taking out the infection prevention capability and integrating it into the material itself, the patent eliminates the need for separate antimicrobial treatments while maintaining bone filling efficacy.

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If antibiotics are added to bone substitute materials, then antimicrobial protection is provided, but the material composition becomes more complex

Engineering Contradiction:
Improvemicrobial growth reductionVSAvoidmaterial composition complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges the bone substitute material (calcium sulfate) and antimicrobial agent (gentamicin sulfate) into a single integrated composition. This combining approach provides antimicrobial protection while maintaining relatively simple material composition, as the antibiotic is incorporated directly into the calcium sulfate matrix rather than requiring complex multi-component formulations.

Inventive Principle:
Principle #5Merging (Combining)

3Object-affected harmful factors

If gentamicin sulfate is included in the composition, then antimicrobial effect is achieved, but the composition requires precise control of antibiotic content

Engineering Contradiction:
Improveinfection preventionVSAvoidantibiotic content control
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent specifies precise parameter ranges for gentamicin sulfate content (0.1-5% by weight) to optimize the balance between antimicrobial efficacy and manufacturing feasibility. By defining specific parameter ranges rather than requiring exact precise values, the patent achieves effective infection prevention while allowing for practical manufacturing tolerances.

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 effectively reduces microbial growth, prevents infections, and supports bone regeneration by sustained release of gentamicin, ensuring improved therapeutic outcomes and safety in bone defect treatments.

Implementation Method 1

The bone substitute materials may contain an antibiotic, which is preferably released from the bone substitute materials with a delayed release

Methodology Applied
Scientific EffectDelayed release:

Data Source

PatentEP4382109A1Use of a composite material
Publication Date: 2024.06.12 HERAEUS MEDICAL GMBH
  • EP4382109A1 patent drawing
  • EP4382109A1 patent drawing
  • EP4382109A1 patent drawing

AI summary

The invention relates to a composition for use in a method for treating a bone defect, comprising calcium sulfate, an alkaline earth carbonate, a binder, and up to 2.5% by weight of gentamicin sulfate, based on the total mass of the composition, and to a manufacturing process for such a composition. The composition can be used as a bone substitute material.