Calcium Sulfate Bone Substitute with Delayed Gentamicin Release

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Solution Overview

Problem

Current bone substitute materials face challenges in effectively addressing microbial infections and ensuring the delayed release of antibiotics, which are crucial for preventing infection in bone cavities, especially in cases where infections are present or at risk during surgical interventions.

Innovation Solution

A composition comprising calcium sulfate, alkaline earth carbonate, a binder, and gentamicin sulfate, where gentamicin is released in a delayed manner, is developed. This composition can be mixed with viable cells such as blood, bone marrow concentrate, or cancellous bone, and is designed to be introduced into bone defects to promote healing while providing antimicrobial protection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antibiotics are added to bone substitute materials to prevent infection, then antimicrobial protection is improved, but the risk of cytotoxic effects increases

Engineering Contradiction:
Improveantimicrobial protectionVSAvoidcytotoxic effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates antibiotics into the bone substitute material during manufacturing, so that antimicrobial protection is established before implantation. This preliminary action ensures that any potential pathogens are addressed immediately upon implantation while allowing control over the release profile to minimize cytotoxicity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent modifies the release kinetics of the antibiotic by changing physical or chemical parameters of the bone substitute material matrix. This controls the concentration and timing of antibiotic release, maintaining effective antimicrobial levels while reducing peak concentrations that could cause cytotoxicity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If antibiotics are released immediately to prevent infection, then antimicrobial efficacy is improved, but the duration of protection is reduced

Engineering Contradiction:
Improveantimicrobial efficacyVSAvoidduration of protection
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent designs the bone substitute material to release antibiotics in a periodic or sustained manner over time, rather than all at once. This creates a temporal pattern of antibiotic release that maintains protective levels throughout the critical healing period while avoiding initial cytotoxic bursts.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent ensures continuous antimicrobial protection by maintaining a steady release of antibiotics from the bone substitute material throughout the implantation site. This continuous action provides ongoing protection against infection without interruption, extending the duration of effective antimicrobial coverage.

Inventive Principle:
Principle #20Continuity of useful action

3Reliability

If high concentrations of antibiotics are used to ensure protection, then antimicrobial reliability is improved, but the risk of harmful side effects increases

Engineering Contradiction:
Improveantimicrobial reliabilityVSAvoidharmful side effects
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent concentrates the antibiotic release locally at the implantation site within the bone substitute material, rather than systemically. This local quality ensures high antimicrobial reliability precisely where needed while minimizing exposure of surrounding healthy tissues to harmful concentrations.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The bone substitute material matrix acts as an intermediary carrier that holds and gradually releases the antibiotic. This intermediary function allows the material to buffer the antibiotic concentration, providing reliable antimicrobial action while filtering out harmful peak concentrations that would cause side effects.

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 composition effectively reduces microbial growth, prevents infection, and supports bone healing by providing a sustained release of gentamicin, reducing the risk of microbial colonization and cytotoxic effects, thereby enhancing therapeutic success in filling bone defects caused by trauma, tumors, or infections.

Implementation Method 1

gentamicin is released in a delayed manner

Methodology Applied
Scientific EffectDelayed release:

Implementation Method 2

The composition effectively reduces microbial growth, prevents infection

Methodology Applied
Scientific EffectAntimicrobial action:

Data Source

PatentUS20240180959A1Use of a composite material
Publication Date: 2024.06.06 HERAEUS MEDICAL GMBH

AI summary

One aspect relates to a composition for use in a therapeutic procedure, which comprises calcium sulfate, an alkaline earth carbonate, a binder, and up to 2.5 percent by weight gentamicin sulfate, based on the total mass of the composition, and to a production method for such a composition. The composition can be used as a bone substitute material.