Catheter Lock Disinfectant Composition
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Solution Overview
Problem
Current catheter lock solutions lack effective anti-microbial properties, particularly against Staphylococcus aureus, and are cytotoxic, failing to prevent biofilm formation and microbial contamination in catheters, which is a significant concern in medical settings due to the risk of infections.
Innovation Solution
A disinfectant composition combining citric acid or its physiologically acceptable salts with poly(hexamethylenebiguanide) (PHMB) or its salts, exhibiting a synergistic anti-microbial effect, achieving a log reduction of Staphylococcus aureus of at least 4.0 after 5 minutes and inhibiting fungal growth, while minimizing cytotoxicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional catheter lock solutions (heparin containing solutions) are used, then anticoagulant activity is provided, but anti-microbial activity is lacking
Solution Approach 1:
The patent combines heparin (providing anticoagulant activity) with citric acid and PHMB (providing anti-microbial activity) into a single catheter lock solution. This merging of multiple functional agents into one composition simultaneously addresses both anticoagulation and anti-microbial protection needs, resolving the contradiction between providing anticoagulant activity and preventing microbial contamination.
Solution Approach 2:
The invention creates a composite disinfectant composition containing multiple active ingredients (heparin, citric acid, and PHMB) with different functions. This composite approach allows the solution to exhibit both anticoagulant properties from heparin and anti-microbial properties from citric acid and PHMB, effectively solving the problem of lacking anti-microbial activity in conventional heparin-based catheter lock solutions.
2Reliability
If high concentrations of alcohol solutions are used as disinfectants, then anti-microbial effect is achieved, but cytotoxicity increases and topical application only is possible
Solution Approach 1:
The patent changes the chemical parameters of the disinfectant composition by using citric acid and PHMB at specific concentrations (citric acid 0.1-10% w/v, PHMB 0.001-0.5% w/v) instead of high concentration alcohol. This parameter change achieves effective anti-microbial activity against S. aureus and other pathogens while significantly reducing cytotoxicity, allowing safe intracatheter application without the harmful effects of high-concentration alcohol solutions.
Solution Approach 2:
The patent introduces citric acid and PHMB as intermediary substances that provide anti-microbial activity through alternative mechanisms compared to alcohol. These intermediaries achieve bactericidal and fungicidal effects through chelation and membrane disruption mechanisms respectively, avoiding the cytotoxic protein denaturation caused by high-concentration alcohol, thus reducing harmful effects while maintaining anti-microbial efficacy.
3Device complexity
If single-agent disinfectants are used, then simplicity is maintained, but synergistic anti-microbial effect and biofilm penetration capability are limited
Solution Approach 1:
The patent merges citric acid and PHMB into a single synergistic composition. Citric acid penetrates and disrupts biofilm matrix through chelation of calcium and other divalent cations, while PHMB penetrates and kills embedded microorganisms through membrane disruption. This merging creates a synergistic effect where the combination achieves greater anti-microbial activity and biofilm penetration capability than either agent alone, while maintaining relative compositional simplicity with just two active ingredients.
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 prevents and eradicates microbial contaminations and biofilms in catheters, demonstrating a synergistic anti-microbial effect against Staphylococcus aureus and fungi like Candida albicans, with reduced cytotoxicity compared to existing solutions.
Implementation Method 1
comprising a combination of components (A) citric acid or a physiologically acceptable salt thereof, and (B) poly(hexamethylenebiguanide) or a physiologically acceptable salt thereof; wherein components A and B are present in an amount exhibiting a synergistic anti-microbial effect
Implementation Method 2
it is necessary that the anti-microbial agent is not only able to kill the free-floating microbes in solution, but also to penetrate the deposit in order to kill these microorganisms in the deeper layers
Data Source
AI summary
The invention relates to a disinfectant composition (i) comprising a combination of citric acid or a physiologically acceptable salt thereof as component (A), and poly(hexamethylene- biguanide) (PHMB) or a physiologically acceptable salt thereof as component (B) and/or (ii) exhibiting a log reduction of staphylococcus aureus of at least 4.0 after a contact time of 5 minutes according to DIN EN 13727 and / or a growth inhibition of Candida and / or S. aureus and the use of said composition for the prevention and/or reduction and/or elimination and/or eradication of microbial contaminations in health care products.