Multi-Enzyme Medical Device Cleaning for Biofilm Removal

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Solution Overview

Problem

Existing cleaning methods for medical devices are inadequate in effectively removing organic soil and biofilm, particularly from medical devices contaminated with antibiotic-resistant microorganisms, leading to a high risk of cross-infection.

Innovation Solution

A cleaning method using a wash liquor comprising two or more enzymes: a protease, an enzyme with DNase activity, and an enzyme with hexosaminidase activity, optionally followed by rinsing, to synergistically reduce biofilm and enhance cleaning efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional washing methods are used to clean medical devices, then the cleaning process is simple and quick, but organic soil and biofilm are not effectively removed

Engineering Contradiction:
Improvecleaning efficacyVSAvoidcleaning process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies composite materials by formulating a cleaning composition that combines multiple enzymes (protease, DNase, hexosaminidase) with surfactants and other cleaning agents. This composite enzymatic system works synergistically to effectively degrade diverse organic soils including biofilms, proteins, and nucleic acids on medical devices, achieving reliable cleaning results that single enzymes cannot accomplish alone.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes parameter changes by optimizing the cleaning process through controlled incubation temperature (30-70°C), pH levels (7-9), and contact time (5-60 minutes). These parameter adjustments maximize enzymatic activity and cleaning efficacy while maintaining process simplicity, allowing the enzymes to effectively break down organic soil without requiring complex procedural changes.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If single enzyme cleaners are used, then the composition is simple, but cleaning effectiveness against diverse organic soil is insufficient

Engineering Contradiction:
Improvebiofilm removal efficiencyVSAvoidnumber of enzymes
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent merges multiple enzymes with complementary functions into a single cleaning composition. The protease degrades proteins, DNase breaks down DNA, and hexosaminidase targets polysaccharides in biofilms. This combination creates a synergistic effect where the enzymes work together to comprehensively remove diverse organic soils that no single enzyme could eliminate alone, achieving high biofilm removal efficiency.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The cleaning composition achieves multi-functionality by incorporating enzymes that target different components of organic soil. The same composition can simultaneously degrade proteins, nucleic acids, and polysaccharides, making it universally effective against various types of biological contamination on medical devices without requiring multiple separate treatment steps.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If thorough cleaning with multiple enzymes is performed, then biofilm removal is significantly improved, but the cleaning composition becomes more complex

Engineering Contradiction:
Improvedisinfection efficacyVSAvoidcleaning composition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The cleaning composition applies self-service by incorporating stabilizers, surfactants, and buffer systems that automatically maintain optimal conditions for enzymatic activity. The composition self-regulates pH and stability, allowing the enzymes to function effectively without requiring complex external control mechanisms or multiple processing steps, thus achieving thorough cleaning while keeping the overall process relatively simple.

Inventive Principle:
Principle #25Self-service

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 method significantly reduces biofilm on medical devices by at least 1-40% compared to cleaning without these enzymes, ensuring thorough disinfection and sterilization, thereby minimizing the transmission of infectious pathogens.

Implementation Method 1

contacting the medical device with a wash liquor comprising two or more enzymes selected from the group consisting of a protease, an enzyme having DNase activity and an enzyme having hexosaminidase activity

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 2

a protease, an enzyme having DNase activity and an enzyme having hexosaminidase activity

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS20250295120A1Cleaning method, use of enzymes and cleaning composition
Publication Date: 2025.09.25 NOVOZYMES AS
  • US20250295120A1 patent drawing

AI summary

Provided is a method for cleaning a medical device comprising contacting the device with a wash liquor comprising two or more enzymes selected from the group consisting of a protease, an enzyme having DNase activity and an enzyme having hexosaminidase activity.