Alkaline Peroxide Tissue Sterilization Preserves Matrix

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Solution Overview

Problem

Current methods for disinfecting and sterilizing animal tissues for tissue engineering and regenerative medicine damage the biochemical constituents and biomechanical properties of the extracellular matrix, leading to less desirable clinical outcomes.

Innovation Solution

A method involving an alkaline soak solution with metal peroxide and a detergent, followed by washing with neutral and weak acidic solutions, and cryopreservation or freeze-drying, is used to disinfect and sterilize animal tissues without damaging the matrix structure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If chemical oxidants (peracetic acid, sodium hypochlorite, hydrogen peroxide) are used for disinfection and sterilization, then bacterial and viral inactivation is achieved, but damage to the tissue matrix structure and biochemical constituents occurs

Engineering Contradiction:
Improvedisinfection effectivenessVSAvoidmatrix structure damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the chemical parameters of the disinfection solution by using alkaline peroxide (pH 10-13) instead of conventional acid-based or neutral oxidants. This parameter change allows effective sterilization while reducing damage to the tissue matrix structure and preserving biochemical constituents.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs a simple, single-use alkaline peroxide solution that can be easily prepared and discarded after use. This approach eliminates the need for complex sterilization systems and expensive equipment, making the process more accessible while achieving effective disinfection.

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

2Reliability

If alcohol or acid/base treatments are applied for sterilization, then microbial contamination is controlled, but alterations in biomechanical properties of the tissue matrix occur

Engineering Contradiction:
Improvesterilization efficacyVSAvoidbiomechanical properties
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent uses alkaline conditions (pH 10-13) combined with peroxide to achieve sterilization without the harsh effects of conventional acids or bases. This parameter change preserves the biomechanical properties of the tissue matrix while maintaining effective sterilization.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If conventional sterilization methods are used throughout the manufacturing process, then microbial control is achieved, but the original basic structure and biochemical constituents of the extracellular tissue matrix are damaged

Engineering Contradiction:
Improvemicrobial controlVSAvoidbiochemical constituents
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent employs alkaline peroxide treatment (pH 10-13) which changes the chemical environment to be less damaging to biochemical constituents while maintaining effective microbial control throughout the manufacturing process.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies alkaline peroxide treatment early in the manufacturing process, before subsequent processing steps. This preliminary action prevents microbial contamination from affecting later stages while preserving the tissue matrix structure for subsequent cell seeding and tissue engineering operations.

Inventive Principle:
Principle #10Preliminary action

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

This method effectively reduces bacterial loads by at least 10^6 without altering the scaffold structure or biomechanical properties, is environmentally safe, and does not leave chemical residues.

Implementation Method 1

The sterilization method in the preparation process procedure is to treat with a chemical oxidant (peracetic acid, sodium hypochlorite, hydrogen peroxide or iodine solution, or the like)

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 2

cryopreserving or freeze-drying the tissue matrix obtained in step (3) in a neutral solution

Methodology Applied
Scientific EffectFreezing: Freezing

Implementation Method 3

cryopreserving or freeze-drying the tissue matrix obtained in step (3) in a neutral solution

Methodology Applied
Scientific EffectFreeze-drying: Freeze Drying

Data Source

PatentUS10701928B2Method for animal tissue material disinfection and sterilization and corresponding animal tissue soak solution
Publication Date: 2020.07.07 BEIJING RUIJIAN GAOKE BIOTECH
  • US10701928B2 patent drawing
  • US10701928B2 patent drawing
  • US10701928B2 patent drawing

AI summary

A method for disinfecting and sterilizing an animal tissue material and a corresponding soak solution for an animal tissue. The method includes placing the animal tissue material into an alkaline soak solution containing a metal peroxide and a detergent, and shaking; removing organic components released from microorganisms and animal tissue cells by soaking and washing in a neutral cleaning solution; washing the tissue matrix with a weak acidic cleaning solution; cryopreserving or freeze-drying the tissue matrix in a neutral solution. The soak solution for the animal tissue contains 0.01˜0.2% (w/v) of the metal peroxide and 0.05˜1.0% (w/v) of the detergent. The animal tissue pretreated by the method is advantageous to the preservation and further decellularization treatment of the tissue for manufacture of an intact scaffold material of a tissue matrix.