Tissue Implant Decellularization via Nuclease and Alkaline Alcohol Treatment

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Solution Overview

Problem

Current methods for preparing decellularized tissue implants lack effective antimicrobial treatments and textural modifications, leading to concerns about pathogen transmission and handling difficulties during surgical procedures.

Innovation Solution

A method involving treatment of tissue materials with a nuclease-containing solution, including antimicrobials like benzyl alcohol, followed by an alkaline alcohol solution, and chlorine dioxide, to decellularize and sterilize tissues while enhancing textural qualities for easier handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If tissue material is treated with traditional decellularization methods, then cellular material is removed, but microbial contamination risk increases and textural properties deteriorate

Engineering Contradiction:

Improvemicrobial safetyVSAvoidpathogen transmission risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines multiple treatment functions into integrated solutions: the nuclease-containing solution simultaneously performs decellularization and antimicrobial treatment, while the alkaline alcohol solution provides both textural modification and sterilization. This merging of functions resolves the contradiction by achieving microbial safety without requiring separate, potentially contaminating treatment steps.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces intermediary substances that mediate between decellularization and sterilization: benzyl alcohol acts as an intermediary antimicrobial agent in the nuclease solution, and sodium hydroxide serves as an intermediary that enables both textural modification and microbial inactivation in the alkaline alcohol solution. These intermediaries allow simultaneous achievement of decellularization and microbial safety.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If tissue material undergoes extensive processing to improve biocompatibility, then pathogen transmission risk decreases, but handling properties during surgery worsen

Engineering Contradiction:

ImprovebiocompatibilityVSAvoidsurgical handling

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes to the tissue material through controlled chemical treatments. The alkaline alcohol solution modifies physical-chemical parameters (pH, alcohol concentration) to simultaneously improve biocompatibility by removing contaminants and enhance handling properties by optimizing tissue texture and flexibility. This resolves the contradiction by finding optimal parameter ranges that satisfy both requirements.

Inventive Principle:

Principle #35Parameter changes

3Object-affected harmful factors

If multiple treatment steps are applied to sterilize tissue, then microbial risk reduces, but processing complexity increases

Engineering Contradiction:

Improvemicrobial contaminationVSAvoidprocessing procedure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges multiple treatment functions into combined solutions: the nuclease-containing solution integrates decellularization and antimicrobial action, while the alkaline alcohol solution combines textural modification and sterilization. This reduces processing complexity by eliminating the need for separate sequential treatments, thereby resolving the contradiction between sterilization effectiveness and procedure simplicity.

Inventive Principle:

Principle #5Merging (Combining)

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 produces tissue implants with improved biocompatibility, reduced microbial risk, and enhanced handling properties, supporting recellularization and providing suitable mechanical strength for reconstructive applications.

Implementation Method 1

treating a tissue material in a nuclease-containing solution

Methodology Applied

Scientific EffectNuclease enzymatic degradation: Enzyme

Implementation Method 2

treating the tissue material with an alkaline alcohol solution. The alkaline alcohol solution comprises sodium hydroxide and ethanol

Methodology Applied

Scientific EffectAlkaline chemical treatment:

Implementation Method 3

The nuclease-containing solution includes an antimicrobial

Methodology Applied

Scientific EffectAntimicrobial action:

Implementation Method 4

treating a tissue material in a nuclease-containing solution that includes benzyl alcohol

Methodology Applied

Scientific EffectSterilization:

Data Source

PatentUS8883408B2Tissue implants for implantation and methods of preparing the same

Publication Date: 2014.11.11 ARTIVION INC

AI summary

A method is provided for preparing a tissue implant for implantation. The method includes harvesting a tissue material from a human or an animal donor, treating the tissue material in a nuclease-containing solution, and thereafter treating the tissue material with an alkaline alcohol solution. The nuclease-containing solution includes an antimicrobial. The alkaline alcohol solution comprises sodium hydroxide and ethanol.