Decellularized Tissue Bioprosthesis Electrophoretic Antigen Removal

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Solution Overview

Problem

Biological heart valve prostheses have poor durability compared to mechanical devices and face challenges with immunological rejection, necessitating the development of durable, non-immunogenic, and viable alternatives that can be used in children and require effective decellularization and antigen extraction processes.

Innovation Solution

A method involving decellularization with sodium dodecyl sulphate (SDS) followed by an improved rinse procedure and electrophoretic treatment to remove electrically charged substances, ensuring the bioprosthesis is substantially free of SDS and antigens, allowing for recellularization and reduced immunogenic response.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If animal tissue is used to produce bioprostheses, then the supply shortage of autologous tissue is overcome, but immunological rejection occurs

Engineering Contradiction:
Improvetissue supplyVSAvoidimmunological rejection
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent applies extraction by removing cellular components and antigens from animal tissue through decellularization processes. Specific methods include using detergents, enzymes, or chemical treatments to extract immunogenic elements while preserving the extracellular matrix structure, thereby eliminating rejection risks while maintaining tissue availability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs parameter changes by modifying the chemical and physical properties of animal tissue through controlled treatment conditions. By adjusting parameters such as pH, temperature, and chemical concentration during decellularization, the tissue is transformed into a non-immunogenic state while preserving its structural integrity and functional properties

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If conventional decellularization methods are used, then antigen extraction is achieved, but durability of the bioprosthesis remains poor

Engineering Contradiction:
Improveantigen extractionVSAvoiddurability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies parameter changes by optimizing decellularization conditions to preserve structural integrity. By carefully controlling treatment parameters such as detergent concentration, exposure time, and temperature, the method removes antigens while maintaining the mechanical strength and structural framework of the tissue, thereby improving durability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials by creating a hybrid structure that combines the natural extracellular matrix with enhanced structural support elements. This composite approach reinforces the tissue framework during decellularization, preventing collapse and maintaining durability while allowing thorough antigen extraction

Inventive Principle:
Principle #40Composite materials

3Object-affected harmful factors

If sodium dodecyl sulphate (SDS) is used for decellularization, then antigen removal is effective, but SDS is difficult to remove from the tissue

Engineering Contradiction:
Improveantigen removalVSAvoidSDS removal
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The patent applies continuity of useful action by implementing extended and repeated rinsing procedures. The tissue is subjected to continuous flow of rinsing solutions over extended periods, with multiple solution changes, ensuring thorough and complete removal of SDS residues while maintaining the decellularization benefits

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The patent employs an intermediary approach by using intermediate rinsing solutions that facilitate SDS removal. Specific rinsing agents or buffer solutions are used as intermediaries to break down and flush out SDS residues more effectively than water alone, enabling complete removal without compromising tissue structure

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 method enhances the durability and immunocompatibility of bioprostheses, enabling effective recellularization and reducing inflammatory responses, thus providing a viable alternative to allogeneic donor tissue with improved mechanical and structural properties.

Implementation Method 1

tissue is decellularized with the ionic detergent sodium dodecyl sulphate (SDS)

Methodology Applied
Scientific EffectIonic detergent action: Surfactant

Implementation Method 2

subjecting tissue to an electrophoretic field to extract at least one electrically charged substance from the tissue

Methodology Applied
Scientific EffectElectrophoresis: Electrophoresis

Data Source

PatentUS8445278B2Process for producing decellularized biological tissues
Publication Date: 2013.05.21 MEDTRONIC INC
  • US8445278B2 patent drawing
  • US8445278B2 patent drawing
  • US8445278B2 patent drawing

AI summary

The present invention provides an electrophoretic system, apparatus, and method of use thereof for the preparation of a tissue-derived bioprosthesis.