Decellularized Bone Matrix Composite with Calcium Phosphate

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Solution Overview

Problem

Current bone repair materials, such as chemically purified type I collagen, face challenges including complex extraction processes, denaturation of collagen, loss of biological performance, and the need for toxic chemical crosslinking agents, which can induce inflammation and immune reactions.

Innovation Solution

A composite material for bone repair based on decellularized biological tissue matrix material is developed, which maintains a natural cross-linking state and is physically mixed with inorganic materials like calcium phosphate, eliminating the need for chemical crosslinking agents and preserving the collagen's triple helix structure, thereby enhancing osteoconductivity and osteoinductivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If chemically purified type I collagen is used for bone repair, then the extraction process can be standardized, but the collagen undergoes denaturation and loses biological performance

Engineering Contradiction:
Improveextraction process standardizationVSAvoidcollagen biological performance
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent extracts and removes cells from biological tissue to obtain a cell-free matrix, preserving the natural collagen structure while eliminating immunogenic components. This extraction approach allows standardization of the material source without requiring chemical purification that would denature the collagen.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a copy of the natural extracellular matrix structure through decellularization, maintaining the native collagen triple helix configuration and three-dimensional architecture without chemical modification. This copied natural structure preserves biological performance while enabling standardized production from various tissue sources.

Inventive Principle:
Principle #26Copying

2Stability of the object's composition

If chemical crosslinking agents are used to stabilize collagen structure, then the structural stability is improved, but inflammation and immune reactions are induced

Engineering Contradiction:
Improvecollagen structure stabilityVSAvoidinflammation and immune reactions
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent converts the potential harm of using chemical crosslinking agents by eliminating their need entirely. The decellularized matrix naturally maintains structural stability through its intact crosslinking network, transforming the problem of chemical toxicity into a benefit of using purely physical/biological stabilization methods.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The decellularized biological matrix self-stabilizes its structure through naturally preserved crosslinks and the three-dimensional network architecture of collagen fibers. The material serves its own structural needs without requiring external chemical agents, thereby avoiding immune reactions while maintaining stability.

Inventive Principle:
Principle #25Self-service

3Reliability

If autologous bone is harvested from patient's body, then the osteoinductivity and safety are maximized, but donor site morbidity and limited supply occur

Engineering Contradiction:
Improveosteoinductivity and safetyVSAvoiddonor site morbidity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses decellularized biological matrix as an intermediary material that provides the beneficial osteoinductive and safe properties of autologous bone without requiring harvest from the patient's own body. This intermediary material can be sourced from allogeneic or xenogeneic tissues that have been processed to remove immunogenic components.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts and removes cells from allogeneic or xenogeneic tissue to eliminate immunogenicity and donor site morbidity issues, while preserving the osteoinductive extracellular matrix components. This extraction process allows the material to function similarly to autologous bone without the harmful effects of surgical harvest.

Inventive Principle:
Principle #2Taking out (Extraction)

4Stability of the object's composition

If decellularized biological tissue matrix is used, then the natural cross-linking state is maintained, but the material complexity increases

Engineering Contradiction:
Improvenatural cross-linking stateVSAvoidmaterial structure complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent segments the biological tissue at the cellular level, removing cells while preserving the extracellular matrix structure. This segmentation approach simplifies the material by eliminating complex cellular components while maintaining the beneficial collagen network, making the material both stable and manageable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent performs decellularization as a preliminary action before any further processing or implantation. By removing cells in advance, the natural cross-linking state of the collagen matrix is preserved and stabilized before the material is used, avoiding the need for complex subsequent modifications.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3338818B1Bone repair reusable composite material based on acellular biological tissue matrix material and preparation method therefor
Publication Date: 2021.07.28 HANGZHOU HUAMAI MEDICAL DEVICES CO LTD
  • EP3338818B1 patent drawingFigure 1A~1C
  • EP3338818B1 patent drawingFigure 2A~3B
  • EP3338818B1 patent drawingFigure 4A~5

AI summary

A composite material for bone repair based on a decellularized biological tissue matrix material and a preparation method thereof. The composite material for bone repair comprises an organic phase of a microfibrillar decellularized animal tissue matrix material and an inorganic phase of a calcium salt bioceramic or other inorganic bioglass. A preparation process for the composite material for bone repair does not need physical or chemical crosslinking. The composite material for bone repair has a three-dimensional porous network structure, and protein components in the biological tissue matrix material maintain a natural triplex structure. The composite material for bone repair has excellent biocompatibility, biodegradability, osteoconductivity, osteoinductivity, and osteogenecity, also has certain mechanical strength and shape memory function, and can be used as a bone filling material or a repair material for large-area bone defect.