Birth Tissue Allograft Processing for Growth Factor Release

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Solution Overview

Problem

Current methods for processing birth tissue allografts, such as amniotic membrane and placental connective tissue matrix, result in reduced availability and delayed release of beneficial compounds like growth factors and extracellular matrix, leading to diminished biological activity and bioavailability.

Innovation Solution

A two-step decellularization process involving a gentle decellularization solution followed by exposure to an acid or base, with neutralization to a pH of 4-8, maintains high levels of growth factors and ECM, enhancing their solubility and release rates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional decellularization process is used to remove cellular material from birth tissue, then cellular debris is removed, but growth factors and extracellular matrix compounds are also lost, reducing biological activity

Engineering Contradiction:

Improvebiological activityVSAvoidgrowth factors and ECM compounds

Core Design Contradiction:

ReliabilityVSLoss of substance

Solution Approach 1:

The decellularization process is divided into multiple sequential steps with progressively harsher conditions. The first step uses mild conditions to remove only cellular material, while subsequent steps gradually increase in intensity to remove remaining cellular debris without excessively damaging beneficial compounds. This segmented approach preserves growth factors and ECM while achieving complete decellularization.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent systematically changes physical and chemical parameters throughout the decellularization process, including pH levels, temperature, and chemical concentration. By carefully controlling and adjusting these parameters in a stepwise manner, the process achieves effective decellularization while minimizing loss of growth factors and extracellular matrix compounds that are sensitive to extreme conditions.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If harsh chemicals are used to ensure complete decellularization, then cellular material is thoroughly removed, but the tissue structure and beneficial compounds are degraded

Engineering Contradiction:

Improvedecellularization completenessVSAvoidtissue structure and compound integrity

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary gentle decellularization steps before introducing harsher chemicals. This preliminary action removes the bulk of cellular material under mild conditions, creating a foundation that allows subsequent harsher steps to focus on residual cellular debris without excessively damaging the tissue structure and beneficial compounds.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The decellularization process employs dynamic adjustment of chemical harshness, transitioning from mild to harsh conditions in a controlled sequence. This dynamic approach allows the process to adapt to the changing state of the tissue, achieving complete decellularization while preserving tissue structure and compound integrity through progressive rather than immediate harsh treatment.

Inventive Principle:

Principle #15Dynamics

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 increases the availability and bioavailability of growth factors and ECM, allowing for immediate and delayed release based on application needs, improving soft tissue healing efficacy.

Implementation Method 1

the first decellularization step involves exposing the birth tissue to a first decellularization solution to remove blood-based cells and/or blood materials

Methodology Applied

Scientific EffectDecellularization:

Implementation Method 2

the second decellularization step involves exposing the clean tissue to a second decellularization solution comprising an acid or a base

Methodology Applied

Scientific EffectAcid/Base hydrolysis: Hydrolysis

Implementation Method 3

followed by a neutralizing step where the second step decellularization solution is neutralized to a pH of 4-8

Methodology Applied

Scientific EffectNeutralization:

Data Source

PatentUS20260053985A1Enhanced birth tissue allografts and methods of manufacture

Publication Date: 2026.02.26 ORBIO INNOVATIONS LLC

AI summary

Provided herein are a method of processing human birth tissue to create a variety of tissue forms that maintain high levels of beneficial compounds and increase tissue availability. Also provided are products made from the processed tissue forms, and application of these products in soft tissue repair and the treatment of wounds.