Silicone Pad Tensioning for Amniotic Membrane Lyophilization

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Solution Overview

Problem

Existing methods for preparing amniotic membrane-based materials face issues such as the amniotic membrane rolling up after separation from the carrier, difficulty in determining lateral orientation, and disruption of the natural structure during lyophilization, leading to tearing and impaired functionality for tissue reconstruction and healing.

Innovation Solution

A method involving the use of a silicone pad with a tensioning system, including a cylindrical shape and a tensioning bar with fixing protrusions, to smoothly and evenly stretch the amniotic membrane, followed by lyophilization, ensuring proper tension and maintaining the membrane's structure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If the amniotic membrane is placed on a mesh textile carrier or nitrocellulose carrier for lyophilization, then the membrane can be processed and dried, but the membrane rolls up immediately after separation from the carrier, making it difficult to determine lateral orientation and manipulate

Engineering Contradiction:
Improveease of processing and lyophilizationVSAvoidease of manipulation and orientation determination
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The patent applies preliminary action by pre-marking the amniotic membrane with orientation indicators (such as colored dots or patterns) before lyophilization. This allows the lateral orientation to be determined easily after the membrane is separated from the carrier, eliminating the manipulation difficulties while maintaining the manufacturing benefits of using a carrier for lyophilization.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces an intermediary marking system (visual indicators such as colored dots, patterns, or symbols applied to the membrane surface) that mediates between the carrier processing step and the final application step. This intermediary marking allows easy orientation determination without affecting the membrane's adhesion to the carrier during lyophilization or its subsequent manipulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If the amniotic membrane is separated completely from the mesh textile carrier, then it can be easily removed, but it separates prematurely and the surgeon cannot determine its correct lateral orientation

Engineering Contradiction:
Improveease of removal from carrierVSAvoidmaintaining correct lateral orientation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by pre-marking the amniotic membrane with orientation indicators before separation from the carrier. This ensures that even when the membrane is completely separated and easily removed, the lateral orientation can be correctly determined using the pre-applied markings, thus maintaining reliability.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If the amniotic membrane is lyophilized on a mesh textile carrier without adequate tension, then the lyophilization process can be completed, but condensation nuclei appear during freezing, disrupting the natural structure and causing tearing

Engineering Contradiction:
Improvecompletion of lyophilization processVSAvoidintegrity of natural structure
Core Design Contradiction:
Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary action by pre-tensioning the amniotic membrane on the lyophilization carrier before the freezing process begins. This preliminary tensioning prevents the formation of condensation nuclei during freezing, thereby maintaining the natural structure and preventing tearing, while still allowing the lyophilization process to be completed.

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

The method produces a lyophilized amniotic membrane that maintains its natural structure, allowing for easy application and ensuring correct orientation, reducing the need for surgical intervention and enhancing the healing process.

Implementation Method 1

clamping, smoothing and tensioning (stretching) the amniotic membrane on the pad

Methodology Applied
Scientific EffectTension: Tension

Implementation Method 2

lyophilization of the material obtained in step d)

Methodology Applied
Scientific EffectLyophilization: Freeze Drying

Data Source

PatentEP4223326B1Method of preparation of amniotic membrane-based material
Publication Date: 2025.08.06 NARODNI CENT TKANI A BUNEK AS
  • EP4223326B1 patent drawingFigure 1~2
  • EP4223326B1 patent drawingFigure 3~7

AI summary

The invention provides a method for processing an amniotic membrane into a material for reconstruction, protection and healing of damaged tissues, the method starting from placenta and comprising the following steps: a) separation of the amniotic membrane from the chorion; b) cleaning of the amniotic membrane in saline solution and mechanical cleaning of the amniotic membrane, c) antibiotic lavage, d) placing the amniotic membrane with the chorionic side onto a pad (1) made of silicone, the pad (1) being provided with a tensioning system on its edges, and clamping, smoothing and tensioning the amniotic membrane on the pad (1), e) lyophilization of the material obtained in step d), f) removing the amniotic membrane from the pad (1), g) optionally fragmentation of the amniotic membrane into a circular shape, h) inserting the lyophilized amniotic membrane into a sterile packaging. Furthermore, the invention provides a material consisting of lyophilized amniotic membrane obtainable by the said method, as well as a pad for carrying out said method.