Self-Sealing Elastomeric Membranes for Prosthetic Implants

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Solution Overview

Problem

Existing prosthetic implants, such as tissue expanders, lack effective and reliable self-sealing capabilities to prevent fluid leaks when punctured or expanded, necessitating improvements in mammary implants and tissue expanders to ensure they do not leak when subjected to needle punctures or increased volumes and pressures.

Innovation Solution

A method of creating self-sealing membranes for prosthetic implants involves applying tension to a first layer of cured elastomeric material, stretching it over a disk, and then applying a second layer of uncured elastomeric material, which is cured while the first layer remains stretched, resulting in a self-sealing membrane with multiple layers under contraction to seal punctures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a patch is attached to cover the mandrel opening to seal the hole, then fluid imperviousness is achieved, but the structure becomes more complex and reliability is reduced due to potential detachment or leakage at the patch interface

Engineering Contradiction:
Improveself-sealing capabilityVSAvoidmulti-layer construction complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the sealing function and structural function into a single integrated self-sealing membrane made of elastomeric material. This membrane simultaneously provides fluid imperviousness and self-sealing capability without requiring separate patches or interfaces, thereby reducing structural complexity while improving reliability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The elastomeric membrane is designed to automatically seal punctures through its inherent elastic properties. When punctured, the material contracts and closes the opening without requiring external intervention, separate sealing components, or complex activation mechanisms, thus achieving self-service sealing that simplifies the overall device structure.

Inventive Principle:
Principle #25Self-service

2Reliability

If the elastomeric material is made thicker to prevent leaks, then leak prevention is improved, but the material becomes less pliable and more difficult to manufacture

Engineering Contradiction:
Improveleak preventionVSAvoidmanufacturing difficulty
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent utilizes the elastic modulus and thickness parameters of the elastomeric material to achieve optimal balance. By carefully selecting these parameters, the membrane provides sufficient leak prevention while maintaining pliability and ease of manufacturing. The self-sealing capability arises from the material's elastic recovery rather than excessive thickness.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention employs a thin yet flexible elastomeric membrane that provides effective sealing through its elastic properties rather than thickness. The material's ability to deform and recover allows it to seal punctures effectively while remaining easy to manufacture and integrate into the implant device.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If multiple layers are applied to enhance self-sealing properties, then sealing effectiveness is improved, but the manufacturing process becomes more complex and time-consuming

Engineering Contradiction:
Improvesealing effectivenessVSAvoidmanufacturing efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The self-sealing membrane can be constructed with multiple elastomeric layers if needed, but each layer is applied using the same streamlined dip-molding process. This segmented approach allows for enhanced sealing effectiveness while maintaining manufacturing efficiency, as the process repetition does not significantly increase complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The elastomeric material is prepared in advance in a liquid or pliable state that allows for easy application and bonding. This preliminary preparation enables rapid coating and curing processes, ensuring that even multi-layer constructions can be manufactured efficiently without significant time or complexity penalties.

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 self-sealing membranes effectively prevent fluid leaks by contracting to seal punctures, offering improved leak prevention and enhanced tensile properties, making them more pliable and easier to manufacture without the need for silicone gel or viscous fluids.

Implementation Method 1

applying tension to a first layer of a cured elastomeric material to stretch the first layer, and while the first layer remains stretched, applying a second layer of an uncured elastomeric material over a first major surface of the first layer

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

curing the second layer of the elastomeric material

Methodology Applied
Scientific EffectCuring: Chemical Bonding

Data Source

PatentEP4301277B1Self-sealing membranes for closing punctures and preventing leaks and methods of making thereof
Publication Date: 2025.07.09 MENTOR WORLDWIDE LLC
  • EP4301277B1 patent drawingFigure 1~3
  • EP4301277B1 patent drawingFigure 4
  • EP4301277B1 patent drawingFigure 5A

AI summary

A method of making a self-sealing membrane for a prosthetic implant includes applying tension to a first layer of a cured elastomeric material to stretch the first layer, and while the first layer remains stretched, applying a second layer of an uncured elastomeric material over a first major surface of the first layer. After the second layer is cured, the tension on the first layer is released, whereupon the first layer returns to a non-stretched configuration for holding the second layer in contraction. The method includes, while the first layer remains stretched, applying a third layer of an uncured elastomeric material over a second major surface of the first layer. After curing the second and third layers, tension is released from the first layer, which returns to the non-stretched configuration for holding the second and third layers in contraction.