Shape-Memory Plug for Fetal Membrane Sealing

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Solution Overview

Problem

Current methods for closing fetal membrane defects during endoscopic surgery are ineffective in preventing premature rupture of membranes and associated complications, as existing sealants fail to reliably seal the defects and prevent fluid leakage.

Innovation Solution

An expandable plug made from shape-memory material, such as crosslinked collagen, that expands when exposed to bodily fluids, effectively sealing the defect without the need for sutures by regaining its original size and maintaining a seal over time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a static collagen plug or gelatin plug is used to seal fetal membrane defects, then the defect is sealed initially, but the seal fails over time due to lack of adaptability to membrane movement and expansion

Engineering Contradiction:
Improvesealing effectivenessVSAvoidduration of seal
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The plug is designed with shape memory capability, allowing it to dynamically change from a compressed delivery state to an expanded sealed state. The plug can adapt its shape and size in response to membrane movement and expansion, maintaining sealing effectiveness over time rather than being a static structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The plug material undergoes phase or state changes in response to environmental conditions (such as temperature or pH changes in the fetal environment), triggering expansion from a compact delivery form to a larger sealing form. This parameter change enables the plug to adapt to membrane dynamics and maintain long-term seal integrity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If sutures are used to close membrane defects, then the defect is sealed, but the procedure becomes more complex and time-consuming

Engineering Contradiction:
Improvedefect closureVSAvoidclosure procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The plug is designed to self-expand and self-seal upon delivery to the defect site. The shape memory material automatically transitions from a compressed state to an expanded sealing state without requiring additional surgical manipulation, suturing, or complex closure procedures, thereby simplifying the overall intervention.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The complex suturing procedure is replaced by extracting the sealing function into a single pre-formed plug device that performs the sealing function independently, eliminating the need for suture materials and suturing techniques.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of operation

If a non-expandable plug is used, then the procedure is simpler, but the plug cannot adapt to membrane expansion and movement during pregnancy

Engineering Contradiction:
Improveprocedure simplicityVSAvoidadaptability to membrane dynamics
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The plug combines procedural simplicity with dynamic adaptability through shape memory technology. The device remains simple to deploy (compressed delivery) but automatically adapts its shape and size in response to membrane dynamics, achieving both ease of operation and adaptability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The plug is delivered in a compressed, nested state within a delivery catheter, simplifying the insertion procedure. Once deployed, it expands from this nested configuration to a larger sealing structure that can adapt to membrane expansion, combining procedural simplicity with functional adaptability.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 expandable plug successfully seals fetal membrane defects by expanding upon contact with amniotic fluid, reducing the risk of premature rupture and associated complications, and remains effective for an extended period, ensuring stable sealing during pregnancy.

Implementation Method 1

the material forming the plug has shape memory

Methodology Applied
Scientific EffectShape memory: Shape Memory Polymer

Implementation Method 2

An expandable plug made from shape-memory material, such as crosslinked collagen, that expands when exposed to bodily fluids

Methodology Applied
Scientific EffectHydrogel expansion: Hydrogel

Data Source

PatentUS20240041443A1Expandable plug
Publication Date: 2024.02.08 STICHTING RADBOUD UNIVERSITAIR MEDISCH CENT
  • US20240041443A1 patent drawing
  • US20240041443A1 patent drawing
  • US20240041443A1 patent drawing

AI summary

The invention relates to the field of medicine. More specifically, the invention relates to an expandable plug for closing a defect in an organ or tissue without the need for sutures, wherein the plug has shape memory. The invention further relates to medical use of such plug.