Fibrinogen Tissue Adhesive Patch Degradation Control

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Solution Overview

Problem

Existing fibrinogen-based tissue adhesive patches remain intact for longer than necessary, causing potential tissue irritation, as they do not degrade rapidly enough to minimize fluid leakage and bleeding.

Innovation Solution

A fibrinogen-based tissue adhesive patch comprising a biocompatible polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film with a specific molecular weight and CL:LA ratio, incorporating fibrinogen and thrombin, and optionally additives for controlled degradation and adhesion, is developed to achieve a predetermined degradation time of less than two weeks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the patch remains intact for a longer duration to ensure continuous sealing, then the sealing reliability is improved, but tissue irritation increases due to prolonged presence of foreign material

Engineering Contradiction:
Improvesealing reliabilityVSAvoidtissue irritation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by modifying the polymer composition parameters (PEG-CL-LA triblock copolymer with specific molecular weight and CL:LA ratio) to control the degradation rate. By adjusting these chemical parameters, the patch maintains structural integrity for sufficient sealing time while ensuring complete degradation within 10-14 days, thus resolving the contradiction between prolonged sealing reliability and reduced tissue irritation.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If the patch degrades rapidly to minimize tissue irritation, then the harmful effects are reduced, but the sealing duration may be insufficient to stop bleeding or leakage

Engineering Contradiction:
Improvetissue irritationVSAvoidsealing duration
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of moving object

Solution Approach 1:

The patent optimizes the polymer parameters (specifically the CL:LA ratio and molecular weight of PEG-CL-LA triblock copolymer) to achieve a balanced degradation profile. This parameter optimization ensures the patch degrades rapidly enough to minimize tissue irritation while maintaining sufficient mechanical integrity for the required sealing duration, typically 10-14 days, thereby resolving the contradiction between rapid degradation and adequate sealing duration.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses composite material design by incorporating fibrinogen and thrombin within the PEG-CL-LA polymer matrix. This composite structure allows the polymer to provide structural support and controlled degradation, while the incorporated coagulants (fibrinogen and thrombin) provide the hemostatic function. The synergistic combination ensures both adequate sealing duration and minimal tissue irritation through controlled degradation.

Inventive Principle:
Principle #40Composite materials

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 patch effectively seals tissues for the required duration, degrading within 10 to 14 days, reducing tissue irritation and maintaining mechanical integrity until bleeding or leakage is stopped.

Implementation Method 1

a biocompatible polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Implementation Method 2

incorporating fibrinogen and thrombin

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentEP3365038B1Improved fibrinogen-based tissue adhesive patch
Publication Date: 2019.07.03 SEALANTIUM MEDICAL
  • EP3365038B1 patent drawingFigure 1A~2
  • EP3365038B1 patent drawingFigure 3

AI summary

An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG- CL-LA) triblock copolymer film into which a fibrinogen-based sealant comprising less than 8 mg/cm 2 fibrinogen and less than 10 IU/cm 2 thrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.