Fibrinogen-Based Tissue Adhesive Patch

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Solution Overview

Problem

Existing tissue sealants rely heavily on fibrinogen for both adhesion and coagulation, requiring large quantities and often incorporating fibrinogen as a free powder, which is inefficient and not fully integrated into the film.

Innovation Solution

A fibrinogen-based tissue adhesive patch with a biocompatible polymer film incorporating fibrinogen, thrombin, and CaCl2, where the fibrinogen sealant is physically integrated into the polymer film, eliminating the need for a mesh or woven components and providing a non-permeable, efficient sealing mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fibrinogen is used as a free powder to support the hemostatic function, then the coagulant effect is achieved, but the fibrinogen is not fully integrated into the film and requires large quantities

Engineering Contradiction:
Improvehemostatic effectVSAvoidfibrinogen quantity
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent combines the polymer film and fibrinogen sealant into a single integrated patch structure. The fibrinogen is incorporated into the polymer matrix during manufacturing, creating a unified device where the film and coagulant function together as one system rather than separate components

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite material by integrating fibrinogen within a polymer matrix. This composite structure allows the polymer to provide structural support and delivery mechanism while the fibrinogen provides hemostatic function, with both components working synergistically in a single material system

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If a backing is used to support the fibrinogen, then the fibrinogen is stabilized, but the backing is not the primary tissue sealing component

Engineering Contradiction:
Improvefibrinogen stabilityVSAvoidmulti-layer structure
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent merges the backing and active sealant components into a single integrated patch. The polymer film itself serves as both the structural backing and the delivery mechanism for the fibrinogen, eliminating the need for separate backing layers while maintaining stability and functionality

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The polymer film performs multiple functions simultaneously: it provides structural support as a backing, serves as a delivery vehicle for the fibrinogen, and acts as the primary tissue sealing component. This multi-functional design eliminates the need for specialized separate components

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If fibrinogen and thrombin are incorporated into the polymer film, then the adhesion and sealing functions are integrated, but the manufacturing process becomes more complex

Engineering Contradiction:
Improveintegrated functionVSAvoidmanufacturing process
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The fibrinogen and thrombin are incorporated into the polymer film during the manufacturing process rather than being added later. This preliminary incorporation ensures proper distribution and integration of the coagulant components within the matrix before the patch is used, simplifying the overall device assembly

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes changes in polymer physical state (melting and solidification) during manufacturing to incorporate the fibrinogen sealant. By heating the polymer above its melting point to allow sealant incorporation, then cooling to solidify the integrated structure, the manufacturing process achieves integration without excessive complexity

Inventive Principle:
Principle #35Parameter changes

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 adheres to tissues while sealing leaks, demonstrating strong adhesion and biodegradability, suitable for various applications including wound closure and fluid leakage, with enhanced adhesion half-life and targeted drug release options.

Implementation Method 1

the fibrinogen acts to attach the polymer film to the tissue

Methodology Applied
Scientific EffectCoagulation: Coagulation

Implementation Method 2

a biocompatible polymer film into which a fibrin-based sealant is incorporated

Methodology Applied
Scientific EffectPhysical incorporation: Absorption (physical)

Data Source

PatentEP2988771B1Fibrinogen-based tissue adhesive patches
Publication Date: 2018.12.19 SEALANTIUM MEDICAL
  • EP2988771B1 patent drawingFigure 1A~1B
  • EP2988771B1 patent drawingFigure 2A~2C
  • EP2988771B1 patent drawingFigure 3A~3C

AI summary

A novel fibrinogen-based tissue adhesive patch is disclosed. The patch comprises a backing made from a non-permeable biocompatible polymer film into which a fibrinogen-based sealant is incorporated. In preferred embodiments of the invention, the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl2. The polymer backing serves to seal the tissue to which the patch is applied, and the sealant acts only to bind the patch to the affected tissue. The patch does not include any mesh or woven component. Methods of production of the patch are also disclosed.