Fibrinogen-Based Tissue Adhesive Patch with Polymer Backing

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Solution Overview

Problem

Existing tissue sealants rely heavily on fibrinogen for both tissue adhesion and coagulation, requiring large quantities and often incorporating fibrinogen as a free powder or distributed throughout the backing, which is inefficient and not primarily utilizing the film component for sealing.

Innovation Solution

A fibrinogen-based tissue adhesive patch with a biocompatible polyurethane polymer backing, where fibrinogen is incorporated into the surface rather than being distributed throughout, acting to attach the backing to tissue upon fluid contact, and comprising fibrinogen, thrombin, and CaCl2 in specific ratios, with optional additives for extended adhesion and biodegradability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fibrinogen is distributed throughout the backing or used as free powder, then coagulation function is achieved, but fibrinogen usage is excessive and adhesion efficiency is reduced

Engineering Contradiction:
Improvecoagulation functionVSAvoidfibrinogen usage
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent incorporates fibrinogen specifically at the surface of the polymer backing rather than distributing it throughout the entire backing structure. This localized placement ensures that fibrinogen is positioned exactly where it is needed for tissue adhesion and coagulation, eliminating waste of the coagulant while maintaining effective hemostatic function.

Inventive Principle:
Principle #3Local quality

2Reliability

If fibrinogen is incorporated into the polymer film, then adhesion to tissue is enhanced, but the film component is not primarily utilized for sealing

Engineering Contradiction:
Improvetissue adhesionVSAvoidsealing efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent divides the functional roles between two distinct components: the polymer backing provides the primary sealing function through its physical barrier properties, while the surface-incorporated fibrinogen provides the adhesion and coagulation function. This segmentation allows each component to optimize its specific role, with the film serving primarily for sealing and the fibrinogen layer providing targeted tissue attachment.

Inventive Principle:
Principle #1Segmentation

3Reliability

If large quantities of fibrinogen are used, then coagulation effectiveness is improved, but cost and material efficiency deteriorate

Engineering Contradiction:
Improvecoagulation effectivenessVSAvoidmaterial efficiency
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent pre-incorporates the required amount of fibrinogen into the surface of the polymer backing during manufacturing, rather than applying it separately at the time of use. This preliminary action ensures that the exact necessary quantity is already in place, eliminating the need for excessive application and preventing material waste while ensuring adequate coagulation effectiveness.

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 patch effectively seals tissues by attaching the polymer backing to the tissue, providing controlled release of fibrinogen and thrombin, enhancing adhesion and biodegradability, and demonstrating efficacy in sealing various bodily fluid leaks without the need for excessive fibrinogen usage.

Implementation Method 1

contact between said adhesive patch, a tissue, and a fluid, activates said fibrinogen sealant such that said activated fibrinogen sealant acts to attach said backing to said tissue

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS11071805B2Fibrinogen-based tissue adhesive patches
Publication Date: 2021.07.27 SEALANTIUM MEDICAL
  • US11071805B2 patent drawing
  • US11071805B2 patent drawing
  • US11071805B2 patent drawing

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 biocompatible polymer film comprises units of a biocompatible block copolymer such as a polyethylene glycol-polycaprolactone-DL-lactide copolymer connected by urethane linkages, and the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl2. In contrast to similar patches known in the art, 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, woven, or non-woven component. Methods of production and use of the patch are also disclosed.