Multi-Layer Fibrin Sealant for Deep Wound Hemostasis

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Solution Overview

Problem

Current methods for initiating blood clotting in severe wounds, especially in situations where immediate medical treatment is unavailable, face challenges in effectively accessing and applying hemostatic products to wounds beneath the body surface, such as penetrating injuries.

Innovation Solution

A fibrin sealant product comprising multiple layers of electrospun dextran support with fibrin sealant agents like thrombin and fibrinogen, designed to dissolve upon contact with liquid, releasing the agents to promote hemostasis and seal wounds, including those leaking cerebral spinal fluid, without leaving residual foreign bodies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional hemostatic products are applied to severe wounds, then blood clotting can be initiated, but it is difficult to access and apply these products to wounds beneath the body surface such as penetrating injuries

Engineering Contradiction:
ImproveEase of application to deep woundsVSAvoidEffectiveness in stopping blood loss
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent employs a thin film structure that can be easily applied to wounds including deep penetrating injuries. The film format allows for simple placement over the wound site without requiring direct access to the deep bleeding area, while still delivering hemostatic agents effectively to the target location.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent uses an intermediary delivery system where hemostatic agents are incorporated into a film or fiber structure that acts as a mediator between the external application and the deep wound site. This intermediary structure facilitates the transport and release of clotting factors at the target location.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If electrospun dextran fibers are used as a hemostatic product, then the product dissolves rapidly in liquid to release agents, but the fibers may not provide sufficient structural support

Engineering Contradiction:
ImproveRapid dissolution and agent releaseVSAvoidStructural support
Core Design Contradiction:
ProductivityVSStrength

Solution Approach 1:

The patent creates composite structures combining electrospun dextran fibers with other materials that provide structural support. The composite nature allows the dextran component to dissolve rapidly and release hemostatic agents while the supporting matrix maintains structural integrity during application and initial wound contact.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The electrospun fiber structure serves multiple functions simultaneously: providing structural support as a scaffold, delivering hemostatic agents through rapid dissolution, and potentially offering additional therapeutic benefits. This multi-functionality resolves the contradiction between needing strength and rapid dissolution.

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

3Reliability

If a fibrin sealant product with multiple layers is created, then hemostatic efficacy is improved, but the product complexity increases

Engineering Contradiction:
ImproveHemostatic efficacyVSAvoidProduct structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the fibrin sealant product into multiple functional layers, each containing specific hemostatic agents or components. This segmentation allows for optimized delivery of different clotting factors while maintaining a structured yet manageable product design that can be manufactured and applied effectively.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent combines multiple hemostatic components and agents into a single integrated multi-layer product structure. This merging approach consolidates what would otherwise require multiple separate applications into one unified product, improving efficacy without proportionally increasing operational complexity.

Inventive Principle:
Principle #5Merging (Combining)

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 fibrin sealant product effectively initiates rapid blood clotting and seals wounds, reducing blood loss and cerebral spinal fluid leakage, while being customizable in shape and size, and biocompatible to minimize immune reactions and foreign body responses.

Implementation Method 1

designed to dissolve upon contact with liquid, releasing the agents

Methodology Applied
Scientific EffectDissolution: Solvation

Implementation Method 2

The cascade involves two pathways that ultimately lead to the production of the enzyme thrombin, which catalyzes the conversion of fibrinogen to fibrin. Fibrin is then cross-linked to form a clot, resulting in hemostasis.

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS10953128B2Fibrin sealant products
Publication Date: 2021.03.23 ST TERESA MEDICAL
  • US10953128B2 patent drawing

AI summary

A fibrin sealant product having a plurality of layers that each includes a dextran support and at least one fibrin sealant agent. The at least one fibrin sealant agent is placed on the dextran support to form each of the layers. The plurality of layers is placed in a stacked configuration to form the fibrin sealant product. A plurality of crimps is dispersed over a surface of the fibrin sealant product to retain the plurality of layers in a position with respect to each other.