Fibrin Sealant for Spinal Disc Leakage

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Solution Overview

Problem

Current fibrin sealant compositions containing corticosteroids for treating disc problems in the spinal area do not provide superior results in reducing nucleus pulposus leakage through annulus fibrosus defects, and they do not effectively restore normal disc height and hydrostatic pressure.

Innovation Solution

Injecting a fibrin sealant composed of fibrinogen and thrombin, reconstituted with additives such as calcium ions, into the spinal area to form fibrin, without corticosteroids, which seals defects in the annulus fibrosus and restores disc height and hydrostatic pressure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If fibrin sealant containing corticosteroids is injected into the disc, then inflammation is reduced, but pain relief and leakage reduction are not superior

Engineering Contradiction:
ImproveinflammationVSAvoidpain relief effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The invention removes corticosteroids from the fibrin sealant composition entirely. The patent demonstrates that corticosteroid-free fibrin sealant provides superior pain relief and leakage reduction compared to corticosteroid-containing formulations, extracting the harmful or ineffective component while maintaining therapeutic benefits through the fibrinogen-thrombin-fibrin mechanism alone.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If conventional fibrin sealant is used, then hemostasis is achieved, but disc height and hydrostatic pressure are not restored

Engineering Contradiction:
ImprovehemostasisVSAvoiddisc height
Core Design Contradiction:
ReliabilityVSShape

Solution Approach 1:

The invention changes the physical and chemical parameters of the fibrin sealant by reconstituting fibrinogen and/or thrombin with solutions containing specific additives (such as calcium ions from calcium chloride). These parameter changes enable the sealant to not only achieve hemostasis but also restore disc height and hydrostatic pressure, addressing both hemostatic and structural requirements.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If fibrinogen and thrombin are reconstituted with solution containing additives, then superior results are achieved, but composition complexity increases

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidsealant composition
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention segments the sealant into separate reconstitutable components (fibrinogen and thrombin) that can be prepared independently with specific additives. This segmentation allows for controlled complexity - each component can be reconstituted with necessary additives (such as calcium ions) to achieve superior results, while the modular structure maintains manageable composition and preparation processes.

Inventive Principle:
Principle #1Segmentation

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

This method provides superior pain relief and effectively reduces nucleus pulposus leakage through annulus fibrosus defects, achieving near-normal hydrostatic pressure without the use of corticosteroids, as demonstrated by improved VAS scores and prolonged pain relief in patients.

Implementation Method 1

The sealant comprises fibrinogen and an activating compound such as thrombin, which form fibrin when mixed

Methodology Applied
Scientific EffectEnzymatic conversion: Enzyme

Implementation Method 2

Calcium ions, such as supplied from calcium chloride, may be included in the fibrin sealant

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS8206448B2Injection of fibrin sealant using reconstituted components in spinal applications
Publication Date: 2012.06.26 PAUZA KEVIN
  • US8206448B2 patent drawing
  • US8206448B2 patent drawing
  • US8206448B2 patent drawing

AI summary

A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.