Corticosteroid-Free Fibrin Sealant for Annulus Fibrosus Defect Sealing
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Solution Overview
Problem
Current fibrin sealants used to treat disc problems, particularly those containing corticosteroids, do not provide superior results in addressing leaks through defects in the annulus fibrosus and restoring normal disc height and hydrostatic pressure effectively.
Innovation Solution
A fibrin sealant composition comprising fibrinogen and thrombin, without corticosteroids, is injected into the spinal area to form fibrin, which can include calcium ions and optional additives, to seal defects in the annulus fibrosus, thereby reducing leakage and restoring disc health.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fibrin sealant containing corticosteroid is injected into the disc, then anti-inflammatory effect is provided, but clinical outcomes and pain relief are inferior compared to corticosteroid-free sealant
Solution Approach 1:
The patent removes corticosteroids from the fibrin sealant composition, extracting the problematic component that caused inferior clinical outcomes while maintaining the essential fibrinogen-thrombin sealing mechanism. This extraction principle resolves the contradiction by eliminating the harmful element without compromising the core therapeutic function.
Solution Approach 2:
The patent changes the compositional parameters of the sealant by excluding corticosteroids and optimizing the fibrinogen-thrombin ratio, along with adjusting calcium ion concentration. These parameter changes improve clinical outcomes and pain relief while maintaining sealant functionality.
2Reliability
If fibrin sealant is injected into the disc, then defects in annulus fibrosus are sealed, but restoration of near-normal hydrostatic pressure and disc height is achieved only without corticosteroids
Solution Approach 1:
The patent extracts corticosteroids from the sealant formulation, removing the component that interfered with optimal sealing and pressure restoration. This allows the fibrin network to form and function without the negative effects of corticosteroid interference.
Solution Approach 2:
The patent uses a composite approach by combining fibrinogen, thrombin, and calcium ions in a specific formulation that works synergistically to achieve both sealing and pressure restoration. The composite material excludes corticosteroids to maintain optimal performance.
3Reliability
If conventional fibrin sealant composition is used, then hemostasis is achieved, but superior pain relief and disc height restoration are not obtained
Solution Approach 1:
The patent optimizes the parameters of the fibrin sealant by adjusting the concentrations of fibrinogen, thrombin, and calcium ions, while excluding corticosteroids. These parameter changes enhance both hemostatic function and pain relief outcomes without increasing formulation complexity.
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 composition provides superior pain relief and effectively seals defects in the annulus fibrosus, restoring near-normal hydrostatic pressure and disc height, outperforming sealants with corticosteroids in clinical outcomes.
Implementation Method 1
The sealant comprises fibrinogen and an activating compound such as thrombin, which form fibrin when mixed
Implementation Method 2
Calcium ions, such as supplied from calcium chloride, may be included in the fibrin sealant
Data Source
AI summary
A method and kit for 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, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.