Fibrin Tissue Patch for Wet Hemostasis
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Solution Overview
Problem
Current tissue sealants and hemostatic agents are inadequate in wet or 'bleeding' applications, lacking optimal adhesive properties, mechanical strength, and durability for effective arterial blood loss prevention.
Innovation Solution
Development of a tissue patch comprising a primer region and a solid matrix of fibrin or fibrinogen, which is cross-linked and configured for application to a tissue surface, using a syringe system to concentrate and polymerize fibrinogen into fibrin, enhancing adhesive properties and mechanical strength.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current tissue sealants and hemostatic agents are used, then they can provide some hemostatic function, but they lack optimal adhesive properties and mechanical strength for wet or bleeding applications
Solution Approach 1:
The invention uses a composite material system consisting of fibrinogen, thrombin, and calcium ions that work together to form a fibrin clot with enhanced mechanical properties. This composite approach combines the adhesive properties of fibrin with the structural strength provided by cross-linked fibrin networks, resolving the contradiction between hemostatic effectiveness and mechanical strength in wet conditions
2Ease of operation
If current tissue sealants are used, then they can be applied relatively simply, but they lack durability and tensile strength for preventing arterial blood loss
Solution Approach 1:
The invention changes the physical and chemical parameters of the sealant by controlling the concentration of fibrinogen, thrombin, and calcium ions, as well as the pH and ionic strength of the solution. These parameter adjustments enable the formation of a durable, tensile-strength-rich fibrin clot that maintains integrity over time while remaining simple to apply
3Adaptability or versatility
If fibrin sealant is used, then it can provide topical hemostasis and tissue approximation, but it degrades physiologically and lacks sufficient tensile strength for suturing
Solution Approach 1:
The invention creates local quality variations within the fibrin clot by controlling cross-linking density and fibrin fiber orientation in different regions. This results in areas of high tensile strength suitable for suturing while maintaining overall biocompatibility and physiological degradation, thus resolving the contradiction between clinical versatility and tensile strength
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 tissue patch provides improved adhesive properties and mechanical strength, allowing effective hemostasis and tissue reinforcement in wet conditions, addressing the shortcomings of existing sealants.
Implementation Method 1
In the presence of thrombin, fibrinogen is converted to fibrin
Implementation Method 2
fibrinogen is converted to fibrin... promotes polymerization and/or cross-linking of the fibrin chains to form long fibrin strands
Implementation Method 3
Factor XIII, which stabilizes the clot, by promoting polymerization and/or cross-linking of the fibrin chains
Implementation Method 4
This process usually occurs in the presence of calcium ions
Data Source
AI summary
Tissue patches and associated systems and methods are described. Certain embodiments are related to inventive systems and methods in which tissue patches can be made quickly and robustly without the use of complicated fabrication or sterilization equipment. For example, in some embodiments, tissue patches are made by applying a compressive force to a liquid medium comprising fibrinogen (and/or fibrin) between two surfaces (e.g., within a syringe or other chamber). A filter can be placed within or near the volume in which the compressive force is applied to the liquid medium such that unwanted material (e.g., water, blood cells, and the like) is passed through the filter while desirable components (e.g., fibrin, fibrinogen, and/or other desirable components) are retained by the filter to form the patch. In this way, the concentration of fibrin (and/or fibrinogen) within the liquid medium can be increased, potentially dramatically, as the compressive force is applied to the liquid-containing composition. In addition, in some embodiments, at least a portion of the fibrinogen and/or fibrin can chemically react (e.g., the fibrinogen can polymerize to form fibrin and/or the fibrin can cross-link) during application of the compressive force. Reaction and concentration can lead to the formation of a highly-concentrated, mechanically robust patch that can be handled relatively easily and provide good structural reinforcement at a wet site, such as a bleeding wound.