Dural Fibrin Sealing for Hard-to-Access CSF Leaks
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Solution Overview
Problem
Existing methods for sealing cerebrospinal fluid (CSF) leaks in the dural space are inefficient due to the difficulty in identifying the leak site and accessing it, especially in anatomically challenging areas, and conventional hemostatic agents are ineffective because CSF lacks sufficient fibrinogen to promote hemostasis.
Innovation Solution
Injecting a fibrinogen-containing solution into the dural space and applying a sealing member with a fibrinogen polymerizing agent, such as thrombin, to increase local fibrinogen concentration and form a polymerized fibrin clot, thereby sealing the leak.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional hemostatic agents are used to seal CSF leaks, then the sealing process is simplified, but the agents are ineffective because CSF lacks sufficient fibrinogen to promote hemostasis
Solution Approach 1:
The patent applies preliminary action by pre-loading fibrinogen into the dural space before the sealing process. The fibrinogen is injected in advance through an applicator, allowing it to be present and ready when the polymerizing agent is applied, thus enabling effective hemostasis despite the naturally low fibrinogen levels in CSF
Solution Approach 2:
The patent changes the parameter of fibrinogen concentration in the dural space from its naturally low level to a high concentration suitable for hemostasis. This is achieved by injecting exogenous fibrinogen solution, thereby altering the chemical composition and concentration parameters to enable effective sealing with conventional hemostatic agents
2Reliability
If hemostatic dressings or sealants are applied to seal CSF leaks, then sealing can be achieved, but difficulty in identifying and accessing the leak site reduces efficacy
Solution Approach 1:
The patent uses an applicator as an intermediary device to deliver fibrinogen directly into the dural space through the dural tissue. This intermediary tool enables access to the interior dural space without requiring direct visualization or complex surgical exposure of the leak site, thus improving ease of operation while maintaining sealing reliability
Solution Approach 2:
The patent transitions from surface-level application of sealants to intradural injection of fibrinogen. By moving the sealing action into the third dimension (inside the dural space), the method bypasses the limitations of external access and allows sealing to occur at the actual leak site regardless of its anatomical location
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 method significantly increases the local fibrinogen concentration to plasma levels, effectively plugging the leak and preventing further CSF loss, thus minimizing health complications.
Implementation Method 1
forming a polymerized fibrinogen or polymerized fibrin clot by contacting the injected fibrinogen-containing solution and the fibrinogen polymerizing agent
Data Source
Figure 1~2
AI summary
A method and kit for stopping cerebrospinal fluid (CSF) leaks, comprising penetrating and passing through a dural tissue an applicator to access an interior dural space, injecting from the applicator a fibrinogen-containing solution into said dural space, applying a sealing member containing a fibrinogen polymerizing agent onto an exterior surface of the dural tissue, and forming a polymerized fibrinogen or polymerized fibrin clot by contacting the injected fibrinogen-containing solution and the fibrinogen polymerizing agent.