Hemostatic Tissue Sealant Patch Adhesive Strength Measurement
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Solution Overview
Problem
Current methods lack a reliable and reproducible way to measure the adhesive strength of hemostatic tissue sealant patches, which is crucial for both design and quality control.
Innovation Solution
Measuring the force required to separate two identical hemostatic tissue sealant patches that are joined by the hemostatic sealant, involving attachment to surfaces, activation of the hemostatic agent, pressing them together, and then applying a force to detach them, allows for accurate and reproducible adhesive strength determination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional methods (tensile strength tester, ASTM D412-98a) are used to measure patch material strength, then mechanical strength can be determined, but adhesive strength of the hemostatic sealant cannot be accurately measured
Solution Approach 1:
The patent uses an intermediary substrate (release film, glass slide, or tissue) to mediate the adhesive strength measurement. The hemostatic sealant is applied between the test patch and the intermediary surface, allowing the adhesive properties to be measured in a controlled manner that conventional tensile testing cannot achieve. This intermediary approach enables accurate measurement of the sealant's adhesive strength to different surfaces.
2Measurement precision
If qualitative adhesion verification is used (cover slip on glass slide), then adhesion can be observed, but quantitative adhesive strength cannot be determined
Solution Approach 1:
The patent replaces the complex qualitative observation method with a standardized mechanical testing approach. By using a tensile strength tester or similar mechanical device to pull the patch away from the substrate at a controlled rate, quantitative adhesive strength data is obtained through force measurement, eliminating the need for complex qualitative assessment while providing precise numerical results.
3Reliability
If hemostatic agent is activated during testing, then realistic adhesive conditions are simulated, but measurement variability increases
Solution Approach 1:
The patent applies preliminary action by pre-activating the hemostatic agent (fibrinogen-thrombin mixture) on the patch or substrate before the adhesive strength test. This allows the hemostatic reaction to begin in advance, creating realistic adhesive conditions while maintaining control over the activation process. The standardized activation protocol ensures consistent and reproducible results across multiple tests.
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 a more reliable and reproducible measurement of adhesive strength, enabling effective quality control and ensuring patches meet predetermined standards.
Implementation Method 1
a hemostatic agent such as fibrin or a combination of fibrinogen and thrombin
Data Source
AI summary
A method for measuring the adhesive strength of a hemostatic tissue patch. Two patches are attached to facing surfaces with a side that would normally seal tissue exposed. Liquid is placed on one of the patches to activate the hemostatic agent, the patches held together long enough to adhere to one another, and then pulled apart. The force necessary to detach them is measured, thereby providing a determination of the adhesive strength of the patch. In contrast to literature methods, the inventive method provides excellent reproducibility.