Method for determining the adhesive force of a hemostatic tissue sealant patch
Inventors
Laub, Orgad • Cohen, Eran • Schwartz, Yotam
Assignees
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Publication Number
US-11662299-B2
Publication Date
2023-05-30
Expiration Date
Abstract
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.
Core Innovation
The invention provides a quantitative, reproducible method for determining the adhesive strength of a hemostatic tissue sealant patch. The method uses a hemostatic tissue sealant patch comprising at least one tissue sealing surface and a hemostatic agent, and determines adhesive strength by measuring adhesive force during detachment of two patches that have been made to adhere to each other.
The method includes attaching a first and a second hemostatic tissue sealant patch to respective first and second surfaces so that the tissue sealing surface of each patch remains exposed. The hemostatic agent is activated on at least one patch, and the tissue sealing surfaces of the hemostatic sealant patches are pressed together for a first predetermined time so that the patches adhere one to the other.
After the first predetermined time, a force is applied opposite in direction from that applied during pressing, and the force required to fully detach the hemostatic sealant patches one from the other is measured to determine adhesive strength. The disclosed approach is stated to improve reproducibility versus prior proxy-based approaches that used other detachment substrates.
The document further describes quality-control use of the adhesive-strength determination, including example adhesive-force datasets and comparative results for a suspect batch versus a regular protocol and for a condition involving an increased amount of fibrinogen.
Claims Coverage
The document provides one independent claim directed to determining adhesive strength of hemostatic tissue sealant patches using a specific double-patch attach/activate/press/detach-and-measure workflow. Dependent claims add multiple inventive features, including patch geometry, attachment options, fluid activation, and quantitative press/detachment-force constraints.
Double-patch workflow for measuring adhesive strength
Attaching a first and a second hemostatic tissue sealant patch to respective surfaces such that the tissue sealing surfaces remain exposed, activating the hemostatic agent on at least one patch, pressing together the tissue sealing surfaces for a first predetermined time to cause adhesion, applying a force opposite in direction from that applied during pressing, and measuring the force required to fully detach the patches to thereby determine adhesive strength.
Circular patch with defined area
The first and second hemostatic tissue sealant patches are circular and each has an area of 2 cm^2.
Threshold detachment-force requirement
Attaching hemostatic tissue sealant patches to surfaces such that detaching each patch from the surface requires at least 50 N of force.
Attachment by gluing or double-sided tape
Attaching hemostatic tissue sealant patches to surfaces using a method selected from gluing or taping with double-sided tape.
Activation using phosphate-buffered saline (PBS)
Applying a phosphate-buffered saline (PBS) solution to the exposed surface of the first hemostatic sealant patch.
Pressing with about 5 N for about 3 minutes
Pressing the tissue sealing surfaces of the hemostatic sealant patches together with a force of about 5 N for about 3 minutes for a first predetermined time.
Overall claim coverage centers on a quantitative adhesive-strength determination method that activates a hemostatic agent, bonds two exposed tissue sealing surfaces by pressing for a first predetermined time, then measures the opposite-direction force required to fully detach the patches. Dependent features further constrain patch form factor and attachment modality, specify PBS-based activation, and add quantitative press and detachment-force conditions.
Stated Advantages
Improved reproducibility compared with prior proxy-based methods.
Enables quality control of hemostatic tissue sealant patches using adhesive-force determination datasets and comparisons between protocols and batches.
Documented Applications
Quality-control protocol use of the adhesive-strength determination, including comparisons for a suspect batch versus a regular protocol and comparisons involving different fibrinogen amounts.
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