Standard Test Method for Strength Properties of Tissue Adhesives in Tension

Abstract

4.1 The utility, range, and efficacy of adhesives in clinical medicine are well documented in the literature. Whether being used as an adhesive, hemostatic, sealant, or carrier for drugs or growth factors, or both, the scope of adhesive use in clinical medicine continues to expand. There are several factors which are vital to the success and efficacy of a medical tissue adhesive, including: (1) adequate tissue bonding strength, (2) tissue compatibility, (3) acceptable biodegradable properties when the adhesive is used internally, (4) availability, (5) ease of application, and (6) cost. 4.2 Medical adhesives are currently used for a variety of applications and tissue types. Applications range from fixation of external tissues to internal application for use with either similar or dissimilar opposing surfaces. While the biological or chemical makeup, or both, of the adhesive may define its characteristics, additional mechanical factors including adhesive volume or method of application, or both, may also contribute significantly toward the performance of the adhesive. In an effort to fairly and adequately quantify adhesive bonding strength for medical adhesives, it is important to develop a consistent, reproducible testing standard for evaluative and comparative purposes. Due to the fact that the adhesives will be used on or in living tissues, a readily available biological testing surface is preferred. 4.3 The data generated from a standardized testing method on biologic tissue may vary from that found in vivo, however, testing results should offer valuable information on the potential bonding capacity and for the preparation of subsequent in vivo experiments. 4.4 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure), is such that the results of a tensile test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors. 4.5 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.