Multilaminate resorbable biomedical device under biaxial loading

Abstract

The design and test of a multilaminate sheet developed for a hernia repair application is presented. As biomaterial applications become more complex, characterization of uniaxial properties becomes insufficient and biaxial testing becomes necessary. A measure of the in-plane biaxial strength of the device is inferred from a ball burst test. The results of this test for different thicknesses of the device are correlated with the uniaxial strength of the material. A biaxial test such as the ball burst test is more indicative of the properties of a planar material than would be a uniaxial test. The interactions in the biaxial mode of failure are of value and can be related back to a classical uniaxial tensile test from the ball burst test. The material used in this study to fabricate the device was a resorbable biomaterial called small intestinal submucosa (SIS). The effects of rehydration on the stiffness and associated ball burst properties of the SIS device were also measured. It is shown that at a rehydration time of 5 min from a reference dry state, steady-state mechanical properties are reached.

Effects of carbodiimide crosslinking conditions on the physical properties of laminated intestinal submucosa

“…In an earlier study, cells were able to infiltrate between the layers of lightly crosslinked constructs due to the low lamination strength (8.1 N/m) while few cells were observed between the layers of the highly crosslinked construct (lamination strength 19.8 N/m). 24 In a previous study investigating laminated structures of small intestinal submucosa without chemical modification, 8 the adhesion strength between the layers was not reported. Our experience has been that without chemical crosslinking the lamination strength is insufficient for surgical use.…”

“…The complex organization of native connective tissues such as pericardium, 1 dura, 2,3 skin, 4 and fascia 5 often can provide the strength needed for surgical repair. One such collagenous tissue, the small intestinal submucosa (SIS), appears to possess the requisite biocompatibility and strength [6][7][8] for use in a variety of applications and has the potential to be remodeled by the host. Applications include tendon, 9 dura, 10 bladder, 11,12 abdominal wall, 13,14 and vascular conduits.…”

Analytically derived material properties of multilaminated extracellular matrix devices using the ball-burst test

“…Xenogeneic porcine small intestinal submucosa (SIS) has been used as biological scaffolds for repair of vascular structures [4][5][6][7][8], lower urinary tract structures [2,9,10], esophageal [11] and musculotendinous defects [12][13][14][15]. However, relatively little has been published regarding the mechanical and material properties of these ECM scaffolds [16][17][18][19][20].…”

Mechanical evaluation and design of a multilayered collagenous repair biomaterial

“…It has been used in several forms in vascular applications and repair of the urinary bladder and Achilles' tendon. [1][2][3][4][5] In these studies, SIS was gradually absorbed by the host organism while concurrently being replaced by host tissue.…”

“…More recently, Whitson et al performed a ball burst test wherein a steel ball was pushed into a sheet of an SIS composite material until it ruptured. 5 The in vivo two-dimensional stress-strain properties cannot be derived from this test because the stress distribution in the tissue is unknown and is not constant throughout the specimen.…”