A. Cordón

Comparison of the mechanical behaviors of biological tissues subjected to uniaxial tensile testing: pig, calf and ostrich pericardium sutured with Gore-Tex

The purpose of this study was to compare the mechanical behavior of calf pericardium, pig pericardium and ostrich pericardium when subjected to tensile testing. Tensile stress was applied to 108 tissue samples, 36 of each type of tissue, until rupture. Groups of three adjacent strips measuring 12 x 2 cm(2) were cut longitudinally. Each group consisted of an unsutured center sample, or control, and the two contiguous samples, that on the right sutured with Gore-Tex at a 90 degrees angle with respect to the longitudinal axis and that on the left sewn with the same suture material at 45 degrees angle. The sutured samples showed a statistically significant loss of resistance (p<0.001) when compared with the corresponding unsutured tissue. The mean stresses at rupture for sutured ostrich pericardium were 21.81 and 20.81 MPa in the samples sewn at 45 degrees and 90 degrees, respectively, higher than those corresponding to unsutured calf and pig pericardium, 14.0 and 11.49 MPa, respectively, at rupture. The analysis of the stress/strain curve shows a smaller difference between sutured and unsutured ostrich pericardium than those observed in the other two biomaterials. These results demonstrate that, in addition to its greater resistance, ostrich pericardium also presents a less pronounced interaction with the suture material. Its capacity to absorb the shearing stress produced by the suture is greater. This report also confirms that the method of selection using paired samples ensures their homogeneity and makes it possible to predict the behavior of a sample by determining that of the other half of the pair.

Chemical treatment and tissue selection: factors that influence the mechanical behaviour of porcine pericardium

Calcification and mechanical failure are the major causes of the loss of cardiac bioprostheses. The chemical treatments used to stabilize the tissue employed are considered to play a fundamental role in the development of these two phenomena, although the problem is multifactorial and the underlying causes are yet to be fully identified. Currently, there is an ongoing search for chemical treatments capable of reducing or eliminating the process of calcification while preserving the mechanoelastic characteristics of the tissue. One of the approaches to this effort is the elimination of the phospholipid component from the biological tissue employed in prosthesis construction. There is evidence that this component may be responsible for the precipitation of calcium salts. The present study compares two delipidating chemical treatments involving chloroform/methanol and sodium dodecyl sulfate (SDS) with the use of glutaraldehyde (GA) alone. For this purpose, porcine pericardial tissue was subjected to tensile strength testing employing a hydraulic simulator. A total of 234 samples were studied 90 treated with GA, 72 treated with chloroform/methanol and 72 treated with SDS. The mean breaking strength was significantly higher in the samples treated with GA (between 43.29 and 63.01 MPa) when compared with those of tissue treated with chloroform/methanol (29.92-42.30 MPa) or with SDS (13.49-19.06 MPa). In a second phase of the study, selection criteria based on morphological and mechanical factors were applied to the pericardial membranes employing a system of paired samples. The mathematical analysis of the findings in one fragment will aid in determining the mechanical behavior of its adjacent twin sample. In conclusion, the anticalcification chemical treatments tested in the experimental model conferred a lesser mechanical resistance than that obtained with GA. On the other hand, the utilization of paired samples was found to be useful in the prediction of the mechanical behavior of porcine pericardial tissue. Nevertheless, in order for our method of selection to be considered the most adequate approach, it will be necessary to validate these findings in dynamic studies involving a real, functional model.

Resistance and elasticity of the suture threads employed in cardiac bioprostheses

The mechanoelastic features of five types of sutures were studied. The breaking stress for each was determined by means of tensile tests in which a constant strain rate was applied, and a tensile test with graduated stress and relaxation defined the elastic limit, i.e. the point beyond which deformation becomes irreversible. The study of the stress-strain curve during this elastic period enabled us to obtain the mathematical function that governs these reversible deformations, which shows excellence of fit (R2 > 0.98). The prime derivative at each point of the resulting functions is the elastic modulus, the best parameter for comparing the elasticities of the suture threads. Since breaking stress alone does not suitably define the mechanical quality of a suture, we propose the use of other parameters during the elastic period, such as percentage of elongation at a point 10 times lower than the elastic limit (safety coefficient of 10), and tensile stress and elastic modulus at the said point, which are more reliable in the assessment of the resistance and elasticity of these threads.

Ostrich pericardium, a biomaterial for the construction of valve leaflets for cardiac bioprostheses: mechanical behaviour, selection and interaction with suture materials

The mechanical behavior of ostrich pericardium was studied for the purpose of assessing its utility in the construction of bioprosthetic cardiac valve leaflets. The tissue was tested biaxially using a hydraulic simulator that subjected it to increasing stress until rupture. One hundred eighty trials were performed, 36 with unsutured pericardium and four series of 36 trials each with pericardium sutured with silk, Prolene, nylon or Gore-Tex. The samples were tested in pairs from three different pericardial regions. One sample from each pair (the predictive specimen) was assessed according to morphological and mechanical criteria, while the other (the predicted or selectable specimen) was subjected only to morphological analysis. The findings show that ostrich pericardium treated with glutaraldehyde according to standard methods has an excellent resistance to rupture in biaxial testing, withstanding stresses of up to 100 MPa, and never lower than 30 MPa. Its resistance to rupture is lowered by suturing, a loss that is less pronounced when silk sutures are used. The results with Gore-Tex are very homogeneous and the elastic behavior of the pericardium/suture unit appears to be similar to that of unsutured tissue, suggesting that the interaction between the two biomaterials is minor. Similar results were observed in the series sutured with Prolene and nylon. The use of paired samples makes it possible to closely estimate the mechanical behavior of the tissue in a given zone by determining that of its mate. The statistical study shows that this estimation is not conditioned by the suture employed, thus validating this approach and providing more precise criteria for tissue selection.

Elastic behaviour of sutured calf pericardium: influence of the suture threads

The purpose of this study was to assess the elastic behaviour of calf pericardium used in the construction of cardiac bioprosthesis valve leaflets, sutured with different types of commercially available sutures: silk, Gore-Tex, Surgilene and nylon. Thirty-two samples (four series of eight samples each) were subjected to tensile strength testing to breakage. The breaking stress (MPa) ranged between 4.89 MPa for samples sutured with Gore-Tex and 5.22 MPa for those sewn with nylon. Three samples from each series were subjected to a stepwise stress test, involving increasing levels of stress followed by return to zero, to define the elastic limit (the cut-off point beyond which strain is no longer reversible). Analysis of the results provided the mathematical functions that govern the elastic behaviour (stress/strain) within the elastic range for each type of sutured sample. The series sutured with Surgilene presented the highest mean value (1.649 MPa). Finally, a statistical study was carried out to determine which series showed the greatest probability of having the least interaction between the thread and the pericardium. Allowing an interval of +/- 10%, Gore-Tex showed the best probability in this respect. However, real fatigue testing is necessary to definitively determine which is the best suture to use.

Uniaxial and biaxial tensile strength of calf pericardium used in the construction of bioprostheses: biomaterial selection criteria.

Using morphological and mechanical criteria and applying a method involving paired samples that is widely employed in epidemiology, we obtained an excellent prediction of the mechanical behavior of the calf pericardium used in the construction of cardiac bioprostheses. The method of selection employed in this study may be a highly useful tool for guaranteeing the mechanical resistance of calf pericardium, with a very low level of error.

ANALYSIS OF SHEARING STRESS IN THE LIMITED DURABILITY OF BOVINE PERICARDIUM USED AS A BIOMATERIAL

The objective of the study was to determine the shearing stress exerted by the suture thread under conditions of normal working stress. Thirty-six samples of calf pericardium, similar to that employed in the manufacture of bioprosthetic cardiac valve leaflets, were subjected to tensile testing. Prior to the trial, a continuous suture was sewn in the central zone of each sample, at a 45° angle to the longest axis of the sample, using commercially-available threads (silk, Gore-Tex, Surgilene and nylon). Application of the Mohr circle for combined wear revealed that the shearing stress ranged between 2.68-fold greater (for samples sewn with silk) and 5.48-fold greater (for samples sewn with nylon) than the working tensile stress in the region of the suture. It is concluded that the shearing stress is responsible for the limited durability of sutured samples of calf pericardium prepared to simulate bioprosthetic cardiac valve leaflets.

Resistance and Stability of A New Method for Bonding Biological Materials Using Sutures and Biological Adhesives

The valve leaflets of cardiac bioprostheses are secured and shaped by sutures which, given their high degree of resistance and poor elasticity, have been implicated in the generation of stresses within the leaflets, contributing to the failure of the bioprostheses. Bioadhesives are bonding materials that have begun to be utilized in surgery, although there is a lack of experience in their use with inert tissues or bioprostheses. Tensile testing is performed until rupture in samples of calf pericardium, a biomaterial employed in the manufacture of bioprosthetic heart valve leaflets. One hundred and thirty-two trials are carried out in three types of samples: intact or control tissue (n = 12); samples transected and glued in an overlapping manner with a cyanoacrylate (n = 60); and samples transected, sewn with a commercially available suture material and reinforced at the suture holes with the same cyanoacrylate (n = 60). Seven days after their preparation, 12 samples from each group, including the controls, are subjected to tensile testing until rupture and the findings are compared. In the stability study, groups of 12 each of the remaining 48 glued and 48 sutured and glued samples underwent tensile testing until rupture on days 30, 60, 90, and 120, after their preparation. The results show that bonding with the adhesive provided a resistance ranging between 1.04 and 1.87 kg, probably insufficient for use in valve leaflets, but also afforded a high degree of elasticity. After 120 days, both the glued and the sutured and glued series show excellent elastic behavior, with no rigidity or hardening of the pericardium. These samples present reversible elongation, or strain, when they surpass their elastic limit at rupture. This finding may be due to a load concentration that is damaging to the pericardium, to the behavior of the tissue as an amorphous material, or perhaps to both circumstances. These results need to be confirmed in future studies as they may be of value in the design and manufacture of cardiac bioprostheses.

Mechanical effects of increases in the load applied in uniaxial and biaxial tensile testing. Part II. Porcine pericardium.

The authors analyzed the mechanical behavior of the calf pericardium employed in the construction of valve leaflets for cardiac bioprostheses. Forty samples of pericardium were subjected to uniaxial tensile testing, 20 as controls and 20 exposed to loads increasing stepwise until rupture, with a return to zero load between each new increment. Another 20 samples were used similarly in biaxial tensile tests involving loads increasing stepwise until rupture, again returning to zero load between steps. The ultimate stresses in the uniaxial study were very similar and were not influenced by the region of pericardial tissue being tested or the increments in load to which the tissue was exposed. The mean stresses at rupture in the stepwise biaxial assays were significantly greater (p<0.01). Using morphological and mechanical criteria for sample selection, it was possible to obtain mathematical fits for the stress/strain relationship in both types of assays, with excellent coefficients of determination (R 2>0.90). In uniaxial tests in which the selection criteria were not applied, the correlation improved as the load increased, a phenomenon that did not occur in the biaxial studies. The values varied throughout the different cycles, adopting exponential forms when the strain was greatest. These variations, which demonstrate that the increase in the energy consumed is a function of the stress applied and of the strain produced, should be good parameters for assessing the changes in the collagen fiber architecture of pericardial tissue subjected to cyclic stress, and may help to detect early failure.

Influence of the Selection of the Suture Material on the Mechanical Behavior of a Biomaterial to be Employed in the Construction of Implants. Part 1: Calf Pericardium

A hydraulic stress simulator was employed to study the mechanical behavior of the calf pericardium used in the construction of cardiac valve leaflets. One hundred eighty pairs of tissue samples were subjected to tensile testing to rupture. One of the two samples from each of 144 pairs (four series of 36 pairs each) was sutured with commercially available threads made of nylon, silk, Prolene or Gore-Tex, while the other sample in each of these pairs was left unsewn. The remaining 36 pairs were employed as controls in which neither of the two samples was subjected to suturing. The sutured tissue samples showed a significant decrease in tensile strength at rupture (range: 11.81 to 26.04 MPa) when compared with unsutured samples (range: 39.38 to 87.96 MPa; p < 0.01). The application of morphological and mechanical selection criteria to maximize the homogeneity of the samples provided excellent fit with respect to the stress/strain curves. This method made it possible to carry out a predictive study of the mechanical behavior of a sutured sample, based on that observed in the corresponding unsutured fragment. The interaction of the different suture materials with the pericardial tissue was also assessed by comparing the mechanical behavior of the sutured samples with that of the control samples. At stresses of less than 0.8 MPa, samples sewn with Gore-Tex were found to show the least difference with respect to the controls, indicating that this material presented the lowest degree of interaction with the pericardium. In conclusion, the degree of the loss of resistance to tearing of the sutured samples is of no value in the selection of the optimal suture material. The selection process applied makes it possible to predict the mechanical behavior in response to suturing of a given unsewn tissue specimen by determining that of its sutured mate. The similarity between the findings in samples sewn with Gore-Tex and in the unsutured controls indicates a lesser degree of interaction between thesuture material and the pericardium employed in the construction of cardiac valve leaflets.