Compliance of Textile Vascular Prostheses Is a Fleeting Reality.

OBJECTIVE: Compliance is considered to be a major property influencing the long term performances of synthetic vascular substitutes that could play a role in anastomotic false aneurysm and intimal hyperplasia stenosis onset. Over the last decades, manufacturers have tried to develop substitutes that mechanically mimic arterial properties and avoid a compliance mismatch at the anastomoses in particular. However, data are missing about how initial compliance properties could change with time. The goal of this study was to evaluate how the compliance of vascular grafts evolves under cyclic loading conditions in vitro. METHODS: The compliance of three different models of commercially available textile polyethylene terephthalate (PET) grafts was evaluated. Tests were performed with and without their original coating. Compliance was assessed with a specific device dedicated to measure the deformations undergone by a graft under cyclic pressure loading conditions, using image analysis software. In each experiment, image analysis was performed under 60 and 140 mmHg pressure loading conditions at loading start (H0) and after three, six, and 24 h (H3, H6, H24) loading time. Average radial, longitudinal, and volumetric compliance was calculated from the obtained images. RESULTS: Twenty-four samples were tested. Results demonstrate that all values decreased significantly within only a few hours. On average, the loss of compliance after 3 h of cyclic loading ranged on average from 35% for longitudinal compliance to 39% for radial compliance and 37% (p < .050) for volume compliance. After 24 h, the loss of radial, longitudinal and volume compliance was respectively 63 ± 3%, 60.5 ± 2% and 61 ± 7%. CONCLUSION: In this in vitro model, PET graft compliance has already decreased significantly within 3 h. The rapid loss of compliance identified in this experimental study helps explain the mismatch mentioned in clinical observations.

Reliability of X7R Multilayer Ceramic Capacitors During High Accelerated Life Testing (HALT).

Multilayer ceramic capacitors (MLCC) are essential components for determining the reliability of electronic components in terms of time to failure. It is known that the reliability of MLCCs depends on their composition, processing, and operating conditions. In this present work, we analyzed the lifetime of three similar X7R type MLCCs based on BaTiO3 by conducting High Accelerated Life Tests (HALT) at temperatures up to 200 °C at 400 V and 600 V. The results were adjusted to an Arrhenius equation, which is a function of the activation energy (Ea) and a voltage stress exponent (n), in order to predict their time to failure. The values of Ea are in the range of 1⁻1.45 eV, which has been reported for the thermal failure and dielectric wear out of BaTiO3-based dielectric capacitors. The stress voltage exponent value was in the range of 4⁻5. Although the Ea can be associated with a failure mechanism, n only gives an indication of the effect of voltage in the tests. It was possible to associate those values with each type of tested MLCC so that their expected life could be estimated in the range of 400⁻600 V.

Design, Degradation Mechanism and Long-Term Cytotoxicity of Poly(L-lactide) and Poly(Lactide-co-ϵ-Caprolactone) Terpolymer Film and Air-Spun Nanofiber Scaffold.

Degradable nanofiber scaffold is known to provide a suitable, versatile and temporary structure for tissue regeneration. However, synthetic nanofiber scaffold must be properly designed to display appropriate tissue response during the degradation process. In this context, this publication focuses on the design of a finely-tuned poly(lactide-co-ϵ-caprolactone) terpolymer (PLCL) that may be appropriate for vascular biomaterials applications and its comparison with well-known semi-crystalline poly(l-lactide) (PLLA). The degradation mechanism of polymer film and nanofiber scaffold and endothelial cells behavior cultured with degradation products is elucidated. The results highlights benefits of using PLCL terpolymer as vascular biomaterial compared to PLLA.

Relation between tensile tests and compliance in polyester textile vascular prostheses.

BACKGROUND: Compliance is one of the mechanical features of a vascular prosthesis (VP) that influences its performances. The goal of the present in vitro study was to attempt characterizing textile VP compliance through mechanical tests proposed in the standards. METHODS: Three different models of commercially available knitted VP (P1, P2, and P3) were studied using longitudinal and circumferential traction tests on coated and uncoated samples. Five samples of each model were considered for each test. The Young modulus was then calculated to indirectly predict the longitudinal and radial compliance of the VP. Moreover, actual compliance was measured on a specific device that regulates the intraluminal pressure of a fluid maintained in the tested VP at 37°C. VP dilatation under pressure load was measured with a digital camera system. RESULTS: The Young modulus variations from one VP to the other were compared with the differences between effective compliance values at radial, longitudinal, and volume level. Although the presented results show differences among the VP, one can observe that the graft materials' Young modulus and the compliance properties are linked together in general. CONCLUSIONS: Although VPs are subjected to multidirectional stresses ex vivo, unidirectional standard mechanical tests, through the measurement of the materials Young modulus, can help predicting their compliance, however, in a limited frame.

Compliance properties of collagen-coated polyethylene terephthalate vascular prostheses.

BACKGROUND: Compliance mismatch between native artery and a prosthetic graft used for infrainguinal bypass is said to be a factor for graft failure. The aim of this study was to develop a technique for measuring the compliance of collagen-coated polyethylene terephthalate (PET) vascular prostheses and to analyze the influence of several key properties on the elastic behavior of the grafts. METHODS: Compliance testing was performed on 3 prostheses with and without internal compliant membrane (ICM). The principle of this test was to study the dimensional changes of prostheses submitted to internal pressure from 30 to 240 mm Hg at intervals of predetermined values. RESULTS: We demonstrated that the ICM created links with the inner surface of the crimps and considerably modified the graft behavior when submitted to internal pressure. The results showed that compliance properties were dependent on the wall thickness and the crimping geometry of textile vascular prostheses. Mechanical analysis predicts the circumferential tensile behavior of these arterial grafts and validates tests for measuring compliance.

Evaluation of an air spinning process to produce tailored biosynthetic nanofibre scaffolds.

We optimised the working parameters of an innovative air spinning device to produce nanofibrous polymer scaffolds for tissue engineering applications. Scanning electron microscopy was performed on the fibre scaffolds which were then used to identify various scaffold morphologies based on the ratio of surface occupied by the polymer fibres on that covered by the entire polymer scaffold assembly. Scaffolds were then produced with the spinning experimental parameters, resulting in 90% of fibres in the overall polymer construct, and were subsequently used to perform a multiple linear regression analysis to highlight the relationship between nanofibre diameter and the air spinning parameters. Polymer solution concentration was deemed as the most significant parameter to control fibre diameter during the spinning process, despite interactions between experimental parameters. Based on these findings, viscosity measurements were performed to clarify the effect of the polymer solution property on scaffold morphology.

Textile heart valve prosthesis: from fabric design criteria to early in-vivo performances.

BACKGROUND AND AIM OF THE STUDY: Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients at high risk for open-chest surgery. Biological valve tissue is, however, a fragile material when folded for small-diameter catheter insertion purposes. Textile polyester is a less fragile material, and could be an alternative replacement for the valve leaflets. The dynamic performances obtained in vitro with a valve prosthesis made from textile have proven in previous studies to be satisfactory. However, as textile is a porous material the interaction processes between the fabric leaflet surfaces and living tissues remain unknown. The study aim was to discuss the fabric design criteria which are best suited to clinical application. METHODS: An appropriate design provided strength, limited porosity and low bulk to the fabric, which was particularly suited for small-diameter catheter insertion purposes. The in-vivo behavior of a non-coated polyester textile valve prototype was then studied in the mitral position in a sheep model. RESULTS: The results showed that limited tissue ingrowth occurred, and Ca deposits tended to stiffen the fabric leaflets after a two-month implantation period, which was not compatible with the survival of the animal. CONCLUSION: The initial results obtained with this non-coated polyester textile valve confirmed that this revolutionary fabric is worthy of further investigation.

Thermally Activated Composite with Two-Way and Multi-Shape Memory Effects.

The use of shape memory polymer composites is growing rapidly in smart structure applications. In this work, an active asymmetric composite called "controlled behavior composite material (CBCM)" is used as shape memory polymer composite. The programming and the corresponding initial fixity of the composite structure is obtained during a bending test, by heating CBCM above thermal glass transition temperature of the used Epoxy polymer. The shape memory properties of these composites are investigated by a bending test. Three types of recoveries are conducted, two classical recovery tests: unconstrained recovery and constrained recovery, and a new test of partial recovery under load. During recovery, high recovery displacement and force are produced that enables the composite to perform strong two-way actuations along with multi-shape memory effect. The recovery force confirms full recovery with two-way actuation even under a high load. This unique property of CBCM is characterized by the recovered mechanical work.

A novel heart valve stent design: mechanical interaction with the aortic root.

Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients with high risk for open chest surgery. Vascular stents clinically used today for non-invasive aortic valve replacement tend, however, to impede the dimension changes of the compliant aortic root over the cardiac cycle. The purpose of the present work is to assess the influence of a novel heart valve stent, designed specifically to limit the traumatism in tissue, on the compliance of the aortic root. A theoretical approach is adopted to model the mechanical behaviour of the different stent parts and assess the compliance modification induced by the stent. The validity of the model is then tested experimentally. Both approaches show that the specific geometry of the stent makes it possible to keep the compliance of the aortic root close to the native root values.

Characterization of an air-spun poly(L-lactic acid) nanofiber mesh.

It was previously showed that PLLA nanofiber mesh promoted good endothelial cell proliferation. A new technique was developed to produce nanofibers by air jet spinning inside the tubular shape of vascular prostheses and to characterize this nanofiber mesh. Polymer macromolecule stability was assessed by gel permeation chromatography. Thermal analyses were conducted with differential scanning calorimetry and dynamic mechanical analysis on PLLA nanofibers obtained with 4% and 7% solutions (w/v) in chloroform. Polyethylene terephthalate (PET) was also treated with atmospheric pressure dielectric barrier discharge under air or nitrogen atmosphere to optimize PLLA nanofiber adherence, assessed by peel tests. Air spinning induced a reduction of number-average molecular weight (M(n)) for the 7% PLLA solution but not for the 4% solution. The nanofibers were more crystalline and less sensible to viscoelastic relaxation as a function of aging in the 4% solution than in the 7% solution. Discharge treatment of the PET promoted identical surface modification on PET film and PET textile surfaces. Moreover, the best PLLA nanofibers adhesion results were obtained under nitrogen atmosphere. This study demonstrates that it is possible to coat the internal side of tubular vascular prostheses with PLLA nanofibers, and provides a better understanding of the air spinning process as well as optimizing nanofibers adhesion.

Textile for heart valve prostheses: fabric long-term durability testing.

The rapid developments and success in percutaneous vascular surgery over the last two decades with the now common stent grafts implantation, make the noninvasive surgery technique today attractive even for heart valve replacement. Less traumatic for the patient and also less time consuming, percutaneous heart valve replacement is however at its beginning and restricted to end of life patients. The noninvasive procedure expects from the heart valve prosthesis material to be resistant and adapted to folding requirements of the implantation process (catheter). Polyester fabric could be a suited material for heart valve implanted percutaneously. Highly flexible and resistant, polyester fabric proved to be well adapted to the dynamic behavior of a valve and polyester (Dacron) is also widely used for vascular grafts implantation and shows good biocompatibility and durability. However, today there's no data available on long-term durability of fabric used as heart valve material. The purpose of this work is to study the long term behavior of a microdenier polyester fabric construction under combined in vitro flexure and tension fatigue stress. In the novel in vitro testing technique presented, a fabric specimen was subjected to combined flexural and tensile fatigue generated by fluid flow under physiological pressure conditions. The results obtained show how flexural properties change with fatigue time, which reflects directly on the suitability of a fabric in such devices. It was also observed that these fabric structural changes directly influence the in vitro behavior of the textile heart valve prosthesis.

Heart valve stent for percutaneous implantation: design optimization.

Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients with high risk for surgery. This technique is at its beginning and stents used for valve prostheses remain standard vascular stents. These stents are, however, not designed to undergo heart valve stress. They do not match the aortic environment geometry, and induce exaggerated tissue traumatism. Reduced implant lifetime may therefore be expected. The purpose of this work is to evaluate in vitro the technical feasibility of noninvasive aortic valve replacement with a novel more specific stent. This stent is especially adapted to its implantation environment, with a design that matches the shape of the aortic root while respecting the valve function. To optimize the device's geometry, the influence of the design parameters on static and dynamic performances is studied in detail. For that purpose, the interaction between the stent and the aortic root is first studied theoretically, to highlight which parameters are relevant for further in vitro experiments. Static and dynamic regurgitation measurements are then performed to set the design parameters so as to optimize the behavior of the device implanted in a mock aortic root.

A poly(L-lactic acid) nanofibre mesh scaffold for endothelial cells on vascular prostheses.

The absence of neoendothelium covering the intimal surface of small-diameter PET vascular prostheses is known to be one cause of failure following implantation in humans. Protein coatings currently used to seal porous textile structures have not shown evidence of in vivo neoendothelium formation. In this study, we covered the inner wall of textile prostheses with a biodegradable synthetic scaffold made of poly(l-lactic) acid (PLLA) nanofibres obtained by an air-spinning process we developed that produces nanofibres by stretching a solution of polymer with a high-speed compressed air jet. The air spinning was designed to process a scaffold that would support good endothelial cell proliferation. Our innovative process enabled us to very rapidly cover textile samples with PLLA nanofibres to determine the influence of air pressure, polymer solution flow rate and polymer concentration on fibre quality. High air pressure was shown to induce a significant number of ruptures. High polymer flow rate stimulated the formation of polymer droplets, and the fibre diameter mean increased for the 4% and 7% polymer concentrations. The adherence and proliferation of bovine aortic endothelial cells was assessed to compare prosthesis samples with or without the PLLA nanofibre scaffold and PET film. The PLLA nanofibres displayed a significantly better proliferation rate, and enabled endothelial cells to proliferate in the monolayer. Our novel approach therefore opens the door to the development of partially degradable textile prostheses with a blood/textile interface that supports endothelial cell proliferation.

In vitro approach to the dilative behavior of knitted vascular prosthetic grafts.

The purpose of this report is to propose an in vitro approach to predicting the long-term dilative behavior of knitted polyester prosthetic grafts. Various techniques were applied to five warp knitted fabric prosthetic grafts in order to determine the following fabric properties: knitted fabric structure, textile structure, number and respective linear density of threads and strands, and length of yarn in each stitch. Following these investigations, the prosthetic grafts underwent testing to determine specific strength at break, breaking extension, and stress-strain curve. On two prosthetic grafts, image analysis was performed during circumferential tensile strength testing in order to monitor changes in structural features as a function of stress. Changes in the distance between two wales and two courses of stitches and stitch surface were measured. In addition to surface deformation, thickness was measured, using an induction sensor. Study of fabric structure showed many differences between the five models made by different manufacturers. Knit fabric structure was Indeforma in three cases and half-tricot in two. Strand number and size varied greatly from one model to another. Pattern also varied from one model to another, with knit stitch density varying from 1 to 3. Specific strength at break testing showed great differences in the mechanical properties of the grafts. These differences were especially obvious in the first part of the rheograms, which reflects the ability of the graft to comply in response to low-strength forces, i.e., much lower than those necessary to cause rupture. Image analysis of stitch behavior under stress further confirmed differences in graft behavior depending on the fabric structure adopted by the manufacturers. The in vitro approach proposed in this study to analyze the fabric characteristics of knitted prosthetic grafts effectively revealed differences in construction and behavior. These differences could account for differences in the dilative behavior of grafts in vivo.

Characterization of polyelectrolyte multilayer films on polyethylene terephtalate vascular prostheses under mechanical stretching.

Layer-by-layer (LBL) polyelectrolyte films offer extensive potentials to enhance surface properties of vascular biomaterials. From the time of implantation, PET prostheses are continuously subjected to multiple mechanical stresses such as important distorsions and blood pressure. In this study, three LBL films, namely (1) poly(sodium 4-styrenesulfonate)/poly(allylamine hydrochloride), (2) poly(L-lysine)/hyaluronan, and (3) poly(L-lysine)/poly(L-glutamic acid) were built on to isolated PET filaments, thread, and vascular prostheses. The three LBL films uniformly covered the surface of the PET samples with rough, totally smooth, and "wrinkled" appearances respectively for (PAH/PSS)(24), (PLL/HA)(24), and (PLL/PGA)(24) systems. We then assessed the behavior of these LBL films, in an aqueous environment [by environmental scanning electronic microscopy (ESEM)], when subjected to unidirectional longitudinal stretches. We found that stretching induces ruptures in the multilayer films on isolated filaments for longitudinal stretches of 14% for (PSS/PAH)(24), 13% for (PLL/PGA)(24), and 30% for (PLL/HA)(24) films. On threads, the rupture limit is enhanced to be respectively 26, 20, and 28%. Most interestingly, we found that on vascular prosthesis no rupture is visible in any of the three multilayers types, even for elongations of 200% (200% undergone by the PET prostheses is representative of those encountered during graft deployment) which by far exceeds elongations observed under physiological conditions (10-20%, blood pressure). In term of mechanical behaviors, these preliminary data constitute a first step toward the possible use of LBL film to coat and functionalize vascular prosthesis.

[Psychological disorders in pregnancy]. / Manifestations psychopathologiques de la grossesse.

If the high level of mental vulnerability marks the postpartum period, there are fewer mental diseases during pregnancy. Nevertheless, this period is marked by the importance of psychological change and the easier accessibility at psychotherapeutic interventions: then, unconscious conflicts can be approached as well as traumatic events. A lot of emotional and behavioral disorders remain within the norm. When the disorders are serious, they must be subjected to both therapeutic and preventive interventions to make sure the pregnancy goes as well as possible until birth and to help establish the mother-baby relationship. At the same time, these interventions are also a means of preventing postpartum disorders, in particularly postpartum depression. Specific disorders' such as denial of pregnancy (approximately 3 for 1,000) must be known, because there is a risk of infanticide. As for mental disorders already known, they involve cooperation between the maternity ward, physicians and the psychiatric department for the follow-up.