Biomedical subjects

R Guidoin

Publications and source records attributed to R Guidoin.

At least 37 records · Page 2Linked to original sources

PubMed1999

Assessing the resistance to calcification of polyurethane membranes used in the manufacture of ventricles for a totally implantable artificial heart.

Ventricles made from segmented polyurethane membranes and used in the fabrication of a totally implantable artificial heart are known to undergo biomaterial-associated calcification. As there is no effective method currently available to prevent such biomaterials from calcifying, a practical solution is to use only materials with a relatively high resistance to calcification, to extend ventricular durability and ensure a longer functional life for the manufactured device. In the present study, an in vitro calcification protocol was used to determine the relative resistance to calcification of six different polyurethanes, namely, Carbothane PC3570A, Chronoflex AR, Corethane 80A, Corethane 55D, Tecoflex EG80A, and Tecothane TT1074A. The results demonstrated that all six polyurethanes did become calcified during the 60-day incubation period in the calcification solution. The degree of calcification was found to be associated with the surface chemistry of the particular polyurethane, with the Tecothane TT1074A exhibiting the highest level. The Corethane 80A and 55D polymers showed a relatively low propensity to calcify. These two membranes can, therefore, be considered as the most appropriate materials for the fabrication of ventricles for a totally implantable artificial heart. In addition, since the calcification occurred primarily at the surface of the membranes, without affecting the bulk microphase structure, the issue of modifying the surface chemistry to reduce the incidence of calcification is discussed.

Biocompatible Materials↗

PubMed1999

In vivo time course studies of the tissue responses to resorbable polylactic acid implants by means of MRI.

Magnetic resonance (MR) imaging and relaxation time measurements of bioresorbable implants made of polylactic acid (PLA), as well as the surrounding tissues, were carried out over a period of 6 months to monitor the implant state and the body's responses, and to determine how these processes are reflected in MR data. Twelve rabbits each received two subcutaneous PLA implants (45 x 10 x 2 mm). Changes in tissue relaxation rates demonstrated inflammation and tissue healing time courses but were not simply linear functions of the tissue water content and so provide new insight into MR characterization of inflammatory processes.

Animals↗

PubMed1999

Comparison of healing in fresh and preserved arterial allografts in the dog.

The use of aortic allografts for the management of vascular prosthetic infections has recently been reintroduced. Impressive results have been obtained; however, the possibility of late degeneration remains a major concern. The healing behavior of aortic allografts, either fresh or preserved, in antibiotic-supplemented nutrient medium at 4 degrees C for 1 week and used as thoracic aorta substitutes in dogs was investigated after 6 months of implantation. Four dogs received a fresh aortic allograft from four different donors, and four dogs received a preserved allograft from two different donors. Autografts in two dogs were performed as controls. The in vivo investigation was conducted to describe (1) the histological characteristics of the arterial wall, (2) the macroscopic and thrombogenic aspect of the luminal surface, (3) the integrity of the endothelial lining by scanning electron microscopy, and (4) its biochemical function by prostacyclin (PGI2) and thromboxane A2 (TXA2) secretion. Immune-mediated reactions directed toward the grafts were measured by sequential screening of donor-specific serum antibody development. All donor-recipient pairs of dogs were major histocompatibility complex (MHC)-incompatible according to a mixed lymphocyte reaction (MLR) assay. From the results of this study we concluded that although preserved arterial allografts exhibited similar surface characteristics as those of fresh allografts in terms of re-endothelialization and long-term graft function, an elicited immune response, a degenerative process in the media, and a hyperplasic reaction in the intima could not be prevented using this method of preservation.

Animals↗

PubMed1999

Lipid uptake in synthetic vascular prostheses explanted from humans.

Previous in vivo studies in humans and dogs have revealed an atherosclerosis-like phenomenon in which lipid penetration within arterial prosthesis wall was observed. The primary goal of the present study was therefore to investigate the occurrence of this lipid retention in ePTFE prostheses implanted in humans and therefore identify potential risk factors related to this phenomenon. Lipid uptake in 367 ePTFE microporous vascular prostheses explanted from humans was studied using Fourier transform infrared spectroscopy. The assignment of the infrared absorption features clearly revealed the presence of strongly bonded unsaturated fatty acids to the microporous structure of the prostheses. A one-way ANOVA statistical analysis showed that the lipid uptake in the synthetic vascular prostheses depended on the duration of implantation of the prosthesis and on the sex of the patient. A two-way ANOVA showed that a relationship existed between the estimated lipid uptake and the internal diameter of the prosthesis. These results confirm that the lipid uptake phenomenon depends on some clinical factors related either to the patients or to the prostheses' morphological parameters.

Aged↗

PubMed1999

Tissue reactions to polypyrrole-coated polyesters: A magnetic resonance relaxometry study.

The electrically conductive properties of polypyrrole (PPy) as a coating on polyester material are very attractive for the manufacture of small diameter blood conduits. However, before these PPy-coated materials can be investigated for their capacity to generate endothelialized luminal surfaces, they must first be studied for their innocuousness in a living environment. The specific goal of the present study was to investigate the in vivo interactions of PPy-coated and noncoated woven polyester materials implanted subcutaneously in rats for prescheduled periods of 2, 5, 10, 20, and 30 days. The in vivo magnetic resonance (MR) relaxation times were computed for a small area of muscle tissue adjacent to the implants. A correlation was concurrently attempted with blood monocyte activation studies as well as histological observations of the tissue-material interface. The progressive pattern of the slower transversal relaxation time (T2s) values revealed a more persistent tissue reaction for the most conductive PPy-coated materials and a shorter acute tissue response as the surface resistivity increased. Similarly, the blood monocyte activation studies indicated that the thickness of the PPy coating, which correlated with the conductivity, was directly related to tissue response. Furthermore, both the MR and biological studies showed that the PPy-coated material with a high surface resistivity displayed the lowest tissue reaction over the entire period of implantation. The results obtained from the blood monocyte activation studies and histological observations correlate well with the noninvasive MR measurements of the body's healing process. The conductive materials with high surface resistivities must be further investigated. Finally, the noninvasive nature of MR relaxometry reveals its outstanding potential for future in vivo investigations of the body's tissue interactions with polymers and nonferromagnetic biomaterials.

Animals↗

PubMed1999

In vivo biocompatibility and degradation studies of polyhydroxyoctanoate in the rat: a new sealant for the polyester arterial prosthesis.

The present study examined the biocompatibility and degradation properties of poly (beta-hydroxy octanoate) (PHO) as an impregnation substrate on arterial prostheses. PHO-impregnated polyester grafts sterilized by ethylene oxide (EO) or gamma (gamma) radiation, and polyester Dacron(R) prostheses impregnated with fluoropolymer, gelatin, or albumin were implanted subcutaneously in rats for periods ranging from 2 to 180 days. The biocompatibility was assessed by quantifying the alkaline and acid phosphatase secretion while performing histological studies at the tissue/prosthesis interface. The degradation was determined by chemical analysis of the EO and gamma-sterilized PHO after implantation using differential scanning calorimetry (DSC), wide angle x-ray diffraction (WAXD), and size exclusion chromatography (SEC). Alkaline phosphatase activity by the sterilized PHO and by the gelatin and albumin grafts was significantly elevated early after implantation in contrast to that of the Dacron and fluoropolymer grafts that occurred later, at 7 and 5 days, respectively The peak of acid phosphatase activity for all of the grafts occurred between 5 and 10 days postimplantation, with the gamma-sterilized PHO grafts recording the greatest activity. Histological study revealed that the tissue incorporation into the graft wall was earlier and more complete for the Dacron and fluoropolymer grafts after 6 months than for the gelatin and albumin grafts, because the latter induced important inflammatory reactions during the resorption of the cross-linked protein substrates. The EO and gamma-sterilized PHO grafts exhibited a similar healing sequence characterized by the development of a collagenous tissue surrounding the prostheses. However, no infiltration of tissue into the graft wall was observed after 6 months, mainly because of the presence of the PHO. Degradation of the EO and gamma-sterilized PHO occurred preferentially by a hydrolytic mechanism as shown by a 30% molecular weight decrease after 6 months. In conclusion, PHO showed good biocompatibility in terms of enzyme activity and tissue reaction. Degradation was a slow, in vivo process controlled primarily by a random hydrolytic reaction and by a local enzymatic attack by macrophages and giant cells.

Acid Phosphatase↗

PubMed1999

Effect of sterilization on the physical and structural characteristics of polyhydroxyoctanoate (PHO).

The present study examined the potential applicability of poly(beta-hydroxy octanoate) (PHO), a bacterial polyester, as a candidate for biomaterial applications, by investigating the effect of sterilization on the physical and structural characteristics of PHO. PHO-cast films were sterilized by either ethylene oxide (EO) gas at 38 degrees C or gamma radiation (2.5 Mrad) in air at room temperature. The physical characteristics of the EO and gamma-sterilized PHO were determined by scanning electron microscopy (SEM) and tensile strength analyses. In addition, various analytical methods were used to detect modifications in the chemical and morphological structure of PHO, namely, electron spectroscopy for chemical analysis (ESCA), Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), wide angle X-ray diffraction (WAXD), and size exclusion chromatography (SEC). The results show that EO sterilization did not modify the chemical and physical characteristics of PHO, however, significant modifications in both the structural and tensile properties were observed with gamma-sterilized PHO. These changes accounted for decreases in both the weight average, number average and melting temperature, and increases in the heat of fusion and tensile strength. No residual EO was detected following sterilization as revealed by head-space chromatography. The physical and structural properties of PHO were shown to be well preserved following EO sterilization, whereas gamma radiation caused random chain scission and physical cross-linking, a frequent phenomenon observed with organic polymers.

Bacteria↗

PubMed1999

Hydrolytic and enzymatic incubation of polyhydroxyoctanoate (PHO): a short-term in vitro study of a degradable bacterial polyester.

The present study examined the degradation behaviour of poly(beta-hydroxy octanoate) (PHO), a bacterial poly(beta-hydroxy alkanoate), following incubation under hydrolytic or enzymatic conditions in vitro. Solution-cast PHO films were incubated in a citrate buffer solution with and without acid phosphatase and in an acetate buffer with and without beta-glucuronidase for periods ranging from 7 to 60 days. The physical characterization of the PHO films was analyzed by SEM and tensile strength studies. In addition, various analytical methods were used to detect modifications in the chemical and morphological structure of the PHO, namely, ESCA, FTIR, DSC, X-ray diffraction, and SEC. The results indicate that the enzymatic conditions selected in the present study induced no significant surface morphological or chemical modifications, and no significant weight loss was observed after 60 days of incubation. However, as revealed by weight average molecular weight Mw and number average molecular weight Mn decreases, changes in the bulk structure of the PHO were observed with acid phosphatase at 28 and 60 days, in contrast to smaller Mw and Mn decreases recorded in both the buffers and the beta-glucuronidase. The tensile properties had decreased following incubation, yet showed no difference under all of the selected conditions. With no weight loss or surface changes, the PHO films incubated in acid phosphatase showed only a chemical hydrolytic process characterized by Mw and Mn decreases with time of incubation. The present study demonstrated that the degradation of PHO films is one of slow, chemical hydrolysis only, perhaps requiring several months of incubation. The hydrophobic nature of the long alkyl pendent chain in PHO may be responsible for this slow process. The inability of enzymes to degrade PHO may be attributed to the latter's poor adsorption capacity, due to its hydrophobic nature, and to a lack of specificity in the catalytic activity of these enzymes.

Acid Phosphatase↗

PubMed1999

Mechanical characteristics of the canine thoracic duct: what are the driving forces of the lymph flow?

This study is designed to better understand the mode of lymph transport, particularly through the extrinsic pumping by external compression of the lymph vessel. The pressure-diameter relationship of lymphatic segments isolated from the canine thoracic duct was examined using a laser optical micrometer measurement system. Results revealed that the thoracic duct displayed a high extensibility or compliance in the physiological pressure range, yet became progressively less so with increasing internal pressure. The calculated incremental circumferential modulus of the thoracic duct under physiological pressure (range of 2 to 6 cm H2O) showed values ranging from 1.2 x 10(4) to 3.61 x 10(5) dyn/cm2. At a pressure of 35 cm H2O, the modulus reached a limiting value of approximately 6.0 x 10(6) dyn/cm2. In the physiological pressure range, the relative wall thickness (h/R0) of the canine thoracic duct was approximately 3.5%, which was much lower than that reported for canine arterial segments and similar in value to that of the canine jugular vein. In conclusion, the pressure-diameter curve of the canine thoracic duct was shown to resemble that of venous vessels. However, the circumferential elastic modulus of the thoracic duct wall was lower than the moduli of veins, proving that lymphatics are more compliant than veins. This suggests lymph flow in the thoracic duct may be better promoted by external compression of the lymphatic vessel.

Animals↗

PubMed1998

In vitro cellular response to polypyrrole-coated woven polyester fabrics: potential benefits of electrical conductivity.

Electrically conducting polypyrrole-treated films have recently been shown to influence the morphology and function of mammalian cells in vitro. This type of polymer represents a possible alternative biomaterial for use in vascular implantation. The present study compared the in vitro biocompatibility of the five different polyester woven fabrics having increasing levels of electrical conductivity ranging from 4.5 x 10(4) to 123 omega/square with that of low density polyethylene and polydimethylsiloxane primary reference materials. Biocompatibility was measured in terms of four different types of in vitro cellular response, including (a) an indirect and (b) a direct control organotypic culture assay using endothelial cells, (c) a polymorphonuclear (PMN) cell activation study using flow-cytometric measurements of CD11/CD18 integrin molecule expression, and (d) a semiquantification of interleukin (IL)-6 mRNA expression on monocytes/macrophages using reverse-transcriptase polymerase chain reaction. The organotypic culture study revealed that the fabrics with high levels of conductivity exhibited lower cell migration, proliferation, and viability. The PMN activation study of blood from 10 healthy adult donors demonstrated that the two most conductive fabrics were able to identify the more reactive donors. The levels of IL-6 mRNA expression by monocytes/macrophages decreased as the conductivity level of the fabrics increased. The results of the present study therefore indicate that high levels of conductivity (< 200 omega/square) on polyester fabrics are detrimental to the growth, migration, and viability of endothelial cells; induce elevated PMN activation; and affect the intracellular metabolism of monocytes. They also point to a specific range of conductivity (10(3) < 10(4) omega/square) which is associated with an optimum in vitro cellular response.

Adult↗

PubMed1998

Fluid filtration across the arterial wall under flow conditions: is wall shear rate another factor affecting filtration rate?

The effect of flow on fluid filtration across an arterial wall was investigated in the canine common carotid artery. The arteries were cannulated in situ to maintain their in vivo length and endothelium intact. The excised vessels were pressurized at 120 mmHg through an overflow head-tank system that provided a constant flow rate to the perfused vessels. Filtration rates across the walls of the carotid arteries tested were measured under 4 different experimental conditions: 1) albumin-free Krebs solution under absent flow condition; 2) albumin-free Krebs solution with flow (148 +/- 8 ml/min); 3) Krebs solution containing 1.0 g/dl bovine serum albumin under absent flow condition; 4) Krebs solution containing 1.0 g/dl bovine serum albumin with flow (148 +/- 8 ml/min). Under absent flow conditions, the addition of albumin to the Krebs solution (1.0 g/dl) led to an approximate 25% drop in filtration rate (p < 0.001). It was found that fluid flow affected the filtration rate of the albumin solution, yet failed to affect the filtration rate of albumin-free solution across the arterial wall. The present study suggests that the change in filtration rate of the albumin solution under flow condition may indicate the change in the luminal surface concentration of albumin due to flow.

Animals↗

PubMed1998

Concentration polarization of low density lipoproteins (LDL) in the arterial system.

The atherogenic lipid concentration at the luminal surface of a blood vessel may vary according to its location in the arterial tree because of regional differences in wall shear rate, blood pressure, and vascular permeability. We therefore hypothesized that these local variations in the luminal surface lipid concentration may contribute to the localization of atherosclerosis. To verify this hypothesis, the transport of low-density lipoproteins from flowing blood to the arterial wall was studied numerically under both steady-state and pulsatile flow conditions. Numerical analysis predicted that "concentration polarization" of LDL may occur in the arterial system under these conditions. In contrast to steady-state flow conditions, the luminal surface LDL concentration varied with time in a cardiac cycle. However, its time-average value was slightly higher than the corresponding value under steady-state flow conditions. The time-average value of the luminal surface LDL concentration was 5 to 14% greater than the bulk concentration in a straight segment of an artery. The luminal surface LDL concentration at the arterial wall was flow-dependent, varying linearly with the filtration rate through the vessel wall and inversely with wall shear rate. This may therefore have some significant implications for the pathogenesis and localization of vascular disorders.

Animals↗

PubMed1998

Lipid concentration profile across the wall of pseudoatherosclerotic synthetic arterial prostheses using FTIR microspectroscopy.

FTIR microscopy is a versatile technique successfully used to probe the subcellular chemical composition of atherosclerostic arterial walls. To design new vascular substitutes that resist lipid uptake (the major cause of the phenomenon referred to as atherosclerosis-like), identifying and understanding lipid distribution within the pseudoatherosclerosed arterial prostheses is of prime importance. Until now, the amount of lipids present within arterial prostheses that had been explanted from either animals (during in vivo trials) or humans (after the failure of vascular grafts) or had been submitted to in vitro investigations could only be measured through the use of histological techniques or radioactive labeling methods. We present here a novel method to quantitatively measure the lipid concentration profile within the wall of arterial prostheses by means of Fourier transform infrared microspectroscopy. Essentially, prostheses are fixed in a 1% osmium tetraoxide aqueous solution under vacuum and radially cut with a 5-micron thickness with a microtome. The sections are then placed onto BaF2 windows and observed with a microscope attached to a FTIR spectrometer with a 30 microns x 50 microns sampling area. The lipid concentration profile is obtained by scanning the prosthesis wall from the inner to the outer surface and reporting the corresponding integrated absorbance between 2700 and 3100 cm(-1) against a calibration curve. The application of this technique constitutes the first quantitative measurement of the concentration of biological molecules within the wall of artificial arterial substitute.

Blood Vessel Prosthesis↗

PubMed1998

Identification and quantification of the crystalline structures of poly(vinylidene fluoride) sutures by wide-angle X-ray scattering and differential scanning calorimetry.

The outstanding biocompatibility of the polyvinylidene fluoride (PVDF) monofilament suture together with other desirable characteristics, such as ease of handling and resistance to biodegradation, makes it an attractive alternative monofilament suture material for cardiovascular surgery. However, to achieve a high performance suture, the polymeric raw material must be exposed to different treatments, which lead to different degrees and types of crystallization. Since these crystalline modifications deeply influence the mechanical characteristics and the biostability of the sutures, the authors hereby propose a method of quantifying the different structures of PVDF using wide angle X-ray diffraction (WAXD) and differential scanning calorimetry (DSC). The commercial devices are achieved by coloring and processing the polymeric raw material. The white and unprocessed 4-0 unswaged suture presents 19% of the alpha phase, 38% of the beta structure, and no gamma form. Coloration increases the amount of the beta phase by 5-9% at the expense of the alpha phase. On the other hand, processing the fibers lead to the conversion of some of the amorphous phase to the gamma structure, the importance of which is 6-7%. Finally, tensile measurements performed on the different PVDF fibers clearly proves that their mechanical characteristics depend on the presence of these crystalline forms in the polymeric structure of PVDF.

Calorimetry, Differential Scanning↗

PubMed1998

Lipid uptake in expanded polytetrafluoroethylene vascular grafts.

PURPOSE: The mechanisms of vascular prosthesis failure are reported to be associated, in part, with an atherosclerotic degenerative process that is related to an abnormal lipid infiltration. The lipid uptake in expanded polytetrafluoroethylene (ePTFE) vascular grafts was reproduced in vitro, and the effect of time on the permeability of these prostheses was studied. METHODS: Water permeability tests were carried out under dynamic flow conditions at various hydrostatic pressures. Lipid uptake was simulated by circulating a phosphatidylcholine suspension inside an expanded Teflon prosthesis under pulsatile or continuous transmural pressure ranging between 80 mm Hg and 180 mm Hg, at a flow rate of 500 mL/min and 2000 mL/min, for a duration ranging from 2 hours to 1 month. RESULTS: Water permeability tests indicated that under hydrostatic pressures of 180 mm Hg and 300 mm Hg, water percolated through the prosthesis wall after an exposure of 720 minutes and 75 minutes, respectively. After exposing the prostheses to the lipid dispersion under the various flow conditions, the fluid convection through the wall occurred. Preferential convection pathways with a constant periodicity were observed across the length of each prosthesis and were, therefore, associated with regularly spaced perforations depicted in the structure of the devices. Phospholipids gradually agglomerated within the prosthesis wall, allowing a restrictive molecular mobility. Infrared spectroscopy results indicated that the lipid uptake depended on the transmural pressure and time of exposure. CONCLUSION: The occurrence of the membrane permeability may be associated with the dilatation and plastic deformation of the prosthesis. Lipid uptake occurs in ePTFE grafts after an aggressive kinetic process.

Blood Vessel Prosthesis↗

PubMed1998

Characterization of abnormalities responsible for immediate rejection of porcine aortic valves for the manufacture of bioprostheses.

Gross observation at the slaughterhouse determines the primary selection of porcine aortic valves for the manufacture of bioprostheses. This step is critical because only valves with significant abnormalities are rejected. The present study validated this selection process by investigating the pathological characteristics of one series of accepted valves and one series of rejected valves. Macroscopy, x-ray examination, light microscopy, and scanning electron microscopy (SEM) were performed on 5 initially rejected valves, 3 leaflets from 3 other initially rejected valves, and 6 valves that successfully passed this first step in the selection process. Abnormalities were macroscopically visible only on the rejected valves and were described as thick white areas, heavy white striations, thin spots, white plaques, and nodules. Individual variability in the structure of each leaflet was more significant in the rejected valves than in the valves that had passed the first inspection. The leaflets of the rejected valves were also irregularly thick with a lack of consistency in the position and prominence of the different layers. The formation of nodules and the presence of white plaques in the inner fibrosa layer were among the pathological features. The initially accepted valves considered defect free under gross observation continued to display some weaknesses, and not all of the valves selected during the first step of the process were suitable to become bioprostheses. Because the manufacturer carries out further quality control inspections at every step of preparation resulting in additional rejections, it is therefore anticipated that all valves with defects will be rejected. None of the rejected valves were defect free, and rejection was fully justified.

Animals↗

PubMed1997

Chemical stability of polyether urethanes versus polycarbonate urethanes.

The relative chemical stability of two commercially available polyurethanes-Pellethane, currently used in biomedical devices, and Corethane, considered as a potential biomaterial-was investigated following aging protocols in hydrolytic and oxidative conditions (HOC, water, hydrogen peroxide, and nitric acid) and in physiological media (PHM, phosphate buffer, lipid dispersion, and bile from human donors). The chemical modifications induced on these polymers were characterized using differential scanning calorimetry (DSC), gel permeation chromatography (GPC), and Fourier transform infrared spectroscopy (FTIR). With the exception of nitric acid, all of the aging media promoted a mild hydrolytic reaction leading to a slight molecular weight loss in both polymers. When aged in water and hydrogen peroxide, Pellethane experienced structural modifications through microdomain phase separation along with an increase of the order within the soft-hard segment domains. The incubation of Pellethane in nitric acid also resulted in an important decrease of the melting temperature of its hard segments with chain scission mechanisms. Moreover, incubation in PHM led to an increase of the order within shorter hard-segment domains. FTIR data revealed the presence of aliphatic amide molecules used as additives on the Pellethane's surface. The incubation of Corethane under the same conditions promoted an almost uniform molecular reorganization through a phase separation between the hard and soft segments as well as an increase of the short-range order within the hard-segment domains. Incubation of this polymer in nitric acid also resulted in a chain scission process that was less pronounced than that measured for the Pellethane samples. Finally, lipid adsorption occurred on the Corethane sample incubated in bile for 120 days. Overall data indicate that polycarbonate urethane presents a greater chemical stability than does polyetherurethane.

Calorimetry, Differential Scanning↗

PubMed1997

In vitro and in vivo studies of a polyester arterial prosthesis with a warp-knitted sharkskin structure.

The present study was undertaken to assess the performance of a new knitted and gelatin-sealed polyester vascular graft that is believed to have greater dimensional stability than current commercial devices. Samples of the uncrimped, crimped, and sealed prosthesis were submitted to a series of in vitro and in vivo trials. Four commercial polyester knitted devices were included as controls for the in vitro tests, which included measurements of the textile and yarn structure and physical, chemical, and thermal properties of the graft, such as water permeability, dilatation, suture retention strength, melting point, and crystallinity index. The in vivo evaluation involved implanting the prototype device as a canine thoraco-abdominal bypass for periods ranging from 4 h to 1 year and assessing the biocompatibility, biofunctionality, and biostability of the explanted specimens. The warp-knitted structure of the prototype device has a unique sharkskin stitch that confers a superior dilatation resistance and suture retention strength to the prosthesis. The animal trial demonstrated that the gelatin ensures initial hemostasis without preclotting. The gelatin is bioresorbed during the first 2 weeks of implantation, which generates a temporary, moderate, acute inflammatory response. An external capsule of granulomatous tissue and an internal collagen capsule are formed between the first and third month. Analysis of the textile and physical properties of the explanted prostheses confirmed there was neither dilatation nor significant changes in structure or mechanical performance during implantation, thus confirming the biostability of this new prototype device and opening the way for clinical trials.

Anastomosis, Surgical↗