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PubMed1993

Biocompatible and biodegradable polyurethane polymers.

This study deals with the opportunities for the synthesis of biocompatible and biodegradable polyurethane adhesives which are suitable for application as wound dressings. Three different synthetic possibilities have been investigated. The relationships between some reaction factors and the final properties of the obtained products are pointed out. The toxicity of the investigated urethane acrylates, polyurethanes and combined polyurethane adhesives is also studied.

Acrylates↗

PubMed1993

Biocompatible hydrogels of controlled hydrophobicity from copolymers of N-vinyl-2-pyrrolidone and furfuryl methacrylate.

Biocompatible copolymers of N-vinylpyrrolidone (P) and furfuryl methacrylate (F) were prepared by free radical polymerization in N,N-dimethylformamide solution at 50 degrees C, using 2,2'-azobisisobutyronitrile as initiator, at low and high conversion. The microstructure of copolymers prepared at low conversion was determined from the composition data by the application of statistical relationships, considering the terminal copolymerization model of Mayo-Lewis, whereas for high conversion copolymers the noticeable difference between the reactivity of F and P was taken into consideration. The swelling behaviour of films prepared from solutions of copolymers with different composition was followed gravimetrically and the diffusion of water was analysed on the basis of the stress relaxation model of copolymer chains. The results obtained are in good agreement with second-order diffusion kinetics, showing that the hydrophilic character of the films is controlled mainly by the content of P in the copolymer systems and the distribution of comonomeric units along the copolymer systems.

Azo Compounds↗

PubMed1993

Fat in bone xenografts: importance of the purification procedures on cleanliness, wettability and biocompatibility.

Xenografting is a promising alternative to allografts and autografts. The remaining lipids in bone are known to influence the biocompatibility. A comparative study of wettability was done on standardized blocks of two biomaterials. A highly purified and defatted bovine bone graft (T650) was found to retain more water (2.06 g/block) than a less defatted biomaterial (T360, 0.3 g/block). Wettability, observed in the laboratory, may reflect an important in vivo property: the rapidity for extracellular fluids and blood cells to invade the graft and carry bone forming cells. When implanted in rabbit cancellous bone, T650 appears to be osteoconductive in a manner that allows trabecular architecture to be restored within 6 months.

Animals↗

PubMed1994

Molecular biointeractions of biomedical polymers with extracellular exudate and inflammatory cells and their effects on the biocompatibility, in vivo.

The stability of biomedical polymers in physiological environments is crucial for the normal operation of devices, as well as determining their effect on the tissue response. Degradation is an important factor in polymer biocompatibility, since the environment of the human body can be aggressive to polymers. Most implanted polymers suffer degradation to some extent, and the kinetics and mechanisms of the processes can be affected significantly by various biologically active species, especially enzymes, lipids, peroxides, free radicals and phagocytic cells. The degradation of poly(caprolactone) and poly(DL-lactic acid) under controlled in vivo conditions was studied using a poly(methyl methacrylate) chamber designed to control the exposure of polymers to physiological environments. In particular they may be designed to allow access of extracellular exudate only or access to cells as well as the fluid. The chambers, sealed with filters of pore size either 0.45 micron (impervious to cells) or 3.0 microns (allowing cells to enter the chamber), were implanted subcutaneously into experimental animals for 10, 20 and 30 wk periods. Degradation and molecular interactions of the polymers were characterized by gel permeation chromatography and scanning electron microscopy. The extracellular exudate formed within the implanted chamber is active in promoting the degradation of some biomedical polymers. Inflammatory cells are involved in the biodegradation of implanted polymers by releasing biologically active species such as free radicals into the area surrounding the implant. The data have demonstrated that the hydroxyl radical is likely to be one of the main causes of polymer degradation.

Animals↗

PubMed1994

Investigation of surface properties of some polymers by a thermodynamic and mechanical approach: possibility of predicting mucoadhesion and biocompatibility.

Mucoadhesive properties of several polymers, such as sodium alginate, hydroxypropylmethyl cellulose, scleroglucan, xanthan gum, polyacrylic acid (Carbopol), and poly co-(methyl vinyl ether-maleic anhydride) (Gantrez), have been investigated by comparing a thermodynamical and a mechanical approach. Surface properties of polymers in the dry state have been studied by contact angle measurements and thermodynamical parameters derived by using different equations. This tensile adhesive strength of polymers in hydration conditions was measured by a modified DuNoy tensiometer. Comparison of the two different approaches has allowed us to conclude that thermodynamical consideration on surface energy can be used to evaluate mucoadhesive properties of materials. Data obtained with the two methods yielded a good linear correlation. Calculation of surface free energy of the considered materials also allowed a prediction of the water-polymer interface free energy: biocompatibility, defined according to the minimal interfacial free energy concept, could consequently be evaluated.

Acrylic Resins↗

PubMed1994

Silastic with polyacrylic acid filler: swelling properties, biocompatibility and potential use in cochlear implants.

We present a new hygroscopic implant material which consists of high-molecular-weight polyacrylic acid (PAA) as a filler in a Silastic matrix. The mixture swells upon immersion in bodily fluids; the degree of swelling depends on the ratio of PAA to Silastic and allows the design of implants that will achieve their final shape and size only after the implantation procedure. In vivo and in vitro biocompatibility tests reveal no adverse cellular or tissue responses. In cochlear implant development the material has been experimentally incorporated into intracochlear electrode arrays which curl after insertion, and in bacteriostatic devices for electrode fixation.

Acrylic Resins↗

PubMed1994

In vitro biocompatibility evaluation of a heparinizable material (PUPA), based on polyurethane and poly(amido-amine) components.

The biocompatibility of a new heparinizable material based on polyurethane and poly(amido-amine) (PUPA) was evaluated both in the heparinized and non-heparinized forms. The quantity of heparin present on the material was measured using radiolabelled heparin and biological tests. Heparin release in plasma from heparinized PUPA was investigated using in vitro methods. The behaviour of PUPA towards cellular and plasmatic blood components was studied. The influence of sterilization on the cytocompatibility response of both heparinized and non-heparinized PUPA was investigated; gamma-rays were found to be a suitable method of sterilization as no toxic response was noticed.

Animals↗

PubMed1996

Selecting valid in vitro biocompatibility tests that predict the in vivo healing response of synthetic vascular prostheses.

We have investigated the usefulness of six in vitro biocompatibility tests in predicting the healing performance of polyester vascular prostheses as observed in previous canine in vivo trials. Vascular grafts were evaluated by using (i) a direct contact (DC) assay, (ii) an extract dilution (ED) assay on murine fibroblast cells, (iii) a DC assay on endothelial cells, (iv) a complement activation study, (v) a leucocyte activation study of CD18 integrin subunit expression on human polymorphonuclear cells (PMNs) and (vi) interleukin-2 receptor expression on lymphocytes. Uncleaned polyester grafts had previously been associated with poor healing and gelatin-impregnated polyester grafts with delayed but satisfactory healing, whereas commercially cleaned polyester grafts had demonstrated excellent healing. Lightweight and heavyweight knitted and woven polyester grafts supplied specifically for this project were studied, each with a different surface condition, i.e. commercially available (CP), uncleaned (UP) and impregnated with gelatin (GP). The UP grafts induced fibroblast cytotoxicity according to the ED assay, poor migration and viability of endothelial cells, and an elevated expression of CD18 and interleukin-2 receptor on PMNs and lymphocytes, respectively. In contrast, the CP grafts promoted good endothelial cell growth, no evidence of cytotoxicity and a weaker cell activation, and the GP grafts were found to be non-cytotoxic, to exhibit a good cellular response and to moderate cell activation. The complement activation assay and the DC assay on fibroblasts were found to be less useful and less discriminating. From this, it is concluded that the two cell activation measurements, the DC assay on endothelial cells and ED assay on fibroblasts, are useful in predicting the in vivo healing response of arterial polyester substitutes.

Analysis of Variance↗

PubMed1995

Influence of corona surface treatment on the properties of an artificial membrane used for Langerhans islets encapsulation: permeability and biocompatibility studies.

An artificial membrane (AN69 Hospal) suitable for pancreatic islets encapsulation was submitted to a physicochemical treatment (corona discharge) to improve its insulin permeability. This effect depends on the duration of the electrical discharge (expressed as the speed of a conveyor belt) and the distance between the electrodes and the membrane. Among the various treatments tested, the most efficient (distance of 5 cm and a speed of 2 cm s-1) produced a three-fold increase in insulin diffusion. This improvement persisted after a protein-coating test which mimics in vivo conditions. At 1 y after the peritoneal implantation, the corona-treated membrane remained biocompatible. Thus, corona discharge treatment may serve to optimize the properties of artificial membranes used for pancreatic islets encapsulation.

Animals↗

PubMed1995

In vitro biocompatibility of a polyurethane catheter after deposition of fluorinated film.

The in vitro biocompatibility of an experimental surface-treated polyurethane was compared with an untreated polyurethane already used for intravascular catheters. The experimental surface was coated with a fluorinated film using a glow discharge treatment. Neither of the catheters was cytotoxic for L929 murine fibroblasts, caused platelet adhesion or release reaction, or changed the mean platelet volume. The surface-treated polyurethane, however, caused a higher adhesion of Staphylococcus aureus than did the untreated one. Therefore, using in vitro testing, it has been ascertained that the examined material, though not being cytotoxic and not modifying platelet behaviour, could favour bacterial adherence.

Bacterial Adhesion↗

PubMed1995

New artificial connective matrix made of fibrin monomers, elastin peptides and type I + III collagens: structural study, biocompatibility and use as tympanic membranes in rabbit.

Experiments leading to the conception and development of a new artificial connective matrix based on collagen-elastin-fibrin associations are presented. Preliminary evaluation of this biomaterial as an artificial tympanic membrane is described. Morphological evaluation was performed by histopathological and scanning electron microscopic studies. Biocompatibility was documented by subcutaneous implantation and experimental grafting in rabbits was performed with histopathological studies of the tympanic grafted membranes. The positive results obtained in this experimental study enable future studies in humans to be prepared.

Animals↗

PubMed1995

In vitro biocompatibility testing of polymers for orthopaedic implants using cultured fibroblasts and osteoblasts.

The biocompatibility of two polymers for potential use as orthopaedic implant materials in an isoelastic hip prosthesis was investigated. The interactions of polyetheretherketone (PEEK) and epoxy resin polymers (with and without carbon fibre reinforcement) with both fibroblasts and osteoblasts were tested using cell protein, intracellular reduced glutathione (GSH), leakage of lactate dehydrogenase and the MTT assay as indices of cellular cytotoxicity. The epoxy resin polymer was slightly cytotoxic to and inhibited the growth rate of fibroblasts (as assessed by total cell protein), and depleted GSH in both cell types. In contrast, the PEEK material did not display overt signs of cytotoxicity and, in fact, increased osteoblast cell protein content. This suggests that, of these two materials, PEEK would be the one of choice for development of an isoelastic implant and, in view of its stimulatory effect on osteoblast protein content, it may encourage ingrowth of bone around the prosthesis and thus minimize joint loosening.

3T3 Cells↗

PubMed1995

Surface properties and biocompatibility of A-B-A type block copolymer membranes consisting of poly(gamma-benzyl-L-glutamate) as the A component and polyisoprene as the B component.

The surface characteristics of A-B-A type triblock copolymer (GIG) membranes consisting of alpha-helical poly (gamma-benzyl-L-glutamate) (PBLG) as the A component and polyisoprene (PI) as the B component were investigated by X-ray photoelectron spectroscopy (XPS) and contact angle measurements. The XPS measurements showed the copolymer composition of the outermost surface to be quite different from the bulk composition. Results of contact angle measurements indicated the existence of an interfacial region between the alpha-helical A component and the B component at the surfaces of the block copolymer membranes. Finally, the results of in vivo tests on tissue compatibility indicate that the GIG block copolymer membranes have good biocompatibility.

Animals↗

PubMed1995

Utilization of activated U937 monocytic cells as a model to evaluate biocompatibility and biodegradation of synthetic calcium phosphate.

The use of calcium phosphate biomaterials as a bone substitute necessitates the use of normative biocompatibility and biodegradation techniques which must be fast, simple and reproducible. In the present study, we have developed an in vitro model to study and to compare different calcium phosphate ceramics. After activation with 1,25-dihydroxy-vitamin D3 and phorbol 12,13-dibutyrate, the monoblastic U937 cells became multinucleated, expressed tartrate-resistant acid phosphatase and several markers of monocyte/macrophage differentiation. Activated U937 cells did not express the vitronectin receptor (VNR) (as revealed using monoclonal antibodies 23C6 or 13C2) but around 25% of the cells were strongly reactive with 211D, a novel monoclonal antibody that recognizes an osteoclast-specific membrane antigenic determinant. These cells remain active/viable with hydroxyapatite (HA) or beta-tricalcium phosphate (beta-TCP) ceramics. In conclusion, activated U937 cells are good candidates to use in a normative in vitro method to evaluate new biomaterials.

Acid Phosphatase↗

PubMed1995

Permeability and biocompatibility of a new hydrogel used for encapsulation of hepatocytes.

A new high-water-content (83%) and highly permeable anionic polyelectrolyte hydrogel was obtained by phase inversion of a polymer solution containing 6% polyacrylonitrile-sodium methallylsulphonate, 91% dimethylsulphoxide and 3% physiological saline solution. Hydrogel-based hollow fibres (HFs) were fabricated with a co-extrusion apparatus in collaboration with Hospal (France). HFs have an internal diameter of 800 microns and a wall thickness of 100 microns. Experimental results demonstrated that hydrogel-based HFs were permeable to albumin (mol. wt 69,000) and human immunoglobulin G (150,000), but were impermeable to immunoglobulins A (170,000) and M (900,000) after 24 h of diffusion. In vitro, the viability of isolated rat hepatocytes injected into the HFs was 64 +/- 6% after 10 d versus 30 +/- 5% for hepatocytes cultured in Petri dishes (P = 0.0001). Under these conditions, the amount of albumin released by encapsulated hepatocytes was 12 +/- 3 micrograms/24 h/10(6) cells at day 10, whereas at that time no albumin was released by hepatocytes cultured in Petri dishes. In vivo, histological study of hydrogel HFs implanted up to 6 wk in the peritoneum of rats revealed a low inflammatory tissue reaction without giant multinucleate cells in the foreign tissue, which decreased after the third week. The survival rate of encapsulated hepatocytes was over 85% 45 d after transplantation in the peritoneum of syngeneic Lewis rats. Therefore, this hydrogel demonstrates highly favourable properties for encapsulation of hepatocytes with regard to its biocompatibility, permeability and ability to maintain hepatocytes in a functional state for prolonged periods.

Analysis of Variance↗

PubMed1996

In vitro biocompatibility of bioresorbable polymers: poly(L, DL-lactide) and poly(L-lactide-co-glycolide).

The acute toxicity of two degradable polymers, a 70:30 poly (L-D, L-lactide) (PLDLA) and a 90:10 poly(L-lactide-co-glycolide) (PLGA), was evaluated by the agar diffusion test and the filter test with L929 mouse fibroblasts. Extracts of the materials prepared in phosphate-buffered saline at 37 and 70 degrees C were assessed for mitochondrial succinate dehydrogenase activity by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT assay) and the incorporation of 5-bromo-2'-deoxyuridine (BrdU) into DNA of BALB 3T3 cells. Both materials revealed no signs of cytotoxicity during the agar diffusions and filter tests. In the MTT and BrdU assays PLDLA and PLGA showed similar results. Cells treated with extracts prepared at 37 degrees C caused slight stimulation of mitochondrial activity. In contrast, cells incubated with the 70 degrees C media revealed a concentration-dependent decrease of mitochondrial activity. DNA synthesis was significantly decreased by the 37 degrees C extracts. As in the MTT assay, the effect of the extracts prepared at 70 degrees C was significantly greater. From these in vitro results it is suggested that PLDLA and PLGA have satisfactory biocompatibility. High concentrations of the degradation products, however, had a toxic influence on the cell culture systems used.

3T3 Cells↗

PubMed1991

Biocompatibility of poly (DL-lactic acid/glycine) copolymers.

In this review the authors discuss the polymer chemical, physical and cell biological aspects of poly (DL-lactic acid/glycine) copolymers, both in vitro and in vivo. The mechanism and rate of degradation and the degree of foreign body reaction were evaluated as a function of the molecular composition of the (co)polymer, its initial molecular weight and changes in crystallinity. Data from the literature concerning poly(lactic acid), poly(glycolic acid) and poly(amino acids) are included in this review. The choice to apply the polymers mentioned was determined by their nature: all are present in the human body as natural residues. Upon degradation, biocompatibility will thus not be impaired. The authors conclude that the degradation mechanism of poly(lactic acid), poly(glycolic acid) and poly(amino acids) are similar, i.e. bulk hydrolysis of ester bonds. The initial molecular weight and the chemical composition, determine the rate of degradation and the degree of foreign body reaction.

Biocompatible Materials↗

PubMed1989

The cage implant system for determining in vivo biocompatibility of medical device materials.

Biocompatibility of an implanted material, drug delivery system, or prosthetic is a dynamic two-way process that involves the time-dependent effects of the host on the material and the material on the host. Implantation of any synthetic material initiates a wound-healing mechanism that is characterized by the inflammatory response. We have developed a novel implant system that enables quantitative as well as qualitative evaluation of the inflammatory response to implanted materials. The cage implant system can be used to quantify the cellular and enzymatic components of inflammation and permits access to study cellular adhesion and interactions with candidate biomaterials. The basic methodology of the implant system is described. The effectiveness of the system is illustrated by comparing the results for three contrasting materials: polyethylene, poly(vinyl-chloride) containing a stabilizer that is cytotoxic, and poly(DL-lactide) containing hydrocortisone acetate.

Animals↗