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At least 343 records · Page 19Linked to original sources

The biocompatibility of hydroxyapatite ceramic: a study of retrieved human middle ear implants.

The biocompatibility of 11 hydroxyapatite auditory canal-wall prostheses and 4 hydroxyapatite incus prostheses implanted for 4 to 40 months was evaluated by light microscopy, scanning electron microscopy, transmission electron microscopy, and Röntgen microanalysis. These 15 prostheses representing 4% of 375 prostheses, has been removed because of unresolved chronic middle ear infection, residual cholesteatoma, or poor fit. The findings confirmed earlier reports on the biocompatibility of hydroxyapatite in vitro, in animals, and in man. An electron-dense layer was found at the interface with bone and fibrous tissue, and a firm bond between the ceramic and bone at the hydroxyapatite ceramic/bone interface developed. Macropores became filled with bone and fibrous tissue, and the tissue in the individual pores was interconnected. Furthermore the incus prostheses were covered with an epithelium similar to that found in the human middle ear. Findings diverging from those made in other studies were the relatively large amount of exudate in the pores, an apparent increase of degradation during infection, and the accumulation of trace elements in one of the canal-wall prostheses. In all likelihood these three phenomena may be attributed to the unfavorable conditions to which these prostheses were exposed during implantation.

Biocompatible Materials↗

Poly(anhydride) administration in high doses in vivo: studies of biocompatibility and toxicology.

Poly(anhydrides) proposed for use as vehicles for controlled drug delivery were administered subcutaneously in Sprague-Dawley rats at two dosage levels (800 mg/kg rat and 2400 mg/kg rat) for a period of eight weeks. Biocompatibility was assessed using a number of methods. Thirty-six clinical chemistry and hematology parameters were monitored throughout the study. Blood values were statistically analyzed for any possible effects due to the implanted polymer. After 8 weeks, rats were sacrificed and complete necropsies were performed. Histological evaluations of 33 organ sites including heart, lung, liver, kidney, and brain were performed. In addition, subcutaneous implant sites were excised and examined both grossly and microscopically. Results from evaluations of blood chemistry and hematology data, organ analyses and local implant site analyses overall demonstrated that the poly(anhydride) biomaterial possessed excellent in vivo biocompatibility.

Animals↗

Biocompatibility of collagen membranes crosslinked with glutaraldehyde or diphenylphosphoryl azide: an in vitro study.

Crosslinking of collagen biomaterials increases their resistance to degradation in vivo. Glutaraldehyde (GA) is normally used to crosslink collagen biomaterial, but is often cytotoxic. Diphenylphosphoryl azide (DPPA) has recently been proposed as reagent, but little is known about its effects on cell behavior. In this study, we determined which collagen membrane was the most biocompatible: Paroguide which is crosslinked with DPPA and contains chondroitin sulfate; Opocrin which is crosslinked with DPPA; Biomed Extend which is crosslinked with GA; and Bio-Gide which is left untreated. Cell proliferation and extracellular matrix macromolecule deposition were evaluated in human fibroblasts cultured on the membranes. The GA-crosslinked Biomed Extend membrane and the not-crosslinked Bio-Gide membrane reduced cell growth and collagen secretion compared with DPPA-crosslinked biomembranes. When Paroguide and Opocrin were compared, better results were obtained with Paroguide. The greatest amount of transforming growth factor beta1, a growth factor involved in extracellular matrix macromolecule accumulation and in tissue regeneration, was produced by cells cultured on Paroguide, with Opocrin second. Our data suggest that the DPPA method is more biocompatible than the GA for crosslinking collagen biomaterials and that membranes made of collagen plus chondroitin sulfate are better than membranes made of pure collagen.

Azides↗

In vivo biocompatibility of three different chemical compositions of Ricinus communis polyurethane.

Alteration in the chemical composition of a biomaterial may be undertaken to improve its biological properties. The aim of this work was to evaluate the biocompatibility of three chemical compositions of Ricinus communis polyurethane (RCP): RCPp (pure RCP), RCP + CaCO(3), and RCP +Ca(3)(PO(4))(2). RCP cylinders were surgically implanted in rabbit femurs. After 8, 12, and 16 weeks, the femurs were removed, fixed, sectioned, ground, and stained by Stevenel's blue/Alizarin red S for light microscopy and histomorphometry. The osseointegration and osseoconductivity were calculated by means of image analysis and the data were submitted to the Kruskal-Wallis test followed by Dunn's test. Osseointegration was already completed after 8 weeks on RCP + Ca(3)(PO(4))(2) because similar values were found from week 8 to 16, whereas it showed a time-dependent increase on RCPp and RCP +CaCO(3). The osseointegration was greater on RCP + Ca(3)(PO(4))(2) in all periods when compared with RCPp, and after 8 and 12 weeks when compared with RCP + CaCO(3). None of the RCP samples presented osseoconductivity. The present results showed that RCP blended with calcium phosphate improved the biocompatibility by both enhancing and accelerating its osseointegration. Based on the absence of osseoconductivity, RCP was considered to be a bioinert material.

Animals↗

In vivo biocompatibility evaluation of cellulose macrocapsules for islet immunoisolation: Implications of low molecular weight cut-off.

Earlier we showed the in vitro suitability of cellulose molecular dialysis membrane of low cut-off for islet immunoisolation. Using a syngenic islet transplantation model, here we report the in vivo biocompatibility status and discuss implications of the low molecular weight cut-off of this membrane. Streptozotocin diabetic mice were transplanted ip with islet grafts in cellulose macrocapsules and monitored for 6 weeks for their blood glucose profiles. Membrane biocompatibility was evaluated by assessing islet graft morphometry, viability, functionality, and tissue reaction against the capsules. Animals (n = 10) attained normoglycemia after 1 week of transplantation and remained nondiabetic throughout a follow-up of 6 weeks. Animals subjected to a glucose tolerance test at the end of the study showed delayed glycemic control, indicating a delayed insulin response. Grafts retrieved after the 15(th) day and after 6 weeks showed viable islets, between 70-80% and approximately 40%, respectively, with morphometric parameters similar to freshly isolated islets. Graft retrievals resulted in a recurrence of hyperglycemia, indicating a functional tissue mass. A mild tissue reaction with a few immunocytes and a very thin fibrous capsular reaction were seen against the macrocapsule membrane. This study points out the in vivo suitability of cellulose membrane for islet immunoisolation. However, applicability of this membrane is limited due to its low cut-off value. Membranes with a higher molecular weight cut-off may render better glycemic control and higher graft viability.

Animals↗

Biocompatibility and hemocompatibility of surface-modified NiTi alloys.

Nickel titanium (NiTi) shape memory alloys have been investigated for several years with regard to biomedical applications. However, little is known about the influences of surface modifications on the biocompatibility of these alloys. The effects of a range of surface treatments were investigated. Cytotoxicity and cytocompatibility studies with both fibroblast and endothelial cells showed no differences in the biocompatibility of any of the NiTi surfaces. The cytotoxicity and cytocompatibility of all surfaces were favorable compared to the controls. The hemolysis caused by a range of NiTi surfaces was no different from that caused by polished 316L stainless steel or polished titanium surfaces. The spreading of platelets has been linked to the thrombogenicity of materials. Platelet studies here showed a significant increase in thrombogenicity on polished NiTi surfaces compared to 316L stainless steel and pure titanium surfaces. Heat treatment of NiTi was found to significantly reduce thrombogenicity, to the level of the control. The XPS results showed a significant decrease in the concentration of surface nickel with heat treatment and changes in the surface nickel itself from a metallic to an oxide state. This correlates with the observed reduction in thrombogenicity.

3T3 Cells↗

Evaluation of biocompatibility of polypyrrole in vitro and in vivo.

In this study, the biocompatibility of the electrically conductive polymer polypyrrole (PPy) with nerve tissue was evaluated in vitro and in vivo. The extraction solution of PPy powder, which was synthesized chemically, was tested for acute toxicity, subacute toxicity, pyretogen, quantitative measure of cell viability, hemolysis, allergen, and micronuclei. The PPy membrane was synthesized electrochemically on the indium tin oxide conductive borosilicate glass. The dorsal root ganglia from 1-3-day-old Sprague-Dawley rats were cultured above PPy membrane and observed by light or scanning electron microscopy. The PPy-silicone tube (PPy membrane on the inner surface of the silicone tube) also synthesized electrochemically was used to bridge across 10-mm sciatic nerve gap in rats. Twenty-four weeks after the operation to rats, the regenerated tissues were observed by electrophysiological and histological techniques. PPy extraction solution showed no evidence of acute and subacute toxicity, pyretogen, hemolysis, allergen, and mutagenesis, and the Schwann cells from the PPy extraction solution group showed better survival rate and proliferation rate as compared with the saline solution control group. The migration of the Schwann cells and the neurite extension from dorsal root ganglia on the surface of PPy membrane-coated glass was better than those of bare glass. There was only lightly inflammation during 6 months of the postoperation, when the PPy-silicone tube bridged across the gap of the transected sciatic nerve. The regeneration of nerve tissue in the PPy-silicone tube was slightly better than that in the plain silicone tube by means of electrophysiological and histological examination. The results of this study indicate that PPy has a good biocompatibility with rat peripheral nerve tissue and that PPy might be a candidate material for bridging the peripheral nerve gap.

Animals↗

Effect of excipient composition on the biocompatibility of bupivacaine-containing microparticles at the sciatic nerve.

Microparticulate formulations are often used for experimental prolongation of nerve blockade. Here we examine the effect of excipient composition on the biocompatibility of bupivacaine-containing microparticles. Lipid-protein-sugar particles (LPSPs) composed of 3% (1.3-microm diameter) and 60% (4.7-microm diameter) (w/w) dipalmitoylphosphatidylcholine (DPPC) were produced by spray drying, containing 10% (w/w) bupivacaine. Rat sciatic nerve blocks with 75 mg of particles produced statistically similar durations of sensory nerve block [3% (w/w) DPPC particles: 301 min; 60% (w/w) DPPC particles: 321 min]. Examination of tissues 1 day after injection revealed large particle deposits and acute inflammation in animals that received 60% (w/w) DPPC particles. There were no visible deposits in those that received 3% (w/w) DPPC particles, and microscopic inflammation was reduced. The difference between groups was similar 4 days after injection. Two weeks after injection, there was no particulate mass in either group, and inflammation had largely resolved. In both groups, moderately severe myotoxicity was seen 1 and 4 days after injection but had largely resolved by 2 weeks. In summary, reduction in particles' DPPC content greatly improved biocompatibility without compromising duration of nerve blockade; the improvement was probably attributable to the enhanced rate of particle resorption.

Animals↗

Biocompatibility of components of a female controlled drug delivery system.

A female controlled drug delivery system (FcDDS) containing sodium dodecyl sulfate as a microbicide, ethylenediaminetetraacetic acid (EDTA) as a synergistic microbicide, and lactic acid as a pH modulator was developed as an intravaginal barrier device against sexually transmitted diseases. The host response of the vagina to the FcDDS was evaluated through biocompatibility tests including cell viability, estrogenicity, and cytotoxicity assays on HeLa cervical cells and NIH:Ovcar-3 ovarian cells. Gel electrophoresis and reverse transcriptase polymerase chain reaction assays on HeLa cervical cell lines were also performed to elucidate the effects of EDTA on the expression of particular proteins of interest. The results of the cell viability test showed no significant difference in viability of cells upon exposure to EDTA at concentrations less than 0.035% that was reported to exert spermicidal activity. EDTA at concentrations less than 0.035% did not cause any cytotoxicity. The results of reverse transcriptase polymerase chain reaction analysis revealed that EDTA induced the expression of a 67-kDa protein in HeLa cells, which was identified as elastin binding protein (a part of the elastin receptor complex). This work has demonstrated that FcDDS containing EDTA is biocompatible and safe to be used as an intravaginal barrier device.

Biocompatible Materials↗

Evaluation of in vivo biocompatibility and biodegradation of photocrosslinked hyaluronate hydrogels (HADgels).

HADgels are newly developed photocrosslinked hyaluronate hydrogels. They are produced from an aqueous solution of a hyaluronan derivative (HAD) in which cinnamic acid is introduced into the carboxyl moiety of hyaluronan using 3-aminopropanol as a spacer. High-energy ultraviolet irradiation of the HAD solution induces photodimerization of cinnamic acid, resulting in the development of a macromolecular network of each hyaluronan to water-insoluble hydrogels. The biocompatibility and biodegradation of HADgels were evaluated by guinea pig intracutaneous injection testing for up to 28 days. By macroscopic and histological observations, HADgels showed good tissue compatibility and did not induce excess inflammation at the injection sites. Biodegradation of the HADgels clearly depended on the degree of crosslinking at the fixed weight concentrations of HAD (0.5% and 1.0%). In addition, serum analyses showed that the injected guinea pigs did not produce specific antibodies against HADgels. These results indicate that HADgels have preferable biocompatibility and can be used as a new class of injectable, absorbable biomaterial, especially for preventing postsurgical adhesion formations.

Alcian Blue↗

Poly(dimethylsiloxane) thin films as biocompatible coatings for microfluidic devices: cell culture and flow studies with glial cells.

Oxygen plasma treatment of poly(dimethylsiloxane) (PDMS) thin films produced a hydrophilic surface that was biocompatible and resistant to biofouling in microfluidic studies. Thin film coatings of PDMS were previously developed to provide protection for semiconductor-based microoptical devices from rapid degradation by biofluids. However, the hydrophobic surface of native PDMS induced rapid clogging of microfluidic channels with glial cells. To evaluate the various issues of surface hydrophobicity and chemistry on material biocompatibility, we tested both native and oxidized PDMS (ox-PDMS) coatings as well as bare silicon and hydrophobic alkane and hydrophilic oligoethylene glycol silane monolayer coated under both cell culture and microfluidic studies. For the culture studies, the observed trend was that the hydrophilic surfaces supported cell adhesion and growth, whereas the hydrophobic ones were inhibitive. However, for the fluidic studies, a glass-silicon microfluidic device coated with the hydrophilic ox-PDMS had an unperturbed flow rate over 14 min of operation, whereas the uncoated device suffered a loss in rate of 12%, and the native PDMS coating showed a loss of nearly 40%. Possible protein modification of the surfaces from the culture medium also were examined with adsorbed films of albumin, collagen, and fibrinogen to evaluate their effect on cell adhesion.

Animals↗

In vitro evaluation of biocompatibility of beta-tricalcium phosphate-reinforced high-density polyethylene; an orthopedic composite.

Beta-tricalcium phosphate-reinforced high-density polyethylene (beta-TCP/HDPE) is a new biomaterial which was made as a copy of bone composition with the aim of replacement of bony tissues. The composite samples were prepared using medical grade TCP powder and granular polyethylene. The raw materials were first compounded and the resulting composite preforms were compression molded into desired shape. The biocompatibility of composite samples with different volume fractions of TCP (20, 30, and 40 vol %) was assessed by proliferation, alkaline phosphatase (ALP), and cell adhesion assays using G-292 osteoblast cells. Cell-material interaction on the surface of the composites was observed by scanning electron microscopy (SEM). The effect of beta-TCP/HDPE on the behavior of G-292 cells was compared with those of a composite and a negative control samples. Results showed the composite samples had a higher proliferation rate of G-292 cells in the presence of composite samples as compared to the composite control sample after 3, 7, and 14 days of incubation period. ALP production after incubation in the presence of composite samples was seen to peak on the day 7. The number of adhered cells on the composite samples was higher than the numbers adhered on composite and negative control samples after the above incubation periods. Morphology investigation of adhered cells by SEM indicated a normal morphology and also many of the cells were in the process of cell division. The above results indicate that beta-TCP/HDPE samples are biocompatible, nontoxic, and in some cases show an increase in the proliferation rate of the cells, ALP production, and cell adhesion as compared to the control counterparts.

Alkaline Phosphatase↗

Extensive H(+) release by bone substitutes affects biocompatibility in vitro testing.

Bone substitutes are widespread in orthopedic and trauma surgery to restore critical bony defects and/or promote local bone healing. Cell culture systems have been used for many years to screen biomaterials for their toxicity and biocompatibility. This study applies a human bone marrow cell culture system to evaluate the toxic in vitro effects of soluble components of different bone substitutes, which are already in clinical use. Different specimens of tricalcium phosphates (TCP) (Vitoss, Cerasorb), nondecalcified bovine bone (Lubboc), demineralized human bone matrices (DBM) (Grafton Flex/Putty), and collagen I/III matrix (ACI-Maix) were tested in Dulbecco's modified Eagle's medium (DMEM) and MesenCult culture solution and compared with a biomaterial-free cell culture. Biocompatibility parameters were cell viability evaluated by phase-contrast microscopy and laser flow cytometry, morphology, and the local H(+) release by bone substitutes. There were significant differences (p < 0.05) between the tested biomaterials and culture solutions. Collagen I/III, non-demineralized bovine bone, and TCP materials showed advantages for cell survival over other tested biomaterials (average values of vital cells/mL MesenCult/DMEM: Collagen I/III: 1090/1083; Vitoss: 893/483; Cerasorb: 471/523; Lubboc: 815/410; Grafton Putty: 61/44; Grafton Flex: 149/57). Especially the DBM materials lead to a significant decrease of pH, which is considered to be a major factor for cell death. DMEM culture solution supports cell survival for those bone substitutes that induce an alkaline reaction, whereas MesenCult media promotes cell vitality in biomaterials, which leads to an acidification of culture solution.

Animals↗

Biocompatibility of subsieve-size capsules versus conventional-size microcapsules.

Biocompatibility of cell-enclosing capsules, defined as suppression of pericapsular cellular reactions, is one of the factors governing the success of enclosed cell transplantation in in vivo cell therapy. Agarose capsules of subsieve size, less than 100 microm in diameter, and conventional size, approximately 300-1,000 microm in diameter, were implanted into the peritoneal cavity and epididymal fat pads of mice and rats, respectively, to determine the effect of a reduction in diameter to subsieve size. The degree of cellular reaction to the subsieve-size capsules was much lower than that of the conventional-size microcapsules, independent of implantation site. The frequency of overgrown subsieve-size capsules retrieved from the peritoneal cavities was less than 5% in contrast to approximately 20% for capsules 387 microm in diameter. In addition, no increase in floating cells, which are generated through capsule stimulation, was observed in the peritoneal cavity only with subsieve-size capsules. From these results, we concluded that subsieve-size capsules are more biocompatible than microcapsules of conventional size.

Adipose Tissue↗

Biocompatibility of poly(ether)urethane-gold nanocomposites.

We have prepared the nanocomposites of a polyether-type waterborne polyurethane (PU) incorporated with different amounts (17.4-174 ppm) of gold (Au) nanoparticles ( approximately 5 nm). The nanocomposite containing a certain amount (43.5 ppm) of gold was previously demonstrated to possess the optimal thermal and mechanical properties, as well as much reduced foreign body reactions in subcutaneous rats. In this study, the surface morphology, biocompatibility, oxidative degradation, and free radical scavenging ability of the nanocomposites were characterized in vitro. The nanocomposite at 43.5 ppm of gold ("PU-Au 43.5 ppm") exhibited different surface morphology confirmed by the atomic force microscope. PU-Au 43.5 ppm also showed enhanced cellular proliferation, reduced platelet and monocyte activation, and much less bacterial adhesion, relative to PU alone or nanocomposites at the other Au contents, in general. This better biocompatibility was associated with the surface morphological change in the presence of Au. The oxidative degradation in PU-Au 43.5 ppm was also inhibited. The increased oxidative stability corresponded to the greater free radical scavenging ability of the nanocomposites.

Biocompatible Materials↗

Synthesis and characterization of biocompatible Fe3O4 nanoparticles.

In this study, magnetite (Fe3O4) nanoparticles with a size range of 8-20 nm were prepared by the modified controlled chemical coprecipitation method from the solution of ferrous/ferric mixed salt-solution in alkaline medium. In the process, two kinds of surfactant (sodium oleate and polyethylene glycol) were studied; then, sodium oleate was chosen as the apt surfactant to attain ultrafine, nearly spherical and well-dispersed (water-base) Fe3O4 nanoparticles, which had well magnetic properties. The size and size distribution of nanoparticles were determined by particle size analyzer. And the magnetite nanoparticles was characterized by X-ray powder diffraction (XRD) analysis, transmission electron microscopy (TEM), electron diffraction (ED) photography, Fourier transform infrared spectrometer (FT-IR), and vibrating-sample magnetometer (VSM). Also the effect of many parameters on the Fe3O4 nanoparticles was studied, such as reaction temperature, pH of the solution, stirring rate and concentration of sodium oleate. And the 5-dimethylthiazol-2-yl-2,5- diphenyltetrazolium bromide (MTT) assay was performed to evaluate the biocompatibility of magnetite nanoparticles. The results showed that the Fe3O4 nanoparticles coated by sodium oleate had a better biocompatibility, better magnetic properties, easier washing, lower cost, and better dispersion than the magnetite nanoparticles coated by PEG.

3T3 Cells↗

In vitro biocompatibility evaluation of poly(3-hydroxybutyrate-co-4-hydroxybutyrate) copolymer in fibroblast cells.

Among the various biomaterials available for tissue engineering and therapeutic applications, microbial polyhydroxyalkanoates offer the most diverse range of thermal and mechanical properties. In this study, the biocompatibility of poly(3-hydroxybutyrate-co-4-hydroxybutyrate) [P(3HB-co-4HB); containing 50 mol % of 4-hydroxybutyrate] copolymer produced by Delftia acidovorans was evaluated. The cytotoxicity, mode of cell death, and genotoxicity of P(3HB-co-4HB) extract against V79 and L929 fibroblast cells were assessed using MTT assay, acridine orange/propidium iodide staining, and alkaline comet assay, respectively. Our results demonstrate that P(3HB-co-4HB) treated on both cell lines were comparable with clinically-used Polyglactin 910, where more than 60% of viable cells were observed following 72-h treatment at 200 mg/mL. Further morphological investigation on the mode of cell death showed an increase in apoptotic cells in a time-dependent manner in both cell lines. On the other hand, P(3HB-co-4HB) at 200 mg/mL showed no genotoxic effects as determined by alkaline comet assay following 72-h treatment. In conclusion, our study indicated that P(3HB-co-4HB) compounds showed good biocompatibility in fibroblast cells suggesting that it has potential to be used for future medical applications.

Animals↗

Preclinical biocompatibility assessment of the EVAHEART ventricular assist device: coating comparison and platelet activation.

Thromboembolism and bleeding remain significant complications of ventricular assist device (VAD) support. Increasing the amount of biocompatibility data collected during preclinical studies can provide additional criteria to evaluate device refinements, while design changes may be implemented before entering clinical use. Twenty bovines were implanted with the EVAHEART centrifugal VAD for durations from 30 to 196 days. Titanium alloy pumps were coated with either diamond-like carbon or 2-methoxyethyloylphosphoryl choline (MPC). Activated platelets and platelet microaggregates were quantified by flow cytometry, including two new assays to quantify bovine platelets expressing CD62P and CD63. Temporally, all assays were low preoperatively, then significantly increased following VAD implantation, before declining to a lower, but still elevated level over 2-3 weeks. MPC-coated VADs produced significantly fewer activated platelets after implant trauma effects diminished. Three animals receiving no postoperative anticoagulation had similar amounts of circulating activated platelets and platelet microaggregates as animals receiving warfarin anticoagulation. Two new methods to quantify bovine activated platelets using antibodies to CD62P and CD63 were characterized and applied. These measures, along with previously described assays, were able to differentiate between two biocompatible coatings and assess effects of anticoagulation regimen in VAD preclinical testing.

Animals↗