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PubMed2004

PEI-based vesicle-polymer hybrid gene delivery system with improved biocompatibility.

Wider use of the transfection agent polymer polyethylenimine (PEI) in vivo has been hampered by its toxicity. In order to examine whether material combining properties of polymers and lipid type of carriers would have improved characteristics, four PEI derivatives were synthesised: The methylation of the branched PEI (25 kDa) created a permanently charged quaternary ammonium derivative. Acylation of these backbones using pendant palmitic acid chains created amphiphilic PEI variants which formed nanoparticles or vesicles. Finally hydrophilic groups were added to the polymer backbone by PEGylation. The materials were characterised and their in vitro and in vivo properties were tested. The modifications improved the materials biocompatibility markedly when compared to the starting material but also reduced transfection efficiency. The material bearing ammonium and palmitoyl groups was 10x less toxic while retaining about 30% of the transfection efficiency in vitro. After intravenous administration in a mouse model the materials also gave rise to GFP transgene expression in the liver. The synthetic strategy altered complex physicochemistry and improved biocompatibility while maintaining in vitro gene expression for most formulations. The strategy of combination of complementary properties of cationic lipids and polymers into a hybrid material may also be applicable to other materials.

Animals↗

PubMed2006

Biocompatibility of glass-ionomer bone cements.

Glass-ionomer cements (GIC) have been extensively used in dentistry for over 30 years. Due to their excellent biocompatibility in dental applications GIC have been formulated for medical applications. The past decade has seen some impressive advances in the development of medical GICs, however these advances have been matched by serious critical problems. This review examines the properties of GICs, which can influence their behaviour in a biological environment. The progress made and the problems encountered in the development of these bone cements will also be addressed. The review will conclude with the research currently being employed to optimise the biocompatibility of these important biomaterials. There is little doubt that GICs compare favourably with alternative bone cements for specific applications, based on in vitro and in vivo studies. There is however, a degree of risk inherent in the use of any medical device or biomaterial. GICs must therefore be used carefully and in accordance with the instructions that are based on a significant body of research data.

Aluminum↗

PubMed1998

The role of flow cytometry in improving biocompatibility in transfusion medicine.

In transfusion medicine, blood and blood components, donors and patients are increasingly confronted with biomaterials. The need to understand the response of human blood to contact with these artificial surfaces has led to multiple studies on the biocompatibility of biomaterials. Up to this time, these investigations have predominantly been performed using physical, immunological and biochemical methods. Many of these approaches are useful in investigating the multiple factors involved in blood-biomaterial interactions. However, they always reflect the overall behaviour of whole cellular populations in local or systemic reactions. The application of multiparameter flow cytometry, on the other hand, provides insight into antigenic expression and changes at the single-cell level. Therefore, the technique of flow cytometry represents a new and powerful way of analysing and improving the biocompatibility of these materials in blood-contacting applications in this field.

Blood Component Transfusion↗

PubMed2003

Biocompatibility of a physiological pressure sensor.

A newly developed fiber optic micropressure sensor was evaluated for biocompatibility using the International Organization for Standardization (ISO) test standard 10993-6. The test material and an inert control (fused silica glass) were tested in New Zealand white rabbits. Four test specimens were implanted in the paravertebral muscles on one side of the spine about 2-5 cm from the mid-line and parallel to the spinal column. Similarly, four control specimens were implanted on the opposite side. The implantation periods were 1, 4, and 12 weeks to ensure a steady state biological tissue response. Four animals were tested at each time period. Macroscopic and microscopic observations were performed to compare the biological reactions between the test and control materials. There was an inflammatory reaction at 1 week which subsided at 4 weeks. There was fibrous tissue growth near the implant that also decreased over time. Most importantly, there was no significant difference in the biological response between the test and control materials. Therefore, we conclude that the pressure microsensor is biocompatible.

Animals↗

PubMed1996

Initial biocompatibility studies of a novel degradable polymeric bone substitute that hardens in situ.

Clinical management of osseous defects often requires bone grafts. The standard for treatment is autogenous bone harvested from sites such as either the iliac crest or the outer table of the calvaria. In addition to the problem of donor site morbidity and the limited supply of graft material, there is the additional operating time associated with harvesting procedures. A synthetic, bone graft substitute that can match the clinical performance of autogenous bone could alleviate these deficiencies. Therefore, a polymeric bone substitute was developed that consists of a four-armed star polymer of poly(dioxanone-co-glycolide) endcapped at each termini with a biocompatible lysine-based diisocyanate crosslinker. The polymer can be mixed with inorganic fillers such as either hydroxyapatite or tricalcium phosphate to form either injectable or moldable putty. The addition of a catalyst (for example, diethylaminoethanol and water) to the polymer produces a crosslinking reaction causing the combination to harden. This reaction is nontoxic, normo-thermic and can be performed in situ. During the course of the polymerization, carbon dioxide is liberated, producing an interconnected porous network within the implant, suitable for bone ingrowth. This paper will describe a preliminary biocompatibility assay of the bone substitute.

Animals↗

PubMed1999

Corrosion and biocompatibility of orthodontic wires.

With the increasing number of orthodontic treatments using devices containing nickel and the growing prevalence of nickel allergy in the average population, biocompatibility studies of these devices have become a topic of major interest. The corrosion behavior of orthodontic wires is a decisive factor determining their biocompatibility. Therefore four nickel-titanium guiding arches, a titanium-molybdenum and a stainless steel wire were analyzed for corrosion behavior under realistic conditions. Pure potentiostatic, pure mechanical and combined potentiostatic and mechanical stresses were applied to the specimens. Subsequently, the surfaces of the wires were investigated employing atomic force microscopy (AFM) and nickel loss was measured with an atomic absorption spectrophotometer. The results yield information about the relative corrosion tendency of the wires under in vitro conditions. The wires examined can be classified into two groups, one with a high and a second group with a low tendency towards corrosion, that is American Orthodontics Memory wire as well as GAC Neo Sentalloy and Ormco Ni-Ti as well as Unitek Nitinol respectively. Although corrosion behavior under clinical conditions can not be directly derived from these results, analyses of wires after clinical usage indicate that changes of wire surfaces might show the same characteristics under in vitro conditions.

Journal Article↗

PubMed1999

Multifunctional biocompatible membrane and its application to fabricate a miniaturized glucose sensor with potential for use in vivo.

A multifunctional membrane with biocompatibility, diffusion-limiting effect, and the ability to curtail the responses of an H(2)O(2) electrode to ascorbate and urate was prepared. It was composed of MB, AB, and CTA, where MB is the copolymer of 2-methacryloyloxyethyl phosphorylcholine (MPC) and n-butylmethacrylate (BMA), AB is the copolymer of acrylamide-2-methylpropane sulfonic acid (AMPS) and BMA, CTA is cellulose triacetate. Investigation of the biocompatibility of this membrane showed that, compared with CTA, relatively few platelets bound to it. The membrane was coated onto the working electrode of a needle-type glucose sensor on which immobilized glucose oxidase membrane has been coated. The sensor did not respond to ascorbate and urate at their concentration normally encountered in blood. Its response was not inhibited by metal ions in blood at usual concentration. The sensor exhibited superior thermostability in addition to a rapid response (<90 seconds in batch operation), good reproducibility (RE<5%), good stability (more than 36 hours continuously in heparinized whole blood), and a wide dynamic range (5-650 mg/dl glucose). The sensor was used to determine glucose in serum. The data obtained from the sensor showed good agreement with that from a clinical autoanalyzer (R=0.973).

Journal Article↗

PubMed1997

Monocyte-biomaterial interaction inducing phenotypic dynamics of monocytes: a possible role of monocyte subsets in biocompatibility.

For the in vitro study of cell-biomaterial surface interactions, the choice of cell type is crucial. In vivo data indicate that during the healing of the implant in the tissues, the pivotal cell types are the macrophages. These cells, upon interaction with any foreign material, might initiate a spectrum of responses, which could lead to acute and chronic inflammatory changes affecting the biocompatibility of the implant. Whether the mechanisms governing the type of evolving inflammatory reaction could be attributed to the macrophages functional differentiation mirrored by monocyte subsets during the polymer interaction, is poorly described. This in vitro study, therefore, attempted to investigate whether different biomaterials influence monocyte cellular activity, determined by the myeloperoxidase level and mitochondrial XTT cleavage, and phenotype dynamics characterized by the presence of CD14, RM 3/1 and 27E10 antigens. It is shown that different polymers exert differential potential to influence monocytes, both in their cellular activity and their phenotypic pattern. Thus, these findings demonstrating material-induced monocyte activation and monocyte phenotype modulation, are suggestive of the monocyte role as reporter cells in evaluating the biocompatibility of a synthetic medical device.

Journal Article↗

PubMed1997

Polyamide 4,6 membranes for the encapsulation of Langerhans islets: preparation, physico-chemical properties and biocompatibility studies.

Porous polyamide 4,6 membranes developed as semi-permeable and biocompatible membranes for the encapsulation of pancreatic islets were prepared by precipitation in water. Different membrane morphologies were obtained by varying the molecular weight of polyamide 4,6, the solvent evaporation time and the composition of the casting solution. Each membrane was submitted to differential scanning calorimetry and water flux measurements to study the total water content and the different kinds of water in correlation with its permeability performances. Their biocompatibility was first evaluated by a surface protein adsorption test. Of the various membranes, the one prepared by immersion in water after 5 minutes of solvent evaporation, of 15% KS200 polyamide 4,6 solution added with 1% of polyvinylpyrrolidone K30 seems to be the most promising. This membrane is characterized by a low adsorption of proteins, a high hydraulic coefficient and an asymmetric structure. Such a membrane represents a good candidate to be an efficient immunological barrier. It also exhibits good glucose and insulin diffusion properties. Moreover, rat islets cultivated on its surface were not affected by its presence and no important cell adhesion was noticed when implanted in mice. This membrane exhibits most of the properties suitable for the islet encapsulation with a view to developing a bioartificial pancreas.

Journal Article↗

PubMed1997

Evaluation of in vitro bioactivity and biocompatibility of Bioglass-reinforced polyethylene composite.

The bioactivity and biocompatibility of Bioglass-reinforced high-density polyethylene composite (Bioglass/HDPE) have been evaluated in simulated body fluid (SBF) and by in vitro cell culture, respectively. The formation of a biologically active hydroxy-carbonate apatite (HCA) layer on the composite surface after immersion in SBF was demonstrated by thin-film X-ray diffraction, infrared spectroscopy and scanning electron microscopy, indicating the in vitro bioactivity of Bioglass/HDPE composites. The HCA layer was formed on the 40 vol% composite surface within 3 days immersion in SBF at a formation rate comparable to those on bioactive glass-ceramics, showing that in vitro bioactivity could be obtained in a composite. Furthermore, the composite was biocompatible to primary human osteoblast-like cells. In comparison with unfilled HDPE and tissue culture plastic control, a significant increase in cellular metabolic activity was found on the composite. Therefore, Bioglass/HDPE composites have a promising biological response as a potential implant material.

Journal Article↗

PubMed2003

Synthesis and biocompatibility of porous nano-hydroxyapatite/collagen/alginate composite.

Porous nano-hydroxyapatite/collagen/alginate (nHAC/Alginate) composite containing nHAC and Ca-crosslinked alginate is synthesized biomimetically. This composite shows a significant improvement in mechanical properties over nHAC material. Mechanical test results show that the compressive modulus and yield strength of this composite are in direct proportion to the percentage of Ca-crosslinked alginate in the composite. Primary biocompatibility experiments in vitro including fibroblasts and osteoblasts co-culture with nHAC/alginate composite indicated the high biocompatibility of this composite. Therefore the composite can be a promising candidate of scaffold material for bone tissue engineering.

Journal Article↗

PubMed2001

Properties of polyvinyl pyrrolidone/beta-chitosan hydrogel membranes and their biocompatibility evaluation by haemorheological method.

The semi-IPN hydrogel membranes of polyvinyl pyrrolidone (PVP) and beta-chitosan were synthesized by crosslinking beta-chitosan with glutaraldehyde. Hydrogel membranes were characterized by spectroscopic, swelling, thermal and mechanical properties. The in vitro biocompatibility of hydrogel membranes was studied by haemorheological method. These hydrogels have water contents in the range of 60-70% with a high fraction contributed by free water (> 45%). The gel composition, amount of cross-linking agent and swelling temperature plays an important role in swelling kinetics of these semi-IPN membranes. Melting temperature (Tm) of membranes increased with a decrease in endothermic peak with increasing beta-chitosan content. The tensile strength of membranes in the dry state was found to be high (29-43 MPa) and it increased with increasing beta-chitosan content. The in vitro haemorheological studies indicated the biocompatible nature of membranes with no significant changes in whole blood and plasma viscosity and red blood cell rigidity.

Journal Article↗

PubMed2003

Affinity adsorption of glucose degradation products improves the biocompatibility of conventional peritoneal dialysis fluid.

BACKGROUND: Reactive carbonyl compounds (RCOs) present in peritoneal dialysis (PD) fluid have been incriminated in the progressive deterioration of the peritoneal membrane in long-term PD patients. They are initially present in fresh conventional heat-sterilized glucose PD fluid and are supplemented during dwell time by the diffusion of blood RCOs within the peritoneal cavity. In the present study, RCO entrapping agents were immobilized on affinity beads to adsorb RCOs both in fresh PD fluid and in PD effluent. METHODS: The RCO trapping potential of various compounds was assessed in vitro first by dissolving them in the tested fluid and subsequently after coupling with either epoxy- or amino-beads. The tested fluids include fresh heat-sterilized glucose and non-glucose PD fluids, and PD effluent. Their RCOs contents, that is, glyoxal (GO), methylglyoxal (MGO), 3-deoxyglucosone (3-DG), formaldehyde, 5-hydroxymethylfuraldehyde, acetaldehyde, and 2-furaldehyde were monitored by reverse-phase high-pressure liquid chromatography. The biocompatibility of PD fluid was assessed by a cytotoxic assay with either human epidermoid cell line A431 cells or with primary cultured human peritoneal mesothelial cells. RESULTS: Among the tested RCO entrapping agents, hydrazine coupled to epoxy-beads proved the most efficient. It lowered the concentrations of three dicarbonyl compounds (GO, MGO, and 3-DG) and those of aldehydes present in fresh heat-sterilized glucose PD fluid toward the low levels observed in filter-sterilized glucose PD fluid. It did not change the glucose and electrolytes concentration of the PD fluid but raised its pH from 5.2 to 5.9. Hydrazine-coupled epoxy-bead also lowered the PD effluent content of total RCOs, measured by the 2,4-dinitrophenylhydrazone (DNPH) method. The cytotoxicity of heat-sterilized PD fluid incubated with hydrazine-coupled epoxy-beads was decreased to the level observed in filter-sterilized PD fluid as the result of the raised pH and the lowered RCOs levels. CONCLUSION: Hydrazine-coupled epoxy-beads reduce the levels of a variety of dicarbonyls and aldehydes present in heat-sterilized glucose PD fluid to those in filter-sterilized PD fluid, without altering glucose, lactate, and electrolytes contents but with a rise in pH. Incubated with PD effluents, it is equally effective in reducing the levels of serum-derived RCOs. RCO entrapping agents immobilized on affinity beads improve in vitro the biocompatibility of conventional heat-sterilized glucose PD fluid. Their clinical applicability requires further studies.

Aldehydes↗

PubMed2001

Semifluorinated symmetrical diethers for intraocular use: synthesis, characterization, and in vitro biocompatibility.

Semifluorinated symmetrical diethers were synthesized using the William ether synthesis. These diethers should have similar properties to perfluorocarbons as are chemical inertness and high oxygen solubility, but in contrast a considerably lower density. With their lower density the damaging of the choroidal tissue of the eye observed with perfluorocarbons should be avoided. The synthesized diethers are inert compounds being stable against nucleophiles, oxidiziers and strong bases. Their density is in the range of 1.1-1.2 g/cm3. Besides the physical and chemical tests we conducted several in vitro biocompatibility tests. The tests comprised induction of hemolysis, the generation of C3a complement, the influence on the production of interleukin1beta, the influence on cell proliferation of a Raji and a Hela cell line (3H-Thymidine uptake) and finally the direct cytotoxic effect on these cell lines. All tested symmetrical diethers were positive in one or more tests and can be expected to be incompatible in vivo. Especially the "short" semifluorinated diethers [(CF3CH2O)2(CH2)3-6] showed a nearly total inhibition of cell proliferation or interleukin1beta release. Further variation of the compounds will be necessary to generate better biocompatible derivates.

Cell Division↗

PubMed2006

Biocompatibility of electrochemical glucose sensors implanted in the subcutis of pigs.

BACKGROUND: Lowering blood glucose concentration slows or prevents the development of complications in diabetes. One of the tools to control glucose levels is continuous glucose measurements. A promising technique involves measurements from glucose sensors implanted directly in skin/subcutis. However, in vivo bioinstability and drift in sensor signals have been reported after implantation, suggestively caused by the infiltration of inflammatory cells and adhesion of proteins to sensor membranes. The aim of this study was to evaluate the in vivo biocompatibility of two electrochemical glucose sensors after implantation in the skin of pigs. METHODS: In vivo biocompatibility of in-house fabricated electrochemical glucose sensors and a commercially available continuous glucose monitoring system (CGMS, Medtronic MiniMed, Northridge, CA) implanted 1 h, 2 h, 24 h, 3 days, or 7 days was examined by histological and immunohistochemical techniques. RESULTS: The extent of inflammation increased significantly as a function of time. The inflammation ranged from an acute focal fibrinous/suppurative dermatitis to a chronic fibrinous and granulating foreign body dermatitis 7 days after implantation. Immunohistochemical stainings showed that heterophilic granulocytes, macrophages, and fibrinogen/fibrinogen fragments D and E were consistent findings. Infiltration of CD3epsilon-positive T-cells was primarily confined to day 7 of implantation. In addition, the pro-inflammatory cytokines interleukin-1 and tumor necrosis factor-alpha played a role in the reaction to sensors. CONCLUSION: The reported in vivo bioinstability of sensors is likely to be caused by protein and cellular biofouling on the sensor membrane. Furthermore, the consistent finding of fibrinogen and fibrinogen fragments D and E at the sensor-tissue interface seems to play an important role in the pathogenesis as it possibly maintains the inflammation by promoting the recruitment of inflammatory cells to the implantation site.

Animals↗

PubMed2005

Myeloperoxidase serves as a marker of oxidative stress during single haemodialysis session using two different biocompatible dialysis membranes.

BACKGROUND: There is increased oxidative stress in patients undergoing haemodialysis (HD); however, little is known of how different dialysis membranes contribute to the oxidative stress induced by the dialysis procedure per se. We therefore studied the influence of two different dialysis membranes on oxidative stress during HD. METHODS: Eight patients undergoing HD three times per week were enrolled in this cross-controlled study. Patients sequentially received HD using polysulphone (PS) and regenerated cellulose (RC) dialysis membranes for 1 week each. Blood samples were collected in the last section of each hollow fibre 0, 15, 120 and 240 min after starting HD. We determined superoxide anion production derived from neutrophils, superoxide dismutase (SOD) and glutathione peroxidase (GPx) derived from washed red cells, plasma myeloperoxidase (MPO), plasma thiobarbituric acid-reactive substances (TBARS), plasma advanced oxidation protein products (AOPP) and serum 8-hydroxy-2'-deoxyguanosine (8-OHdG). RESULTS: Leukocyte numbers, including neutrophils, lymphocytes and monocytes, decreased significantly after 15 min of dialysis, more so with RC than with PS membrane. For both membranes, superoxide anion production transiently increased during the first 15 min whereas the post-dialysis production was decreased. Plasma MPO levels persistently increased during dialysis with the two membranes. Moreover, the increase was more marked with RC than with PS membrane. AOPP and 8-OHdG levels increased progressively when using RC membranes. There were no significant differences in SOD, GPx, TBARS, AOPP and 8-OHdG levels between the two membranes. CONCLUSIONS: The biocompatibility of the dialyser affects oxidative stress production during a single dialysis session. The measurement of MPO may serve as a reliable marker of the degree of oxidative stress induced using dialysis membranes of different biocompatibilities.

Adult↗

PubMed1992

Cellulose-based haemodialysis membranes: biocompatibility and functional performance compared.

Regenerated cellulose membranes are widely used in the treatment of renal failure. The presence of hydroxyl (OH) groups on the membrane surface plays an important role in initiating complement activation and also influences thrombogenicity. The OH groups may be masked or reduced by alteration of the manufacturing process of the membrane. We have undertaken a clinical study of four cellulose-based membranes (Cuprophan, Hemophan, cellulose acetate, and cellulose triacetate) in which the hydroxyl groups of the membrane have been replaced and the magnitude of replacement has varied from less than 1% to greater than 80%, to assess the role that these modifications play in functional performance, biocompatibility (neutropenia, leukocyte activation, anaphylatoxin generation, and hypoxaemia). Our findings indicate that there does not appear to be a straightforward correlation between the numbers of hydroxyl groups replaced and modification of biocompatibility, suggesting that not all hydroxyl groups behave in a similar way.

Cellulose↗

PubMedDate not supplied

Comparison of three commercially available hollow fiber oxygenators: gas transfer performance and biocompatibility.

The new generation of oxygenators have improved blood flow pathways that enable reduction in priming volume and, thus, hemodilution during cardiopulmonary bypass (CPB). We evaluated three oxygenators and two sizes of venous reservoirs in relation to priming volume, gas transfer, and blood activation. To compare priming volume, gas transfer, and biocompatibility of three hollow fiber oxygenators and two different size venous reservoirs, 60 patients were randomly allocated in groups to undergo cardiopulmonary bypass. In each group, an oxygenator with a different surface area and priming volume was used: 1.8 m2 and 220 ml (group 1, n = 23), 2.2 m2 and 290 ml (group 2, n = 20), and 2.5 m2 and 270 ml (group 3, n = 17). In groups 1 and 3, a large soft shell (1900 ml) venous reservoir was used, whereas in group 2, a smaller soft shell (600 ml) venous reservoir was used. Gas transfer was assessed by calculating the oxygen transfer rate for each group and per square meter for each oxygenator group. Partial arterial oxygen pressure (paO2) and partial arterial carbon dioxide pressure (paCO2) between the groups were assessed with forward stepwise regression analysis. Biocompatibility was evaluated through measurement of platelet numbers, complement activation products (C3b/c), coagulation (thrombin anti-thrombin III complex), and fibrinolysis (plasmin anti-plasmin complex). No differences were found in oxygen transfer rate per group. However, when correcting the oxygen transfer rate for surface area, group 1 demonstrated a higher oxygen transfer rate compared with group 2 (p < 0.05) at an FiO2 of 40 and 60% and compared with group 3 at an FiO2 of 60 and 70%. The regression analysis showed that the average arterial PO2 was the highest in group 3, i.e., 79.2 mm Hg higher than in group 1 (p < 0.001) and 73.5 mm Hg higher than in group 2 (p < 0.001). Group 3 also had the lowest average arterial pCO2, 0.57 mm Hg lower than in group 1 (p = 0.004) and 0.81 mm Hg lower than in group 2 (p < 0.001). During CPB, platelet numbers decreased significantly in all groups (p < 0.001), without differences between the groups. C3b/c levels increased in all groups during CPB. At cessation of CPB the C3b/c level in group 2 (398 nmol/L(-1)) was significantly higher compared to group 1(251 nmol/L(-1); p < 0.05) and group 3 (303 nmol/L(-1); p < 0.05). Thrombin anti-thrombin III complexes and plasmin anti-plasmin complex complexes increased during CPB to significantly high levels at cessation of CPB, but there were no differences between the groups. The oxygenator with the smallest surface area and lowest priming volume (group 1) had the highest oxygen transfer rate per square meter and showed the least blood damage, as depicted by complement activation. The oxygenator with the largest blood contact surface area and improved geometric configuration (group 3) showed the lowest oxygen transfer rate per square meter. However, this oxygenator elevated oxygen partial pressure the most and reduced carbon dioxide partial pressure the most. In group 2, where a smaller venous reservoir was used, the highest blood activation was observed.

Aged↗