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PubMed2002

Mechanical and in vitro testing of aerosol-gel deposited titania coatings for biocompatible applications.

The biocompatible properties of sol-gel litania have increased the interest in the mechanical properties of this material in the form of functional coatings for prosthetic applications. In the present work. titania coatings with thicknesses of 1 microm have been prepared using the aerosol gel process. The main objective has been to evaluate the mechanical properties of the coatings and to prove their in-vitro biocompatibility. For this purpose, the hardness and Young's modulus of the coatings were measured by nanoindentation with loads in the 6-30 mN range. A continuous increase of these magnitudes was observed for the coatings treated at increasing sintering temperatures (150-800 degrees C). The hardness and the Young's modulus ranged between 15.8-19.5 GPa and 142-186 GPa, respectively. This behaviour has been confirmed by measurements of the plastic energy of deformation in 10 mN full loading unloading tests and by determination of the mean indentation creep under 30 mN loads. The films were additionally characterised by XRD. FTIR and ellipsometry to study the chemical and structural changes produced by sintering. Biocompatibility tests are very conclusive. Cells seeded on aerosol-gel titania coatings grow while adhered onto the surface. These coatings are thus of potential interest for the enhancement of the properties of prosthetic TiAlV alloys.

Aerosols↗

PubMed2002

Effects of organic matrix proteins on the interfacial structure at the bone-biocompatible nacre interface in vitro.

The biocompatibility and potential osteoinductivity of nacre have favored its use as a bone-grafting material. The present study is to investigate the interfacial structure at the bone-nacre interface resulting from organic matrix proteins, which emphasizes the mechanism of bone-bonding ability and biocompatibility of the shell tissues such as nacre and biogenic calcite. To understand the interfacial reaction, the zeta potential measurements, provide for a unique method to quantify the actual state of the interface in situ, were used for synthetic and biogenic calcium carbonate suspensions with respect to pH and the organic matrix as an additive. The zeta potentials and surface charge density show that the organic matrix proteins are main charge regulators, resulting in the stabilized tissue properties as compared with synthetic crystals. Also, in forming calcium carbonate crystals with the additives, the conformation of organic matrix has an important role in the understanding of the newly formed interfacial structure. The result provides the primary role of the organic matrix proteins in controlling the formation of interfacial structure and biocompatibility with bone as well as the stability of biogenic tissues. And it gives a new insight into the usefulness of zeta potential measurement to describe the in vivo interaction between the bone and implants.

Adsorption↗

PubMed2002

Properties and biocompatibility of chitosan films modified by blending with PEG.

Chitosan (beta-1,4-D-glucosamine), a polysaccharide with excellent biological properties, has been widely used in biomedical fields, but many barriers still exist to its broader usage due to its chemical and physical limitations. Further work is needed to improve these properties, but changes of the chemical and physical properties will influence its biocompatibility, so the biological attribute of modified chitosan must be evaluated. In this study, the biocompatibility of chitosan modified by several methods was carefully evaluated at the cellular and protein levels using different physical and biological methods. The results provide a theoretical basis for screening biomaterials. We studied the properties of five kinds of materials made by blending chitosan with different types of polyethylene glycol (PEG). The properties included physical and chemical properties, such as mechanical strength, static contact angle, spectroscopy, thermodynamic attributes and so on. The mechanical properties were slightly improved with the proper amount of PEG, but the improvement was not obvious and was destroyed by the wrong proportion of PEG. Cultures of the cells and amounts and structures of the adsorbed proteins on different materials showed that the PEG effectively improved the biocompatibility of the materials. The PEG enhanced the protein adsorption, cell adhesion, growth and proliferation, but the effects were impaired by excessive PEG. The experiments also demonstrated that the optimum PEG concentration helped to maintain the natural structure of the protein adsorbed on the materials and that maintaining the natural structure benefited cell growth. Analysis of the results based on the intramolecular and intermolecular interaction forces leads to a basic theory for the modification of biomaterials.

3T3 Cells↗

PubMed2002

Easy assessment of the biocompatibility of Ni-Ti alloys by in vitro cell culture experiments on a functionally graded Ni-NiTi-Ti material.

The biocompatibility of nickel-titanium alloys was investigated by single-culture experiments on functionally graded samples with a stepwise change in composition from pure nickel to pure titanium, including an Ni-Ti shape memory alloy for a 50:50 mixture. This approach permitted a considerable decrease of experimental resources by simultaneously studying a full variation of composition. The results indicate a good biocompatibility for a nickel content up to about 50%. The cells used in the biocompatibility studies comprised osteoblast-like osteosarcoma cells (SAOS-2, MG-63), primary human osteoblasts (HOB), and murine fibroblasts (3T3).

3T3 Cells↗

PubMed2002

Biocompatibility and degradation of poly(ether-ester) microspheres: in vitro and in vivo evaluation.

Microspheres of a hydrophobic and a hydrophilic poly(ether-ester) copolymer were evaluated for their in vitro and in vivo biocompatibility and degradation. The microspheres prior to and after sterilization were tested for in vitro cytotoxicity. The in vivo biocompatibility of the poly(ethylene glycol) terephthalate and poly(butylene terephthalate) (PEGT/PBT) microspheres was evaluated subcutaneously and intramuscularly for 24 weeks in rabbits. The in vivo degradation of the microspheres was studied microscopically and compared to the in vitro degradation. The in vitro and in vivo studies showed the biocompatibility of the microspheres of both the hydrophobic and the hydrophilic PEGT/PBT copolymer. Extracts of these microspheres showed no cytotoxic reactivity in the in vitro cytotoxicity test. Sterilization of the microspheres by gamma irradiation did not affect the cytotoxicity. PEGT/PBT microspheres injected subcutaneously and intramuscularly in rabbits showed a mild tissue response in vivo, in terms of the inflammatory response, the foreign body reaction and the granulation tissue response. Although an in vitro degradation experiment showed a decrease in molecular weight due to hydrolysis, the in vivo degradation of the microspheres was slower than previously published.

Animals↗

PubMed2003

Devitrification of ionomer glass and its effect on the in vitro biocompatibility of glass-ionomer cements.

The effects of devitrification of an ionomer glass with a molar composition 4.5SiO(2).3Al(2)O(3).1.5P(2)O(5).3CaO.2CaF(2) on cement formation and in vitro biocompatibility were investigated. Differential thermal analysis was used to study the phase evolution in the glass, and to determine the heat treatments for production of glass-ceramics. X-ray diffraction patterns from glass frit heat-treated at 750 degrees C for 2h contained peaks corresponding to apatite (JCPDS 15-876), whereas for samples heat-treated at 950 degrees C for 2h apatite and mullite (JCPDS 15-776) were the major phases detected. Transmission electron microscopy (TEM) confirmed that apatite and apatite-mullite phases were present after heat treatments at 750 degrees C and 950 degrees C respectively. Glass and glass-ceramics were ground to prepare <45microm powders and glass ionomer cements were produced using a ratio of 1g powder: 0.2g PAA: 0.3g 10% m/v tartaric acid solution in water. In vitro biocompatibility was evaluated using cultured rat osteosarcoma (ROS) cells. Scanning electron microscopy (SEM) showed that cells colonised the surfaces of cements prepared using untreated ionomer glass and glass crystallised to form apatite (750 degrees C/2h). However, quantitative evaluation using MTT and total protein assays indicated that more cell growth occurred in the presence of cements prepared using ionomer glasses crystallised to apatite than cements prepared using untreated glass. The least cell growth and respiratory activity was observed on cements made with crystallised glass containing both apatite and mullite. It was concluded that the controlled devitrification of ionomer glasses could be used to produce GIC bone cements with improved biocompatibility.

Animals↗

PubMed2004

Magnesia-doped HA/beta-TCP ceramics and evaluation of their biocompatibility.

The sintering behavior, mechanical properties and biocompatibility of magnesia (MgO)-doped HA/TCP biphasic ceramics were studied. Pure HA/TCP ceramics showed poor sinterability due to the phase transformation of beta- to alpha-TCP. MgO-doped HA/TCP ceramics showed high density without any phase transformation of beta-TCP up to 1300 degrees C, for MgO dopants incorporated into the beta-TCP preferably and increased thermal stability of beta-TCP. However, the addition of MgO higher than a critical content, suppressed grain growth of HA/TCP ceramics and lowered sinterability. The optimum amount of MgO doping was 1 wt%, which lead 99% relative density and higher mechanical properties than HA or beta-TCP ceramics. From in vitro test and in vivo test, 1 wt% MgO-doped HA/TCP ceramics showed a good biocompatibility without cytotoxicity. After implantation under the muscle of rabbits, beta-TCP phase was dissolved from the surface and a biological apatite covered the surface. These results proved that MgO addition increased drastically the sintering and mechanical properties of HA/beta-TCP ceramics without altering the biological safety and biocompatibility of the original composite.

Animals↗

PubMedDate not supplied

HEMA/MMMA microcapsule implants in hemiparkinsonian rat brain: biocompatibility assessment using [3H]PK11195 as a marker for gliosis.

Microencapsulation of dopamine-secreting cells in biocompatible, semi-permeable polymer membranes has been proposed as an alternative strategy for dopamine replacement for Parkinson's disease. In order to assess the viability of this proposal, dopamine-secreting PC12 cells were immunoisolated via microencapsulation in a 75:25 2-hydroxyethyl methacrylate/methyl methacrylate (HEMA/MMA) copolymer. A submerged nozzle-liquid jet method was used to produce small diameter (400 microm) microcapsules, which were stereotaxically implanted in the denervated striatum of hemi-Parkinsonian rats. A 96% survival rate was associated with the implantation surgery and no deleterious side effects were apparent. Light microscopy revealed good biocompatibility between the HEMA/MMA copolymer and the host brain, as evidenced by the absence of gross tissue damage at the neuronal tissue/capsule interface. Autoradiographic analyses using [3H]PK11195 as marker for reactive astrocytes revealed a moderate inflammatory response, confined to the immediate vicinity of the injection tract. Quantitative analyses indicated that the local tissue response did not differ significantly between brains implanted with PC12-containing capsules and those implanted with vehicle-containing capsules. Taken together, these results support the biocompatibility of HEMA/MMA copolymer as well as the feasibility and safety of stereotaxic implantation of microcapsules.

Animals↗

PubMed1998

DNA image cytometry and Ag-NORs-staining application in biocompatibility studies on human osteoblast cells in vitro.

We report here the study of the biocompatibility of a bone graft material, the Pyrost, using a previously established in vitro model of human osteoblasts. The effect of this material on cell proliferation was evaluated by the MTS assay. Results indicated the absolute absence of cytotoxic or cytostatic effect of Pyrost on cultured osteoblasts. Viability rate was more than 90% in cells cultured with the material compared to the control. Morphological analysis, undertaken by scanning electron microscopy showed a good adhesion and a spreading of osteoblasts in contact with the material that was colonized by cultured cells. In the second part of this work, we have introduced two methods as complementary biocompatibility tests: DNA image cytometry and interphase Ag-NORs quantification. DNA content was measured in cells cultured with or without Pyrost for 3, 9, 15 and 30 days. The determination of DNA indicated that the majority of osteoblasts population was diploid without aneuploidy. The DNA index and cell distribution profile in DNA histograms were similar in all cell populations. The Ag-NORs amount was used as a parameter for cell kinetic evaluation. We have measured the Ag-NORs index like DNA quantification. The proliferation rate, evaluated by Ag-NORs counts in osteoblasts cultured with or without the material, was identical. However, a decrease in Ag-NORs index was observed from day 3 to day 15 of incubation. These results showed a satisfactory biocompatibility of the Pyrost in human osteoblasts culture. The material did not alter cell viability and had no inducing effect either on proliferation rate or on cell ploidy as demonstrated by DNA image cytometry and Ag-NORs proteins staining.

Aged↗

PubMed2000

Biocompatibility evaluation of sol-gel coatings for subcutaneously implantable glucose sensors.

The objective of the current investigation is to determine the soft-tissue biocompatibility of sol-gel matrices which can be used to optimize the properties of implantable glucose sensors. The biocompatibility of sol-gel matrices with heparin, dextran sulphate, Nafion, polyethylene glycol, and polystyrene sulphonate was examined in vitro in simulated body fluid and with cell culture experiments using human dermal fibroblasts. Finally, an in vivo study was performed. Therefore, sol-gel coated polystyrene discs were inserted subcutaneously in the back of rabbits. After 4 and 12 weeks, the implants with surrounding tissue were retrieved and processed histologically. In simulated body fluid, the formation of a granular calcium phosphate precipitate was observed. Cell proliferation on polyethylene glycol, Nafion, and heparin coated substrates was comparable to control samples and significantly higher than on dextran sulphate and polystyrene sulphate coated substrates. Light microscopic evaluation of the retrieved in vivo samples showed a fair tissue reaction to all materials. Histomorphometric analysis demonstrated that there were no differences in tissue response to the different sol-gel coatings. In conclusion, sol-gel matrices exhibit a fair biocompatibility both in vitro and in vivo. These results will form the basis for further research into the real merits of sol-gel coatings in optimizing the properties of subcutaneously implantable glucose sensors.

Animals↗

PubMed1998

Biocompatibility testing of ABA triblock copolymers consisting of poly(L-lactic-co-glycolic acid) A blocks attached to a central poly(ethylene oxide) B block under in vitro conditions using different L929 mouse fibroblasts cell culture models.

The biocompatibility of ABA triblock copolymers consisting of poly(L-lactide-co-glycolide) A blocks attached to a central poly(ethylene oxide), (PEO), B block was investigated under in vitro conditions. The ABA triblock copolymer was compared to commercially available Poly(D,L-lactide-co-glycolide) (PLGA) and reference materials in different L929 cell culture models according to the procedure recommended by the International Standard Organization (ISO). Different preparation methods: namely extraction, indirect contact and direct contact with polymer samples were compared. The extraction method seems to be the most sensitive assay, allowing estimates of IC50 values. ABA and PLGA polymers showed excellent compatibility with L929 fibroblasts with all preparation techniques used. The influence of polymer composition and molecular weight on degradation rate as well as in vitro biocompatibility was then investigated. Changes in pH and osmolarity as well as lactic acid content of the extracts were determined and compared to in vitro degradation data of polymer films in phosphate buffered saline at 37 degreesC evaluating molecular weight (GPC) and massloss (gravimetry). An acceleration of the degradation rate of the ABA triblock copolymers with increasing PEO content was observed. The in vitro cytotoxicity studies demonstrated that the three ABA polymers were well tolerated by fibroblasts in cell culture. One ABA polymer batch ABA2 showed unusual in vitro cytotoxicity in L929 fibroblasts, possibly related to the molecular weight of the PEO used for this particular batch or residual glycolic acid. Cell culture models for biocompatibility testing of polymers according to ISO are useful as screening models in characterizing biodegradable polymers, but they cannot replace animal testing. The extraction method in combination with the MTT assay allows quantitative ranking of cytotoxic properties with high sensitivity.

Animals↗

PubMed1998

Biocompatibility aspects of new stent technology.

Stent implantation represents a major step forward since the introduction of coronary angioplasty. As indications continue to expand, better understanding of the early and late biocompatibility issues appears critical. Persisting challenges to the use of intracoronary stents include the prevention of early thrombus formation and late neointima development. Different metals and designs have been evaluated in animal models and subsequently in patients. Polymer coatings have been proposed to improve the biocompatibility of metallic stents or to serve as matrix for drug delivery and they are currently undergoing clinical studies. The promises of a biodegradable stent have not yet been fulfilled although encouraging results have recently been reported. Continuous low dose-rate brachytherapy combining the scaffolding effect of the stent with localized radiation therapy has witnessed the development and early clinical testing of radioactive stents. The combined efforts of basic scientists and clinicians will undoubtedly contribute to the improvement of stent biocompatibility in the future.

Angioplasty, Balloon, Coronary↗

PubMed2002

Uveal and capsular biocompatibility of hydrophilic acrylic, hydrophobic acrylic, and silicone intraocular lenses.

PURPOSE: To evaluate the long-term response of 6 types of 3-piece intraocular lenses (IOLs) by assessing the cellular reaction on the anterior IOL surface, the behavior of posterior and anterior capsule fibrosis, and flare. SETTING: Department of Ophthalmology, Medical School, University of Vienna, Vienna, Austria. METHODS: One hundred eighty eyes were prospectively randomized to receive 1 of 6 IOLs: hydrophilic acrylic Hydroview (Bausch & Lomb) or MemoryLens (ORC); hydrophobic acrylic AcrySof MA60BM (Alcon) or AMO Sensar AR40 (Allergan); hydrophobic silicone CeeOn 920 or CeeOn 911A (Pharmacia). The patients had standardized cataract surgery, postoperative medication, and follow-up. One year after surgery, 155 eyes were assessed. The cellular reaction was evaluated by specular microscopy of the anterior IOL surface. Anterior and posterior capsule opacification (PCO) was assessed semiquantitatively by biomicroscopy. Flare was measured with a Kowa FC-1000 laser flare-cell meter. RESULTS: Regarding uveal biocompatibility, the hydrophobic acrylic IOLs showed the highest incidence of late foreign-body cell reaction (AcrySof, 30%; AR40, 17%) followed by the hydrophilic acrylic (MemoryLens, 8%; Hydroview, 4%) and silicone (CeeOn 920, 4%; CeeOn 911A, 0%) (P =.0044). In all cases, the cellular reaction was low grade and clinically insignificant. Regarding capsular biocompatibility, some eyes developed lens epithelial cell (LEC) outgrowth on the anterior IOL surface. The highest incidence was in the hydrophilic acrylic group (Hydroview, 85%; MemoryLens, 27%) followed by the hydrophobic acrylic (AcrySof, 4%; AR40, 3%). No silicone IOL had LECs on the anterior surface. The difference among IOL groups was significant (P =.0001). Anterior capsule opacification was more predominant in the hydrophobic IOL groups. Posterior capsule opacification of the central 3.0 mm area was lowest in the groups with a sharp-edged optic (CeeOn 911A, AcrySof) followed by the round-edged silicone (CeeOn 920), hydrophobic acrylic (AR40), and hydrophilic acrylic IOLs (P =.0001). There was a significant difference in flare between the AR40 lens and the Hydroview, MemoryLens, CeeOn 911A, and CeeOn 920 (P <.004). There was no statistically significant difference in the postoperative cell count at 1 year. The power calculation showed that the sample size was sufficient. CONCLUSIONS: The differences in cellular reaction, although clinically mild in normal eyes, indicate that there were more giant cells with hydrophobic acrylic IOLs and an increased tendency toward LEC outgrowth with hydrophilic lenses. The incidence of PCO was lowest in the hydrophobic IOL groups, especially in groups with a sharp-edged optic. Second-generation silicone IOLs with a sharp edge had good uveal and capsular biocompatibility 1 year after surgery.

Acrylic Resins↗

PubMedDate not supplied

Continuous curvilinear capsulorhexis and intraocular lens biocompatibility.

PURPOSE: To study the influence of continuous curvilinear capsulorhexis (CCC) on poly(methyl methacrylate) (PMMA) intraocular lens (IOL) biocompatibility. METHODS: Biocompatibility was assessed by measuring the postoperative blood-aqueous barrier breakdown and the cellular reaction at the anterior capsule-IOL interface. In a prospective study, 30 consecutive eyes, normal except for having extracapsular cataract extraction (ECCE) with CCC by a single surgeon, has laser flare and cell measurements and specular microscopy of the anterior IOL surface at 1 day, 1 week, and 1 and 3 months postoperatively. RESULTS: In addition to the foreign-body reaction previously described in eyes that had other capsulotomy types, the eyes in this study also had a lens epithelial cell (LEC) reaction. The severity of the foreign-body reaction and postoperative aqueous flare and cells was significantly less in eyes with an intact CCC than in those with rim tears in the capsulorhexis and in those having an ECCE with a linear or can-opener capsulotomy, as previously reported. CONCLUSIONS: Continuous curvilinear capsulorhexis improves the biocompatibility of PMMA IOLs to a degree that could be of clinical benefit. In eyes with CCC, most cells seen on the anterior IOL surface were LECs.

Biocompatible Materials↗

PubMed1996

Biocompatibility of peritoneal dialysis solutions and host defense.

The relationship of peritoneal dialysis fluid and biocompatibility in peritoneal host defense is an area of great importance in clinical practice. This article reviews current biocompatibility research and examines the relationship of biocompatibility to peritoneal host defense and susceptibility to infection.

Biocompatible Materials↗

PubMedDate not supplied

Layer-by-layer engineering of biocompatible, decomposable core-shell structures.

The objective of the present investigation was to fabricate composite colloidal particles consisting of a sacrificial, decomposable template of biodegradable nature covered with biocompatible polyelectrolyte multilayers using the layer-by-layer sequential adsorption technique. Poly-dl-lactic acid and poly(dl-lactic-co-glycolic acid) were chosen to design the microparticulate template, and a preliminary feasibility study was carried out with poly(styrene sulfonate sodium)-poly(allylamine hydrochloride) as shell components. The properties of both core-shell and hollow structures obtained by core dissolution were characterized by confocal laser scanning microscopy, microelectrophoresis, scanning force microscopy, and scanning electron microscopy. The concept was then extended to biocompatible polyelectrolytes as shell wall building blocks to deduce stable hollow capsules with tailored properties. Uniform, complete coating with oppositely charged polyelectrolyte pairs was achieved for all the combinations investigated. The results demonstrate that polyester microparticles could serve as viable alternative components to conventionally employed templates to derive hollow capsules with defined size, shape, and shell thickness. With all the components used for fabrication being biocompatible, these polyelectrolyte capsules may find interesting applications in the fields of biology, biochemistry, biotechnology, and drug delivery.

Biocompatible Materials↗

PubMedDate not supplied

Biocompatibility evaluation of different alginates and alginate-based microcapsules.

Biocompatibility of biomaterials and biomaterial-based medical devices is a critical issue for the long-term function on multiple therapeutic systems. In the past few years, there has been an increasing interest in producing more biocompatible biomaterials and in developing novel assays to analyze the quality of the products. In this study, a battery of in vitro techniques to assess the biocompatibility of alginates with different compositions and purities and alginate-based microcapsules is presented. Study of the protein and polyphenol content of the alginates revealed clear differences between the nonpurified and the purified alginates. A similar behavior was observed when the mitogenic activity and the tumor necrosis factor-alphasecretion induced by the alginates were assessed. Interestingly, when the latter two techniques were adapted to evaluate the different alginate microcapsules, a correlation with the results obtained for the alginate samples was observed. These results reinforce the idea of using the full battery of assays here reported to screen alginates and alginate-based microcapsules before implantation.

Alginates↗

PubMedDate not supplied

Novel biodegradable aliphatic poly(butylene succinate-co-cyclic carbonate)s bearing functionalizable carbonate building blocks: II. Enzymatic biodegradation and in vitro biocompatibility assay.

In a previous study, we have reported chemical synthesis of novel aliphatic poly(butylene succinate-co-cyclic carbonate) P(BS-co-CC)s bearing various functionalizable carbonate building blocks, and this work will continue to present our new studies on their enzymatic degradation and in vitro cell biocompatibility assay. First, enzymatic degradation of the novel P(BS-co-CC) film samples was investigated with two enzymes of lipase B Candida Antartic (Novozyme 435) and lipase Porcine Pancreas PPL, and it was revealed that copolymerizing linear poly(butylene succinate) PBS with a functionalizable carbonate building block could remarkably accelerate the enzymatic degradation of a synthesized product P(BS-co-CC), and its biodegradation behavior was found to strongly depend on the overall impacts of several important factors as the cyclic carbonate (CC) comonomer structure and molar content, molar mass, thermal characteristics, morphology, the enzyme-substrate specificity, and so forth. Further, the biodegraded residual film samples and water-soluble enzymatic degradation products were allowed to be analyzed by means of proton nuclear magnetic resonance (1H NMR), gel permeation chromatograph (GPC), differential scanning calorimeter (DSC), attenuated total reflection FTIR (ATR-FTIR), scanning electron microscope (SEM), and liquid chromatograph-mass spectrometry (LC-MS). On the experimental evidences, an exo-type mechanism of enzymatic chain hydrolysis preferentially occurring in the noncrystalline domains was suggested for the synthesized new P(BS-co-CC) film samples. With regard to their cell biocompatibilities, an assay with NIH 3T3 mouse fibroblast cell was conducted using the novel synthesized P(BS-co-CC) films as substrates with respect to the cell adhesion and proliferation, and these new biodegradable P(BS-co-CC) samples were found to exhibit as low cell toxicity as the PLLA control, particularly the two samples of poly(butylene succinate-co-18.7 mol % dimethyl trimethylene carbonate) P(BS-co-18.7 mol % DMTMC) and poly(butylene succinate-co-21.9 mol % 5-benzyloxy trimethylene carbonate) P(BS-co-21.9 mol % BTMC) were interestingly found to show much better cell biocompatibilities than the PLLA reference.

Animals↗