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PubMed2003

Biocompatibility and other properties of acrylic bone cements prepared with antiseptic activators.

Acrylic bone cements prepared with activators of reduced toxicity have been formulated with the aim of improving the biocompatibility of the final material. The activators used were N,N-dimethylaminobenzyl alcohol (DMOH) and 4,4'-dimethylamino benzydrol (BZN). The toxicity, cytotoxicity, and antiseptic action of these activators were first studied. DMOH and BZN presented LD50 values 3-4 times higher than DMT, were less cytotoxic against polymorphonuclear leucocytes, and possessed an antimicrobial character, with a high activity against the most representative microorganisms involved in postoperative infections. The properties of the acrylic bone cements formulated with DMOH and BZN were evaluated to determine the influence of these activators on the curing process and the physicochemical characteristics of the cements. A decrease of the peak temperature was observed for the curing with DMOH or BZN with respect to that of one commercially available formulation (CMW 3). However, residual monomer content and mechanical properties in tension and compression were comparable to those of CMW 3. The biocompatibility of acrylic bone cements containing DMOH or BZN was studied and compared with CMW 3. To that end, intramuscular and intraosseous implantation procedures were carried out and the results were obtained from the histological analysis of the surrounding tissues at different periods of time. Implantation of rods of cement into the dorsal muscle of rats showed the presence of a membrane of connective tissue, which increased in collagen fibers with time of implantation, for all formulations. The intraosseous implantation of the cements in the dough state in the femur of rabbits, revealed a higher and early osseous neoformation, with the presence of osteoid material surrounding the rest of the cured material, for the cement prepared with the activator BZN in comparison with that obtained following the implantation of the cement cured with DMOH or DMT (CMW 3).

Alcohols↗

PubMed2004

Biocompatibility and osseointegration of beta-TCP: histomorphological and biomechanical studies in a weight-bearing sheep model.

The aim of the study was to investigate the biocompatibility, degradation, and biomechanical properties of beta-TCP (Cerasorb) in a weight-bearing sheep model. beta-TCP implant prototypes were implanted in the tibial head of adult merino sheep. After 6 and 12 months material explants were harvested for biomechanical, histological, and histomorphometrical analysis. Corresponding bone specimens of the intact bone of the contralateral leg were used as controls in the biomechanical test. Compression tests showed higher values for maximum fracture load, yield strength, and compression modulus after 6 and 12 months compared to control. Microscopically, the implants showed good osteoconduction and were incorporated into the bone; however, relevant amounts of beta-TCP were still present after 12 months. Histomorphological results revealed that beta-TCP had partially degraded between implantation and 6 months, but its share remained constant between 6 and 12 months. The bone volume fraction in the area of the implant (46% +/- 6.5%) was initially higher than in the corresponding bone area of the contralateral leg (31% +/- 9.6%), but after 12 months declined to 29% +/- 9.4% (control: 33% +/- 8.3%), while the share of beta-TCP remained constant at 36% +/- 12.2%. These findings were supported by microradiographic data. In conclusion, in a weight bearing implantation model beta-TCP showed good biocompatibility, osseointegration and beginning degradation, even though it was not further degraded between 6 and 12 months.

Animals↗

PubMed2005

Biocompatible oligochitosans as cationic modifiers of alginate/Ca microcapsules.

In the past, it has been proven that by properly adjusting the molecular mass of the oligochitosan samples, it is possible to optimize the formation of rigid, biocompatible capsules with semipermeable membranes under physiological conditions. In this study, the feasibility of four oligochitosan samples, with varying molar masses (M(n) in range 3-5 kDa), as biocompatible coatings of alginate/Ca capsules was investigated. By selection of appropriate depolymerization and purification methods we obtained oligochitosan samples that appeared to be noncytotoxic for C(2)C(12) myoblasts and did not influence the mammalian cell metabolism especially in relative short time during the process of capsule formation. Furthermore, oligochitosans can be used as a tool to reduce the membrane cut-off of the alginate capsules. However, such reduction, as well as mechanical resistance of formed microcapsules, depend on MM of the cationic polysaccharide and the chemical composition of the alginate (mannuronic/guluronic acid ratio). Here, we address that the use of low molar mass chitosan (< 5000 g/mol) permits the formation of mechanical stable capsules at physiological pH, which represents a strong advantage over other chitosan-based chemistries.

Alginates↗

PubMed2005

Biocompatibility and functionality of the degradable polymer alkylene bis(dilactoyl)-methacrylate for screw augmentation in vivo.

Recently, a new degradable polymer has been developed on the basis of alkylene bis(dilactoyl)-methacrylate as an alternative material for screw augmentation. The polymer has been investigated in vitro and in a short-term experiment in rabbits exhibiting promising results. The aim of the present study was to investigate its long-term biocompatibility and mechanical functionality in a large animal model. The polymer was used for screw augmentation in the cancellous bone of the femoral condyle and tibia epiphysis of 12 sheep and was compared to polymethylmethacrylate (PMMA) augmented and nonaugmented screws. After an implantation period of 6 months, bone, regional lymph nodes, and several organs were histologically evaluated. The mechanical efficacy was investigated by a biomechanical pullout test. A lot of mononuclear macrophages and multinuclear foreign body giant cells with incorporated polymer particles indicate strong inflammatory reactions. Large osteolysis zones with osteoclasts were found in the surrounding polymer. The polymer was fragmented but not substantially degraded. Polymer particles were also found in the regional lymph nodes. Lung, liver, kidney, and spleen did not show any pathological signs. The pullout force of screws augmented with the new polymer was significantly reduced in comparison to PMMA augmented and nonaugmented screws, respectively. It was concluded that the material has poor biocompatibility and cannot be recommended for clinical application as screw augmentation material.

Animals↗

PubMed2006

Foldable micropatterned hydrogel film made from biocompatible PCL-b-PEG-b-PCL diacrylate by UV embossing.

Foldable hydrogel films with micropatterns measuring 480 microm by 45 microm by 54 microm by 2 cm (width of microchannel by width of microwall by height of wall by length of pattern) were made by UV embossing of a block copolymer of polycaprolactone (PCL) and poly(ethylene glycol) (PEG), specifically PCL-b-PEG-b-PCL-diacrylate (DA), with a polydimethylsiloxane mold. The mold was treated with Ar/CF(4) plasma to simultaneously promote microchannel filling and demolding, and the glass substrate was modified with 3-(trimethoxysilyl) propyl acrylate to promote hydrogel adhesion to avoid delamination of the gel during demolding. The micropatterned hydrogel film was detached from the glass substrate by freeze-drying. As the films were demolded, the microstructured pattern was well replicated in the hydrogel. The gel pattern dimensions shrank with freeze-drying and increased with water swelling, but under both conditions, the gel micropattern morphology was perfectly preserved. PCL-b-PEG-b-PCL-DA hydrogel was found to have good biocompatibility compared with PEGDA hydrogel. A micropattern with a smaller microchannel width of 50 microm was also made. Micropatterned foldable and biocompatible hydrogel films have potential applications in the construction of tissue-engineering scaffolds.

Acrylates↗

PubMed2006

UV-embossed microchannel in biocompatible polymeric film: application to control of cell shape and orientation of muscle cells.

This article shows that ultra violet (UV) micro-embossing can be successfully used for fabricating biocompatible micropatterned films with microchannels separated by high aspect ratio microwalls. Eight series of micropatterns were investigated; the width of the microwall was either 10 or 25 microm and that of the microchannel either 40, 80, 120, or 160 microm. The material investigated was principally polyurethane diacrylate. The UV-embossed micropattern was extracted with methanol, converting the micropatterns from cytotoxic to biocompatible. The typical UV embossing method was modified by using a marginally adhesive polyester substrate, which facilitates demolding but is removable before methanol extraction to avoid fragmentation of the embossed micropatterns. The effect of the micropatterns on A7r5 smooth muscle cells and C2C12 skeletal muscle cells was investigated. The dimensions of both channel and wall have significant effects on the elongation of both muscle cells. In the narrower 40-microm channel, the C2C12 cells merged together to form myofibers. These results indicate that UV-embossed micropatterns may present a useful scaffold for in vitro cell shape and orientation control needed in vascular and muscle tissue engineering.

Animals↗

PubMed2007

Biocompatibility of resin-based dental materials applied as liners in deep cavities prepared in human teeth.

BACKGROUND: Since only a few data have been published concerning the effects of resinous dental materials on the pulp-dentin complex, the aim of this study was to evaluate the biocompatibility of resin-based materials applied as liners in deep cavities prepared in human teeth. METHODS: After preparing class V cavities, the following dental materials were applied on the axial walls: group 1, Vitrebond (VIT; 3M ESPE); group 2, Ultra-Blend Plus (UBP; Untradent); and group 3, Clearfil SE Bond (CSEB; Kuraray). In group 4 (control), the hard-setting calcium hydroxide cement Dycal (CH; Caulk/Dentsply) was used. The teeth extracted at 7 days or between 30 and 85 days after the clinical procedures were processed for histological evaluation. RESULTS: For all the experimental and control groups, most of specimens exhibited no pulpal response or slight inflammatory reaction associated with slight tissue disorganization at 7-day period. Moderate inflammatory pulpal response occurred only in one tooth (RDT = 262 microm) of group 3 in which transdentinal diffusion of resin components was observed. CONCLUSION: The resin-based dental cements VIT and UBP as well as the bonding agent CSEB presented acceptable biocompatibility when applied in deep cavities prepared in sound human teeth.

Adolescent↗

PubMed2007

Histological biocompatibility of new, non-absorbable glaucoma deep sclerectomy implant.

We performed this study to compare the intrascleral biocompatibility of three materials: non-absorbable hydrogel contact lens polymer, non-absorbable silicone rubber, and absorbable cross-linked sodium hyaluronate. Intrascleral implantation of three different materials was performed in 13 healthy, pigmented rabbits. Implants of methacrylic hydrogel, silicone rubber, and cross-linked sodium hyaluronate were implanted in 10, 8, and 8 eyes, respectively. The animals were euthanized at 7, 30, 180, and 360 days post implantation. The eyes were enucleated and immediately fixed in 10% buffered formalin. Semithin sections were cut and stained with hematoxylin-eosin. Light microscope analysis of the specimens was performed. The least severe inflammatory reaction was observed with cross-linked sodium hyaluronate implants. The number of inflammatory cells in proximity to methacrylic hydrogel and silicone implants at all periods of follow up was similar. The thickest fibrous capsule was observed with silicone implants (average, 28.38 +/- 11.17 microm). This area was thinner with methacrylic hydrogel implants (average, 14.90 +/- 5.57 microm) and was thinnest around sodium hyaluronate implants (average, 7.21 +/- 2.33 microm). For each type of implant, the wall on the conjunctival side of the fibrous capsule was significantly thicker than the wall on the choiroidal side. The space between the implant, scleral flap, and bed was filled soon after surgery with connective tissue rich in vessels. In our study, cross-linked sodium hyaluronate had the highest intrascleral biocompatibility. Although the inflammatory responses of the sclera to methacrylic hydrogel and silicone rubber were similar in nature, a thicker fibrous capsule was generated around silicone implants.

Animals↗

PubMed1991

Biocompatible controlled release polymers for delivery of polypeptides and growth factors.

The development of biocompatible, controlled release systems for macromolecules has provided the opportunity for researchers and clinicians to target and deliver, on site, biologically active factors. This advance has also facilitated the purification and characterization of a number of important biomolecules. These systems include controlled release delivery systems which release proteins through porous polymer matrices, degradable polymeric delivery systems, and modulated polymer release systems. These areas of research will be reviewed with regards to their design, release kinetics, and biocompatibilities. The utilization of these systems to release such biologically important polypeptides as growth factors (e.g., fibroblast growth factor, epidermal growth factor, transforming growth factor-B) as well as a number of important inhibitory factors (e.g., nitrosoureas, angiogenesis inhibitors) in both in vivo and in vitro studies will be discussed.

Animals↗

PubMed2004

Biocompatibility studies on fibrin glue cultured with bone marrow mesenchymal stem cells in vitro.

By culturing bone marrow mesenchymal stem cells of rabbits with fibrin glue in vitro, the biocompatibility of fibrin glue was investigated to study whether this material can be used as scaffolds in bone tissue engineering. After 2-months old New Zealand rabbits had been anesthetized, about 4-6 ml of bone marrow were aspirated from rabbit femoral trochanter. The monocytes suspension was aspirated after bone marrow was centrifuged with lymphocyte separating medium and cultured primarily. Then the cells were divided into two groups: one was cultured with complete medium and the other with induced medium. The cells of the two groups were collected and inoculated to the culture plate containing fibrin glue. In the control group, cells were inoculated without fibrin glue. The implanted cells and materials were observed at different stages under a phase-contrast microscope and scanning electron microscope. MTT and alkaline phosphatase (ALP) were measured. Bone marrow mesenchymal stem cells grew on the surface of fibrin glue and adhered to it gradually. Cells light absorption value (A value) and the ALP content showed no significant difference. Fibrin glue had no inhibitory effect on cell morphology, growth, proliferation and differentiation. It has good biocompatibility and can be used as scaffold materials for bone marrow mesenchymal stem cells in bone tissue engineering.

Animals↗

PubMed1992

Analysis of the biocompatibility of magnetic porous tricalcium phosphate ceramics in rat femurs.

A new biomaterial, magnetic porous tricalcium phosphate ceramics (MPTCP), may be used for repairing defects in bones as a substitute for bone grafting. This study was designed to examine its biocompatibility and the systemic toxicity. The ceramic sections, approximately 15.3 mg, were implanted into both proximal femurs of 10 male and 10 female albino SW rats. An equal number of male and female animals served as sham-operated controls. Implantation of MPTCP ceramics in rat femurs had no deleterious effects on body weight, organ/body weight ratio, and on blood, liver and kidney functions. Plasma levels of inorganic phosphorus were significantly elevated in rats implanted with MPTCP ceramics. Alkaline phosphatase values in plasma in the experimental group were equal to those in the control group. Photomicrographs, radiographs and scanning electron photomicrographs of the rat femurs implanted with MPTCP ceramics demonstrated excellent bone association with implants and growth of some new bone into MPTCP ceramics. In conclusion, MPTCP ceramics are biocompatible and suitable for the reconstruction of bones.

Animals↗

PubMed1999

Superior biocompatibility of heparin-bonded circuits in pediatric cardiopulmonary bypass.

BACKGROUND: Heparin bonding of pediatric cardiopulmonary bypass circuits may decrease activation of blood compartments as inflammatory responses. We studied the biocompatibility of heparin-bonded circuits in infant cardiac surgery. METHODS: Twenty-four infants undergoing elective cardiac surgery were randomly assigned to either a nonheparin-bonded control circuit (n = 12) or a fully heparin-bonded circuit (n = 12) including membrane oxygenator, reservoir, and all tubing. Blood samples were used to identify differences in complement activation and cytokine release between groups during and after cardiopulmonary bypass. The postbypass oxygenation index was also compared. RESULTS: The C3 activation product in the heparin-bonded group was significantly lower during (p < 0.01) and just after (p < 0.05) cardiopulmonary bypass. No statistically significant difference in C4 activation products was observed. Lower interleukin-6 and tumor necrosis factor-alpha were found immediately after cardiopulmonary bypass (p < 0.05) and a higher mean postbypass oxygenation index was also seen (p < 0.05) in the heparin-bonded group. CONCLUSION: We found that a heparin-bonded cardiopulmonary bypass circuit reduced inflammatory response and improved oxygenation in pediatric cardiac surgery. These results suggest that the superior biocompatibility of the bonded circuit may reduce pulmonary complications.

Cardiac Surgical Procedures↗

PubMed2004

Intra-articular treatment of arthritis with microsphere formulations of paclitaxel: biocompatibility and efficacy determinations in rabbits.

OBJECTIVES: To assess the biocompatibility of controlled release microspheres prepared from different polymeric biomaterials in various size ranges in rabbit synovial joints and based on these data, design and evaluate the efficacy of an intra-articular, paclitaxel-loaded microspheres formulation in rabbit models of arthritis. METHODS: Paclitaxel-loaded microspheres of poly(lactide-co-glycolide) (PLGA), poly(L-lactic acid) (PLA) and poly(caprolactone) (PCL) were prepared in different size ranges and inflammatory responses monitored following injection into healthy rabbit joints. The efficacy of 20% paclitaxel-loaded PLA microspheres (35-105 microm size range) injected intra-articularly into antigen and carrageenan induced rabbit models of arthritis was monitored. RESULTS: Polymeric microspheres in the 35-105 microm size range were biocompatible whereas smaller microspheres (1-20 microm) produced an inflammatory response. Efficacy studies showed that injection of 20% paclitaxel-loaded PLA microspheres significantly reduced all measures of inflammation in the antigen arthritis rabbit model. CONCLUSIONS: Paclitaxel-loaded PLA microspheres in the 35-105 microm size range, released paclitaxel in a controlled manner over several weeks, and may be a potential formulation for the intra-articular treatment of inflammation in arthritic conditions.

Animals↗

PubMed1997

Improved biocompatibility but limited graft survival after purification of alginate for microencapsulation of pancreatic islets.

Graft failure of alginate-polylysine microencapsulated islets is often interpreted as the consequence of a non-specific foreign body reaction against the microcapsules, initiated by impurities present in crude alginate. The aim of the present study was to investigate if purification of the alginate improves the biocompatibility of alginate-polylysine microcapsules. Alginate was purified by filtration, extraction and precipitation. Microcapsules prepared from crude or purified alginate were implanted in the peritoneal cavity of normoglycaemic AO-rats and retrieved at 1, 2, 3, 6, 9, and 12 months after implantation. With crude alginate, all capsules were overgrown within 1 month after implantation. With purified alginate, however, the portion of capsules overgrown was usually less than 10%, even at 12 months after implantation. All recipients of islet allografts in capsules prepared of purified alginate became normoglycaemic within 5 days after implantation, but hyperglycaemia reoccurred after 6 to 20 weeks. With intravenous and oral glucose tolerance test, all recipients had impaired glucose tolerance and insulin responses were virtually absent. After graft failure, capsules were retrieved (80-100%) by peritoneal lavage. Histologically, the percentage of overgrown capsules was usually less than 10% and maximally 31%. This small portion cannot explain the occurrence of graft failure. The immunoprotective properties of the capsules were confirmed by similar if not identical survival times of encapsulated islet allo- and isografts. Our results show that purification of the alginate improves the biocompatibility of alginate-polylysine microcapsules. Nevertheless, graft survival was still limited, most probably as a consequence of a lack of blood supply to the encapsulated islets.

Alginates↗

PubMed2002

Biocompatibility, encrustation and biodegradation of ofloxacine and silver nitrate coated poly-L-lactic acid stents in rabbit urethra.

The purpose of this study was to evaluate the biocompatibility, encrustation and biodegradation properties of silver nitrate and ofloxacine blended caprolactone-L-lactide copolymer coated self-reinforced poly-L-lactic acid (SR-PLLA) urospirals in situ in the male rabbit urethra. SR-PLLA urospirals coated with 10% by weight silver nitrate or 5% by weight ofloxacine blended copolymer or pure copolymer were inserted into the posterior urethra of 18 male rabbits. No prophylactic antibiotics were given. The animals were sacrificed 1 or 6 months after insertion. Urethral tissue reactions were histologically scored semiquantitavely and the appearence of the stents assessed using scanning electron microscopy. The biodegradation time of SR-PLLA stents was remarkably reduced by the caprolactone coating. Silver nitrate and ofloxacine blended copolymer coated urospirals caused less tissue reaction than urospirals with a pure copolymer coating. Silver nitrate coating effectively prevented biofilm formation and stent encrustation. Silver nitrate and ofloxacine blended copolymer coated SR-PLLA urospirals had good biocompatibility properties in rabbit urethra. In particular, coating with silver nitrate may provide possibilities of preventing bacterial adhesion to bioabsorbable stents.

Animals↗

PubMed2001

Biocompatibility of silver nitrate and ofloxacine coated bioabsorbable SR-PLLA rods.

The purpose of this study was to evaluate the biocompatibility of silver nitrate and ofloxacine coatings of bioresorbable self-reinforced poly-L-lactic acid (SR-PLLA) rods. SR-PLLA rods coated with pure poly(caprolactone-co-L-lactide) or blended with silver nitrate (10, 5 or 2 weight-%) or ofloxacine (5 or 2 weight-%) were implanted in the dorsal muscles of 25 male rabbits. Tissue reactions caused by implantation trauma were seen 1 week after implantation. The positive control and 10 w-% silver nitrate coating showed the most marked reactions 1 month after implantation. Only sparse reactions were seen 6 months after implantation. Tissue reactions were scored semi-quantitatively. As a result of this study, we concluded that silver nitrate or ofloxacine coatings up to five w-% did not alter the good biocompatibility of SR-PLLA essentially. The method may lead to the possibility of preventing bacterial adhesion to urological stents during insertion.

Absorbable Implants↗

PubMed2000

Biocompatible alginate from freshly collected Laminaria pallida for implantation.

A simple procedure is described for the extraction and purification of alginate from the inner stipes of the kelp Laminaria pallida. Alginate yield was about 10-15% of the dry mass, with a 70:30 mannuronic/guluronic acid ratio. Analysis of the purified alginate revealed a low polyphenol content while proteins were below detection level. The purified alginate was highly viscous, with 10-15 mPa s and 281 mPa s for a 0.1% and 0.5% solution, respectively, indicating a very high molecular mass (larger than 250 kDa). Bead formation occurred in the presence of divalent cations, but also in the presence of artificial serum (FCSIII) without added divalent cations. The biocompatibility of the alginate was tested with the in vitro mice lymphocyte test as well as by implantation of Ba2+ cross-linked beads beneath the kidney capsule of BB/OK rats. There was no evidence for significant mitogenic activity or fibrotic reaction. Biocompatibility of the alginate was also demonstrated by the encapsulation of human chondrocytes into Ca2+ cross-linked alginate beads. Immobilized chondrocytes grew and remained functional (i.e. they produced collagen).

Alginates↗

PubMed2005

Influence of polyglecaprone 25 (Monocryl) supplementation on the biocompatibility of a polypropylene mesh for hernia repair.

BACKGROUND: Supplementary polyglecaprone 25 (Monocryl) monofilaments were added to a lightweight pure monofilament polypropylene mesh (PP mesh) to improve intraoperative handling (PP+M mesh). This study was designed to evaluate the influence of this additional supplementation on the biocompatibility in a rodent animal model. METHODS: Two mesh materials, a composite mesh (PP+M) and the pure polypropylene variant (PP), were compared after subcutaneous implantation in a standardized rat model. Histological analysis of the inflammatory response was performed after 28, 56 and 84 days of implantation. Material absorption, inflammatory tissue reaction, fibrosis and granuloma formation were investigated, as well as the percentage of proliferating and apoptotic cells at the interface. RESULTS: Both mesh materials showed a slight foreign body reaction involving mainly macrophages and foreign body giant cells. Total absorption of the Monocryl filaments of the PP+M mesh occurred between 56 and 84 days of implantation. Both the inflammatory and the fibrotic reaction were decreased (n.s.) in the PP+M mesh group compared to the pure PP mesh. Whereas the percentage of proliferating cells showed no significant difference, the rate of apoptotic cells was significantly decreased in the PP+M mesh group over the whole implantation period. CONCLUSION: Compared to the pure polypropylene mesh, our data confirm that the use of a polypropylene mesh supplemented with absorbable Monocryl filaments is feasible without additional short-term mesh-related complications in the experimental model or negative side effects on biocompatibility.

Animals↗