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PubMedDate not supplied

Biocompatibility of Delrin 150: a creep-resistant polymer for total joint prostheses.

A thermoplastic polymer, Delrin 150 (polyoxymethylene homopolymer), with creep resistance ten times that of ultrahigh-molecular-weight polyethylene, is used as a material for total joint prostheses. A study was made of the local and systemic host response to this polymer when implanted in three different mammalian species. 316 LC stainless steel was used as a control. The materials were implanted into muscle and bone as solid cylinders. A total of 446 samples were implanted into 74 animals. The duration of implantation ranged from 2 weeks to 2 years. A semi-quantitative evaluation of local tissue reaction was performed. For each implant, 16 histological criteria were graded for severity of host tissue reaction. The liver, spleen, kidneys, pancreas, and lungs from each animal were also studied for evidence of systemic toxicity. The polymer implants exhibited a mild tissue reaction with the same characteristics as the control. Local tumor formation, bone osteolysis, and surrounding muscle necrosis were not seen. No pathological changes compatible with systemic toxicity by Delrin 150 were observed in the study of the organs. Delrin 150 in solid form did not exhibit local or systemic toxicity and is therefore biocompatible by this study. Powder implantation studies should be performed to simulate tissue response to wear particles.

Animals↗

PubMedDate not supplied

The biocompatibility of a dental Ag-Pd-Cu-Au-based casting alloy and its structural components.

The biocompatibility of type III casting gold alloy, an Ag-Pd-Cu-Au-based dental casting alloy and its two main structural components, a CuPd-rich and an Ag-rich phase, was studied after subcutaneous implantation for 7 weeks in 20 guinea pigs. The Ag-Pd-Cu-Au alloy was surrounded by a capsule of immature collagen with fibroblasts and an increased vascular supply. The CuPd-rich component induced and maintained an acute inflammation with highly vascularized granulation tissue. The tissue reaction to the Ag-rich component and the Au-based alloy was slight. Ten of the guinea pigs were sensitized to PdCl2 prior to the implantation period, but this caused no enhanced tissue reaction, except for an increase in the number of mast cells around three of the alloys.

Animals↗

PubMedDate not supplied

Microheterophase structure, permeability, and biocompatibility of A-B-A triblock copolymer membranes composed of poly(gamma-ethyl L-glutamate) as the A component and polybutadiene as the B component.

A-B-A block copolymers (EBE) consisting of poly(gamma-ethyl L-glutamate) as the A component and polybutadiene as the B component were synthesized. The microheterophase structure of these block copolymers, as observed microscopically, was less distinct than that of the block copolymer (GBG) composed of poly(gamma-benzyl L-glutamate) as the A component. This was attributed to the better compatibility of the ethyl group with polybutadiene block, compared with the benzyl group. The observed micelle size of various microheterophase structures ranged from 350 to 480 A, which agreed well with the micelle size estimated from a thermodynamic study. From the measurement of water permeation through the EBE block copolymer membranes, the contributions of the interfacial region between the alpha-helical polypeptide domain and polybutadiene domain to the permeability coefficient were concluded to be higher than those of poly(gamma-methyl L-glutamate)-polybutadiene block copolymer (MBM) membranes, i.e., more hydrophilic domain seemed to exist in EBE membranes than in MBM membranes. The results of in vivo tests on the tissue compatibility indicate that the EBE block copolymer membranes have good biocompatibility.

Animals↗

PubMed1986

In vivo biocompatibility studies. VII. Inflammatory response to polyethylene and to a cytotoxic polyvinylchloride.

The cellular biocompatibility of low-density polyethylene and a cytotoxic polyvinylchloride were investigated using an in vivo cage implant system. Components of the inflammatory response (white cells, extra-cellular alkaline and acid phosphatase, the complement component C3, and total protein content) were monitored over a 21-day implantation period. Scanning electron microscopy was used to evaluate the morphologic condition of leukocytes adherent to the implanted polymers. Prior to implantation, each polymer was evaluated using an established primary acute toxicity screen. The results showed that the cytotoxic polyvinylchloride stimulated an intense acute phase inflammatory response, and at later observation periods, an intense and increasing chronic inflammatory response. In contrast, the polyethylene promoted relatively small increases in the acute and chronic phases of inflammation; the overall cellular response being essentially resolved by the third week after implantation. The initial toxicity screen of each polymer suggested that the observed differences in inflammation were primarily caused by the release from the polyvinylchloride of the added cytotoxic agent (dioctyltinbisoctylmercaptoacetate).

Acid Phosphatase↗

PubMed1986

Bioerodible polyanhydrides as drug-carrier matrices. II. Biocompatibility and chemical reactivity.

The biocompatibility of bioerodible polyanhydrides and toxicology of the polymer breakdown products were assessed. Poly-[bis (p-carboxy-phenoxy) propane anhydride] (PCPP), Poly(terephthalic acid anhydride) (PTA), and their copolymers with sebacic acid were tested. The polymers did not provoke inflammatory responses in the corneas of rabbits over a six week implantation period. Subcutaneous implantation studies of PCPP in rats over a six month period showed no evidence of inflammatory cells and only slight tissue encapsulation by layers of fibroblastic cells. The degradation products of the polymers were nonmutagenic, noncytotoxic, and had a low teratogenic potential. The in vitro growth of mammalian cells on the polymers was unaffected as measured by cell morphology and cell growth rate. The chemical reactivity of the polyanhydrides with reactive model drugs, para substituted anilines, was also examined. Amides were formed when the drugs were injection molded with the polyanhydrides at 120 degrees C. However, no reaction was observed using compression molding at room temperature. No reaction occurred between the polymer and the drug during the hydrolytic degradation of the matrix at 37 degrees C.

Anhydrides↗

PubMedDate not supplied

The biocompatibility of solution cast and acetone-extracted cast Biomer.

The cellular response to films of cast Biomer and acetone-extracted Biomer were investigated over a 21-day implantation period, using an in vivo cage implant system. Film samples were characterized by scanning electron microscopy (SEM), attenuated total reflectance infrared (ATR-IR), electron spectroscopy for chemical analysis (ESCA) and by contact angle measurements before implantation, and by SEM and ESCA after implantation and cleaning. Cellular and protein components of the inflammatory response were analyzed at periodic observation points after implantation. In addition, film samples were retrieved at 4, 7, and 21 days after implantation and analyzed for leukocyte adhesion by light microscopy and SEM. The results demonstrated that cast Biomer contains an extractable fraction, which when removed significantly improves the biocompatibility of the material.

Animals↗

PubMed1987

Tissue biocompatibility of kevlar aramid fibers and polymethylmethacrylate, composites in rabbits.

Two groups of female NZW rabbits were implanted in the paravertebral muscles with aramid (du Pont Kevlar aramid 49) fibers and aramid-polymethylmethacrylate (PMMA) composites for 14 and 28 days. Rabbits were killed at these times periods, necropsies performed, sites scored for gross tissue response, and tissue specimens containing the implants removed for histopathological evaluation. A mild fibrous tissue reaction was observed around all implants containing aramid fiber similar to that observed around the silicone control implant. Some foreign body giant cells were also present adjacent to the fibers. An intense necrotic inflammatory reaction was present around the positive control material (PVC Y-78). The tissue response to implantation of aramid fiber and fiber-PMMA composites indicates that aramid is a biocompatible material.

Acrylic Resins↗

PubMed1988

In vitro simulation of biocompatibility of Ti-Al-V.

The presented data are the result of a reappraisal of the biocompatibility properties of titanium alloys. An in vitro study has been conducted using Hanks' solution with four different additional compounds (EDTA, l-leucine, Na-citrate, and 8-hydroxyquinoline). A measurable dissolution rate was observed for Ti and Al in a solution containing EDTA and for Ti, Al, and V for a solution containing Na-citrate. The dissolution kinetics are discussed and explained in terms of the composition of the surface layers. The results contain useful introductory information for an extended study of media allowing representative in vitro simulation of the in vivo behavior of titanium alloys.

Alloys↗

PubMed1988

Analysis of the biocompatibility of ALCAP ceramics in rat femurs.

Ceramics composed of aluminum, calcium, and phosphorus oxides (ALCAP) were tested for compatibility as bone replacement biomaterials. Implantation of ALCAP ceramics in rat femurs had no deleterious effect on body weights, organ/body weight ratios, muscle, bone, blood, and kidney function. Aluminum resorbed from ALCAP ceramic bone implants was excreted in the urine and was not deposited in adjacent muscle. Plasma levels of aluminum were not elevated in rats implanted with ALCAP ceramics. Alkaline phosphatase activity of excised implant sites indicated greater bone formation in ALCAP ceramic implants than in bone autografts. Radiographs and implant histology demonstrated excellent bone association with implants and ingrowth of new bone into ALCAP ceramic implants. ALCAP ceramics are biocompatible and suitable for reconstruction of bone.

Alkaline Phosphatase↗

PubMed1990

In vitro biocompatibility of polyetheretherketone and polysulfone composites.

Short carbon fiber reinforced composites could potentially replace some of the metal alloys used in orthopedic implants. In particular, polysulfone and, more recently, polyetheretherketone have been considered as the matrix material for carbon fiber reinforced composite implant materials. ASTM standards F813 and F619 for direct contact cell culture evaluation and extraction were employed to determine the in vitro biocompatibility of a carbon fiber composite of polyetheretherketone, PEEK, in comparison to a carbon fiber reinforced polysulfone composite. The cell cultures were assessed qualitatively by microscopy and quantitatively using an enzyme assay to determine cytotoxicity. Overall, the cellular response to the PEEK and polysulfone composites were negligible indicating that further in vivo studies with these materials are appropriate.

Animals↗

PubMed1990

Biocompatibility of a polyether urethane, polypropylene oxide, and a polyether polyester copolymer. A qualitative and quantitative study of three alloplastic tympanic membrane materials in the rat middle ear.

The biocompatibility of porous implants made of Estane 5714 F1 polyether urethane, polypropylene oxide, and a poly(ethylene oxide hydantoin) and poly(tetramethylene terephthalate) segmented polyether polyester copolymer (HPOE/PBT copolymer), which were selected as candidates for an alloplastic tympanic membrane, was assessed after implantation in rat middle ears for periods of up to 1 year. Implantation of the materials led to tissue reactions initially associated with the wound-healing process, whereas after 1 month not only the presence of macrophages and foreign-body giant cells surrounding the implant materials but also implant degradation were characteristic for a foreign-body reaction. Macrophages and foreign-body giant cells dominated the picture of the tissue surrounding polypropylene oxide. The altered morphology of these cells, the persistent infiltration of the implantation sites by exudate cells, and the premature death of five rats in the 1-year group suggest that polypropylene oxide degradation was accompanied by the release of toxic substances. Estane and copolymer degradation did not induce tissue responses reflecting implant toxicity, and tympanic membranes given these alloplasts showed a normal healing pattern. Inclusions in the cytoplasm of macrophages associated with degradation and phagocytosis of all of the polymers under study were found to contain iron, silicon, titanium, and aluminum. Growth of fibrous tissue and bone, the latter into Estane and HPOE/PBT copolymer implants, indicated appropriate implant fixation by tissue, although macrophages and foreign-body giant cells were present as well. Especially the fixation of copolymer by ingrowth of bone seems promising in terms of the amount of bone in the pores and the electron-dense bone/copolymer interface. The latter is indicative for bonding osteogenesis. The HPOE/PBT copolymer is a better candidate for alloplastic tympanic membrane than Estane, and the use of polypropylene oxide cannot be recommended.

Animals↗

PubMed1990

The behavior of alloplastic tympanic membranes in Staphylococcus aureus-induced middle ear infection. I. Quantitative biocompatibility evaluation.

The biocompatibility of dense Silastic implants and porous implants made of Estane 5714 F1 polyether urethane, polypropylene oxide, and an HPOE/PBT segmented polyether polyester copolymer was evaluated during an induced Staphylococcus aureus middle ear infection. The middle ear response to infection seemed not to be affected by the presence of implants made of either of the polymers. Light microscopical morphometry and transmission electron microscopy showed degradation of the porous implants under study, but not of Silastic implants, which were invariably surrounded by a fibrous capsule. This finding, combined with the degree of porous implant degradation, the composition of the tissues surrounding the implants, and the tissue/biomaterial interface reactions are consistent with the results obtained in the noninfected middle ear. Round-cell infiltrates however, were predominantly associated with implants made of polypropylene oxide and HPOE/PBT copolymer; while the presence of (phagocytosed) microbial debris was associated with copolymer. The present findings indicate that with respect to implant behavior in infected surroundings Estane is the best porous material, whereas the behavior of Silastic implants did not deviate from that in non-infected ears.

Animals↗

PubMed1994

Effect of esterase on methacrylates and methacrylate polymers in an enzyme simulator for biodurability and biocompatibility testing.

Current in vitro biocompatibility methods do not evaluate the degradation of biomaterials after contact with enzymes that might be present in the oral or systemic environment. In this study, two methods of in vitro enzyme degradation and a method for the separation of the degradative products by high performance thin-layer chromatography (HPTLC) are reported. In the first method two dental adhesives, Scotchbond and Scotchbond II, and two dental composites, Heliomolar and P-50, were evaluated. These materials were incubated with four different enzymatic preparations for periods of up to 72 h. The enzymes were lipase, esterase, and liver enzyme extracts from both mouse and rat. Chloroform soluble products extracted from the aqueous phase were examined by HPTLC for decomposition products resulting from enzyme activity. The second method was similar, but analyzed the aqueous fraction directly without chloroform extraction. In this method five dental restorative materials, P-50, P-30, Scotchbond II, Silux, and Silux Plus, were incubated with a nonspecific porcine liver esterase. In addition to the polymerized biomaterials, monomers containing methacrylic acid units were also hydrolyzed with esterase and analyzed by ion chromatography to establish the sensitivity of the enzyme simulator. Each biomaterial presented thin-layer zones not present before enzymatic action. These experiments provide support that aqueous enzymatic action may facilitate the hydrolytic weakening of polymeric biomaterials.

Animals↗

PubMed1994

Biocompatibility and tissue regenerating capacity of crosslinked dermal sheep collagen.

The biocompatibility and tissue regenerating capacity of four crosslinked dermal sheep collagens (DSC) was studied. In vitro, the four DSC versions were found to be noncytotoxic or very low in cytotoxicity. After subcutaneous implantation in rats, hexamethylenediisocyanate-crosslinked DSC (HDSC) seldom induced an increased infiltration of neutrophils or macrophages, as compared with normal wound healing; whereas new formation of collagen was observed. DSC crosslinked with glutaraldehyde (GDSC) followed by reaction with NaBH4 shortly after implantation showed an increased infiltration of neutrophils with a deviant morphology. Furthermore, a high incidence of calcification was observed, which may explain the minor ingrowth of giant cells and fibroblasts, and the poor formation of new rat collagen. Acyl azide-crosslinked DSC (AaDSC) first induced an increased infiltration of macrophages, and then of giant cells, both with high lipid formation. AaDSC degraded at least twice as slowly as HDSC and GDSC, finally leaving a matrix of newly formed rat collagen. Samples crosslinked with 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide hydrochloride and N-hydroxysuccinimide (ENDSC) induced the same mild cellular reaction as HDSC; whereas, similar to AaDSC, the degradation rate was slow and an optimal rat collagen matrix was formed. Of the crosslinked DSC samples, ENDSC seems most promising for tissue regeneration.

Animals↗

PubMed1994

Synthetic scleral reinforcement materials: I. Development and in vivo tissue biocompatibility response.

The surgical treatment of pathological myopia involves the placement of a band cut from donor sclera around the back of the globe to provide support and to prevent elongation that leads to retinal detachment and blindness. In the search for a synthetic material that would overcome the disadvantages of the donor tissue band, we tested 11 types of bands made from 14 polymers in rabbit eyes. Bands were cut from porous and solid materials, as well as porous materials coated with solids and solid materials with porous patches affixed to the posterior surface. Criteria for suitability and biocompatibility included ease of placement and suturing, stable positioning, and absence of long-term tissue response on a cellular level. Testing included evaluation by the surgeons performing the implantations, measurement of the distance between the band and the globe, determination of fibrous capsule thickness and amount of collagen deposition, and enumeration of macrophages accumulated at the band/capsule interface. Based on the results of these studies, two of the porous materials (expanded polytetrafluoroethylene and porous polyurethane fabric) and two of the composite materials (porous polyurethane fabric coated with polyacrylonitrile and silicone with microvilli cut into the posterior surface) were selected for further study.

Animals↗

PubMed2004

In vitro degradation and biocompatibility of poly(DL-lactide-epsilon-caprolactone) nerve guides.

Bridging nerve gaps by means of autologous nerve grafts involves donor nerve graft harvesting. Recent studies have focused on the use of alternative methods, and one of these is the use of biodegradable nerve guides. After serving their function, nerve guides should degrade to avoid a chronic foreign body reaction. The in vitro degradation, in vitro cytotoxicity, hemocompatibility, and short-term in vivo foreign body reaction of poly((65)/(35) ((85)/(15) (L)/(D)) lactide-epsilon-caprolactone) nerve guides was studied. The in vitro degradation characteristics of poly(DLLA-epsilon-CL) nerve guides were monitored at 2-week time intervals during a period of 22 weeks. Weight loss, degree of swelling of the tube wall, mechanical strength, thermal properties, and the intrinsic viscosity of the nerve guides were determined. Cytotoxicity was studied by measuring the cell proliferation inhibition index (CPII) on mouse fibroblasts in vitro. Cell growth was evaluated by cell counting, while morphology was assessed by light microscopy. Hemocompatibility was evaluated using a thrombin generation assay and a complement convertase assay. The foreign body reaction against poly(DLLA-epsilon-CL) nerve guides was investigated by examining toluidine blue stained sections. The in vitro degradation data showed that poly(DLLA-epsilon-CL) nerve guides do not swell, maintain their mechanical strength and flexibility for a period of about 8-10 weeks, and start to lose mass after about 10 weeks. Poly(DLLA-epsilon-CL) nerve guides were classified as noncytotoxic, as cytotoxicity tests demonstrated that cell morphology was not affected (CPII 0%). The thrombin generation assay and complement convertase assay indicated that the material is highly hemocompatible. The foreign body reaction against the biomaterial was mild with a light priming of the immunesystem. The results presented in this study demonstrate that poly((65)/(35) ((85)/(15) (L)/(D)) lactide-epsilon-caprolactone) nerve guides are biocompatible, and show good in vitro degradation characteristics, making these biodegradable nerve guides promising candidates for bridging peripheral nerve defects up to several centimeters.

Animals↗

PubMed2003

Enhanced solubility of paclitaxel using water-soluble and biocompatible 2-methacryloyloxyethyl phosphorylcholine polymers.

The purpose of this study was to enhance the water-solubility of paclitaxel (PTX) using an amphiphilic 2-methacryloyloxyethyl phosphorylcholine (MPC) polymer as the solubilizer. PTX is an antineoplastic drug effective for various cancers, especially for ovarian and breast cancers. However, its solubility in aqueous medium is quite low, less than 0.1 microg/mL in water. We prepared the amphiphilic MPC polymers containing hydrophobic units to form aggregates and provide hydrophobic domains in water. The most effective polymer to dissolve the PTX was poly[MPC-co-n-butyl methacrylate(BMA) (PMB30W)] with 70 mol % of the BMA unit. The inside polarity of PMB30W aggregate was the same as that of ethanol, which is a good solvent for dissolving PTX. The diameter of PMB30W aggregate containing 1 mg/mL of PTX was 50 nm in aqueous medium. The concentration of PTX in the PMB30W aqueous solution reached 5.0 mg/mL. The solution was transparent and PTX did not precipitate even when the solution was stored at room temperature for 1 month. Animal experiments indicated that the PMB30W has no adverse effect even when the polymer solution is injected into the bloodstream. From the PMB30W/PTX solution, we prepared by the solvent evaporation method a PMB30W film containing PTX with good transparency. The PMB30W film containing PTX easily dissolved in water to give a clear solution. We conclude that the water-soluble amphiphilic MPC polymers are good solubilizers for PTX as injectable and biocompatible drug formulations.

Antineoplastic Agents, Phytogenic↗

PubMed2003

In vitro biocompatibility assessment of sulfonated polyrotaxane-immobilized polyurethane surfaces.

Sulfonated polyrotaxanes (PRx-SO(3)'s), in which sulfonated alpha-cyclodextrins (alpha-CDs) were threaded onto the poly(ethylene glycol) (PEG) segments in a PEG-b-poly(propylene glycol) (PPG)-b-PEG triblock copolymer (Pluronic) capped with benzyloxycarbonyl (Z)-L-phenylalanine (Z-L-Phe), were prepared as a novel surface-modifying biomaterial. Surface modification of the polyurethane (PU) was carried out by blending the PRx-SO(3)'s with a PU solution, followed by solution casting. The incorporated PRx-SO(3)'s led to the enhanced hydrophilicity by changing the surface properties of the PU matrix. Modified PUs showed the stable entrapment of the PRx-SO(3)'s with little extraction into water and enhanced mechanical properties after exposure to water compared to the PU control. The incorporated PRx-SO(3)'s repelled the proteins and kept them from closely approaching the surface areas, prevented platelet activation by thrombin, and effectively repelled bacteria. These results suggest that both the supramolecular structure of the polyrotaxanes and exposure of the sulfonated groups onto the surfaces contribute to these phenomena. Thus, surface modification with PRx-SO(3)'s is suggested to be useful for the fabrication of biocompatible medical devices.

Biocompatible Materials↗