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  • Articles  (35)
  • biocompatibility  (35)
  • Wiley-Blackwell  (34)
  • Springer  (1)
  • American Chemical Society
  • Technology  (35)
  • 1
    Electronic Resource
    Electronic Resource
    Multifunctional Biocompatible Membrane and Its Application to Fabricate A Miniaturized Glucose Sensor with Potential for Use In Vivo (1999)
    Springer
    Biomedical microdevices 1 (1999), S. 155-166 
    Details
    ISSN: 1572-8781
    Keywords: MPC ; BMA ; AMPS ; biocompatibility ; cellulose triacetate ; diffusion-limiting effect ; glucose sensor ; needle type ; glucose oxidase ; serum ; whole blood
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: Abstract A multifunctional membrane with biocompatibility, diffusion-limiting effect, and the ability to curtail the responses of an H2O2 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).
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1009952625595
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  • 2
    Electronic Resource
    Electronic Resource
    Long-term ingrowth and apposition of porous hydroxylapatite implants (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 36 (1997), S. 560-563 
    Details
    ISSN: 0021-9304
    Keywords: bone ; implant ; hydroxylapatite ; biocompatibility ; histomorphometric implant saturation ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Bone implant materials are often used to fill in bone gaps that frequently result from orthognathic and craniofacial reconstruction. The substrate hydroxylapatite (HA) is commonly implanted into the bone voids, resulting from these conditions due to its established biocompatibility and osteoconductive properties. The porous structure of HA provides a three-dimensional guideline for fibrovascular ingrowth, facilitating the process that ultimately results in the deposition of new bone. Porous HA (Interpore, 200) implants were implanted in the mandible or maxilla of nine humans and removed after 14-30 months (19.1-month mean). There was no evidence of an inflammatory response. The sample composition and apposition against the implant were determined using point counting and a digitizing tablet and software. Percent ingrowth in available space (%IAS) was defined as %Bone/(%Bone + %Void). A new measure of implant saturation (%IAS - %Apposition of bone) was established to help determine the fundamental manner in which long-term HA implants incorporate bone. In the mean, the samples were composed of 27% bone, 21% void, and 53% implant. The apposition percentages averaged 60% bone, 16% void, and 24% soft tissue. The %IAS averaged 58%, and implant saturation averaged -3%, indicating that a near-balance between the implant and surrounding bone has been established. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 560-563, 1997.
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  • 3
    Electronic Resource
    Electronic Resource
    Osteogenic cell cytotoxicity and biomechanical strength of the new ceramic Diopside (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 37 (1997), S. 100-107 
    Details
    ISSN: 0021-9304
    Keywords: Diopside ; biocompatibility ; osteogenic cell (MC3T3-E1) ; biomechanical strength ; apatite wollastonite-containing glass-ceramic (AWGC) ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Diopside was prepared by sintering a powder compact composed of CaMgSi2O6 at 1573K for 2 h. In order to clarify the biocompatibility of Diopside, the cytotoxicity of Diopside against the osteogenic cell line MC3T3-E1 and the bone-Diopside interface strength were examined. On both the 14th and 21st days of incubation of MC3T3-E1 cells with Diopside, ALP activities were not significantly lower than those of the CTRL. TEM photographs of MC3T3-E1 on Diopside after 14 days of incubation showed active secretion of crystals from osteoblast-like cells. Scanning electron microscopic analysis showed that the cells on Diopside formed multiple cell layers similar to those on the CTRL both 14 and 21 days after incubation. These results showed that Diopside had no cytotoxic effect on MC3T3-E1. The pulling test showed that failure loads of Diopside were significantly lower than those of AWGC. Histologically, there was no fibrous tissue or foreign body reaction at the bone interface. SEM-EPMA showed that Diopside had attached to the bone via a calcium-phosphorus layer. SEM back-scattered electron imaging showed that the Diopside plate had degraded to a porous state 12 weeks after implantation. These findings indicate that Diopside is a biodegradable ceramic. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 100-107, 1997.
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  • 4
    Electronic Resource
    Electronic Resource
    Assessment of wrought ASTM F1058 cobalt alloy properties for permanent surgical implants (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 38 (1997), S. 229-234 
    Details
    ISSN: 0021-9304
    Keywords: cobalt alloy ; implant ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The behavior of the ASTM F1058 wrought cobalt-chromium-nickel-molybdenum-iron alloy (commonly referred to as Elgiloy® or Phynox) is evaluated in terms of mechanical properties, magnetic resonance imaging, corrosion resistance, and biocompatibility. The data found in the literature, the experimental corrosion and biocompatibility results presented in this article, and its long track record as an implant material demonstrate that the cobalt superalloy is an appropriate material for permanent surgical implants that require high yield strength and fatigue resistance combined with high elastic modulus, and that it can be safely imaged with magnetic resonance. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 38: 229-234, 1997
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  • 5
    Electronic Resource
    Electronic Resource
    Fibroblast growth factor-2 alters the effect of eroding polylactide-polyglycolide on osteogenesis in the bone chamber (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 40 (1998), S. 567-576 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; erodible polymer ; fibroblast growth factor-2 ; osteogenesis ; polylactide-polyglycolide ; porous ingrowth ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The effects of recombinant human fibroblast growth factor-2 (rhFGF-2) in the presence of eroding 50:50 poly(DL-lactide-co-glycolide) (PDLLG) on acute bone healing were studied in the optical bone chamber (BCI). BCIs were loaded with disks of PDLLG surrounded by one of four rhFGF-2 doses. Fifty-two female rabbit right tibias were implanted. Commencing the third week post implantation (W3) healing in the BCI compartment was observed weekly, using intravital microscopy, until W8. The doses were: unloaded, loaded with polymer only, and polymer plus 0.5, 1.0, and 10 μg rhFGF-2. Videotaped and photographed bone images were measured and analyzed using a frame-grabber digitizing system. Comparison with controls revealed that ossification rates were significantly above normal in rabbits loaded with polymer plus any of the rhFGF-2 doses. Comparison with polymer-only BCIs showed that PDLLG plus any of the three rhFGF-2 doses was linked with ossification rates significantly higher than baseline. The results indicated that FGF-2 in the dose range studied effectively can overcome the retarding effects of eroding polymer on ossification that has been reported by this laboratory. Interpretation of the retarding effects of the polymer disks, although consistent with previously studied washer-shaped devices of the same material, was complicated by a difference in erosion rate. This result supports the notion that erodible device geometry is a major factor in determining biocompatibility and must be considered in the design of carriers. Accordingly, programming of dose specificity for delivering a given polypeptide cytokine to a given host site must allow for the inhibitory effects of an eroding carrier and the influence of device geometry on these effects and erosion. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 567-576, 1998.
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  • 6
    Electronic Resource
    Electronic Resource
    Grafting of PEO to polymer surfaces using electron beam irradiation (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 40 (1998), S. 153-163 
    Details
    ISSN: 0021-9304
    Keywords: PEO ; electron beam irradiation ; polymer surface modification ; biocompatibility ; XPS ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A new method was developed for binding poly(ethylene oxide) (PEO) to polymer surfaces that involves the use of electron beam irradiation in two steps. In the first, methacrylic acid was grafted and polymerized to a polymer surface, changing it from hydrophobic to hydrophilic. Exposure of this surface to aqueous PEO solutions resulted in strong hydrogen bonding of the PEO, which was covalently grafted in a second radiation step. The PEO grafts were stable; they could not be removed with extensive washing with water, soaking in basic solution, or gentle mechanical scraping. Both monolayers and multilayers of PEO were formed. The density of the monolayers were found to have little dependence on the molecular weight or concentration of the PEO solution; multilayers could be controlled by varying the viscosity of the PEO solution and the method of application. The PEO-grafted monolayers were tested for their ability to prevent protein adsorption of cytochrome-c, albumin, and fibronectin. Monolayers of star PEO were the most effective, at best showing a 60% decrease in adsorption from untreated controls. One million molecular weight linear PEO monolayers were almost as effective as star monolayers, and 35,000 g/mol linear PEO was bound too closely to the surface, owing to its small size, to have much impact in preventing protein adsorption. The reason for the continued protein adsorption was believed to be due to a close grafting of the PEO to the surface, as well as the grafted methacrylic acid chains being long enough to extend through the PEO monolayer, thus being accessible on the surface. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 153-163, 1998.
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  • 7
    Electronic Resource
    Electronic Resource
    Biocompatibility analysis of different biomaterials in human bone marrow cell cultures (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 40 (1998), S. 301-306 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; biomaterials ; human bone marrow cell culture ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A cell culture system for biocompatibility testing of hip implant materials is described. Human bone marrow cells have been chosen because these cells are in direct contact with the biomaterial after implantation in situ. The sensitivity of this method is evaluated for materials which are already being used as implants in humans and animal, e.g., hydroxyapatite (HA) ceramic, pure titanium, and ultra-high-molecular-weight polyethylene (UHMWPE). As indicative parameters of biocompatibility primary cell adherence, cell number, cell proliferation, production of extracellular matrix, cell vitality, and cell differentiation are described. After 2 weeks in culture, obvious differences between the biomaterials with respect to the indicative parameters could be observed. Cell numbers were greatest on the HA specimens. In the case of titanium alloys, we observed a decreased number of cells. The production of extracellular matrix was high for the HA ceramics but reduced for titanium specimens. The polymers allowed only a few adherent cells and showed no signs of extracellular matrix production. The results can be correlated astonishingly well to animal experiments and clinical experiences. Therefore, we suggest that this cell culture system seems to be a useful tool for biocompatibility testing of bone implantation materials. It also helps reduce animal experiments. With the help of flow cytophotometry, we analyzed the influence of biomaterials on large numbers of cells with respect to differentiation. There were similar populations of T cells and monocytes on all specimens tested. Extended B-cell and granulocyte populations, however, were observed with titanium and UHMWPE. Most osteocalcin-containing cells adhered to the HA ceramics. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 301-306, 1998.
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  • 8
    Electronic Resource
    Electronic Resource
    In vitro biocompatibility assessment of a nickel-titanium alloy using electron microscopy in situ end-labeling (EM-ISEL) (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 154-161 
    Details
    ISSN: 0021-9304
    Keywords: nickel-titanium ; biocompatibility ; genotoxicity ; immunogold labeling ; electron microscopy ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Shape memory nickel-titanium (NiTi) alloys are potential candidates for biomedical applications. However, their equiatomic composition (50 wt% Ni) is controversial, and concerns have been raised about their biocompatibility level because of the carcinogenicity potential. The relative in vitro genotoxicity of NiTi therefore was evaluated and compared to commercially pure titanium (cpTi), 316L stainless steel (SS 316L), and positive and negative controls. To do so, human peripheral blood lymphocytes were cultured in semiphysiological medium that previously had been exposed to the biomaterials. The electron microscopy in situ end-labeling (EM-ISEL) assay then was performed in order to provide quantification of in vitro chromatin DNA single-stranded breaks (SSBs). Chromosomes and nuclei were harvested and exposed to exonuclease III, which amplifies DNA lesions at 3′ ends of breaks. After random priming, incorporation of biotin-dUTP was labeled by immunogold binding, which then was detected using electron microscopy. Cellular chromatin exposed to the positive control demonstrated a significantly stronger immunogold labeling than when it was exposed to NiTi, cpTi, SS 316L extracts, or the untreated control. Moreover, gold particle counts, whether in the presence of NiTi, cpTi, or the negative control medium, were not statistically different. NiTi genocompatibility therefore presents promising prescreening results towards its biocompatibility approval. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 154-161, 1998.
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  • 9
    Electronic Resource
    Electronic Resource
    Biocompatibility of poly(etherurethane urea) containing dehydroepiandrosterone (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 192-201 
    Details
    ISSN: 0021-9304
    Keywords: polyurethane ; dehydroepiandrosterone ; biocompatibility ; biostability ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Poly(etherurethane urea) (PEUU) elastomers, with their broad range of mechanical properties and high biocompatibility, are used clinically for medical applications. However, the possibility exists for the ether soft segment of PEUU to degrade in long-term uses. To retard degradation, antioxidants that scavenge reactive oxygen intermediates are added. In this study, we incorporated dehydroepiandrosterone (DHEA), which functions by the alternate mechanism of modulating or down-regulating adherent macrophage activity, to retard the biodegradation of PEUUs. Biocompatibility of PEUU samples containing 1% DHEA, 5% DHEA, and 5% vitamin E (α-tocopherol) by weight were studied in vivo and in vitro. The biocompatibility was initially evaluated by examination of the inflammatory cellular exudate. Compared to PEUU without additives and PEUU with 5% vitamin E, the addition of 5% DHEA to PEUU caused a decrease in the total leukocyte exudate concentration at 4 days. The addition of 5% DHEA also caused lower macrophage adhesion and FBGC formation compared to the other materials at 7 days. Despite these short-term effects, the biocompatibility at later time points (14, 21, and 70 days) was similar for all materials. Transmission infrared analysis of the materials revealed that more than 70% of the DHEA had leached out of the samples by 3 days implantation. Furthermore, through attenuated total reflectance Fourier transform analysis and scanning electron microscopy, it was determined that unlike vitamin E, DHEA did not enhance long-term PEUU biostability. The effect of DHEA on inflammatory cell activity appeared to be dose dependent, with improved biocompatibility in vivo for higher loading levels of DHEA, but the overall effect was limited owing to the rapid diffusion of the water-soluble DHEA from the PEUU. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 192-201, 1998.
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  • 10
    Electronic Resource
    Electronic Resource
    Microgrooved subcutaneous implants in the goat (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 42 (1998), S. 634-641 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; subcutaneous implant ; implant surface ; microgrooves ; in vivo ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: We investigated the behavior of microgrooved implants in soft tissue using polystyrene implantable disks, either smooth or microgrooved (1-10 μm) on both sides. The implants were placed subcutaneously in a goat for 1, 4, or 12 weeks. Light and transmission electron microscopy showed that fibrous capsule formation around the implants was fairly uniform. After 1 week the implants were covered with a fibrous capsule about 80 μm thick. The collagen matrix was loose, and many inflammatory cells were present. After 4 weeks the matrix was more dense and contained many newly formed blood vessels. At the implant surface a layer of inflammatory cells about 10 μm thick had accumulated. Finally, after 12 weeks the matrix had densified. One cellular layer of inflammatory cells was present at the implant surface. We carried out histomorphometric measurements of capsule thickness, inflammatory layer thickness, and the number of blood vessels. Capsule thickness appeared not to decrease with time. Further, these measurements showed that there were no differences in tissue reaction between smooth and microgrooved implants. On the basis of our observations, we suggest that 1 μm deep and 1-10 μm wide microgrooves do not influence tissue response around polystyrene implants in soft tissue. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 42, 634-641, 1998.
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  • 11
    Electronic Resource
    Electronic Resource
    Biocompatibility response to modified Baerveldt glaucoma drains (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 43 (1998), S. 99-107 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; biomaterials ; collagen ; glaucoma drains ; wound healing ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Glaucoma implants are designed to increase fluid outflow from the eye in order to decrease intraocular pressure and prevent damage to the optic nerve. The implant consists of a silicone tube that is inserted into the anterior chamber at one end and is attached at the other end to a silicone plate that is sutured to the outside of the globe beneath the conjunctiva. The glaucoma “implant” becomes a “drain” over the first 3 to 6 postoperative weeks as the silicone plate is enclosed by a fibrous capsule that allows a space to form into which fluid can drain and from which fluid can be absorbed by the surrounding tissues. Ideally, the size and thickness of the capsule (the filtering bleb) that surrounds the plate is such that the amount of fluid that passes through the capsule is identical to the amount of fluid produced by the eye at an intraocular pressure of 8 to 14 mmHg. The most common long-term complication of these implants is failure of the filtering bleb 2 to 4 years after surgery due to the formation of a thick fibrous capsule around the device. Micromovement of the smooth drainage plate against the scleral surface may be integral to the mechanism of glaucoma implant failure by stimulating low-level activation of the wound healing response, increased collagen scar formation, and increased fibrous capsule thickness. To test this hypothesis, we modified seven Baerveldt implants by adding porous cellular ingrowth material to the posterior surface of the drainage plate. Seven modified and five unmodified implants were placed in adult rabbit eyes. After 6 months, we found that the fibrous capsule around the modified implants was significantly thinner than the capsule surrounding the unmodified implants (p 〈 0.05), particularly on the surface between the porous ingrowth material and the sclera (p 〈 0.05). Although type I collagen predominated in the fibrous capsules around both types of implants, the amount of type III collagen in the capsules around the modified implants was significantly less than the amount around the unmodified implants (p 〈 0.05). We believe that these data suggest a reduction in the wound healing response to the modified implants, with greater stability of capsule thickness. Long-term studies are needed to verify that the stability of the capsules around the modified implants persists over a period of years, in which case this type of modification may prove useful in prolonging the functional life of these devices in the surgical treatment of glaucoma. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 43: 99-107, 1998
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  • 12
    Electronic Resource
    Electronic Resource
    Culture materials affect ex vivo expansion of hematopoietic progenitor cells (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 36 (1997), S. 347-359 
    Details
    ISSN: 0021-9304
    Keywords: hematopoietic cultures ; biocompatibility ; culture materials ; serum-free medium ; CD34+ cells ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Ex vivo expansion of hematopoietic cells is important for applications such as cancer treatment, gene therapy, and transfusion medicine. While cell culture systems are widely used to evaluate the biocompatibility of materials for implantation, the ability of materials to support proliferation of primary human cells in cultures for reinfusion into patients has not been addressed. We screened a variety of commercially available polymer (15 types), metal (four types), and glass substrates for their ability to support expansion of hematopoietic cells when cultured under conditions that would be encountered in a clinical setting. Cultures of peripheral blood (PB) CD34+ cells and mononuclear cells (MNC) were evaluated for expansion of total cells and colony-forming unit-granulocyte monocyte (CFU-GM; progenitors committed to the granulocyte and/or monocyte lineage). Human hematopoietic cultures in serum-free medium were found to be extremely sensitive to the substrate material. The only materials tested that supported expansion at or near the levels of polystyrene were tissue culture polystyrene, Teflon perfluoroalkoxy, Teflon fluorinated ethylene propylene, cellulose acetate, titanium, new polycarbonate, and new polymethylpentene. MNC were less sensitive to the substrate materials than the primitive CD34+ progenitors, although similar trends were seen for expansion of the two cell populations on the substrates tested. CFU-GM expansion was more sensitive to substrate materials than was total cell expansion. The detrimental effects of a number of the materials on hematopoietic cultures appear to be caused by protein adsorption and/or leaching of toxins. Factors such as cleaning, sterilization, and reuse significantly affected the performance of some materials as culture substrates. We also used PB CD34+ cell cultures to examine the biocompatibility of gas-permeable cell culture and blood storage bags and several types of tubing commonly used with biomedical equipment. While many of the culture bag materials gave satisfactory results, all of the tubing materials severely inhibited total cell and CFU-GM expansion. Taken together, our results show that many materials approved for blood contact or considered biocompatible are not suitable for use with hematopoietic cells cultured in serum-free medium. As hematopoietic cultures are scaled up for a variety of clinical applications, it will be essential to carefully examine the biocompatibility of all materials involved. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 347-359, 1997.
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  • 13
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    Crosslinking density and resorption of dimethyl suberimidate-treated collagen (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 36 (1997), S. 478-486 
    Details
    ISSN: 0021-9304
    Keywords: collagen ; crosslinking density ; glutaraldehyde ; dimethyl suberimidate ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Collagen was purified from bovine Achilles tendon and crosslinked with dimethyl suberimidate (DMS) and glutaraldehyde (GTA). Under optimal conditions, the shrinkage temperature (TS) was raised to 74°C for collagen crosslinked with DMS and to 80°C for those crosslinked with GTA. Crosslinking density measurements were done on the hydrothermally denatured collagen by the method based on the Flory-Rehner equation. GTA treatment was found to introduce more number of crosslinks than DMS. The maximum tension attained during heating (after shrinkage has occurred) was greater for GTA-treated collagen than for DMS and control. The control collagen membranes broke during heating (at 73°C), while for the crosslinked membranes the tension kept on increasing up to 100°C. The crosslinking density correlated well with the data determined from the in vitro and in vivo degradation studies. Uncrosslinked and DMS crosslinked collagen membranes were more susceptible to degradation by enzymes in vitro, while GTA-treated collagen was highly resistant to degradation. The biocompatibility of the collagen membranes was studied by subcutaneous implantation in rats. Uncrosslinked collagen membranes degraded within 14 days with the formation of granulation tissue. DMS crosslinked membranes degraded within 21 days and the area was replaced by numerous fibroblasts and newly formed collagen. No calcification was observed. For GTA-treated membranes, necrosis was observed after 7 days implantation and by 14 days the membrane had started to calcify. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 478-486, 1997.
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  • 14
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    Tissue response to fast-setting calcium phosphate cement in bone (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 37 (1997), S. 457-464 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; bone ; calcium phosphate cement ; fast-setting ; hydroxyapatite ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Fast-setting calcium phosphate cement (FSCPC) is a promising new bioactive cement with a significantly short setting time (approximately 5-6 min) compared to conventional calcium phosphate cement (c-CPC) (30-60 min) at physiologic temperatures. As a result of its ability to set quickly, it is applicable in surgical procedures where fast setting is required. In this study, FSCPC was implanted in rat tibiae to evaluate tissue response and biocompatibility. FSCPC was converted to hydroxyapatite (HAP) in bone faster than c-CPC in the first 6 h. By 24 h, significant amounts of both FSCPC and c-CPC had been converted to HAP. The conversion of FSCPC into HAP further proceeded gradually, reaching 100% within 8 weeks. Infrared spectroscopic analysis disclosed the deposition of B-type carbonate apatite, which is a biological apatite contained in human dentin or bone, on the surface of the FSCPC. Histologically, FSCPC showed a tissue response similar to that of c-CPC. A slight inflammatory reaction was observed in the soft tissue apposed to both cements in the early period, and new bone was formed along the surface of the FSCPC at the adjacent bone. However, no resorption of either cement by osteoclasts or macrophages was observed within 8 weeks. We conclude that FSCPC is superior to c-CPC in clinical applications in oral and maxillofacial, orthopedic, plastic, and reconstructive surgery, since it shows a faster setting time and higher mechanical strength in the early period that are required in these surgical procedures, as well as osteoconductivity and excellent biocompatibility similar to that of c-CPC. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 457-464, 1997.
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  • 15
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    Histochemical and morphometric observations on the new tissue formed around mammary expanders coated with pyrolytic carbon (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 40 (1998), S. 307-313 
    Details
    ISSN: 0021-9304
    Keywords: pyrolytic carbon ; mammary tissue expanders ; biocompatibility ; image analysis ; cellular proliferation ; MIB-1 ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The authors investigated tissue reaction around implanted silicone expanders, focusing on clinical morphological and morphometrical aspects. For use in breast reconstruction in post mastectomy patients, the surface of a medical-grade silicone elastomer was modified, without changing its bulk properties, by the addition of a pyrolytic carbon film. The presence of lipophagy, the number of foreign-body giant cells of histiocytic origin, and the number of MIB-1 positive nuclei (an index of proliferation for the reactive stromal population) were all seen to be influenced by the pyrolytic carbon coating. Indeed, all these parameters were lower in the membrane formed around Carbofilm™-coated expanders, thus demonstrating the effective protective properties of pyrolytic carbon coating. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 307-313, 1998.
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  • 16
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    In vitro sister chromatid exchange induced by glass ionomer cements (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 40 (1998), S. 545-550 
    Details
    ISSN: 0021-9304
    Keywords: glass ionomer cement ; sister chromatid exchange ; genotoxicity ; biomaterial ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The genotoxicity of three glass ionomer cements used in dentistry, manufactured by American (Vitrebond™), Japanese (Fuji I™), and European (Ketac Cem™) companies were examined. The cement components were mixed according to the manufacturers' instructions and allowed to set for two defined times: 1 h or 1 week, before extracting them, as established by ISO standard 10993 part 12. To highlight sister chromatid exchange during mitosis, the extracts then were tested with human peripheral lymphocytes in the presence or absence of metabolic activation with S9 mix. The test performed was a genotoxicity test as provided for in standard EN 30993 part 3. Vitrebond™ resulted in direct genotoxicity and was strongly cytotoxic both in the extracts performed at 1 h and those at 1 week if they were allowed to set without photoactivation. Fuji I™ was noncytotoxic and showed only uncertain indirect genotoxicity in the extracts at 1 h; genotoxicity was not present in the extracts at 1 week. Ketac Cem™ cement was not genotoxic nor was it cytotoxic either at 1 h or 1 week. The authors concluded that of the three cements tested the European cement Ketac Cem™ passed one of the tests suggested by the EEC standard for assessing genotoxicy. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 545-550, 1998.
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    Perfluorodecalin modifies the pattern of cell arrangement and induces loss of neurites in rat retinal cultures (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 608-613 
    Details
    ISSN: 0021-9304
    Keywords: perfluorodecalin ; retina ; cell cultures ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Perfluorodecalin (PFD), a high specific weight, water-immiscible perfluorocarbon, previously studied as a potential blood substitute, now is used widely in the field of ophthalmic surgery as a tool for maneuvering intraocular tissues and as a short- or medium-term vitreous substitute. In in vivo experiments, several types of lesions in retinal tissue have been described in conjunction with long-term PFD treatment. To better evaluate the biological effects of PFD on retinal cells, we tested it on primary cultures of rat retina seeded on special cyclopore wells that allow the culture to be fed from the bottom side while the top side is in contact with the water-immiscible compound. We found that PFD changed the pattern of cell arrangement and induced loss of neurites. The modification of cell arrangement was less evident at the periphery of the wells where the amount of PFD, and consequently the pressure exerted, was lower. This observation suggests that the changes may be due more to a physical than to a toxic effect of PFD. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 608-613, 1998.
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    Flow cytometry for assessing biocompatibility (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 649-656 
    Details
    ISSN: 0021-9304
    Keywords: flow cytometry ; cell culture ; biocompatibility ; biomaterials ; implants ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Flow cytometry (FCM) was examined as a possible procedure for measuring in vitro the biocompatibility of implant materials for orthopedic and dental surgery. The human osteoblast-like cell line MG63 was grown on hydroxyapatite (HA) and P2O5 glass-reinforced HA composite discs and compared with the same cells grown on polystyrene culture dishes. While morphological observation at the light and electron microscopic levels showed no major deleterious effects, FCM indicated that cell size was somewhat reduced, particularly by growth on the HA composite. Moreover, this material also appeared to delay the progression of the cells from the G0/G1 into the S phase of the cell cycle. In addition to this low level of inhibition of cell growth relative to control cultures, FCM analysis also demonstrated that the glass-reinforced HA caused some down-regulation of the expression of osteocalcin and fibronectin, two antigens which play a vital part in the integrity and function of bone and soft connective tissue, respectively. These results thus show, first, that although HA and the HA composite used in these experiments were generally biocompatible, they nevertheless had certain suboptimal effects on the cells; and second, that FCM could be a highly useful procedure for effectively screening and evaluating important biological responses to implant materials. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 649-656, 1998.
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    Poly(α-hydroxyacids) for application in the spinal cord: Resorbability and biocompatibility with adult rat Schwann cells and spinal cord (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 42 (1998), S. 642-654 
    Details
    ISSN: 0021-9304
    Keywords: biodegradable implants ; lactic and glycolic acid polymers ; biocompatibility ; Schwann cells ; axonal regeneration ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Future surgical strategies to restore neurological function in the damaged human spinal cord may involve replacement of nerve tissue with cultured Schwann cells using biodegradable guiding implants. We have studied the in vitro and in vivo degradability of various aliphatic polyesters as well as their effects on rat Schwann cells in vitro and on spinal cord tissue in vivo. In vitro, cylinders made of poly(D,L-lactic-co-glycolic acid) 50:50 (PLA25GA50) started to degrade at 7 days, compared with 28 days for cylinders made of poly(D,L-lactic acid) (PLA50). This faster degradation of PLA25GA50 was reflected by a much higher absorption of water. In vivo, after implantation of PLA25GA50 or PLA50 cylinders between the stumps of a completely transected adult rat spinal cord, the decrease in molecular weight of both polymers was similar to that found in vitro. In vitro degradation of poly(L-lactic acid) (PLA100) mixed with increasing amounts of PLA100 oligomers also was determined. The degradation rate of PLA100 mixed with 30% oligomers was found to be similar to that of PLA50. In vitro, PLA25GA50 and the breakdown products had no adverse effect on the morphology, survival, and proliferation of cultured rat Schwann cells. In vivo, PLA25GA50 cylinders were integrated into the spinal tissue 2 weeks after implantation, unlike PLA50 cylinders. At all time points after surgery, the glial and inflammatory response near the lesion site was largely similar in both experimental and control animals. At time points later than 1 week, neurofilament-positive fibers were found within PLA25GA50 cylinders or the remains thereof. Growth-associated protein 43, which is indicative of regenerating axons, was observed in fibers in the vicinity of the injury site and in the remains of PLA25GA50 cylinders. The results suggest that poly(α-hydroxyacids) are likely candidates for application in spinal cord regeneration paradigms involving Schwann cells. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 42, 642-654, 1998.
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    Biocompatibility of nickel-titanium shape memory metal and its corrosion behavior in human cell cultures (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 35 (1997), S. 451-457 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; nitinol ; shape memory alloy ; corrosion ; human cell cultures ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Nickel-titanium alloy (Nitinol) is a metallic biomaterial that has a unique thermal shape memory, superelasticity, and high damping properties. Nitinol is potentially very useful in orthopedic surgery, for example. At present, there are not enough confirmative biocompatibility data available on Nitinol. The aim of our study was to clarify the primary cytotoxicity and corrosion rate of Nitinol in human cell cultures. Comparisons were made with stainless steel (Stst), titanium (Ti), composite material (C), and control cultures with no test discs. Human osteoblasts (OB) and fibroblasts (FB) were incubated for 10 days with test discs of equal size, 6 × 7 mm. The cultures were photographed and the cells counted. Samples from culture media were collected on days 2, 4, 6, and 8, and the analysis of metals in the media was done using flameless atomic absorption spectrophotometry. The proliferation of FB was 108% (Nitinol), 134% (Ti) (p 〈 0.02), 107% (Stst), and 48% (C)(p 〈 0.0001) compared to the control cultures. The proliferation of OB was 101% (Nitinol), 100% (Ti), 105% (Stst), and 54% (C) (p 〈 0.025) compared to the controls. Initially, Nitinol released more nickel (129-87 μg/L) into the cell culture media than Stst (7 μg/L), but after 2 days the concentrations were about equal (23-5 μg/L versus 11-1 μg/L). The titanium concentrations from both Nitinol and Ti samples were all 〈20 μg/L. We conclude that Nitinol has good in vitro biocompatibility with human osteoblasts and fibroblasts. Despite the higher initial nickel dissolution, Nitinol induced no toxic effects, decrease in cell proliferation, or inhibition on the growth of cells in contact with the metal surface. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 35, 451-457, 1997.
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    Glass peek composite promotes proliferation and osteocalcin production of human osteoblastic cells (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 36 (1997), S. 137-144 
    Details
    ISSN: 0021-9304
    Keywords: PEEK ; composite ; biocompatibility ; cell culture ; osteoblasts ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: An isoelastic intramedullary implant has been developed using a composite of polyetheretherketone and 10% random, chopped E-glass fibers (GPEEK). The effect of this novel material on human bone cells has not been defined. The objective of this study was to test whether GPEEK supported the proliferation of the human bone cell line MG63, which exhibits osteoblastlike characteristics. Cells (1 × 105/mL) were propagated on GPEEK discs with three different surface roughnesses (3, 6, and 9 μm) and on polystyrene plates, for comparison. The reaction of MG63 osteoblastlike cells to the GPEEK polymer composite was analyzed by determination of cell yield, osteocalcin production, and levels of alkaline phosphatase. The viable cells that were retrieved from the GPEEK discs of all three surface roughness had an approximate sixfold increase in number. Osteoblastic function of the cells, indicated by osteocalcin production, was unimpaired after a 5-day culture on the three surfaces of GPEEK. The highest level of osteocalcin was produced by osteoblastic cells propagated on GPEEK with a 9-μm surface roughness. The levels of alkaline phosphatase of these cells were similarly greater for the different degrees of surface roughness. Overall, this study demonstrates that GPEEK supported proliferation of osteoblastlike cells and provided a favorable environment for the continued production of osteocalcin in vitro. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 137-144, 1997.
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    Biocompatibility of alumina ceramic and polyethylene as materials for pivot bearings of a centrifugal blood pump (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 36 (1997), S. 381-386 
    Details
    ISSN: 0021-9304
    Keywords: alumina ceramic ; polyethylene ; biocompatibility ; centrifugal blood pump ; pivot bearing ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The double pivot bearings in the Gyro C1E3 centrifugal blood pump incorporate a high-purity alumina (Al2O3) ceramic and an ultra-high-molecular-weight polyethylene (UHMWPE). This centrifugal pump has been developed as a completely sealless pump for long-term usage. The combination of Al2O3 and UHMWPE are the materials of choice for the acetabular bearing in artificial joints, which have proven to be clinically reliable for over 10 years. Previous studies have examined the biocompatibility of Al2O3 and UHMWPE as bulky implant materials. The present study investigated this material as a blood-contacting material using a standard assessment in vitro and in vivo analysis. The examined items were systemic toxicity, sensitization (guinea pig maximization test), cytotoxicity (elution test), mutagenicity (Ames test), direct contact hemolysis, and thrombogenicity. The studies were performed according to the United States Pharmacopoeia and published previous studies. The samples of both Al2O3 and UHMWPE demonstrated no differences from the negative controls in all tests. These findings indicate that both Al2O3 and UHMWPE are biocompatible materials for double-pivot bearings in the centrifugal blood pump. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 381-386, 1997.
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    Subconjunctival biocompatibility of a viscous bioerodable poly(ortho ester) (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 39 (1998), S. 277-285 
    Details
    ISSN: 0021-9304
    Keywords: poly(ortho ester) ; biocompatibility ; degradation ; sterilization ; opthalmology ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The biocompatibility of a viscous poly(ortho ester) (POE) intended for prolonged intraocular drug delivery was studied. This hydrophobic and bioerodable carrier was subconjunctivally injected in rabbits and evaluated both clinically and histologically. To assess the cause of the triggered transient acute inflammatory reaction, the two monomers, the intermediate and final degradation products, and the local toxicity of different solvents used during the polymer preparation were tested. Since the two initial monomers and the intermediate degradation products induced only moderate inflammation, the main acute inflammatory reaction is attributed to the formation of an acidic by-product, which has been monitored in vitro by measuring the progressive decrease of the environmental pH. The influence of the sterilization procedure on tissue biocompatibility was established by comparing two polymers of similar molecular weight: one after γ-sterilization, and an aseptically synthesized one. The biocompatibility was significantly improved by avoiding irradiation of the polymer. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 39, 277-285, 1998.
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    Modulation of the tissue reaction to biomaterials. II. The function of T cells in the inflammatory reaction to crosslinked collagen implanted in T-cell-deficient rats (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 39 (1998), S. 398-406 
    Details
    ISSN: 0021-9304
    Keywords: T cells ; phagocytosis ; collagens ; biocompatibility ; biomaterials ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Unwanted tissue reactions are often observed resulting in events such as early resorption of the biomaterial, loosening of the implant, or a chronic (immunologic) response. From immunologic studies it is known that inflammatory reactions can be modulated by use of (anti)-growth factors or anti-inflammatory drugs. Before this can be employed with respect to biomaterials, the role of individual factors (humoral and cellular) has to be studied. In this part of the investigation, the role of T cells was studied by use of T-cell-deficient (nude) rats and control (AO) rats. Hexamethylenediisocyanate-crosslinked dermal sheep collagen (HDSC) was selected as the test material. The results showed that T cells or T cell-related factors played a prominent role in the attraction of macrophages and the formation of giant cells, their antigen presentation, and their phagocytotic capacity. As a consequence, degradation of HDSC was strongly delayed. This study also showed that infiltration of fibroblasts and creation of stromal areas in HDSC was restricted to areas subjected to degradation. However, in time, absence of T cells resulted in increased formation and maturation of autologous rat collagen. Results obtained suggest that the inflammatory reaction to biomaterials might be modulated by controlling T-cell activation. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 39, 398-406, 1998.
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    Quantification of the inflammatory response in exudates to three polymers implanted in vivo (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 39 (1998), S. 637-641 
    Details
    ISSN: 0021-9304
    Keywords: quantification of inflammatory reaction in vivo ; flow cytometry ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Flow cytometry was used to quantify an inflammatory reaction in vivo as a new approach to evaluating the biocompatibility of biomaterials. The exudate formed inside cylindrical tubes composed of polyvinyl chloride (PVC), silicone elastomer (SIL), or polyurethane (PU) implanted subcutaneously in the dorsal region of rats was collected over a 3-week period. The volume, number of cells, and concentration of fibrinogen were determined in the exudate for the three biomaterials. The exudate was analyzed using a flow cytometry technique after labeling of the leukocytes with a monoclonal anti-CD45 antibody. Fibrinogen rose progressively over the 3-week period for the three polymers. After the different leukocyte lines were identified in rat blood samples, their determination in the exudate revealed differences among the three biomaterials. At day 2, PVC induced a predominantly neutrophilic inflammatory reaction whereas PU and SIL gave a mixture of monocytes and neutrophils. At day 9, the aspect of the cytograms was different, but the identification of the subpopulations was still possible. At day 23, the number of cell events became too low to distinguish the subpopulations. An even more detailed approach might be possible using specific labeling for each leukocyte line to establish a comparison among the three biomaterials. Flow cytometry associated with histomorphometric assessment might provide a precise quantitative in vivo test for determining the biocompatibility of materials. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 39, 637-641, 1998.
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    In vivo biocompatibility evaluation of nickel-titanium shape memory metal alloy: Muscle and perineural tissue responses and encapsule membrane thickness (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 481-488 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; Nitinol ; shape memory alloy ; tissue response ; perineural response ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Nickel-titanium shape memory alloy (Nitinol) has properties that could be very useful in surgical applications. Thermal shape memory, superelasticity, and high damping properties make such alloys behave differently compared to other implant metals. There has previously been a lack of sufficient evidence on the biocompatibility of Nitinol. The purpose of this study was to evaluate general soft tissue response and biocompatibility to Nitinol in vivo, and to clarify neural and perineural responses, previously unreported. Seventy-five rats were randomized into three groups. Test specimens were implanted into paravertebral muscle and near the sciatic nerve. A comparison was made between Nitinol, stainless steel, and Ti-6Al-4V. The animals were euthanized at 2, 4, 8, 12, and 26 weeks after implantation. General morphologic and histologic observations were made under light microscopy. Semiautomatic computerized image analysis was used to measure the encapsule membrane thickness around the implants. The muscular tissue response to Nitinol was clearly nontoxic, regardless of the time period. The overall inflammatory response to Nitinol was very similar to that of stainless steel and Ti-6Al-4V alloy. There were no necroses, granulomas, or signs of dystrophic soft tissue calcification. The immune cell response to Nitinol remained low. Only a few foreign-body giant cells were present. The detected neural and perineural responses were also clearly nontoxic and nonirritating with Nitinol. No qualitative differences in histology between the different test materials could be seen. At 8 weeks, the encapsule membrane of Nitinol was thicker than that of stainless steel (mean 62 ± 25 μm vs. 41 ± 8 μm). At the end of the study, the encapsule thickness was equal to all the materials tested. We concluded that Nitinol had good in vivo biocompatibility after intramuscular and perineural implantation in rats in the 26-week follow-up. Based on the results of the present study, Nitinol appears to have good potential for clinical use. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 481-488, 1998.
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    Assessment of an experimental bone wax polymer plus TGF-β1 implanted into calvarial defects (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 584-592 
    Details
    ISSN: 0021-9304
    Keywords: transforming growth factor-beta1 (TGF-β1) ; wax-like polymer ; biodegradation ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The study reported describes an experimental biodegradable polymer ceramic composite with wax-like handling properties that was combined with 2.0 μg of recombinant human transforming growth factor beta (rhTGF-β1). The polymer/rhTGF-β1 combination was introduced into standard-sized calvarial defects in rabbits to evaluate biodegradability, biocompatibility, hemostasis control, and bone promotion. The experimental wound model was a standard-sized circular calvarial defect 8 mm in diameter. The experimental design included 24 skeletally mature New Zealand white rabbits divided evenly between two time periods (6 and 12 weeks) and among three experimental treatments (untreated defects and defects treated with polymer with or without rhTGF-β1). Evaluations consisted of clinical examinations, standardized radiography, radiomorphometry, as well as histology and histomorphometry. Data were analyzed by an Analysis of Variance (ANOVA) and Fisher's Protected Least Significant Difference test at each time period (level of significance p≤ 0.05). Radiomorphometry data indicated that standard-sized defects treated with the wax-like polymer alone and the polymer plus 2.0 μg of TGF-β1 were significantly more radiopaque than control sites at both 6 and 12 weeks. Histomorphometric data revealed the amount of new bone was significantly greater at 6 weeks in the polymer plus 2.0 μg of TGF-β1 and in the control group than in the polymer alone. Moreover, at 12 weeks, there was significantly more new bone in the control than in either the polymer alone or the polymer plus 2.0 μg of TGF-β1. We speculate the incomplete biodegradation of the polymer ceramic composite contributed to the radiopacity and may have retarded osseous regeneration. It is important that the bone wax-like polymer material was biocompatible and acted as a hemostatic agent. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 584-592, 1998.
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    Comparative histological evaluation of new tyrosine-derived polymers and poly (L-lactic acid) as a function of polymer degradation (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 41 (1998), S. 443-454 
    Details
    ISSN: 0021-9304
    Keywords: poly(lactic acid) ; subcutaneous implantation ; tyrosine-derived polymers ; poly(DTE carbonate) ; poly(DTE adipate) ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Previous studies demonstrated that poly(DTE carbonate) and poly (DTE adipate), two tyrosine-derived polymers, have suitable properties for use in biomedical applications. This study reports the evaluation of the in vivo tissue response to these polymers in comparison to poly(L-lactic acid) (PLLA). Typically, the biocompatibility of a material is determined through histological evaluations as a function of implantation time in a suitable animal model. However, due to changes that can occur in the tissue response at different stages of the degradation process, a fixed set of time points is not ideal for comparative evaluations of materials having different rates of degradation. Therefore the tissue response elicited by poly(DTE carbonate), poly(DTE adipate), and PLLA was evaluated as a function of molecular weight. This allowed the tissue response to be compared at corresponding stages of degradation. Poly(DTE adipate) consistently elicited the mildest tissue response, as judged by the width and lack of cellularity of the fibrous capsule formed around the implant. The tissue response to poly(DTE carbonate) was mild throughout the 570 day study. However, the response to PLLA fluctuated as a function of the degree of degradation, exhibiting an increase in the intensity of inflammation as the implant began to lose mass. At the completion of the study, tissue ingrowth into the degrading and disintegrating poly(DTE adipate) implant was evident while no comparative ingrowth of tissue was seen for PLLA. The similarity of the in vivo and in vitro degradation rates of each polymer confirmed the absence of enzymatic involvement in the degradation process. A comparison of molecular weight retention, water uptake, and mass loss in vivo with two commonly used in vitro systems [phosphate-buffered saline (PBS) and simulated body fluid (SBF)] demonstrated that for the two tyrosine-derived polymers the in vivo results were equally well simulated in vitro with PBS and SBF. However, for PLLA the in vivo results were better simulated in vitro using PBS. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 41, 443-454, 1998.
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    Biocompatibility study of a biological tissue fixed with a naturally occurring crosslinking reagent (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 42 (1998), S. 568-576 
    Details
    ISSN: 0021-9304
    Keywords: biological tissue ; crosslinking reagent ; genipin ; subcutaneous implant ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A recognized disadvantage of the currently available chemical reagents used to fix bioprostheses is the potential toxic effects a recipient may be exposed to from residues. It is therefore desirable to provide a crosslinking reagent that is of low cytotoxicity and can form stable and biocompatible crosslinked products. To achieve this goal, a naturally occurring crosslinking reagent - genipin - was used by our group to fix biological tissues. Genipin can be obtained from its parent compound geniposide, which can be isolated from the fruits of Gardenia jasminoides ELLIS. In our previous feasibility study, it was found that the cytotoxicity of genipin is significantly lower than both glutaraldehyde and an epoxy compound. Additionally, it was shown that genipin can form stable crosslinked products. The present study further investigates the biocompatibility of a genipin-fixed porcine pericardium implanted subcutaneously in a growing rat model. The fresh, glutaraldehyde-, and epoxy-fixed counterparts were used as controls. It was noted that the inflammatory reaction of the genipin-fixed tissue was significantly less than its glutaraldehyde- and epoxy-fixed counterparts. Also, the genipin-fixed tissue has tensile strength and resistance against in vivo degradation comparable to the glutaraldehyde-fixed tissue. Additionally, the calcium content of the genipin-fixed tissue measured throughout the entire course of the study was minimal. Nevertheless, further study in calcification for the genipin-fixed tissue should be conducted in a blood-contact environment. The results obtained in this subcutaneous study indicate that genipin is a promising crosslinking reagent for biological tissue fixation. However, further durability testing in vitro and in vivo are needed to determine the relative functional merits of this new crosslinker. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 42, 568-576, 1998.
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    Behavior of bone marrow cells cultured on three different coatings of gel-derived bioactive glass-ceramics at early stages of cell differentiation (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 42 (1998), S. 433-442 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; glass-ceramic ; bone marrow cells ; osteoblast ; osteoclast ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Previous studies have shown different macrophage responses to three compact pellets (with slightly different chemical composition) of gel-derived bioactive glass-ceramics of the CaO-P2O5-SiO2 system. In the present study primary bone marrow cells directed in vitro to form osteoblastic or osteoclastic cells were cultivated on glass slides coated by these three glass-ceramics. Glass slides were used as controls. In osteoblastic cultures alkaline phosphatase activity varied, depending on the type of coatings. Northern analysis showed high mRNA expressions of bone-related proteins on both the glass-ceramics and control glass. Mineralized nodules were not formed on the control glass, but coating glass slides with the glass-ceramics promoted mineralization without any substantial differences between the types of coatings. In osteoclastic cultures, the normal morphology of tartrate resistant acid phosphatase-positive multinucleated cells on standard culture plates was altered on the control glass and the glass-ceramics. The number of these cells differed, depending on the type of coatings, with no particular differences in the arrangement of F-actin by these cells. These analyses demonstrate complete biocompatibility of the glass-ceramic coatings but not the control glass, on which the cells failed to form mineralized nodules. The phenotype expression of the cells appeared to be influenced by microstructure, surface roughness, and the general character of the coatings rather than their surface reactivity. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 42, 433-442, 1998.
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    The effects of calcium phosphate particles on the growth of osteoblasts (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 37 (1997), S. 324-334 
    Details
    ISSN: 0021-9304
    Keywords: biocompatibility ; calcium phosphate ; particle ; osteoblast ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: With advances in ceramics technology, calcium phosphate bioceramics have been applied as bone substitutes for several decades. The focus of this work is to elucidate the biocompatibility of the particulates of various calcium phosphate cytotoxicities. Four different kinds of calcium phosphate powders, including β-tricalcium phosphate (β-TCP), hydroxyapatite (HA), β-dicalcium pyrophosphate (β-DCP), and sintered β-dicalcium pyrophosphate (SDCP), were tested by osteoblast cell culture. The results were analyzed by cell count, concentration of transforming growth factor-β1 (TGF-β1), alkaline phosphatase (ALP), and prostaglandin E2 (PGE2) in culture media. The changes were most significant when osteoblasts were cultured with β-TCP and HA bioceramics. The changes in cell population of the β-TCP and HA were quite low in the first 3 days, then increased gradually toward the seventh day. The changes in TGF-β1 concentration in culture medium inversely related to the changes in cell population. The ALP titer in the culture media of the β-TCP and HA were quite high in the first 3 days, then decreased rapidly between the third and seventh days. The concentrations of PGE2 in the culture media tested were quite high on the first day, decreased rapidly to the third day, and then gradually until the seventh day. The changes in the β-DCP and SDCP were quite similar to those of HA and β-TCP but much less significant. We conclude that HA and β-TCP have an inhibitory effect on the growth of osteoblasts. The inhibitins effects of the HA and β-TCP powders on the osteoblast cell cultures possibly are mediated by the increased synthesis of PGE2. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 324-334, 1997.
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    New anionic polyelectrolyte hydrogel for corneal surgery (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 37 (1997), S. 548-553 
    Details
    ISSN: 0021-9304
    Keywords: hydrogel ; biocompatibility ; permeability ; complement activation ; AN-69 dialysis membrane ; synthetic biopolymers ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A new high-water-content (78%) anionic polyelectrolyte hydrogel was obtained by phase inversion (demixion) of a polymer solution containing 9.0% poly(acrylonitrile sodium methallylsulphonate), 85.0% dimethylformamide, and 6.0% saline solution (0.9% NaCl). The hydrogel is permeable to water, saline, urea, creatinine, glucose, human albumin, and saline-dissolved oxygen. Investigation of the interactions between human serum and surfaces prepared with the new yielded hydrogel, compared to serum interaction with silica-free silicone (RTV), regenerated cellulose (Cuprophan), MMA/PVP copolymer (Lidofilcon), PMMA (Perspex), PTFE (Gore-Tex), and poly(acrylonitrile sodium methallylsulphonate) hemodialysis membrane (AN-69), showed the hydrogel and hemodialysis membrane (both prepared with AN-69 copolymer) to be the only materials devoid of complement (C′)-activating ability. © 1997 John Wiley & Sons, Inc. J. Biomed Mater Res, 37, 548-553, 1997.
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    Human osteoblast-like cells (MG63) proliferate on a bioactive glass surface (1997)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 37 (1997), S. 394-400 
    Details
    ISSN: 0021-9304
    Keywords: Bioglass® ; tissue culture ; biocompatibility ; bone ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Bioglass®, a resorbable glass, previously has been evaluated as a bone graft substitute using cells of animal origin. Limited information is available on its effect on human cells. The objective of this study was to test the hypothesis that Bioglass® supports viability and proliferation of human bone cells. As a prototype of human bone cells, the osteoblast cell line MG63 was used and propagated on Bioglass® disks. MG63 cells also were seeded onto disks made of titanium (Ti-6Al-4V) and of cobalt chrome (Co-Cr-Mo) alloys. The number of viable cells recovered was similar for Bioglass®, titanium, and polystyrene control surfaces. Significantly fewer cells were recovered from CoCr (P 〈 0.05) compared to Bioglass®, Ti-6 Al-4v, and polystyrene surfaces. The proportion of cells undergoing DNA synthesis, estimated by thymidine uptake, was significantly greater on Bioglass® and titanium surfaces (P 〈 0.05) than on the CoCr surface. There were detectable differences in cell morphology on these biomaterials. Functional capacity was tested by assay of osteocalcin production and no differences were detectable among the different biomaterials. This study supports the hypothesis that 45S5 Bioglass® provides a favorable environment for human osteoblast proliferation and function. Bioglass® may have clinical potential as a bone graft substitute, a bioactive grout, or an implant coating for promoting bony ingrowth in uncemented prostheses. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 394-400, 1997
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    The interface of bone microstructure and an innovative coating: An X-ray diffraction study (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 40 (1998), S. 86-91 
    Details
    ISSN: 0021-9304
    Keywords: X-ray diffraction ; ceramic ; external fixation ; coating ; biocompatibility ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The in vivo compatibility and degradation aspects of an innovative coating to be sprayed onto titanium implants were investigated. The surface of fluorinated apatite (fHA), consisting of fluorhydroxyapatite plasma sprayed in a vacuum atmosphere, was treated with carbonate to improve its biological compatibility. fHA coating was compared with titanium implants coated (a) with hydroxyapatite (HA) by the traditional plasma spraying, and (b) with titanium oxide (TiOx). Screw-shaped implants were inserted in the cortical bone of sheep tibiae. X-ray diffraction (XRD) analysis of bone tissue and coatings was carried out at 2, 4, 12 and 36 weeks after surgery. The crystallographic habit of the implant-facing bone, as well as the structural stability of the coating, were evaluated. For each time period and type of ceramic bone apatite lattice at the interface, no significantly different reference apatite lattice and no foreign peak were recorded. Two weeks after implantation, the bone at the interface was strongly unmineralized in all samples; after 4 weeks, poorly mineralized bone microareas decreased. At 12 weeks, the newly formed bone tissue at the interface with both the new coating and HA coating was shown to be fully mineralized; this crystallographic habit was retained at 36 weeks, when particle release from the tested material was lower compared to the controls. The XRD pattern of bone apatite surrounding the coating particles was unmodified. The innovative coating did not alter the mineralization process at the interface. It improved implant osteointegration, mainly due to a limited release of particles. Consequently, clinical performance of external fixation treatment could be improved by modifying the chemical composition of the implant surface. © 1998 John Wiley & Sons, Inc. J Biomed Mater Res, 40, 86-91, 1998.
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    Effects of new machinable ceramic on behavior of rat bone cells cultured in vitro (1998)
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 43 (1998), S. 215-225 
    Details
    ISSN: 0021-9304
    Keywords: enstatite ; biocompatibility ; in vitro ; osteoblasts ; Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The behavior of cultured rat bone cells growing on modified polyethylene terephthalate (mPET), glass, and machinable ceramic substrates containing enstatite (MgO, SiO2) and glass (CaO-P2O5-Al2O3) was studied. Cell attachment was measured directly on the substrates using an image analysis system. Electron microscopy observations and the MTT test revealed that cells are able to spread and proliferate on the material surface, keeping a healthy ultrastructure on all materials tested in the present study. After having colonized the surface of the materials, as shown by immunocytochemistry, the cells synthesize an osteoid-like matrix composed of osteocalcin, type I collagen, and fibronectin fibrils. The titration of alkaline phosphatase activity showed that the cells grown on the ceramic exhibit a greater osteogenic activity than those grown on controls (glass and mPET). This osteogenic activity results in a mineralization of the extracellular matrix in cultures on ceramic or plastic whereas only few calcium phosphate crystallite traces were revealed by Von Kossa staining on glass. Enstatite constitutes, therefore, an environment compatible with in vitro bone cell life. © 1998 John Wiley & Sons, Inc. J. Biomed Mater Res (Appl Biomater) 43: 215-225, 1998
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