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  • 1
    Electronic Resource
    Electronic Resource
    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 237-242 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Because of the recent trend in total hip arthroplasty to achieve direct contact of the endoprosthesis with cortical bone, comparison of bone apposition from cortical bone and cancellous bone was performed. The response of cortical and cancellous bone to hydroxylapatite was also compared. Implants in cortical bone demonstrated a higher interface shear strength and more bone apposition than those in cancellous bone over all time periods tested. Hydroxylapatite coating increased the interfacial shear and bone apposition in cortical bone at all time periods and in both the 3- and 6-week cancellous bone models. The potential effect of stress shielding (and subsequent bone resorption) by femoral stems ingrown with cortical bone is discussed. © 1995 John Wiley & Sons, Inc.
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  • 2
    Electronic Resource
    Electronic Resource
    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 249-258 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Ions released from implant surfaces are suspected of playing some role in osteolysis surrounding metal prostheses. To understand how ions may affect osteogenesis, previous work exposed osteogenic cells to metal ions to study acute cytotoxic responses. The purpose of this study was to assess the long-term effects of sublethal ion concentrations on osteogenic cell proliferation and function. Bone marrow stromal cells were harvested from juvenile rats and exposed to solutions of ions associated with Co-Cr-Mo and Ti-6Al-4V implants. Cells were cultured for up to 4 weeks and assayed for total protein, alkaline phosphatase, osteocalcin, and calcium. Other than V+5, none of the ions affected cell proliferation, indicating that the chosen concentrations were sublethal as desired. V+5 elicited delayed gross toxicity not previously observed during acute experiments. At the chosen concentrations, Co+2, Cr+6, Mo+6, and Co-Cr-Mo alloy elicited little effect on cell proliferation and moderate effects on matrix mineralization. Cultures exposed to Ti+4, Al+3, and Ti-6Al-4V alloy also showed no decrease in cell number, but did show near total suppression of osteocalcin secretion and matrix mineralization. These results suggest that ions released from Ti alloy implants may interfere with osteoblastic cell differentiation, contributing to periprosthetic osteolysis by impairing normal osteogenesis. © 1995 John Wiley & Sons, Inc.
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  • 3
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 267-282 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Crestal bone loss is observed around various designs of dental implants. A possible cause of this bone loss is related to the stresses acting on periimplant bone. To investigate the relationship between stress state and bone loss, two-dimensional finite element models corresponding to bucco-lingual and mesio-distal sections of canine mandibles with one of two designs of porous-coated dental implants were analyzed. A fully porous-coated design consisting of a solid Ti6A14V core had a porous coating over the entire outer surface of the implant component, while a partially porous-coated design had the porous coating over the apical two-thirds of the implant surface only. Occlusal forces with axial and transverse components were assumed to act on the implant with interface bonding and effective force transfer at all porous coat-bone interfaces and no bonding for the non-porous-coated regions. The results of the analysis indicated that at most implant aspects (buccal, lingual, mesial, and distal), the equivalent stresses in crestal bone adjacent to the coronal-most, non-porous-coated zone of the partially porous-coated implants were lower than around the most coronal region of the fully porous-coated implants. The region of lower stresses around the partially porous-coated implants corresponded to observed areas of crestal bone loss in animal studies, suggesting that crestal bone loss in this case was due to bone disuse atrophy. A number of parameters of the finite element models were varied to determine the effect on the resulting stress fields and, therefore, possible long-term bone remodeling. Based on differences in observed bone structures by histological examination and results of finite element analyses with fully and partially porous-coated implants, an equivalent stress equal to 1.6 MPa was determined to be sufficient to avoid bone loss due to disuse atrophy in the canine mandibular premolar region. © 1995 John Wiley & Sons, Inc.
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  • 4
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
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  • 5
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A quantitative method of reporting surface degradation of the ultra-high molecular weight polyethylene (UHMWPE) tibial component from retrieved total knee replacements (TKR) was developed. Specific features include a qualitative assessment expressing the patterns in which the damage was detected as well as a quantitative summary of the observed degradation mechanisms. In addition, a method of measuring lower limb alignment changes with time is described and related to the observed damage patterns. Two case studies are presented. One case illustrated that changes in alignment resulted from factors other than wear. The damage observed on the tibial plateau appeared to occur subsequent to the changes in alignment. The second case illustrated that the wear of the UHMWPE tibial insert lead to the changes in the overall lower limb alignment. The methods described provide additional information regarding TKR failure mechanisms compared to reporting methods currently available. In particular, the collection of temporal alignment data at clinical follow-up visits enhanced the assessment of the retrieved TKR. © 1995 John Wiley & Sons, Inc.
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  • 6
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The purpose of this study was to determine whether small, phagocytosable particles of titanium alloy (Ti) and high-density polyethylene (HDPE) have an adverse effect on bone ingrowth. The bone harvest chamber (BHC) was implanted bilaterally in the proximal tibial metaphysis of six mature rabbits. The BHC has a transverse 1-mm wide pore providing a continuous canal through the chamber for tissue ingrowth. After an initial 6-week period for osseointegration of the BHC, the contents of the canal were harvested repeatedly at 3 weekly intervals. This could be done with the chamber in place, without disturbing its exterior surface or the surrounding bone. The carrier solution, 1% sodium hyaluronate (Healon) was implanted first. In subsequent implantations, Healon was mixed with particles of HDPE or Ti averaging 4.7 ± 2.1 and 3.0 ± 2.6 μm, respectively. The contralateral chamber was left empty and served as a control. The chambers were harvested repeatedly, alternating experimental and control sides. The sections from the control side, and those containing Healon alone demonstrated extensive trabecular bone in a fibrovascular stroma. The sections containing Ti alloy particles were qualitatively and quantitatively similar to the control sections and those containing Healon, except for the presence of small black granules of Ti alloy, dispersed in the fibrovascular stroma or phagocytosed by scattered macrophages. The sections containing HDPE particles were infiltrated and engulfed by mononuclear and multinuclear histiocytic cells in a highly fibrous stroma. The majority of the multinucleated cells present were interpreted as being foreign body giant cells. Less trabecular bone was seen in the HDPE group compared to the other groups. Using the parameters chosen for this experiment, it would appear that small, phagocytosable HDPE particles are more deleterious to net formation of bone compared to particles of Ti alloy. © 1995 John Wiley & Sons, Inc.
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  • 7
    Electronic Resource
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 55-64 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: This study deals with a three-point flexure test for the metal-ceramic bond involving geometrically simple specimens (alloy strips partly coated with ceramic) that can be fabricated with reasonable expenditure and sufficient reproducibility. The calculation of the stress distribution in such specimens with the aid of the finite-element method (FEM) is presented. The aim of this numerical analysis is: to investigate the stress distribution in a ceramometallic specimen with dimensions that, in a large number of experiments, have proven to lead to debonding at one end of the ceramic veneer instead of a crack in the middle of the veneer; and to assign a bond strength to the measured critical bending force that takes into account the influence of the Young's modulus of the alloy as well as a possible deviation of the thickness of the metal substrate from the standard value. Bond strength values of a variety of metal-ceramic combinations are demonstrated. These experimental results demonstrate the reproducibility of the test method as well as its sensitivity to diverse parameters. The presented method is proposed as an alternative to another flexure bond test nominated for international standard. In this test ceramometallic strips are bent over a rod to a 90° angle of the specimen ends, subsequently flattened, and the fracture surface visually inspected for adherence of the ceramic to the alloy substrate along the predominant part of the middle third of the specimen. It is clear that such a test can at most deliver qualitative results. © 1995 John Wiley & Sons, Inc.
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  • 8
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 87-87 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
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  • 9
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
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  • 10
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 105-108 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Four different brands of bone cement (Palacos R, Simplex P, Sulfix, CMW 1) were tested for exothermic changes during polymerization at atmospheric pressure and under partial vacuum of 0.2 bar. Palacos R was also mixed at four pressure levels (1.0, 0.2, 0.12, and 0.05 bar). The peak temperature in the bone cement was 46 to 124 °C, depending on the measuring point. There was no difference in peak temperature or duration of temperature increase above 50 °C during the curing of cement whether mixed at atmospheric pressure or under partial vacuum at different pressure levels. © 1995 John Wiley & Sons, Inc.
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  • 11
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 99-104 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A major problem in fracture treatment by external fixation is screw loosening, which often results in reduced stability and can lead to prolonged treatment. A load-carrying experiment was conducted to determine whether coating implants with bioactive hyroxyapatite (HA) increases screw stability. Twelve HA-coated ASIF screws with 3 different macroporosities were inserted in 12 sheep that had already been fitted with a 6-pin external fixator for the treatment of a tibial osteotomy. The same number of uncoated polished steel screws served as controls. Although initial stability was not different for HA-coated screws, average removal torque after a 9-week implantation period increased with increasing macroporosity of the HA coating (p 〈.002). Instability of some screws was accompanied by histologic findings of cartilagenous tissue and proliferation of periosteal callus. Near the threads in the tibial cortex and in the shaft area of the screw were seen large numbers of HA particles that had been sheared off during implantation as well as during screw removal because of high contract forces between the HA coating and bone. Particulate debris of HA particles as well as the release of small bone fragments during explantation is likely to be unavoidable since HA adherence to bone is greater than adherence to steel after several weeks of implantation. © 1995 John Wiley & Sons, Inc.
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  • 12
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 125-128 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Porous polyurethane foams were prepared from Daro foam components with a range of mechanical properties to simulate human trabecular bone. Ratios of 10.0:5.0, 10.0:7.9, and 10.0:10.0 isocyanate to resin were mixed, cured, and cut into cubes. Properties were determined from uniaxial compression to 50% of the original cube height at a strain rate of 1.2 mm/s. Electron microscopy was used to characterize the foam structure. Average compressive yield stress values, ultimate compressive stresses, and elastic moduli ranged from 4.44 to 2.79, 5.61 to 3.28, and 134.0 to 110.1 MPa, respectively, for the three formulations. The foam materials showed a similar morphology of spherical bubbles, and the average bubble size tended to decrease as the ratio of isocyanate to resin increased even though the bubble size differences were not statistically significant. The results indicate that large blocks of foam can be prepared with consistent mechanical properties simulating a range of trabecular bone properties so that implants can be tested for various patient populations. © 1995 John Wiley & Sons, Inc.
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  • 13
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 129-135 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Bioabsorbable films show promise in preventing postoperative interfacial tissue adhesion. Absorbable polymers in film form are generally more sensitive to chemical environments, due to their large surface area to volume ratio. The in vivo environment contains lipids such as cholesterol, triglycerides, and phospholipids, which are known to affect the degradation of permanent and absorbable polymeric biomateials. Preliminary investigations of in vitro lipid exposure of bioabsorbable poly(ortho ester) (POE) films for implant use are described. POE has been studied previously for use in controlled drug delivery and fracture fixation. Six-week in vitro exposure of 65:35 POE films to a cholesterol emulsion (1 g/L) showed no apparent difference in hydrolytic degradation rates of mechanical properties or mass loss compared to deionized water exposed films. Decreases of 28 and 6% in inherent viscosity were observed after 5 weeks for cholesterol and deionized water exposed films, respectively, suggesting cholesterol may have some effect. Further examination of the data, due to sample variation, revealed that clear, uniform films showed only minor changes in mass loss and mechanical properties after 6 weeks in either of the in vitro media. But slightly cloudy films possessing microscopic bubbles showed accelerated degradation in both media, indicating the effect of cholesterol was inconclusive due to sample variation. Control of the microbubble formation process could have utility in controlling hydrolytic degradation of POE films. © 1995 John Wiley & Sons, Inc.
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  • 14
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 171-174 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Grit blasting is a common procedure of roughening surfaces to promote physical attachment of porous coatings, but it has been shown to reduce fatigue strength. Shot peening is known to increase fatigue strength by inducing compressive surface stresses; however, it is not known how subsequent grit blasting affects these benefits. This study examines the endurance limits, Se, of ELI grade Ti-6A1-4V specimens under rotating cyclic bending, including polished (control); belted and beaded; belted, beaded, and grit blasted; and belted, beaded, shot peened, and grit blasted. Belting and beading resulted in a slight increase in Se; grit blasting caused a 15% reduction in Se from polished. Fifty percent of this reduction was recovered when shot peening preceded grit blasting, suggesting that residual compressive surface stresses, induced by peening, were not eliminated by the blast process. Roughness averages and RMS values did not correlate with Se trends. SEM results showed classical fatigue fractures, consistent with surface crack initiation. © 1995 John Wiley & Sons, Inc.
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  • 15
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 175-183 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Concentrated fibrinogen was prepared from whole blood by cryoprecipitation or chemical precipitation and combined with thrombin to make fibrin glue (FG). Surgical application of FG include control of bleeding, adhesion of tissues, and sealing of tissue defects. The purpose of this study was to compare cryoprecipitation (cryo) of fibrinogen to precipitation using ethanol, ammonium sulfate (AS), and poly(ethylene glycol) (PEG). Our results suggest that AS precipitation is as effective as cryo in yielding fibrin glues with high bond strengths and is more effective than ethanol and PEG precipitation. In addition, the volume of FG per milliliter of plasma is greater after AS precipitation than after a single freeze-thaw cycle. It is concluded that AS is an efficient means for preparing FG from autologous blood. © 1995 John Wiley & Sons, Inc.
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  • 16
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 185-190 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Biological materials have been used as prosthetic devices such as heart valves, vascular grafts, and pericardial patches. These biological materials have to be fixed with crosslinking reagents and sterilized subsequently before they can be implanted in humans. Recently, a new crosslinking reagent, epoxy compound, has been used to fix bioprostheses. In this fixation technique, heparin may be ionically bound on the tissue surface. It has been shown that the amount of heparin bound to the tissue surface is proportional to the quantity of protamine impregnated in the biological tissues. However, it is not known if the impregnation of protamine will affect the crosslinking density of the biological tissues. This study was designed to compare the crosslinking densities of the epoxy compound fixed biological tissues with or without heparinization. Fresh porcine aortic valves procured from a slaughter house were first impregnated in various concentrations of protamine sulfate (0, 0.5, 1.0, or 1.5%) for about 30 min. The porcine aortic valves were then crosslinked in a 4% epoxy compound solution (Denacol® EX-313). The porcine samples were taken out at various elapsed fixation periods: 18, 25, 48, 72, 96, and 120 h. Finally, the crosslinked porcine aortic valves were heparinized in a 0.5% sodium heparin solution for about 1 h. The crosslinking densities of the porcine leaflet and the aortic wall of each sample were determined by measuring their shrinkage temperatures. It was revealed that the impregnation of various concentrations of protamine did not seem to significantly alter the shrinkage temperatures of the porcine leaflet and the aortic wall throughout the entire fixation process (p 〉 0.05). This indicated that the impregnation of protamine did not significantly change the crosslinking density of the biological tissues. However, it was found that protamine tended to discolor the tissue and to stiffen the porcine leaflet and the aortic wall. Although the impregnation of protamine did not seem to significantly alter the crosslinking density of the epoxy compound fixed biological tissues, the increase of the stiffness of the heparinized tissues may cause concerns in some clinical applications. © 1995 John Wiley & Sons, Inc.
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  • 17
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 209-211 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Reducing the porosity of bone cement substantially strengthens the cement in fatigue. However, concern has been raised that reducing the porosity of the cement would increase the shrinkage of the cement and thus compromise the cement-bone interface. We measured diametral shrinkage of cement mantles prepared with and without centrifugation of the cement. Four cement preparations (centrifuged and uncentrifuged mixed with monomer at either room temperature or 0°C) were used to form cement mantles of four different thicknesses (2, 4, 6, and 8 mm) around a stainless steel rod. We conclude that porosity reduction dramatically increases the fatigue strength of bone cement without substantially changing the diametral dimensions of the polymerized cement when studied in the shape and volume of a cement mantle that would be used for total hip replacement. © 1995 John Wiley & Sons, Inc.
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  • 18
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    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 6 (1995), S. 225-230 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The distal migration of polyethylene wear debris appears to be a major cause of loosening and osteolysis of cementless total hip arthroplasties. The use of modern cementing techniques, circumferential porous or hydroxyapatite (HA) coating has been advocated as a means of preventing access of the particles to the bone-implant interface. The purpose of this study was to compare the ability of different methods of implant fixation to prevent wear debris migration. Three each of smooth, porous-coated, HA-coated, and cemented hemiarthroplasties were implanted in the right hip of 12 dogs. Polyethylene particles were injected into the hip once a month for 4 months and then the femurs were sectioned. The percentage bone ingrowth was 8% for the smooth, 38% for the porous, and 83% for the HA-coated sections. Infiltration of the interface membrane by histiocytes containing polyethylene particles, and endosteal scalloping or osteolysis were found on all sections of the smooth prostheses. No particles or osteolysis were found on any sections of the other three types of prostheses. Capsular and lymph node sections from all dogs revealed histiocytic infiltration with numerous polyethylene particles present. It is concluded that the use of cement, porous, or HA coating prevents or delays access of the polyethylene wear debris to the bone-implant interface. No one of these methods of fixation proved more advantageous in the 5-month limit of this study. © 1995 John Wiley & Sons, Inc.
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  • 19
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Thrombosis remains a significant and potentially catastrophic complication of polyethylene terephthalate (Dacron) prosthetic vascular graft implantation. Numerous attempts have been made to create a novel surface that reduces the adverse effects of blood interaction with the material. The purpose of this study was to create reactive groups on Dacron without significantly altering the chemical and physical properties of the biomaterial. These groups would then serve as “anchor sites” for covalent attachment of the blood protein albumin to the surface, thus creating a more biocompatible surface. Denier reduction, an established textile chemistry procedure that creates carboxyl groups on the fiber surface via hydrolysis of the material, was performed at 100°C using sodium hydroxide concentrations of 0.5, 1.0, 2.5, and 5.0% (treated materials referred to as 0.5% hydrolyzed etc.). Tensile strength determination of hydrolyzed materials revealed no statistically significant difference in material strength between control, 0.5, and 1.0% hydrolyzed materials; the 2.5 and 5.0% hydrolyzed materials had significant strength loss as compared to the controls. Significant fiber weight loss occurred in the 1.0, 2.5, and 5.0% hydrolyzed Dacron segments. The 0.5% hydrolyzed material did not have any significant weight loss. Covalent linkage of 125I-albumin to these modified materials using the crosslinker 1-ethyl-3-(3-dimethyl aminopropyl)-carbodiimide hydrochloride (EDC) resulted in the 0.5% hydrolyzed material having the greatest protein binding (330 ng/mg Dacron, 2.4-fold greater than control). Incubation of the 0.5% hydrolyzed material with EDC and various concentrations of 125I-albumin resulted in the 14.80 m̈M solution permitting the greatest binding per milligram Dacron (330 ng/mg Dacron). Scanning electron microscopy, performed blindly, revealed no change in the 0.5% hydrolyzed Dacron as compared to untreated Dacron. The 5.0% hydrolyzed Dacron, however, had noticeable structural damage on the outer periphery of the fiber surface. Observation of the untreated Dacron with nonspecifically bound albumin showed scattered areas of albumin adherent to the fiber surface whereas covalent linkage of albumin to the 0.5% hydrolyzed Dacron via EDC crosslinking showed numerous albumin moieties on each fiber. This study demonstrates that a clinically accepted biomaterial (Dacron) can be chemically modified, without significantly altering the physical and chemical characteristics of the biomaterial, in order to covalently bind albumin to the fiber surface. Thus, these results serve as foundation for creating potential novel biomaterials without significantly altering the properties of the original biomaterial. © 1995 John Wiley & Sons, Inc.
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  • 20
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    Journal of Applied Biomaterials 6 (1995), S. 19-26 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The use of multiple-component systems in orthopedic surgery gives the surgeon increased flexibility in choosing the optimal implant, but introduces the possibility of interfacial corrosion. Such corrosion could limit the longevity of prostheses due either to tissue reactions to corrosion products, or to device failure. The incidence and nature of corrosion of modular total hips was evaluated in a consecutive series of 79 retrieved implants from University Hospitals of Cleveland. Surfaces were examined with stereo- and scanning electron microscopy. Several laboratory studies were undertaken to examine mechanisms that might contribute to the initiation of corrosion. The first set of experiments investigated the effect of head neck extension; the second study looked at the effect of material combinations on fretting corrosion and crevice corrosion. Analysis of retrieved implants demonstrated that fretting corrosion played a major role in the initiation of interface corrosion, and that a correlation existed between corrosion and length of neck extensions. Laboratory studies showed that longer head neck extensions may be more susceptible to fretting corrosion because of an instability at the interface. Short-term mixedmetal corrosion studies demonstrated that the coupling of cobalt and titanium alloys did not render the interface more susceptible to corrosion. It is hypothesized that fretting corrosion contributes to the initiation of modular interface corrosion, and that the problem can be reduced by design changes that increase the stability of the interface. © 1995 John Wiley & Sons, Inc.
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  • 21
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    Journal of Applied Biomaterials 6 (1995), S. 35-41 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: In ligament replacement cases where the artificial ligament has worn and partially or totally ruptured, the released wear particles have been associated with a chronic synovitis that inhibits integration of the ligament and contributes to the ultimate failure of the device. In this study, the biological response to ligament wear particles from nine different artificial ligaments was quantitatively evaluated in vivo. Wear particles, the majority of which were 〈7 μm, were generated in vitro. These particles were injected into rabbit knee joints, and the biological response as well as the systemic migration of the particles were evaluated histologically after 4 weeks. The extent of the inflammatory reaction to the ligament wear particles was found to be significantly (p 〈 0.05) influenced by the type of material implanted. No particles were found in the regional lymph nodes or in the spleen, liver, kidney, or lung. © 1995 John Wiley & Sons, Inc.
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  • 22
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    Journal of Applied Biomaterials 6 (1995), S. 43-53 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Two experimental methods for restoring flexor tendon sheath integrity and preventing adhesions around traumatized flexor tendons utilizing artificial tendon sheaths made of either hydroxyapatite (HAp) or alumina were studied in a flexor tendon-trauma model and compared to a standard tendon sheath repair and a control. Eighty toes were divided equally into a control group, a sheath repair group, an HAp group, and an alumina group. Profundus tendons in zone II were divided and repaired after sublimis excision in all groups. In the sheath repair group, the flexor sheath was also repaired after suturing the tendon. In artificial sheath groups, sheaths made of HAp and alumina were placed over the repair sites to protect them from the surrounding tissues. In the control group, after repairing the tendon, the flexor sheath was excised and no artificial sheaths were used. Each toe was immobilized in a plaster cast for 3 weeks. After three weeks, the plaster cast was removed followed by the removal of the sheaths in the artificial sheath groups through a small incision in the skin in zone II. Active mobilization was encouraged in each group. Postoperative adhesions were examined at 3, 6, 9, and 12 week intervals by using light microscopic techniques. To further explore the effects of artificial sheaths on tendon healing, transmission electron microscopy was done for the HAp and alumina groups at 3, 6, and 12 week intervals. Results demonstrated decreased severity of postoperative adhesions in the HAp as well as in the alumina groups in comparison with the sheath repair and controls. A space resembling the fibro-osseous canal was formed around the tendon after removing the sheaths. This space remained patent until 12 weeks, 9 weeks after removing the sheaths, and a newly formed tendon sheath-like structure lined by synovial cells and with a peritenon-like structure over the tendon surface was observed. In the sheath repair and control groups, the severity of adhesions was decreased with the passage of time, to some extent due to unrestricted mobility. However, a newly formed tendon sheath or peritenon-like structure was not observed. Electron microscopic studies confirmed good healing at the suture in the HAp and alumina groups with no evidence of necrosis. These results are qualitative in nature as no statistical tests were performed. From these results we conclude that if the tendon is separated from the surrounding granulation tissue by a barrier with good biocompatibility, the tendon can heal with fewer adhesions. Artificial sheaths may be used to reduce adhesions in severe injuries of the hand where postoperative immobilization is necessary due to fractures, vascular, or nerve injuries. © 1995 John Wiley & Sons, Inc.
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  • 23
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    Journal of Applied Biomaterials 6 (1995), S. 65-68 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A natural poly(hydroxybutyrate-co-9% hydroxyvalerate) copolyester was processed into a three-dimensional porous foam structure by salt leaching/solvent casting with previously sieved sodium chloride salts. Laboratory-built P(HB-9% HV) foams and commercial collagen sponges were cut into small rectangular specimens, sterilized, and prewetted using ethanol, rinsed with Dulbecco's minimum essential medium + 10% serum culture media, and seeded with fibroblasts isolated from canine anterior cruciate ligaments. The fibroblast cultures into such porous substrates were performed from 0 to 35 days by incubation (5% CO2) at 37°C. It demonstrated that the P(HB-HV) sustained a cell proliferation rate similar to that observed in collagen sponges, up to at least 35 days, with a maximal cell density on the day 28 in culture. On the other hand, the P(HB-HV) materials kept their structural integrity during the culture period while the collagen foams contracted greatly. Further, the total protein production after 4 weeks in culture was found to be twice as high (190 ± 10%) in the P(HB-9% HV) foam than in the collagen foam. Porous P(HB-HV) materials appear to be adequate polymeric substrates for cell cultures. However, further evaluations are still required to confirm such preliminary results. © 1995 John Wiley & Sons, Inc.
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  • 24
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    Journal of Applied Biomaterials 6 (1995), S. 69-74 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Neodymium-iron-boron magnets are being increasingly used in orthodontic and orthopedic appliances. The purpose of this study was to investigate the in vitro cytotoxicity of these new “super” magnets. A modified agar overlay technique was performed using both L929 mouse fibroblasts and adult human oral mucosal fibroblasts. The neodyium-iron-boron magnets were tested in the following forms: uncoated magnetized, uncoated demagnetized, parylene coated demagnetized, and parylene coated magnetized. Results revealed that uncoated magnetized, uncoated demagnetized, and parylene coated magnetized were cytotoxic to both L929 mouse fibroblasts and human oral mucosal fibroblasts. However the parylene coated demagnetized neodymium magnets were only cytotoxic to the human mucosal fibroblasts. This study supports the hypothesis that these are cytotoxic effects of possibly corrosion products and of magnetism. The specific toxic effects of parylene were not examined in this present study. Statistical analysis (Mann-Whitney U-test, p = 0.014) suggested that, in this experiment, the human oral mucosal fibroblasts were more sensitive to the effects of these rare earth magnets. With the evidence of a biological effect, the use of implanted magnets must at present be limited until the safety can be assured. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995) 
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    Keywords: Chemistry ; Polymer and Materials Science
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  • 26
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    Journal of Applied Biomaterials 6 (1995), S. 75-83 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A new bone cement was developed with the purpose of reducing the adverse biological effects during cementation of implants. This bone cement is characterized by lower exotherm, low release of monomer, low residual content of monomer, and retained physical properties. The essential innovation was substitution of half of the methylmethacrylate (MMA) in the monomer with long chain, high molecular weight, less volatile, and less soluble methacrylates (n-decylmethacrylate, isobornyl-methacrylate), as well as alteration of the accelerator system to a mix of dihydroxypropyl-p-toluidine and N,N-dimethyl-p-toluidine. The powder contains butyl-methacrylate-MMA copolymers. These measures lower the glass-transition temperature, and permit more complete mixing in an integrated package, mixing, and delivery system consisting of a vacuum packed, double chamber pouch. The porosity was reduced to about 2% and the largest voids measured 0.1 mm. The polymerization exotherm was reduced to 58 °C. The compressive strength was 82 MPa, the four-point bending strength 55 MPa, the flexural modulus 2.24 GPa, the tensile strength 32 MPa, and the shear strength 36 MPa. The fracture toughness was 0.89 MPa √cm. These mechanical properties together with the fatigue life were on level with manually mixed, conventional PMMA bone cements. © 1995 John Wiley & Sons, Inc.
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    Notes: A Synthetic composite bone graft material, composed of fibrillar collagen, hydroxyapatite, and tricalcium phosphate, was evaluated in canine femoral shaft defects and compared to ungrafted defects and defects grafted with autogenous bone. The results of mechanical testing of the grafted femora in torsion at 1 year postoperatively were previously reported. This report details the histological and microscopic features of the graft sites. The results of this study suggest that the healing of the graft site is not yet complete at 1 year and that healing may be more complete in defects that received the synthetic graft as compared to ungrafted sites and autogenous bone graft. The bone tissue appears to respond to the graft particles as if they were bone particles. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 109-116 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The effects of metal ions released from orthopedic implants on nearby bone cells remain largely unknown. The purpose of this study was to examine the acute toxicity of metal ions on osteogenic cells derived from bone marrow. Bone marrow stromalcells were cultured with metal ions found in commonly used orthopedic implants, that is, Ti-6Al-4V, Co-Cr-Mo, and 316L stainless steel. Solutions of individual ions and combinations representing the alloy composition were prepared from atomic absorption standards and added to the cultures to give concentrations ranging from 50 ppb to 5o ppm. After a 48-h period of exposure to ions, the bone marrow cultures were examined for effects of cytotoxicity by measuring total cell number, total cell protein, and mitochondrial activity. Cr6+ was grossly cytotoxic; Co2+, Mo6+, Fe3+, and Ni2+ were moderately cytotoxic; and Ti4+, Al3+, V5+, and Mn2+ were minimally toxic, as determined by the assays used. Ion solutions representing Co-Cr-Mo and 316L stainless steel were moderately toxic; solutions representing Ti-6Al-4V were toxic at only the highest concentrations used. The observed cytotoxicity was time-dependent, with irreversible toxic effects being initiated following as short as a 3- to 6-hour exposure. These results show that metal ions associated with Co-Cr-Mo and 316L stainless steel are toxic to osteogenic cells at concentrations approximating those measured in the fibrous membrane encapsulating orthopedic implants. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 117-123 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The main function of the intervertebral disc is to transmit and attenuate compressive and torsional forces, and stabilize the intervertebral joint. Unfortunately, the disc may be displaced or damaged due to trauma or disease causing the nucleus to herniate and protrude into the vertebral canal or intervertebral foramen. Pressure on the spinal nerve may cause pain or paralysis in the area of its distribution. At present, the surgical procedures used to alleviate this condition include disc excision, and/or spinal fusion. A more desirable situation would involve removing the nucleus pulposus and part or all of the annulus fibrosis and implanting a suitable biofunctional equivalent. Such a prostheis should attenuate stresses and prevent abnormal stress at adjacent intervertebral joints. Maintenance of normal disc height would prevent impingement of the posterior facet joints and facet joint syndrome. In a previous companion paper (J. Applied Biomat. 5:125-132; 1994), the mechanical behavior of disc prostheses manufactured from fiber reinforced, elastomeric thermoset resins were examined. In order to develop devices which were more practical from a manufacturing standpoint and extremely reproducible, the fiber reinforced thermoset resins were replaced by multi-durometer thermoplastic elastomeric materials. In the present paper, the mechanical properties of thermoplastic multicomponent desings have been investigated. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 137-144 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Topics: Medicine , Technology
    Notes: The research field of biomaterials and surgical implants has matured to a point suggesting that a formal and comprehensive education is now required to handle all professional issues related to biomaterials and implant development. A professional curriculum is proposed for a discipline of biomaterials science and engineering on a graduate level. The curriculum includes the definition of an essential knowledge base and describes two track options for a study period of 3 years. Lists of prerequisites as well as required and suggested courses are presented and discussed. Continuing education courses are presented as examples. A quick vision of the immediate future of the field enforces the need for biomaterials professionals to take the lead in bringing the field into the next century. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995) 
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  • 32
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    Journal of Applied Biomaterials 6 (1995), S. 167-169 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A novel drug delivery system for osteomyelitis was developed using porous hydroxyaptite blocks (HA-b) loaded with antibodies by centrifugation. In the study, 10 mm3 HA-b was placed in a container and mixed with antibiotic solution; the antibiotic was then loaded into the pores of the HA-b by centrifuging at 1500 rpm for 15 min. Slow release of HA-b in both moist form and dried form (by heating at 160°C) was tested after loading with the antibiotic arbekacin sulfate (ABK), 1-N-(S)-4 amino-2-hydroxybutyryl dibekacin. To estimate the concentration of antibiotic, both forms of HA-b were placed in 3 mL of phosphate buffered saline (PBS), which was replaced every 48 h. In both groups, which were loaded with 70 mg ABK per one block of HA (concn 0.5 μg/mL) which is sufficiently high to control most pathogens, was maintained for 21 exchanges of PBS (after 42 days). Minimum inhibitory concentration for methicillin-resistant Staphylococcus aureus (MRSA), 3.13 μg/mL, was maintained until nine exchanges took place (after 18 days). The centrifugation method is wsimple, and driked ABK produced by heating loaded HA-b is particularly useful in clinical applications for osteomyelitis. © 1995 John Wiley & Sons, Inc.
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  • 33
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    Journal of Applied Biomaterials 6 (1995), S. 191-197 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: In this study, reinforced poly(L-lactic acid) (PLLA) fibers made by a dry-spinning/hot-drawing process were evaluated for use as a suture. The initial tensile strength of the PLLA fibers was lower than the initial tensile strength of the commercially available sutures: PDS, VicrylTM, silk, and Ethilon™. However, after 12 weeks immersion in a phosphate saline buffer at 37°C, PDS sutures have lower tensile strength than PLLA sutures and the tensile strength of Vicryl™ was unmeasurable because of fragmentation. Initially, PLLA fibers distinegrated into fibrils during degradation triggering an inflammatory response comparable to degradable multifilament sutures. However, the intensity of the inflammatory response against the PLLA fibers decreased and after 80 weeks implantation in the muscle layer of the abdominal wall of rats it was comparable to the one against Ethilon™. The inflammatory response against Ethilon™, which is considered to be nondegradable, increased in the same period, probably due to the change in shape. In practice, the handling characteristics of PLLA sutures are superior to the monofilament sutures like PDS and EthilonTM and comparable with the multifilament sutures like VicrylTM and silk. The knot security, but this remains to be investigated. It is concluded that dry-spun/hot-drawn (reinforced) PLLA fibers have the potential for use as long-term degradable suture material. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 203-208 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Applied Biomaterials 6 (1995), S. 223-223 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Applied Biomaterials 6 (1995), S. 213-218 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: The occlusion and stability of five synthetic plugs used to restrict the femoral canal prior to cemented arthroplasty was assessed. A model was employed consisting of a hollow wooden dowel to simulate the canal, with adapters fixed to both ends to accommodate cement insertion and pressurization, and to produce a closed distal cavity. Three different canal diameters within the range accommodated by the plug selected were employed to assess insertion force, distal pressure during both insertion and pressurization of acrylic cement, and plug migration and leakage for each device. There was a wide variation among plugs in the magnitudes of the force and distal pressure upon plug insertion. During cement pressurization, cement leakage and/or plug migration was noted in all trials, and either of these events resulted in pressure rises in the distal cavity. Most notably, differences of only 0.5 mm in the diameter of the canal resulted in marked changes in the occlusion and stability achieved. It is concluded that for the range of canal sizes anticipated intraoperatively, these synthetic plugs appear deficient to varying extents in their ability to occlude or remain stable in the intramedullary canal. © 1995 John Wiley & Sons, Inc.
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    Notes: The purpose of this study was to compare hydroxyapatite (HA)-coated titanium (Ti) and HA-coated cobalt-chrome (CoCr) implants in the distal femur of the rabbit by evaluating bone apposition and interfacial shear strength. Bilateral cylindrical implants with a plasma sprayed 50-m̈m thick HA coating were press-fit into the metaphyseal cancellous bone of the lateral femoral condyles in a transverse fashion, and the animals were sacrificed at 2, 4, and 8 weeks postimplantation. Mechanical strength of the interface between HA and bone was measured using the pushout method. For histologic analysis, the fractional linear extent of bone apposition was quantitated. No differences were found in the interfacial shear strength between the Ti and CoCr at any time period. The amount of bone apposition increased significantly at each time interval for both substrate metals, but there were no significant differences between the two substrates at any of the time periods studied. The HA-coated CoCr implants performed in a similar manner to the HA-coated Ti implants, both mechanically and histologically, suggesting that HA-coated CoCr implants deserve further study as a viable alternative to Ti for the biological fixation of total joint components in orthopaedic surgery. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 243-248 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Topics: Medicine , Technology
    Notes: Historically, pyrolytic carbon has been a material for cardiovascular applications, but it has several properties suited for orthopedic uses as well. Pyrolytic carbon has an elastic modulus similar to bone and is highly fatigue resistant, but has not been used in orthopedics because of poor fixation to bone. Plasma sprayed hydroxylapatite (HA) has significantly improved the bonding of bone to titanium alloy implants. The effect of plasma-sprayed HA on pyrolytic carbon implants was investigated in this study. Cylindrical samples were implanted through a single cortex in Beagle femurs. The animals were sacrificed after 8 weeks, and a mechanical push-out test was performed on the implants immediately after explantation. Samples were microradiographed, stained for histology, and examined histomorphometrically. Interface strength for each type of implant was calculated. Pyrolytic carbon showed almost no attachment strength with an average strength value of 1.59 MPa. HA-coated pyrolytic carbon (8.71 MPa) yielded the same interfacial strength as HA-coated titanium (8.71 MPa). Histology revealed that bone was in direct apposition to all implants, both HA coated and noncoated. Failures occurred between the core material and the coating, or within the coating, but not at the bone/HA interface. Histomorphometry results confirmed that the two types of HA-coated implants had more bone apposition than the uncoated pyrolytic carbon implants. It was concluded that a plasma sprayed HA coating significantly improves the bone fixation of pyrolytic carbon. © 1995 John Wiley & Sons, Inc.
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  • 39
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    Notes: Heparin oligosaccharides with different anticoagulant activities were prepared and immobilized onto pyrolytic carbon coated graphite (PC) heart valve materials commonly used in mechanical heart valve prostheses. Prior to immobilization, PC surfaces were modified by radio-frequency plasma polymerized N-vinyl-2-pyrrolidone (PPNVP) thin films (∼ 100 nm) and derivatized to provide surface hydroxyl groups. Cleaved, low affinity heparin (C-heparin) with factor Xa inhibition activity of 107 to 130 IU/mg, was prepared by partial deaminative cleavage of commercial crude heparin, and high-affinity heparin (HA-heparin) with factor Xa inhibition activity of 550 to 1000 IU/mg was prepared by fractionation of C-heparin using agarose-ATIII affinity chromatography. C-heparin and HA-heparin were immobilized to surface modified PC by reductive amination. Anticoagulant activity of the heparin immobilized surfaces was determined by chromogenic assay for the inhibition of factor Xa. Highest surface anticoagulant activity was measured on C-heparin immobilized surfaces (64.0 ± 7.3 mIU/cm2) compared with HA-heparin immobilized surfaces (27.2 ± 12.2 mIU/cm2), suggesting higher binding of C-heparin than HA-heparin on the modified PC surfaces. Immobilized surfaces were evaluated under dynamic flow conditions, by subjecting samples to shear stress of up to 206 dyn/cm2 in the presence of 5% albumin solution or human plasma. Anticoagulant activity of the immobilized heparin was retained, although reduced, and the modified surfaces showed evidence for protein resistance. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 283-288 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: The effect of sodium fluoride on the polarization resistance of titanium was investigated. Titanium plates were exposed to sodium chloride solutions with increasing fluoride concentrations. This was done at pH 7 and 4 at 37°C. The polarization resistance technique was chosen because it is the only electrochemical corrosion test procedure that allows sequential measurements of the same specimen and provides a quantitative basis to estimate corrosion currents unlike measurements of the potential. The results showed a large decrease in polarization resistance with increasing fluoride concentration at pH 4. The polarization resistance at pH 7 remained constant after a slight decrease at a very high value, even with a high fluoride concentration. The results clearly confirm that titanium is attacked by fluoride in an acidic environment. The clinical implications are that fluoride rinses or fluoride gels must have a neutral pH if there is a titanium containing device in the oral environment despite the less prophylactic effectiveness. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 303-304 
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    Keywords: Chemistry ; Polymer and Materials Science
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  • 42
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    Journal of Applied Biomaterials 6 (1995), S. 1-7 
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    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Surgical implants need to be free from contaminants before implantation. The effectiveness of a presently used Clemson bioengineering cleaning (CBC) protocol was evaluated for cleaning three different biomaterials (titanium, aluminum oxide, and polyethylene terephthalate, PET) contaminated with three different contaminants (calcium chloride, zinc chloride, and hexadecane). Radiolabeled tracer analysis (RTA), with the use of liquid scintillation, was used as the surface analytical technique to quantitatively determine the removed from the biomaterial surface. On average, the ultrasonic cleaning step removed 99.96% of all three contaminants from both titanium and aluminum oxide. The CBC protocol did not sufficiently clean PET fabric contaminated with hexadecane leaving 11.76% of the contaminant after the ultrasonic step. With the use of isopropyl alcohol in series with 1% Liquinox, the ultrasonic step cleaned the fabric soiled with hexadecane within 30 min, removing 99.85% of the hexadecane initially on the surface. RTA proved to be an excellent method of quantifying surface contamination on implant materials, and for assessing the effectiveness of cleaning protocols in question. © 1995 John Wiley & Sons, Inc.
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    Notes: In research animals, the immune adjuvant activity of silicone in eliciting antibodies to associated protein antigens is now well established. In humans, the immune adjuvant activity of silicone remains controversial. Clusters of data from various research groups are beginning to define the boundary conditions for future large epidemiological studies. In that spirit, this manuscript reports pilot clinical data from a serological study conducted 3 years ago and reported previously in this journal. Sera from a self-selected symptomatic population of patients with breast implants were assayed for elevated concentrations of antibodies showing binding avidity to silicone surface associated antigens [anti-SSAA(x)]. In that study of 249 patients, two distinct statistically significant subgroups were identified on the basis of the serological assay alone: patients without any elevated anti-SSAA(x) (negative) and patients with elevated anti-SSAA(x) (positive) (p 〈 0.001). In this study, a clinical survey returned by 226 of those patients was correlated with the previously acquired serological findings. The 11 most common clinical complaints reported by the 199 anti-SSAA(x) negative patients and by the 27 anti-SSAA(x) positive were compared and their frequencies analyzed. The 199 anti-SSAA(x) negative patients, as a group, showed a lower frequency of a variety of signs and symptoms compared to the 27 anti-SSAA(x) positive patients. Statistically significant differences were seen in three of the symptoms: fever, foot pain, and sleep disturbance (p 〈 0.05). In addition, the syndrome of fever in the absence of local chest pain was a significantly associated with anti-SSAA(x) positivity (p 〈 0.001). © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 161-165 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: We performed a histomorphological and morphometric analysis of the effects of short daily periods of micromotion and phagocytosable particles of high density polyethylene (PE) on bone ingrowth into a 1 × 1 × 5 mm canal within a titanium chamber in rabbits. The micromotion chamber (MC) was implanted in the tibia of nine mature New Zealand white rabbits. After osseointegration and first harvest of tissue, 40 micromotions (amplitude = 0.5 mm) were applied daily at a rate of 1 Hz for a 3-week period. The tissue within the chamber was then harvested. For the second treatment, PE particles (108/mL) were placed within the canal. The tissue in the chamber was harvested 3 weeks later. The next treatment was a 3-week rest period, in which neither micromotion nor particles were utilized; a harvest followed. The final treatment combined PE particles and micromotion, followed by a harvest 3 weeks later. Sections from control harvests contained extensive trabecular bone arranged longitudinally throughout the canal in a fibrovascular stroma. Micromotion produced longitudinally oriented fibrous tissue within the chamber. PE particles were associated with macrophages, surrounding and engulfing the birefringent particles. The combination of particles and micromotion produced a fibrous stroma laden with macrophages. PE particles and micromotion, alone or together, produced a similar effect in inhibiting bone ingrowth, compared to nonmoved chambers without particles. In this short-term experiment, no additive or potentiating effect of these two stimuli could be demonstrated. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 199-202 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
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    Notes: The biological effects of the corrosion products of neodymium iron boron (Nd2Fe14B) magnets are largely unknown. The aim of this study was to identify the types of corrosion product and to evaluate the effect of the corrosion products (CP) of Nd2Fe14B magnets on the proliferation of human oral mucosal fibroblasts. Uncoated Nd2Fe14B magnets were stored in saline at 37°C for 6 months and the corrosion products collected. 100 μL of a cell suspension (human oral mucosal fibroblasts [4 × 104 cell/mL]) was aliquoted into 72 wells of a 96-well plate, the remaining plates receiving culture medium only. After 12 h incubation at 37°C, each well then received 100 μL of either (A) culture medium, (B) 100% CP, (C) 50%, or (D) 0% CP. The plates were reincubated at 37°C for a further 48, 96 or 144 h. Fibroblast proliferation was assessed using the methylene blue uptake/elution technique. The compounds in the corrosion product were examined using quantitative X-ray analysis. Statistical analysis (ANOVA, Bonferroni's test 0.05, SAS v 6.04), showed that at each time point, the cell numbers in groups B, C. and D were significantly lower than group A. Within groups B, C, and D no significant differences were found, despite the suggestion of a dose response effect. Fibroblast proliferation in the presence of corrosion products was significantly lower than with culture medium. Fibroblast proliferation did occur in the presence of 0, 50, and 100% CP. The actual corrosion products appeared to be salts of iron but 3.2% (±0.6) of neodymium chloride (NDCl3) was found. © 1995 John Wiley & Sons, Inc.
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    Journal of Applied Biomaterials 6 (1995), S. 219-221 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Applied Biomaterials 6 (1995) 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Biomedical Materials Research 29 (1995) 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Biomedical Materials Research 29 (1995), S. 19-24 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: We performed a transcortical push-out test to determine the effect of surface roughness of hydroxyapatite (HA)-coated implants on bone-implant shear strength in a canine model. Hydroxyapatite- and alumina-coated SUS316L with the same surface roughness (roughness average: Ra = 5 μm) and HA-coated Ti-6Al-4V (Ra = 8.4 μm), sintered HA (Ra = 0.9 μm), and dense alumina (Ra = 1.3 μm) were inserted into the dog's femur. The interface shear strength of the dense alumina was significantly lower than that of other implants at both 4 and 12 weeks after implantation. At 4 weeks after implantation, the interface shear strength of the alumina-coated SUS316L was significantly lower than that of other implants (P 〈 .05) except the dense alumina, but at 12 weeks, there was no significant difference between the implant types except the dense alumina. This indicates that the surface roughness of the HA coating affects the enhancement of the bone-implant interface shear strength at the early period after implantation, and that a surface roughness of several micrometers does not influence the bond strength between bone and HA. A scanning electron microscopic study indicated that in almost all cases at 12 weeks, the failure site after push-out testing was the coating-substrate interface, not the coating-bone interface. Therefore, protection of the coating-substrate interface from direct shear loading is needed. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 47-57 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: The morphology of bone may be influenced by many factors, including electromechanical ones such as electric potentials, electric fields, or zeta potentials. Stress-generated potential studies in bone and particle electrophoresis studies using calcium-deficient hydroxyapatite have shown that the zeta potential depends on the composition of the steeping fluid and steeping time. To better quantify and understand these in situ potential changes in bovine cortical bone, the effects of alterations in calcium, phosphate, and fluoride concentrations in Neuman's Fluid (NF), which simulates in vivo bone extracellular fluid, were investigated using particle electrophoresis. The zeta potential increased in magnitude with increased calcium concentration in NF in as little as 17 min. Increasing phosphate concentration in NF also increased the zeta potential magnitude. These results provide support for a structural model of the bone matrix surface-bone fluid interface, which incorporates the bone surface proper (composed of collagen, mineral, and boundary regions), stationary layer (in which ions, ionic complexes, and proteins may be adsorbed), and bone extracellular fluid. These results, coupled with those of previous studies, indicate that the protein phase probably has an important role in the determination of the physiologic zeta potential; the role of the mineral phase may also be important. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 89-99 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: Dense, sintered, slip-cast hydroxyapatite rods were implanted transfemorally in young adult rats. The femora were excised after 2 and 4 weeks and, following fixation, either embedded in methyl methacrylate for light microscopy, decalcified and prepared for transmission electron microscopy, or freeze fractured in liquid nitrogen for scanning electron microscopic analysis. The latter was performed on the two tissue fragments that remained after freeze fracturing, from which the first contained the implants and the second comprised tissue that had been immediately adjacent to the hydroxyapatite rods. Undecalcified light microscopic sections revealed extensive bone tissue formation around and in contact with the hydroxyapatite rods. The initial bone matrix apposed to the implant surface, as demonstrated with scanning electron microscopy, was either composed of globular deposits or an organized network of collagen fibers. The deposits, which ranged in size from 0.1-1.1 μm, fused to form a cement-like matrix to which collagen fibers were attached. Degradation of the hydroxyapatite surface resulted in the presence of unidirectionally aligned crystallites, with which the newly formed bone matrix was closely associated. Ultrastructural analysis of the bone-hydroxyapatite interface with transmission electron microscopy revealed a 50-600-nm-wide collagen-free granular zone, comprising one or more 40-100-nm-thick electron-dense layer(s). These structural arrangements most probably partially represent the globular deposits and proteinaceous material adsorbed onto and partially in the degrading hydroxyapatite surface. Although the latter change in surface topography may have enhanced bonding of the cement-like matrix to the hydroxyapatite, the cause for this change in topography and the type of bond formed are, at present, unknown. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 138-138 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Biomedical Materials Research 29 (1995), S. 309-314 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: This study assessed the effectivenness of finite element analysis in predicting the stress intensity factor (KIC) for three types of dental materials: a glass ionomer, a dental amalgam, and a composite resin. Laboratory tests were conducted on small single-edge notch specimens loaded in three-point bending to determine values for fracture toughness (KQ). Using the dimensions measured for each laboratory specimen, a J integral approach was employed to calculate KIC using finite element analysis. Both two-dimensional plane strain and three-dimensional models were used in determining KIC for each specimen, and these values were compared to the KQ values obtained from laboratory tests. The results indicated that no significant differences existed between laboratory results and those obtained from both two- and three-dimensional finite element models (P 〉 .85). For the three-dimensional model, values for KIC were found to vary across the specimen thickness, with the values at the center of the specimen closely paralleling those obtained from the two-dimensional plane strain J integral technique was as effective as the three-dimensional technique in calculating values for KIC. © 1995 John Wiley & Sons, Inc.
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    Notes: A novel device containing cephalexin as a model drug using a self-setting bioactive cement based on CaO—SiO2—P2O5 glass was investigated. The device consisted of 95 wt/wt% glass powders and 5 wt/wt% cephalexin powder hardened within 5 min after mixing with a phosphate buffer. After setting, in vitro drug release from homogeneous orheterogeneous drug-loaded cement pellets in a simulated body fluid (SBF) at pH 7.25 and 37°C continued for over 4 weeks. The hardened cement gradually formed low-crystallinity hydroxyapatite with high bioactivity in hard bone tissue and reduced in volume by about 5% during dissolution testing in SBF. Consequently, 30% of the loaded drug was squeezed from the cement system at the initial stage of the drug release, and the remainder released more slowly. Because the heterogeneous system consisting of the cement and drug-loaded pellet avoided the drug-squeezing effect, it showed a longer drug release term than the homogeneous drug-loaded cement. The heterogeneous system using the hardened cement after soaking in SBF at 37°C for 10 days showed very slow drug release at the initial stage because it completely avoided the drug-squeezing effect, and the release was a zero-order pattern. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 73-80 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: The passivating surface oxide on titanium is one of the elements considered in the explanation of the favorable biolgic response of this metal in implant applications. In the present study, transmission electron microscopy was used to identify the crystal structure and morphology of the oxide film on commercially pure titanium specimens befor and after immersion in simulated physiologic fluids. The results show that the oxide layer is composed mainly of anatase and rutile, both of which are tetragonal in structure. Although the simulated physiologic fluids did not induce an observable change in the crystal structure for the immersion times investigated, the results indicate an immersion-induced change in microstructure from a finegrained to a coarser-grained structure. The grain growth observed could be attributed to the growth of the native oxide crystals; however, it most likely results from the formation of a new oxide layer. The results also support oxide thickening as one of the processes associated with passive dissolution of titanium. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 113-119 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: When V79 metabolic cooperation (MC) assay was performed to detect tumor-promoting activities, inhibitory activities on the gap-junctional intercellular communication were first detected in both extracts prepared from polyetherurethane (PEU) and silicone. The former inhibited more strongly than the latter. Furthermore, the lowest effective concentrations in MC assay correlated well with the values of the total active incidences obtained by histologic evaluation of the 2-year implantation test in rats. Poly(tetramethylene oxide) (PTMO) showed the highest inhibitory activities among the constituents of PU. Thus, the shorter the chain length of PTMO, the stronger the inhibitory activities of PTMO in MC assay. PTMO moiety may play an important role in the tumor-promotion stage during tumorigenesis induced by PU. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 127-131 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: A method of tissue digestion using sodium hydroxide was applied to the isolation and recovery of ultra-high-molecular-weight polyethylene (UHMWPE) particles from tissues around failed total hip replacements. Density gradient ultracentrifugation of the digested tissues was performed to separate the UHMWPE from cell debris and other particulates. Fourier transform infrared spectroscopy and differential scanning calorimetry (DSC) verified that the recovered particles were UHMWPE. When viewed by scaning electron microscopy, individual particles were clearly observed and were either rounded or elongated. The majority were submicron in size. The application of this method to the study or particles from periprosthetic tissues may elucidate aspects of biomaterial particles size and shape that are important to the biologic response to, and clinical outcome of, total joint replacement. © 1995 John wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995) 
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  • 63
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    Notes: B-cell stimulation for the purpose of evoking an effective neutralizing humoral immune response is a surface phenomenon that is exquisitely specific to antigen conformation. Consequently, successful delivery of antigen, such as would be desired in a vaccine, entails preservation of an antigen's apparent native surface (conformational) properties. Prior to testing the actual vaccinating efficacy of delivered antigens, the surface properties could be assessed through a variety of in vitro and in vivo assays in which the measurement standard would be the properties of the antigens in their native state (whole virus). Using surface modified nanocrystalline carbon and calcium-phosphate ceramic particulates (carbon ceramics and brushite), we evaluated the surface activity of immobilized non-nuclear material extracted from HIV-1. Physical characterization showed that the particles with immobilized antigen („HIV decoys“) measured 50 nm in diameter (HIV = 50-100 nm) and exhibited the same ξ potentials as whole (live) HIV. In vitro testing showed that the HIV decoys were recognized by both conformationally nonspecific and specific monoclonal antibodies, were recognized by human IgG from HIV antibody-positive patients, and could promote surface agglomeration among malignant T-cells similar to live HIV. Last, in vivo testing in three vaccinated animal species showed that the HIV decoys elicited humoral and cellular immune responses similar to that evoked by whole (live) HIV. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 943-950 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: Mechanical properties of titanium-zirconium binary alloys were investigated in order to reveal their possible use for new biomedical materials and to collect useful data for alloy design through a hardness test, a tensile test, and optical microscopy. The hardness of the alloy containing 50% zirconium was approximately 2.5 times as large as the hardness of pure titanium and pure zirconium. Tensile tests showed a similar tendency. No changes between hardness of as cast specimens and as homogenized specimens were observed, nor were changes in microstructures noted. Comparisons between the Ti-6Al-4V alloy and the Ti-Zr-6Al-4V alloy indicated that a titanium-zirconium alloy could provide a base material for a new biomedical alloy. From these results, it was concluded that new alloys for biomedical materials should be designed as titanium-zirconium base alloys. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 987-992 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: Transmission electron microscopy was used to examine the interface between metal implant materials and bone cells. Specifically, neonatal rat calvaria osteoblasts were cultured on CoCrMo alloy and on 316L stainless steel discs (mechanically polished to a 0.3 μm finish) in Dulbecco's Modified Eagle Medium (supplemented with 10% fetal bovine serum, 50 μg/mL ascorbic acid, and 10 mM ß-glycerophosphate) under standard, sterile, cell culture conditions for 14 to 28 days. At the end of the prescribed time periods, the cells were fixed and embedded in resin before removing the metal substrates using an electrolytic dissolution technique and a 7% NaCl solution. Transmission electron microscopic examination of stained, ultrathin sections of the biological samples revealed an intact interface with microscopic details characteristic to the cell line and similar to those reported in the literature for animal and explant studies. The osteoblasts exhibited continous contact and intimate apposition to both the CoCrMo and stainless steel substrate surfaces and grew in multilayered structures; an electron dense layer (composed of mucopolysaccharides and proteins) was observed at the surface of both substrates; collagen fibrils and mineralized foci were observed in the extracellular matrix interspersed among the multilayered osteoblasts. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 1033-1033 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: There is currently very little information to suggest that polymer materials used to make vascular catheters differ in their risk of infection. A rabbit model of subcutaneous Staphylococcus aureus infection was used to determine the relative risk of infection associated with silicone, polyurethane, polyvinylchloride, and Teflon® catheters. Seven days after catheter implantation and inoculation with S. aureus, catheters were observed for gross purulence and quantitatively cultured. Silicone catheters were found to have a greater risk of grossly apparent infection (purulence) and a greater number of organisms removed from catheters by quantitative culture than the other three catheter materials (P 〈 .01). The risk of infection associated with silicone catheters decreased (P 〈 .05) if the S. aureus inoculation was delayed for 2 days or if the histology of the inflammatory response around the four catheter materials was evaluated at either 2 or 7 days after catheter insertion with or without S. aureus inoculation. Silicone catheters had greater associated inflammation (P 〈 .05) with or without S. aureus inoculation. These results suggest that silicone catheter materials may have unique properties that increase the risk of infection after implantation. Further studies should be done to understand the mechanism(s) of these observations. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 673-675 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Journal of Biomedical Materials Research 29 (1995), S. 1155-1163 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: Biocompatibility is an important factor in the development of orthopedic implants as well as in the development of new tissue culture devices. Polysulphone has been used for orthopedic implants because of its mechanical properties, ease of sterilization, molding capacity, and biocompatibility. Therefore, polysulphone has been chosen as the prime material for the construction of tissue culture devices to be used for the cultivation of osteogenic cells (preosteoblastlike MN7 cells and primary bone marrow fragments), as well as complete fetal long bone explants under space flight conditions. Whereas polysulphone did not interfere with the proliferation in early stages of bone-forming cells, we show that leachable factors within the polysulphone polymer prevented the final steps of matrix formation as measured by collagen synthesis and matrix mineralization. These data argue against polysulphone as a material for orthopedic implants. © 1995 John Wiley & Sons, Inc.
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    Notes: Efforts to expand treatment options for articular cartilage repair have increasingly focused on the implantation of cell-polymer constructs. The purpose of this study is to determine the suitability of porous D,D-L,L-polylactic acid as a carrier for delivering repair cells obtained from rib perichondrium into full-thickness articular cartilage defects. In vitro characterization of perichondrocyte-polylactic acid composite grafts was combined with in vivo assessment of the early articular cartilage repair in a clinically relevant model. Using a fluorescent double-stain protocol to visualize live and dead cells in situ, primary cells cultured from perichondrium were found to be capable of attaching to and surviving within a porous D,D-L,L-polylactic acid matrix. These perichondrocyte-polylactic acid composite grafts were then implanted within osteochondral defects drilled into the left medial femoral condyles of 16 adult New Zealand white rabbits. Experimental animals were sacrificed 6 weeks after implantation and the repair tissue was evaluated grossly, histologically, and biochemically. Grossly, 96% (15/16) of the experimental animals demonstrated repairs consisting of a smooth, firm neocartilage which appeared similar in color and texture to the surrounding articular surface. Matrix staining for cartilaginous protein was seen surrounding chondrocyte-like cells in the cartilage regions of the repair. Cellular alignment was found to be related to scaffold architecture. These results suggest that scaffolds composed of porous D,D-L,L-polylactic acid support the growth of cartilaginous repair tissue and are compatible with both in vitro and in vivo survival of chondrogenic cells. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 1167-1174 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: Submicron ultrahigh-molecular-weight polyethylene (UHMWPE) wear particles from total joint prostheses may contribute to implant failure through particle-mediated aseptic loosening. The purpose of this study was to examine the microstructure of virgin UHMWPE powder to determine its morphology for future comparison with wear debris. A new method of low-voltage scanning electron microscopy (LVSEM) in an oil-free vacuum was applied, which produced high-resolution images of UHMWPE micromorphology, while minimizing specimen damage and obviating the need for image processing. GUR 415 UHMWPE virgin powder particles were examined by using routine high-voltage SEM, LVSEM, and image analyses. LVSEM showed that UHMWPE particles were composed of submicron-size spherical subparticles connected by numerous nanometer-size fibrils. These spherical subparticles had a highly textured surface morphology seen only by LVSEM. Fracture of the nanometer-size fibrils was observed. Routine high-voltage SEM obfuscates the intricate and delicate UHMWPE micromorphology as well as the damage done by the accompanying high-voltage electron. This study suggests that the micromorphology of wear particles previously studied with routine high-voltage SEM was overlooked or damaged, justifies the need for LVSEM in future studies, and raises the question of what is the true morphology of polyethylene wear debris retrieved from human tissues. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 1185-1191 
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: A comparative evaluation of various biomaterials for their resistance to bacterial colonization and encrustation in infecred urine is an important area in urological biomaterials research. This article describes an in vitro dynamic perfusion system that allows four reactors containing 24 1-in. catheter samples (6 per reactor) to be simultaneously perfused at a constant flow rate by synthetic urine. A common urease-producing urinary pathogen, Proteus mirabilis, was maintained at a level of 106 colony-forming units/mL for 7 days in the dynamic perfusion reactors. The pH and bacterial population were monitored every 24 h and the percentage of encrustation on latex and hydrogel-coated commercial catheter materials gave reproducible results in three different runs, 15.2 ± 3.65% and 13.8 ± 2.58%, respectively. A major issue of inlet clogging due to ascending bacteria or ammonia has been rectified using a dismountable inlet assembly. An incubator coupled with a cooling system allowed accurate temperature maintenance of 37°C in all four reactors. Results from scanning electron microscopy of some latex samples are also presented. © 1995 John Wiley & Sons, Inc.
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  • 76
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: In vivo degradation of polyetherurethanes (PEUs) was studied using two kinds of PEUs, U-3 and U-8, coated on a base film of ethylene/vinyl alcohol copolymer (EVAL). U-3 is a nonsegmented PEU prepared from 4,4′-diisocyanato-diphenylmethane (MDI) and poly(tetramethylene oxide) (PTMO 1000). U-8 is a segmented PEU prepared from MDI, PTMO 1000, and 1,4-butanediol. Previous studies of PEUs were conducted using gel permeation chromatography and scanning electron microscopy. In this study, the explanted materials were examined with contact angle measurement, ATR-FTIR, and nuclear magnetic resonance (NMR) spectroscopies. All data obtained by these methodologies indicate that the PTMO/MDI oligomers diffused to the material surface in the early stage of implantation. Then, the lowmolecular-weight fraction of the oligomers leached out from the surface to the exudate. Degradation became dominant after 2-4 weeks. In the case of PU-8, the PTMO fraction decreased approximately 35-40% from the surface at 24 weeks postimplantation. In the case of PU-3, the loss of coating material (U-3) on the base film (EVAL) was observed after 10 weeks. The PTMO fraction of the surface U-3 remained on EVAL at 6 weeks postimplantation, however, it was 64% of the initial material. The molecular weight of the U-3 remaining on EVAL also decreased. Degradation of U-3 occurred more rapidly than that of U-8. The data obtained with our materials were insufficient in determining evidence of oxidative degradation with IR or NMR spectra. © 1995 John Wiley & Sons, Inc.
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  • 77
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    Journal of Biomedical Materials Research 29 (1995), S. 811-821 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Biomer/poly(N-isopropylacrylamide)/[poly(NiPAAm)] thermosensitive polymer blends were prepared and their application as heparin-releasing polymer coatings for the prevention of surface-induced thrombosis was examined. The advantage of using poly(NiPAAm)-based coatings as heparin-releasing polymers is based of the unique temperature-dependent swelling of these materials. At room temperature, i.e., below the lower critical solution temperature (LCST) of poly(NiPAAm), the Biomer/(poly(NiPAAm)) coatings are highly swollen. The high swelling enables fast loading of hydrophilic macromolecules (e.g., heparin) into the coating by a solutions sorption technique. At a body temperature, i.e., above the LCST of poly(NiPAAm) the coatings are in a deswollen state and the absorbed macromolecules may be slowly released from a dense coating via a diffusion controlled mechanism. Biomer/poly(NiPAAm)) coatings were obtained by blending and coprecipitation of the two linear polymers, Biomer and (poly(NiPAAm). The structure and water-swelling properties of the coatings were examined. Significant differences in water swelling at room temperature (RT) and 37°C were observed as a result of the thermosensitivity of poly(NiPAAm). The surface structure of the coatings in dry and swollen states at RT and 37°C was examined by scanning electron microscopy. Heparin was loaded into the coatings via a solution sorption at room temperature. Kinetic studies of heparin loading demonstrated that maximum loading was obtained within 1 h. The in vitro (37°C) release profiles were characterized by a rapid initial release due to the squeezing effect of the collapsing polymer network, followed by a slower release phase controlled by heparin diffusion through the dense coating. The short-term antithrombogenicity of intravenous polyurethane catheters coated with heparin-releasing Biomer/poly(NiPAAm) thermosensitive coating was evaluated in a canine animal model. The results show that the heparin release from Biomer/poly(NiPAAm)-coated surfaces resulted in a significant reduction of thrombus formation on test surfaces in contact with venous blood as compared to control surfaces. © 1995 John Wiley & Sons, Inc.
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  • 78
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    Keywords: Chemistry ; Polymer and Materials Science
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    Topics: Medicine , Technology
    Notes: In the development of three-dimensional cell-polymer synthetic matrices for tissue regeneration, visualization of cells growing in these porous structures can be difficult. The focus of this study was the development and use of a novel method that would allow for visualization of osteoblasts inside opaque matrices. The morphologic responses and phenotypic characterization of osteoblasts as they attach, spread, and migrate through a porous three-dimensional biodegradable polymer-ceramic matrix in vitro were studied using immunofluorescence and confocal laser scanning microscopy (CLSM). CLSM offers several advantages over the most commonly used imaging methods [traditional light microscopy and scanning electron microscopy (SEM)]. CLSM filters out-of-focus background and provides more structural details of cells. In addition, CLSM does not require extensive sample preparation as does SEM. When used in conjunction with fluorescence-labeled antibodies to identify cells and their products, it can characterize morphology of growing cells and successfully determine phenotypic function. Using monoclonal antibody to osteocalcin, a bone cell-specific protein, cells throughout the matrix were found to have preserved osteoblast-like phenotype with growth. The morphology of cells throughout the matrix was found to be similar to osteoblast cells grown on tissue culture polystyrene and consisted of spread polygonal forms. Using the technique of CLSM with immunofluorescent antibodies, we have demonstrated for the first time that these three-dimensional degradable polymer matrices can support osteoblast growth and phenotypic expression throughout its structure. © 1995 John Wiley & Sons, Inc.
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  • 79
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    Journal of Biomedical Materials Research 29 (1995), S. 905-905 
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    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
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  • 80
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    Journal of Biomedical Materials Research 29 (1995), S. 893-899 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
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    Notes: There is much discussion about the toxic effect of vanadium and aluminum contained in Ti—6Al—4V alloy for prosthetic implants. The goal of the present investigation was to develop new titanium alloys with sufficient mechanical properties using more biocompatible alloying elements: zirconium, tin, niobium, tantalum, and palladium. The relative growth rates of L929 and MC3T3-E1 cells were significantly higher when cultured with the extraction of Ti—10Zr—8Nb—2Ta—0.2Pd or Ti—15Zr—4Nb—2Ta—0.2Pd alloys than when cultured with the extraction of Ti—6Al—4V ELI alloy. The tensile strength, elongation, and reduction of area for Ti—15Sn—4Nb—2Ta—0.2Pd alloy were 989 MPa, 14.4%, and 49.3%, respectively, surpassing Ti—6Al—4V ELI alloy (ASTM F138—84); those for Ti—15Zr—4Nb—2Ta—0.2Pd alloy were 725 MPa, 23.6% and 54.9%, respectively. More than 15% addition of tin as well as zirconium deteriorated the tensile properties. Titanium release into a 5% hydrochloric acid solution from the new titanium alloys was 20-50 μg/cm2 per day, though that from Ti—6Al—4V ELI alloy was 1300 μg/cm2 per day. The optimum alloy compositions are Ti—15Zr—4Nb—2Ta—0.2Pd and Ti—15Sn—4Nb—2Ta—0.2Pd, judging from cytocompatibility, corrosion resistance, and mechanical properties. The former is characterized by its high level cytocompatibility and corrosion resistance, while the latter is characterized by mechanical properties. © 1995 John Wiley & Sons, Inc.
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  • 81
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    Journal of Biomedical Materials Research 29 (1995), S. 907-907 
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    Keywords: Chemistry ; Polymer and Materials Science
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  • 82
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: In this study, the influence of surface morphology and wettability of both degradable and nondegradable polymer films on the inflammatory response after subcutaneous implantation in the rat was investigated. Degradable nonporous, porous, and “combi” (porous with a nonporous layer on one side) poly(L-lactic acid) (PLLA) films and nondegradable polytetrafluoroethylene (PTFE) and (porous) expanded PTFE (e-PTFE) were used. Contact angles measurements indicate that PLLA is more hydrophillic than PTFE. Assessment of the inflammatory response was performed after various periods of implantation (up till 180 days), with both conventional light microscopy and immunohistochemistry using monoclonal antibodies (mAbs). The inflammatory response observed initially can largely be considered as part of the wound healing reaction, and up till day 40 the inflammatory response against PLLA was minimally more intense than against PTFE (porous as well as nonporous). From day 40 on, the PLLA films provoke a more intense inflammatory response as compared to the PTFE films. Both porous PLLA and the porous side of the “combi” PLLA film provoke a more intense inflammatory response than nonporous PLLA and the nonporous side of the “combi” PLLA film, respectively. In general, PTFE and e-PTFE films provoke an inflammatory response which is minimally more intense than the one provoked by the sham operation. Almost no ingrowth of tissue was observed in the porous e-PTFE films. In contrast, there was abundant tissue ingrowth in and an inflammatory response against porous PLLA. It can be concluded that biodegradable PLLA films provoke a more intense inflammatory response than nondegradable PTFE films. Also, porosity enhances the inflammatory response. However, porosity enhances the inflammatory response only when the wettability of a biomaterial permits cellular ingrowth. © 1995 John Wiley & Sons, Inc.
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  • 83
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: A rat bone marrow cell culture was used to evaluate the osteogenic potential of amorphous and crystalline thin calcium phosphate (Ca/P) coatings. The coatings were deposited on titanium discs using a radiofrequency magnetron sputter procedure. Amorphous and crystalline plasma spray Ca/P coated and noncoated titanium discs served as reference material. The cellular behavior was analyzed with quantitative (attachment and proliferation rates) and qualitative (scanning electron microscopy) techniques. No significant differences were found in cell attachment and proliferation rates between the various materials. Scanning electron microscopy showed extracellular matrix formation after 18 days of culture on amorphous plasma-sprayed and the two types of magnetron sputtered coatings. Furthermore, no severe degradation of the magnetron sputtered coatings was observed. They even appeared to induce apatite formation. On basis of the results, we conclude that magnetron sputtering appears to be a promising method to manufacture bioactive ceramic coatings. © 1995 John Wiley & Sons, Inc.
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  • 84
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    Journal of Biomedical Materials Research 29 (1995), S. 993-997 
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    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
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    Notes: Human squamous epithelial cells produce lower amounts of laminin and fibronectin when cultured on DEAE-dextran than when cultured on gelatin-coated polystyrene (Biotechnol. Bioeng., 33:1235). The epithelial cells also spread much more slowly on DEAE-dextran than they do on gelatincoated polystyrene. To determine if the low level of matrix production by cells grown on DEAE-dextran contributed to the slowness of cell spreading on this substrate, microcarriers made from DEAE-dextran were treated with exogenous laminin (10 μg/cm2 of surface area) and then examined for ability to support cell adhesion. Squamous epithelial cells spread as rapidly on the laminin-treated DEAE-dextran as they did on gelatin-coated polystyrene (much more rapidly than on untreated DEAE-dextran). This indicates (1) that laminin can bind to DEAE-dextran in a fashion that is biologically usable by anchorage-dependent cells, and (2) that when laminin is bound to DEAE-dextran, the failure of squamous epithelial cells to rapidly spread is overcome. These data support the hypothesis that failure of the cells to synthesize an intact extracellular matrix on DEAE-dextran is responsible, at least in part, for the slowness with which cells spread on this substrate. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 1005-1016 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
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    Notes: Contact activation of the intrinsic pathway of porcine blood plasma coagulation is shown to be a steep exponential-like function of procoagulant surface energy, with low activation observed for poorly water-wettable surfaces and very high activation for fully water-wettable surfaces. Test procoagulants studied were a system of oxidized polystyrene films with varying wettability (surface energy) and glass discs bearing close-packed self-assembled silane monolayers (SAMs) with well-defined chemistry consisting of 12 different terminating chemical functionalities. A monotonic trend of increasing coagulation activation with increasing water wettability was observed for the oxidized polystyrene system whereas results with SAM procoagulants suggested a level of chemical specificity over and above the surface energy trend. In particular, it was noted that coagulation activation by SAMs terminated with —CO2H was much higher than anticipated based on surface wettability whereas —NH3⊕-terminated SAMs exhibited very low procoagulant activity. SAMs terminated in —(CH2)2(CF2)7CF3 behaved as anticipated based on surface energy with very low procoagulant activity and did not exhibit special properties sometimes attributed to perfluorinated compounds. Quantitative ranking of the inherent coagulation activation properties of procoagulant surfaces was obtained by application of a straightforward phenomenological model expressed in a closed-form mathematical equation relating coagulation time to procoagulant surface area. Fit of the model with a single adjustable parameter to experimental measurements of porcine platelet-poor plasma coagulation time was very good, implying that assertions and simplifications of the model adequately simulated reality. Two important propositions of the model were that (1) the number of putative “activating sites” scaled linearly with procoagulant surface area, and (2) contact activation of the plasma coagulation cascade was catalytic in the sense that these activating sites were not consumed or “poisoned” by irreversible or slowly reversible protein adsorption during coagulation. An extension of the coagulation model proposed that procoagulant activation properties scale exponentially with the surface density of polar (acid-base) sites, which, in turn, was related to procoagulant wettability. © 1995 John Wiley & Sons, Inc.
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  • 86
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    Keywords: Chemistry ; Polymer and Materials Science
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    Topics: Medicine , Technology
    Notes: This study assessed three in vitro techniques designed to measure the thrombogenicity of vascular grafts. All techniques immersed vascular grafts in rotating blood. In the gravimetric analysis, the weight of adherent thrombi was recorded at 2 min intervals for 20 min. In the torque analysis, a microviscometer continuously recorded the amount of torque developed as the graft rotated for 20 min. In the thrombin analysis, the blood sample was analyzed for fibrinopeptide A production indicating fibrinogen clevage. Expanded polytetrafluoroethylene grafts were treated by removal of air nuclei (denucleation), binding of heparin, or binding of polyethylene oxide (PEO). The gravimetric analysis determined that the time at which each group experienced clot initiation was as follows: control after 6 min, denucleation after 14 min, heparin after 18 min, and PEO after 10 min. Similarly, in the torque analysis all treatment groups significantly delayed the initial increase in torque from 8.0 min for control to 12.5 min for denucleation (P 〈 .01), 〉 20 min for heparin (P 〈 0.1), and 12 min for PEO (P 〈 .05). The thrombin analysis determined that coagulation activity was reduced relative to control at 12 min with the denucleation group (P 〈 .05) and heparin group (P 〈 .01) and at 18 min with all treatment groups (P 〈 .01). The similarity of results among the techniques increases confidence that each measurement accurately predicts in vitro thrombogenicity. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 591-594 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The bone-implant interface formed in a canine distal femur was examined by means of a Raman microprobe using an implant model designed to test calcium phosphate surface coatings. By using the 960 cm-1 band of calcium phosphate to characterize the interface and adjacent mineral, we obtained spatial and compositional information about the attachment of bone to the synthetic calcium phosphate coating on a titanium support. The interface between bone and the synthetic calcium phosphate is approximately 30-40 μm in width. © 1995 John Wiley & Sons, Inc.
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  • 88
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    Journal of Biomedical Materials Research 29 (1995), S. 627-633 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Experiments were undertaken to determine whether hexavalent chromium was released during corrosion of orthopedic implants. Uptake of chromium (Cr) by cells and separation using amberlite resin were the methods used to determine that hexavalent Cr was present. We used salts of chromium as trivalent chromium (chromic chloride) and hexavalent chromium (potassium dichromate) to verify that the amberlite separation technique separates hexavalent Cr into the upper phase and trivalent Cr into the lower phase. The use of the salts also verified that only the hexavalent Cr became red blood cell-associated and that most of this was intracellular rather than membrane bound. The use of the amberlite separation technique demonstrated that the hexavalent Cr in the red blood cells was rapidly reduced to trivalent Cr. Cellular uptake of chromium was documented in red blood cells following corrosion of stainless-steel and cobalt-chromium implants in vivo, in the red blood cells of patients undergoing total joint revisions, and in fibroblasts subjected to products of fretting corrosion of stainless-steel and cobalt-chromium implants. Thus, corrosion of implants can lead to the release of the biologically active hexavalent chromium into the body. This chromium is rapidly reduced to trivalent chromium in cells. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 663-671 
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    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The ability to organize cells in three dimensions (3D) is an important component of tissue engineering. This study sought to develop an extracellular matrix (ECM) equivalent with a physicochemical structure capable of supporting neurite extension from primary neural cells in 3D. Rat embryonic day 14 striatal cells and chick embryonic day 9 dorsal root ganglia extended neurites in 3D in agarose hydrogels in a gel concentration-dependent manner. Primary neural cells did not extend neurites above a threshold agarose gel concentration of 1.25% wt/vol. Gel characterization by hydraulic permeability studies revealed that the average pore radius of a 1.25% agarose gel was 150 mm. Hydraulic permeability studies for calculating average gel pore radius and gel morphology studies by environmental and scanning electron micrography showed that the average agarose gel pore size decreased exponentially as the gel concentration increased. It is hypothesized that the average gel porosity plays an important role in determining the ability of agarose gels to support neurite extension. Lamination of alternating nonpermissive, permissive, and nonpermissive gel layers facilitated the creation of 3D neural tracts in vitro. This ability of agarose hydrogels to organize, support, and direct neurite extension from neural cells may be useful for applications such as 3D neural cell culture and nerve regeneration. Agarose hydrogel substrates also offer the possibility of manipulating cells in 3D, and may be used as 3D templates for tissue engineering efforts in vitro and in vivo.
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    Journal of Biomedical Materials Research 29 (1995), S. 679-679 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
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    Journal of Biomedical Materials Research 29 (1995), S. 701-705 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: We evaluated the microstructural characteristics of newly formed bone tissue at the interface with cement. The bone-cement interfaces of the femoral components of nine hip prostheses retrieved after loosening were investigated by means of X-ray diffraction on microareas and microhardness. The bone far from the interface of two stable prostheses was used as a control. The newly formed bone adjacent to cement in the loosened prostheses showed a maturity degree lower than that of bone adjacent to cement in stable prostheses. The lattice parameters of bone apatite did not show significant variations as compared to the reference values. Bone trabeculae at the interface with loosened prostheses often showed an osteoid lining characterized by a strongly demineralized lamellar and haversian structure. Radioopaque cement particles are sometimes found in the trabecular bone tissue around the prosthesis. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 721-728 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Monosize, biodegradable poly(ethylcyanoacrylate) (PECA) microspheres in the size range of 0.5-2.5 μm were prepared by a relatively new polymerization technique, the so-called dispersion polymerization. The polymerizations were performed by using a stabilizer system containing a poly(ethyleneoxide)/poly(propyleneoxide) (PEO/PPO) copolymer and dextran in the aqueous HCl solution as a dispersion medium. Phosphoric acid was used as a catalyst, stabilizer, monomer concentrations, and the pH of dispersion medium on the monomer conversion, average size, and size distribution of the PECA microspheres were studied. The resultant microspheres size was mainly controlled by PEO/PPO copolymer and HCl concentrations. To explain the degradation mechanism, the degradation of monosize PECA microspheres was studied in in vitro conditions. The partially degraded beads were observed by electron microscopy. The results indicated that the degradation of monosize PECA microspheres occurred mainly by surface erosion. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 749-756 
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    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: This article reports the development of micropatterning technology fo cultured cells by precise surface regional modification via photochemical fixation of phenyl azidoderivatized polymers on polymer surfaces. Photoreactive polymers prepared in this study included poly(N,N, -dimethylacrylamide-co-3-azidostyrene), bis-4-azidobenzamide-polyethylene glycol, and poly(styre-co-3-azido-styrene). The photochemical fixation of these photoreactive polymers consisted of three steps: (1) coating of a photoreactive polymer on a material surface, (2) ultraviolet irradiation through a photomask, and (3) removal of nonreacted polymer by a solvent. Electron spectroscopy for chemical analysis and water contact angle measurement were employed for surface characterization. Two different types of regionally modified surfaces were prepared; one was a hydrophilic polymer regionally fixed on a tissue culture dish and the other was a hydrophobic polymer regionally fixed on poly(vinyl alcohol) (PVA). Photochemical surface microfabrication permits μ-order dimensional precision, which was verified by the micropatterned tissue formation of bovine aorta endothelial cells (ECs) when ECs were seeded on these surfaces. ECs adhered, spread, and confluently proliferated only on uncoated tissue culture dish surfaces or hydrophobic regions on PVA. Thus, the regionally differentiated cell adhesional regions were created by photo chemically driven surface microprocessing. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995) 
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    Keywords: Chemistry ; Polymer and Materials Science
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  • 95
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    Journal of Biomedical Materials Research 29 (1995), S. 803-810 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Composites composed of microcrystalline calcium-deficient hydroxyapatite (HAp) and collagen were formed at 38°C via an acid-base reaction between calcium phosphate precursors in the presence of a collagen matrix. Formation of composites having HAp:collagen weight ratios of 4.5:1, 11:1, and 22:1, along with that of pure mineral were investigated. Isothermal calorimetry and X-ray diffraction indicated complete reaction within 5 h resulting in hardened monoliths. The rate of HAp formation increased with an increase in the proportion of collagen present. Electron microscopy indicated that the acceleratory effect of collagen was associated with the provision of nucleation sites for HAp crystallization. Analysis of the solution chemistry also showed that collagen affected the calcium and phosphate concentrations and the pH. While collagen was shown to effect the kinetics of HAp formation, the rate limiting step, as shown by X-ray diffraction and solution chemistry, was the dissolution of the acidic calcium phosphate precursor, CaHPO4. Preliminary mechanical data indicated that the Young's modulus, yield strength, and work to fracture were at the lower end of the range of those values reported for bone. The porosities observed in these composites suggest that they might be osteoinductive while their compositions should allow their eventual resorption. Thus, microstructure, kinetics, and mechanical data suggest that these composites might be suitable as bone substitutes which form in vivo. © 1995 John Wiley & Sons, Inc.
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  • 96
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    Keywords: Chemistry ; Polymer and Materials Science
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    Notes: Methanol extracts prepared from three polyetherurethanes (PEUs), namely PU4, PU6, and PU8, which were synthesized using 4,4′-diphenylmethanediisocyanate, poly(tetramethylene oxide), and 1,4-butanediol, showed an inhibitory action on the gap-junctional intercellular communication in a V79 metabolic cooperation (MC) test system. However, the inhibitory potentials of methanol extracts did not correlate with the tumorigenic potential of the polyurethanes in 1-year rat implantation studies. When the MC test was carried out using glass dishes partly coated with low molecular weight PEU, the inhibitory activity was clearly detected on the surface of the polyurethane coating but not on that of the noncoated glass area. The inhibitory activity of the three PEUs investigated using polyurethanecoated dishes correlated with the values of the polyurethane's tumorigenic potential in the rat implantation study. Various polyurethanes containing polybutadiene (PBD), hydrogenated polybutadiene (HPBD), or a fluoropolyether glycol (FPEG) as the soft segment were also tested using coated dishes in the MC assay. The threshold inhibitory response of FPEG-PU was 10-fold less than that of PU4, and neither PBD-PU nor HPBD-PU showed any inhibition in the MC test system. Both the FPEG and aliphatic soft segment containing polyurethanes decreased, and had minimal influence on the gap junctional intercellular communication. Thus, the tumor-promoting potential of PBD-PU, HPBD-PU, and FPEG-PU was considered to be lower than those of the PEUs based on these in vitro test results. © 1995 John Wiley & Sons, Inc.
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    Journal of Biomedical Materials Research 29 (1995), S. 867-873 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Corrosion has been reported at the modular interfaces of total joint replacement implants, but with conflicting theories as to the cause of such damage. The modular design itself leaves the interface susceptible to galvanic, crevice, or fretting corrosion, or a combination of the three. The purpose of this study was to quantify the effect of material combination on fretting corrosion of orthopedic alloys. Each test specimen consisted of a two-hole plate with spherical countersinks of a two cortical bone screws. The plates and screws were made of either Ti6Al4V or wrought cobalt-chromium-molybdenum (CCM), and were tested in all mixed-metal and similar-alloy combinations. Fretting corrosion experiments were conducted for 14 days in 10% calf serum, according to ASTM F897. Corrosion damage was evaluated by weight-loss measurements, atomic absorption spectrophotometry and scanning electron microscopy analyses. The results indicated that Ti6Al4V suffered relatively severe damage when fretted against itself, as a result of adhesive galling. The extent of titanium damage was reduced considerably, however, when Ti6Al4V was fretted against wrought CCM. In contrast, there was essentially no difference in wrought CCM damage when the alloy was fretted against itself compared to fretting against Ti6Al4V. Finally, in similar-alloy combinations, Ti6Al4V suffered more severe damage than wrought CCM. © 1995 John Wiley & Sons, Inc.
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  • 98
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 29 (1995), S. 875-881 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Four prototype cementless hip stems were tested following the ISO 7206 protocol for the assessment of the endurance properties and compared with a cast Cr—Co—Mo (ASTM F75) commercially available stem which was used as reference design. All the tested stems were similar in shape and size, but with some substantial differences. The first was made of forged Ti6Al4V alloy (ASTM F136). The second, made of the same material, featured a central hole intended to reduce the bending stiffness of the stem itself. The third was identical to the second but for a small tooling notch in one of the fillets of the hole. The fourth was similar to the first but had a coating of sintered titanium beads in the proximal part. All of these modifications were made to evaluate the effect of fatigue strength of intentional or unintentional features commonly found in commercial stems. The forged Ti6Al4V alloy was found to be substantially stronger than the cast ASTM F75 Cr—Co—Mo alloy. However, tooling notches or sintered coatings were found to dramatically reduce this strength. Thus, the Ti6Al4V alloy calls for an accurate design process, especially when complex shapes or sintered structures are required. © 1995 John Wiley & Sons, Inc.
    Additional Material: 8 Ill.
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  • 99
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 29 (1995), S. 901-904 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A long-term study of titanium miniplates, which are in wide clinical use, was conducted to clarify their usefulness as a permanent fixing device. We examined by scanning electron microscopy the surfaces of removed plates and the accumlation of titanium in the organs of Japanese white rabbits. Two years after implantation the titanium plates were only slightly corroded. In addition, marked titanium accumulation was noted in the organs, especially in the lungs. However, the accumulation of titanium in the organs of animals with left distomolar mandibular fracture was highest at 3 months after implantation, and then gradually decreased over 2 years. Titanium miniplates have recently been used clinically in humans and no adverse reactions have yet been reported. The present findings suggest the use of titanium miniplates as permanent fixing devices. © 1995 John Wiley & Sons, Inc.
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  • 100
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 29 (1995), S. 917-928 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A new methodology to improve the hemocompatibility of polyurethane (medical grade Pellethane D-55) surfaces is reported. The approach is essentially based on a photochemical immobilization reaction. Two new conjugate molecules, compounds 2 and 3, were prepared. They consist of (i) dipyridamole, a well-known inhibitor of platelet activation, and a vasodilating drug with clinical application, for instance before and during pecutaneous transluminar coronary angioplasty (Dottering); and (ii) an aryl azide, a moiety that exhibits marked photoreactivity. In 2, the dipyridamole unit is directly linked to the aryl azide (via an ester bond), while a short spacer chain separates both units in 3. Upon irradiation of 2 or 3, adsorbed onto the polyurethane foil, the aryl azide is converted into a highly reactive species which reacts with a nucleophilic group on the polymer surface. In this way, the dipyridamole is covalently linked to the polymer. The underlying principle is also used in photoaffinity labeling, a well-known technique in biochemical studies on enzyme structure and function. From UV extinction experiments it could be deduced that the surfacedensity of immobilized 2 is 4.9 nmol/cm2. The surface density for 3 was 14.6 nmol/cm2. The surfaces were subjected to an in vitro thrombin generation assay. This assay gives a valuable impression about the hemocompatibility of artificial surfaces. These experiments revealed that the clotting times were substantially prolonged as a result of the photoimmobilization of dipyridamole. This was especially the case for immobilized 3. This effect cannot be readily explained. Possibly, the enhanced activity of immobilized 3 is due to the spacer chain. An alternative explanation is that the surface density is larger for 3 than for 2. In addition, the photomodified surfaces were incubated with platelet-rich blood plasma (37°C, 30 min) and subsequently examined by scanning electron microscopy. The morphology of the blood platelets adhered to the surface also showed that hemocompatibility increased in the order untreated polyurethane 〈 polyurethane with immobilized 2 〈 polyurethane with immobilized 3. Future work will concentrate on evaluation of the role of the spacer (length, hydrophilicity, etc.), as well as on the possible use of this approach with respect to the construction of biomaterials with improved in vivo biocompatibility, in particular hemocompatibility. © 1995 John Wiley & Sons, Inc.
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