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At least 775 records · Page 43Linked to original sources

PubMed1975

Biocompatible implants for the sustained zero-order release of narcotic antagonists.

Implantable, sustained release drug delivery devices offer benefits not obtained through oral ingestion or injection. These include delivery at a constant therapeutic rate, thus avoiding adverse intermittent and massive dose effects, as well as reliance upon patients taking their prescribed dosages. The drawbacks to their widespread acceptance have been their inability to maintain a zero-order release rate over an extended period of time and poor biocompatibility. Devices capable of satisfying these requirements have been developed and tested extensively for in vitro release of the narcotic antagonist cyclazocine. By using implant models prepared from Hydron, a hydrophilic polymer known to exhibit excellent tissue compatibility, we have found that the release rate could be precisely regulated by proper geometry, copolymer composition, concentration of ionogenic groups and cross-link density. Devices in such varied forms as capusles, barrier-film coated tablets and bulk polymerized rods have been tested in vitro for periods approaching 1 year.

Biocompatible Materials↗

PubMed1975

An ultrastructural study of the biocompatibility of poly(2-hydroxyethyl methacrylate) in bone.

Because of the unique properties for swelling in a fluid medium and variable modulus of elasticity, hydrophilic methacrylates may be of potential usefulness for implanting prosthetic devices in bone. To investigate the biocompatibility, electron micrographic studies were done on specimens of poly(2-hydroxyethyl methacrylate) imbedded in bone for varying periods of time. Ultrastructural examination revealed progressive ossification of surrounding connective tissue up to the tissue polymer junction over a 6 month period. There was no evidence of inflammatory response. Based upon this study, it would appear that bone adjusts to an implant of hydrophilic methacrylate by ossification to the implant junction. This supports continued studies into the usefulness of this material as an implant.

Acrylates↗

PubMed1976

Reconstruction of the canine Achilles and patellar tendons using dacron mesh silicone prosthesis. I. Clinical and biocompatibility evaluation.

Surgical replacement of the Achilles and patellar tendons using Dacron mesh silicone prostheses was performed in 15 mature beagle dogs. This part of the study includes clinical evaluation, gross inspection at autopsy of regrown tendons, and histological determination of biocompatibility of prosthetic implants. Functional continuity and integrity of prosthetic patellar tendons have been established by evaluating the biologic-prosthetic interface and the mechanical properties of regrown tendon tissue around and through the Dacron silicone replacements. Results of prosthetic Achilles tendons were less satisfactory because of difficulties in suturing to a muscle and its fascia. Although the prosthetic tendon did not regrow through the tube, it provided a structure for regrowth around it. The regrown tendons became nearly ten times the normal cross-sectional area after three to four months and decreased to two to three times after 13 months. Histological studies indicate that in the absence of infection, the Dacron mesh silicone tendon was well tolerated for periods up to 13 months. Overall results are encouraging and warrant further investigation although the regenerative capacity of human patellar and Achilles tendons is unknown.

Achilles Tendon↗

PubMed1976

Biocompatibility of materials for total joint replacement.

The clinical use of total joint prostheses demands absolute biocompatibility of the materials employed. The purpose of this experiment was the bioassay of some materials considered as possible candidates for use in total joint prostheses as load-bearing members or as wear-resistant surfaces. Some materials already in use were also tested. 316L stainless steel was used as a control. The materials were implanted as a standardized rod and in particulate form. An average of 12 samples per material were implanted in soft tissue for six months and a total of 145 rabbits were used in this study. Twenty-five materials including metals, polymers, and ceramics were tested in solid and powdered form. A semiquantitative evaluation of local tissue reaction and a study of organs was performed. Polymers and metallic materials showed in general a mild tissue reaction. Ceramics, which some authors describe as the best tolerated materials, elicited variable tissue responses. Some of these (glass-ceramics) presented very poor tissue tolerance. The least reactive, titanium oxide, titanium aluminate, and aluminum oxide, presented a degree of tissue reaction comparable to that of corrosion resistant metals, but not superior to them. Moderate reactivity was the general rule for particulate materials except for the Pyroceram glass-ceramics, polymides, and Teflon. Ultrahigh molecular weight polyethylene in particulate form elicited a rather cellular tissue response, a fact to be considered when projecting long-term results in total joint arthroplasty. No pathological changes compatible with systemic toxicity by materials tested were observed in the study of the organs.

Animals↗

PubMed1976

Mechanism of failure of biocompatible-treated surfaces.

In recent years, significant advances have been made in treating surfaces to enhance their biocompatibility. This has generally involved the chemical attachmet of very thin molecular coatings to a substrate. Because failure of coated surfaces occurs often, an investigation of the stability of one such molecular coating was undertaken. The specific system studied is a polytetrafluoroethylene polymer (Teflon) with organic macromolecules of heparin ionically bonded to the polymer through use of an intermediate bonding agent. Polymers properly treated in this fashion have been shown to have excellent antithrombogenic properties. To investigate the molecular stability of the heparin coating, the surface heparin concentration of a properly coated sample was reduced by using three different methods: exposure of bonding agent to a suitable solvent; mechanical flexing; and ultrasonic vibration in saline solution...

Ammonium Chloride↗

PubMed1976

Biocompatibility studies on surgical-grade titanium-, cobalt-, and iron-base alloys.

An animal model system for the investigation of the influence of in vivo-produced metallic corrosion products upon tissues has been developed. Externally applied electrical stimulation produces the corrosion over a short period of time, and a poststimulation period is allowed for tissue stabilization. Tissue reaction adjacent to the metallic alloys shows fibrous tissue capsules and metallic corrosion product contamination. These preliminary studies show that this animal model and methodology may provide a technique for investigating long-term tissue biomaterial interactions and the influence of iron (316L), cobalt (Vitallium), and titanium (Tivanium) alloy corrosion products upon the susceptibility of tissues to various biocompatibility challenges.

Animals↗

PubMed1976

Biocompatibility of nitinol alloy as an implant material.

The biocompatibility of nitinol alloy as a potential implant material was investigated through in vivo studies on beagles. A high-purity alloy was fabricated into prototype bone plates and implanted into the femurs of beagles. Commercial cobalt-chromium (Co-Cr) alloy bone plates served as reference controls, an additional control data were obtained from beagles subjected to "sham" operations. The bone plates were removed from the animals and examined after exposures of 3, 6, 12, and 17 months. There was no evidence of either localized or of general corrosion on the surfaces of the bone plates and screws. Gross clinical, radiological, and morphological observations of the tissue at the implantation sites during the autopsies uncovered no signs of adverse tissue reactions resulting from the implants. Histological analyses were performed on samples of muscle and bone adjacent to the implantation sites, and of tissues removed from such organs as the liver, spleen, brain, and kidneys. No significant differences were noted between samples taken from controls and those taken from dogs exposed to the implants. Neutron activation analyses were carried out on suitable samples. The analysis data suggest that there is no metallic contamination in the organs due to the implants; however, there does appear to be some chromium contamination from the Co-Cr alloy implants in the adjacent bone. On the basis of the totality of the data, it is concluded that nitinol alloy is sufficiently compatible with dog tissue to warrant further investigation of its potential as a biomaterial.

Activation Analysis↗

PubMed1978

Biocompatibility tests of components of an implantable cardiac assist device.

A permanently implantable in-series left ventricular assist device, the dynamic aortic patch (DAP), has been tested in chronic animal experiments. The DAP replaces a section of the intrathoracic aortic wall. Hemothorax and hematocele at the implantation site have been complications in recent experiments. Primary postoperative hemorrhage was ruled out, and the biocompatibility of all components was therefore examined. Dacron velour, Teflon felt, conductive polyurethane, segmented polyether polyurethane, and Teflon-coated polyester fiber sutures were implanted in the pleural cavities of dogs and tested in vitro by culturing canine saphenous vein explants on them. In vivo experiments demonstrated that all components elicited mild to moderate inflammatory reactions, but hematocele occurred only when the components were implanted in the aorta with direct blood contact and exposed to arterial blood pressures. In vitro, cells were cultured on all components with no signs of toxic reactions. These results indicated that the host tolerated all implant components without major inflammatory responses. However, histological data indicated that chronic slow bleeding into or through the Dacron velour in contact with the arterial blood serum could account for hemothorax or hematocele formation. Therefore, a configuration of the assist device using materials impermeable to blood may obviate these difficulties.

Animals↗

PubMed1981

Biocompatibility of echinoderm skeleton with mammalian cells in vitro: preliminary evidence.

The physical and chemical properties of echinoderm skeleton are reviewed. A method is described for preparing cell-free, sterile echinoderm skeletal plates (ossicles) which were used as porous substrates for cell cultures. Ossicles of the starfish Pisaster ochraceus were evaluated as substrates for the culture of three mammalian cell lines. Each line grew vigorously on ossicles, and fibroblasts quickly infiltrated their porous microstructure. Echinoderm skeletal plates provide a simple, convenient alternative to coverslips and porous membranes for SEM or correlated SEM/TEM studies of cell behavior. More importantly, the preliminary evidence for biocompatibility presented suggests that native echinoderm skeleton has potential use as a biomaterial and, because of its microstructure and relative solubility; deserves evaluation as a kind of biodegradable ceramic.

Animals↗

PubMed1981

Toxicology and biocompatibility of bioglasses.

Evidence for the lack of toxicity of various bioglass formulations has been deduced from studies carried out, both in vivo and in vitro, in several different centers. Recent studies of the authors, described here, include testing of solid bioglass implants in the soft tissues of rats and rabbits for time periods of up to eight weeks. Two new techniques are described for the toxicological testing of particulate biomaterials. These tests, which involve rat peritoneal macrophages in culture and a mouse pulmonary biomaterial embolus model, indicate the biocompatibility of bioglass powders. Thus, the surface activity so critical in bone adhesion is without toxic effect in non-osseous tissues in contact with solid bioglass implants. Should wear occur and produce particulate bioglass, the material should be eliminated without consequence.

Animals↗

PubMed1982

Sulfonated poly(vinylidene fluoride) as a biomaterial: immobilization of urokinase and biocompatibility.

The adsorption of urokinase (UK) on sulfonated poly(vinylidene fluoride) (PVDF) films was examined. The amount of adsorbed UK on sulfonated PVDF films increased linearly with the degree of the ion exchange capacity (IEC) of sulfonated film. Moderately sulfonated PVDF film (IEC = 0.25 meq/g) adsorbed 3 IU/cm2 UK, and highly sulfonated film (IEC = 0.54 meq/g) adsorbed 5 IU/cm2 UK. All UK-immobilized PVDF films were active for ten weeks. The presence of the sulfonated films in the culture of rat lymphocytes did not result in any change of their viability. The implant of the film (IEC greater than 0.48 meq/g) into the subcutaneous layer of rats resulted in the cell infiltration composed of lymphocytes and plasma cells or the blastogenesis within the surrounding tissues of the implant and the regional lymph nodes. On the contrary, the implant of the films (IEC less than 0.27 meq/g) did not exert any visible changes, indicating that the lightly sulfonated films may be applicable in the sense of biocompatibility in vivo.

Animals↗

PubMed1983

Preparation of a biocompatible albumin-coated ion exchange resin for bilirubin removal from the blood of jaundiced newborns.

Removal of bilirubin by hemoperfusion with ion exchange resin particles is suggested to replace exchange transfusion of blood of jaundiced infants in some cases of unconjugated hyperbilirubinemia. The hemoperfusion system developed here consists of a packed bed of a macroreticular resin which is made biocompatible by a coating of a monomolecular layer of albumin. The choice of the appropriate ionic form of the resin and the proper albumin coating and crosslinking procedure assures a high bilirubin adsorption capacity and excellent blood compatibility of the resin. The albumin coated resin removes in vitro 80-90% of the bilirubin initially present in the plasma. The results encourage in vivo clinical studies.

Adsorption↗

PubMed1983

In vivo biocompatibility studies. I. The cage implant system and a biodegradable hydrogel.

A cage implant system has been utilized to examine the in vivo biocompatibility of a biodegradable hydrogel, poly(2-hydroxy-ethyl-L-glutamine) (PHEG). This system permits the quantitative determination of the components of the inflammatory exudate which surrounds the implanted polymer within the cage system. This system permits the serial examination of exudate components without sacrificing the animal. In addition, this system allows the subsequent removal of the polymer for surface and mechanical studies. Following implantation of the biodegradable hydrogel, quantitative and differential white cell counts of the exudates were determined over a 21-day period. In addition, concomitant extracellular enzyme analyses for alkaline phosphatase, acid phosphatase, prostatic acid phosphatase, leucine amino-peptidase, and Cathepsin B1 were determined. Corresponding control samples from exudates of the cage implant without the polymer were also determined. The two-tailed Student's t-test for unpaired samples was used to statistically compare the control and implanted polymer values for these respective analyses at the various time periods. A comparison of the cellular response for the control system and the PHEG system did not show statistically significant differences during the first 7 days following implantation. The acute inflammatory response, polymorphonuclear leukocyte predominant, was followed by a mild chronic inflammatory response, macrophage and lymphocyte predominant, and during this time period, 8-14 days, macrophages were present in significantly larger numbers for the PHEG system when compared to the control values. Enzymic analysis of the exudates revealed statistically significant differences between control and PHEG values at time intervals where no differences were noted in cell density or population. These results are discussed in terms of cell-polymer interactions leading to cellular activation and enhanced enzyme exocytosis by the inflammatory cells. Stress-strain measurements on implanted PHEG samples showed that significant in vivo degradation had occurred during the acute inflammatory phase of the response, i.e., the first 7 days.

Acid Phosphatase↗

PubMed1983

Biocompatibility test procedures for materials evaluation in vitro. I. Comparative test system sensitivity.

Relative sensitivity of in vitro biocompatibility test systems was explored. Cellular responses of 12 standardized cell lines to 20 materials representing a range of toxicity were measured. Each cell line and material combination was tested in duplicate using four different culture methods, and each culture plate was examined by two graders. Results of the tissue culture assays were compared to those obtained for the same materials in vivo using a 5-day rabbit intramuscular implant assay. Methods involving measurement of cellular growth (colony counts or percent of confluence) in serum-fortified media extracts of test samples were generally more sensitive and discriminating than those in which test materials were placed directly in cell cultures (measurement of zone of growth inhibition). There was good agreement between graders for all test methods. Antibiotics were not used in the test program. Based upon sensitivity, reproducibility, ability to discriminate materials, and grader agreement, 4 of the 12 cell lines and 2 of the 4 test methods appeared most suitable for screening and evaluation of materials. Agreement of results using these four cell lines with intramuscular implantation tests for the 30 materials ranged from 60 to 90%.

Animals↗

PubMed1983

Macroporous hydrogel membranes for a hybrid artificial pancreas. II. Biocompatibility.

A histological evaluation of the biocompatibility of a new porous hydrogel membrane made of 2-hydroxyethyl methacrylate (2-HEMA) was performed. Isolated membranes and diffusion chambers made of this material and filled with rabbit pancreas were implanted in diabetic rats for periods of up to 8 1/2 months. Histologic evaluation showed that this polymer elicits minimal tissue reaction within the first 7 weeks but some increase in granulation tissue and fibrosis thereafter. A component of this tissue reaction is neovascularization, and many blood vessels were noted immediately adjacent to the membrane's surface. Calcification of the membrane was also progressive but could be minimized by formulations resulting in the incorporation of acid groups throughout the hydrogel and on its surface. Diffusion chambers made of this new material show promise for use in a "hybrid" artificial pancreas for the treatment of diabetes.

Animals↗

PubMed1983

Structure-biocompatibility relationship of condensation polymers.

Various condensation polymers including polyamides, polyesters, polyethers, polysulfonamides, polysulfonate, polyphosphonate, polyimide, polyamide-imides, polyimide, polyamide-imides, polyester-amides, etc. have been prepared and evaluated for their biocompatibility by a cell culture method. Cell attachment and cell growth are influenced by the chemical structures of the tested polymers. Aliphatic polyamides exhibited considerably different cell growth behavior than aromatic polyamides.

Biocompatible Materials↗

PubMedDate not supplied

In vivo validation of a cell culture test for biocompatibility testing of urinary catheters.

Biocompatibility tests have been compared for their suitability as routine safety tests for urinary catheters. Latex catheters from five manufacturers were tested by each of the following four methods: (1) a cell culture cytotoxicity assay of catheter extracts, (2) intracutaneous injection of the extracts into rabbits, (3) intramuscular implant of catheter pieces into rabbits, (4) catheterization of sheep (mucous membrane irritation). The rabbit intracutaneous and intramuscular tests are both current pharmacopoeial methods for ascertaining the suitability of polymers for medical use. The four tests each showed a cell or tissue response ranging from no detectable change to severe damage, according to the catheter batch or brand, and they each identified the same samples as most toxic and least toxic. However, they differed in sensitivity. The sheep test and the cell culture assay discriminated between catheters of intermediate toxicity and ranked as toxic catheters not identified as such by the two pharmacopoeial tests. The sheep test most closely approximates clinical usage, but is impractical for routine use. The cell culture assay is a suitable alternative. It also has the advantages of a clearly defined endpoint, good sensitivity, reproducibility, speed, and reduced animal usage.

Animals↗

PubMedDate not supplied

Biocompatibility test procedures for materials evaluation in vitro. II. Objective methods of toxicity assessment.

Methods of assessing the biocompatibility of materials for use in medical devices were evaluated. Ten materials were tested using quantitative, objectively graded in vitro biochemical and functional assays employing four cell lines (CCL 1, 74, 76, and 131) used in previous work and five primary cell types (human lymphocytes, polymorphonuclear leukocytes, and mixed leukocytes, mouse macrophages, and mouse embryo). The biochemical methods (DNA synthesis, protein synthesis, and ATP activity) demonstrated good agreement in toxicity ranking of the materials, regardless of which cell culture was used and, also, the cell cultures responded similarly for each method. Methods that measured functional characteristics of cells (adhesion and phagocytosis) were highly sensitive but had low toxicity ranking agreement and reproducibility. Assays (defined as method and cell culture combinations) using cell lines were more reproducible than assays using primary cell types. Significant differences in sensitivity were noted among the assay systems for particular material types. The in vitro assays were more sensitive to differences in material composition than was a 90-day assay by subcutaneous implantation in rats.

Adenosine Triphosphate↗