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Biomedical subjects

P Urbanski

Publications and source records attributed to P Urbanski.

12 recordsLinked to original sources

Reevaluation of ethylene oxide hemolysis and irritation potential.

The in vitro hemolytic and in vivo mucosal irritation potential of ethylene oxide (EO) was investigated with standard procedures used to determine the biocompatibility of medical devices. Test solutions containing EO at concentrations of 25, 50, 100, 250, 500, 1,250, 2,500, 5,000, or 10,000 microg/mL were prepared in saline to simulate a worst-case aqueous extraction of standard medical devices containing 125, 250, 500, 1,250, 2,500, 6,250, 12,500, 25,000, or 50,000 microg/g of EO, respectively. Concentrations of EO up to 500 microg/mL were not hemolytic ( < 5% hemolysis after a 4-h exposure), whereas > or =1250 microg/mL of EO resulted in significant hemolysis. Hamster cheek pouches exposed to cotton pellets saturated with EO at concentrations of up to 2500 microg/mL for 4 h with a recovery period of 14 days were without effects attributable to EO. However, at > or =5000 microg/mL of EO, significant histomorphological alterations of the buccal mucosa were observed and attributed to EO exposure. It was concluded that solutions of EO of up to 500 microg/mL representing an aqueous extract of a general medical device containing at least 2500 microg/g of EO residue do not result in significant hemolysis and irritation.

Animals↗

Intermediate-term results with 1,019 carbomedics aortic valves.

BACKGROUND: A retrospective study was conducted to evaluate the intermediate-term outcome in patients with the Carbomedics aortic valve prosthesis. METHODS: The study included 1,019 primary valve replacements between 1989 and 1997. Seventy-two percent of patients were men; mean (standard deviation) age was 61 (10) years. The preoperative New York Heart Association functional class was III or IV in 70% of patients. Follow-up at 9 years was 99.6% complete, comprising 2,730 patient-years (mean, 2.7 years). RESULTS: Patient survival, including operative deaths, was 80% at 7 years. The linearized death rate was 2.9%/year. Statistically significant risk factors for mortality were diabetes, pure valve insufficiency, advanced age at operation, and advanced preoperative functional class. Linearized rates were thrombosis, 0.1%/year; thromboembolism, 1.0%/year; hemorrhage, 1.7%/year; endocarditis, 0.1%/year; paravalvular leak, 0.1%/year; reoperation, 0.1%/year; and all events, 3.0%/year. The 7-year estimates of freedom from complications were thrombosis, 99%; thromboembolism, 93%; hemorrhage, 89%; endocarditis, 99%; paravalvular leak, 99.7%; reoperation, 99%; and all events, 82%. No structural valve failure was observed. CONCLUSIONS: The low incidence of valve-related complications favors the continued use of the Carbomedics valve in the aortic position.

Adolescent↗

Glass wool-H2O2/CoCl2 test system for in vitro evaluation of biodegradative stress cracking in polyurethane elastomers.

Environmental stress cracking (ESC) in polyetherurethanes has been demonstrated in animal models. However, duplication of this phenomenon in vitro has been a challenge. The glass wool-H2O2/CoCl2 test system was designed to provide oxidation components found in vivo, i.e., hydroxyl radical (HO.), molecular oxygen (O2), and superoxide (O2-.) required for auto-oxidation of polyetherurethanes. The in vitro test is not only reliable in duplicating the characteristics of in vivo stress cracking in polyetherurethanes at 37 degrees C, but also accelerates ESC as much as seven times. The test results on several types of polyurethanes showed that Tecothane 80A was as vulnerable to biodegradative stress cracking in vitro as Pellethane 2363-80A, while the new generation of polyurethanes, Corethane, demonstrated great resistance against stress cracking.

Biodegradation, Environmental↗

Human plasma alpha 2-macroglobulin promotes in vitro oxidative stress cracking of Pellethane 2363-80A: in vivo and in vitro correlations.

It is hypothesized in this study that the phenomenon of environmental stress cracking (ESC) in polyetherurethane is caused by a synergistic action of biological components in the body fluids, oxidative agents, and stress. An in vitro system is designed to mimic the in vivo system; human plasma contains certain biological components that can act as a stress cracking promoter, while H2O2 (Co) solution provides an oxidative reaction comparable to that observed in the respiratory burst of adherent macrophages and foreign-body giant cells. It is demonstrated that the phenomenon of in vivo stress cracking in Pellethane 2363-80A is duplicated by an in vitro system that involves a pretreatment of prestressed specimens with human plasma at 37 degrees C for 7 days followed by oxidation in 10% hydrogen peroxide with 0.10M cobalt chloride at 50 degrees C for 10 days. The pretreatment with plasma has a synergistic effect with the oxidation by H2O2 (Co) treatment to produce ESC. A plasma component responsible for promoting stress cracking in Pellethane polyurethane is identified to be alpha 2-macroglobulin (alpha 2M).

Animals↗

Abdominal wall actinomycosis associated with use of an intrauterine device: a case report.

The association between pelvic actinomycosis and the use of intrauterine devices is well established. However, abdominal wall actinomycosis without clinical involvement of the pelvic organs has been reported only once in the literature. The authors present a second case, which occurred in a 24-year-old woman who was using a copper 7 intrauterine device.

Abdominal Muscles↗

Cellular interactions with biomaterials: in vivo cracking of pre-stressed Pellethane 2363-80A.

The phenomenon of stress cracking of Pellethane 2363-80A (PEU) was investigated using the cage implant system. A cytotoxic polyvinylchloride (PVC) and a silicone rubber containing an anti-inflammatory steroid were used to create inflammatory environments in which the biostability of the pre-stressed PEU was tested. These coimplants provided alternative in vivo environments to study in vivo polymer interactions. The inflammatory responses to the implanted cages were monitored by analyzing the exudates aspirated from the cages at different implantation times over 21 days. The pre-stressed PEU specimens were retrieved after 5, 10, and 15 weeks postimplantation and examined by optical microscopy (OM) and scanning electron microscopy (SEM). The results support the conclusion that in vivo cracking of stressed (strained) Pellethane 80A is related to cell-polymer interactions. Severe cracking or rupture of the implanted PEU specimens was observed as early as 5 weeks postimplantation. Molecular chain degradation of the implanted specimens was evident from molecular weight measurements. Neither surface cracking nor degradation of macromolecules was found on the pre-stressed PEU specimens with the added cytotoxic PVC implanted over 15 weeks. No cracking was observed on the pre-stressed specimens in the presence of steroid silicone rubber, even after 10 weeks implantation.

Animals↗

Isolation of HIV-1 from monocytes of individuals negative by conventional culture.

To improve isolation of human immunodeficiency virus (HIV) from purified monocytic cell populations, a differential culture technique was applied to blood from HIV-seropositive individuals, culture-negative for HIV by routine culture. When 206 individuals were grouped by percentage of CD4+ lymphocytes, increases in viral isolation rates were significantly associated with declines in percentage of CD4+ cells (P less than .0001). Of 158 asymptomatic individuals, 78% had greater than 400 CD4+ lymphocytes/mm3. Only 19% were culture-positive using routine methods. Separation of peripheral blood mononuclear cells (PBMC) into purified lymphocyte and monocyte subpopulations for 12 asymptomatic patients and subsequent HIV culture of each purified subpopulation using three different indicator cell lines resulted in 100% virus recovery from purified monocytes cultured in the U-937 promonocytic cell line. Culture of purified lymphocytes in U-937 cells did not increase the isolation rate, whereas culture of patient PBMC in U-937 indicator cells and in allogeneic monocytes resulted in a 50% increase in HIV isolation. A monocytic indicator cell line added to routine culture methods may improve virus recovery from asymptomatic individuals.

Acquired Immunodeficiency Syndrome↗

The in vivo auto-oxidation of polyether polyurethane by metal ions.

The first large scale use of polyether polyurethane elastomers in long term human implants was as insulation for cardiac and neurologic pacing leads. While the performance of these polymers has generally been very good over a 14-year period, several failure mechanisms have been discovered that involve interactions between the devices, materials and the body. One of these is auto-oxidation of soft segment ether through the intermediate action of certain transition metal ions, derived from conductor wires by corrosion processes. Biologically produced oxidants appear to be an accelerating factor. In this study, Pellethane 2363-80A tubing containing conductor coils or mandrels of various metals or controls were implanted in rabbits. Explants were analyzed as a function of implant time by optical and scanning electron microscopy, electron dispersive analysis by X-ray, stress-strain, FTIR, GPC and AA spectrophotometry. Only cobalt produced bulk oxidative degradation while surface damage was found in the presence of cobalt bearing alloys. No evidence of significant auto-oxidation was found in the presence of silver, nickel, chromium, molybdenum, iron, titanium, platinum, 304 stainless steel, glass or empty tubing. The combination of polyether polyurethane and metals (especially those containing cobalt) in an implantable device must be carefully evaluated for biostability prior to human use.

Biocompatible Materials↗

Regression of oral hairy leukoplakia during zidovudine therapy.

We describe two patients with human immunodeficiency virus infection and oral hairy leukoplakia whose tongue lesions resolved on oral zidovudine therapy. During therapy, each patient had a measurable reduction in human immunodeficiency virus antigen corresponding with clinical regression of oral lesions. The clinical course suggests that zidovudine may have contributed to the resolution of these lesions either indirectly through immunologic improvement or through an antiviral effect.

Acquired Immunodeficiency Syndrome↗

Autooxidative degradation of implanted polyether polyurethane devices.

While certain polyether polyurethanes have been shown to be biostable, undesirable interactions between polymer, the body environment and device can occur. For example, the corrosion products of metallic parts can cause relatively rapid autooxidation of polyether soft segments. This phenomenon was first demonstrated in our laboratories by immersing polyurethane test specimens in metal ion solutions of different oxidation potentials. Subsequently, the mechanism was reasonably duplicated by immersing Pellethane 2363-80A insulated cardiac pacing leads in 3%, 37 degrees C hydrogen peroxide. In vivo studies after 1 year show that corrosion products from pure Co and Fe produce the most rapid degradation of the polyurethane.

Animals↗