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PubMed1990

Blood compatibility of PEO grafted polyurethane and HEMA/styrene block copolymer surfaces.

HEMA/styrene (HEMA/STY) block copolymers and poly(ethylene oxide) 4,000 M.W. (PEO4K) grafted Biomer (B-PEO4K) surfaces have been synthesized, characterized, and evaluated as blood-contacting materials. These surfaces have demonstrated improved blood compatibility, compared to Biomer, in in vitro and ex vivo experiments. Biomer vascular grafts (6 mm I.D. 7 cm in length) were fabricated by a dip coating process. The luminal surface was modified either with PEO grafting, HEMA/STY coating, or Biomer coating (control). These surface-modified grafts were implanted in the abdominal aortas of dogs and evaluated for graft patency and protein adsorption. Surface protein layer thickness was measured by transmission electron microscopy (TEM). B-PEO4K and Biomer showed thick multilayers of adsorbed proteins (1000-2000 A) after 3 weeks to 1 month implantation. In contrast, HEMA/STY only showed a monolayer protein thickness (less than 200 A), even after 3 months. Visualization of adsorbed plasma proteins (albumin, IgG, and fibrinogen) was performed with scanning electron microscopy (SEM)/TEM using an immunogold double antibody technique. The pattern of protein distribution showed high concentrations of fibrinogen and IgG, and less albumin adsorbed onto Biomer and B-PEO4K. In contrast, HEMA/STY showed a patchy protein distribution pattern with high concentrations of albumin and IgG, and relatively less fibrinogen. Adsorbed monolayer patterns showed improved compatibility over multilayered proteins. The Biomer and B-PEO4K grafts occluded within 1 month, while HEMA/STY grafts were patent for over 3 months. The thin and stable adsorbed protein layer on HEMA/STY surfaces may be associated with the microdomain structures of the surface, and will play an important role in long-term in vivo blood compatibility. This manuscript will evaluate the long-term in vivo performance of these polymers, analyze the extent of protein adsorption onto the surfaces, and correlate protein layer thickness to the thrombogenicity of the polymer surfaces.

Adsorption↗
PubMed1992

Formation of a multilayer cellular lining on a polyurethane vascular graft following endothelial cell sodding.

Small-diameter (less than 6 mm) clinically available vascular grafts often fail due in part to the inherent thrombogenicity of artificial polymers. Transplantation of endothelial cells onto the lumen of these vascular grafts has been suggested as one method to overcome this thrombogenicity. We have developed a compliant polyurethaneurea (PEUU) 4-mm graft with a luminal surface modified by a glow discharge gas plasma. Autologous microvessel endothelial cells were isolated from canine falciform ligament fat, were transplanted onto the luminal surface of the grafts using an intraoperative isolation and sodding technique, and both endothelial-cell-treated and non-cell-treated grafts were placed as bilateral carotid interposition grafts in a canine model. After 5 weeks of implantation, explanted control (non-cell-treated) grafts exhibited a deposition of platelets, white cells and fibrin characteristic of a thrombogenic surface. MVEC sodded grafts exhibited a multicellular lining within but distinct from the lumen of the PEUU graft. The blood-contacting surface of this lining exhibited an antithrombogenic endothelial cell monolayer. We suggest that the PEUU graft supported the initial deposition of MVEC and development of and endothelial cell lining. During the 5 weeks of implantation this lining continued to proliferate and detached from the PEUU graft substratum. The final neocellular lining exhibited a luminal diameter and histological features similar to a native artery.

Animals↗
PubMed1993

Variations between Biomer lots. 2: The effect of differences between lots on in vitro enzymatic and oxidative degradation of a commercial polyurethane.

In vitro degradation of two lots of Biomer, a commercial poly(ether urethane urea), has been investigated in order to understand possible mechanisms for in vivo degradation. Two lots of Biomer, BSUA001 and BSP067, were used in the study. Lot BSUA001 contained a poly(diisopropylaminoethyl-methacrylate), an ultraviolet-stabilizing additive. This additive was absent in lot BSP067. Samples of each lot were exposed to two hydrolytic enzymes, papain and leucine aminopeptidase, and to hydrogen peroxide for 24 h. The extent of degradation was assessed using high-pressure gel permeation chromatography and x-ray photoelectron spectroscopy (XPS). Statistically significant changes in the molecular-weight distribution occurred in lot BSP067 for all three treatments. Only the hydrogen peroxide treatment resulted in statistically significant changes in the molecular weight of lot BSUA001. XPS data for samples of lot BSUA001 that had been treated with hydrogen peroxide revealed the formation of nitroso groups and protonated amines at the surface. The data suggest that surface chemistry is important for enzyme catalyzed degradation, while permeability is important for degradation by hydrogen peroxide.

Biocompatible Materials↗
PubMed1993

Protein adsorption and platelet adhesion onto polyurethane grafted with methoxy-poly(ethylene glycol) methacrylate by plasma technique.

Graft polymerization of methoxy-poly(ethylene glycol) methacrylate, an ester of methacrylic acid and monomethoxy-poly(ethylene glycol) (PEO), was performed onto a polyetherurethane (PU) film and tube under different polymerization conditions by a plasma treatment technique. The surface of grafted PU film was characterized by staining with dye, x-ray photoelectron spectroscopy, contact angle, and zeta potential. All these measurements indicated that water-soluble chains were immobilized on the PU surface, their location being restricted to the film surface region. The PU surface showed reduced protein adsorption in vitro and reduced platelet adhesion in vitro and ex vivo. The optimum graft density suppressing the protein adsorption was as low as 5 micrograms cm(-2). When a small amount of dimethacrylate was added to the monomer solution for graft polymerization to introduce crosslinking in the grafted layer, protein adsorption was further slightly reduced. The extent of reduction in serum albumin adsorption was always less than that of gamma-globulin. Although platelet adhesion was largely reduced by the surface graft polymerization, a definite amount of protein was always adsorbed to the grafted surface.

Adsorption↗
PubMed2003

Novel human endothelial cell-engineered polyurethane biomaterials for cardiovascular biomedical applications.

A tri-block coupling-polymer composed of 4,4'-methylenediphenyl diisocyanate and poly (ethylene oxide) (PEO), abbreviated MPEO, was used as the template surface-modifying additive (SMA), based on which selected amino acids (lysine, arginine, glycin, and aspartic acid) and RGD peptide were respectively conjugated as functional endgroups of the PEO spacer-arms through sulfonyl chloride-activation routes. After the immobilization of biofunctional factors, the SMA-MPEO derivatives were noncovalently introduced onto the biomedical poly(ether urethane) (PEU) surfaces by physical blending methods. The SMA synthesis and PEU surface modification were monitored and analyzed by nuclear magnetic resonance spectroscopy, attenuated total reflection-infrared spectroscopy, and X-ray photoelectron spectroscopy. The human umbilical vein endothelial cells (HUVECs) were collected and harvested manually by collagenase digestion. The cell culture was performed respectively on the MPEO derivative-modified PEU surfaces and also on the surfaces of the commercially available polystyrene cell-culture plates (TCPS) for control. The cell adhesion rates and cell proliferation rates of the in vitro cultivated HUVEC were measured using flow cytometry. The individual cell viability rates were determined with MTT assay. The cell morphologies of the living HUVECs were investigated by optical inverted microscopy, and more detailed information was acquired from scanning electrical microscopy. The results indicated that the efficacy of SMA functional endgroups was the dominant factor for HUVEC compatibility; the proper-sized PEO spacers (M(w) 2 k) could support and mobilize the functional endgroups, optimizing the surface (interface) environment for the cell growth. As the endgroups of the SMA-MPEO derivatives and the bio-functional factors, the basic amino acids (lysine and arginine) demonstrated similar performances to that of the widely acknowledged cell growth-promoter, RGD peptide, which were superior to TCPS. Therefore, these MPEO derivative-modified PEU materials are promising to serve as novel polymeric permanent implants or interventional devices for cardiovascular biomedical applications.

Biocompatible Materials↗
PubMed2003

Biodegradation of polyurethane under fatigue loading.

A method utilizing expansion of a diaphragm-type film specimen was developed to study in vitro biodegradation of poly(etherurethane urea) (PEUU) under conditions of dynamic loading (fatigue). A finite element model was used to describe the strain state, which ranged from uniaxial at the edges of the film to balanced biaxial tensile strain at the center. During testing, the film was exposed to a H(2)O(2)/CoCl(2) solution, which simulated in vivo oxidative biodegradation of PEUU. The extent of chemical degradation was determined by infrared analysis. Physical damage of the film surface was characterized by optical microscopy and scanning electron microscopy. Dynamic loading did not affect the rate of degradation relative to unstressed and constant stress (creep) controls in regions of the film that experienced primarily uniaxial fatigue; however, degradation was accelerated in regions that experienced balanced biaxial or almost balanced biaxial fatigue. It was concluded that the combination of dynamic loading and biaxial tensile strain accelerated oxidative degradation in this system. Chemical degradation produced a brittle surface layer that was marked by numerous pits and dimples. Physical damage of the surface in the form of cracking occurred only in fatigue experiments. Cracking was not observed in unstressed or creep tests. Cracks initiated at the dimples produced by chemical degradation, and propagated in a direction that was determined by the strain state.

Biocompatible Materials↗
PubMed2003

Effect of strain and strain rate on fatigue-accelerated biodegradation of polyurethane.

A diaphragm-type film specimen was used to study in vitro degradation of poly(etherurethane urea) (PEUU) under conditions of dynamic loading. This geometry allowed both uniaxial and biaxial loading in a single experiment. During testing, the film was exposed to a H(2)O(2)/CoCl(2) solution that simulated in vivo oxidation of PEUU. The combination of dynamic loading and biaxial tensile strain accelerated oxidative degradation. The effects of biaxial strain magnitude and strain rate were examined separately by increasing the frequency of fatigue loading from 0 to 1 Hz with constant maximum biaxial strain and by changing the maximum biaxial strain while maintaining constant strain rate. In the ranges of biaxial strain energy (0.17 to 0.55 MPa) and strain rate (0 to 46% s(-1)) tested, the rate of degradation increased with increasing strain rate whereas strain magnitude had essentially no effect on degradation rate. Although loading conditions affected the rate of oxidative degradation, ATR-FTIR analysis suggested that in all cases the mechanism of degradation did not change. Chemical degradation produced a brittle crosslinked surface layer marked by dimpling and pitting, as observed with scanning electron microscopy. Pits served as stress concentrators and initiated environmental stress cracks under dynamic loading but not under static (creep) loading. Small pits were sufficient to initiate cracks at higher strain rates whereas only large pits initiated cracks at lower strain rates. Consequently, a higher strain rate produced more profuse cracking.

Biodegradation, Environmental↗
PubMed2006

Sub-micron texturing for reducing platelet adhesion to polyurethane biomaterials.

Platelet adhesion is a key event in thrombus development on blood-contacting medical devices. It has been demonstrated that changes to the chemistry of a material surface can reduce platelet adhesion. In this work, it is hypothesized that sub-micron surface textures may also reduce adhesion via a decrease in the surface area of material with which platelets can make contact, and hence a decreased probability of interaction with adhesive ligands. A polyether(urethane urea) was textured with two different sizes of sub-micron pillars using a replication molding technique that did not alter the material surface chemistry. Adhesion of platelets was assessed in a physiologically relevant shear stress range of 0-67 dyn/cm2 using a rotating disk system. Platelets were immunofluorescently labeled and adhesion was compared on smooth and textured samples. Platelet adhesion was greatest at low shear stress ranging from 0 to 5 dyn/cm2, and sub-micron textures were observed to reduce platelet adhesion in this range. Additionally, non-adherent platelets did not demonstrate large-scale activation after exposure to textured samples. We conclude that surface textures with sub-platelet dimensions may reduce platelet adhesion from plasma to polyether(urethane urea) at low shear stress.

Animals↗
PubMed1988

Comparison among five mutagenicity assays in workers producing polyurethane foams.

Thirty-two male individuals exposed to isocyanates and amines during the production of plastic foams and 20 male referents were studied by cytogenetic methods (chromosomal aberrations, sister chromatid exchanges and micronuclei in lymphocytes) and by urinary mutagenic assays (thioether concentrations and mutagenic activity with Salmonella TA98 and E. Coli WP2 uvrA). The occupational exposure was monitored by measurements of toluene diisocyanate and N-methylmorpholine in work-room air. The levels were below the current Swedish hygienic standards. Although all parameters, except the sister chromatid exchanges, showed increased mean values for the exposed group compared to the referents, only the urinary thioether concentrations differed significantly. The study was, however, non-conclusive with regard to a genetic effect of the occupational exposure as measured by the cytogenetic parameters. This may be due to the low exposure level. In the micronuclei frequencies there was a significant effect of age. Smoking significantly affected the SCE frequencies, the thioether concentrations and the mutagenic activities in the Salmonella assay. There were statistically significant correlations between the urine specimens collected during one working day and the following morning with regard to the mutagenic activities in the Salmonella and E. coli assays, and in the thioether concentrations as well. The association between the different cytogenetic and urinary mutagenic assays were weak but there were several statistically significant correlation coefficients, indicating that the variables may have a common metabolic background.

Adult↗
PubMed1978

[Biological compatibility of polyurethan (PUR) (author's transl)].

After implantation of a disc (thickness: 0.25 mm, diam: 1.5 mm) of PUR in the anterior chamber of rabbits through a lancet incision, the reactions of iris, aqueous, and cornea were observed for six months at regular intervals using slit-lamp photography. 'Steeping' materials were as compatible as nonsteeping materials. At the place where the disc touched the iris one could see during a half-year period hyperemia iridis and foreign-substance granuloma of the iris. The cause of these reactions is a toxin in the PUR. Mechanical irritants as a cause could be excluded through the method utilized in the experiment.

Animals↗