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Biocompatibility and implantation properties of 2 differently braided, biodegradable, self-reinforced polylactic acid urethral stents: an experimental study in the rabbit.

PURPOSE: Biodegradable urethral stents have been in clinical use for more than 10 years. To solve the problems connected with the helical spiral configuration of the stents used to date we developed a new tubular mesh configuration and evaluated the biocompatibility properties and degradation time of 2 differently braided stents in the rabbit urethra. MATERIALS AND METHODS: The biodegradable, self-expanding stents were made of self-reinforced polylactic acid polymer blended with BaSO4 (Alfa Chem, Kings Point, New York). Two braiding patterns, namely a diamond 1/1 and a regular 2/2 + 1 (Prodesco, Perkasie, Pennsylvania), were used to produce a tubular mesh configuration. Stainless steel stents with 1/1 braiding served as controls. The stents were inserted into the posterior urethra of 36 male rabbits. The animals were sacrificed after 1 week, 1 month, 6 months or 12 months. Light microscopy and scanning electron microscopy analyses were done. RESULTS: Tissue reactions to operative trauma were seen in all specimens at week 1. The changes gradually abated in the biodegradable stent groups, whereas chronic inflammatory changes and fibrosis were increasingly seen with metallic stents after 6 months. Epithelial hyperplasia increased with time for all stent types and materials. As expected, stent fragmentation started at 6 months. CONCLUSIONS: Biodegradable polymers are suitable materials for braided urethral stents. However, the braided configuration of the stent with a decreased mass of material does not prevent the development of epithelial hyperplasia. The biodegradable, self-expanding, braided stents functioned well in the rabbit urethra and are suitable for clinical studies.

Absorbable Implants↗

Methods for assessment of biodegradability of plastic films in soil.

Traditional and novel techniques were tested and compared for their usefulness in evaluating biodegrad-ability claims made for newly formulated "degradable" plastic film products. Photosensitized polyethylene (PE), starch-PE, extensively plasticized polyvinyl chloride (PVC), and polypropylene (PP) films were incorporated into aerobic soil. Biodegradation was measured for 3 months under generally favorable conditions. Carbon dioxide evolution, residual weight recovery, and loss of tensile strength measurements were supplemented, for some films, by gas chromatographic measurements of plasticizer loss and gel permeation chromatographic (GPC) measurement of polymer molecular size distribution. Six- and 12-week sunlight exposures of photosensitized PE films resulted in extensive photochemical damage that failed to promote subsequent mineralization in soil. An 8% starch-PE film and the plasticized PVC film evolved significant amounts of CO(2) in biodegradation tests and lost residual weight and tensile strength, but GPC measurements demonstrated that all these changes were confined to the additives and the PE and PVC polymers were not degraded. Carbon dioxide evolution was found to be a useful screening tool for plastic film biodegradation, but for films with additives, polymer biodegradation needs to be confirmed by GPC. Photochemical cross-linking of polymer strands reduces solubility and may interfere with GPC measurements of polymer degradation.

Journal Article↗

Efficacy and safety of biodegradable osteofixation devices in oral and maxillofacial surgery: a systematic review.

The use of osteofixation devices should be evidence-based if uncomplicated bone healing is to be achieved. Numerous studies describe and claim the advantages of biodegradable over titanium devices as a bone fixation method. Here, we systematically review the available literature to determine the clinical efficacy and safety of biodegradable devices compared with titanium devices in oral and maxillofacial surgery. In addition, related general aspects of bone surgery are discussed. We conducted a highly sensitive search in the databases of MEDLINE (1966-2005), EMBASE (1989-2005), and CENTRAL (1800-2005) to identify eligible studies. Eligible studies were independently evaluated by two assessors using a quality assessment scale. The study selection procedure revealed four methodologically 'acceptable' articles. Owing to the different outcome measures used in the studies, it was impossible to perform a meta-analysis. Therefore, the major effects regarding the stability and morbidity of fracture fixation using titanium and biodegradable fixation systems were qualitatively described. Any firm conclusions regarding the fixation of traumatically fractured bone segments cannot be drawn, due to the lack of controlled clinical trials. Regarding the fixation of bone segments in orthognathic surgery, only a few controlled clinical studies are available. There does not appear to be a significant short-term difference between titanium and biodegradable fixation systems regarding stability and morbidity. However, definite conclusions, especially with respect to the long-term performance of biodegradable fixation devices used in maxillofacial surgery, cannot be drawn.

Absorbable Implants↗

Drug-eluting biodegradable poly-D/L-lactic acid vascular stents: an experimental pilot study.

PURPOSE: To evaluate in vivo a new drug-eluting biodegradable vascular stent with respect to biocompatibility, neointimal hyperplasia formation, and reliability. METHODS: Self-expanding biodegradable poly-96L/4D-lactic acid (PLA) stents with 2 drugs (PLA + dexamethasone [DEX] and PLA + simvastatin [SIM]) and 2 different coatings (PLA + P(D,L)LA and PLA + polycaprolactone [PCL]) were compared with a self-expanding stainless steel Wallstent. The stents were implanted in both common iliac arteries of 8 pigs. Prior to sacrifice at 1 month, angiography was performed to determine patency. Specimens were harvested for quantitative histomorphometry; vascular injury and inflammation scores were assigned to the stented iliac segments. RESULTS: All stented arteries were angiographically patent. The mean luminal diameter (3.05 mm) and area (30.36 mm2) of DEX-eluting PLA stents were decreased compared to other stents (PLA + P(D,L)LA: 3.66 mm and 43.92 mm2; PLA + SIM: 4.21 mm and 56.48 mm2; PLA + PCL: 4.19 mm and 54.64 mm2; Wallstent: 5.01 mm and 81.19 mm2). Wallstents and DEX-eluting PLA stents induced minimal intimal hyperplasia: PLA + DEX: 0.16 mm, PLA + P(D,L)LA: 0.35 mm, PLA + SIM: 0.33 mm, PLA + PCL: 0.29 mm, and Wallstent: 0.18 mm. The vascular injury scores demonstrated only mild vascular trauma for all stents. Only mild to moderate inflammatory reaction was noted around stent struts with a vascular inflammation score. CONCLUSIONS: Biodegradable polymer stents appear to be biocompatible and reliable, causing minimal neointimal hyperplasia. Furthermore, the new biodegradable poly-D/L-lactic acid stent can be used as a local drug delivery vehicle. The DEX-eluting PLA stent reduces neointimal hyperplasia. The findings show a need for further investigation to prove the efficacy and safety of this new biodegradable drug-eluting stent.

Absorbable Implants↗

Simulation of DEHP biodegradation and sorption during the anaerobic digestion of secondary sludge.

Di-ethylhexyl phthalate (DEHP) has commonly been found in the sludge of municipal wastewater treatment plants especially during anaerobic processing. It is slowly biodegradable under anaerobic conditions. Due to its high hydrophobicity, sorption-desorption processes can be rate-limiting for the compound biodegradation. In this study, the anaerobic biodegradation of DEHP was investigated through batch kinetic experiments and dynamic transitions of a continuous stirred tank reactor (CSTR) fed with secondary sludge contaminated with DEHP. A widely accepted model (ADM1) was used to fit the anaerobic digestion of secondary sludge and was properly extended to account for DEHP removal, in which mass transfer processes are also involved. It was shown that DEHP removal was limited by the transfer of DEHP within the solid fraction. The criterion selected for the distinction of the two sites was whether the compound sorbed in those sites was bioavailable for biodegradation or not. Thus, the aqueous phase and the surface of the biosolids were considered as suitable sites for the compound to be bioavailable and the main bulk of the solid matrix was regarded as sites, where the compound remains "protected" against biodegradation. The model, fitted to the batch experimental data, was able to predict DEHP removal in the CSTR operated at various HRTs.

Anaerobiosis↗

[Orthopaedic applications for biodegradable and absorbable internal fixation of fractures].

OBJECTIVE: To illustrate the effect and complication of orthopedic applications for biodegradable and absorbable internal fixation of fractures, and to indicate the existent problem and research aspect currently. METHODS: The recent literatures on orthopedic applications and study of biodegradable and absorbable internal fixation for fractures were reviewed. The effect of biodegradable materials on bone healing was summarized. RESULTS: It is good for the stability of fracture fixation and result of treatment. The biodegradable and absorbable internal fixation fractures had no adverse effect on bone healing. CONCLUSION: There will be more widespread application for biodegradable and absorbable materials in orthopedics, but the intensive research should be carried out to prevent its complication.

Absorbable Implants↗

Annuloplasty for valve repair with a new biodegradable ring: an experimental study.

BACKGROUND AND AIM OF THE STUDY: The biodegradable ring was recently developed for mitral and tricuspid annuloplasty. The study aim was to assess the histological biocompatibility of the biodegradable ring and orifice area growth in a porcine model. METHODS: The smallest (size 16) biodegradable ring was implanted into the tricuspid annulus of 16 juvenile pigs. All animals were followed up by transthoracic echocardiography to evaluate tricuspid valve function. Animals were sacrificed at one, three, six, nine and 12 months after implantation. Macroscopic and histological analyses were performed on three sections per ring implantation site. Parameters from the study group were compared to those obtained from control animals that underwent cardiopulmonary bypass without ring implantation. RESULTS: Histological examination showed that the biodegradable ring was gradually replaced by fibrous tissue, with complete hydrolytic degradation within six months. The thickness of the dense fibrous tissue reached that of the initial ring at 12 months. No fibrous tissue development was observed in control animals. Echocardiography showed no signs of tricuspid valve dysfunction, a preserved ventricular contractility, and physiological growth of the tricuspid valve orifice. Macroscopic measurement of the valve orifice area confirmed that the generated fibrous tissue allows for physiological growth of the native annulus. CONCLUSION: The concept of annulus remodeling using a biodegradable ring which preserves the growth potential of the native annulus opens new perspectives for valve repair procedures in the pediatric population. An undoubted contribution is also made to evolving annuloplasty technology.

Absorbable Implants↗

Demonstration of efficient trichloroethylene biodegradation in a hollow-fiber membrane bioreactor.

Rapid cometabolism of trichloroethylene (TCE) by pure cultures of Methylosinus trichosporium OB3b PP358 was demonstrated in a two-stage hollow-fiber membrane bioreactor over the course of 3 weeks. PP358 was grown in a continuous-flow chemostat and circulated through the shell of a hollow-fiber membrane module (HFMM), while TCE contaminated water (160 to 1450 micrograms/L) was pumped through the fiber lumen (fiber interior). In parallel-flow HFMM biological experiments, 82% to 89% of the influent TCE was removed from the lumen (5.1-min residence time) with 99% of the transferred TCE undergoing biodegradation. Biological experiments in a larger capacity baffled radial-flow HFMM resulted in 66% to 99% TCE transferred and 93% to 96% TCE biodegradation at lumen residence times of between 1.5 and 3.7 min. Biodegradation was maintained throughout the experiments at pseudo-first-order biodegradation rate constants of 0.41 to 2.8 L/mg TSS/day. Best-fit computer modeling of the baffled radial-flow biological process estimated mass transfer coefficients as large as 2.7 x 10(-2) cm/min. The computer model was also shown to simulate the experimental results quite well.

Biodegradation, Environmental↗

Kinetic model of biosurfactant-enhanced hexadecane biodegradation by Pseudomonas aeruginosa.

Many sites of environmental concern contain groundwater contaminated with nonaqueous phase liquids (NAPL). In such sites interfacial processes may affect both the equilibrium and kinetic behavior of the system. In particular, insoluble hydrocarbon partitioning and microbial biodegradation of insoluble hydrocarbon are influenced by the physicochemical and interfacial characteristics of the system. A mechanistic model describing the influence of biological surfactants on microbial biodegradation of liquid-phase insoluble hydrocarbon and subsequent reduction of nonaqueous-phase liquid hydrocarbon is presented. The model consists of six coupled differential equations which use lumped kinetic parameters to describe surfactant micelle formation and diffusion to the microbial cell, nonlinear kinetic expressions for microbial growth and degradation of insoluble hydrocarbon, kinetic spatial descriptions of the change in NAPL-phase droplet size and the organic phase volume fraction with time, as well as equilibrium partitioning expressions for hydrophobic organic contaminant partioning into the surfactant micelle. The model is validated by comparison to data obtained for hexadecane degradation in a well-mixed batch system by the biosurfactant producing microorganism Pseudomonas aeruginosa strain PG201 as well as for nonproducing mutants' growth and hexadecane biodegradation in the presence of exogenously added biosurfactant. Experimentally determined biological growth parameters, as well as physical parameters such as hydrocarbon droplet size, were applied in the kinetic model. Parameter sensitivity analysis was performed on the physical and biological parameters in the model. The parameter sensitivity analysis indicates that for the biological system examined the rate of hydrocarbon solubilization and micellar transport to the cell controls the rate at which cellular uptake and biodegradation of insoluble hydrocarbon occurs. Practical aspects relating to use of the model for support of surfactant-based bioremediation efforts are discussed.

Alkanes↗

Soya lecithin effects on the aerobic biodegradation of polychlorinated biphenyls in an artificially contaminated soil.

The effects of the phytogenic surfactant soya lecithin (SL) on the aerobic biodegradation of polychlorinated biphenyls (PCBs) spiked into a synthetic soil were studied. Soil was spiked with both biphenyl (4 g/kg) and Fenclor 42 (1,000 mg/kg) and treated in aerobic batch slurry-phase microcosms (17.5% w/v). Microcosms were prepared either with or without the exogenous aerobic PCB-dechlorinating bacterial co-culture ECO3 (inoculum:10(8) CFU/mL). In some inoculated microcosms, SL was added at 15 or 30 g/kg. Indigenous bacteria having the capability of metabolizing biphenyl and 2-chlorobenzoic acid were found to develop in the microcosms during the experiment, and were responsible for the significant PCB biodegradation and dechlorination observed in the uninoculated controls. The addition of ECO3 bacteria resulted in only a slight PCB biodegradation increase. In the presence of SL, a higher availability of biphenyl- and chlorobenzoic acid-degrading bacteria and higher PCB biodegradation and dechlorination yields were observed; the effects increased proportionally with the concentration of the applied SL. A significant decrease of soil ecotoxicity was also revealed in SL-supplemented microcosms. At both concentrations, SL was found to be a good carbon source for both the indigenous and ECO3 bacteria, as well as a product capable of enhancing the PCB bioavailability in the microcosms.

Aerobiosis↗

Biodegradation of crude oil across a wide range of salinities by an extremely halotolerant bacterial consortium MPD-M, immobilized onto polypropylene fibers.

The bacterial consortium MPD-M, isolated from sediment associated with Colombian mangrove roots, was effective in the treatment of hydrocarbons in water with salinities varying from 0 to 180 g L(-1). Where the salinity of the culture medium surpassed 20 g L(-1), its effectiveness increased when the cells were immobilized on polypropylene fibers. Over the range of salinity evaluated, the immobilized cells significantly enhanced the biodegradation rate of crude oil compared with free-living cells, especially with increasing salinity in the culture medium. Contrary to that observed in free cell systems, the bacterial consortium MPD-M was highly stable in immobilized systems and it was not greatly affected by increments in salinity. Biodegradation was evident even at the highest salinity evaluated (180 g L(-1)), where biodegradation was between 4 and 7 times higher with immobilized cells compared to free cells. The biodegradation of pristane (PR) and phytane (PH) and of the aromatic fraction was also increased using cells immobilized on polypropylene fibers.

Avicennia↗

Biodegradation of gasoline by gellan gum-encapsulated bacterial cells.

Encapsulated cell bioaugmentation is a novel alternative solution to in situ bioremediation of contaminated aquifers. This study was conducted to evaluate the feasibility of such a remediation strategy based on the performance of encapsulated cells in the biodegradation of gasoline, a major groundwater contaminant. An enriched bacterial consortium, isolated from a gasoline-polluted site, was encapsulated in gellan gum microbeads (16-53 microm diameter). The capacity of the encapsulated cells to degrade gasoline under aerobic conditions was evaluated in comparison with free (non-encapsulated) cells. Encapsulated cells (2.6 mg(cells) x g(-1) bead) degraded over 90% gasoline hydrocarbons (initial concentration 50-600 mg x L(-1)) within 5-10 days at 10 degrees C. Equivalent levels of free cells removed comparable amounts of gasoline (initial concentration 50-400 mg x L(-1)) within the same period but required up to 30 days to degrade the highest level of gasoline tested (600 mg x L(-1)). Free cells exhibited a lag phase in biodegradation, which increased from 1 to 5 days with an increase in gasoline concentration (200-600 x mg L(-1)). Encapsulation provided cells with a protective barrier against toxic hydrocarbons, eliminating the adaptation period required by free cells. The reduction of encapsulated cell mass loading from 2.6 to 1.0 mg(cells) x g(-1) bead caused a substantial decrease in the extent of biodegradation within a 30-day incubation period. Encapsulated cells dispersed within the porous soil matrix of saturated soil microcosms demonstrated a reduced performance in the removal of gasoline (initial concentrations of 400 and 600 mg x L(-1)), removing 30-50% gasoline hydrocarbons compared to 40-60% by free cells within 21 days of incubation. The results of this study suggest that gellan gum-encapsulated bacterial cells have the potential to be used for biodegradation of gasoline hydrocarbons in aqueous systems.

Bacteria↗

Measurement of biodegradability parameters for single unsubstituted and methylated polycyclic aromatic hydrocarbons in liquid bacterial suspensions.

Substrate depletion experiments were conducted to characterize aerobic biodegradation of 20 single polycyclic aromatic hydrocarbons (PAHs) by induced Sphingomonas paucimobilis strain EPA505 in liquid suspensions. PAHs consisted of low molecular weight, unsubstituted, and methyl-substituted homologs. A material balance equation containing the Andrews kinetic model, an extension of the Monod model accounting for substrate inhibition, was numerically fitted to batch depletion data to estimate extant kinetic parameters including the maximal specific uptake rates, q(max), the affinity coefficients, K(S), and the substrate inhibition coefficients, K(I). Strain EPA505 degraded all PAHs tested. Applied kinetic models adequately simulated experimental data. A cell proliferation assay involving reduction of the tetrazolium dye WST-1 was used to evaluate the ability of strain EPA505 to utilize individual PAHs as sole energy and carbon sources. Of the 22 PAHs tested, 9 supported bacterial growth. Evaluation of the biokinetic data showed that q(max) correlated highly with transmembrane flux as theoretically estimated by a diffusion model, pointing to transmembrane transport as a potential rate-determining process. The biodegradability data generated in this study is essential for the development of quantitative structure-activity relationships (QSARs) for biodegradability and for modeling biodegradation of simple PAH mixtures.

Biodegradation, Environmental↗

Mechanical properties of biodegradable polymers and composites proposed for internal fixation of bone.

The mechanical properties of biodegradable polymers and composites proposed for use in internal fixation (in place of stainless steel) are crucial to the performance of devices made from them for support of healing bone. To assess the reported range of properties and degradation rates, we searched and reviewed papers and abstracts published in English from 1980 through 1988. Mechanical property data were found for poly(lactic acid), poly(glycolic acid), poly(epsilon-caprolactone), polydioxanone, poly(ortho ester), poly(ethylene oxide), and/or their copolymers. Reports of composites based on several of these materials, reinforced with nondegradable and degradable fibers, were also found. The largest group of studies involved poly(lactic acid). Mechanical test methods varied widely, and studies of the degradation of mechanical properties were performed under a variety of conditions, mostly in vitro rather than in vivo. Compared to annealed stainless steel, unreinforced biodegradable polymers were initially up to 36% as strong in tension and 54% in bending, but only about 3% as stiff in either test mode. With fiber reinforcement, reported highest initial strengths exceeded that of stainless steel. Stiffness reached 62% of stainless steel with nondegradable carbon fibers, 15% with degradable inorganic fibers, but only 5% with degradable polymeric fibers. The slowest-degrading unreinforced biodegradable polymers were poly(L-lactic acid) and poly(ortho ester). Biodegradable composites with carbon or inorganic fibers generally lost strength rapidly, with a slower loss of stiffness, suggesting the difficulty of fiber-matrix coupling in these systems. The strength of composites reinforced with (lower modulus) degradable polymeric fibers decreased more slowly. Low implant stiffness might be expected to allow too much bone motion for satisfactory healing. However, unreinforced or degradable polymeric fiber reinforced materials have been used successfully clinically. The key has been careful selection of applications, plus use of designs and fixation methods distinctly different from those appropriate for stainless steel devices.

Biocompatible Materials↗

The biodegradation mechanism of calcium phosphate biomaterials in bone.

This study was undertaken to understand the biodegradation mechanisms of calcium phosphate (Ca-P) biomaterials with different crystallization. Two types of sintered Ca-P porous ceramic (HA and beta-TCP) and a Ca-P bone cement (CPC) were implanted into cavities drilled in rabbit femoral and tibiae condyles. The results have shown that a material biodegradation was rapid in the beta-TCP and the CPC, but very weak in the HA. This biodegradation presented a decrease of material volume from the periphery to the center as well as a particle formation causing phagocytosis by numerous macrophages and multinucleated giant cells in the CPC. In the beta-TCP, there was a peripheral and central decrease of material volume as well as an absence of particle formation or visible phagocytosis. The process of biodegradation is considered to be directly influenced by the type of material crystallization. The sintered bioceramics processed at a high temperature exhibit good crystallization and are primarily degraded by a process dependent on interstitial liquids. However, the bone cement is formed by physicochemical crystallization and is degraded through a dissolution process associated with a cellular process.

Animals↗

Brain biocompatibility of a biodegradable, controlled-release polymer in rats.

We report the biocompatibility in the rat brain of a controlled-release, biodegradable polymer, the polyanhydride poly-[bis(p-carboxyphenoxy)propane-sebacic acid] copolymer (PCPP-SA) in a 20:80 formulation. The biodegradable polyanhydride can be used for drug delivery directly into the brain, circumventing the difficulties posed by the blood-brain barrier and avoiding the consequences of having to administer toxic doses systematically to reach therapeutic doses in the central nervous system. The tissue reaction in the presence of PCPP-SA was compared to that seen with other standard neurosurgical implants. Fifty-six adult Sprague-Dawley rats were assigned to one of seven groups and underwent bilateral frontal lobe implantation of PCPP-SA (42 hemispheres), Surgicel (oxidized regenerated cellulose) (35 hemispheres), or Gelfoam (absorbable gelatin sponge) (35 hemispheres). None of the animals showed any behavioral changes or neurological deficits suggestive of either systemic or localized toxicity from the biodegradable polyanhydride, all surviving to the scheduled data of sacrifice. PCPP-SA evoked a well localized inflammatory reaction, comparable to that of Surgicel, which resolved as the PCPP-SA polymer degraded over five weeks. The biodegradable polyanhydride has been shown in this study to be nontoxic and biocompatible in the rat brain, when compared to standard neurosurgical implants.

Animals↗

Neocartilage formation in vitro and in vivo using cells cultured on synthetic biodegradable polymers.

Cartilaginous implants for potential use in reconstructive or orthopedic surgery were created using chondrocytes grown on synthetic, biodegradable polymer scaffolds. Chondrocytes isolated from bovine or human articular or costal cartilage were cultured on fibrous polyglycolic acid (PGA) and porous poly(L)lactic acid (PLLA) and used in parallel in vitro and in vivo studies. Samples were taken at timed intervals for assessment of cell number and cartilage matrix (sulfated glycosaminoglycan [S-GAG], collagen). The chondrocytes secreted cartilage matrix to fill the void spaces in the polymer scaffolds that were simultaneously biodegrading. In vitro, chondrocytes grown on PGA for 6 weeks reached a cell density of 5.2 x 10(7) cells/g, which was 8.3-fold higher than at day 1, and equalled the cellularity of normal bovine articular cartilage. In vitro, the cell growth rate was approximately twice as high on PGA as it was on PLLA; cells grown on PGA produced S-GAG at a high steady rate, while cells grown on PLLA produced only minimal amounts of S-GAG. These differences could be attributed to polymer geometry and biodegradation rate. In vivo, chondrocytes grown on both PGA and PLLA for 1-6 months maintained the three-dimensional (3-D) shapes of the original polymer scaffolds, appeared glistening white macroscopically, contained S-GAG and type II collagen, and closely resembled cartilage histologically. These studies demonstrate the feasibility of culturing isolated chondrocytes on biodegradable polymer scaffolds to regenerate 3-D neocartilage.

Animals↗

Oxidative biodegradation mechanisms of biaxially strained poly(etherurethane urea) elastomers.

As part of ongoing studies in polyurethane biostability and biodegradation, we have investigated an in vitro system to test strained poly(etherurethane urea) (PEUU). Recently, we utilized this system to reproduce in vivo stress cracking in strained Pellethane. In this study, strained PEUU was tested to determine whether it degrades through a common mechanism with Pellethane and to further examine the steps involved in this degradation. Biaxially strained PEUU elastomers were treated with an alpha 2-macroglobulin (alpha 2-Mac) protein solution followed by an oxidative H2O2/CoCl2 treatment. Characterization of the strained PEUU specimens was performed with attenuated total reflectance-Fourier transform infrared spectroscopy, scanning electron microscopy (SEM), electron spectroscopy for chemical analysis, and contact angle analysis. The results from these characterization techniques provide conclusive evidence that biodegradation of PEUU and Pellethane occurs through a common mechanism. Chemical changes to the PEUU include cleavage of the polyether soft segments and urethane linkages, leaving the hard segment domains unaffected. SEM analysis shows that this chain cleavage leads to the development of severe pitting and cracking of the PEUU surface. In addition, the in vitro degradation accurately reproduces the in vivo degradation chemically and physically. This result verifies that the primary species responsible for biodegradation of PEUUs, in vivo, are hydroxyl and/or hydroperoxide radicals. alpha 2-Mac pretreatment increases the rate of degradation compared to direct treatment in H2O2/CoCl2. As the PEUU soft segment chains are cleaved, the degradation products are extracted into the treatment solution or environment. Finally, a new biodegradation mechanism of PEUUs is presented that involves crosslinking of the polyether soft segments.

Adsorption↗