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  • 1
    ISSN: 1573-4838
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: Abstract In this study in vitro predegradation at elevated temperatures, used to obtain an increased degradation rate, was investigated. The in vitro degradation was followed by mass loss, molecular weight loss and changes in thermal properties. Two biodegradable polymers, the homopolymer PLLA and a copolymer PLA96 (96% L4%D lactide), were hydrolytically degraded at 90°C in a phosphate buffered solution. Both polymers, PLLA and PLA96, showed an initial linear degradation rate, but with longer implantation periods the degradation rate decreased and total degradation was best described as an asymptotic. Mass loss of the copolymer PLA96 was twice that of PLLA. The chemical analysis of the in vitro predegraded polymers coincided for both the decrease in molecular weight and the thermal properties with physiologically degraded poly(lactide). The results of this study show that although the degradation temperature is well above the glass transition temperature and not comparable to physiological temperatures, there seems to be good correlation between the in vitro degraded material and physiologically degraded material. In vitro predegradation enables investigation of the entire degradation process of a polymer in a short-term study. Moreover, in vitro predegradation allows direct comparison of the degradation rate of various polymers.
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  • 2
    ISSN: 1573-4838
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: Abstract To investigate the mechanical and physical properties of, and the histological reaction to, as-polymerized poly(96L/4D-lactide) (PLA96), a degradation study was performed in vitro and in rats. The PLA96 studied had a molecular weight (Mw) of 1.5×106 g/mole. Test samples were implanted subcutaneously in the back of rats or put in phosphate-buffer. The mechanical and physical properties of PLA96 showed major changes during the first 3 weeks of degradation. Tensile strength (δb), impact strength and Mw decreased rapidly. The heat of fusion (ΔH m), a measure for crystallinity, increased whereas the melting temperature (T m) remained almost constant. The mechanical properties were lost completely after 7 weeks of degradation. After 55 weeks, both water absorption and mass loss had reached approximately 30%, and Mw had decreased to 15×103 g/mole. ΔH m had slightly increased further but T m remained unchanged. The measurements during degradation in vitro did not show significant (p〉0.05) differences from the measurements during degradation in vivo. The histological reaction to PLA96 could be characterized as a mild foreign body reaction without signs of inflammation.
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  • 3
    ISSN: 1573-4838
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: To test the mechanical and physical properties of two types of poly(96L/4D-lactide) (PLA96) implants and to evaluate their suitability for repair of large orbital floor defects, a study using an in vitro set-up was performed. Implants, 0.2 mm thick and 28 mm in diameter, were produced by either an extrusion process (type A) or by direct machining (type B) and had a molecular weight % MathType!MTEF!2!1!+-% feaafiart1ev1aaatCvAUfeBSjuyZL2yd9gzLbvyNv2CaerbuLwBLn% hiov2DGi1BTfMBaeXatLxBI9gBaerbd9wDYLwzYbItLDharqqtubsr% 4rNCHbGeaGqiVu0Je9sqqrpepC0xbbL8F4rqqrFfpeea0xe9Lq-Jc9% vqaqpepm0xbba9pwe9Q8fs0-yqaqpepae9qq-f0-yqaqVeLsFr0-vr% 0-vr0db8meaabaqaciGacaGaaeqabaWaaeaaeaaakeaacaqGOaWaa0% aaaeaacaWGnbaaamaaBaaaleaacaqG3baabeaakiaacMcaaaa!3CA8!\[{\text{(}}\overline M _{\text{w}} )\] of 64×103 and 146×103 g/mole, respectively, after γ-sterilization with a dose of 25 kGy. The implants were tested over 8 weeks in an apparatus simulating the human orbit with a 3.1 cm2 orbital floor defect under a static load corresponding to a retrobulbar pressure of 13 mm Hg as well as unloaded. Both implant types were able to counteract the applied static load without fracturing or excessive sagging. The type A implants sagged more than the type B implants (2.3±0.1 mm versus 1.0±0.0 mm, p〈0.01) but retained and even increased their strength during the study whereas the type B implants showed a gradual strength-loss. In the clinical setting the observed sagging in both types would not have resulted in positional changes of the eyeball. It is concluded that with respect to the mechanical properties, both types of PLA96 implants tested are suitable for repair of large orbital floor defects.
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  • 4
    Electronic Resource
    Electronic Resource
    Springer
    Journal of materials science 5 (1994), S. 575-581 
    ISSN: 1573-4838
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: High molecular weight as-polymerized poly(I-lactide) (PLLA) has been successfully used for fracture fixation and orbital floor reconstruction in animals and humans. As this PLLA takes more than 3 years to resorb, a method was developed to obtain insight into the final cellular degradation process of the PLLA by means of short-lasting animal experiments. Pre-degraded PLLA particles (〈 500 μm) were implanted subcutaneously in the backs of 14 rats. Two different methods of sterilization (regular steamsterilization and gamma-irradiation) and implantation vehicles (gelatin capsules and hydroxypropyl-methylcellulose (HPMC)) were used to examine the biological behaviour of the pre-degraded PLLA. Two rats were sacrificed at 48 h, 3 days and 1, 2, 4, 8, 16 weeks following the operation. The tissues were examined using light microscopy and transmission electron microscopy. Gel permeation chromatography (GPC) and differential scanning calorimetry (DSC) were used to characterize the PLLA material. GPC measurements of the pre-degraded PLLA revealed a M n of 5500. Upon hydrolysation the crystallinity of the PLLA increased by about 60% and the heat of fusion was 86 J g-1. Deterioration of the mechanical and physical properties due to the two sterilization methods was negligible. No differences in cellular response were observed between the densely packed PLLA particles (gelatin capsules) and the particles scattered over the tissue (HPMC-gel). The present study enabled an early observation of the late degradation phase of PLLA.
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  • 5
    ISSN: 1573-4838
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: During degradation of high molecular weight as-polymerized poly(l-lactide) (PLLA) late complications such as swelling of the subcutaneously implanted bone plates have been observed in patients. However, in the same patients the intraosseously implanted PLLA screws did not give rise to any complications. To investigate a possible difference in the degradation and histological response due to the site of implantation, subcutaneous and intraosseous implantation studies are necessary. In the present study rods of PLLA and a copolymer poly(96l/4d-lactide) (PLA96) and predegraded PLLA and PLA96 were implanted intraosseously in rabbit tibiae. In vitro predegradation at elevated temperatures was used to obtain an enhanced degradation rate to simulate long-term physiological degradation. Animals were sacrificed after a postoperative period varying from 2 to 26 weeks. The predegraded PLLA and PLA96 implants showed a high rate of fragmentation and internalization of particles by macrophages. In the medullary cavity large fields of macrophages and, with the predegraded PLA96 implants, haemorrhages and infiltrates were noted, but no osteolytic changes were observed in the cortical bone. It can be concluded that, based on the disintegration of the implants and the accompanying histological reaction, a reaction similar to that found with subcutaneous implants in former studies had occurred. This indicates that not only the site of implantation, subcutaneous or intraosseous, but a number of other factors will affect the degradation process and the corresponding histological response.
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  • 6
    Electronic Resource
    Electronic Resource
    New York, NY [u.a.] : Wiley-Blackwell
    Journal of Applied Biomaterials 2 (1991), S. 23-28 
    ISSN: 1045-4861
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: As-polymerized poly(L-lactide) test rods were sterilized by seven different specially designed computer-operated autoclaving programs. As a control, common hospital sterilization was performed. In all cases, the molecular weight decreased after sterilization. A short time high-temperature sterilization lead to less molecular weight decrease than a low sterilization temperature cycle with a longer sterilization time. Regular hospital sterilization significantly reduced the elongation at break and also resulted in a decrease of 35% in tensile strength. The program causing minimal damage to the material properties was studied in detail. This program, with a steriliztioan period of 60 s and 129°C, was effective for PLLA steriliztation and also looks very promising for sterilization of other thermo- and moisture-labile polymers.
    Additional Material: 1 Ill.
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  • 7
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 29 (1995), S. 173-179 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: To evaluate the biocompatibility of in vitro predegraded as polymerized poly(L-lactide) (PLLA), a cage implant system was used to investigate white cell and enzyme concentrations with time. The use of a cage permits in a serial fashion a quantitative and qualitative measurement of exudate components formed around an implant. Subcutaneously in rats, caped cages manufactured from stainless-steel mesh were implanted with in vitro predegraded, as-polymerized PLLA, as-polymerized PLLA cylinders, and empty cages serving as controls. In vitro predegradation was used to simulate the degradation products of long-term in vitro degradation. Predegraded PLLA particles were obtained by in vitro hydrolysis at elevated temperatures. The first 7 days of implantation were characterized by an acute inflammatory reaction; the exudate extracted from the cages showed predominantly neutrophils for all types of implants. After day 7, there was a more chronic inflammatory reaction with predominantly macrophages and lymphocytes. There were no significant differences in the total leukocyte concentration or macrophage concentration for any of the cages in the period from 10-21 days. Extracellular enzyme activity also did not show any significant differences among the three types of cages. A possible explanation for the absence of any significant differences could be that the in vitro predegraded particles were sieved before implantation, thus eliminating all small particles (≤ 70 μm) that are probably mandatory to provoke an increased cellular reaction. © 1995 John Wiley & Sons, Inc.
    Additional Material: 4 Ill.
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  • 8
    Publication Date: 1995-03-01
    Print ISSN: 0142-9612
    Electronic ISSN: 1878-5905
    Topics: Biology , Mechanical Engineering, Materials Science, Production Engineering, Mining and Metallurgy, Traffic Engineering, Precision Mechanics , Medicine
    Published by Elsevier
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  • 9
    Publication Date: 1991-01-01
    Print ISSN: 0142-9612
    Electronic ISSN: 1878-5905
    Topics: Biology , Mechanical Engineering, Materials Science, Production Engineering, Mining and Metallurgy, Traffic Engineering, Precision Mechanics , Medicine
    Published by Elsevier
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