Juha-Pekka Nuutinen

Effect of gamma, ethylene oxide, electron beam, and plasma sterilization on the behaviour of SR-PLLA fibres in vitro

- The aim of this study was to evaluate the effect of various sterilization processes on the physical and mechanical properties of self-reinforced bioabsorbable fibres made out of polylactide (PLLA). The samples were sterilized using plasma, ethylene oxide (one and two cycles), gamma (25 kGy at room temperature, 25 kGy in dry ice, and 2 × 25 kGy at room temperature), and electron beam (15, 25, and 55 kGy) sterilization. The intrinsic viscosity, crystallinity, and mechanical properties (modulus of elasticity, yield strength, and ultimate tensile strength) were tested before and immediately after each sterilization treatment, as well as up to 30 weeks in vitro. Compared with unsterilized fibres, the intrinsic viscosity was markedly decreased after radiation sterilization (gamma and electron beam) and the loss in mechanical properties was accelerated during in vitro degradation. Plasma and ethylene oxide (one and two cycles) did not markedly alter the properties of the samples after sterilization or during in vitrodegradation. These data are important for determining the effect of various sterilization processes on the physical and mechanical properties of polylactidebased materials and can be used to predict how fast degradation of the mechanical properties of the self-reinforced PLLA will occur. They can also be used to tailor the degradation kinetics to optimize implant design.

Mechanical properties and in vitro degradation of bioresorbable knitted stents

- The aim of this study was to characterize the mechanical properties and in vitro degradation of bioresorbable knitted stents. Each stent was knitted using a single self-reinforced fibre made out of either PLLA or 96L/4D PLA or 80L/20G PLGA. The mechanical and physical properties of the fibres and stents were measured before and after gamma sterilization, as well as during in vitro degradation. The mechanical properties of the knitted stents made out of bioresorbable fibres were similar to those of commercially available metallic stents. The knitting geometry (loop height) had a marked effect on the mechanical properties of the stents. The rate of in vitro degradation in mechanical and physical properties for the PLLA and 96L/4D PLA stents was similar and significantly lower than that of the 80L/20G PLGA stents. The 80L/20G PLGA stents lost about 35% of their initial weight at 11 weeks. At this time, they had lost all their compression resistance strength. These data can be used as a guideline in planning further studies in vivo.

Theoretical and experimental evaluation of the radial force of self-expanding braided bioabsorbable stents

This study was carried out to evaluate if the analytical model developed by Jedwab and Clerc for calculating the mechanical properties of metallic braided stents is also valid for bioabsorbable braided stents. An analytical model could be used to shorten the development cycle of stents by reducing the amount of in vitro testing. Jedwab and Clerc derived formulae for longitudinal stiffness and radial pressure stiffness. The longitudinal stiffness was defined by measuring the stent elongation under load. The radial pressure stiffness was defined from the slope of the load-displacement curve measured with the testing method described by Agrawal and Clark where a collar is placed around the stent to compress it. The radial pressure stiffness was measured with and without lubrication to evaluate the effects of friction between the stent and collar and in the stent structure itself. Two bioabsorbable braided stents and one metallic braided stent were used in the measurements. The metal stent test results were consistent with what was reported by Jedwab and Clerc. However, the analytical model was not applicable to bioabsorbable stents. This was mainly due to the larger fibre diameter of the bioabsorbable stents, which prevents the fibres from freely collapsing when the stent diameter decreases. The analytical model is based on an assumption that the fibres behave independently. However, the testing method described by Agrawal and Clark provided a useful tool to compare the radial force of self-expanding stents.

Mechanical properties and in vitro degradation of bioabsorbable self-expanding braided stents.

The aim of this study was to characterize the mechanical and self-expansion properties of braided bioabsorbable stents. In total four different stents were manufactured from PLLA fibres using a braiding technique. The changes in radial pressure stiffness and diameter recovery of the stents were determined initially, and after insertion and release from a delivery device. The braided stents were compared to three commercially available metallic braided stents. The changes in physical and mechanical properties of the PLLA fibres and stents during in vitro degradation were investigated. After release from the delivery device, the PLLA stents did not fully recover to their original diameter. The radial pressure stiffness of the bioabsorbable stents was similar to that of the metallic stents. The in vitro degradation study showed that the stents would keep at least half of their initial radial pressure stiffness for more than 22 weeks.

Mechanical properties and in vitro degradation of self-reinforced radiopaque bioresorbable polylactide fibres

The aim of this study was to evaluate the effect of the radiopaque filler, barium sulfate (BaSO4), on the mechanical properties of self-reinforced bioresorbable fibres. The bioresorbable polymer was a copolymer of L- and D-lactide with an L/D monomer ratio of 96 :4 (96L/4D PLA). The fibres were manufactured using an extrusion and a drawing process. Three different methods of processing the composites were studied. The materials were blended prior to extrusion. In the first method, the BaSO4 powder was mixed with the polymer granulates by hand (manual blending). The blend was then processed using a twin-screw extruder. The second and third methods utilized a single-screw extruder. In the second method, the BaSO4 powder was manually mixed with the polymer prior to extrusion. In the third method, the BaSO4 powder was mechanically attached on the polymer granulates (mechanical blending) prior to extrusion. The mechanical and chemical properties of the radiopaque bioresorbable fibres were measured after processing and during in vitro degradation. The fibres were gamma, plasma or EtO sterilized. There was no statistical difference in the mechanical properties of the fibres when manufactured using the twin-screw extrusion with manual blending or the single-screw extrusion with mechanical blending. The gamma sterilization markedly decreased the initial intrinsic viscosity of all fibres, whereas the plasma and EtO sterilization methods had no effect on the initial intrinsic viscosity. During in vitro testing, the loss in the intrinsic viscosity occurred at the same rate whether the fibres were loaded with the barium sulfate or not.

Fixation properties of a biodegradable "free-form" osteosynthesis plate.

The Inion FreedomPlate, a free-form osteosynthesis plate, is a biodegradable plate with just pilot holes for drilling. The construction of the plate allows the surgeon a placement of screws in optimal position. The screw heads can either be countersunk into the plate or cut off. Furthermore, the plate can be cut and contoured to match the bone. The aim of this study was to determine the mechanical properties of the Inion FreedomPlate compared to a conventional biodegradable plate. Acrylic pipes were fixed together with plates and screws. Tensile and cantilever bending tests were performed to measure the fixation properties. In the tensile test, the samples were loaded with a constant speed of 5 mm/min until failure of fixation. The yield load, maximum failure load, and initial stiffness were recorded, and the failure mode was visually determined. In the cantilever bending test, the samples were loaded with a constant speed of 50 mm/min (with a moment arm of 45 mm) until failure of fixation. The yield bending moment and initial stiffness were recorded, and the failure mode was determined. The results of the study show that the new free-form plate provides at least as strong fixation as the tested conventional biodegradable plate. No clinically relevant difference was found between free-form plates fixed with into-the-plate countersunk screws and those fixed with screws without heads.

Pullout strength of a biodegradable free form osteosynthesis plate

The Inion(®) Free Form Plate is a newly designed biodegradable plate. After drilling through the plate and tapping, a biodegradable screw can be inserted, followed by removal of the screw head. As an alternative a countersink screw can be used. Aim of the study was to compare the mechanical properties of the 1.4 mm Free Form Plate with the 2.0 mm conventional shaped plate. Mechanical testing of the plate pullout strength was conducted for the Inion(®) Free Form Plate fixed with an Inion OTPS™ 2.0 × 20 mm Screw. In addition, the failure mode was reported. Overlapping confidence levels were found with regard to the yield load, first peak load and maximum load, when comparing the Free Form Plate and the conventional 4-hole plate. The Free Form Plate fixed with a screw with head and countersink showed the highest stability at maximum load. The results of the mechanical stability testing showed no significant differences between the tested plates. The main failure mode was a failure of the screw shaft. The results of the current investigation imply that the 1.4 mm Free Form Plate could be used as an alternative to the 2.0 mm conventional shaped plate.