This article provides an overview of the connection between the microstructural state and the mechanical response of various bioresorbable polylactide (PLA) devices for medical applications. PLLA is currently the most commonly used material for bioresorbable stents and sutures, and its use is increasing in many other medical applications. The non-linear mechanical response of PLLA, due in part to its low glass transition temperature (T g ≈ 60 °C), is highly sensitive to the molecular weight and molecular orientation field, the degree of crystallinity, and the physical aging time. These microstructural parameters can be tailored for specific applications using different resin formulations and processing conditions. The stress-strain, deformation, and degradation response of a bioresorbable medical device is also strongly dependent on the time history of applied loads and boundary conditions. All of these factors can be incorporated into a suitable constitutive model that captures the multiple physics that are involved in the device response. Currently developed constitutive models already provide powerful computations simulation tools, and more progress in this area is expected to occur in the coming years.

PLLA is a commonly used biodegradable polymer in stent designs because it is non-toxic and easily eliminated from the body. However, very little is known about the effect of loading conditions on the degradation rate. Rajagopal and Wineman developed a model of polymer degradation which is driven by load applied to the fiber [1]. Soares et. al. further developed this model for use with PLLA stent fibers under tensile loading conditions [2]. In this model the degradation rate is linearly related to deformation through the radius in the (IB, IIB) plane. Both models predict that greater deformation will induce a higher degree of degradation.

Understanding how polymers such as PLLA degrade in vivo will enhance biodegradable stent design. This study examined the effect of static and dynamic loads on PLLA stent fibers in vitro. The stent fibers (generously provided by TissueGen, Inc.) were loaded axially with 0 N, 0.5 N, 1 N, or 0.125-0.25 N (dynamic group, 1 Hz) and degraded in PBS at 45 °C for an equivalent degradation time of 15 months. Degradation was quantified through changes in tensile mechanical properties. The mechanical behavior was characterized using the Knowles strain energy function and a degradation model. A nonsignificant increase in fiber stiffness was observed between 0 and 6 months followed by fiber softening thereafter. A marker of fiber softening, β, increased between 9 and 15 months in all groups. At 15 months, the β values in the dynamic group were significantly higher compared to the other groups. In addition, the model indicated that the degradation rate constant was smaller in the 1-N (0.257) and dynamic (0.283) groups compared to the 0.5-N (0.516) and 0-N (0.406) groups. While the shear modulus fluctuated throughout degradation, no significant differences were observed. Our results indicate that an increase in static load increased the degradation of mechanical properties and that the application of dynamic load further accelerated this degradation.

Computational modeling is critical to medical device development and has grown in its utility for predicting device performance. Additionally, there is an increasing trend to use absorbable polymers for the manufacturing of medical devices. However, computational modeling of absorbable devices is hampered by a lack of appropriate constitutive models that capture their viscoelasticity and postyield behavior. The objective of this study was to develop a constitutive model that incorporated viscoplasticity for a common medical absorbable polymer. Microtensile bars of poly(L-lactide) (PLLA) were studied experimentally to evaluate their monotonic, cyclic, unloading, and relaxation behavior as well as rate dependencies under physiological conditions. The data were then fit to a viscoplastic flow evolution network (FEN) constitutive model. PLLA exhibited rate-dependent stress-strain behavior with significant postyield softening and stress relaxation. The FEN model was able to capture these relevant mechanical behaviors well with high accuracy. In addition, the suitability of the FEN model for predicting the stress-strain behavior of PLLA medical devices was investigated using finite element (FE) simulations of nonstandard geometries. The nonstandard geometries chosen were representative of generic PLLA cardiovascular stent subunits. These finite element simulations demonstrated that modeling PLLA using the FEN constitutive relationship accurately reproduced the specimen's force-displacement curve, and therefore, is a suitable relationship to use when simulating stress distribution in PLLA medical devices. This study demonstrates the utility of an advanced constitutive model that incorporates viscoplasticity for simulating PLLA mechanical behavior.

No abstract