Full-field microscale strain measurements of a nitinol medical device using digital image correlation.

Computational modeling and simulation are commonly used during the development of cardiovascular implants to predict peak strains and strain amplitudes and to estimate the associated durability and fatigue life of these devices. However, simulation validation has historically relied on comparison with surrogate quantities like force and displacement due to barriers to direct strain measurement-most notably, the small spatial scale of these devices. We demonstrate the use of microscale two-dimensional digital image correlation (2D-DIC) to directly characterize full-field surface strains on a nitinol medical device coupon under emulated physiological and hyperphysiological loading. Experiments are performed using a digital optical microscope and a custom, temperature-controlled load frame. Following applicable recommendations from the International DIC Society, hardware and environmental heating studies, noise floor analyses, and in- and out-of-plane rigid body translation studies are first performed to characterize the microscale DIC setup. Uniaxial tension experiments are also performed using a polymeric test specimen to characterize the strain accuracy of the approach up to nominal stains of 5%. Sub-millimeter fields of view and sub-micron displacement accuracies (9nm mean error) are achieved, and systematic (mean) and random (standard deviation) errors in strain are each estimated to be approximately 1,000µÏµ. The system is then demonstrated by acquiring measurements at the root of a 300µm-wide nitinol medical device strut undergoing fixed-free cantilever bending motion. Lüders-like transformation bands are observed originating from the tensile side of the strut that spread toward the neutral axis at an angle of approximately 55°. Despite the inherent limitations of optical microscopy and 2D-DIC, simple and relatively economical setups like that demonstrated herein could provide a practical and accessible solution for characterizing cardiovascular implant micromechanics, validating computational model strain predictions, and guiding the development of next-generation material models for simulating superelastic nitinol.

Venous Biomechanics of Angioplasty and Stent Placement: Implications of the Poisson Effect.

PURPOSE: To characterize the Poisson effect in response to angioplasty and stent placement in veins and identify potential implications for guiding future venous-specific device design. MATERIALS AND METHODS: In vivo angioplasty and stent placement were performed in 3 adult swine by using an established venous stenosis model. Iron particle endothelium labeling was performed for real-time fluoroscopic tracking of the vessel wall during intervention. A finite-element computational model of a vessel was created with ADINA software (version 9.5) with arterial and venous biomechanical properties obtained from the literature to compare the response to radial expansion. RESULTS: In vivo angioplasty and stent placement in a venous stenosis animal model with iron particle endothelium labeling demonstrated longitudinal foreshortening that correlated with distance from the center of the balloon (R2 = 0.87) as well as adjacent segment narrowing that correlated with the increase in diameter of the treated stenotic segment (R2 = 0.89). Finite-element computational analysis demonstrated increased Poisson effect in veins relative to arteries (linear regression coefficient slope comparison, arterial slope 0.033, R2 = 0.9789; venous slope 0.204, R2 = 0.9975; P < .0001) as a result of greater longitudinal Young modulus in veins compared with arteries. CONCLUSIONS: Clinically observed adjacent segment narrowing during venous angioplasty and stent placement is a result of the Poisson effect, with redistribution of radially applied force to the longitudinal direction. The Poisson effect is increased in veins relative to arteries as a result of unique venous biomechanical properties, which may be relevant to consider in the design of future venous interventional devices.

Fatigue and in vivo validation of a peritoneum-lined self-expanding nitinol stent-graft.

PURPOSE: To assess the fatigue and in vivo performance of a new stent-graft incorporating bovine peritoneum lining that is designed for application in peripheral vascular occlusive disease. METHODS: Bovine peritoneum-lined stent-grafts were subjected to accelerated in vitro pulsatile fatigue and axial/torsional fatigue testing designed to simulate 10 years of physiological strain on the devices. At specified times the devices were evaluated for stent fracture, suture failure, or tissue tearing. Seven dogs underwent bilateral common iliac artery (CIA) balloon angioplasty injury with unilateral placement of the peritoneum-lined stent-graft. Angiography and intravascular ultrasound were performed prior to treatment, after treatment, and prior to sacrifice at 30 days. Vessels were perfusion fixed and histologically evaluated at 5 regions: above stent, proximal stent, mid stent, distal stent, and below stent. RESULTS: No evidence of stent, suture, or tissue failure was present during or after pulsatile and axial/torsional fatigue testing. At 30±0.3 days after implantation, all vessels were patent. The average lumen area at explantation across stented vessels was 25.45 mm(2). Lumen areas tended to be reduced above (23.57 mm(2)) and below (24.17 mm(2)) the stent. Lumen areas were consistent across stented regions at explantation (proximal stent 27.80 mm(2), mid stent 25.88 mm(2), and distal stent 25.81 mm(2)). The mean neointimal area in peritoneum-lined stents was 2.02±1.52 mm(2), with a neointima:media ratio of 1.03±0.50. These values were significantly lower in the above and below stent areas than in the stented regions, but there was no difference in either measure within the proximal, mid, or distal stent. CONCLUSION: The custom-designed peritoneum-lined stent-graft is promising for clinical peripheral applications due to its ability to resist relevant long-term physiological stresses and outstanding short-term patency rates in canine implantations.

Histopathologic evaluation of nitinol self-expanding stents in an animal model of advanced atherosclerotic lesions.

AIMS: The histologic response to self-expanding stent implantation into advanced atherosclerotic lesions has not been systematically investigated. We tested the hypothesis of whether gradual expansion of advanced atherosclerotic plaques by self-expanding stents would be an appropriate method to seal atherosclerotic lesions without causing plaque disruption as is usually observed with balloon-expandable stents. METHODS AND RESULTS: Twelve New Zealand white rabbits were fed an atherogenic diet (1% cholesterol) followed by arterial denudation and injection of washed autologous erythrocytes. Nitinol self-expanding stents of two different stent designs and strengths (n=12 for SX and n=12 for Micro-SX) were implanted into the previously formed lesions within the abdominal aorta six weeks following injection of erythrocytes. Four weeks following stent implantation, animals were sacrificed, specimens harvested and processed for histology. Histomorphometry was performed on stented and adjacent non-stented regions. Atherosclerotic lesions were composed of foam cells, cholesterol clefts and necrotic plaque. While SX stents showed an unfavourable outcome with respect to vessel remodelling and the percentage of uncovered stent struts, Micro-SX stents had fewer uncovered stent struts, less positive remodelling and less plaque injury. CONCLUSIONS: Nitinol Micro-SX self-expanding stents might be a valuable approach to seal high risk atherosclerotic lesions.