Inferior vena cava (IVC) filters are used to prevent pulmonary embolism (PE) in patients with deep vein thrombosis for whom anticoagulation is contraindicated. IVC filters have been shown to be effective in trapping embolized clots and preventing PE; however, among the commercially available designs, the optimal balance of clot capture efficiency, clot dissolution, and prevention of to vena cava occlusion is unknown. Clot capture efficiency has been quantified in numerous in vitro studies, in which model clots are released into a mock circulation system, with the relative capture efficiency of various IVC filters analyzed statistically. In general, two-stage filters have been found to be more efficient than one-stage filters. However, other factors may play a role in the ultimate dissolution of clots and in the overall effect of the resulting blood flow on caval vasculature. Clot dissolution has been shown to increase with increasing wall shear stress, while low and oscillating wall shear stresses are known to have a deleterious effect on vessel walls, causing intimal hyperplasia. This paper describes the effect of IVC filters on blood flow, velocity patterns, and wall shear stress by flow visualization and computational fluid dynamics.

A set of test samples, all containing ultrasonically equivalent tissue-mimicking material, was produced and measurements of ultrasonic speed and ultrasonic attenuation coefficients were made at seven laboratories using various techniques. The ultrasonic speed values agree well with one another, having a spread of about 0.3 per cent; thus, speed values for tissue parenchyma appearing in the literature are likely to be accurate. Values of ultrasonic attenuation coefficients agree fairly well with one another, with differences between individual values and the group mean of generally less than 20 per cent of the group mean.

A new approach for characterizing high intensity focused ultrasound (HIFU) transducers is presented. The technique is based upon the acoustic streaming field generated by absorption of the HIFU beam in a liquid medium. The streaming field is quantified using digital particle image velocimetry, and a numerical algorithm is employed to compute the acoustic intensity field giving rise to the observed streaming field. The method as presented here is applicable to moderate intensity regimes, above the intensities which may be damaging to conventional hydrophones, but below the levels where nonlinear propagation effects are appreciable. Intensity fields and acoustic powers predicted using the streaming method were found to agree within 10% with measurements obtained using hydrophones and radiation force balances. Besides acoustic intensity fields, the streaming technique may be used to determine other important HIFU parameters, such as beam tilt angle or absorption of the propagation medium.

Sacral maldistribution could be minimized by using injection rates > or = 6 ml/min (2 ml/20 s), for all of the side-port spinal needles used in this model study. When very slow injection rates (2 ml/min) are used, peak dye concentrations varied inversely and significantly with needle internal diameter and orifice area.

The purpose of this study was first to evaluate the clot capture efficiency and capture location of six currently-marketed vena cava filters in a physiological venous flow loop, using synthetic polyacrylamide hydrogel clots, which were intended to simulate actual blood clots. After observing a measured anomaly for one of the test filters, we redirected the focus of the study to identify the cause of poor clot capture performance for large synthetic hydrogel clots. We hypothesized that the uncharacteristic low clot capture efficiency observed when testing the outlying filter can be attributed to the inadvertent use of dense, stiff synthetic hydrogel clots, and not as a result of the filter design or filter orientation. To study this issue, sheep blood clots and polyacrylamide (PA) synthetic clots were injected into a mock venous flow loop containing a clinical inferior vena cava (IVC) filter, and their captures were observed. Testing was performed with clots of various diameters (3.2, 4.8, and 6.4 mm), length-to-diameter ratios (1:1, 3:1, 10:1), and stiffness. By adjusting the chemical formulation, PA clots were fabricated to be soft, moderately stiff, or stiff with elastic moduli of 805 ± 2, 1696 ± 10 and 3295 ± 37 Pa, respectively. In comparison, the elastic moduli for freshly prepared sheep blood clots were 1690 ± 360 Pa. The outlying filter had a design that was characterized by peripheral gaps (up to 14 mm) between its wire struts. While a low clot capture rate was observed using large, stiff synthetic clots, the filter effectively captured similarly sized sheep blood clots and soft PA clots. Because the stiffer synthetic clots remained straight when approaching the filter in the IVC model flow loop, they were more likely to pass between the peripheral filter struts, while the softer, physiological clots tended to fold and were captured by the filter. These experiments demonstrated that if synthetic clots are used as a surrogate for animal or human blood clots for in vitro evaluation of vena cava filters, the material properties (eg, elastic modulus) and dynamic behavior of the surrogate should first be assessed to ensure that they accurately mimic an actual blood clot within the body.

No abstract

We studied a French modified fluid gelatin (MFG), substituting it for hydroxyethyl starch (HES) in leukapheresis procedures using three currently available blood cell separators, and observing its effects on the function of platelets and granulocytes. As a cell-collecting agent, we found MFG to be as effective as HES with intermittent flow centrifugation (Haemonetics), and slightly less so with one continuous flow device (IBM 2997). MFG was clearly less effective than HES with the Fenwal CS-3000 continuous flow separator, although we have reason to believe it would be possible to improve efficiency with this machine by changing the operating variables. Tests of platelet and granulocyte function showed negligible alteration with either agent and no difference between them. MFG disappears much more rapidly from the circulation than HES (after a single injection, it is undetectable by the third day). Reaction frequency with MFG was about the same as that of HES, with perhaps somewhat more frequent allergic manifestations.

We present advanced particle image velocimetry (PIV) processing, post-processing, and uncertainty estimation techniques to support the validation of computational fluid dynamics analyses of medical devices. This work is an extension of a previous FDA-sponsored multi-laboratory study, which used a medical device mimicking geometry referred to as the FDA benchmark nozzle model. Experimental measurements were performed using time-resolved PIV at five overlapping regions of the model for Reynolds numbers in the nozzle throat of 500, 2000, 5000, and 8000. Images included a twofold increase in spatial resolution in comparison to the previous study. Data was processed using ensemble correlation, dynamic range enhancement, and phase correlations to increase signal-to-noise ratios and measurement accuracy, and to resolve flow regions with large velocity ranges and gradients, which is typical of many blood-contacting medical devices. Parameters relevant to device safety, including shear stress at the wall and in bulk flow, were computed using radial basis functions. In addition, in-field spatially resolved pressure distributions, Reynolds stresses, and energy dissipation rates were computed from PIV measurements. Velocity measurement uncertainty was estimated directly from the PIV correlation plane, and uncertainty analysis for wall shear stress at each measurement location was performed using a Monte Carlo model. Local velocity uncertainty varied greatly and depended largely on local conditions such as particle seeding, velocity gradients, and particle displacements. Uncertainty in low velocity regions in the sudden expansion section of the nozzle was greatly reduced by over an order of magnitude when dynamic range enhancement was applied. Wall shear stress uncertainty was dominated by uncertainty contributions from velocity estimations, which were shown to account for 90-99% of the total uncertainty. This study provides advancements in the PIV processing methodologies over the previous work through increased PIV image resolution, use of robust image processing algorithms for near-wall velocity measurements and wall shear stress calculations, and uncertainty analyses for both velocity and wall shear stress measurements. The velocity and shear stress analysis, with spatially distributed uncertainty estimates, highlights the challenges of flow quantification in medical devices and provides potential methods to overcome such challenges.