Sandy F. C. Stewart

Hyperbaric Dye Solution Distribution Characteristics after Pencil-point Needle Injection in a Spinal Cord Model

Background: The flow-rate limiting and directional characteristics of caudally directed microcatheters, which lead to intrathecal maldistribution of hyperbaric 5% lidocaine, are believed to have contributed to at least 11 cases of cauda equina syndrome. The authors investigated the distribution characteristics of hyperbaric dye solutions via caudally directed side-port needles at various rates of injection in a spinal cord model to determine the potential for maldistribution. Methods: Using a digital video image processing technique, we injected a hyperbaric solution of phthalocyanine blue dye through caudally directed side-port needles into a supinely oriented transparent spinal canal model filled with simulated cerebrospinal fluid. Injections via commonly used spinal needles (24-gauge and 25-gauge Sprotte, and 25-gauge and 27-gauge Whitacre) were recorded using five injection rates (2, 4, 6, 8, and 16 ml/ruin). Results: For all needles tested, injection rate had a significant effect on the peak dye concentration (P < 0.0001). Injection rates 6 ml/ruin (2 ml/20 s) resulted in peak dye concentrations of less than 168 mg/1 (extrapolated concentration of 1% lidocaine). Injection via the 24-gauge Sprotte needle, which has a larger orifice area and internal diameter, resulted in significantly lower peak dye concentrations than via the smaller Whitacre needles tested (P < 0.05). Conclusions: Sacral maldistribution could be minimized by using injection rates < 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.

Multilaboratory Particle Image Velocimetry Analysis of the FDA Benchmark Nozzle Model to Support Validation of Computational Fluid Dynamics Simulations

This study is part of a FDA-sponsored project to evaluate the use and limitations of computational fluid dynamics (CFD) in assessing blood flow parameters related to medical device safety. In an interlaboratory study, fluid velocities and pressures were measured in a nozzle model to provide experimental validation for a companion round-robin CFD study. The simple benchmark nozzle model, which mimicked the flow fields in several medical devices, consisted of a gradual flow constriction, a narrow throat region, and a sudden expansion region where a fluid jet exited the center of the nozzle with recirculation zones near the model walls. Measurements of mean velocity and turbulent flow quantities were made in the benchmark device at three independent laboratories using particle image velocimetry (PIV). Flow measurements were performed over a range of nozzle throat Reynolds numbers (Re(throat)) from 500 to 6500, covering the laminar, transitional, and turbulent flow regimes. A standard operating procedure was developed for performing experiments under controlled temperature and flow conditions and for minimizing systematic errors during PIV image acquisition and processing. For laminar (Re(throat)=500) and turbulent flow conditions (Re(throat)≥3500), the velocities measured by the three laboratories were similar with an interlaboratory uncertainty of ∼10% at most of the locations. However, for the transitional flow case (Re(throat)=2000), the uncertainty in the size and the velocity of the jet at the nozzle exit increased to ∼60% and was very sensitive to the flow conditions. An error analysis showed that by minimizing the variability in the experimental parameters such as flow rate and fluid viscosity to less than 5% and by matching the inlet turbulence level between the laboratories, the uncertainties in the velocities of the transitional flow case could be reduced to ∼15%. The experimental procedure and flow results from this interlaboratory study (available at http://fdacfd.nci.nih.gov) will be useful in validating CFD simulations of the benchmark nozzle model and in performing PIV studies on other medical device models.

In vitro modeling of spinal anesthesia. A digital video image processing technique and its application to catheter characterization.

BackgroundMaldistribution of intrathecal local anesthetic has recently been implicated as a contributor to neurotoxic injury. In vitro modeling can be used to understand the distribution of anesthetic agents within the subarachnoid space. We describe an in vitro modeling technique that uses digital video image processing and its application to catheter injection of local anesthetic. MethodsA clear plastic model of the subarachnoid space, including a simulated spinal cord and cauda equina, was filled with lactated Ringers solution. Phthalocyanine blue dye of known concentration was injected into the model through small-bore (28-G) and large-bore (18-G) catheters. Injections were performed at a variety of controlled rates and sacral catheter positions, and the propagation of dye throughout the model was recorded on videotape, digitized by computer, and converted to a two-dimensional image of dye concentration. A subset of data was compared with results obtained from spectrophotometric analysis. ResultsThere was a strong correlation (r = 0.98) between data obtained with analysis by digital video image processing and those obtained spectrophotometrically. Catheter size, catheter angle, and injection rate significantly influenced the distribution and peak concentration of simulated anesthetic. No major differences in distribution or peak concentration were observed with the two types of 28-G catheters. ConclusionsThe digital video image processing technique can be used to quantify anesthetic distribution rapidly within a model of the subarachnoid space without disturbing the distribution. The current results demonstrate a strong dependence of anesthetic distribution on catheter angle, catheter size, and injection rate. Comparisons between 28-G catheters suggest that the difference in reported incidence of cauda equlna syndrome associated with different 28-G catheters cannot be explained on the basis of differences in anesthetic distribution

Effects of transducer, velocity, Doppler angle, and instrument settings on the accuracy of color Doppler ultrasound

The accuracy of a commercial color Doppler ultrasound (US) system was assessed in vitro using a rotating torus phantom. The phantom consisted of a thin rubber tube filled with a blood-mimicking fluid, joined at the ends to form a torus. The torus was mounted on a disk suspended in water, and rotated at constant speeds by a motor. The torus fluid was shown in a previous study to rotate as a solid body, so that the actual fluid velocity was dependent only on the motor speed and sample volume radius. The fluid velocity could, thus, be easily compared to the color Doppler-derived velocity. The effects of instrument settings, velocity and the Doppler angle was assessed in four transducers: a 2.0-MHz phased-array transducer designed for cardiac use, a 4.0-MHz curved-array transducer designed for general thoracic use, and two linear transducers designed for vascular use (one 4.0 MHz and one 6.0 MHz). The color Doppler accuracy was found to be significantly dependent on the transducer used, the pulse-repetition frequency and wall-filter frequency, the actual fluid velocity and the Doppler angle (p < 0.001 by analysis of variance). In particular, the phased array and curved array were observed to be significantly more accurate than the two linear arrays. The torus phantom was found to provide a sensitive measure of color Doppler accuracy. Clinicians need to be aware of these effects when performing color Doppler US exams.

Effects of an Artery/Vascular Graft Compliance Mismatch on Protein Transport: A Numerical Study

Small-diameter vascular graft failure by intimal hyperplasia and thrombosis may result from flow disturbances and disruption of chemical transport in the fluid at the distal anastomosis, because of compliance mismatch between the graft and host artery. In previous studies, lower-than-normal wall shear stress (WSS), particle trapping, and high particle residence times were observed at the distal anastomosis due to a pulsatile tubular expansion effect caused by nonuniform radial deformations. This study was undertaken to examine effects of compliance and radius mismatch on the distribution of a model protein released at the graft–fluid interface. Finite element simulations of end-to-end vascular grafting were performed under pulsatile flow, using fluid–structure coupling to give physiologic wall displacements. Results showed that protein is convected smoothly downstream in a uniform compliant tube. A compliance mismatch disturbed the transport, causing positive and negative gradients in the concentration profile at the distal anastomosis. This was seen when the graft and artery radii were matched at zero pressure and at mean arterial pressure; low WSSs were only observed in the former case. Thus the distal intimal hypertrophy seen in noncompliant grafts may be caused partly by decreased WSS, and partly by concentration gradients of dissolved chemicals affecting chemotaxis of cells.

A ROTATING TORUS PHANTOM FOR ASSESSING COLOR DOPPLER ACCURACY

A rotating torus phantom was designed to assess the accuracy of color Doppler ultrasound. A thin rubber tube was filled with blood analog fluid and joined at the ends to form a torus, then mounted on a disk submerged in water and rotated at constant speeds by a motor. Flow visualization experiments and finite element analyses demonstrated that the fluid accelerates quickly to the speed of the torus and spins as a solid body. The actual fluid velocity was found to be dependent only on the motor speed and location of the sample volume. The phantom was used to assess the accuracy of Doppler-derived velocities during two-dimensional (2-D) color imaging using a commercial ultrasound system. The Doppler-derived velocities averaged 0.81 +/- 0.11 of the imposed velocity, with the variations significantly dependent on velocity, pulse-repetition frequency and wall filter frequency (p < 0.001). The torus phantom was found to have certain advantages over currently available Doppler accuracy phantoms: 1. It has a high maximum velocity; 2. it has low velocity gradients, simplifying the calibration of 2-D color Doppler; and 3. it uses a real moving fluid that gives a realistic backscatter signal.

Aliasing-tolerant color Doppler quantification of regurgitant jets

Conservation of momentum transfer in regurgitant cardiac jets can be used to calculate the flow rate from color Doppler velocities. In this study, turbulent jets were simulated by finite elements; pseudocolor Doppler images were interpolated from the computations, with aliasing introduced artificially. Jets were also imaged by color Doppler in an in vitro flow system. To suppress aliasing errors, jet velocities were fitted iteratively to a fluid mechanical model constrained to match the orifice velocity (measured without aliasing by continuous-wave Doppler). At each iteration, the model was used to detect aliased velocities, which were excluded during the next iteration. Iteration continued until the flow rate calculated by the model and number of calculated nonaliased pixels were unchanged. The good correlations between measured and calculated flow rates in the experimental (R2 = 0.933) and computational studies (R2 = 0.990) suggest that this may be a clinically useful approach even in aliased images. Published by Elsevier Science Inc.

Multi-Laboratory Uncertainty Analysis of PIV-Measured Flow Quantities Relevant to Blood Damage in the FDA Nozzle Model

Particle image velocimetry (PIV) has been used in regulatory submissions to the FDA for pre-clinical and post-market evaluations of flow fields in medical devices, such as artificial heart valves, blood pumps, and stents. The velocity and shear fields obtained from the PIV experiments are also used to validate computational fluid dynamics (CFD) data accompanying the submissions. However, previous studies have questioned the accuracy of PIV measurements in regions of high shear and low velocity (regions prone to hemolysis and thrombosis). Currently, there is no clear estimate of the amount of uncertainty involved in measuring various flow parameters in these high-risk regions. The objective of this study was to perform an inter-laboratory PIV study in a simplified nozzle model and quantify the uncertainties involved in measuring flow quantities relevant to blood damage, such as near-wall velocity, viscous and Reynolds shear stresses, size and velocity within recirculation regions, and for estimating an index of hemolysis.© 2011 ASME

Not All Mesalamine Enema Bottles Are Created Equal

Severe scrub typhus usually presents as multiple organ damage including encephalitis, cardiomyopathy, hepatitis, renal failure, acute respiratory distress syndrome, disseminated intravascular coagulopathy (DIC), and septic shock (1) . Hemorrhage is a rare complication associated with scrub typhus and the actual mechanism is not fully understood. As we know, atraumatic hemoperitoneum over the perisplenic area is related to a variety of infectious diseases such as malaria, infectious mononucleosis, viral hemorrhagic fever, and infective endocarditis (2) . All of these underlying microbes will lead to a pathological spleen manifested as splenomegaly or splenic infarction that easily results in splenic hemorrhage (3) . In addition, systemic eects of thrombocytopenia and DIC contribute to the bleeding tendency as well. Although scrub typhus shares many of the clinical features mentioned above, the rate of spontaneous bleeding is far less than predicted. Recently, with the increasing knowledge of scrub typhus, early recognition of eschar in an endemic area, and eective antibiotic treatment, the natural course of O. tsutsugamushi infection progressing to DIC is usually blockaded. E is public health improvement in management of scrub typhus is consistent with the & ndings of Liu et al. (4) in which fewer events of hemorrhage, nephrotic renal disease, and thrombocytopenia were observed in patients with scrub typhus than in those with viral hemorrhagic fever on initial presentation. Returning to our case, the mechanism of spontaneous perisplenic hemorrhage may not only be related to severe scrub typhus with characteristics of splenomegaly and DIC, but also to coagulopathy secondary to co-existing microbial infection (5) . In summary, this case emphasized that complication of severe scrub typhus should be listed in the dierential diagnosis of atraumatic perisplenic hemoperitoneum.

Mechanical Performance of Generic and Proprietary Enema Bottles

Enemas containing the anti-inflammatory drug mesalamine are an effective treatment for a distal form of inflammatory bowel disease (IBD). An IBD patient discovered that a generic mesalamine enema was more difficult and painful to use than the proprietary version. A study was initiated to determine whether these differences were measurable in the laboratory using conventional mechanical test equipment. Differences among three bottle types (the proprietary brand and two generic versions) were quantified by mechanical testing. The compressive force required to squeeze the drug from each bottle was measured, tensile testing was performed on the bottle wall, and stiffness of the nozzle tips was studied via bend testing. The thickness of the bottle walls and the inner diameter (ID) of the nozzles were also recorded. The work required to expel the drug from the generic versions during bottle compression was significantly greater than for the proprietary (p <0.01). This was likely due to the wall thickness being greater in the generics; the elastic moduli of the three bottles were similar. The ID of the nozzles was smaller for the generic bottles, suggesting additional resistance to flow. Increased flow resistance was also observed for bottles in which lubricant obstructed the nozzle opening. The work required to bend the nozzle was greater in the generics than in the proprietary (p<0.01). These differences between the generic and proprietary bottles are consistent with the patients subjective experience. Poor bottle performance may adversely affect patient compliance with this treatment. Improved bottle design (such as tighter tolerances for wall thickness, nozzle ID, and nozzle stiffness) and manufacturing controls (e.g., preventing the nozzle lubricant from impeding delivery of the drug) could be achieved through the development of a standard specification for enema bottles. An optimal bottle design is suggested.