An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review--from device classification and clinical studies to the final marketing application--FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.     

Chemical composition and nutritional quality of tehineh (sesame butter)

The chemical composition and nutritional quality of tehineh, a paste of dehulled roasted sesame seeds, from Saudi Arabia and other countries, were studied. Results showed 24.7% protein, 58.9% fat, 2.3% fiber, 3.0% ash and <1.0% moisture. The tehineh contained relatively high amounts (mg/100 g) of P (692), Mg (362), Fe (7.19), Cu (1.96), Mn (1.46) and Zn (7.82) and low amounts of Ca (61) and Se (0.05). Gas-liquid chromatography (GLC) analysis of the oil revealed percentages of 42.4 for oleic, 39.7 for linoleic, 9.8 for palmitic and 6.4 for stearic acid. Lysine was the only limiting amino acid with a chemical score of 64, while the sulphur-containing amino acids (methionine + cystine) and tryptophan were present in amounts exceeding the requirement of the FAO/WHO (1973) reference protein. The in vitro protein digestibility (IVPD) value of 83.3% and the calculated protein efficiency ratio (C-PER), 2.14, were slightly higher than those of sesame seeds and both values were lower than the IVPD and C-PER of 90.0% and 2.50, respectively, for ANRC casein.     

Electromagnetic Resistive Drift Instability in Current Carrying Low Temperature Tokamak Edges

It is shown that the purely growing electrostatic rippling mode can couple with the shear Alfven wave to give rise to an oscillatory electromagnetic instability in tokamak edge regions. This mechanism can be one of the causes of electromagnetic fluctuations observed near plasma edges. This instability can occur only in the very low temperature regions where resistivity fluctuations can become important due to large electron-ion collision frequency.     

Low-loss high power RF switching using multifinger AlGaN/GaN MOSHFETs

We demonstrate a novel RF switch based on a multifinger AlGaN/GaN MOSHFET. Record high saturation current and breakdown voltage, extremely low gate leakage current and low gate capacitance of the III-N MOSHFETs make them excellent active elements for RF switching. Using a single element test circuit with 1-mm wide multifinger MOSHFET we achieved 0.27 dB insertion loss and more than 40 dB isolation. These parameters can be further improved by impedance matching and by using submicron gate devices. The maximum switching power extrapolated from the results for 1A/mm 100 /spl mu/m wide device exceeds 40 W for a 1-mm wide 2-A/mm MOSHFET.     

The optimisation of higher order resampling methods in a multiprocessor environment

The processing of images obtained from satellites often involves highly repetitive calculations on very large amounts of data. This processing is extremely time consuming when these calculations are performed on sequential machines. Parallel computers are well suited to handling computationally expensive operations such as higher order interpolations on large data sets. This paper decribes work undertaken to develop parallel implementations of a set of resampling procedures on an Alliant VFX/4. Each resampling procedure implemented has been optimised in three stages. First, the algorithm has been restructured, where two-dimensional resampling is performed by two one-dimensional resampling operations. Second, each procedure has been reprogrammed in such a way that the autoparallelisation provided by the FX/Fortran compiler has been exploited. Thirdly, data dependent analysis of each procedure has been performed in order to achieve full optimization of each procedure; each procedure has been restructured where appropriate to circumvent vectorisation and concurrency inhibiting data dependencies. The nature and extent of the code optimization achieved for each procedure is presented in this paper. The original code for the most computationally expensive procedure, as targeted at a sequential machine, was found to have an execution time of 4900 seconds on the Alliant VFX/4 when compiled with regular compiler optimization options. Following algorithmic redesigning and reprogramming of the code, as indicated in stage 1 and stage 2, the execution time was reduced to 248 seconds. Restructuring of the code following data dependency analysis indicated in stage 3 in order to avoid data dependencies and allow concurrency and vectorisation, further reduced execution time to 162 seconds. The consequence of this work is that higher-order resampling methods which had not previous been practical are now routinely performed on the Alliant VFX/4 at the University of Dundee.     

Calcium phosphate/calcium oxalate crystal association in urinary stones: implications for heterogeneous nucleation of calcium oxalate

PURPOSE: Most stones contain more than one type of crystals, and some combinations, such as calcium phosphate/calcium oxalate, are more common than others. Epitaxy between the crystals has been suggested to play a role in growth of such stones. The specific aim of this study is to investigate the involvement of calcium phosphate in crystallization of calcium oxalate. MATERIALS AND METHODS: Twenty calcium oxalate stones or stone fragments were examined using various microscopic techniques, including scanning, transmission and back-scattered electron microscopy. Similarly, calcium oxalate stones induced on a plastic foreign body implanted inside urinary bladders of laboratory rats were also investigated. Examination of the interface between calcium phosphate and calcium oxalate crystals was emphasized. RESULTS: Close association between crystals of calcium phosphate and calcium oxalate were found in both the human and rat stones. All crystals examined were associated with an organic matrix on the surface and contained copious amounts of organic material within the crystalline entities. Interface between the crystals also appeared to be occupied by organic matrix. CONCLUSIONS: Results of this and other studies from our laboratory indicate that epitaxy between various crystals, even though theoretically possible, appears unlikely in vivo. The appearance of specific crystalline combinations in stones is probably a result of the urinary environment being conducive for crystallization of those components. Heterogeneous nucleation of calcium oxalate is most probably induced by biological elements, including membranous cellular degradation products.     

Design and control of an olefin metathesis reactive distillation column

This paper considers the design and control of a reactive distillation column in which one reactant is consumed and two products are formed (A?B+C). The volatilities are α_B>α_A>α_C, i.e. the reactant is intermediate boiling between the two products. The metathesis of 2-pentene is considered as the demonstrative example. The column has a single feed of the intermediate boiling reactant. The distillate contains mostly light component and the bottoms mostly heavy.Three designs are considered: the base case (low-conversion/low-pressure), a low-conversion/high-pressure case and a high-conversion/high-pressure case. The base design is obtained from the literature, and the other two steady-state designs are optimized with respect to the total annual cost. All the designs are found to be openloop stable. Five control structures are studied for the base design. Then the best two structures are applied to the remaining two designs. This category of reactive distillation exhibits less challenging problems than other categories since it uses a single feed, which eliminates the need for the control structure to perfectly balance two fresh feeds.Simulation results demonstrate that effective dynamic control is provided by a control structure that uses two temperatures to maintain the purities of both product streams. No internal composition measurement is required. This structure is found to be robust and stable and rejects loads and tracks setpoints very well.     

Reactive brazing of ceria to an ODS ferritic stainless steel

This research study shows that a ceria ceramic can be bonded to an ODS ferritic stainless steel (MA956) by reactive brazing using a Ag₆₈-Cu_27.5-Ti_4.5 interlayer. The ability to join these materials provides an alternative to the current ceramic interconnects used in the development of solid oxide fuel cells. Initial results show that the ceramic-metal bonds survived the bonding process irrespective of the degree of porosity within the ceria ceramic. Metallographic analyses indicate that a reaction zone formed along the ceria/braze interface, which was not only titanium rich, but also consisted of a mixture of copper oxides. When the ceramic-metal bonds were exposed to high bonding temperatures or when subjected to thermal cycling at 700°C, this reaction layer increased in thickness and had a detrimental affect on the mechanical strength of the final joints.     

Enhancement of computed tomography liver contrast using iomeprol-containing liposomes and detection of small liver tumors in rats

RATIONALE AND OBJECTIVES: We evaluated iomeprol-containing liposomes (Lipiom), a new contrast medium for computed tomography (CT) liver scanning, in an animal model of chemically induced hepatocellular carcinomas and other liver tumors in rats. METHODS: Liver tumors were induced by administration of carcinogens to rats, either 0.55% (w/w) 1'-hydroxysafrole in the diet or induction by 3'-methyl-4-diethylaminoazobenzene followed by promotion with carbon tetrachloride. CT scanning was performed 1-3 hr after intravenous injection of iomeprol-containing liposomes. RESULTS: After injection of iomeprol-containing liposomes at a dose of 70 mg of liposome-entrapped iodine per kilogram of body weight, the normal liver parenchyma showed a contrast enhancement, in Hounsfield units, of more than 60% over the control value before bolus. Liver tumors with no or few Kupffer cells were not enhanced and appeared as dark areas within the normal parenchyma. Tumors and pretumoral lesions devoid of Kupffer cells, as small as 3 mm in diameter, could be distinguished using this non-invasive method. CONCLUSION: CT liver scanning after injection of iomeprol-containing liposomes appears to be promising method for detecting liver tumors and focal liver lesions.     

Rheology of concentrated solutions of hyperbranched polyesters

The solution rheology of different generations of hyperbranched polyesters in N‐methyl‐2‐pyrrolidinone (NMP) solvent was examined in this study. The solutions exhibited Newtonian behavior over a wide range of polyester concentrations. Also, the relative viscosities of poly(amidoamine) (PAMAM) dendrimers in ethylenediamine were compared with those of the hyperbranched polyesters in NMP. Both types of dendritic polymers have relative viscosities that are exponential functions of their molar fraction in solution. The slopes of these relative viscosity curves show a linear relationship with respect to the generation number. PAMAM dendrimers have the greater slopes for each generation, reflecting their relatively larger intrinsic viscosity values.