Water jet indentation for local elasticity measurements of soft materials.

We present a novel elastography method for soft materials (100Pa-100kPa) based on indentation by a µm-sized water jet. We show that the jet creates a localized deformation ("cavity") of the material that can be easily visualized. We study experimentally how cavity width and depth depend on jet speed, height, incidence angle and sample elasticity. We describe how to calibrate the indenter using gels of known stiffness. We then demonstrate that the indenter yields quantitative elasticity values within 10% of those measured by shear rheometry. We corroborate our experimental findings with fluid-solid finite-element simulations that quantitatively predict the cavity profile and fluid flow lines. The water jet indenter permits in situ local stiffness measurements of 2D or 3D gels used for cell culture in physiological buffer, is able to assess stiffness heterogeneities with a lateral resolution in the range 50-500µm (at the tissue scale) and can be assembled at low cost with standard material from a biology laboratory. We therefore believe it will become a valuable method to measure the stiffness of a wide range of soft, synthetic or biological materials.

Size exclusion chromatography with evaporative light scattering detection as a method for speciation analysis of polydimethylsiloxanes. II. Validation of the method for analysis of pharmaceutical formulations.

The aim of this study was to demonstrate the usefulness of the size exclusion chromatography with evaporative light scattering detection (SEC-ELSD) method in the identification and quantitative analysis of polydimethylsiloxanes (PDMS). The process of validation for the method was conducted, and the values obtained were compared with the acceptance criteria. Particularly important was the conclusion that SEC-ELSD method showed a high specificity for PDMS. PDMS is an organosilicon polymer and for this reason, it does not exist as a concrete chemical species. Depending on the length of the chain, PDMS can be toxic for organism. So far, the SEC-ELSD method has not been applied for the control of pharmaceutical products containing such PDMS as dimeticone or simeticone. The safety of use and effectiveness of such pharmaceutical products relies on the control of their quality. Therefore, the analytical methods and procedures that meet acceptance criteria for qualitative and quantitative analysis of the PDMS should be used. In the case of the analysis of pharmaceutical products, the acceptance criteria are established and recommended by, for example, the Pharmacopoeias, the U.S. Food and Drug Administration (FDA), the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). The progress of knowledge, however, requires the development of new analytical tools which are able to solve incoming problems. In the case of pharmaceutical formulations containing PDMS, which are used not only by adults but also by children, it is necessary to use analytical methods which are characterized by a high specificity.

Randomized controlled clinical study on the accuracy of two-stage putty-and-wash impression materials.

PURPOSE: The accuracy of dental impression taking is one major factor influencing the fit of crowns and fixed partial dentures. The aim of this study was to determine the accuracy of three-dimensional (3-D) tooth surface and subgingival tooth surface reproduction using three different silicone materials and the two-stage putty-and-wash technique. MATERIALS AND METHODS: From 24 probands, three impressions each were taken with Express STD Putty/Wash (3M ESPE), Optosil/Xantopren L (Heraeus Kulzer), and an experimental ultralight body/putty material (3M ESPE) in a randomized order. The preliminary impression was cut according to established procedures for the two-stage putty-and-wash technique. Master casts were manufactured with a standardized procedure and optically digitized. The 3-D accuracy was analyzed with a computer-aided procedure. The Express STD putty-and-wash impressions were used as a reference. Linear models were used for the statistical analysis. RESULTS: Mean deviations of 27.0 microm and -23.6 microm were found for Optosil/Xantopren L and 26.5 microm and -22.6 microm for the experimental material when analyzing 3-D surface reproduction. The tooth surface (buccal/oral) significantly influenced the accuracy of the surface reproduction. Optosil/Xantopren L showed a more complete reproduction of the subgingival tooth surface than either the experimental or reference materials. CONCLUSION: The accuracy of the 3-D tooth surface reproduction as well as the reproduction of the subgingival tooth surface was not favorably influenced when the ultralight wash material was used with established cutting procedures for the preliminary impression.

Dimensional accuracy of 3 silicone dental impression materials.

This study was carried out to measure the dimensional changes in silicone impression material, which can affect the fitness of the prosthesis. Using both single and double mix techniques, 20 impression samples for each of 3 different proprietary silicones, Xantopren-H, President and Fulldent, were made. Selected measurements were made on the stone casts made from each impression. In all 3 cases, the single mix gave more accurate casts than the double mix technique. The Xantopren-H impressions had the most accurate dimensions.

Variability in the properties of silicone gel breast implants.

Several generations of silicone gel breast implants have been produced by implant manufacturers. The primary material usually viewed as the base material in the manufacture of implants is polydimethylsiloxane. Polymeric reactions are notorious for their variability and nonuniformity. The elastomer used in different types of implants can have vastly different properties. Furthermore, the material properties associated with a particular type of implant can vary considerably from one lot to the next. Considering the various designs, styles, and manufacturing techniques associated with silicone gel implants, knowledge of the original properties of the implants before implantation is important in determining the effects of aging in vivo. This study was conducted to investigate differences in key mechanical and chemical properties of silicone gel breast implant materials. The two types of implants chosen for analysis were Silastic I and Silastic II control implants. Material property data were determined for both types of controls and significant differences were found in their values. Lot-to-lot variability was also investigated and found to be significant.

Prospective comparative evaluation of stapled versus transected silastic ring gastric bypass: 6-year follow-up.

BACKGROUND: The effect of transecting vs. stapling the stomach in continuity in the banded gastric bypass (GBP) operation was studied. METHOD: 50 patients, 25 in each group, were enrolled into a prospective study to determine if transecting the stomach vs. stapling it in continuity in performing GBP for obesity decreases the incidence of gastro-gastric fistula formation without increased morbidity. RESULTS: The patient profiles in the 2 groups were very similar. The peri-operative complications included 1 splenic capsular injury in each group, controlled without a splenectomy. There was 1 anastomotic leak in the stapled and 1 bleeding from the cut edge of the bypassed stomach in the transected group, both requiring re-operations in the immediate postoperative period. There was no peri-operative mortality. The percent follow-up after 6 years was 80% and 88% in the stapled and transected groups respectively. The incidence of late complications of solid food intolerance, ventral incisional hernia, cholelithiasis and small bowel obstruction was similar in both groups. There were 8 gastro-gastric fistulas in the stapled group and 1 in the transected group. The reduction in body mass index and percent excess weight loss (66%) were similar in both groups. CONCLUSION: The incidence of gastro-gastric fistula may be reduced in GBP procedures by transecting the stomach as opposed to stapling it in continuity, without an increase in morbidity or mortality or any loss in the effectiveness of the operation.

On the use of primary reference grade polydimethylsiloxane.

There has been an increase in the use of primary reference material as a standard for identifying the cellular response to biomaterials. One such material is NHLBI-DTB polydimethylsiloxane (PDMS). The PDMS was developed for blood contacting studies and is composed of PDMS backed on one side with mylar. The results of implantation studies of two different publications are discussed in light of the different materials and different surface topographies of each of the materials. The appropriateness of in vivo studies using this reference material is questioned.

[In vitro studies of pancreatic enzyme substitution]. / In-vitro-Untersuchungen zur Pankreasenzymsubstitution.

In-vitro activity of 14 commercial pancreatin preparations, commonly used in the Federal Republic of Germany, were tested. All had been declared by their manufacturers to contain more than 6000 FIP (Fédération International Pharmaceutique) units of lipase and to be acid resistant. The declared lipase and amylase amounts were found to be present in 11 of the 14 preparations. Three of the 14 preparations, said to be acid resistant were found not to be so in buffer with falling pH values between 4.0 and 2.5, so that there occurred an, at times marked, loss of enzyme activity. Most noticeable was the poor solubility of most preparations at pH 6.6. Only three of the 14 liberated their total enzyme content within 60 minutes, as they should for theoretical reasons, based on the relatively short duodeno-cecal transit time.