Process Or Composition For Sterility Or Package Integrity Test Patents (Class 436/1)
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Patent number: 8546097Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.Type: GrantFiled: November 13, 2009Date of Patent: October 1, 2013Assignees: Baxter International Inc., Baxter Healthcare S.A.Inventors: Leo Martis, Mehul Patel, Joseph A. Giertych, James W. Mongoven, Jacqueline A. Kunzler, William F. Owen, Jr.
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Publication number: 20130252340Abstract: The method comprises the following steps: bonding at least one chemical, optically luminescent compound (3) onto at least one indicator element (6) for testing the treatments (14), wherein at least one luminescence property of the chemical compound (3) can be changed; assigning at least one indicator element (6) to the object (1); wherein the indicator element (6) and the object (1) are simultaneously subjected to the same conditions of the energy-introducing treatment (14); changing the luminescence property of the chemical compound (3), wherein the level of the change to the luminescence property depends upon the energy-introducing treatment (14); irradiating (13) the chemical compound (3) with electromagnetic radiation directed onto the indicator (6) for excitation of the luminescence during the energy-introducing treatment or following the energy-introducing treatment (14).Type: ApplicationFiled: November 28, 2011Publication date: September 26, 2013Inventors: Thomas Haertling, Anton Mayer, Jörg Opitz, Jürgen Schreiber, Susan Derenko, Christiane Wetzel
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Patent number: 8541195Abstract: A testing unit and a method of testing a sterilization packaging unit for microbial contamination of sterilized objects after they have been sterilized are disclosed. The testing unit includes a dry matrix for accommodating a nutrient medium and a receptacle containing a liquid. By applying the liquid onto the matrix, the matrix is provided with a nutrient medium. In the method, the testing unit is inserted into the sterilization packaging unit which is sterilized and stored. At a desired point in time, the receptacle is opened in order to produce the nutrient medium in the matrix. After a possible multiplication of microbes on the matrix, an observation of microbes takes place. The invention also relates to a sterilization packaging unit which has a rigid outer casing and is suitable for the application of the method.Type: GrantFiled: January 24, 2011Date of Patent: September 24, 2013Inventor: Hartmut Dunkelberg
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Publication number: 20130224866Abstract: A medical device, such as a vascular access device, is disclosed for providing access to a medical fluid flow path for the introduction or withdrawal of medical fluids to and from the flow path. The access device includes an indicator for providing a visual indication when the access device has been exposed to an antiseptic agent. The indicator includes a substrate and a microporous layer disposed on the substrate. The microporous layer is made from a polymer material having an index of refraction from about 1.25 to about 1.6 and is configured to change from a substantially opaque state to a substantially transparent state upon exposure to an antiseptic solution. The microporous layer resumes the substantially opaque state after a period of time.Type: ApplicationFiled: April 18, 2013Publication date: August 29, 2013Applicants: Baxter International Inc.Inventors: Baxter International Inc., Baxter Healthcare S.A.
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Patent number: 8517835Abstract: A video game controller with a position sensor and a proximity sensor provides user input signals for use in determining game states. The video game controller can have a board or deck like surface similar to that of a skateboard, and the proximity sensor can be used to determine if a grab of the board has been attempted. A video game associated with the video game controller can provide a skateboard or other game in which a skateboard and skateboarding character are responsive to a game player's manipulation of the video game controller.Type: GrantFiled: February 20, 2009Date of Patent: August 27, 2013Assignee: Activision Publishing, Inc.Inventors: Patrick Dwyer, Nick Ehrlich, Matt Knowles, Scott Krager, Arnab Sen, David M. Tibbetts, Joshua Tsui, Peter J. Sauerbrei
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Publication number: 20130210153Abstract: A pouch (2) includes: a first, inner, envelope (1) which is closed, delimiting a first space (6) forming a pouch stricto sensu (1) intended for receiving a biopharmaceutical product or device; a second, outer, envelope (8) which is closed, delimiting a second space (9) in which is located the first envelope/pouch stricto sensu (1); a spacer element (11); at least one tracer gas located in the first space (6) or in the intermediate space (14) at a partial pressure different from that of the intermediate space or of the first space; and at least one colorimetric detection layer (12), responding to the concentration of tracer gas which reaches it by changing from a first color to a second color, and being an integral part of a wall (3, 4) of the first envelope/defined pouch (1) and/or of a wall (13) of the second envelope and/or of the spacer element.Type: ApplicationFiled: August 22, 2011Publication date: August 15, 2013Applicant: SARTORIUS STEDIM BIOTECH S.A.Inventors: Lars Bottcher, Martin Dahlberg
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Patent number: 8497129Abstract: A medical instrument including a body member and an indicator component. The indicator component includes a mechanism for identifying when reprocessing of the medical instrument has occurred.Type: GrantFiled: March 17, 2006Date of Patent: July 30, 2013Assignee: Ethicon Endo-Surgery, Inc.Inventor: Aaron C. Voegele
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Patent number: 8497080Abstract: The method of the invention pertains to determining signal transduction activity in a tissue section by immunohistochemistry techniques. The expression level of the receptor of interest is determined as well as the expression levels of one or more effector molecules of the receptor signal transduction pathway. Furthermore a combined ratio of expression levels of effector molecules in subcellular compartments with the receptor expression was found to have prognostic significance.Type: GrantFiled: February 5, 2013Date of Patent: July 30, 2013Assignees: HistoRx, Inc., Yale UniversityInventors: Mark Gustavson, Jennifer Giltnane, Marisa P. Dolled-Filhart, Robert L. Camp, David L. Rimm
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Patent number: 8492162Abstract: An electronic system for tracking and monitoring articles to be subjected to a sterilization cycle is disclosed. The method uses a sterilization indicator and electronically links sterilization information with the articles subjected to the sterilization process. The indicator allows a sterilization cycle to be monitored without the need for a user to subjectively distinguish between color, quality or intensity of display patterns.Type: GrantFiled: February 19, 2010Date of Patent: July 23, 2013Assignee: 3M Innovative Properties CompanyInventors: Roland C. Kippenhan, Steven S. Kirckof, Philip A. Bolea, Richard M. Rumble, Rodney K. Hehenberger, Ramon T. Ignacio
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Patent number: 8470601Abstract: An apparatus for indicating biological content within a container is provided. The apparatus includes a medical sterilization container having a cover removably attached to the medical sterilization container. An enclosable, sterilizable interior compartment is formed by the medical sterilization container and the cover, wherein the interior compartment is sized to house at least one medical instrument. A biological indicator is located at least partially in communication with the interior compartment, wherein the biological indicator provides at least one indication of biological content within the interior compartment after the medical sterilization container and cover are subjected to a sterilization process.Type: GrantFiled: November 16, 2011Date of Patent: June 25, 2013Assignee: Symmetry Medical Manufacturing, Inc.Inventors: Tony Foley, Gary T. Dane
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Patent number: 8431077Abstract: This invention concerns a hydrogen peroxide sterilization device, with injection of hydrogen peroxide vapor, provided with a vaporizer that feeds a sterilization chamber, with a dose that varies in function of the control performed by a computer or control unit. The vaporizer works with a pressure inferior to the atmospheric one and is heated by an electrical resistance heater, or by micro-waves. All the vaporization process is made in vacuum, by heat or ultra-sounds. The filling of the sterilant agent is made drop-by-drop by a capillary tube which transforms the liquid into a pulverized gas. The computer controls the electrical valve following the dosing pump from the pressure and/or temperature information that comes from various pressure and/or temperature sensors, whereby the pressure inside the chamber is maintained during the sterilization process in a constant predefined value, appropriate to use simple cellulose-base paper or paper composed to the packaging of the devices.Type: GrantFiled: July 10, 2007Date of Patent: April 30, 2013Inventor: Helder da Costa Goncalves
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Patent number: 8420335Abstract: The present invention provides a method of testing the ability of a test compound to bind to and optionally modulate the activity of a protein of the JMJD2 subfamily of Jumonji proteins. The method comprises incubating a test compound with a protein of the JMJD2 subfamily of Jumonji proteins, a co-factor of said protein and, optionally, a substrate for demethylation. The method of the invention can be used for screening large numbers of compounds to identify a group of compounds that are candidate compounds for clinical use for treatment of certain cancers especially prostate cancers. Other compounds that do not have activity in the screening assays can be eliminated from further consideration as candidate compounds. The method of the invention therefore has utility in the pharmaceutical industry.Type: GrantFiled: March 14, 2007Date of Patent: April 16, 2013Assignee: Kobenhavns UniversitetInventors: Paul Cloos, Karl Agger, Jesper Christensen, Klaus H. Hansen, Kristian Helin
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Patent number: 8420338Abstract: Disclosed herein are compositions and methods for measuring the level of MG53 found in a biological fluid as a biomarker for a disease or disorder, e.g., tissue damage, exercise capacity or a muscle-related disease or disorder. In addition, the invention relates to targeting the native MG53 found in the blood as a therapeutic approach.Type: GrantFiled: November 5, 2011Date of Patent: April 16, 2013Assignee: University of Medicine and Dentistry of New JerseyInventors: Noah Weisleder, Jianjie Ma
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Patent number: 8394597Abstract: The invention relates to a method for detecting endotoxins in a sample.Type: GrantFiled: December 20, 2004Date of Patent: March 12, 2013Assignee: Hyglos Invest GmbHInventors: Roman Meyer, Michael Schütz, Holger Grallert, Renate Grassl, Stefan Miller
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Patent number: 8389225Abstract: The present invention relates to a bio-silica chip comprising a silica-binding protein and a fabrication method thereof, and more particularly to a bio-silica chip in which a fusion protein of a silica-binding protein and a probe protein is immobilized on a chip comprising a silica layer, a fabrication method thereof and a method of using the bio-silica chip to detect interactions with biomaterials. The bio-silica chip will be very useful in biosensors, etc., because the bio-silica chip is advantageous in that it does not cause non-specific protein binding in the detection of protein-DNA, protein-ligand, protein-antibody, protein-peptide, protein-carbohydrate, protein-protein and cell-biomaterial interactions. Also, in the method for fabricating the bio-silica chip, a probe chip can be selectively immobilized on a silica device chip, which is widely used in biosensors, without a chemical surface treatment process.Type: GrantFiled: March 24, 2009Date of Patent: March 5, 2013Assignee: Korea Advanced Institute of Science and TechnologyInventors: Sang Yup Lee, Tae Jung Park, Yang Kyu Choi, Bon Sang Gu, Jae Hyuk Ahn
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Patent number: 8372594Abstract: The present invention relates to the use of protein expression profiles of sPLA2 isoforms with clinical relevance to osteoarthritis (OA). In particular, the invention provides methods for diagnosing OA or determining risk factors for development of OA based on expression of sPLA2-IIA.Type: GrantFiled: January 22, 2010Date of Patent: February 12, 2013Assignees: Case Western Reserve University, Brigham and Womens Hospital, The University of WashingtonInventors: David M. Lee, Eric Boilard, Michael H. Gelb, Reuben Gobezie
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Patent number: 8372593Abstract: The invention provides methods and kits for detecting conformationally altered proteins, such as prions or other proteins associated with disease states, in a sample. The methods comprise selectively capturing and separating complexes of peptide and conformationally altered protein from substances that interfere with detection of such complexes, and preferably amplification of the detection signal b addition of a second double-labeled peptide.Type: GrantFiled: February 14, 2006Date of Patent: February 12, 2013Assignee: Adlyfe, Inc.Inventors: Cindy S. Orser, Tao Pan, Jasmeet Sethi
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Patent number: 8367351Abstract: The method of the invention pertains to determining the signal transduction activity in a tissue section by immunohistochemistry techniques. The expression level of the receptor of interest is determined as well as the expression levels of one or more effector molecules of the receptor signal transduction pathway. Furthermore a combined ratio of expression levels of effector molecules in subcellular compartments with the receptor expression was found to have prognostic significance.Type: GrantFiled: May 7, 2007Date of Patent: February 5, 2013Assignees: Historx, Inc., Yale UniversityInventors: Mark Gustavson, Jennifer Giltnane, Marisa P. Dolled-Filhart, Robert L. Camp, David L. Rimm
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Patent number: 8361735Abstract: The invention relates to quality control of analytical assays, particularly NAT assays of blood samples containing nucleic acids. A control panel containing quantified amounts of substances known to interfere with an analytical assay is used and compared with a reference sample in the analytical assay. A comparison of the assay results interference panel validates the assay and can serve as a periodic quality control check for the analytical assay as well as related methods and protocols. The use of the control panel of the invention can also determine whether interfering substances are present and establish under what conditions the analytical assay reliable.Type: GrantFiled: November 29, 2011Date of Patent: January 29, 2013Assignee: Life Technologies CorporationInventor: Michael J Eck
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Patent number: 8361742Abstract: A method and system for rapidly detecting Candida on the skin of a host, such as an infant with diaper rash, is provided. The method includes contacting a dermal sample with a colorant that exhibits a certain spectral response (e.g., color change) in the presence of Candida. For example, the colorant may change from a first color to a second color, from colorless to a color, or from a color to colorless. The colorant is typically capable of differentiating between Candida (e.g., Candida albicans) and other microorganisms commonly associated with diaper rash, such as S. aureus and E. coli. Thus, when a dermal sample is placed into contact with the colorant, the color change may simply be observed to determine whether the infection is caused by Candida. If the color change occurs to a certain extent (e.g., from yellow to bright red), it may be determined that the test sample contains Candida. Likewise, if a color change occurs to a lesser extent (e.g.Type: GrantFiled: July 27, 2010Date of Patent: January 29, 2013Assignee: Kimberly-Clark Worldwide, Inc.Inventors: Stephanie M. Martin, Andrew M. Long, III, John Gavin MacDonald, Jason Lye
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Patent number: 8357083Abstract: The present invention provides a sterilization confirmation tester and a test pack which enables effective sterilization to be confirmed in a simple and sure manner by providing a simulation of the structure of an endoscope and so forth. The sterilization confirmation tester according to the present invention has a function of confirming effective sterilization treatment after sterilization performed by a sterilization apparatus. The sterilization confirmation tester includes a structure corresponding to at least one of the components which form the endoscope.Type: GrantFiled: April 25, 2011Date of Patent: January 22, 2013Assignee: Olympus CorporationInventors: Yuki Nagai, Maiko Shiga, Yosuke Kanamori, Sawako Sato, Kaori Obi
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Publication number: 20130017609Abstract: The invention relates to an apparatus (200), which comprises a first substance (220) in a microchannel (210) of the apparatus configured to react to a physical phenomenon or chemical phenomenon directed to the apparatus for providing an indication, which originates from the physical phenomenon or chemical phenomenon directed to the apparatus and indicates an occurrence of the physical phenomenon or chemical phenomenon directed to the apparatus. The invention also relates to a method, which is performed by means of the apparatus and a device, which comprises the apparatus.Type: ApplicationFiled: December 31, 2009Publication date: January 17, 2013Applicant: BASF SEInventors: Markku Känsäkoski, Eero Hurme, Leena Hakalahti, Raimo Korhonen, Antti Kemppainen
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Patent number: 8349573Abstract: The present invention relates generally to detection of occult blood. In particular, the present invention provides a device and methods for the simultaneous detection of hemoglobin and transferrin in fecal samples, which permit a more sensitive diagnosis of occult blood in fecal sample and a differential diagnosis of bleeding of the upper GI tract versus the lower GI tract.Type: GrantFiled: August 31, 2011Date of Patent: January 8, 2013Inventors: John Wan, Zhijing Wan
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Patent number: 8338128Abstract: Suitable dyes are used herein to indicate the presence of microbial contamination by spraying them onto surfaces in the form of an aqueous solution. The dye solution may also be allowed to dry, thus producing the dried residue of an aqueous solution. It's believed that these dyes change color in response to a change in polarity of the environment. Since water is a polar solvent and most bacteria are made from non-polar substances, the presence of bacteria changes the polarity of the environment, triggering a change visible by the unaided eye.Type: GrantFiled: March 30, 2010Date of Patent: December 25, 2012Assignee: Kimberly-Clark Worldwide, Inc.Inventors: Jason Lye, John Gavin MacDonald, Ning Wei, Stephanie M. Martin
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Patent number: 8309313Abstract: The invention provides glycated peptides and glycated fragments and glycated variants thereof, antibodies and aptamers which bind thereto, compositions and kits comprising the same, related conjugates, and a database comprising data indicating the concentration of glycated peptides present in diabetic and non-diabetic persons. The invention also provides a method of monitoring glycemic control, a method of treating or preventing diabetes, a method of preventing a complication of diabetes, a method of monitoring the status of diabetes, a method of determining the efficacy of a diabetes treatment, as well as methods of detecting diabetes or a predisposition thereto.Type: GrantFiled: March 6, 2007Date of Patent: November 13, 2012Assignee: The United States of America, as represented by the Secretary, Department of Health and Human ServicesInventor: Perry J. Blackshear
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Publication number: 20120252125Abstract: An indicator composition for indicating that an article has undergone an ethylene oxide sterilization process is provided. The indicator composition includes at least one pyridine derivative that reacts with moist ethylene oxide to provide an irreversible color change of the composition.Type: ApplicationFiled: March 28, 2012Publication date: October 4, 2012Applicant: lllinois Tool Works Inc.Inventor: Shobha Shakher Puntambekar
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Patent number: 8277749Abstract: The present invention relates to a time temperature indicator comprising at least one indicator compound in a first isomeric form, which is converted into a second isomeric form of said indicator compound in a valence isomerization reaction without migration of an atom or chemical group attached to said indicator compound in a time and temperature dependent manner, wherein the formation of the second isomeric form is detectable by monitoring a physical characteristic of the indicator. The present invention also relates to a method of manufacturing such a time-temperature indicator comprising the steps of (a) embedding in or atop a matrix said indicator compound; and (b) inducing the formation of a metastable state of said embedded indicator compound.Type: GrantFiled: January 24, 2005Date of Patent: October 2, 2012Assignee: Freshpoint Holdings S.A.Inventors: Yoav Levy, Dietrich Haarer
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Patent number: 8268238Abstract: A system for recovery of a sterilant gas mixture from a sterilizer chamber is disclosed. The system includes a gas recovery tank, a sterilizer chamber in gaseous communication with the gas recovery tank and a gas recovery assembly coupled to the gas recovery tank and the sterilizer chamber. The gas recovery assembly is configured to transfer a sterilant gas mixture including at least one sterilant gas between the sterilizer chamber and the gas recovery tank. The system further includes an analyzer assembly coupled to the sterilizer chamber, the analyzer assembly including at least one sterilant gas sensor configured to detect density of the sterilant gas and a control module coupled to the analyzer assembly and to the gas recovery assembly. The control module includes at least one control module configured to determine at least one of a transfer pressure and flammability of the sterilant gas mixture as a function of the density of the sterilant gas.Type: GrantFiled: August 23, 2010Date of Patent: September 18, 2012Assignee: Tyco Healthcare Group LPInventors: Douglas E. Bondar, Michael L. Bongiovi
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Patent number: 8268623Abstract: A method and means for identifying the authenticity and the genuine nature of a solid or liquid bulk material, by incorporating a marking composition containing at least one trace ion into the said bulk material, whereby the total concentration of the incorporated trace ions in the market bulk material is chosen to be lower than the corresponding concentration of the same ions in standard sea water. The authenticity and the genuine nature or the adulteration level of the marked bulk material can be tested in-the-field using electrochemical sensors, and confirmed in the laboratory using a method such as atomic absorption spectroscopy, ion chromatography or mass spectrometry.Type: GrantFiled: October 28, 2011Date of Patent: September 18, 2012Assignee: SICPA Holding SAInventors: Thomas Tiller, Sylvain Jaquier, Xavier Marguerettaz
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Patent number: 8246442Abstract: A game of chance is disclosed that looks like a multi-line gaming machine having a matrix of rows and columns of positions for displaying slot symbols or cards to a player. A player wagers to play one or more games but the actual pay lines are dynamically determined by events that occur during the course of game play, not before. Per the teaching of the invention a number of bonus pay lines and their routing are dynamically determined during the course of game play of slots or cards dependent on choices made by a player during game play.Type: GrantFiled: January 6, 2010Date of Patent: August 21, 2012Inventor: Robert P Barrie
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Patent number: 8241860Abstract: Provided are rapid and sensitive cell-free assay methods for detecting and/or measuring specific bimolecular or higher order interactions via reassembly of a split monomeric reporter protein, and methods of detecting or identifying modulators of such interactions by the effect on the signal provided by the reassembled split reporter protein. This methodology is adaptable to protein-protein, protein-peptide, protein-nucleic acid, protein-methylated or nonmethylated nucleic acid and other small or large molecule ligands and binding proteins.Type: GrantFiled: November 3, 2008Date of Patent: August 14, 2012Assignee: The Arizona Board of Regents of Behalf of the University of ArizonaInventors: Indraneel Ghosh, Cliff I. Stains, Jason R. Porter, Benjamin Jester, Jennifer Furman
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Patent number: 8241918Abstract: A beverage dispensing device including a housing, a tapping device for dispensing a beverage, a beverage container connectable with the tapping device, a freshness indicator device, a data input unit for recording replacement of the beverage container, a temperature sensor for measuring the storage temperature of the beverage, a temperature controller for adjusting the cooling temperature of a chiller, a storage unit for storing the freshness criteria, and a processing unit. The temperature sensor transmits the current beverage storage temperature to the processing unit and the processing unit calculates, depending on a recorded storage temperature period and based on stored freshness criteria, the actual freshness of the beverage, the time left until expiry of the freshness of the beverage and/or the date of expiry of the freshness of the beverage. The processing unit transmits the calculated data to the display.Type: GrantFiled: June 13, 2007Date of Patent: August 14, 2012Assignee: Koninklijke Philips Electronics N.A.Inventors: Guenter Zeitler, Matthias Bertram, Christian Baeumer
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Patent number: 8232064Abstract: The invention relates to the detection and quantitation of cyclodextrins and cyclodextrin derivatives in solutions comprising a protein. The invention further relates to methods of evaluating pharmaceutical preparations for the presence of residual cyclodextrins.Type: GrantFiled: December 5, 2005Date of Patent: July 31, 2012Assignee: Biogen Idec MA Inc.Inventors: Zoran Sosic, Rulin Qian, James Ahern, Rohin Mhatre
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Patent number: 8183045Abstract: The present invention provides a device capable of exhibiting a time-temperature dependence that comprises an upper layer carrying a first reactant selected from a group of materials such as chelating agents and a base layer carrying a second reactant adapted to react with the first reactant upon triggering. A barrier layer is provided between the upper layer and the base layer. Visual characteristic is changed depending on time and temperature after triggering had occurred while the device is not susceptible to environmental conditions and can be stored in room temperature.Type: GrantFiled: August 21, 2005Date of Patent: May 22, 2012Assignee: Skyrad, Ltd.Inventor: Ori Faran
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Publication number: 20120122226Abstract: An apparatus for indicating biological content within a container is provided. The apparatus includes a medical sterilization container having a cover removably attached to the medical sterilization container. An enclosable, sterilizable interior compartment is formed by the medical sterilization container and the cover, wherein the interior compartment is sized to house at least one medical instrument. A biological indicator is located at least partially in communication with the interior compartment, wherein the biological indicator provides at least one indication of biological content within the interior compartment after the medical sterilization container and cover are subjected to a sterilization process.Type: ApplicationFiled: November 16, 2011Publication date: May 17, 2012Applicant: SYMMETRY MEDICAL MANUFACTURING, INC.Inventors: Tony Foley, Gary T. Dane
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Patent number: 8173379Abstract: A method of determining a concentration of analytes of interest in a sample reaction mixture is disclosed. The method can include measuring intensities of the polarized fluorescence of at least one comparative reaction mixture containing different, known amounts of the analytes of interest, and measuring the intensities of the polarized fluorescence of a sample reaction mixture. The method can also include determining the preliminary concentrations of the analytes of interest in the sample reaction mixture by comparing the measured intensities of the sample reaction mixtures at various time points. The margin of error for the preliminary concentration of the analytes of interest in the sample can be determined at the various time points. Finally, the concentration of the analytes of interest in the sample reaction mixture can be determined by comparing the preliminary concentrations and the respective margin of error at the given time points.Type: GrantFiled: July 15, 2008Date of Patent: May 8, 2012Assignee: Aokin AGInventors: Frank Mallwitz, Ursula Dahmen-Levison, Derek Levison, Stuart Levison
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Patent number: 8173380Abstract: A diagnostic test kit for detecting an analyte residing in a test sample is provided. The kit employs a lateral flow device that contains a membrane. A metering channel is formed in the membrane that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay. Such a metering channel is particularly effective for embodiments in which the test sample has a relatively low volume, such as less than about 100 microliters, in some embodiments from about 0.5 to about 25 microliters, and in some embodiments, from about 1 to about 10 microliters. For example, whole blood drops obtained from patients with a lancet typically have a volume of less than about 3 microliters. Despite their low volume, the present inventors have discovered that the blood drops may still be accurately analyzed for the presence of an analyte using lateral flow detection techniques.Type: GrantFiled: August 31, 2010Date of Patent: May 8, 2012Assignee: Kimberly-Clark Worldwide, Inc.Inventors: Kaiyuan Yang, Ning Wei, Shawn Ray Feaster
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Patent number: 8163234Abstract: The invention relates to a method for characterizing the bioindicators in sterilization processes using an autoclave and the like, in which a bioindicator is kept in the same conditions as the sterilization chamber (2) and extracted after a predetermined time interval. For this purpose the chamber (2) has, passing through it, a tube (5) on the ends of which valves (8-9, 10-11) are mounted, said valves allowing the insertion, from above, of a bioindicator sample and its extraction from below, when required, without a significant loss of sterilizing agent. Alternatively, the duct (5) may also be arranged outside the sterilization chamber (2) and kept in communication therewith by a bypass connection.Type: GrantFiled: March 23, 2006Date of Patent: April 24, 2012Assignee: Fedegari Autoclavi SpAInventor: Fortunato Fedegari
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Patent number: 8163508Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.Type: GrantFiled: July 12, 2011Date of Patent: April 24, 2012Assignee: The Trustees of Columbia University in the City of New YorkInventors: John O'Connor, Steven Birken, Galina Kovalevskaya
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Patent number: 8153387Abstract: A method for immobilizing glycoprotein is disclosed. A surface is provided. Next, a boronic acid is contacted to the surface. The boronic acid is represented as Y—R—B—(OH)2 and includes a boronic acid group (B—(OH)2), a linker R, and a functional group Y, in which the boronic acid is bonded to the surface via the functional group Y. A glycoprotein is contacted to the boronic acid, wherein two spatially adjacent hydroxyl groups of a carbohydrate chain form a boronate ester with the boronic acid group of the boronic acid to immobilize the glycoprotein. The goal of site-specific and covalent protein immobilization without interfering the binding affinity of an antibody to antigen may be thus achieved with the reaction of boronic acid and the carbohydrate chain of Fc region.Type: GrantFiled: June 24, 2009Date of Patent: April 10, 2012Assignee: National Tsing Hua UniversityInventors: Chun-Cheng Lin, Mu-Lin Chen, Po-Chiao Lin, Yu-Ju Chen, Shu-Hua Chen
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Patent number: 8142714Abstract: The invention relates to the use of a cleaning agent that contains surfactants and has a pH value of at least 11 when diluted in an aqueous solution and ready for use. Said cleaning agent is used to destabilize prions during mechanical and manual cleaning and/or disinfection of medical and/or surgical instruments and appliances. It has been recognized that this combination enables a reliable destabilization of prions during the mechanical reconditioning of surgical instruments.Type: GrantFiled: January 28, 2003Date of Patent: March 27, 2012Assignee: Chemische Fabrik Dr. Weigert GmbH & Co. KGInventors: Petra Tiarks, Jurgen Staffeldt
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Patent number: 8129189Abstract: The present invention relates to an indicator of sterilization and/or use, which may be affixed to or integrated in a limited use device. The indicator may include a plurality of layers wherein each of the layers includes a membrane. The indictor may also include indicia of the number of uses disposed between the layers. The membranes may breach upon the sterilization or use of the limited use device, wherein the device is exposed to a given environment, such as various gasses, steam, liquids, UV, plasma, etc. In addition, more than one membrane may be provided between each indicia, wherein each membrane may respond to a different environment.Type: GrantFiled: September 12, 2008Date of Patent: March 6, 2012Inventor: David B Spenciner
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Patent number: 8119358Abstract: The invention describes biomarkers which can be used to predict the likelihood that an individual will develop Diabetes. The biomarkers can also be used to screen large groups in order to identify individuals at risk of developing Diabetes.Type: GrantFiled: April 18, 2008Date of Patent: February 21, 2012Assignee: Tethys Bioscience, Inc.Inventors: Michael S. Urdea, Michael P. McKenna, Patrick A. Arensdorf
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Patent number: 8110144Abstract: Disclosed are processes for sterilization of cyanoacrylate adhesive compositions, the compositions, comprising 2-cyanoacrylate ester monomers, so produced and a method for assaying the effectiveness of the sterilization process. The process comprises heating the adhesive composition to from about 70° C. to about 140° C. for an effective amount of time. The effectiveness of the process can be assayed by disposing bacterial spores in the cyanoacrylate monomer, exposing the composition to a dry heat sterilization process, transferring the cyanoacrylate composition to a sterile aldose solution, transferring and exposing the sample to a nutrient medium which supports germination and growth of viable spores, incubating the samples, and determining the presence or absence of growth.Type: GrantFiled: September 17, 2004Date of Patent: February 7, 2012Assignee: Chemence Medical, Inc.Inventor: Carlos R. Morales
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Patent number: 8105794Abstract: The present invention relates to an assay which can be used on nasal secretions. The assay is used to determine the cause of nasal secretions, for example whether the secretions are due to an allergic reaction or a non-allergic reaction.Type: GrantFiled: February 4, 2011Date of Patent: January 31, 2012Assignee: Toxcure LLCInventor: Christopher Shaari
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Patent number: 8097461Abstract: The invention relates to quality control of analytical assays, particularly NAT assays of blood samples containing nucleic acids. A control panel containing quantified amounts of substances known to interfere with an analytical assay is used and compared with a reference sample in the analytical assay. A comparison of the assay results interference panel validates the assay and can serve as a periodic quality control check for the analytical assay as well as related methods and protocols. The use of the control panel of the invention can also determine whether interfering substances are present and establish under what conditions the analytical assay reliable.Type: GrantFiled: November 15, 2007Date of Patent: January 17, 2012Assignee: Life Technologies CorporationInventor: Michael J. Eck
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Publication number: 20110312096Abstract: Chemical indicator compositions comprising a bismuth compound; elemental sulfur; and a compound with relatively high water solubility which makes the composition alkaline when exposed to water vapor at an elevated temperature; a chemical indicator comprising a substrate and the composition coated on at least a portion of a major surface of the substrate; and methods of making and using the chemical indicator are disclosed.Type: ApplicationFiled: June 15, 2011Publication date: December 22, 2011Inventors: David A. Whitman, David M. Read, Ranjani V. Parthasarathy, Kevin D. Landgrebe, Anthony E. Bennett
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Patent number: 8071386Abstract: A method and means for identifying the authenticity and the genuine nature of a solid or liquid bulk material, by incorporating a marking composition containing at least one trace ion into the said bulk material, whereby the total concentration of the incorporated trace ions in the market bulk material is chosen to be lower than the corresponding concentration of the same ions in standard sea water. The authenticity and the genuine nature or the adulteration level of the marked bulk material can be tested in-the-field using electrochemical sensors, and confirmed in the laboratory using a method such as atomic absorption spectroscopy, ion chromatography or mass spectrometry.Type: GrantFiled: May 19, 2004Date of Patent: December 6, 2011Assignee: SICPA Holding SAInventors: Thomas Tiller, Sylvain Jaquier, Xavier Marguerettaz
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Patent number: 8062857Abstract: The present invention relates to a method for diagnosing myocardial infarction in a subject who suffers from acute coronary syndrome and has a cardiac troponin level which is detectable but lower than the level that is considered as being indicative for a myocardial infarction. Moreover, the present invention relates to a method for identifying a subject being susceptible to cardiac intervention, wherein the subject suffers from acute coronary syndrome and has a cardiac troponin level which is detectable but lower than a level that is considered as being indicative for a myocardial infarction. The methods of the present invention are based on the determination of H-FABP and, optionally, myoglobin in a sample of the subject and comparing the amount of H-FABP and, optionally, myoglobin to reference amounts.Type: GrantFiled: November 23, 2009Date of Patent: November 22, 2011Assignee: Roche Diagnostics Operations, Inc.Inventors: Georg Hess, Hendrik Huedig, Rosemarie Kientsch-Engel, Dietmar Zdunek
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Patent number: 8062854Abstract: A method is described for enriching procaryotic DNA, said method including the steps of contacting at least one procaryotic DNA with at least one protein or polypeptide which is capable of specifically binding to non-methylated CpG motifs, and separating the protein/polypeptide-DNA complex. Moreover, the application relates to a kit for carrying out said method.Type: GrantFiled: August 8, 2003Date of Patent: November 22, 2011Assignee: SIRS-Lab GmbHInventors: Karl-Hermann Schmidt, Eberhard Straube, Stefan Russwurm