Testing For Sterility Condition Patents (Class 435/31)
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Patent number: 11579054Abstract: An extraction system for testing microbial contamination includes a biocompatible outer vessel that has a side wall and a biocompatible suspension system that is positionable within an interior of the biocompatible outer vessel. The biocompatible suspension system includes a horizontal member on which a sample may be supported and a securement mechanism that is engagable with the side wall of the biocompatible outer vessel to maintain the suspension system at a desired position within the biocompatible outer vessel.Type: GrantFiled: April 11, 2019Date of Patent: February 14, 2023Assignee: ALLOSOURCEInventors: Arthur Joslyn, Kenneth Blood, Jan Zajdowicz, Lauren Kapushion, Amy Kippen, Samantha White, Donald White
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Patent number: 11579127Abstract: An indicator and method of use thereof, and indicator system and method of use thereof are provided to determine the degree of an oxidative treatment. An indicator is incorporated into the oxidative treatment. The object and the indicator are subjected to the oxidative treatment. A discoloration of the indicator occurs based on an oxidation of the polymer by a process condition of the oxidative treatment oxidizing the polymer. The discoloration of the indicator is measured against a threshold color value to determine the degree of the oxidative treatment.Type: GrantFiled: June 11, 2019Date of Patent: February 14, 2023Assignee: ASP Global Manufacturing GmbHInventor: Roger Vu
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Patent number: 11516603Abstract: Hearing aid devices, methods of manufacture, methods of use, and kits are provided. In certain aspects, the hearing aid devices comprise an apparatus having a transducer and a retention structure comprising a shape profile corresponding to a tissue of the user, and a layer of elastomer.Type: GrantFiled: August 31, 2020Date of Patent: November 29, 2022Assignee: Earlens CorporationInventors: Peter Dy, Rodney Perkins, James Silver, Jake Olsen, Paul Rucker, Kyle Imatani, Bryan Flaherty, Daniel Hallock, Iljong Lee, Ketan Muni
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Patent number: 11490983Abstract: Disclosed is a catheterization package including catheterization-package components and a catheterization tray configured to facilitate a catheterization procedure. The catheterization-package components include a urinary catheter fluidly connected to a urine-drainage bag and a sampling-port access device configured to fluidly connect to a urine-sampling port of the urinary catheter or the urine-drainage bag for aseptic collection of one or more urine samples. The catheterization tray includes at least a first compartment, a second compartment, and a third compartment configured to hold the catheterization-package components. The first compartment is configured to hold the urinary catheter. The second compartment is connected to the first compartment by an intercompartment connection. The second compartment is configured to hold the urine-drainage bag. The third compartment is configured to hold the sampling-port access device.Type: GrantFiled: April 23, 2019Date of Patent: November 8, 2022Assignee: C. R. Bard, Inc.Inventors: Tracey E. Knapp, Eric Rehm, Nick Austerman, Sarah Skelton, Caroline Bunn, Robert M. Hine, Brandt Davis
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Patent number: 11473120Abstract: A reference test body for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product, wherein the reference test body has a cavity, a nutrient medium, at least one opening, and at least one cover provided with a number of holes and covering the at least one opening. A constancy of test conditions can be monitored in this way. The invention further relates to an associated use, an associated test chamber, and an associated method.Type: GrantFiled: May 29, 2019Date of Patent: October 18, 2022Assignee: Aesculap AGInventors: Selina Kammerer, Daniel Kiessling
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Patent number: 11085065Abstract: The biological functionality of living microbial spores is modified using phenotypic engineering to endow the resulting modified spores with novel functionality that extends the usefulness of the spores for a variety of practical applications including, for example, sterility testing, the release of active compounds, and cell-based biosensing systems. An embodiment entails engineering Bacillus spores to acquire synthetic new functions that enable the modified spores to sense and rapidly transduce specific germination signals in their surroundings. The newly acquired functions allow the spores to perform, for example, as self-reporters of cellular viability, self-indicating components of cell-based biosensors, and in other analytical systems. Also disclosed are methods for testing adequate sterility of a system by using engineered spores.Type: GrantFiled: June 19, 2017Date of Patent: August 10, 2021Inventor: M. Boris Rotman
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Patent number: 11054420Abstract: The present invention relates to moving microorganisms to a surface, where they are grown in the presence and absence of antimicrobials, and by monitoring the growth of the microorganisms over time in the two conditions, their susceptibility to the antimicrobials can be determined. The microorganisms can be moved to the surface through electrophoresis, centrifugation or filtration. When the movement involves electrophoresis, the presence of oxidizing and reducing reagents lowers the voltage at which electrophoretic force can be generated and allows a broader range of means by which the target can be detected. Monitoring can comprise optical detection, and most conveniently includes the detection of individual microorganisms. The microorganisms can be stained in order to give information about their response to antimicrobials.Type: GrantFiled: November 30, 2017Date of Patent: July 6, 2021Assignee: Accelerate Diagnostics, Inc.Inventors: David A. Goldberg, David C. Howson, Steven W. Metzger, Daniel A. Buttry, Steven Scott Saavedra
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Patent number: 11028454Abstract: The present application relates to methods for producing materials having viable micro-organisms incorporated therein. More particularly, the materials are produced under high temperature and/or high pressure conditions, and the micro-organisms are incorporated in the material before or during these conditions. Also provided are micro-organisms that remain viable under these conditions and have different applications, depending on the nature of the material.Type: GrantFiled: September 24, 2009Date of Patent: June 8, 2021Assignee: ResiluxInventors: Johan Mertens, Lynda Beladjal, Frank Devlieghere, Sam Verbrugghe, Benedikt Sas, Filip Du Prez, Tom Anthierens, Assia Ouchchen
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Patent number: 10907126Abstract: A biological sterilization indicator includes a housing having a first enclosure and a second enclosure, an ampule containing a liquid growth medium, and an insert disposed at least partially in the first enclosure. A portion of the ampule may be disposed inside the first enclosure. The insert may have a platform including a top surface, an abutment surface, and a side surface, as well as a first void disposed in the platform and configured to allow passage of a first volume of the liquid growth medium into the second enclosure and a second void disposed through at least a portion of the side surface and configured to allow passage of a second volume of the liquid growth medium into the second enclosure.Type: GrantFiled: March 1, 2016Date of Patent: February 2, 2021Assignee: ASP GLOBAL MANUFACTURING GMBHInventor: Benham Amin
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Patent number: 10561751Abstract: A sterilization assembly of a mobile device includes a bacteria detection device, a microwave sterilization device, and a processor. The bacteria detection device detects a bacterial count on the mobile device by emitting light waves and receiving reflected light waves and analyzing a wavelength change in the reflected light waves. The microwave sterilization device emits microwaves to kill the bacteria. The processor sends a detection signal to the bacteria detection device to control the bacteria detection device to detect the bacterial count, and sends a sterilization signal to the microwave sterilization device to control the microwave sterilization device to emit the microwaves. The bacteria detection device sends detection feedback information to the processor. The microwave sterilization device sends sterilization feedback information to the processor.Type: GrantFiled: April 25, 2019Date of Patent: February 18, 2020Assignees: Fu Tai Hua Industry (Shenzhen) Co., Ltd., HON HAI PRECISION INDUSTRY CO., LTD.Inventor: Yong-Xing Yang
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Patent number: 10457973Abstract: A method for rapidly determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device. The method includes providing a defined surrogate protein having a predetermined sequence representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device. The defined surrogate protein having the predetermined sequence is subjected to sterilization, deimmunization, or disinfection. The effectiveness of the sterilization deimmunization, or disinfection is rapidly determined by determining if the defined surrogate protein has been destroyed.Type: GrantFiled: February 14, 2019Date of Patent: October 29, 2019Assignee: ONEighty°C Technologies CorporationInventor: Theresa L. O'Keefe
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Patent number: 10246731Abstract: A method for rapidly determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device. The method includes providing a defined surrogate protein having a predetermined sequence representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device. The defined surrogate protein having the predetermined sequence is subjected to sterilization, deimmunization, or disinfection. The effectiveness of the sterilization deimmunization, or disinfection is rapidly determined by determining if the defined surrogate protein has been destroyed.Type: GrantFiled: March 29, 2017Date of Patent: April 2, 2019Assignee: ONEighty°C Technologies CorporationInventor: Theresa L. O'Keefe
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Patent number: 9750829Abstract: A method for removing microorganisms from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention. Microorganisms such as bacteria, particularly B. Diminuta, are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a B. Diminuta LRV greater than about 9, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. Another method for removing microorganisms such as bacteria and Mycloplasma, includes passing the liquid through a porous nanofiber containing filtration medium having a microorganism LRV greater than about 8, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. The filtration medium can be in the form of a fibrous electro spun polymeric nanofiber liquid filtration medium mat.Type: GrantFiled: March 19, 2010Date of Patent: September 5, 2017Assignee: EMD Millipore CorporationInventors: Mikhail Kozlov, Wilson Moya, Gabriel Tkacik
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Patent number: 9611086Abstract: Surgical wrappers and related methods are provided. A reusable surgical wrapper can include a first layer that includes a fabric having at least one of synthetic fibers or synthetic yarns. In some embodiments, a surgical wrapper can include a first layer comprising a first fabric that repels fluids forming a first face of the surgical wrapper. A second layer can be provided that includes a second fabric forming a second face of the surgical wrapper. A seam binding can be disposed around at least a portion of an outer edge of the first fabric and an outer edge of the second fabric to join the first layer and the second layer to form a dual layered surgical wrapper.Type: GrantFiled: November 12, 2012Date of Patent: April 4, 2017Inventor: Rea Hinson, Jr.
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Patent number: 9522001Abstract: Surgical appliance kit and system for releasably securing a surgical appliance to a surgical field and method of assembling the surgical appliance kit. The surgical appliance kit and system includes a surgical tray having the surgical appliance and a plurality of hook-and-loop attachment members disposed thereon. A cover is attached to the surgical tray and covers the surgical appliance and the plurality of attachment members. In use, a “hook” attachment member is adhesively attached to the surgical appliance and a “loop” attachment member is adhesively attached to the surgical field. The hook attachment member is placed into engagement with the loop attachment member. In this manner, the surgical appliance is releasably secured to the surgical field, so that the surgical appliance will not inadvertently fall from the surgical field.Type: GrantFiled: April 12, 2012Date of Patent: December 20, 2016Assignee: Operating Room Innovations, Inc.Inventors: Phong Duy Bui, Ruel Flores Salvador
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Patent number: 9410180Abstract: A biological sterilization indicator (BI) system and method. The system can include a BI and a reading apparatus comprising a well. The BI can include a housing, which can include a first portion, and a second portion movable between a first “unactivated” position and a second “activated” position. The reading apparatus can detect at least one of (i) when the well is empty; (ii) when the biological sterilization indicator is positioned in the well with the second portion of the housing in the first position, and (iii) when the biological sterilization indicator is positioned in the well with the second portion of the housing in the second position. The method can include detecting at least one of the above conditions, which can be used to detect an activation status of the biological sterilization indicator.Type: GrantFiled: October 28, 2011Date of Patent: August 9, 2016Inventors: Jeffrey C. Pederson, Sailaja Chandrapati, Bryan S. Behun, Barry W. Robole, Leroy J. Longworth, Kaileen Chen
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Patent number: 9260741Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.Type: GrantFiled: December 5, 2013Date of Patent: February 16, 2016Assignee: Bracco Imaging S.P.A.Inventors: Robert C. Williams, Jr., Patrice Marchildon
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Patent number: 9228221Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.Type: GrantFiled: June 18, 2014Date of Patent: January 5, 2016Assignee: Bracco Imaging S.p.A.Inventors: Robert C. Williams, Jr., Patrice Marchildon
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Patent number: 9228220Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.Type: GrantFiled: December 5, 2013Date of Patent: January 5, 2016Assignee: Bracco Imaging S.p.A.Inventors: Robert C. Williams, Jr., Patrice Marchildon
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Patent number: 9228222Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.Type: GrantFiled: June 18, 2014Date of Patent: January 5, 2016Assignee: Bracco Imaging S.p.A.Inventors: Robert C. Williams, Jr., Patrice Marchildon
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Publication number: 20150147773Abstract: A combined sterilization indicator incubator and reader system, including a sterilization indicator vial containing one of a variety of selected biological indicators and a liquid, at least two incubator blocks, each incubator block independently operable to incubate the sterilization indicator vial at a plurality of independently selectable temperatures, each of the incubator blocks including at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures; a light source, a photodetector and a control system configured to operate the combined system to determine the efficacy of a variety of sterilization processes. The system calculates and compares a slope to a predetermined threshold slope for the biological indicator, and provides output based only on the comparison of the calculated slope to the predetermined threshold slope without first determining either a baseline or a minimum value of the output from the photodetector.Type: ApplicationFiled: November 26, 2013Publication date: May 28, 2015Applicant: American Sterilizer CompanyInventors: Phillip P. FRANCISKOVICH, Tricia A. CREGGER, Paul VODKIN
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Publication number: 20150147408Abstract: A Method Validation Unit (MVU) for the evaluation of the level of sterilisation in a sterilisation method involving the use of a fluid at or near the supercritical pressure and temperature for that fluid, wherein the MVU comprises a sterilisation indicator housed within a gas-permeable container, wherein the sterilisation indicator comprises an indicator medium and a population of one or more colony forming units (CFUs), and wherein the indicator medium comprises one or more structural features representative of the internal structure of a material to be sterilised in the sterilisation method.Type: ApplicationFiled: May 30, 2013Publication date: May 28, 2015Applicant: Austrialian Biotechnologies PTY. LimitedInventors: Simon Jonothan Berry, Sharon Bryce, Jerome Alon Goldberg
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Patent number: 9012173Abstract: The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.Type: GrantFiled: February 14, 2014Date of Patent: April 21, 2015Assignee: American Sterilizer CompanyInventors: Phillip P. Franciskovich, Tricia A. Cregger
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Patent number: 8969029Abstract: A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.Type: GrantFiled: October 12, 2009Date of Patent: March 3, 2015Assignee: 3M Innovative Properties CompanyInventors: Sailaja Chandrapati, Jeffrey C. Pederson, Heather M. Webb, Jeffrey D. Smith, Kurt J. Halverson, Bryan S. Behun, Peter D. Ludowise
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Publication number: 20140356899Abstract: A protocol process is provided for testing and evaluating Bacillus spores. The process includes isolating a sample of the spores, providing an environmental matrix of exposure condition elements, determining a midpoint for each control range between the low and high extremities, selecting condition elements from the matrix, with each condition element corresponding to a first condition, subjecting the sample to the condition elements from the matrix, counting survival spores for each condition element, performing a response surface methodology (RSM) analysis from the survival spores, and determining coefficients that satisfy a relation for k conditions. The matrix has control ranges of temperature, relative humidity and exposure duration, the control ranges extending from a low extremity to a high extremity. The first condition is one of the low and high range extremities and remaining conditions occupying the midpoint for a corresponding control range. All condition elements are uniquely distinguishable.Type: ApplicationFiled: April 2, 2014Publication date: December 4, 2014Applicant: United States of America as represented by the Secretary of the NavyInventors: Tony L. Buhr, Claire M. Wells, Alice A. Young, Edward J. Prokop, III, John R. Crigler
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Patent number: 8859222Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. 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: August 23, 2013Date of Patent: October 14, 2014Assignees: Baxter International Inc., Baxter Healthcare S.A.Inventors: Leo Martis, Mehul Patel, Joseph A. Giertych, James W. Mongoven, Jacqueline A. Kunzier, William F. Owen
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Publication number: 20140273072Abstract: A sterilization indicator, including a first compartment containing a genetically engineered biological indicator, and a second compartment containing an enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during sterilization, and to permit the enzyme substrate to contact the biological indicator after the biological indicator has been exposed to the sterilization medium; in which the genetically engineered biological indicator comprises at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and the test organism is free of any active or activatable repressor gene that would inhibit expression of the reporter gene if present in the test organism or sterilization indicator, and the indicator enzyme and the enzyme substrate are selected such that enzymatic action of the indicator enzyme upon the enzyme substrate yields a detectable signal.Type: ApplicationFiled: March 15, 2013Publication date: September 18, 2014Applicant: AMERICAN STERILIZER COMPANYInventors: Phillip P. Franciskovich, Tricia A. Cregger, William A. Yirava
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Publication number: 20140273073Abstract: A sterilization indicator for oxidative sterilants, comprising a first compartment comprising spores of one or more microorganism species, wherein the spores have been pretreated with and comprises a compound comprising a transition metal ion that is reactive with an oxidative sterilant; a second compartment comprising a growth medium and adapted to combine contents of the first compartment with contents of the second compartment for incubation after the sterilization indicator has been exposed to an oxidative sterilant; and an agent disposed in the growth medium and selected to indicate viability of the spores after the sterilization indicator has been exposed to the oxidative sterilant.Type: ApplicationFiled: March 15, 2013Publication date: September 18, 2014Applicant: AMERICAN STERILIZER COMPANYInventors: Phillip P. Franciskovich, Tricia A. Cregger
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Patent number: 8828714Abstract: The sterilizing effect of particle irradiation on microorganisms for the sterilizing treatment thereof can be evaluated. The evaluation can be done by supplying microorganisms in the space inside a container (8), allowing particles (7) for the sterilizing treatment of microorganisms to irradiate the microorganisms, sampling the microorganisms by a sampling means (6) after the irradiation of the particles (7) and measuring the sampled microorganisms. The microorganisms as the subject for the sterilizing treatment can be a combination of one or more members selected from the group consisting of bacteria, mycete, viruses and allergens. As the particles, for example, positive ions, negative ions, and gases of positive ions and negative ions in mixture, charged particles such as ? rays and ? rays, various plasma gas particles, particles such as ozone and radical particles, and particles of chemical agent can be used.Type: GrantFiled: June 13, 2012Date of Patent: September 9, 2014Assignee: Sharp Kabushiki KaishaInventors: Kazuo Nishikawa, Hisaharu Yagi, Yoshihiro Shimizu, Tetsuyuki Ohtani, Hideo Nojima, Miyuki Aoki
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Patent number: 8822174Abstract: A sterilization indicator for oxidative sterilants, comprising a first compartment comprising spores of one or more microorganism species, wherein the spores have been pretreated with and comprises a compound comprising a transition metal ion that is reactive with an oxidative sterilant; a second compartment comprising a growth medium and adapted to combine contents of the first compartment with contents of the second compartment for incubation after the sterilization indicator has been exposed to an oxidative sterilant; and an agent disposed in the growth medium and selected to indicate viability of the spores after the sterilization indicator has been exposed to the oxidative sterilant.Type: GrantFiled: March 15, 2013Date of Patent: September 2, 2014Assignee: American Sterilizer CompanyInventors: Phillip P. Franciskovich, Tricia A. Cregger
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Patent number: 8822173Abstract: The present invention relates to a wound dressing or a wound swab, which allows the detection of at least three enzymes selected from the group consisting of lysosyme, elastase, cathepsin G and myeloperoxidase using colored substrate agents for these enzymes. These enzyme substrates can be bound to medically acceptable polymers or fibers.Type: GrantFiled: July 16, 2013Date of Patent: September 2, 2014Assignee: Eva Wehrschutz-SiglInventor: Eva Wehrschütz-Sigl
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Publication number: 20140227735Abstract: A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.Type: ApplicationFiled: April 21, 2014Publication date: August 14, 2014Inventor: Joseph P. Dalmasso
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Patent number: 8802392Abstract: The present invention provides method of detecting a predetermined biological activity. The method includes using an aqueous mixture comprising a first indicator reagent with a first absorption spectrum and a second indicator reagent. The second indicator reagent is converted by the predetermined biological activity to a second biological derivative with a second emission spectrum. The first absorbance spectrum includes detectable absorbance in at least a portion of wavelengths present in the second emission spectrum. The first indicator reagent is received and concentrated from an aqueous liquid by a substrate, facilitating the detection of the second biological derivative.Type: GrantFiled: October 28, 2011Date of Patent: August 12, 2014Assignee: 3M Innovative Properties CompanyInventors: Sailaja Chandrapati, Heather M. Webb, Jeffrey C. Pederson, Kurt J. Halverson, Brian R. Engel
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Patent number: 8785141Abstract: The invention aims at providing an adsorbent for bacterial toxins, a method for removal of such toxins by adsorption, and an adsorber packed with said adsorbent. Provided are an adsorbent for bacterial toxins, which comprises a water-insoluble porous material having a mode of pore radius of 20 angstroms to 1,000 angstroms, a method for removal of bacterial toxins using said adsorbent, and an adsorber packed with said adsorbent.Type: GrantFiled: August 24, 2001Date of Patent: July 22, 2014Assignee: Kaneka CorporationInventors: Tamiji Fujimoto, Fumiyasu Hirai, Shigeo Furuyoshi
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Patent number: 8778629Abstract: A sterility test method includes: selecting strain and culture medium, preparing bacterial cultures, transcribing fingerprint characteristics in thermograms as indices to verify the characteristics, drawing the thermodynamic parameters of the thermogram, determining the positive judgment index and performing sterility test for the samples. A fully-enclosed bacteria collecting ampoule incubator includes bacteria collecting ampoule system, sample and liquid feeding system and peristalsis liquid discharge system. The sample and liquid feeding system is connected with the bacteria collecting ampoule system by the liquid intake tube; and the bacteria collecting ampoule system is connected with the peristalsis liquid discharge system by the liquid drainage tube. The invention is characterized by short inspection time, high sensitivity, high automation and accurate test results on microbial contamination. It can also provide the overall process curve on the growth conditions.Type: GrantFiled: June 28, 2011Date of Patent: July 15, 2014Assignee: 302 Military Hospital of ChinaInventors: Dan Yan, Xiaohe Xiao, Ping Zhang, Yongshen Ren, Cheng Jin
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Patent number: 8765398Abstract: A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.Type: GrantFiled: May 11, 2011Date of Patent: July 1, 2014Assignee: Mesa Laboratories, Inc.Inventor: Joseph P. Dalmasso
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Publication number: 20140171444Abstract: The present invention provides aryl- or heteroaryl-diketo acid compounds effective to inhibit an activity of a Mycobacterial malate synthase enzyme or to inhibit a malate synthase activity in other bacteria having the enzyme. The compounds may be phenyl- naphthyl-, or thienyl-substituted diketo acids and carboxylate derivatives thereof. Also provided are methods of treating tuberculosis or other pathophysiological conditions associated with a malate synthase enzyme with the inhibitory compounds and methods of in silico design of the inhibitory compounds. In addition, the present invention provides the inhibitory compounds designed by this method. Furthermore, three-dimensional X-ray crystal structures of the Mycobacterial malate synthase complexed with the inhibitory compounds are provided. Further still a method for stabilizing an aromatic or heteroaromatic diketo acid or its prodrug or close analog in solution by derivatizing at least the ortho position on the aromatic ring is provided.Type: ApplicationFiled: March 3, 2014Publication date: June 19, 2014Applicant: THE TEXAS A&M UNIVERSITY SYSTEMInventors: Joel S. Freundlich, James C. Sacchettini, Inna V. Kriger, Thomas R. Ioerger, Vijay Gawandi
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Publication number: 20140162307Abstract: The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.Type: ApplicationFiled: February 14, 2014Publication date: June 12, 2014Applicant: American Sterilizer CompanyInventors: Phillip P. Franciskovich, Tricia A. Cregger
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Publication number: 20140154670Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.Type: ApplicationFiled: December 5, 2013Publication date: June 5, 2014Applicant: Bracco Imaging S.p.AInventors: Robert C. Williams, JR., Patrice Marchildon
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Publication number: 20140154671Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.Type: ApplicationFiled: December 5, 2013Publication date: June 5, 2014Applicant: Bracco Imaging S.p.AInventors: Robert C. Williams, JR., Patrice Marchildon
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Publication number: 20140099233Abstract: The present disclosure provides a monitoring device comprising a test composition, a test element comprising a test portion to which the test composition is releasably adhered, a detection reagent, and a container comprising a first end with an opening and a second end opposite the first end. The test composition comprises a predetermined quantity of tracer analyte. The container is configured to receive the test portion and configured to be operationally coupled to an analytical instrument. The tracer analyte and the detection reagent each are capable of participating in one or more chemical reaction that results in the formation of a detectable product. A method of using the monitoring device to assess the efficacy of a washing process is also provided.Type: ApplicationFiled: October 1, 2013Publication date: April 10, 2014Applicant: 3M INNOVATIVE PROPERTIES COMPANYInventors: G. MARCO BOMMARITO, MANJIRI T. KSHIRSAGAR, TING LIU, TIMOTHY J. NIES, SWARNALATHA SWAMINATHAN
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Patent number: 8673590Abstract: The invention provides a microorganism having an ability to produce a protein having a dipeptide synthesizing activity and in which an activity of the protein to transport a dipeptide in a microbial cell to theoutside of the microbial cell is higher than that of a parental strain.Type: GrantFiled: April 4, 2008Date of Patent: March 18, 2014Assignee: Kyowa Hakko Bio Co., Ltd.Inventors: Mikiro Hayashi, Kazuhiko Tabata, Makoto Yagasaki, Yoshiyuki Yonetani
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Publication number: 20130337490Abstract: The present disclosure provides a system for inspecting a package (1040) having a substance subject to spoilage. An electromagnetic signal (e.g., a terahertz frequency signal) is directed to the package (1040), and an attenuated signal is received and sampled to generate a set of data points. A peak within the set of data points is detected, and the data points are shifted with respect to time to align the detected peak with a predetermined time. The set of shifted data points are compared to a mathematical model to determine whether the substance in the package (1040) is spoiled.Type: ApplicationFiled: December 13, 2011Publication date: December 19, 2013Applicant: ABBOTT LABORATORIESInventors: Alvin Horatio Mundell, Barbara Ann Ribble
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Publication number: 20130323779Abstract: Presently disclosed is a lighting system and methods of using the lighting system for in vitro potency assay for photofrin. The lighting system includes a lamp housing, a first lens, an infrared absorbing filter, an optical filter, and a second lens. The lamp housing includes a lamp and a light-port. In operation, broad spectrum light from the lamp exits the lamp housing by passing through the light-port. The first lens then collimates the broad spectrum light that exits the lamp housing through the light-port. The infrared absorbing filter then passes a first portion of the collimated broad spectrum light to the optical filter and absorbs infrared light of the broad spectrum light. The optical filter then passes a second portion of the collimated broad spectrum light to the second lens. The second lens then disperses the second portion of the collimated light to provide uniform irradiation of a cell culture plate. A method of using the lighting system for studying a photosensitizer is also disclosed.Type: ApplicationFiled: November 29, 2012Publication date: December 5, 2013Applicant: PINNACLE BIOLOGICS, INC.Inventor: Michael S. Roberts
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Publication number: 20130302849Abstract: A biological sterilization indicator (BI) and method of using same. The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a first fluid path positioned to fluidly couple the first chamber and the second chamber, and a second fluid path positioned to allow displaced gas to move out of the second chamber. The method can include moving displaced gas out of the second chamber via the second fluid path as a sterilant is moved into the second chamber via the first fluid path and/or as the liquid is moved into the second chamber via the first fluid path.Type: ApplicationFiled: October 28, 2011Publication date: November 14, 2013Inventors: Jeffrey D. Smith, Jeffrey C. Pederson, Sailaja Chandrapati, RuthAnn R. Duda
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Publication number: 20130273594Abstract: Sterilization indicators that include a unique porous carrier, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.Type: ApplicationFiled: December 20, 2011Publication date: October 17, 2013Applicant: 3Innovative Properties CompanyInventors: Francois Ahimou, G. Marco Bommarito, Tushar A. Kshirsagar
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Publication number: 20130273593Abstract: Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.Type: ApplicationFiled: December 20, 2011Publication date: October 17, 2013Applicant: 3M Innovative Properties CompanyInventors: William E. Foltz, Francois Ahimou, G. Marco Bommarito, Robert A. Asmus, Louis C. Haddad, Tushar A. Kshirsagar
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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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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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Patent number: 8541224Abstract: A method for retention testing sterilizing grade filters comprises: a) providing a stock of Acholeplasma laidlawii; b) growing up the stock of A. laidlawii for about 24 hours or less in a single serum-free growth medium that supports cell growth to a high titer and yields a cellular morphology where the cells are small, deaggregated and spherical, thereby producing a bacterial culture; c) challenging a test filter by filtering the bacterial culture through the test filter at a known challenge level, thereby producing a filtrate downstream of the test filter; and d) detecting concentration of A. laidlawii in the filtrate. Serum-free growth media for cultivating or storing A. laidlawii are also described.Type: GrantFiled: January 2, 2013Date of Patent: September 24, 2013Assignee: EMD Millipore CorporationInventors: Shawn Bates, Kerry Roche Lentine, Nada Bsat