Abstract: A disposable respirator has a strap fastening system that facilitates ease of donning and comfort during wear. More specifically, the respirator includes a pull-strap fastening component and a strap configuration that provides a tight seal over the mouth and nose of the user, yet be easily donned and comfortable to wear.

Abstract: The present disclosure describes a cecostomy tube having a head with an opening and a valve. There is a flexible catheter with a lumen having proximal and distal ends, the proximal end of the catheter in fluid communication with the opening in the head, a portion of the catheter extending away from the head to define the distal end. The catheter also has walls defining inside and outside surfaces from the opening defined in the head to the distal end of the catheter. There is a retainer provided on the distal end of the catheter. The retainer can change shape from a first profile or configuration to a second profile where the second profile is larger than the first profile and the second profile is adapted to retain the cecostomy tube in place in a body. The device may be placed in a single, initial surgical operation.

Abstract: The present disclosure describes a cecostomy tube having a head with an opening and a valve. There is a flexible catheter with a lumen having proximal and distal ends, the proximal end of the catheter in fluid communication with the opening in the head, a portion of the catheter extending away from the head to define the distal end. The catheter also has walls defining inside and outside surfaces from the opening defined in the head to the distal end of the catheter. There is a retainer provided on the distal end of the catheter. The retainer can change shape from a first profile or configuration to a second profile where the second profile is larger than the first profile and the second profile is adapted to retain the cecostomy tube in place in a body. The device may be placed in a single, initial surgical operation.

Abstract: A lateral flow assay device includes a housing, and a test strip disposed within the housing having a membrane with a detection region and a collection region. A sample meter includes a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed adjacent the collection region of the membrane. The test sample component is transferable from the storage section to the collection region for subsequent migration to the detection region. An activatable isolation mechanism is provided within the housing and is disposed so as to isolate portions of the sample meter storage section upon activation thereof such that a defined length of the storage section is presented to the collection region of the membrane.

Abstract: Disclosed are methods and devices for continuous in vivo monitoring of a potential bacterial infection site. Disclosed devices may be utilized to alert patients and/or health care providers to the presence of pathogenic bacteria at an early stage of a hospital acquired infection, thereby providing for earlier intervention. Disclosed methods utilize optical fibers to deliver an excitation signal to an area in which pathogenic bacteria may exist. In the presence of the excitation signal, bacterial pathogens may autofluoresce with a unique spectral signature. Upon generation of a fluorescent emission, an optically detectable emission signal may be transmitted to a detection/analysis device. Analysis of the characteristics of the emission signal produced in response to the excitation signal may be used to determine the presence or concentration of pathogens at the site of inquiry, following which real time information may be transmitted to medical personnel via a wireless transmission system.

Abstract: A pressure indicator for cuffed tracheal tubes is provided. This indicator uses an indicator balloon on the proximal end of the inflation lumen and in fluid communication with the tracheal tube cuff. As the pressure in the cuff changes, the balloon will inflate and deflate. An indicator needle rests on the balloon and moves in response to the inflation and deflation of the balloon, thus showing the state of inflation of the cuff.

Abstract: A lateral flow assay device for detecting the presence or quantity of an analyte in a test sample is provided. The device comprises a chromatographic medium that defines a detection zone, wherein a crosslinked network is non-diffusively immobilized within the detection zone. The crosslinked network contains a small molecule indicator that is configured to undergo a detectable color change in the presence of the analyte.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: A blood sampling device includes a lancet having a skin piercing member disposed at an end thereof. The lancet is slidable within and releasably engaged with an elongated lancet guide that remains stationary with use of the device. A shell is axially movable relative to the lancet guide between a rest position and an actuate position, with the lancet being spring loaded within the lancet guide by movement of the shell from the rest position to the actuate position.

Abstract: A method for fabricating and assessing the quality of printing on substrates used for chemical or biological array testing, and method for ascertaining relative consistency of the deposit reproducibility is described. Generally, the method involves: providing a substrate, providing a solution mixture of a capture moiety and a colorant; depositing an amount of said solution mixture onto said substrate, monitoring the substrate such that the visible indicator colorant manifests in a co-extensive fashion as with the capture moiety on the substrate. In another aspect, the invention relates to a sensor or assay device comprising a physical complex of a number of capture agents and an amount of colorants adhere to least a part of a surface of a substrate.

Abstract: Various modifications to a porous substrate, such as employed in lateral flow assay devices, to regulate or modify the flow rate and/or flow path pattern of a fluid through the porous substrate is described. The lateral flow assay device has a porous substrate matrix in fluid communication with a flow-rate control zone having a number of flow-rate control devices arranged as features in or on a substrate surface or laminates thereof in a body. The flow-rate control devices may include: a density gradient, porosity gradient, ion affinity gradient, micro-channels, and combinations thereof.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A finger cover, such as a finger wipe that can fit onto a human finger, is provided with an improved seam structure. The cover includes a pocket member having an open end for the insertion of a finger. The pocket member is formed by a first panel attached to a second panel along a flush outwardly facing circumferential edge seam. The seam is less than about 1 millimeter (mm) in width and about 1 mm in height. Additional reinforcing weld points may be provided at various locations along the seam.

Abstract: Disclosed are methods and devices for continuous in vivo monitoring of a potential bacterial infection site. Disclosed devices may be utilized to alert patients and/or health care providers to the presence of pathogenic bacteria at an early stage of a hospital acquired infection, thereby providing for earlier intervention and improved recovery rates from bacterial infection. Disclosed methods utilize optical fibers to deliver an excitation signal to an area in which pathogenic bacteria may exist. In the presence of the excitation signal, bacterial pathogens may autofluoresce with a unique spectral signature. Upon generation of a fluorescent emission, an optically detectable emission signal may be transmitted to a detection/analysis device.

Abstract: Disclosed are methods and devices for continuous in vivo monitoring of a potential infection site. Disclosed devices may be utilized to alert patients and/or health care providers to the presence of a pathogen at an early stage of a hospital acquired infection, thereby providing for earlier intervention and improved recovery rates from bacterial infection. Disclosed methods utilize implantable devices for location at an in vivo site. The implantable device is held in conjunction with an optical fiber that detects and transmits an optically detectable signal generated in the presence of a pathogen. Upon generation of the emission, the optically detectable emission signal may be transmitted to a portable detection/analysis device. Analysis of the characteristics of the emission signal produced may be used to determine the presence or concentration of pathogens at the site of inquiry, following which real time information may be transmitted to medical personnel, for instance via a wireless transmission system.

Abstract: A disposable respirator comprising a strap fastening system that facilitates ease of donning and comfort during wear is disclosed. More specifically, the respirator includes a pull-strap fastening component and a strap configuration that provides a tight seal over the mouth and nose of the user, yet be easily donned and comfortable to wear.

Abstract: A lateral flow assay device for detecting the presence or quantity of an analyte in a test sample is provided. The device comprises a chromatographic medium that defines a detection zone, wherein a crosslinked network is non-diffusively immobilized within the detection zone. The crosslinked network contains a small molecule indicator that is configured to undergo a detectable color change in the presence of the analyte.

Abstract: A lateral flow assay device includes a housing, and a test strip disposed within the housing having a membrane with a detection region and a collection region. A sample meter includes a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed adjacent the collection region of the membrane. The test sample component is transferable from the storagesection to the collection region for subsequent migration to the detection region. An activatable isolation mechanism is provided within the housing and is disposed so as to isolate portions of the sample meter storage section upon activation thereof such that a defined length of the storage section is presented to the collection region of the membrane.