Abstract: A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Abstract: An integrated sampling device defines a first opening and a second opening. The first opening is connected to a channel for drawing fluid automatically towards a test media upon incision by an incision portion. The second opening is positioned over the test media allowing manual sampling of fluid if the channel fails to draw a sufficient amount of fluid onto the test media.

Abstract: A system and method is provided for detecting concentration of an analyte in a fluid. A first container includes (i) an optical cavity detection region, (ii) a reservoir for one or more modifiers of one or more optical properties of the optical cavity detection region, and (iii) a set of one or more bounding regions through which objects in the fluid can transfer into the container. The optical cavity detection region and the reservoir define separate areas of the first container. The movement of the one or more modifiers between the reservoir and the optical cavity detection region is responsive to changes in concentration of the analyte. A second container includes an optical cavity detection region, and a set of one or more bounding regions through which objects in the fluid can transfer into the container. Also provided are optical components for guiding light into the optical cavity detection regions of the first and second containers.

Abstract: A system and method is provided for detecting concentration of an analyte in a fluid. The method comprises detecting an optical property of a first region of two or more regions in a system, the first region located in a container having a reservoir for one or more modifiers of one or more optical properties of the first region. The movement of the one or more modifiers is responsive to changes in concentration of the analyte. A next step detects an optical property of a second region of the two or more regions in the system, the second region located in a container having a reservoir for one or more modifiers of one or more optical properties of the second region. The movement of the one or more modifiers is responsive to changes in concentration of a compound, where the compound is something other than the analyte.

Abstract: A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Abstract: An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

Abstract: An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

Abstract: One aspect of the invention provides a patient tissue state monitoring system with a light source; a light detector; a probe adapted to be inserted into a patient to transmit light from the light source to an organ tissue site and to direct light from the organ tissue site to the detector; and a processor programmed to determine tissue state with respect to a tissue site pre-dysoxia point from a fluorescence emission detected by the detector (such as by determining tissue NADH concentration) and to provide an indication of tissue state through an output device (such as by displaying a numerical value corresponding to the fluorescence emission).

Abstract: Systems and methods for the sampling of bodily fluid from an incision in the skin include test strips which are positioned adjacent to the skin and which include features to inhibit the passage of the bodily fluid between the skin and the underside of the test strip. One system utilizes a sealing member located on the bottom surface of the test strip and positioned to provide a fluid tight seal with the skin. A second system includes a recessed surface aligned with the inlet opening of the test strip to preclude contact of the bodily fluid directly with the bottom surface of the test strip. A third system involves the use of a hydrophobic surface on the underside of the test strip to inhibit wicking of the bodily fluid along the test strip. The present invention further encompasses the combination of the foregoing sampling systems with each other, and with incising, expressing and/or testing systems and methods, particularly in a single, integrated device.

Abstract: An integrated sampling device defines a first opening and a second opening. The first opening is connected to a channel for drawing fluid automatically towards a test media upon incision by an incision portion. The second opening is positioned over the test media allowing manual sampling of fluid if the channel fails to draw a sufficient amount of fluid onto the test media.

Abstract: An integrated bodily fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a lancet for forming the incision in the skin. A housing is coupled to the lancet. The housing defines at least in part a capillary channel with an opening. The capillary channel is sized to draw the bodily fluid from the incision via capillary action. A test strip is positioned along the capillary channel for analyzing the fluid. In one form, a flexible sheet extends from the housing proximal the opening of the capillary channel for drawing the bodily fluid into the opening of the capillary channel. In another form, the lancet is slidably received inside the channel. During lancing, the lancet extends from the housing to form the incision. Fluid from the incision is drawn into the channel and is deposited on the test strip for analysis.

Abstract: An analyte detection system is provided with calibration information uniquely specific to the set of test strips to which the sample is to be applied. The calibration information may be stored in permanent memory of the testing device, such that the device is discarded after use of all the test strips in a kit, or it may be stored in a calibration chip accompanying the set of test strips and distributed therewith, thereby enabling re-use of the testing device with a different set of test strips and associated calibration chip.

Abstract: An integrated sampling device defines a first opening and a second opening. The first opening is connected to a channel for drawing fluid automatically towards a test media upon incision by an incision portion. The second opening is positioned over the test media allowing manual sampling of fluid if the channel fails to draw a sufficient amount of fluid onto the test media.

Abstract: A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Abstract: An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

Abstract: A device for sampling body fluid includes a housing having a sleeve at a forward end thereof which is displaceable in response to being pressed against a user's skin to trigger the firing of a lancet. After the lancet is removed from the incision, the sleeve is repeatedly pressed against the skin to depress a ring of body tissue in surrounding relationship to the incision to express body fluid outwardly through the incision. A pusher member is then actuated to push a capillary tube through a front end of the housing for drawing-in body fluid. The lancet is a disposable lancet which includes a body supporting a skin-lancing member and the capillary tube. The disposable lancet passes through an upper end of a lancet carrier when being installed or removed. The device cannot be armed until the disposable lancet is installed in the housing, because the capillary tube functions to push a safety device to a non-safety position.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Abstract: This involves non-invasive glucose measurement processes for determining blood glucose level in the human body. After achieving a static level of glucose at a surface of the skin over some period of time, the glucose may then be measured by a variety of different processes. A sample of the glucose may also first be extracted from the skin and this sample may then be measured. Clearly, these processes are especially suitable for monitoring glucose levels in the human body, and is especially beneficial to users having diabetes mellitus. These procedures may be used for other analyte materials that are found in appropriate regions of the outer skin.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.