Abstract: A meter is provided that includes an improved user interface that enables the user to take a specific action, leading them directly to data input options. Such a user interface could be used to input first selected information, such as whether a test was premeal or postmeal, immediately after receiving a result. Optionally, the user interface may include the ability to add an additional comment after inputting the first selected information. Provision of such a user interface would facilitate simpler capture of the first selected information each time the user performs a test, leading to an enhanced understanding of a patient's level of glycemic control. Designing a user interface to enable first selected information to be entered by a user directly after receiving a result is more likely to engage a patient by making it easy and simple to enter important information. This may enable capture of the information thought to be most pertinent e.g.

Abstract: Devices for determining the concentration of an analyte in a fluid are provided. Also provided are systems and kits for use in practicing the subject methods.

Abstract: A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue and a shaft portion. The tissue penetration element is disposed in proximity to the tissue of the patient. The tissue penetration element is driven distally towards the tissue of the patient. Contact is made between the tip and the tissue of the patient. The tip is advanced into the tissue during a penetration stroke to a position of maximum inward displacement. The tissue penetration element is displaced proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke. The tip is removed from the tissue.

Abstract: An analyte testing device housing a lancet cartridge and a test strip cartridge is described. The testing device simplifies analyte testing/monitoring by providing an actuator and linkage mechanism that: (i) cocks a lancing device, (ii) exposes a test strip for use; and (iii) advances the lancet cartridge. The testing device also includes conversion electronics, which receives a signal from a test trip and converts the signal into readable data.

Abstract: An analyte testing device includes an analyte sensor, a lancet, and a mechanism with an actuator that operates to independently expose the analyte sensor and advance the lancet into position for use. The analyte sensor is preferably included in an analyte sensor cartridge that houses a plurality of sensors. Similarly, the lancet is preferably included in a lancet cartridge that houses a plurality of lancets. The actuator can be a lever configured to expose the analyte sensor and advance the lancet into position with a single motion (e.g., pulling the lever). The actuator also preferably operates to cock a hammer in preparation for lancing a body member to draw a blood sample. The mechanism can be a linkage coupled with the actuator and configured to engage the analyte sensor and lancet.

Abstract: A test strip for testing a blood sample is provided with a fluid transport feature to facilitate transport of a blood sample obtained from a lancing operation through a capillary channel to a measurement site. A fluid transport path is defined on the major face of the strip terminating at the mouth of the capillary channel. The fluid transport path includes a depending portion at one end opposite the mouth of the channel. The depending portion extends away from the strip on the side facing the fluid sample, such that a droplet of fluid sample contacting the depending portion is directed toward the mouth of the capillary channel. Thereafter the sample moves by capillary action to the measurement site.

Abstract: The invention is directed to an apparatus and method for blood sample acquisition and testing. The apparatus incorporates a test strip having a blood sample volume detection area in which a blood sample is accumulated and a minimum blood sample volume is detected. Once a minimum blood sample volume is detected, the test strip is moved with respect to the blood sample extraction site so that a bending surface of the test strip is presented to the blood sample, utilizing the surface tension of the blood sample droplet to facilitate movement of the blood sample to a measurement site on the strip where blood glucose in the sample is measured.

Abstract: A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Abstract: A body fluid sampling system is provided for use on a tissue site. A container has at least one guide chamber and a driver. A plurality of penetrating members are included. At least one sample receiving unit is configured to be coupled to the driver and advanced out of the guide chamber of the container and receiving body fluid at a receiving site. A penetrating member is integrated with the sample receiving unit to carry out a lancing movement towards a body part containing the body fluid.

Abstract: A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Abstract: A blood glucose sampling device is provided. The blood glucose sampling device includes a sensor cartridge having a plurality of blades oriented in a common direction of rotation about a central point. Each blade includes a test strip having a test region defined radially from the central point at a proximal end and a capillary aligned with a distal end of the test region and extending to an outer edge of the blade. Each blade also includes a cleaning element positioned adjacent to the test strip. A lancet is affixed to a lancet cartridge and aligned with the capillary formed in the test strip. A housing removably encloses the cartridges and includes an outer grip that surrounds a circumference of the housing and is shaped to fit between a thumb and finger. A test passage formed in the outer grip through which the test strip and lancet are positioned.

Abstract: A body fluid sampling device comprises an elastic membrane arranged at a part of a hermetically sealed housing having a communication path with a check valve and a needling means arranged beneath the membrane. As the membrane is pressed by a fingertip, the needling means needles through the membrane and further the skin of the fingertip to exude blood. As the fingertip is then separated from the membrane, the exuded blood is efficiently introduced into the housing due to the negative pressure produced in the internal region by the elastic movement of the membrane.

Abstract: The invention relates to a blood taking device (1), in particular, for newborn babies and small children or small animals, comprising a blood taking vessel (2), provided on the front end thereof with a cannula (5) with a sharpened tip (4), whereby a porous, gas-permeable limiting element (8) which automatically stops the flow of taken blood, is arranged by pressing in the blood taking vessel (2) in a defined position. The rear end of the blood taking vessel (2) is sealed by a plug (11) which may be temporarily opened for taking blood (11), which dispenses the taken blood by means of a stroke running in a sealed manner in the blood taking vessel (2), which empties under pressure at least a part amount of the blood retained before the limiting element (8).

Abstract: A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Abstract: The invention relates to a lancet, comprising a base body (2), which has a test region (3) on an upper face for analyzing a body fluid sample, a lancing element (4) extending from the base body (2) for puncturing the skin of a patient, and a capillary structure (5) for transporting a body fluid sample from the lancing element (4) to the test region (3). According to the invention, the capillary structure (5) comprises a section that causes fluid to be transported in a direction that, in a top view of the upper face of the base body (2), has a component perpendicular to the longitudinal direction of the lancing element (4).

Abstract: A test unit cartridge for holding a plurality of test units includes a first test unit that contains a first analyte sensor and a second test unit that contains a second analyte sensor. The first and second analyte sensors use first and second reagents to detect first and second analytes, respectively. The first analyte is different from the second analyte and the first and second test units are functionally non-fungible. The plurality of test units can also include a third test unit that contains two analyte sensors having two reagents for detecting two different analytes using one fluid sample. A method of using the test unit cartridge is also described, which comprises loading the cartridge into an analyte testing device and cocking an actuator of the device that is configured to (i) expose an analyte sensor of a test unit, (ii) ready a lancet, and (iii) advance a lancet cartridge.

Abstract: A test unit cartridge for holding a plurality of test units includes a first test unit that contains a first analyte sensor and a second test unit that contains a second analyte sensor. The first and second analyte sensors use first and second reagents to detect first and second analytes, respectively. The first analyte is different from the second analyte and the first and second test units are functionally non-fungible. The plurality of test units can also include a third test unit that contains two analyte sensors having two reagents for detecting two different analytes using one fluid sample. A method of using the test unit cartridge is also described, which comprises loading the cartridge into an analyte testing device and cocking an actuator of the device that is configured to (i) expose an analyte sensor of a test unit, (ii) ready a lancet, and (iii) advance a lancet cartridge.

Abstract: A piercing system has a carrier band carrying piercing elements with test elements disposed in-between. The carrier band holder, which is coupled to a piercing drive, holds a segment of the carrier band and moves together with the segment and a piercing element at the segment during lancing. A wind-up roll displaces the band in a band transport direction. A measuring device measures analyte concentration of a bodily fluid sample received by a test element. A segment of the band having an unused test element is guided past a carrier band segment disposed in the holder or behind the holder in the band transport direction. The two carrier band segments are pressed against each other for transferring the sample from the piercing element to the test element. A method for transferring a bodily fluid sample from a piercing element to a test element is described.

Abstract: An integrated lancing test strip device includes a lancet configured to form an incision in tissue and a test strip coupled to the lancet for analyzing body fluid. A retention mechanism acts as a detent to hold the lancet in a static position relative to the test strip before forming the incision. The retention mechanism is configured to release the lancet for retracting the lancet relative to the test strip to reduce smearing of body fluid by the lancet during collection of the fluid with the test strip. In one form, the retention mechanism includes breakable tabs that are broken to release the lancet, and the lancet is retracted via translational movement. The retention mechanism in another form includes one or more dimples that release the lancet when the lancet is retracted via rotational motion. In a further form, the entire integrated device is rotated to collect fluid.

Abstract: A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

Abstract: A meter is provided that includes an improved user interface that enables the user to take a specific action, leading them directly to data input options. Such a user interface could be used to input first selected information, such as whether a test was premeal or postmeal, immediately after receiving a result. Optionally, the user interface may include the ability to add an additional comment after inputting the first selected information. Provision of such a user interface would facilitate simpler capture of the first selected information each time the user performs a test, leading to an enhanced understanding of a patient's level of glycemic control. Designing a user interface to enable first selected information to be entered by a user directly after receiving a result is more likely to engage a patient by making it easy and simple to enter important information. This may enable capture of the information thought to be most pertinent e.g.

Abstract: An analytical system for detecting an analyte in a body fluid comprises a disposable integrated puncturing and analyzing element and a reusable analytical system. The integrated element includes a puncturing element having a tip for generating a puncture wound in a body part and an elongated flat test strip having a top side and a bottom side. The integrated element is held in a holder such that, in a sample application position of the test strip, the top side of the test strip is facing upward. A sample application area for manual application of a drop exiting from the puncture wound of the body part is provided on the top side of the test strip such that, in the sample application position, the drop is applied to the sample application area from directly above.

Abstract: An integrated blood glucose measuring device is described that has blood glucose metering device, a glucose metering test strip storage mechanism attachable to the metering device, a test strip feeding mechanism for feeding a single test strip from the storage mechanism for blood intake. The metering device, the test strip storage mechanism and the test strip feeding mechanism are integrated into a single device for blood glucose measurement. In another embodiment, a lancet mechanism is attachable to a side of the metering device and thus the metering device, the storage mechanism, the test strip feeding mechanism, and the lancet mechanism are integrated into a single device for blood glucose measurement.

Abstract: A lancing device including a replaceable multi-lancet cartridge. The lancing device includes a drive mechanism, an activation mechanism, and an advancing mechanism. The advancing mechanism includes a linear-pull slide controls an indexing mechanism, a charger mechanism, and a cap-displacement mechanism. The indexing mechanism sequentially advances the lancets to an active position. The charger mechanism charges the drive mechanism and removes the lancet caps. And the cap-displacement mechanism moves the separated caps from the lancing stroke path. The activation mechanism then releases the charged lancet to traverse the lancing stroke path to pierce the subject's skin. Some embodiments include an anti-reverse mechanism to prevent reuse of the lancets, and some include an emergency lancet reuse mechanism that permits emergency reuse of the last lancet. And some embodiments include a movable depth-control wall for providing control and adjustment of the lancing penetration depth.

Abstract: Example embodiments relate to a portable blood glucose meter reader, including a housing member including an internal spring, a compartment configured to store test strips in alignment with the internal spring, a releasing member configured to dispense one of the plurality of stored test strips, and a plurality of storage members each configured to store a needle.

Abstract: A lancet device includes a hollow housing defining a cavity and having a proximal end and a distal end and a slider slidable at least partially within the cavity along a longitudinal axis from an outward position to a pushed position. The slider extends outside of the cavity beyond the proximal end when it is in the outward position. A needle holder holding a needle is rotatable about and translatable along the longitudinal axis when moved from an initial position to an extended position. When the needle holder is in the initial position, the slider is in the outward position. When the needle holder is in the extended position, the lance extends beyond the proximal end. Sliding of the slider to the pushed position enables a first biasing member to urge the needle holder toward the extended position. A second biasing member can be present in the lancet device.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: The invention relates to analyte monitoring/drug (pharmaceutical agent) delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The electronics portion includes a processor and associated circuitry (e.g., memory, supporting electronics and the like), a motor or the like, a sensor, a power supply (e.g., battery) and optionally an interface. In general, the processor controls the operation of the device and is data communication with the actuator, motor, sensor and interface. The invention provides for autonomous operation, that is, without intervention of the user.

Abstract: An assembly is described that combines blood chemical analysis with lancing in a single multiple-test disposable cartridge. The penetrating members can be assembled and sterilized without damaging the analytical chemistry, and the functioning of the present radical disc cartridge mechanism is not substantially modified.

Abstract: The present disclosure provides electrode structures and integrated electrode structures having one or more conductive materials coextruded with one or more dielectric materials. The disclosed electrode structures can be configured for use as analyte sensors. Also provided, are methods of making and using the electrode structures and integrated electrode structures described herein.

Abstract: A disposable diagnostic article comprising a lancing element that can be pierced into a body part and a collection area formed on the lancing element for body fluid obtained by the puncture is disclosed. The lancing element can comprise at least two bent parts folded towards each other such that the at least two bent parts can partially delimit the collection area.

Abstract: A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet along a path into the tissue site, and a manual switch for a user interface input.

Abstract: An analyte testing device includes an analyte sensor, a lancet, and a mechanism with an actuator that operates to independently expose the analyte sensor and advance the lancet into position for use. The analyte sensor is preferably included in an analyte sensor cartridge that houses a plurality of sensors. Similarly, the lancet is preferably included in a lancet cartridge that houses a plurality of lancets. The actuator can be a lever configured to expose the analyte sensor and advance the lancet into position with a single motion (e.g., pulling the lever). The actuator also preferably operates to cock a hammer in preparation for lancing a body member to draw a blood sample. The mechanism can be a linkage coupled with the actuator and configured to engage the analyte sensor and lancet.

Abstract: A medical system and method to operating the medical system is presented. A patient storage element is assigned to a patient comprising identification information identifying the patient. A medical device has a contaminating patient application. A medical device storage element on the medical device comprises use information. A clearing device receives the identification information from the patient storage element and the use information from the medical device storage element and analyzes the use information. If in analyzing the use information it is found that application of the medical device to the patient is allowed, a clearance signal is outputted. If in analyzing the use information it is found that application of the medical device to the patient is not allowed, the identification information is analyzed. If in analyzing the identification information it is found that application of the medical device to the patient is allowed, a clearance signal is outputted.

Abstract: A blood component measurement device has a puncturing unit provided inside a housing and having a puncture needle; a button unit for advancing and retreating the puncture needle; a contact mechanism coming into contact with the skin of a person to be measured; and a holder for displaceably holding the puncturing unit. The blood component measurement device also has an introduction section at the substantially center of a contact member. After the skin is punctured by the puncture needle provided at the substantially center of the mechanism, the introduction section introduces blood to testing paper when the contact member of the contact mechanism is displaced in a sliding manner along a guide member.

Abstract: The invention relates to a puncturing system for generating a puncture wound for obtaining a sample of a body fluid, comprising a press-on part to be pressed onto a body part in which a puncture wound is to be generated, a triggering means, by the actuation of which a user can trigger a puncturing motion of a puncturing element after the press-on part is pressed on, and a testing facility for determining at least one test parameter on which a sample-obtaining probability depends. A securing facility is also provided that, in a locked state, locks the triggering means such that no puncturing motion can be triggered, and, in a triggering state, releases the triggering means such that a puncturing motion can be triggered by actuation thereof, whereby the securing facility is transitioned from the locked state to the triggering state by the testing facility when the test parameter determined by the testing facility meets defined minimum requirements.

Abstract: A body fluid sampling device is provided. A mesh may be used to guide blood or fluid to travel directly from the wound to an analyte detecting port on the cartridge. Thus the volume of blood or body fluid produced at the wound site irregardless of its droplet geometry can be reliable and substantially completely transported to the analyte detecting member for measurement.

Abstract: A method and apparatus (2) for obtaining a sample of blood. An embodiment includes an apparatus (2) which integrates lancing (12), sample collection, and analysis. The presence of patients finger on the active sampling area can be sensed by monitoring the pressure applied by the finger on the device (2).

Abstract: Integrated lancing and analyte measurement systems are provided which minimize the number of actions required to operate the systems, accomplished in part by combining two or more user steps into one.

Abstract: A blood sampling device designed to divert attention from the pain involved in the puncture of the skin tissue by increasing comfort when lancing the skin by affecting the sensation and perception of pain. Projections on the distal end of a skin pricker contact the skin surface to confuse the nerves in the area of the prick to make the prick less noticeable.

Abstract: In one aspect, a body fluid sampling device is provided using a penetrating member to extract fluid from an anatomical feature. The device comprises a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature and a non-spring based, penetrating member retractor for moving the penetrating member outbound away from the anatomical feature. The penetrating member actuator may be adapted to move the penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.

Abstract: In one aspect, a body fluid sampling device is provided using a penetrating member to extract fluid from an anatomical feature. The device comprises a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature and a non-spring based, penetrating member retractor for moving the penetrating member outbound away from the anatomical feature. The penetrating member actuator may be adapted to move the penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.

Abstract: A body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.

Abstract: A device is provided for fluid delivery. The device comprises a cartridge having a plurality of cavities and a plurality of penetrating members. The plurality of penetrating members are each at least partially contained in cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from openings on said cartridge to penetrate tissue. Each of the penetrating members comprises a needle with a lumen coupled to a canister containing a material to be injected.

Abstract: A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

Abstract: A tip (41) for use with a lancing device (11). A wall extends upwardly from a base and forms a substantially saddle-shaped distal surface for interfacing with a patient's skin. An opening (43) extends entirely through the tip. The tip (41) is movably received by a pressure sleeve assembly. The pressure sleeve assembly includes a housing (37) and a pressure sleeve movable between first and second positions. A spring (35) is connected between the housing (37) and the pressure sleeve. A lancet (21) is rigidly fixed to the housing (37) and is covered when the pressure sleeve is in the first position and exposed through the substantially saddle-shaped distal surface (42) of the tip (41) when the pressure sleeve is in the second position. The substantially saddleshaped distal surface (42) gathers the patient's skin toward the center of the tip to facilitate expressing blood from a lanced site.

Abstract: A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Abstract: A lancing device and a cartridge of lancets are operable to sequentially advance each lancet to an active position for use in sampling a bodily fluid. An alignment mechanism precisely aligns the lancets in the active position to promote smooth operation and prevent jamming. The alignment mechanism includes at least one register element and at least one spring-biased element movable between engaged and retracted positions. In an example embodiment, one spring-biased arm extends from the lancing-device housing and includes a protrusion, and a series of recessed register surfaces are defined in a carrier for the lancets. In the engaged position, the spring-biased protrusion fully mates with the register recess under the spring-biasing influence to precisely align the active lancet. And in the retracted position, the spring-biased protrusion is deflected from engagement with the register recess as the carrier is advanced to advance a fresh lancet into the active position.

Abstract: Analysis system for automatically performing a skin prick analysis by pricking the skin for producing a sample of body liquid and detecting an analyte contained in the sample. The analysis system comprises a magazine with a plurality of compartments each containing a lancing element and an analysis element, and a reusable hand-held instrument having a drive assembly. The drive assembly is adapted for driving at least the following movements by manually generated mechanical force: a coupling movement by which one of the lancing elements is coupled to the drive assembly; a puncturing and sample collection movement of one of the lancing elements contained in the magazine and coupled to the drive assembly; and a remaganizing movement by which the test element is transported back into the compartment of the magazine.

Abstract: A method of controlling a penetrating member is provided. The method comprises providing a lancing device comprising a penetrating member driver having a position sensor and a processor that can determine the relative position and velocity of the penetrating member based on measuring relative position of the penetrating member with respect to time; providing a predetermined velocity control trajectory based on a model of the driver and a model of tissue to be contacted. In some embodiments, a feedforward control to maintain penetrating member velocity along said trajectory.