Abstract: A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Abstract: An integrated lancet and test strip for measuring an analyte level is provided. The test strip includes a protrusion at a sample receiving end of the test strip, and a notch at a body receiving end of the test strip. Further, a method of measuring an analyte level in a sample of bodily fluid using the integrated lancing and testing meter is also provided. Still further, a method of making a plurality of test strips for use in an integrated lancet and test strip is also provided.

Abstract: A body fluid sampling unit includes a puncture device including a needle having a sharp needle point and a drive mechanism for operating the needle to puncture a living body surface with the needle point, a tip including an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a test paper for detecting a predetermined component in the body fluid, and a tip body mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the test paper; and a case including a mechanism containing section for containing the puncture mechanism so that the needle point of the puncture mechanism can be moved by the drive means, and a sampling implement containing section for containing the body fluid sampling implement so that the tip can be taken out.

Abstract: This invention is regard to an analysis device that analyze a specific component in bodily fluid extracted from the skin using an analysis tool. The analysis device comprise a laser beam oscillation section that emits a laser beam for extracting the bodily fluid from the skin, and a detection mechanism that detects whether or not the analysis tool exists at a target position. The analysis device is adapted to emit the laser beam from the laser beam oscillation section when the analysis tool is detected by the detection mechanism.

Abstract: Arrangements are provided including a fluid transport tube, or a needle, having a first end and a second end opposite the first end, and a lumen having an inner diameter. At least one fluid transport enhancing projection is disposed in the lumen and extends from the second end toward the first end. A discreet, wearable blood glucose monitor including such arrangements is also described.

Abstract: A body fluid sampling unit includes a puncture device including a needle having a sharp needle point and a drive mechanism for operating the needle to puncture a living body surface with the needle point, a tip including an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a test paper for detecting a predetermined component in the body fluid, and a tip body mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the test paper; and a case including a mechanism containing section for containing the puncture mechanism so that the needle point of the puncture mechanism can be moved by the drive means, and a sampling implement containing section for containing the body fluid sampling implement so that the tip can be taken out.

Abstract: A device (302) for sampling and/or analyzing blood or other body fluid of a subject. A housing (306) contains a plurality of lancets (308) and optionally includes test elements (324) to take up a sample of blood, an evaluation system and a display. A complete system that can be handled as a single device, for example in the form of a wristwatch, includes a multiplicity of test elements (324) and lancets (308), which can be brought successively to a working position to perform multiple measurements. A cassette or carrier (320) includes multiple lancets (308) and/or test elements (324), for insertion into the device.

Abstract: The present invention provides a method and a device for piercing a body part and determining whether a sufficient volume of blood has been withdrawn. A lancing element is rapidly inserted into a body part in a forward phase and retracted quickly to a lesser puncturing depth. Subsequently, the lancing element is retracted slower than during the first retraction movement and the distance retracted during the second retraction is shorter than the first retraction movement. During the second retraction movement, body fluid is collected in a collection phase by a capillary structure of the lancing element. Contact between the lancing element and the body fluid is detected after the forward phase at the beginning and the end of a waiting period.

Abstract: An incision device capable of preventing inadvertent firing, and including a covered attached to the device. The incision device comprises a housing, and a lancet guide assembly having lancet guides and a lancet body. The lancet body further comprises a lancet blade. The lancet blade is covered by a removable protective cover having a stopper which prevents a trigger arm from being moved so as to fire the lancet blade.

Abstract: The present invention relates to an analyzing instrument (1A) which includes a capillary (31), a fluid feed port (20) for introducing a sample liquid to the capillary (31), and a fluid feed promoter (6) for promoting the introduction of the sample liquid into the feed port (20). The capillary (31) of the analyzer (1A) may be formed on a substrate (2) for example. The fluid feed promoter (6) may include at lease one of a water-absorbing layer having a higher water-absorbing capacity than the substrate (2) and an adhesive layer having a greater adhesion to the skin than the substrate (2).

Abstract: A lancing member (2) is integrally provided with a cap (29) for covering a needle (21). Upon or after being attached to a holder (5) of a lancing device (A), the lancing member (2) is rotated relative to a cap (29) by a rotator (C). As a result, the boundary (28) between the cap (29) and the lancing member (2) is broken easily to expose the needle (21).

Abstract: An improved penetrating tissue system is provided that reduces pain when penetrating tissue by providing controlled depth and velocity of penetration, stimulation and pressure to the targeted tissue without breaching a sterile environment. The system has user interfaces, human interfaces and low volume sample chambers.

Abstract: A device for use with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

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: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid. In one embodiment, the collection zone includes a plurality of holes, e.g., 3 or more holes, or 50 to 100 holes. The hole size may be small, e.g., having a diameter of 0.01 to 0.5 mm. The holes may or may not extend through the lancet. In some embodiments, the holes have a depth of 50 to 500 ?m. In other embodiments, the collection zone is porous, or is a roughened area. The collection zone can take up a very small volume of body fluid, e.g., 3 to 10 nL, in a very short time period, e.g., less than 0.5 seconds. In other embodiments, the device further comprises a fluid receiving means spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially.

Abstract: A body fluid sampling unit includes a puncture device including a needle having a sharp needle point and a drive mechanism for operating the needle to puncture a living body surface with the needle point, a tip including an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a test paper for detecting a predetermined component in the body fluid, and a tip body mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the test paper; and a case including a mechanism containing section for containing the puncture mechanism so that the needle point of the puncture mechanism can be moved by the drive means, and a sampling implement containing section for containing the body fluid sampling implement so that the tip can be taken out.

Abstract: A sampling module includes a housing and a penetrating member positioned in the housing. An attachment device is coupled to the housing. The attachment device is tiltably attached to a tissue interface that permits the tissue interface surface to tilt. The tissue interface includes an opening for the penetrating member to pass there through.

Abstract: A multiple use analyte sensing assembly that includes a long, thin conductor. A plurality of sensing sites are spaced along the conductor and each sensing site includes a membrane system adapted to create a current when placed into contact with body fluid containing the analyte. The assembly also includes a housing, having an aperture, an uptake spool and a payout spool, the conductor being wrapped about the payout spool before the sensing assembly is used. A sensor positioning actuator turns the uptake spool to move each sensing site, in sequence, to the housing aperture and then to the uptake spool. The assembly also includes a skin broaching assembly, having a multiplicity of lancets and a lancet positioning actuator adapted to move each lancet to the aperture. In addition, a lancet use actuator is adapted to move each lancet at least partially through the aperture and then back again.

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 circuit board for body fluid collection includes a plurality of measurement units including a puncture needle and an electrode for making contact with a body fluid collected by puncturing with the puncture needle, the plurality of measurement units being arranged in parallel in a predetermined direction, and a support portion extending along the parallel arrangement direction and supporting the plurality of measurement units, wherein the support portion is rolled so that the plurality of measurement units can be disposed radially.

Abstract: A circuit board for body fluid collection include a first substrate including a puncture needle; a second substrate disposed at an upstream side of the first substrate in a direction of puncturing with the puncture needle with a space provided therebetween; a flexible insulation layer that extends between the first substrate and the second substrate; and a conductive pattern provided on the flexible insulation layer, the conductive pattern integrally including an electrode, a terminal, and a wiring that electrically connects the electrode and the terminal.

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, drive mechanism, kneading or vibration mechanism, optional suction system, 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 for receiving the sample and providing testing or analysis indication or readout for the user. In one configuration, the lancing needle may be withdrawn very slightly from the point of maximum penetration to create an opening in which blood can pool before being suctioned through to device.

Abstract: A moving coil tissue penetration device includes a magnetic source that produces a magnetic field in a magnetically active region. A cylindrical coil is secured to a translation substrate and disposed at least partially within the magnetically active region. A sharpened member is configured to penetrate tissue and mechanically coupled to the translation substrate.

Abstract: Provided is a blood testing apparatus capable of measuring a blood sugar level while keeping the operability, even if the remaining battery life is short. This blood testing apparatus includes a casing (12) having a cylindrical opening cylinder (12b), a blood sensor (22) mounted removably in the opening cylinder (12b) of the casing (12) for analyzing the blood, a blood introducing portion (34) formed in the blood sensor (22) and having an opening for storing this opening with the blood having flown from the skin by a pierce, a laser emitting device (13) disposed in the casing (12) for causing a laser beam to pierce the skin through the inside of the opening cylinder (12b) of the casing and the opening of the blood introducing portion (34), and a needle piercing unit (18) disposed in the casing for piercing the skin with the needle through the opening of the blood introducing portion (34).

Abstract: A moving coil tissue penetration device includes a magnetic source that produces a magnetic field in a magnetically active region. A cylindrical coil is secured to a translation substrate and disposed at least partially within the magnetically active region. A sharpened member is configured to penetrate tissue and mechanically coupled to the translation substrate.

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.

Abstract: A foldable instrument (10) adapted to determine an analyte concentration of a fluid sample using a test sensor is disclosed. The instrument comprises a first portion (12) including a display (22) and a second portion (14) pivotally coupled to the first portion by a pivot mechanism (23). The second portion includes a user-interface mechanism (16a-c). One of the first portion (12) and second portion (14) includes at least one opening (18) formed therein. The opening is adapted to receive a test sensor. The instrument is adapted to be folded into a closed position and unfolded into an open position by rotating one of the first portion and second portion about the pivot mechanism (23).

Abstract: A self contained disposable test unit for testing body fluid comprises a body member and a support member. The support member is moveable with respect to the body member between a first position and a second position. The support member includes a body part receiving surface for receiving a patient's body part. A lancet is carried by the body member and includes a lancet tip capable of piercing the skin of a patient to produce fluid flow. A test member is capable of interacting with body fluid to aid in the determination of information about body fluid components. A capillary member is capable of directing fluid flow to the test member. A pressure cup is capable of exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary, and a calibration member is provided for containing information for facilitating calibration of the test unit.

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: A lancet device for generating a puncture wound in a skin surface, comprising a housing, in which a lancet can be moved on a puncturing path, a lancet drive with a drive rotor that can be driven by a drive spring, a lancet coupling mechanism that transforms a rotational motion of the drive rotor into a puncturing and returning motion of the lancet during a working cycle of the lancet drive, a reference element that is mobile relative to the lancet and relative to the housing and is fixed in a defined position relative to the lancet drive during the puncturing and rests against the surface of the skin with a contact surface thereof such that a puncture wound with a reproducible puncturing depth is generated by the puncturing motion, and a reference element coupling mechanism that is coupled to the lancet drive in order to move the reference element. The invention further relates to a suitable lancet drive assembly for a lancet device of this type.

Abstract: In one embodiment of the present invention a lancet is provided that has a sharpened distal tip, a shaft portion and a proximal drive head. The proximal drive head has a transverse dimension that is substantially larger than a transverse dimension of the shaft portion adjacent to the proximal drive head.

Abstract: A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Abstract: A medical 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 that is moved in and out to operate an indexing ratchet mechanism, a cam-guided charger mechanism, and a cam-guided lancet cap displacement mechanism. The indexing ratchet mechanism sequentially advances the lancets in the cartridge to an active position. The cam-guided charger mechanism charges the drive mechanism and separates the cap from the active lancet. And the cam-guided cap displacement mechanism moves the separated cap from the lancing stroke path of the active lancet. The activation mechanism then releases the charged active lancet to traverse the unobstructed lancing stroke path to pierce the subject's skin at a desired lancing site.

Abstract: A circuit board for body fluid collection includes a circuit board portion including an insulating layer and a conductor pattern which is supported by the insulating layer and in which an electrode, a terminal to be connected to a device for measuring the component of a body fluid, and a wire which electrically connects the electrode and the terminal are integrally provided. The circuit board for body fluid collection comprises a puncture needle for extracting the body fluid by performing puncturing, which is formed integrally with the circuit board portion and which is protruded from the circuit board portion, and a guard portion for guarding the tip of the puncture needle, which is arranged in opposition to the puncture needle in the lower flow side in the puncture direction of the puncture needle.

Abstract: A method for manufacturing a carrier tape comprising lancets and corresponding products in which a plurality of disposable lancets having a lancet tip for piercing a user's skin are provided on a carrier tape that is or can be wound onto a spool and used for obtaining a sample of body fluid. The lancets can each be arranged in a package and the lancet packages formed in this manner can be applied individually to the carrier tape and fastened thereon.

Abstract: An analysis instrument (2) has a hole (23) for allowing a laser beam, which is applied to a skin to withdraw bodily fluids, to advance through it and also has a cover (25) for closing an opening (23B), into which the laser beam enters, of the hole (23) and allowing the laser beam to pass through it. The analysis instrument (2) has electrodes (20, 21) stacked one upon another while being electrically connected and having through-holes (20A, 21A) defining the hole (23). Preferably, the analysis instrument (2) further has a gas discharge flow path (26) for discharging gas in the hole (23) to the outside.

Abstract: A system and method is provided for the capture of bodily fluid upon lancing of a patient. In one embodiment, the fluid sample capture aperture mesh (320) ring is placed in the pathway of a finger penetrating member (340). The aperture mesh ring has a center clearance area that allows the penetrating member to pierce the skin unobstructed. The aperture mesh ring may contain a series of fluid sampling meshes as to allow the release bodily fluid to “wick” into the fluid sampling meshes for transport to the respective sensor. The invention may also relate to a method of improving the fluidic flow through a membrane mesh structure for the transportation of bodily fluids from a point of sampling to a point of measurement.

Abstract: These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Abstract: Provided are skin incision instrument to efficiently incise minimal portions and a method for incising skin with the skin incision instrument.

Abstract: This invention relates to a lancing apparatus (A1) used for inserting an insertion element (21) into a human skin (Sk) for sampling a body fluid. The lancing apparatus (A1) includes a housing (1) with a cylindrical portion (12) brought into contact with the skin (Sk), a negative pressure generator (6) that generates a negative pressure inside the cylindrical portion (12) to cause the skin (Sk) to swell upward, and a detector (5) that detects that the skin (Sk) has been raised to a predetermined height inside the cylindrical portion (12).

Abstract: The present invention provides a method and a device for piercing a body part and determining whether a sufficient volume of blood has been withdrawn. A lancing element is rapidly inserted into a body part in a forward phase and retracted quickly to a lesser puncturing depth. Subsequently, the lancing element is retracted slower than during the first retraction movement and the distance retracted during the second retraction is shorter than the first retraction movement. During the second retraction movement, body fluid is collected in a collection phase by a capillary structure of the lancing element. Contact between the lancing element and the body fluid is detected after the forward phase at the beginning and the end of a waiting period.

Abstract: Analyte monitoring devices and methods therefore are provided. The devices integrate various functions of analyte monitoring, e.g., sample acquisition and testing.

Abstract: A sensor for blood component analysis, which allows even a trace amount of blood to be led to an analysis portion reliably. The sensor for blood component analysis includes a substrate, a spacer, and a cover. The cover is disposed on the substrate with the spacer intervening between the cover and the substrate, whereby a space that serves as an analysis portion and a channel for leading blood to the analysis portion is formed inside the sensor. Through holes are formed in the substrate and the spacer, respectively, so that a common through hole through which a needle of a lancet can pass is formed when the spacer is disposed on the substrate. The through hole of the spacer communicates with the channel and a top of the through hole of the spacer is covered with the cover, whereby a lancing portion is formed by the common through hole and a portion of the cover covering the top of the through hole of the spacer.

Abstract: Methods and apparatus are provided for manufacturing an analyte detecting device. In one embodiment, the apparatus comprises a housing; a penetrating member driver; a cartridge containing a plurality of penetrating members; a display on the cartridge; a linear slider on the housing, the slider coupled to a rod; and the rod moving with the slider, the rod having at least one roller. The device uses the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.

Abstract: The invention concerns a test tape device for analyzing a body fluid having a carrier tape (36), a plurality of lancing elements (12) arranged on the carrier tape (36) which are provided with a tip (40) that can puncture a body part and a collecting structure (44) that takes up the body fluid obtained during the puncture, and test fields (14) mounted on the carrier tape (36) each being associated with a lancing element (12) and can have body fluid applied thereto. According to the invention it is proposed that the lancing elements (12) are each movably attached to the carrier tape (36) by a coupling member (38) and that a used lancing element (12) can be brought into contact with a test field (14) by a transfer movement from a usage position distant from a test field (14) into a contact position so that body fluid can be transferred from the collecting structure (44) onto the test field (14).

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: 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.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, and the device further comprising a fluid receiving means remote spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.