Abstract: This invention generally relates to a method for producing an analytical system, and to a analytical system for detecting an analyte in a body fluid. The analytical system comprises a test element and a lancet which is movable relative to the test element and which is received on the test element. The lancet is connected to the test element via an elastomer spring.

Abstract: The test strip stabilizes skin prior to incision by a lancet tip. The innovative test strip includes a pair of skin contacting tabs that apply pressure linearly to the skin to stretch the skin taut. Beneficially an incision by a lancet tip to an accurate depth can be formed on the taut skin. Moreover, pressure from the tabs is applied linearly to the skin which results in a higher ratio of pressure to surface that can be reached as compared to applying pressure laminarily to skin. Some manufacturing techniques of the skin contacting tabs include cutting or stamping through all of the layers and test area of the test strip to form these tabs. These techniques increase the manufacturing efficiency and cost savings associated with test strips and integrated lancet testing devices. Contamination from other sampling events is eliminated since the test strips are disposed of after each use.

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 test strip ejection mechanism, for use with a test strip receiving port and a test strip, includes a framework, an elongated shape memory alloy (SMA) strip (e.g., a SMA wire), a slider, and a heating module. The SMA strip has first and second ends that are attached to the framework and exhibits a solid state transition temperature. The slider is configured to travel along the framework. The heating module is configured to heat the SMA strip from a temperature below the solid state transition temperature to a temperature above the solid state transition temperature. Moreover, the SMA strip and slider are configured such that the slider travels along the framework under an applied force exerted on the slider by the SMA strip as the shape memory strip is heated from a temperature below the solid state transition temperature to a temperature above the solid state temperature by the heating module.

Abstract: The invention concerns a process for producing a diagnostic test element for analyzing a body fluid in which a lancing member that can puncture a body part is provided with a collecting channel for body fluid obtained by the puncture, wherein the collecting channel exhibits capillary action, and wherein a sensor member for an optical or electrochemical measurement is connected to the lancing member. According to the invention, the sensor member and the lancing member can be joined together as interlocking connecting components wherein a measuring element of the sensor member is inserted into the collecting channel through an insertion opening of the lancing member.

Abstract: An integrated disposable includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing at least a portion of a lancet to maintain the sterility of the lancet. The lancet packet and the sterility sheet, in particular, allow the lancet to be sterilized separately from the test strip. The lancet in one form is incorporated into a lancet tape that is sterilized in a continuous, reel-to-reel sterilization process. The lancet tape in one form is sterilized using an electron beam sterilization process. With electron beam sterilization, sterilization is enhanced by irradiating both sides of the tape with electron beams. Sterilization can adversely affect chemical reagents in the test strip. To alleviate this chemistry degradation issue, the lancet packet is attached to the test strip after the lancet is sterilized.

Abstract: A blood sensor to be used in a blood test apparatus, more specifically speaking, a blood sensor which can be easily attached to a blood test apparatus and detached therefrom. Namely, a blood sensor to be detachably attached to a blood test apparatus having a plural number of connectors, which comprises: a supply channel to which blood is supplied; a detection section provided in the supply channel; an electrode system formed in an area including the detection section; a plural number of connection terminals electrically connected to each electrode of the electrode system respectively; and a standard electrode serving as a standard for differentiating these connection terminals. The connectors are connected respectively to the connection terminals and the standard electrode of the blood sensor having been attached to a definite position of the blood test apparatus.

Abstract: A unique technique for maintaining the sterility and integrity of a lancet tip. One or more lancet tips are sandwiched between a first web and a second web of material to protect the sterility of the lancet tips. The first and second webs are heat fused together to form a structure that covers and encapsulates the lancet tips to protect the integrity of the lancet tips. The structure is cut to form individual protective caps to detachably cover each of the lancet tips.

Abstract: Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip. The instrument has a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring surrounds a skin contact opening and is adapted for pressing against the skin. The skin contact opening has an opening area corresponding to a circle with a diameter of at least 1.5 mm and at most 4 mm, and the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N.

Abstract: An apparatus that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient.

Abstract: A lancing unit (U1) includes a lancing member (2), an auxiliary part (3) which is separate from the lancing member (2), and a supporter (1) detachably supporting these. Preferably, the lancing unit (U1) further includes a cap (29) which covers a needle (21) of the lancing member (2) and which is detachable from the lancing member (2), and the lancing member (2) is supported by the supporter (1) via the cap (29).

Abstract: A system is provided for withdrawing small amounts of body fluid from an animal or human. The system includes a holder and a disposable lancing unit attached to the holder. The lancing unit also includes an open capillary channel for transporting the body fluid and piercing the skin.

Abstract: An arrangement comprises a puncturing instrument including a cylindrical box, a plurality of puncturing needles held in an axially serially connected state, a locking member for locking the puncturing needle cartridge at an axial predetermined position, and an elastic urging member urging the puncturing needle cartridge in one direction, and a puncturing needle replacing jig which allows the setting of a puncturing position for the puncturing needle cartridge and the discarding of used puncturing needles, in order to enter into a subsequent puncturing action after the puncturing of the puncturing needle. Thus, it is an object to provide, in an instrument for puncturing the surface of a living body, a highly safe puncturing instrument set having a plurality of puncturing needles, capable of continuous puncturing action by a simple operation.

Abstract: A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Abstract: A blood test apparatus having a simple constitution whereby stable measurement can be conducted by surely sampling the blood in an amount being small but sufficient for the test without placing too much burden on a patient. When a first skin contact sensor of this apparatus detects the skin, driving of a negative pressure unit is initiated. Thus, the skin rises and comes into contact with a second skin contact sensor. After piercing into the skin, the negative pressure supply is once ceased. Next, the negative pressure is applied again for a definite period of time. Thus, the opening in the skin is broadened, which facilitates the flow out of the blood.

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: An agent injection device is provided that is capable of injecting an agent to a known predetermined tissue depth. An injection member has an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time. A controllable driver is coupled to the elongate injection shaft and is configured to drive the injection member into target tissue. A velocity control system is in communication with the controllable driver and is configured to control the velocity of the elongate injection shaft.

Abstract: The present invention provides a lancing apparatus (A) which includes a lancet (3) which is movable to advance in a first direction from a deeper portion in a housing (2) toward a front end of a cylindrical member (8) and an analysis component (4) disposed in the cylindrical member (8). The analysis component (4) is movable in a second direction opposite to the first direction upon receiving a force in the second direction. When skin (S) bulges, the analysis component (4) moves in the second direction following the bulging of the skin, whereby blood (b) bleeding from the skin (S) is properly introduced to the analysis component (4).

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: A body fluid sampling system for use on a tissue site has a housing and a penetrating member driver at least partially within the housing. At least one cartridge is in the housing. The cartridge includes an analyte sensor in a sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member. A penetrating member is associated with the sample chamber. Each penetrating member, and its associated sample chamber, has a combined occupied volume of no more than about 5.0 cm3. The penetrating member is at least partially co-located with the analyte sensor in the sample chamber. The sample chamber receives body fluid from a wound in tissue created by a penetrating member, and the analyte sensor determines analyte levels using a body fluid sample of less than about 1 microliter. A transport mechanism engages the cartridge. The penetrating member is operatively engaged with the penetrating member driver when moved into position by the transport mechanism.

Abstract: The present invention relates to an analytical aid comprising a base body, a lancet and a test element. The base body comprises two subsidiary bodies hingedly connected to one another, the first subsidiary body carrying the lancet with lancet tip, and the second subsidiary body carrying the test element with test field and a sample application site. In an unused position of the analytical aid, the subsidiary bodies are arranged substantially in a common plane and the lancet is protected by a seal connected to the first subsidiary body and is separated from the test field of the test element. The two subsidiary bodies are pivotable relative to one another out of the common plane and the seal is openable so that the lancet tip is released for use.

Abstract: The invention relates to a pricking device (1) for taking a blood sample, comprising a movable holding device (10) for pricking means (5), a linear guide element (11) for guiding the movable holding device, means (12) for driving the movable holding device and a release device (31) for releasing the pricking movement (6) of the pricking means. When the release device has been manually actuated, the movable holding device can be moved in a translatory manner by the drive means. Said drive means comprise a curved path (20) in which the movable holding means is directly engaged, enabling the pricking device to have a particularly simple structure.

Abstract: A diagnostic tape cassette especially for blood sugar tests comprises a test tape which is provided with a plurality of test fields for analysing body fluid, and a housing for receiving the test tape. The housing may have at least one housing part formed from a metal support and moulded-on plastic with integrated functional elements.

Abstract: A blood test apparatus negatively pressurizes a vicinity of a site to be punctured for collecting blood at an appropriate time without resorting to a special operation. More specifically, a blood test apparatus includes a housing having an opening; a puncturer; a first sensor that detects contact of a front face of the opening with a site to be punctured; a negative pressure generator that negatively pressurizes an inside of the opening; and a blood sensor that collects blood. The negative pressure generator starts when the first sensor detects the contact of the front face of the opening with the site to be punctured.

Abstract: A lancing device having improved guidance features and a drive mechanism subassembly that is generically compatible with a variety of outer housing configurations, and an improved assembly method for fabricating a lancing device.

Abstract: A hand-held analyzer for collecting a sample of blood from the scalp of a fetus and measuring the pH of the blood sample. The analyzer includes a probe with a blunt proximal end that facilitates a firm and positive placement of the probe against the scalp. The probe includes a capillary tube for collecting blood and an extensible lancet which at rest is positioned within the capillary tube. During operation, the lancet is extended to make an incision in the scalp. The lancet then retreats, and blood flows into the capillary tube. Sensors for measuring pH are in liquid communication with the capillary tube. A display on or near the hand-held analyzer shows a readout of the fetal scalp blood pH. Measuring the pH of the fetal scalp blood in utero can provide early detection of acidosis and likely hypoxia.

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: The device comprises a body (2) and placed therein a needle assembly (1) and a push button (3) located in the upper portion of the body (2), whereas the needle assembly (1) has in its lower portion a sheathed piercing needle (5), and the push button (3) has in its upper portion a press surface, and between the body (2) and the needle assembly (1) a return spring (27) is placed. The push button (3) is coupled with the needle assembly (1) by means of abutting surface elements (15, 44), whereas during the movement of the push button (3) and after resting the needle assembly (1) on the element (20) of the body (2) and after performing the full-depth piercing, one of the abutting surface elements (15, 44) bends, releasing the needle assembly (1) from the thrust of the push button (3), whereupon the needle assembly (1) retracts to the inside of the body by means of the return spring (27).

Abstract: A lancing device, an embodiment of which controls the advancement and retraction of a lancet by monitoring the position of the lancet in conjunction with a lancet controller which incorporates a feedback loop for modulating the lancet driver to follow a predetermined tissue lancing profile.

Abstract: A blood sample test device has a continuous strip sensor which is advanced through the device so that multiple blood sample tests can be conducted on a single strip. The device is provided with a sprocket having an encoder which engages sprocket holes on the strip to precisely control the advancement of the strip through the device.

Abstract: A lancing system can include a device body having a lancing end, a lancing mechanism including a lancing shaft slideably coupled with the lancing end of the body, a main shaft slideably coupled with the body and having an actuating end disposed inside the body, a piston coupled to the main shaft and disposed within the body, a spring coupled to the piston, a release mechanism adapted to selectively couple with the main shaft, and a depth controller removably coupled to the lancing end of the body. A method can include coupling a lance having a needle and a base to the lancing shaft, choosing to use a depth controller having a spacer with a top surface and an opening, engaging a lancing surface with the depth controller, actuating the lancing mechanism, penetrating the lancing surface, and contacting the top surface of the spacer with the base.

Abstract: A method of masking pain resulting from a lancing system can include moving a first portion and a second portion of a lancing assembly in a first direction, stopping the first portion of the lancing assembly from further moving in the first direction, thereby causing a first vibration, allowing the first portion to move in a second direction while the second portion continues moving in the first direction, and lancing a surface with the first portion while the first vibration is occurring. A system for lancing a surface and masking resulting pain may include a device body having an end adapted to sealingly engage the surface, means for creating a first portion of a vacuum, means for causing a vibration, and a lancing mechanism coupled to the body and adapted to lance the surface while the first portion of the vacuum and the vibration are acting on the surface.

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. In one form, a firing mechanism has a blade that punctures and slits the sterility sheet during the firing cycle to reduce the chance of cross contamination between the lancet and the test strip prior to use. This allows an operator to load and subsequently remove an unused integrated lancing test strip without compromising the sterility of the lancet. The lancet includes an engagement opening in which the blade of the firing mechanism engages the lancet. The engagement opening is configured to reduce the chance of the blade becoming dull.

Abstract: A lancing system can include a device body having a lancing end and a free end, a lancing shaft having an actuating end, a stop coupled to the body, a lancing spring coupled to the lancing shaft, a main shaft having an actuating end, and a shaft coupler having at least two separable portions for removably coupling the lancing shaft to the main shaft, wherein a first portion is coupled to the actuating end of the lancing shaft and a second portion is coupled to the actuating end of the main shaft. A method of extracting blood can include coupling the actuating end of the main shaft to the actuating end of the lancing shaft, moving the lancing shaft toward the free end of the device body, stopping the lancing shaft, uncoupling the actuating ends, and moving the lancing shaft toward a surface to be lanced.

Abstract: A lancing system can include a device body having a sealing device coupled to a lancing end, a lancing shaft slideably coupled to the lancing end, a lancing spring coupled to the lancing shaft, a release mechanism, a main shaft slideably coupled with a free end of the device body in communication with the release mechanism, a piston coupled to the main shaft, a vacuum spring coupled to the piston, and a shaft coupler having at least two separable portions for removably coupling the lancing shaft to the main shaft. The system can include a lance tool having an insertion portion and a removal portion. A method can include creating a first portion of a vacuum, lancing a surface, and creating a second portion of a vacuum.

Abstract: A lancing system can include a first device body having a lancing end and a free end, the lancing end including a sealing device, a lancing assembly having a lance coupler slideably coupled with the lancing end, a main shaft slideably coupled with the body, a first piston disposed within the body, wherein the lancing assembly is adapted to create a vacuum prior to lancing and dissipate the vacuum at a controlled rate. The system can include a second device body fluidicly coupled to the first device body and having a second shaft and a second piston. A method of extracting blood can include coupling the sealing device to a surface, creating a vacuum, lancing the surface, and dissipating the vacuum at a controlled rate.

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 and a processor coupled to the drive force generator capable of changing the direction and magnitude of force exerted on the lancet during the lancing cycle. The driver further includes a human interface on the housing providing at least one output for communicating with the patient.

Abstract: A sampling module includes a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel. A cover sheet is disposed over the lancet and a lancet channel that captures the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.

Abstract: In some aspects, an analyte sensor is provided for obtaining and detecting an analyte concentration level in a bio-fluid sample. The analyte sensor has a sensor body including a semiconductor material, an active region coupled to the sensor body, and a lancet provided on the analyte sensor. The conductor may include a fiber having a core of a conductive material and a semiconductor cladding surrounding the core. Numerous other aspects are provided.

Abstract: An analytical aid including a base, a lancet and a test element. The lancet includes a lancet point and a distal end of the lancet can be attached to the base. At least the lancet point is located in a recess in the base and the recess can be closed by a cover as long as the analytical aid is in an unused state. The base includes a predetermined breaking point or position, at which the base is broken into two segments when stress is applied. The predetermined breaking point is arranged such that the lancet point is exposed for use when the base breaks at the predetermined breaking point. A test element is attached to the base.

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: The present invention relates to a compression device for stimulating the efflux of a body fluid from a body part. The device has a compression unit with a pressure-application region made of a deformable material, the region being formed to generate a repulsive force between the body part and the compression unit. The repulsive force passes through a force maximum then decreases to serve as an indication that the body part is guided sufficiently firmly and far enough onto the compression unit.

Abstract: A blood test apparatus having a simple constitution whereby stable measurement can be conducted by surely sampling the blood in an amount being small but sufficient for the test without placing too much burden on a patient. When a first skin contact sensor of this apparatus detects the skin, driving of a negative pressure unit is initiated (time point 166a). Thus, the skin rises and comes into contact with a second skin contact sensor (time point 166b). After piercing into the skin at time point 166c, the negative pressure supply is once ceased. Next, the negative pressure is applied again at time point 166d for a definite period of time. Thus, the opening in the skin is broadened, which facilitates the flow out of the blood (16).

Abstract: A method of penetrating tissue is provided. The method uses a lancet driver to advance a lancet into the tissue; advancing the lancet at a first desired velocity in a first layer of tissue; advancing the lancet at a second desired velocity in a second layer of tissue; and advancing the lancet at a third desired velocity in a third layer of tissue. In one embodiment, the method may including using a processor having logic for controlling velocity of the lancet in each layer of tissue.

Abstract: A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Abstract: A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable to cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

Abstract: A one touch laser lancing type blood glucose measurement device, a strip, and the method using it. In particular, the invention relates to a one touch laser lancing type blood glucose measurement device, a strip, and the method using it, which performs blood gathering and blood glucose measurement at the same time, using laser beams generated in a laser module. The laser beams are irradiated into a finger passing a hole of a strip with a focusing lens converging the laser beams, a protect window, and the hole to gather blood, then the blood is absorbed into the strip for measuring blood glucose.

Abstract: A housing retains a lancet body which encloses a needle whose tip is covered by a cap. The cap has a head provided with flanges. These flanges locate within notches at the end of the housing on only two sides of the housing. The location of the flanges within the notches holds the lancet within the body, before use, so as to compress a spring positioned between a head and a slotted portion of the housing. When the device is to be used, the head of the cap is rotated through 90° so as to detach the cap from the rest of the lancet body and release the flanges from the notches. This allows the lancet body to be actuated by a sprung-loaded trigger-release mechanism, when required, so that the tip of the needle projects momentarily through the opening at the end of the housing and then bounces back.

Abstract: A method of obtaining a test sample from a specimen using a lancet system includes engaging a lancet driver against a drive wing of a lancet system, the lancet system having a major portion of a lancet member slidably engaged within a lancet carrier and a sensor strip with a sample chamber attached to the lancet carrier, the lancet system having a lance connected to a first end of a lancet body of the lancet member wherein the lance is movable from a retracted position within the lancet carrier to an extended position outside the lancet carrier, the drive wing extending outwardly and transversely from the lancet body, the major portion of the lancet member having a sinuous portion with a distal end restricted from movement by the lancet carrier, the sinuous portion being non-compressible when initially disposed within the lancet carrier wherein the drive wing prevents the sinuous portion from being compressed, moving the drive wing with the lancet driver a predetermined distance causing the lancet tip to move