Abstract: The invention relates to a medical aid which comprises a lancet. The lancet is at least partially enclosed by a packaging that comprises a flexible film section. The lancet is arranged displaceably between upper and lower protective sections of the packaging. The flexible film section is detachably connected, along at least one segment of its first and second lateral edges, to an additional flexible film section or one of the protective sections. The flexible film section is connected to an additional flexible film section or one of the protective sections near the lancet tip via a detachable connection to enclose the lancet tip in the packaging. The proximal ends of the lower and upper protective sections can be bent apart to create an opening in the packaging at the detachable connection through which part of the lancet is pushed out from the packaging in the proximal direction.

Abstract: An electrochemical sensor includes a base plate provided with a concave part formed on one of surfaces thereof, a fluid channel formed so that a bottom part of the concave part and the other one of the surfaces of the base plate are communicated with each other, a plurality of electrodes formed on the concave part; a reagent fixed on the electrodes, a cover which covers the concave part, and an air channel which causes the inside and outside of the concave part to be communicated with each other.

Abstract: A method is provided for controlling a lancet velocity profile. A velocity of a moving lancet is measured at a known position. The measured velocity of the lancet is compared with an appropriate velocity for the lancet at the known position. A force is applied to the lancet to adjust the velocity of the lancet.

Abstract: Embodiments of the present invention relate to a test strip container which provides easy access to test strips. The test strip container includes a lower housing, an upper housing, and a retaining member configured to releasably retain the test strips in a nested configuration. The nested configuration of the test strip container provides easy access to test strips by arranging the test strips so that they extend radially outward from the retaining member. The radial arrangement of the test strips operates to separate the test strips so that test strip users may easily select a single test strip from a plurality of test strips. Alternatively, the test strip container includes a lower housing, an upper housing, and a retaining member configured to releasably retain the test strips in a longitudinal configuration.

Abstract: A single-use indicator is provided and is particularly well suited for use with a surgical catheter device. The indicator includes an absorbent filament or wick which is placed in a transparent or translucent indicator lumen of a multi-lumen catheter. The lumen is provided with at least one side port. When the catheter is inserted into a blood vessel, blood enters the indicator lumen through the side port and is absorbed by the filament, thus turning the filament red or purple in color. When the instrument is removed from the blood vessel, the stained filament is clearly visible as an indicator that the instrument has been used. Because the filament is trapped inside a lumen of a relatively long catheter, it is difficult or impossible to remove it during a remanufacturing process.

Abstract: A blood component measurement device (10) has a puncturing unit (18) provided inside a housing (12) and having a puncture needle (16); a button unit (20) for advancing and retreating the puncture needle (16); a contact mechanism (68) coming into contact with the skin of a person to be measured; and a holder (14) for displaceably holding the puncturing unit (18). The blood component measurement device (10) also has an introduction section (94) at the substantially center of a contact member (70). After the skin is punctured by the puncture needle (16) provided at the substantially center of the mechanism (68), the introduction section (94) introduces blood to testing paper (100) when the contact member (70) of the contact mechanism (68) is displaced in a sliding manner along a guide member (72).

Abstract: A lancet integrated test element (LIT) includes an incision forming member that has a cutting end configured to form an incision in tissue. A test element is attached to the incision forming member to test fluid from the incision. The test element has a sampling end with a sample opening through which the fluid is collected. The test element is bendable from a first state where the cutting end of the incision forming member is retracted from the sampling end of the test element to a second state where at least a portion of the cutting extends past the sampling end of the test element to form the incision in the tissue.

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 blood glucose meter having a test strip port and an adjustable lancet device disposed at the same end of the device body is disclosed. The device body further includes an enclosure at the proximal end of the device body which houses a test strip storage vial and which facilitates one-handed opening and closing of the vial to simplify access to test strips contained therein. The enclosure is further provided with a window which allows the reading of the lot numbers on the label of the test strip vial therein without necessitating removal of the vial. A data connector is also provided on the device body for communication access, such as to upload data from other devices or to download data to other devices.

Abstract: The present invention generally relates to a blood withdrawal system for withdrawing blood for diagnostic purposes. The blood withdrawal system comprises housing with a lancet, which can be moved within the housing. The housing also includes a lancet drive with a drive spring and a cocking mechanism that includes an actuation element. The blood withdrawal system of the present invention also includes a lancet ejection mechanism that can be moved from an active position to remove the lancet to a passive position where such removal of the lancet is not possible.

Abstract: The invention is related to a lancet wheel (1) having a plurality of lancets (2) in a ring-shaped arrangement, the lancets (2) comprising a lancet body (4) that ends in a lancet tip (3). A lancet wheel (1) according to the invention has a carrier (5) that carries the lancets (2), whereby the lancets (2) are connected to the carrier (5) via bars (7, 7a, 7b, 7c) that allow for mobility of the lancets (2) relative to the carrier (5).

Abstract: A centesis instrument, wherein a patient applies a contact part to a palm, a finger, or an arm in the state of gripping an outer tube by hand and presses the outer tube against its measured portion. A third coiled spring is compressed to increase spring power. When the outer tube reaches a prescribed position, the tip face of the vertical portion of a centesis button reaches a hole part, and a projected part is allowed to be pressed. When the patient presses a button body from a direction perpendicular to the axis of the button body by using a finger at that position, a locking piece is separated from a locking part and the centesis needle of a centesis needle unit is instantaneously projected from the opening part of the contact part to the measured portion by the spring power of the third coiled spring for centesis. Thus, a prescribed amount of blood can be taken out from the measured portion.

Abstract: For an assembly for receiving body fluids comprising a sampling element (10) that has a collecting area (12) for collecting body fluid obtained by a puncture, it is proposed that the collecting area is formed by a longitudinal slot (12) which is elongated as a capillary that is open on both sides via side openings (28, 30) on the sampling element (10).

Abstract: The invention concerns a test device, in particular for blood sugar tests, comprising a lancing element which is provided with a lancing component for producing a skin puncture, and a protecting element shielding the lancing element at least in the area of the lancing component. According to the invention it is proposed that the lancing element has a collecting structure for collecting body fluid from the skin puncture and that the protecting element comprises a protecting foil to cover the collecting structure and a holding body for holding the protecting foil on the lancing element.

Abstract: A device is constructed so as to define a capillary channel that draws a body fluid form a proximal portion of the capillary channel toward a distal portion. A counterbore defining a “ledge” not substantially normal to the center line of channel causes the meniscus of body fluid to be “biased” into a non-radially-symmetric shape. In one example, the bias draws the body fluid toward a testing element that is set into a groove in the main body of the device. In another example, hydrophilic and/or hydrophobic regions are created on or in device to produce the biasing effect. In certain configurations, device requires less blood to be drawn into the capillary channel for a successful test than if the biasing effect were not created.

Abstract: The various embodiments disclosed herein are devices that deliver electrical stimulation and/or vibration stimulation to the surface of skin in proximity to insulin injections and/or glucose testing in order to decrease or eliminate the pain of these procedures.

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: A lancing unit (U) includes a support member (1) provided with engagement means (19A) which is inserted into a housing (4) of a lancing apparatus (A) for engagement with an engagement surface (24a) of a lancing member (2) when the lancing member (2) is mounted to a movable member (5) of the lancing apparatus. The removal of the lancing member (2) from the movable member (5) after the lancing member (2) is mounted to the movable member (5) can be easily and reliably performed by inserting the engagement means (19A) into the housing (4) and then pulling the engagement means out of the housing (4).

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

Abstract: 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 control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: The invention relates to a lancing system, comprising test elements, lancing elements, test elements each assigned to a lancing element and a hand-held device comprising a holder, which during a puncture holds a lancing element and a test element assigned to it, a lancing drive, which during a puncture moves the holder out of a starting position into a piercing position and back into the starting position, a light-sensitive sensor for analyzing a body fluid sample taken up by a test element, and a light source for illuminating the test element. According to the invention, the sensor is disposed in a housing, the outside of which the holder touches in the starting position.

Abstract: An actuator for driving a test element is disclosed. The test element can comprise a lancet for perforating the skin of a living organism. The actuator can comprise an engaging part for engaging and driving the test element in a lancing motion. The actuator can further comprise a lancing actuator and a lancing spring. The lancing actuator can bias the lancing spring by executing a forward movement and thereby can exert a biasing force on the engaging part. The actuator can further comprise a latch element. The latch element can be a force-sensitive latch element for exerting a retention force to hold back the engaging part. The retention force can counteract the biasing force. The latch element can release the engaging part when the biasing force exerted by the lancing actuator exceeds the retention force exerted by the latch element, thereby allowing the test element to perform the lancing motion.

Abstract: An analyte determination analysis system with a disposable integrated sample acquisition and analysis element is disclosed. A piercing element has a tip for generating a bodily puncture wound and a test strip having a body fluid sample receiving zone to perform an analysis on a body fluid sample. A reusable analysis instrument comprises a coupling unit that couples the integrated sample acquisition and analysis element to a drive that drives a piercing element in a piercing movement comprising two phases: a propulsion phase wherein the piercing element moves on a puncture path in a puncture direction and a retraction phase wherein the piercing element moves opposite to the puncture direction after reaching a reversal point. A measuring and analysis unit measures a variable characteristic for the determination of the analyte and determines a desired analysis result on the basis of the measurement. The sample receiving zone of the test strip forms a sample contact.

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 present invention includes a system for withdrawing body fluids. The system includes a drive unit having a plunger which is moved from a resting position into a lancing position in order to carry out a lancing process and a lancing unit containing a lancet with a needle. The plunger and lancet are coupled together by a form fit in order to carry out a lancing process. The invention additionally concerns a method for temporarily extending a needle from a device for withdrawing body fluid as well as a lancing unit that can be attached to the drive unit.

Abstract: An insertion device may include a base adapted to be carried by a patient, and a housing attached to the base, the housing having a fluid connector arranged for movement relative to the base. A pair of interactive elements including a first interactive element may be supported on the base and a second interactive element supported on the housing at a location to be interactable with the first interactive element when the fluid connector is moved to a predetermined position. Circuitry may be configured to detect an interaction between the first interactive element and the second interactive element when the fluid connector is in the predetermined position, the circuitry configured to provide a signal or a change in state in response to detecting the interaction between the first interactive element and the second interactive element.

Abstract: Single-use blade lancet device includes a body having a rear end and a front end that includes a blade tip opening. A trigger is mounted to the body. A blade member is movably mounted within the body and includes a front end and a rear end. The blade member is movable between a first retracted position, an extended position, and a second retracted position. A biasing arrangement biases the blade member from the first retracted position towards the extended position and then towards the second retracted position. A guiding arrangement guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position. During movement of the blade member, the guiding arrangement ensures that blade member maintains substantially the same orientation with respect to the body. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Abstract: An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen includes a skin piercing member and an analyte sensor coupled together.

Abstract: An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen includes a skin piercing member and an analyte sensor coupled together.

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

Abstract: The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., to the skin and/or from the skin. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, to for example, using pain scales such as the Wong-Baker FACES Pain Scale. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject.

Abstract: A blood test apparatus has a housing, a blood sensor, and a plurality of connectors. The blood sensor has a plurality of connection terminals that are electrically connected with each electrode of the electrode system; and a reference terminal that serves as a reference. The plurality of connectors are configured to connect to the plurality of connection terminals and the reference terminal of the blood sensor attached at a predetermined position in the blood test apparatus, respectively. And also, relations between the reference terminal and each of the plurality of connection terminals are measured to identify the reference terminal automatically.

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 device is constructed so as to define a capillary channel that draws a body fluid form a proximal portion of the capillary channel toward a distal portion. A counterbore defining a “ledge” not substantially normal to the center line of channel causes the meniscus of body fluid to be “biased” into a non-radially-symmetric shape. In one example, the bias draws the body fluid toward a testing element that is set into a groove in the main body of the device. In another example, hydrophilic and/or hydrophobic regions are created on or in device to produce the biasing effect. In certain configurations, device requires less blood to be drawn into the capillary channel for a successful test than if the biasing effect were not created.

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 of includes a drive force generator for advancing the lancet along a path into the tissue site, and a sensor configured to detect lancet position along said path during the lancing cycle.

Abstract: The invention is directed to an integrated device for sampling and testing an analyte. The device generally comprises a housing, a lancing device for sampling an analyte, a test strip for substantially capturing at least a portion of the analyte, and a display unit for displaying a result corresponding to the captured portion of the analyte. The invention is further directed to methods for sampling and testing. For example, one method comprises performing a single operation to sample an analyte, to capture the sampled analyte, to perform testing on the sampled analyte, and to display a result corresponding to the performed test. A method such as this can be carried out using an integrated sampling and testing device of the invention, for example, by placing the device the device on a test site of a subject, such as a patient, and performing the single operation to obtain a test result.

Abstract: Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

Abstract: The present invention provides an integrated measuring device that includes a blood collection system for collecting blood for diagnostic purposes. The blood collection system comprises an electric motor which provides energy for propelling a lancet. The blood collection system comprises a mechanical energy store in which the electric energy that is converted by the motor is stored in the form of mechanical energy. The use of a mechanical energy store allows the use of known mechanical drive elements. The blood collection system can also be electrically activated and is thus easy to use for the operator. The motor can also be coupled to another system component, such as a test strip or lancet drum, to operate it.

Abstract: The present invention is directed to an automated vessel puncture device, methods of mapping three-dimensional views of subcutaneous vessels and methods for providing simultaneous real-time diagnostic assay.

Abstract: An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen includes a skin piercing member and an analyte sensor coupled together.

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 lancing device for use with a lancet for obtaining a blood sample is disclosed. The lancing device comprises a housing; a probe disposed in the housing; and a probe actuator for linearly displacing the probe. The probe is configured for releasably engaging a lancet and is provided with sliding surfaces for slidably engaging a pair of guides. Each sliding surface has a radius of curvature centered about a curvature defining axis, the curvature defining axis being coincident with a central longitudinal axis of the lancet when the lancet is engaged by the probe. The sliding surfaces are continually biased against the pair of guides such that when the lancet is engaged by the probe, the lancet is prevented from translating in any other direction than in a direction parallel to its central longitudinal axis during linear displacement of the probe.

Abstract: An integrated lancet and testing striplet for measuring a body analyte level in a health care regimen includes a skin piercing member and an analyte sensor coupled together.

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: The present invention relates to a health monitoring device for measuring blood or tissue indicators and a strip cassette. The device comprises a body having first and second openings, a piercing means being connected to the body and having a piercing head, the piercing means being arranged to extend from the first opening and cockable and releasable for piercing the skin with the piercing head, and a space, into which a number of sensor strips can be arranged so that the strips can be brought out from the body one at a time. The device further comprises a shutter that is functionally connected to the body and has a first position arranged to tightly close the first and second openings, and a second position for allowing one sensor strip to be pushed from the first opening into sampling position and for exposing the first and second openings.

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: A puncture device is constituted such that a plunger (2) is provided with a lever (3) which is partially restricted in rotation, and a forward urging force is obtained by a contraction restorative force of a tension spring (4), and the tension spring (4) is again expanded with the lever (3) as a leverage when the plunger (2) further moves forward due to its inertia from a position where no urging force is not applied, and the plunger (2) is urged backward by a restorative force of the re-expansion. Further, a puncture needle cartridge is provided with a lancet body (203) having a puncture needle, and a puncture needle holder (201) in which the lancet body (203) is movably stored, and further, the lancet body (203) has an arm means (302) and the puncture needle holder (201) contains a to-be-latched means (303) that cooperates with the arm means (302).

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 a drive force generator and a penetrating member operatively coupled to the force generator. The force generator moves the member 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. The drive force generator is configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of the tissue. A tissue stabilizing member is associated with the device and at least partially surrounds an impact location of the penetrating member on the tissue site.

Abstract: The invention relates to a system for withdrawing body fluid from a body part via a withdrawal site located on the surface of the body part, with at least one sensor for detecting at least one variable dependent on the location or state of the withdrawal site, and with an evaluation unit for evaluating the at least one variable detected by the at least one sensor and for triggering a reaction, dependent on the value of the detected variable, in the system for withdrawing body fluid, said reaction serving to prepare the system for puncturing the surface of the body part, and with at least one puncturing device for creating an opening in the body at the withdrawal site. The invention further relates to an integrated analysis system, to a method for configuring a system for withdrawal of body fluid, and to a method for selecting a menu item from a menu for controlling a system for withdrawing body fluid from a body part.