Abstract: A cartridge for a testing device and method of testing using the testing device with the cartridge is disclosed. The cartridge includes a plurality of lancet needles, a plurality of test strips, and a mechanism allowing the cartridge to be mounted to the testing device. The method provides for puncturing a surface of skin using the testing device by arranging the testing device against a user's skin, triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user's skin, placing an amount of blood on one of the plurality of test strips, and rotating the cartridge to another position.

Abstract: A cartridge is configured to be inserted into a meter, the cartridge comprises a housing having an aperture, and end face and a side wall; at least one testing member disposed within the housing; a removable seal; and a knob attached in a fixed positional relationship with the seal, wherein when the seal is in a sealed condition a part of the seal covers the aperture and is secured to the housing around the aperture so as to provide a moisture impermeable barrier and the knob is located adjacent the side wall of the housing.

Abstract: A safety blood lancet device includes an outer sleeve. A fixing tube fixed in the outer sleeve has a cantilever hook. A carrier is elastically inserted into the fixing tube, and in which a lancet is separably installed at a front end thereof, a rear tip which is at a rear end of the outer sleeve and connected with a rear end of the carrier so as to load the carrier by pulling the carrier toward a rear side. A female nut is separably coupled to the outer sleeve. A front tip is rotatably installed at a front end of the female nut and in which a needle of the lancet protrudes through a front end thereof when the carrier is shot. A rear end of the fixing tube is selectively inserted into a safety cap and is elastically installed toward a front side of the outer sleeve.

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

Abstract: A single-use lancet cartridge for inserting into a multi-use lancet driver assembly of a meter housing includes an elongated lancet housing with an open end, a lancet within the lancet housing and movable between a retracted and resting orientation to a piercing orientation through the open end, and a re-use prevention component that is a rotated drive wing incorporated within the lancet cartridge and oriented to cooperatively engage with a driver piston of the multi-use lancet driver assembly only one time thereby preventing the lancet from being moved into a piercing orientation a second time.

Abstract: Apparatus for eliciting a blood sample, the apparatus comprising; a testing member rotatably mounted on a shaft; and an aperture for positioning a body part of the user relative to the edge of the testing member, wherein an edge of the testing member is shaped such as repeatedly to exert pressure on the skin of a user when the testing member is rotated.

Abstract: Various systems and methods of operating an analyte measurement device is provided. The device has a display, user interface, processor, memory and user interface buttons. In one example, one of the methods can be achieved by measuring an analyte with the analyte measurement device; displaying a value representative of the analyte; prompting a user to activate a test reminder; and activating the test reminder to remind a user to conduct a test measurement at a different time. Other methods and systems are also described and illustrated.

Abstract: The present application relates to an apparatus for eliciting a blood sample. The apparatus has a housing having an aperture. A shaft extends in the housing. A first part of a testing member is mounted on the shaft and a second part of a testing member is configured to co-rotate with the first part. A lancet protrudes radially from the second part. The second part is configured, in the presence of a force exerted against the testing member by an actuator, to translate relative to the first part from a retracted position to a skin penetrating position in which the lancet is displaced towards the aperture.

Abstract: A lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is provided. The lancet housing assembly comprises an outer facing side and an inner facing side. An opening is located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device. A floor extends between the outer facing side and the inner facing side and having a reagent material. A lancet structure having a skin penetrating end and a blood transport portion adjacent the skin penetrating end is located in housing assembly. The blood transport portion is arranged and configured receive the amount of blood from the skin penetrating end and to carry the amount of blood away from the skin site and to the reagent material.

Abstract: This liquid sample measurement device is provided with: a lancet mounting part to and from which a lancet device having a skin contact section for puncturing skin can be attached and detached; a sensor mounting part to which a biosensor, which is spotted with blood that comes out from the punctured skin, can be attached; and a measurement part that uses the biosensor attached to the sensor mounting part to measure the amounts of substances in the blood. The liquid sample measurement device includes a feature that makes it necessary to replace a lancet device that has been attached to the lance mounting part and has punctured skin, each time a lancet device is used to puncture skin.

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

Abstract: An apparatus for eliciting a blood sample comprises a housing, an aperture in a wall of the housing, an aperture cover moveable between a first position in which the aperture is covered and a second position in which the aperture is uncovered, the aperture cover comprising a sealing member configured to seal the aperture on a first side of the wall when the aperture cover is in the first position and a user-contactable part extending from the sealing member through the aperture to the second side of the wall and configured to allow a user to move the aperture cover between the first and second positions.

Abstract: Analysis system for determining an analyte in a body fluid is presented. The system comprises a reusable analysis instrument and a magazine having a plurality of integrated sample acquisition and analyzing elements. Each element comprises a puncturing element and an analyzing element. A coupling unit couples the integrated sample acquisition and analyzing element to a drive. The magazine comprises a housing having a plurality of elongate neighboring chambers separated by two side walls running in a longitudinal. The chambers contain the integrated sample acquisition and analyzing element. The chambers have an exit opening allowing for the at least partial exiting of the puncturing element. The chambers of the magazine are accessible to a coupling element that can be formfitting coupled to the coupling structure of the puncturing element, when the puncturing element is in the chamber of the magazine and the magazine is located in a holder.

Abstract: Apparatus comprising a housing having an aperture configured to receive a body part of a user, a capacitive sensor supported on the housing and a controller configured to use the capacitive sensor to determine whether a body part of a user is present within the aperture and to permit lancing of the body part only when it is determined that the body part of the user is present in the aperture.

Abstract: The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member.

Abstract: The present application relates to an apparatus for eliciting a blood sample. The apparatus has a housing having an aperture. A shaft extends in the housing and is received through a hole in a test member. A lancet protrudes radially from the test member. The hole is configured to allow the test member to translate relative to the shaft, in the presence of a force exerted on the test member by an actuator, from a retracted position to a skin penetrating position in which the lancet is displaced towards the aperture.

Abstract: An apparatus for eliciting a blood sample is presented having a lancet for lancing a body part of a user and a cleaning member of absorbent material operable to clean a surface of the body part, the apparatus being configured such that in use the lancet is moved to lance a body part of a user and subsequently the cleaning member is moved to contact the body part of the user so as to remove blood from the surface of the body part prior to collection of the blood sample from the surface of the body part.

Abstract: A body fluid sensing device with a body fluid capture structure and a body fluid measurement sensor positioned in the body fluid capture structure. A capacitance sensor is coupled to the body fluid measurement sensor. The capacitance sensor is used to assist in the positioning of a body part relative to the body fluid capture structure.

Abstract: This disclosure provides equipment and processes for blood glucose management. Embodiments may comprise a lancet device that includes a base that supports a lancet and a cover. The cover can move controllably from an un-depressed position to a depressed position when a predetermined force is applied. The cover can provide access to the lancet in the depressed position. In another aspect, a biological test kit may include a reusable module and a disposable module. The disposable module may include one or more lancet devices such as that described above to collect a biological sample, one or more strip stations supporting biological strips and a disposable module connector. The reusable module may support measuring equipment to measure a property of the biological sample and a reusable module connector that engages removably with the disposable module connector.

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. An analyte detecting member is positioned to receive fluid from a wound created by the penetrating member. The detection member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 ?L of the fluid. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Abstract: A lancing system comprising a lancing elements carrier tape carrying a plurality of lancing elements, a tape transport unit for moving the lancing elements consecutively into a usage position by transporting the lancing elements carrier tape, a lancing drive for causing a lancing element located in the usage position to perform a lancing movement, and test elements with detection reagents for analyzing a body fluid sample obtained by a puncture is presented. Additionally, a test elements carrier tape is provided, which carries the test elements. The lancing elements carrier tape and the test element carrier tape are located on top of one another with tape sections that carry unused test elements or unused lancing elements.

Abstract: A test tape device is disclosed herein for use with a replaceable analytical tape cassette, where the device includes a housing having a cassette compartment covered by a cassette door and a housing opening for sample application, a protective cover that can be moved between a closed position covering the housing opening and a release position allowing access to the housing opening and a door lock for retaining the cassette door in the closed position, wherein the protective cover is coupled with the door lock via an interlocking mechanism, such that the door lock can only be unlocked in the release position of the cover.

Abstract: A blood separation and testing system for a blood sample is disclosed. The blood separation and testing system includes a blood sampling transfer device adapted to receive a blood sample, a blood separation device, and a blood testing device. The blood separation device is adapted to receive a portion of the blood sampling transfer device such that with the blood sampling transfer device received within the blood separation device and a rotational force applied to the blood sampling transfer device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The blood testing device is adapted to receive a portion of the blood sampling transfer device to analyze the plasma portion of the blood sample and obtain test results.

Abstract: A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

Abstract: A blood sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer.

Abstract: A biological fluid sampling device adapted to receive a blood sample and includes a housing having a reservoir disposed therein and a first cavity in fluid communication with the reservoir is disclosed. The biological fluid sampling device includes a first test element removably receivable within the first cavity and a lancet having a puncturing element. Additionally, the housing may include a second cavity in fluid communication with the reservoir and a second test element removably receivable within the second cavity. With the blood sample received within the reservoir of the biological fluid sampling device, the first test element and the second test element are adapted to receive a portion of the blood sample. In this manner, the biological fluid sampling device allows for a blood sample to be collected on a plurality of test elements simultaneously. In one embodiment, the biological fluid sampling device contains a sample stabilizer.

Abstract: A blood collection device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood collection device separates a plasma portion from a cellular portion. After separation, the blood collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood collection device of the present disclosure also provides a closed collection and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The blood collection device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood collection device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

Abstract: The invention concerns a disposable diagnostic part comprising a lancing element (14) which is designed for puncturing the skin (26) and has a collecting channel (16) for taking up body fluid, and comprising a detection element (18) which has a test layer (42) provided with reagents for the detection of an analyte in the body fluid and is disposed in the collecting channel (16). In order to ensure an improved stability and biocompatibility it is proposed that the detection element (18) is provided with a sealing layer (20) that is applied to the test layer (42) and covers the reagents.

Abstract: A lancing device (e.g., pen) having an integrated thermoelectric (e.g., Peltier) cooler. The lancing device includes an elongated heat accumulator having a lumen along which a piston having a lancet thereon translates back and forth. A Peltier device and a cooling ring are thermally interconnected to one end of the heat accumulator and include central apertures through which the lancet can extend. The lancing device also includes an integrated battery and microcontroller for supplying and regulating power to the Peltier device. Upon a current being sent through the Peltier device, a cold side of the Peltier device and hence the cooling ring gives up thermal energy and reduces in temperature. The cooling ring can then be placed about a body tissue (e.g., skin) for a period of time (e.g., 3-5 seconds) to desensitize the body tissue, and then the lancet can be fired to puncture the body tissue.

Abstract: There is provided a microneedle bio-sampling apparatus including: an bio-sampling body enabling a microneedle to be inserted into human skin; and a blocking unit installed in the bio-sampling body and preventing the microneedle from moving to the skin again to prevent repeated bio-sampling by the microneedle. Since the microneedle bio-sampling apparatus is configured to prevent repeated bio-sampling of a single-use microneedle, secondary infection to other part of a human body or a different person due to blood, human anatomy, or the like, that may remain in a microneedle after the microneedle is used once otherwise in case of repeated bio-sampling of a microneedle, can be prevented.

Abstract: A lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is provided. The lancet housing assembly includes a housing structure comprising multiple lancet compartments. At least one of the lancet compartments comprises an outer facing side and an inner facing side. An opening is located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device. A floor extends between the outer facing side and the inner facing side. A reagent material is located on the floor and within the lancet compartment. A lancet structure is located in the at least one lancet compartment. The lancet structure comprises a skin penetrating end and a blood transport portion adjacent the skin penetrating end. The skin penetrating end, when extended through the opening, is shaped and sized to penetrate the patient's skin at the skin site to provide an amount of blood.

Abstract: A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

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: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Abstract: A lancing device having a domed structure that can be depressed by application of a force by a user's finger so as to expose the tip of a needle. The domed structure is configured to move from a non-depressed state to a depressed state in a manner that allows for the piercing the users finger. The domed structure may then recoil to its original, non-depressed position upon the user ceasing to apply the force.

Abstract: Lancet device including a first housing. A first guide wall is disposed within the first housing. The first guide wall includes an opening. A cap removably mounted to the first housing. A needle holding member for holding a lancet. At least a portion of the needle holding member being able to move within the opening. A first spring for biasing the needle holding member toward an extended position. The first spring surrounding a portion of the needle holding member and being disposed between the first guide wall and a shoulder of the needle holding member. A movable trigger having a first position and a second position. A movable second housing including a proximal end, a distal end and a second guide wall arranged at the proximal end. The second guide wall including an opening. A portion of the needle holding member being able to move within the opening of the second guide wall.

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 lancing device formed from a main body and a cap. The main body is configured from a lower housing, an upper housing extending over a portion of the lower housing, and an actuator operatively engaged to the upper and lower housings with the actuator extending along the portion of the lower housing not covered by the upper housing. The upper housing further includes an actuator button, wherein a lancet may be placed within the body such that movement of the actuator from a first position to a second position away from said endcap cocks the lancet for firing, which is achieved by depressing the actuator button. Conveniently, the lancing device is configured for tactile recognition in the palm of a human hand and may preferably be operated one handed and without visual observation.

Abstract: The present invention provides a liquid sampling, storage, transfer and delivery device comprising housing containing a porous nib. The porous nib in the device contacts the sample, collects the sample, stores the sample, transports the sample inside its porous matrix and releases the sample from the porous matrix upon demand.

Abstract: A tape cassette for a medical handheld device is disclosed as comprising a carrier tape, which carries test fields for assaying a sample of a human or animal bodily fluid and/or lancets as functional elements, a supply chamber, in which a supply section of the carrier tape comprising unused functional elements is positioned, a winding unit, in order to wind up the carrier tape and draw it through a tape exit opening of the chamber, so that the functional elements may be brought sequentially into a usage position. The carrier tape in the tape exit opening is oriented transversely to the supply section positioned in the supply chamber.

Abstract: The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

Abstract: The invention concerns a test system comprising a test device which has a lancing drive and an optical measuring device, and at least one test unit that is inserted into the test device as a disposable article, preferably in a magazine. According to the invention it is proposed that the measuring device can be directly coupled to a detection element of the test unit by means of an optics adapter on the device side, where a free end of the spring-loaded optics adapter lies against the detection element in a force-locking manner.

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

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 lancing device integrated with a sensing strip and method of making and using the same are provided. A lance and analyte sensing strip are combined in a single, preferably disposable, device. In a preferred embodiment, a slot is provided in a support member so the lance can be engaged by a lance driver and driven into the skin producing a bodily fluid sample from a wound. The sensing area of the sensing strip is adjacent to the wound location reducing dexterity requirements for patients.

Abstract: The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member.

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. An analyte detecting member is positioned to receive fluid from a wound created by the penetrating member. The detection member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 ?L of the fluid. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Abstract: Arrangements are provided including a base having a bore disposed therein extending from a first surface of the base through a second surface of the base, a fluid transport tube having a first end, a second end opposite the first end, and a lumen having an inner diameter, at least the second end of the tube being received within the bore of the base, and at least one fluid transport enhancing groove having at least a first section disposed in the second surface of the base and in fluid communication with the bore.

Abstract: A meter system for analyzing body fluids includes a supply magazine for storing a stack of test elements, a meter for analyzing fluid samples, and a transport system for transporting test elements from the supply magazine to the meter. The test element in one embodiment includes a lancet integrated test element that has a lancet coupled to a test strip. The transport system is configured to minimize damage to the test element. In one form, the transport system includes a shuttle that slides the top-most test element from the stack onto a connection portion of the meter. In another form, the transport system includes a drum that rotates to transport test elements from the supply magazine to a testing position and, once used, to a waste magazine for disposal. In a further form, the transport system includes a disc that rotates to transport the test elements.

Abstract: A puncturing system includes a carrier tape carrying multiple lancets and having position marks, a housing comprising a conveying facility for positioning the lancets and a housing opening, a puncturing drive for accelerating a lancet positioned in a usage position, a storage medium for storing distance values that depend on distances between the lancets of the carrier tape and position marks allocated to the respective lancets, a sensor for detecting position marks in a detection position through which the position marks proceed upon motion of the carrier tape, and a control unit that controls the conveying facility. To position a lancet in the usage position, the control unit stops the conveying facility upon the carrier tape moving a positioning distance. The length of the positioning distance depends on the distance between the lancet to be positioned and the detected position mark and is determined by the control unit.