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

Abstract: A 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: Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Abstract: A tissue penetrating system includes a plurality of cartridges, each with a distal port and a proximal port. A plurality of penetrating members are provided, each being coupled to a cartridge. Each penetrating member has a sharpened distal tip and a shaft portion slidably disposed within the cartridge. A seal is formed by a fracturable material between the penetrating member and the cartridge. The seal is positioned at one or both of a distal port or a proximal port of the cartridge. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

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

Abstract: A lancing device includes a housing for containing a lancet. A lancet driver couples with and moves the lancet within the housing. A skin interface cap has an opening defined therein to expose at least part of the lancet when moved by the driver. A sliding frame is coupled to the housing and to the skin interface cap. The frame being adjustable relative to the housing for accordingly adjusting said cap relative to the housing, whereby an extent to which the lancet is exposed through the opening is adjustable by adjusting the sliding frame.

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 lancet device includes a shot prevention mechanism for preventing re-shooting using a used lancet, that inhibits movement to a shot-ready completion state where a puncture body is held at different positions within a casing before and after use. A holding position of the puncture body within the casing before use is different than a holding position after use. When the used lancet is fitted to a main body, a stopper plate does not operate, and a setting release button remains in a depressed state and does not pushed up.

Abstract: A reconfigurable integrated lancet system comprises a testing device having a housing, a lancet holding device frame, a lancet, and at least one connection mechanism. The lancet holding device frame is adapted to fasten around a periphery of the housing of the testing device. The lancet holding device frame has a first lock receiving region. The lancet has a second lock receiving region. The at least one connection mechanism has a first locking end and a second locking end. The first locking end is adapted to interact within the first lock receiving region of the lancet holding device frame, to connect the connection mechanism to the lancet holding device frame. The second locking end is adapted to interact within the second lock receiving region of the lancet, to connect the connection mechanism to the lancet.

Abstract: A lancing device is adapted for use in firing a lancet into the skin of a patient to acquire a blood sample and, subsequent thereto, calculating and displaying the concentration of glucose in the acquired sample. In one embodiment, the device comprises a lancet and a torsion spring coupled to the lancet through a lancet holder. The torsion spring includes inner, middle and outer rings which are concentrically configured, a plurality of activation spring arms which connect the middle and outer rings and a plurality of return spring arms which connect the inner and middle rings. In use, the plurality of activation and return spring arms can be independently transformed between energized and de-energized states using a single, button-shaped mechanism. Rotation of the mechanism is used to energize the activation and return spring arms.

Abstract: A pricking device is provided that allows a protruding tip of a distal end portion of a pricking member to be shielded from surround as much as possible and removed from an injector assembly. The lancet assembly 100 contains a lancet 101 and a protective cover 102, characterized in that (1) the lancet comprises a lancet body 104, lancet cap 106 and a pricking member 105, the pricking member is disposed in the lancet body and the lancet cap while straddling them members, and the distal end portion 124 of the pricking member is enclosed by the lancet cap; and (2) the protective cover is disposed around the lancet body, so that it is able to move to a position, after pricking, around the distal end portion of the pricking member that protrudes forward from the lancet body.

Abstract: A kit for obtaining an endoarterial biopsy sample from a patient including packaging material enclosing one or more kit components; the kit components include instruments use to perform a surgical procedure; and the kit includes separate phase specific packaging parts.

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 disposable is within the housing. The disposable includes an analyte sensor in a sample chamber that is 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 have a combined occupied volume of no more than about 5.0 cm3.

Abstract: Embodiments of the present invention provide magnetic lancet devices and methods for driving a lancet. For example, a magnetic lancet device may include a driving mechanism having a plurality of magnets and a lancet coupled to the driving mechanism. A magnetic interaction between the plurality of magnets is configured to drive the lancet from an engaged position to a penetrating position.

Abstract: The invention concerns lancets with a lancet needle, the tip of the lancet needle being embedded in an elastic material. Furthermore the invention concerns lancets where the tip of the lancet needle is surrounded by a hollow body which partially consists of an elastic material that can be pierced by the tip of the lancet needle during the lancing process and which reseals the tip of the lancet needle in the hollow body when it is retracted. In addition the invention concerns a lancet magazine in which the lancets are accommodated in individual chambers, each chamber having an opening through which the tip of the lancet needle can pass, which is sealed by an elastic material. Finally the invention concerns the use of an elastic material as a component of a lancet or a lancet magazine to maintain the sterility of at least the tip of a lancet needle in the unused state and to hygienically protect at least the tip of a lancet needle in the used state.

Abstract: A lancet-release mechanism is adapted to be incorporated into a lancing device. The lancing device is adapted to receive a lancet assembly therein. The lancing device is adapted to move the lancet assembly between a resting position, a cocking position, and a puncture position. The lancet-release mechanism comprises a lancet holder and a cantilever beam. The lancet holder forms a central aperture. The central aperture is adapted to receive the lancet assembly therein. The lancet holder further forms a plurality of protuberances thereon. The cantilever beam has a projection extending therefrom. The projection is adapted to engage the plurality of protuberances located on the lancet holder The projection is adapted to separate the plurality of protuberances from each other so as to enlarge the central aperture.

Abstract: A tissue penetrating system includes a plurality of cartridges, each with a distal port and a proximal port. A plurality of penetrating members are provided, each being coupled to a cartridge. Each penetrating member has a sharpened distal tip and a shaft portion slidably disposed within the cartridge. A seal is formed by a fracturable material between the penetrating member and the cartridge. The seal is positioned at one or both of a distal port or a proximal port of the cartridge. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Abstract: A lancet device (10) having an internal magnet (20) and the forces emanating therefrom driving and retracting a collar (30) and a lancet (60). The device has a steady state condition (SS) wherein the device is at rest and in equilibrium. The device can be armed and activated to puncture. Once puncturing has occurred the device returns to a steady state condition. A lancet method involves positioning both a magnet (20) and a member (30) capable of being affected thereby with a lancet (60) in communications with one of either the magnet or the member, positioning either the member (30) or the magnet (20) to an armed position wherein the magnetic forces from the magnetic affect the member, and releasing the one of either the member or the magnet from the armed position permitting movement between the member and magnet by at least, in part, the magnetic forces, resulting in the movement of the lancet from a withdrawn position to the piercing position.

Abstract: A multi-use micro-sampling or lancing device (10) having an outer housing (12), a lancet holder (32) that engages a lancet (30) and constrains the lancet along a controlled and predefined path of travel during the lancing stroke, and a drive mechanism with a pair of opposed, off axis torsion springs (80,82) working in tandem to drive and return the lancet holder through its lancing stroke.

Abstract: A skin penetrating system is provided with a drive force generator and a disposable housing member. A plurality of penetrating members are positioned in the disposable housing member. Each penetrating member is coupled to the drive force generator. A plurality of analyte detecting members are each associated with a penetrating member and are positioned in the disposable housing member. Each analyte detecting member is positioned in a sample chamber. The sample chambers have openings for transport of a body fluid into the sample chamber. Each analyte detecting member is configured to determine a concentration of an analyte in a body fluid. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Abstract: A lancing device includes a lancing mechanism, a floating probe and a pressure tip. The lancing mechanism includes a lancet carriage, a lancet holder slidably connected to the lancet carriage, and a lancet attached to the lancet holder. The pressure tip of the lancing device is configured for engaging a target site and creating a target site bulge. The floating probe is adapted to floatably contact the target site bulge and to operatively interact with the lance carriage to control a penetration depth of the lancet into the target site bulge. A method for lancing a target site includes providing the lancing device describe above and contacting the pressure tip of the lancing device with the target site. The pressure tip is then urged towards the target site to create a target site bulge with the floating probe of the lancing device floating on a surface of the target site bulge.

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 bodily fluid sampling device includes a flexible test strip, a lancet, and a deflection mechanism. The test strip is biased to be positioned over the incision site formed by the lancet. The deflection mechanism positions the test strip away from the incision site during lancing so as to allow the lancet to have clear access to the incision site. Due to the flexible nature of the test strip, after lancing the incision, the test strip returns to the original position so as to collect fluid from the incision.

Abstract: A skin pricking lancet (101) comprising a needle (104), a body (102) for holding the needle (104) and a cap (103) for shielding at least the tip of the needle (104). At least one cap engagement formation (106) is formed on the body (102), and at least one body engagement formation (108) is formed on the cap (103). The body engagement formation (106) is configured to form a releasable mechanical interlock with the cap engagement formation (108), thereby securing the cap (103) to the body (102) in the shielded position.

Abstract: In order to provide a lancet which has a simple structure and which can secure safety, in particular, after use, and a lancet device including the same, a lancet (20) includes a casing (22), and a puncture body (23) which is accommodated in the casing (22) so as to be movable in a puncturing direction. For removing the lancet (20) from a main body (30), the lancet (20) has a convex portion (22b) formed on an inner surface (22a) of the casing (22) and a recessed portion (groove (23c)) formed on the puncture body (23), which form fitting for holding the puncture body (23) so as to be immovable in the puncturing direction in the casing (22).

Abstract: The invention relates to a reusable piercing aid, containing a lancet, an energy store for transmission of energy stored in the energy store to the lancet in order to carry out a piercing movement, a charging device for charging the energy store, and a control unit, wherein the control unit is designed in such a way that, following the piercing movement, it controls the charging device such that, following the piercing movement, the energy store is automatically charged with energy for the next piercing movement of the lancet.

Abstract: The present invention relates, in general, to lancing elements for use in drawing bodily fluids out of a patient and, more particularly, to an improved lancing element including first and second elements positioned relative to each other such that an incision formed by the first element is held open by the second element and bodily fluids are pulled up the lancing element by surface tension on the first and second lancing elements.

Abstract: The invention concerns a handle-shaped tool-holder instrument comprising a drive shaft (2) for a tool (7) and capable of being slid into the instrument (1) along the longitudinal axis from the rear of the instrument to be coupled with the tool-holding part (8) in a tool-holding head (4) at the front of the instrument, said tool-holding head Z(4) being mounted angularly steerable about a fixed axis (5) at the front of the instrument, means (3?, 9) being provided to lock the steerable head (4) in any selected angular position.

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

Abstract: A 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 skin incision device has a casing with a bottom surface and a slot formed therein, a cover positioned on the casing and slidable in a direction toward the bottom surface, a blade positioned in the casing adjacent the slot, an actuator cooperative to a position between the cover and interior of the casing, and a carriage. The actuator engages the blade by its horizontal displacement triggered by slidable movement of the cover toward the bottom surface of the casing. The carriage element guides movement of the blade between a pre-actuated position and a post-actuated position. The blade extends outwardly of the bottom surface with a fixed depth of cut during a horizontal movement of the blade through the slot.

Abstract: A safety lancet device has a casing, a driver assembly and a needle hub with a needle. The driver assembly and the needle hub are mounted within the casing. The driver assembly comprises a container, a pressing unit, a controller, a pushing unit and a resilient unit. The needle hub is controlled by the driver assembly to make the needle momentarily protrude. After the needle is used, the location of the driver assembly keeps the needle from protruding. When a new needle hub replaces the used needle hub, the driver assembly will return to the original location before use and can drive the needle momentarily from the casing. Users will not forget to change the used needle. Furthermore, the safety lancet device will decrease the danger of infection.

Abstract: A device for obtaining body fluid is described which has at least one lancet comprising a lancet body and a tip. The lancet has at least one structure with an altered stiffness which can also be referred to as a bending region. This structure preferably has a lower or reduced stiffness than the remaining lancet body such that the lancet can be bent in this region when a force acts thereon. In this process, the orientation of the tip is changed relative to the remaining lancet body. This change in orientation is preferably out of the lancet body plane.

Abstract: A lancing device is used with a lancet for lancing body tissue to result in a wound for bleeding. An improved lancing device has a priming knob having a slanted priming notch rotatably connected to the lancing device about an axis of rotation generally parallel to a central axis of the lancing device and a strike path of a lancet carrier. Rotation, translation, or both rotation and translation of the priming knob allows a user to prime the lancing device.

Abstract: A housing having an actuator mechanism and a replaceable carousel having a series of lancets. The carousel is removably received in the housing and the actuator mechanism is operable to actuate the individual lancets. In exemplary embodiments the lancing device has, amongst other features, key and detent mechanisms for orienting and securing the carousel in the housing, tangentially configured lancets for compactness, actuator alignment features for aligning the actuator with the lancets, charging mechanisms for ease in charging the lancets for launching, and shutter mechanisms for retaining the lancets in the housing after launching. Also included is a method for lancing using a lancing device according to the invention.

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.

Abstract: A puncturing system for obtaining a body fluid sample includes a lancet that is accelerated by a puncturing drive for a puncturing motion in the direction of puncturing, whereby the puncturing system comprises an adjustment facility for adjusting the puncturing depth up to which a lancet penetrates into the body of a patient during a puncture. The adjustment facility includes a limit stop element that can be moved transverse to the direction of puncturing and comprises a first side that faces the body of a patient during a puncture and a second side having a limit stop surface against which a limit stop that is connected to the lancet hits during a puncture. The distance from the limit stop surface to the first side of the limit stop element with respect to the lancet changes as the limit step element is moved in a direction transverse to the direction of puncturing.

Abstract: Lancet device including a skin engaging end that includes a lancet opening through which a lancet needle may extend, a movably mounted holding member configured to receive a lancet, and a combined triggering and cocking system structured and arranged to move the holding member to a retracted position during a cocking phase and to cause the holding member to move to an extended position during a triggering phase. A method of puncturing a surface of skin using the lancet device includes disposing the skin engaging end against a user's skin and manually activating the combined triggering and cocking system. 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: A lancet includes a proximal mounting platform; a shuttle biasing spring extending distally from the mounting platform; a shuttle having distally protruding needle, the shuttle being mounted on the shuttle biasing spring; a housing first section having a tubular first section side wall engagingly fitted to the mounting platform and fitted in telescopic relation to a tubular second section side wall of a housing second section which has a distal needle passing opening; a shuttle cocking mechanism including a shuttle shoulder having a shoulder distal face, two spaced apart and resilient shuttle engaging arms extending distally from the mounting platform and tilted toward each other and having inwardly protruding grip fingers positioned to fit over the shoulder distal face and thus engage the shuttle shoulder, and having outwardly ramped distal arm tips obstructing and deflecting re-entry of the shuttle between the engaging arms.

Abstract: The present invention relates to lancet device by which a lancet is displaceable along a piercing path to generate a piercing wound in a skin surface, in particular to obtain body fluid for diagnostic purposes. To achieve performance of a piercing movement which is low in noise and shock, the lancet drive may include a control unit for regulating the piercing depth of the lancet and the lancet may be implemented to oscillate freely out in the piercing direction without delimitation by a mechanical piercing depth stop.

Abstract: A method is provided for analyte measurement by a user using an analyte measurement device. An analyte measurement is provided with a plurality of penetrating members and analyte sensors. Each analyte sensor is positioned in a sample chamber with a volume no greater than 1 ?l. Each sample chamber has a working electrode, reference electrode and a counter electrode. The working electrode has a conductor, an enzyme and a mediator. A penetrating member and an unused analyte detecting member are presented into an active position. The following steps are then performed: (a) the penetrating member is fired to prick the skin and bring a fluid sample to the analyte detecting member, (b) the analyte level is measured, and (c) it takes no more than 10 seconds from the step of presenting the penetrating members and unused analyte into the active position through the step of measuring the analyte level.

Abstract: The present invention relates to a health monitoring device for measuring blood or tissue indicators and a strip cassette suitable for use in connection with the device. The device comprises a body (6) having a first opening (5) and a second opening (4), a piercing means (7) having a piercing head and connected to the body, the piercing means being arranged to extend from the first opening of the body and being cockable and further releasable for piercing the skin with the piercing head, and a space (17) arranged in connection with the body, into which space a number of sensor strips (12) can be arranged so that the strips can be brought out from the body one at a time.

Abstract: A lancing device comprises a lancet holder and a lancet-release mechanism. The lancet holder forms an aperture. The aperture is adapted to receive a lancet assembly therein. The lancet holder is adapted to move the lancet assembly between a resting position, a cocking position, and a puncture position. The lancet-release mechanism includes a release button located adjacent to and external from the lancing device and a beam attached to the release button. The beam extends into the lancing device and the lancet holder. The beam is adapted to engage the lancet assembly. The release button and attached beam are adapted to eject the lancet assembly from the lancet holder.

Abstract: An endcap for a lancing device, having a contact face defining an opening, wherein the contact face includes one or more surface contour features for directing body fluid toward the opening upon rocking of the lancing device with the contact face in contact with the skin surrounding the lancing site.

Abstract: A skin penetrating system includes a housing member and a penetrating member positioned in the housing member. An analyte detecting member is coupled to a sample chamber. The analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 ?L of a body fluid disposed in the sample chamber. A tip of the penetrating member is configured to extend through an opening of the sample chamber.

Abstract: The present invention relates to a lancet device, by which a lancet can be displaced along a piercing path for generating a piercing wound in a skin surface, in particular to obtain bodily fluid for diagnostic purposes, comprising a lancet drive having drive means to generate a drive force for a piercing movement of the lancet along the piercing path in the direction toward the skin surface. According to the present invention, the lancet drive comprises a magnet, by which a magnetic retention force oriented opposite to the drive force may be generated, and the lancet drive also comprises triggering means, by which the retention force may be reduced enough that the lancet is accelerated in the direction toward the skin surface under the effect of the drive force generated by the drive means.

Abstract: An end cap is removably attachable to a lancing device and comprises an end cap, a plurality of release buttons, and a plurality of engagement mechanisms. The end cap has an external surface. The plurality of release buttons is accessible from external the end cap housing. Each of the plurality of engagement mechanisms is attached to one of the plurality of release buttons. The plurality of engagement mechanisms is adapted to engage a lancet assembly. The depression of the plurality of release buttons towards the external surface of the end cap housing causes the plurality of engagement mechanisms to engage the lancet assembly.

Abstract: The invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded, and an analytical test element which is permanently connected to the lancet body. In addition the invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of an elastic material, and an analytical test element which is permanently connected to the lancet body. Finally the invention concerns a process for manufacturing such an analytical device.

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 lancing device comprises a lancet assembly and a lancet holder. The lancet assembly has a groove formed thereon. The lancet holder forms a central aperature adapted to receive the lancet assembly. The lancet holder includes a ridge extending into the central aperture. The ridge is adapted to engage the groove of the lancet assembly. The lancet holder is adapted to move the lancet assembly between a resting position, a cocking position, and a puncture position.