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. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

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 voice coil based penetrating member driver. A plurality of penetrating members are included. A transport mechanism is configured to engage the cartridges. Each of the cartridges is operatively engaged with the penetrating member driver when moved into position by the transport mechanism.

Abstract: A lancet for the extraction of blood includes a base portion of plastics material, a lancet needle of a metallic material held in the base portion and having a pointed end section protruding from the base portion, a head portion of plastics material integrally connected to the base portion by a preset breaking zone, and cooperating cam means on the base and head portions. The head portion can be removed from the base portion thereby exposing the pointed end section of the lancet needle by exerting a rotational force to one of the base and head portions relative to the other. The lancet needle is embedded in the head portion prior to the removal thereof. The cam means comprises pairs of cooperating cam sections on the base and head portions engaging with each other upon relative rotation between these portions for creating an axial movement of the head portion relative to the base portion thereby causing a rupture of the preset breaking zone.

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 mL of the fluid. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

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

Abstract: 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 &mgr;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: 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 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: 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 voice coil based penetrating member driver. A plurality of penetrating members are included. A transport mechanism is configured to engage the cartridges. Each of the cartridges is operatively engaged with the penetrating member driver when moved into position by the transport mechanism. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Abstract: A device for use with a penetrating member driver to penetrate tissue is provided. The device includes a single cartridge coupled to a plurality of penetrating members and operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue; A plurality of optical analyte sensors are coupled to the single cartridge and positioned to receive body fluid from a wound in the tissue created by the penetrating member.

Abstract: A tissue penetrating system includes a plurality of penetrating members each having a tip. A penetrating member driver is coupled to the plurality of penetrating members. A support is provided with a plurality of openings. Each opening receives a penetrating member. Each tip of a penetrating member is uncovered during launch of a penetrating member by the penetrating driver member. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

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 coupled to a cartridge and having 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.

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 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. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

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: A body fluid sampling system for use on a tissue site includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

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: The present invention generally relates to an automatic lancing device for withdrawing a blood sample, comprising a pushing member positioned at a back end of a body and a rotatable cap combined with a front end of the body for regulating the combination length of the body and the ejection length of a lancet, thereby obtaining a blood sample exactly at a desired position without misoperation and adjusting the penetration length of lancet according to depth of the skin.

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 mL of the fluid.

Abstract: A skin penetrating system includes a housing member. A plurality of penetrating members are positioned in the housing member. A plurality of analyte detecting members are each associated with a penetrating member. Each analyte detecting member includes a sample chamber and an opening for transport of a body fluid into the 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 &mgr;L of a body fluid disposed in the sample chamber. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Abstract: A cap for a lancing device for lancing dermal tissue is provided. The cap includes a cap body having a proximal end for connecting to the distal end of the housing of the lancing device and a contact ring attached to the distal end of the cap body. The contact ring includes an opening for a portion of the lancet of the lancing device to pass therethrough. The contact ring has a multi-contoured surface oriented generally about an axis distinct from the axis of motion of the lancet. The multi-contoured surface is designed to pressure the dermal tissue to facilitate expression of a fluid sample after lancing the dermal tissue. The fluid sample can include blood, interstitial fluid, or both.

Abstract: A reusable ceramic skin-piercing device. The skin-piercing device is capable of piercing the skin so as to make a sample of biological fluid available for an assay. In one embodiment, the skin-piercing device includes a skin-piercing element which is heated prior to use to a sufficiently high temperature to kill or deactivate pathogenic microorganisms. The device is heat-sterilized, being heated by passing an electrical current through a resistive element in thermal contact with the heat-conducting ceramic piercer. In another embodiment, the skin-piercing device includes a sleeve of elastomeric material with a sterilizing agent disposed in contact with the skin-piercing element. The sterilizing agent sterilizes the skin-piercing element after use. The skin-piercing element is made of a hard refractory ceramic material. The ceramic material is optionally a composite, for example, a composite of a ceramic material and a metal, or multiple ceramic materials.

Abstract: A disposable lancet combined with a reagent carrying strip which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact with the strip. The reagent carrying strip is connected to the lancet, e.g. by molding. One end of the lancet is sharpened for piercing the skin. The strip is sheet-like and has a first side and a second side, which sides are both accessible for the user, such that the reagent carrying strip can be inserted into a blood glucose meter. A weakened tear line is provided at a connection between the lancet and an edge of the reagent carrying strip so that the reagent carrying strip may be easily disconnected from the lancet.

Abstract: A skin pricker has an elongate housing containing a spring-loaded lancet which, when released from a rearward, cocked position by a trigger, shoots forward momentarily to project the tip of its needle through one end of the housing. The lancet is then prevented by a spring ratchet from being returned again to the cocked position. The cocking can be done through a twist-and-pull cap initially covering the needle tip and extending through that one end of the housing, the user pushing the cap to retract the lancet from its initial position. To guard against the lancet being prematurely pulled forwards by the cap and being trapped against cocking by the ratchet, the lancet has a formation that will engage a part of the trigger.

Abstract: A lancing mechanism for puncturing skin is provided. The lancing mechanism comprises a lance having a penetration end which is adapted to puncture skin. The penetration end of the lance is movable from a first position to a second position during a forward stroke and between the second position and the first position during a return stroke. A forcing plunger applies a force to the lance to move the lance from the first position to the second during the forward stroke. The forcing plunger is adapted to engage the lance during the forward stroke to move the penetration end of the lance from the first position to the second position and to disengage the lance when the penetration end of the lance approaches the second position. A first resilient member coupled to the lance moves the first end of the lance from the second position to the first position during the return stroke.

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: An apparatus and method is disclosed for obtaining and measuring constituents in a sample of body fluid. The apparatus includes a member which is sized to penetrate into at least the dermal layer of skin to collect a sample of body fluid located within the dermal layer.

Abstract: Blood lancet system for blood withdrawal for diagnostic purposes with a housing, a lancet holder movable in the housing for holding an exchangeable lancet, and a lancet drive for driving the pricking movement of the lancet holder with the lancet contained herein. The housing has a cap at the front end in pricking direction which can be removed in order to remove a used lancet from the lancet holder. The lancet and the housing cap are coupled, during the attachment of the housing cap, by a coupling mechanism comprising coupling elements matched to each other and enabling the extraction of the lancet from the lancet holder simultaneously with removing the housing cap.

Abstract: System for withdrawing body fluid from a body part in particular the finger pad, comprising a compression unit that is deformed when the body part is pressed against it and increases the internal pressure in a region of the body part, and a withdrawal device. Deformation of the compression unit partially converts the primary pressing movement into a secondary movement which leads to an increase in the internal pressure in a region of the body part. The invention also comprises a system for stimulating the outflow of body fluid using a deformable compression unit.

Abstract: A lancet body 15 is molded around a needle or blade, in which the inner end of the needle body which is unsharpened has an L-shape bend at the unsharpened end. The bend, when embedded in the plastic which forms the body of the lancet, secures the needle against removal. The method involves the bending substantially perpendicularly of the unsharpened end of the lancet needle or blade to be substantially perpendicular with the elongate body of the blade. The needle or blade is placed within a jig interiorly of the plastic mold. The jig includes spaced opposed clamps and a single orienting support to the bent portion of the needle. The body of the lancet is relieved in many areas to reduce material cost and has a molded tab cover eliminating a loose part such as a separate cover.

Abstract: A lancet having a coupling profile that is compatible with lancet holding features of standard lancing devices, but is keyed for mounting in a non-standard lancing device having a cooperating keyed coupling profile; a lancing device having a keyed lancet coupling for receiving a correspondingly keyed lancet but preventing use of unauthorized lancets; and a method of preventing use of unauthorized lancets with a lancing device.

Abstract: An improved depth adjustable cap of lancing device, including a lancet cover 3 with hole A 12 and an adjustable cover with hole B 13. The cover is set on the top of lancet cover 3. The two parts are joint up by screw structure and rotary position structure. Its character is: the adjustable cover is separated into a front cover 11 with hole B 13, a back ring 10 and two pieces of semi-circles. The semicircles from a set shape. The front cover 11 locates in one end of the shape and the back ring 10 located in the other end. There is a screw structure between one semi-circle and lancet cover 3. When rotating the adjustable cover, the rotary position structure makes the adjustable cover move intermittently. And “clicks” can be heard. The screw structure makes the hole B move along the axes to control the exposed lancet length. This program separates the original inner set into four simple parts. Then assemble them into a whole part and weld them with ultrasonic.

Abstract: A lance is provided for puncturing skin and producing a sample of blood. The lance comprises a spring having a first end and a second end disposed between a needle and a base wherein the first end of spring is coupled to the base and the second end of the spring is coupled to the needle.

Abstract: A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Abstract: A tissue penetration device and method of using same that may include a lancet module or sampling module. The sampling module may optionally be in a cartridge configuration and include sampling and analyzing functions, which may be integrated.

Abstract: A lancet having a blood-collecting needle with a safety feature, can prevent blood-mediated infections of AIDS, hepatitis, or other pathogenic bacteria due to careless impalement of a person collecting blood or handling waste disposition thereafter, by disposing a cap with a blood-collecting needle and repositioning the point end of the needle inside the cap via a return spring after collecting blood.

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 lancet assembly comprising an elongated lancet and a plurality of cooperative members at least some of which are movable relative thereto so as to selectively orient the lancet in a covered position, operative position or protected position. The plurality of members each comprise at least one coded structure visually indicative of the lancet being in one of the aforementioned positions dependent at least in part on which one or more of the coded structures are predominantly observable. The coded structures may comprise color codings which may be visually distinguishable or visually indistinguishable from one another. Coded structures other than color codings may be utilized.

Abstract: A single use lancet device having a housing, a lancet with a piercing tip movably disposed in the housing and structured to move between a cocked orientation and a piercing orientation, and a driving assembly structured to move the lancet into the piercing orientation. A retention member and an engagement hub are further provided and structured to be cooperatively engaged with one another upon the lancet being disposed in the cocked orientation so as to maintain the lancet in the cocked orientation until released by an actuation assembly. Specifically, the actuation assembly is structured to move between an actuated and an un-actuated orientation, movement into the actuated orientation releasing the retention member and the engagement hub from their cooperative engagement with one another and thereby result in movement of the lancet into the piercing orientation.

Abstract: System for withdrawing small amounts of body fluid comprising a drive unit which has a holder which is moved from a first into a second position when the drive unit is activated, and a disposable lancing unit which has a holding area that is removably positioned in the holder, the proximal end of an elongate capillary structure comprising at least one capillary channel for transporting body fluid being connected to the holding area and the distal end of the capillary structure being suitable for piercing skin, wherein the distal end of the capillary structure is located outside the skin when the holder is arranged in a first position and in the second position is inserted into the skin up to the puncture depth, characterized in that the at least one capillary channel is open to the outside in an area which comprises at least a part of the longitudinal extension of the capillary structure.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with the sealable chamber; (b) a vacuum pump in communication with the sealable chamber; (c) a device for forming an unobstructed opening in an area of skin from which a sample is to be collected, preferably a lancing assembly, the device positioned within the sealable chamber; (d) a movable support for supporting and positioning a port for a fluid collector in the sealable chamber, the movable support capable of moving the port within the sealable chamber between a first position and a second position; and (e) a stop for aligning the fluid collector.

Abstract: A new tip for a conventional lancer that provides for improved blood flow from a lancet puncture site not located on a patient's finger. The new lancer tip includes a plurality of crenellations that exert rotational force on the skin surrounding the lancet puncture site when the lancer is rotated to enhance blood flow from the lancet puncture site.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring.

Abstract: A cassette containing cartridges for sampling blood from a patient. The cassette includes a container for storing a plurality of cartridges and at least one cartridge in the container. The cartridge includes a cartridge case and a lancet. The lancet has a tip and is housed in the cartridge case. The lancet can be driven to extend the tip outside the cartridge case for lancing the skin of the patient to yield blood. The container has a compartment that contains at least one cartridge. A cartridge from the compartment can be loaded onto a glucometer that drives the lancet in the cartridge to lance the skin of a patient.

Abstract: A piercing instrument (12) for obtaining a non-activated drop of blood (B) by capillary puncture is formed by depositing a coating agent (20) on the exterior surface of the piercing instrument (12). The coating agent comprises compounds that inhibit the activation of blood.

Abstract: A lancet body (2) is integrally molded with a cap (3) for a firing device, the cap concealing the needle tip (5). the cap (3) can be used to insert the lancet (1), which is held while the cap is twisted off. The cap (3) is then fitted to the firing device to provide an apertured platform to be held against the skin and through which the needle tip (5) will momentarily project. The cap (3) has to be deformed to fit, and on being removed and recovering its natural shape internal lugs (14) catch hold of the released lancet (1) and remove that as well.

Abstract: Body fluid is sampled from a skin incision by placing a ring against the skin and repeatedly applying an elastic pressing force to the ring, whereby a stimulator surface of the ring depresses a ring of skin and body tissue in surrounding relationship to the incision to force body fluid from the incision. The stimulator surface is inclined at an angle of 10 to 65 degrees; a width of the stimulator surface is from 5 mm to 20 mm, and an inner diameter of the stimulator surface is no less than 6.0 mm.

Abstract: An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid.

Abstract: An adjustable endcap for a lancing device includes a basecap and a twistcap. The basecap includes a post with detents thereon. At least one finger is provided on the basecap adjacent the post. The twistcap includes at least one helical track on its outer surface into which the finger extends when the twistcap is mounted on the post. The twistcap also includes a plurality of grooves on an inner surface for engagement with the detents. As the twistcap is rotated on the post, the interaction of the finger and track causes the twistcap to move toward and away from the basecap and to adjust the penetration depth of a lance reciprocally mounted in the lancing device.

Abstract: A lancet assembly having a lancet holder and a triggler enclosing a lancet structure. The triggler is partially inserted into a lancet holder from the distal end. The holder is provided with a rigid internal spring holder to receive the spring-loaded lancet structure. The lancet structure is provided with a body coupled to a spring which extend from the proximal end of the body. The spring has a linear axis of compression which coincide with the longitudinal axis of the lancet assembly. A lancet is attached to the body with the sharp tip pointing towards the distal end. The triggler interacts with the lancet holder via a triggering element to maintain the spring in a compressed state such that the lancet structure is in a stable standby position which is not easily triggered by accidental bumps on the assembly.

Abstract: Device for withdrawing Blood for Diagnostic Purposes. A lancet holder (8) for holding a lancet (7) and a lancet drive (12) having a loadable elastic drive spring (15) are provided within an elongated housing (2). The relaxing motion of the drive spring (15) is converted into a puncturing motion, after release of a locking device, to move the lancet (7), held by the lancet holder (8), at high speed in the puncturing direction until its tip exists out of an exit opening (5) of the housing (2). An improved handling and simultaneous minimization of pain is achieved by providing a two-sided rotary/translatory transmission (25) in the housing (2), wherein a) the input side (24) of the rotary/translatory transmission (25) transforms the motion of a loading button (17), protruding out of the rear end (16) of the housing.