Abstract: An analytical system for detecting an analyte in a body fluid comprises a disposable integrated puncturing and analyzing element and a reusable analytical system. The integrated element includes a puncturing element having a tip for generating a puncture wound in a body part and an elongated flat test strip having a top side and a bottom side. The integrated element is held in a holder such that, in a sample application position of the test strip, the top side of the test strip is facing upward. A sample application area for manual application of a drop exiting from the puncture wound of the body part is provided on the top side of the test strip such that, in the sample application position, the drop is applied to the sample application area from directly above.

Abstract: An integrated lancing test strip device includes a lancet configured to form an incision in tissue and a test strip coupled to the lancet for analyzing body fluid. A retention mechanism acts as a detent to hold the lancet in a static position relative to the test strip before forming the incision. The retention mechanism is configured to release the lancet for retracting the lancet relative to the test strip to reduce smearing of body fluid by the lancet during collection of the fluid with the test strip. In one form, the retention mechanism includes breakable tabs that are broken to release the lancet, and the lancet is retracted via translational movement. The retention mechanism in another form includes one or more dimples that release the lancet when the lancet is retracted via rotational motion. In a further form, the entire integrated device is rotated to collect fluid.

Abstract: By moving a control member 3 in a predetermined direction from a wait position, a lancing device A can perform a lancet retreat operation for retreating a lancet holder 2 to locate a lancet 9 at a predetermined retreated position and a lancet detachment operation for pushing out the lancet 9 forward of the lancet holder 2 after a lancing operation. The control member 3 returns to the wait position by action of a return member 7 both after the lancet retreat operation and after the lancet detachment operation. Thus, the lancing device A is convenient.

Abstract: A lancet device includes a hollow housing defining a cavity and having a proximal end and a distal end and a slider slidable at least partially within the cavity along a longitudinal axis from an outward position to a pushed position. The slider extends outside of the cavity beyond the proximal end when it is in the outward position. A needle holder holding a needle is rotatable about and translatable along the longitudinal axis when moved from an initial position to an extended position. When the needle holder is in the initial position, the slider is in the outward position. When the needle holder is in the extended position, the lance extends beyond the proximal end. Sliding of the slider to the pushed position enables a first biasing member to urge the needle holder toward the extended position. A second biasing member can be present in the lancet device.

Abstract: The present invention relates to a puncture device 1 for moving a puncture element 21 in a piercing direction N1 and for piercing a target site with the puncture element 21. The puncture device 1 is for moving a second member 42 retaining the puncture element 21 in the direction N1 and in a direction N2 by the rotational motion of a third member 40 as a first member 41 moves in the directions N1 and N2. The puncture device 1 further comprises a piercing depth adjusting mechanism 6 of adjusting a piercing depth of the puncture element 21 to the target site by regulating a rotation angle of the third member 40.

Abstract: A lancing device comprises a main housing, a movable housing and a pushbutton. The main housing encloses a portion of a lancing mechanism. The lancing mechanism includes a lancet holder attached to a shaft. The lancet holder receives a lancet and has a slot formed therein. The lancing mechanism moves between a rest position, a cocked position, and a puncture position. The movable housing is adjacent to the main housing. The movable housing moves from a rest position to a cocking position and a lancet-release position. The pushbutton allows the lancing mechanism to move from the cocked position to the puncture position upon depression of the pushbutton. The pushbutton includes a lancet-release tab that extends into the slot formed in the lancet holder and engages the lancet. The lancet is released from the lancet holder in response to the continued depression of the pushbutton and the movable housing is moved from the rest position to the lancet-release position.

Abstract: Double-ended lancet unit for a lancet device. The unit includes a lancet body having a first end and a second end and being sized and configured to frictionally engage with a holding member of the lancet device. A first lancet needle projects from the first end and a second lancet needle projects from the second end and/or a lancet needle member has oppositely arranged pointed ends and is movably mounted to the lancet body. The body is made of a material different from that of the first and second needles or the pointed ends. First and second removable caps are respectively removably connected to the first and second ends. At least one of the first and second removable caps are re-installable on one of the first and second ends of the double-ended lancet unit. The unit is installable on the lancet device and each of the first and second needles or the pointed ends is structured and arranged to prick a user's skin to obtain a blood sample and is not usable for fluid injection.

Abstract: The invention relates to analyte monitoring/drug (pharmaceutical agent) delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The electronics portion includes a processor and associated circuitry (e.g., memory, supporting electronics and the like), a motor or the like, a sensor, a power supply (e.g., battery) and optionally an interface. In general, the processor controls the operation of the device and is data communication with the actuator, motor, sensor and interface. The invention provides for autonomous operation, that is, without intervention of the user.

Abstract: A robotic medical system comprises a medical instrument assembly having a retainer, a serial array of instruments disposed in the retainer, a chamber, and an instrument driver. The robotic medical system further comprises a user interface configured for generating at least one command signal, a drive unit coupled to the first mechanism, second mechanism, and instrument driver, and an electric controller configured, in response to the command signal(s), for directing the drive unit to linearly displace the array of instruments within the retainer, to displace a selected one of the instruments from the retainer into the chamber, and to distally advance the instrument driver within the chamber to engage the selected instrument.

Abstract: The present disclosure provides electrode structures and integrated electrode structures having one or more conductive materials coextruded with one or more dielectric materials. The disclosed electrode structures can be configured for use as analyte sensors. Also provided, are methods of making and using the electrode structures and integrated electrode structures described herein.

Abstract: An analyte testing device includes an analyte sensor, a lancet, and a mechanism with an actuator that operates to independently expose the analyte sensor and advance the lancet into position for use. The analyte sensor is preferably included in an analyte sensor cartridge that houses a plurality of sensors. Similarly, the lancet is preferably included in a lancet cartridge that houses a plurality of lancets. The actuator can be a lever configured to expose the analyte sensor and advance the lancet into position with a single motion (e.g., pulling the lever). The actuator also preferably operates to cock a hammer in preparation for lancing a body member to draw a blood sample. The mechanism can be a linkage coupled with the actuator and configured to engage the analyte sensor and lancet.

Abstract: The invention relates to a puncturing system for generating a puncture wound for obtaining a sample of a body fluid, comprising a press-on part to be pressed onto a body part in which a puncture wound is to be generated, a triggering means, by the actuation of which a user can trigger a puncturing motion of a puncturing element after the press-on part is pressed on, and a testing facility for determining at least one test parameter on which a sample-obtaining probability depends. A securing facility is also provided that, in a locked state, locks the triggering means such that no puncturing motion can be triggered, and, in a triggering state, releases the triggering means such that a puncturing motion can be triggered by actuation thereof, whereby the securing facility is transitioned from the locked state to the triggering state by the testing facility when the test parameter determined by the testing facility meets defined minimum requirements.

Abstract: An biopsy apparatus includes a pressure and vacuum generator including a first cylinder and a first piston movably disposed within the cylinder. The cylinder has a pressure generating region and a vacuum generating region. The biopsy apparatus also includes an outer cannula and an inner cannula having a lumen. The inner cannula is movably disposed within the outer cannula, and the vacuum generating region is in one-way fluid communication with the inner cannula lumen.

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

Abstract: A method and apparatus (2) for obtaining a sample of blood. An embodiment includes an apparatus (2) which integrates lancing (12), sample collection, and analysis. The presence of patients finger on the active sampling area can be sensed by monitoring the pressure applied by the finger on the device (2).

Abstract: Integrated lancing and analyte measurement systems are provided which minimize the number of actions required to operate the systems, accomplished in part by combining two or more user steps into one.

Abstract: A gripper device for use in a lancet device for generating a sample of a body fluid. In the lancet device, a plurality of lancets can be provided in succession on a carrier element in an application position. The gripper device is equipped to seize one lancet at a time in the application position and carry out a piercing movement using the lancet. The gripper device includes at least one stop element, which is equipped to stop the lancet in the application position and temporarily prevent further movement of the carrier element. The gripper device further includes at least one positioning element, which is equipped to position the lancet during the piercing movement in a direction transverse to a piercing direction. The gripper device can further include at least one counter-gripper, which is equipped to cooperate with the stop element whereby the lancet can be held with a form fit.

Abstract: Assembly for a testing or lancet device. The assembly includes a lancet and a member. The member has an opening that allows a portion of a needle of the lancet to pass therethrough.

Abstract: In one aspect, a body fluid sampling device is provided using a penetrating member to extract fluid from an anatomical feature. The device comprises a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature and a non-spring based, penetrating member retractor for moving the penetrating member outbound away from the anatomical feature. The penetrating member actuator may be adapted to move the penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.

Abstract: The present invention provides a lancet system having a lancet tip protected by a sterile protector. The sterile protector includes a weakened portion near the tip end of the protector, which, during a puncturing operation, separates or tears in order to release the lancet tip. Other embodiments of the present invention include a pricking aid and/or lancet system provided as a magazine for holding a plurality of lancets. Each lancet of the plurality has a sterile protector as described above.

Abstract: A disposable lancing device including: a housing; a spring member; a lancet having a skin puncture needle, the spring member and the lancet being housed within the housing such that a needle tip of the skin puncture needle is adapted to be projected out from the housing under urging of the lancet by the spring member to perform skin puncture procedure; and a protective cap having a needle passage hole and covering the needle tip of the skin puncture needle, the protective cap being adapted to separate from the skin puncture needle and rotate so that the needle passage hole of the protective cap is positioned on a path of projection of the skin puncture needle, and the skin puncture procedure is performed with the protective cap supported on the housing.

Abstract: A measurement system is provided which comprises an analysis device with at least one of a measurement function and a sample collection function, and also at least one magazine configured to receive at least one consumer element therein. The magazine comprises a magazine housing having a pair of openings. The magazine is designed as an exchangeable magazine that can be selectively operatively connected to the analysis device. The analysis device further comprises a closure mechanism having at least one sealing element which is designed to convey at least one consumer element from one of the openings. The sealing element is further configured to sealingly close the openings of the magazine when the sealing element is disposed therein.

Abstract: Adjustable Single-use lancet device that includes a body. A trigger is mounted to the body. A skin engaging end includes a lancet opening through which a lancet needle extends. A holding member is movably mounted within the body and includes a front end a rear end. The front end receives a lancet needle. A stop surface moves with the holding member. A cam disk includes cam surfaces which can be contacted by the stop surface. The cam disk is configured to rotate at least partially. The cam disk rotates about an axis that is not parallel to an axis running through at least one of the lancet opening and the holding member. Once caused to move to the extended position by the trigger, the holding member is prevented from moving back to the retracted position. 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 device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Abstract: An apparatus for lancing skin and collecting a liquid sample. The apparatus having a housing with an outer periphery and a rotatable arm having a lance to puncture the skin. A sample collection area is attached to the arm. The arm of the apparatus rotates from a first position to a second position. As the arm rotates, the lance extends beyond the housing allowing the lance to contact the user's skin and create a lance site. As the arm continues to move to the second position, the lance is brought out of contact with the user's skin and back within the housing while the collection area is brought into position. When the arm is located in the second position, the collection area is in substantially the same location as the lance site on the user's skin.

Abstract: A lancet assembly includes a lancet and a lancet holder that houses the lancet, wherein the lancet includes a lancet body, a lancet cap and a pricking component, the pricking component is situated in both of the lancet body and the lancet cap, the tip of the pricking component is covered with the lancet cap, and the lancet cap and the lancet body are integrally connected together by a bridging component when the lancet cap is pressed in the pricking direction with the lancet body attached to the lancet holder, the bridging component is broken so that the lancet cap is separated from the lancet body. Thereafter, when the separated lancet cap is pressed further: in the pricking direction, the separated lancet cap moves to a position that is off the pricking pathway of the pricking component.

Abstract: A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Abstract: Disclosed is a process for manufacturing packaged lancets. The steps of the process include providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body, enveloping at least the lancet tip with at least one foil, whereby the at least one foil forms a first and a second portion that overlap at least partly, and sealing the at least one foil with a laser beam at least at the edges of the first and second portion of the overlapping foil.

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

Abstract: 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: A blood test apparatus has a housing with an opening, and a plunger that moves back and forth inside the housing, the plunger having a projecting member. A fixing member fixes the plunger, which is provided in the housing. A blood sampling cartridge, in which a blood sensor, a puncturer, and a holder that holds the blood sensor and the puncturer, are integrated. The blood sampling cartridge is removably attached to the opening. The puncturer includes a lancet, one end of which is held by the plunger, and a blood collection needle attached to an other end of the lancet. A measuring circuit measures a signal obtained from the blood sensor to analyze components in the blood.

Abstract: A puncturing system includes a support tape (1) that supports a plurality of lancets (2), a first reel (3) onto which the support tape (1) with unused lancets (2) is wound, a second reel (4) on which portions of the support tape with used lancets (2) are to be wound, a winding mechanism which, by turning the second reel (4), brings the lancets (2) supported by the support tape (1) to a position of use one after another and thus unwinds the support tape (1) from the first reel (3) and winds it onto the second reel (4), and a puncturing drive mechanism (7) with which lancets (2) located in the position of use are accelerated in order to puncture the skin. The support tape (1) between the first and second reels (3, 4) is twisted only in one direction of rotation by at least a quarter turn, preferably by at least a half turn.

Abstract: A contact activated incision device, comprises a housing defining a cavity, and a longitudinal axis extends between a proximal end and a distal end of the housing. A slider is slidable with respect to the housing along the longitudinal axis and at least partially positioned outside of the housing. A roller is mounted on the housing and rotatable about an axis perpendicular to the longitudinal axis. A blade assembly is mounted on the roller and has a blade, wherein the blade is movable from a retracted position to an extended position and to a final position, at the retracted position the blade is positioned in the cavity, at the extended position the blade extends at least partially beyond the proximal end of the housing, and at the final position the blade is positioned in the cavity.

Abstract: A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue. The tissue penetration element is disposed in proximity to the tissue of the patient. A lancing cycle is initiated. The lancing cycle advances the tip into the tissue during a penetration stroke and displaces the tissue penetration element proximally over a withdrawal stroke. Tissue data is acquired based on an interaction between the tissue penetration element and the tissue during at least a portion of the lancing cycle.

Abstract: A moving coil tissue penetration device includes a magnetic source that produces a magnetic field in a magnetically active region. A cylindrical coil is secured to a translation substrate and disposed at least partially within the magnetically active region. A sharpened member is configured to penetrate tissue and mechanically coupled to the translation substrate.

Abstract: A lancet has a generally tubular body (1). A hollow insert (4) with a closed end plugs one end of the body (1), and it has a co-axial projection (5) forming a sharp tip proud of that end of the body. The body (1) and insert (4) are simultaneously formed by twin shot moulding, the body being of polyethylene and the insert being of a liquid crystal polymer which will create a sharp tip of adequate strength.

Abstract: A system is provided that controls movement of a lancet. One or more processors execute program instructions and receive a data set. The program instructions are executed to cause the processor to, cause force to be applied to the lancet to thereby cause the lancet to move in a first direction toward a target, monitor position and speed of the lancet as the lancet moves in the first direction, adjust the application of force to the lancet as the lancet moves in the first direction to achieve a desired speed of the lancet, and adjust the application of force to the lancet when the lancet contacts the target so that the lancet penetrates the target within a desired range of speed.

Abstract: A system for detecting abnormal tissue in a patient including an introducer cannula having a proximal opening and a distal opening. The system further includes a surgical instrument configured for selective insertion through the cannula. The surgical instrument further includes a tissue cutting opening positioned relative to the distal end of the introducer cannula when fully inserted through the introducer cannula. The system also includes a sensor configured to detect at least one property of the tissue of the patient. The sensor is located at a fixed distance relative to the distal end of the introducer cannula when the surgical instrument is inserted into the introducer cannula.

Abstract: A lancet belt has a first belt tape with a longitudinal axis and an adhesion material disposed on an adhesion side of the tape. A second belt tape has a longitudinal axis disposed on the adhesion side of the first tape with the longitudinal axes of the first belt tape and the second belt tape being substantially parallel. A plurality of lancets are disposed between the first belt tape and the second belt tape. Longitudinal axes of the lancets are substantially orthogonal to the longitudinal axes of the first and second belt tapes.

Abstract: A moving coil tissue penetration device includes a magnetic source that produces a magnetic field in a magnetically active region. A cylindrical coil is secured to a translation substrate and disposed at least partially within the magnetically active region. A sharpened member is configured to penetrate tissue and mechanically coupled to the translation substrate.

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 the penetrating member is uncovered during launch of the penetrating member by the penetrating member driver. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Abstract: A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

Abstract: 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 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 pedicle access device that has particular application for positioning a pedicle screw during a minimally invasive spinal fusion surgical procedure. The pedicle access device includes a positioning needle having a hollow tube and a specially designed tip that conforms with a facet complex of a vertebra proximate a pedicle. A targeting needle having a pointed end is inserted through the hollow tube of the positioning needle, and is secured thereto so the tip of the targeting needle extends out of the end of the positioning needle. The tip of the targeting needle allows the positioning needle to be accurately positioned on the pedicle, and the specially configured tip of the positioning needle allows it to be secured thereto without slipping.

Abstract: Lancing devices are disclosed having a carriage slidably disposed within the housing and a lancet carrier configured to directly receive and hold the lancet. The lancet carrier is engaged within the carriage and movable relative to and independently of the carriage between a forward incision position and a rearward cocked position. A trigger assembly has a user accessible first portion and a second portion attached to the carriage and movable with the carriage along the longitudinal axis. The second portion is configured to maintain the lancet carrier in the rearward cocked position and the first portion is configured to release the lancet carrier from the rearward cocked position.

Abstract: A lancet, a lancing device, a method of loading a lancet into a lancing device, and methods of manufacturing and utilization thereof are disclosed. The lancet may have a needle, a body attached to the base of the needle, arm members attached to the body, and a tip cover attached to the arm members and slidably attached to the needle, wherein at least one of the tip cover and the body is selectively moveable between an operative configuration and a protective configuration. The lancing device may have a lancet holder having surfaces which retain the lancet. The method of loading a lancet may involve providing the lancet in a protective configuration and inserting the lancet into a lancet holder of the lancing device, such that the tip cover or the body is selectively moveable between an operative configuration and a protective configuration.

Abstract: The invention relates to a lancet having a flat shaft (1) which has an upper side (1c) and a lower side (1b), the shaft (1) forming at a front end (2) a cutter (1a) which ends in a point (2), the cutter (1a) having on the underside (1b) two cutting edges (4), which run together at the point (2), and the shaft (1) having at least one depression (3) on its underside (1b) to receive a sample. The invention provides for the shaft, on its upper side (1c), to merge into the cutter (1a) at two edges (5) which run together at a vertex (6), and for the upper side (1c) of the cutter (1a) between the vertex (6) and the front end (2) to be curved convexly, as seen in cross section.

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

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