Abstract: A body fluid sampling system is provided for use on a tissue site. In one embodiment, the system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members.

Abstract: The present invention provides a lancet assembly which eliminates the need to remove a resin cover encapsulating a pricking element. Upon inserting a lancet structure into a lancet holder, a force which separates a lancet cover encapsulating the sharp tip portion of the pricking element from a lancet body is generated, and this force is allowed to act on the lancet cover and the lancet body to thereby expose, within the lancet holder, the sharp tip portion of the pricking element encapsulated by the lancet cover and to locate the opening of the lancet holder in front of the sharp tip portion of the pricking element.

Abstract: A device (302) for sampling and/or analyzing blood or other body fluid of a subject. A housing (306) contains a plurality of lancets (308) and optionally includes test elements (324) to take up a sample of blood, an evaluation system and a display. A complete system that can be handled as a single device, for example in the form of a wristwatch, includes a multiplicity of test elements (324) and lancets (308), which can be brought successively to a working position to perform multiple measurements. A cassette or carrier (320) includes multiple lancets (308) and/or test elements (324), for insertion into the device.

Abstract: A lancing member (2) is integrally provided with a cap (29) for covering a needle (21). Upon or after being attached to a holder (5) of a lancing device (A), the lancing member (2) is rotated relative to a cap (29) by a rotator (C). As a result, the boundary (28) between the cap (29) and the lancing member (2) is broken easily to expose the needle (21).

Abstract: An incision device capable of preventing inadvertent firing, and including a covered attached to the device. The incision device comprises a housing, and a lancet guide assembly having lancet guides and a lancet body. The lancet body further comprises a lancet blade. The lancet blade is covered by a removable protective cover having a stopper which prevents a trigger arm from being moved so as to fire the lancet blade.

Abstract: The present invention relates to an analyzing instrument (1A) which includes a capillary (31), a fluid feed port (20) for introducing a sample liquid to the capillary (31), and a fluid feed promoter (6) for promoting the introduction of the sample liquid into the feed port (20). The capillary (31) of the analyzer (1A) may be formed on a substrate (2) for example. The fluid feed promoter (6) may include at lease one of a water-absorbing layer having a higher water-absorbing capacity than the substrate (2) and an adhesive layer having a greater adhesion to the skin than the substrate (2).

Abstract: A lancet assembly is disclosed which eliminates the need for removing a resin cover that covers a pricking element. When a lancet structure is inserted into a lancet holder, a force is applied so as to separate a lancet cover, that encloses a distal end of a pricking element, from a lancet body so that the distal end of the pricking element which has been enclosed by the lancet cover is exposed in the lancet holder, and the opening of the lancet holder is positioned in front of the distal end of the pricking element. The lancet structure has a trigger which launches the pricking element of which the distal end is exposed, when the lancet structure is continually pushed into the lancet holder.

Abstract: Provided are a blood collecting puncture device having high safety which can hygienically maintain the inside of a magazine and prevent infection, and the magazine. A blood collecting puncture device (100) has a blood collecting puncture device body (101) removably incorporating a magazine (107) for housing lancets for puncturing human skin. The blood collecting puncture device body (101) has a first housing section (501) for housing not-yet-used lancets (303) and a second housing section (507) for housing used lancets to be disposed of. When a rotor (402) is rotated, individual lancets are sequentially conveyed on a one-by-one basis to a stock position (502), a puncture position (503), and a disposal position (504), and this causes a not-yet-used lancet to be housed in the first housing section (501) and also causes a used lancet to be housed in the second housing section (507), so that the lancets are separately housed in spaces isolated from each other.

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: An improved penetrating tissue system is provided that reduces pain when penetrating tissue by providing controlled depth and velocity of penetration, stimulation and pressure to the targeted tissue without breaching a sterile environment. The system has user interfaces, human interfaces and low volume sample chambers.

Abstract: The invention relates to a lancet wheel comprising multiple annularly positioned lancets (3), which have a lancet body (3b) that is made of metal and ends in a lancet tip (3a), and a carrier (5), to which the lancets (3) are connected via radially running webs (6), which allow raising of the lancets (3) into the usage position. According to the invention, it is provided that the lancets (3) are radially aligned, and the webs (6) have a plastic body, which predefine an intended bending point, around which the webs (6) are bent to raise the lancets (3). Furthermore, the invention relates to a method for producing a lancet wheel.

Abstract: A puncture device capable of preventing needle stick accidents and of reducing the burden on patients during operation. In this puncture device, a puncture needle cartridge comprises: a lancet body having a puncture needle at one end with the other end being to be held by a puncture instrument body; a protective cap; and a puncture needle holder engaged with the lancet body to rotate together with the lancet body about a rotation axis P. A mounting member rotates together with the puncture needle holder with a boss guided by a slit through being pressed by the puncture needle cartridge in a direction of mounting in a case, and is mounted in the case. The protective cap, formed integrally with the lancet body, is prevented from rotating by being grasped and is separated from the lancet body with the rotation of the mounting member.

Abstract: A lancet having a lancet body and a sharp lancing tip extending from the lancet body, the lancet body including at least one flexing engagement fin, which is resiliently deformable upon insertion into a receiver of a lancing device. The outer dimension of the lancet effectively self-adjusts to conform to a wide range of receiver inner dimensions, and as such, the lancet of the present invention enables universal application with a larger range of lancing devices than previously known lancets.

Abstract: Moveable tissue engaging members and methods of fabricating and using the same are provided.

Abstract: A body fluid sampling unit includes a puncture device including a needle having a sharp needle point and a drive mechanism for operating the needle to puncture a living body surface with the needle point, a tip including an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a test paper for detecting a predetermined component in the body fluid, and a tip body mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the test paper; and a case including a mechanism containing section for containing the puncture mechanism so that the needle point of the puncture mechanism can be moved by the drive means, and a sampling implement containing section for containing the body fluid sampling implement so that the tip can be taken out.

Abstract: A lancing device is provided for use with a removable lancet. The lancing device includes a housing and a lancet carrier slidably disposed within the housing and adapted to receive the lancet. A user-actuated ejection slide is mounted to the housing to eject the lancet from the lancet carrier. A locking member is pivotally mounted to the housing. As the ejection slide moves forward, it rotates the locking member to block forward movement of the lancet carrier during ejection. The locking member is configured so that substantially all of the force exerted on it by the lancet carrier is transmitted to the housing via the pivotal mounting.

Abstract: A sampling module includes a housing and a penetrating member positioned in the housing. An attachment device is coupled to the housing. The attachment device is tiltably attached to a tissue interface that permits the tissue interface surface to tilt. The tissue interface includes an opening for the penetrating member to pass there through.

Abstract: A method of controlling a penetrating member is provided. The method comprises providing a lancing device comprising a penetrating member driver having a position sensor and a processor that can determine the relative position and velocity of the penetrating member based on measuring relative position of the penetrating member with respect to time; providing a predetermined velocity control trajectory based on a model of the driver and a model of tissue to be contacted. In some embodiments, a feedforward control to maintain penetrating member velocity along said trajectory.

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 self contained disposable test unit for testing body fluid comprises a body member and a support member. The support member is moveable with respect to the body member between a first position and a second position. The support member includes a body part receiving surface for receiving a patient's body part. A lancet is carried by the body member and includes a lancet tip capable of piercing the skin of a patient to produce fluid flow. A test member is capable of interacting with body fluid to aid in the determination of information about body fluid components. A capillary member is capable of directing fluid flow to the test member. A pressure cup is capable of exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary, and a calibration member is provided for containing information for facilitating calibration of the test unit.

Abstract: A lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

Abstract: The present invention relates to a lancet device 2 which is attached to a puncture device and is used for piercing a target site, and which retains a lancet 4 having a puncture needle in an internal space 35 of a casing 3. The casing 3 has a visible region 36 through which a leading end of the lancet 4 is visually recognizable. The casing 3 comprises, for example, a main body 30 which has the internal space 35, and a cover 31 which covers a part of the internal space35. The visible region 36 has an opened part in the internals space 35 which is not covered by the cover 31 and is adjacent to the cover 31.

Abstract: In one embodiment of the present invention a lancet is provided that has a sharpened distal tip, a shaft portion and a proximal drive head. The proximal drive head has a transverse dimension that is substantially larger than a transverse dimension of the shaft portion adjacent to the proximal drive head.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: A lancet device for generating a puncture wound in a skin surface, comprising a housing, in which a lancet can be moved on a puncturing path, a lancet drive with a drive rotor that can be driven by a drive spring, a lancet coupling mechanism that transforms a rotational motion of the drive rotor into a puncturing and returning motion of the lancet during a working cycle of the lancet drive, a reference element that is mobile relative to the lancet and relative to the housing and is fixed in a defined position relative to the lancet drive during the puncturing and rests against the surface of the skin with a contact surface thereof such that a puncture wound with a reproducible puncturing depth is generated by the puncturing motion, and a reference element coupling mechanism that is coupled to the lancet drive in order to move the reference element. The invention further relates to a suitable lancet drive assembly for a lancet device of this type.

Abstract: The device is built of a housing (1), wherein a push button (3) is positioned, and the puncturing needle (5), wherein the push button (3) has arms (7, 8) to guide the push button (3) inside the housing (1), and a driving spring (11), one end of which is linked to the push button (3), and the other end drives the puncturing needle (5), and the puncturing needle (5) has breakable wings (17, 18), which rest against the breaking edge (19) of the housing (1). The device has moreover two return springs (13, 14), each of which is connected to one of the arms (7, 8) of the push button (3), and two side juts (15, 16), each of which is positioned between one of the return springs (13, 14) and the other end of the driving spring (11).

Abstract: A lancet device is configured for performing a puncture by mounting a lancet including a puncture needle to the tip of a puncture body holder. The lancet device has a simple configuration that makes it possible to strengthen the retaining force for retaining the lancet when the lancet is used. In the lancet device, an insertion portion of a puncture body that is inserted into a mounting portion of the puncture body holder is retained by means of the frictional force. A fastening member provided in a main body side makes contact with the outer peripheral portion of the mounting portion of the puncture body holder and inwardly fastens the mounting portion when the fastening member is moved in the puncture direction relative to the puncture body holder.

Abstract: A medical lancing device including a replaceable multi-lancet cartridge. The lancing device includes a drive mechanism, an activation mechanism, and an advancing mechanism. The advancing mechanism includes a linear-pull slide that is moved in and out to operate an indexing ratchet mechanism, a cam-guided charger mechanism, and a cam-guided lancet cap displacement mechanism. The indexing ratchet mechanism sequentially advances the lancets in the cartridge to an active position. The cam-guided charger mechanism charges the drive mechanism and separates the cap from the active lancet. And the cam-guided cap displacement mechanism moves the separated cap from the lancing stroke path of the active lancet. The activation mechanism then releases the charged active lancet to traverse the unobstructed lancing stroke path to pierce the subject's skin at a desired lancing site.

Abstract: The present invention provides a method and a device for piercing a body part and determining whether a sufficient volume of blood has been withdrawn. A lancing element is rapidly inserted into a body part in a forward phase and retracted quickly to a lesser puncturing depth. Subsequently, the lancing element is retracted slower than during the first retraction movement and the distance retracted during the second retraction is shorter than the first retraction movement. During the second retraction movement, body fluid is collected in a collection phase by a capillary structure of the lancing element. Contact between the lancing element and the body fluid is detected after the forward phase at the beginning and the end of a waiting period.

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

Abstract: This invention relates to a lancing apparatus (A1) used for inserting an insertion element (21) into a human skin (Sk) for sampling a body fluid. The lancing apparatus (A1) includes a housing (1) with a cylindrical portion (12) brought into contact with the skin (Sk), a negative pressure generator (6) that generates a negative pressure inside the cylindrical portion (12) to cause the skin (Sk) to swell upward, and a detector (5) that detects that the skin (Sk) has been raised to a predetermined height inside the cylindrical portion (12).

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 lancet for use with a lancing device, the lancet having a body with releasable engagement features for engagement with a cooperating portion of a lancing device, a sharp needle, and a removable endcap. A coupling portion of the lancet has a non-circular profile. The endcap includes a receptacle for covering the sharp lancet tip after use, and a sheath portion with relief openings to reduce bending of the needle during manufacture or during removal of the endcap.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Abstract: Systems, methods and devices are provided for invasive reduced-pain blood sampling and testing, the devices including, a horizontally-disposed finger support element configured to support the finger thereupon, a finger holding element adapted, in a closed position, to radially grip the finger on said support element near to a tip thereof and configured to force blood into said tip, a lancet housing element disposed vertically underneath the finger support element for piercing the finger tip with a lancet while said finger tip is gripped by said finger holding element and supported by said finger support element; and a test strip conveying element adapted to be received by the finger support element after retraction of the lancet housing element thereby bringing a test strip into direct contact with a predetermined volume of blood from said finger support element thereby effecting a blood test.

Abstract: A lancet device for puncturing the skin of mammals, in particular of a human, includes a punch element, a manipulator, and a bushing element for the internal, axially displaceable reception of the punch element. The punch element on its free end has a lancet, provided with a sharp tip, for intentionally entering the skin. The lancet, by means of a force acting in the axial direction on the free end of the bushing via the punch element can be made to enter the skin from the end of the bushing outward with a preadjustable momentum, and a blocking arrangement using an axially slidable sleeve inside the bushing is provided, which, once the lancet has entered the skin, prevents the possibility of a reentry by locking itself within the bushing.

Abstract: A microsampler puncturing system for collecting a body fluid from a body part is described, comprising a sample collection unit having a piercing element, and a puncturing instrument having a drive, by which a sample collection unit is movable on a movement path for piercing the piercing element into the skin of the body part and withdrawing it in a piercing and retraction movement, a setting device for setting the puncturing depth of the piercing wound to be generated, and a control device for controlling the piercing and retraction movement having the following sequentially executed movement phases: a forward phase, a retraction phase, and a collecting phase (S). The setting device is settable independently of the chronological mean <dr> of the defined residual puncturing depth (dr), with reference to the collecting phase.

Abstract: A lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

Abstract: A portable medical device for communication of medical data information has a medical device part that includes a first processor and first storage means, and means for executing one or more medical related functions, a communication device part comprising a second processor, second storage means, and communication means. The medical device part and the communication device part are connected allowing for exchange of data information according to a predetermined protocol. The exchange of communication may be under the control of the medical device part, but the functionalities of each device part otherwise is separated providing for easy interchangeability of the communication device part or the medical device part. Also disclosed is a method for communication of medical data information.

Abstract: Methods and apparatus are provided for closing incisions within biological tissue. In one embodiment, a device and method are provided for suturing biological tissue, such as, for example, an organ or blood vessel. The suturing apparatus is particularly well suited for suturing an incision made in an artery, such as the femoral artery, following a catheterization procedure. The device eliminates the need to apply pressure to a patient's thigh for an extended period of time, and eliminates many of the complications and costs associated with the creation of a thrombus patch. In addition, the device comprises an improved handle portion which enables the physician to quickly and easily apply suture. The handle portion is very reliable and easy to manipulate. The suturing may be used in combination with existing catheter sheath introducers.

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

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 body fluid collecting device is used by mounting a tip with a puncture needle and a front end opening at the front end portion thereof for allowing the puncture needle to pass therethrough. The device additionally includes a device body, having a contact part for fitting skin thereto, a tip mounting part having a storage space formed therein capable of storing the tip, a pump for depressurizing the inside of the storage space, and a movable means. The movable means is capable of moving the front end portion of the tip mounting part along a longitudinal direction of the puncture needle, and within a specified range, when the storage space is depressurized by the pump under a condition in which the tip is stored in the storage space, the skin is fitted to the contact part, and the front end opening is sealed.

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: An apparatus having a shaft that can sense the depth of penetration, for penetrating into an object (the substrate). The substrate being penetrated has impedance that varies according to the depth under a surface of the substrate. The shaft has a tip for penetration and has conductive ends near to the tip of the shaft. A change of impedance of material of the object between the conductive ends can be sensed to provide information on the depth of penetration. A processor can be provided external to the object being penetrated by the shaft to gather and process the impedance information to determine whether the desired depth has been achieved.

Abstract: A process for manufacturing packaged lancets, comprising the steps: 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 build a first and a second portion that overlap at least partly, sealing the at least one foil with a laser beam at least at the edges of the first and second portion of the overlapping parts.

Abstract: The present invention is generally directed towards the field of lancing aids in which disposable lancet systems are used. The lancet system according to the invention has a needle body which surrounds the needle tip in a lancet system in a protective manner and also comprises a protection against re-use of an ejected lancet system.

Abstract: A piercing device, a blood inspection device, and a piercing method that facilitate timing management for piercing. The piercing device has a housing (22), a laser emission device (26) being piercing means provided in the housing (22), a holding section (25) provided facing the laser emission device (26), negative pressure means (28) for applying negative pressure to a negative pressure chamber (28a) provided at the holding section (25), an electric circuit section (27) for controlling the negative pressure means (28), a first skin sensor (28b) for causing the laser emission device (26) to prepare for operation, and a timer (27k) for automatically outputting a preparation-for-piercing-is-ready signal based on an output from the first skin sensor (28b). Based on the output from the timer (27k), the laser emission device (26) being the piercing means emits a laser beam (26h) to perform piercing.

Abstract: A device for expressing blood from a wound site formed in dermal tissue is constructed, in one embodiment, in the shape of a cap which can be removably mounted onto a lancing instrument. The blood expression device includes an annular support member and a plurality of movable fingers integrally formed onto the support member in a spaced apart relationship, the free ends of the plurality of fingers together defining a generally circular opening. Each finger is adapted for pivotal displacement in such a manner that its free end projects into the circular opening. In use, the free ends of the plurality of fingers are disposed in contact against the dermal tissue immediately surrounding the wound site. As the device is urged downward onto the dermal tissue, the free ends of the plurality of fingers collapse inward and pinch into the dermal tissue so as to create a uniform ring of pressure around the wound site which, in turn, results in the expression of blood.

Abstract: A blood sampling device includes a lancet having a skin piercing member disposed at an end thereof. The lancet is slidable within and releasably engaged with an elongated lancet guide that remains stationary with use of the device. A shell is axially movable relative to the lancet guide between a rest position and an actuate position, with the lancet being spring loaded within the lancet guide by movement of the shell from the rest position to the actuate position.