Abstract: A system for analyzing a bodily fluid is described, which contains at least one lancing element, such as a lancet, stored in a first magazine, and at least one test element with a detection area, stored in a second magazine, the detection area containing reagents if necessary for use in detecting the analyte. The system also includes a housing, which encloses at least part of the first magazine and the second magazine and includes an opening for placement of a body part. At least one of the lancing elements and at least one of the test elements are located below the opening, and one of the magazines is located at least partly between the opening and the other magazine. The two magazines may at least partially overlap. The lancing element and the test element may be moved toward the opening so the body part resting on the opening can be lanced with the lancing element and the emerging bodily fluid can be collected using the test element at the same opening.

Abstract: The invention relates to a puncturing system with 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), a puncturing drive mechanism (7) with which lancets (2) located in the position of use are accelerated in order to puncture the skin. According to the invention, 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 puncture device is constituted such that a plunger (2) is provided with a lever (3) which is partially restricted in rotation, and a forward urging force is obtained by a contraction restorative force of a tension spring (4), and the tension spring (4) is again expanded with the lever (3) as a leverage when the plunger (2) further moves forward due to its inertia from a position where no urging force is not applied, and the plunger (2) is urged backward by a restorative force of the re-expansion. Further, a puncture needle cartridge is provided with a lancet body (203) having a puncture needle, and a puncture needle holder (201) in which the lancet body (203) is movably stored, and further, the lancet body (203) has an arm means (302) and the puncture needle holder (201) contains a to-be-latched means (303) that cooperates with the arm means (302).

Abstract: A puncturing device for generating a puncture wound to sample a body fluid is provided and comprises a press-on part or contact element to be pressed against a body part to generate a puncture, a test sensor for measuring a test parameter value, and an analytical unit for determining whether the value of the measured test parameter satisfies a predefined minimum requirement for successful sampling. In one embodiment, the value of the test parameter is monitored during a waiting period by the test sensor once the value satisfies the predefined minimum requirement. After the waiting period has elapsed, so long as the values of the test parameter monitored during the waiting period are in a range of values that predicts sampling to be successful, the analytical unit initiates a puncture.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Abstract: A body fluid testing device includes a test strip, an incision forming member, and a housing. The test strip includes an expression surface. In addition, the test strip is attached to the housing to form a cavity, and the cavity slidably receives the incision forming member. The body fluid testing device is positioned over the incision site where the incision forming member makes an incision. The user presses the expression surface against the skin to express body fluid. The cavity collects body fluid via capillary action, and the test strip analyzes the body fluid.

Abstract: Embodiments of a needle insertion system and method are disclosed. One method embodiment includes transmitting a sound beam along an axis to contact a blood vessel; receiving the reflected sound beam from the blood vessel; processing the reflected sound beam to detect the location of the blood vessel; and, responsive to the detection, receiving a needle in a guideway that is oriented parallel to the axis.

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

Abstract: A lancing device according to the present invention includes: a housing; a moving body movable relatively to the housing for forward movement of a needle; a driving mechanism for forward movement of the moving body; a hollow pressing portion at a front end of the housing for contact with a part where a puncture is to be made; and a pump mechanism capable of causing a vacuum to act inside the pressing portion. The pump mechanism is capable of adjusting the vacuum. The pump mechanism includes for example: a moving portion capable of reciprocating in a first direction and a second direction away from the first direction. Preferably, the adjustment of the vacuum is made by changing the number of reciprocations of the moving part in the first and the second directions.

Abstract: A return spring arrangement for a lancet (6) is provided by a pair of undulating plastic webs (14) formed integrally with the lancet. The undulations of the two webs (14) are shown out of phase with one another. These webs (14) are flexible and thus are caused to concertina when the tips (15) of the webs hit the interior of a lancet holder on release of a drive spring. The energy stored within the collapsed webs (14) is then released to drive the lancet back within the lancet holder. This positive return of the lancet ensures that a needle (5) will retract safely into the lancet holder, after operation, and does not rely on the spring being locked into the lancet holder and onto the lancet.

Abstract: A method and apparatus for obtaining a sample of blood. An embodiment consists of an apparatus which integrates lancing, 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.

Abstract: A pricking device having an accurate pricking function, an automatic safe post-use discarding function and a re-use inhibiting function is disclosed. The pricking device is easy and simple to operate, simple in structure and is high in productivity to reduce production costs. The pricking device is made up of a lancet unit and a housing unit. The lancet unit includes a needle. The lancet unit is formed by a unit body member, a restoration member and a resilient piece for lock molded as one with one another. The unit body member operates to cause the needle to pop out from the housing unit in connection with a pricking operation. The restoration member controls the operation of movement of the unit body member as it stores a force of elasticity in it. After the pricking operation, the needle is returned into the inside of the housing unit under the so stored force of elasticity of the restoration member.

Abstract: A puncturing device includes a band-shaped lancet carrier carrying a plurality of lancets, a transport mechanism for positioning the lancets sequentially in a launch position by moving the band-shaped lancet carrier, a lancet drive for accelerating one of the lancets from the launch position for a puncturing movement, the lancet drive comprising an energy storage for providing energy for the acceleration of the lancet, a trigger element for triggering the lancet drive to release energy from the energy storage to accelerate the lancet for a puncturing movement, and a housing which comprises at least two housing parts and encloses the band-shaped lancet carrier and the lancet drive, the housing having an opening against which a body part is pressed for puncturing by the lancet positioned in the launch position, wherein the transport mechanism comprises at least one part which is arranged in a fixed position with respect to the housing.

Abstract: A device for receiving a body fluid for analysis, comprising a container and at least one sample-receiving unit which can be impinged upon by the body fluid at a receiving point and which can be extracted from a guide chamber of the container by means of a drive unit. According to the invention, a coupling device is provided in order to couple the sample receiving unit to the drive unit to ensure back and forth movement between the guide chamber and the receiving point.

Abstract: A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Abstract: The present invention provides a lancing device designed for minimizing pain to the user, comprising a probe with cam profile responsible for controlling the lancet speed such that the lancet enters the skin relatively fast, decelerates smoothly and gradually to zero velocity at maximum depth of penetration and retracts slowly and controllably. The housing of the lancet comprises of leaf springs and set of guides for minimizing or eliminating pitching or vibration of the lancet during lancing, hence reducing the pain experienced by the user. The lancing device is further equipped with a gear-damper system for minimizing or eliminating noise produced during lancing process.

Abstract: A puncturing system has a carrier tape carrying multiple lancets, a device housing comprising a conveying facility for moving the lancets into a usage position consecutively by moving the carrier tape in a conveying direction, a puncturing drive for accelerating one of the lancets that is positioned in the usage position in a puncturing motion, an opening in the device housing for touching against a body part in which a puncture is to be made by the puncturing motion of one of the lancets, an actuation facility for driving the conveying facility, and an unlockable interlock comprising a stop that blocks further transport of the carrier tape as soon as one of the lancets has reached the usage position.

Abstract: A trocar assembly including a low-profile retractable shield deployable adjacent to a cutting element with a cross-sectional area which is small relative to the total cross-section of the assembly.

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. Each tip of a penetrating member is uncovered during launch of the penetrating member by the penetrating member driver. A support is provided with a plurality of openings. Each opening receives a penetrating member.

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: A lancet assembly has a lancet body with a needle end, a sinuous portion end, and a slot, a lancet tip connected to the needle end, a sinuous portion connected to the sinuous portion end, an anchor structure connected to the sinuous portion. The lancet assembly may also include a lancet enclosure having an elongated chamber with a needle end, an anchor end in communication with the elongated chamber opposite the needle end, and a lancet enclosure slot in communication with the elongated chamber and spaced from the needle end. The anchor end is configured to receive and hold the anchor structure in a substantially static position. The elongated chamber is sized to receive in sliding engagement the lancet tip, the lancet body where the lancet body slot is in communication with the lancet enclosure slot and the sinuous portion and to permit slidable movement of the lancet tip through the open end between a retracted position and an extended position.

Abstract: A blood glucose measuring system includes a lancet assembly and a meter for use with the lancet assembly. The lancet assembly has a lancet member with a lance, a lancet body having a drive wing extending outwardly from a side, and a sinuous portion, and an elongated carrier having a lancet member recess to contain the lancet member. The elongated carrier has an open end, a closed end, a side elongated opening for receiving the drive wing therethrough, and an anchoring member operatively connected to the end of the sinuous portion. The meter includes a measuring circuit, a lancet trigger, and a lancet driver where the lancet driver includes a driver piston engageable with the lancet trigger and a charging member that operatively engages with the driver piston to move the driver piston into an armed position and to stop the driver piston when released from the armed position.

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: A lancing device for sampling blood or other body fluid of a subject includes a reusable housing and a disposable cassette. The cassette contains a plurality of lancets held in a storage plane. An active lancet is moved transversely from the storage plane into a firing plane, into engagement with a drive mechanism for actuation to lance the subject's skin. After actuation, the used lancet is returned to the storage plane. Each lancet includes a protective endcap that is removed from the lancet just prior to use and then is replaced onto the lancet after use.

Abstract: A tissue penetration device includes a penetrating member driver and a cartridge. A plurality of penetrating members are integrated with the cartridge. Each penetrating member is coupled to the penetrating member driver when advanced along a path into a tissue target. 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: A lancing device comprises a lancet drive to cause a lancet to effect a puncturing movement, a housing that encloses the lancet drive, and a touching element with an opening for applying a part of a body in which a prick wound is to be produced, the touching element being movable relative to the lancet drive for the purpose of adjusting the puncturing depth in a puncturing direction. The touching element is connected rotatably by means of a screw thread to an intermediate piece and is movable in the puncturing direction, while the intermediate piece is rotatable and movable relative to the housing. A guide prevents rotation of the touching element relative to the housing, and the touching element is enclosed by the intermediate piece at least over part of its length.

Abstract: A lancing system comprising a lancet with a handle portion to and a needle bearing portion, the needle bearing portion retaining a thin needle protected by a safety cap. The safety cap includes first and second chambers, where the first chamber acts as a sheath and the second chamber having a surface positioned to compromise the structure of the needle when the needle bearing portion of the lancet body is inserted into the second chamber.

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 return spring arrangement for a lancet (6) is provided by a pair of undulating plastic webs (14) formed integrally with the lancet. The undulations of the two webs (14) are shown out of phase with one another. These webs (14) are flexible and thus are caused to concertina when the tips (15) of the webs hit the interior of a lancet holder on release of a drive spring. The energy stored within the collapsed webs (14) is then released to drive the lancet back within the lancet holder. This positive return of the lancet ensures that a needle (5) will retract safely into the lancet holder, after operation, and does not rely on the spring being locked into the lancet holder and onto the lancet.

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

Abstract: A lancet integrated test element (LIT) includes an incision forming member that has a cutting end configured to form an incision in tissue. A test element is attached to the incision forming member to test fluid from the incision. The test element has a sampling end with a sample opening through which the fluid is collected. The test element is bendable from a first state where the cutting end of the incision forming member is retracted from the sampling end of the test element to a second state where at least a portion of the cutting extends past the sampling end of the test element to form the incision in the tissue.

Abstract: A device for use in penetrating tissue to obtain a body fluid sample is provided. A cartridge may be included. A plurality of penetrating members are slidably coupled to the cartridge. Each penetrating member has a distal end that is sufficiently sharp to pierce tissue. Each penetrating member may be moveable relative to the other ones of the penetrating members so that the sharpened distal ends extend radially outward to penetrate tissue. The penetrating members are elongate members without molded attachments.

Abstract: A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Abstract: A lancet having a slider with a puncture needle holding mechanism at one end thereof, and having a cam ring with a continuous cam groove, rotatable about a support shaft, and with a cam ring claw and an anti-return claw restricting the rotation. The lancet also having a ring spring applying a force to rotate the cam ring, having a rotatable stopper arm holding and releasing the rotation of the cam ring, and having a rotatable ratchet restricting the direction of rotation of the cam ring. A puncture needle unit including a puncture needle body integrally molded with a protrusion fitted to the lancet, a rotation stop rib, a puncture needle, and a puncture needle cap lightly pressed into the puncture needle body.

Abstract: Blood samples can be collected without substantial contamination from ambient air, such that the blood sample may be analyzed accurately for gaseous components such as oxygen and carbon dioxide. An embodiment of the device has integrated actuation, lancing, and sample acquisition components, which in some embodiments are miniatuized and/or disposable.

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: This invention relates to a blood lancet device that is used to collect a small quantity of blood from a human body. More specifically, it relates to a blood lancet device that: can control the depth of the lancet needle's penetration of the skin; can push the lancet to eject; can accurately collect blood by ensuring linear motion; and can reduce the pain involved in blood collection.

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: A lancing device comprising a movable parallelogram-shaped rack. The rack rotates a linearly fixed pinion which drives a slider-crank system. The slider-crank system in turn drives a lance holder. The parallelogram-shaped rack defines one or more predetermined paths along which the pinion moves. The lance holder is prevented from being extended beyond a predetermined depth when the pinion reaches a predetermined position along the one or more predetermined paths. The pinion is mechanically stopped from further progress by intersecting two legs of the parallelogram-shaped rack. Teeth of the rack may be modified to reduce the change the pinion may jam in the rack.

Abstract: Blood samples can be collected without substantial contamination from ambient air, such that the blood sample may be analyzed accurately for gaseous components such as oxygen and carbon dioxide. An embodiment of the device has integrated actuation, lancing, and sample acquisition components, which in some embodiments are miniaturized and/or disposable.

Abstract: A self-powered lancing drive system and lancing technique uses permanent magnets to initially store the potential energy that is converted to kinetic energy for extending a lancet during lancing. This self-powered lancing drive system is a pure permanent magnet drive that is highly reliable under numerous operating conditions. Permanent magnets can produce stronger magnetic fields at smaller sizes as compared to electromagnets. In one form, the lancing system has a drive permanent magnet that is kept fixed or stationary while the lancet magnet travels along the firing path. With the drive magnet being stationary, the lancet experiences fewer fluctuations in the magnetic field. The lancet vibrates less and is driven straighter into the tissue. In another form, a retraction magnet is positioned at the end of the firing path of the lancet, near the tissue, to enhance retraction of the lancet.

Abstract: A lancet depth adjustment assembly structured to be used use with a lancet device of the type including a lancet disposed movably within a housing so as to pass into a piercing orientation wherein a piercing tip of the lancet protrudes from a piercing aperture defined in the housing. The lancet depth adjustment assembly includes a depth adjustment element movably secured in overlying relation to the piercing aperture of the housing and having a piercing access including one or more openings structured to permit passage of the piercing tip of the lancet therethrough. The depth adjustment element is structured to be interposed between a finger of a patient and the piercing aperture so as to define a spacing therebetween, and accordingly define a depth to which the piercing tip, which protrudes a defined amount from the housing, penetrates the body part.

Abstract: A lancing device has a carousel of lancets removably received in a housing. In exemplary embodiments, the lancing device includes a sterility cap positioning mechanism that removes sterility caps from the lancets for actuation and afterwards replaces the sterility caps onto the lancets. Preferably, the lancing device includes a lancet advancing mechanism that automatically advances sequential lancets of the lancet carousel for charging and actuating, and a drive mechanism for actuating the lancets. Also provided are replacement lancet carousels, which include a cylindrical carrier with axial openings and a plurality of the lancets axially oriented in the openings.

Abstract: Lancing system for extracting a body fluid from the skin of a human or animal comprising a needle element (3) for lancing the skin, a lancing device (2) which includes a lancet drive (15a), by which a lancing movement of the needle element (3) coupled with the lancet drive by means of a coupling mechanism (28) is driven in lancing direction, wherein the lancing device (2) comprises a housing (4) with a housing opening (5) at its in lancing direction front end and the housing opening (5) is surrounded by a housing skin contact surface (7) which is pressed against the skin when using the lancing device (2), the needle element (3) is moved on a predetermined lancing path in a lancing direction in a forward phase of the lancing movement until its tip (3c) enters the skin in order to create a wound and in a return phase of the lancing movement following the reaching of a reversal point corresponding to the lancing depth (S) in the skin is retracted again, a lancing depth reference element (8) with a reference 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 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: Devices and methods of delivering therapeutic agents to tissue are provided, which provide reduced outflow of therapeutic agents from an injection site. The methods include delivering one or more clot-promoting substances, such as platelets, fibrin and/or thrombin, to the injection site to entrap the therapeutic agent in the injection site. Devices include devices that are suitable for use in the provided methods.

Abstract: The invention relates to a medical aid which comprises a lancet (2) with a proximal end (5) and a distal end, the lancet (2) having a lancet body (4) and, at the proximal end (5), a lancet tip (3). The lancet (2) is at least partially enclosed by a packaging that comprises at least one flexible film section (7, 8) having a distal end (12), a proximal end (16), a first lateral edge and a second lateral edge. The lancet (2), at least partially enclosed by the packaging, is arranged displaceably between an upper protective section (9) and a lower protective section (10). The at least one flexible film section (7, 8) is detachably connected, along at least one segment of its first and second lateral edges, to an additional flexible film section (7, 8) or to one of the protective sections (9, 10).

Abstract: Disclosed is an adjustable tip for a blood lancet device that is adjustable between several distances for varying the depth of skin puncture by a lancet needle. The adjustable tip includes a sleeve having a helical groove with spaced depressions and an end cap placed over and attached to the sleeve. The end cap includes a lug that fits with the helical groove of the sleeve to secure the end cap to the sleeve.

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.