Abstract: Sheathed cutting device. An exemplary device for discreetly piercing a skin of a patient can comprise a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, and a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, wherein the plunger is slidable into the proximal end of the body, causing the cutting member to extend from the distal end of the body.

Abstract: An apparatus comprises a housing, a testing member rotatably mounted in the housing, a lancet protruding from an edge of the testing member and having a piercing end, and a cover configured to cover at least the piercing end of the lancet and to be displaced from the piercing end of the lancet during actuation of the testing member.

Abstract: The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

Abstract: Provided is a safety lancet including a reload double prevention structure for preventing a sliding block having a lancet needle from being reloaded to obtain blood, thereby fundamentally preventing reuse of the safety lancet. In addition, the safety lancet guides the sliding block to be straightly discharged without shaking, thereby minimizing pain when the lancet needle is inserted into a skin. The safety lancet includes an outer case forming a space part therein, an inner case sliding along the space part of the outer case, and having a through hole in a front end thereof, and a sliding block coupled to the inner case to straightly move along an inner portion of the inner case, and elastically supported within the outer case by a coil spring, wherein the sliding block comprises a lancet needle having an end protruding from a front end thereof, and a pair of loading hooks on both sides of a rear end thereof to engage with engagement protrusions of the inner case.

Abstract: A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge.

Abstract: A device for sampling and/or analyzing blood or other body fluid of a subject. A housing contains a plurality of lancets and optionally includes test elements 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 and lancets, which can be brought successively to a working position to perform multiple measurements. A cassette or carrier includes multiple lancets and/or test elements, for insertion into the device.

Abstract: Lancet device including a first housing. A first guide wall is disposed within the first housing. The first guide wall includes an opening. A cap removably mounted to the first housing. A needle holding member for holding a lancet. At least a portion of the needle holding member being able to move within the opening. A first spring for biasing the needle holding member toward an extended position. The first spring surrounding a portion of the needle holding member and being disposed between the first guide wall and a shoulder of the needle holding member. A movable trigger having a first position and a second position. A movable second housing including a proximal end, a distal end and a second guide wall arranged at the proximal end. The second guide wall including an opening. A portion of the needle holding member being able to move within the opening of the second guide wall.

Abstract: A lancet carrier for an integrated lancet sensor assembly incorporating a lance cover includes an elongated body with a bottom, an open top, a body open end and a body closed end, a lancet-receiving recess with a recess bottom surface, the recess extending between the open end and the closed end, and a trough-forming member forming a trough with a trough open end in communication with the body open end, the trough-forming member longitudinally extending a predefined distance along the bottom from the body open end, the trough replacing a portion of the recess bottom surface at the body open end.

Abstract: The invention concerns a test device, in particular for blood sugar tests, comprising a lancing element which is provided with a lancing component for producing a skin puncture, and a protecting element shielding the lancing element at least in the area of the lancing component. According to the invention it is proposed that the lancing element has a collecting structure for collecting body fluid from the skin puncture and that the protecting element comprises a protecting foil to cover the collecting structure and a holding body for holding the protecting foil on the lancing element.

Abstract: A medical lancing device including a replaceable multi-lancet cartridge. The lancing device includes an advancing mechanism that advances lancets within the cartridge into an active position, separates a protective cap from the active lancet, and energize a drive mechanism of the lancing device. A cap displacement mechanism moves the separated cap out of the travel path of the active lancet. In a first example embodiment, the cap displacement mechanism includes a cantilevered spring arm that displaces the detached cap of the active lancet. In a second example embodiment, the cap displacement mechanism includes a spring-biased cam-driven plunger that displaces the detached cap of the active lancet. Then an activation mechanism releases the energized active lancet to traverse the unobstructed lancing stroke path to pierce the subject's skin at a desired lancing site.

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

Abstract: A method and apparatus for creating minimal skin incisions and soft tissue tunnels, particularly useful in the insertion of transverse or oblique screws through a bone and the holes in a locking nail embedded within the intra-medullary cavity of the said bone. A unique surgical tool, as described herein, is used in conjunction with the novel method herein described, wherein the surgical tool is used in conjunction with a targeting guide and targeting guide tunnel to create skin and soft-tissue tunnels that are precise, of minimal size, and minimally traumatic for the patient, and very quick and easy for the surgeon to create and to repair.

Abstract: The present invention provides an improved arterialized earlobe blood collection device, and an improved process for blood analysis. The device and the process of the invention can be used in many unsual and/or risky situations, including collecting arterialized blood in space missions under microgravity environment and within ambulances or the like. The process of the present invention enables easier and faster blood analysis, since the blood collector device of the invention is coupled with an analyzing apparatus so as no blood or needle manipulation is required.

Abstract: A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Abstract: The invention concerns a device for collecting body fluids which has at least one lancet comprising a lancet body with at least two tips of different lengths. The device is characterized in that it has a selection means with the aid of which only one tip is selected before the lancing. This selection means can have different functions and shapes. The selection means is used to select a tip from a plurality of lancet tips which have different lengths and make only this tip available for use in the lancing process. Since the various tips are attached to a lancet body, it is, for example, possible to use a bending element which bends one of the various tips out of the plane of the lancet body in order to provide only one lancet tip for use. This is especially preferable for lancet tips that are arranged linearly relative to one another.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: The invention relates to a lancing system, comprising test elements, lancing elements, test elements each assigned to a lancing element and a hand-held device comprising a holder, which during a puncture holds a lancing element and a test element assigned to it, a lancing drive, which during a puncture moves the holder out of a starting position into a piercing position and back into the starting position, a light-sensitive sensor for analyzing a body fluid sample taken up by a test element, and a light source for illuminating the test element. According to the invention, the sensor is disposed in a housing, the outside of which the holder touches in the starting position.

Abstract: A blood glucose sampling device is provided. The blood glucose sampling device includes a sensor cartridge having a plurality of blades oriented in a common direction of rotation about a central point. Each blade includes a test strip having a test region defined radially from the central point at a proximal end and a capillary aligned with a distal end of the test region and extending to an outer edge of the blade. Each blade also includes a cleaning element positioned adjacent to the test strip. A lancet is affixed to a lancet cartridge and aligned with the capillary formed in the test strip. A housing removably encloses the cartridges and includes an outer grip that surrounds a circumference of the housing and is shaped to fit between a thumb and finger. A test passage formed in the outer grip through which the test strip and lancet are positioned.

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: 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 body fluid sampling device is provided. A mesh may be used to guide blood or fluid to travel directly from the wound to an analyte detecting port on the cartridge. Thus the volume of blood or body fluid produced at the wound site irregardless of its droplet geometry can be reliable and substantially completely transported to the analyte detecting member for measurement.

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 lancet device for obtaining a blood sample from a finger or at an alternate site of a patient. The lancet device includes a body and a lancet, the lancet being movable between a retracted position in which the lancet tip is disposed within the body and an extended position in which the lancet tip extends beyond the body. The device is cocked by compressing a U-shaped spring steel accessible on opposite sides of the body, the U-shaped spring steel being coupled to the lancet. Once cocked, a pawl retains the U-shaped spring steel in a compressed state. The device is fired by contacting the patient where sampling is to occur with one end of an actuator, the opposite end of the actuator serving to release the pawl from the U-shaped spring steel.

Abstract: The present invention includes a system for withdrawing body fluids. The system includes a drive unit having a plunger which is moved from a resting position into a lancing position in order to carry out a lancing process and a lancing unit containing a lancet with a needle. The plunger and lancet are coupled together by a form fit in order to carry out a lancing process. The invention additionally concerns a method for temporarily extending a needle from a device for withdrawing body fluid as well as a lancing unit that can be attached to the drive unit.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Abstract: A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Abstract: 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: 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: 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 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: 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 soft tissue biopsy device is provided which allows for the recovery of a biopsy of tissue flat in shape, particularly suitable for lymph node biopsy. The device includes twin opposing primary blades preferably aligned in parallel planes, to cut the upper and lower surfaces of the biopsy. A detachment blade is provided to cut the side walls and distal ends of the biopsy. In a preferred embodiment, each primary blade has a sharpened tip set at an angle with a sharpened point to assist tissue penetration. The detachment blade, preferably has inwardly curving flexible sharpened tips at its distal end, and is attached to the handle at its proximal end by a slider such that when in a retracted position, the detachment blade is retracted from the tip of the twixt blades; and when in an advanced position, the tip of the detachment blade abuts the tip of the twin blades.

Abstract: A puncturing system includes a carrier tape carrying multiple lancets and having position marks, a device housing that comprises a conveying facility for positioning the lancets consecutively in a usage position by moving the carrier tape in a conveying direction and has a housing opening for touching against a body part in which a puncture is to be made by a puncturing motion of one of the lancets, a puncturing drive for accelerating one of the lancets that is positioned in the usage position for the puncturing motion, a storage medium on which distance values for the lancets are stored, the distance values depending on distances between the lancets of the carrier tape and position marks allocated to the respective lancets, a a sensor for detecting position marks in a detection position through which the position marks proceed upon a motion of the carrier tape that is effected by the conveying facility, and a control unit that is connected to the sensor for controlling the conveying facility, wherein, in ord

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: A medical lancing device including a clam-shell housing that holds a replaceable multi-lancet cartridge. A control mechanism includes a linear-pull slider that is moved in and out to operate various mechanisms of the device. An interlock mechanism includes at least one rib on the slider that engages at least one finger on the housing to lock the housing closed when the slider is in a retracted or only partially extended position. And the interlock mechanism includes at least one void on the slider that aligns with at least one finger on the housing to permit the housing to be opened when the slider is in a fully extended position.

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: 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 sampling device (20) having a housing (24) with a lancet cartridge (22) mounted therein. The lancets (26) of the lancet cartridge (22) are interconnected by a flexible web (28). The lancet cartridge (22) is not positively engaged within the housing (24) and can be easily removed. The housing (24) has an opening (42) with an adjacent flexible or compressible fin (60) for dampening the motion of the lancet (26). The lancet cartridge (22) has at least one lancet (26) with an endcap, and the housing has a cap-removal mechanism (74) for separating the endcap from the housing (24). Anti-tampering features prevent opening of the device when the lancet cartridge (22) is oriented with a lancet (26) in a firing position.

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

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

Abstract: A body fluid sampling system for use on a tissue site has a housing and a penetrating member driver at least partially within the housing. At least one disposable is within the housing. The disposable includes an analyte sensor in a sample chamber that is configured to receive body fluid from a wound in tissue created by a penetrating member. A penetrating member is associated with the sample chamber. Each penetrating member and its associated sample chamber have a combined occupied volume of no more than about 5.0 cm3.

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

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

Abstract: A drilling guide cannula, having a serrated distal end in the form of axially moveable teeth which enables all or most of the teeth to maintain biting contact with the bone surface, essentially independently of the curvature of the bone surface and the drilling angle. The cannula outer wall incorporates a number of pins arranged circumferentially around the drilling bore. These pins slide axially relative to the cannula, preferably in bored holes or in channels formed within the wall of the cannula. Each of the secondary pins has a sharpened distal end, each constituting a moveable tooth. The cannula is applied to the bone to be drilled at the desired drilling position and angle, and the pins are forced axially towards the bone surface. The pins take up the contour of the bone surface and each pin bites into the bone surface to rigidly position the drilling guide cannula.

Abstract: A medical lancing device including a replaceable multi-lancet cartridge. The lancing device includes an advancing mechanism that advances lancets within the cartridge into an active position, separates a protective cap from the active lancet, and energize a drive mechanism of the lancing device. A cap displacement mechanism moves the separated cap out of the travel path of the active lancet. In a first example embodiment, the cap displacement mechanism includes a cantilevered spring arm that displaces the detached cap of the active lancet. In a second example embodiment, the cap displacement mechanism includes a spring-biased cam-driven plunger that displaces the detached cap of the active lancet. Then an activation mechanism releases the energized active lancet to traverse the unobstructed lancing stroke path to pierce the subject's skin at a desired lancing site.

Abstract: A lancet device for obtaining a blood sample from a finger or at an alternate site of a patient. The lancet device includes a body and a lancet, the lancet being movable between a retracted position in which the lancet tip is disposed within the body and an extended position in which the lancet tip extends beyond the body. The device is cocked by compressing a U-shaped spring steel accessible on opposite sides of the body, the U-shaped spring steel being coupled to the lancet. Once cocked, a pawl retains the U-shaped spring steel in a compressed state. The device is fired by contacting the patient where sampling is to occur with one end of an actuator, the opposite end of the actuator serving to release the pawl from the U-shaped spring steel.