Abstract: Apparatuses, methods, and systems are disclosed for accelerated ergonomic collection of capillary blood. An apparatus and system include a blood collection module with a proximal portion including a vacuum generation chamber, a distal portion including a blood collection chamber, a concave mid portion including a pressure equalization channel configured to equalize reduced air pressure. The apparatus further includes a sealing surface to stably seal the blood collection module to the skin around a collection site and a slide latch actuated by a lengthwise sliding motion. Also included is a lancet carrier with linearly-arranged lancet strips to puncture rows of blood extraction slits in the collection site. The apparatus also includes an angled transfer port with a low-resistance non-microfluidic blood flow channel to a transfer module, then to a plasma separation module with a multilayer laminate and plasma separation membrane. Methods for accelerated ergonomic collection of capillary blood are disclosed.

Abstract: The present disclosure relates to a blood collection device, including: a shell; a blade seat, arranged in the shell; an elastic component for providing an elastic force for pivoting the blade seat; a triggering portion, including an operating end and an abutting end, wherein the triggering portion has a first position and a second position for pivoting, the operating end extends to the outside of the shell, the abutting end is located in the shell, based on the operation of the operating end, the triggering portion is suitable for pivoting from the first position that prevents the blade seat from pivoting to the second position that allows the blade seat to pivot based on the elastic force of the elastic component, wherein: a cooperation column is arranged in the shell and is located at the upper side of the triggering portion spaced from the triggering portion; and an elastic arm is connected to the upper side of the triggering portion, the end part of the elastic arm includes a blocking portion, the end pa

Abstract: Apparatuses, systems, and methods for sternal locators for placement of an intraosseous device into the sternum of a human patient.

Abstract: Methods and Devices to monitor the level of at least one analyte are provided.

Abstract: Devices and methods for withdrawing bodily fluid from a subject are disclosed herein. In some embodiments, a handheld device can include a housing having an opening, a skin-piercing assembly, and an actuator coupled to the skin-piercing assembly. The skin-piercing assembly can include a casing, a drive member pivotably mounted within the casing and carrying a blade, and a biasing member coupling the drive member to the casing. The actuator can be movable relative to the housing from a first position to a second position. In the first position, the drive member can engage the casing to maintain the biasing member in a biased configuration. Movement of the actuator from the first position to the second position can disengage the drive member from the casing to permit the biasing member to drive the blade at least partially through and/or across the opening in the base.

Abstract: A developer cartridge may include: a first gear having a small-diameter gear portion and a large-diameter gear portion; and a second gear including: a first columnar portion centered on a second axis; a second columnar portion having a smaller diameter than the first columnar portion; a first engagement portion extending along a portion of a peripheral surface of the first columnar portion and engageable with the small-diameter gear portion; a second engagement portion extending along a portion of a peripheral surface of the second columnar portion and positioned closer to a housing than the first engagement portion in an axial direction and engageable with the large-diameter gear portion; and a protruding portion protruding in the axial direction and rotatable together with the first engagement portion and the second engagement portion. The second engagement portion may engage the large-diameter gear portion after the first engagement portion engages the small-diameter gear portion.

Abstract: A lancing device including a latch that pivots between a non-blocking position allowing a lancet carrier and a lancet to advance and retract through a first forward and reverse lancing stroke and a blocking position preventing further/excess/secondary oscillation of the lancet carrier and lancet. The pivotal latch can pivot about an axis perpendicular (e.g., for an L-shaped latch) or parallel/coaxial (e.g., for a sleeve latch) to the advancement and retraction motion of the lancet carrier and lancet.

Abstract: A biopsy incision device (100) comprising a proximal side (101), to be arranged on a skin surface, and a distal side (102), said distal side (102) comprising a blade actuator (103) associated with at least one cutting blade (104), is provided. The blade actuator (103) and said at least one cutting blade (104) being suspended at a pivoting point (105) on said distal side (102), such that said blade actuator (103) and said at least one cutting blade (104) may pivot around a pivoting axis (A), such that said at least one cutting blade (104) may cut said skin surface.

Abstract: An impact biopsy device is disclosed. The impact biopsy device may be configured to displace various cutting elements, such as an outer tubular member and cutting element and a cannula to sever a tissue sample from a patient. The impact biopsy device may comprise an actuation system configured to transfer displacement or force to the cutting elements by the impact of an element on another element.

Abstract: Devices and methods for withdrawing bodily fluid from a patient are disclosed herein. A handheld device configured in accordance with the present technology can include a housing having an opening, a skin-piercing assembly located at least partially within the housing, and an actuator movable relative to the housing along a deployment direction. The skin-piercing assembly can include a skin-piercing feature and a biasing member. The biasing member can be coupled to the skin-piercing feature to bias the skin-piercing feature along the deployment direction. Movement of the actuator along the deployment direction to a predetermined position can increase a load on the biasing member to at least a partially loaded state. Movement of the actuator along the deployment direction beyond the predetermined position can release the load on the biasing member so that the biasing member actively drives the skin-piercing feature along the deployment direction.

Abstract: The present embodiments relate generally to systems and methods for measuring an analyte in a host. More particularly, the present embodiments provide sensor applicators and methods of use with pushbutton activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing, all in one smooth motion. Some embodiments contemplate engagement of the transmitter with the housing after release of the applicator.

Abstract: An intraosseous device, comprising a cannula through which life-saving fluids are transfusible into or out of bone marrow of a target bone when the cannula is penetrated into the target bone; a stylet which is engageable with the cannula; and means for causing penetration of the stylet and cannula, when mutually engaged, to a predefined depth ? within the target bone with respect to an outer surface of the target bone, the depth ? being irrespective of a thickness of tissue above the target bone.

Abstract: A skin pricking device includes a housing having an opening formed in a proximal end thereof; a spring mounted lancet including a needle within a casing having body and cap parts, interconnected by a separable coupling. The cap part has a cap projecting through the opening allow a user to grip and remove the cap. The device further includes a trigger for firing the lancet. Turning the cap part moves the entire lancet, engaging a trigger stop surface on the distal body part of the lancet with a trigger catch and further biasing the trigger to block the lancet. Further turning of the cap part over a second angle relative to the housing causes the cap part to move in a proximal direction by a further, second distance, thereby axially separating the cap part from the body part, whereby the cap part can then be removed from the device.

Abstract: In one aspect, the present disclosure relates to a method for harvesting biological tissue.

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 blood sampling device includes a housing and a lancet supporting a lancet needle or tip, the lancet and needle being urged or urgeable in a pricking direction. A trigger mechanism is moveable to a fire position for releasing the lancet to travel in the pricking direction. A removable safety cap initially covers the lancet needle. The lancet has an initial position in which movement of the trigger mechanism to its fire position is blocked and an intermediate position in which the trigger mechanism may be moved to its fire position. The intermediate position is obtainable only on removal of the safety cap.

Abstract: An apparatus and method for introducing portals into bone is described herein. An example apparatus for introducing portals into bone includes a handle, a base, and a driving member. The driving member can be made to project past the base by operating the handle. The base is detachable from the handle. The apparatus also includes a guide coupled at a first end to the handle and at a second end to the base. The base is detachably coupled to the guide. A base coupling detachably coupling the base to the guide includes an actuating member movable between a coupled configuration wherein the base is coupled to the guide and an uncoupled configuration wherein the base is released from the guide. The actuating member is arranged so that motion of the handle toward the base moves the actuating member from the coupled configuration to the uncoupled configuration.

Abstract: There is provided an injector having an improvement in a linear launching profile. The injector of the present invention is used for launching a lancet to provide a pricking. The injector of the present invention comprises a plunger capable of launching the lancet in a pricking direction, an injector housing which surrounds the plunger, and an injector cap capable of being attached and detached with respect to the injector housing. In particular, an inner face of the injector cap is provided with a rib, and the rib and the plunger moving for the pricking are capable of contacting with each other.

Abstract: A system and method for rapidly determining ambient temperature in a fluid-analyte meter. The meter includes a housing defining an interior space and an area for receiving a fluid sample. A processor and a first temperature sensor are disposed within the interior space of said the housing. A second temperature sensor is disposed on the housing. One or more processors are configured to determine a first temperature value from temperature data received from the first temperature sensor. The processor(s) are also configured to apply a variable current to a temperature-adjustment source such that the second temperature sensor is adjusted to a predetermined steady-state temperature value different from the first temperature value. The processor(s) are further configured to determine an ambient temperature of an exterior space of the housing based on the applied variable current, pre-determined steady-state temperature, and received first temperature values.

Abstract: A lancing device having a housing with a proximal end, a distal end and a longitudinal axis. The lancing device also has a lancet carrier translationally supported with respect to the housing. The lancet carrier has a proximal end and a distal end. The lancing device additionally has a charging mechanism and/or an ejection mechanism adapted to pivot into the lancing device for engaging portions of the lancet carrier to perform the same.

Abstract: The invention relates to a blocking mechanism for a skin incision device and to a method of controlling of a skin incision device by a blocking mechanism. The blocking mechanism comprises a blocking means and a trigger means, which by, respectively, a fixing means and a locating means are mounted in a housing of the cooperating incision device, and which are provided with an engaging means configured to cooperate mutually with each other so that an inadvertent firing of the blocking mechanism and an inadvertent actuation of the incision device prior to use of the device as well as a re-use of the device is not possible, and an indication of a state of use of the device by the blocking means and the trigger means is unambiguous.

Abstract: An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44,90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

Abstract: Reducing the volume or drag on skin or sharpness of the penetrating member entering the wound during the cutting process will reduce the pain associated with lancing, and result in less power desired for retraction of the penetrating member from the skin. A variety of other penetrating member configuration as shown in the application.

Abstract: It is an object of this disclosure to facilitate a series of puncture-related operations in a puncture instrument. In a main case of a puncture instrument, a main rod is provided. An injector rod is mounted to a main rod and includes a lancet holder on one end side. An actuating rod is mounted to the injector rod and has an engagement component on the other end side. A first biasing member biases the injector rod toward the first end side. A manipulation component is provided so as to be slidable in and out through an opening on the other end side of the main case. A locking member is axially supported rotatably by a portion of the main rod between the manipulation component and the injector rod. The locking member includes a first engaged part, a second engaged part and a second biasing member.

Abstract: A lancing device (121) substantially reduces wobble in a lancet (151) used to lance a site. The lancet (151) is removably received by a cartridge (161), which is movably received by the lancing device (121). The lancet (151) is movable between a first position in which a penetrating member (153) connected to the lancet (151) is unexposed and a second position in which the penetrating member is exposed outside of the lancing device (121) for lancing a site. A spring (171) is connected to the cartridge (161) to return the lancet (151) to the first position after the site is lanced.

Abstract: According to the invention a safety device for a pre-filled syringe comprises a substantially cylindrical and hollow support body and a hollow needle shield slideably arranged relative to the support body. The support body comprises at least one resilient arm and the hollow needle shield or a needle shield assembly comprises at least one curved actuation ramp. The curved actuation ramp protrudes in a lateral direction (L) perpendicular to a central axis (A) of the safety device. The curved actuation ramp comprises a first lateral dimension (L1) at a proximal end of the needle shield and a second lateral dimension (L2) exceeding the first lateral dimension (L1) at a distal end of the needle shield. The resilient arm engages the curved actuation ramp when the needle shield is slid relative to the support body.

Abstract: A tissue penetration device includes a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source. A magnetic member is disposed at least partially in the magnetically active region. A permanent magnet is disposed at a proximal end of the magnetically active region for zeroing the position of the magnetic member while the tissue penetration device is inactive.

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: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

Abstract: Methods and apparatus are provided for manufacturing an analyte detecting device. In one embodiment, the apparatus comprises a housing; a penetrating member driver; a cartridge containing a plurality of penetrating members; a display on the cartridge; a linear slider on the housing, the slider coupled to a rod; and the rod moving with the slider, the rod having at least one roller. The device uses the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.

Abstract: A tissue penetrating system has a housing member, a plurality of penetrating members positioned in the housing member and a plurality of sample chambers. Each sample chamber is associated with a penetrating member. A tissue stabilizing member has a tissue interface surface configured to be applied to a tissue surface and provide for spontaneous flow of blood for sample capture. The tissue stabilizing member is coupled to the housing.

Abstract: A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet along a path into the tissue site, and a manual switch for a user interface input.

Abstract: An automatic sensor inserter is disclosed for placing a transcutaneous sensor into the skin of a living body. According to aspects of the invention, characteristics of the insertion such as sensor insertion speed may be varied by a user. In some embodiments, insertion speed may be varied by changing an amount of drive spring compression. The amount of spring compression may be selected from a continuous range of settings and/or it may be selected from a finite number of discrete settings. Methods associated with the use of the automatic inserter are also covered.

Abstract: A lancing device includes: a cover section, a part of which is provided with an opening; a main body held on the cover section and configured to be movable in a predetermined direction from the opening relative to the cover section; a lancing unit which is launched in the predetermined direction; and an operating section configured to launch the lancing unit when the operating section is pushed by applying a force in the predetermined direction, wherein the lancing unit is launched when the force is applied to the operating section in the predetermined direction with regulating a movement of the main body in the predetermined direction, and the main body moves, instead of pushing the operating section, by applying the force in the predetermined direction without regulating the movement of the main body in the predetermined direction is disclosed.

Abstract: A blood analyzer device has a housing with a top section coupled to a bottom section, a driver and a plurality of penetrating members housed in a disposable positionable in the housing. A gripper engages each penetrating member. A manually actuated button advances the disposable to move penetrating members into launch positions. A power is source coupled to the driver. A display is at the housing.

Abstract: A medical puncturing device having a wicking element disposed on a portion of the medical puncturing device is disclosed. The wicking element allows a user to remove a first drop of blood upon puncturing the skin using the medical puncturing device. In this manner, a subsequent drop of blood can be used to test their blood to determine their blood glucose level for proper insulin dosing.

Abstract: An apparatus and method for introducing portals into bone is described herein. An example apparatus for introducing portals into bone includes a handle, a base, and a driving member. The driving member can be made to project past the base by operating the handle. The base is detachable from the handle. The apparatus also includes a guide coupled at a first end to the handle and at a second end to the base. The base is detachably coupled to the guide. A base coupling detachably coupling the base to the guide includes an actuating member movable between a coupled configuration wherein the base is coupled to the guide and an uncoupled configuration wherein the base is released from the guide. The actuating member is arranged so that motion of the handle toward the base moves the actuating member from the coupled configuration to the uncoupled configuration.

Abstract: Systems, devices, and methods for delivering an implant to the orbit. In some instances, the systems may include a delivery device having a tongue member and a handle. The delivery device may further include an ejector configured to deliver an implant from the tongue member. The delivery device may also include a piercing member configured to create an opening in tissue. The systems may further include a piercing member for creating an opening in tissue. In some instances, the piercing member may have a first blade member rotatably connected to a second blade member.

Abstract: Systems, devices, and methods are provided that enable the sensing of an analyte level within, e.g., the dermal layer of the skin of a subject. These systems, devices, and methods can utilize modalities that increase perfusion in an area local to a dermal sensor.

Abstract: A lancet-release mechanism is adapted to be incorporated into a lancing device. The lancing device is adapted to receive a lancet assembly therein. The lancing device is adapted to move the lancet assembly between a resting position, a cocking position, and a puncture position. The lancet-release mechanism comprises a lancet holder and a cantilever beam. The lancet holder forms a central aperture. The central aperture is adapted to receive the lancet assembly therein. The lancet holder further forms a plurality of protuberances thereon. The cantilever beam has a projection extending therefrom. The projection is adapted to engage the plurality of protuberances located on the lancet holder. The projection is adapted to separate the plurality of protuberances from each other so as to enlarge the central aperture.

Abstract: A test device and a rotation module thereof are provided. The rotation module includes a rotation body and a driving element. The rotation body includes a shaft, a position limiting element, a reciprocation element, and a rotation element. The shaft is pivoted in a housing. The position limiting element and the reciprocation element are telescoped on the shaft, respectively. The rotation element engages with the shaft and is located between the position limiting element and the reciprocation element. The driving element is slideably disposed in the housing and coupled to a groove of the reciprocation element. When the driving element moves back and forth, the driving element drives the reciprocation element to rotate back and forth relative to the position limiting element through the groove. The rotation element is pushed by the reciprocation element to rotate along a rotation direction relative to the position limiting element.

Abstract: The invention relates to analyte monitoring/drug delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The invention can optionally provide for calibration without intervention of the user and can also provide for semi-continuous monitoring for day and night time. The invention can provide up to four, or more, weeks of operation. The invention can provide for a device that is relatively small in size, and therefore unobtrusive. The invention can also provide for device with remote control and interactive electronics. The invention may be also used for the delivery of various pharmaceutical agents.

Abstract: An apparatus and method for introducing portals into bone is described herein. An example apparatus for introducing portals into bone includes a handle, a base, and a driving member. The driving member can be made to project past the base by operating the handle. The base is detachable from the handle. The apparatus also includes a guide coupled at a first end to the handle and at a second end to the base. The base is detachably coupled to the guide. A base coupling detachably coupling the base to the guide includes an actuating member movable between a coupled configuration wherein the base is coupled to the guide and an uncoupled configuration wherein the base is released from the guide. The actuating member is arranged so that motion of the handle toward the base moves the actuating member from the coupled configuration to the uncoupled configuration.

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 device, method and assembly for nicking skin is disclosed. The device includes a lumen is that is slideable over an introducer needle, and a blade at the end of the device. The device may include a shield for restricting advancement of the device during a skin nicking procedure. The device may also include a retractable blade or guard as a safety and nicking customization feature. A recess can also be shaped in the device for slideably attaching the device to an introducer needle hub.

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 lancing device having a drive mechanism whereby unidirectional motion of the drive mechanism drives a lancet along an advancing portion and a retraction portion of a lancing stroke. A rotationally mounted crank member or a translationally mounted shuttle of the drive mechanism operate upon an associated linkage and/or a cam path portion of the lancet carrier to drive the carrier along the lancing stroke. Spring biased members optionally drive the mechanism and/or limit its extent of travel.

Abstract: A system for determining an analyte in a body fluid includes a magazine comprising two partial magazines, one including chambers containing analysis elements having a sample contact zone and a reagent system containing a reagent, whose reaction with the body fluid results in a change of a variable, and another including chambers containing puncturing elements having a tip having a capillary channel, which forms a fluid connection between the tip and a sample transfer zone of the puncturing element. The system may also include an analysis instrument having a puncturing drive for driving a puncturing element on a movement path, a mounting for receiving the magazine such that one chamber of the magazine at a time is located in a functional position, in which a puncturing element in the chamber can be moved by the puncturing drive, and a measuring and evaluation apparatus for measuring the change of the variable.

Abstract: The invention relates to a piercing device for taking blood for medical analyses, comprising a base body, comprising at least one needle which is arranged therein and a tip which can be extended, comprising a needle holding element which encloses the needle at least in part and a drive unit for driving a movement of the needle together with the needle holding element with respect to the base body.

Abstract: Assembly for use on a device includes a member comprising a plurality of lancet needles arranged generally parallel to each other and one of a cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip and a cap comprising a plurality of openings which are each sized to allow one of the lancet needles to pass therethrough. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.