An improved diagnostic analyte monitoring device has partially retractable hollow guide needles for the intradermal placement of diagnostic elements fixedly connected to measuring means within this device obviating the need to remove the guide needle and to connect the diagnostic elements to measuring means after placement into the skin. A flexible surface adhering to the skin serves for the subcutaneous implantation of the diagnostic elements within the guide needles and partial retraction of the guide needles exposes the active surface to body fluid, actuated by means designed for easy handling and safe operation. Concentration-time profiles of endogenous and exogenous analytes measured with the device are used to improve drug treatment modalities on an individualized basis.

Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device.

A dermal patch for collecting a physiological sample includes a housing with a collection chamber, a sample channel and a pin within a receptacle of the housing. The sample channel is configured to direct a physiological sample drawn from a subject to the collection chamber. The pin is removably positioned within the receptacle and is configured to move from an undeployed position to a deployed position. The pin is configured to seal the receptacle when in the undeployed position and is further configured to facilitate generation of negative pressure in the sample channel when the pin is moved from the undeployed to the deployed position.

A lancing device with a depth-adjustment mechanism including an adjustably-positioned stop surface, a movable control member operably coupled thereto, and a resiliently deflectable leg that engages the stop surface and a lancet carrier to provide a soft stop for the lancet carrier. The lancet carrier deflects the leg in a forward phase of the lancing stroke, and then the leg contacts the stop surface to stop the forward motion of the lancet carrier at an extended lancing position. The stop surface can be adjustably positioned so that different portions thereof are engaged to stop the lancet carrier at deeper or shallower positions. In example embodiments, the depth-adjustment mechanism includes a rotary dial and an extension arm of the leg, with the dial including a rotary wheel and a rotary shaft extending axially therefrom, the wheel forming the movable adjustment member, and the shaft forming the adjustably positioned stop surface.

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

A single-use compression lancing device includes a bottom housing, a top housing, and a lancet. The lancet is generally configured for selective interengagement and guidance within the bottom and top housings. The top housing is configured for slidingly engaging the bottom housing such that manipulation of the top housing relative to the bottom housing causes a sharp tip portion of the lancet to protrude from an opening of the top housing. In one form, at least one arm extending from the lancet interengages a portion of the top housing such that the lancet is retracted within a portion of the bottom housing.

An improved disposable puncture depth adjustable safety lancet includes a shell, a lancet core, a spring and a trigger; wherein: the shell has an adjusting ring to adjust the puncture depth in the front end; the adjusting ring is sleeved clearance-fit at the outside of the trigger head; the adjusting ring and the shell are connected in a rotational way in the peripheral direction, and are connected in a fixed way in the axial direction, and a rotational locating structure is set between the adjusting ring and the shell in the rotation direction; the adjusting ring is equipped with the rotating step face or rotating bevel on the inner wall, and rotate the adjusting ring to be in the different locating positions and the rotating step face or rotating bevel meets the collision face of lancet core in the different axial positions, thereby changing the puncture depth of needle tip.

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.

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.

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.