Lancet assemblies for puncturing the skin and creating an incision. Upon activation, the disclosed assemblies are configured to move through a firing sequence in which a puncturing instrument extends through an aperture in the device and then is retracted back into a housing of the device and cannot be re-fired. The assemblies are designed so that the aperture in contact with the incision site does not move relative to the incision site during the firing sequence. Accordingly, the tolerance of the assembly is reduced and the reliability of the incisions created by the assembly, including the depth and width of such incisions, is increased.

A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

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.

A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

A blood sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer.

A blood separation and testing system for a blood sample is disclosed. The blood separation and testing system includes a blood sampling transfer device adapted to receive a blood sample, a blood separation device, and a blood testing device. The blood separation device is adapted to receive a portion of the blood sampling transfer device such that with the blood sampling transfer device received within the blood separation device and a rotational force applied to the blood sampling transfer device, a plasma portion of the blood sample is separated from a cellular portion of the blood sample. The blood testing device is adapted to receive a portion of the blood sampling transfer device to analyze the plasma portion of the blood sample and obtain test results.

The present invention generally relates to devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications, for example, devices for delivering and/or withdrawing fluid from subjects, e.g., through the skin. In some embodiments, the device includes a system for accessing an extractable medium from and/or through the skin of the subject at an access site, and a pressure regulator supported by a support structure, able to create a pressure differential across the skin at at least a portion of the access site. The device may also include, in some cases, a sensor supported by the support structure for determining at least one condition of the extractable medium from the subject, and optionally a signal generator supported by the support structure for generating a signal relating to the condition of the medium determined by the sensor.

A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

A microbiopsy device for taking biological samples, comprising a body including two or more cutting elements for cutting tissue to form a biological sample; and a chamber inside the body for receiving and retaining the biological sample, the chamber having an opening between the cutting elements, wherein the cutting elements are arranged to cut a section of tissue having a width of less than 1 mm.