A sample collection and testing device for analyzing blood is provided that includes a controller, a fluid flow pathway, a pump configured to move fluid through the fluid pathway, and an optical fluid measurement element configured to measure a light intensity of the fluid in the fluid flow pathway. The controller is configured to: start the pump to move a blood sample in the fluid flow pathway, receive a signal from the optical fluid measurement element indicating a detection of a leading edge of the blood in the fluid flow pathway, stop the pump to stop the moving of the blood in the pathway, receive a plurality of light intensity measurements from the optical measurement element, each light intensity measurement measured at a corresponding point of time, and provide a mapping of the light intensity measurements into an indication of a coagulation of the blood sample over a time period.

An arrangement for producing a sample of body fluid from an opening created in a skin surface at a sampling site including a cartridge with a plurality of compartments and a plurality of sampling sites, and a detector assembly. Each sampling site includes a skin-penetration member having a first end configured to pierce the surface of the skin and an inner lumen in communication with the first end, a spring actuator operatively associated with the skin-penetration member, and a needle hub connecting the skin-penetration member and the spring actuator. The needle hub includes a reagent pad and the spring actuator is configured to drive the skin-penetration member to form the wound opening. Each compartment at least partially encloses the skin-penetration member, the spring actuator, and the needle hub of a respective sampling site.

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.

A test cartridge includes an adjustable lancet. The adjustable lancet is controlled by a controller. The adjustable lancet automatically detects a subject's finger, adjusts the lancet's height, pricks the finger to draw blood, moves a tube to collect the blood, moves the tube away from the finger, and empties the blood from the tube into a vial or receptacle. The adjustable lancet may include safety features to prevent the lancet to trigger when the subject's fingernail is facing the lancet, to control the amount that the lancet pierces the subject's finger, and/or to prevent the reuse of a test cartridge for multiple persons or multiple times by the same person. The adjustable lancet may include a massager wheel and/or a pressure bar to rub the subject's finger after the finger is pierced to facilitate drawing of the blood from the finger.

A device for collecting a blood sample is provided. The device includes a collection unit, at least one capillary tube, a vacuum connector, and a storage unit. The collection unit has a top window for receiving the blood sample, a top surface, and a channel communicated with the top window. The at least one capillary tube is disposed in the collection unit and has a top end adjacent to the top window of the collection unit. The vacuum connector extends from the collection unit and communicates with the channel to provide a negative pressure by removing air in the channel. The storage unit is disposed under the collection unit for storing the blood sample.

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed. In some cases, the device itself may be shipped or analyzed. For example, in some embodiments, a portion of the device may be sealed such that the substrate is contained within an airtight portion of the device, optionally containing desiccant. Other aspects are generally directed at other devices for receiving blood (or other bodily fluids), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

A sample handling device includes a reservoir for holding a fluid medium. A channel system used in connection with the reservoir includes a dilution portion for a sample to be analyzed with a measurement device. The sample is arranged to be transferred from the dilution portion to the measurement device by the fluid medium. A set of capillary channels in the dilution portion is arranged to be filled by capillary action to collect an established quantity of the sample to be diluted by the fluid medium. A pump transfers the fluid medium from the reservoir to the channel system. The pump includes at least one plunger, a seal separating the reservoir and the channel system and a delivery system of potential energy including a compressible element configured to provide repeatable transfer of the fluid medium from the reservoir to the channel system.

Devices are provided to automatically access blood from beneath or within skin. These devices include an injector configured to drive a needle into the skin and subsequently to retract the needle from the skin. These devices additionally include a seal to which suction is applied. To drive the needle into the skin, the needle is first driven through the seal, creating at least one hole in the seal. The suction applied to the seal acts to draw blood from the puncture formed in the skin by the needle, through the at least one hole in the seal, and to a sensor, blood storage element, or other payload. These devices can be wearable and configured to automatically access blood from skin, for example, to access blood from the skin at one or more points in time while a wearer of a device is sleeping.

A vacuum assisted lancing system for blood extraction can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state, and an opening for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system can include structure for selectively commencing dissipation of the vacuum and a fixed or adjustable depth controller. A method of manipulating a surface for blood extraction can include coupling the lancing system to the surface, blocking the opening, creating a vacuum, moving the lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum by unblocking the opening.

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.