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.

Devices systems and methods for fluid extraction and delivery to human or animal hosts are described. In embodiments, microneedles are employed to provide low infection risk and painless access to and administration of fluids. The disclosed embodiments address, among others, issues of cost, portability, ease of use in remote settings including use by untrained personnel, and others.

The present invention generally relates to systems and methods for delivering and/or withdrawing a substance or substances such as blood or interstitial fluid, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for withdrawing or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to withdraw blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be withdrawn from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. Other aspects of the present invention are directed at other devices for withdrawing blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

Systems and method are disclosed for determining a concentration of an analyte in a fluid (e.g., blood). The system can draw blood from a patient and deliver the blood to a sample cell. A particular component of the fluid (e.g., plasma) may be separated and/or positioned such that the concentration of the analyte is measured in the particular component of the fluid (e.g., plasma). The sample cell can include a sample container that has two window pieces. The system can have a fluid passage having a tip configured to mate with a multi-lumen catheter without leaking. The multi-lumen catheter can have proximal and distal ports. A fluid pressure system can be configured to periodically draw fluid from vasculature through a proximal intravascular opening and the proximal port while maintaining a low pressure and/or flow rate to thereby reduce risk of reversing the fluid flow in a vessel and drawing infusates upstream into another intravascular opening.

An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

In some embodiments, the present invention generally relates to the separation of blood within a device to form plasma or serum. In some embodiments, the present invention generally relates to the removal of fluids, such as blood, contained within a device. In one aspect, the present invention is generally directed to systems and methods for receiving blood from a subject and processing the blood to form plasma or serum. For example, a device may be applied to the skin of a subject to receive blood from the subject and pass the blood through a separation membrane, which separates the blood into plasma and a portion concentrated in blood cells. As another example, blood or plasma may be allowed to clot within the device and serum (the unclotted portion of the blood) may be withdrawn from the device. The device may contain, in some cases, a vacuum source such as a pre-packaged vacuum to facilitate receiving of blood and/or passage of the blood through the separation membrane to produce plasma or serum. In certain embodiments, plasma, serum, or other fluids may be removed from the device by inserting a needle into a portion of the device that has reduced pressure, expelling gas into the device through the needle, then receiving plasma, serum, or other fluids through the needle.

Systems for rapid and accurate analyte measurement are described. For example, periodic glucose measurements can be achieved with high accuracy in a critical care environment by drawing blood into a device more than once per hour, analyzing blood (for example using infrared radiation through plasma). Safety and accuracy can be achieved by improved fluid control and avoidance of clotting. Data can be conveyed (e.g., displayed) to a user. A user can be allowed to annotate the data. For example, a touchscreen or other interface can allow addition of notes on a running graph of data, indicating events or other items of interest that may correspond to data readings or to particular times.

Upon blood collection with a disclosed blood collecting apparatus, a part of a flow path adjacent to a suction drain mechanism is filled with a liquid different from the blood. A gas is inserted in the flow path between the liquid with which the part of the flow path adjacent to the suction drain mechanism is filled and a target blood to be collected. The suction drain mechanism pushes and pulls the gas by pushing and pulling the liquid during a standby time between collection and next collection, thereby controlling movement of the target blood. The suction drain mechanism pushes and pulls the liquid and the gas during the standby time, whereby the target blood is continuously moved. This allows prevention of coagulation of the target blood in the flow path.