The present invention generally relates to systems and methods for monitoring and/or providing feedback for drugs or other pharmaceuticals taken by a subject. In one aspect, the present invention is directed to devices and methods for determining a species within the skin of a subject; and producing feedback to a subject based on the determination of the species. The feedback may be, for example, visual, audible, tactile, a change in temperature, etc. In some cases, information regarding the determination of the species may be transmitted to another entity, e.g., a health care provider, a computer, a relative, etc., which may then provide feedback to the subject in some fashion. In some cases, the feedback may be directly indicative of the species. However, the feedback may also be indirect in some embodiments.

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.

This disclosure relates to a system and method for drawing blood from a user by skin puncture instead of venous puncture and storing it for analysis. The system includes a receptacle configured to engage an area of skin of the user at a blood draw location and store blood drawn from the user; a lancet device disposed within the receptacle configured to puncture the skin of the user at the blood draw location; a vacuum device configured to reduce a pressure within the receptacle such that the skin at the blood draw location is drawn into the receptacle before the lancet device punctures the skin, and to enhance blood flow while blood is drawn from the user; and a housing configured to house the receptacle, the lancet device, and the vacuum device. The receptacle, the lancet device, and the vacuum device may be modular and removably coupled with the housing.

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, in some cases, may be interfaced with external equipment to determine an analyte contained within a fluid contained within or collected by the device. For example, the device may be mounted or engaged on an external holder, the device may include a port for transporting fluid out of the device, the device may include a window for interrogating a fluid contained within the device, or the like. 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.

A blood collection tube includes a body, a chamber, a vacuum port, and a cap. The cap includes a first septum, a first conduit having an inlet extending from the first septum and an outlet in fluid communication with the chamber, a second septum, and a second conduit extending radially from the second septum to the first conduit. When a fluid source is fluidically connected to the first septum or the second septum, and a vacuum is applied at the port, the vacuum draws fluid from the fluid source, through the first or second septum, and into the first conduit. A blood collection device includes a vacuum pump and a plurality of reservoirs containing concentrated blood additives. The tube and device form a system for collecting blood samples at low vacuum to tubes previously stored at atmospheric pressure. The system prevents risk of misidentification, mislabeling, or incorrect ordering of tubes.

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.

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member. Other aspects of the present invention are directed at other devices for receiving 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.

The invention relates to a device for connecting a cannula to a container under reduced pressure, in particular a blood culture flask, including an inflow opening for connecting to the cannula or to a connection tube connected to the cannula, an outflow opening for connecting to a hollow pin for piercing a closure of the container, and a tight fluidic connection of the inflow opening to the outflow opening. According to the invention, a reservoir which is separated from the fluidic connection and contains a specified gas quantity is connected to the fluidic connection with the interposition of a valve which is preferably open towards the fluidic connection.

The present invention provides systems and methods for monitoring whole blood drawn from a mammalian subject, the system including a fluid delivery device in fluid connection, at a first end, with a vein (or other blood vessel) of the subject, a valve device at a second end of the fluid delivery device, a whole blood monitoring apparatus for measuring a hemoglobin count for example in a blood sample conveyed by the fluid delivery device from the mammalian subject and a processor adapted to analyze data received from the hemoglobin monitoring apparatus to monitor the subject and further to detect if the subject is suffering from internal bleeding.

A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has a first state in which a negative pressure differential produced from an external source such as the fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.