Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

A sensor module is disclosed herein. The sensor module includes a skin piercing member carried by the carrier. The skin piercing member has a skin piercing end positioned opposite from a base end. The skin piercing member defines a lumen that extends along the central longitudinal axis from the skin piercing end toward the base end and the lumen having a lumen axis. The sensor module also includes a blood sample analysis zone located entirely within the lumen of the skin piercing member and a capillary flow stop for stopping capillary flow at a predetermined location within the lumen of the skin piercing member. The sensor module includes an elongated working electrode positioned within the lumen. The working electrode has a length that extends along the lumen axis where at least a section of the working electrode is positioned within the analysis zone. The working electrode includes sensing chemistry.

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.

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.

A lancing device utilizing tail handle to load and adjust depth, includes a shell, an ejection pin, and a tail handle. The tail handle rotates fit with shell in circumferential direction of lancing device and slides fit with shell in axial direction of lancing device; the tail handle has forward sliding limit relative to shell in axial direction; passive impact surface is arranged corresponding to active impact surface on ejection pin for adjusting puncture depth and loading, and passive impact surface is formed by spiral action surface on tail handle; in use state, rotating tail handle will drive position of impact point on passive impact surface to change in axial direction of lancing device, thereby adjusting lancet tip puncture depth; pulling the tail handle backward will force the passive impact surface to come into contact with the active impact surface, and drive the ejection pin to be loaded and locked.

A collection device (10) which directs a flow of blood into a container (14) and provides a controlled blood flow path that ensures blood flow from a collection site to a collection container is disclosed.

A blood sample collector can be used to collect a blood sample from a subject. The blood sample collector can be placed in a receptacle of a spectrometer to measure spectral data from the blood sample while the blood sample separates. The container may comprise a window to allow light such as infrared light to pass through the container, with the blood sample at least partially separating within the container between spectral measurements, which can provide improved accuracy of the measurements and additional information regarding the sample. The container may comprise an elongate axis and the container configured for placement in the spectrometer receptacle with the elongate axis extending toward a vertical direction in order to improve gravimetric separation of the blood sample. The spectrometer can be configured to measure the blood sample at a plurality of heights along the sample as the sample separates.

A biological fluid collection device that is adapted to receive a blood sample is disclosed. The biological fluid collection device includes a housing, a puncturing element transitionable between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein at least a portion of the puncturing element extends through the housing, and a cartridge removably connectable to a portion of the housing. After collecting a blood sample, the cartridge is removable from the housing and the cartridge is able to transfer the blood sample to a point-of-care testing device. The biological fluid collection device provides a closed system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer.

A device for collecting a physiological sample from a subject includes a lancet and a cartridge configured to couple to the lancet. The needle is configured to puncture the subject's skin. The lancet is configured to automatically deploy the needle when coupled to the lancet which allows the needle to puncture the subject's skin and draw a physiological sample. The device further includes a vial disposed within the cartridge. The vial is configured to receive the drawn physiological sample.