Herein, systems and methods are disclosed including a sample acquisition component (SAC) for user-friendly sample collection, a separation component for optional separation of plasma, and one or more stabilization components for stabilizing analytes. In a particular embodiment, the system and methods are directed towards sample collection and stabilization with optional sample separation. Other embodiments can perform any combination of collection, separation, stabilization or detection.

A disposable lancing device contains: a first casing, a second casing, and a needle holder. The first casing includes a close segment, an open segment, a slideway, two tilted contact faces, a fixing portion, two recesses, and two push fringes. The second casing includes an accommodation chamber, two limitation extensions, and multiple drive protrusions. A forcing face is defined on the second casing opposite to the two limitation extensions, and a through hole is defined on a center of the forcing face. The through hole has a protruded rib. The needle holder includes a collection needle having a syringe needle, and the needle holder further includes a trigger spring, a return spring, and two symmetrical flexible wings. The two symmetrical flexible wings include two driving segments configured to abut against the two symmetrical flexible wings to flexibly retract inward by using the two tilted contact faces.

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.

A pen format liquid collection device includes an elongate generally tubular housing (12, 112, 212, 312) able to be held by hand and having an opening at one end, and at least one liquid take-up element (30, 130, 230, 330) mounted in the housing so as to be positioned or positionable to project at the opening, the at least one liquid take-up element then further postionable by hand manipulation of the housing to contact a volume of liquid to thereby take-up a sample of the liquid to be analysed. At least one retention element (230a, 330a) is supported in the housing. The at least one liquid take-up element and the at least one retention element are arranged whereby they are relatively movable into contact, and the at least one retention element is adapted on contact to in turn take-up the sample and retain the sample or a component thereof for in situ analysis or later recovery while protected within the housing. The liquid take-up element is preferably a capillary.

A biological fluid sampling device for collecting a blood sample from a separate vascular access device and for ejecting a portion of the collected sample to a point-of-care testing device for analysis is provided. The biological fluid sampling device includes a body enclosing a reservoir. The reservoir has an internal volume sufficient to contain enough blood for use in a diagnostic test. The sampling device further includes: an access lumen extending from a distal end of the body for establishing fluid communication between a separate vascular access device and the reservoir; an outflow lumen also in fluid communication with the reservoir; and a removable vented cap attached to the outflow lumen including a gas permeable vent in gaseous communication between the reservoir and ambient air. In addition, several sample and transfer devices are provided for obtaining a sample from a subject and transferring the sample to a point-of-care testing device.

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.

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, 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 receiving 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 receive 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 received 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. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. 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.

Herein, systems and methods are disclosed including a sample acquisition component (SAC) for user-friendly sample collection, a separation component for optional separation of plasma, and one or more stabilization components for stabilizing analytes. In a particular embodiment, the system and methods are directed towards sample collection and stabilization with optional sample separation. Other embodiments can perform any combination of collection, separation, stabilization or detection.

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

A device for extracting a body fluid and testing a predetermined analyte or property of the fluid is provided. The device comprises a hollow needle having a channel linking a base end and a tip, a collection chamber having an input end in fluid communication with the channel, a testing chamber, a solution chamber and a flow control. The collection chamber comprises a capillary wick configured to transport at least a fraction of the body fluid away from the input end. The testing chamber comprises a testing unit including a reacting material configured to react to a predetermined analyte or property of the fluid and the solution chamber comprises a buffer solution. A flow control is also provided for a transfer of the buffer solution from the solution chamber to the collection chamber and a transfer of the body fluid from the collection chamber to the testing chamber.