The present invention generally relates to collecting, determining and/or transmitting information associated with the process of receiving bodily fluid through a device opening and/or delivering substances to a subject. In one aspect, the device includes an information collecting portion and a fluid receiving portion. In another aspect, the two portions are constructed and designed to attach to one another. In one embodiment, actuation of one of the portions causes the other portion to actuate. Methods of time keeping and information transmission are also discussed.

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

A device which, in a shallow region including the epidermal layer or the dermal layer, can administer a target even in extremely small amounts. This includes a puncture needle which, in a flat puncture unit for puncturing the shallow region, has a groove and a through-hole which constitute a recess that extends through part of or the entire thickness of the puncture unit; and a casing which houses the puncture needle so as to allow the puncture needle to advance. By part or all of a flow agent containing the drug being arranged in the groove and the through-hole, the drug is positioned with respect to the puncture unit. The device is designed such that a flow agent in the amount of 10-1000 nL is dosed in the shallow region per puncture.

Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess.

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

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.

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.

The disclosed apparatus, systems and methods relate to the collection of bodily fluids through the use of gravity and microfluidic properties by way of a collector. The collector can make use of microfluidic networks connected to collection sites on the skin of a subject to gather and shuttle blood into a reservoir by a combination of capillary action and gravitational forces. The collected fluid is moved through the microfluidic networks and into the reservoir by a variety of approaches.

The current invention concerns an integrated medical device for a self-collection test, which allows for both puncturing and collecting a blood sample.

Sheathed cutting device. An exemplary device for discreetly piercing a skin of a patient can comprise a body having a proximal end and a distal end, a cutting member attached to a plunger, the cutting member and the plunger positioned at least partially within the body, and a biasing member configured to bias the cutting member to an initial position whereby the cutting member is positioned fully within the body, wherein the plunger is slidable into the proximal end of the body, causing the cutting member to extend from the distal end of the body.