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example, blood or plasma may be allowed to clot within the device and serum (the unclotted portion of the blood) may be withdrawn from the device.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.

A microneedle has a proximal end portion and a distal end portion and defines a lumen. The proximal end portion is configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge. The proximal end portion includes a base surface that is configured to be placed in contact with a surface of a target tissue. The distal end portion of the microneedle includes a beveled surface. The beveled surface defines a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5.

A method of making a needle guard includes providing a mold having a portion defining a volume, the volume being a hollow cylinder with non-uniform walls with a pair of slots therein, the slots being open at one end and closed at the other end, the pair of slots having a major portion of constant width. The walls are thicker at the other end than at the one end. The method includes filling the volume with polymer and releasing a molded part from said mold and cooling a molded part resulting from the filling and releasing such that temperature that the widths of the pair of slots is non-uniform after cooling. The needle guard has upper and lower jaws defining a channel and coming together at a hinge. A winged needle can be inserted between the jaws, with the wings of the winged needle passing through slots between the jaws.

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.

A fluid control device includes an inlet configured to be placed 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 sequestration portion that can be vented or evacuated. The fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to the sequestration portion and a second state in which (1) the initial volume is sequestered in the sequestration portion, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow through at least a portion of the fluid control device and into the fluid collection device. The fluid control device can transition automatically or in response to an actuation of a portion of the fluid control device after the sequestration portion receives the initial volume.

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.

Fill stations and base stations are provided for personal pump systems. The fill stations may be opened and closed to accept a reservoir and to allow fluid to be introduced into the reservoir for use with personal pump systems. The fill stations may hold the reservoir at a tilt relative to an underlying surface and may discourage overfilling of the reservoir. The filling stations may also include viewing windows having fluid lines marked thereon for indicating volume of fluid within the reservoir.

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, e.g., whether the species is present, the concentration of the species, whether a by-product of a reaction involving the species is present, whether a compound affected by the species is present, etc. However, the feedback may also be indirect in some embodiments. For example, the subject may be presented with an external reward, e.g., based on the determination of the species within the skin. For instance, a reward such as cash, coupons, songs, discounts, personal items, etc., may be offered based on the level of compliance of the subject. Still other aspects of the invention are generally directed to kits involving such devices (with or without the drug to be monitored), methods of promoting such systems, or the like.

A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.