An apparatus comprises a diffuser, a connection tube section forming a tubular fluid passage, a first indicating element section that indicates a measurement related to a body fluid disposed between a distal end and the connection tube section, a second indicating element section that indicates that the first indicating element section is suitable for use, and a housing having a generally tubular body. The diffuser is at least partially disposed in the generally tubular body. A fluid chamber adapted to receive fluid is cooperatively defined by the housing and the diffuser. The first indicating element section is visibly disposed in a first section of the housing. The second indicating element section is disposed within the fluid chamber. A micro-needle collector to draw the fluid from a source to the distal end is attachable to the distal end.

Improvements in and relating to blood sampling devices A blood sampling device includes a housing and a lancet supporting a lancet needle or tip, the lancet and needle being urged or urgeable in a pricking direction. A trigger mechanism is moveable to a fire position for releasing the lancet to travel in the pricking direction. A removable safety cap initially covers the lancet needle. The lancet has an initial position in which movement of the trigger mechanism to its fire position is blocked and an intermediate position in which the trigger mechanism may be moved to its fire position. The intermediate position is obtainable only on removal of the safety cap.

A device for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the device including a collection cup subassembly having a cantilevered, concave slide for transporting blood down and away from a blood sampling location; a mid-body subassembly couplable to the collection cup assembly and including a housing having a proximal end and a distal end and defining a plenum space; and a plunger subassembly having a first end and a second end and including a plunger formed at the second end and one or more lancet elements attached to the plunger. Advantageously, the plunger and lancet elements are structured and arranged to translate through the mid-body subassembly and the collection cup subassembly to the blood sampling location.

A blood sampling device includes a housing and a lancet supporting a lancet needle or tip, the lancet and needle being urged or urgeable in a pricking direction. A trigger mechanism is moveable to a fire position for releasing the lancet to travel in the pricking direction. A removable safety cap initially covers the lancet needle. The lancet has an initial position in which movement of the trigger mechanism to the fire position is blocked and an intermediate position in which the trigger mechanism may be moved to the fire position. The intermediate position is obtainable only on removal of the safety cap.

The present invention relates to a device for collecting body fluids including (a) a fluid receiving part including a fluid receiving space in which an internal low pressure less than an external atmospheric pressure is formed; (b) a fluid collection part including a hollow microstructure connected to form an open system with the fluid receiving space of the fluid receiving part; and (c) a microstructure hollow barrier for blocking the hollow of the microstructure to maintain the internal low pressure formed in the fluid receiving means.

Pen-type lancing device of the re-usable type wherein a lancet body having a needle/tip is inserted; standard spring type actuator (urging member); skin touching forward face having a textured surface for pain relieve; sleeve having internal stop(s) so that the lancet does not overshoot. Also a pen-type lancing device of the re-usable type wherein a lancet body having a needle/tip is inserted; elastomer type urging member for driving the lancet; triggering means (denoted “actuating means”). Further a pen-type lancing device of the reusable type wherein a lancet body having a needle/tip is inserted; standard spring type actuator (urging member) for driving the lancet; alignment splines and cooperating alignment portion(s) for guiding the lancet movement. Even further a method of assembling a blood sampling device in which it does not matter what rotational orientation the components are assembled in.

The present invention generally relates, in certain aspects, to relatively small devices applied to the skin, modular systems, and methods of use thereof. In some aspects, the device is constructed and arranged to have more than one module. For instance, the device may have a module for delivering to and/or withdrawing fluid from the skin and/or beneath the skin of a subject and a module for transmitting a signal indicative of the fluid delivered to and/or withdrawn from the skin and/or beneath the skin of the subject, a module for analyzing a fluid withdrawn from the skin and/or beneath the skin of the subject, or the like. In some embodiments, the modules are connectable and/or detachable from each other, and in some cases, the connections and/or detachments may be performed while the device is in contact with the subject, e.g., while affixed to the subject. In some embodiments, the device may be repeatedly applicable to the skin of the subject to deliver to and/or withdraw fluid from the skin and/or beneath the skin of a subject, e.g., at the same location, or at different locations on the skin of the subject. In some aspects, the devices may be self-contained and/or have a relatively small size, and in some cases, the device may be sized such that it is wearable and/or able to be carried by a subject. For example, the device may have a mass and/or dimensions that allow the device to be carried or worn by a subject for various periods of time, e.g., at least about an hour, at least about a day, at least about a week, etc., or no more than about an hour, no more than about 10 min, etc.

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 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.

An apparatus comprises a diffuser, a connection tube section forming a tubular fluid passage, a first indicating element section that indicates a measurement related to a body fluid disposed between a distal end and the connection tube section, a second indicating element section that indicates that the first indicating element section is suitable for use, and a housing having a generally tubular body. The diffuser is at least partially disposed in the generally tubular body. A fluid chamber adapted to receive fluid is cooperatively defined by the housing and the diffuser. The first indicating element section is visibly disposed in a first section of the housing. The second indicating element section is disposed within the fluid chamber. A micro-needle collector having pipettes to draw the fluid from a source to the distal end is attachable to the distal end.