This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.

A safety needle device is disclosed comprising a hub, needle cannula, housing, tether, retractable sleeve, locking member and spring element. The tether is slidably disposed in the housing, the tether having a slot with an enlarged first guide path and a narrowed second guide path extending distally from the enlarged first guide path. The retractable sleeve is configured to move between an initial position, retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula.

Blood collection assemblies with safety features are disclosed. The assemblies have a housing for receiving a vacutainer, which has a septum that penetrates a sharp needle tip. The disclosed assemblies further have a shield for covering the other end of the needle following use to prevent accidental contact with the distal needle tip. The shield is spring loaded so that the spring force moves the shield over the needle. The shield can be secured or held in an initial position and allowed to move to cover the needle upon actuation or activation of an activator unit.

Exemplary embodiments provide automatic injection devices, housing components for automatic injection devices and methods for fabricating the same. An exemplary housing of an automatic injection device may be overmolded with one or more gripping surfaces to facilitate gripping and manipulation of the automatic injection device by a user when performing an injection. In an exemplary embodiment, an overmolded left gripping surface may extend along a left side of the housing and an overmolded right gripping surface may extend along a right side of the housing opposite to the left side.

Provided herein is an instrument delivery device including an instrument, a housing having a proximal end and a distal end and defining an inner volume configured to movably receive the instrument, a coupling device positioned at the distal end of the housing and including a lock configured to couple the housing to a proximal connector of the catheter assembly, and an advancement member configured to move relative to the housing to move the instrument between a first position and a second position. A scrubbing cap is engaged with the lock that includes a scrubbing insert, a housing having a connector portion configured to engage with the lock, a holder portion configured to retain the scrubbing insert therein, and a seal that seals the scrubbing insert within the holder portion. The scrubbing cap is engaged with the lock so as to be removable from the instrument delivery device.

Exemplary embodiments include a sample collection device having a tube with an inner seal producing a sequestered lower compartment. In certain embodiments, the sequestered compartment may have a stabilizing reagent. The device may also have a cap suited towards the sample type being stored in the tube. In some cases, the cap may pierce the inner seal to allow a liquid sample to mix with the stabilizing reagent. In the case of liquid samples, a funnel may be used to aid in the deposition of the sample. In other cases, a swab or similar collection tool can be inserted into the tube, piercing the inner seal, and the cap will retain the swab in the cap. The device can be used for the collection of saliva, swab, or other samples at home without clinical supervision. The samples can be transported and stored for further analysis of the sample for DNA, RNA, or other biological components.

A safety connector has a needle, and includes a tubular protective sleeve with a distal section, having a movable wall portion arranged in the peripheral wall thereof. The movable wall portion is selectively movable between a retracted position and a protection position. In the retracted position, the movable wall portion is aligned with the peripheral wall of the proximal section of the tubular protective sleeve. In the protection position, the movable wall portion projects into the inner space of the tubular protective sleeve.

A method of constructing a point-of-care diagnostic apparatus and fluid storage and delivery apparatus therefor is provided. The method of constructing the fluid storage and delivery apparatus includes providing a flexible upper layer having a reservoir; providing a flexible lower layer having a valve member; providing a rigid substrate having an upper surface, a lower surface and a through port; disposing a fluid in the reservoir; and sandwiching the rigid substrate between the upper and lower layers and bonding the upper layer to the upper surface of the rigid substrate with the reservoir registered with the through port and bonding the lower layer to the lower surface of the rigid substrate with the valve member registered with the through port. The method of constructing the point-of-care diagnostic apparatus includes fixing the fluid storage and delivery apparatus to a rigid base in selective fluid communication with a reaction chamber.