A biological fluid separation device and a separation process that allows for efficient separation of plasma from a blood sample is disclosed. A biological fluid separation device of the present disclosure is adapted to receive a blood sample having a cellular portion or cells and a plasma portion or plasma. A biological fluid separation device of the present disclosure separates plasma from cells using a track-etched membrane and cross-flow filtration.

Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device.

Systems and methods for autonomous intravenous needle insertion are disclosed herein. In an embodiment, a system for autonomous intravenous insertion include a robot arm, one or more sensors pivotally attached to the robot arm for gathering information about potential insertion sites in a subject arm, a medical device pivotally attached to the robot arm, and a controller in communication with the sensors and the robot arm, wherein the controller receives the information from the sensors about potential insertion sites, and the controller selects a target insertion site and directs the robot arm to insert the medical device into the target insertion site.

A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

Various embodiments of the present disclosure describe a diversion device that traps an initial flow of blood in a diversion chamber of the diversion device. The diversion chamber may be defined, in part, by a housing shell, a housing base, and a filter. The filter may be a porous material that allows air, but not blood, to flow through it. After the diversion chamber is filled, a subsequent flow of blood may be directed into a collection vessel through an internal conduit of the diversion device.

Fluid collection/injection device comprises a body having a front end, a back end, and a main hollow section arranged between the front and back ends and a needle hub securing section arranged on the front end and being structured and arranged to receive therein a needle member. The fluid collection/injection device is structured and arranged to utilize at least an operational mode, an operational mode, and a post-use mode. In the installation mode, the needle member is coupled to the body via the needle hub securing section. In the operational mode, fluid passes through the needle member and into or out of a receptacle inserted into the main hollow section.

An apparatus includes a transfer adapter, a puncture member, a disinfection member, and a fluid reservoir. The transfer adapter has a proximal end portion and a distal end portion, and defines an inner volume configured to receive the puncture member. The transfer adapter is coupled to the disinfection member. The distal end portion of the transfer adapter includes a port fluidically coupled to the puncture member and configured to be placed in fluid communication with a bodily-fluid of a patient. The proximal end portion is configured to receive a portion of the fluid reservoir to allow the fluid reservoir to be moved within the inner volume between a first position, in which a surface of the fluid reservoir is placed in contact with the disinfection member, and a second position, in which the puncture member punctures the surface to place the puncture member in fluid communication with the fluid reservoir.

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is 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 substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member. 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.

A point-of-care blood collection and dispensing device for use with a luer lock access device, the point-of-care collection and dispensing device including a distal engagement portion, wherein at least a part of the distal engagement portion is configured to engage a needle of the luer lock access device, and a sidewall portion, wherein at least part of the sidewall portion is formed of a flexible material capable of being compressed. The device also includes a fluid chamber configured to hold a blood sample, the fluid chamber bound at least partially by the distal engagement portion and the sidewall portion, as well as an opening, wherein the opening is sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed.

Systems and methods for autonomous intravenous needle insertion are disclosed herein. In an embodiment, a system for autonomous intravenous insertion include a robot arm, one or more sensors pivotally attached to the robot arm for gathering information about potential insertion sites in a subject arm, a medical device pivotally attached to the robot arm, and a controller in communication with the sensors and the robot arm, wherein the controller receives the information from the sensors about potential insertion sites, and the controller selects a target insertion site and directs the robot arm to insert the medical device into the target insertion site.