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.

Sample processing methods and systems to collect a biological sample. A device may be configured collect a predetermined volume of a sample in sample chamber, and seal the chamber upon activation. The device may be further configured to mix the mix the sample with a predetermined volume of a reagent and/or mix the sample and the reagent in a pre-determined ration.

A bodily-fluid transfer 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 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.

A blood pack donation system configured for use with a lab-on-a-chip device for biomarker collection during whole blood donation including a blood collection container, a biomarker collection container, a first flow path connected to an opening in the blood collection container and to a first outlet opening of a lab-on-a-chip device, a second flow path connected to an opening in the biomarker collection container and to a second outlet opening of the lab-on-a-chip device, and a third flow path connected to a needle and to an inlet opening of the lab-on-a-chip device. The system may be used in a single pass collection procedure. A second version includes a fourth flow path connected to the first flow path and to the third flow path, with a plurality of flow control components that selectively control flow to provide a single pass collection procedure or a multiple pass collection procedure.

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.

Various embodiments pertain to syringes having needles that automatically retract, and including syringe assemblies in which there is a means for damping any impact of the retracting needle, slowing the retracting needle, dissipating the kinetic energy of the needle, or the like, so as to lessen any jolt or disturbance experienced by the user.

A fluid-handling cassette comprising a plurality of diaphragm valves and pumps is configured to have its actuation ports located along a thin or narrow edge of the cassette. Actuation channels within the cassette lead from the actuation ports to actuation chambers of the valves and pumps in a space between plates that comprise the cassette. The individual plates have a nominal thickness that is sufficient to provide a rigid ceiling for the actuation channels, but sufficiently thin to minimize the overall thickness of the cassette. The cassette can be plugged into or unplugged from an actuation receptacle or a manifold by its narrow edge. A plurality of such cassettes can be stacked together or spaced apart from each other to form a cassette assembly, providing for a convenient way to install and remove the cassette assembly from its actuation receptacle. The arrangement allows for an improved way of connecting a complex cassette assembly to its associated pressure distribution manifold without the use of a plurality of flexible connecting tubes between the two.

Devices and methods for withdrawing bodily fluid from a subject are disclosed herein. In some embodiments, a handheld device can include a housing having an opening, a skin-piercing assembly, and an actuator coupled to the skin-piercing assembly. The skin-piercing assembly can include a casing, a drive member pivotably mounted within the casing and carrying a blade, and a biasing member coupling the drive member to the casing. The actuator can be movable relative to the housing from a first position to a second position. In the first position, the drive member can engage the casing to maintain the biasing member in a biased configuration. Movement of the actuator from the first position to the second position can disengage the drive member from the casing to permit the biasing member to drive the blade at least partially through and/or across the opening in the base.

The invention provides devices that improve tests for detecting specific cellular, viral, and molecular targets in clinical, industrial, or environmental samples. The invention permits efficient detection of individual microscopic targets at low magnification for highly sensitive testing. The invention does not require washing steps and thus allows sensitive and specific detection while simplifying manual operation and lowering costs and complexity in automated operation. In short, the invention provides devices that can deliver rapid, accurate, and quantitative, easy-to-use, and cost-effective tests.

Apparatus and methods for a single, handheld device that provides for both insertion of a catheter and collection of a fluid. Some embodiments further include a needle that assists in the insertion of the catheter into a blood vessel, and which includes a retraction feature that protects the user from an accidental needle stick when the device is ready for disposal. Still further embodiments include a protective cover that prevents a user from accidentally being stuck by a second needle used for the introduction of the patient's blood into a collection device.