Abstract: A catheter system having one or more needle position indicators to assist an operator in withdrawing the introducer needle to a “parked” position, as part of a catheterization procedure, wherein the needle position indicator provides a visual indication to the operator.

Abstract: Apparatus and methods for providing controlled pressure-flow pulses which purge a catheter system with turbulent flow flushing. Accomplishment of such controlled pressure-flow pulses is provided by a variety of inventive devices including a special plunger rod for a conventional syringe, other interactive parts for conventional syringes, an in-line catheter attachable device which automatically generates the controlled pressure-flow pulses and also single pulse, digitally operated devices.

Abstract: Flow cytometers including light collection enhancers are provided. In embodiments, the subject flow cytometers include a flow cell, a light source, an objective lens for focusing particle-modulated light propagating within a first light collection cone and a light collection enhancer configured to collect particle-modulated light propagating along an optical path within a second light collection cone and redirect the collected light such that it is back-propagated along the same optical path and focused by the objective lens for detection. Light collection enhancers of interest include a reflective optical element (e.g., a mirror) and a condenser lens positioned between the reflective optical element and the flow cell. Methods for analyzing a sample are also provided.

Abstract: The subject invention provides a drug delivery device for injecting medicament which includes a tubular reservoir; a stopper slidably disposed in the reservoir; a spring for moving the stopper in the reservoir; at least one needle, the needle having a distal end for insertion into a patient, and a lumen extending proximally from the distal end, the lumen being in direct or indirect communication with the reservoir; a needle driver for displacing the needle; and an actuator. Activation of the actuator causes the spring to move the stopper and the needle driver to displace the needle. The needle moves relative to, and separately from, the reservoir with the needle being displaced. Advantageously, with the subject invention, a drug delivery device is provided wherein a needle is moved, relative to the reservoir, in being displaced for injection. This permits control of the needle displacement separate from the reservoir.

Abstract: Sensors are disclosed that detect whether a cannula is properly inserted to its full depth in a subject's skin. The sensors may be used with a blood glucose monitor, or with a continuous insulin infusion pump, infusion set, or other system involving intermittent or continuous testing and/or drug delivery.

Abstract: A flush syringe for use in maintaining intravenous catheters, wherein the flush syringe can more efficiently and effectively flush the catheters by providing a pulsating, pulsatile, and/or pulsative flow of fluid that can be produced using momentum of the fluid moving. A steady force applied to a plunger while flushing can provide the pulsating, pulsatile, and/or pulsative flow of the fluid to the catheters.

Abstract: A catheter assembly may include a catheter adapter that includes a distal end, a proximal end, and an inner surface forming a lumen. The lumen may extend between the proximal end and the distal end. The catheter assembly may also include a cannula and a cannula hub. The cannula hub may include an outer portion disposed outside of the catheter adapter and an inner portion disposed within the catheter adapter. The cannula may extend distally from the inner portion. In response to the outer portion sliding proximally along an outer surface of the catheter adapter, the cannula may be withdrawn proximally into the catheter adapter. The outer portion may be configured to slide proximally to a locked position in which the cannula hub is locked with respect to the catheter adapter, and a distal tip of the cannula is disposed within the catheter adapter.

Abstract: Light detection systems for measuring light (e.g., in a flow stream) are described. Light detection systems according to embodiments include a light scatter detector, a brightfield photodetector and an optical adjustment component configured to convey light to the light scatter detector and to the brightfield photodetector. Systems and methods for measuring light emitted by a sample (e.g., in a flow stream) and kits having a light scatter detector, a brightfield photodetector and a beam splitter component are also provided.

Abstract: Packages comprising a film surrounding the sterile medical device are described and including a tear-enabling feature and a gripping feature enabling a user to use a finger, a thumb or an end of a tool to apply a sufficient tearing force to cause the tear-enabling feature to tear and move the first end of the package away from the second end of the package using only one hand and to expose the sterile medical device to be accessed for use. Also described are methods of packaging a sterile medical device.

Abstract: Provided is a wearable, self-contained drug infusion or medical device capable of communicating with a host controller or other external devices via a personal area network (PAN). The medical device utilizes a PAN transceiver for communication with other devices in contact with a user's body, such as a physiological sensor or host controller, by propagating a current across the user's body via capacitive coupling. The wearable nature of the medical device and the low power requirements of the PAN communication system enable the medical device to utilize alternative energy harvesting techniques for powering the device. The medical device preferably utilizes thermal, kinetic and other energy harvesting techniques for capturing energy from the user and the environment during normal use of the medical device. A system power distribution unit is provided for managing the harvested energy and selectively supplying power to the medical device during system operation.

Abstract: A hard seal, positive displacement pump is provided which may be included within a fluid delivery system. The pump includes a housing, a sleeve disposed radially within the housing, and a piston disposed radially within the sleeve. An outer shape of a first end of the sleeve contacts a correspondingly-shaped inner shape of a first end of the housing, thereby sealing the first end of the sleeve within the first end of the housing. The piston is radially and axially moveable within the sleeve, and an axially-reciprocating motion of the piston within the sleeve opens and closes a pump chamber defined between a first end of the piston and a first end of the sleeve.

Abstract: Syringe assemblies are provided including a partially pre-filled syringe barrel and a plunger rod that incorporates one or more retention elements on the plunger rod that prevents solution from entering a non-sterile area of the syringe when the plunger rod is pulled back. Methods to manufacture a sterilized partially-filled pre-fill syringe assembly are also disclosed.

Abstract: An injection monitoring device includes a syringe having a barrel configured to contain a medicament and a plunger configured to be displaced linearly into the interior of the barrel to dispense the medicament, a flange positioned between a proximal end and a distal end of the injection monitoring device and configured to be gripped during performance of the injection, and one or more force sensors positioned to detect data associated with an amount of force applied to the injection monitoring device during performance of an injection.

Abstract: A container assembly is disclosed including an outer container, a hollow inner member, and a closure. The outer container has a closed bottom, an open top, and a sidewall extending therebetween. The hollow inner member is disposed within the outer container and has an inner surface defining at least one capillary channel. The inner member includes a first end adjacent to the open top of the outer container and has an outer periphery seated against the sidewall of the outer container. The closure has a proximal end and a distal end. The closure proximal end is seated at least partially within the first end of the inner member to seal the outer container and inner member and define a fluid collection chamber. The closure distal end defines a recessed area shaped to direct fluid under capillary action to the at least one capillary channel in the inner member.

Abstract: Systems and methods for optimizing detection of optical signals indicating the presence of an analyte of interest in a blood sample are described. In one aspect, a blood culture test vial having a sensor is inoculated with the blood sample, light at an excitation frequency of the sensor is transmitted to the test vial, an intensity of a plurality of fluorescence signals emitted from the test vial is measured, and the plurality of measured fluorescence signals are normalized using by a reference signal that is not dependent on a measured intensity of a fluorescence signal emitted from the test vial. In another aspect, a measurement system measures fluorescence signals from one or more reference vials performing in extreme pH conditions. Fluorescence signals emitted from test vials inoculated with samples under test are measured and compared to the signals measured from the one or more reference vials to address or mitigate variability in hardware components of the measurement system.

Abstract: Disclosed herein are methods, compositions, and kits for barcoding nucleic acids. For example, particles for barcoding are provided, where the particle comprises: a first plurality of oligonucleotide barcodes each comprising a target-binding region, and a second plurality of oligonucleotides each comprising a target-specific target-binding region.

Abstract: Flush syringe assemblies are described herein. Such flush syringe assembly may include a barrel including a side wall defining a chamber, a collar mounted on a distal wall of the barrel and surrounding an elongate tip. A cap may be attached to the collar via a hinge. The flush syringe assembly may also include a cap attached to the collar via a hinge. A ring may be disposed around the collar with a locking element that engages with a corresponding mating locking projection on the cap. The cap may include a slanted surface. The slanted surface of the cap may include one or more ribs made of an elastomeric material.

Abstract: An infusion set includes a base (221) and a flexible catheter (242) movable from a first catheter position disposed substantially entirely within the base (221) to a second catheter position in which a free end of the catheter (242) is disposed externally of the base (221). An introducer needle (234) is located within the catheter (242) and is movable between a first introducer needle position disposed substantially entirely within the base (221) and a second introducer needle position in which a free end of the introducer needle (234) is disposed externally of the base (221). A spring (281) is activated to move the catheter (242) from the first to the second catheter position and the introducer needle (234) from the first to the second introducer needle position to facilitate insertion of the catheter (242).

Abstract: A medicament delivery system (1) and method for determining an occlusion comprising a reservoir (4) that carries a medicament, a pump (3) connected to the reservoir (4) that draws the medicament out of the reservoir (4) for medication delivery, and an occlusion sensor (600) connected to the reservoir (4) that senses whether an occlusion is present wherein the occlusion sensor (600) is secured to an outer surface of the reservoir (4), the occlusion sensor (600) provides resistance output (630) to control electronics (8), and the control electronics (8) determines whether an occlusion is present based on the resistance output (630). The occlusion sensor (600) can be a strain gauge bonded onto a mid-section of an outer surface of a flexible reservoir (4) to provide a sensitive strain reading.

Abstract: Aspects of the disclosure include a system for performing cytometry that can be operated in three operational modes. In one operational mode, a fluorescence image of a sample is obtained by exciting one or more fluorophore(s) with a top-hat-shaped excitation beam with a plurality of beams that are radiofrequency shifted relative to one another. In another operational mode, a sample can be illuminated successively over a time interval by a laser beam at a plurality of excitation frequencies in a scanning fashion to generate an image of the sample from the detected fluorescence. In another operational mode, the system can be operated to illuminate a plurality of locations of a sample concurrently by a single excitation frequency (e.g., a horizontal extent), which is generated, e.g., by shifting the central frequency of a laser beam by a radiofrequency and detected fluorescence is used to analyze the sample.