Becton Dickinson Patente

Aspects of the present disclosure include systems for classifying cells (e.g., single cells) of a sample in a flow stream such as from biological parameters determined from feature vectors. Systems according to the disclosure include a light source configured to irradiate cells of a sample in a flow stream, a light detection system having a photodetector to detect light from the irradiated cells and a processor having memory operably coupled to the processor where the memory includes instructions stored thereon, which when executed by the processor, cause the processor to receive two or more data sets, where each of the two or more data sets is associated with one of a plurality of data modes, apply an algorithm to convert each of the two or more data sets into a feature vector based on the associated data mode, receive a classification task regarding the two or more data sets and apply one or more of a plurality of classification models to the feature vector based on the received classification task to determine a class. Methods for using the subject systems are also described. Non-transitory computer readable storage media are also provided.

Systems and methods for providing gain-independent flow cytometry data are disclosed. In some implementations, sample median fluorescence intensities (MFIs) may be maintained irrespective of the gain detector settings. In some such implementations, the numerical scale used to represent MFI may correspond to the true intensity of the input signal. As a result, quality control (QC) procedures may instead focus on maintaining resolution performance of the flow cytometer. For example, the QC procedures may instead focus on maximizing a signal-to-noise ratio (SNR) for one or more photodetectors. In some such implementations, the frequency with which such QC procedures are performed may be reduced (e.g., from a daily procedure to a weekly or even monthly procedure). In some such implementations, it may be unnecessary to perform repeated QC procedures to ensure consistent sample MFIs over time.

Aspects of the present disclosure include methods for calibrating spectral data signals (e.g., flow cytometer data). Methods according to certain embodiments include irradiating a particle of a sample having a fluorophore in a flow stream with a light source, detecting light from the irradiated particle with a light detection system having a photodetector, generating spectral data signals in response to the detected light, calibrating the generated spectral data signals based on a calibration scaling factor and a calculated abundance of the fluorophore. Systems and non-transitory computer-readable storage media configured to carry out the subject methods are also provided.

Aspects of the present disclosure include systems for detecting and classifying a cancerous cell in a whole blood sample in a flow stream. Systems according to certain embodiments include a light source configured to irradiate cells of a whole blood sample in a flow stream, a light detection system comprising a photodetector capturing an image of light emitted from the irradiated cells and a processor having memory operably coupled to the processor where the memory includes instructions stored thereon, which when executed by the processor, cause the processor to apply a neural network to the captured image to detect a presence of a cancerous cell in the whole blood sample having a minimum concentration of the cancerous cell and determine a classification of the cancerous cell of a plurality of classifications. In some instances, the neural network is trained using images of a sample tagged with a fluorophore ground truth marker. Methods for using the subject systems to detect and classify cancerous cells in a whole blood sample are also described. Non-transitory computer readable storage media are also provided.

A biological liquid collection device designed to draw blood using an "atmospheric-balanced vacuum" to ensure the blood is exposed to the sample atmospheric partial pressure oxygen and partial pressure carbon dioxide levels as found in standard arterial blood gas syringes, resulting in blood gas sample stabilization during collection and a superior vacuum shelf-life by reducing the gas permeation rate through the plastic tube. The biological liquid collection device comprises a collection module for receiving a biological liquid sample, an evacuated container having an open end and a closed end wherein the evacuated container contains the collection module therein, and a closure for closing the open end of the evacuated container. The evacuated container comprises a gas composition that is substantially equal to the gas composition of the atmosphere outside of the evacuated container. A method for forming the atmospherically balanced vacuum collection device is also provided.

A device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port; a blood collector attachment removably connected to the holder; and a collection container removably connected to the blood collector attachment, the container defining a collection cavity, wherein a collection container detachment member is provided between the blood collector attachment and the collection container to releasably attach the collection container to the blood collector attachment.

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.

A probe delivery device can include a probe delivery mechanism that facilitates advancing a probe through an IV catheter. The probe delivery mechanism can be housed within a compartment of the probe delivery device and can include a probe that extends from the compartment into a fluid pathway formed within the probe delivery device. A portion of the probe delivery mechanism can extend out from the housing to enable a clinician to advance and retract the probe. The probe delivery device may include a vacuum tube receiver or a connector to enable a blood draw or fluid injection to be performed using the probe delivery device.

Provided herein is a syringe holder syringe holder for enabling measurement of a syringe barrel having a cylindrical main body and a flange positioned at a proximal end of the cylindrical main body. The syringe holder includes at least one rack comprising a top plate including a plurality of top holding apertures, a bottom plate including a plurality of bottom holding apertures, and a plurality of vertical members extending between the top and bottom plates, to space the top plate apart from the bottom plate. Each top holding aperture is aligned with a respective bottom holding aperture, with respective vertically aligned top and bottom holding apertures forming a receptacle configured to receive a syringe barrel therein. A diameter of the top holding aperture of each receptacle in the rack is incrementally different from the diameters of the top holding apertures of the other receptacles.

Aspects of the present disclosure include methods for generating a bitmap from a data plot of light detected from particles in a flow stream. Methods according to certain embodiments include detecting light from particles in a flow stream, generating a data plot of measurements of the detected light, where the data plot includes one or more regions each having a population of particles, calculating a set of vertices that form a boundary for each region in the data plot, identifying a type of algorithmic transformation associated with each vertex in the set of vertices, generating a bitmap of each region of particles such that the bitmap of each region includes a set of vertices that correspond to the vertices of each region in the data plot and identifying an algorithmic transformation for applying to each vertex in the bitmap of each region. Systems and integrated circuit devices (e.g., field programmable gate arrays) having programming for generating a bitmap according to the subject methods are also provided.

A vascular access device may include a housing and an instrument disposed within the housing. The housing may include a proximal end, a distal end, a slot, and an advancement tab. The advancement tab may be configured to move linearly along the slot between a retracted position and an advanced position. A proximal end of the instrument may be coupled to the advancement tab such that, in response to the advancement tab moving from the retracted position to the advanced position, the distal tip of the instrument may be advanced beyond the distal end of the housing into a catheter assembly and/or vasculature of a patient.

A disinfection cap is described for connection to a medical connector, the disinfection cap including a housing having a top wall and sidewall forming a cavity, a blockage feature disposed on the top wall of the cavity, the blockage feature for fluidly blocking a hub of a luer connector, disinfectant or antimicrobial agent disposed within an open cell foam structure within the cavity. The open cell foam structure releasing the disinfectant or antimicrobial agent as the open cell foam structure is depressed by the hub of the luer connector.

A biological fluid collection system including a collection module for collecting a small sample of blood and transferring a portion of the sample into a device or instrument for analyzing the sample such as a point-of-care or a near-patient-testing device including blood collection devices for collecting and transferring venous and arterial blood samples are disclosed.

A valve assembly for a drug delivery device includes a valve housing having a first side and a second side positioned opposite from the first side, a cannula having a first end and a second end positioned opposite the first end, a pierce plate having a body and a piercing member extending from the body, with the body defining a coiled elongate member, and a valve boot connected to the valve housing and defining an interior space. The valve boot is configured to move from a pre-use position where the first end of the cannula and the piercing member of the pierce plate are received within the interior space to a use position where the piercing member of the pierce plate and the first end of the cannula extend outside of the valve boot and the interior space.

Flow cells including sample injection needles for operatively coupling a sample injection line to a body of a flow cell are provided. The subject sample injection needles include: a sample injection needle adaptor having a sample tube adapter fixed to a needle for delivering sample fluid from a sample injection line to a flow cell body; and a clamp for operatively coupling the sample injection needle to the flow cell body. Also provided are kits including the subject sample injection needles and flow cytometers having the subject flow cells as well as methods of use and assembly thereof.

Robotic systems for automated sample preparation are provided. Systems of interest include a plurality of sample processing modules, a plurality of robotic components integrated with the sample processing modules, a processor comprising memory operably coupled to the processor wherein the memory comprises instructions stored thereon, which when executed by the processor, cause the processor to control the sample processing modules and the robotic components to: operate the sample processing modules and robotic components to prepare a plurality of samples for flow cytometric analysis, and an operable connection among the processor, the sample processing modules and the plurality of robotic components. Systems according to certain embodiments further include a flow cytometer, wherein the plurality of robotic components are further integrated with the flow cytometer, wherein the memory further comprises instructions stored thereon, which when executed by the processor, cause the processor to control the sample processing modules, the robotic components and the flow cytometer to: load each prepared sample of the plurality of samples into the flow cytometer, and operate the flow cytometer to analyze each prepared sample of the plurality of samples, wherein the operable connection operably connects the processor, the sample processing modules, the flow cytometer and the plurality of robotic components. Methods of use and configuration or design of systems are also provided.

Certain aspects relate to systems and usage techniques for modular lateral flow assay reader devices that can receive a number of different modules having a barcode scanning input device and optional network connectivity capabilities. A barcode scanning module can provide a simple input method that reduces errors compared to manual data entry. A network connectivity module can enable transmission of test results over a public network for standardizing, tracking and electronically connecting test results from assay reader devices located throughout a network. Such devices can programmatically implement a simplified workflow whereby pressing a single button readies the device for imaging, analyzing, and data storage/transmission and, in some implementations, configures the device to operate in one of a plurality of device operation modes.

Aspects of the present disclosure include flow cytometers having variable depth sample line injection tubes. Flow cytometers according to certain embodiments include a flow cell; and a sample injection tube (SIT) assembly comprising a sample line operably coupled to the flow cell; wherein the SIT assembly is configured to provide for variable sample line depth in a sample container. Methods of cytometrically processing samples, e.g., in analysis and/or sorting applications, are also provided.

Aspects of the present disclosure include flow cytometers having a pneumatically driven sample autoloader. Flow cytometers according to certain embodiments include a flow cell; and a pneumatically driven sample autoloader configured to automatically obtain a sample from a sample container and convey the sample to the flow cell. Methods of cytometrically processing samples, e.g., in analysis and/or sorting applications, are also provided.

Provided herein is a method for manufacturing a prefilled syringe. The method includes providing a prefilled syringe including a syringe barrel defining a chamber containing a fluid therein and a stopper axially sealing the fluid in the chamber, with the stopper including one or more ribs forming a sealing surface with the syringe barrel. The method also includes performing a terminal steaming process on the prefilled syringe, with the terminal steaming process including a first steaming cycle that exposes the syringe to steam at a set temperature and a set pressure and a second steaming cycle that exposes the syringe to steam at the set temperature and the set pressure. Performing of the terminal steaming process reduces a diameter of at least one rib of the one or more ribs, to reduce a contact pressure between the stopper and the syringe barrel.

Disclosed herein include embodiments of a system, a device, and a method for sorting a plurality cells of a sample. A plurality of raw images comprising pixels of complex values in a frequency space can be generated from a plurality of channels of fluorescence intensity data of fluorescence emissions of fluorophores, the fluorescence emissions being elicited by fluorescence imaging using radiofrequency-multiplexed excitation in a temporal space. Spectral unmixing can be performed on the raw images prior to a sorting decision being made.

A medical device (100), comprising a hub (102) or housing (118) having a push tab (112) including a main portion extending radially from an upper surface of the hub (102) or housing (118), and at least one anti-rotation feature (114, 116) for resisting rotation of the hub (102) or housing (118). A cannula (103) is directly or indirectly connected to the hub (102) or housing (118). The medical device (100) may be a catheter, the cannula (103) may be a catheter tube, and the hub (102) or housing (118) may be a catheter hub or an introducer needle tip shield of the catheter (100).

Aspects of the present disclosure include methods for assessing collinearity between autofluorescence spectra of particles in a sample. Methods according to the present disclosure include irradiating a sample having particles in a flow stream with a light source in a flow cytometer, detecting light from the irradiated particles with a light detection system having a photodetector, measuring autofluorescence spectra generated by the particles in the sample and assessing collinearity between the autofluorescence spectra generated by two or more different particles in the sample. Systems and non-transitory computer-readable storage media configured to carry out the subject methods are also provided.

An infusion adapter for connection with an infusion fluid container includes a connection portion configured to engage an injection port of an infusion fluid container, and a port configured to connect to an intravenous line, with the port in fluid communication with the connection portion. The connection portion includes a retaining ring extending radially outward from the connection portion, with the retaining ring configured to securely connect the infusion adapter to the infusion fluid container to substantially prevent disconnection of the infusion adapter from the infusion fluid container once the infusion adapter is connected to the infusion fluid container. The retaining ring includes an indicator configured to provide visualization of insertion of the connection portion into an injection port of an infusion fluid container.

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

A mold assembly (25) for forming a stopper (10), including a first mold plate (26) defining a cavity therein configured to form a distal end of the stopper and at least a portion of a first rib (20a) extending around a perimeter of the stopper; a second mold plate (28) defining a cavity therein configured to form a portion of the stopper, and a distal surface that abuts at least a portion of the first mold plate, wherein the distal surface is configured to form a first portion of a substantially planar surface of the first rib; and a third mold plate (30) defining a cavity therein configured to form a portion of the stopper, and a distal surface that abuts at least a portion of the first mold plate, wherein the distal surface of the third mold plate is configured to form a second portion of the substantially planar surface of the first rib.

A device for obtaining a blood sample, the device including a holder for receiving a sample source, the holder having an actuation portion and a port, a container engagement portion connected to the holder, and a collection container removably connectable to the container engagement portion, the container defining a collection cavity, wherein the container engagement portion allows the collection container to rotate between a first position in which the collection container is spaced from the port and a second position in which the collection container is in fluid communication with the port.

A biological fluid collection device (10) that receives a sample (12) and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications is disclosed. A biological fluid collection device of the present disclosure is able to effectuate distributed mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this manner, a biological fluid collection device of the present disclosure enables blood micro-sample management, e.g., passive mixing with a sample stabilizer and controlled dispensing, for point-of-care and near patient testing applications. Advantageously, a biological fluid collection device of the present disclosure includes an internal vacuum (28). In this manner, a biological fluid collection device of the present disclosure eliminates the need for additional vacuum creating components that must be connected to the biological fluid collection device during use.

PIVCs with extension sets can include one or more flow diverting features for maximizing the amount of flushing that occurs within the interior of the catheter adapter. These flow diverting features can therefore minimize the amount of residual blood, medicament, or other fluid that may exist within the catheter adapter after the PIVC has been flushed via the extension set. The flow diverting features may be in the form of structural modifications to the side port of the extension set, separate components that are contained within the side port or catheter adapter, integrated components within the side port or catheter adapter, other features or some combination of any of these features.

Aspects of the present disclosure include methods for modulating a photodetector in a light detection system (e.g., in a flow cytometer). Methods according to the present disclosure include irradiating with a light source a sample having particles in a flow stream, detecting light from the particles in the sample with a photodetector where the voltage of the photodetector is modulated between a first voltage and a second voltage at a modulation frequency, generating data signals from the light detected from the particles at one or more of the first photodetector voltage and at the second photodetector voltage and determining one or more parameters of the particle from the generated data signals. Systems and non-transitory computer-readable storage media configured to carry out the subject methods are also provided.

A specimen collection container assembly including a collection tube having a first open end and a second open end, and an interior reservoir formed within the collection tube. The assembly further includes a cap configured to be couplable to the collection tube to close the first open end, as well as a plug configured to be couplable to the collection tube to close the second open end. The collection tube also includes a flat mouth portion extending 360° around the first open end.

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