Abstract: The present disclosure provides a method for of determining the level of circulating tumor cells (CTCs) in a sample having blood cells from a patient comprising obtaining a test sample from a human subject; enriching circulating tumor cells (CTC); hybridizing the enriched cells in the sample with labeled nucleic acid probes that hybridize to regions of chromosomal DNA; evaluating the signal pattern for the selected cells by detecting fluorescence in situ hybridization from cells; detecting CTCs based on the pattern of hybridization to the labeled nucleic acid probes to said selected cells; and identifying the subject at risk for the development of lung cancer when the number of CTC per sample is above a predetermined cutoff value.

Abstract: In some embodiments, a non-transitory processor-readable medium stores code representing instructions to be executed by a processor. The code includes code to cause the processor to receive a plurality of sets of images associated with a sample treated with fluorescence in situ hybridization (FISH) probes. Each image from that set of images is associated with a different focal length using a fluorescence microscope. Each FISH probe can selectively bind to a unique location on chromosomal DNA in the sample. The code further causes the processor to identify cell nuclei in the images. The code further causes the processor to apply a convolutional neural network (CNN) to each set of images. The CNN is configured to identify a probe indication from a plurality of probe indications for that set of images. The code further causes the processor to identify the sample as containing circulating tumor cells.

Abstract: An infant support and stabilization cushion seat to provide a safe and secure containment and retainment of an infant in a sitting position. The support cushion seat is formed of a resilient shape retaining foam core with a yielding encapsulating surface cover material defining a contoured child receiving area therewithin. An insertable access retainment tray portion overlies a portion of the child receiving area with deflectable under child placement and retrieval returning to the original orientation, once released.

Abstract: An exercise apparatus having a resilient band attachment assembly for use with an exercise ball. An exercise ball engagement ring provides multiple attachment points for resilient bands selectively and adjustably secured thereto. During use, a user rests a portion of their body on the exercise ball while pulling the resistant straps elongating same for varied resistance depending on strap length, diameter and attachment point within the ball engagement ring.

Abstract: An exercise apparatus having a resilient band attachment assembly for use with an exercise ball. An exercise ball engagement ring provides multiple attachment points for resilient bands selectively and adjustably secured thereto. During use, a user rests a portion of their body on the exercise ball while pulling the resistant straps elongating same for varied resistance depending on strap length, diameter and attachment point within the ball engagement ring.

Abstract: An infant support and stabilization cushion seat to provide a safe and secure containment and retainment of an infant in a sitting position. The support cushion seat is formed of a resilient shape retaining foam core with a yielding encapsulating surface cover material defining a contoured child receiving area therewithin. An integrated access retainment tray portion overlies a portion of the child receiving area and is deflectable for child placement and retrieval returning to the original orientation, once released.

Abstract: The invention relates generally to fluid processing and, in particular aspects, processing fluids for detection, selection, trapping and/or sorting of particulate moieties. Sheath flow devices described allow isolation of target species from fluid samples while avoiding non-specific binding of unwanted species to the surfaces of the separation device. Biological fluid processing, detection, sorting or selection of cells, proteins, and nucleic acids is described. The invention finds particular use in diagnostic settings, analyzing a patient's medical condition, monitoring and/or adjusting a therapeutic regimen and producing cell based products.

Abstract: The invention relates generally to fluid processing and, in particular aspects, processing fluids for detection, selection, trapping and/or sorting of particulate moieties. Sheath flow devices described allow isolation of target species from fluid samples while avoiding non-specific binding of unwanted species to the surfaces of the separation device. Biological fluid processing, detection, sorting or selection of cells, proteins, and nucleic acids is described. The invention finds particular use in diagnostic settings, analyzing a patient's medical condition, monitoring and/or adjusting a therapeutic regimen and producing cell based products.

Abstract: A system for sorting and trapping magnetic target species includes a microfluidic chamber designed to receive and then temporarily hold magnetic particles in place within the module. A pre-processing module may mix a sample and magnetic particles to cause certain species in the sample to be labeled. The micorfluidic chamber may include a mechanism to move magnetic particles within the chamber. A post-processing module or the microfluidic chamber may be used to separate the labeled species from the magnetic particles by adding a release reagent. The magnetic particles and/or their payloads may be released and separately collected at an outlet of the chamber or the post-processing module.

Abstract: A system for sorting and trapping magnetic target species includes a microfluidic trapping chamber designed to receive and then temporarily hold magnetic particles in place within the module. An external magnetic source moves relatives to the fluid chamber as the magnetic particles flow the device in the fluidic medium. The magnetic particles flowing into the module are trapped there while the other sample components (non-magnetic) continuously flow through and out of the station, thereby separating and concentrating the species captured on the magnetic particles. The magnetic particles and/or their payloads may be released and separately collected at an outlet after the sample passes through the trapping module.

Abstract: The invention relates generally to fluid processing and, in particular aspects, processing fluids for detection, selection, trapping and/or sorting of particulate moieties. Sheath flow devices described allow isolation of target species from fluid samples while avoiding non-specific binding of unwanted species to the surfaces of the separation device. Biological fluid processing, detection, sorting or selection of cells, proteins, and nucleic acids is described. The invention finds particular use in diagnostic settings, analyzing a patient's medical condition, monitoring and/or adjusting a therapeutic regimen and producing cell based products.

Abstract: Flexible pouch and flexible cartridge devices for fluid sample processing, related methods of making and using, related manufacturing systems and related instrumentation systems are described. Flexible pouches provide broad advantage in a wide variety of fields by overcoming the need for complex instrumentation, dedicated devices, and relatively high cost in conventional fluid sample devices. Flexible cartridge devices are particularly advantageous in control of fluid handling, rapid adaptation to a number of configurations by the end user, multiple uses for a single configuration, and in cost and ease of manufacture.

Abstract: A system for sorting and trapping magnetic target species includes a microfluidic trapping module designed to receive and then temporarily hold magnetic particles in place within the module. The magnetic particles flowing into the module are trapped there while the other sample components (non-magnetic) continuously flow through and out of the station, thereby separating and concentrating the species captured on the magnetic particles. The magnetic particles and/or their payloads may be released and separately collected at an outlet after the sample passes through the trapping module.

Abstract: An infant support cushion to provide a safe and secure environment for containment and retainment of an infant in a sitting position. The support cushion is provided with a resilient foam cushion body with a child receiving opening centrally therein and a contoured extremity receiving portions defined by an access opening inwardly from its perimeter front edge surface by oppositely disposed extending cushion arm portions. Interlinking fastener elements maintain the arm portions in an engaged closed position maintaining corresponding central opening therewithin and contoured extremity receiving portions for the infant's leg.

Abstract: Instrumentation and method for treatment of a spinal structure, comprising an elongate member including a deformable distal portion having an initial configuration for placement within the spinal structure and a deformed configuration wherein the distal portion is outwardly deformed to form a cavity in the spinal structure. The elongate member comprises a cannula member and an actuator member that is removably positioned within the cannula member and configured to transition the deformable distal portion from the initial configuration toward the deformed configuration. The actuator member is selectively removed from the cannula member to provide a passageway for delivery of a material into the cavity formed in the spinal structure.

Abstract: Instrumentation and method for treatment of a spinal structure, comprising an elongate member including a deformable distal portion having an initial configuration for placement within the spinal structure and a deformed configuration wherein the distal portion is outwardly deformed to form a cavity in the spinal structure. The elongate member comprises a cannula member and an actuator member that is removably positioned within the cannula member and configured to transition the deformable distal portion from the initial configuration toward the deformed configuration. The actuator member is selectively removed from the cannula member to provide a passageway for delivery of a material into the cavity formed in the spinal structure.