Abstract: Systems and methods that facilitate visualization and identification of lumens of a multi-lumen brachytherapy device are disclosed. In one embodiment, visualization and identification can be attained by modifying a feature of at least one of the lumens relative to the other lumens. The feature may include a marking on the lumen, a diameter of the lumen or a composition of the lumen. In an additional embodiment, for brachytherapy devices in which multiple lumens are coupled to a distal end point such as a rigid connection member, visualization and identification of the lumens can be attained by modifying a feature of the rigid connection member. It will be readily appreciated that visualization and identification can be further enhanced through a combination of two or more of the techniques described herein.

Abstract: An automated sample processing system includes a sample input adapted to receive at least one sample container holder manually provided by a user, a consumable input adapted to receive one or more unused consumable supplies manually provided by a user, a waste output adapted to receive used consumable supplies, an automated processing apparatus, and a sample output, wherein the automated processing apparatus includes a decapper adapted to remove a lid from the at least one sample container, at least one agitator adapted to agitate and thereby homogenize the contents of the at least one sample container, a sample collector adapted to remove fluid specimen from the at least one sample container and transfer the specimen to at least one output carrier, and a capper adapted to replace the lid on the at least one sample container.

Abstract: An automated system for preparing a plurality of cytological specimens from a plurality of fluid samples in vials includes an apparatus for collecting a monolayer of cells from each sample and transferring the cells to a microscope slide for fixing, staining, and inspection. The system includes a first loading station for receiving the sample vials, a second loading station for receiving consumables such as filter membranes, a slide dispenser, and an unloading area for removing completed specimen slides. To maintain one-to-one correlation between the samples and specimens produced therefrom, the system includes a subsystem for identifying each sample and permanently marking each slide with corresponding indicia prior to transferring the specimen thereto.

Abstract: A device for sealing a cervical opening includes a support structure, and a seal coupled to the support structure, the seal having a surface for abutting against tissue next to the cervical opening, wherein the seal is tiltable relative to the support structure. A device for sealing a cervical opening includes a support structure, and a member coupled to the support structure, wherein the member is inflatable to create a seal for abutting against cervical tissue. A device for sealing a cervical opening includes a seal having a surface for contacting tissue next to the cervical opening, an opening formed on the surface of the seal, and a vacuum port, wherein the opening is in fluid communication with the vacuum port.

Abstract: An automated system for preparing a plurality of cytological specimens from a plurality of fluid samples in vials includes an apparatus for collecting a monolayer of cells from each sample and transferring the cells to a microscope slide for fixing, staining, and inspection. The system includes a first loading station for receiving the sample vials, a second loading station for receiving consumables such as filter membranes, a slide dispenser, and an unloading area for removing completed specimen slides. To maintain one-to-one correlation between the samples and specimens produced therefrom, the system includes a subsystem for identifying each sample and permanently marking each slide with corresponding indicia prior to transferring the specimen thereto.

Abstract: Embodiments of luer-type needle-free valve devices are disclosed. One of the novel aspects of the invention is its ability to transform from an open state to a closed state. The open position eliminates the potential for a differential pressure to exist between the volume connected to the inlet and outlet of the valve fitting. The closed position enables the device to maintain a differential pressure between the volume connected to the inlet and outlet of the valve fitting. The invention is useful in manufacturing sterile medical devices by allowing all surfaces to communicate with the sterilizing agent when the valve is in an open configuration when it is in a closed position.

Abstract: A method and system for achieving hemostasis (the stoppage of bleeding) is described. RF (radio frequency) energy is used to ablate the surface of tissue to stop bleeding. The depth of destruction of the tissue can be controlled so as to desiccate and coagulate the tissue. In one implementation, an electrode carrier including bipolar electrodes is applied to the tissue, and RF energy transmitted through the bipolar electrodes to ablate the tissue. A layer of desiccated tissue can be created as well as coagulation of the tissue to achieve hemostasis.

Abstract: A method for tissue ablation is described. An RF applicator including an electrode carrier with one or more bipolar electrodes thereon is positioned at a target tissue site for tissue ablation. A current at an initial current level is passed through the one or more bipolar electrodes to the target tissue site to apply an initial power density to destroy tissue for an initial time period. A vacuum source in fluid communication with the RF applicator is employed to remove moisture generated during ablation away from the target tissue site. After the initial time period, the power density is ramped up by increasing the current passed through the one or more bipolar electrodes to the target tissue site for a second time period.

Abstract: An apparatus for processing a specimen from a fluid sample includes a first set of one or more microfluidic channels configured to deliver the sample fluid to a filter disposed on an inflatable bladder configured to transfer the specimen from the filter to a slide. The apparatus is configured to collect an approximate monolayer of particles and includes a second set of one or more microfluidic channels configured to remove fluid flowing through the filter disposed on the inflatable bladder. The apparatus also includes a pressure source, a sample container connected to the pressure source and the first set of one or more microfluidic channels, a fluid flow gauge configured to measure a fluid flow rate through the filter, and a stain source connected to the first set of one or more microfluidic channels.

Abstract: Embodiments of passive vent valve devices are disclosed. One of the novel aspects of the invention is its ability to transform from a packaging configuration to a use configuration. The packaging configuration allows sterilization gases to penetrate into the device through standard valve openings as well as through vented mesh openings. Passage of gas into the device, in turn, provides a means of sterilizing all surface areas in the device. Alternatively, when the valve is placed in a use configuration, the passage of gas through the vented mesh is inhibited providing a sealed environment that functions as a valve. The invention is useful in manufacturing sterile medical devices by allowing all surfaces to communicate with the sterilizing agent when the valve is in a packaging configuration or when it is in a use configuration.

Abstract: Systems and methods that facilitate visualization and identification of lumens of a multi-lumen brachytherapy device are disclosed. In one embodiment, visualization and identification can be attained by modifying a feature of at least one of the lumens relative to the other lumens. The feature may include a marking on the lumen, a diameter of the lumen or a composition of the lumen. In an additional embodiment, for brachytherapy devices in which multiple lumens are coupled to a distal end point such as a rigid connection member, visualization and identification of the lumens can be attained by modifying a feature of the rigid connection member. It will be readily appreciated that visualization and identification can be further enhanced through a combination of two or more of the techniques described herein.

Abstract: Methods and products for the detection of oncofetal fibronectin indicating molecules in samples are provided. Methods for imaging of oncofetal fibronectin are provided. In some methods provided herein, the sample is treated with a reagent and/or contacted with a non-specific binder. Provided are methods for testing subjects to ascertain health and disease status and to assess the risk of developing a disease or condition. Methods for detecting the presence of oncofetal fibronectin indicating molecules by a variety of methods such as immunoassays and mass spectrometry also are provided. Methods and products for detection of oncofetal fibronection for selection of concepti are provided.

Abstract: Devices and methods are disclosed for the direct visualization and localization of a target area within a body lumen through the optically clear walls of a graduated catheter. An elongated catheter has proximal and distal ends, an anchor, graduated markings, and outer and inner surfaces defining a catheter wall. The anchor establishes a secure relationship between the catheter and an anatomical feature. The graduated markings are disposed along a length of the catheter. The outer surface of the catheter wall is configured for contacting a body lumen and the inner surface of the catheter wall defines a main lumen disposed along a length of the elongated catheter. The catheter wall is transparent along a length to provide visualization of the graduated markings via a visualization tool positioned in the main lumen. In one embodiment, a catheter may have a substantially circular cross-section and include an arc-shaped transparent window.

Abstract: A uterine cavity length measuring device includes a first elongate member including a lumen and a plurality of apertures extending between the lumen and an exterior surface of the first elongate member, and a second elongate member including a lumen, and at least one aperture located at a distal end extending from the lumen of the second elongate member to an exterior surface, where the second elongate member is positioned within and is configured to move within the lumen of the first elongate member and where the first elongate member and second elongate member provide a fluid path from a proximal end of the lumen in the second elongate member, through the lumen in the second elongate member to the at least one aperture located at the distal end of the second elongate member and to at least one of the plurality of apertures in the first elongate member.

Abstract: A method and system for achieving hemostasis (the stoppage of bleeding) is described. RF (radio frequency) energy is used to ablate the surface of tissue to stop bleeding. The depth of destruction of the tissue can be controlled so as to desiccate and coagulate the tissue. In one implementation, an electrode carrier including bipolar electrodes is applied to the tissue, and RF energy transmitted through the bipolar electrodes to ablate the tissue. A layer of desiccated tissue can be created as well as coagulation of the tissue to achieve hemostasis.

Abstract: A brachytherapy treatment device includes at least one tubular insertion member and an expandable member. The tubular insertion member has proximal and distal ends and at least one radiation source lumen disposed along its length and branching at the distal end to provide a plurality of selectable radiation source lumens each configured to receive a radiation source. The expandable member is disposed on and surrounding the distal end of the tubular insertion member. In another embodiment, a brachytherapy treatment device may also include a plurality of selectable radiation source lumens forming an arcuate shape with respect to the longitudinal axis. Additional brachytherapy treatment devices and methods for performing brachytherapy and for forming an asymmetric radiation dosing profile are also disclosed.

Abstract: Apparatus for single-handed control of a microscope are disclosed. In one embodiment, a first controller, such as a first rotary controller, is configured for manipulation by a hand of a user to adjust a position of a microscope stage. Another controller, such as a second rotary controller, is configured and arranged relative to the first rotary controller for manipulation by an extended finger of the same hand to review, e.g., scroll through, previously identified portions of a biological specimen while the user's first hand may or may not remain in contact with the first rotary controller. In this manner, the user may continue to review the previously identified specimen portions without having to look away from the microscope.

Abstract: Methods, systems and computer readable media for processing one or more biological specimens carried by specimen slides. Images of objects in a specimen are acquired and objects of interest in the acquired images are identified. Additional images of identified objects of interest may be acquired at multiple wavelengths. Cellular features of objects of interest are extracted from images and may be used for classifying the specimen, e.g., as normal or suspicious/abnormal, based a probabilistic model that utilizes the extracted features.

Abstract: The present invention relates to a method and system for classifying biological specimen. A number of objects of interest are identified in a biological specimen. The nuclear area and nuclear integrated optical density for each object of interest in the specimen are measured and used for generating a scatter plot. The specimen is classified as normal or suspicious based on the distribution of points within the scatter plot.

Abstract: A brachytherapy treatment device includes an insertion member, an expandable chamber, and first and second immiscible fluids. The insertion member has proximal and distal ends. The expandable chamber is disposed on the distal end of the insertion member and has an inner surface defining a three-dimensional volume. First and second immiscible fluids are disposed within the expandable chamber and have different radiation absorption properties. At least one of the first and second immiscible fluids forms a fluid radiation shield having a predetermined orientation within the three-dimensional volume. First and second immiscible fluids may have different densities and utilize fluid buoyancy to form an symmetric fluid radiation shield to create an asymmetric radiation dosing profile relative to an inner boundary of a treatment site.