Abstract: A sample collection and detection device includes a collection cavity. The device further includes a sample collector. The sample collector comprises a collection rod and an absorption element, and the absorption element has a hollow cavity. A part of the collection rod is received in the hollow cavity of the absorption element. A first lug for blocking and locating the absorption element is arranged on the collection rod. Also provided is a method for collecting and detecting sample using the sample collection and detection device.

Abstract: A method includes hermetically sealing a medical device within a pouch, the pouch including peeling panels that are free from one another. The pouch is placed within a tray and the peeling panels are attached to unloading handles of the tray. The unloading handles are releasably coupled together. The method further includes simultaneously separating the unloading handles and the peeling panels to open the pouch and expose the medical device for removal thereof.

Abstract: A method and corresponding test kit is provided for the determination of whether a non-consensual sexual encounter between known individuals has occurred when previous consensual relations have taken place between the known individuals.

Abstract: In various embodiments of the invention, a tissue biopsy sampling device is located or oriented on a site within a body cavity or canal with a retention device. In various embodiments of the invention, a tissue biopsy sampling device is retained or held in place on a desired specific location on the epithelial tissue with the retention device. In various embodiments of the invention, the epithelial tissue within the cavity or canal is presented to the tissue biopsy sampling device using the retention device. In various embodiments of the invention, the retention device is used to assist withdrawal of the tissue biopsy sampling from within the body cavity or canal.

Abstract: The invention relates to methods and compositions for restoring normal microbiota in pre-term newborns or newborns delivered by Cesarean section and methods for preventing or ameliorating diseases associated with delivery by Cesarean section or pre-term birth comprising administering to said newborns at the time of birth or shortly thereafter an effective amount of a vaginal microbiota inoculum obtained from the newborn's mother or a donor or an effective amount of a probiotic composition. The invention also relates to a device for collecting maternal vaginal microbiota from the vaginal canal of a patient. The device can have a housing forming a cavity, an absorbent material removable disposed within the cavity, and a deployment element disposed in the housing and movable along a length of the housing. The movement of the deployment element can displace the absorbent material out of the cavity and in to the vaginal canal.

Abstract: The present disclosure provides systems, methods, devices, and kits for analysis of vaginal biological samples. A device for the analysis of vaginal biological samples can include a sample collector, an extractor, and an assay cartridge. A method for the analysis of vaginal biological samples can include detecting the presence or absence of a pathology, a disease, an immune disorder, a reproductive disorder of a subject. The method may further comprise preserving, storing, or transporting the vaginal biological samples. A kit for the analysis of vaginal biological samples can include probe, reagents and instructions for detecting a nucleic acid in the vaginal biological samples.

Abstract: Methods and apparatus for rapid, culture free pathogen detection. The methods utilize optical spectroscopy techniques to identify and/or characterize pathogens in a sample via the detection of unique properties and/or analytes that are specific to particular pathogens.

Abstract: Device for surface sampling, comprising: a flat material layer comprising a surface portion and a circumferential edge portion defining the boundary of the surface portion, further comprising a sampling volume, wherein the sampling volume is adapted to comprise a filler device for filling out the sampling volume, a protective layer arranged on the surface portion of the material layer by an adhesive arranged on the material layer, wherein a portion of the protective layer extends beyond the boundary of the surface portion for facilitating a removal of the protective layer from the material layer.

Abstract: A sampling probe, having a housing, with a flange at housing's proximal end, and an internal step ring including a protruding follower tab toward housing's distal end. The sampling probe further includes a shaft inside the housing, with a brush at shaft's distal end and a handle at shaft's proximal end. The shaft includes a solid proximal section, and a spirally grooved distal section, engaging the housing's follower tab. A retracting compression spring is positioned on the spirally grooved distal section of the shaft inside the housing. With the sampling probe distally inserted in a vagina canal for a Pap smear, pushing the shaft handle distally, the brush at the end of the shaft protrudes out of the housing rotationally, taking a cell sample, followed by the retracting compression spring retracting the brush back into the housing when the shaft handle is released, completing the Pap smear.

Abstract: An improved two-part swab applicator is provided, having a handle section and a receptacle section that are engaged through coupling and an end cap. A stem having a swab attached at one end is encompassed by both sections with the swab nesting within the receptacle section. The receptacle section has a hollow body and a plurality of ribs on the body to prevent the applicator from rolling and the liquid from spilling. The receptacle section may also have a collar with one or more notches to prevent rolling of the receptacle section. The end cap may have a collar with one or more notches that prevent the handle section and/or the applicator from rolling and catches any drips of the liquid when the swab is removed for use. The end cap also has a plurality of ribs on its body that prevents the applicator from rolling.

Abstract: A sample collecting device for collecting samples of cellular material includes an outer tubular member, an inner tubular member and a swab having a tip. At least one guiding element supports and slidably arranges the swab in the inner tubular member such that there is a free space around the swabbing tip. A flexible valve is arranged at a distal end of the outer tubular member. In a storage configuration, the valve is closed and seals the distal end of the outer tubular member. In a sampling configuration, the valve is open such that the swab is slidable to extend through the distal end of the outer tubular member without contacting the valve. A swab kit for collecting and storing samples of cellular material from body cavities includes a sample collecting device and a sealable container adapted to receive and store at least a part of the sample collecting device.

Abstract: The present invention relates generally to a sampling apparatus and a method for bodily fluids, and, more specifically, a blood sampling apparatus and a method for using the same. A blood collection system includes a housing having at least one open end, and an absorbent material positioned within the housing. The absorbent material has at least one end positioned proximate the at least one open end of the housing. A method of collecting blood samples includes positioning an absorbent material near a source of blood, holding the absorbent material with a housing, the absorbent material absorbing a volume of blood, and moving the housing and absorbent material to a position where the absorbent material can dry.

Abstract: Disclosed herein are various implementations of a fiber optic shape-sensing system comprising a plurality of optical fibers helically twisted and rigidly bonded to form a linearly-running shape-sensing bundle for measuring position, bend, and twist of the shape-sensing bundle, wherein each optical fiber from among the plurality of optical fibers comprises a single core. Several such implementations of the systems further comprise an array of Fiber Bragg Gratings (FBGs) disposed within the core of each single-core optical fiber from among the plurality of single-core optical fibers.

Abstract: Device (1) for surface sampling, comprising: a material layer (2) comprising a surface portion (2c) and a circumferential edge portion (2d) defining the boundary of the surface portion (2c), further comprising a sampling volume (2a), wherein the sampling volume (2a) is adapted to comprise a filler device (2b) for filling out the sampling volume (2a), a protective layer (3) arranged on the surface portion (2c) of the material layer (2) by an adhesive (4) arranged on the surface portion (2c) of the material layer (2), wherein the device (1) further comprises a removal device (12), wherein the removal device (12) is fixedly arranged to the material layer (2), wherein the removal device (12) further comprising a removal surface portion (12a), wherein the removal surface portion (12a) is adapted to provide a lower adhesion against a surface compared to the adhesive (4), wherein the removal surface portion (12a) is facing essentially the same direction as the surface portion (2c).

Abstract: A vaginal fluid monitoring device includes an absorbent layer, wherein the absorbent layer is configured to be in proximity to flow of vaginal fluid; an electrochemical detection system configured to obtain data regarding at least one analyte in a vaginal fluid, said electrochemical detection system in fluid communication with the absorbent layer; and wherein the vaginal fluid monitoring device is configured to be coupled with a feminine hygiene product.

Abstract: The present invention relates generally to methods and materials pertaining to assays, for example immunoassays, for biomarkers in body fluids e.g. blood. The invention also relates to diagnostic or screening methods for infections, and methods of differentiating between infectious and non-infectious conditions in mammals, particularly equines, for monitoring response to anti-infective/antibiotic therapy. The invention further relates to a test fluid collection system adapted to permit dilution and analysis of the collected test fluid. The invention further relates to monitoring exertional rhabdomyolysis in equines, and assay devices for all these things.

Abstract: There is provided a protective cover including: an installation section configured to be installed on an arm that supports an imaging device, the arm including a plurality of links joined to each other by one or a plurality of joint sections; and a protective section configured to cover the imaging device.

Abstract: Methods, apparatuses and systems for collecting cells from a body lumen are described. A system may include a cell collection device comprising an abrasive material configured to collect cells from the body lumen by scraping a surface of the body lumen. The cell collection device may have a first end with a first diametric dimension and a second end with a second diametric dimension, wherein the second diametric dimension is larger than the first diametric dimension.

Abstract: A device for collecting a biological sample in a patient includes a collection portion having a first axial end portion and a second axial end portion. The second axial end portion has a collapsed position and an expanded position. The second axial end portion moves in an axial direction relative to the first axial end portion when the second axial end portion moves between the collapsed position and the expanded position. The second axial end portion extends axially into the first axial end portion and has a concave shape when in the collapsed position. The second axial end portion is convex when in the expanded position.

Abstract: A disposable cartridge can be used for biofluid sample collection, preparation, and mixing with reagents. After sample collection, the cartridge can be inserted into a reader for sample analysis. This system can be used for detecting and measuring analytes, such as drugs, in saliva for example. This is useful for point of test detection of drugs in applications such as workplace drug testing and driving under the influence of drugs testing.

Abstract: A pipette device, including a container having a predetermined space therein, in one end of which a nozzle is formed and the other end of which is opened; a first fixing member whose one end is detachably coupled to the other end of the container; a second fixing member coupled to the other end of the first fixing member; and a pumping member that is inserted into the second fixing member such that an opened end portion faces the other end of the container and delivers internal air into the container by changing shape when it is pressed, wherein the opened end portion of the pumping member is fixed between the first fixing member and the second fixing member by coupling of the first fixing member and the second fixing member.

Abstract: A biological sample collection, storage, and transport device includes a collection assembly and a sheath, wherein the collection assembly includes a support shaft, a swab head, and a handle, the swab head mechanically couples to a distal support shaft end, the handle couples to a proximal support shaft end, and the collection assembly slideably couples to the sheath and is configurable in a retracted position with the swab head entirely disposed within the sheath or an extended position with the swab head extending outside of the sheath. A distal sheath end includes an aperture, the aperture having a circumference large enough to allow the swab head to pass through said aperture when the collection assembly is configured in the extended position, and a seal is applied to the distal sheath end after the swab head has collected a biological sample and the collection assembly has been reconfigured into the retracted position.

Abstract: A system and a method for a medical diagnostic device are described herein. The medical diagnostic device can include an outer sleeve having a hollow interior and open distal and proximal ends, the outer sleeve being defined by a substantially tubular configuration including a proximal section having a substantially conical shape. A core is configured to be inserted axially within the outer sleeve. The core includes an axial inner cavity. The core is further defined by a proximal section having a conical shape substantially conforming to the proximal section of the outer sleeve. The core retains a diagnostic assembly, that can include at least one of a sample collecting assembly and an imaging assembly, that can be integrally or interchangeably attached and wherein the device can be utilized for self-patient or single patient use.

Abstract: A biological sample collection device 10 is disclosed including a shaped sample collecting tip 20a, said tip at least being formed from a fibrous material mixed with a liquid to form a pulp, said pulp being solidified to form the shape of the tip.

Abstract: A swab assembly for collecting a specimen from a patient includes an elongated shaft having a proximal end, a distal end, and a notch between its proximal and distal ends; a sheath having a proximal end, a distal end, and a lumen extending between its proximal and distal ends, wherein a portion of the elongated shaft is disposed within the sheath lumen, and the sheath is slidable relative to the elongated shaft; and a collection tip coupled to the distal end of the elongated shaft and configured for obtaining the specimen. The sheath is slidable between a first position in which the shaft notch is disposed within the sheath lumen and wherein the sheath protects the elongated shaft from breaking at the notch, and a second position in which the shaft notch is exposed out of the sheath lumen.

Abstract: The present invention relates to a dispensing mechanism (2) for delivery of pharmaceutical forms (4) into body holes and an applicator (I) comprising the novel dispensing mechanism (2). The pharmaceutical form dispensing mechanism (2) Comprises a rod (2A) connected to a flexible member (2B). One end of the rod is free from constraints in order to allow its axial movement. The other end of the rod is cooperatively connected to said flexible member (2B). The flexible member has a rounded or angular shape, being able to be deformed and being provided with shape memory. The flexible member (2B) extends in a direction perpendicular to the direction of a compression force applied to it and recovers its original shape when said compression force is withdrawn, thereby imparting, respectively, a forward or rearward movement to the rod (2A), namely when a part (2C) thereof is immobilized in the body (3) of the applicator.

Abstract: Devices, and methods of use thereof, are provided for the collection of a biological sample during insertion into a human orifice. The device may include a body piece, an insertion piece extending from one end of the body piece, and a handle connected to the other end of the body piece. Upon rotation of the handle, a shaft housed within the body piece, with a collection end at a distal portion thereof, is extended from a retracted position to an extended position, such that the collection end exits an opening within the insertion piece. The angle of the body piece relative to the insertion piece may be configured for self-sampling of a vaginal sample in a seated position. The collection end may be a swab with a plurality of pinwheeling fins having leading edge oriented to collect the biological sample when the shaft is rotated in a given direction.

Abstract: A method for the detection, identification and enumeration of microorganisms in a porous support including reaction medium powder throughout its thickness, the support having been dry-impregnated throughout its thickness by a dehydrated reaction medium. Further, a device is used and enables the method to be carried out.

Abstract: An assistive sample collection and storage assembly for collecting, transferring and storing a biological sample includes a sample collection device having a first portion and a second portion. The first portion is configured to receive a sample collection member. The assembly includes a sample storage device comprising a sample substrate configured to receive at least a portion of the biological sample from the sample collection member. The assembly is configured to exist in a first state and a second state. The sample collection member is disposed at a determined distance from the sample substrate in the first state. At least a portion of the sample collection member is in physical contact with at least a portion of the sample substrate in the second state. The sample collection member is configured to apply a determined amount of contact force between the collection member and the sample substrate in the second state of the assembly.

Abstract: An applicator for administering a liquid to a selected location of a patient includes a main body having an interior cavity and a flexible outer wall. A frangible ampoule is configured to contain the liquid and configured to be positioned within the interior cavity of the main body. A hypodermic tube having a proximal end attached to the main body and a distal end. An applicator tip attached to the distal end of the hypodermic tube to dispense the liquid.

Abstract: A system and method for eluting a sample from a swab are presented. The system includes a chamber dimensioned to receive at least a portion of the length of at least one swab, a fluidic channel connected to the chamber, and an actuator. The chamber has at least one wall being a flexible film. The fluidic channel is configured to at least one of introduce and expel liquids from the chamber. The actuator is configured to contact an outer surface of the flexible film such that movement of the actuator against the outer surface of the flexible film causes a respective movement of the at least one swab when the at least one swab is disposed next to an inner surface of the flexible film. The respective movement of the at least one swab elutes the sample from the at least one swab into the chamber.

Abstract: A biopsy device comprises a body, a needle, a cutter, and a tissue sample holder. The tissue sample holder comprises an outer cup and a cap. A tray retains severed tissue samples from a biopsy procedure. In some versions, the tray is selectively detachable from the cap in a one-handed operation by the user. The tray may be ejected into a sample container, such as a formalin cup. The cap may include a threaded portion that is configured to engage a complementary threaded portion of a sample container to seal the sample container once the tissue samples have been transferred to the sample container from the tissue sample holder of the biopsy device. One or more ports may be provided in the cap to manage excess fluid within the outer cup of the tissue sample holder, and/or to provide integrated access for a marker delivery device.

Abstract: More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.

Abstract: A biopsy system comprises an introducer and a biopsy device. The introducer comprises a cannula and at least two leaves. The cannula comprises an ovular cross-section, an open distal end and an open proximal end. The ovular cross-section defines a lumen extending between the open distal end and the open proximal end. The ovular cross-section of the cannula includes at least two flat sides. The at least two leaves extend distally from the open distal end. At least a portion of each of the at least two leaves extend from a respective flat side of the at least two flat sides of the cannula. The biopsy device comprises a body and an elongate needle. The elongate needle extends distally from the body. The elongate needle includes an ovular cross-section defining two straight sides. The cannula of the introducer is configured to slidably receive the elongate needle of the biopsy device.

Abstract: The present invention comprises methods and devices comprising a cutting element used to contact circumferentially and longitudinally the surface walls of the endocervical canal to provide for broad and complete contact of the intended surface with the device, resulting in attainment of a sufficient volume and comprehensive tissue sample for analysis as an endocervical curettage or screening pap smear. The device may provide for a reservoir for the obtained sample to be contained when removing from the cervical canal and vagina. The device may be comprised of a detachable means or be of a material that allows the user to cut the sampling head of the device for placement in collection means to maximize the amount of tissue or cells being sent to the laboratory for analysis.

Abstract: Methods, devices and systems facilitate gastric retention of a variety of therapeutic devices. devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus wherein a retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

Abstract: Collection devices, kits and methods related to sample collection and analysis can be used to collect and store samples (e.g., biological samples) from a variety of sources and optionally, for analysis of such samples (e.g., forensics analysis, medical diagnostics, etc.). Methods of production and use thereof are described herein. A device for collecting a sample (e.g., a sample including nucleic acid) includes an outer protective housing and a collection tip operably coupled to a carrier. The collection tip includes a hydrophilic and at least partially soluble material (e.g., hydrophilic and at least partially soluble polycaprolactone (PCL)) and is movable (e.g., retractable) from a first protected position within the outer protective housing to a second collecting position outside the outer protective housing.

Abstract: A specimen collection or a specimen collection and testing device having an embossed or raised section. In one embodiment the device includes a first panel with one or more apertures for receiving specimen and a second panel having a removable tab, the removable tab aligned with the one or more apertures when the device is assembled such that depositing specimen through the one or more apertures deposits the specimen on the removable tab. A cover has one or more embossed (or raised) sections that align with the one or more apertures when the cover overlays the first panel, thus helping to prevent adherence of the specimen to the inner surface of the cover.

Abstract: Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. The reader component may communicate with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Abstract: The invention includes a method of detecting the presence or absence of mold in a sample. The method can include the step of applying a sample suspected of containing the mold to a growth medium, optionally fragmenting the sample, associating the sample with a labeling agent, and detecting the presence or absence of the mold by detection of the labeling agent. The invention can also include a medium for growing mold that includes a stimulation agent.

Abstract: The present invention provides devices and methods for detecting and capturing molecular biomarkers from a subject in situ. Specifically, the devices contain an array of microneedles to which are attached probes specific for one or more biomarkers of interest. The devices can be used directly on a subject (e.g., via skin piercing) in detecting the biomarkers in the body of the subject (e.g., tissues, blood stream).

Abstract: Described is a system for the stabilization, conservation and storage of a nucleic acid, wherein the system comprises a test tube and a preferably freeze-dried stabilization mixture. Upon addition of a viscous bodily fluid to the mixture, the mixture dissolves and stabilizes the nucleic acid present in the bodily fluid.

Abstract: The present invention is directed to a method and a device for accurately guiding a chest tube to an intended position within a pleural cavity of an animal or human being. There is also provided a kit-of-parts comprising a catheter and a catheter guiding device according to the present invention.

Abstract: Methods of using a biological sample collection device comprising a collection portion and a body portion, the body portion including a holding portion for holding a biological sample storage medium, and a sample transfer means, such as a cover. The collection portion can be arranged in a first position separated from the body portion for collecting a sample, and in a second position at least partly between the sample transfer means and the holding portion, with the sample transfer means being operable to push the collection portion towards a position at which the holding means is arranged to hold the biological sample storage medium, enabling a sample held in the collection portion to be transferred to the latter.

Abstract: A method for transferring a quantity of analytes comprising at least stages of: predisposing a substantially homogeneous mixture of a predetermined initial quantity of at least an analyte and a liquid, obtaining a known concentration value or known amount of the analyte in the mixture; introducing into the mixture at least a collecting portion (3) of a sampling device (1) having a support body (2), the collecting portion (3) comprising a plurality of fibers (6) attached to and arranged on a first portion (2a) of the support body (2) by means of flocking, in order to define a flocked collecting portion (3) or a flocked tampon, such as to collect a part of the mixture on the collecting portion (3); and extracting the collecting portion (3) of the sampling device (1) of the mixture, retaining on the sampling portion (3) a predetermined known quantity of the mixture to be transferred.

Abstract: The methods and apparatus of the present invention allow the evaluation of inflammation of the esophagus. Measurements may be utilized, for example, to diagnose a disease of the esophagus, to monitor inflammation of the esophagus, or to access the treatment of a disease of the esophagus. In one embodiment, the invention comprises a method for measuring esophageal inflammation comprising deploying a device into the esophagus of a subject, removing the device after a predetermined period of time, analyzing the device for a diagnostic indicator of esophageal inflammation and evaluating the diagnostic indicator to diagnose esophageal inflammation.

Abstract: The field of the present invention pertains to a controlled transfer biological collection device using a dry solid storage and transfer medium and a method for the collection of biological material of interest (genetic or proteinaceous material) in a form suitable for storage and/or subsequent analysis. Specifically, the present invention provides for a sampling device that controls the transfer of the biological sample to the storage medium by holding the storage medium and a moveable sample collection member having an analyte collection surface. The invention further provides for a method not only for storing a biological analyte on this collection device but also for analyzing the stored biological analyte using methods that are suited for automated analyzing systems.

Abstract: The present invention relates generally to a system and method for measuring the structural characteristics of an object. The object is subjected to an energy application processes and provides an objective, quantitative measurement of structural characteristics of an object. The system may include a device, for example, a percussion instrument, capable of being reproducibly placed against the object undergoing such measurement for reproducible positioning. The structural characteristics as defined herein may include vibration damping capacities, acoustic damping capacities, structural integrity or structural stability.

Abstract: The present disclosure relates to a surgical instrument for sampling molecules in an organ which can be accessed directly or via a surgical portal, including: a device for capturing the molecules, a stylet supporting the capture device, capable of entering the organ, a guide for inserting the stylet into the body as far as the organ, wherein the distal end of the guide is provided with a damping block intended to come to bear upon the organ.

Abstract: The present invention provides methods to concentrate cells onto microparticles, to concentrate the microparticles, and to detect the cells. The present invention also includes unitary sample preparation and detection devices to be used in accordance with the methods.