Abstract: A system for aseptic collection of mammalian amniotic fluid. The system includes a cannula having an attachment end and external end. The attachment end provides a concentric opening to a hollow chamber disposed about a central passage. The hollow chamber has a port disposed adjacent to the external end permitting at least a partial suction to be established within the hollow chamber, the attachment end thereby suctionally attached to a surface when the attachment end is disposed upon the surface. The central passage provides access to a central portion of the surface surrounded by the concentric opening of the hollow chamber. An extraction needle is disposed within the central passage of the cannula and presented to the central portion of the surface. The extraction needle penetrates the central portion of the surface and extracts amniotic fluid there beneath. An associated method of use is also provided.

Abstract: A urinary catheter assembly includes an intermittent urinary catheter disposed in a cavity formed by a handle, and a connector, and a sleeve attached between the handle and the connector. The connector has a drain. The drain is formed by an outer wall of the connector separated from an inner wall of the connector by a channel.

Abstract: A female urinary catheter deployment device includes a housing, an inner tip, an outer tip, a catheter, and an actuator. The outer tip is moved into the vicinity of the urethral opening of a female urethra. The outer tip is then moved from a closed condition to an open condition so as to expose a proximal end of the inner tip and position the proximal end of the inner tip within the urethra. The actuator is then moved with respect to the housing so as to proximally advance a proximal end of the catheter through and out of the proximal end of the inner tip and into the urethra. The proximal end of the catheter is further advanced through the urethra and into the bladder so as to drain urine from the bladder, through the catheter, and out of the housing.

Abstract: The present disclosure describes systems and apparatuses related to a bronchial isolation tube, a laryngeal mask or similar device, and/or adapters and connectors for use with the same, as well as methods for using the same. In an exemplary airway device, the device may comprise a mask portion being defined at a distal end of the airway device, and may be configured and dimensioned to be positioned in a hypopharyngeal area of a patient to cover and seal around a glottis of the patient; and a channel portion extending from a proximal end of the airway device to the mask portion. The channel portion may include first and second channels, wherein the second channel may obliquely merge with the first channel proximate to an opening of the first channel. In an exemplary embodiment, a third channel may form a combined pharyngeal-gastric access channel.

Abstract: The present invention is a simple-to-use IV placement assist device with an added safety feature. A catheter advancer is slidably integrated with a base to guide advancement of a catheter linearly along the insertion path of the needle and catheter. A safety feature is engaged by a movable component moving from a first position to a second position, such movable enabling relative movement between the base and catheter advancer and/or catheter assembly, rotation of the needle about its length axis, and/or minor advancement of the catheter assembly to sheath the tip of the needle. The IV placement assist device stabilizes and guides the critical needle insertion and catheter advancement steps of a complication-prone and very common procedure.

Abstract: Described is a catheter for being retained inside the body for extended periods, and a catheter mating device that can connect to the catheter to move the catheter inside of the body or remove it from the body. The catheter mating device has a stem with an apparatus at its distal end. The apparatus is moveable between a first position and a second position. When in its first position, the distal end is configured to fit in the proximal end of the catheter. When in its second position, the distal end engages the proximal end of the catheter and connects the catheter mating device to the catheter.

Abstract: Medical waste collection manifolds that that may connect to a vacuum system to create suction, such that liquid, semi-solid, or solid biological or medical waste may be collected are provided. The manifold may be configured to collect hazardous waste in a manner to ensure proper containment.

Abstract: A surgical system includes a bronchoscope, an extended working channel defining an elongated passageway and adapted to extend through the bronchoscope, and a valve in fluid communication with the passageway of the extended working channel. The surgical system further includes an elongated surgical instrument configured and dimensioned to be inserted through the extended working channel. During operation, a fluid is able to flow from the valve and through the extended working channel such that the fluid travels within an annular area surrounding the elongated surgical instrument positioned within the extended working channel.

Abstract: Featured herein is a surgical airway device (10) that is constructed and arranged to be placed into the mouth of a patient to maintain a surgical airway in the patient. Also featured is a method of using such a surgical airway device (10). The surgical airway device (10) has a flange (20) that is constructed and arranged to be located outside of the mouth, an inner tube (21) that defines a working channel (22) defining an anterior opening in the flange (20) and located proximate the lips, and a posterior end (26) located in the back of the mouth. There is an outer tube (70) that is generally coaxial with, spaced from and fully or partially surrounds the inner tube (21), wherein a coaxial gap (80) is located between at least part of the outer tube (70) and the inner tube (21). There is a first lumen (30) that is in fluid communication with the working channel (22) and a second lumen (40) that is in fluid communication with the coaxial gap (80).

Abstract: A catheter assembly includes a protective tip defining an interior chamber between its proximal and distal ends. A protective lubricious sleeve is positioned within the interior chamber. A catheter of the assembly is configured to be advanced proximally into and through the interior chamber to position at least a portion of the catheter within the protective sleeve, with the protective sleeve being retained upon the catheter as at least a proximal portion of the catheter exits the proximal end of the protective tip and is advanced through a body lumen. A second sleeve may be associated with the protective tip and configured to extend distally from the protective tip to remain outside of the body lumen during use and receive a more distal portion of the catheter.

Abstract: Various embodiments of the present invention include a cannula coated or compounded with a material to extend the wear time for a patient by reducing inflammation and therefore increasing the time that the cannula may remain inserted, thereby increasing the effectiveness of the drug delivered using the cannula. The material may include a hydrophilic material, an anti-microbial material, an anti-inflammatory material, anti-thrombogenic material, or a combination of any of these materials.

Abstract: Device for sampling tear fluid that comprises: an extraction element (202) adapted to be applied on the eye to draw tear fluid therefrom, comprising at least one tube (209) and a distal portion (201) with at least one opening (207), a collection vessel (203), connected to said tube (209), suction means (210) adapted to continuously draw tear fluid from the eye to the collection vessel (203), through the extraction element (202) for a period higher than 10 minutes once the extraction element (202) is in place.

Abstract: Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a certain volume of sample from a source of bodily fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample to the patient. The analyte monitoring system can include an automated blood withdrawal system that is configured to withdraw blood from the patient's vasculature at low pressure and/or withdrawal rates so as to reduce or prevent contamination of the withdrawn fluid from the infusion fluids.

Abstract: A device for dilating an ostium of a paranasal sinus of a human or animal subject may include: a handle; an elongate shaft having a proximal end coupled with the handle and extending to a distal end; a guidewire disposed through at least a portion of the shaft lumen; a dilator having a non-expanded configuration and an expanded configuration; and a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft.

Abstract: Medical waste collection manifolds that that may connect to a vacuum system to create suction, such that liquid, semi-solid, or solid biological or medical waste may be collected are provided. The manifold may be configured to collect hazardous waste in a manner to ensure proper containment.

Abstract: An apparatus comprises a detection indicator, a housing, and an exoskeleton in which the housing nests. The detection indicator is configured to furnish a visual indication upon contact with a fluid responsive to a characteristic of the fluid. The housing comprises an interior chamber configured to receive the fluid and to provide contact between the fluid and the detection indicator. The housing is configured to removably engage a conduit coupled to a source of a fluid sample, which may be a lumen inserted into a patient to receive fluid therefrom. In methods for use with the apparatus, a sample is collected, a characteristic is measured by the apparatus, and the apparatus is disconnected so as to avoid leakage of the sample and exposure of personnel.

Abstract: Apparatus and methods for a single, handheld device that provides for both insertion of a catheter and collection of a fluid. Some embodiments further include a needle that assists in the insertion of the catheter into a blood vessel, and which includes a retraction feature that protects the user from an accidental needle stick when the device is ready for disposal. Still further embodiments include a protective cover that prevents a user from accidentally being stuck by a second needle used for the introduction of the patient's blood into a collection device.

Abstract: A placental blood extraction device comprises a receptacle for receiving a placenta with umbilical cord, the receptacle comprising a compartment arranged to receive the placenta; and a tube extending from the compartment for receiving the umbilical cord; wherein the receptacle is selectively removable from the device for receiving the placenta. The placental blood extraction device may comprise a pressure application device for applying pressure to a placenta, the pressure application device comprising a plurality of pressing members for applying pressure on a plurality of regions of the placenta.

Abstract: Technologies are generally described for detecting the presence of anastomotic leakage in the abdominal cavity through a dual action catheter placed in the vicinity of a surgery site. A portion of the dual action catheter may be affixed around the surgery site, for example, coiled around the surgery site on the intestine. Through openings on the catheter near the surgery site, a neutral fluid such as saline solution may be injected and extracted through the same openings resulting in retrieval of fluids in the same are. By testing the extracted fluids, chemical and biochemical activity within the abdominal cavity may be determined in order to gauge the start of any anastomotic leakage.

Abstract: Catheters include a catheter tube and an echogenic structure extending from a proximal portion of the catheter tube to a distal end of the catheter tube where a portion of the echogenic structure is at least partially formed in the distal end of the catheter tube. Such catheters may exhibit improved echogenicity. Methods of forming a tool for a clinical procedure performed upon a subject utilizing ultrasound guidance include forming a catheter and forming a portion of an echogenic structure within a distal end of the catheter. Methods of ultrasound guidance for a clinical procedure performed upon a subject may include such catheters.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.

Abstract: An apparatus includes a catheter, an introducer having a first member and a second member, a locking mechanism coupled to a distal end of the first member and configured to couple the introducer to a peripheral intravenous line, and an actuator coupled to the catheter. The actuator is configured to move from a first configuration, in which the catheter is disposed within the introducer, toward a second configuration to move the second member to a distal position relative to the first member. A portion of a guide of the second member being distal to the first member when the second member is in the distal position. The actuator is configured to move relative to the second member to be placed in the second configuration when the second member is in its distal position such that the catheter is disposed within and extending past an end of the peripheral intravenous line.

Abstract: System and methods are provided for treating a patient that include a delivery device sized for introduction into a target site within a patient's body, a source of one or more therapeutic and/or diagnostic agents coupled to the delivery device, and a tubular member sized for introduction into the patient's vasculature to isolate the thoracic duct. Once the thoracic duct is isolated, fluid may be removed from the thoracic duct, e.g., to prevent the agents that transit from the target site into the thoracic duct from entering the patient's vasculature, and/or to modulate flow through the thoracic duct to modulate concentration and/or resident time of the agents at the target site. The one or more agents may include particles sized for preferential transit into the lymphatic system.

Abstract: Methods and devices are provided for transporting fluid between a body and an external source. More particularly, the methods and devices provided can be used to transport blood from a body. In one exemplary embodiment, a system is provided for transporting fluid between a body and an external source. The system can include a collection catheter that is sized to fit inside a catheter that is placed in the body and configured to have its distal end extend beyond a distal end of the catheter that is placed in the body. Various methods for transporting fluid from the body to an external source are also provided.

Abstract: Device for sampling tear fluid that comprises: an extraction element (202) adapted to be applied on the eye to draw tear fluid therefrom, comprising at least one tube (209) and a distal portion (201) with at least one opening (207), a collection vessel (203), connected to said tube (209), suction means (210) adapted to continuously draw tear fluid from the eye to the collection vessel (203), through the extraction element (202) for a period higher than 10 minutes once the extraction element (202) is in place.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular member may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: A micro-volume blood transfer device to facilitate the collection of small volumes of clean arterial blood from patients who may be volume restricted for blood loss such as low-birth weight infants.

Abstract: Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a sample from a source of fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample. The analyte monitoring system can be connected to the fluid source via a connector that is configured to improve fluid flow and reduce blood clotting risk. These goals can be accomplished, for example, by employing coatings in or on a connector, positioning a resilient substance at or near the junction, by reducing dead space volume, by using resiliency to improve fit, by extending a portion of one connector to better mate with a portion of another connector, etc.

Abstract: Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a certain volume of sample from a source of bodily fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample to the patient. The analyte monitoring system can be connected to the source of bodily fluid via a connector that is configured to maintain uniform velocity across the connector and reduce the dead space volume.

Abstract: A method is provided to collect liquid, such as pancreatic juice water, and saline, from a body cavity of a subject. In the method, a tool is inserted through the body cavity to reach a target site in the body cavity. A body position of the subject is adjusted such that the wall surface of the body cavity including the target site intersects with a direction of gravitational force and the liquid present in the body cavity gathers on the wall surface intersecting with the direction of gravitational force. A recess is formed to be concaved on the wall surface in the direction of the gravitational force by making the tool press the wall surface of the body cavity. Therefore, the liquid present or discharged in the body cavity is accumulated in the recess. The liquid accumulated in the recess is taken out of the body of the subject.

Abstract: The present application relates to a molecular exchange device (1) for use with an analysis and control apparatus and a method of manufacturing a molecular exchange device.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.

Abstract: An infusion and blood collection device allows clean blood collections into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies after initial installation. The device optionally includes passive control of the blood collection flow rate to prevent contamination of the collected blood draw with the IV therapy fluid being simultaneously infused through the angiocatheter. A blood collection method uses an infusion and blood collection device to draw a clean blood sample from a patient and into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies.

Abstract: A tray (100) for accommodating a coiled medical device, such as a catheter assembly (700), includes a first compartment (101), a second compartment (102), and a third compartment (103). The catheter assembly (700) and devices associated with a catheterization procedure, such as syringes (701,702) containing sterile water and lubricating jelly and a specimen container (703) can be disposed within the tray. Printed instructions (1001) can be included with the tray (100). One or more layers of wrap material (2200) can be folded about the tray (100) to enclose the tray (100) and other items, such as an additional layer of wrap material (2701), packaged liquid hand sanitizer (2401), and packaged gloves (2402). When a health care services provider (3101) unfolds the wrap material, the same can be used to create a sterile field beneath a patient (3201).

Abstract: A bone marrow aspiration assembly including an outer cannula and an inner cannula. The inner cannula is moved only radially about a longitudinal axis thereof with respect to the outer cannula to selectively align inner openings of only one of distal, intermediate, and proximal opening groups of the inner cannula with outer openings of only one of distal, intermediate, and proximal opening groups of the outer cannula to permit aspiration therethrough.

Abstract: A sampling hub directs a medical device towards a target area. The hub may have some of: a hub body; a lumen passing between openings at the front end and the rear end, the lumen allowing for passage of an elongate element through the entire lumen; the bottom of the hub body may be flat; the top of hub body preferably is sloped downwardly; the lumen is preferably sloped downwardly to enable guidance of the elongate body towards the target area; and an area surrounding the opening of the lumen at the rear end configured to receive a support for the elongate element, the support for the elongate element having a diameter in the support larger than a diameter of the elongate element.

Abstract: A liquid sampling catheter contains a lumen filled by a sampling cannula with a hollow lumen and either a closed or open distal tip. Attached to the proximal end of the device is a modular blood storage component. The sampling stick slides through the patient's skin or through a seal and in-dwelling lumen on a corresponding sampling hub to sample blood from a patient. This embodiment establishes a simple, standardized, and quick procedure for sampling small amounts of bodily liquids such as blood for a variety of analyte tests.

Abstract: An improved, injection or blood removal device for intravenous access has a port with a septum at the exterior end of an intravenous catheter, a coupling element having an adhesive surface for securing attachment onto the skin, an injection or blood sampling unit, a connecting cannula piercing the septum of the port, and means to secure functional assembly. Attachment of the device to the skin covering or close to the intravenous puncture site and without long communicating tubes allows ambulant injection of drugs or measuring of concentration-time profiles of exogenous and endogenous analytes to improve treatment modalities on an individualized basis.

Abstract: This present invention provides real-time in vivo sampling via ultra-small volume microdialysis of the intervertebral disc to assay single molecules of interest. The invention consists of three lumena, two that are capped with a membrane capable of sampling tissues via diffusion. A guide wire can provided between these two lumena so that they may be extended beyond the housing of the three lumena and directed via the guide wire. The third lumen can be utilized for injection or aspiration. Theoretically, agents including treatments such as stem cells or pharmaceutical agents may be introduced to the disc via this third lumen and the real-time effects may be assayed with the first two lumena. The three lumena may be placed adjacent to each other or in a concentric fashion to minimize the total size of the device.

Abstract: The present invention provides a diagnostic method comprising continuously monitoring and transmitting urine output and urine flow rates of a catheterized patient to means which correlate the same with at least one of renal perfusion, renal function, fluid status, polyuria, oleguria, hypoperfusion, hemorrhage shock and GFR.

Abstract: The present invention provides a diagnostic method comprising continuously monitoring and transmitting urine output and urine flow rates of a catheterized patient to means which correlate the same with at least one of renal perfusion, renal function, fluid status, polyuria, oleguria, hypoperfusion, hemorrhage shock and GFR.

Abstract: An apparatus for performing phlebotomy through a peripheral intravenous line. The apparatus includes an introducer and a catheter configured to advance the catheter through a peripheral intravenous line. A y-adapter with a port of larger diameter is configured to receive the catheter and place in fluid communication with the peripheral intravenous line. When advanced the catheter is configured to transport a bodily fluid (i.e. blood) to a volume outside of the body.

Abstract: The present disclosure generally pertains to a device and system for preventing urinary backflow into the urinary tract of a patient. The device comprises a one-way valve which allows for unobstructed urine flow in the direction of the urine towards the urine collection container and away from the catheter. The device prevents backflow into the catheter in situations where the urine collection container is raised above the level of the bladder. The components on the exit side of the valve are coated with an antimicrobial substance to prevent bacterial contamination of the system. The exit volume also contains a silver coated high surface area element to serve as an antibacterial kill site. The inlet side of the device has a volume and access port for urine sampling, with a one-way valve element providing isolation from contamination from the urine collection system.

Abstract: Methods for treating a patient using therapeutic renal neuromodulation and associated devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to biomarker sampling in the context of neuromodulation devices, systems, and methods. Some embodiments, for example, are directed to catheters, catheter systems, and methods for sampling biomarkers that change in response to neuromodulation. A system can include, for example, an elongated shaft and a neuromodulation and sampling assembly having a neuromodulation and a sampling element.

Abstract: A point of care fluid testing system for determining properties of a fluid comprises a patient connection, a primary fluid routing portion, a pump, a secondary fluid routing portion, and a flushing fluid connection. The patient connection connects the system to a patient. The primary fluid routing portion has a pump region, a fluid transfer region, and an in-line testing region. The pump region pumps the fluid sample from the patient to the testing portion and back to the patient. The in-line testing region evaluates a first characteristic of the fluid sample. The fluid transfer region transmits a portion of the fluid sample out of the primary fluid routing portion. The secondary fluid routing portion includes an off-line testing portion that receives the portion of the fluid sample transmitted from the fluid transfer region. The off-line testing portion evaluates a second characteristic of the fluid sample.

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: A disposable real-time closed catheter urine output monitoring system. The monitoring system of the invention can measure urine outputs at both high and low urine flow in real time, using a pressure chamber in the form of a hollow body having an input port for coupling to a tube connected to a catheter for collection of urine from a patient, an exit port coupled to a collection container and a vent port, such that air may flow through the vent, but urine is blocked by the vent. A sensor measures flow from the exit port of the pressure chamber into the collection container, and a pressure sensor may be included to measure pressure in the pressure chamber. The invention also provides a method of using the apparatus in a real-time monitoring system.

Abstract: Described herein are devices, systems, kits and methods for measuring intra-abdominal pressure (IAP) from a patient catheterized with a urinary catheter system. Devices may include a bypass lumen configured to connect to a pressure transducer, a sampling port connector connected to the bypass lumen, a drain tube housing configured to at least partially enclose a portion of the drain tube of a urinary catheter system, and a clamp mechanism. The sampling port connector may be configured for removable attachment to the sampling port of the urinary catheter system to form a fluid connection between the urinary catheter system and the bypass lumen of the IAP device. The clamp mechanism may be configured to controllably occlude the lumen of the urinary catheter system drain tube.

Abstract: A drainage and/or collection system (1) for biological fluids includes at least one conduit (40) for transporting a biological fluid (F) from a catheter (10) to a collection device (50) and a gas pressure source (70) configured to feed a gas (G) into the at least one conduit (40) between the catheter (10) and the collection device (50). The gas (G) causes the biological fluid (F) arranged in the at least one conduit (40) to drain into the collection device (50). A method includes inserting a catheter (10), draining a fluid (F) into a collection device (50) via a conduit (40), and introducing gas (G) into the conduit (40) so as to force fluid (F) remaining in the conduit (40) into the collection device (50).

Abstract: The present invention relates to a method of enriching free fetal nucleic acids from a cervical sample. The enriched fetal nucleic acids can be used in a variety of procedures including, detection of a trait of interest such as a disease trait, or a genetic predisposition thereto, gender typing and parentage testing.