Abstract: A sealing arrangement for a medical introducer having a distal end for introduction into a patient's blood vessel. The introducer includes a flexible sealing member having an aperture for introduction of a guide wire or other medical device therethrough. A constraining structure, such as a washer, tightly contacts and surrounds the sealing member just proximal to an enlarged diameter flange at the distal end of the sealing member. The inner diameter of the constraining member is less than the outer diameter of the flange providing a constraint on the sealing member and lessening the distortion of the sealing member normally occasioned when a device is pulled outwardly or proximally through the introducer away from the patient. When the constraining structure is a washer, the washer is easily assembled to the introducer by simply being fitted into an annular notch formed just proximal to the distal end of the sealing member.

Abstract: A rotatable connection between a tubular member and an elongate wire of a catheter for allowing rotational movement of the tubular member relative to the elongate wire. The rotatable connection includes a first tube secured to the tubular member and a second tube secured to the elongate wire. The second tube is disposed around the first tube and rotatable relative to the first tube. The longitudinal axis of the tubular member is offset from the longitudinal axis of the elongate wire to allow a guidewire to extend through the tubular member and along the side of the elongate wire.

Abstract: The present invention relates to a multiple-use intravenous (IV) catheter assembly septum and septum actuator. In particular, the present invention relates to an IV catheter assembly having a stationary septum actuator and a blood control septum, wherein the blood control septum is configured to slide within a catheter adapter of the IV catheter assembly between a compressed state and an uncompressed state. When in the compressed state, a slit of the blood control septum is opened and the septum comprises stored compressive potential energy. When the septum is released from the compressed state, the stored compressive potential energy is release and the blood control septum is restored to its original shape, thereby closing the septum's slit.

Abstract: A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity adapts to tissue tracts of different widths. The surgical instrument includes a proximal member, a distal member, and a sleeve extending between the proximal member and the distal member and defining a longitudinal passage therein. The proximal member includes an inflatable member that selectively adjusts the radial dimension of the proximal member. A ring member may be separately insertable by a user during a surgical procedure into the space directly adjacent to the radially-inner surface of the inflatable member, so as to selectively provide rigidity to the proximal member.

Abstract: A luer connector including a housing with first end including a male luer tip and a second end. The connector further includes a rigid valve member having a first opened end and a second closed end and a resilient member configured to couple the valve member and the housing. The housing further includes a rigid conduit positioned within the housing and in fluid communication with the second end of the housing, the rigid conduit adapted to engage the first opened end of the valve member. The housing defines a first internal volume when the valve member is in a first position and a second, smaller volume when the valve member is in a second position.

Abstract: An introducer sheath assembly (10) having a sheath tube (12), a hub (16), a valve (30) and a valve-retaining cap (50) on the proximal end of the hub. The cap (50) is so secured to the hub (16) as to have a closed, locked position and also an open position permitting access to the interior of the hub and the valve (30) while the cap (50) remains secured to the hub (16).

Abstract: The present invention relates to a balloon catheter system for sealing puncture points or openings in body cavities, hollow organs or in percutaneous drainage operations in mammals, consisting of a filling catheter on the distal end of which a first balloon can be filled with the filling medium is arranged with a further balloon arranged proximally spaced apart therefrom. The balloons close the puncture point or the opening on the two sides in the filled state of the balloon. A hollow needle open at the shaft or the shaft end can be guided in the lumen of the filling catheter for filling the two balloons with the filling medium, wherein the shells of the two balloons enclose the shaft of the filling catheter. The filling catheter in each case has an opening arranged in the balloon lumen to fill the two balloons.

Abstract: A releasably locking dilator and sheath assembly and methods for releasing the dilator from the sheath and longitudinally splitting the sheath. The assembly includes a dilator having a dilator hub and a sheath having a sheath hub. The sheath hub may have a valve and has two opposing winged tabs, each tab having a perpendicular portion and an angled portion as well as a female threaded portion. The dilator hub has a male threaded portion designed to engage the female threaded portion of the sheath hub. The dilator is released from the sheath by rotating the dilator 90° in relation to the sheath and pulling the dilator out of the sheath. The sheath is longitudinally split by creating a couple on each of the winged tabs thereby forcing the sheath and the sheath hub to split longitudinally. With the sheath and sheath hub split longitudinally, the sheath is removed from around a catheter while leaving the catheter in place.

Abstract: A medical connector for use in a fluid pathway includes a substantially transparent housing having a proximal end with a proximal opening and a distal end with a distal opening, and a cavity extending therebetween. The connector provides a substantially visible fluid flow path extending through a substantial portion of the connector.

Abstract: A method providing a medical connector for use in a fluid pathway including a substantially transparent housing having a proximal end with a proximal opening and a distal end with a distal opening, and a cavity extending therebetween. The connector provides a substantially visible fluid flow path extending through a substantial portion of the connector.

Abstract: Embodiments of a catheter insertion device are discussed comprising: an approximately hollow cylindrical catheter sleeve, at whose distal end a catheter is attached; a needle sleeve with a hollow needle, which is attached thereto and which, when ready for use, extends through the catheter sleeve and the catheter, and; a needle protective element that is arranged inside the catheter sleeve while being able to move on the needle. Said needle protective element has an engaging section that engages with an engaging device, which is formed in the vicinity of the needle tip, when the hollow needle is withdrawn from the catheter sleeve. A check valve is placed inside the catheter sleeve between the catheter and the needle protective element. The hollow needle, when ready for use, extends through said check valve, and the check valve automatically closes once the needle is withdrawn.

Abstract: The peritoneal dialysis catheter includes a thin, flexible tube, a catheter connector at a distal end of the tube, and a cylindrical cover surrounding at least a portion of the catheter connector. The catheter connector includes a tip that is configured to attach to a dialysis tubing assembly. The tip can include an externally threaded surface. A peripheral wall of the cover can surround or shield the externally threaded surface of the tip. The peritoneal dialysis catheter can include a cap, which can be removably attached to the tip.

Abstract: Disclosed herein are disinfecting caps that can be used to cover and disinfect both a male medical connector and needleless injection site when not in use or when disconnected from each other. The caps contain a disinfecting agent.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A valve assembly (10) for controlling a flow of fluid includes a housing (30) having a passageway (33), and a valve sheath (40) disposed interiorly of the housing, at least substantially along the housing passageway. The valve sheath includes a cylindrical valve body (42) having a pair of generally wedge-shaped voids (50A, 52A) formed along opposing longitudinal sides of the valve body. Each of the wedge-shaped voids comprises first and second inwardly-directed sides that converge to define a generally linear edge. The edges are disposed along the valve body in a generally diagonal orientation with respect to a longitudinal axis through the valve body. The respective linear edges are structured and aligned in the valve body to meet along a passageway through the valve body interior in a manner to selectively close the valve body interior passageway, and to yield to permit passage of an interventional device therethrough.

Abstract: The invention relates to a closure cap for a container for receiving medical liquids, in particular a BFS vial which is produced by a blow-fill seal process, and to a BFS container with such a closure cap. The closure cap according to the invention has a cover part and an edge part, with an injection part arranged in the cover part. The injection part has an outwardly directed connection part with a conical recess for receiving the cone stem of a needleless injection syringe in a seal-forming manner, and an inwardly directed closure part which has a self-sealing membrane for closing the recess of the connection part. The self-sealing membrane is slotted. The closure cap according to the invention allows a liquid to be injected without use of an injection needle.

Abstract: Systems and methods for sealing and venting a septum of an intravenous catheter device. Implementations of the present invention include a compact, molded septum that is retained within an inner lumen of a catheter adapter such that slowed or stopped flow of air and/or a fluid is permitted to pass between the compact septum and an inner wall surface of the catheter adapter via one or more fluid pathways. In some instances, a snap ring is provided to secure the position of the compact septum within the catheter adapter, a fluid pathway being provided through the snap ring.

Abstract: Disclosed herein are disinfecting caps that can be used to cover and disinfect both a male medical connector and needleless injection site when not in use or when disconnected from each other. The caps contain a disinfecting agent.

Abstract: A trocar and cannula assembly with improved conical valve that incorporates a plurality of ribs to restrict and/or otherwise influence valve movement, and a plurality of improved convolutes and bumps to enhance performance characteristics.

Abstract: A collapsible valve for use in a needleless access connector to reduce the priming volume of the needleless access connector. A needleless access connector with a small priming volume. A method of connecting a first medical device to a second medical device with a needleless access connector with a small priming volume.

Abstract: A urinary catheter connector system having a housing; a catheter connector port supported by the housing and configured to attach to a urinary catheter; a urine exit port supported by the housing and configured to connect to a urine collection device; an irrigation port supported by the housing and configured to receive an irrigation syringe; a channel in the housing fluidly connecting the catheter connector port, the urine exit port and the irrigation port; and a valve supported by the housing and adapted to cooperate with the irrigation syringe to shut off flow of fluid and air to the urine exit port when the irrigation syringe is inserted and allow for flow of fluid and air to the urine exit port when the irrigation syringe is removed. The invention also includes methods of using the system.

Abstract: A neutral pressure split-septum luer access device is described for receiving a luer lock connector. The septum has a plurality of elastomeric columns projecting laterally within a chamber. Each elastomeric column is under sufficient compression so that the columns are bowed and the column strength is reduced by bowing, but the slit sealing force is high. This configuration places the lower portion of the slit in a tightly sealed configuration which is never-the-less receptive to penetration by the male luer which causes the columns to bow further and collapse precipitously with the elastomeric force of the collapsing mass of the columns being carried distally to displace and pop open the central slit distal the tip of the male luer. The septum further provides a transverse separation between the columns and a distal sealing portion so the force of the displacement force to the sealing portion is reduced.

Abstract: A luer medical connector having a male luer body for connection with a female luer assembly which includes a female luer body, a fluid channel insert within the female luer body, an elastomeric seal between the female luer body and the male luer body, and an elastomeric stopper at a proximal end of the female luer body.

Abstract: The present invention generally provides methods and devices for removing fluid from a surgical instrument. Surgical access devices and seal systems are generally provided having one or more valves or seal assemblies to create a closed system between the outside environment and the environment in which the surgical access device is being inserted. In one embodiment, a seal assembly is provided and can include a seal having an opening configured to receive a surgical instrument therethrough and a fluid remover in the form of a sorbent element, a scraper element, a wicking element, or any combination thereof can be associated with the seal and configured to remove fluid from the opening and/or a surgical instrument.

Abstract: The present disclosure relates to a valve or seal of the type adapted to allow the introduction of an instrument or object therethrough. In particular, the valve disclosed herein is adapted to maintain a substantially fluid-tight seal with a surgical instrument and is used during a minimally invasive surgical procedure. The valve disclosed herein incorporates one or more bladder members adapted to retain a fluid therein that are associated by one or more interstitial members.

Abstract: A device for delivering a drug comprising an elongate hollow body having a first longitudinal end and a second longitudinal end. The hollow body includes a radially outer peripheral wall, which surrounds a radially inner, and elongate hollow space. The peripheral wall of the hollow body has at least one drug outlet opening between the two longitudinal ends.

Abstract: A connector for a medical use comprising a fitting secured to a chamber, the fitting being provided at its center with a needle encased at least in its terminal portion in the recess of an elastic seal having, across the thickness of its free end, a slit or the like, the elastic seal being further provided with a ring. A terminal end of the elastic seal has a deformable peripheral rim overlapping the end of said ring.

Abstract: In a blood-flow-path connector (10) and blood bag system (12), a blocking part (74) is provided in a hollow section (68c) in a tubular body (68), and a communicating part (70) that is axially movable within the hollow section (68c) is disposed. By moving the communicating part (70) relative to the tubular body (68) in a pushing direction, the blocking part (74) is penetrated or pressed to be opened; thus, a flow-path in the tubular body (68) and a flow-path in the communicating part (70) come to communicate with each other.

Abstract: An improved safety occluder and method of use provides an occluder for an infusion set having a first, occluding position, a second, non-occluding position which returns to the first, occluding position when the occluder's plunger is released, and a third, non-occluding position which retains the plunger in a configuration which allows fluid flow through the infusion set. The occluder may also include a locking mechanism to prevent accidental movement of the plunger out of the first, occluding position.

Abstract: A surgical seal assembly, includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, a seal having an inner seal portion defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage and a guide mounted to the seal housing. The guide has an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom. The inner guide portion defines a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing. The inner guide portion is relatively compliant to accommodate initial offset or angled entry of the surgical instrument.

Abstract: A hemostasis mechanism includes a deformable seal, and a plunger guided for translation within a housing to displace a fluid to a clearance extending between the deformable seal and the housing. The displaced fluid increases fluid pressure in the clearance to deform the deformable seal into sealing contact with a medical device. An actuator for the plunger includes a linkage having arms rotatable about first and second axes, and configured such that their rotation is converted into translation of the plunger. The linkage is adjustable from a retracted configuration to an advanced, cammed-over configuration.

Abstract: A tether holder has a locking portion, for securing a proximal end of a tether, and a pin portion that may fit within a receptacle of a handle assembly of a tool. A distal member of an inner assembly of the tool engages an implantable medical device, from which the tether extends, through at least one lumen of the inner assembly and out through a proximal port of the handle assembly, which is located in proximity to the receptacle. An enlarged distal-most portion of a deployment tube of the tool contains the distal member and the device, and is moveable, relatively to the inner assembly and the device, to deploy the device out through a distal opening of the tool. The handle assembly may also include a flush lumen and a tether engaging conduit, both in fluid communication with the at least one lumen of the inner assembly.

Abstract: An embodiment in accordance with the present invention provides a valve including a housing having a top portion and a bottom portion. The top portion of the housing defines a first and second nozzle, and the bottom portion of the housing defines an opening. A diaphragm has an open position and a closed position, and the diaphragm is disposed between the top portion of the housing and the bottom portion of the housing. A first fluid flow path between the first nozzle and the second nozzle is defined by the housing and the diaphragm, when the diaphragm is in the closed position. A second fluid flow path between the opening and the first nozzle is defined by the housing and the diaphragm, when the diaphragm is in the closed position. Such a valve can be used for a number of purposes including hemodialysis procedures.

Abstract: A method of placing a catheter into a patient while preventing disadvantageous escape of fluid from the patient comprises providing a catheter secured to a valve hosing. The catheter has a proximal end, a distal end and an interior lumen. The valve housing has a first port, a second port, and a fluid path running between the first and second ports. The catheter and the valve housing have a hollow needle extending therethrough. The method further comprises piercing the patient's skin, thereby inserting the catheter into the patient. The method further comprises holding the catheter and valve housing in place while removing the hollow needle through the catheter and valve housing. The hollow needle passes through the first and second ports of the valve housing.

Abstract: An on-body injector and method of use including an on-body injector for use with an injection device. The on-body injector includes a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port. The button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.

Abstract: A medical connector for minimizing leakage of fluids during connection and disconnection is described. The medical connector includes a body having an inlet port, at least one outlet port adjacent to a male luer portion of the body, and a fluid path between the inlet port and the at least one outlet ports. A retractable seal adjacent to the male luer portion of the body and blocks the outlet ports of the body when the male luer portion of the medical connect is in a disconnected state. The retractable seal is positioned on the body such that it is moved away from the outlet ports upon insertion of the male luer portion of the medical connector into a medical access device thereby unblocking the outlet ports and creating a fluid path through the medical connector.

Abstract: A male member (1) includes a tubular member (10) and a cover (20) covering at least a tip (11) of the tubular member. A lateral hole (14) that communicates with a flow path (13) is formed in an outer peripheral surface of the tubular member. The cover includes an outer peripheral wall (21) that can be deformed elastically by compression and a head part (23) that is provided at one end of the outer peripheral wall. The head part includes an interior cavity (24) into which the tubular member is inserted, and a slit (25) is formed in an innermost part (24a) of the interior cavity. In a state where the outer peripheral wall is not deformed by compression, an inner peripheral surface of the interior cavity contacts closely with the outer peripheral surface of the tubular member so as to block the lateral hole, and the tip of the tubular member and the innermost part of the interior cavity are spaced apart from each other.

Abstract: A drip chamber having an upper reservoir that is separated from a lower reservoir via a filter assembly, wherein a distance between the filter assembly and a bottom surface of the drip chamber is selected to prevent dislodged air bubbles of the filter assembly from being drawn into an intravenous fluid line that is coupled to the bottom surface of the drip chamber, during an infusion procedure.

Abstract: A hemostasis valve for a vascular introducer includes a valve body having a seal region with opposed substantially planar proximal and distal end surfaces and a central axis extending through the seal region perpendicular to the proximal and distal end surfaces. The seal region has a first grouping of circumferentially arranged and equidistantly spaced linear cuts extending radially outward from the central axis, and through the seal region from the proximal end surface to the distal end surface. The seal region has a second grouping of circumferentially arranged and equidistantly spaced linear cuts in the distal end surface extending tangentially outward from the first grouping of linear cuts, and partially from the distal end surface to a depth short of the proximal end surface to facilitate passage of a variety of sizes of medical devices through the seal region.

Abstract: An access assembly is provided.

Abstract: Caps can be used to cover and disinfect medical connectors. Some caps can create a seal with the medical connectors to prevent antiseptic from entering a fluid paths defined by a connector. Support members can aid in creating or maintaining the seal.

Abstract: A method of making a delivery device (10) for therapeutic agent, drug or vaccine is disclosed. The method includes providing a flat panel wafer, forming a plurality of reservoirs, with each reservoir defining a cavity, within the flat panel wafer, and attaching a cover layer (20) across the plurality of reservoirs. The method also includes filling the plurality of reservoirs with at least one of a therapeutic agent, drug, and vaccine to form a plurality of filled reservoirs, and providing a housing portion adjacent each of the plurality of filled reservoirs to form a composed layer. The method also includes separating the composed layer into a plurality of delivery devices, wherein each delivery device includes a reservoir. The delivery device may be suitable for self-injection use.

Abstract: A catheter for use in medical applications is disclosed. The catheter comprises tubing with a tip hole at one end and an end portion at the other end. Fluid exits the catheter at the tip hole thereof. One or more alternative fluid pathway(s) are provided on the sidewall of the catheter to permit outflow of fluid medication from the catheter to ensure proper delivery of the medication to the intended target area, particularly when the tip opening is occluded or restricted for any reason.

Abstract: A catheter includes a pressure actuated seal within a manifold. A catheter body is coupled with the manifold, and a manifold lumen and a catheter lumen are configured to receive pressurized fluids. The pressure actuated seal includes a pressure actuated seal element having a seal element lumen. The seal element lumen is in communication with the manifold and catheter lumens. The pressure actuated seal element is deformable between an open configuration and a sealed configuration. In the sealed configuration, the pressurized fluids in the manifold press on the pressure actuated seal element along a first seal face. The pressure actuated seal element compresses inwardly around the seal element lumen according to a pressure of the pressurized fluids. In the open configuration, the pressure actuated seal element relaxes in an absence of the pressurized fluids, and the seal element lumen is open and configured to allow passage of an instrument.

Abstract: A positive-displacement needleless access connector is disclosed that has a housing with a first luer fitting at a proximal end thereof, a base with a second luer fitting at a distal end thereof, and a valve element with a proximal end that creates a seal at the first luer fitting and fastens to the base so that a surface of the valve element is substantially flush with a surface of the base.

Abstract: Skin port connectors for use as part of a percutaneous gastrostomy tube assembly and methods for connecting such a device to such an assembly are disclosed.

Abstract: The present invention extends to a blood control catheter valve for use in a catheter adapter. The blood control catheter value employs an actuator for bypassing a septum to open the blood control catheter valve. The actuator includes flexible retention arms positioned on one end which retract into the body of the actuator while the end of the actuator passes through the septum, and then expand outwardly to maintain the actuator positioned within the septum. This design facilitates the manufacturing of catheter adapters (as well as blood control catheter valves and other components that attach to the catheter adapter) because the design can reduce the tolerance requirements of such components. Further, the design provides a reliable blood control catheter valve that does not require the catheter adapter to be increased in size to accommodate the valve.

Abstract: A hernia repair implant includes a first layer for facing a body structure having a hernia defect to cover the defect while promoting tissue growth into the first layer from the body structure. The implant also includes a second layer opposed to the first layer and made of anti-adhesion material to prevent growth of tissue into the second layer from body structures contacting the second layer. Furthermore, the implant includes at least one engagement strap connected to the first layer and extending therefrom to terminate at a free end. The engagement strap defines opposed thin edges and opposed flat surfaces extending between the edges. At least one barb extends from at least one edge and/or at least one flat surface of the strap and is configured to impede motion of the strap in only a single direction.

Abstract: An access port for the introduction of a needle cannula tip into an IV tube set includes a rigid tubular housing and a resilient member disposed adjacent an inlet of the housing. The resilient member includes an axial perforation extending through the resilient member, and is normally closed by a resilient character of the resilient member. A depression is defined in a proximal face of the resilient member, and includes sidewalls extending between the proximal face and the axial perforation to guide the needle cannula tip toward the axial perforation as a needle cannula associated with the needle cannula tip is introduced into the access port.

Abstract: A seal assembly for a surgical access assembly includes a housing defining a center, first and second ring members, an inner seal member, and first and second centering mechanisms. The first ring member is disposed within the housing and includes the inner seal member coupled thereto and extending radially inwardly therefrom. The second ring member is disposed within the housing annularly about the first ring member. The inner seal member is configured to sealingly receive a surgical instrument inserted through the housing. The first centering mechanism is configured to bias the first ring member towards a concentric orientation relative to the second ring member. The second centering mechanism is concentrically disposed about the first centering mechanism and is configured to bias the second ring member towards a concentric orientation relative to the center of the housing.