Abstract: A catheter assembly for cannulating an ostium of a coronary sinus of a heart comprises an outer catheter member and an inner catheter member. The outer catheter member has a distal end portion including a deflectable distal end and a lumen extending through the deflectable distal end, wherein the distal end portion includes regions of varying stiffness and has a pre-formed curvature. The inner catheter member is slidably and rotatably disposed within the lumen of the outer catheter member, and has a distal end portion including a distal end, and a lumen extending through the distal end. The distal end portion of the inner catheter member has regions of varying stiffness and a pre-formed curvature. The outer and inner catheter members are configured such that relative translation and rotation of the outer and inner catheter members causes the distal end of the outer catheter member to assume a plurality of two and three dimensional shapes.

Abstract: A splittable cannula includes a radiopaque marker placed at or near the distal end of the cannula. The radiopaque marker may be a unitary piece, or may consist of several portions. The cannula may include a sheath or catheter body with a grooved score line running along a portion of the sheath body and a radiopaque marker located at a distal end of the body and abutting the body. The radiopaque marker may be located within the lumen of the sheath, may be embedded in the sheath wall, or may be affixed to the external sheath wall. The radiopaque marker may be scored, notched, grooved, or contain apertures longitudinally. The notches, grooves, apertures, and/or score lines in both the sheath or catheter body and the radiopaque marker serve to provide a weakened tear path. An electrode lead may be coupled with the radiopaque marker.

Abstract: An insertion sheath and related methods include a tube member and a shape memory feature. The tube member defines an insertion lumen. The shape memory feature is positioned at a distal end portion of the tube member. The shape memory feature provides a monofold shape in the tube member when in a first state, and a radially expanded shape in the tube member in a second state upon application of an expansion force. The shape memory feature returns the monofold shape after removal of the expansion force. The insertion sheath may function as an access to closure sheath that is suitable for use as a procedural insertion sheath when treating the patient and a closure insertion sheath when sealing closed the vascular puncture.

Abstract: The present disclosure is directed to methods and compositions for clearing and cleaning enteral feeding tubes. More particularly, the composition is an ingestible gel composition that comprises enzymes for degrading buildup in enteral feeding tubes, carrageenan, and divalent metal ions or a source thereof. The carrageenan present in the composition stabilizes the enzymes at room temperatures, allowing for long-term storage of the composition. Upon injecting the gelled composition into the feeding tube, body heat from the patient melts the gel, and the enzymes are released to act on debris present in the feeding tube.

Abstract: Catheter assembly (100) having at least one lumen (150 or 160) and joined to hub (106). While the lumen inner diameter(s) remain constant from distal end (144) of the catheter (140) to proximal end (142), the outer catheter diameter increases proximate the hub (106) providing increased resistance to kinking during connection and disconnection from medical apparatus. The increased proximal catheter diameter preferably is sufficiently large to plug the proximal end of an introducer sheath through which the catheter is inserted during patient placement, to plug the proximal sheath end and minimize blood aspiration therethrough, and later serves to fill the vascular insertion upon complete catheter insertion after removal of the introducer sheath again to minimize blood aspiration through the vascular incision. The catheter may have two lumens (150,160) or more, joined to respective extension tubes in hub (106). The two lumens may each have a respective inner diameter of between about 0.020 in and 0.025 in.

Abstract: A sheath for delivering a lead or other device into a body lumen is adapted to be removed from around the delivered lead or device via a longitudinally extending feature. This feature of the sheath may be a ripcord, a seam or interlocking features the releasably engage one another.

Abstract: A tearaway introducer sheath assembly (100,200) having an integrated valve (300). The valve is seated within a valve housing (222) defined by the hub portion (200) of the sheath (200). The valve (300) includes a pair of distally extending opposed side walls or flaps (324) extending to converge at a distal tip (328) having a virtual opening (334) therethrough. The valve further includes a pair of tensioners (340) along outer surfaces of the opposed side walls (324) that extend radially outwardly to engage and bear against the interior valve housing surface (230) to press the opposed side walls (324) together at the distal tip (328) for sealing, both when a dilator extends through the valve and sheath and afterward upon removal of the dilator.

Abstract: An infection-preventing gastrostomy catheter kit to be used in the gastrostomy, which can pass an intragastric retainer of a catheter easily and reliably through an infection-preventing sheath by an easy maneuver, and which can reduce the diameter of the infection-preventing sheath. The catheter kit comprises: a gastrostomy catheter 20 including a flexible, hollow PEG tube 21 reinforced with filaments 24, an deformable intragastric retainer 23 positioned at the trailing end of the PEG tube 21, and a tapered member 22 positioned at the leading end of the PEG tube 21 for retaining the leading end portion 40a of a guide wire 40 inserted from a leading end hole 22a thereof; and an infection-preventing sheath 1 including a flexible, hollow tubular body 2, and a socket member having a socket 4 positioned at the trailing end of the tubular body 2 for retaining the intragastric retainer 23, and pins 5, thereby removably sheathing the gastrostomy catheter 20.

Abstract: A medical device for insertion into a body having a surface covered by a detachable cover. The cover may be detached from the surface and removed from the body while the device is inserted in the body. The device may be, for example, a catheter, cannula, drain, stent, pacemaker, or electrode.

Abstract: A sheath for delivering a lead or other device into a body lumen is adapted to be removed from around the delivered lead or device via a longitudinally extending feature. This feature of the sheath may be a ripcord, a seam or interlocking features the releasably engage one another.

Abstract: Disclosed is an infection preventive catheter kit for preventing the infection of the wound. A percutaneous endoscopic gastrostomy (PEG) catheter 20 is inserted into an infection preventive cover 10, which is provided with a socket 13 at a distal end thereof. A head portion 15a of a guide wire 15 which is inserted into the PEG catheter 20 through a top end thereof and an in-stomach remaining member 23 provided at a distal end of the PEG catheter 20 are engaged with (fixed to) the socket 13 of the infection preventive cover 10 by a pin 14 penetrating the socket 13.

Abstract: The present invention is a catheter having a tube and including mechanisms that provide precision control over insertion and retraction of the catheter tube. The catheter is particularly adapted for introduction into the pulmonary system. The catheter includes an insertion depth control mechanism that acts as a stop and provides a tactile indication to the person inserting the catheter tube that a predetermined position has been reached. The catheter also includes an anti-bunching mechanism to prevent bunching of a protective sleeve disposed around the catheter tube, thereby reducing interference from the sleeve during insertion of the catheter tube.

Abstract: The present invention is a method for accessing the abdominal cavity of a patient in order to perform a medical procedure therein. In one embodiment the method includes the step of inserting a guide wire into the upper gastrointestinal tract, via a gastric opening in the gastric wall and an abdominal opening in the abdominal wall of the patient, the guide wire having a first end that extends from the mouth of the patient, and a second end that extends from the abdominal opening of the patient. The method further includes providing an access device in the form of an elongated sheath having a lumen therethrough, attaching the first end of the guide wire to the distal end of the elongated sheath, and pulling the second end of the guide wire to position the access device into the upper gastrointestinal tract, wherein the distal end of the access device extends into the abdominal cavity while the proximal end of the access device extends out of the mouth of the patient.

Abstract: An autoinjector useful for, inter alia, providing an injection of liquid medicament is disclosed, which includes a needle depth adapter for achieving a desired injection depth.

Abstract: A medical apparatus and method of use for implanting a percutaneous catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve comprising a wall surrounding an interior elongate passageway. The passageway extends from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin so that the sleeve distal end resides subcutaneously. The sleeve outer peripheral surface carries a layer of porous material intended to be placed just under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway is dimensioned to snugly accommodate the outer surface of catheter while permitting the catheter to slide relative to the sleeve.

Abstract: Some embodiments relate to a catheter system having a changeable or adjustable working length. The catheter system can comprise a proximal end, a distal end, and a first axial lumen configured to receive a guidewire formed through at least a portion of the catheter body. A first opening can be formed through a portion of the catheter body and be in communication with the first lumen. The sheath can be rotatable, axially movable, or otherwise changeable from at least a first position to a second position, wherein the sheath can substantially cover the first opening in the catheter body in the first position, and can substantially expose the first opening in the catheter body in the second position.

Abstract: The present invention relates generally to devices and systems for detecting infection within catheters. In particular, the present invention provides catheter testing systems configured to sterilely collect a biological sample from the interior of a catheter for purposes of testing the biological sample (e.g., for the presence of fibrin, sepsis, etc.).

Abstract: The present invention relates to medical devices which are adapted for application to a skin surface of a user and comprise a transcutaneous device which is supplied in a sterile condition. Thus, a medical device is provided, comprising a mounting surface adapted for application to the skin of a subject, a first portion having a first end adapted to penetrate the skin of the subject, and a second portion in fluid communication with the first portion and having a second end. The device further comprises enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial aseptic state, to a second configuration in which the ends of the first and second portions are allowed to communicate with the exterior through the enclosure means, wherein the enclosure means does not enclose the mounting surface.

Abstract: A suction catheter assembly, particularly adapted for neonatal use includes a distal manifold body including a rotatable connector for connection to an endotracheal tube, a ventilating port member and an ancillary catheter receiving port member. The manifold body is rotatably joined to a catheter tube seal housing. The seal housing includes an irrigation port member. A catheter tube wiper seal and a filter member are disposed in the seal housing which is joined to a suction control valve assembly by an elongated flexible sheath defining an enclosed space through which the catheter tube extends between the valve assembly and the manifold. A resilient closure member actuator and slide lock member are engageable with a closure member of the valve assembly.

Abstract: An introducer sheath is described. The introducer sheath may include a tubular body. The tubular body may extend from a distal end toward a proximal end. The tubular body may include a lumen. The lumen may at least partially be defined by a wall. A channel may be disposed within the wall. The channel may be configured to receive a guidewire. The tubular body may include an expandable portion expandable to increase a cross-sectional area of the lumen.

Abstract: An introducer sheath is disclosed. The introducer sheath may include a tubular portion extending between a proximal end and a distal end. The tubular portion may include an inner portion forming a lumen and an outer portion disposed partially around the inner portion. The inner portion and the outer portion may extend between the proximal end and the distal end. At least a portion of the inner portion may be exposed between the proximal end and the distal end. A method for manufacturing an introducer sheath is disclosed. A method for performing a medical procedure is disclosed.

Abstract: An endoscopic bite block system for increasing the speed and efficiency of an endoscopic procedure. The endoscopic bite block system includes a base member including a central opening and at least one tube attachment, a channel member latitudinally extending from an outer edge of the central opening and a strap member removably attached to the base member, wherein the strap member removably attaches the base member to the mouth of the patient.

Abstract: A device that shields internal organs and tissues from medical procedures performed within a patient's body, especially in the chest cavity where ablation and related procedures are performed in or near the heart, includes a catheter body, a distal section, and a barrier member that can be inflated with fluid to act as a barrier to extreme temperatures and physical trauma, and be deflated to a smaller size to facilitate entry and removal from the patient's chest cavity. In a more detailed embodiment, the barrier member is a balloon that can protects the esophagus, which can be provided with folds and shape memory elements so that the balloon expands and collapses into predetermined configurations. Fluid is fed to and drawn from the barrier member via an irrigation tubing that extends along a catheter shaft and is in communication with a lumen of a deflectable tubing section that extends through an interior cavity of the barrier member. The catheter can be adapted for uni- or bi-directional deflection.

Abstract: A catheter introducer system is provided with a catheter sheath having a valve providing for a friction fit around a catheter. The friction fit is selectively adjustable to vary between a first configuration for longitudinal movement of the catheter through the valve and a second configuration for holding the catheter longitudinally in place. The valve may include a chuck to grip the catheter radially. The chuck may include an annular base and an opposed annular clamp, and a washer disposed between the base and the clamp. At least one of the base and the clamp may include a beveled surface that forces the washer radially inwardly as the base and the clamp are drawn together. The system also includes one or more dilators layered within the sheath. One or more of the dilators may include a preformed arcuate portion configured to access a targeted branched vessel. The layered dilators and sheaths are typically softer and more hydrophilic proceeding from the innermost dilator out to the sheath.

Abstract: According to one exemplary embodiment, a surgical instrument for insertion in an incision during surgical treatment and removal of tissue includes an inner elongated needle having an ovoid shape and a bore extending therethrough; and a hollow sleeve that surrounds the ovoid shaped needle such that two side regions of the needle contact an inner surface of the sleeve at two locations so as to define a pair of fluid channels that are located between convex outer surfaces of the needle and the inner surface of the sleeve. The shape of the sleeve, when deformed by insertion of the needle, is configured to be received within the incision during the surgical treatment and removal of the tissue so as to plug opposite ends of the incision and provide an at least substantially closed surgical site.

Abstract: A protective sheath for a winged needle has a hilt with a keyhole for releasably receiving a length of tubing. Methods of the invention include forming a U-shaped bend in the tubing and inserting it into the keyhole prior to packaging.

Abstract: An anticontamination cover prevents the biotic contamination of a gastrostomy catheter when the gastrostomy catheter is inserted through the mouth into the stomach for percutaneous, endoscopic gastrostomy. The anticontamination cover includes an elongate covering tube having a closed distal end and an open base end, and a loop attached to and projecting from the outside surface of the distal end of the covering tube. An opening is formed in a part of the distal end of the covering tube opposite a part of the distal end to which the loop is attached. A loop of the gastrostomy catheter inserted in the covering tube is passed through the opening of the distal end of the covering tube.

Abstract: A percutaneous endoscopic gastrostomy catheter kit includes a percutaneous endoscopic gastrostomy catheter, a sheath entirely enclosing the percutaneous endoscopic gastrostomy catheter, a fixing device integrally provided to an end of the sheath, an end of the catheter being arranged at the fixing device, and a breaking thread for breaking a portion of the fixing device and a portion of the sheath.

Abstract: The Huber needle is drawn into a protective cap and sheath arrangement after use for disposal purposes. The cap is tethered to a housing in which the needle is mounted by the sheath. The sheath is made of a film material that has a high tensile strength and a low percent of elongation, such as polyester. The sheath is initially mounted about the needle in a collapsed accordion-like condition between the cap and housing. When the cap is moved along the needle, the sheath is played out over the needle. The cap houses a spring clip to snap over a bore through which the needle is retracted to prevent re-emergence of the needle. The flexible nature of the sheath allows the sheath to pass about the two legs of the Huber needle.

Abstract: A materials delivery instrument is provided and includes an outer sheath and an instrument movably mounted within the outer sheath. The instrument includes a treatment lumen extending substantially the length of the instrument for receipt of treatment material. A super elastic wire is positioned in at least a distal end of the instrument. The super elastic wire forms a loop in an unstressed state to allow the instrument to encircle an anastomosis formed between a pair of tubular tissue sections. The super elastic wire is in a stressed state when the instrument is retracted within the outer sheath and in the unstressed state when the instrument is extended from the outer sheath to enclose the anastomosis. A proximal end of the super elastic wire is oriented substantially perpendicular to a plane formed by the loop to allow the instrument to lie parallel to the tubular tissue sections during the spraying of the anastomosis.

Abstract: An apparatus and method for access to the inside of a body includes a transparent sheath with a radiopaque marking and fastener for securing a guidewire or catheter. The transparent sheath permits objects located within and near the sheath to be visualized with an external imaging system. Objects located near the sheath can also be observed with an imaging device disposed inside the sheath. The radiopaque marker permits accurate positioning of the sheath in the body. The sheath can be inserted into the body over an interventional device. A fastener prevents migration of a guidewire or catheter during the procedure.

Abstract: A valve for surgical or medical instruments includes a passage that can be at least partially sealed by twisting a flexible section (1) of the passage wall, an element for rotating a mobile end (3) of flexible section (1), characterized in that the actuating element includes a cable for transmitting movement to mobile end (3) of the flexible section. Also described is a surgical or medical instrument including a valve as detailed.

Abstract: The present invention relates to a handheld medication delivery device comprising first and second mutually displaceable housing parts (1, 2) optionally being operatively connected by a first resilient member thereby allowing the medication delivery device to be in a non-compressed state and in a compressed state.

Abstract: The system (2) includes a catheter drive unit (22) and a catheter (24) extending therefrom movably mounted to a catheter drive sled (26). The catheter drive unit rotates and translates the catheter core (34) within the catheter sheath (36). The sled has a serrated, conical drive unit interface (82), with a bag-piercing tip (86) mateable with a translator drive output (92) so that a sterile drape (112) enclosing the catheter drive unit is automatically pierced when the catheter drive unit is mounted to the sled. A control unit (6) is spaced apart from the catheter drive unit and provides power and commands to the catheter drive unit and receives information and data from the catheter drive unit. The rotator and translator drive motors (54, 90) are operated from both the control unit and the catheter drive unit. Both the control unit and catheter drive unit have translation displacement displays (10, 30).

Abstract: A catheter that comprises a sheath that is connected at opposing ends to concentric tubes that move relative to each other in a manner that alternatively covers and exposes a medical device loaded onto the catheter. A portion of the sheath is arranged so as to invert upon itself so that axial movement of one tube relative to the other simultaneously moves the inversion point over or away from the device, alternatively covering or exposing the device.

Abstract: A catheter assembly includes an outer catheter member having a distal flexible end. An inner catheter member is movably disposed within the outer catheter member. Optionally, a handle assembly is coupled with the outer catheter member and the inner catheter member, where the handle assembly is adapted to slide the inner catheter member relative to the outer catheter member.

Abstract: A sheath for delivering a lead or other device into a body lumen is adapted to be removed from around the delivered lead or device via a longitudinally extending feature. This feature of the sheath may be a ripcord, a seam or interlocking features the releasably engage one another.

Abstract: A gastronomy tube device includes an expandable distal retention portion that is self-expanding. The device includes a removable sheath that circumferentially expands the self-expanding distal retention portion. The distal retention portion preferably is biased into an outer diameter that is greater when released from the sheath than when constrained by it.

Abstract: A suction device includes an elongated suction tube having a suction tip at a distal end thereof, and a proximal end that is connectable to a suction source. A collar is slidable along the suction tube from a retracted position to a deployed position. A sleeve is provided having a proximal end fixed relative to the proximal end of the suction tube, and a distal end configured with the collar so as to move therewith and cover the suction tube in the deployed position of the collar. A wiper seal is contained within collar in sliding frictional engagement around the suction tube.

Abstract: A method for inserting a multiple catheter assembly into a patient. The assembly (100) includes a first catheter (110) having a first distal end region (114) and an outer surface (120) defining at least a first lumen (122). A second catheter (130) has a second distal end region (134) and a second outer surface (140) defining at least a second lumen (142) The outer surfaces (120,140) of the first and second catheters are releasably joined by a splittable bond (180) for allowing the first and second distal tips (116,136) to be at least partially longitudinally split from each other. The method includes the steps of separating the first and second distal end regions, and inserting the first and second distal end regions in juxtaposed relation to each other through the incision and into the area to be catheterized.

Abstract: Double ended wire guides are manufactured so that either end, or both ends sequentially, may be inserted into a patient. The ends are different, so that the inventory requirements of wire guides are minimized. For example, a wire guide may have a straight end and an angled end, either end suitable for use on the patient. The wire guides may also differ in other characteristics, such as the stiffness or the diameters of the distal and proximal portions. The wire guide may also be stored in a package, the package including a fitting so that wetting solution may be injected into the package to wet the wire guide and prepare it for use.

Abstract: A catheter apparatus for delivery of fluids to and/or withdrawal of fluids from a blood vessel in a body includes a catheter having at least two lumens and a sheath attached to the proximal end of the catheter. The sheath is positionable over an entire length of the catheter while the catheter is within the blood vessel and is adapted for direct attachment to the body. The sheath may provide protective and/or sterilization functions for the multi-lumen catheter.

Abstract: An imaging device such as a catheter has a plurality of infusion holes adapted to infuse liquid into the blood stream while substantially preventing radial jetting. An example imaging catheter includes an elongated member, having distal and proximal ends, an axis, a lumen along the axis, and an outer surface. Preferably, a plurality of infusion holes are defined along the axis of said elongated member between the lumen and the outer surface. The plurality of infusion holes may be tapered from the outer surface to the lumen. Further, the plurality of infusion holes may be angled outwardly toward the proximal end of the elongated member. The size, shape, spacing and configuration of the infusion holes may be varied as desired.

Abstract: Apparatus for delivering a quantity of fluid to bone marrow of a bone or providing access to remove fluids from a target site is provided. The apparatus may include a driver, a plunger operating and cartridge assembly mechanism, a cartridge assembly having a fluid reservoir and a bone penetrating needle.

Abstract: The present invention relates to a device for controlling movement of a catheter that is at least partially disposed therein a urinary catheter pouch. The invention particularly relates to a catheter movement control device for use with a urinary catheter pouch which aids in preventing the catheter from moving back into the pouch once the catheter has been deployed. The device makes it easier to use a urinary catheter contained in a urinary catheter pouch. This is especially true for those with disabilities that would have difficulty gripping the catheter within the pouch.

Abstract: A guidewire straightener assembly (50,200,300,400) including a guidewire tube (56,250,450) with a tubular passage therethrough having a first diameter and a distal end, optionally including a collar (58,260,462) having a second diameter larger than the first diameter. The assembly also includes a guidewire straightener (10,210,410) having a distal end (12,212,412), a proximal end (14,214,414) having an exterior surface with a diameter sized to fit within the guidewire tube, and a longitudinal passageway (18,218,418) therethrough sized to accept the guidewire (52,202,402). The proximal end of the guidewire straightener further includes a biasing member (20,220,420) with at least one finger (26,216,416) therealong. The assembly further includes a guidewire (52,202,402) disposed within the tubular passage and the longitudinal passageway(18,218,418).

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: A Safety Arteriovenous Fistula (AVF) winged safety needle device provides a safety feature including a protective shield with handling wings, which when placed in cooperating relationship, allows accommodation of a blood collection needle and a hub. The Safety AVF provides a reliable and user friendly first releasable locking mechanism in an insertion position and a second unreleaseable locking mechanism in a protected position. The Safety AVF also allows for rotation of the needle after cannulation in order to maximize blood or fluid flow to or from a vessel.

Abstract: An indwelling needle 1 is composed of a cylindrical body 3, a needle 4 having a sharp edge 4a at a tip thereof, a cylindrical hub 5 which retains a proximal end of the needle 4 and which advances and retracts along the main body 3, and a protective cover 6 which advances and retracts along the main body 3 to project leftward, in the drawings, from the main body 3, and a spring 7 elastically installed between the hub 5 and the protective cover 6. A first engaging portion 11b of an actuating lever 11 provided on the body is engaged with a first projection 6a of the protective cover and a second through-hole 22b in the hub to allow a first retention mechanism A to retain the indwelling needle in a use state. The first engaging portion is moved upward to release the first retention mechanism. This separates the protective cover and the hub from each other under the elastic force of a spring.

Abstract: A method of maintaining sterility of fluidic medication in a fluidic medication container despite repeated extractions of the fluidic medication is provided. Also, a method of injecting a patient with fluidic medication without exposing the fluidic medication to ambient air is provided. The method may comprise the steps of providing a syringe with a sterilized variable fluid chamber with sterilized gas wherein the syringe is in a retracted position. A needle of the syringe is inserted into the fluidic medication container and the sterilized gas in the sterilized variable fluid chamber is transferred into the fluidic medication container to pressurize the same. Thereafter, fluidic medication is transferred from the fluidic medication container into the sterilized variable fluid chamber. The needle is removed from the fluidic medication container and inserted into the patient. The patient is injected with the fluidic medication in the sterilized variable fluid chamber.