Abstract: A safety interlock for use in a medical device having a control system for controlling operation of the medical device includes a central tubular portion defining a fluid passage for passing fluid through the safety interlock. An outer ring portion is adapted for mounting the safety interlock in the medical device. A spoked connector portion connects the central tubular portion to the outer ring portion so that the outer ring portion is spaced radially outwardly from the central tubular portion in opposed relation with at least a portion of the central tubular portion. The safety interlock is adapted for mounting in the medical device in a path of electromagnetic radiation from a source of electromagnetic radiation such that the central tubular portion reflects the electromagnetic radiation to a electromagnetic radiation detector when properly loaded on the medical device.

Abstract: A method for making a deflectable catheter includes positioning a flexible element along a catheter liner. A flexible element distal portion extends along at least a portion of a deflectable distal end portion of the catheter liner. At least one anchor is engaged to the flexible element distal portion. The anchor extends at least part way around the flexible element distal portion. An encapsulant is positioned around at least the flexible element distal portion and the deflectable distal end portion.

Abstract: An infusion mechanism for treating an intraluminal site in a patient includes an infusion catheter having an elongate body with a proximal body end defining at least one fluid supply orifice, and a distal body end. The elongate body defines a high head loss lumen in fluid communication with a first set of side ports defining a proximal infusion zone. The elongate body further defines a low head loss lumen in fluid communication with a second set of side ports defining a distal infusion zone.

Abstract: The invention relates to a design for securing tubes, catheters, drains, or other tubular medical devices within the body of a mammal, for example a human, and methods of securing same. The invention includes a first tubular body and at least one second tubular body. The first tubular body includes an outer surface, an inner surface defining a lumen extending longitudinally at least partially through a length of the tubular body, a wall at least partially defined by the outer surface and the inner surface, and a longitudinal axis. The at least one second tubular body includes an outer surface, an inner surface defining a lumen extending longitudinally through the second tubular body, and a wall at least partially defined by the outer surface and the inner surface. The second tubular body is disposed through the wall of the first tubular body transversely to the longitudinal axis.

Abstract: A guide wire comprising an elongate, flexible core having a proximal region, a proximal end, a distal region, and a distal end; and a plurality of wire strands wrapped helically parallel to one another and disposed on at least a portion of the distal region of the core.

Abstract: The invention relates to a catheter for introducing into a hollow human or animal organ. Said catheter comprises a catheter tip that protrudes forwards and a region that is encased by an expandable tubular hollow body and that is situated behind the catheter tip. Said catheter is characterised in that a wire spiral is located in the encased region. It can also be advantageous to provide a radiopaque ring, in particular a platinum, gold or tungsten ring, on a hollow shaft of the catheter, together with several rib-type projections running around the hollow shaft and projecting from the latter, in a region in front of and/or behind the radiopaque ring.

Abstract: A system and its method of use for identifying a patient's urethral anatomic course for the precise placement of a treatment element into the patient's prostate, wherein a echo-opaque catheter is introduced into a urethra until its echogenic and radio-opaque portion is generally aligned with a treatment site of the prostate. An image probe is positioned relative to the treatment site and the urethra and is activated to obtain a real time image of the prostate, and urethra. The echo-opaque catheter may be made of an elongated flexible catheter, which is coated with, incorporate with or enclosed by materials that enhances the ultrasound and radio visualization.

Abstract: An intravascular catheter that exhibits the combined features of superior flexibility, softness, radiopacity and oval/kink resistance. The catheter includes an elongate shaft having a proximal region, a distal region and a lumen extending therethrough. The proximal region of the shaft includes an inner lubricious polymer layer, a reinforcement layer and an outer layer. The reinforcement layer comprises a braid having one or more metallic members and a plurality of polymer members wherein each polymer member comprises a plurality of monofilaments, preferably formed of LCP. The polymer members of the braid provide improved flexibility and softness in addition to high burst pressure. The metallic member(s) of the braid provide improved radiopacity and oval/kink resistance. The catheter may also include a longitudinal member extending along the reinforcement layer.

Abstract: A central venous catheter is provided having an outer tubular member and an inner tubular member that are preferably formed as a single integrated tube containing polymer material of different durometer and varying amounts of radiopaque filler material. The polymer durometer of the inner tubular member is higher than the polymer durometer of the outer tubular member. The percentage by weight of the filler material contained in the inner tubular member is higher than that of the outer tubular member. The combination of the higher durometer inner tubular member and the lower durometer outer tubular member along the length of the tube provides the desired tensile strength, hardness, chemical resistance and fatigue resistance and at the same time provides the desired flexibility and radiopacity.

Abstract: An object of the present invention is to provide a guidewire having high safety and improved flexibility and rotation followability. This guidewire has an inner coil that surrounds a distal side portion of a core shaft, and an outer coil that surrounds the inner coil and the distal side portion of the core shaft. A front end of the outer coil and a front end of the inner coil are joined to a tip of the core shaft by a tip plug. Further, the guidewire has a coil joint that joins only the outer coil and the inner coil to each other. With this configuration, the flexibility of the inner coil is maintained. Moreover, rotation of a proximal side of the guidewire is transmitted to the inner coil not only from the core shaft but also from the outer coil. This leads to improvement in rotation followability.

Abstract: A radiopaque marker configured for being securing to a tubular member adapted for introduction into a patient and having relief sections to provide localized accommodation of diametrical-circumferential dimensional reduction.

Abstract: An intravascular catheter may include a distal end for insertion and a proximal end. The distal end for insertion may terminate with a tip. It may define at least two openings, of which one is proximal-most in the distal end. The distal tip may include a first radiopaque marker that is discretely positioned at the proximal-most opening and radiographically distinguishes the proximal-most opening from the rest of the distal end. The distal tip may also include a second radiopaque marker that marks the tip.

Abstract: A method for determining by an x-ray projection a position of a target radiopaque marker disposed on a catheter in a subject's body, comprising assigning a landmark in the body as a reference point compensated for periodic movements of the body, determining an auxiliary location relative to the reference point using at least one additional radiopaque marker disposed on the catheter and based on the auxiliary location determining the position of the target radiopaque marker with respect to the reference point.

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: The intravascular catheter has two segments; a proximal segment with high stiffness and a distal segment with lower stiffness. The catheter can also have an intermediate segment of lower stiffness than the proximal segment and higher stiffness than the distal segment. The catheter comprises a polymeric inner tube, a reinforcing inner jacket which is spirally wound over the inner tube and which becomes progressively softer from a proximal end to a distal end, and a polymeric outer sheath extruded over the inner jacket according to the teachings of U.S. Pat. No. 5,445,624. The reinforcing jacket comprises helical coiled wires or fibers of various materials and layers wound over the inner tube in order to provide improved multi-axial mechanical properties, such as torque, compression, tension and anti-kinking characteristics.

Abstract: A guidewire having a longitudinal axis includes an inner ribbon coil wound in a first direction, an outer ribbon coil wound in a second direction opposite the first direction wherein the inner ribbon coil is coaxially arranged within the outer ribbon coil and configured to prevent the inner ribbon coil from interlocking with the outer ribbon coil, and a plurality of connection points along the longitudinal axis of the guidewire wherein the plurality of connection points affixes the inner ribbon coil to the outer ribbon coil.

Abstract: The instant invention provides silencer expression cassettes for delivery of RNAi therapy. The silencer cassettes of the instant invention encode an RNAi agent and lack means for replication within a host cell, inverted terminal repeats and further lacking one or more selectable markers. Optionally, the silencer cassettes lack CpG dinucleotides and/or the RNAi agent is within a scaffold of a naturally occurring miRNA. The composition comprising the silencer cassettes of the instant invention, as well as methods of use and suitable systems are also provided.

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: Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

Abstract: Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

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

Abstract: A medical device with improved flexibility characteristics and methods of using the same. The medical device may include a proximal end, a distal end, and an intermediate region. In at least some embodiments, the column strength or flexibility of the intermediate portion is generally greater than the column strength or flexibility at the distal end.

Abstract: A retrograde coronary sinus perfusion catheter including a tubular catheter body having a proximal end, a distal end, and an inner lumen, and an inflatable balloon spaced proximally from the distal end of the catheter body, wherein the balloon is echogenically enhanced.

Abstract: A guidewire device comprising a micro-fabricated elongated outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end and a plurality of fenestrations made through said outer surface and said interior surface into a least a portion of said lumen; an outer elastomer laminate layer in contact with at least a portion of said outer surface and filling at least a portion of said plurality of fenestrations; and an inner member disposed within a substantial portion of said lumen, and embodiments thereof.

Abstract: A catheter device comprising: a micro-fabricated elongated outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, wherein said outer member is formed from two or more different stock materials, and embodiments thereof.

Abstract: Catheters such as guide catheters can be configured for delivery of devices to vasculature portions such as intracranial spaces while retaining a desired level of flexibility. A catheter having an elongate shaft can include removable support means that can provide column support to the elongate shaft. The elongate shaft can include anchoring means that releasably secure the removable support means. The catheter can be deployed within a patient's vasculature, followed by deploying the removable support means.

Abstract: A multilumen catheter assembly and method of making the catheter assembly is provided that involves providing a plurality of tubes, each tube having a first end, a second end, at least one lumen, and at least one surface, selectively heating at least a portion of the surface of at least a first tube of the plurality of tubes, and contacting the selectively heated portion of the tube with a portion of the surface of a second tube to form a multilumen catheter shaft that is joined together along at least a portion of the length of the catheter shaft.

Abstract: An apparatus is provided and, in one example embodiment, includes a catheter coupled to a channel. The catheter includes a first set of holes in which materials may pass. The channel defines a pathway that extends along a portion of the catheter. The channel can interface with a second set of holes that are different from the first set of holes and access to the channel occurs via the second set of holes and not the first set of holes. The channel receives a substance that is delivered to an area close to or at the area in which the channel resides and the substance is delivered via the second set of holes. In more specific embodiments, the catheter includes a distal end that is rounded. In still other embodiments, the second set of holes are spaced equidistant from one another, and the channel interfaces with a syringe that delivers the substance.

Abstract: Methods and kits for delivering pharmaceutical agents to the adventitia and other regions outside the external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent.

Abstract: A catheter device comprising a proboscis shaft and a proboscis disposed within the proboscis shaft. In certain embodiments, the catheter device further comprises an elongate tubular member, wherein the proboscis shaft is disposed within the elongate tubular member. In certain embodiments, the catheter device comprises a tissue surface engagement structure, which has a first configuration and a second configuration. In the second configuration, the tissue surface engagement structure presents a larger transverse profile in comparison to the first configuration. The tissue surface engagement structure may have any of various designs, including an expandable assembly and a hinged assembly. In certain embodiments, a deformable cushion is positioned at the distal end of the proboscis shaft. The deformable cushion comprises a pocket that is filled with a reshapeable material. In certain embodiments, the proboscis shaft comprises a longitudinally compressible portion.

Abstract: A tissue penetrating catheter that is usable to advance a tissue penetrator from within a blood vessel, through the wall of the blood vessel to a target location. The catheter includes at least one stabilizing device thereon for stabilizing catheter prior to advancing the tissue penetrator. The tissue penetrator may extend through a lumen in the body of the catheter and project transversely through an exit port. The stabilizing device may be located closely adjacent to the exit port, or may surround the exit port. The stabilizing device may be one or more balloons, or other mechanical structure that is expandable into contact with the inner luminal wall of the blood vessel. Desirably, the exit port is forced into contact with the blood vessel wall to shorten the distance that the tissue penetrator projects from the catheter body to the target location. The catheter is particular useful for forming blood flow tracts between blood vessels, in particular in coronary revascularization procedures.

Abstract: The preparation and use of medical devices having an outer layer over a visibility material-loaded inner layer is disclosed herein.

Abstract: The preparation and use of medical devices having radiopaque and echogenic materials including coated tungsten and/or tungsten carbide particles are disclosed herein.

Abstract: An intracorporeal catheter, such as a guiding catheter, employed for intraluminal procedures is disclosed. The catheter generally has an elongated catheter shaft including a polymeric inner layer and a non-radiopaque outer polymeric layer, along with a radiopaque reinforcing structure disposed between the inner and outer layers. In one embodiment, the reinforcing layer consists of multiple drawn filled tubes braided or wound together. The drawn filled tubes may have a stainless steel outer jacket clad over a radiopaque inner core, or the drawn filled tubes may have a radiopaque outer jacket clad over a stainless steel core. In another embodiment, the reinforcing layer may consist of multiple wires containing radiopaque alloys braided or wound together, wherein at least two of the wires consist of different radiopaque alloys. The strands of the reinforcing structure may have a circular or a rectangular transverse cross-sectional shape.

Abstract: A deflection and support catheter provided for improved manipulation of elongated medical devices used during percutaneous procedures in difficult to reach situations. In particular, the deflection and support catheters can facilitate placement of guidewires, guide catheters, and intervention devices such as angioplasty balloons and stent delivery devices.

Abstract: The present invention is a handle for controlling the deflection of a distal end of a catheter body. The catheter body includes first and second deflection wires that extend through the catheter body from the distal end of the catheter body. The handle comprises a slide base, an adjustment knob, a first slide and a second slide. The slide base includes a first end, a second end, and a slide compartment longitudinally extending through at least a portion of the slide base. The adjustment knob is rotateably connected to the first end of the slide base and includes a hole extending through the knob, wherein at least a portion of an inner diameter of the hole includes an internal right thread and an internal left thread. The first slide is located in the slide compartment, is adapted to be coupled to the first deflection wire, and includes an external right thread. The second slide is located in the slide compartment, is adapted to be coupled to the second deflection wire, and includes an external left thread.

Abstract: A guidewire exchange device is configured to exchange a guidewire associated with a guidewire port in a medical device. The guidewire exchange device is further configured to interface with the medical device at the guidewire port, remove the guidewire from the medical device, and insert a replacement guidewire.

Abstract: A catheter including an abutment located within the catheter body lumen.

Abstract: A deflecting guide catheter for use in minimally invasive medical procedures such as the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The catheter includes an elongated tubular portion having various durometers along its length and at least one puller wire attached to an anchor band near the distal end. The deflecting guide catheter is used to provide a means for guiding a plication device or other medical instrument into a desired position within the vasculature or heart chambers of a patient.

Abstract: A central venous catheter is provided having a proximal tube segment, a distal tube segment and a transition tube segment interposed between the proximal and distal tube segments which are preferably formed as a single integrated tube containing polymer material of different durometer and varying amounts of radiopaque filler material. The polymer durometer of the proximal segment is higher than the polymer durometer of the distal segment. By contrast, the percentage by weight of the filler material contained in the distal segment is higher than that of the proximal segment. The variation in the polymer durometer and the filler amount along the length of the tube provide the desired tensile strength, hardness, chemical resistance and fatigue resistance at the proximal segment and at the same time provide the desired flexibility and radiopacity at the distal segment.

Abstract: A microcatheter for delivering embolic agent to a vascular site is provided. The microcatheter has a biocompatible or biocompatible and biodegradable tip which can be detachably engaged to the microcatheter body by a thermoplastic sleeve. Once the embolic agent is delivered to the desired vascular site, the tip of the microcatheter is often entrapped within the mass of the liquid embolic fluid. Using the microcatheter, the clinician can retract the microcatheter at a predetermined retraction force thereby disengaging the tip from the microcatheter body allowing for easier removal of the microcatheter.

Abstract: An infusion catheter includes a catheter body having a proximal end, a distal end, and two or more lumens extending therethrough. The infusion catheter also includes an infusion tube having a proximal end, a distal end, and one or more ports disposed therethrough. The first lumen of the catheter body is in fluid communication with the lumen of the infusion tube. A central member has a distal end connected to the distal end of the infusion tube, a proximal end, and a proximal portion slidably received in the second lumen of the catheter body. The infusion tube is disposed relative to the central member such that axial advancement of the central member relative to the catheter body radially collapses the infusion tube over the central member and axial retraction of the central member relative to the catheter body radially expands the infusion tube about the central member.

Abstract: Systems for less invasive medical procedures comprise a filter device mounted on an integrated guiding structure and an aspiration catheter. These components can be used together or separately, and the system can be used with other medical devices that are designed for less invasive procedures, such as procedures in a patient's vasculature. The filter device can involve improved torque coupling with a torque coupler associated with a resilient member that correspondingly also provides increased flexibility relative to an overtube that forms a tube for the remaining portions of the device. An actuation tool for the filter device used a systematic loading procedure for proper loading of the corewire and overtube into the actuation tool. A fiber cartridge comprises fibers loaded as a bundle into the cartridge for delivery with the ends of the fibers respectively bonded to radiopaque markers that can be visualized to come together when the filter is properly deployed.

Abstract: A marker band and medical devices such as catheters and guidewires that include a marker band. A marker band may include a generally cylindrical body portion having one or more slots or openings defined therein. The marker band is configured for being secured to a medical device. Methods of making and using a marker band and a medical device having a marker band are also disclosed.

Abstract: A long nose manipulatable catheter is described herein. The catheter generally comprises a flexible joint region defining a main lumen and an adjacent wire lumen. The wire lumen has an opening near or at a distal end of the flexible joint region and a push/pull wire can be pushed or pulled through the wire lumen. The catheter assembly may also comprise at least one radio-opaque marker band for securing the push/pull wire. The joint region has a predetermined length sized to affect a flexure of the joint and is generally located at the distal end of the catheter. The joint region itself may be varied to extend distally from where the braid terminates, or it may extend to encompass a portion of the braid. By varying a length of the joint region, the amount of curvature and flexure of the joint region can be controlled.

Abstract: A catheter having a radiopaque marker. The radiopaque marker is disposed on a distal end of the catheter tube and is configured to allow for simple and efficient identification of the location of a predetermined drainage bore on an X-ray or other radiographic technique. In one implementation, the radiopaque marker is associated with the catheter tube such that inclusion of the radiopaque marker does not increase the outer diameter or decrease the inner diameter of the tube.

Abstract: A catheter device that is useable to penetrate from a blood vessel in which the catheter device is positioned to a target location comprises a flexible catheter advanceable into the first blood vessel, a tissue penetrator lumen adapted to receive an operative tissue penetrator which is usable to penetrate from the blood vessel to the target location when properly aimed. Further said catheter including an imaging transducer fixedly mounted on or within the catheter body to provide an imaging signal from which an image of the target location can be obtained. The catheter device may include an imageable marker on the catheter to form on the image obtainable from the imaging signal a penetrator path indication that indicates the path that will be followed by the tissue penetrator when the tissue penetrator exits from the catheter. Alternatively, or addition thereto, the imaging transducer may comprise a plurality of imaging elements which are located so that the penetrator path indication can be obtained.

Abstract: An assembly for delivering nutritional products to the jejunum of a patient through a stoma formed through the abdominal wall and the stomach wall. A first tubular member is alignable such that the proximal end communicates with an area exterior of the patient, and the distal end is disposed within an interior space of the stomach of the patient. At least a portion of the distal end within the stomach interior space is configured for maintaining the stomach wall in apposition with the abdominal wall. A second tubular member is alignable such that the proximal end communicates with an area exterior of the patient, and the distal end extends into the jejunum of the patient. A hub positioned in the stoma has a first opening communicating with the first tubular member, and a second opening communicating with the second tubular member. Respective closure members may be provided for selectively sealing the first and second openings.

Abstract: A flexible laminate composition and methods for manufacturing same are provided. The flexible laminate composition includes one or more discrete and separate layers of a radiopaque material wherein the radiopaque layer is applied via a solvent to a layer that is composed of a plastic material. The laminate composition can be formed into a radiopaque marker band that can be used with a medical device, such as a catheter, for radiographic imaging. The laminate composition as an alternative can also be utilized to form the catheter or other suitable medical device.

Abstract: The present invention generally relates to a medical surgical device and specifically a wire guide for percutaneous placement within a body cavity. The flexibility of the wire guide may be varied while it is in place within the body vessel.