Abstract: In an embodiment, the invention provides a catheter suitable for use in performing a procedure within a vessel, lumen or organ of a living having a distal end which is steerable, such as upon the application of compression. The catheter may be of the over the wire type, or alternatively may be a rapid exchange catheter. The catheter may provide for a rotating element which may be used to open a clogged vessel, or alternatively to provide information about adjacent tissues, such as may be generated by imaging or guiding arrangements using tissue detection systems known in the art, e.g., ultrasound, optical coherence reflectometry, etc. For rapid exchange catheters having a rotating element, there is provided an offset drive assembly to allow the rotary force to be directed from alongside the guidewire to a location coaxial to and over the guidewire.

Abstract: A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a dual function medical device. The dual function medical device may include an inner guidewire. An outer guidewire may be disposed about the inner guidewire. The outer guidewire may include a tubular member having a plurality of slots formed therein. A torque member may be coupled to the dual function medical device. The torque member may be configured to independently attach to the inner guidewire and the outer guidewire.

Abstract: Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient's skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient's skin to a second position remote from the patient's skin. Systems, methods, and other embodiments are disclosed.

Abstract: A guide wire (400, 500, 600, 700, 800, 900, 1000, 1200, 1300) is adapted for use in magnetic resonance imaging systems. The guide wire has a shaft region (402) and a distal tip region (404). The shaft region comprises a composite shaft (406) comprising reinforcing fibers aligned with a length extension (403) of the shaft region. The fibers extend at least partially into the distal tip region. The fibers form a taper (410) within the distal tip region. The distal tip region comprises a sensor (504, 604, 702, 704, 804, 904, 1006, 1008). The shaft comprises a cable (502, 602, 702, 704, 802, 902, 1002, 1004). The cable is connected to the sensor.

Abstract: An agent delivery catheter that includes an anti-whipping feature, improved assembly of distal parts and/or accuracy/repeatability of needle delivery to a target tissue. Additional features include fitting a catheter with a pneumatic delivery device for delivery of a therapeutic agent without using a needle.

Abstract: An instrument for facilitating insertion of a catheter through a subcutaneous tunnel includes a tunneling stylet defining a longitudinal axis and having leading and trailing ends, a bifurcated segment adjacent the leading end of the tunneling stylet and a releasable cover releasably mountable to the leading end of the tunneling stylet to substantially enclose the bifurcated segment. The bifurcated segment includes first and second elements adapted for reception within respective lumens of a catheter.

Abstract: Various methods and devices for inserting a guidewire into the body are provided. In one embodiment, a guidewire insertion device is provided and includes and outer sheath having an outer surface and an inner lumen extending therethrough, and a dilator having an inner lumen extending therethrough and having a length greater than a length of the outer sheath. A guidewire can be configured to extend through the inner lumen of the dilator such that the guidewire is removably and replaceably disposable within the dilator and coupled thereto. A locking mechanism can be effective to selectively configure the guidewire between a locked position in which the guidewire is stationary relative to the dilator and an unlocked position in which the guidewire is movable relative to the dilator.

Abstract: The present application relates to orogastric tube guides and to related systems and methods. The orogastric tube guides and systems can be used to direct an orogastric tube into the esophagus of a patient during any medical or surgical procedure where placement of an orogastric tube is indicated or used.

Abstract: An introducer sheath is configured to inhibit or prevent a distal section from being curled even when the wall thickness thereof is reduced, an introducer sheath is formed from a sheath tube that has a hollow section into which an elongated body can be inserted, and includes a sheath distal section and a sheath main body section. In the sheath for an introducer, the sheath distal section is formed to be harder than the sheath main body section.

Abstract: A system and method for anchoring a round catheter pull wire within the distal end of a catheter. A steering deflection mechanism includes a pull ring having a plurality of apertures and one or more receiving slots. The method includes affixing one or more round pull wires to the one or more receiving slots of the pull ring. The shape of the round wire and manner of affixing the wire to the pull ring provide a steering assembly that can withstand greater pull forces while maintaining design integrity.

Abstract: The present document describes a pressure guidewire comprising: a shaft tube with a proximal section; a middle section extending from the proximal section of the shaft tube, the middle section having greater flexibility than the proximal section; an inner hypotube installed substantially within the middle section for optimal mechanical properties; a pressure sensor with a communication means routed through the middle section and the proximal section; and a sensor housing for receiving the pressure sensor. There are also described methods for joining the inner hypotube to the shaft tube.

Abstract: A steerable delivery device comprising an outer sheath and an inner sheath disposed within the outer sheath, wherein the outer sheath includes a first tubular element, a steerable portion adapted to be steered, and wherein in a cross section along the steerable portion the first tubular element includes a first section of a first material with a first durometer and a second section of a second material with a second durometer different than the first durometer.

Abstract: An infrared detector and image projector system is set forth comprising an IR imager/projector for capturing an image of a vein and a needle and projecting the image on a surface; and a discrimination and guidance system for discriminating the needle from the image, calculating parameters of the needle and based on these parameters causing the IR imager/projector to project the image of the needle and vein and additional information to assist in visualizing needle alignment with the vein and insertion through tissue into the vein.

Abstract: Disclosed herein is a removable cap for connection to an input port of a catheter, comprising a proximal end having a lumen configured to house a guidewire therethrough; a distal end configured to reversibly mate with a luer lock of the input port of a catheter, the distal end having a lumen configured to house the guidewire therethrough; and a tubular body between the proximal end and the distal end, wherein the tubular body comprises an anti-migration feature transformable between a first configuration to allow slidable movement of the guidewire within the cap in a first direction toward the patient, and a second configuration to prevent slidable movement of the guidewire within the cap in the first direction toward the patient. Systems and methods are also disclosed.

Abstract: The present invention discloses a vibration imparting device having an attachment mechanism 5 that supports a guiding catheter 10a to be inserted into a body, and a vibrating portion 4 that is located outside the body and imparts vibration of non-ultrasonic frequency to the guiding catheter 10a via the attachment mechanism 5. That enables a catheter to be easily inserted into a lesion area of the body.

Abstract: Apparatus and methods providing intra-luminal access and, in particular, to needle, catheter, and guidewire structures and methods of using the same to access a vascular or other body tissue lumen.

Abstract: Medical devices are described. More particularly, medical devices and methods for the identification and treatment of bodily passages, such as sinus cavities, are described herein. An exemplary medical device comprises an elongate member, a handle, and a wire member. The elongate member is moveable between a first straight, or substantially straight, configuration to a second curved configuration.

Abstract: A tunneler device is provided which includes a handle, a shaft extending distally from the handle, a connecting device including a body supported on a distal end of the shaft configured to be received within a lumen of a catheter, and a resilient separation prevention device supported on the connecting device. The resilient separation prevention device is inwardly deflectable towards the connecting device upon insertion of the connection device into the lumen of the catheter and biased towards a non-deflected position in engagement with an inner surface of the catheter to prevent retraction of the connecting device from the catheter.

Abstract: A medical implant delivery system maintains an orientation between a guidewire lumen of an inner member of the system and a rapid-exchange port in an outer member. The medical device is disposed intermediate the inner and outer members and in friction or pressure-fit contact with the outer member. Once the guidewire lumen of the inner member and the rapid exchange port of the outer member are oriented, the friction or pressure-fit operates to maintain the orientation until deployment of the medical implant. Orientation is further maintained by a telescoping coupling of the guide wire lumen with the rapid exchange port.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device includes a pressure sensing guidewire. The pressure sensing guidewire may include an elongate shaft including a core wire having a distal portion and a coil disposed over the distal portion. A pressure sensor may be disposed along the distal portion of the core wire and within the coil. One or more leads may be coupled to the pressure sensor. An opening may be formed in the coil that provides access to the pressure sensor.

Abstract: Systems and methods are described herein that improve control of a shapeable or steerable instrument using shape data. Additional methods include preparing a robotic medical system for use with a shapeable instrument and controlling advancement of a shapeable medical device within an anatomic path. Also described herein are methods for altering a data model of an anatomical region.

Abstract: An apparatus for deflecting a distal portion of a catheter, a sheath, a medical device, or other flexible elongate member may generally include a handle portion, a pair of adjusting knobs, and deflection wires. The adjusting knobs may be rotatably coupled to the handle portion and operably coupled to the deflection wires. The deflection wires may be in further communication with the distal portion of the flexible elongate member. Rotation of the adjustment knobs may translate or otherwise displace particular deflection wires with respect to the rest of the flexible elongate member, thereby causing the distal portion of the flexible elongate member to deflect. Further, the deflection wires may be oriented such that the distal portion of the flexible elongate member may be deflected in a multitude of directions.

Abstract: An endovascular sheath apparatus 2 is provided. The endovascular sheath apparatus 2 includes an inner tube 12 that includes a lumen 26 for introducing medical fluids or devices and an outer surface. The apparatus 2 further includes an outer tube 22 with an interior surface. The outer and inner surfaces define a cavity 28 therebetween. The apparatus 2 still further includes a stiffening component 20 which in one embodiment includes a braided material that is at least partially received in at least part of the cavity 28. An actuating mechanism 18 cooperates with the stiffening component 20. A method of providing intravascular delivery of a sheath includes the steps of providing an inner tube 12; positioning a stiffening component 20 around the inner tube 12; and deploying an actuating mechanism 18 that cooperates with the stiffening component 20, a stiffness characteristic of which being adjustable extra-corporeally by movement of the actuating mechanism in combination with the stiffening component.

Abstract: Complex steerable catheter visualization and tissue manipulation systems and their methods of use are disclosed herein. The deployment catheter is articulated using various steering mechanisms. Tissue visualization is accomplished from the visualization hood at the distal end of the deployment catheter, the hood having an ability to expand and other features to facilitate visualization and articulation at the tissue surface.

Abstract: Described is a guide catheter for guiding other medical devices into or through a body lumen, comprising: a polymeric, tubular inner liner having a textured inner surface; and, a polymeric jacket bonded to an exterior of the inner liner; wherein the texture of the inner surface of the inner liner reduces the coefficient of friction between the inner liner and the other medical devices.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include an elongate tubular member having a proximal region, a distal region, and a slot formed in the tubular member between the proximal region and the distal region. The proximal region of the tubular member may be configured to shift between a first configuration and a collapsed configuration. The guide extension catheter may also include an elongate shaft for shifting the proximal region between the first configuration and the collapsed configuration.

Abstract: A steerable, multifunction radiofrequency (RF) catheter probe for providing improved steerability plus variable rigidity of RF catheter probes. The features of the invention include the ability to reversibly vary the rigidity of catheter probes and to configure the shape of the distal end of catheter probes as required by the application.

Abstract: A guidewire having high rotational torque transmissibility and high pushing torque transmissibility and having favorable restorability is provided. The guidewire has an outer coil having a tapered coil portion constituted by at least one strand wound to decrease an outer diameter toward a front end of a core shaft and an inner coil arranged inside the outer coil. An outer diameter on a front side of the inner coil arranged on a front side of the tapered coil portion is smaller than an outer diameter on a rear side of the inner coil.

Abstract: A remote guidance system for a medical device is provided that is capable of use with magnetic resonance imaging and other environments with a relatively high level of electromagnetic interference. In one embodiment, a fluid control system controls delivery of fluid to a fluid conduit supplying a fluid chamber of a fluid housing. A piston disposed within the fluid chamber moves in response to a change in fluid displacement in the chamber and causes corresponding movement of the medical device within a body. In another embodiment, means are provided for controlling a connector coupled to the medical device at a location outside the body wherein movement of the connector causes a corresponding movement of the medical device. A sensor generates a signal indicative of a characteristic associated with movement of the medical device. The sensor includes an optic fiber that transmits a light wave indicative of the characteristic.

Abstract: A medical wire guide may include a mandril having a distal tip, a first coil coupled with the distal tip of the mandril, and a second coil configured to releasably engage with the mandril or the first coil. The second coil comprises a distal tip and defines an inner cavity dimensioned to contain a distal tip of the first coil when the second coil is engaged with the mandril or the first coil.

Abstract: An ultrasound system has a catheter including an elongate flexible catheter body having at least one lumen extending longitudinally therethrough. The catheter further includes an ultrasound transmission member extending longitudinally through the lumen of the catheter body, the ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end coupled to the distal end of the catheter body. The distal end of the catheter body is deflectable. The ultrasound system also includes a sonic connector that connects the ultrasound transmission member to an ultrasound transducer. The ultrasound system also provides a method for reverse irrigation and removal of particles.

Abstract: The present application discloses a handle configured to receive a catheter. The handle comprises a port that communicates with a lumen of the catheter and a mechanism is provided that moves the end of the catheter for positioning. The guide wire traverses a reservoir located in the handle. In particular, the handle comprises an enclosure with a conduit and a reservoir, where the conduit extends through the enclosure from the left side to the right side and the reservoir space has a curved or concave base. The bottom side and top side of the handle converge into a tapered point on the left side.

Abstract: Guide extension catheters and methods of manufacturing and using guide extension catheters are disclosed. An example guide extension catheter may include a distal sheath having a proximal opening, a distal opening, and a central lumen extending therebetween. The guide extension catheter may also include a proximal shaft having an outer diameter smaller than an outer diameter of the distal sheath, the proximal shaft including a distal opening. The guide extension catheter may also include a coupling member for securing the distal sheath to the proximal shaft. The coupling member may include a distal portion attached to the distal sheath and a proximal portion disposed within the distal opening of the proximal shaft.

Abstract: With a push device for the axial insertion of an elongate, flexible body (8, 10), in particular of a flexible tube, a cable or similar elements into a sheath, and axial force introduction unit (19, 20, 47, 49) is provided, which by way of a non-positive fit or a positive fit, applies a push movement onto the elongate body and is arranged in a stationary manner relative to the sheath (2) or is guided on a predefined movement path.

Abstract: A method and apparatus are disclosed for a medical device, including a means for enhancing visibility under imaging which, while reducing the local mechanical strength, avoids compromising the overall device effectiveness or safety. Visibility under imaging is increased by a non-uniform distribution of visibility-enhancing features as a function of the local stresses expected during use. One embodiment is for a medical device comprising an elongate member having proximal and distal regions, wherein the distal region comprises: a first echogenic region including a plurality of circumferential first region cuts, each of the first region cuts having a first region cut volume; and a second echogenic region, distal of the first echogenic region, including a plurality of circumferential second region cuts, wherein each of the second region cuts has a second region cut volume greater than said first region cut volume.

Abstract: A steerable device, such as a steerable catheter, may include a control handle and an insertion shaft extending outwardly therefrom. In use, the insertion shaft is navigated to an area of interest for examination and/or treatment thereof. The steerable device may include a steering system that controls the deflection angle of the distal end of the insertion shaft in two or more non-planar directions for navigating the insertion shaft to the area of interest. The steering system may also include a locking mechanism for arresting or partially arresting the movement of the distal end of the insertion shaft in a first direction independent of arresting or partially arresting the movement of the distal end in a second non-planar direction.

Abstract: Control systems and methods for a remote joint use position measurements to determine and control the force that an actuator applies to the joint through a linkage. The use of force and feedback allows control of a medical instrument having a linkage that provides non-negligible compliance between the joint and a proximal actuator and particularly allows precise instrument operation even when the position of the distal joint cannot be directly related to the proximal motor position.

Abstract: A steering mechanism for a catheter includes a tubular member defining a passage. The tubular member has a longitudinally extending, bend-enhancing portion formed at a predetermined region of the tubular member. An actuator is received in the passage of the tubular member, with the distal part of the actuator being fastened to a distal part of the tubular member.

Abstract: A cannula includes a hollow cylindrical body which is open at one end and closed at the other end. A slot extends from the open end toward the closed end, terminating with an opening that is larger in width than the slot, the width being measured in a direction perpendicular to the longitudinal direction in which the slot extends. The opening allows the passage of a guide wire for relative sliding. The configuration of the cannula is such that the end of the wire coming out of the cannula through the opening cannot, once inserted into the openings, penetrate into the part of the cannula beyond the opening between the latter and the closed end of the cannula.

Abstract: Apparatus and method for delivering and deploying an intravascular device into the vessel including an outer and inner tube that are axially linked by a housing structure at the proximal end of the catheter, and a retractable sleeve structure having a middle tube and sleeve tip. The sleeve tip is sealed to the inner tube at the distal end, and continuously extends into the middle tube. At the proximal end of the sleeve structure, the middle tube is sealed to either a housing structure or slideable proximal ring, forming a sealed chamber between the inner tube and the sleeve structure. A radial space is formed between the sleeve tip and the inner tube optimized for intravascular device placement. During retraction of the sleeve structure, the fold of the sleeve tip peels away from the device, which expands to its deployed state while minimizing axial forces and friction.

Abstract: An elongate medical device having an axis comprises an inner liner, a jacket radially outward of the liner, a braid comprising metal embedded in the jacket, a sensor, and at least one wire electrically connected to said sensor. The at least one wire is one of: embedded in the jacket and optionally disposed helically around the braid; extending longitudinally within a tube which extends generally parallel to the device axis and wherein the tube is embedded in the jacket; and disposed within a lumen, wherein the lumen extends longitudinally within the jacket.

Abstract: Various forms of anti-clog suction tips apparatus are disclosed. For example, an anti-clog suction tip apparatus includes a suction tip assembly having a suction tip with a suction opening at a first end thereof for removing debris through suction, a hose attachment portion for attaching the suction tip assembly to a suction source, and an ejection wire channel. The apparatus further includes an ejection wire assembly having an ejection wire extending within the channel and an ejection button integral with or connected to the ejection wire. Applying a force to the ejection button advances the ejection wire through the channel such that an end portion of the ejection wire enters the suction tip and dislodges debris clogging the suction tip. The ejection wire may include an enlarged end portion such as, for example a ball tip. One or more of the components of the apparatus may be single-use and disposable.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal shaft having a first outer diameter. A distal sheath may be attached to the proximal shaft and may have a second outer diameter greater than the first outer diameter. A trackable tip member may be attached to the distal sheath and extending distally therefrom. The trackable tip member may define a guidewire lumen therein.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal outer diameter. A removable stiffening member may be disposed adjacent to the proximal member. A distal sheath member may be attached to the proximal member. The distal sheath member may have a distal outer diameter greater than the proximal outer diameter.

Abstract: A distal perfusion sheath (DPS) is provided for cases where blood perfusion is needed for downstream arteries (distal) to the insertion point of the DPS within the target artery. The ability to provide distal perfusion with the DPS allows the DPS to be positioned in the target artery for long periods without causing lack of blood flow (ischemia) to an extremity that the target artery supplies. In embodiments, the DPS can still be used for surgical arterial access while allowing blood flow downstream.

Abstract: An apparatus for deploying a needle within a lumen is provided. The apparatus includes a housing having a threaded bushing radially disposed therein. The bushing rigidly couples with a nose cone having a guide tip disposed at an end opposite the bushing for penetrating an arterial wall of a lumen. During operation, a user incrementally advances the bushing within the housing, thereby incrementally advancing the guide tip into the lumen. The nose cone also includes a flex guide having a slot configuration which couples with the guide tip which deploys into the lumen along with the guide tip.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal outer diameter. A distal sheath member may be attached to the proximal member. The distal sheath member may have a proximal sheath portion and a distal sheath portion. The proximal sheath portion may have an outer diameter greater than the proximal outer diameter. The proximal sheath portion may have a first cross-sectional profile. The distal sheath portion may have a second cross-sectional profile different from the first cross-sectional profile.

Abstract: A production method of a medical wire includes a melting portion forming process that forms an massive melting portion in a wire end by melting and solidifying the wire end of a wire; and a joining process that contacts the melting portion with a joined part, and melts and solidifies the melting portion and the joined part to form a fusion portion, thereby joining the wire end and a joined part via a fusion portion.

Abstract: An introduction system and method of use is provided. The introduction system includes a catheter assembly, a member, and a tactile indicator. The member is configured to be introduced through the catheter assembly and the tactile indicator is configured to provide a tactile sensory input when the member reaches a predetermined position relative to the catheter assembly. As such, the tactile indicator provides increased resistance to the relative motion between the member and catheter assembly when the member reaches the predetermined position.