Abstract: The present invention provides systems, devices, and methods employing fiber optic shape and position tracking. The systems, devices, and methods permit measurement of and continuous tracking of the shape and position of objects whose shape dynamically changes with time. Applications include tracking and monitoring of endoscopes for diagnostic and surgical procedures.

Abstract: An endovascular device (1, 100, 200, 300) having a distal end (2), a proximal end (4) and a body portion (3) therebetween. The body portion is made of a multiple filament helically wound row (A) of wires (5), provided with a sealing coating (14) on the inside surface or the outside surface or both. The device may be a catheter (1), a sheath, an introducer, a delivery device, a pusher (100), an embolization coil delivery device (300), or a receptacle (208) for an expandable prosthesis (220) used with a delivery device (200). From 2 to 12, and preferably from 4 to 8, wires (5) are used in the row, and fewer wires may be used proceeding toward the distal end (2) for greater flexibility. The helically wound row of wires transmits torque and provides pushability to the device while resisting kinking, and enables a small outside diameter for reaching very small vessels and extending through very tortuous vessels.

Abstract: An elongate medical device configured for navigation through a lumen is provided. The device includes an elongate shaft having a proximal portion and a distal portion. The distal portion includes a first interlocking connector. The device further includes a loop portion operably connected to the distal portion. The loop portion includes a second interlocking connector configured for connecting to the first interlocking connector. A medical system is also provided including a catheter and a wire guide. A method of making a wire guide is provided.

Abstract: Described herein are multi-part instrument systems and methods of use. The instrument can include an inner and outer body member where the inner body member is adapted to dock with the outer body member. When docked, driving the outer body member via a manipulation section can control the inner body. In use, an inner body member can be removed and replaced by a different inner body member to change the tool end effector. Alternatively, driving a manipulation section of the inner body member can control the outer body member. The outer body member can be disposable while the inner body member is reusable.

Abstract: The guide wire is a guide wire includes a distal portion and a main body portion. This guide wire is provided with a first curve portion; a second curve portion included on the distal side of aforesaid first curve portion and curved to the opposite direction with respect to aforesaid first curve portion; a third curve portion included on the distal side of aforesaid second curve portion and curved to the opposite direction with respect to aforesaid second curve portion, wherein a line contacting with both aforesaid first curve portion and aforesaid third curve portion has an obtuse angle with respect to an axis line of aforesaid main body portion.

Abstract: Packaging including a coiled and optionally prelubricated catheter, its distal end insertable into the urethra, a slidable hygienic sheath, a proximal catheter end for voiding urine from the distal end through the assembly to the proximal end. Mutually rotatable elements providing for withdrawal of the catheter from its coiled state to an extended state, and retraction of the catheter back to its coiled state. Methods of extending the catheter, inserting it into the urethra, and voiding urine through the catheter, without requiring complete removal from the catheter packaging. A kit including automatic extrusion of the catheter's distal end upon package opening, and a water pouch for hydrophilic lubrication, and sanitary wipes for reducing the likelihood of infection. A catheter within a flexible and optionally coiled tube, a slidable hygienic sheath covering a catheter's distal end that can move along the length of the catheter during insertion.

Abstract: The invention is directed to a guidewire having a distal section with multiple distally tapered core segments with at least two contiguous distally tapering core segments in which the most distal tapered core segment preferably has a greater degree of taper than the proximally contiguous tapered core segment. The invention is also directed to an elongated intracorporeal device, preferably a guidewire or section thereof, that has a core member or the like with a plurality of contiguous tapered segments having taper angles that are configured to produce a linear change in stiffness over a longitudinal section of the device. The device may also have a core section with a continuously changing taper angle to produce a curvilinear profile that preferably is configured to produce a linear change in stiffness of the core over a longitudinal section of the device.

Abstract: A steerable wire-guide comprises an elongate member having a longitudinal axis. The elongate member comprises a leading portion and a body portion. The leading portion comprises a loop and the body portion comprises a first wire and a second wire. The first and second wires are movable relative to each other such that relative movement of the first wire with respect to the second wire directs the leading portion in a first direction, which is at an angle relative to the longitudinal axis, and relative movement of the second wire with respect to the first wire directs the leading portion in a second direction different from the first direction.

Abstract: Guidewires and methods useable in conjunction with image guidance systems to facilitate performance of diagnostic or therapeutic tasks at locations within the bodies of human or animal subjects.

Abstract: Medical guide wire assembly comprising a guide wire having a proximal end and a distal end, at least one physiology parameter sensor, and that the proximal end of the guide-wire is provided with an elongated connector part, having connection electrodes, for insertion into a connector housing provided with an elongated tubing adapted to achieve electrical and mechanical connection to the elongated connector part, the connector housing is in its turn electrically or wirelessly connectable to a physiology monitor. The guide wire is provided with a core wire running essentially along the entire guide wire. A sensor signal processing circuitry is arranged in connection with the physiological sensor and is adapted to generate a processed sensor signal in response of a sensed parameter. The sensor signal processing circuitry comprises a modulation unit arranged to modulate the processed sensor signal and to generate a modulated sensor signal.

Abstract: Medical systems, devices and methods are provided for coupling a wire guide to a previously introduced wire guide in intracorporeal procedures, and generally include a supplemental wire guide and a tracking element. The tracking element defines a first passageway and a second passageway. The first passageway is sized to receive the previously introduced wire guide and the second passageway is sized to receive the supplemental wire guide. The supplemental wire guide is attached to the tracking element in a coupled configuration and detached from the tracking element in a decoupled configuration for independent translation of the supplemental wire guide.

Abstract: High radiopacity is achieved in a polymeric marker by combining a polymeric resin, a powdered radiopaque agent having uniformly shaped particles of a specific particle size distribution and a wetting agent. The method to produce the marker calls for the blending and pelletization of these materials followed by extrusion onto support beading. The resulting supported tubing is subsequently cut to length with the beading still in place. After ejection of the beading remnant the marker is slipped into place on the device to be marked and attached by melt bonding. Marking of a guidewire allows lesions to be measured while the marking of balloon catheters allow the balloon to be properly positioned relative to a lesion.

Abstract: Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Abstract: An apparatus for performing medical procedures on an anatomical body includes an extension with an element near its distal end to be extended into the body, and a driver that moves the extension axially into the body, and that causes flexure of the distal end of the extension. The movement and flexure of the extension is driven by the driver from the proximal end of the extension, and an electronic controller directs the operation of the driver.

Abstract: A steering tool including an internal tube disposed inside an external tube, the internal and external tubes being arranged for longitudinal axial movement relative to one another, wherein a distal end of the internal tube is fixedly joined to a distal end of the external tube, and at least one of the internal and external tubes is slotted near the distal end thereof, and wherein the longitudinal axial movement causes bending of the distal ends of the tubes.

Abstract: A composite material for medical devices includes a superelastic shape memory alloy configured or constituting a matrix and a metal oxide which is dispersed in the matrix.

Abstract: A guide wire for use in a medical procedure having a shapeable tip integral with and made from the distal end of a superelastic nitinol distal section of the guide wire, wherein the shapeable tip can be finger kinked. Such a guide wire includes an elongated core made from a superelastic nitinol alloy at the distal end, the distal end of the elongated core having a tapered section leading to a shapeable distal tip. The shapeable tip is an extension of the distal end of the nitinol distal section, and includes permanent strain hardening from at least two different radial directions imparting crystallographic texture in the radial directions that eliminate superelasticity so that permanent deformation can be achieved with finger pressure.

Abstract: A guide wire incorporating a handle that incorporates a handle at the proximal end of said guide wire, the handle incorporating a guide wire actuator slidably disposed upon an actuator rail, the guide wire actuator being affixed to the proximal end of the guide wire and a guard rail contained within the actuator rail that prevents buckling of the proximal end of the guide wire. The handle can be connected to a catheter device amalgamating the guide wire and the catheter, allowing the catheter and guide wire to be operated simultaneously while also enabling the guide wire to be advanced or torqued independently of the catheter device.

Abstract: A method of manufacturing a guidewire having a discrete length. The method includes the steps of feeding a first end of a corewire into an extrusion device, gripping the first end of the corewire with a gripping apparatus, and extruding a first extrusion material onto an outer surface of the corewire while the gripping apparatus pulls the corewire through the extrusion device to form an extrusion jacket on the outer surface of the corewire. The corewire has a predetermined length corresponding to a length of the guidewire.

Abstract: Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Ultrasound catheter devices generally include an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. Improved features of ultrasound catheters include catheter bodies and ultrasound transmission members with increasing distal flexibility, guidewire tubes allowing contact between a guidewire and an ultrasound transmission member, distal heads with improved guidewire lumens, and torquable proximal housings for enhancing disruption of blood vessel occlusions.

Abstract: A robotic system for flexible needle steering under ultrasound imaging. A robot is used to steer the needle along a predetermined curved trajectory by maneuvering the needle base. The needle tip position is detected by an ultrasound sensor and the tracking error of the needle tip from a predetermined needle path is input to a controller which solves the inverse kinematic based on the needle position, and the needle and tissue properties. The control algorithm uses a novel method to detect the elastic properties of the tissue by analyzing tissue motion at the region in front of the needle tip. The inverse kinematic solution may be performed on a model of the needle as a flexible beam having laterally connected virtual springs to simulate lateral forces exerted by the tissue elasticity. The system is able to direct the needle to a target within the tissue while circumventing forbidden regions.

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 catheterization device that may be designed by use of an adaptive genetic algorithm computational fluid dynamics approach, as well as other Global Optimization methods that may include simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods that is able to maximize/optimize the dwell time of an infused agent in the vicinity of a vascular lesion. The device may have an internal by-pass channel that allows the blood upstream of the lesion to continue its pulsatile flow through the vessel in the part of it occluded by the lesion, while simultaneously allowing the disbursement and maximal dwell time of an antithrombolytic or other diagnostic or therapeutic agent needed to treat the lesion.

Abstract: A vessel locator apparatus (30) having a locator housing, and an elongated cavity defined in the locator housing, is described. The vessel locator apparatus include a superelastic wire (46) positioned at least partially in the elongated cavity, the superelastic having a proximal end and a distal end. The superelastic wire may have an elongated portion extending in a substantially longitudinal direction and a distal locator portion having an original shape configuration. The original shape configuration of distal locator portion may include a first curved segment, a second curved segment, an intermediate segment extending between the first curved segment and the second curved segment, and an end segment extending between the second curved segment and the distal end of the superelastic wire. A method of locating a vessel, such as a blood vessel, using a vessel locator apparatus is also described.

Abstract: A guidewire has a coil with a side of the coil winds having solid physical connections between the coil winds to prevent the connected coil wind side from expanding resulting from the application of force by an actuating member. The application of longitudinal force to the coil causes the unconnected coil wind side to expand while the connected side does not expand, resulting in the guidewire assuming a different configuration.

Abstract: A guidewire for use in a medical procedure includes an elongate guide member dimensioned for insertion within a body vessel of a subject. The guide member includes an elongate body segment and a leading tip segment. The elongate body segment defines a longitudinal opening, and the leading tip segment is adapted and dimensioned to articulate relative to the elongate body segment about a single axis. A control element extends through the longitudinal opening of the elongate body segment and is longitudinally movable through manual manipulation of a clinician to cause corresponding articulating movement of the leading tip segment.

Abstract: A pressure sensor wire assembly measures pressure inside a body of a patient. The assembly comprises a pressure sensor element for measuring pressure and to generate a pressure sensor signal representative of the pressure, and a pressure sensor wire having the pressure sensor element at its distal portion, and adapted to be inserted into the body in order to position the sensor element within the body. A sensor signal adapting circuitry is an integrated part of the assembly, wherein the pressure sensor signal is applied to the adapting circuitry which is adapted to automatically generate an output pressure signal, related to the sensor signal, in a standardized format such that the measured pressure is retrievable by an external physiology monitor. The assembly further comprises an external pressure sensor to measure the pressure outside the patient's body and to generate external pressure values in dependence thereto.

Abstract: A guidewire includes a first junction that joins a distal end of an inner coil body and a portion of a core shaft positioned a non-zero distance away from a distal end toward a proximal end; a second junction that joins a proximal end of the inner coil body and the core shaft; a third junction that joins a distal end of the outer coil body and the distal end of the core shaft; and a fourth junction that joins a proximal end of the outer coil body and the core shaft. The outer coil body includes a tapered coil portion and a uniform-diameter coil portion. The inner coil body is disposed inside the uniform-diameter coil portion of the outer coil body. The inner coil body is joined to the core shaft at only the first and second junctions but is not joined to the outer coil body.

Abstract: A medical device formed of a coil with repeating loops, each loop forming a polygon and each successive loop being slightly rotated with respect to its adjacent loops to form a spiral configuration. The polygon in a preferred embodiment is a triangle, and the repeating triangular loop coil can be used as a guidewire in a stent delivering catheter. The guidewire can further include a stiff core wire that is disposed within the triangular loop coil, where the stiff core wire includes tapered sections that reduce the stiffness in the distal direction. The coil can include multiple sections of different loop shapes, including circular, to alter the stiffness of the guidewire to meet the needs of the application.

Abstract: There is provided a medical guidewire which reduces the resistance with a curved guiding catheter, and has improved durability that can keep the resistance reduced for a long time. A core shaft of the medical guidewire has a second cylindrical part, with a smaller diameter than that of a coiled body, on a proximal end side of the coiled body. This second cylindrical part is coated with a hydrophilic material. Further, the hydrophilic material coated on the second cylindrical part has a larger thickness than a hydrophilic material coated on the coiled body.

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 guidewire having flexible or floppy proximal and distal end portions is used for percutaneously accessing a branch vessel through a deployed prosthesis having at least one fenestration near an ostium of the branch vessel. The prosthesis is delivered and deployed via a first percutaneous access site. The guidewire extends over the outside surface of the deployed prosthesis and extends through the at least one fenestration. The flexible distal end portion is snared via a second percutaneous access site and is pulled in a direction towards the second percutaneous access site until the flexible proximal end of the guidewire is located adjacent to the branch vessel. A guide catheter is then advanced over the guidewire until it cannulates the branch vessel. The flexible proximal end of the guidewire may then be advanced into the branch vessel and used for delivery of a branch vessel prosthesis.

Abstract: Embodiments of the invention include a guidewire for use in a medical procedure. Embodiments of the invention may include a guidewire having an elongate core wire where the core wire is unground, has a length, and a substantially uniform cross-section. A thermoplastic material is extruded with the core wire and surrounds a portion of the core wire. Another embodiment is directed to a method of manufacturing a guidewire including providing an unground core wire having a length, providing a thermoplastic material, and extruding the thermoplastic material onto the core wire such that a portion of the wire is surrounded by the thermoplastic material.

Abstract: An elongated surgical manipulator apparatus and method of operating enables determination of the shape of a flexible portion of the elongated surgical manipulator and/or the location of an arbitrary point thereon, as well as a measure of a contact force exerted on a distal portion of the manipulator. A plurality of fiber optics are operatively coupled with the manipulator, each of the fiber optics including a plurality of fiber Bragg gratings for determination of the shape and/or position. Each of the fiber optics further includes a fiber optic strain gauge such as a Bragg grating or a Fabry-Perot resonator at a distal portion of the elongated surgical manipulator that is isolated from the strain associated with the bending of the manipulator. The fiber optic strain gauges at the distal portion may thus be used to detect a force vector (magnitude and direction) imposed on the distal portion.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, side-loading electrical connectors for use with intravascular devices are provided. The side-loading electrical connector has at least one electrical contact configured to interface with an electrical connector of the intravascular device. A first connection piece of the side-loading electrical connector is movable relative to a second connection piece between an open position and a closed position, wherein in the open position an elongated opening is formed between the first and second connection pieces to facilitate insertion of the electrical connector between the first and second connection pieces in a direction transverse to a longitudinal axis of the intravascular device and wherein in the closed position the at least one electrical contact is electrically coupled to the at least one electrical connector received between the first and second connection pieces.

Abstract: Medical guide wire assembly comprising a guide wire having a proximal end and a distal end, at least one physiology parameter sensor, and that the proximal end of the guide-wire is provided with an elongated connector part, having connection electrodes, for insertion into a connector housing provided with an elongated tubing adapted to achieve electrical and mechanical connection to the elongated connector part, the connector housing is in its turn electrically or wirelessly connectable to a physiology monitor. The guide wire is provided with a core wire running essentially along the entire guide wire. A sensor signal processing circuitry is arranged in connection with the physiological sensor and is adapted to generate a processed sensor signal in response of a sensed parameter. The sensor signal processing circuitry comprises a modulation unit arranged to modulate the processed sensor signal and to generate a modulated sensor signal.

Abstract: A medical device has a distal member with a configuration that can be changed by means of a control handle with a control assembly employing a rotational cam, a shaft, and a pulley, where the rotational cam is rotationally mounted on a portion of the control handle for rotation by a user. The rotational cam operates on the shaft to move it proximally or distally depending on the direction of rotation which in turn rotates the pulley to draw or release a puller wire to change the configuration of the distal member of the medical device. The shaft is oriented along a diameter of the control handle. The shaft has two ends which extends through two axial guide slots in the portion of the control handle to sit two opposing helical tracks formed on inner surface of the rotational cam. The guide slots are parallel with the longitudinal axis of the control handle and therefore maintain the shaft's diametrical orientation as the rotational cam is rotated to move the shaft proximally or distally.

Abstract: A guide wire for advancing a medical device such as a catheter through a patient's body lumen which has an elongated core with proximal and distal core section, a flexible tubular member such as a coil on the distal end. The wire core includes surface textures that are translated into the overlying coating. Alternatively, the coating has its own surface texture. The surface textures include randomly or non-randomly spaced bumps, divots, ridges, helical grooves, longitudinal grooves, undulations, etc.

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.

Abstract: A guide wire arrangement is provided. The guide wire arrangement includes an elongate coil element having two opposing ends; a force transmitting element arranged at one of the two opposing ends of the coil element; a sensor assembly arranged in the coil element at a predefined distance away from the force transmitting element; and a core wire extending from the force transmitting element to the sensor element through the coil element; wherein the coil element is configured to allow the core wire to be moveable relative to the sensor assembly and the sensor assembly is configured to detect movement of the core wire relative to the sensor assembly upon force impact on the force transmitting element.

Abstract: A controller for use with a guidewire, such as a vascular guidewire, provides a mechanism for gripping and applying a torque to the guidewire without the need to thread the guidewire axially through the controller and at a location close to a point of access of the guidewire. In one embodiment, the controller includes a side-access, multi-part assembly including a collet or other gripping element that applies a uniform radially inward force on the guidewire. In another embodiment, for use with guidewires having active electrically controllable elements, the controller integrally or removably incorporates a switch or other mechanism to initiate an energized state. The controller thereby permits ergonomic, single-handed control of an electronically steerable guidewire, including axially displacing, torquing and steering the guidewire.

Abstract: An object of the present invention is to provide a guidewire having high safety and improved flexibility and rotation followability, and capable of directing a catheter with ease. A guidewire of the present invention 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. The core shaft has a second flat part in flattened shape in substantially contact with an inner peripheral surface of the inner coil. With this configuration, the distal side portion of the guidewire is protected by a double coil structure, while having high torsional stiffness. This leads to improvement in safety and rotation followability, while allowing a catheter to be directed with ease.

Abstract: The present invention is an interventional guidewire particularly adapted for use in percutaneous transluminal angioplasty (PTA) procedures. A guidewire of this invention enhances peripheral vascular access for either diagnostic or therapeutic vascular or arterial procedures by having opposing ends of different stiffnesses. Retrograde dorsalis pedis artery access to upper body vascular occlusions is a particularly preferred application of this invention.

Abstract: A guide wire placement and removal tool is provided that includes a handle mounted to a shaft connected to a wire engagement mechanism disposed opposite the handle. The mechanism includes a housing aligned with the shaft to enable the wire to pass therethrough, and a moveable engagement member biased into a locking position within the housing to engage a wire positioned therein. The mechanism also includes a release member that can be selectively engaged with the engagement member to disengage the engagement member from the wire to allow the wire to move with regard to the tool. Once the release member is released, the engagement member is biased back into a locking engagement with the wire to securely hold the wire within the tool.

Abstract: Gastrointestinal apparatus (10) is provided, including a guiding element (16) and an inflatable mechanical device (96), adapted to pull the guiding element (16) through a colon of a patient. A gastrointestinal tool (12) is shaped to define a bore (14) therethrough, and the guiding element (16) is adapted to pass through the bore (14). Other embodiments are also described.

Abstract: A medical guidewire having distal tip coil that includes a twisted ribbon wire construction. The distal tip coil is mounted to the distal end of the distal core section of the guidewire. The coil is made from a flat ribbon wire with a polygonal, preferably rectangular, cross-section that is twisted along the length of the wire. The twisted, flat ribbon wire creates a tip coil that has a roughened, undulating surface at the outer circumference that, whether coated or bare, is perceptible to the physician or cardiologist when pushing or torquing the guidewire in an interventional procedure.

Abstract: A method of confirming the location of an elongate member configured for placement within a patient's sinus cavity comprises introducing the elongate member through a nasal passageway to place a distal tip of the elongate member in a test position, the elongate member configured to emit illuminating light via the distal end of the elongate member. The location of the light is then viewed through the patient's skin to confirm the positioning of the elongate member.

Abstract: A guidewire includes a core shaft and a coil body wound around an outer periphery of the core shaft. A distal end portion of the core shaft and a distal end portion of the coil body is fixed to each other to form a most distal end portion. The coil body includes a linear portion and a bent portion, the linear portion extending in a distal direction from a proximal end of the coil body, the bent portion being provided on a distal side of the liner portion. The core shaft and the coil body located in the bent portion are fixed to each other with a fixing member.

Abstract: An object of the present invention is to provide a guidewire capable of obtaining a sufficient tip load, and also preventing as much as possible a distal portion from being twisted or bent. The guidewire has an outer coil and an inner coil. The outer coil has a taper coil portion with its outer diameter gradually decreasing toward the front end of the core shaft. The inner coil surrounds a distal side portion of the core shaft inside the outer coil. The rear end of the inner coil is joined only to the core shaft on the front side of a position where the taper coil portion of the outer coil has a maximal outer diameter.