Abstract: A lumen re-entry system includes a helically wound coil having open proximal and distal ends, and defining a longitudinal movement axis. The helically wound coil includes a distal segment that is relaxed relative to a proximal segment. A tip deflection wire is attached to the relaxed distal segment and coaxially disposed relative to the helically wound coil. Movement of the tip deflection wire moves the lumen re-entry system from an advancement configuration in which the open distal end of the helically wound coil is substantially aligned with the longitudinal movement axis to a deflected configuration. The lumen re-entry system also includes a puncture wire slidably received within the helically wound coil and having a distal puncture tip.

Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices include at least one pressure sensing component positioned within a distal portion of the device. In some instances, a plurality of conductors are electrically coupled to the pressure sensing component and a potting material covers the electrical connections between the plurality of conductors and the pressure sensing component. In some instances, the potting material has a durometer hardness between about 20 Shore A and about 50 Shore A, a moisture absorption rate of about 0% per twenty-four hours, a linear shrinkage of 0%, a coefficient of thermal expansion (m/m/-° C.) of between about 1.0×10?5 and about 5.0×10?4, and a volume resistivity (?-cm) between about 6.0×1013 and about 1.0×1014. Methods of making and/or assembling such intravascular devices/systems are also provided.

Abstract: A tether subassembly, which may be employed by a tool that deploys an implantable medical device, includes a test segment for verification of adequate fixation of the device at an implant site. When the device is located in proximity to a distal opening of the tube, a tether first length extends through an attachment structure of the device and within an elongate tube of the tool, a tether second length extends alongside the tether first length within the tube, and the test segment is located in proximity to the distal opening. The test segment is configured so that only a tug force, applied to the tether first length, and greater than or equal to a predetermined force, can pull the test segment through an aperture, either of the delivery tool or of the device. The predetermined force corresponds to a minimum adequate fixation force for the device.

Abstract: Intravascular devices, systems, and methods are provided. In one embodiment, an intravascular system includes an intravascular device and a computing device in communication with the intravascular device, the computing device operable to: present a set of mode options to a user at a user display device; receive a mode selection from the presented set of mode options; determine a set of operating parameters based on the mode selection; receive a first set of medical sensing data; and process the first set of medical sensing data according to the operating parameters, wherein the computing device is further operable to determine the set of operating parameters based on at least one of a previous mode selection, a user preference, an operative course of a medical procedure, patient information, the first set of medical sensing data, a second set of medical sensing data, a status indicator, or a sensing device identifier.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Abstract: A thrombectomy catheter includes a catheter body having a catheter lumen. An outflow orifice is positioned along a catheter perimeter. A fluid jet emanator communicates with a high pressure tube. The fluid jet emanator includes at least one jet orifice for directing a fluid jet from the fluid jet emanator through the catheter lumen toward the outflow orifice. The fluid jet emanator provides a jet stream from the catheter body through the outflow orifice. The jet stream includes first and second stream portions. An entrainment fluid flow circuit includes at least the first stream portion, and the entrainment fluid flow circuit entrains particulate and macerates the particulate therein. An exhaust fluid flow path includes the second stream portion, and the exhaust fluid flow path draws entrained particulate from the entrainment fluid flow circuit at a location exterior to the catheter body and directs it toward the catheter proximal portion.

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: An occluding device apparatus includes an embolization coil with a distal end and a proximal end with an opening and an attacher that is threaded through the opening at the proximal end of the embolization coil. The apparatus further comprises a delivery kit for delivery of the embolization coil in a body cavity. The kit comprises a guide catheter for percutaneous introduction of the embolization coil and an inner catheter slidably disposed within the guide catheter during insertion. The inner catheter comprises a proximal end and a distal end. The inner catheter further includes a hub disposed adjacent the proximal end. The kit further comprises a guide wire slidably disposed within the inner catheter. The guide wire provides a path during insertion thereof within a body cavity. The kit further comprises a pushwire to advance the embolization coil through the inner catheter.

Abstract: A catheter is described having one or more markers and one or more marker sections.

Abstract: There is provided a microcatheter having a proximal solution lumen and a distal tip portion with a guidewire lumen. The microcatheter and methods of use thereof allows for introduction of solution into a vessel while manipulating the guidewire and/or the microcatheter itself. The solution may be a contrast solution, for viewing of the vessel, a therapeutic or diagnostic solution, or any other type of solution.

Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices are guide wires that include a capacitive pressure-sensing component disposed at a distal portion of the guide wire. Methods of making such intravascular devices, including various manufacturing and assembling techniques, are disclosed. Systems associated with such intravascular devices and methods of using such devices and systems are also disclosed.

Abstract: A transseptal guidewire and methods for perforating the intra-atrial septum of the heart are disclosed. The transseptal guidewire has an elongated body, an end section biased in a curved configuration to define a proximal curve, and a distal section biased in a curved configuration to define a distal curve, the distal curve being oriented in a direction generally opposite that of the proximal curve.

Abstract: A biopsy marking apparatus for placing a radiopaque marker at the location of a percutaneous biopsy. The biopsy marking apparatus comprises an introducer in combination with a radiopaque marker. The introducer ejects the radiopaque marker at the location of the biopsy. The introducer is configured to completely eject the radiopaque marker and prevent it from being subsequently drawn into the introducer as the introducer is removed from the biopsied tissue mass. The radiopaque marker has enhanced radiopaque characteristics and enhanced non-migration characteristics.

Abstract: A containing catheter for facilitating sequential treatment operations therethrough, is provided. The containing catheter comprises a median portion comprising an elongated, substantially tubular member, and a distal portion, comprising a distal stiff member. A catheterization apparatus is provided, comprising the containing catheter and an elongated inner catheter insertable into the containing catheter. A method of catheterization is provided, comprising providing the containing catheter, stiffening a portion of the containing catheter and inserting the stiffened containing catheter into a body conduit of a patient.

Abstract: A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism. The guide wire movement mechanism includes an integrated guide wire locking and rotation mechanism configured for rotation of the guide wire and for securely locking and unlocking the guide wire to the guide wire movement mechanism. The balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism.

Abstract: An apparatus for introducing an implant into a hollow anatomical structure. The apparatus comprises a storage unit; an elongate vascular implant stored inside the storage unit and having a distal end; and a pushrod at least partially stored inside the storage unit and having a distal end coupled to the distal end of the implant. The implant diverges from adjacency with the pushrod as the implant extends away from the distal end of the pushrod, such that the pushrod forms a force application region near the distal end of the pushrod. The force application region is accessible for force application but separated from the implant.

Abstract: This application describes an overtube device that gives diagnostic and/or therapeutic access to body cavities using natural orifices of the body. The overtube includes an elongate flexible body having a distal portion deflectable in response to activation of a control cable. Proximal features of the overtube include an insufflations port and seals for minimizing loss of insufflations pressure around the shafts of instruments passed through the tube. In some embodiments, retractor elements are including on the distal portion of the overtube.

Abstract: A catheter having an internal advancing mechanism that can advance stiffening wires or other devices, has a catheter with a catheter body, a tip section distal the catheter body, a device extending through at least the catheter body, and a control handle proximal the catheter body, where the control handle has an advancing mechanism with a threaded member, an adjustment member, and a guided member to which the device is connected, and the advancing mechanism is configured to advance and retract the device along the catheter body as controlled by a user. Each of the threaded member and the adjustment member has a generally cylindrical configuration. The threaded member has an outer surface configured with a helical guide channel. The adjustment member is configured to guide the guided member to move within the helical guide channel to advance and retract the device. The adjustment member can be rotatable over the threaded member by the user to control advancement and retraction of the device.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. A containment assembly comprising a containment jacket adapted to be deployed inside bone; and a dividing wall that separates the interior of the containment jacket into a proximal region and a distal region, the dividing wall having an opening for providing access to the distal region from the proximal region.

Abstract: A system for ablating internal heart tissue in an ablation pattern on a surface of the tissue within the heart. The system includes an ablation catheter with a distal end having an ablating tip portion operative to allow selective ablation of tissue. A guiding device is engageable with the ablation catheter and includes a tissue anchoring portion operable to engage with tissue proximate to the tissue to be ablated so as to temporarily anchor the guiding device relative to the tissue. Engagement of the guiding device with the ablation catheter operates to assist with guiding the ablating tip portion in moving along the pattern. Various devices and methods of use are further disclosed.

Abstract: A catheter is described having one or more markers and one or more marker sections.

Abstract: A medical guidewire system including an inner member having an outer diameter and an outer member having an inner diameter, the inner diameter being larger than the outer diameter. The inner and outer members are relatively slidable to adjust a stiffness of the guidewire system. The lumen of the outer member forms a gap for fluid flow therethrough. A connector to the inner member and a fluid infusion channel communicating with the gap for injection of fluid through the gap to exit a distal portion of the outer member.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Abstract: A guidewire includes a core shaft including a distal end portion and a proximal end portion, an outer coil disposed so as to cover the distal end portion, and an inner coil disposed inside of the outer coil. The outer coil includes a first bent portion that is bent at a first angle in a first direction. The inner coil includes a second bent portion that is bent at a second angle in the first direction. The second angle is larger than the first angle.

Abstract: Exemplary insertion tools for facilitating insertion of an electrode array into a bodily orifice include a stylet assembly having a stylet configured to be inserted into a lumen of the electrode array, a slide assembly configured to at least partially house the stylet assembly, and a handle assembly configured to engage at least a portion of the slide assembly. The slide assembly may be configured to selectively disengage from the handle assembly. The stylet assembly may be configured to selectively disengage from the slide assembly while the stylet is still inserted into the lumen of the electrode array. Corresponding systems and methods are also described.

Abstract: A medical device tunneling system, and a method of using the same, to subcutaneously route trocars, also commonly referred to as tunnelers, or introducers, having a cannula, stylet, and a guidewire stylet, inside a patient during a surgical procedure, such as a ventriculoperitoneal hydrocephalus shunt implantation, from a proximal entry point to a distal end point, in order to subcutaneously route and implant a medical device, such as shunt tubing, in a patient.

Abstract: Arrangements are disclosed in which proximal portions of a marker wire are effectively secured. In one embodiment, a proximal portion of the marker wire is positioned inside a tubular member that allows for slidable movement of the marker wire within the tubular member. In some embodiments, a proximal portion of the marker wire is coupled to a spring member. Some embodiments also disclose a movement-resisting member having flaps that contact the surface of the marker wire and resist movement of the marker wire in one or more directions.

Abstract: The releasable torque device obviates the need for removal of the wire introducer in order to torque or manipulate a vascular or other guide wire and/or catheter in a medical procedure, and further obviates the need to remove the torque device for wire and/or catheter introduction. The device may include a base cylinder and an inflation cylinder defining a variable fluid volume therebetween. As the inflation cylinder is pushed toward the base cylinder, the fluid is forced through a port in the inner wall of the inflation cylinder and between a tubular inner cylinder and an inflatable guide wire grip within the inner cylinder to squeeze the grip onto the guide wire passing axially therethrough. Alternatively, the device only has a central tube and an inflatable guide wire grip therein, using a remotely disposed fluid pump and reservoir supplying fluid to the tube and guide wire grip.

Abstract: A steerable probe comprises a body and drive means arranged to drive the probe through a sample. The body comprises at least three body sections extending parallel to each other along the probe and each movable relative to the others along the probe. The drive means is arranged to move each of the body sections in turn relative to the others thereby to drive the probe through the sample.

Abstract: A medical guidewire system including an inner member having an outer diameter and an outer member having an inner diameter, the inner diameter being larger than the outer diameter. The inner and outer members are relatively slidable to adjust a stiffness of the guidewire system. The lumen of the outer member forms a gap for fluid flow therethrough. A connector to the inner member and a fluid infusion channel communicating with the gap for injection of fluid through the gap to exit a distal portion of the outer member.

Abstract: A medical guidewire system including an inner member having an outer diameter and an outer member having an inner diameter, the inner diameter being larger than the outer diameter. The inner and outer members are relatively slidable to adjust a stiffness of the guidewire system. The lumen of the outer member forms a gap for fluid flow therethrough. A connector has a first end portion connected to the outer member, a second end portion connected to the inner member and a fluid infusion channel communicating with the gap for injection of fluid through the gap to exit a distal portion of the outer member.

Abstract: A system and method for deploying an occluding device that can be used to remodel an aneurysm within the vessel by, for example, neck reconstruction or balloon remodeling. The system comprises an introducer sheath and an assembly for carrying the occluding device. The assembly includes an elongated flexible member having an occluding device retaining member for receiving a first end of the occluding device, a proximally positioned retaining member for engaging a second end of the occluding device and a support surrounding a portion of the elongated flexible member over which the occluding device can be positioned.

Abstract: An interventional guidewire assembly with improved guidewire control includes a guidewire and a housing having a first opening that accommodates the guidewire and a second opening. The assembly further includes an actuator that passes through the second opening that is actuated by a finger in a direction substantially perpendicular to an axis of the guidewire. The assembly further includes a clamp operably coupled to the actuator that compresses the guidewire to couple the guidewire to the housing when pressure is applied to the actuator. The assembly further includes a return spring that supplies pressure to remove the clamp from the guidewire.

Abstract: Embodiments of the disclosure describe an example guide extension catheter. The guide extension catheter may include a proximal shaft having a proximal end, a distal end, the distal end having an attachment region. The guide extension catheter may further include a distal sheath having a proximal end, a distal end and a lumen extending therebetween. The distal sheath may include an outer layer, inner layer and an intermediate reinforcing member disposed between the inner layer and the outer layer. Moreover, the distal sheath is attached to the attachment region adjacent to the reinforcing member.

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 locking mechanism for a medical device to selective lock a first elongate member from longitudinal movement relative to a second elongate member of the medical device. The locking mechanism includes a flexible tubular member disposed in a bore of a handle assembly of the medical device, and an actuator, such as a cam member having a cam or eccentric surface. Pivotable movement of the actuator from a first position to a second position compresses or deforms the flexible tubular member against the first elongate member to lock the first elongate member from longitudinal movement relative to the handle assembly.

Abstract: A medical device for advancement over a guidewire includes a number of lumens therein including a working channel lumen, one or more control wire lumens, and a guidewire lumen. A flexible support within the device includes number of interlocking elements that resist longitudinal compression, transfer rotational torque, and can bend side to side. The flexible support also includes a slot that is aligned with the guidewire lumen. An outer jacket includes a perforation, slot, slit, or thinned area that is aligned with the slot in the support member and the guidewire lumen in order to allow a device such as a guidewire to be removed from the guidewire lumen and through the support member.

Abstract: In order to provide a catheter which can be operated even when it is deformed inside a bent blood vessel and whose movable part can be easily bent and the movable part thus bent is firmly kept in this shape, a catheter includes: a fluid-driven actuator including: a balloon; a restricting member for restricting inflation of the balloon in a short axis direction of the catheter; and a tube which is less stretchable in a long axis direction of the catheter than the balloon is, according to a cross-sectional view of the fluid-driven actuator taken along the short axis direction of the catheter, the tube being eccentrically provided with respect to the restricting member.

Abstract: Embodiments of the present invention comprise a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. In some embodiments, the guidewire further comprises a mandrel disposed within the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user. Methods of manufacturing and using the guidewire are also disclosed.

Abstract: According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Abstract: A delivery system is disclosed which can be used to deliver an ocular implant into a target location within the eye via an ab interno procedure. In some embodiments, the implant can provide fluid communication between the anterior chamber and the suprachoroidal or supraciliary space while in an implanted state. The delivery system can include a proximal handle component and a distal delivery component. In addition, the proximal handle component can include an actuator to control the release of the implant from the delivery component into the target location in the eye.

Abstract: A system and method for implanting and stabilizing spinal cord stimulators in an epidural space of the spinal column of a patient to prevent or limit axial movement of the stimulators once implanted in the epidural space. The system includes a drill assembly, a guide wire assembly, and a guide wire receiver. The drill assembly includes a cannula, a drill for creating access points in the patient's spinal column for implanting the stimulators, and an incremental drill adjuster for drilling into the patient's lamina a pre-set, discrete distance. The guide wire assembly includes a hollowed guide wire sleeve, a guide wire housed within the sleeve, and a magnet disposed on a proximal end of the guide wire assembly. The guide wire receiver includes a scoop for receiving and catching the magnet to assist in feeding the stimulators through the epidural space.

Abstract: An introducer assembly for introducing a stent-graft or other device into a vessel of a patient is provided with a dilator tip which is naturally curved, preferably to be substantially a U-shape. The dilator tip is flexible so as to be able to become substantially straight with a guide wire therein and yet to be able to curve back towards its natural curvature during deployment of an implant. The curvature of the dilator tip can ensure that the dilator tip does not cause damage to the vessel wall during deployment of an implant carried thereon, as can occur with straight dilator tips.

Abstract: According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Abstract: According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Abstract: A steerable multi-polar lead shaft assembly includes a core member extending longitudinally through the shaft assembly, a plurality electrically conductive elements disposed within the core member, a plurality of steering wires circumferentially distributed about the core member. A control mechanism for a steerable catheter, such as the steerable multi-polar lead assembly, includes a mounting portion adapted to engage a steerable shaft, a stem extending from the mounting portion, a swivel joint arranged at a proximal end of the stem, a control yoke rotatably mounted on the swivel joint, adapted to engage a plurality of steering wires of the steerable catheter, and a handle connected with the yoke, adapted for direct manipulation by a user.

Abstract: The present invention relates to a model based positioning system that includes a positioning device having at least one transmitter configured to be in a tracking environment, e.g. inserted into a body, a receiver having a plurality of receiver elements arranged outside the tracking environment, a control unit configured to measure amplitude and/or phase information of a signal transmitted from the at least one transmitter and received at each receiving element, and a memory unit M for storing a model for each receiving element. The control unit is also configured to estimate the position P of the positioning device by comparing the model for each receiving element with the measured received signal for each receiving element.

Abstract: A sphenocath including a sheath assembly including a sheath hub with a sheath tube extending therefrom with a passage extending from a proximal end of the sheath hub to a distal end of the sheath tube; a catheter assembly including a catheter hub with a catheter tube extending therefrom with a passage extending from a proximal end of the catheter hub to a distal end of the catheter tube; wherein the catheter assembly passes through the sheath assembly with a portion of the catheter hub engaging a portion of the sheath hub to limit relative rotation between the hubs while permitting relative axial movement such that in an initial non-extended position the distal end of the catheter tube is proximate to the distal end of the sheath tube. A system further including a guidewire is also provided. A method of inserting the catheter tube is also provided.

Abstract: A distal embolic protection device for dedicated use in cerebral arterial blood vessels is described. The distal embolic protection device comprises a variable-thickness micro-guidewire and a collapsible filtering device mounted on the microguidewire over two mobile attachment points so that in its collapsed configuration, the thickness of the microguidewire and the filtering device at this region is less than or equal to 0.017 inch (0.432 mm) in thickness to be able to pass through existing conventional microcatheters. The mobile attachment points allow for rotatory and longitudinal mobility of the microguidewire while the filtering device is stable thereby decreasing the risk of trauma to the fragile cerebral arterial blood vessels. Preferably, the filtering device comprises an expansion assembly, e.g., a plurality of struts attached to a filter membrane that are in a folded position which self expand to the desired dimensions within the cerebral blood vessels.

Abstract: A coaxial guide catheter to be passed through guide catheter having a first lumen, for use with interventional cardiology devices that are insertable into a branch artery that branches off from a main artery. The coaxial guide catheter is extended through the lumen of the guide catheter and beyond the distal end of the guide catheter and inserted into the branch artery. The device assists in resisting axial and shear forces exerted by an interventional cardiology device passed through the second lumen and beyond the flexible distal tip portion that would otherwise tend to dislodge the guide catheter from the branch artery.