Abstract: Apparatus for use in deploying medical devices. The apparatus includes a wire having a diameter such that the wire can appropriately be used with either a corresponding over-the-wire configured catheter or a rapid-exchange configured catheter. The wire has a location at which it can be easily fractured, when desired, in order to convert the length of the wire from a length for use in an over-the-wire configuration to a rapid-exchange configuration.

Abstract: The invention relates to a guide wire for a medical instrument, which has a guide wire core (2) and a sheathing (3) that surrounds the guide wire core at least in sections. According to the invention, the sheathing (3), at least in a shaft section (5) joined to an end section (4), is provided with a rigidity greater than that of the guide wire core. The invention is for use, e.g. in medical instruments for magnetic resonance tomography (MRT) suitable applications.

Abstract: A method and apparatus for releasably securing a wire guide to an elongate medical device for introduction into a work site with the bodily lumen of a patient. An elongate engagement member is configured to engage the wire guide while it is coupled to the elongate medical device and is configured so as to prevent relative movement between the wire guide and the elongate medical device. The elongate engagement member includes an adjustable handle assembly for adjusting the relative position of the distal end of the elongate engagement member relative to the elongate medical device.

Abstract: The present invention provides low profile intravascular ultrasound catheters adapted to access sites within the patient's body through narrow blood vessels, e.g., the radial artery. In an embodiment, a low profile catheter comprises an catheter sheath, a short guidewire receiver attached to the distal end of the catheter sheath, and a telescope assembly at the proximal end. The catheter sheath comprises a main portion and a tapered portion for increased flexibility toward the distal end of the catheter. In one embodiment, a rotatable and translatable imaging core is received within the catheter sheath for ultrasound imaging. A short guidewire receiver is used to allow the imaging core to be advanced farther distally with respect to the distal end of the catheter. In an embodiment, the catheter sheath extends through a portion of the telescope assembly to provide enhanced support of the imaging core within the telescope assembly.

Abstract: A system for arterial access for delivery of treatment devices is provided. In one embodiment, the system comprises a guidewire and a catheter. The catheter comprises a handle and a shaft. The shaft may be a steerable/deflectable tip shaft with a lumen adapted to allow passage of the guidewire at least partially there through. A passive sheath may also be provided to be delivered over the shaft. The handle controls the steerable/deflectable tip shaft and may be used to deflect the distal tip of the shaft.

Abstract: A device for introduction into a vessel including a main elongated element having a main elongated element proximal end and a main elongated element distal end, a balloon positioned at the main elongated element distal end, and a core wire attached to the device at a core wire attachment point and including an internal core wire portion positioned in the main elongated element and an external core wire portion positioned distally with respect to the internal core wire portion and positioned in parallel relation and external to the balloon.

Abstract: A spiral catheter device and mechanism for placement thereof. The spiral catheter device comprises a catheter body including at least one helically coiled portion, with the interior region of the helix forming a tracking region for passage of a wire guide.

Abstract: An insertion device for use in assisting with the placement of a medical device within the body of a patient is disclosed. For example, the insertion device can be employed to assist with the placement of an introducer, which provides a conduit for insertion of a catheter into the body. In one embodiment, the insertion device comprises a needle that is removably disposed within a bore defined by the medical device, and a needle retraction assembly. The needle retraction assembly can position the needle in any one of a first position wherein a distal tip of the needle is disposed a predetermined distance distal to a distal end of the medical device, a second position wherein the needle distal tip is disposed distal but proximate to the distal end of the medical device, and a third position wherein the needle distal tip is retracted within the medical device bore.

Abstract: A support catheter that can be used to aid positioning of a guidewire and other medical devices. The support catheter includes a catheter body having a length, and a supporting structure formed or disposed in or on the catheter body. The catheter support structure, whether alone or in combination with the other portions of the support catheter, provides flexibility, stiffness, and torqueability to the support catheter.

Abstract: An venous access catheter is combined with a needle, guidewire, and actuator where the needle is disposed coaxially over the guidewire and the catheter is disposed coaxially over the needle. A hub at a proximal end of the access catheter includes a wiping element to clean blood from the needle and guidewire as they are removed and a side port to allow connection of fluids after the access catheter is placed.

Abstract: A method, apparatus, and kit for marking the opening between the fallopian tube and the uterus (tubal ostia) are provided. A marking dye provided in a marking assembly including a fluid dispenser coupled to a catheter having an open end and a guide wire. The catheter is inserted into the uterus and to a position adjacent the tubal ostia. When properly inserted, the fluid dispenser is activated to cause fluid to flow through the catheter and to the wall of the uterus to provide a mark. Once the mark is provided, endometrial ablation process can be provided in the uterus. The marks can then be used to guide the insertion of tubal occlusion devices.

Abstract: One embodiment is a medical device comprising an elongate catheter having a proximal end, a distal end, and a lumen extending therethrough and a tip disposed at the distal end of the elongate catheter, the tip extending distally of the distal end of the catheter, the tip comprising a soft body portion and a rigid ring distal the soft body portion.

Abstract: An evacuation sheath assembly and method of reducing or removing a blockage within a vessel without permitting embolization of particulate matter is provided. The evacuation sheath assembly includes a first elongate tubular member, having proximal and distal ends and a main lumen configured to be placed in fluid communication with a blood vessel. An expandable member is provided on a distal portion of the tubular member and is configured to form a seal with the blood vessel. The evacuation assembly further includes a second elongate tubular member having proximal and distal ends and an inflation lumen configured to be placed in fluid communication with the expandable member and a gas inflator. The gas inflator includes a high pressure gas source and a mechanism for regulating the pressure of the gas delivered by the gas inflator.

Abstract: A method and apparatus for releasably securing a wire guide to an elongate medical device for introduction into a work site with the bodily lumen of a patient. An elongate engagement member is configured to engage the wire guide while it is coupled to the elongate medical device and is configured so as to prevent relative movement between the wire guide and the elongate medical device.

Abstract: A dual lumen guidewire support catheter for accurately crossing a chronic total occlusion in a vessel is disclosed. The dual lumen guidewire support catheter includes a first lumen portion and a second lumen portion sharing a common side and a common distal end. The first lumen portion can be a rapid exchange or over-the-wire portion, while the second lumen portion is an over the wire portion. One or both of the portions can include a discontinuity to enable removal of a guidewire following placement through or at an occlusion or lesion.

Abstract: A structure includes a main tube 2 that contains a needlelike tubular body lumen 10 through which a needlelike tubular body 3 is inserted, with a distal section 4 of the main tube 2 having a first guide wire insertion section 33 and second guide wire insertion section 35, respectively containing a first guide wire lumen 38 and second guide wire lumen 52 through which a first guide wire 32 and second guide wire 34 are inserted. This structure further has a support tube 62 whose tip remains a free end, wherein this support tube 62 accepts a part of the second guide wire 34 extending out of the second guide wire lumen 52 and thereby supports the second guide wire insertion section 35.

Abstract: A catheter insertion apparatus with visual indication of needle penetration of a blood vessel and placement of the catheter cannula within the blood vessel, using blood vessel pressure to indicate needle penetration by the presence of blood within a transparent chamber within the apparatus and the displacement of a plunger to create a negative pressure on the cannula and thus allowing blood to be visible within the catheter hub thereby indicating the introduction of the cannula into the blood vessel.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator and a medical article. A track can extend in a proximal direction from the dilator. The needle hub can slide along at least a portion of the track between a first position and a second position. The device can further include a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position. The device can further include a guidwire that can bend such that the guidewire can both pass through the needle hub at one end and attach to the needle hub at another end.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes a needle body and hub. The device further includes a dilator coaxially disposed and slideable over the needle body and a medical article. A viewing space is disposed between the dilator and the medical article with at least one passageway or conduit connecting the viewing space with the interior bore of the needle body. The passageway is defined at least in part by openings through the sides of the needle and dilator. At least a portion of the conduit or passageway can be defined by one or more grooves between the needle and dilator. The device can further include a guidewire and an interlock between the guidewire and the needle and/or dilator. The device can further include one or more stops disposed between the guidewire and the needle and/or dilator to limit the extent to which the guidewire can be moved (e.g., advanced) relative to the needle or inhibit such relative movement (e.g.

Abstract: A medical device and method are provided for accessing a side branch in an artery. The device includes a catheter having a sidewall, an internal lumen, and a side port formed through the sidewall. A perforating guide wire has a proximal portion within the internal lumen and a distal portion arranged to be movable out of the side port. The guide wire can be delivered through the side port to a side branch artery when the catheter is deployed to a location with the side port aligned with the side branch artery. In another embodiment, the catheter has inner and outer telescoping tubes with offset exit ports formed therein. The telescoping tubes can be used to change the degree of deflection of the perforating guide wire by changing the relative positions of the offset exit ports.

Abstract: System and method that is directed to medical treatments of organs having anatomical spaces, such as (but not limited to) the heart and the pericardial space. Specifically, an apparatus and method is provided for safely accessing anatomical spaces with surfaces to deliver medical devices or media into such spaces, or to remove fluids from such spaces. The methods and apparatus may include a first elongated member with a sharp tip used to penetrate the surface surrounding the anatomical space with a second elongated member with a helical tine used to engage the surface and lift the surface away from the underlying anatomical space. Once the first elongated member has incised the surface, it is removed, and the incision may be used as a point of entry for delivering media or medical devices into the anatomical space, or for carrying out further medical procedures.

Abstract: A guidewire can include a shaft or core wire that has a distal section configured for access to a vascular treatment site and a proximal section configured for intervention at a vascular treatment site. At least a portion of the distal section of the shaft or core wire can have a diameter that is greater than a diameter of the proximal section.

Abstract: A support catheter for stowing and exchanging guidewires and other working elements comprises a catheter body having a proximal region and a distal region. A single, contiguous lumen is formed from the proximal region through the distal region and has a larger proximal cross-sectional area than distal cross-sectional area.

Abstract: In at least one embodiment of the present invention, a catheter for insertion into a patient's body is provided. The catheter comprises an elongated member having a proximal portion extending to a distal portion. A lumen is formed through the proximal and distal portions. The elongated member is formed of a polymeric material including shape memory polymers having a first phase transition temperature and a second phase transition temperature that is less than the first phase transition temperature but is greater than about room temperature. The elongated member has a first configuration at about room temperature for insertion into the patient's body and self-configures to a second configuration at a first temperature of at least the second phase transition temperature for fluid communication with the patient's body. At least a portion of the lumen has a larger flow area in the second configuration than in the first configuration.

Abstract: A guidewire for antegrade guidance of vascular interventions of a lower limb artery via a common femoral artery into a superficial femoral artery of a human patient. When in unloaded condition, the guidewire has, at its distal end, a rounded or floppy tip (4). A curved deflection section (5) is located closely proximal of the tip (4) and extends over an angle of curvature such that the rounded tip (4) is spaced from a continuation of an axis of a section proximally neighboring the curved deflection section (5). The curved deflection section (5) has a flexibility causing the curved deflection section (5) to spring back to substantially its original shape after elastic deformation to a straightened condition. A rotation preventer, a kit and a method for facilitating insertion of a guidewire into the superficial femoral artery are also described.

Abstract: A pressure connection device for a guidewire unit that is operated with a pressure medium is provided. A return valve is mounted in the interior of a tube end section of a pressure medium tube of the guidewire unit, the return valve opening for introducing the pressure medium into the pressure medium tube and closing in order to prevent the pressure medium from escaping from the pressure medium tube, and/or a connecting body accommodates the tube end section of the pressure medium tube and has a pressure medium-controlled tube holding element which secures the tube end section to the connecting body in a fluid-tight manner when impinged upon with pressure and, in a pressure-relieved state, releases it so it can be detached from the connecting body.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: Improved anastomosis devices having structural upgrades to increase ease of use while simultaneously increasing patent safety. The anastomosis device can include an introducer member having an introducer rod and an introducer cap to provide additional support to a catheter portion of the anastomosis device such that damage associated with installation of the catheter, deployment of tissue approximating structures and/or removal of the catheter can be minimized. The anastomosis device can further include a valve cap designed to constrain and reinforce a thin-walled section of a proximal funnel portion of the anastomosis device such that ballooning of the thin-walled section under the influence of a pressurized inflation fluid can be avoided during inflation as well as a time of tissue approximation and tissue healing.

Abstract: Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Abstract: Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Abstract: Systems and methods for treating a vessel include devices having a main elongated element with a balloon at its distal end, an auxiliary elongated element wherein a distal end of the auxiliary elongated element is proximal to the balloon, and a core wire having a internal core wire portion and an external core wire portion, wherein the external core wire portion is external to the balloon. In some embodiments, a distal connecting element is attached to the distal end of the balloon. In some embodiments, the distal connecting element is positioned at a rotational distance from the auxiliary elongated element. In some embodiments, the balloon is a fixed wire balloon. Inflation of the balloon causes guidewires positioned within the device and external core wires to be pushed up against the lesion, providing a focused force for cracking the lesion.

Abstract: An insertion tool for inserting a catheter into a body of a patient is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.

Abstract: An introducer sheath includes a elongated sheath configured to be inserted into a blood vessel. The elongated sheath includes a central lumen configured to allow a surgical implement or medical device to pass therethrough. The introducer sheath also includes a hemostatic valve operatively connected to the sheath. The hemostatic valve is configured to prevent blood in the blood vessel from exiting the introducer sheath assembly when the elongated sheath is located in the blood vessel. The hemostatic valve includes a plurality of seals supported by a housing, including a front seal configured to provide a hemostatic seal with a guide wire, and a rear seal configured to provide a hemostatic seal with a range of sizes of implements and devices. The housing is configured to provide strain recovery for strain induced by displacement forces generated during movement of the implement or medical device through the plurality of seals.

Abstract: A sheath shaped and dimensioned for reducing trauma and easing insertion thereof includes an inner sheath member shaped and dimensioned to fit around a guidewire in a manner permitting relative movement, the inner sheath member including an inner sheath tip having a primary bevel and a circumferential conical surface. The sheath also includes an outer sheath member shaped and dimensioned to fit around the inner sheath member in a manner permitting relative movement. The outer sheath member includes an outer sheath tip having a primary bevel and a circumferential conical surface.

Abstract: A sheath shaped and dimensioned for reducing trauma and easing insertion thereof includes an inner sheath member, the inner sheath member including an inner sheath tip having a primary bevel and a circumferential conical surface. The sheath also includes an outer sheath member shaped and dimensioned to fit around the inner sheath member in a manner permitting relative movement. The outer sheath member includes an outer sheath tip having a primary bevel and a circumferential conical surface.

Abstract: A medical device is provided including a catheter shaft having a lumen extending therethrough with a splittable wall portion along a side of the lumen, and a tube that extends through at least a portion of the lumen and is configured to provide a patent path of fluid communication.

Abstract: An apparatus includes a catheter for an intrathecal drug delivery system and a stylet having a curved forward end. Preferably, the curved forward end has a shape in the form of a “J” or a “C.” Also preferably, the catheter has a distal end that conforms to the curved forward end of the stylet. Thus, the present invention provides a catheter having a blunt forward end that minimizes the risk of penetrating the substance of the spinal cord. Additionally, the curved forward end of the stylet can be formed of a springy material so that it straightens out during the processes of insertion through a guide needle and retraction from the needle.

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: An introducer set includes an introducer and dilator along with an extension in a sealed sterile peal open package. The extension is available for use during procedures where the puncture access site to the patient is close enough to the site to be treated in the patient that the physician's hands and/or head may be positioned in the fluroscopic area while the physician is attempting to maneuver a wire guide to a desired location. When the extension is attached to the introducer, the physician may perform a procedure, such as an antigrade stick in the lower leg of a patient, while maintaining their hands and head outside of the fluroscopic area while direct radiation is being supplied and the wire guide is being maneuvered to a desired treatment location.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The medical article is disposed over and slideable over the needle. A flash space is provided anywhere between the needle and the outer surface of the medical article. The flash space communicates with a bore of the needle, as well as a variable volume chamber. The variable volume chamber can then draw fluid from the flash space into the chamber.

Abstract: A first guidewire structure includes a medical guidewire having a working portion which is extendable beyond a distal end of a medical instrument. The working portion has a length, and the working portion is tapered for substantially one-hundred percent of the length. A second guidewire structure includes a medical guidewire having a working portion, wherein the working portion has a length, and wherein the working portion includes a tapered portion for over fifty percent of the length. A third guidewire structure includes a medical guidewire having a working portion. The working portion has a length, and the working portion includes a plurality of lengthwise-adjoining segment pairs for over fifty percent of the length. Each segment pair consists essentially of a non-tapered segment having a substantially constant cross section and a tapered segment lengthwise adjoining the non-tapered segment. Methods are described for using medical instruments having the guidewire structures.

Abstract: A catheter capture device comprising a urethral sound and a sleeve that utilizes balloon inflation to capture the catheter. A catheter capture device comprising a urethral sound and a clamshell device. The clamshell device comprises two halves, one of which comprises two pins. One pin passes through the lateral holes in the tip of the catheter, and the other pin fits into a notch in the bottom half of the clamshell device. A catheter capture device comprising a urethral sound, a sleeve and a pin that passes through the lateral holes in the tip of the catheter. A catheter capture device comprising a urethral sound, a wire and a nodule, wherein the nodule captures the catheter by lodging in the tip of the catheter. The nodule could be a ball, hook, crimped wire or similar object. A method of capturing a catheter in an obese or non-obese patient.

Abstract: A needle-like tubular body (12) with its tip formed as a needle, a first guide wire (14), and a second guide wire (16) are inserted into a main tube (10). A first opening and a second opening (28 and 36) through which a first guide wire and a second guide wire (14 and 16) are respectively extended out of the main tube (10) are provided in the main tube (10). A projection aperture (32) through which the needle of the needle-like tubular body (12) is projected out of the main tube (10) is provided in the main tube (10). A support tube (60) that supports the part of the second guide wire (16) extending from the second opening (36) is further provided in the main tube (10).

Abstract: A hybrid guidewire, a method for manufacturing the hybrid guidewire including co-extruding a core inside a sheath in bulk, cutting the core and sheath to a desired length, and shaping a distal and proximal portion of the guidewire depending on the desired application.

Abstract: A cannula system for removing fluid from a patient's vasculature includes a cannula and an obturator. The cannula includes a proximal end, a distal end, and an elongate flexible tube extending therebetween. The cannula has a central lumen. The obturator is sized for insertion into the cannula's central lumen and is also configured to extend beyond the cannula distal end. A tapered portion at the cannula's distal end provides a smooth transition and an interference fit between the cannula and the obturator. The obturator includes an obturator central lumen and an opening at its distal end that is sized to receive a guidewire.

Abstract: A dedicated distal protection guidewire having proximal and distal stops disposed about an elongated core wire is disclosed. A guidewire in accordance with the present invention includes an elongated core wire having a relatively stiff proximal section and a relatively flexible distal section, a distal stop disposed about a portion of the elongated core wire, and a proximal stop disposed about a portion of the elongated core wire proximal the distal stop. The distal stop may be formed from an enlarged outer diameter portion on the elongated core wire, or may be formed from an object disposed about and secured to a portion of the elongated core wire. The proximal stop may include an O-ring disposed within a recessed surface on the elongated core wire, or an annular ring having several circumferentially disposed notches.

Abstract: In a medical guide wire 1, a flexible core wire 2 is made of austenitic stainless steel wire treated with a solid solution procedure, and tightly drawn with a whole cross sectional reduction ratio as 90%-99%. Upon forming a head plug 41 at a distal end 21 by welding a distal end tip of the core wire 2 to a distal end tip of a helical spring body 3, a eutectic alloy is used as a welding member 4. The eutectic alloy has a predetermined melting temperature so as to reduce a thermal influence against the core wire 2, thereby improving a mechanical strength property of the core wire 2 so as to lengthwisely reduce and diametrically minimize the head plug 41.

Abstract: A puncture device that reliably acts on the target body site is proposed. The puncture device includes a luminal puncture body 2 having a projection opening 2a on the side surface; a tube 3, accommodated in the puncture body 2, having an acting part 3a that acts on the inside of the body; and a leading means 4 for projecting the acting part 3a of the tube 3 towards the side from the projection opening 2a. The leading means 4 includes a wire 5 inserted in the tube 3, and a moving means 6 for moving the wire 5 in the length direction of the puncture body 2, the moving means 6 adjusting the moving amount of the wire 5 to project the wire 5 from the projection opening 2a. The acting part 3a of the tube 3 can be projected by the projection of the wire 5.

Abstract: A wire guide and a method for its percutaneous guidance within a body vessel are provided. The wire guide includes an outer component for insertion into the body vessel and a core wire disposed in the outer component and movable between first and second positions. The core wire includes an engaging portion that extends from the outer component to engage the body vessel when the core wire is in the second position.

Abstract: A central venous catheter kit enables health care workers quickly and controllably gain ultrasound supported access to vascular tissue for catheterization. Ultrasound support requires gel for reducing acoustic impedance and reflectance loss, which gel is included in the kit, as well as at least two newly conceived devices, the first for gripping the guide wire in an otherwise gelled environment, and the second for marking the skin for proper needle localization. State of the art kit components are thus included in the kit, in addition to the scanning gel and the noted device(s). The devices each comprise certain finger- or digit-grippable structure, and textured surfacing for enhancing the frictional contact between the user's digits and the devices.