Abstract: The invention is directed to a self-expanding stent for implantation into a body lumen, such as an artery. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common longitudinal stent axis and interconnected by a plurality of interconnecting members placed on the stent in a collinear arrangement such as to create at least one continuous spine which extends along the length of the stent. The invention is also directed to a stent delivery system for implantation of a stent in a vessel which includes an outer tubular member having a restraining sheath and an inner tubular member having a distal end which has a compressed stent mounted thereto. The proximal end of the inner tubular member is connected to a housing assembly which prevents the inner tubular member from moving when the outer tubular member is retracted to deploy the stent.

Abstract: A method of positioning a main stent at a vessel bifurcation such that a side opening in the main stent is positioned at the ostium of a branch vessel, comprising: positioning a main guidewire in the main vessel such that a distal end of the main guidewire extends past the bifurcation; advancing a stent delivery system to a position proximate the bifurcation, the stent delivery system comprising a catheter with a flexible side sheath attached thereto, wherein the catheter is received over the main guidewire, and wherein the main stent is positioned over the catheter with the flexible side sheath positioned to pass through the interior of the main stent and out of the side opening in the main stent; advancing a branch guidewire through the flexible side sheath attached to the catheter and into the branch vessel; and subsequently, advancing the catheter over the main guidewire while advancing the flexible side sheath over the branch guidewire while viewing relative movement of a marker positioned on the flexibl

Abstract: A method is provided for delivering a drug to a selected tissue region within a patient's body with a catheter having a deployable puncturing element, a drug delivery element and an orientation element on a distal portion thereof. The distal portion of the catheter is percutaneously introduced into a blood vessel, and directed endovascularly to a vessel location adjacent to the selected tissue region. The puncturing element is oriented towards the selected tissue region, and deployed to access the selected tissue region. A drug is delivered with the drug delivery element to the selected tissue region.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

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

Abstract: Implantable or insertable medical devices are provided, which comprises: (a) a biocompatible polymer; and (b) at least one therapeutic agent selected from an anti-inflammatory agent, an analgesic agent, an anesthetic agent, and an antispasmodic agent. The medical devices are adapted for implantation or insertion at a site associated with pain or discomfort upon implantation or insertion. In many embodiments, the therapeutic will be selected from at least one of (i) ketorolac and pharmaceutically acceptable salts thereof (e.g., ketorolac tromethamine) and (ii) 4-diethylamino-2-butynylphenylcyclohexyl glycolate and pharmaceutically acceptable salts thereof (e.g., oxybutynin chloride). Also provided are uses for the implantable or insertable medical devices, which uses comprise reducing pain or discomfort accompanying the implantation or insertion of such devices. Further uses may comprise reducing microbial buildup along the device.

Abstract: An intravascular catheter having a multi-layered distal tip including an inner layer, an intermediate layer and an outer layer wherein the intermediate layer is formed of a polymeric material loaded with a high percentage of radiopaque agent, and the inner and outer layers are formed of readily bondable materials which substantially cover the intermediate layer to thereby increase surface area contact and bond strength therebetween.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

Abstract: A catheter assembly comprising a shaft and at least one flexible radiopaque marker affixed with the shaft. Flexibility of radiopaque marker is achieved by using a segmented band of radiopaque material or a coiled band formed by winding a wire or hollow tube filled with radiopaque material. The flexible radiopaque marker may be affixed with the shaft by an adhesive, by swaging, by crimping, by soldering, or by spring-action tension fit against the shaft.

Abstract: An improved guiding member for use within a body lumen having a unique combination of superelastic characteristics. The superelastic alloy material has a composition consisting of about 30% to about 52% (atomic) titanium, and about 38% to 52% nickel and may have one or more elements selected from the group consisting of iron, cobalt, platinum, palladium, vanadium, copper, zirconium, hafnium and niobium. The alloy material is subjected to thermomechanical processing which includes a final cold working of about 10 to about 75% and then a heat treatment at a temperature between about 450° and about 600° C. and preferably about 475° to about 550° C. Before the heat treatment the cold worked alloy material is preferably subjected to mechanical straightening. The alloy material is preferably subjected to stresses equal to about 5 to about 50% of the room temperature ultimate yield stress of the material during the thermal treatment.

Abstract: A catheter having a catheter lumen defined by a catheter wall wherein at least a portion of the catheter wall has at least one radiopaque member. The at least one radiopaque member comprises a body and a weakened portion. The body has a body length, a body thickness and a body circumference. The weakened portion is defined by the body and has a weakened portion length, a weakened portion thickness and a weakened portion width, the weakened portion thickness being less than the body thickness.

Abstract: Methods and apparatuses for positioning a radiation source in vivo relative to radio-opaque markers on a catheter that delineate a therapeutic treatment length so that a therapeutic dose of radiation is delivered along the therapeutic treatment length.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

Abstract: A guide catheter has properties that promote enhanced visibility of the guide catheter using fluoroscopic or ultrasonic imaging techniques. The tip of the guide catheter may incorporate a material that is both fluoro and echo visible. The first material also may be provided in various amounts along the length of the guide catheter. In addition, the guide catheter may incorporate a reinforcing braid that includes one or more strands of a second material that is radio-opaque. As a result, the result guide catheter achieves improved radio-opacity and echogenicity.

Abstract: A cellular transfer catheter (10) is provided for implantation of cellular material into the uterus of a patient. The catheter includes a first component (11, 13) of a first material (26) which has a passageway (16) extending therethrough, and a second component (12) of a second material (27) having a higher durometer than the first material and suitable for assisting passage of the first component (11, 13) through a cervix and into the uterus of the patient. The first component (11, 13) includes a region (20) closely adjacent its distal end (18) having an ultrasonic reflectivity detectably different from the reflectivity of adjacent parts.

Abstract: Apparatus includes an elongated flexible catheter having proximal and distal end portions, with fluidly connected coaxial lumens extending therebetween, and a diameter sufficiently small for insertion into a patient's intraluminal passageways. One or more treating elements are positionable within one of the lumens and movable between the proximal and distal portions by fluid flowing through the lumens. The distal portion includes a distal guide wire lumen having a proximal exit port distally located relative to the treatment elements positioned at the distal portion. To simultaneously achieve stiffness along the proximal portion and flexibility along the distal portion, the inner and/or outer coaxial members may be of more than one-piece construction. The inner and/or outer members may also be stepped or bumped in diameter to decrease the pressure and fluid transit times within the catheter. A balloon may be added to the distal portion for positioning the catheter or performing angioplasty.

Abstract: An apparatus having an insertable portion for holding a position sensor is disclosed. The position sensor can transmit a signal indicative of its position with respect to a field generator. The insertable portion of the catheter has fiducial markings that are detectable by an imaging modality when the insertable portion is inserted into the anatomical body. After the insertable portion has been inserted into the anatomical body, the fiducial markings can be detected to facilitate registration of the position sensor held in the insertable portion to the anatomical body. The apparatus also has a fixing mechanism for releasably fixing the insertable portion to the anatomical body. When the insertable portion is inserted into the anatomical body to a location of interest, the fixing mechanism rigidly fixes the insertable portion of the catheter to a part of the anatomical body near the location of interest. The fixing mechanism can comprise a screw, or, at least one barb.

Abstract: A guidewire compatible for use with magnetic resonance systems is made from a non-metallic material with a high specific electric impedance, preferably constructed primarily of a glass body. Possible material selections for the glass body include quartz. Further enhancements to the present invention are as follows. Moreover, the glass body may be sheathed in a protective polymer layer, which is also non-metallic and tends to improve the physical characteristics of the guidewire. The sheath may preferably be reinforced with a number of reinforcing fibers, which may be made from carbon, borium, aramide and also various types of glass fibers. If necessary to obtain the desired physical performance of the guidewire, including high flexibility at the distal end, a distal portion of the guidewire may be constructed of metal components according to designs known in the art. Such a metal tip portion may be made of nitinol, and should be substantially shorter than the wavelength of the magnetic resonance field.

Abstract: A guidewire having an elongated core having a radiopaque marker on a distal portion of the core and a plurality of indicia on the proximal extremity of the core to facilitate measurement of an intracorporeal location such as a stenotic region within a patient's coronary artery. The guidewire is first positioned within the patient with the distal radiopaque marker at one end of the intracorporeal location and an indicia representing a base reference point is noted on the proximal portion of the guidewire which extends out of the patient. The guidewire is then moved so that the distal radiopaque marker is located at or adjacent to the other end of the intracorporeal location and another indicia on the proximal portion of the guidewire adjacent to the reference point. The distance between the two indicia on the proximal extremity of the guidewire is a measurement of intracorporeal length.

Abstract: A tip for attachment, in use, to the distal end of a catheter for insertion into a body lumen. The tip comprises an attachment region. The attachment region is formed from a material selected to have at least one characteristic having a first parameter of a predetermined value to enable attachment at the tip in use.

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

Abstract: A method and apparatus for providing a high-quality representation of a volume having a real-time 3-D reconstruction therein of movement of a catheter, wherein its real-time movement is determined using a lower-quality representation of only a portion of the volume. Movement of the catheter is detected in a 2-D X-ray fluoroscopy image and is reconstructed in a 3-D angiography (X-ray) reconstruction. Described is a catheter design for easier detection, and a technique for 3-D reconstruction of a catheter from real-time 2-D fluoroscopic images and stored 3-D angiography data, so as to present the 3-D reconstructed catheter in the common coordinate frame.

Abstract: The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheter which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passageway-forming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter.

Abstract: An infusion catheter for delivering drugs or other agents to selected sites in an organism, such as a human. In an alternate embodiment, a catheter system is disclosed having an infusion catheter and a pump that may be implanted or disposed outside the organism. In either embodiment, the free end of the catheter bears a rounded tip that has at least one elution hole for discharging an agent or drug to a selected site. The catheter has a tubular inner liner that is integral with the tip. The inner liner and tip are formed from a drug compatible polymeric material that is relatively nonporous and unreactive with the agent to be infused. A biocompatible flexible elastomeric tubular jacket surrounds the inner liner and a portion of the tip excluding that portion containing the elution hole or holes.

Abstract: A transvascular system for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter having a distal portion with puncturing, orientation, drug delivery, and imaging elements. The puncturing element is deployable for penetrating the vessel wall to access the tissue region. The orientation element, e.g. a “cage” including a plurality of struts and/or a radiopaque marker, has a predetermined relationship with the puncturing element, the imaging element detecting the location of the orientation element with respect to the tissue region to orient the puncturing element. The catheter is percutaneously introducing into the vessel, the puncturing element is oriented towards the tissue region, the puncturing element is deployed to access the tissue region, and the drug is delivered to the tissue region.

Abstract: An introducer system has a splittable sheath which includes a marker band. The marker band allows the sheath to be viewed under fluoroscopy while inserted within a patient, and while still allowing a medical device to be introduced therethrough. In addition, the marker band allows for the sheath to be split using a slitter in a longitudinal direction which permits the sheath to be removed from the venous system without having to be withdrawn over an end of the medical device. The marker band has perforations, comprises a mesh structure, or can comprise a braid structure, which each allow for the sheath, and the marker band, to be slittable.

Abstract: Several improvements are provided in the design of a catheter shaft to reduce costs and improve performance. In one aspect, a small notch is fabricated into a catheter tube by a nonlaser process such as electric discharge machining (EDM) or mechanical grinding. This notch in the catheter tube is necessary for fluid communication between the catheter lumen and a balloon or other element in communication with the tube. Use of a nonlaser process reduces the costs of fabrication while ensuring a high degree of structure integrity. In another aspect, a method is provided to produce a nonuniform polymer coating on a catheter shaft to reduce friction and to maintain a catheter with a low profile. In another aspect, the catheter is provided with a radiopaque marker which is more visible and is more effective at identifying the location of a balloon. The marker is moved closer to a distal balloon by placing it within an adhesive taper adjacent the balloon.

Abstract: The present invention comprises a tubular catheter shaft defining at least one catheter shaft lumen and a radiopaque band made of a polymeric material loaded with a radiopaque material of greater than 40% by weight, suitable for visualization under fluoroscopy in catheters in the range of 3 French to 5 French. The distal soft tip is formed of a relatively flexible polymeric material, loaded with radiopaque material which is less radiopaque than the radiopaque band. The radiopaque band's proximal end adjoins the distal end of the catheter shaft. The radiopaque band's distal end adjoins the proximal end of the distal tip to form an attachment junction. A tubular sleeve fits coaxially over the radiopaque band, the distal end of the catheter shaft and the proximal end of the distal soft tip.

Abstract: A medical catheter comprising a guide wire shaft having an inner diameter defining an inner lumen and an outer diameter, the guide wire shaft having a proximal portion and a distal portion, an inflation lumen tube defining an inflation lumen, the inflation lumen tube having a proximal end and a distal end, the guide wire shaft extending distal to the inflation lumen tube, an inflatable balloon having a proximal end and a distal end, the balloon distal end being sealingly affixed to the distal end of the inner lumen tube, the balloon proximal end being sealingly affixed to the distal end of the inflation lumen tube, the balloon being in fluid communication with the inflation lumen and at least one marker band being imbedded in the distal portion of the guide wire shaft, the marker band being positioned between the proximal end and the distal end of the inflatable balloon such that the marker band can be viewed under fluoroscopy.

Abstract: A flow directed catheter for use in medical diagnostic or therapeutic procedures having a strain relief segment between the relatively stiff proximal section of the catheter and the floppy distal tip portion in which the strain relief segment is formed of a polymeric material containing a radiopaque agent.

Abstract: An apparatus and method for selective delivering fluid into a fluid vessel is provided. In the method, a delivery catheter (2) is advanced over a guide wire (30) to a target location within fluid vessel, such as a restriction or blockage. After reaching the target location, therapeutic fluid is supplied under pressure into an axial lumen 12 of the delivery catheter. The fluid is inhibited from passing through the open distal end of the catheter so that the fluid will preferentially flow radially outward through a plurality of lateral infusion ports (20) in the delivery catheter. The guide wire may also be retracted into the catheter to deliver the fluid axially through the open distal end of the catheter.

Abstract: A catheter is provided either with an x-ray-opaque marker or with a device for generating a vibratory signal for transmission along a guide wire within the catheter in order to indicate the position of the catheter.

Abstract: A tubular member for manufacture of medical devices insertable into body lumens. The tubular member includes an inner tubular member, and outer tubular member, and a lumen through the inner tubular member. The outer tubular member has a plurality of radiopaque segments formed of radiopaque material incorporated into the tube polymeric material. One tubular member has highly radiopaque segments separated by less radiopaque segments at intervals greater than the radiopaque segment length, such that the radiopaque segments serve as marker bands. Another tubular member has long radiopaque segments separated by less radiopaque segments at intervals less than the radiopaque segment length, such that the less radiopaque segments serve as marker bands. Marker bands can be located at either regular intervals to aid in measuring internal dimensions or at significant structural locations to aid in catheter positioning.

Abstract: The catheters in a family thereof in which each of the catheters has substantially the same configuration and adapted to perform the same function, but in which the catheters in the family differ from each other in at least one respect, are provided with radiographically distinguishable indicia by which each of the members of the family can be distinguished from the others by direct observation of its radiographic image.

Abstract: A catheter including fluoroscopic marker components disposed in the catheter distal end portion to provide enhanced fluoroscopic visibility of the catheter end portion. Various embodiments of the marker include a cylindrical plug disposed within the catheter tip, a half section catheter tip, a longitudinal stripe along a sidewall of the catheter end portion, and multiple combinations of marker plugs and marker stripes to provide enhanced in vivo fluoroscopically visible catheter disposition information to the physician. An enhanced embodiment of the present invention includes an orientation marker that is disposed on the steering handle, particularly on the control knob, to provide visual and tactile information to the catheter user regarding the direction to manipulate the control knob in order to maneuver the catheter distal end portion.

Abstract: Radiopaque catheter and method of manufacture thereof having a first layer and a second layer in a coaxial arrangement wherein each of the layers has a radiopaque filler material intermixed therewith. The radiopaque filler materials and/or the concentrations thereof may be the same or different for each of the layers. Further, the plastic binder material used for each of the layers may be the same or different. By selecting a high concentration of a highly radiopaque filler material for an inner layer and a lower concentration of a radiopaque filler that is selected to provide a relatively smooth surface, the X-ray visibility of the catheter may be maximized while still maintaining a relative smooth outer surface.

Abstract: A torquable guiding catheter for use in mapping the wall of a heart of the patient with a mapping catheter having a distal extremity and a mapping device carried by the distal extremity and carrying a plurality of electrodes for engaging the wall of the heart. The basket-like device is movable between expanded and contracted positions and in a contracted position having an outside diameter no greater than a predetermined diameter. The torquable guiding catheter comprises a flexible elongate braided shaft assembly having proximal and distal extremities and having a smooth outer surface and also having a smooth inner surface defining a lumen extending from the proximal extremity to the distal extremity. The flexible elongate braided shaft assembly includes a braid formed of flat metal ribbon extending from the proximal extremity to the distal extremity and having plastic covering the braid having a Shore hardness durometer ranging from 55D to 75D.