Abstract: A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

Abstract: A catheter exchange member is provided for reducing exchange time when replacing one catheter (or similar device) with another in the vascular anatomy of a patient. The catheter exchange member includes a tubular body having a proximal and a distal end and a central lumen. A tapered fixture having a distal port and a proximal opening which is larger than the distal port is attached to the tubular body at the distal port. An elongate shaft is attached to and extends proximally from either the tapered fixture or the tubular body. The exchange member is preferably used within a conventional guiding catheter where the tubular body is advanced through a distal end of the guiding catheter and into the coronary artery while the tapered fixture remains in the guiding catheter. This configuration allows various therapeutic and diagnostic devices to be stored within the guiding catheter just proximal to the tapered fixture.

Abstract: Apparatus and method are described for introducing an imaging catheter to the coronary vasculature. A guiding catheter is introduced so that the distal end of the guiding catheter engages a coronary os. The distal end of the guiding catheter is shaped so that a mark on the distal end is oriented in a predetermined orientation relative to the coronary vasculature. An imaging catheter is then introduced through the guiding catheter and an image of the mark is produced with the imaging catheter while in the guiding catheter. In this manner, the relative orientation of the produced image and the coronary vasculature is known.

Abstract: A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

Abstract: Apparatus and method are described for introducing an imaging catheter to the coronary vasculature. A guiding catheter is introduced so that the distal end of the guiding catheter engages a coronary os. The distal end of the guiding catheter is shaped so that a mark on the distal end is oriented in a predetermined orientation relative to the coronary vasculature. An imaging catheter is then introduced through the guiding catheter and an image of the mark is produced with the imaging catheter while in the guiding catheter. In this manner, the relative orientation of the produced image and the coronary vasculature is known.

Abstract: A catheter exchange member is provided for reducing exchange time when replacing one catheter (or similar device) with another in the vascular anatomy of a patient. The catheter exchange member includes a tubular body having a proximal and a distal end and a central lumen. A tapered fixture having a distal port and a proximal opening which is larger than the distal port is attached to the tubular body at the distal port. An elongate shaft is attached to and extends proximally from either the tapered fixture or the tubular body. The exchange member is preferably used within a conventional guiding catheter where the tubular body is advanced through a distal end of the guiding catheter and into the coronary artery while the tapered fixture remains in the guiding catheter. This configuration allows various therapeutic and diagnostic devices to be stored within the guiding catheter just proximal to the tapered fixture.

Abstract: Apparatus and method are described for introducing an imaging catheter to the coronary vasculature. A guiding catheter is introduced so that the distal end of the guiding catheter engages a coronary os. The distal end of the guiding catheter is shaped so that a mark on the distal end is oriented in a predetermined orientation relative to the coronary vasculature. An imaging catheter is then introduced through the guiding catheter and an image of the mark is produced with the imaging catheter while in the guiding catheter. In this manner, the relative orientation of the produced image and the coronary vasculature is known.

Abstract: The claimed invention provides an improved tracking tip for use with a work element in a catheter system having a flexible tubular catheter body. Use of a tracking tip according to the present invention will facilitate advancement of the work element within the catheter body and will substantially eliminate the possibility that the work element will puncture the catheter body. Preferred embodiments will comprise a wire coil and will often include a rounded end member, which may be in the form of a solder ball, at the distal tip of the wire coil. In some embodiments, the rounded end member may be coated with a lubricant or a suitable non-stick material to further improve tracking of the work element within the catheter body.

Abstract: A catheter system includes a catheter sheath and a flexible working shaft within a working lumen of the sheath. The sheath includes a monorail-type guidewire lumen at its distal end, and a stiffening member is provided adjacent a side port of the monorail guidewire lumen to inhibit prolapse of the catheter as it is introduced past a bend or curve over a guidewire. In a first embodiment, the stiffening member may be secured directly within a working lumen of the catheter body. In a second embodiment, the stiffening member may be attached to a distal end of the working shaft, typically an imaging core.

Abstract: A guidewire is provided having a malleable segment extending beyond a superelastic tip portion of the guidewire. Such a configuration provides a guidewire which is resistant to kinking and plastic deformation in the superelastic portion, but which has a distal segment which can be shaped by a physician immediately prior to use in a surgical procedure. The malleable segment can be attached to the distal end of the superelastic tip portion, or alternatively, can result from a malleable coating on a portion of the superelastic tip, wherein the coating is thick enough to allow the coated portion of the tip to be formed into a desired shape. The malleable segment can be radiopaque to ease fluoroscopic visualization of the guidewire. In addition, the entire guidewire located proximally to the malleable segment can be fabricated from a superelastic alloy to provide resistance to kinking and plastic deformation along virtually the entire length of the guidewire.

Abstract: The present invention provides an improved drive shaft for use in a catheter system having a rotating imaging or interventional work element. A drive shaft according to the present invention is formed at least in part of a material having super elastic properties. This material provides an advantageous combination of column strength and torsional rigidity with the ability to sustain substantial bending without permanent deformation. Preferred embodiments are formed as hollow tubes to allow electrical conducting wires to be disposed within the body of the drive shaft. Some embodiments combine relatively rigid proximal segments with relatively flexible distal segments to allow for entry of the work element into narrow and twisting regions of a patient's vascular system.

Abstract: The present invention provides improvement usable with an intravascular catheter having a single common distal lumen with a reduced profile connected to two or more proximal lumens. The catheter will be loadable over a guidewire into a region of interest within a patient's vascular system. According to one aspect of the present invention, means are provided to ensure that the guidewire enters into a desired one of the proximal lumens. In a preferred embodiment, a special tool is provided to achieve this. According to a second aspect of the present invention, the catheter is provided with a proximal housing and an axially expandable member to shield the rotating parts at the proximal end of the catheter and to allow for convenient movement of a work element within the catheter body.

Abstract: An ultrasonic imaging catheter comprises a flexible catheter body having a rigid housing at its distal end. A tapered flexible end piece is secured to the distal end of the rigid housing, and a flexible guide wire tube extends in parallel to both the housing and the flexible end piece from the catheter body. The guide wire tube defines a guide wire lumen capable of receiving a movable guide wire, and the combined structure of the housing, flexible end piece, and flexible guide wire tube minimize constriction of the guide wire as it passes through the guide wire lumen.

Abstract: A guidewire system for use in catheter exchanges avoids the need for a separate exchange wire by connecting an extension wire to the proximal end of the guidewire thereby increasing the effective length of the guidewire to permit a catheter exchange. The proximal end of the guidewire is attached to the distal end of the exchange wire by a disconnectable reattachable connection which avoids deformation of the connected joint.

Abstract: An ultrasonic imaging catheter comprises a catheter body having a distal end and a proximal end. An ultrasonic imaging transducer is located within the distal end and is arranged to produce an image in an image plane which is generally normal to the axial direction of the catheter. An ultrasonically opaque element is attached to the catheter body and disposed through the image plane so that an image artifact or marker appears on the resulting ultrasonic image. The artifact corresponds to the location on the catheter where the element is located. A fluoroscopic marker is also provided on the catheter body, typically located proximally of the region where the ultrasonic imaging transducer and other components are located. The fluoroscopic marker has a geometry selected so that the marker has a unique appearance depending on the rotational orientation of the catheter when viewed by fluoroscopy.