Abstract: A bifurcation stent delivery catheter includes a first branch balloon, a second branch balloon adjacent the first branch. A centering balloon is optionally disposed distal of the second branch balloon. The balloons are coupled by a coupling device to a main shaft of a catheter. The coupling device allows axial forces to be transmitted from the main shaft to the balloons while allowing the balloons to rotate axially relative to the main shaft with ease. The coupling device functions as an axial rotational joint. The coupling device can have a flexible tubular member that connects the balloons to the main shaft, the tubular member having a torsional flexibility greater than that of the main shaft. The coupling device can have a tubular wall having a cut extending circumferentially around the tubular wall and protective boot covering the cut. The coupling device can have a wound member that allows the axial rotation.

Abstract: Various improved catheter marking arrangements are described. In a first aspect of the invention, the catheter includes an expandable member (such as for example, a balloon, a stent, etc.). A pair of radiopaque end markers mark the distal and proximal ends of the expandable member. Additionally, a radiopaque intermediate marker is provided that marks an intermediate position on the expandable member. The intermediate marker may be used to mark important points on the expandable member. The markers are sized and positioned such that a surgeon utilizing the catheter in a surgical procedure would be able to readily differentiate the markers in a fluoroscopic image to determine the location of the item marked by the orientation of the catheter. In various other aspects of the invention, the intermediate marker is arranged to mark a position on the expandable member that constitutes a line of demarcation for an agent (such as a drug) carried by a balloon.

Abstract: This invention describes a guidewire placement device for facilitating the delivery of multiple guidewires to the branches of a tubular system. The invention also includes a method for placing guidewires in the branches of a tubular system using a device in accordance with the present invention, while mitigating guidewire entanglement. The present invention may be utilized during percutaneous treatment of vascular and non-vascular disease, and in particular to complement the use of balloon angioplasty and the deployment of balloon-expanded or self-expanding stents into a bifurcated vessel system.

Abstract: The present invention relates to a catheter having a soft distal tip that can be manufactured at lower cost than catheters in the prior art. In one embodiment, the catheter is produced by coupling a soft sleeve to the distal end of a catheter tube. The sleeve may affixed to the catheter tube under temperature and pressure conditions that cause the proximal end of the sleeve to taper against the outer surface of the catheter tube, avoiding or minimizing discontinuities in the insertion profile of the catheter, and that also cause the inner wall of the sleeve to taper against the distal end of the catheter tube, avoiding or minimizing discontinuities in the lumen of the catheter.

Abstract: Disclosed are stent delivery apparatus and methods for moving a balloon catheter carrying a stent through a body vessel without the stent slipping from the balloon are provided. In general, the stent delivery system includes a stent stopper that impedes the stent from slipping from the balloon. The stent stopper is sized to serve as a barrier to the stent as it is carried on the balloon. In a specific embodiment, the stent stopper is formed from a material that encircles the proximal end of the balloon and abuts the proximal end of the stent. The stent stopper material expands with expansion of the balloon and collapses with deflation of the balloon. In some embodiments, the stent stopper material has a thickness that is about equal to or greater than the thickness of the stent so as to form a barrier against the stent and impede the stent from slipping off the proximal end of the balloon.

Abstract: The present invention relates to a catheter for POBA or stent delivery applications. More specifically, the present invention relates to a balloon catheter having a soft distal tip member and methods for manufacturing the same.

Abstract: A contoured intraluminal stent for deployment proximate a bifurcated vessel is disclosed. The contoured stent is configured to seat within a side branch of the bifurcated vessel so as to acceptably cover a curvilinear ostium defined at the intersection of the side branch with a main branch of the vessel. A stent deployment system includes a first guidewire positioned in the vessel main branch and a second guidewire that extends through the main branch and into the vessel side branch, wherein the intersection of the branches defines an ostium having a three-dimensionally curvilinear shape. A balloon catheter is tracked along the second guidewire to a position in the side branch proximate the ostium. A contoured stent disposed about the balloon includes a proximal end that defines a curvilinear profile that at least approximately matches the curvilinear shape of the ostium when the stent is deployed in the side branch.

Abstract: A stent delivery catheter system for accurately positioning a stent in a bifurcated vessel is disclosed. The system includes a catheter having a terminal portion and distal tip that is placed in a main branch of the vessel proximate the bifurcation. A fixed guidewire is attached to distal tip. A port is defined in the terminal portion of the catheter. The port is aligned with an ostium of a side branch of the bifurcated vessel to allow the passage of a stent delivery device, such as a balloon catheter having a stent crimped thereon, into the side branch. Radiopaque bands are positioned on opposite ends of the port. A positioning balloon is included on a surface of the catheter opposite the port and is selectively inflatable to position the radiopaque bands adjacent the side branch ostium. The radiopaque bands are referenced to place the stent proximate the side branch ostium.

Abstract: A catheter tip for attachment with an intravascular balloon catheter that is used within a body lumen is disclosed. The catheter tip includes a body portion having a base that is attached to the balloon catheter. The base defines a proximal end of the catheter tip. A head that is attached to the body portion defines a distal end of the catheter tip. An axial cavity, cooperatively defined by the body portion and the head, extends longitudinally from the proximal to the distal end of the catheter tip. The axial cavity receives a first guidewire along which the catheter is moved within the body lumen. An outer surface of the head is shaped in a predetermined manner to control the magnitude of deflection of a second guidewire that is often twisted about the first guidewire in the lumen so as to prevent catheter obstruction by the guidewires during catheter procedures.

Abstract: A stent delivery system is disclosed for delivering and deploying a radially expandable stent at a strategic orientation and location in a body vessel. The delivery system includes an elongated flexible tubular shaft sized suitably for insertion into the body vessel, first and second inflatable members disposed adjacent the distal end of the elongated shaft and an endoprosthesis disposed about the first and second inflatable members. The delivery system further includes a tip assembly which during to advancement of the delivery system is configured as a single tip assembly, wherein prior to deployment of the expandable endoprosthesis, the tip assembly is split into a first tip and a second tip, wherein one of the tips remains in a main branch and the second tip is advanced into a side branch lumen to align the endoprosthesis prior to deployment.

Abstract: A guidewire apparatus for a medical device that includes an expandable guidewire section that can be locked in an expanded state. In one use, the expandable section can be temporarily locked to a working element of a medical device to facilitate the transmission of torque from the guidewire to the medical device. Hence, this configuration may be utilized to aid in orientation of the working element with a vessel side branch by providing the user with the ability to apply a rotational force to the distal end of the stent delivery system. Another use includes docking the expandable section near an opening into a guidewire lumen at the catheter tip. This configuration is particularly useful in forming a smooth transition between the guidewire and the catheter tip to reduce the phenomenon of fish-mouthing.

Abstract: The invention includes a catheter having an elongate main body having a proximal section and a distal section. The elongate main body further includes a plurality of stiffening members disposed along the length of the elongate main body. At least one stiffening member includes a plurality of clusters including helical turns or rotations disposed circumferentially about a tubular member and along the length of the cluster. The clusters can be configured to vary flexibility along the length of the tubular member. The catheter can include a sheath having a stationary section and a retractable section.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: A catheter arrangement is described that is arranged to permit a guide wire or other structure to be fed laterally from the region of an expandable working element. The catheter includes an elongate flexible tubular member and an inflatable structure carried by a distal portion of the flexible tubular member. The flexible tubular member has a guide wire lumen and at least one fluid supply lumen that is in fluid communication with the inflatable structure. The inflatable structure includes at least one, and preferably two, inflatable members (which may take the form of balloons). In the case of two inflatable members, the first and second inflatable members are radially spaced about the guide wire lumen such that at least one gap is formed between the inflatable members. With this arrangement, the distal end of a guide wire may be advanced through the guide lumen and out of a side opening such that the guide wire passes laterally between the first and second inflatable members.

Abstract: A stent delivery system is disclosed for delivering and deploying a radially expandable stent at a strategic orientation and location in a body vessel. The delivery system includes an elongated flexible tubular shaft sized suitably for insertion into the body vessel. A stent deployment assembly includes a distal transition portion supporting a dilator device adapted for radial expansion about a longitudinal axis of the deployment assembly from a non-expanded condition to a radially expanded condition. The dilator device is configured to support the stent thereon in the non-expanded condition and in predetermined orientation relative the deployment assembly. A rotational clutch assembly rotatably mounts the transition portion to a distal portion of the tubular shaft such that the deployment assembly is substantially torsionally isolated from the tubular shaft, about a longitudinal axis of the clutch assembly.

Abstract: A stent delivery system is disclosed for delivering and deploying a radially expandable stent at a strategic orientation and location in a body vessel. The delivery system includes an elongated flexible tubular shaft sized suitably for insertion into the body vessel. A stent deployment assembly includes a distal transition portion supporting a dilator device adapted for radial expansion about a longitudinal axis of the deployment assembly from a non-expanded condition to a radially expanded condition. The dilator device is configured to support the stent thereon in the non-expanded condition and in predetermined orientation relative the deployment assembly. A rotational clutch assembly rotatably mounts the transition portion to a distal portion of the tubular shaft such that the deployment assembly is substantially torsionally isolated from the tubular shaft, about a longitudinal axis of the clutch assembly.