Abstract: The catheter (5) with a flexible tip (20) includes a manifold (25) at the proximal end, a flexible catheter body (40) having a proximal end and a distal end, a balloon (15) at the distal end and a distal flexible tip (20). The catheter is designed for operation as an "over the wire" catheter and would be compatible with a flexible guidewire, such as guidewire (30). The flexible tip invention also would be compatible with "rapid exchange" or "single operator exchange" catheters. Flexible tip (20) extends distally from balloon (15) and guidewire shaft (55). In the preferred embodiment flexible tip (20) is formed from distal material of balloon (15). The length of the flexible tip (20) will vary depending on the path that catheter (5) must travel through the artery to get to its desired location. The length of the tip will balance the pushability desired versus the flexibility desired.

Abstract: The present invention comprises a catheter method of manufacture. The method includes the provision of a subassembly of a lubricious liner and reinforcement. Over the subassembly, a shaft tube, transition tube, and soft tip tube are placed in an abutting relationship to each other, forming an assembly. A first tube of heat shrink is advanced over the assembly, heat is applied to fuse the assembly, and the first heat shrink is removed. Subsequently, the soft tip of the catheter is shaped using a second tube of heat shrink, which is placed over the distal end of the assembly. Heat is applied to the second heat shrink to cause the tip material to flow and to draw the tip material over the distal end of the lubricious liner. The second heat shrink is removed, completing the catheter manufacture.

Abstract: A dilation catheter having a balloon inflation shaft with an inflation lumen into which a stiffening wire extends and a guidewire shaft having a guide wire lumen adjacent to the balloon. The stiffening wire includes at least two stepped diameter reductions along its length to vary stiffness from a stiff proximal end providing improved pushability to a less stiff distal end providing improved trackability. A manifold at the inflation shaft proximal end includes a handle for adjusting the distance the stiffening wire extends into the inflation lumen to allow stiffness to be optimized. The handle includes a tubular flange frictionally engaging the manifold to prevent inadvertent handle movement. The balloon inflation shaft and guidewire shafts are bonded together in a manner producing an assembly having a circular cross section for improved connection to a circular balloon and improved catheter performance.

Abstract: What is disclosed is a stent delivery system comprising an inflation shaft having an expandable balloon sealingly mounted at the distal end thereof and a tubular sheath having the inflation shaft longitudinally running therethrough. The tubular sheath has an expandable sheath at the distal end thereof with the balloon longitudinally running therethrough and an expandable stent mounted on the expandable sheath. Also disclosed is a method of delivering a stent into a body lumen. The method comprises the steps of providing an inflation shaft having an expandable balloon sealingly mounted at the distal end thereof and providing a tubular sheath having the inflation shaft longitudinally running therethrough. The expandable sheath has the balloon longitudinally and slidingly running therethrough, and an expandable stent is mounted on the expandable sheath. The stent is positioned in the body lumen at the treatment site and the balloon is inflated simultaneously with the expandable sheath to deploy the stent.

Abstract: Methods and apparatus for implanting a radially expandable stent and separate film within a body vessel. The film is separate from the stent and releasably retained thereon during advancement of the stent to the body vessel. Some methods according to the present invention include steps of providing a collapsed, radially expandable stent; providing a film that is separate from the stent, the film being provided in sheet form; wrapping the film around at least a portion of the stent; and releasably securing the film around the stent with at least one suture or by releasably attaching the first end of the film to a second end of the film. The apparatus according to the present invention include a collapsed, radially expandable stent and a film separate from the stent. The film is releasably attached around the stent by a suture or by releasably attaching the first end of the film to the second end of the film.

Abstract: A method and apparatus for a closed end catheter system comprising a catheter body defining a tool lumen sized to receive an elongated tool. The distal end of the tool lumen has a plug therein. A guidewire lumen extends within the catheter body and is sized to receive a guidewire. The guidewire lumen extends along at least a portion of the length of the tool lumen such that the tool lumen and the guidewire lumen are in a biaxial relationship. The elongated tool has a distal tip and a working portion near the distal tip. Two marker bands are affixed to the catheter body and are separated from each other by a distance of not less than the length of the working portion of the tool. The elongated tool extends longitudially through the tool lumen such that when the distal end of the tool rests against the plug, the working portion of the tool is located between the first and second marker bands.

Abstract: Disclosed is a medical catheter comprising a guidewire shaft defining a guidewire lumen. A distal tip extension defines a distal tip extension lumen having at a proximal end thereof a distal end of the guidewire shaft sealingly affixed therein. The inflatable balloon has a body portion, a tail portion and a cone shaped portion. The cone-shaped portion extends between the distal end of the body portion and the proximal end of the tail portion. The balloon tail portion is sealingly affixed to the distal tip extension such that the proximal end of the distal tip extension extends proximally from the proximal end of the balloon tail portion, the distal end of the distal tip extension extends distally from the distal end of the balloon tail and the distal end of the guidewire shaft is in alignment with the proximal end of the balloon tail portion.

Abstract: An intravascular catheter system for implanting a radially expandable stent within a body vessel including a catheter comprising an inner lumen tube, an inflation lumen tube, an inflatable balloon and at least one free standing built-up layer affixed to the outer diameter of the inner lumen tube, the built-up layer being internal to the balloon. A stent is mounted coaxially upon the balloon, the built-up layer extends coaxially within the stent but does not extend beyond the proximal and distal ends of the stent. The built-up layer is sufficiently thick as to cause the balloon to expand evenly and the stent to deploy uniformly. The method of manufacturing the built-up layer includes forming the layer from shrink wrap tubing or alternatively forming the layer from molded ultraviolet light curing adhesive.

Abstract: A sheath arrangement for spiral balloon catheters which permits improved perfusion during dilation of a body vessel. Methods of making the sheath and assembling the sheath onto a balloon and the resulting sheathed balloon catheter are included. A tube sized to fit over a spiral balloon is cut, preferably by laser cutting, to form ribs extending from the tube ends with collars at the distal ends of the ribs. Preferably, the tube ends are trimmed to match the balloon spiral lobes. The sheath is placed over the spiral balloon, bonded to the balloon lobes. The collars are secured to the catheter adjacent to the balloon. When the balloon is expanded to dilate a body vessel, blood can freely pass through the interlobe channels while the sheath prevents entry of arterial intima from entering into the channels. The rib and collar arrangement securely maintains the sheath in place on the balloon.

Abstract: The present invention relates to a guidewire which comprises an elongated core of a substantially solid cross-section having a distal end portion, the distal end portion having a plurality of notches therein, the notches having a depth of 5-25% of the diameter of the proximal end. The proximal end of the guidewire has a diameter in the range of 0.005-0.040 inches, the notches defining a continuous helix with a constant depth. The guidewire also comprises a helically wound spring, the spring having a plurality of coils defining a lumen. At least part of the distal end portion of the elongated core being received within the lumen.

Abstract: A spiral balloon perfusion catheter assembly having a retaining wire and method of making the balloon. Also, a retaining wire for such a catheter and method of forming the retaining wire. A typical spiral catheter balloon has a spiral configuration of lobes and channels mounted on a catheter extending beyond the balloon ends. A retaining wire formed from a shape memory alloy is configured to have a central region having a spaced spiral configuration conforming to the spiral balloon channel and end regions configured to have a contiguous spiral configuration conforming to the catheter diameter. When placed over a spiral balloon, the central spiral region prevents expansion of the channel when the balloon is inflated, while the end regions secure the retaining wire to the catheter. Preferred shape memory alloys comprise nickel and titanium.

Abstract: A method and apparatus for a guide wire extension docking system for angioplasty including a guide wire and an extension wire to facilitate exchanging a balloon dilatation catheter comprising a guide wire having a proximal end and a distal end, an extension wire having a proximal end and a distal end, a hypotube having a proximal end, a distal end, an inner diameter and an outer diameter, the outer diameter of the hypotube being equal to the diameter of the extension wire, the proximal end of the hypotube being permanently affixed to the distal end of the extension wire, the distal end of the hypotube having a tongue extending distally and a spring coil with a proximal end, a distal end, an inner diameter and an outer diameter, the outer diameter of the spring coil being equal to the outer diameter of the hypotube, the spring coil having a length approximately twice the length of the tongue, the outer diameter of the spring coil being permanently affixed to the tongue such that the proximal end of the spring

Abstract: A mounting and transfer device and method for installing a stent on a delivery device that inserts the stent into a body lumen. The device includes a generally cylindrical mandrel for receiving and frictionally holding a stent, a handle at a first end of the mandrel and a guide rod extending axially from the second of the mandrel. The second end of the mandrel has a conical recess surrounding the guide rod exit. In use, a stent is placed on the mandrel, the distal end of the guide rod is fully inserted into a guide wire lumen at an end a delivery system such as a catheter and the stent is slid from the mandrel onto the balloon and crimped in place. A tube of heat shrinkable material may be placed over the stent on the mandrel and heat shrunk to lightly press against the stent. The tube and stent are transferred to the balloon and crimped.

Abstract: A stent mounting device and method of using the device comprising a disposable device for holding a stent, into which a delivery system such as a balloon catheter can be inserted, and the stent crimped onto the delivery system, after which the delivery system and mounted stent are removed from the device. A stent is carried in a channel formed by four corner segments of four co-axillay arranged spaced blocks. Two adjacent blocks are elastically mounted in each of two parallel, opposed, cooperating actuators. The corner segments form an elongated channel sized to retain a conventional stent. Two elastic rods are placed between opposite blocks in opposite actuators. When the actuators are pressed together the rods are deformed to provide pressure transverse to the line of pressure, so that the cross sectional area of the channel is decreased in both directions, crimping the stent uniformly onto a delivery system.

Abstract: The present invention relates to over-the-wire PTCA balloon catheters (5), and more particularly, to a rapid exchange catheter with the guidewire lumen (50) at the distal tip. The present invention discloses a rapid exchange medical catheter having a wire guiding means external to the shaft (35) for slidably mounting over the guidewire (55), the wire guiding means being a short tubular member having a proximal end and a distal end extending proximally from the distal end of the shaft (35) and terminating before the distal end of the balloon therapy means.

Abstract: An intravascular catheter system for implanting a radially expandable stent within a body vessel including a catheter comprising an inner lumen tube, an inflation lumen tube, an inflatable balloon and at least one free standing built-up layer affixed to the outer diameter of the inner lumen tube, the built-up layer being internal to the balloon. A stent is mounted coaxially upon the balloon, the built-up layer extends coaxially within the stent but does not extend beyond the proximal and distal ends of the stent. The built-up layer is sufficiently thick as to cause the balloon to expand evenly and the stent to deploy uniformly. The method of manufacturing the built-up layer includes forming the layer from shrink wrap tubing or alternatively forming the layer from molded ultraviolet light curing adhesive.

Abstract: The present invention is accomplished by providing a dilatation balloon catheter with a flexible tip comprising a catheter body having proximal and distal ends with an outer shaft defining an inflation lumen. The catheter body has a coaxial inner guidewire shaft defining a guidewire lumen. An inflatable balloon is mounted at the distal end of the catheter body, the balloon has an outer diameter, an inner diameter, a distal end and a proximal end. The proximal end of the balloon is in fluid communication with the distal end of the inflation lumen and the distal end of the balloon is sealingly mounted to the guidewire shaft. The guidewire shaft extends distal to the distal end of the balloon, the guidewire shaft has an outer diameter and a step down area. The guidewire shaft Step down area begins just proximal to the distal end of the balloon. The guidewire shaft step down area has an outer diameter which is less than the outer diameter of the guidewire shaft.

Abstract: A device for mounting a stent on a delivery system such as a balloon catheter and methods of making and using the device. Typically, the device includes an elongated, preferably transparent body having an axial aperture and two axial grooves in the outside surface. A stent is located in the axial aperture, preferably in a correspondingly configured recess. A sleeve of low friction, preferably transparent, material is situated inside the stent with the stent in tension on the sleeve. To mount the stent on the a balloon catheter or the like, the balloon is inserted into the sleeve with the balloon preferably in compression. The position of the balloon within the device is visible through the sleeve and body. The sleeve is pulled out of the aperture, then the body is split along the grooves and removed.

Abstract: The present invention is for a stent delivery guide catheter to be used in percutaneous transluminal coronary angioplasty (PTCA). The stent delivery guide catheter consists of a guide catheter body having proximal and distal ends with a cylindrical outer wall and a coaxial inner wall defining a inner lumen. A bladder is formed between the inner and outer walls and is in fluid communication with an inflation lumen. A radially expandable and compressible stent is located inside the guide catheter body and is removably attached to the inner wall in the area of the bladder. In use, a balloon catheter is slid inside the guide catheter with the balloon positioned under the stent. When the bladder is inflated, the stent is compressed radially inward and is deposited on the balloon catheter. The present invention can also be used without the stent to facilitate the exchange of an over-the-wire balloon catheter. The balloon catheter is pulled proximal to the inflatable bladder inside the guide catheter.

Abstract: A method of manufacture is disclosed for a PTCA guiding catheter. The catheter includes a lamination of an inner structural polymer tube, a lubricating means disposed on the inside of the inner structural polymer tube, a reinforcement means embedded at least partially within the inner structural polymer tube, and an outer structural polymer tube embedded at least partially within the reinforcement means and fused at least partially to the inner structural polymer tube.