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.

Abstract: A method apparatus for a radially expandable stent for implantation within a body vessel, comprising a first wire formed winding and a second wire formed winding. The first wire formed winding has a hollow cylindrical shape including a preformed pattern such as a sinusoidal wave form and being wound into a continuous helix the length of the stent. The second wire formed winding has a hollow cylindrical shape including a preformed pattern such as a sinusoidal wave form and being wound into a continuous helix the length of the stent. The second winding helix is opposite that of the first winding helix. The second winding has a greater inner diameter than the outer diameter of the first winding. The second winding is coaxial with the first winding, the pattern of the first winding symmetrically intersects with the pattern of the second winding to form a uniform series of crossings thereby permitting even expansion of the first and second windings.

Abstract: A catheter guidewire having an elongate core wire, an elongate tube defining a tube lumen, the proximal end of the tube being affixed to the distal end of the core wire. The tube has a smooth exterior surface and one or more plug segments filling the tube lumen, each plug segment having a stiffness less than that of the core wire and less than that of the proximally preceding plug segment. The proximal end of the proximal most plug segment is affixed to the distal end of the core wire, the distal end of the tube is affixed to the distal most plug segment. A smoothly rounded distal tip extends beyond and is affixed to the distal end of the tube. The tube may be formed of a super-elastic metallic member or formed from a synthetic resin. The tube wall thickness is preferably between 0.002 inches and 0.005 inches.

Abstract: The present invention is accomplished by providing a method and apparatus for a radially expandable stent for implantation within a body vessel, comprising a large wire formed winding segment and 2 small wire formed winding segments. The large wire formed winding segment has a hollow cylindrical shape including a preformed pattern such as a sinusoidal wave form being wound into a continuous helix the length of the stent. The second and third wire formed winding segments have a hollow cylindrical shape including a preformed pattern such as a sinusoidal wave form wound into a continuous helix. The uniform pattern of the first, second and third wire segments permit uniform expansion of the stent. The second and third winding segments have more wire per unit surface area than the first winding segment. The second winding segment proximal end is attached to the distal end of the second winding segment to form a ring. The second winding segment is attached to the proximal end of the first winding segment.

Abstract: The present invention is for a guided locking balloon protector (10) for a dilatation catheter balloon (30) which consists of a proximal cylindrical component (15) with a distal end and a proximal end and a distal cylindrical component (20) with a distal end and a proximal end. The proximal cylindrical component (15) has two longitudinally opposed raised ribs (55) defining a slot (60) and a inner diameter (40) that can slidably fit over the balloon (25). The distal cylindrical component (20) has a inner diameter (65) that can slidably fit over balloon (25) and a integral rib (75) extending proximally from the proximal end, the integral rib (75) is sized to fit in the slot (60) and is approximately the length of the proximal cylindrical component (15). Affixed to the proximal end of the integral rib (75) is a downwardly extending locking tab (80).

Abstract: The present invention is for a two piece balloon protector (5) which consists of an cylindrical tube (10) and an inner elastomeric member (15). The inner elastomeric member (15) has a outer diameter that is smaller than the inner diameter of cylindrical tube (10) and fits inside of the cylindrical tube (10). The proximal end of the inner elastomeric member (15) has a return flange (30) that fits around the proximal end of cylindrical tube (10). To install the balloon protector (5) over the dilatation catheter balloon (20), cylindrical tube (10) is held fixed while the inner elastomeric member (15) is pulled longitudinally at its distal end, thus stretching the material, decreasing the longitudinal cross-section and creating a larger inner diameter in inner elastomeric member (15).

Abstract: A system for exchanging a smaller guide catheter with a larger guide catheter without removal of the coronary guide wire during angioplasty. An extender guide catheter is connected to the end of the implanted guide catheter, such as with a connector member. A larger guide catheter is advanced over the extended and implanted guide catheters into the aorta and the latter guide catheters are removed.

Abstract: A catheter formed of an elongated shaft with a dilatation balloon at the distal end includes a guide wire lumen external to the balloon. The guidewire lumen extends from the distal tip of the catheter to a proximal port distal from the proximal end of the catheter. The shaft is formed of a proximal hypotube and a distal spring coil. In some embodiments, the wire lumen extends the full length of the catheter and includes apertures for drug delivery or perfusion. A core wire is included to enhance the pushability of the catheter and support the balloon.

Abstract: A catheter with a guidewire shaft (1) with a proximal end which is free to move, the proximal end of the catheter having either a dual lumen (14) embodiment or a single lumen (6) embodiment. The dual lumen (14) embodiment has a stiffening wire lumen (17) through which a stiffening wire (12) extends and an inflation lumen (16) which is in fluid communication with the balloon (3). The single lumen (6) embodiment has a stiffening wire lumen (21) through which the stiffening wire (20) extends with the stiffening wire (20) defining an inflation lumen (22) which is in fluid communication with the balloon (3). A method of changing the stiffness of the distal end of a catheter is disclosed including, placing a stiffening wire (12) in an inflation lumen (5) or placing a stiffening wire (20) in a stiffening wire lumen (21) and advancing the stiffening wire up to the proximal end of the balloon (3) and stopping when the desired level of stiffness is achieved.

Abstract: A therapeutic catheter and used in percutaneous transluminal coronary angioplasty with the catheter comprising a shaft (5) a soft tip assembly. The assembly consists of a transition tube (15), a soft tip tube (20), and plug tube (25). The assembly is surrounded by a shrink wrap means. An infrared source (45) is applied to the interface of the shaft (5) and transition tube (15) with the heat being propagated to the transition tube (15) and the soft tip tube (20). The transition tube (15) is formed of materials having a tensile strength of at least 150% of the materials comprising the soft tip tube (20).

Abstract: A guidewire extension assembly for use in angioplasty to facilitate exchanging a balloon dilitation catheter that includes a guidewire and an extension wire that are releasably connected thus avoiding the need to use a separated exchange wire. The proximal end of the guidewire and the distal end of the extension wire either have one or more slots or one or more keys and when joined together cream a guidewire extension system utilizing a keyed joint connection. The key, when inserted in the slot, is held in place by frictional engagement to connect the distal end of the extension wire to the proximal end of the guidewire. The keyed connection between the guidewire and the extension wire makes it simple to attach the wires together, transfers torsional forces between the wires without the fear of the wires coming apart or unscrewing and is readily disconnected/reconnected when required.

Abstract: A catheter comprising a soft tip segment (5), a transition segment (11), and a shaft segment (3). The soft tip segment (5) has at least two ungular sections (6, 7) removed from the proximal end. The distal end of the transition segment (11) is bonded to the proximal end of the soft tip (5) segment. The transition segment (11) is comprised of materials having substantially higher tensile strength than the soft tip (5) segment. The distal end of the shaft (3) is bonded to the proximal end of the transition segment (11). The distal end of the shaft (3) has at least two ungular sections (2, 4) removed.

Abstract: The present invention is accomplished by providing a catheter manifold (15) having a manifold catheter lumen (115) extending longitudinally therethrough plus a rotationally symmetrical, conically tapering, elastomeric distal seal (65) for gripping the catheter shaft (70), the proximal end of the distal seal (65) having a smaller diameter than the distal end, the distal end of the manifold catheter lumen (115) being conically tapered and sized for a friction fit with the distal seal (65) when the distal seal (65) is inserted into the distal end of the manifold catheter lumen (115), the distal seal (65) having a longitudinally extending distal seal catheter lumen (120).

Abstract: A system for inserting and exchanging a dilatation catheter (18) using a lockable guidewire (23) and a guide catheter (17). The locking mechanism is engaged when a hypotube (31) is retracted in the locking section (8) and exposes the radially expanding corewire (30) which locks the guidewire (23) in place in the guiding catheter (17). The guiding catheter (17) may have a modified catheter inner surface (13) lined with a means for frictional engagement with the radially expanding corewire (30). In one embodiment the guiding catheter (17) can be lined with a threaded means complementary to radially expanding corewire (30) helical coil for mechanically holding the lockable guidewire (23) in place. Once locked, the guidewire (23) remains fixed in relation to the lesion (20) during the exchange of a dilatation catheter (18).

Abstract: The present invention is accomplished by providing a catheter with a shaft having a balloon affixed to the distal end, a core wire extending throughout the shaft and throughout the balloon, the core wire having a tube surrounding the distal end, a sleeve defining a guidewire lumen extending parallel, and exterior to the shaft and to the exterior to the balloon. In yet another embodiment the catheter shaft has a balloon affixed to the distal end and a sleeve defining a guidewire lumen extending parallel and exterior to the shaft and to the balloon exterior. In yet another embodiment the catheter shaft has a balloon affixed to the distal end and a core wire extending throughout the shaft and throughout the balloon with the core wire having a tube surrounding the distal end. In each embodiment the balloon is compressed to itself to form a compressed area just distal to the distal balloon cone for separating the balloon inflation lumen from a sleeve lumen.

Abstract: A hollow, cylindrical protector for a dilatation catheter balloon. The disclosed protector is made from silicone tubing having a coating on at least an inner surface thereof for enhancing the lubricity of the protector and thus facilitating easy installation of the protector over a dilatation catheter's balloon. In this way, the risk of damage to the balloon resulting from protector installation is reduced. In the disclosed embodiment, the inner surface of a silicone balloon protector is coated via vacuum deposition or the like with parylene. The parylene-coated protector is then slid over a deflated and wrapped dilatation catheter balloon. The catheter is then subjected to elevated temperatures for the purposes of heat-setting. The elevated temperatures cause the silicone protector to be reduced in diameter, further reducing the balloon's profile. Also, the compression and heating causes the balloon material to heat-set, increasing the reliability of symmetrical deflation and re-wrap of the balloon.