Abstract: An intravascular medical catheter and method of manufacturing a medical catheter are provided herein. The medical catheter includes a catheter shaft having an inner liner, a reinforcing section and an outer shell. As provided herein, a groove is formed in the outer shell of the catheter shaft near a distal end of the catheter shaft with a laser. The groove can be filled with a fill section which is made of a relatively soft material. This improves the flexibility of the distal end so that the medical catheter has improved tracking and movement in the body vessel. Further, because the reinforcing section is continuous under the groove, the catheter shaft is durable and inhibits kinking during movement in the body vessel.

Abstract: An intravascular catheter system and method of manufacture for implanting a radially expandable stent within a body vessel. The catheter system includes a shaft defining an inflation lumen in fluid communication with a balloon on the distal end of the shaft. A stent is mounted coaxially upon a balloon. The balloon has ridges impressed in the outline of the stent for at least a portion of the stent. The ridges are sized to receive the stent so as to cause the balloon to expand evenly and the stent to deploy uniformly. In an alternative embodiment the balloon may additionally have a polymeric surface layer exhibiting a higher coefficient of friction than the underlying material against the stent material. The surface layer may be provided as a high friction polymeric coating on a formed balloon or as a coaxial extrusion of a high friction polymeric material over the underlying balloon tubing material.

Abstract: An expandable percutaneous introducer sheath is disclosed which can be selectively enlarged to accommodate a range of sizes of interventional devices. The introducer sheath can retain an enlarged size without requiring an additional support member. The introducer sheath comprises an outer tube which contains expandable gaps along the length of the outer tube, expandable leaflets which are connected to the outer tube, an inner tubular member which is insertable into the outer tube, and a detent means to retain the enlarged size of the outer tube. The outer tube has a cross-sectional profile which is both kink resistant and minimizes the size of the puncture wound in the vasculature by providing a helix in the outer tube. An inner tubular member is inserted into the lumen of the outer tube and, because of the interference fit of the lumen outer tube to the outer diameter of the inner tubular member, the lumen of the outer tube enlarges at the expandable gaps.

Abstract: An apparatus and method of making a thinwall guide catheter useful in delivery of therapeutic devices through a body vessel. The method comprises braiding a flat wire over the surface of a cylindrical core, placing a heat bondable polymer tube over the braid, surrounding the polymer tube with a heat shrink sleeve, heating the assembly to a temperature and for a time period sufficient to expand the core into braid interstices and bond the polymer tube to substantially only the outer surface of the braid and finally removing the heat shrink sleeve and core. The resulting guide catheter has approximately half the wall thickness of prior guide catheters and has excellent column stiffness and kink resistance.

Abstract: An intravascular medical catheter and method of manufacturing a medical catheter are provided herein. The medical catheter includes a guidewire shaft, a sleeve, and a balloon. The sleeve is attached to the guidewire shaft while a distal tail of the balloon is thermally bonded to the sleeve. Because of the sleeve, the distal tail of the balloon can be thermally bonded even if the guidewire shaft is made of a material which is thermally incompatible with the balloon. Thus, for example, a medical catheter can be made with an HDPE guidewire shaft and a balloon made of PEBA, PET, Polyurethane, or Nylon. The resulting medical catheter has a catheter tip which is durable, flexible, and has a relatively low profile for good tracking in the body vessel and good lesion crossing.

Abstract: A medical catheter comprising a distal shaft having a greater flexibility than the proximal shaft. The proximal shaft has a helical end portion of reduced outer diameter which is integral with and extending from the distal end of the proximal shaft. The helical end portion slidingly fits within a portion of the proximal end of the distal shaft. The helical end portion is bonded to at least a portion of the distal shaft to form a fluid-tight seal. The pitch of the helical end portion may be constant or variable. The helical turns may be abutting or spaced apart. A guidewire shaft centrally extends longitudinally through the proximal and distal shaft such that fluid can be transmitted through the proximal and distal shaft, exterior to the guidewire shaft.

Abstract: Crimping sleeves, devices and methods of crimping stents onto delivery devices are disclosed. The stent is located within a channel formed by a crimping sleeve including a set of crimping elements located about the channel. The crimping elements are connected by rotatable links such that compressing at least two opposing crimping elements together results in a reduction in the diameter of the channel and crimping of a stent located therein on a delivery device located therein.

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: An apparatus for centering a radiation delivery device at a selected location in a body vessel such as a coronary artery. An elongated catheter is insertable into the body vessel until the catheter head is in the desired position. The catheter has a guidewire lumen, inflation lumen and treatment lumen running lengthwise. The catheter head includes an expandable mechanism for engaging the vessel internal wall with the treatment lumen centered in the vessel. At least one channel is provided extending past the expandable mechanism so that a fluid, such as blood, can perfuse past the catheter head. A radiation delivery device, such as a wire having a radiation source at the distal end can be inserted into the treatment lumen to uniformly irradiate the vessel wall at the selected location.

Abstract: Radially-expandable stents are provided with improved longitudinal flexibility and stability, improved torsional flexibility and stability, improved trackability and conformability, and improved hoop strength. The stents combine the advantages typically associated with wire stents with those typically associated longitudinal stability.

Abstract: A guidewire for use in a catheter comprising a unitary core wire, a distal tip and an elongate tube. The core wire has a body segment and a transition segment, the body segment being of substantially uniform outer diameter with a distal end serially disposed proximal to the transition segment proximal end, the transition segment being more flexible than the body segment, and progressively reduced in cross-section from the body segment. The smoothly rounded distal tip is affixed to the distal end of the transition segment. The elongate tube defines a tube lumen, the core wire transition segment extends longitudinally through the tube, the tube having a uniform outer diameter equal to the outer diameter of the body segment, the proximal end of the tube being affixed to the proximal end of the transition segment, the distal end of the tube being affixed to the distal tip. 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.

Abstract: A method and apparatus for a radially expandable stent for implantation within a body vessel, comprising a first and second wire having a series of alternating peaks and valleys. The valleys of the first wire are braided with the peaks of the second wire forming a braided region with the interwoven first and second wire being wound into a continuous helix having a hollow cylindrical shape. The peaks of the first wire of the continuous helix may be welded to the adjacent valleys of the second wire of the continuous helix. The peaks and valleys of the first wire may symmetrically intersect with the peaks and valleys of the second wire to form a uniform series of crossings thereby permitting even expansion of the first and second wires. The proximal end of the first wire may be attached to the proximal end of the second wire. The distal end of the first wire may be attached to the distal end of the second wire.

Abstract: An intravascular catheter system and method of manufacture for implanting a radially expandable stent within a body vessel. The catheter system comprises a shaft defining an inflation lumen in fluid communication with a balloon on the distal end of the shaft. A stent is mounted coaxially upon a balloon. The balloon has ridges impressed in the outline of the stent for at least a portion of the stent. The ridges are sized to receive the stent so as to cause the balloon to expand evenly and the stent to deploy uniformly. In an alternative embodiment the balloon may additionally have a polymeric surface layer exhibiting a higher coefficient of friction than the underlying material against the stent material. The surface layer may be provided as a high friction polymeric coating on a formed balloon or as a coaxial extrusion of a high friction polymeric material over the underlying balloon tubing material.

Abstract: A medical device for use in supporting a luminal surface of a human or animal body comprising a catheter, a stent mounted on the distal end of the catheter, the stent comprising a hollow cylindrical first wire segment and a hollow cylindrical second wire segment, and a means on the catheter for releasing the stent in the expanded diameter from the catheter. The first wire segment forms a plurality of spaced-apart first wire segment elements each extending 360 degrees around the hollow cylinder, each of the first wire segment elements having a plurality of extendible portions which permit the first wire segment elements to be expanded from the unexpanded diameter to a second, expanded diameter, the first wire segment proximal end having a straight tail extending proximally and longitudinally therefrom.

Abstract: A method and apparatus for forming perfusion balloons from thermoplastic materials. A helical member having a cross section corresponding to a desired perfusion channel cross section is placed in a tubular mold in contact with the mold wall. A thermoplastic tube is inserted into the helical member in the mold. The assembly is heated to the glass transition temperature of the tube and the tube is pressurized to expand into contact with the helical member and mold wall. After cooling, the formed balloon is removed from the mold. The helical member has a "T" shaped, or rectangular, or square, or triangular cross section. Limited pre-pressure and pre-stretch are preferably applied prior to the tube expansion and post forming tube conditioning may be used. Axial stretching of the tube in a mold, with our without the helical member, by microprocessor controlled air actuators provides highest quality balloons having selected wall thicknesses.

Abstract: A radial guiding catheter comprising a first straight leg connected to a first curve. The first curve has an angle such that the first curve can be disposed just proximal to the coronary ostium. The first curve is connected to a second straight leg. The second straight leg is connected to a second curve such that the second curve can be disposed within the aortic valve. The second curve has a direction opposite the first curve. The second curve is connected to a third straight leg. The distance between the second straight leg and the third straight leg is sufficient to cause the distal end of the first straight leg to engage the left coronary artery. The third straight leg is connected to a third curve, the third curve having a direction opposite the second curve such that the third curve is disposed along the ridge of the brachial artery.

Abstract: A medical catheter comprising a catheter shaft defining an inflation lumen and a guidewire shaft defining a guidewire lumen. The guidewire shaft is coaxial with the catheter shaft and runs longitudinally through the catheter shaft extending distally beyond the distal end of the catheter shaft. The catheter has an inflatable balloon having a proximal tail and a distal tail. The proximal tail is mounted at the distal end of the catheter shaft, the distal tail is mounted on the guidewire shaft. The balloon is in fluid communication with the inflation lumen. A distal stopper is sealingly affixed between the outer diameter of the guidewire shaft and the inner diameter of the distal tail. A proximal stopper is sealingly affixed between the outer diameter of the catheter shaft and the inner diameter of the proximal tail. The distal and proximal stopper are annular in shape and are in length shorter than the balloon tail and are of uniform circumferential thickness.

Abstract: A balloon for use in a catheter, wherein the balloon is formed from an aromatic polyester, preferably a blend of a major component comprising an aromatic polyester, and a minor component comprising a compatible secondary thermoplastic semicrystalline polymer having a crystallinity less than that of the aromatic polyester of the major component.

Abstract: The present invention is for a guide wire comprising a core wire with a first diameter and the distal end having at least one section having a second, lesser diameter and a radiolucent coil surrounding the distal end at the second core wire diameter with a radiopaque wire located at the distal end within the radiolucent coil and a means for securing the radiopaque wire to the core wire.