Abstract: A low profile device for simultaneous angioplasty and occlusion includes an angioplasty balloon and an occlusion element which adjoin a common catheter. The occlusion element may be either self-expanding (in which case it is deployed with a sheath that surrounds the catheter) or non-self-expanding (in which case it is deployed with a pull wire that passes through the catheter). The angioplasty balloon is inflated with fluid that either passes through the catheter or a separate tube (or lumen) that adjoins the catheter.

Abstract: A balloon catheter having improved flexibility in and about its distal end is provided. The flexibility of the catheter is determined in part by improving the properties of a wire or catheter located within the area where the balloon is mounted. In one aspect of the present invention, connecting wires extend through the balloon from the distal end of a catheter body to the proximal end of a core wire. The core wire extends distally away from the connecting wires and the catheter body. In another aspect of the present invention, a core wire is provided having a proximal end extending within the balloon into the catheter tubular body but is not mounted therein. This allows the proximal end of the core wire to “float” within the tubular body, such that when the catheter is advanced through the vasculature of a patient, the core wire may move longitudinally within the tubular body.

Abstract: The present invention provides an improved core wire for use in a medical catheter. In one aspect, the invention provides a core wire with a shapeable tip and method of using the same. A core wire previously made superelastic is subject to additional processing to remove its superelasticity thereby allowing the material to be shapeable to aid in advancing the core wire through a blood vessel or other body cavities. In another aspect of the present invention, a method is provided for securing the core wire to the distal end of an elongated catheter tubular body. The tubular body is mechanically crimped onto the core wire to secure the core wire in place. This crimping method has been found to increase the strength of the bond between the core wire and the catheter tube so that greater pull force is required to break the core wire off from the catheter.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel in which an occlusive device is first delivered and activated at a site distal to the occlusion to at least partially occlude the vessel. A therapy catheter is then introduced to treat the occlusion and a debris removal device is delivered to aspirate debris from the vessel. The present invention eliminates the need for a separate irrigation catheter and irrigation fluid which allows the procedure to be performed quickly and efficiently, and is especially useful in the removal of occlusion from saphenous vein graft, the coronary and carotid arteries, arteries above the aortic arch and vessels of similar size and pressure.

Abstract: Aspiration catheters and methods for the treatment of an occlusion in a blood vessel. These catheters and methods are especially useful in the removal of occlusions from saphenous vein grafts, the coronary and carotid arteries, arteries above the aortic arch and even smaller vessels. The catheters of the present invention are provided in either over-the-wire or in single operator form. Radiopaque markers are preferably incorporated into distal ends of the catheters, and visual markers are incorporated into the proximal end of the catheters, to facilitate their positioning within the body. The catheters are provided with varying flexibility along the length of the shaft, such that they are soft and flexible enough to be navigated through the vasculature of a patient without causing damage, but are stiff enough to sustain the axial push required to position the catheter properly and to sustain the aspiration pressures.

Abstract: The present invention provides an apparatus for performing angioplasty or vascular intervention procedures. The apparatus of the present invention comprises a catheter apparatus comprised of a superelastic hollow guidewire, a balloon member and a flexible tip. The superelastic hollow guidewire of the invention is preferably a hypotube of nitinol alloy. The use of nitinol alloy as hollow guidewire provides a catheter apparatus having high flexibility and torqueability as well as small cross sectional diameter.

Abstract: The present invention provides an improved core wire for use in a medical catheter. In one aspect, the invention provides a core wire with a shapeable tip and method of manufacturing the same. A core wire previously made superelastic is subject to additional processing to remove its superelasticity thereby allowing the material to be shapeable to aid in advancing the core wire through a blood vessel or other body cavities. In another aspect of the present invention, a method is provided for securing the core wire to the distal end of an elongated catheter tubular body. The tubular body is mechanically crimped onto the core wire to secure the core wire in place. This crimping method has been found to increase the strength of the bond between the core wire and the catheter tube so that greater pull force is required to break the core wire off from the catheter.

Abstract: Disclosed herein is an improved core wire for use in a medical catheter. In one aspect, a tapering core wire is incorporated into the distal end of a catheter. The catheter has a tubular body. Both ends of an inflatable balloon are mounted to the tubular body. The core wire extends from the distal end of the tubular body. In one embodiment, substantially all of the taper of the core wire occurs in the extending portion of the core wire over a length of at least 15 mm but no more than 60 mm. In another aspect, a core wire with a shapeable tip and method of manufacturing the same are provided. A core wire previously made superelastic is subject to additional processing to remove its superelasticity thereby allowing the material to be shapeable to aid in advancing the core wire through a blood vessel or other body cavities. In another aspect of the present invention, a method is provided for securing the core wire to the distal end of an elongated catheter tubular body.

Abstract: Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Abstract: A radiation delivering catheter is positioned away from the walls of the vessel to be treated, e.g. at a stenosis site, so that the radiation flux impacting the walls is more uniform. In one embodiment, one or more balloons are used, and in another, one or more expandable structures. In other embodiments, a radiation source residing within a balloon is shielded from the vessel walls when the balloon is not inflated, but exposes the vessel walls to radiation when the balloon is inflated.

Abstract: Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port. Also disclosed herein is an inflation adaptor for moving the sealer portion within the catheter to establish or close the fluid pathway between the inflation port and the inflatable balloon.

Abstract: Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port. Also disclosed herein is an inflation adaptor for moving the sealer portion within the catheter to establish or close the fluid pathway between the inflation port and the inflatable balloon.

Abstract: Disclosed herein is a compliant catheter balloon with an improved elastic response and reduced longitudinal expansion, and a method of forming the same. The balloon comprises a SEBS block copolymer, which is longitudinally pre-stretched during the balloon manufacture process. In order to control the working length of a balloon on a catheter, at least one adhesive stop is provided on the catheter which prevents adhesive from wicking into the working length of the balloon. Preferably, a pair of thermoset tubings with an outer diameter size close to the size of the inner diameter of the balloon are inserted on the distal portion of the catheter. After the proper placement of the balloon, the adhesive is applied at the balloon's proximal and distal ends. As the adhesive wicks to the balloon, the thermoset tubings will eventually stop the adhesive to prevent further wicking of adhesive into the balloon's working length.

Abstract: A device for occluding a vessel employs one of a number of different expansion members joined to one or more elongate members. The expansion member may include a braid, one or more coils, ribs, a ribbon-like structure, a slotted tube, or a filter-like mesh. If the expansion member is enclosed by a suitable membrane, the device seals with the vessel wall to partially or completely occlude the vessel. A perforated membrane may be used to permit the perfusion of blood. The expansion member may be self-expanding, or it may be expanded by engaging it with one of the elongate members. Alternatively, the expansion member may be expanded by heating it.

Abstract: Several improvements are provided in the design of a catheter shaft to reduce costs and improve performance. In one aspect, a small notch is fabricated into a catheter tube by a nonlaser process such as electric discharge machining (EDM) or mechanical grinding. This notch in the catheter tube is necessary for fluid communication between the catheter lumen and a balloon or other element in communication with the tube. Use of a nonlaser process reduces the costs of fabrication while ensuring a high degree of structure integrity. In another aspect, a method is provided to produce a nonuniform polymer coating on a catheter shaft to reduce friction and to maintain a catheter with a low profile. In another aspect, the catheter is provided with a radiopaque marker which is more visible and is more effective at identifying the location of a balloon. The marker is moved closer to a distal balloon by placing it within an adhesive taper adjacent the balloon.

Abstract: Disclosed herein is a catheter for use in an emboli containment system. In one embodiment, the catheter has a tubular body with a metallic braid construction. Two lumen extend through the tubular body, the lumen being in a side-by-side configuration. One of the lumen functions as an inflation lumen, and is in fluid communication with an inflatable balloon mounted on the distal end of the catheter. The second lumen is adapted to receive other therapeutic catheters which comprise the emboli containment system.

Abstract: An integrated inflation/deflation device provides easy, precise delivery of a small amount of fluid for proper inflation of a low volume surgical balloon and similarly provides easy and fast deflation of the balloon. A preferred embodiment includes a low volume syringe and large syringe mounted together within a housing. A port in the low volume syringe is in communication with the large syringe barrel. The low volume syringe plunger is controlled by a knob disposed on the housing. The large syringe is used to prime the surgical balloon system, including a catheter, and the low volume syringe delivers a precise, predetermined volume of fluid to inflate the balloon. The low volume syringe is also used to deflate the balloon. Preferably, indicia on the housing adjacent the knob direct the required rotation of the knob to deliver the correct volume of fluid to be injected to match a balloon of a given size and shape so that the balloon is properly inflated.

Abstract: A low profile device for simultaneous angioplasty and occlusion includes an angioplasty balloon and an occlusion element which adjoin a common catheter. The occlusion element may be either self-expanding (in which case it is deployed with a sheath that surrounds the catheter) or non-self-expanding (in which case it is deployed with a pull wire that passes through the catheter). The angioplasty balloon is inflated with fluid that either passes through the catheter or a separate tube (or lumen) that adjoins the catheter.

Abstract: Several improvements are provided in the design of a catheter shaft to reduce costs and improve performance. In one aspect, a small notch is fabricated into a catheter tube by a nonlaser process such as electric discharge machining (EDM) or mechanical grinding. This notch in the catheter tube is necessary for fluid communication between the catheter lumen and a balloon or other element in communication with the tube. Use of a nonlaser process reduces the costs of fabrication while ensuring a high degree of structure integrity. In another aspect, a method is provided to produce a nonuniform polymer coating on a catheter shaft to reduce friction and to maintain a catheter with a low profile. In another aspect, the catheter is provided with a radiopaque marker which is more visible and is more effective at identifying the location of a balloon. The marker is moved closer to a distal balloon by placing it within an adhesive taper adjacent the balloon.

Abstract: The present invention provides an apparatus for performing angioplasty or vascular intervention procedures. The apparatus of the present invention comprises a catheter apparatus comprised of a superelastic hollow guidewire, a balloon member and a flexible tip. The superelastic hollow guidewire of the invention is preferably a hypotube of nitinol alloy. The use of nitinol alloy as hollow guidewire provides a catheter apparatus having high flexibility and torqueability as well as small cross sectional diameter.