Abstract: Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together.

Abstract: A medical device, such as a catheter, having an alternative design distal tip, and method of using and making the same. In some embodiments, the distal tip includes a flared portion that extends away from the longitudinal axis of the medical device, and in some cases can be folded back so as to be atraumatic to tissues when advancing through a body orifice.

Abstract: An intravascular device having a tubular shaft with an outer wall and an inner wall which divides the outer wall into two or more lumens. The shaft also includes one or more regions of modified flexibility extending longitudinally along the outer wall. Absent the regions of modified flexibility, the inner wall would create an imbalance of material and flexibility about the center axis of the shaft. The regions of modified flexibility are positioned to reduce any such imbalance, thereby providing more uniform flexibility. The regions of modified flexibility also provide for more uniform torque transmission, and thereby reduce whipping effects. The regions of modified flexibility may comprise one or more regions of decreased wall thickness in the outer wall, one or more spines extending longitudinally along the outer wall, or a combination thereof.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated.

Abstract: A guide wire, and a method for the manufacture thereof, having a core and a plastic jacket enclosing the core. The plastic jacket comprises a proximal portion formed of a first plastic material and a distal jacket portion formed of a second plastic material. The distal end of the proximal jacket portion and the proximal end of the distal jacket portion substantially abut each other and are of substantially equal outer diameters so as to form a smooth transition between the proximal and the distal jacket portions. According to another aspect, there is provided a guide wire with a selectively formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion with a hydrophilic coating and a proximal portion without a hydrophilic coating. According to another aspect, there is provided a guide wire having a formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion that is more radiopaque than a proximal portion.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated.

Abstract: A guide wire, and a method for the manufacture thereof, having a core and a plastic jacket enclosing the core. The plastic jacket comprises a proximal portion formed of a first plastic material and a distal jacket portion formed of a second plastic material. The distal end of the proximal jacket portion and the proximal end of the distal jacket portion substantially abut each other and are of substantially equal outer diameters so as to form a smooth transition between the proximal and the distal jacket portions. According to another aspect, there is provided a guide wire with a selectively formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion with a hydrophilic coating and a proximal portion without a hydrophilic coating. According to another aspect, there is provided a guide wire having a formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion that is more radiopaque than a proximal portion.

Abstract: A stent delivery system having one or more stent retaining sleeves. The at least one sleeve having at least one lubricant application port, the at least one lubricant application port defining an opening through the at least one sleeve. The opening constructed and arranged to allow a lubricious substance to pass through the at least one sleeve and at least partially coat a portion of the balloon and/or stent positioned thereunder.

Abstract: A guide wire, and a method for the manufacture thereof, having a core and a plastic jacket enclosing the core. The plastic jacket comprises a proximal portion formed of a first plastic material and a distal jacket portion formed of a second plastic material. The distal end of the proximal jacket portion and the proximal end of the distal jacket portion substantially abut each other and are of substantially equal outer diameters so as to form a smooth transition between the proximal and the distal jacket portions. According to another aspect, there is provided a guide wire with a selectively formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion with a hydrophilic coating and a proximal portion without a hydrophilic coating. According to another aspect, there is provided a guide wire having a formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion that is more radiopaque than a proximal portion.

Abstract: A catheter for use in angioplasty includes a shaft formed from an elongated metallic tube and has an inflatable balloon at its distal end. A plastic tube connects a distal end of the metallic tube to a proximal end of the balloon. The metallic and plastic tubes thus define a lumen for providing inflation pressure to the balloon. A metallic core member is attached to the metallic tube and extends distally therefrom through the plastic tube and balloon. The distal end of the balloon is sealably secured to the core member. A tip body is connected to the core member distally of the balloon, with a short guide wire lumen being defined on the tip body. The guide wire lumen is adapted to slidably receive a guide wire which then extends along the catheter exteriorly of the balloon.

Abstract: An improved expandable removal element (16) for an atherectomy device wherein the expandable removal element (16) is movable between an expanded position and a contracted position. In one embodiment of the present invention, a single drive shaft (92) is operatively connected to the distal end of the expandable material removal element (16) for rotating the removal element (16). A catheter (178) may surround a portion of the drive shaft (92). The catheter (178) is shiftable with respect to the drive shaft (92) for moving the material removal element between the expanded position and the contracted position. In another embodiment of the present invention, dual coaxial drive shafts are employed. The inner drive shaft (312) and the outer drive (314) are shiftable with respect to one another for moving the removal element (252) between the expanded position and the contracted position. The present invention also describes several embodiments for an improved removal element (252).

Abstract: An improved expandable removal element (16) for an atherectomy device wherein the expandable removal element (16) is movable between an expanded position and a contracted position. In one embodiment of the present invention, a single drive shaft (92) is operatively connected to the distal end of the expandable material removal element (16) for rotating the removal element (16). A catheter (178) may surround a portion of the drive shaft (92). The catheter (178) is shiftable with respect to the drive shaft (92) for moving the material removal element between the expanded position and the contracted position. In another embodiment of the present invention, dual coaxial drive shafts are employed. The inner drive shaft (312) and the outer drive (314) are shiftable with respect to one another for moving the removal element (252) between the expanded position and the contracted position. The present invention also describes several embodiments for an improved removal element (252).

Abstract: The present invention is a device and method for controlling longitudinal movement of a tube relative to a shaft slidably disposed within the tube, especially in the catheterization of a patient. An operative segment on the shaft cooperates with an ancillary tool to create a coupling force field between the shaft and the tool. The tube can then be moved over the shaft while the coupling force field operates through the tube to restrict the movement of the shaft. In a preferred embodiment, the shaft is a guide wire and the tube is a catheter with a lumen for slidably receiving the guide wire, while the coupling force field is created magnetically. In one embodiment, the operative segment is borne on a short guide wire extension which is selectively securable to a standard guide wire.

Abstract: A catheter for use in angioplasty includes a shaft formed from an elongated metallic tube and has an inflatable balloon at its distal end. A plastic tube connects a distal end of the metallic tube to a proximal end of the balloon. The metallic and plastic tubes thus define a lumen for providing inflation pressure to the balloon. A metallic core member is attached to the metallic tube and extends distally therefrom through the plastic tube and balloon. The distal end of the balloon is sealably secured to the core member. A tip body is connected to the core member distally of the balloon, with a short guide wire lumen being defined on the tip body. The guide wire lumen is adapted to slidably receive a guide wire which then extends along the catheter exteriorly of the balloon.

Abstract: The present invention is a device and method for controlling longitudinal movement of a tube relative to a shaft slidably disposed within the tube, especially in the catheterization of a patient. An operative segment on the shaft cooperates with an ancillary tool to create a coupling force field between the shaft and the tool. The tube can then be moved over the shaft while the coupling force field operates through the tube to restrict the movement of the shaft. In preferred embodiment, the shaft is a guide wire and the tube is a catheter with a lumen for slidably receiving the guide wire, while the coupling force field is created magnetically. In one embodiment, the operative segment is borne on a short guide wire extension which is selectively securable to a standard guide wire.

Abstract: An improved expandable removal element for an atherectomy device wherein the expandable removal element is movable between an expanded position and a contracted position. In one embodiment of the present invention, a single drive shaft is operatively connected to the distal end of the expandable material removal element for rotating the removal element. A catheter surrounds a portion of the drive shaft. The catheter is shiftable with respect to the drive shaft for moving the material removal element between the expanded position and the contracted position. In another embodiment of the present invention, dual coaxial drive shafts are employed. The inner drive shaft and the outer drive are shiftable with respect to one another for moving the removal element between the expanded position and the contracted position. The present invention also describes several embodiments for an improved removal element.

Abstract: An improved expandable removal element for an atherectomy device wherein the expandable removal element is movable between an expanded position and a contracted position. In one embodiment of the present invention, a drive shaft is operatively connected to the distal end of the expandable removal element for rotating the removal element. A catheter surrounds a portion of the drive shaft. The catheter is shiftable with respect to the drive shaft for moving the material removal element between the expanded position and the contracted position. In another embodiment of the present invention, dual coaxial drive shafts are employed. The inner drive shaft and the outer drive are shiftable with respect to one another for moving the removal element between the expanded position and the contracted position. The present invention also describes several embodiments of a removal element for increasing the durability and effectiveness of the removal element.

Abstract: An intravascular occlusion material removal device for removing vascular occlusion material in a vascular lumen comprises an expandable material removal element movable between an expanded position and a contracted position. The material removal element has a distal end and a proximal end. A drive shaft is operatively connected to the distal end of the expandable material removal element for rotating the removal element. A catheter surrounds a portion of the drive shaft. The catheter has a distal end for operatively variably contacting the proximal end of the material removal element such that the removal element is rotatable with respect to the catheter. The catheter is shiftable with respect to the drive shaft for moving the material removal element between the expanded position and the contracted position. A number of novel methods for removing vascular occlusion material are also provided.

Abstract: A guide wire, and a method for the manufacture thereof, having a core and a plastic jacket enclosing the core. The plastic jacket comprises a proximal portion formed of a first plastic material and a distal jacket portion formed of a second plastic material. The distal end of the proximal jacket portion and the proximal end of the distal jacket portion substantially abut each other and are of substantially equal outer diameters so as to form a smooth transition between the proximal and the distal jacket portions. According to another aspect, there is provided a guide wire with a selectively formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion with a hydrophilic coating and a proximal portion without a hydrophilic coating. According to another aspect, there is provided a guide wire having a formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion that is more radiopaque than a proximal portion.

Abstract: An improved guide for a medical insertion device includes a core, a jacket of hydrophobic polymer surrounding the core, and a mixture of hydrophobic and hydrophilic polymer coated onto the jacket. The hydrophobic polymer of the coating is the same as or compatible with the hydrophobic polymer of the jacket, resulting in improved bonding between the jacket and coating. The hydrophilic polymer of the coating provides a slippery surface which facilitates insertion of the device into a vein or other organ. The hydrophilic polymer has reduced tendency to leach or dissolve away, because it is ensnared with the hydrophobic polymer of the coating.