Abstract: A medical device for the treatment of a sinus opening includes a handle, a grooming sheath, a rail, a guide wire, a balloon catheter and a balloon catheter movement mechanism. The handle has a proximal end, a distal end and a longitudinal axis along the length of the handle. The grooming sheath has a distal end and a proximal end with the proximal end of the grooming sheath being attached to the distal end of the handle. The rail has a distal end and a proximal end and disposed partially within the grooming sheath to define an annular lumen is between the rail and the grooming sheath. The guide wire operatively extends from the distal end of the rail and the balloon catheter is disposed at least partially in the handle and annular lumen.

Abstract: A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism.

Abstract: A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism.

Abstract: A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism. The guide wire movement mechanism includes an integrated guide wire locking and rotation mechanism configured for rotation of the guide wire and for securely locking and unlocking the guide wire to the guide wire movement mechanism. The balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism.

Abstract: A medical device, and a system and packaged kit containing the medical device for the treatment of a sinus opening is described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and an irrigation lumen the proximal and. The shaft system has a proximal shaft section and a distal shaft section. An inflatable balloon is attached to the distal shaft section in a position that is proximal to said distal end. The irrigation tip is distal to the balloon on the distal shaft section and has a tip opening and one or more radially facing openings. A method for treating a sinus opening includes inserting a system that includes the medical device, a sinus guide catheter and a sinus guide element into a patient's anatomy, dilating the sinus opening and irrigating a target in the nasal anatomy.

Abstract: An apparatus and method for providing a co-extruded, tapered multi-layer shaft. A co-extruded, tapered multi-layer shaft may be fabricated by selecting a first material for the inner layer of the shaft and a second material for the outer layer of the shaft. The first and second materials are then co-extruded by a co-extrusion system including a puller with programmable tapering capabilities. The system forms a hollow tubing having an inner layer and an outer layer, wherein the tubing has the desired tapered characteristics. The result is a tapered tubular shaft having an inner layer and an outer layer.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

Abstract: An apparatus and method for providing a co-extruded, tapered multi-layer shaft. A co-extruded, tapered multi-layer shaft may be fabricated by selecting a first material for the inner layer of the shaft and a second material for the outer layer of the shaft. The first and second materials are then co-extruded by a co-extrusion system including a puller with programmable tapering capabilities. The system forms a hollow tubing having an inner layer and an outer layer, wherein the tubing has the desired tapered characteristics. The result is a tapered tubular shaft having an inner layer and an outer layer.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section. Dual lumen and concentric distal shaft sections are describes.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

Abstract: A perfusion dilatation catheter is disclosed which has an improved distal catheter shaft portion with a tubular member extending within the balloon provided with an expanded coil support incorporated within the wall of the tubular member. The coil is preferably closer to the inner surface than the outer surface of the tubular member. Also disclosed are improved catheter shaft sections in a perfusion portion proximal to the balloon, one with a reinforced inflation tube depending into the guidewire lumen and another having three separate lumens, a central guidewire lumen and a pair of inflation lumens on opposing sides of the tubular structure defining the guidewire lumen.

Abstract: A method and system for maintaining the position of a guiding member, such as a guidewire, within a patient's vascular system, particularly within a guiding catheter disposed within the patient's vascular system, while an intravascular catheter slidably mounted on the guiding member is withdrawn and a replacement catheter is advanced over the guiding member. One presently preferred embodiment includes a guiding sheath having an inner lumen extending the length thereof with an engaging device slidably disposed with the guiding sheath. The guidewire engaging device is torqued from its proximal end which extends out of the proximal end of the guiding catheter so that the flexible distal end wraps around the guidewire tightly enough to maintain the position of the guidewire while withdrawing or advancing a catheter over the guidewire. The distal portion of the guidewire engaging device is preferably a pseudoelastic NiTi alloy which is in a stable austenite phase at body temperature (37.degree. C.

Abstract: A method and system for maintaining the position of a guiding member, such as a guidewire, within a patient's vascular system, particularly within a guiding catheter disposed within the patient's vascular system, while an intravascular catheter slidably mounted on the guiding member is withdrawn and a replacement catheter is advanced over the guiding member. One presently preferred embodiment includes a guiding sheath having an inner lumen extending the length thereof with an engaging device slidably disposed with the guiding sheath. The guidewire engaging device is torqued from its proximal end which extends out of the proximal end of the guiding catheter so that the flexible distal end wraps around the guidewire tightly enough to maintain the position of the guidewire while withdrawing or advancing a catheter over the guidewire. The distal portion of the guidewire engaging device is preferably a pseudo elastic NiTi alloy which is in a stable austenite phase at body temperature (37.degree. C.