Abstract: The present invention relates to a guidewire having a shaped three dimensional guide section. In the preferred embodiment the guide section is helical, and exerts an outward radial force on a lumen the guidewire is constrained in. The outward radial force can be measured or calculated according to methods of the present invention. Also described is a system comprising a guidewire and catheter where the force of the catheter exerts on a body lumen can also be calculated. Apparatus and methods of making the guidewire are also disclosed, as well as alternative embodiments of the guidewire.

Abstract: The present invention comprises a guidewire having a compressible guide section capable of deflecting a catheter to abut a lumen wall. The compressible guide section exerts an outward radial force while it is at least partially compressed within a lumen. The guide section permits a physician to precisely locate a catheter within a body lumen and adjust a catheter tip orientation to be directed to a particular side of a body lumen. A method is disclosed for properly matching a guidewire and a catheter to operate together in the present invention, along with a force measuring instrument to assist in measuring a catheter's resistance force value. This method and systems of the present invention involve determining the exact force relationship between the compressible guide section and the resistance of the catheter in vitro.

Abstract: The present invention relates to a guidewire having a shaped three dimensional guide section. In the preferred embodiment the guide section is helical, and exerts an outward radial force on a lumen the guidewire is constrained in. The outward radial force can be measured or calculated according to methods of the present invention. Also described is a system comprising a guidewire and catheter where the force the catheter exerts on a body lumen can also be calculated. Apparatus and methods of making the guidewire are also disclosed, as well as alternative embodiments of the guidewire.

Abstract: Apparatus and methods for treating in-stent restenosis are described for removing stenotic material from within previously stented regions of a patient's vasculature. The apparatus includes a catheter system having a stenotic material removal mechanism mounted on a distal portion of an elongated inner catheter. A sensing means, such as one or more sensing electrodes, are positioned on an outer surface of the apparatus. In addition, the apparatus optionally includes control means for diametrically expanding the stenotic material removal mechanism for effective recanalization of the stent. A coaxial outer catheter is provided for aspirating stenotic material which is removed from within the stent. In addition, embolic filter apparatus are described for collecting the stenotic material removed from within the stent.

Abstract: Apparatus and methods are provided for restoring and maintaining an open passage or lumen in a body conduit, such as a blood vessel, which has become stenosed or occluded. The apparatus includes a stent which is specially adapted for inhibiting restenosis within the stent after implantation in a body passage. In various embodiments, the apparatus also includes a catheter or other device for operating the stent to inhibit restenosis within the stented region of the body passage. The methods presented include implanting the stent within a body passage, typically a blood vessel such as a coronary artery, which has become stenosed or occluded, and operating the stent to inhibit ingrowth of stenotic material which would result in restenosis of the stented region.

Abstract: A system is provided having a catheter, a torque member extending longitudinally through a lumen of the catheter, a removal mechanism secured to a distal end of the torque member, and a guidewire having a guide section that extends through a lumen of the removal mechanism. The guide section defines a curved profile that is diametrically larger than the dimension of the removal mechanism. The guide section of the guidewire is adapted to be positioned inside a passageway of the occluding material, and provides a curved path along which the removal mechanism can be advanced inside the passageway of the occluding material to separate and remove occluding material.

Abstract: An apparatus and method of making a guidewire with a preformed three dimensional profile is described. The Apparatus comprises a mandrel having a screw thread for receiving a core wire and at least one securing means for holding the core wire onto the mandrel. The core wire must be retained under tension in order to properly impart the desired shape into the core wire. A system and method of using the apparatus is disclosed comprising the steps of loading the core wire onto the mandrel, securing the core wire and mandrel and then heating the assembly until the wire takes the desired shape.

Abstract: Apparatus and methods for treating in-stent restenosis are described for removing stenotic material from within previously stented regions of a patient's vasculature. The apparatus includes a catheter system having a stenotic material removal mechanism mounted on a distal portion of an elongated inner catheter. A sensing means, such as one or more sensing electrodes, are positioned on an outer surface of the apparatus. In addition, the apparatus optionally includes control means for diametrically expanding the stenotic material removal mechanism for effective recanalization of the stent. A coaxial outer catheter is provided for aspirating stenotic material which is removed from within the stent. In addition, embolic filter apparatus are described for collecting the stenotic material removed from within the stent.

Abstract: Apparatus and methods are provided for recanalizing stented regions within the vasculature which have become restenosed. A shearing body is displaced within the stented region in order to dislodge the stenotic material from an interface envelope defined by the inner surface of the stent. Usually, the shearing body will be compliant and sized slightly larger than the stent in order to remove stenotic material substantially uniformly around the entire interface envelope. The shearing body may be in the form of a brush, helical row, spaced-apart disks, solid compressible body, or a variety of other specific configurations.

Abstract: Apparatus and methods are provided for recanalizing stented regions within the vasculature which have become restenosed. A shearing body is displaced within the stented region in order to dislodge the stenotic material from an interface envelope defined by the inner surface of the stent. Usually, the shearing body will be compliant and sized slightly larger than the stent in order to remove stenotic material substantially uniformly around the entire interface envelope. The shearing body may be in the form of a brush, helical row, spaced-apart disks, solid compressible body, or a variety of other specific configurations.