Prolifix Medical, Inc.

Greg R Patterson

James J Leary

Ronald G Williams

David J Kupiecki

Kathy M Mah

G Ronald Williams

James D Passafaro

Timothy B McFann

Roger W Perkins

Joan Huynh

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.

Guidewire for positioning a catheter against a lumen wall

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. The methods comprise operating the stenotic material removal mechanism within a body vessel, typically a coronary artery or other artery, which has become restenosed or otherwise occluded following the initial stent placement, and sensing the proximity or contact between the stenotic material removal mechanism and the stent within the arterial wall so that the stenosis can be effectively recanalized without damaging the stent. The sensing means may be used to indicate an unsafe condition that might lead to stent damage, in response to which, the stenotic material removal mechanism may be manually or automatically deactivated. Alternatively or additionally, the sensing means may be used to indicate an appropriate endpoint for the stenotic material removal process.

Apparatus and method for controlled removal of stenotic material from stents

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. The stent may be operated manually to inhibit or remove ingrowth of stenotic material, for example by introducing a catheter which acts on the stent, or the stent may operate automatically to inhibit or remove ingrowth of stenotic material without manual intervention.

Vascular stent for reduction of restenosis

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.

Methods and systems for treating obstructions in a body lumen

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. The methods comprise operating the stenotic material removal mechanism within a body vessel, typically a coronary artery or other artery, which has become restenosed or otherwise occluded following the initial stent placement, and sensing the proximity or contact between the stenotic material removal mechanism and the stent within the arterial wall so that the stenosis can be effectively recanalized without damaging the stent. The sensing means may be used to indicate an unsafe condition that might lead to stent damage, in response to which, the stenotic material removal mechanism may be manually or automatically deactivated.

Apparatus and method for controlled removal of stenotic material from

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.

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Pleasanton, CA, United States of America

Greg R Patterson