Abstract: The present invention relates to: (1) guidewire support/placement catheters; (2) support/placement catheters with imaging; (3) atherectomy catheters, (4) atherectomy catheters with imaging, (5) occlusion crossing catheters, and (6) occlusion crossing catheters with imaging as well as methods for using them to treat disorders (and particularly peripheral artery disease) and systems including them.

Abstract: Marker levels and forms can be modulated in patients having vascular disease when sufficient vascular tissue is removed. The markers can be, e.g., from tissue, blood or lymph. The markers are typically involved in molecular pathways which are in turn modulated. Atherectomy catheters are used for accomplishing sufficient removal of vascular tissue to effect the modulations.

Abstract: A method of removing material from a blood flow lumen includes providing a device having a cutting element and an opening, the cutting element being movable relative to the opening. The method then includes advancing the device through a patient's vascular system to the blood flow lumen. Finally, the method involves moving the cutting element and the opening relative to the blood flow lumen so that a continuous piece of material is severed by the cutting element and directed into the opening as the cutting element and opening move through the blood flow lumen, the continuous piece of severed material being directed into the device for removal from the patient. The method may include providing a device having a rotatable cutter that, in some embodiments, is not parallel to the longitudinal axis of the device, is movable, has retracted and deployed positions, or any combination thereof.

Abstract: Methods of evaluating treatments for vascular disease are described. The treatments can include administration of pharmaceutical, chemical, or biological agents. Vascular tissue is removed from a first site in a vascular lumen and optionally analyzed. A treatment is administered to the patient, followed by removal of a second portion of vascular tissue from a second site. The vascular tissue from both the first and second site are compared to learn the effect of the treatment. Treatments can include placement of prosthetic devices such as stents in the lumen. Whether or not the vascular tissue recurs at a site after removal can be monitored as a measure of the success of a given treatment.

Abstract: Lumenectomy material is tested to determine the presence or likelihood of a condition of a patient. The lumenectomy material is in the form of at least one continuous tissue strand collected in vivo from an inner surface of a body lumen of the patient. The presence of at least one marker of a disease is determined. The disease may be hypertension, hyperlipidemia, depression, obesity, metabolic syndrome, insulin resistance, kidney damage, or diabetes. The patient is identified as having or as likely to develop the disease if a marker of the disease is identified in the lumenectomy material of the patient.

Abstract: Described herein are atherectomy catheters, systems and methods that include longitudinally displaceable drive shafts that drive actuation of one or more cutters at the distal end of the catheter. The catheters described herein may include one or more imaging sensors for imaging before, during or after cutting tissue. In some variations the imaging sensor may be rotated around the perimeter of the catheter independently of the rotation of the cutter. Also describe herein are imaging catheters that may be used without cutters.

Abstract: A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

Abstract: A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

Abstract: Marker levels and forms can be modulated in patients having vascular disease when sufficient vascular tissue is removed. The markers can be, e.g., from tissue, blood or lymph. The markers are typically involved in molecular pathways which are in turn modulated. Atherectomy catheters are used for accomplishing sufficient removal of vascular tissue to effect the modulations.

Abstract: The present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis. Methods of predicting restenosis in a stenosed peripheral artery may include quantitative histology of the vessel. For example, a method of treating a stenosed artery (and particularly a peripheral artery) may include the steps of determining a level of hypercellularity and one or more of the lipid-richness and extent of inflammatory cell inclusion in the tissue. An index of restenosis based on the hypercellularity and lipid richness and/or extent of inflammatory cell inclusion in the tissue may be determined. Systems for treating or preventing restenosis may include one or more imaging modalities for imaging tissue regions and determining the level of hypercellularity and one or more of the degree of lipid-richness and the extent of inflammatory cell inclusion in the tissue region.

Abstract: A debulking catheter comprising a tissue debulking assembly for removing a continuous strand of material from a body lumen. Catheters of the present invention generally include a catheter body having proximal and distal portions and a tissue debulking assembly disposed at least partially within the distal portion. The tissue debulking assembly is radially movable to expose at least a portion of the assembly through a window on the catheter body. The catheter is advanced transluminally through the body lumen to contact material in the body lumen and remove a plane of continuous material that has a length that is typically longer than a length of the window on the catheter. The continuous material may be directed into a collection chamber. Thereafter, the material may be removed from the collection chamber and preserved or tested.

Abstract: Lumenectomy material is tested to determine the presence or likelihood of a condition of a patient. The lumenectomy material is in the form of at least one continuous tissue strand collected in vivo from an inner surface of a body lumen of the patient. The presence of at least one marker of a disease is determined. The disease may be hypertension, hyperlipidemia, depression, obesity, metabolic syndrome, insulin resistance, kidney damage, or diabetes. The patient is identified as having or as likely to develop the disease if a marker of the disease is identified in the lumenectomy material of the patient.

Abstract: Lumenectomy material is tested to determine the efficacy of a test drug in a patient population having a cardiovascular condition. The material is removed from at least a first and a second patient and tested for one or more markers of a cardiovascular condition. The first patient is administered the test drug, and the second patient is administered a placebo. At a later date, more lumenectomy material is removed and tested for the same marker or markers. The presence, absence or amount of the markers is compared in the first patient receiving the drug and the second patient receiving the placebo to determine whether the drug is effective in the patient population. The drugs tested include drugs believed to be effective in treating a cardiovascular condition. The markers used can include any marker that can indicate the effectiveness of the drug being tested.

Abstract: Lumenectomy material is tested to determine the presence or likelihood of a condition of a patient. The lumenectomy material is in the form of at least one continuous tissue strand collected in vivo from an inner surface of a body lumen of the patient. The presence of at least one marker of a disease is determined. The disease may be hypertension, hyperlipidemia, depression, obesity, metabolic syndrome, insulin resistance, kidney damage, or diabetes. The patient is identified as having or as likely to develop the disease if a marker of the disease is identified in the lumenectomy material of the patient.

Abstract: A debulking catheter comprising a tissue debulking assembly for removing a continuous strand of material from a body lumen. Catheters of the present invention generally include a catheter body having proximal and distal portions and a tissue debulking assembly disposed at least partially within the distal portion. The tissue debulking assembly is radially movable to expose at least a portion of the assembly through a window on the catheter body. The catheter is advanced transluminally through the body lumen to contact material in the body lumen and remove a plane of continuous material that has a length that is typically longer than a length of the window on the catheter. The continuous material may be directed into a collection chamber. Thereafter, the material may be removed from the collection chamber and preserved or tested.

Abstract: Material removed by a debulking catheter from a body lumen can be preserved. Materials can be collected from many different patients and/or from multiple procedures on individual patients. Data which describe the properties or qualities of the removed material and/or the patient and/or the patient's family or environment can be stored on computer readable media. The stored data can be used to draw correlations, to stratify groups of patients, to provide risk assessments, to provide diagnoses and/or prognoses. Further tests can be done on the stored materials at later times after the procedures have been completed.

Abstract: A method of removing material from a blood flow lumen generally includes providing a device having a cutting element and an opening, advancing the device through the blood flow lumen to a site where material is to be removed, forcing the opening toward a wall of the site where material is to be removed, and moving the cutting element and the opening so that material in the blood flow lumen is cut by the cutting element and directed into the opening for removal as the cutting element and opening are moved through the blood flow lumen. In some embodiments, the device may be deflected or bent to force the opening toward a wall to remove material. The cutting element may be rotatable and may have an axis that is movable, that is not parallel to the longitudinal axis of the device, or both. In some embodiments, the cutting element is movable between retracted and deployed positions for advancing the device to a site for treatment and for removing material, respectively.

Abstract: Catheter-based Optical Coherence Tomography (OCT) systems utilizing an optical fiber that is positioned off-axis of the central longitudinal axis of the catheter have many advantage over catheter-based OCT systems, particularly those having centrally-positioned optical fibers or fibers that rotate independently of the elongate body of the catheter. An OCT system having an off-axis optical fiber for visualizing the inside of a body lumen may be rotated with the body of the elongate catheter, relative to a handle portion. The handle may include a fiber management pathway for the optical fiber that permits the off-axis optical fiber to rotate with the catheter body relative to the handle. The system may also include optical processing elements adapted to prepare and process the OCT image collected by the off-axis catheter systems described herein.

Abstract: Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Abstract: Described herein are catheters for use with Optical Coherence Tomography (OCT) that include an optical fiber core having a first refractive index and an interface medium having a second refractive index, where the first and second refractive indexes are mismatched such that receiving electronics configured to receive optical radiation reflected from the reference interface and the target operate in a total noise range that is within 5 dB of the shot noise limit. These OCT catheters may include a silicon die mirror having a reflective coating that is embedded in the interface medium. The optical fiber can be fixed at just the distal end of the catheter, and may be managed within a handle that is attached to the proximal end of the catheter body, and is configured to allow rotation of the both catheter body and the optical fiber relative to the handle.