Abstract: Apparatus and methods are described for effective removal of emboli or harmful fluids during therapeutic and diagnostic vascular procedures, such as angiography, balloon angioplasty, stent deployment, laser angioplasty, atherectomy, and intravascular ultrasonography. A catheter with an occluder mounted at its distal end creates an occlusion proximal to the lesion and provides a pathway for introducing a treatment catheter. Prior to, during or subsequent to the procedure, suction is activated to establish retrograde flow to remove emboli from the site. Additionally, a thin catheter with a distal fluid ejection nozzle may be introduced distal to the treatment site to rinse emboli from the treatment site. The suction flow and/or ejected fluid flow may be varied in a pulsatile manner to simulate regular blood flow and/or perturb settled emboli into being captured that may otherwise not be collected. The method establishes a protective environment before any devices enter the treatment site.

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: A debulking catheter comprising a debulking assembly for debulking a body lumen. The catheters of the present invention can include a flexible proximal portion coupled to a rigid distal portion. A tissue debulking assembly can be disposed within the rigid portion to debulk the body lumen. In exemplary embodiments, the rigid portion is rotatably coupled to the flexible portion such that rotation or deflection of the rigid portion, relative to the flexible portion, can expose the tissue debulking assembly through a window in the catheter to debulk the body lumen.

Abstract: An atherectomy catheter is provided for excising and imaging material in a body lumen. In one embodiment, the catheter comprises a catheter body, a cutting blade, and an imaging device. The cutting blade is mounted on the catheter body and configured to move between a first position and a second position relative to an aperture or cutting window. When the cutting blade is in the second position, the blade substantially closes the aperture on the catheter body. The imaging device which is mounted on or otherwise coupled to the cutting blade is configured to be in an imaging position when the cutting blade substantially closes the aperture or cutter window. This allows the imaging device to survey material within the cutting zone of the atherectomy catheter. By allowing the imaging device to view materials within this cutting zone, material may be imaged and then removed from the body lumen without having to reposition the catheter between each step.

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 patient population can comprise as little as two individuals or as many as dozens, hundreds or thousands of patients. The drugs tested include drugs believed to be effective in treating a cardiovascular condition.

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: 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: A catheter is provided, which includes a cutting element having one or more raised elements. The cutting element has a cup-shaped surface at the distal end that may be smooth and continuous except for the raised elements.

Abstract: Catheters, kits, and methods are provided for removing material from a body lumen. The catheters and methods may be used in a variety of body lumens, including but not limited to coronary and other arteries. In general, the catheter has a cutting element that cuts material while the material is engaged by a material capture device on the catheter body. Preferably, the material capture device tensions the material during cutting, which reduces the amount of cutting force required. The material capture device typically follows a path that draws material into the catheter body. Preferably, but not necessarily, the material capture device may be arranged on the catheter body to advance along a path outwardly from the catheter body into the material and then inwardly towards the catheter body to tension the material. The cutting element on the catheter body moves between a first position and a second position to cut the material while in tension.

Abstract: The control of fluid introduction into and out of body conduits such as vessels, is of great concern in medicine. As the development of more particular treatments to vessels and organs continues it is apparent that controlled introduction and removal of fluids is necessary. Fluid delivery and removal from such sites, usually referred to as irrigation and aspiration, using fluid exchange devices that control also need to be considerate of potential volume and/or pressure in the vessel or organ are described together with catheter and lumen configurations to achieve the fluid exchange. The devices include several electrically or mechanically controlled embodiments and produce both controlled and localized flow with defined volume exchange ratios for fluid management. The applications in medicine include diagnostic, therapeutic, imaging, and uses for the introduction or removal of concentrations of emboli within body cavities.

Abstract: A tissue cutting device includes a sizing element which detects the diameter of the vessel in which the cutting device is positioned. The sizing element is coupled to the cutting element so that the amount of the cutting element that is exposed varies in response to movement of the sizing element.

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 patient population can comprise as little as two individuals or as many as dozens, hundreds or thousands of patients. The drugs tested include drugs believed to be effective in treating a cardiovascular condition.

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 tissue cutting device includes a sizing element which detects the diameter of the vessel in which the cutting device is positioned. The sizing element is coupled to the cutting element so that the amount of the cutting element that is exposed varies in response to movement of the sizing element.

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: 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: 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: An atherectomy catheter is provided for excising and imaging material in a body lumen. In one embodiment, the catheter comprises a catheter body, a cutting blade, and an imaging device. The cutting blade is mounted on the catheter body and configured to move between a first position and a second position relative to an aperture or cutting window. When the cutting blade is in the second position, the blade substantially closes the aperture on the catheter body. The imaging device which is mounted on or otherwise coupled to the cutting blade is configured to be in an imaging position when the cutting blade substantially closes the aperture or cutter window. This allows the imaging device to survey material within the cutting zone of the atherectomy catheter. By allowing the imaging device to view materials within this cutting zone, material may be imaged and then removed from the body lumen without having to reposition the catheter between each step.