Devices, systems, and methods for performing atherectomy including delivery of a bioactive material
Devices, systems, and methods are employed to perform an atherectomy in an identified region to restore patency to arterial lesions. A bioactive material is introduced into the identified region before, after or during performing the atherectomy. The bioactive material can be introduced, e.g., on a balloon coated with the bioactive material, which is expanded in contact with the identified region to deliver the bioactive material. The bioactive material can be, e.g., at least one of a restenosis-inhibiting agent, a thrombus-inhibiting agent, and an anti-inflammatory agent.
1 . A method of treating a region of a blood vessel comprising:
identifying for treatment a region of a blood vessel having an occlusive material,
deploying into the identified region a vascular device comprising a catheter body having at its distal end a cutter assembly comprising a housing having at least one opening and a cutter having at least one helical cutting surface configured to rotate about the central axis relative to the housing to cut and convey occlusive material from the identified region proximally into the housing, a drive mechanism at a proximal end of the catheter body, a torque shaft coupled to the drive mechanism and extending through the catheter body and coupled to the cutter to rotate the helical cutting blade about the center axis relative to the housing, and a conveyor mechanism helically wound about the torque shaft in a direction common with the helical cutting blade to rotate and thereby convey the occlusive material conveyed into the housing by the helical cutting blade further proximally along the catheter body for discharge without supplement of a vacuum pump,
performing an atherectomy in the identified region by operating the drive mechanism to rotate the helical cutting surface to cut and convey occlusive material from the identified region proximally into the housing, the drive mechanism also operating to rotate the conveyor mechanism to convey the occlusive material further proximally along the catheter body for discharge without supplement of a vacuum pump, and
introducing into the identified region a bioactive material before, after or during performing the atherectomy in the identified region.
2 . A method of treating a region of a blood vessel comprising:
identifying for treatment a region of a blood vessel having an occlusive material,
deploying into the identified region a vascular device comprising a catheter body having at its distal end a cutter assembly comprising a housing having at least one opening and a cutter having at least one helical cutting surface configured to rotate about the central axis relative to the housing to cut and convey occlusive material from the identified region proximally into the housing, a drive mechanism at a proximal end of the catheter body, and a deflecting mechanism at the proximal end of the catheter body for deflecting the distal end of the catheter body relative to a center axis of the catheter body,
performing an atherectomy in the identified region by operating the drive mechanism to rotate the helical cutting surface to cut and convey occlusive material from the identified region proximally into the housing, and deflecting the distal end of the catheter body relative to a center axis of the catheter body, and rotating the distal end of the catheter body while the distal end is deflected to sweep the cutter assembly in an arc about the center axis to cut the occlusive material in a region larger than an outside diameter of the cutter assembly, and
introducing into the identified region a bioactive material before, after or during performing the atherectomy in the identified region.
3 . A method according to claim 1 or 2
wherein introducing into the identified region a bioactive material comprises introducing at least one of a restenosis-inhibiting agent, a thrombus-inhibiting agent, and an anti-inflammatory agent.
4 . A method according to claim 1 or 2
wherein introducing into the identified region a bioactive material comprises introducing into the identified region a balloon coated with a bioactive material, and
expanding the balloon in contact with the identified region to deliver the bioactive material.
5 . A method according to claim 1 or 2 and further including
visualizing the identified region before, during, and after performing the atherectomy.
6 . A method according to claim 1 or 2 and further including
after conveying at least some of the occlusive material from the identified region, placing a stent structure in the identified region.
7 . A method according to claim 6 and further including
after placing the stent structure, performing an atherectomy to remove residual occlusive material from the stent structure.
8 . A method according to claim 6 and further including
after placing the stent structure, introducing into the stent structure a bioactive material.
9 . A method according to claim 6 and further including
after placing the stent structure, introducing into the stent structure a bioactive material comprising at least one of a restenosis-inhibiting agent, a thrombus-inhibiting agent, and an anti-inflammatory agent.
10 . A method according to claim 1 or 2
wherein the blood vessel is a peripheral blood vessel.
11 . A method according to claim 1 or 2
wherein the blood vessel is a peripheral blood vessel in a leg.
12 . A method according to claim 1 or 2
wherein the blood vessel is a peripheral blood vessel in a leg below a knee.