Devices, systems, and methods for debulking restenosis of a blood vessel

• US 20110152906A1
• Filed: 02/24/2011
• Published: 06/23/2011
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Inventors: Chee, Uriel Hiram, To, John T., Danek, Christopher James, Hann, Brenda, Escudero, Paul Quentin, Pombo, August Christopher, Smith, Torrey
• Granted Patent: US 10,226,275 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils

Abstract

Devices, systems, and methods are employed to restore patency to arterial lesions, e.g., by debulking restenosis in a blood vessel or within a stent or coil.

Claims

1. A method for debulking restenosis of a blood vessel comprising:

identifying a region of restenoisis of a blood vessel,

deploying into the 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 tissue from the restenosis 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 tissue from the restenosis further proximally along the catheter body for discharge without supplement of a vacuum pump,

operating the drive mechanism to rotate the helical cutting surface to debulk the restenois by cutting and conveying tissue from the restenosis proximally into the housing, and

operating the drive mechanism to rotate the conveyor mechanism to convey the tissue from the restenosis further proximally along the catheter body for discharge without supplement of a vacuum pump.

3. A method according to claim 1 or 2

wherein at least a portion of the region of restenosis is within a stent structure.

4. A method according to claim 1 or 2 and further including

introducing into the region a bioactive material.

5. A method according to claim 1 or 2 and further including

introducing into the region a bioactive material comprising at least one of a restenosis-inhibiting agent, a thrombus-inhibiting agent, and an anti-inflammatory agent.

6. A method according to claim 1 or 2 and further including

introducing into the region a balloon coated with a bioactive material, and

expanding the balloon in contact with the region to deliver the bioactive material.

7. A method according to claim 1 or 2 and further including

visualizing the region before, during and after debulking the restenosis.

8. A method according to claim 1 or 2

wherein the blood vessel is a peripheral blood vessel.

9. A method according to claim 1 or 2

wherein the blood vessel is a peripheral blood vessel in a leg.

10. A method according to claim 1 or 2

wherein the blood vessel is a peripheral blood vessel in a leg below a knee.

11. A method according to claim 3 and further including

performing an atherectormy to remove tissue from within the stent structure.

12. A method according to claim 3 and further including

performing an atherectormy to debulk restenosis of the stent structure.

13. A method according to claim 1 or 2

wherein the region of restenosis in entirely within a stent structure.

15. A method according to claim 13

wherein the blood vessel is a peripheral blood vessel.

16. A method according to claim 13

wherein the blood vessel is a peripheral blood vessel in a leg.

17. A method according to claim 13

wherein the blood vessel is a peripheral blood vessel in a leg below a knee.

2. A method for debulking restenosis of a blood vessel comprising:

identifying a region of restenoisis of a blood vessel,

deploying into the 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 tissue from the restenosis 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,

operating the drive mechanism to rotate the helical cutting surface to debulk the restenois by cutting and conveying tissue from the restenosis proximally into the housing,

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 tissue from the restenosis in a region larger than an outside diameter of the cutter assembly.

14. A method according to claim 14 and further including

introducing into the region a balloon coated with a bioactive material, and

expanding the balloon in contact with the region to deliver the bioactive material.