ATHERECTOMY DEVICES AND METHODS

• US 20080004647A1
• Filed: 12/06/2006
• Published: 01/03/2008
• 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: To, John, Danek, Christopher James
• Granted Patent: US 8,361,094 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/3784 : both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments

Abstract

The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.

Claims

1. A method for non-invasively imaging a vessel, the method comprising:

advancing a device having a first lumen and a second lumen;

delivering a contrast agent through the first lumen of the device into the vessel at a location adjacent to an occlusion in the vessel, where the occlusion prevents flow of the contrast agent distally to the occlusion;

aspirating the contrast agent from the vessel through the second lumen; and

non-invasively imaging the contrast agent in the vessel.

2. The method of claim 1, where the occlusion comprises a total occlusion.

3. The method of claim 1, further creating a passage through the occlusion with the device.

4. The method of claim 3, where the device further includes a cutter assembly located at the distal end of the device, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween;

and where creating the passage comprises rotating the cutter assembly such that the cutter removes portions of the occlusion.

5. The method of claim 3, where the device further includes a coring cutter, and where the coring cutter creates the passage through the occlusion.

6. The method of claim 1, further comprising passing a guidewire through the occlusion.

7. The method of claim 1, where the device further includes a cutter assembly located at the distal end of the device, further comprising sweeping the cutter assembly in an expanded profile to remove portions of the occlusion.

8. The method of claim 1, further comprising conveying debris from the occlusion through the device.

9. The method of claim 8, where the device further comprises at least one helical conveyor member extending therethrough such that that rotation conveyor member causes debris to move through the device.

10. The method of claim 1, where the device further comprises a burr rotatably located on a tip of the device, and where the occlusion comprises a fibrous cap, the method further comprising rotating the burr against the fibrous cap.

11. A method for circulating a contrast agent in a vessel proximal to a site of a total occlusion, the method comprising:

advancing a device to the site, where the total occlusion prevents fluid flow distally through the vessel;

delivering the contrast agent to the site through the device;

aspirating the contrast agent from the site through the device; and

non-invasively imaging the contrast agent in the vessel.

12. The method of claim 11, where the device comprises at least two lumens, where a first lumen delivers the contrast agent, and the second lumen aspirates the contrast agent.

13. The method of claim 11, creating a passage through the occlusion with the device until the non-invasive imaging shows the contrast agent to pass through the site of the occlusion.

14. The method of claim 13, where the device further includes a cutter assembly located at the distal end of the device, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween;

and where creating the passage comprises rotating the cutter assembly such that the cutter removes portions of the occlusion.

15. The method of claim 13, where the device further includes a coring cutter, and where the coring cutter creates the passage through the occlusion.

16. The method of claim 11, further comprising passing a guidewire through the occlusion.

17. The method of claim 11, where the device further includes a cutter assembly located at the distal end of the device, further comprising sweeping the cutter assembly in an expanded profile to remove portions of the occlusion.

18. The method of claim 11, further comprising conveying debris from the occlusion through the device.

19. The method of claim 18, where the device further comprises at least one helical conveyor member extending therethrough such that that rotation conveyor member causes debris to move through the device.

20. The method of claim 11, where the device further comprises a burr rotatably located on a tip of the device, and where the occlusion comprises a fibrous cap, the method further comprising rotating the burr against the fibrous cap.

21. A method for circulating fluid for contrast, the method comprising:

inserting a support catheter within the blood vessel, where the support catheter comprises a support catheter body having a proximal end and a distal end, the distal end containing at least one port on the surface for injection or aspiration of fluid;

injecting the fluid for contrast through a lumen or port in the support catheter body; and

aspirating the fluid for contrast into a lumen or port in the support catheter body.

22. The method of claim 21, where the support catheter is centered within the blood vessel using at least one basket or at least one balloon.

23. The method of claim 21, further comprising:

inserting a catheter body having a coring cutter assembly within the blood vessel;

driving the coring cutter assembly through the tough fibrous cap in the vessel to form a first body opening in the vessel;

removing the coring cutter assembly from the body;

inserting a second cutter assembly with a guidewire, where the guidewire is inserted through the first opening.

24. The method of claim 23, where the coring cutter assembly contains a shoulder that rests upon the support catheter.

26. The method of claim 23, where the coring cutter collects the cored-out portion of the tough fibrous cap.

25. The method of 23, where the coring cutter assembly comprises a helical groove or cylinder to drive itself through the tough fibrous cap.

27. A method for clearing a total occlusion from a vessel, the method comprising:

advancing a support catheter the vessel and adjacent to the occlusion, centering the support catheter the vessel and adjacent to the occlusion;

advancing a lumen creating device within the support catheter to the occlusion; and

creating a passage in the occlusion with the lumen creating device.

28. The method of claim 27, further comprising circulating a contrast agent adjacent on a single side of the occlusion to visualize the vessel adjacent to the occlusion.

29. The method of claim 28, where circulating the contrast agent comprises injecting the contrast agent to the vessel through the support catheter and aspirating the contrast agent from the vessel through the support catheter.

30. The method of claim 28, where circulating the contrast agent comprises injecting the contrast agent to the vessel through the lumen creating device and aspirating the contrast agent from the vessel through the lumen creating device.

31. The method of claim 27, where the lumen creating device is selected from the group consisting of a cutting device, a laser catheter, an RF probe, and an RF guidewire.

32. The method of claim 27, where the lumen creating device comprises a coring cutting device.

33. The method of claim 27, where the lumen creating device further comprises a shoulder to limit the degree of which the lumen creating device extends from the support catheter.

34. The method of claim 27, where the lumen creating device device further includes a cutter assembly located at the distal end of the device, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween;

and where creating the passage comprises rotating the cutter assembly such that the cutter removes portions of the occlusion.

35. The method of claim 27, further comprising passing a guidewire through the passage.

36. The method of claim 27, further comprising conveying debris from the occlusion through the lumen creating device.

37. The method of claim 36, where the device further comprises at least one helical conveyor member extending therethrough such that that rotation conveyor member causes debris to move through the device.

38. The method of claim 27, where the lumen creating device further comprises a burr rotatably located on a tip of the lumen creating device, and where the occlusion comprises a cap, the method further comprising rotating the burr against the cap.

39. The method of claim 27, where the cap is a fibrous cap or a calcific cap.