Apparatus and method for removing stenotic material from stents

• US 5,882,329 A
• Filed: 02/12/1997
• Issued: 03/16/1999
• Est. Priority Date: 02/12/1997
• Status: Expired due to Fees

• Current Assignee: Prolifix Medical Incorporated
• Original Assignee: Prolifix Medical Incorporated
• Inventors: Williams, G. Ronald, Leary, James J., Patterson, Greg R.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/798,722
• Time in Patent Office: 762 Days
• Field of Search: 606/159, 604/49, 604/52, 604/53, 604/22, 604/280, 604/264
• US Class Current: 604/500
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/320012 Brushes
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00

Abstract

Apparatus and methods are provided for recanalizing stented regions within the vasculature which have become restenosed. A shearing body is displaced within the stented region in order to dislodge the stenotic material from an interface envelope defined by the inner surface of the stent. Usually, the shearing body will be compliant and sized slightly larger than the stent in order to remove stenotic material substantially uniformly around the entire interface envelope. The shearing body may be in the form of a brush, helical row, spaced-apart disks, solid compressible body, or a variety of other specific configurations.

Claims

1. A method for removing stenotic material from within a stent within a blood vessel, said method comprising:

displacing a shearing body within the blood vessel so that it dislodges stenotic material from around an interface envelope defined by the stent within the stenotic material.

2. A method as in claim 1 further comprising collecting the dislodged stenotic material.

3. A method as in claim 2 wherein the collecting step comprises aspirating the dislodged material into a catheter disposed within the blood vessel near the stent.

4. A method as in claim 3 wherein the collecting step comprises trapping the dislodged material within the shearing body or a filter structure disposed adjacent to the shearing body.

5. A method as in claim 4 further comprising the steps of determining the interior diameter of the interface envelope and selecting a shearing assembly which has a width which is greater than the interior diameter of the interface envelope.

6. A method as in claim 5 wherein the selecting step comprises selecting a shearing body which has a width which is from 1% to 25% greater than that of the interior diameter of the interface envelope.

7. A method as in claim 1 wherein the displacing step comprises rotating the shearing body or translating the shearing body axially through the stent.

8. A method as in claim 7 wherein the shearing body is compliant, further comprising releasing the shearing body from constraint so that the shearing body radially expands on one side of the stented region prior to translating therethrough.

9. A method as in claim 7 further comprising expanding the shearing body to a preselected width.

10. A method as in claim 1 wherein the shearing body comprises a helical row.

11. A method as in claim 10 wherein the helical row comprises helically aligned radially oriented filaments.

12. A method as in claim 10 wherein the helical row comprises a helically wrapped continuous web of material.

13. A method as in claim 1 wherein the shearing body comprises a surface which is elongated in the direction of the blood vessel.

14. A method as in claim 13 wherein the elongated surface is tapered at at least one end, with said one end having a smaller width than other portions of the shearing body surface.

15. A method as in claim 1 wherein the shearing body has a width which is greater than the interior diameter of the interface envelope defined by the stent.

16. A method as in claim 1 wherein at least a portion of the shearing body has a generally round cross-section.

17. A method as in claim 1 wherein at least a portion of the shearing body has a polygonal cross-section.

18. A method as in claim 1 wherein the shearing body comprises a brush.

19. A method as in claim 1 wherein the shearing body comprises a cage.

20. A method for removing stenotic material from within a stent within a blood vessel, said method comprising:

positioning a catheter on one side of the stent;

translating a shearing body through the stent toward a distal end of the catheter to dislodge stenotic material from an interface envelope defined by the stent, and

aspirating the dislodged stenotic material into the distal end of the catheter.

21. A method as in claim 20 wherein the shearing body has a width which is greater than the interior diameter of the interface envelope defined by the stent.

22. A method as in claim 21, further comprising the steps of determining the interior diameter of the interface envelope and selecting a shearing assembly which has a width which is greater than the interior diameter of the interface envelope.

23. A method as in claim 22, wherein the selecting step comprises selecting a shearing assembly which has a width which is from 1% to 25% greater than that of the interior diameter of the interface envelope.

24. A method as in claim 20, wherein the shearing body comprises a helical row.

25. A method as in claim 24, wherein the helical row comprises helically aligned radially oriented filaments.

26. A method as in claim 24, wherein the helical row comprises a continuous web of material.

27. A method as in claim 20, wherein the shearing body comprises a surface which is elongated in the direction of the blood vessel.

28. A method as in claim 27, wherein the elongated surface is tapered at at least one end, with said one end having a smaller width than other portions of the shearing body surface.

29. A method as in claim 20 further comprising expanding the shearing body to a preselected width.

30. A method as in claim 29 wherein the expanding step comprises axially shortening the shearing body to cause transverse expansion.

31. A method as in claim 20 wherein the shearing body is compliant, further comprising releasing the shearing body from constraint so that the shearing body radially expands on one side of the stented region prior to translating therethrough.

32. A method as in claim 20 further comprising rotating the shearing body so that it circumferentially sweeps the interface envelope as it is being axially translated through the stent.

33. A method as in claim 20, wherein at least a portion of the shearing body has a generally round cross-section.

34. A method as in claim 20, wherein at least a portion of the shearing body has a polygonal cross-section.

35. A method as in claim 20, wherein the shearing body comprises a brush.

36. A method as in claim 20, wherein the shearing body comprises a cage.

37. An improved method for recanalizing a stented region in a blood vessel that has become restenosed, said method being of the type wherein stenotic material within the stented region is dislodged with a percutaneously introduced interventional catheter, wherein the improvement comprises:

introducing an interventional catheter having a shearing body near a distal end thereof wherein at least a portion of the shearing body has a cross-sectional geometry which is sufficiently large to engage the entire interior surface of the stent when the shearing body is displaced within the stent; and

displacing the shearing body within the stented region so that stenotic material is dislodged uniformly along an interface envelope defined by the stent.

38. An improved method as in claim 37, wherein the displacing step comprises at least one of rotating the shearing body and translating the shearing body.

39. An improved method as in claim 37, wherein the displacing step comprises both rotating and translating the shearing body.

40. An improved method for recanalizing a stented region in a blood vessel that has become restenosed, said method being of the type wherein stenotic material within the stented region is dislodged with a percutaneously introduced interventional catheter, wherein the improvement comprises:

rotating and translating a compliant shearing body through the stented region, wherein at least a portion of the compliant shearing body has a width which is greater than the diameter of the stent so that the shearing body is compressed by the stent as it passes therethrough.

41. An improved method as in claim 40, wherein the compliant shearing body comprises at least one component selected for the group consisting of a brush, a helical row, and a cage.

42. An improved method as in claim 40, wherein at least one end of the shearing body is tapered and wherein the tapered end enters the stented region first as the shearing body is translated therethrough.

43. An improved method for recanalizing a stented region in a blood vessel that has become restenosed, said method being of the type wherein stenotic material within the stented region is dislodged with a percutaneously introduced interventional catheter, wherein the improvement comprises:

rotating and translating a tapered shearing body through the stented region, wherein a small width end of the tapered shearing body enters the stented region first.

44. An improved method as in claim 43, wherein the shearing body is compliant.

45. An improved method as in claim 43, wherein the shearing body comprises at least one component selected from the group consisting of a brush, a helical row, and a cage.

46. An improved method for recanalizing a stented region in a blood vessel that has become restenosed, said method being of the type wherein stenotic material within the stented region is dislodged with a percutaneously introduced interventional catheter, wherein the improvement comprises:

rotating and translating a helical shearing body through the stented region.

47. An improved method as in claim 46, wherein the helical shearing body is tapered in a spiral configuration, wherein a small end of the spiral enters the stented region first as the shearing body is translated therethrough.

48. An improved method as in claim 46, wherein the helical shearing body comprises helically aligned filaments.