Expandable pullback atherectomy catheter system

• US 4,886,061 A
• Filed: 02/09/1988
• Issued: 12/12/1989
• Est. Priority Date: 02/09/1988
• Status: Expired due to Term

• Current Assignee: Arrow International Investment Corporation (Teleflex Incorporated)
• Original Assignee: Medinnovations Incorporated
• Inventors: Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Lewis, Ralph
• Application Number:
  US07/153,912
• Time in Patent Office: 672 Days
• Field of Search: 128/304, 128/305, 128/751, 128/754, 128/755, 604/22, 604/105, 604/108, 604/267
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi

Abstract

Disclosed is an Expandable Pullback Atherectomy Catheter (EPAC) comprising a distal tip portion capable of assuming two diameters. The distal tip portion includes an expandable cutting means and an expandable tissue collecting means. The catheter is guided in an artery to the stenosis and the distal tip is urged past the stenosis while being maintained in a compressed state by a sheathing catheter. The sheathing catheter is withdrawn allowing the cutting means and collecting means to expand. The stenotic tissue is removed by pulling the distal tip back in a retrograde direction while the cut tissue is captured in the collecting means. Additional structural details are provided to prevent injury to the inner wall of an artery and to avoid total obstruction of the artery during the antherectomy procedure.

Claims

1. An apparatus for deployment within a vessel of a living body for removing obstructing tissue on the inner wall of said vessel, the apparatus comprising:

catheter means having a distal portion with a first more proximal region for cutting said obstructing tissue, and a second most distal region for collecting said obstructing tissue after it has been cut from the vessel wall, and said distal portion being capable of assuming a first and a second diameter, said second diameter being larger than said first diameter;

cutting means located at said first more proximal region of said distal portion of the catheter means for cutting said obstructing tissue as the catheter means is pulled back in a retrograde direction through said obstruction tissue;

tissue collecting means having a proximal and a distal end located at said second most distal region of said distal portion of the catheter means for collecting said obstructing tissue as it is cut from the vessel wall;

deployment means for selectively causing said distal portion to assume said first or second diameter; and

centering means on aid distal portion of the catheter means for engaging the inner wall of the vessel when said distal portion assumes said second diameter and for preventing the cutting means from contacting and cutting the inner wall of said vessel.

2. The apparatus of claim 1 wherein said collection means is a collection chamber formed of a flexible, deformable plastic.

3. The apparatus of claim 2 wherein said collection chamber is porous for allowing small particulate matter and blood plasma and cells to flow therethrough.

4. The apparatus of claim 2 wherein said collection chamber is treated with heparin.

5. The apparatus of claim 1 wherein said collection means is slidably connected to said cutting means so that rotation of said cutting means does not cause rotation of said collection means.

6. The apparatus of claim 1 wherein said cutting means comprises a radially expandable conical cutter having a multiplicity of radial cutting spokes.

7. The apparatus of claim 6 wherein said radial cutting spokes are curved.

8. The apparatus of claim 1 wherein said deployment means comprises a sheathing catheter having a diameter slightly larger than said first diameter of said distal portion of the catheter means so that when the sheathing catheter surrounds said distal portion, said distal portion assumes said first diameter, and when the sheathing catheter does not surround said distal portion, said distal portion assumes said second diameter.

9. The apparatus of claim 1 wherein said tissue collecting means is positioned at the distal end of said distal portion of the catheter means and said cutting means is positioned at the proximal end of said distal portion of the catheter means.

10. The apparatus of claim 1 wherein the distal end of said tissue collecting means has a diameter smaller than the proximal end of said tissue collecting means.

11. The apparatus of claim 1 wherein said tissue collecting means is conical in shape.

12. The apparatus of claim 1 wherein said deployment means surrounds and compresses said distal portion of the catheter means for causing said distal portion to assume said first diameter.

13. The apparatus of claim 12 wherein said deployment means is a sheathing catheter.

14. The apparatus of claim 12 wherein said deployment means is a guiding catheter.

15. The apparatus of claim 1 wherein said centering means comprises a shoulder having a diameter larger than the diameter of said cutting means and forming the outside of the proximal end of said tissue collecting means so that when said distal portion of the catheter means assumes said second diameter, the shoulder causes the walls of the tissue collecting means to engage the inner wall of the vessel to prevent said cutting means from cutting the wall of the vessel.

16. The apparatus of claim 15 wherein said shoulder is deformable to follow the deformation of the tissue collecting means when the distal portion of said catheter means assumes said first and second diameters.

17. The apparatus of claim 1 wherein said catheter means is coated with a lubricant for facilitating insertion into a vessel.

18. The apparatus of claim 1 and further comprising means for rotating said cutting means while said catheter means is pulled back through said obstructing tissue.

19. The apparatus of claim 1 wherein said cutting means is mechanically vibrated while said catheter means is pulled back through said obstructing tissue.

20. The apparatus of claim 1 wherein said cutting means is connected to an electrical current to perform electrocautery while said catheter means is pulled back through said obstructing tissue.

21. A method for removing obstructing tissue from a vessel within a living body using a catheter system having a distal portion comprising a cutting means and a tissue collection means, said distal portion being capable of assuming a first and second diameter, said first diameter being smaller than said second diameter, said method comprising the steps of:

advancing said catheter system with said distal portion in said first diameter position, through said vessel until the distal portion is just beyond the obstructing tissue;

causing said distal portion of the catheter means to assume said second diameter;

pulling said catheter system back in a retrograde direction through said obstructing tissue to place said cutting means in contact with the obstructing tissue and said cutting means to be of sufficient hardness to form a sharp cutting edge to cut said obstructing tissue away from the wall of the vessel while the cut tissue is collected in the collection means; and

withdrawing said catheter system from the vessel along with the cut and collected obstructing tissue.

22. The method of claim 21 wherein said catheter system is advanced through the vessel over a guidewire.

23. The method of claim 21 wherein said catheter system is advanced through the vessel within a guiding catheter.

24. The method of claim 21 wherein said distal portion of the catheter system is caused to assume said first diameter before it is withdrawn from the vessel.

25. The method of claim 21 wherein said vessel is an artery.

26. The method of claim 21 wherein said vessel is a bypass vein.

27. The method of claim 21 wherein said vessel is an artificial graft.

28. The method of claim 21 wherein said obstructing tissue is plaque.

29. The method of claim 21 wherein said obstructing tissue is thrombus.

30. The method of claim 21 wherein said obstructing tissue is both plaque and thrombus.

31. The method of claim 21 wherein said vessel is a ureter.

32. The method of claim 21 wherein said vessel is a urethra.

33. The method of claim 21 wherein said vessel is a tube in the reproductive system.

34. The method of claim 21 wherein said vessel is a tube in the digestive tract.

35. An apparatus for deployment within a vessel of a living body for removing obstructing tissue from said vessel, the apparatus comprising:

catheter means having a distal portion capable of assuming a first and a second diameter, said second diameter being larger than said first diameter;

tissue cutting means located proximally to said distal portion of said catheter means, said cutting means being of sufficient hardness to form a sharp cutting edge or grinding surface to cut said obstructing tissue away from the vessel wall;

tissue collecting means located at said distal portion of said catheter means and being capable of assuming said first of second diameter and being located distally relative to said tissue cutting means, said tissue collecting means being capable of collecting said obstructing tissue after it has been cut from the vessel wall;

deployment means for selectively causing said distal portion to assume said first or second diameter

36. The apparatus of claim 35 wherein said cutting means is mounted on a separate second catheter in such a manner as to be concentric with said catheter means.

37. A method for removing obstructing tissue from a vessel within a living body using a catheter system having a distal portion comprising a tissue collection means, said distal portion being capable of assuming a first and second diameter, said first diameter being smaller than said second diameter, said method comprising the steps of:

advancing said catheter system with said distal portion in said first diameter position through said vessel until the distal portion is just beyond the obstructing tissue;

causing said distal portion of the catheter system to assume said second diameter;

placing a cutting means of sufficient hardness to form a sharp cutting edge or grinding surface in contact with the obstructing tissue and cutting said obstructing tissue away from the wall of the vessel;

collecting the cut tissue in said tissue collection means; and

withdrawing said catheter system from the vessel along with the cut and collected obstructing tissue.

38. The method of claim 37 wherein said cutting means is mounted on a separate second catheter.