Pullback atherectomy catheter system

• US 4,765,332 A
• Filed: 07/14/1986
• Issued: 08/23/1988
• Est. Priority Date: 07/14/1986
• Status: Expired due to Term

• Current Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Original Assignee: Medinnovations Incorporated
• Inventors: Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US06/885,139
• Time in Patent Office: 771 Days
• Field of Search: 128/24 A, 128/305, 128/304, 128/328, 604/22, 604/267, 604/268, 604/264
• US Class Current: 606/159
• 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 2017/22038 with a guide wire

Abstract

An atherectomy apparatus and method is disclosed for the purpose of surgical excision of atheromas which typically consist of plaque deposits that cause narrowing (stenosis) of an artery. The apparatus, called a pullback atherectomy catheter, cuts and collects obstructive material into a collection chamber as the catheter is pulled back through obstructive material within a human vessel such as an artery.

Claims

1. An atherectomy apparatus comprising:

a member having a distal portion adapted to be advanced through an obstructed arterial lumen, said member including,

a cylindrical cutting blade means having a cutting edge facing toward the proximal end of said apparatus for cutting obstructive material as said member is pulled back through said lumen; and

,

a means for securing the cut material within a collection chamber that is integrally formed within said cutting blade means, whereby removed material is retained without the cooperation of a second member requiring motion relative to said cutting blade means, and wherein said means for securing cut material within said collection chamber comprises a shoulder portion positioned in cooperation with said cutting blade means to form therebetween a restricted entrance mouth to said collection chamber, so as to retain cut material in said collection chamber.

2. The apparatus of claim 1, wherein said shoulder portion is a cylindrical form, and wherein the outer diameter of a distal region of said cylindrical form is slightly smaller than the diameter of said cutting blade means, so as to form said restricted entrance mouth therebetween.

3. An atherectomy apparatus, comprising:

a member having a distal portion adapted to be advanced through an obstructed arterial lumen, said member including,

a cylindrical cutting blade means having a cutting edge facing toward the proximal end of said apparatus for cutting obstructive material as said member is pulled back through said lumen; and

,

a means for securing the cut material within a collection chamber that is integrally formed within said cutting blade means, whereby removed material is retained without the cooperation of a second member requiring motion relative to said cutting blade means, and wherein said member includes an interior passageway that is adapted to fit around a guide wire so that said member can be advanced along said guide wire.

4. An atherectomy apparatus, comprising:

a member having a distal portion adapted to be advanced through an obstructive arterial lumen, said member including,

a cylindrical cutting blade means having a cutting edge facing toward the proximal end of said apparatus for cutting obstructive material as said member is pulled back through said stenotic lumen;

a means for securing the cut material within a collection chamber that is integrally formed within said cutting blade means, whereby removed material is retained without the

cooperation of a second member requiring motion relative to said cutting blade means; and

,

an ultrasonic means operably coupled to said distal portion for causing vibratory motion of said distal portion.

5. An atherectomy apparatus comprising:

a distal portion adapted to be advanced through an arterial stenotic lumen;

a cylindrical cutting blade having a circular cutting edge facing toward the proximal end of said apparatus for cutting stenotic material as said circular cutting edge is pulled back through stenotic lumen, said circular cutting edge having a first and largest diameter;

a hollow chamber formed within said apparatus between said cylindrical cutting blade and a cylindrical inner portion of said distal member having a second and smallest diameter; and

,

a second guide portion fixedly attached at its distal end to the proximal end of said cylindrical inner portion, having a third and intermediary diameter larger than said second diameter but less than said first diameter and cooperating with said cylindrical inner portion and said cylindrical cutting blade to form a hollow collection chamber having a restricted entrance mouth, so as to retain the cut stenotic material in said hollow chamber.

6. The apparatus of claim 5, wherein the distal end of said distal portion is shaped so as to include a forward guiding means for guiding said member as it is advanced through said stenotic lumen.

7. The apparatus of claim 6, wherein said forward guiding means has a conically shaped surface.

8. The apparatus of claim 7, wherein said conically shaped surface has at least two different slopes.

9. The apparatus of claim 5, wherein said circular cutting edge is serrated so that rotation of said circular cutting edge will enhance cutting during pullback.

10. The apparatus of claim 5, wherein said apparatus is operably connected to a catheter cylinder having a proximal end extending external to said living body.

11. The apparatus of claim 10, wherein said catheter cylinder and said apparatus contains an internal passageway so that fluid can be injected through said internal passageway to the site of said stenotic lumen.

12. The apparatus of claim 5, further comprising a means for rotating said distal portion as said apparatus is pulled back through the stenotic lumen.

17. The apparatus of claim 5, wherein the exterior surface of said distal portion is polished to reduce its coefficient of friction.

18. The apparatus of claim 5, wherein the exterior surface of said distal portion is coated with a substance to reduce its coefficient of friction.

19. The apparatus of claim 18, wherein said exterior surface is coated with Teflon.

20. The apparatus of claim 5, wherein said cutting edge is made from a hard metal sharpened to form a sharp cutting edge.

13. An atherectomy apparatus comprising:

a guide wire adapted to be advanced in an antegrade direction so as to penetrate through an obstructed arterial lumen;

a member having a distal portion adapted to be advanced through said obstructed arterial lumen, said member having an inner lumen adapted to fit around said guide wire so that said distal portion can be advanced along said guide wire; and

said member including,

a removing means having a cutting blade facing toward the proximal end of said member and a collection chamber integrally formed within said cutting blade for cutting and collecting obstructive material as said cutting blade is pulled back through said arterial lumen.

14. The apparatus of claim 13, wherein said cutting blade has a circular cutting edge and wherein said removing means collects obstructive material without the cooperation of a second member requiring motion relative to said cutting blade.

15. The apparatus of claim 13, wherein said cutting blade is serrated.

16. The apparatus of claim 13, further comprising a means for rotating said distal portion as said apparatus is pulled back through said obstructed arterial lumen.

21. An atherectomy catheter, comprising:

a catheter having a distal portion adapted to be advanced through a stenotic lumen in a tubular vessel of a living body, said distal portion comprising,

a cutting cylinder having a sharpened edge, said sharpened edge facing toward the proximal end of said catheter tip for removing stenotic material as said distal portion is pulled back through said stenotic lumen;

a guiding cylinder located at the proximal end of said distal portion for guiding said distal portion as it is pulled back through said stenotic lumen, said guiding cylinder having an outer diameter slightly less than the diameter of said sharpened edge, so that a gap is formed therebetween;

a conical guiding surface located at the distal end of said distal portion for guiding said distal portion as it is advanced through said stenotic lumen;

a hollow chamber formed within said distal portion, wherein the gap formed between said sharpened edge and said guiding catheter forms the mouth to said hollow chamber so that said hollow chamber will collect stenotic material removed from the interior of said stenotic lumen;

an inner passageway running the length of said catheter and said distal portion, said passageway adapted to fit around a guide wire so that said distal portion can be advanced along said guide wire.

22. The catheter of claim 21, wherein the outer diameter of said guiding cylinder is approximately the diameter of the narrowed stenotic lumen.

23. The catheter of claim 21, wherein said conical guiding surface has a front portion having a relatively steep conical slope and a back portion having a relatively shallow slope.

24. The catheter of claim 21, wherein the outer surface of said cutting cylinder is treated to reduce its coefficient of friction.

25. The catheter of claim 21, wherein said gap formed between said sharpened edge and said guiding cylinder measures 10 to 80 mils.

26. The catheter of claim 21, wherein said sharpened edge is serrated so that rotation of said distal portion will enhance cutting action of the sharpened edge.

27. A method for removing obstructive material from an artery in a living body, comprising the steps of

advancing a guide wire so that its distal end extends beyond an arterial obstruction,

advancing the distal portion of an atherectomy catheter along the guide wire and beyond the obstruction;

pulling back said atherectomy catheter thereby causing a cutting edge that faces toward the proximal end of said atherectomy catheter and forms the mouth of a collection chamber to both cut and collect obstructive material into said collection chamber during the same single pullback motion.

28. The method of claim 27 further including the step of rotating said cutting edge during said pull back step.

29. A method for improving arterial blood flow by:

percutaneously passing a guiding catheter forward through the arterial system of a living body until its distal end is proximal to a stenosis;

deploying a guide wire and a pullback atherectomy catheter by advancing the guide wire until the distal end of the guide wire passes through the stenotic lumen and advancing the distal portion of the pullback atherectomy catheter to a position just proximal to the stenosis;

advancing the pullback atherectomy catheter through the stenotic lumen; and

,

pulling said catheter back through said stenotic lumen thereby causing a cutting edge that faces toward the proximal end of said catheter to remove stenotic material.

30. The method of claim 29, further comprising the steps of:

collecting the removed material from the stenosis in a hollow chamber formed within said distal portion of said pullback atherectomy catheter, said hollow chamber having an opening beneath said cutting edge; and

removing said pullback atherectomy catheter with stenotic material from said living body.

31. The method of claim 29, wherein said deploying step involves first advancing said guide wire through the stenotic lumen and then advancing the pullback atherectomy catheter along said guide wire.

32. The method of claim 29, wherein said deployment involves first assembling said guide wire in said pullback atherectomy catheter and then advancing the assembly through said guiding catheter.

33. The method of claim 29, wherein said pullback atherectomy catheters include said distal portions of progressively larger diameter which are used for progressively increasing the area of the stenotic lumen.

34. The method of claim 29, wherein the distal end of said guiding catheter is given a preformed shape to suit a particular arterial geometry.

35. The method of claim 29, further comprising the step of employing an angioplasty balloon catheter procedure to further dilate the stenotic lumen.

36. An atherectomy apparatus, comprising:

a member having a distal portion adapted to be advanced through an obstructive arterial lumen, said member including,

a cylindrical cutting blade means having a cutting edge facing toward the proximal end of said apparatus for cutting obstructive material as said member is pulled back through said lumen;

a means for securing the cut material within a collection chamber that is integrally formed within said cutting blade means, whereby removed material is retained without the cooperation of a second member requiring motion relative to said cutting blade means; and

,

an electrocautery cutting means having an electrical current means electrically grounded to said living body and also having a second connection to said distal portion for enhancing removal of obstructive material.