Guide wire following tunneling catheter system and method for transluminal arterial atherectomy

• US 4,898,575 A
• Filed: 06/10/1988
• Issued: 02/06/1990
• Est. Priority Date: 08/31/1987
• Status: Expired due to Term

• Current Assignee: Medinnovations Incorporated
• Original Assignee: Medinnovations Incorporated
• Inventors: Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/205,541
• Time in Patent Office: 606 Days
• Field of Search: 128/305, 128/304, 128/751-758, 128/348.1, 128/344, 128/305.1, 128/310, 604/22
• US Class Current: 604/22
• 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 17/3207 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2217/005 with suction drainage system

Abstract

An atherectomy catheter is advanced over a guide wire in the anterograde direction to the site of an arterial stenosis. The distal end of the catheter is centered around the guide wire which has been previously advanced through the stenotic lumen. The catheter is then advanced over the guide wire with its sharpened distal end cutting through the stenosis. The atherectomy catheter can also employ rotation or vibration or an electrocautery current to enhance the catheter'"'"'s cutting action. Suction applied at the catheter'"'"'s proximal end is used to enhance the collection of plaque cut from the stenosis at the catheter'"'"'s distal end so that the cut plaque enters a single passageway that lies between the outer surface of the guide wire and the inner surface of the cylindrical catheter.

Claims

1. A guide wire following tunneling catheter system for percutaneous transluminal atherectomy, comprising:

a guide wire with distal and proximal ends and adapted to be advanced within a patient'"'"'s arterial system and to penetrate through an arterial stenosis;

a tunneling catheter with distal and proximal ends having for most of its length a single, thin walled, cylindrical tube with a single inner cylindrical surface extending for most of the length of said tunneling catheter, said inner cylindrical surface being adapted to fit around said guide wire so that said tunneling catheter can be advanced along said guide wire to said arterial stenosis, and wherein a passageway is formed between said inner cylindrical surface of said tunneling catheter and the outer surface of said guide wire, said passageway being in fluid communication between said distal and proximal ends of said tunneling catheter, said distal end of said tunneling catheter including a centering means operably attached to said tunneling catheter for centering the distal end of said tunneling catheter around said guide wire and within the interior passageway of the stenosis, wherein said centering means is a centering cylindrical member whose outer diameter is smaller than that of said tunneling catheter, wherein the distal end of said centering cylindrical member extends out from the distal end of said tunneling catheter and wherein the proximal end of said centering cylindrical member is operably attached to said distal end of said tunneling catheter; and

,

a cutting means located near the distal end of said tunneling catheter for cutting through said arterial stenosis as said tunneling catheter is advanced along guide wire.

2. The catheter system of claim 1, further comprising a separator member that is secured within the interior lumen of said distal end of said tunneling catheter wherein the interior surface of said distal end of said tunneling catheter and the external surface of said centering cylindrical member means forms an annular chamber, and wherein said separator member includes at least one hole allowing said annular chamber to be in fluid communication with said interior lumen of said tunneling catheter.

3. The catheter system of claim 1, wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and wherein said proximal end of said tunneling catheter is operably coupled to a suction means located external to said patient, for applying suction to said interior lumen for drawing out portions of plaque into said interior lumen.

4. The catheter system of claim 1, wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and wherein said proximal end of said tunneling catheter is operably coupled to a fluid injection means located external to said patient for injecting a fluid through said interior lumen into the vicinity of said arterial stenosis.

5. The catheter system of claim 1 wherein said cutting means is a sharpened edge forming a mouth at the distal end of said tunneling catheter.

6. The catheter system of claim 5, wherein said sharpened edge is a cylindrical cutting edge for cutting a cylindrical bore of plaque from said arterial stenosis.

7. The catheter system of claim 1, wherein said tunneling catheter and said centering cylindrical member are fixedly attached in such a way as to allow creation of at least one hole between said tunneling catheter and said centering cylindrical member thus allowing fluid communication between said interior lumen of said tunneling catheter and the interior of the artery undergoing atherectomy.

8. The catheter system of claim 1, wherein said cutting means has at least one sharpened edge forming at least one mouth at the distal end of said tunneling catheter.

9. A guide wire following catheter system for percutaneous transluminal atherectomy, comprising:

a guide wire with distal and proximal ends, and adapted to be advanced within a patient'"'"'s arterial system and to penetrate through an arterial stenosis, said guide wire being essentially flexible throughout its length that lies within the stenotic artery and being free of any substantial protuberance at its said distal end; and

a tunneling catheter with distal and proximal ends and having for most of its length a single, thin wall tube having an outer cylindrical surface and an inner cylindrical surface, said inner cylindrical surface forming an interior lumen and being adapted to fit around said guide wire so that said tunneling catheter can be advanced along said guide wire to said arterial stenosis; and

,

a cutting means located at the distal portion of said tunneling catheter for cutting through said arterial stenosis as said tunneling catheter is advanced along said guide wire, said cutting means having at least one cutting edge and having at least one opening into which the cut plaque enters as said cutting means is advanced through the stenotic plaque, and wherein none of said cutting edges extends outward from said outer cylindrical surface of said tunneling catheter and wherein said cutting means is precluded from cutting through said guide wire during rotation of said tunneling catheter as a result of said inner cylindrical surface of said tunneling catheter being a smooth cylindrical surface and being free of a cutting edge which could cut through said guide wire and wherein the inner diameter of said distal end of said tunneling catheter is only slightly larger than the outside diameter of said guide wire so that said distal end of said tunneling catheter is substantially centered about said guide wire; and

wherein said tunneling catheter has a passageway formed between said inner cylindrical surface of said tunneling catheter and the outer surface of said guide wire, said passageway being in fluid communication between said distal and proximal ends of said tunneling catheter and being a means for collecting and removing cut plaque as said cutting means is advanced over said guide wire so as to cut the stenotic plaque.

10. The catheter system of claim 9, wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to a suction means located external to said patient for applying suction to said passageway for drawing cut portions of plaque into said passageway.

11. The catheter system of claim 9, wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to a fluid injection means located external to said patient for injecting a fluid through said passageway into the vicinity of said arterial stenosis.

12. The catheter system of claim 11, wherein said fluid is a radio-opaque dye.

13. The catheter system of claim 9 wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to a rotary driving means located external to said patient for applying rotational motion to said cutting means of said tunneling catheter so as to enhance the cutting of the plaque.

14. The catheter system of claim 9 wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to a source of electrocautery current means located external to said patient for applying an electrocautery current to siad cutting means of said tunneling catheter so as to enhance the cutting of the plaque by applying a high density electric current through the tissue that is being cut.

15. The catheter system of claim 9 wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to an ultrasonic vibration means located external to said patient for applying mechanical vibration to said cutting means of said tunneling catheter so as to enhance the cutting of the plaque.

16. The catheter system of claim 9, wherein said cutting means is a sharpened edge forming a mouth at the distal end of said tunneling catheter.

17. The catheter system of claim 16, wherein said sharpened edge is a cylindrical cutting edge for cutting a cylindrical bore of plaque from said arterial stenosis.

18. The catheter system of claim 9, wherein said proximal ends of both said tunneling catheter and said guide wire are adapted to extend external to said patient and wherein said catheter system further comprises:

a control handle fixedly attached to the proximal end of said tunneling catheter, said control handle having a hollow interior portion that is in communication with the interior lumen of said tunneling catheter;

a first entry into said hollow interior portion of said control handle having a sealing means for forming a seal around a section of said guide wire, said sealing means permitting said control handle and said tunneling catheter to be moved longitudinally along said guide wire; and

,

a second entry into said hollow interior portion of said control handle adapted to form a port in fluid communication with said interior lumen of said tunneling catheter.

19. The catheter system of claim 9 further comprising a guiding catheter having an interior lumen and adapted to be advanced within said patient'"'"'s arterial system to the site of said arterial stenosis, wherein said guide wire and said tunneling catheter are adapted to be advanced through said guiding catheter to the site of said arterial stenosis.

20. The catheter of claim 9 wherein said guide wire cooperates with said inner cylindrical surface of said tunneling catheter at its distal end so as to limit the radial displacement of said cutting means so as to center said cutting means about the lumen of the stenosis.

21. A guide wire following tunneling catheter system for percutaneous transluminal atherectomy, comprising:

a guide wire with distal and proximal ends, and adapted to be advanced within a patient'"'"'s arterial system and to penetrate through an arterial stenosis, said guide wire being essentially flexible throughout its length that lies within the stenotic artery; and

a tunneling catheter with distal and proximal ends and having for most of its length a single, thin walled tube having an outer cylindrical surface and an inner cylindrical surface, said inner cylindrical surface forming an interior lumen and being adapted to fit around said guide wire so that said tunneling catheter can be advanced along said guide wire to said arterial stenosis; and

a cutting means located at the distal portion of said tunneling catheter for cutting through said arterial stenosis as said tunneling catheter is advanced along said guide wire, said cutting means having at least one cutting edge and having at least one opening into which the cut plaque enters as said cutting means is advanced through the stenotic plaque; and

wherein said tunneling catheter has a passageway formed between said inner cylindrical surface of said tunneling catheter and the outer surface of said guide wire, said passageway being in fluid communication between said distal and proximal ends of said tunneling catheter and being a means for collecting and removing the cut plaque as said cutting means is advanced over said guide wire so as to cut the stenotic plaque; and

wherein said tunneling catheter has a radial motion restraining means at its most distal extremity for limiting the radial motion of said cutting means relative to said guide wire, said radial restraining means having a cylindrical hole, the diameter of said hole being substantially smaller than the diameter of said inner cylindrical surface of said tunneling catheter and said hole having a smooth interior cylindrical surface to prevent said cutting means from cutting said guide wire during rotation of said tunneling catheter, and said hole being sized to form a sliding fit over said guide wire so as to center said distal end of said cutting means around said guide wire as said cutting means is advanced through the stenotic plaque.

22. The catheter system of claim 21, wherein said tunneling catheter is operably attached to a rotating means at its proximal end for rotating said tunneling catheter as it is advanced over said guide wire in order to facilitate the cutting action of said cutting means as the distal end of said tunneling catheter is advanced over said guide wire and through said arterial stenosis.

23. The catheter system of claim 21, wherein said at least one cutting edge bores a cylindrical hole through the plaque of said arterial stenosis.

24. The catheter system of claim 21, wherein said tunneling catheter is rotated within a guiding catheter as said cutting means at said distal portion of said tunneling catheter is advanced along said guide wire and through said arterial stenosis.

25. The catheter system of claim 21, wherein said tunneling catheter is coupled to an ultrasonic vibration means so as to mechanically vibrate the distal end of said tunneling catheter as it is advanced through said arterial stenosis.

26. The catheter system of claim 21, wherein a high density electrocautery current is applied through the plaque as said tunneling catheter is advanced through said arterial stenosis.

27. The catheter system of claim 21, wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to a suction means located external to said patient for applying suction to said passageway for drawing cut portions of plaque into said passageway.

28. The catheter system of claim 21, wherein said proximal end of said tunneling catheter is adapted to extend external to said patient and is operably coupled to a fluid injection means located external to said patient for injecting a fluid through said passageway into the vicinity of said arterial stenosis.

29. A percutaneous transluminal atherectomy procedure comprising the steps of:

advancing a guide wire with distal and proximal ends through a patient'"'"'s arterial system and penetrating through an arterial stenosis, said guide wire being essentially flexible throughout that portion of its length that lies within the stenotic artery and being free of any substantial protuberance at its said distal end;

advancing a tunneling catheter with distal and proximal ends over said guide wire, said tunneling catheter having for most of its length a single, thin walled, cylindrical tube having an outer cylindrical surface and an inner cylindrical surface, said inner cylindrical surface forming an interior lumen and being adapted to fit around said guide wire thus forming a passageway between said inner cylindrical surface of said tunneling catheter and the outer surface of said guide wire and having said outer cylindrical surface of said tunneling catheter free of protuberances wherever it lies within the arterial system, said distal end of said tunneling catheter including a centering means operably attached to said tunneling catheter for centering the distal end of said tunneling catheter around said guide wire and within the interior passageway of the stenosis, wherein said centering means is a centering cylindrical member whose outer diameter is substantially smaller than the outer diameter of said tunneling catheter, wherein the distal end of said centering cylindrical member extends out from the distal end of said tunneling catheter and wherein the proximal end of said centering cylindrical member is operably attached to said distal end of said tunneling catheter;

advancing a cutting means located at the distal portion of said tunneling catheter through said arterial stenosis as said tunneling catheter is advanced along said guide wire, said cutting means having at least one cutting edge and having at least one opening into which the cut plaque enters as said cutting means is advanced through the stenotic plaque; and

having none of said cutting edges extending outward from said outer cylindrical surface of said tunneling catheter; and

collecting and removing the cut plaque as said cutting means is advanced over said guide wire so as to cut through said arterial stenosis.

30. The procedure of claim 29, further comprising the step of:

applying suction to the proximal end of said tunneling catheter, thereby drawing plaque cut by said cutting means into said interior lumen.

31. The procedure of claim 29, further comprising the step of:

applying a rotational motion to said tunneling catheter as it is advanced through the stenotic plaque.

32. The procedure of claim 29, further comprising comprising the step of:

applying an ultrasonic vibration to said tunneling catheter to enhance the cutting action of its distal sharpened edge.

33. The procedure of claim 29, further comprising the step of:

applying an electrocautery current to said tunneling catheter to enhance its cutting action by applying a high density electric current to the tissue that is being cut.

34. The procedure of claim 29, further comprising the step of:

advancing and later retracting said tunneling catheter through a guiding catheter that is placed within the arterial lumen.

35. The procedure of claim 29, further comprising the step of:

using conventional percutaneous transluminal balloon angioplasty to further dilate the stenotic lumen after a guide wire following tunneling catheter was used for the initial removal of some stenotic plaque.

36. A guide wire following tunneling catheter system for percutaneous transluminal atherectomy, comprising:

a guide wire with distal and proximal ends and adapted to be advanced within a patient'"'"'s arterial system and to penetrate through an arterial stenosis;

a tunneling catheter with distal and proximal ends and having for most of its length a single, thin walled, cylindrical tube having an outer cylindrical surface and an inner cylindrical surface, said inner cylindrical surface forming an interior lumen being adapted to fit around said guide wire thus forming a passageway between said inner cylindrical surface and the outer surface of said guide wire and having said outer cylindrical surface of said tunneling catheter free of protuberances wherever it lies within the arterial system, said tunneling catheter being capable of being advanced along said guide wire to said arterial stenosis, said distal end of said tunneling catheter including a centering means operably attached to said tunneling catheter for centering the distal end of said tunneling catheter around said guide wire and within the interior passageway of the stenosis, wherein said centering means is a centering cylindrical member whose outer diameter is substantially smaller than the outer diameter of said tunneling catheter and whose inner diameter is sized to be just slightly larger than the outside diameter of said guide wire so as to move slideably along said guide wire;

a cutting means located near the distal end of said tunneling catheter for cutting through said arterial stenosis as said tunneling catheter is advanced along said guide wire;

a suction means operably attached to said tunneling catheter at its proximal end which is adapted to extend external to said patient; and

,

a rotating means operably attached to said tunneling catheter at its proximal end which is adapted to extend external to the patient for rotating said tunneling catheter while simultaneously applying suction and advancing said tunneling catheter over said guide wire and through said arterial stenosis.