Method for accessing the coronary arteries from the radial or brachial artery in the arm

• US 5,492,530 A
• Filed: 02/02/1995
• Issued: 02/20/1996
• Est. Priority Date: 02/07/1994
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cathco, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/384,277
• Time in Patent Office: 383 Days
• Field of Search: 604/49, 604/50-52, 604/280-283, 604/95, 604/264, 606/191, 606/192, 606/194
• US Class Current: 604/510
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

The present invention is a method for using an improved guiding catheter that eliminates the need for an introducer sheath or a separate Tuohy-Borst "Y" adaptor, thus reducing the time and expense for performing artery opening procedures. Furthermore, the guiding catheter with straightening dilator as described herein allows the hole in the wall of the femoral artery in the groin, or even more advantageously, the radial artery in the arm to be approximately 2 French sizes smaller in diameter as compared to the hole that would be created if an introducer sheath is also used. The advantages of the present invention are accomplished by utilizing a guiding catheter with a dilator that has a stiffened and/or curved distal section that can be used to straighten the distal section of the guiding catheter as it is advanced through the arterial system. The guiding catheter plus dilator can then be used in a manner similar to an introducer sheath to percutaneously enter the artery by being advanced over a previously placed guide wire. Once the distal ends of the dilator and the guiding catheter are placed near the ostium of the coronary artery, the dilator and guide wire are withdrawn which allows the guiding catheter to assume its normal bent shape (e.g., a Judkin'"'"'s bend) near its distal end. The cardiologist can then, by well known techniques, place the guiding catheter'"'"'s distal end in the ostium of a coronary artery. Any of several well known procedures can then be performed including angiography, balloon angioplasty, atherectomy or stent placement.

Claims

1. A method for accessing human arteries without the use of an introducer sheath, the method comprising the following steps:

(a) percutaneously inserting an arterial access needle through an arterial access site on the skin until the needle point is situated within the artery;

(b) place a guide wire through the access needle and into the arterial lumen;

(c) remove the access needle leaving the guide wire in place;

(d) advance a guiding catheter system over the guide wire and into the arterial lumen, the guiding catheter system comprising;

an elongated hollow tube having a central passageway throughout its entire length and also having proximal and distal ends and a distal section, the hollow tube'"'"'s distal end being tapered for easy introduction into a blood vessel and the distal section having a bend adapted to facilitate introduction into and retention within the ostium of an artery; and

a dilator having an elongated body and having a central passageway throughout its entire length which central passageway is adapted to slide snuggly over a guide wire, the dilator also having proximal and distal ends and a distal section and also having a handle located at the dilator'"'"'s proximal end, the dilator being tapered at its distal end, the dilator being adapted to slide snuggly through the central passageway of the elongated tube;

(e) remove the dilator and guide wire from the elongated tube;

(f) advance the distal end of the guiding catheter system into the ostium of an artery;

(g) perform an artery opening or angiographic procedure; and

(h) remove the guiding catheter system from the patient'"'"'s arterial system.

2. The method of claim 1 wherein the arterial access site is over the radial artery in the arm.

3. The method of claim 1 wherein the arterial access site is over the brachial artery in the arm.

4. The method of claim 1 wherein the artery into which the guiding catheter system'"'"'s distal end is placed is a coronary artery.

5. The method of claim 1 wherein the artery into which the guiding catheter system'"'"'s distal end is placed is a carotid artery.

6. The method of claim 1 wherein the artery into which the guiding catheter system'"'"'s distal end is placed is a renal artery.

7. The guiding catheter system of claim 1 wherein the entire length of the dilator is straight.

8. The guiding catheter system of claim 1 wherein the distal sections of the elongated hollow tube and the dilator are each curved.

9. The method of claim 1 wherein the guiding catheter system further comprises a Tuohy-Borst fitting integrally attached as a one-piece construction at the hollow tube'"'"'s proximal end, the Tuohy-Borst fitting including a threaded base, a threaded nut and an elastomer gland that can be tightened around the dilator by screwing the threaded nut onto the threaded base.

10. The method of claim 9 wherein the dilator is placed within the elongated hollow tube to form an essentially straight, tube-dilator assembly when an indicator mark on the threaded base is aligned with an indicator mark on the threaded nut.

11. The method of claim 9 wherein the distal sections of the elongated hollow tube and the dilator are each curved and further, the dilator includes a key at its proximal end that fits into a keyway in the threaded nut of the Tuohy-Borst fitting.

12. The method of claim 9 wherein the Tuohy-Borst fitting has a side arm tube joined to the Tuohy-Borst fitting'"'"'s threaded base, the side arm tube having distal and proximal ends.

13. The method of claim 12 wherein the side arm tube has a female Luer fitting at its proximal end.

14. The method of claim 12 wherein the side arm tube has a stop cock at its proximal end.

15. The method of claim 9 wherein the gland of the Tuohy-Borst fitting includes a half "O" ring on its interior surface.

16. The method of claim 9 wherein the gland of the Tuohy-Borst fitting is fabricated from a soft elastomer which elastomer includes a powdered Teflon.

17. The method of claim 9 wherein the gland of the Tuohy-Borst fitting is fabricated from a soft elastomer which elastomer includes a powdered graphite.

18. The method of claim 1 including the following additional steps:

(i) retain a guide wire in the artery after the guiding catheter system is removed;

(j) advance together a conventional introducer sheath including an introducer sheath dilator percutaneously through the arterial access site and over the guide wire until most of the length of the introducer sheath lies within the arterial lumen; and

(k) remove the guide wire and introducer sheath dilator leaving the introducer sheath placed percutaneously in the aerial lumen.

19. The method of claim 1 wherein at least one distal section near the dilator'"'"'s distal end is stiffer than the remaining sections of the dilator so as to resist bending at such at least one distal section.