Fixed wire catheter exchange device

• US 5,318,527 A
• Filed: 12/22/1992
• Issued: 06/07/1994
• Est. Priority Date: 12/22/1992
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Hyde, Gregory M., Lee, Kee S., Becker, Jon A.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/995,478
• Time in Patent Office: 532 Days
• Field of Search: 604/96, 604/95, 604/280, 604/281, 604/282, 604/171, 604/164, 604/163, 606/194, 606/192, 128/656-658, 128/772
• US Class Current: 604/95.04
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A system for removing an in-place intravascular device such as a catheter or guidewire from a patient'"'"'s body lumen such as from a coronary artery and advancing a catheter or other similar device through the vascular system until its distal end is located at a desired location within the vascular system. The system includes an exchange catheter, which may be a dilatation catheter, having a flexible strand forming a loop at the distal end of the catheter which is adapted to be disposed about the guidewire or catheter which is in-place within the patient. The loop is tightened about the elongated intraluminal in-place device to be removed so that the catheter can be advanced over the in-place device until the distal end of the catheter is at a desired location within the patient'"'"'s vasculature. The catheter may be used to perform a diagnostic or therapeutic procedure such as an angioplasty or a replacement device may be advanced through an inner lumen and out the distal end of the catheter.

Claims

1. An intraluminal system for removing an elongated device, which has proximal and distal ends and which is disposed within a patient'"'"'s body lumen, without loss of access to a lumenal region about the distal end of the elongated device, comprising:

a) an elongated exchange member having proximal and distal ends; and

b) a flexible strand extending from the distal end of the exchange member and forming at least a partial loop which is configured to be disposed about and slidable over the elongated device to be removed to facilitate advancement of the exchange member over the elongated device to a desired location within the patient'"'"'s body lumen.

2. The intraluminal system of claim 1 wherein the strand forms essentially a complete loop.

3. The intraluminal system of claim 1 including means to tighten the loop about the elongated device to be removed.

4. The intraluminal system of claim 3 wherein the means to tighten the loop adjusts the length of the loop.

5. The intraluminal system of claim 3 wherein the means to tighten the loop is operable from the proximal end of the exchange member.

6. The intraluminal system of claim 1 wherein the flexible strand is formed of a superelastic alloy.

7. The intraluminal system of claim 6 wherein the superelastic alloy consists essentially of about 30 to about 52% titanium and the balance nickel and up to about 10% of one or more additional alloying elements selected from the group consisting of iron, cobalt, chromium, platinum and palladium in amounts of up to about 3% each and copper and vanadium in amounts up to about 10 each.

8. The intraluminal system of claim 1 wherein the elongated exchange member has an inner lumen extending proximally from a port in the distal end of the exchange member.

9. The intraluminal system of claim 8 wherein at least one length of the flexible strand extends within the inner lumen.

10. The intraluminal system of claim 8 wherein an elongated stylet is slidably disposed within the inner lumen of the exchange member and an end of the flexible strand is secured to a distal portion of the stylet.

11. The intraluminal system of claim 8 wherein at least one length of the strand extends through the inner lumen to the proximal end of the elongated exchange member.

12. The intraluminal system of claim 11 wherein the flexible strand has an end secured to a distal portion of the exchange member.

13. An intraluminal system for advancing an elongated catheter over on elongated intraluminal device disposed within a patient'"'"'s body lumen to a lumenal region about a distal portion of the elongated intraluminal device comprising:

a) an elongated catheter having proximal and distal ends and an inner lumen extending therein to a port in the distal end thereof;

b) an elongated flexible strand disposed within the inner lumen of the catheter with a portion of the strand extending out the port in the distal end of the catheter and forming a loop exterior thereto adapted to be disposed about the elongated intraluminal device disposed within the patient'"'"'s body lumen to facilitate advancement of the catheter over the elongated intravascular device to a desired location within the patient'"'"'s body lumen.

14. The intraluminal system of claim 13 including an elongated stylet extending within the inner lumen of the elongated catheter.

15. The intraluminal system of claim 14 wherein an end of the flexible strand is secured to a distal portion of the stylet.

16. The intraluminal system of claim 13 wherein a portion of the strand extends through the inner lumen of the catheter.

17. The intraluminal system of claim 16 wherein the portion of the flexible strand extending through the inner lumen of the catheter has a free end extending out the proximal end of the catheter which may be pulled to tighten the loop about the elongated intraluminal member.

18. The intraluminal system of claim 13 wherein the catheter has means on a distal portion to perform an intraluminal procedure.

19. The intraluminal system of claim 18 wherein the means for performing an intraluminal procedure is a dilatation balloon which has an interior in fluid communication with an inflation lumen extending through the catheter.

20. A method of advancing a catheter over an elongated intravascular device disposed within a patient'"'"'s vascular system comprising:

a) providing an elongated catheter having proximal and distal ends, a first inner lumen extending therein to a first port in the distal end of the catheter, a flexible strand extending from the distal end of the catheter and forming a loop exterior thereto;

b) disposing the loop formed by the flexible strand about the intravascular device disposed within the patient'"'"'s vascular system; and

c) advancing the catheter within the patient'"'"'s vascular system with the loop formed by the flexible strand sliding over the intravascular device disposed within the patient'"'"'s vascular system until the distal end of the catheter is at a desired location within the patient'"'"'s vascular system.

21. The method of claim 20 including withdrawing the elongated intravascular device from the patient'"'"'s vascular system leaving the catheter in place.

22. The method of claim 20 wherein the loop is tightened about the intravascular device before the catheter is advanced over the intravascular device.

23. The method of claim 21 including advancing a replacement intravascular device through a second inner lumen of the catheter until the replacement device extends out of the distal end of the catheter.

24. A method for performing an angioplasty procedure within a patient'"'"'s artery, comprising:

a) providing an elongated dilatation catheter having proximal and distal ends, a first inner lumen extending therein to a first port in the distal end of the dilatation catheter, an inflatable dilatation balloon on a distal portion of the dilatation catheter, a second inner lumen extending therein to an interior of the balloon, and a flexible strand which extends through the first inner lumen and out of the port in the distal end of the dilatation catheter and which forms a loop exterior thereto;

b) disposing a proximal portion an intravascular device disposed within the patient'"'"'s artery within the loop;

c) advancing the dilatation catheter into and within the patient'"'"'s artery, with loop sliding on the intravascular device, until the distal end of the dilatation catheter is located at a desired location within the patient'"'"'s artery; and

d) inflating the dilatation balloon within a stenosis within the patient'"'"'s artery to perform an angioplasty procedure.

25. The method of claim 24 including withdrawing the elongated intravascular device from the patient'"'"'s artery, leaving the dilatation catheter in place.

26. The method of claim 24 wherein the loop is tightened about the elongated intravascular device before advancing the dilatation catheter within the patient'"'"'s artery.

27. The method of claim 25 wherein a replacement intravascular device is advanced through the first inner lumen, out the port in the distal end of the dilatation catheter into the patient'"'"'s artery.

28. The method of claim 27 wherein the replacement intravascular device is a guidewire.

29. The method of claim 28 wherein the dilatation catheter is advanced further within the patient'"'"'s artery over the replacement guidewire.

30. A balloon dilatation catheter assembly, comprising:

a) an elongated catheter shaft having proximal and distal ends, a first inner lumen extending therein to a port in the distal end of the shaft and a second inner lumen extending therein to a location proximal to the distal end of the shaft;

b) an expandable dilatation balloon on a distal portion of the catheter shaft having an interior in fluid communication with the second inner lumen;

c) a flexible strand disposed within the first inner lumen with a portion of the strand extending out the port in the distal end of the catheter shaft and forming a loop which is adapted to be mounted about an elongated intravascular device disposed within the patient'"'"'s artery to facilitate advancement of the catheter over the elongated intravascular device to a desired location within the patient'"'"'s artery.

31. The balloon dilatation catheter of claim 30 wherein an elongated stylet is disposed within the first inner lumen and an end of the flexible strand is secured to a distal portion of the stylet.

32. A stylet suitable for disposition within an inner lumen of an intravascular catheter, comprising:

a) an elongated core member having a tapered distal portion;

b) a flexible member having proximal and distal ends and being secured to the tapered distal portion of the core member;

c) an elongated flexible strand having one end secured to the distal end of the flexible member.

33. The stylet of claim 32 wherein the flexible strand is formed of a superelastic alloy.

34. The stylet of claim 33 wherein the superelastic alloy contains titanium and nickel.

35. The stylet of claim 33 wherein the superelastic alloy consists essentially about 30 to about 52% titanium and the balance nickel and up to 10% other alloying elements.

36. The stylet of claim 35 wherein the other alloying element are selected from the group consisting of iron, cobalt, chromium, platinum and palladium in amounts of up to 3% each and copper and vanadium in amount of up to 10% each.