Catheter and guidewire system with flexible distal portions

• US 5,507,301 A
• Filed: 12/28/1994
• Issued: 04/16/1996
• Est. Priority Date: 11/19/1993
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Brooks, Dennis L., Wasicek, Lawrence D.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/365,324
• Time in Patent Office: 475 Days
• Field of Search: 604/96-103, 604/170, 606/192-196, 128/772, 128/656-658
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A guidewire having a core member with proximal, intermediate and distal sections and a flexible coil on the distal section and a catheter assembly or kit with such guidewire. The proximal section of the core may be substantially longer than the combined lengths of both the intermediate and distal sections and has a diameter which is at least 0.001 inch greater than the diameter of the intermediate section. The intermediate section has a diameter which is at least 0.002 inch greater than the diameter of the distal section. Improved pushability and a greater flexibility in the distal and intermediate sections are obtained. A catheter which is used with the guidewire has a proximal section of about 100 cm and a distal section of at least about 15 cm in length and an inner lumen having diameter of at least 0.003 inch less than the inner diameter of the inner lumen in the proximal section.

Claims

1. A guidewire configured for advancement within a patient'"'"'s coronary artery comprising:

a) a core member which includes

an elongated proximal core section;

an intermediate core section having a diameter of at least about 0.001 inch less than the diameter of the proximal section, and

a distal core section having a diameter of at least 0.002 inch less than the diameter of the intermediate section; and

b) a flexible member disposed about the distal core section and having an outer diameter not more than about 0.0015 inch greater than the diameter of the intermediate core section.

2. The guidewire of claim 1 wherein the proximal core section has a length of at least 100 cm and a diameter between about 0.01 and about 0.02 inch.

3. The guidewire of claim 1 wherein the intermediate core section has a length of at least 3 cm.

4. The guidewire of claim 1 wherein the distal core section has a length of at least 3 cm.

5. The guidewire of claim 1 wherein the distal core section has a flattened distal tip.

6. The guidewire of claim 1 wherein the flexible member is a helical coil.

7. The guidewire of claim 5 wherein the helical coil has a plurality of longitudinally expanded turns in a distal portion.

8. The guidewire of claim 6 wherein the helical coil has a distal portion which is more highly radiopaque than a proximal portion of the coil.

9. The guidewire of claim 1 wherein the individual lengths of the intermediate and distal core sections are about 15 to about 30 cm.

10. The guidewire of claim 1 wherein the length of the proximal core section is at least 40 cm.

11. The guidewire of claim 1 wherein a tapered transition section is provided between the proximal core section and the intermediate core section.

12. The guidewire of claim 1 wherein a tapered transition section is provided between the intermediate core section and the distal core section.

13. The guidewire of claim 1 wherein the intermediate core section has a length of at least 10 cm.

14. The guidewire of claim 1 wherein the distal core section has a length of at least 10 cm.

15. An over-the-wire dilatation catheter comprising:

a) an outer tubular member having a relatively long proximal section with an inner lumen extending therein and a relatively short distal section with an inner lumen extending therein, with the inner lumen within the distal section having a diameter less than the diameter of the inner lumen within the proximal section;

b) an inner tubular member with a proximal section having a length less than the length of the proximal section of the outer tubular member, a distal section with a length greater than the length of the distal section of the outer tubular member and an inner lumen extending therein with the portion of the inner lumen within the proximal section having a diameter at least 0.002 inch greater than the inner diameter of the portion of the inner lumen within the distal section, the diameter of the inner lumen within the proximal section being about 0.01 to about 0.022 inch and the diameter of the inner lumen within the distal section being about 0.008 to 0.015 inch;

c) an inflation lumen extending between the exterior of the inner tubular member and the interior of the outer tubular member; and

d) an inflatable dilatation member on the distal section of the outer tubular member having an interior in fluid communication with the inflation lumen extending between the inner and the outer tubular members.

16. The dilatation catheter of claim 15 wherein the inner diameter of the outer tubular member is about 0.002 to about 0.004 inch greater than the outer diameter of the inner tubular member.

17. The dilatation catheter of claim 15 wherein the length of the proximal section of the inner tubular member is about 1 to about 10 cm less than the proximal section of the outer tubular member.

18. An over-the-wire dilatation catheter assembly comprising:

a) an over-the-wire dilatation catheter which includes

an outer tubular member having a proximal portion with a length of at least 100 cm and an inner lumen extending therein, a distal portion with a length of at least about 15 cm and an inner lumen extending therein which has a diameter of not more than about 0.003 inch less than the minimum inner diameter of the lumen in the proximal portion;

an inner tubular member with a proximal portion having a length less than the length of the proximal portion of the outer tubular member but at least 90 cm and a distal portion with a length of at least 20 cm but greater than the length of the distal portion of the outer tubular member,

an inflation lumen extending between the inner and outer tubular members,

a guidewire receiving inner lumen extending within the inner tubular member, the portion of the guidewire receiving inner lumen within the distal section of the inner tubular member having a smaller diameter than the guidewire receiving inner lumen within the proximal section of the inner tubular member,

an inflatable dilatation member on the distal portion of the outer tubular member having an interior in fluid communication with the inflation lumen extending between the inner and the outer tubular members; and

b) a guidewire slidably disposed within the guidewire receiving inner lumen within the inner tubular member of the dilatation catheter, the guidewire including

a proximal core section having a length of at least about 100 cm and a diameter between about 0.012-0.02 inch,

an intermediate core section having a diameter of at least about 0.002 inch less than the diameter of the proximal section,

a distal core section having a diameter of at least about 0.002 inch less than the diameter of the intermediate section, and

a flexible coil disposed about and secured to the distal core section and having an outer diameter not more than about 0.0015 inch greater than the diameter of the intermediate core section.

19. The over-the-wire dilatation catheter assembly of claim 18 wherein the intermediate core section of the guidewire has a length of at least 10 cm.

20. The over-the-wire dilatation catheter assembly of claim 18 wherein the distal core section has a length of at least 10 cm.

21. An angioplasty kit comprising:

a) an over-the-wire dilatation catheter which includes

an outer tubular member having a proximal portion with a length of at least about 100 cm and an inner lumen extending therein, a distal portion with a length of at least about 15 cm and an inner lumen extending therein which has a diameter of about 0.003 inch less than the minimum inner diameter of the proximal portion;

an inner tubular member with a proximal portion having a length less than the length of the proximal portion of the outer tubular member but at least about 90 cm and a distal portion with a length of at least about 20 cm but greater than the length of the distal portion of the outer tubular member,

an inflation lumen extending between the inner tubular member and the outer tubular member;

a guidewire receiving inner lumen extending within the inner tubular member with the diameter of the inner lumen in the proximal portion thereof having a larger diameter than the inner lumen extending within the distal section thereof,

an inflatable dilatation member on the distal portion having an interior in fluid communication with the inflation lumen extending between the inner and the outer tubular members; and

b) a guidewire configured to be slidably disposed within the guidewire receiving inner lumen within the inner tubular member of the dilatation catheter which includes

a proximal core section having a length of at least about 100 cm and a diameter between about 0.010 and about 0.02 inch,

an intermediate core section having a diameter of at least about 0.001 inch less than the diameter of the proximal section,

a distal core section having a diameter of at least about 0.002 inch less than the diameter of the intermediate section; and

a flexible coil member disposed about and secured to the distal core section and having an outer diameter not more than about 0.0015 inch greater than the diameter of the intermediate core section.

22. The angioplasty kit of claim 21 wherein the intermediate core section of the guidewire has a length of at least 10 cm.

23. The angioplasty kit of claim 21 wherein the distal core section of the guidewire has a length of at least 10 cm.