Catheter with enhanced flexibility

• US 6,193,686 B1
• Filed: 06/30/1999
• Issued: 02/27/2001
• Est. Priority Date: 06/30/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Long, Chi Le, Estrada, Edward A., Stamberg, Barbara E., Wantink, Kenneth L., Chow, Mina W. B.
• Primary Examiner(s): MENDEZ, MANUEL A
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US09/345,664
• Time in Patent Office: 608 Days
• Field of Search: 604/103.06, 604/103.05, 604/103.08, 604/103.12, 604/103.04, 604/103.09, 604/103.11, 604/96.01, 606/192, 606/194
• US Class Current: 604/103.09
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient'"'"'s body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section. Dual lumen and concentric distal shaft sections are describes. Additionally, over-the-wire constructions are described in which the inner and outer tubular members forming part of the distal shaft section extend the length of the catheter.

Claims

1. An intravascular balloon catheter comprising:

a) an elongated shaft having proximal and distal ends, an inflation lumen extending therein and a guidewire receiving lumen extending through at least a distal portion of the elongated shaft;

b) a proximal shaft section having proximal and distal ends and a portion of the inflation lumen, the distal end of the proximal shaft section being tapered in the distal direction to smaller transverse dimensions;

c) a distal shaft section having a distal end, a port in the distal end, at least part of the guidewire receiving lumen extending within the distal shaft section to the port in the distal end, and at least part of the inflation lumen extending within the distal shaft section to a location proximal to the distal end of the distal shaft section;

d) an inflatable balloon on the distal shaft section having an interior in fluid communication with the inflation lumen therein; and

e) an intermediate shaft section extending between the proximal and distal shaft sections and having a tubular reinforcing member within the tubular reinforcing member and with the proximal end of the tubular reinforcing member secured to a distal extremity of the proximal shaft section proximal to the distal end of the proximal shaft section and the distal end of the tubular reinforcing member being secured within the inflation lumen in the distal shaft section.

2. The balloon catheter of claim 1 wherein the intermediate shaft section includes and inner tubular support member with proximal and distal ends and disposed within the tubular reinforcing member, the inner tubular support member extending proximally over and secured to at least a portion of the distal end of the proximal shaft section.

3. The balloon catheter of claim 2 including an outer jacket disposed about at least part of the proximal shaft section.

4. The balloon catheter of claim 3 wherein the outer jacket disposed about the proximal shaft section extends distally beyond the distal end of the inner tubular support member.

5. The balloon catheter of claim 4 wherein the portion of the outer jacket which extends beyond the distal end of the tubular reinforcing member has a smaller outer diameter than the portion of the outer jacket surrounding the tubular reinforcing member.

6. The balloon catheter of claim 5 wherein the outer jacket has an inner layer formed of a first polymeric material and an outer layer formed of a second polymeric material.

7. The balloon catheter of claim 1 wherein the distal shaft section has an inner tubular member and an outer tubular member disposed about the inner tubular member along a substantial portion of the length thereof.

8. The balloon catheter of claim 7 wherein at least part of the inflation lumen within the distal shaft section is defined between the outer tubular member and the inner tubular member.

9. The balloon catheter of claim 7 wherein the inner tubular member of the distal shaft section has an interior which defines at least in part the guidewire receiving lumen extending within the distal shaft section.

10. The balloon catheter of claim 7 wherein the inner tubular member of the distal shaft section has a proximal extremity which is adjacent to the tubular reinforcing member.

11. The balloon catheter of claim 7 wherein the inner tubular member of the distal shaft section is formed at least in part by a helical coil.

12. The balloon catheter of claim 11 wherein the helical coil of the inner tubular member is formed of metallic material.

13. The balloon catheter of claim 11 wherein the inner tubular member of the distal shaft section has an outer layer disposed about an exterior portion of the helical coil and an inner layer on an interior portion of the helical coil.

14. The balloon catheter of claim 13 wherein the inner liner of the helical coil is formed of lubricious polymeric material.

15. The balloon catheter of claim 7 wherein the outer tubular member of the distal shaft section has a proximal extremity which is disposed about a proximal extremity of the inner tubular member and a portion of the tubular reinforcing member.

16. The balloon catheter of claim 15 wherein the proximal extremity of the outer tubular member of the distal shaft section is sealingly disposed about the proximal extremity of the inner tubular member and the tubular reinforcing member.

17. The balloon catheter of claim 16 wherein the inner tubular member of the distal shaft section is formed at least in part by a helical coil and further includes and outer layer disposed about the helical coil and formed of a polymeric material which can be heat fused to the proximal extremity of the outer tubular member of the distal shaft section.

18. The balloon catheter of claim 16 further including an outer jacket disposed about at least a part of the proximal shaft section and formed of a polymeric material which can be heat fused to the tubular reinforcing member of the intermediate shaft section.

19. The balloon catheter of claim 18 wherein the distal shaft section inner and outer tubular members define therebetween, at least in part, the portion of the inflation lumen extending within the distal shaft section, the defined inflation lumen portion extending to a location proximate to the balloon and being in fluid communication with the interior of the balloon.

20. The balloon catheter of claim 7 wherein the inner tubular member extends to the proximal end of the catheter.

21. The balloon catheter of claim 7 wherein the outer tubular member extends to the proximal end of the catheter.

22. The balloon catheter of claim 1 wherein the distal shaft section has a dual lumen portion with the inflation lumen and the guidewire receiving lumen extending therein are side by side and a parallel relationship.