Catheter with spiral cut transition member

• US 6,475,209 B1
• Filed: 03/24/2000
• Issued: 11/05/2002
• Est. Priority Date: 10/15/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Volk, Angela Kornkven, Larson, Christopher R.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Lam, Ann Y
• Application Number:
  US09/534,870
• Time in Patent Office: 956 Days
• Field of Search: 604/523, 604/524, 604/525, 604/526, 604/527, 604/103.01, 604/104.01, 604/264
• US Class Current: 604/525
• 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 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A spiral cut transition member is disclosed for controlling the transition in stiffness of a catheter from a stiffer more pushable proximal section to a more flexible and trackable distal section and increasing kink resistance. The transition member has a spiral cut provided therein to vary the flexibility of the transition member over its length. The pitch of the spiral cut can be varied to facilitate a gradual transition in flexibility along the catheter. The transition member may be used in conjunction with any type of catheter including single-operator-exchange type catheters, over-the wire type catheters, and/or fixed-wire type catheters.

Claims

1. A catheter assembly, comprising:

an elongate outer tube having a transition in flexibility;

an elongate inner member having a proximal end and a distal end, the inner member being co-axially disposed within the lumen of the outer tube to form an annular lumen therebetween, the inner member having a transition in flexibility; and

a transition tube co-axially disposed within the annular lumen between the inner member and outer tube, the transition tube positioned adjacent at least a portion of the transition in flexibility of the inner member, and having a spiral cut therethrough along at least a portion thereof, wherein the transition tube overlaps at least a portion of the transition in flexibility of the inner member.

2. A catheter assembly according to claim 1, wherein the transition tube has in order a first end region, an intermediate region, and a second end region, wherein only the first end region is secured to the inner member.

3. A catheter assembly according to claim 2, wherein the second end region is more flexible than the first end region.

4. A catheter assembly according to claim 2, wherein the first end region is secured to the shaft proximate the transition in flexibility of the inner member.

5. A catheter assembly according to claim 1, wherein the transition tube is formed from a stainless steel hypotube.

6. A catheter assembly, comprising:

an elongate outer tube having a proximal outer section and a distal outer section joined together at a junction, the distal outer section being more flexible than the proximal outer section;

an elongate inner tube having a proximal end and a distal end with a guide wire lumen extending therethrough, the inner tube being co-axially disposed within the lumen of the outer tube to form an annular lumen therebetween, the inner tube having a transition in flexibility; and

a transition tube co-axially disposed within the annular lumen between the inner and outer tubes, the transition tube having a proximal end and a distal end with a side wall extending from the proximal end to the distal end defining a lumen therethrough, the proximal end of the transition tube being located proximal of the junction and the distal end of the transition tube being located distal of the Junction, the side wall of the transition tube having a spiral cut therethrough along at least a portion thereof, wherein the transition tube overlaps at least a portion of the transition in flexibility of the inner member.

7. A catheter assembly according to claim 6, wherein the flexibility of the transition tube gradually changes along the spiral cut portion of the transition tube.

8. A catheter assembly according to claim 7, wherein the spiral cut has a pitch that decreases along the spiral cut portion toward the distal end of the transition tube.

9. A catheter assembly according to claim 8, wherein the pitch of the spiral cut decreases at a substantially constant rate along the spiral cut portion toward the distal end of the transition tube.

10. A catheter assembly according to claim 8, wherein the pitch of the spiral cut decreases at a variable rate along the spiral cut portion toward the distal end of the transition tube.

11. A catheter assembly according to claim 6, wherein the inner tube has in order a proximal portion, an intermediate portion, and a distal portion, the proximal portion having a first outer diameter, the distal portion having a second outer diameter that is smaller than the first outer diameter, and the intermediate portion having an outer diameter that tapers from the first outer diameter to the second outer diameter.

12. A catheter assembly according to claim 11, wherein the transition tube is secured to the intermediate portion of the inner tube.

13. A catheter assembly according to claim 11, wherein the intermediate portion of the inner tube has a bump and the transition tube frictionally secured thereon.

14. A catheter assembly according to claim 6, wherein the side wall of the transition tube defines an inner surface and an outer surface, wherein at least a spaced part of the inner surface is spaced from the inner tube and at least a spaced part of the outer surface is spaced from the outer tube, at least when the catheter assumes a substantially straight configuration in and around the transition tube.

15. A catheter assembly according to claim 14, wherein the spaced part of the inner surface of the transition tube engages the inner tube and the spaced part of the outer surface of the transition tube engages the outer tube when the catheter assumes a bent configuration in and around the transition tube.

16. A catheter assembly according to claim 6, wherein the transition tube has in order a first end region, an intermediate region, and a second end region, wherein only the first end region is secured to the inner tube.

17. A catheter assembly according to claim 6, wherein the transition tube is secured to the inner tube proximal of the junction.

18. A catheter assembly according to claim 17, wherein the transition tube is secured to the inner tube using an adhesive.

19. A catheter assembly according to claim 6, wherein the spiral cut is formed using a laser beam.

20. A catheter assembly according to claim 6, wherein the transition tube is formed from a stainless steel hypotube.

21. A catheter assembly according to claim 20, wherein the hypotube is heat-treated.

22. A catheter assembly according to claim 6, wherein the transition tube is formed from a polymer.

23. A catheter assembly according to claim 6, wherein the catheter is a catheter having a type selected from the group consisting of a single-operator-exchange type catheter, an over-the wire type catheter, and a fixed-wire type catheter.