Catheter with a pre-shaped distal tip

• US 8,403,912 B2
• Filed: 01/19/2011
• Issued: 03/26/2013
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: McFerran, Sean, Farnholtz, Roger, Barry, Gitanjali V., Armstrong, Kristen C.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/009,569
• Publication Number:
  US 20110112514A1
• Time in Patent Office: 797 Days
• Field of Search: 604523-528, 604/529
• US Class Current: 604/525
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• 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 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

Catheters having a pre-shaped tip configuration are disclosed. A catheter in accordance with an illustrative embodiment of the present invention can include an elongated tubular shaft equipped with a distal tip section having a pre-shaped tip configuration that can be used to facilitate tracking of the device through particular locations of the vasculature. The catheter may include a number of features that transition the stiffness and flexibility characteristics of the device and provide a means to radiographically visualize the catheter within the body.

Claims

1. A catheter comprising:

an elongated tubular shaft having a proximal shaft section, an intermediate shaft section, a distal shaft section, a length, and an interior lumen extending through the length adapted to slidably receive a guidewire;

wherein the elongated tubular shaft includes an inner layer extending from a proximal end of the elongated tubular shaft to a distal end of the elongated tubular shaft;

wherein the proximal shaft section includes a first outer layer segment comprising a relatively high durometer polymeric material, and the distal shaft section includes a second outer layer segment comprising a relatively low durometer polymeric material;

wherein the intermediate shaft section includes a third outer layer segment comprising a polymeric material having a durometer intermediate to the first outer layer segment and the second outer layer segment, and a fourth outer layer segment comprising a polymeric material having a durometer intermediate to the first outer layer segment and the second outer layer segment that is different from the third outer layer segment;

wherein the elongate tubular shaft further includes a first intermediate layer segment disposed between the inner layer and the first, second, third, and fourth outer layer segments and terminating distally at a first location within the distal shaft section proximal to the distal end, and a second intermediate layer segment disposed between the inner layer and the first, second, third, and fourth outer layer segments and extending distally from the first location to a second location proximal to the distal end; and

a distal tip section having a pre-shaped tip configuration.

2. The catheter of claim 1, wherein the inner layer includes a hydrophilic polymer.

3. The catheter of claim 1, wherein the third outer layer segment has a durometer greater than the fourth outer layer segment.

4. The catheter of claim 1, further comprising an outer coating of lubricious material disposed along all or a portion of the elongated tubular shaft.

5. The catheter of claim 1, further comprising a first radiopaque marker encased within the second outer layer segment.

6. The catheter of claim 5, further comprising second radiopaque marker encased within the second outer layer segment proximal to the first radiopaque marker.

7. The catheter of claim 1, further comprising a first coil segment comprising three wire coil layers disposed along the length of the elongated tubular shaft from a first location at or near the proximal end to a second location along the intermediate shaft section.

8. The catheter of claim 7, wherein the first coil segment is entirely encased within the first, third, and fourth outer layer segments.

9. The catheter of claim 7, further comprising a second coil segment extending from the second location to a third location along the distal shaft section proximal to the distal end.

10. The catheter of claim 9, wherein the second coil segment is entirely encased within the second and fourth outer layer segments.

11. The catheter of claim 9, wherein the second coil segment is more flexible than the first coil segment.

12. The catheter of claim 1, wherein the pre-shaped tip configuration comprises an angled tip configuration.

13. The catheter of claim 12, wherein the distal tip section includes a first straight section of the elongated tubular shaft, a curved section of the elongated tubular shaft extending distally of the first straight section, and a second straight section of the elongated tubular shaft extending distally from the curved section;

wherein the curved section is configured to orient the distal end of the elongated tubular shaft at an angle of about 35 degrees to about 55 degrees relative to a longitudinal axis of the elongated tubular shaft.

14. The catheter of claim 1, wherein the pre-shaped tip configuration comprises a J-shaped tip configuration.

15. The catheter of claim 14, wherein the distal tip section includes a first straight section of the elongated tubular shaft, a curved section of the elongated tubular shaft extending distally of the first straight section, and a second straight section of the elongated tubular shaft extending distally from the curved section;

wherein the curved section is configured to orient the distal end of the elongated tubular shaft in a proximal direction such that the distal end is disposed proximally of a distal-most portion of the curved section.

16. The catheter of claim 1, wherein the pre-shaped tip configuration comprises a C-shaped tip configuration.

17. The catheter of claim 16, wherein the distal tip section includes a first straight section of the elongated tubular shaft, a first curved section of the elongated tubular shaft extending distally of the first straight section, a second straight section of the elongated tubular shaft extending distally from the first curved section, and a second curved section of the elongated tubular shaft extending distally from the second straight section;

wherein the distal tip section is configured to orient the distal end toward the proximal end at an oblique angle to a longitudinal axis of the elongated tubular shaft.

18. The catheter of claim 1, wherein the pre-shaped tip configuration comprises an S-shaped tip configuration.

19. The catheter of claim 18, wherein the distal tip section includes a first straight section of the elongated tubular shaft, a first curved section of the elongated tubular shaft extending distally of the first straight section, a second straight section of the elongated tubular shaft extending distally from the first curved section, a second curved section of the elongated tubular shaft extending distally from the second straight section, a third straight section extending distally from the second curved section, a third curved section extending distally from the third straight section, and a fourth straight section extending distally from the third curved section;

wherein the distal tip section is configured such that the third straight section crosses a longitudinal axis of the elongated tubular shaft and the fourth straight section crosses the longitudinal axis such that the distal end is disposed on an opposite side of the longitudinal axis from the third curved section and is oriented non-parallel to the longitudinal axis.

20. The catheter of claim 1, wherein the pre-shaped tip configuration comprises a curved tip configuration;

wherein the distal tip section includes a first straight section of the elongated tubular shaft and a curved section of the elongated tubular shaft extending distally of the first straight section;

wherein the curved section is configured to orient the distal end of the elongated tubular shaft at an angle of approximately 90 degrees to a longitudinal axis of the elongated tubular shaft.