Catheter with a pre-shaped distal tip

• US 7,896,861 B2
• Filed: 10/13/2009
• Issued: 03/01/2011
• Est. Priority Date: 10/21/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Armstrong, Kirsten C., Farnholtz, Roger, Barry, Gitanjali V., McFerran, Sean
• Primary Examiner(s): Stigell; Theodore J
• Application Number:
  US12/577,841
• Publication Number:
  US 20100030191A1
• Time in Patent Office: 504 Days
• Field of Search: 604523-532
• 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 end, a proximal shaft section, an intermediate shaft section, a distal shaft section, a distal end, a length extending from the proximal end to the distal end, and an interior lumen adapted to slidably receive a guidewire, each of said proximal, intermediate, and distal shaft sections including an outer layer of material having a different durometer adapted to transition the stiffness of the elongated tubular shaft from a relatively stiff configuration along the proximal shaft section to a relatively flexible configuration along the distal shaft section;

wherein the interior lumen of the elongated tubular shaft includes an inner layer or coating of lubricious material;

wherein the proximal shaft section extends for at least about 76% of the length of the elongated tubular shaft;

an intermediate layer disposed between the elongated tubular shaft and the inner layer or coating, the intermediate layer comprising;

a first intermediate layer segment disposed about the inner layer along a portion of the proximal, intermediate, and distal shaft sections; and

a second intermediate layer segment disposed about the inner layer along a portion of the distal shaft section, the second intermediate layer segment extending distally from the first intermediate layer segment to a location proximal to the distal end of the elongated tubular shaft;

wherein the second intermediate layer segment is more flexible than the first intermediate layer segment;

a reinforcement comprising a first coil segment having a plurality of wire coil layers encased within the outer layers of the proximal and intermediate sections and a second coil segment extending distally from the first coil segment, the second coil segment comprising a single wire coil layer encased within the outer layers of the intermediate and distal sections;

wherein the first coil segment extends proximally to a strain relief member at the proximal end of the elongate tubular shaft;

wherein the first and second coil segments each have a coil pitch, wherein the coil pitch of the second coil segment is greater than the coil pitch of the first coil segment; and

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

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

3. The catheter of claim 1, wherein the outer layer of material forming the proximal shaft section has a durometer greater than the outer layer of material forming the distal shaft section.

4. The catheter of claim 1, wherein the outer layer of material forming the intermediate shaft section has a durometer greater than the outer layer of material forming the distal shaft section and a durometer less than the outer layer of material forming the proximal shaft section.

5. The catheter of claim 4, wherein the outer layer of the intermediate shaft section comprises a first outer layer segment formed of a first material, and a second outer layer segment formed of a second material different than the first material.

6. The catheter of claim 5, wherein the first material of said first outer layer segment has a durometer greater than the second material of said second outer layer segment.

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

8. The catheter of claim 1, further comprising a first radiopaque marker encased within the distal shaft section of the elongated tubular shaft.

9. The catheter of claim 8, further comprising a second radiopaque marker encased within the distal shaft section of the elongated tubular shaft proximal to the first radiopaque marker.

10. The catheter of claim 1, wherein the elongated tubular shaft includes radiopaque filler.

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

12. The catheter of claim 1, wherein said pre-shaped tip configuration comprises a multi-curved tip configuration.

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

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

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

16. The catheter of claim 1, further comprising a mandrel disposed within the interior lumen of the elongated tubular shaft.