Balloon catheter with flexible radiopaque polymeric marker

• US 6,540,721 B1
• Filed: 12/29/1999
• Issued: 04/01/2003
• Est. Priority Date: 12/29/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Rice, Cheryl, Lee, Jeong S., Voyles, Carolyn
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Lam, Ann Y
• Application Number:
  US09/474,620
• Time in Patent Office: 1,189 Days
• Field of Search: 604/96.01, 604/103.1, 604/103.11, 604/103.12, 604/264
• US Class Current: 604/103.1
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An elongated intracorporeal device, more specifically, a balloon catheter having an elongate shaft with a distal section. The distal section of the shaft has a distal inner tubular member with an inflatable balloon disposed about the distal inner tubular member. A radiopaque marker formed at least in part of a polymer is disposed on the distal inner tubular member. The flexible radiopaque marker can be formed either by doping a desired portion of the distal inner tubular member with an appropriate radiopaque material, or preforming the radiopaque marker from a polymer doped with a radiopaque material and subsequently securing the radiopaque marker to the distal inner tubular member.

Claims

1. A balloon catheter having an elongate shaft with a proximal section and a relatively short distal section, the distal section comprising:

a) a distal inner tubular member comprising a first polymer, and having a longitudinal axis, an outer surface and an inner surface;

b) an inflatable balloon disposed about the distal inner tubular member, and having a proximal end, a distal end, and an interior disposed between the proximal and distal end; and

c) a tubular flexible radiopaque marker comprising a second polymer located at the distal inner tubular member and disposed within the inflation member interior, having an inner surface and an outer surface that is substantially radially congruent with the outer surface of the distal inner tubular member, such that the longitudinal transition between the outer surface of the marker and the outer surface of the distal inner tubular member is smooth.

2. The balloon catheter of claim 1 wherein the radiopaque marker comprises a portion of the distal inner tubular member which has been doped with a radiopaque material.

3. The balloon catheter of claim 1 wherein the radiopaque marker comprises a discrete member which is secured to the distal inner tubular member.

4. The balloon catheter of claim 3 wherein the radiopaque marker is fused by heat and pressure to the distal inner tubular member.

5. The balloon catheter of claim 3 wherein the radiopaque marker is bonded with a polymeric adhesive to the distal inner tubular member.

6. The balloon catheter of claim 1 wherein the inner surface of the radiopaque marker is disposed between the inside surface of the distal inner tubular member and the outside surface of the radiopaque marker.

7. The balloon catheter of claim 1 wherein the inner surface of the radiopaque marker is substantially radially congruent with the inside surface of the distal inner tubular member.

8. The balloon catheter of claim 1 wherein the radiopaque marker is substantially longitudinally coextensive with the inflatable balloon.

9. The balloon catheter of claim 1 wherein the radiopaque marker is about 1 to about 50 mm in length.

10. The balloon catheter of claim 1 wherein the polymer of the radiopaque marker is doped with a radiopaque material.

11. The balloon catheter of claim 10 wherein the radiopaque material is selected from the group of materials consisting of tungsten, bismuth, tantalum, barium and compound or alloy thereof.

12. The balloon catheter of claim 1 wherein the polymer of the radiopaque marker is comprised of a material selected from the group consisting of polyethylene, polyether block amide, alpha olefin copolymers, polyester and polyamide.

13. The balloon catheter of claim 1 wherein the radiopaque marker is about 1 to about 40 mm in length.

14. The balloon catheter of claim 1 wherein the radiopaque marker comprises a first radiopaque marker and further comprising a second radiopaque marker disposed on the distal inner tubular member.

15. The balloon catheter of claim 14 wherein the first radiopaque marker is disposed at a proximal end of the balloon and the second radiopaque marker is disposed at a distal end of the inflatable balloon.

16. The balloon catheter of claim 1 wherein the radiopaque marker is axially disposed between a proximal end of the inflatable balloon and a distal end of the inflatable balloon.

17. The balloon catheter of claim 1 wherein the polymer of the radiopaque marker has a shore hardness that is selected such that the combined longitudinal flexibility of the radiopaque marker and a portion of the distal inner tubular member axially coextensive with the radiopaque marker is substantially equal to, or less than the nominal longitudinal flexibility of the distal inner tubular member axially adjacent the radiopaque marker.

18. The balloon catheter of claim 1 wherein the first polymer is a different material than the second polymer.

19. The balloon catheter of claim 1 wherein the first polymer and the second polymer is the same material.