Angioplasty balloon with an expandable external radiopaque marker band

• US 5,759,174 A
• Filed: 01/29/1997
• Issued: 06/02/1998
• Est. Priority Date: 01/29/1997
• Status: Expired due to Term

• Current Assignee: Cathco, Inc.
• Original Assignee: Cathco, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/790,447
• Time in Patent Office: 489 Days
• Field of Search: 604/96, 604/100, 604/101, 604/104-106, 604/264, 604/280, 606/191, 606/192, 606/194, 606/198, 606/195, 623/1, 128/656-658
• US Class Current: 604/103.1
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An expandable external radiopaque marker band is situated external to the balloon of a balloon angioplasty catheter typically at the balloon'"'"'s longitudinal center. When the balloon is inflated to dilate an arterial stenosis, the external radiopaque marker band is moved radially outward by the balloon thereby forcing the external radiopaque marker band into the arterial wall. When the balloon is then deflated, the external radiopaque marker band remains in place against the wall of the dilated stenosis. The balloon angioplasty catheter can then be removed from the artery while the expanded external radiopaque marker band remains in place to indicate (typically) the center position of the dilated stenosis. The external radiopaque marker band is typically made from a dense, radiopaque metal such as tantalum, gold, platinum or an alloy of those dense metals.

Claims

1. A balloon catheter having a distal section with an inflatable balloon located at that distal section and having one expandable external radiopaque marker band located coaxially around and external to the inflatable balloon, the longitudinal length of the external radiopaque marker band when it is deployed being less than one-third the length of the cylindrical section of the balloon when the balloon is inflated.

2. The balloon catheter of claim 1 wherein the one external radiopaque marker band is located at the longitudinal center of the balloon.

3. The balloon catheter of claim 1 wherein the balloon catheter is a balloon angioplasty catheter and the balloon is an angioplasty balloon.

4. The balloon catheter of claim 1 wherein the balloon catheter is an elastic balloon catheter and the balloon is an elastic balloon.

5. The balloon catheter of claim 1 wherein the balloon catheter also has at least one non-expandable radiopaque marker band located within the balloon of the balloon catheter.

6. The balloon catheter of claim 5 wherein there are two non-expandable radiopaque marker bands located inside the balloon of the balloon catheter.

7. The balloon catheter of claim 5 wherein there is only one non-expandable radiopaque marker band and it is located proximal to the longitudinal position of the expandable external radiopaque marker band.

8. The balloon catheter of claim 1 wherein the external radiopaque marker band is fabricated from a metal having a specific gravity greater than 9.0.

9. The balloon catheter of claim 8 wherein the metal is pure tantalum.

10. The balloon catheter of claim 8 wherein the metal is an alloy containing tantalum.

11. The balloon catheter of claim 8 wherein the metal is pure gold.

12. The balloon catheter of claim 8 wherein the metal is an alloy of gold.

13. The balloon catheter of claim 8 wherein the metal is pure platinum.

14. The balloon catheter of claim 8 wherein the metal is an alloy of platinum.

15. A method for marking a specific location in a blood vessel of a human subject, the method comprising:

(a) placing a balloon angioplasty catheter having a distal section and having at that distal section an angioplasty balloon with one external radiopaque marker band mounted externally to and coaxially around the angioplasty balloon through the blood vessel until the external radiopaque marker band is situated at a position within the blood vessel that is to be marked;

(b) inflating the angioplasty balloon thus radially expanding the external radiopaque marker band at the site to be marked the external radiopaque marker band then having a longitudinal length that is less than one-third the length of the cylindrical section of the inflated balloon;

(c) deflating the angioplasty balloon and removing the balloon angioplasty catheter from the patient'"'"'s blood vessel; and

(d) retaining the radially deployed external radiopaque marker band at the location within the blood vessel that was to be marked.

16. The method of claim 15 wherein the site to be marked is at the center of an arterial stenosis.

17. The method of claim 15 wherein the specific location within the blood vessel that is to be marked is at an arterial stenosis and the inflation of the angioplasty balloon simultaneously dilates the stenosis and deploys the external radiopaque marker band radially outward into the wall of the dilated stenosis thus providing a radiopaque marker at one specific location.