Introducer sheath for the ostial placement of a stent

• US 20040111143A1
• Filed: 12/06/2002
• Published: 06/10/2004
• Est. Priority Date: 12/06/2002
• Status: Abandoned Application

• Current Assignee: Ostial Solutions, LLC (Merit Medical Systems, Inc.)
• Original Assignee: Ostial Solutions, LLC (Merit Medical Systems, Inc.)
• Inventors: Fischell, Robert E., Fischell, Tim A.
• Application Number:
  US10/310,209
• Publication Number:
  US 20040111143A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents

Abstract

Disclosed is a catheter that has the form of an introducer sheath having an expandable radiopaque flange situated at the sheath'"'"'s distal end. The distal end of the flange is adapted to be placed at the ostial plane of a stenosed artery. Also disclosed is a method for accurately placing a stent at the ostium of an artery that would have an ostial stenosis. Examples of such arteries that have ostial stenoses are the right and left main coronary arteries, a saphenous vein graft as used in coronary bypass surgery and the renal arteries. The sheath is placed within a guiding catheter that has its distal end located close to the ostium of an artery where there is a stensosis. When the introducer sheath is advanced beyond the distal end of the guiding catheter, a flange expands at the end of the sheath. The flange is then pushed forward until its distal end is at the ostial plane of the ostium of the stenosed artery. A stent on a stent delivery system can then be positioned accurately relative to the expanded flange.

Claims

1. An introducer sheath for facilitating the placement of the proximal end of a stent within ±

2 mm of the ostial plane of an artery that has an ostial stenosis, the sheath having an expandable distal portion that has a distal plane, the sheath being adapted to be placed within a guiding catheter and being further adapted for placement of its distal plane so as to be substantially co-planar with the ostial plane of the artery when the guiding catheter is urged forward in a distal direction.

2. The sheath of claim 1 wherein the expandable distal portion of the sheath is generally radiopaque.

3. The sheath of claim 1 wherein the expandable distal portion of the sheath is in the form of an expandable flange.

4. The sheath of claim 3 wherein the expandable flange is formed from a radiopaque plastic material.

5. The sheath of claim 3 wherein the expandable flange is formed from a radiopaque metal.

6. The sheath of claim 3 wherein the expandable flange is formed from a combination of a plastic material and a metal, the combination being generally radiopaque.

7. The sheath of claim 1 wherein the expandable flange is generally in the shape of a flower that has at least two petals.

8. The sheath of claim 1 wherein the expandable flange has at least four petals.

9. The sheath of claim 1 wherein the expandable distal portion has an outer diameter of less than 10 mm.

10. A method for placing the proximal end of a stent within an artery that has an ostial stenosis so that the stent'"'"'s proximal end is positioned within ±

2 mm of the artery'"'"'s ostial plane, the method including the following steps;

a) advancing an introducer sheath that has an expandable distal portion within a guiding catheter with the expandable distal portion in its unexpanded state;

b) causing the expandable distal portion to expand in a region beyond the distal end of the guiding catheter to form an expanded flange;

c) urging the guiding catheter in a forward, distal direction so that a distal plane of the expanded flange is placed substantially co-planar with the ostial plane of the artery that has the ostial stenosis; and

d) positioning a stent within the stenosis of the artery so that the stent'"'"'s proximal radiopaque marker band is situated relative to the distal plane of the expanded flange of the sheath so that the stent'"'"'s proximal end is located within ±

2 mm of the ostial plane.

11. The method of claim 10 wherein the sheath'"'"'s expanded flange is generally shaped in the form of a flower with at least two petals.

12. The method of claim 10 wherein the expanded flange is generally radiopaque.

13. The method of claim 10 wherein the expandable distal portion is in the form of an expandable balloon that is adapted to be inflated so as to form a distal plane that can be placed essentially co-planar with the ostial plane of the artery.