Means and method for the accurate placement of a stent at the ostium of an artery

• US 20080082155A1
• Filed: 10/18/2007
• Published: 04/03/2008
• Est. Priority Date: 05/30/2006
• Status: Active Grant

• Current Assignee: Merit Medical Ireland, Limited (Merit Medical Systems, Inc.), Merit Medical Systems, Inc.
• Original Assignee: Ostiel Solutions, LLC
• Inventors: Zyzelewski, Mark, Fischell, Tim, Fischell, David, Fischell, Robert
• Granted Patent: US 7,651,520 B2
• 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Disclosed is an ostial stent positioner that has the form of a wire for most of its length and having a short cylinder with a longitudinal slit and expandable legs situated at the positioner'"'"'s distal end. The slit cylinder with its attached wire acts as an introducer sheath to introduce a stent delivery system with a stent into the artery that is to be stented. A second aspect of the present invention 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. Also disclosed are designs for the slit cylinder that provides a variable diameter so as to fit snugly within guiding catheters having different inside diameters.

Claims

1. An introducer sheath type of ostial stent positioner for facilitating the placement by an operator of the proximal end of a stent within ±

2 mm of the ostial plane of an artery that has an ostial stenosis, the positioner having a wire extending for most of its length that is attached to a variable diameter cylinder that has an adjustable outer diameter that becomes essentially the same dimension as the inside diameter of a guiding catheter into which the cylinder is placed, the variable diameter cylinder being designed to exert a gentle outward force against the interior wall of the guiding catheter, the wire extending for most of the length of the positioner having a distal section and a proximal section with the distal section being shorter in length and smaller in diameter as compared to the proximal section of the wire, the variable diameter cylinder also being fixedly attached to at least two expandable distal legs that end with radiopaque feet that form a distal plane when they are pushed in a distal direction out of the distal end of the guiding catheter and against the interior wall of the aorta, the positioner being designed for placement of the distal plane of the radiopaque feet to be substantially co-planar with the ostial plane of the artery when the ostial stent positioner is urged forward in a distal direction after the expandable distal legs have been expanded radially outward beyond the distal end of the guiding catheter through which the positioner can be placed.

2. The positioner of claim 1 where the variable diameter cylinder is adapted to be placed into guiding catheters having diameters that lie between 4 Fr and 14 Fr.

3. The positioner of claim 1 where the wire has a handle at its proximal end to facilitate the handling of the positioner by the operator.

4. The positioner of claim 3 where the handle is formed from a plastic material having a color that is distinctly different from the gray color of a guide wire.

5. The positioner of claim 1 where the expandable legs have feet that are formed from a radiopaque metal or coated with a radiopaque metal.

6. The positioner of claim 5 where the feet on the expandable legs have an outside diameter when expanded that lies between 4 and 15 mm.

7. The positioner of claim 1 where the positioner has expandable legs that are formed from a combination of a plastic material and a metal, the combination being generally radiopaque.

8. The positioner of claim 1 where the variable diameter cylinder has expandable legs that are generally in the shape of a flower that has at least two petals.

9. The positioner of claim 8 where the cylinder'"'"'s expandable legs form at least four petals.

10. The positioner of claim 1 where the variable diameter cylinder of the ostial stent positioner has a wedge-like surface for easy placement into the distal end of a guiding catheter, the wedge-like structure having an angle “

A”

that lies between 10 and 30 degrees.

11. The positioner of claim 1 where the variable diameter cylinder of the ostial stent positioner has a slit in its outer circumferential surface so as to have an outside diameter that is variable depending on the inside diameter of the guiding catheter into which the cylinder is inserted.

12. The positioner of claim 11 where the slit cylinder that is attached to the expandable legs has an angle where the slit cylinder is joined to the distal wire section that is less than 30 degrees.

13. The positioner of claim 1 where the variable diameter cylinder of the ostial stent positioner has a helical, flat wire, cylinder structure so as to have an outside diameter that is variable depending on the inside diameter of the guiding catheter into which the cylinder is inserted.

14. The positioner of claim 1 where both the distal and proximal sections of the wire extending for most of the length of the positioner is formed from the metal Nitinol.

15. The positioner of claim 1 where the variable diameter cylinder is formed from a shape memory alloy.

16. The positioner of claim 15 where the shape memory alloy that is used to form the variable diameter cylinder is super elastic Nitinol.

17. 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) placing an introducer sheath type of ostial stent positioner that has at least two expandable distal legs into a guiding catheter with the expandable legs in an unexpanded state, the expandable legs having at least some portion that is radiopaque and the expandable legs being attached to a cylinder that is less than 10% as long as the length of the guiding catheter and the positioner having a wire for most of its length that has a smaller diameter distal section as compared to the diameter of the longer proximal section;

b) causing the expandable legs to expand in a region beyond the distal end of the guiding catheter;

c) urging the ostial stent positioner in a forward, distal direction so that a distal plane of the expanded legs 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 legs of the positioner so that the stent'"'"'s proximal end is located within ±

2 mm of the ostial plane of the artery when the stent is deployed.

18. The method of claim 17 where the positioner'"'"'s expanded legs are generally shaped in the form of a flower with at least two petals.

19. The method of claim 17 where the expanded legs have at least some portion that is formed from a radiopaque metal or coated with a radiopaque metal.

20. The method of claim 17 where the expanded legs are attached to a variable diameter cylinder that is formed from a shape memory alloy.

21. The method of claim 20 where both the expanded legs and the variable diameter cylinder are both formed from a shape memory alloy.

22. The method of claim 17 where the cylinder is a variable diameter cylinder that seeks an outside diameter that is substantially the same as the inside diameter of the guiding catheter into which the variable diameter cylinder is inserted.

23. The method of claim 22 where the variable diameter cylinder is a slit cylinder.

24. An introducer sheath type of ostial stent positioner for facilitating the placement by an operator of the proximal end of a stent within ±

2 mm of the ostial plane of an artery that has an ostial stenosis, the positioner having a wire extending for most of its length that is attached to a variable diameter cylinder that is adapted to be placed within a guiding catheter, the outside diameter of the variable diameter cylinder being substantially the same as the inside diameter of the guiding catheter into which the variable diameter cylinder is inserted, the length of the variable diameter cylinder being less than 10% of the length of the guiding catheter, the variable diameter cylinder also being attached to at least two expandable distal legs that end with radiopaque feet that form a distal plane when they are pushed in a distal direction out of the distal end of the guiding catheter and against the interior wall of the aorta, the positioner being designed for placement of the distal plane of the radiopaque feet to be substantially co-planar with the ostial plane of the artery when the ostial stent positioner is urged forward in a distal direction after the expandable distal legs have been expanded radially outward beyond the distal end of the guiding catheter.

25. The positioner of claim 24 where the variable diameter cylinder is a slit cylinder.

26. 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) placing an introducer sheath type of ostial stent positioner that has at least two expandable distal legs with radiopaque feet into a guiding catheter with the expandable legs in an unexpanded state, the legs being attached to a short cylinder;

b) positioning the guiding catheter with its distal section within the aorta aligned generally perpendicular to the ostial plane;

c) causing the expandable legs to expand in a region beyond the distal end of the guiding catheter;

d) moving the ostial stent positioner in a forward direction so that the distal plane of the feet of the expanded legs is placed substantially co-planar with the ostial plane of the artery that has the ostial stenosis; and

e) 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 legs of the positioner so that the stent'"'"'s proximal end is located within ±

2 mm of the ostial plane of the artery when the stent is deployed.

27. The method of claim 26 where the positioner'"'"'s expanded legs are generally shaped in the form of a flower with at least two petals.

28. The method of claim 26 where the feet of the expanded legs have at least some portion that is formed from a radiopaque metal or coated with a radiopaque metal.

29. The method of claim 26 where the short cylinder to which the expanded legs are attached is a variable diameter cylinder.

30. The method of claim 29 where both the expanded legs and the variable diameter cylinder are both formed from a shape memory alloy.