Rotating balloon expandable sheath bifurcation delivery

• US 20040172119A1
• Filed: 02/27/2003
• Published: 09/02/2004
• Est. Priority Date: 02/27/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Eidenschink, Tracee
• Granted Patent: US 7,367,989 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A medical device comprises a balloon catheter shaft having a catheter balloon. An outer balloon or sheath is disposed about the catheter balloon and is freely rotatable about the catheter balloon.

Claims

1. A medical device comprising:

a balloon catheter shaft having a catheter balloon, the catheter balloon having a length, a sheath disposed about the catheter balloon, the sheath being substantially freely rotatable about the catheter balloon, no portion of the sheath being more than about 5 centimeters proximal to a most proximal portion of the balloon.

2. The medical device of claim 1, wherein the balloon catheter shaft defines a first guide wire lumen, and the sheath at least partially defines a second guide wire lumen.

3. The medical device of claim 2, wherein a stent is disposed at least partially about the sheath.

4. The medical device of claim 3, wherein the stent is constructed and arranged for use in a bifurcation.

5. The medical device of claim 3, wherein the stent is at least partially self-expanding.

6. The medical device of claim 1, wherein the sheath is at least partially constructed of a shape memory material.

7. The medical device of claim 3, wherein the stent is at least partially constructed of a shape memory material.

8. The medical device of claim 1, wherein the sheath is constructed of at least one homogeneous layer.

9. The medical device of claim 8, wherein the sheath comprises an inner surface, at least a portion of the inner surface having a lower frictional interface than an adjacent portion.

10. The medical device of claim 8, wherein the sheath is constructed with a soft durometer polymer.

11. The medical device of claim 1, wherein the sheath is at least partially constructed of multiple layers.

12. The medical device of claim 11, wherein at least one of the layers is constructed of a first material having different properties from a second material found in at least one other layer.

13. The medical device of claim 11, wherein an inner layer of the sheath is in contact with the balloon, the inner layer constructed of at least one low friction material.

14. The medical device of claim 13, the low friction material is selected from the group consisting of PTFE, HDPE, or any combination thereof.

15. The medical device of claim 11, wherein there is an outer layer of a soft durometer polymer suitable for securing a stent to the sheath.

16. The medical device of claim 1, wherein the sheath has an expanded state when the balloon is in an expanded condition and an unexpanded state when the balloon is in an unexpanded condition.

17. The medical device of claim 16, wherein the sheath rotates substantially freely about the balloon when the sheath is in both the unexpanded state and the expanded state.

18. The medical device of claim 1, further comprising at least one safety tether.

19. The medical device of claim 18, wherein the at least one safety tether is a pullwire, the pullwire being positioned external of at least one of the guide wire lumens.

20. The medical device of claim 18, wherein the at least one safety tether is a pullwire, the pullwire being disposed in at least one of the guide wire lumens.

21. The medical device of claim 1, wherein the balloon has at least one balloon cone distal to the distal most portion of the sheath and at least one balloon cone proximal to the proximal most portion of the sheath.

22. The medical device of claim 1, further comprising at least one marker band disposed about the balloon catheter shaft, the at least one marker band being positioned adjacent to at least one end of the sheath, the marker band having a greater diameter than the cross-sectional diameter of the sheath.

23. The medical device of claim 22, wherein the at least one marker band includes at least one marker band that has at least one radiopaque portion.

24. The medical device of claim 2, wherein a rotating collar is positioned about the second wire lumen and the balloon catheter shaft.

25. The medical device of claim 24, wherein a first longitudinal lock is positioned about the second wire lumen and proximal to the rotating collar, and a second longitudinal lock is positioned about the balloon catheter shaft and distal to the rotating collar such that the longitudinal position of the sheath and collar is maintained.

26. The medical device of claim 24, wherein a hypotube having a distal end and a proximal end is engaged to the sheath at the distal end of the hypotube and to the collar at the proximal end.

27. The medical device of claim 26, wherein the hypotube is spiral cut.

28. The medical device of claim 26, wherein the hypotube is at least partially constructed of stainless steel.

29. The medical device of claim 26, wherein the hypotube is at least partially constructed of a polymer.

30. The medical device of claim 26, wherein the proximal end of the hypotube is disposed in a second guide wire lumen of the collar.

31. The medical device of claim 26, wherein the proximal end of the hypotube is engaged to an outside surface of the collar.

32. The medical device of claim 1 wherein the sheath has a length that is substantially the same as the length of the catheter balloon.

33. The medical device of claim 1 wherein the balloon has a body portion with a cone portion distal to the body portion and a cone portion proximal to the body portion, the sheath disposed about the body portion and having a length substantially the same as the length of the body portion of the catheter balloon.

34. The medical device of claim 1 wherein the length of the sheath is no greater than 2 centimeters longer than the length of the balloon.

35. The medical device of claim 1 wherein the sheath extends distally from a location proximal to the proximal end of the catheter balloon.

36. The medical device of claim 35 wherein the sheath extends distally from a location equal to or less than 2 centimeters proximal to the proximal end of the catheter balloon.

37. The medical device of claim 8, wherein the sheath is constructed of a polymer with a durometer hardness of less than about 55D.

38. The medical device of claim 1 wherein the sheath is a balloon.

39. A medical device comprising:

a balloon catheter shaft having a catheter balloon, an outer balloon disposed about the catheter balloon, the outer balloon being substantially freely rotatable about the catheter balloon.