Ostial stent

• US 20060106455A1
• Filed: 11/12/2005
• Published: 05/18/2006
• Est. Priority Date: 11/12/2004
• Status: Active Grant

• Current Assignee: Mirus LLC
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Furst, Joseph G., Sachar, Ravish
• Granted Patent: US 7,455,688 B2
• Time in Patent Office: Days
• US Class Current: 623/1.310
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An improved medical device for use in the treatment of stenosis of the ostium of tubular organs, such as, but not limited to blood vessels. The improved medical device includes a configuration and design that enables at least one end region of the improved medical device to flare outwardly.

Claims

1. A medical device designed to be positioned within a vascular structure, said medical device including a body portion and a flaring section, said body portion having a body diameter, said flaring section having a flaring diameter, said body diameter and said flaring diameter being different when said sections are in an expanded state, said flaring diameter being at least about 25% greater than a minimum body diameter of said body portion in an expanded state, said flaring section has a maximum flare angle in said expanded state that is greater than 90°

relative to a longitudinal axis of said body portion.

2. The graft as defined in claim 1, wherein said flaring section and said body portion having substantially the same diameter in a non-expanded state.

3. The graft as defined in claim 1, wherein said body portion has a substantially uniform diameter in said expanded state.

4. The graft as defined in claim 1, wherein said flaring section has a nonlinear rate of flaring in said expanded state.

5. The graft as defined in claim 1, wherein said flaring section has a maximum flare angle in said expanded state that is less than about 160°

relative to a longitudinal axis of said body portion.

6. The graft as defined in claim 1, wherein at least a portion of said flaring section has a flare angle in said expanded state of less than 90°

relative to a longitudinal axis of said body portion and at least a portion of said flaring section has a flare angle in said expanded state of greater than 90°

relative to the longitudinal axis of said body portion.

7. The graft as defined in claim 1, wherein said flaring section, said body section or combinations thereof include a shape memory material.

8. The graft as defined in claim 1, including a disengagable physical hindrance that at least partially maintains said body portion and said flaring section in an unexpanded form.

9. The graft as defined in claim 8, wherein said physical hindrance includes an adhesive, a sheath or combinations thereof.

10. The graft as defined in claim 1, wherein said body portion, said flaring section or combinations thereof includes one or more layers of porous material, non-porous material, or combinations thereof.

11. The graft as defined in claim 10, wherein said non-porous material includes parylene or any derivative thereof.

12. The graft as defined in claim 1, wherein said body portion, said flaring section or combinations thereof includes at least one biological agent.

13. The graft as defined in claim 11, wherein said body portion, said flaring section or combinations thereof includes at least one biological agent.

14. The graft as defined in claim 12, wherein said biological agent includes trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

15. The graft as defined in claim 13, wherein said biological agent includes trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

16. A medical device designed to be positioned within a vascular structure, said medical device including a body portion and a flaring section, said body portion having a body diameter, said flaring section having a flaring diameter, said body diameter and said flaring diameter being different when said sections are in an expanded state, said flaring section forming a substantially uniform and single structure in said expanded state, said flaring section and said body portion formed of substantially the same material, said flaring diameter being at least about 25% greater than a minimum body diameter said body portion in an expanded state, said body portion constituting a majority of a longitudinal length of said medical device, said flaring section has a maximum flare angle in said expanded state that is greater than 90°

and less than about 160°

relative to a longitudinal axis of said body portion, said flaring section has a nonlinear rate of flaring in said expanded state.

17. The graft as defined in claim 16, wherein said medical device includes a self-expanding body portion, a self-expanding flaring section, or combinations thereof.

18. The graft as defined in claim 16, wherein medical device has a generally uniform structural pattern for said flaring section and said body portion in said expanded state.

19. The graft as defined in claim 16, including a disengagable physical hindrance that at least partially maintains said body portion and said flaring section in an unexpanded form.

20. The graft as defined in claim 19, wherein said physical hindrance includes an adhesive, a sheath or combinations thereof.

21. The graft as defined in claim 16, wherein said body portion, said flaring section or combinations thereof includes one or more layers of porous material, non-porous material, or combinations thereof.

22. The graft as defined in claim 21, wherein said non-porous material includes parylene or any derivative thereof.

23. The graft as defined in claim 16, wherein said body portion, said flaring section or combinations thereof includes at least one biological agent.

24. The graft as defined in claim 22, wherein said body portion, said flaring section or combinations thereof includes at least one biological agent.

25. The graft as defined in claim 23, wherein said biological agent includes trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

26. The graft as defined in claim 24, wherein said biological agent includes trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

27. A method of stenting the ostium of a tubular organ comprising the steps of:

a) inserting a medical device partially into said ostium, said medical device including a body portion and a flaring section, said body portion having a body diameter, said flaring section having a flaring diameter, said body diameter and said flaring diameter being different when said sections are in an expanded state, said flaring diameter being at least about 25% greater than a minimum body diameter of said body portion in an expanded state, said flaring section having a maximum flare angle in said expanded state that can be greater than 90°

relative to a longitudinal axis of said body portion; and

,

b) expanding said medical device to cause said body portion to expand in at least a portion of said tubular organ and to cause said flaring section to substantially fully cover said ostium and to at least partially inhibit vasculature ingrowth in regions covered by said expanded flaring section, said flaring section in an expanded position substantially covering at least about 0.5 mm of a region about said ostium, at least a portion of said flaring section having a flare angle in said expanded state that is greater than 90°

relative to a longitudinal axis of said body portion.

28. The method as defined in claim 27, wherein at least a portion of said flaring section having a flare angle in said expanded state that is less than 90°

relative to a longitudinal axis of said body portion

29. The method as defined in claim 27, wherein said medical device includes a self-expanding body portion, a self-expanding flaring section, or combinations thereof.

30. The method as defined in claim 27, wherein medical device has a generally uniform structural pattern for said flaring section and said body portion in said expanded state.

31. The method as defined in claim 27, wherein said flaring section and said body portion are formed of the same material.

32. The method as defined in claim 27, wherein said body portion constitutes a majority of a longitudinal length of said medical device.

33. The method as defined in claim 27, wherein said flaring section has a nonlinear rate of flaring in said expanded state.

34. The method as defined in claim 27, wherein said body portion, said flaring section or combinations thereof includes one or more layers of porous material, non-porous material, or combinations thereof.

35. The method as defined in claim 34, including the step of at least partially controlling molecular diffusion of at least one biological agent through said layer of non-porous material.

36. The method as defined in claim 35, wherein said non-porous material includes parylene or any derivative thereof.

37. The method as defined in claim 27, wherein said body portion, said flaring section or combinations thereof includes at least one biological agent.

38. The method as defined in claim 37, wherein said biological agent includes trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

39. The method as defined in claim 27, including the step of at least partially expanding said medical device by a balloon.

40. The method as defined in claim 27, including the step of at least partially expanding said medical device by removing a physical hindrance on said medical device.

41. The method as defined in claim 40, wherein said physical hindrance includes an adhesive, a sheath, or combinations thereof.

42. The method as defined in claim 41, including the steps of:

inserting said medical device by use a sheath type delivery system into the ostium of a tubular organ; and

,

retracting the sheath to permit said medical device to at least partially expand to said expanded state.

43. The method as defined in claim 42, wherein a balloon is used to at least partially assist in the expansion of said medical device.

44. The method as defined in claim 42, including the steps of:

maintaining at least a portion of said medical device in an unexpanded state by use of an adhesive during insertion of said medical device in said vascular structure;

inserting said medical device by use of delivery system into the ostium of a tubular organ; and

,

inflating a balloon to at least partially cause said medical device to expand and to at least partially break adhesion by said adhesive between said balloon and said medical device.

45. The method as defined in claim 27, including the steps of inserting a second stent in the tubular organ and closely adjacent to said medical device after said medical device has been at least partially expanded, and expanding said second stent such that a portion of said second stent contacts at least a portion of said flaring section of said medical device and causes said portion of said flaring section to flare further outwardly.

46. The method as defined in claim 45, wherein said second stent is deployed extending from the left main coronary artery into said left anterior descending artery or said left circumflex artery.

47. The method as defined in claim 27, wherein said medical device is at least partially formed by MEMS technology.