Bifurcation stent with crushable end and method for delivery of a stent to a bifurcation

• US 20060079956A1
• Filed: 08/10/2005
• Published: 04/13/2006
• Est. Priority Date: 09/15/2004
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Eigler, Neal L., Shanley, John F., Diaz, Stephen Hunter, Litvack, Frank
• Application Number:
  US11/200,765
• Publication Number:
  US 20060079956A1
• Time in Patent Office: Days
• US Class Current: 623/1.350
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/954 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

A bifurcation stent includes a first end which is deformable or crushable at a lower force than a second end. The crushable first end and more rigid second end of the bifurcation stent allow one end of the stent to remain expanded in tissue supporting configuration in a side branch of a vessel bifurcation while the other end is easily crushed against the side wall of the main vessel into which it extends. A method of supporting a bifurcated body lumen with the bifurcation stent involves delivering the bifurcation stent in an unexpanded configuration to a bifurcation in a body lumen, positioning the bifurcation stent with the distal portion substantially within a side branch vessel of the bifurcation and the proximal crushable portion substantially within the main vessel, expanding the bifurcation stent, and expanding a main vessel stent along side the bifurcation stent and thereby crushing at least a portion of the crushable proximal portion of the bifurcation stent against the main vessel wall.

Claims

1. A method of supporting a bifurcated body lumen, the method comprising:

delivering an bifurcation stent in an unexpanded configuration to a bifurcation in a body lumen, the bifurcation stent having a distal portion and a crushable proximal portion which is deformable at a lower force than the distal portion;

positioning the bifurcation stent with the distal portion substantially within a side branch vessel of the bifurcation and the proximal portion substantially within the main vessel;

expanding the bifurcation stent into a seated arrangement in the side branch vessel;

expanding a main vessel stent along side the bifurcation stent and thereby crushing at least a portion of the crushable proximal portion of the bifurcation stent against the main vessel wall.

2. The method of claim 1, further comprising locating the unexpanded bifurcation stent in the side branch vessel by a visual indication.

3. The method of claim 1, further comprising locating the unexpanded bifurcation stent in the side branch vessel by a tactile indication.

4. The method of claim 1, wherein the crushable proximal portion of the bifurcation stent is formed with deformable portions having a smaller width than deformable portions of the distal portion of the device.

5. The method of claim 1, wherein the crushable proximal portion of the stent is formed with deformable portions having a smaller thickness than deformable portions of the distal portion of the device.

6. The method of claim 1, wherein the crushable proximal portion of the stent is formed of a different material than the distal portion allowing the crushable proximal portion to be deformed more easily than the distal portion.

7. The method of claim 1, wherein the crushable proximal portion of the stent is formed of a different strut configuration than the distal portion allowing the crushable proximal portion to be deformed more easily than the distal portion.

8. A method of supporting a bifurcated body lumen, the method comprising:

delivering a pre-crushed stent into a side branch vessel of a bifurcation, the pre-crushed stent having a distal tubular tissue supporting portion and a proximal crushed portion;

arranging the pre-crushed stent with the distal tubular tissue supporting portion substantially within a side branch vessel of the bifurcation and the proximal crushed portion extending into a main vessel of the bifurcation; and

expanding the distal tubular tissue supporting portion of the stent within the side branch.

9. The method of claim 8, further comprising delivering a main vessel stent to the main vessel adjacent an opening of the side branch vessel, and expanding the main vessel stent into contact with the crushed portion of the pre-crushed stent.

10. The method of claim 8, wherein the pre-crushed stent is delivered on a balloon catheter having a balloon positioned within the distal tubular portion of the pre-crushed stent.

11. The method of claim 10, wherein the balloon catheter passes through a side hole in the pre-crushed stent and along an outside surface of the crushed portion of the pre-crushed stent.

12. The method of claim 11, wherein the balloon catheter aligns the side hole in the pre-crushed stent with the opening into the side branch vessel of the bifurcation.

13. A pre-crushed stent comprising a continuous tubular body expandable from a delivery configuration to an expanded tissue supporting configuration, the body at the delivery configuration having a first tubular tissue supporting segment and a second crushed portion connected to the first tubular portion.

14. The pre-crushed stent of claim 13, wherein the second crushed portion has a strut arrangement which is the same as the first tubular portion.

15. The pre-crushed stent of claim 13, wherein the second crushed portion has a strut arrangement which is different from the first tubular portion.

16. The pre-crushed stent of claim 13, wherein the second crushed portion is crushed such that a first side of the tube is in contact with a second side of the tube substantially eliminating any tube lumen at the second portion.

17. The pre-crushed stent of claim 13, wherein the first tubular portion includes a drug.

18. A stent and delivery system comprising:

a pre-crushed stent comprising a continuous tubular body expandable from a delivery configuration to an expanded tissue supporting configuration, the body at the delivery configuration having a first tubular tissue supporting portion and a second crushed portion connected to the first tubular portion; and

a balloon catheter comprising a balloon positioned within the first tubular tissue supporting portion of the pre-crushed stent.

19. The system of claim 18, wherein the balloon catheter extends outside of the second crushed portion.

20. The system of claim 18, wherein the second crushed portion has a strut arrangement which is the same as the first tubular portion.

21. The system of claim 18, wherein the second crushed portion has a strut arrangement which is different from the first tubular portion.

22. The system of claim 18, wherein the second crushed portion is crushed such that a first side of the tubular portion is in contact with a second side of the tubular portion substantially eliminating any tube lumen at the second crushed portion.

23. The system of claim 18, wherein the balloon catheter extends through a side opening between struts on the circumferential surface of the stent.

24. The system of claim 18, wherein the pre-crushed stent includes a drug.

25. A method of delivering a stent to a bifurcated body lumen, the method comprising:

delivering an expandable stent in an unexpanded configuration to a bifurcation in a body lumen, the bifurcation having a main vessel and a side branch vessel;

at least partially expanding a proximal portion of the stent;

advancing a distal end of the stent into the side branch vessel of the bifurcation until a junction between the expanded proximal portion and an unexpanded distal portion of the stent is seated into the opening of the side branch vessel; and

expanding the distal portion of the stent in the side branch vessel.

26. The method of claim 25, wherein the proximal portion of the stent is expandable by application of a first force applied by inflating a balloon catheter to a first pressure, and the distal portion of the stent is expandable by application of a second force greater than the first force by inflating the balloon catheter to a second pressure.

27. The method of claim 26, wherein the proximal portion of the stent is formed with deformable elements having a smaller width than deformable elements of the distal portion of the device.

28. The method of claim 26, wherein the proximal portion of the stent is formed with deformable elements having a smaller thickness than deformable elements of the distal portion of the device.

29. The method of claim 26, wherein the proximal portion of the stent is formed of a different material than the distal portion allowing the proximal end to be deformed more easily than the distal end.

30. The method of claim 26, wherein the proximal portion of the stent is formed of a different strut configuration than the distal portion allowing the proximal portion to be deformed more easily than the distal portion.

31. The method of claim 25, wherein the stent is expanded by a first balloon catheter, the first balloon catheter is removed and a second stent is expanded in a main vessel passing across the side vessel opening of the bifurcation.

32. The method of claim 31, wherein the expansion of the second stent crushes at least a portion of the proximal end of the stent against a wall of the main vessel.

33. A bifurcation stent and delivery system comprising:

a stent comprising a continuous tubular body expandable from a delivery configuration to an expanded tissue supporting configuration, the body having a distal tubular tissue supporting portion configured to be positioned within a side branch vessel of a bifurcation and a proximal crushable portion connected to the distal tubular portion and configured to be positioned within a main vessel lumen adjacent the bifurcation, the proximal tubular having a crush strength less than the distal tubular portion; and

a balloon catheter comprising a balloon connected to a distal end of an elongated catheter shaft, the stent positioned on the balloon.

34. The stent of claim 33, wherein the distal tubular portion has an axial length equal to or greater than the proximal tubular portion.

35. The stent of claim 33, wherein the proximal tubular portion is crushable by a force which is 80% or less of a force required to crush the distal tubular portion.

36. The stent of claim 33, wherein the stent comprises a structure of substantially non-deforming struts interconnected by deformable hinges.

37. The stent of claim 36, wherein the hinges in the proximal crushable portion have a cross section less than the hinges in the distal tubular tissue supporting section.

38. The stent of claim 33, wherein the distal tubular tissue supporting portion includes a drug.

39. The stent of claim 38, wherein the proximal crushable portion does not include a drug.

40. The stent of claim 33, wherein the proximal tubular portion is crushable by a force which is 60% or less of a force required to crush the distal tubular portion.

41. The stent of claim 33, wherein the stent includes a drug and a portion of the stent corresponding to the ostium of the bifurcation includes a higher drug concentration than a remainder of the stent.