Methods and apparatus for luminal stenting

• US 8,591,566 B2
• Filed: 12/03/2012
• Issued: 11/26/2013
• Est. Priority Date: 02/23/2012
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Huynh, Andy, Farhat, Lawrence, Newell, Gabriel
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US13/692,021
• Publication Number:
  US 20130226276A1
• Time in Patent Office: 358 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 606/108
• US Class Current: 623/1.11
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A stent delivery system, a core assembly, and methods of operating the same are provided. The delivery system can comprise a catheter and the core assembly. The core assembly can comprise a constraining member, protruding member, a core member, and a stent extending along the core member. The tubular constraining member can be spaced apart from the core member and define a capture area. The protruding member can be disposed along the core member at least partially distal of the capture area. The stent can have a first portion disposed within the capture area and a second portion, distal to the first portion, extending across or over an outer surface of the protruding member so that the protruding member and the constraining member cooperate to inhibit expansion of the first portion of the stent.

Claims

1. A method of operating a stent delivery system within a vessel of a patient, comprising:

positioning a catheter in the vessel, the catheter having a lumen defining an axis extending between a proximal end and a distal end, such that the catheter distal end is at a treatment site;

positioning a core assembly within the catheter lumen, the core assembly having (i) an elongate member comprising a distal end, (ii) an intermediate portion comprising a distal end positioned at the member distal end, (iii) a stent having a distal portion and being carried by the intermediate portion, and (iv) a distal cover coupled to the member distal end, the distal cover being capable of rotating about a longitudinal axis with respect to the member, the core assembly being positioned within the lumen such that the intermediate portion distal end is positioned axially adjacent the catheter distal end with at least a portion of the distal cover extending in a space within the lumen radially between the intermediate portion distal end and the catheter distal end;

distally advancing the core assembly relative to the catheter to permit expansion of the stent distal portion, the expansion urging the distal cover away from the intermediate portion; and

proximally withdrawing the core assembly into the catheter such that the intermediate portion is positioned axially adjacent to the catheter distal end with the distal cover positioned out of the space.

2. The method of claim 1, wherein during proximal withdrawal of the core assembly into the catheter, the distal cover is positioned out of the space to provide a clearance between the intermediate portion and the catheter.

3. The method of claim 1, further comprising releasing the stent at the treatment site within the vessel.

4. The method of claim 3, further comprising proximally withdrawing the core assembly from the lumen while maintaining the catheter distal end in place at the treatment site.

5. The method of claim 4, further comprising inserting a second core assembly into the lumen, the second core assembly being configured to deliver a second stent at the treatment site.

6. The method of claim 1, wherein proximally withdrawing the core assembly comprises everting a free first end of the distal cover from a proximally oriented position to a distally oriented position.

7. The method of claim 6, wherein the distal cover is coupled to the core assembly at a distal cover second end, the first end being positioned distally relative to the second end when the distal cover is everted.

8. A method of operating a stent delivery system within a blood vessel of a patient, comprising:

positioning a catheter in the vessel, the catheter having a lumen extending between a proximal end and a distal end, such that the catheter distal end is at a treatment site;

advancing a core assembly distally within the catheter, the core assembly having (i) a distal portion, (ii) a distal cover extending from the distal portion, and (iii) a stent having a distal portion and being carried by the core assembly, the distal cover being capable of rotating about a longitudinal axis with respect to the distal portion, the core assembly being advanced within the catheter such that the distal cover extends proximally from the distal portion and an annular space between the distal portion and the catheter;

distally advancing the core assembly relative to the catheter to permit expansion of the stent distal portion, the expansion urging the distal cover radially away from the core assembly; and

proximally withdrawing the core assembly into the catheter such that the distal cover extends distally through the annular space.

9. The method of claim 8, wherein during proximal withdrawal of the core assembly into the catheter, the distal cover extends distally through the annular space to provide a clearance between the catheter and an intermediate portion of the core assembly proximal to the distal cover.

10. The method of claim 8, wherein proximally withdrawing the core assembly comprises everting a free first end of the distal cover from a proximally oriented position to a distally oriented position.

11. The method of claim 10, wherein the distal cover is coupled to the core assembly at a distal cover second end, the first end being positioned distally relative to the second end when the distal cover is everted.

12. A method of operating a stent delivery system within a blood vessel of a patient, comprising:

positioning a catheter in the vessel, the catheter having an inner wall and a lumen extending between a proximal end and a distal end, such that the catheter distal end is at a treatment site;

positioning a core assembly within the lumen, the core assembly comprising a distal cover extending in a proximal direction to at least partially cover a distal portion of a stent supported on the core assembly, the distal cover being capable of rotating about a longitudinal axis with respect to the core assembly, at least a portion of the distal cover being interposed between the stent distal portion and the inner wall;

distally advancing the stent distal portion beyond the catheter distal end to permit expansion of the stent distal portion; and

proximally withdrawing the core assembly into the lumen, the distal cover being retracted into the lumen in an everted configuration and oriented distally from the core assembly.

13. The method of claim 12, wherein the distal cover comprises an elongate flexible material having a first end and a second end, the material being coupled to the core assembly at the second end, and wherein proximally withdrawing the core assembly comprises everting the distal cover, such that the first end moves from a first configuration, in which the first end is located proximally relative to the second end, to a second configuration, in which the first end is located distally relative to the second end.

14. The method of claim 12, wherein the distal cover comprises a plurality of elongate flexible strips having first ends and second ends, the second ends being coupled to the core assembly, wherein proximally withdrawing the core assembly comprises everting the distal cover, such that the first ends are drawn together distal to the second ends.

15. The method of claim 12, wherein proximally withdrawing the core assembly comprises retracting the distal cover into the catheter, such that the distal cover extends distally through an annular space between the core assembly and the inner wall.

16. A core assembly, comprising:

a core member having an intermediate region and a distal tip;

a stent extending over the core member intermediate region and comprising a distal portion; and

a distal cover comprising a first end and a second end, the second end being coupled to the distal tip, the distal cover having a delivery orientation in which the first end (i) extends proximally relative to the distal tip and (ii) at least partially surrounds the stent, the distal cover being capable of rotating about a longitudinal axis with respect to the core member, the distal cover being movable from the delivery orientation to an everted orientation wherein the first end is positioned distally relative to the second end.

17. The core assembly of claim 16, wherein the distal cover comprises one or more elongate strips of material.

18. The core assembly of claim 16, wherein the distal cover comprises no more than two elongate strips of material.

19. The core assembly of claim 16, wherein the distal cover extends along at least about one third of the stent.

20. The core assembly of claim 16, wherein the core member comprises a wire.

21. The core assembly of claim 16, wherein the second end of the distal cover is rotatably coupled with respect to the core member.

22. The core assembly of claim 21, wherein the stent is configured to rotate about the core member at least in part due to the rotatable coupling of the distal cover.

23. The core assembly of claim 16, wherein the stent is mounted to the core member, the core member being configured to distally advance the stent through a catheter.

24. The core assembly of claim 16, wherein in the delivery orientation, the distal cover second end is coupled to the core member at a location distal to a distal end of the stent.

25. The core assembly of claim 16, wherein in the delivery orientation, the distal cover extends over between about 1 mm to about 3 mm of the stent.

26. The core assembly of claim 16, wherein the distal cover at least partially surrounds less than an entire length of the stent.

27. The core assembly of claim 26, wherein in the delivery orientation, the distal cover at least partially surrounds only a distal portion of the stent.

28. The core assembly of claim 16, wherein the stent is rotatable with respect to the core member.

29. The core assembly of claim 16, wherein the core member comprises a protruding member capable of rotating about the longitudinal axis with respect to the core member.

30. The core assembly of claim 29, wherein the protruding member comprises an outer surface configured to grip the stent between a catheter wall and the protruding member.

31. A core assembly, comprising:

a core member having an intermediate region;

a stent extending over the core member intermediate region; and

a distal cover comprising a first end and a second end, the second end being coupled to the core member so as to be capable of rotating about a longitudinal axis with respect to the core member, the distal cover having a delivery orientation in which the first end extends proximally relative to the intermediate region, the distal cover being movable from the delivery orientation to an everted orientation wherein the first end is positioned distally relative to the second end.

32. The core assembly of claim 31, wherein the second end of the distal cover is coupled indirectly to the core member.

33. The core assembly of claim 32, wherein the second end of the distal cover is coupled indirectly to the core member distal of the stent.

34. The core assembly of claim 31, wherein the core member comprises a hypotube.

35. The core assembly of claim 31, wherein the distal cover at least partially surrounds less than an entire length of the stent.

36. The core assembly of claim 31, wherein the core member comprises a protruding member capable of rotating about the longitudinal axis with respect to the core member.

37. The core assembly of claim 31, wherein the stent is rotatable with respect to the core member.

38. The core assembly of claim 31, wherein in the delivery orientation, the distal cover at least partially surrounds only a distal portion of the stent.

39. A core assembly for delivering a stent to an intracranial blood vessel, comprising:

a core member configured for advancement into the intracranial blood vessel;

a stent extending over the core member; and

a distal cover comprising a first end and a second end, the second end being coupled to the core member so as to be capable of rotating about a longitudinal axis with respect to the core member, the distal cover having a delivery orientation in which the first end extends proximally relative to a distal end of the core assembly, the distal cover being movable from the delivery orientation to an everted orientation wherein the first end is positioned distally relative to the second end.

40. The core assembly of claim 39, wherein the second end of the distal cover is coupled indirectly to the core member.

41. The core assembly of claim 39, wherein the distal cover at least partially surrounds less than an entire length of the stent.

42. The core assembly of claim 39, wherein the core member comprises a hypotube.

43. The core assembly of claim 39, wherein the core member comprises a protruding member capable of rotating about the longitudinal axis with respect to the core member.

44. The core assembly of claim 39, wherein the stent is rotatable with respect to the core member.