Bi-directional stent delivery system

• US 8,864,811 B2
• Filed: 10/25/2010
• Issued: 10/21/2014
• Est. Priority Date: 06/08/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: VENITI, Inc. (Boston Scientific Corporation)
• Inventors: Kao, Stephen
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US12/911,604
• Publication Number:
  US 20110301685A1
• Time in Patent Office: 1,457 Days
• Field of Search: 623/1.11, 623/1.12
• 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 2/9517 handle assemblies therefor
• 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 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

Abstract

A bi-directional stent delivery system includes an inner elongate shaft, a radially expandable prosthesis disposed over the inner elongate shaft, an outer elongate shaft, and a shuttle sheath disposed over the radially expandable prosthesis. The distal portion of the inner shaft is releasably coupled to the distal portion of the shuttle sheath, and the distal portion of the outer shaft is releasably coupled the proximal portion of the shuttle sheath. Distal advancement of the inner shaft advances the shuttle sheath distally when the outer shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a proximal end to a distal end. Proximal retraction of the outer shaft retracts the shuttle sheath proximally when the inner shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a distal end to a proximal end thereof.

Claims

1. A bi-directional stent delivery system, said system comprising:

an elongated inner shaft having a proximal portion and a distal portion;

a radially expandable prosthesis disposed over the inner shaft, the prosthesis having a radially collapsed configuration and a radially expanded configuration, wherein in the collapsed configuration the prosthesis is adapted to be delivered through a vasculature, and in the expanded configuration the prosthesis engages a vessel wall;

an elongated outer shaft having a proximal portion and a distal portion; and

a shuttle sheath having a proximal portion and a distal portion, the shuttle sheath disposed over the radially expandable prosthesis and releasably lockable to the inner shaft and the outer shaft,

wherein the stent delivery system is configured to be selectively actuated between a proximal deployment configuration and a distal deployment configuration, when the stent delivery system is in the proximal deployment configuration, the shuttle sheath is locked with the inner shaft and unlocked from the outer shaft such that distal advancement of the inner shaft advances the shuttle sheath distally relative to the outer shaft, thereby allowing the prosthesis to radially expand from a proximal end thereof to a distal end thereof, and

when the stent delivery system is in the distal deployment configuration, the shuttle sheath is unlocked from the inner shaft and locked with the outer shaft such that proximal retraction of the outer shaft retracts the shuttle sheath proximally relative to the inner shaft, thereby allowing the prosthesis to radially expand from the distal end thereof to the proximal end thereof.

2. The system of claim 1, wherein the inner shaft comprises a lumen extending between the proximal and distal portions, the lumen configured to slidably receive a guidewire.

3. The system of claim 1, wherein the prosthesis comprises a first stent.

4. The system of claim 3, further comprising a second stent unattached and axially separated from the first stent by a gap.

5. The system of claim 3, wherein the first stent comprises a self-expanding stent.

6. The system of claim 3, wherein the first stent comprises a nickel titanium alloy.

7. The system of claim 1, wherein the outer shaft comprises a lumen extending between the proximal and distal portions thereof.

8. The system of claim 1, wherein the shuttle sheath has a length greater than or equal to the length of the radially expandable prosthesis.

9. The system of claim 1, wherein the shuttle sheath constrains the prosthesis along substantially the entire length of the prosthesis.

10. The system of claim 1, wherein the shuttle sheath has a proximal end, a distal end, and a lumen extending therebetween.

11. The system of claim 1, wherein the shuttle sheath comprises a substantially cylindrical sheath.

12. The system of claim 1, further comprising a distal coupling mechanism, the distal coupling mechanism releasably coupling the distal portion of the inner shaft to the distal portion of the shuttle sheath.

13. The system of claim 12, wherein the distal coupling mechanism comprises a bayonet coupling.

14. The system of claim 12, wherein the distal coupling mechanism comprises a threaded region on the distal portion of the inner shaft and a corresponding threaded region on the distal portion of the shuttle sheath.

15. The system of claim 12, wherein the distal coupling mechanism comprises a helical region on the distal portion of the inner shaft and a corresponding helical region on the distal portion of the shuttle sheath.

16. The system of claim 12, wherein the distal coupling mechanism comprises one or more of a snap fit, an interference fit, a barbed connector, a locking mechanism, a rotatable key lock, a linear key lock, a threaded bushing, a twist lock, a magnetic coupling, or a frangible connector.

17. The system of claim 1, further comprising a proximal coupling mechanism, the proximal coupling mechanism releasably coupling the distal portion of the outer shaft to the proximal portion of the shuttle sheath.

18. The system of claim 17, wherein the proximal coupling mechanism comprises a bayonet coupling.

19. The system of claim 17, wherein the proximal coupling mechanism comprises a threaded region on the distal portion of the outer shaft and a corresponding threaded region on the proximal portion of the shuttle sheath.

20. The system of claim 17, wherein the proximal coupling mechanism comprises a helical region on the distal portion of the outer shaft and a corresponding helical region on the proximal portion of the shuttle sheath.

21. The system of claim 17, wherein the proximal coupling mechanism comprises one or more of a snap fit, an interference fit, a barbed connector, a locking mechanism, a rotatable key lock, a linear key lock, a threaded bushing, a twist lock, a magnetic coupling, or a frangible connector.

22. The system of claim 1, wherein the inner shaft and the outer shaft each have a threaded region and are releasably lockable with the shuttle sheath by the threaded region of the respective inner or outer shaft threadably engaging a threaded region of the shuttle sheath, wherein rotation of the inner shaft in a first direction locks the inner shaft with the shuttle sheath and rotation of the inner shaft in a second direction opposite the first direction unlocks the inner shaft from the shuttle sheath, and wherein rotation of the outer shaft in the first direction unlocks the outer shaft from the shuttle sheath and rotation of the outer shaft in the second direction locks the outer shaft with the shuttle sheath.

23. The system of claim 1, wherein the inner shaft and the outer shaft each have a helix and are releasably lockable with the shuttle sheath by the helix of the respective inner or outer shaft helically engaging a helix of the shuttle sheath, wherein rotation of the inner shaft in a first direction locks the inner shaft with the shuttle sheath and rotation of the inner shaft in a second direction opposite the first direction unlocks the inner shaft from the shuttle sheath, and wherein rotation of the outer shaft in the first direction unlocks the outer shaft from the shuttle sheath and rotation of the outer shaft in the second direction locks the outer shaft with the shuttle sheath.

24. The system of claim 1, wherein the inner shaft is releasably lockable with the shuttle sheath with a first bayonet coupling mechanism having a slot in a first orientation, and the outer shaft is releasably lockable with the shuttle sheath with a second bayonet coupling mechanism having a slot in a second orientation opposite the first orientation of the first slot, and wherein rotation of the inner shaft in a first direction locks the inner shaft with the shuttle sheath and rotation of the inner shaft in a second direction opposite the first direction unlocks the inner shaft from the shuttle sheath, and wherein rotation of the outer shaft in the first direction unlocks the outer shaft from the shuttle sheath and rotation of the outer shaft in the second direction locks the outer shaft with the shuttle sheath.

25. The system of claim 1, further comprising a middle shaft concentric with the inner and the outer shafts, and disposed therebetween.

26. The system of claim 25, wherein the prosthesis is disposed over the middle shaft and in direct engagement therewith.

27. The system of claim 26, wherein the middle shaft comprises an outer surface that is substantially smooth.

28. The system of claim 25, wherein the middle shaft comprises a proximal stent stop and a distal stent stop, the proximal stent stop disposed proximally of the proximal end of the prosthesis, and the distal stent stop disposed distally of the distal end of the prosthesis, wherein the proximal stent stop prevents proximal movement of the prosthesis beyond the proximal stent stop, and the distal stent stop prevents distal movement of the prosthesis beyond the distal stent stop.

29. The system of claim 28, wherein the proximal stent stop comprises one or more of a ring, a band, a step, a bushing, or a sleeve, that prevent proximal movement of the prosthesis beyond the proximal stent stop.

30. The system of claim 28, wherein the distal stent stop comprises one or more of ring, a band, a step, a bushing, or a sleeve, that prevents distal movement of the prosthesis beyond the distal stent stop.

31. The system of claim 1, further comprising an actuator mechanism operably coupled with the inner and outer shafts to slidably move the inner and outer shafts at least one of proximally or distally relative to each other, the actuator mechanism configured to allow an operator to selectively lock and unlock the inner and outer shafts with the shuttle sheath.

32. The system of claim 1, further comprising an intravascular ultrasound device configured to allow visualization of the prosthesis and surrounding tissue.