BI-DIRECTIONAL STENT DELIVERY SYSTEM

• US 20110301685A1
• Filed: 10/25/2010
• Published: 12/08/2011
• 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
• Granted Patent: US 8,864,811 B2
• Time in Patent Office: Days
• 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 inner elongate shaft having a proximal portion and a distal portion;

a radially expandable prosthesis disposed over the inner elongate 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 patient'"'"'s vasculature, and in the expanded configuration the prosthesis engages a vessel wall;

an outer elongate 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,

wherein 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, and

wherein 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 thereof to a distal end thereof, and

wherein 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 thereof to a 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 stent.

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

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 is threadably engaged with the shuttle sheath, and the outer shaft is also threadably engaged with the shuttle sheath, and wherein the threads engaging the inner shaft with the shuttle sheath have a first orientation, and the threads engaging the outer shaft with the shuttle sheath have a second orientation opposite of the first orientation such that rotation of the inner shaft in a first direction couples the inner shaft with the shuttle sheath and rotation of the inner shaft in a second direction opposite the first direction disengages the inner shaft from the shuttle sheath, and wherein rotation of the outer shaft in the first direction disengages the outer shaft from the shuttle sheath and rotation of the outer shaft in the second direction engages the outer shaft with the shuttle sheath.

23. The system of claim 1, wherein the inner shaft is helically engaged with the shuttle sheath, and the outer shaft is also helically engaged with the shuttle sheath, and wherein the helix engaging the inner shaft with the shuttle sheath have a first orientation, and the helix engaging the outer shaft with the shuttle sheath have a second orientation opposite of the first orientation such that rotation of the inner shaft in a first direction couples the inner shaft with the shuttle sheath and rotation of the inner shaft in a second direction opposite the first direction disengages the inner shaft from the shuttle sheath, and wherein rotation of the outer shaft in the first direction disengages the outer shaft from the shuttle sheath and rotation of the outer shaft in the second direction engages the outer shaft with the shuttle sheath.

24. The system of claim 1, wherein the inner shaft is coupled with the shuttle sheath with a first bayonet coupling mechanism having a slot in a first orientation, and the outer shaft is coupled with the shuttle sheath with a second bayonet coupling mechanism having a slot in a second orientation opposite the first slot, and wherein rotation of the inner shaft in a first direction couples the inner shaft with the shuttle sheath and rotation of the inner shaft in a second direction opposite the first direction disengages the inner shaft from the shuttle sheath, and wherein rotation of the outer shaft in the first direction disengages the outer shaft from the shuttle sheath and rotation of the outer shaft in the second direction engages 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 stopping element disposed proximally of a proximal end of the prosthesis, and the distal stopping element disposed distally of a distal end of the prosthesis, wherein the proximal stopping element prevents proximal movement of the prosthesis, and the distal stopping element prevents distal movement of the prosthesis.

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

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

31. The system of claim 1, further comprising an actuator mechanism disposed near a proximal end of the delivery system, the actuator mechanism operably coupled with the inner and outer shafts, thereby allowing an operator to couple and uncouple the inner and outer shafts with the shuttle sheath, and wherein the actuator mechanism is also configured to slidably move the inner and the outer shafts both proximally and distally.

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

33. A bi-directional method for deploying a prosthesis at a treatment site in a patient, said method comprising:

providing a delivery catheter comprising a prosthesis having a proximal end and a distal end, the prosthesis in a collapsed configuration and disposed on the delivery catheter;

delivering the prosthesis to the target treatment site;

selecting a deployment direction for the prosthesis, wherein the deployment direction comprises radially expanding the prosthesis from the proximal end thereof to the distal end thereof, and radially expanding the prosthesis from the distal end thereof to the proximal end thereof;

removing a constraint from the prosthesis thereby permitting the prosthesis to radially expand in the selected deployment direction;

radially expanding the prosthesis from the collapsed configuration to an expanded configuration in the selected deployment direction so that the expanded prosthesis engages tissue at the target treatment site; and

withdrawing the delivery catheter from the patient and leaving the prosthesis deployed at the target treatment site.

34. The method of claim 33, wherein the prosthesis comprises a first stent.

35. The method of claim 33, wherein the prosthesis comprises a second stent unattached and axially separated from the first stent by a gap.

36. The method of claim 33, wherein delivering the prosthesis comprises advancing the delivery catheter through vasculature of the patient to the target treatment site.

37. The method of claim 33, wherein the delivery catheter has a proximal end, a distal end, and a lumen therebetween, and delivering the prosthesis comprises slidably advancing the delivery catheter over a guidewire disposed in the lumen.

38. The method of claim 33, wherein delivering the prosthesis comprises positioning the prosthesis in a vein.

39. The method of claim 38, wherein the vein comprises the iliac vein.

40. The method of claim 33, wherein the delivery catheter comprises an inner elongate shaft and a shuttle sheath disposed over the prosthesis, and selecting the deployment direction for the prosthesis comprises:

coupling the inner elongate shaft with the shuttle sheath;

distally advancing the inner elongate shaft distally thereby advancing the shuttle sheath distally away from the prosthesis; and

radially expanding the prosthesis from the proximal end thereof to the distal end thereof.

41. The method of claim 40, wherein coupling the inner elongate shaft with the shuttle sheath comprises threadably engaging the inner elongate shaft with the shuttle sheath.

42. The method of claim 40, wherein coupling the inner elongate shaft with the shuttle sheath comprises helically engaging the inner elongate shaft with the shuttle sheath.

43. The method of claim 40, wherein coupling comprises coupling the inner elongate shaft and the shuttle sheath with a bayonet coupling.

44. The method of claim 40, wherein the delivery catheter further comprises an outer elongate shaft, and selecting the deployment direction further comprises:

decoupling the outer elongate shaft from the shuttle sheath.

45. The method of claim 44, wherein decoupling the outer elongate shaft from the shuttle sheath comprise threadably disengaging the outer elongate shaft from the shuttle sheath.

46. The method of claim 44, wherein decoupling the outer elongate shaft from the shuttle sheath comprise helically disengaging the outer elongate shaft from the shuttle sheath.

47. The method of claim 44, wherein decoupling comprises releasing a bayonet coupling between the outer elongate shaft and the shuttle sheath.

48. The method of claim 33, wherein the delivery catheter comprises an outer elongate shaft and a shuttle sheath disposed over the prosthesis, and selecting the deployment direction for the prosthesis comprises:

coupling the outer elongate shaft with the shuttle sheath;

proximally retracting the outer elongate shaft thereby retracting the shuttle sheath proximally away from the prosthesis; and

radially expanding the prosthesis from the distal end thereof to the proximal end thereof.

49. The method of claim 48, wherein coupling the outer elongate shaft with the shuttle sheath comprises threadably engaging the outer elongate shaft with the shuttle sheath.

50. The method of claim 48, wherein coupling the outer elongate shaft with the shuttle sheath comprises helically engaging the outer elongate shaft with the shuttle sheath.

51. The method of claim 48, wherein coupling comprises coupling the outer elongate shaft and the shuttle sheath with a bayonet coupling.

52. The method of claim 48, wherein the delivery catheter further comprises an inner elongate shaft, and selecting the deployment direction further comprises:

decoupling the inner elongate shaft from the shuttle sheath.

53. The method of claim 52, wherein decoupling the inner elongate shaft from the shuttle sheath comprises threadably decoupling the inner elongate shaft from the shuttle sheath.

54. The method of claim 52, wherein decoupling the inner elongate shaft from the shuttle sheath comprises helically decoupling the inner elongate shaft from the shuttle sheath.

55. The method of claim 52, wherein decoupling comprises releasing a bayonet coupling between the inner elongate shaft and the shuttle sheath.

56. The method of claim 33, wherein the delivery catheter comprises a shuttle sheath disposed over the prosthesis, and removing the constraint comprises distally advancing the shuttle sheath away from the prosthesis so that the prosthesis is unconstrained from radial expansion in a direction extending from the proximal end of the prosthesis to the distal end of the prosthesis.

57. The method of claim 33, wherein the delivery catheter comprises a shuttle sheath disposed over the prosthesis, and removing the constraint comprises proximally retracting the shuttle sheath away from the prosthesis so that the prosthesis is unconstrained from radial expansion in a direction extending from the distal end of the prosthesis to the proximal end of the prosthesis.

58. The method of claim 33, wherein radially expanding the prosthesis comprises self-expanding a stent.

59. The method of claim 33, wherein withdrawing the delivery catheter from the patient comprises withdrawing the delivery catheter from the patient'"'"'s vasculature.

60. The method of claim 33, wherein the prosthesis comprises two prostheses, the method comprising:

selecting a first deployment direction for the first prosthesis;

radially expanding the first prosthesis in the first deployment direction; and

radially expanding the second prosthesis in a second deployment direction opposite of the first deployment direction.

61. The method of claim 33, further comprising visualizing the expanded prosthesis.

62. The method of claim 61, wherein visualizing comprises observing the expanded prosthesis with ultrasound or fluoroscopy.

63. The method of claim 33, further comprising retracting the radially expanded prosthesis into a shuttle sheath;

repositioning the prosthesis; and

radially expanding the prosthesis.

64. The method of claim 33, further comprising dilating the radially expanded prosthesis with an expandable member.