APPARATUS AND METHODS FOR DELIVERY OF MULTIPLE DISTRIBUTED STENTS

• US 20070100424A1
• Filed: 11/28/2006
• Published: 05/03/2007
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: French, Ron, Andreas, Bernard, Chew, Sunmi, Will, Allan, Gifford, Hanson, Deem, Mark
• Granted Patent: US 7,905,913 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

Blood vessels and other body lumens are stented using multiple, discreet stent structures. Stent structures may be balloon expandable or self-expanding and are delivered by a delivery catheter which is repositioned to spaced-apart delivery sights. By coating the stents with particular biologically active substances, hyperplasia within and between the implanted stents can be inhibited. An exemplary delivery catheter comprises a catheter body having both a pusher rod for advancing the stents relative to a sheath and a reciprocatable delivery catheter for implanting the stents.

Claims

1. An apparatus for treating a body lumen comprising:

a flexible catheter shaft having proximal and distal ends;

an expandable member attached to the catheter shaft near the distal end, the expandable member being expandable to an expanded configuration having an expanded length; and

a radially-expandable tubular prosthesis releasably coupled to the catheter shaft, a deployed portion of the prosthesis being expandable to a deployed configuration having a deployed length;

wherein the expanded length and the deployed length are each selectively changeable from the proximal end of the catheter shaft.

2. The apparatus of claim 1, further comprising:

a first adjustment mechanism controllable from the proximal end of the catheter shaft for selectively changing the expanded length; and

a second adjustment mechanism controllable from the proximal end of the catheter shaft for selectively changing the deployed length.

3. The apparatus of claim 2, wherein the first adjustment mechanism comprises a sheath having a distal extremity axially movable over the expandable member and a proximal extremity extending to the proximal end of the catheter shaft, the distal extremity being adapted to constrain a proximal portion of the expandable member from expanding while a distal portion of the expandable member is expanded.

4. The apparatus of claim 2, wherein the second adjustment mechanism comprises a separation member adapted to separate the deployed portion from a retained portion of the prosthesis, the retained portion remaining unexpanded when the deployed portion is expanded.

5. The apparatus of claim 4, wherein the separation member is mounted to a sheath having a distal extremity that covers the prosthesis and is retractable to expose the deployed portion of the prosthesis.

6. The apparatus of claim 2, wherein the second adjustment mechanism comprises a pusher member axially movable along the catheter shaft and adapted to apply a distally-directed force to the prosthesis.

7. The apparatus of claim 4, wherein the prosthesis comprises a plurality of separable prosthetic segments and the separation mechanism separates a first group of the prosthetic segments in the deployed portion from a second prosthetic segment which is retained unexpanded on the catheter shaft.

8. The apparatus of claim 1, further comprising a sheath having a distal extremity axially movable over the expandable member and a proximal extremity extending to the proximal end of the catheter shaft, the distal extremity being adapted to constrain a proximal portion of the expandable member from expanding while a distal portion of the expandable member is expanded.

9. The apparatus of claim 1, further comprising a pusher member axially movable relative to the expandable member and adapted to apply a distally-directed force to the prosthesis.

10. The apparatus of claim 1, further comprising a separation member near the distal end of the catheter shaft adapted to separate the deployed portion from a retained portion of the prosthesis, the retained portion remaining unexpanded when the deployed portion is expanded.

11. The apparatus of claim 10, wherein the separation member is mounted to a sheath having a distal extremity that covers the prosthesis and is retractable to expose the deployable portion of the prosthesis.

12. The apparatus of claim 11, wherein the separation member engages the prosthesis such that the retained portion of the prosthesis is retractable in conjunction with the sheath.

13. The apparatus of claim 1, wherein the expanded length may be selectively changed independently of the deployed length.

14. The apparatus of claim 1, further comprising a mechanism controllable from the proximal end of the catheter shaft for selectively changing both the expanded length and the deployed length.

15. The apparatus of claim 1, wherein the prosthesis comprises a plurality of separable prosthesis segments and wherein a first group of the prosthetic segments is in the deployed portion and at least a second prosthetic segment is retained unexpanded on the catheter shaft.

16. The apparatus of claim 15, wherein the prosthesis segments are connected before radially expanding.

17. The apparatus of claim 16, wherein the prosthesis segments are connected by links which are separable upon expansion to disconnect the first group of prosthetic segments from the second prosthetic segment.

18. The apparatus of claim 17, wherein the first group of prosthetic segments remain connected after expansion.

19. The apparatus of claim 17, wherein the prosthesis segments are connected by bioerdoable links.

20. The apparatus of claim 1, wherein the prosthesis segments are unconnected to each other before radially expanding.

21. An apparatus for treating a body lumen comprising:

a flexible catheter shaft positionable in the body lumen and having proximal and distal ends;

an expandable member attached to the catheter shaft near the distal end, the expandable member being expandable to an expanded configuration having an expanded length;

a radially-expandable tubular prosthesis releasably coupled to the catheter shaft, a deployed portion of the prosthesis being expandable to a deployed configuration having a deployed length;

a first adjustment mechanism controllable from the proximal end for selectively changing the expanded length without removing the catheter shaft from the body lumen; and

a second adjustment mechanism controllable from the proximal end for selectively changing the deployed length without removing the catheter shaft from the body lumen.

22. The apparatus of claim 21, wherein the first adjustment mechanism comprises a sheath having a distal extremity axially movable over the expandable member and a proximal extremity extending to the proximal end of the catheter shaft, the distal extremity being adapted to constrain a proximal portion of the expandable member from expanding while a distal portion of the expandable member is expanded.

23. The apparatus of claim 21, wherein the second adjustment mechanism comprises a separation member adapted to separate the deployed portion from a retained portion of the prosthesis, the retained portion remaining unexpanded when the deployed portion is expanded.

24. The apparatus of claim 23, wherein the separation member is mounted to a sheath having a distal extremity that covers the prosthesis and is retractable to expose the deployed portion of the prosthesis.

25. The apparatus of claim 21, wherein the second adjustment mechanism comprises a pusher member axially movable along the catheter shaft and adapted to apply a distally-directed force to the prosthesis.

26. The apparatus of claim 23, wherein the prosthesis comprises a plurality of separable prosthetic segments and the separation mechanism separates a first group of the prosthetic segments in the deployed portion from a second prosthetic segment which is retained unexpanded on the catheter shaft.

27. The apparatus of claim 26, wherein the prosthesis segments are connected before radially expanding.

28. The apparatus of claim 27, wherein the prosthesis segments are connected by links which are separable upon expansion to disconnect the first group of prosthetic segments from the second prosthetic segment.

29. The apparatus of claim 27, wherein the first group of prosthetic segments remain connected after expansion.

30. The apparatus of claim 26, wherein the prosthetic segments are connected by bioerdoable links.

31. The apparatus of claim 23, wherein the prosthetic segments are unconnected to each other before radially expanding.

32. An apparatus for treating a body lumen comprising:

a flexible catheter shaft positionable in the body lumen and having proximal and distal ends;

an expandable member attached to the catheter shaft near the distal end, the expandable member being expandable to an expanded configuration having an expanded length; and

a plurality of radially-expandable tubular prostheses releasably coupled to the catheter shaft, the prostheses being separable from each other to allow a first group of the prostheses to be expanded at the same time while at least a second prosthesis remains unexpanded on the catheter shaft;

wherein the expanded length and the number of prostheses in the first group are each selectively changeable from the proximal end without removing the catheter shaft from the body lumen.

33. The apparatus of claim 32, further comprising a sheath having a distal extremity axially movable over the expandable member and a proximal extremity extending to the proximal end of the catheter shaft, the distal extremity being adapted to constrain a proximal portion of the expandable member from expanding while a distal portion of the expandable member is expanded.

34. The apparatus of claim 32, further comprising a pusher member axially movable relative to the expandable member and adapted to apply a distally-directed force to the prostheses.

35. The apparatus of claim 32, further comprising a separation member adapted to separate the first group of prostheses from the second prosthesis.

36. The apparatus of claim 35, wherein the separation member is mounted to a sheath having a distal extremity that covers the prostheses and is retractable to expose the first group of the prostheses.

37. The apparatus of claim 36, wherein the separation member engages the second prosthesis such that the second prosthesis is retractable in conjunction with the sheath.

38. The apparatus of claim 32, wherein the expanded length may be selectively changed independently of the number of prostheses in the first group.

39. The apparatus of claim 32, further comprising a mechanism controllable from the proximal end of the catheter shaft for selectively changing both the expanded length and the number of prostheses in the first group.

40. The apparatus of claim 32, wherein the prostheses are connected before radially expanding.

41. The apparatus of claim 40, wherein the prostheses are connected by links which are separable upon expansion to disconnect the first group of prostheses from the second prosthesis.

42. The apparatus of claim 40, wherein the first group of prostheses remain connected after expansion.

43. The apparatus of claim 40, wherein the prostheses are connected by bioerdoable links.

44. The apparatus of claim 32, wherein the prostheses are unconnected to each other before radially expanding.

45. The apparatus of claim 32, wherein the prostheses are adapted to be radially expanded by the expandable member.

46. The apparatus of claim 32, wherein the expandable member is expandable without expanding the prostheses.