Controlled deployable medical device and method of making the same

• US 10,219,925 B2
• Filed: 03/13/2014
• Issued: 03/05/2019
• Est. Priority Date: 06/04/2008
• Status: Active Grant

• Current Assignee: Gore Enterprise Holdings Incorporated
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Flury, Keith M., Gendron, Michelle L., Zukowski, Stanislaw L.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): Hollm, Jonathan
• Application Number:
  US14/208,441
• Publication Number:
  US 20140194968A1
• Time in Patent Office: 1,818 Days
• Field of Search: 606108, 623 111- 112, 623 123, 623 135
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

Controlled deployable medical devices that are retained inside a body passage and in one particular application to vascular devices used in repairing arterial dilations, e.g., aneurysms. Such devices can be adjusted during deployment, thereby allowing at least one of a longitudinal or radial re-positioning, resulting in precise alignment of the device to an implant target site.

Claims

1. An apparatus, comprising:

a catheter having a proximal end portion and distal end portion and defining a lumen;

a stent having a stent inner surface, a stent outer surface, and a stent lumen defined by the stent inner surface, the proximal end of the catheter being positioned inside of the stent lumen;

a graft member arranged about the stent, the stent and the graft forming a bifurcated medical device having a trunk and legs;

a sheath configured to constrain the stent and graft in a delivery diameter and to release which causes a portion of the stent and graft to expand to an intermediate diameter that is larger than the delivery diameter; and

a movable element threaded through the graft member such that a first end and a second end of the movable element extend circumferentially about the stent in opposing directions and extend through the distal end portion of the catheter such that the first and second ends are tensionable, the movable element defining the intermediate diameter to which the portion of the stent and graft expand to upon release of the sheath,

wherein the movable element is movable between a first direction to radially compress the portion of the stent from the intermediate diameter and a second direction opposite the first direction to allow expansion of the portion of the stent from the intermediate diameter to a deployed diameter of the stent, the movable element being separable from the graft member to allow withdrawal of the movable element after deployment of the stent and graft member.

2. The apparatus of claim 1, wherein the movable element is an elongated element that extends through and exits the lumen of the catheter at the distal end portion of the catheter.

3. The apparatus of claim 1, wherein the movable element comprises a filament.

4. The apparatus of claim 3, wherein the filament comprises a wire.

5. The apparatus of claim 3, wherein the filament comprises a polymer.

6. The apparatus of claim 5, wherein the polymer comprises a fluoropolymer.

7. The apparatus of claim 6, wherein the fluoropolymer comprises polytetrafluoroethylene.

8. The apparatus of claim 7, wherein the polytetrafluoroethylene comprises expanded polytetrafluoroethylene.

9. The apparatus of claim 1, wherein the graft member is positioned on the stent inner surface of the stent.

10. The apparatus of claim 1, wherein the proximal end of the catheter is positioned on the stent inner surface of the stent.

11. The apparatus of claim 1, wherein the stent is incorporated into an internal wall structure of the graft member.

12. The apparatus of claim 1, wherein the graft member is positioned on the stent outer surface.

13. An apparatus, comprising:

a catheter having a proximal end portion and distal end portion;

a bifurcated stent having a trunk with a stent inner surface, a stent outer surface, and a stent lumen defined by the stent inner surface, the proximal end of the catheter being positioned adjacent the stent outer surface and outside of the stent lumen;

a sheath configured to constrain the stent in a delivery diameter and to release which causes at least a portion of the stent to expand to an intermediate diameter that is larger than the delivery diameter; and

a movable element extending about the stent outer surface such that a first end and a second end of the movable element extend circumferentially about the stent in opposing directions and extend through the distal end portion of the catheter such that the first and second ends are tensionable, the movable element defining the intermediate diameter to which the stent expands to upon release of the sheath,

wherein the movable element is movable between a first direction to radially compress at least a portion of the stent from the intermediate diameter and a second direction opposite the first direction to allow radial expansion of the at least a portion of the stent from the intermediate diameter to a deployed diameter of the stent, the movable element being separable from the stent to allow withdrawal of the movable element after deployment of the stent.

14. The apparatus of claim 13, further comprising a graft member arranged about at least a portion of the stent.

15. The apparatus of claim 14, wherein the movable element is an elongated element that extends through and exits the lumen of the catheter at the distal end portion of the catheter.

16. The apparatus of claim 14, wherein the movable element is arranged circumferentially around the stent and threaded through the graft member and not through the stent.

17. The apparatus of claim 14, wherein the movable element is threaded through the graft member and not through the stent.

18. The apparatus of claim 14, wherein the stent is incorporated into an internal wall structure of the graft.

19. The apparatus of claim 14, wherein the movable element comprises a filament.

20. The apparatus of claim 19, wherein the filament comprises a wire.

21. The apparatus of claim 19, wherein the filament comprises a polymer.

22. The apparatus of claim 21, wherein the polymer comprises a fluoropolymer.

23. The apparatus of claim 22, wherein the fluoropolymer comprises polytetrafluoroethylene.

24. The apparatus of claim 23, wherein the polytetrafluoroethylene comprises expanded polytetrafluoroethylene.

25. The apparatus of claim 19, wherein the filament is arranged circumferentially around the graft member and is threaded between adjacent undulations of the stent.

26. The apparatus of claim 14, wherein the graft member is positioned on the stent inner surface.

27. The apparatus of claim 14, wherein the graft member is positioned on the stent outer surface.

28. An apparatus, comprising:

a catheter having a proximal end portion and distal end portion and defining a lumen;

a stent having a stent inner surface, a stent outer surface, and a stent lumen defined by the stent inner surface, the proximal end of the catheter being positioned inside of the stent lumen;

a graft member arranged about the stent;

a sheath configured to constrain the stent and graft in a delivery diameter and to release which causes a portion of the stent and graft to expand to an intermediate diameter that is larger than the delivery diameter; and

a movable element threaded through the graft member such that a first end and a second end of the movable element extend circumferentially about the stent in opposing directions and extend through the distal end portion of the catheter such that the first and second ends are tensionable, the movable element defining the intermediate diameter to which the portion of the stent and graft expand to upon release of the sheath,

wherein the movable element is movable between a first direction to radially compress the portion of the stent from the intermediate diameter and a second direction opposite the first direction to allow expansion of the portion of the stent from the intermediate diameter to a deployed diameter of the stent, the movable element being separable from the graft member to allow withdrawal of the movable element after deployment of the stent and graft member.