SLEEVES FOR EXPANDABLE MEDICAL DEVICES

• US 20140046430A1
• Filed: 10/23/2013
• Published: 02/13/2014
• Est. Priority Date: 11/16/2010
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Shaw, Edward E.
• Granted Patent: US 9,592,143 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/954 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery profile for delivery within the vasculature by at least one sleeve. The implant may be constrained to other diameters, such as an intermediate configuration having a diameter larger than the delivery profile and smaller than the deployment diameter. The sleeves may be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant may comprise a number of side branch fenestrations or fenestratable portions.

Claims

1. A device for treating a vessel comprising:

an expandable stent graft having a main lumen and a target portion;

a sleeve wrapped circumferentially around the expandable stent graft, wherein the sleeve comprises a sheet of material having opposite first and second major surfaces, the sleeve having a first plurality of openings and a second plurality of openings each extending between the first major surface and the second major surface, the sleeve having a lateral opening proximate to the target portion and extending between the first major surface and the second major surface;

a primary coupling member cooperating with the first plurality of openings for releasably coupling portions of the sheet of material to one another to form a first seam to constrain the expandable stent graft in a collapsed configuration for delivery within the vessel; and

a secondary coupling member cooperating with the second plurality of openings for releasably coupling portions of the sheet of material to one another to form a second seam to restrict expansion of the expandable stent graft toward an intermediate configuration after displacement of the primary coupling member from the first plurality of openings, the intermediate configuration being larger than the collapsed configuration and smaller than a fully deployed configuration engaged with the vessel.

2. The device of claim 1, wherein the second seam is hidden beneath the first seam.

3. The device of claim 1, wherein the first seam and second seam are generally parallel with a longitudinal axis of the expandable stent graft.

4. The device of claim 1, wherein the target portion comprises a side branch fenestration.

5. The device of claim 1, wherein the target portion comprises a fenestratable portion that is punctured to form a side branch fenestration.

6. The device of claim 1, wherein upon displacement of the primary and secondary coupling members from the primary sleeve, the target portion is exposed between opposing edges of the sheet of material.

7. The device of claim 1, wherein edges of the first and second major surfaces through which the plurality of openings extend comprise radiopaque markers.

8. The device of claim 1, wherein the target portion includes a drug eluting element.

9. A device for treating a vessel comprising:

an expandable stent graft having a main lumen and a target portion;

a primary sleeve and a secondary sleeve each wrapped circumferentially around a common portion of the expandable stent graft, each of the primary and secondary sleeves having a sheet of material with opposite first and second major surfaces and a plurality of openings each extending between the first and second major surfaces, each of the primary and secondary sleeves having a lateral opening proximate to the target portion and extending between the first and second major surfaces;

a primary coupling member cooperating with the first plurality of openings for releasably coupling portions of the sheet to one another to form a first seam to constrain the expandable stent graft in a collapsed configuration for delivery within the vessel; and

a secondary coupling member cooperating with the second plurality of openings for releasably coupling portions of the sheet to one another to form a second seam to restrict expansion of the expandable stent graft toward an intermediate configuration after displacement of the primary coupling member from the first plurality of openings, the intermediate configuration being larger than the collapsed configuration and smaller than a fully deployed configuration engaged with the vessel.

10. The device of claim 9, wherein the second seam is hidden beneath the first seam.

11. The device of claim 9, wherein the first seam and second seam are generally parallel with a longitudinal axis of the expandable stent graft.

12. The device of claim 9, wherein the target portion comprises a therapeutic agent eluting element disposed beneath at least one of the primary and secondary sleeves such that a therapeutic agent is exposed upon opening of the at least one of the primary and secondary sleeves.

13. The device of claim 9, wherein each sheet of material has opposite and spaced apart first and second edges which are held together by one of the primary and secondary coupling members.

14. The device of claim 13, wherein the first and second edges are generally parallel.

15. The device of claim 14, wherein the target portion is positioned between the first and second edges of the sheet of material.

16. The device of claim 9, wherein the first seam and second seam are generally parallel with a longitudinal axis of the expandable stent graft.

17. The device of claim 9, wherein the target portion comprises a side branch fenestration.

18. The device of claim 9, wherein the target portion comprises a fenestratable portion that is punctured to form a side branch fenestration.

19. The device of claim 9, wherein edges of the first and second major surfaces through which the plurality of openings extend comprise radiopaque markers.

20. The device of claim 9, wherein the target portion includes a drug eluting element.