SLEEVES FOR EXPANDABLE MEDICAL DEVICES AND METHODS OF MAKING THE SAME

• US 20140135895A1
• Filed: 11/11/2013
• Published: 05/15/2014
• Est. Priority Date: 11/12/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Norris, Patrick M., Andress, Murray F.B.
• Granted Patent: US 9,387,105 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable

Abstract

The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is surrounded and constrained by one or more constraining sleeves. One or more of these sleeves comprise an end profile with a desired shape.

Claims

1. A medical device comprising:

an expandable implant having a lumen comprising a central axis; and

a constraining sleeve having a first end profile and a second end profile, wherein the constraining sleeve surrounds at least a portion of the expandable implant and constrains the expandable implant in a configuration having a diameter less than the diameter of an unconstrained diameter of the expandable implant, and wherein the first end profile and the second end profile are non-perpendicular.

2. The medical device of claim 1, wherein the expandable implant is a stent-graft.

3. The medical device of claim 1, wherein the constraining sleeve maintains the expandable implant in a compressed configuration suitable for endoluminal delivery.

4. The medical device of claim 1, wherein the constraining sleeve comprises a sheet of material having first and second major surfaces and a plurality of openings extending from the first major surface to the second major surface and a first coupling member cooperating with the plurality of openings for releasably coupling portions of the sheet to one another to form the constraining sleeve.

5. The medical device of claim 4, further comprising a second plurality of openings extending from the first major surface to the second major surface and a second coupling member cooperating with the second plurality of openings for releasably coupling portions of the sheet to one another to form a reduced diameter constraining sleeve, wherein the reduced diameter constraining sleeve is configured to constrain the expandable implant to a delivery configuration and wherein removal of the second coupling member causes the constraining sleeve to constrain the expandable implant to an intermediate configuration.

6. The medical device of claim 1, wherein a perimeter of the second end profile is greater than a perimeter of the first end profile.

7. The medical device of claim 1, wherein a face formed by the second end profile has an angle relative to the central axis of the expandable implant between about 30 degrees and about 60 degrees.

8. The medical device of claim 1, wherein a face formed by the second end profile has an angle relative to the central axis of the expandable implant between about 60 degrees and about 90 degrees.

9. The medical device of claim 1, wherein the constraining sleeve is ePTFE.

10. An implantable medical device comprising:

an expandable implant having lumen comprising a central axis; and

a first constraining sleeve; and

a second constraining sleeve having an end profile, wherein a face formed by the end profile has an angle less than 90 degrees relative to the central axis of the lumen.

11. The implantable medical device of claim 10, wherein the second constraining sleeve surrounds at least a portion of the expandable implant and constrains the expandable implant in an intermediate configuration.

12. The implantable medical device of claim 10, wherein the first constraining sleeve surrounds at least a portion of the expandable implant and constrains the expandable implant in a delivery configuration.

13. The implantable medical device of claim 10, wherein the first constraining sleeve comprises a first plurality of openings and a first primary coupling member cooperating with the first plurality of openings for releasably coupling portions of the sheet to one another to form the first constraining sleeve.

14. The implantable medical device of claim 10, wherein the second constraining sleeve comprises a second plurality of openings and a second primary coupling member cooperating with the second plurality of openings for releasably coupling portions of the sheet to one another to form the second constraining sleeve.

15. The implantable medical device of claim 10, wherein the first constraining sleeve and the second constraining sleeve are ePTFE.

16. A sleeve comprising:

a sheet of material having a first and second end, wherein one of the first and second ends comprises a two dimensional shape comprising a first line and a second line, wherein the first line and the second line are not parallel to each other.

17. The sleeve of claim 16, wherein the sheet of material comprises ePTFE.

18. The sleeve of claim 16, wherein the first line and the second line are symmetrical to each other.

19. The sleeve of claim 16, wherein the first line and the second line are asymmetrical to each other.

20. The sleeve of claim 16, wherein the sheet of material comprises a plurality of openings and a coupling member cooperating with the plurality of openings for releasably coupling portions of the sheet of material to one another to form a tubular sleeve.