SYSTEMS AND METHODS OF DEPLOYMENT OF ENDOLUMINAL DEVICES

• US 20140142681A1
• Filed: 08/05/2013
• Published: 05/22/2014
• Est. Priority Date: 08/10/2012
• 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.
• Granted Patent: US 9,486,349 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable

Abstract

A removable sleeve extends around an expandable stent graft to constrain the expandable stent graft toward a collapsed configuration. The sleeve is held together by a coupling member to constrain the expandable device toward the collapsed configuration for endoluminal delivery to a vascular treatment site. The sleeve is openable by displacing the coupling member away from the sleeve to allow outward expansion of the expandable device toward an expanded configuration. The sleeve is separate from the expandable device so as to be removable from the treatment site after deployment of the expandable device.

Claims

1. A catheter assembly comprising:

a catheter having a leading end, a trailing end and a lumen extending between the leading end and the trailing end;

an expandable device positioned toward the leading end of the catheter, the expandable device having a collapsed configuration suitable for endoluminal delivery of the expandable device to a vascular treatment site and an expanded configuration having an outer peripheral dimension larger than the outer peripheral dimension of the collapsed configuration;

a primary sleeve extending around the expandable device, wherein the primary sleeve comprises a sheet of material having first and second major surfaces and a plurality of openings extending between the first major surface and the second major surface; and

a primary coupling member engaged with the openings in the primary sleeve for releasably coupling portions of the sheet to one another to constrain the expandable device toward the collapsed configuration,

wherein the primary sleeve includes a distal portion that extends over the expandable device and is openable by disengaging the primary coupling member from the primary sleeve to allow outward expansion of the expandable device toward the expanded configuration, the primary sleeve being separate from the expandable device and having a proximal portion accessible by a user to facilitate removal of the primary sleeve from the treatment site after expansion of the expandable device toward the expanded configuration.

2. The catheter assembly as set forth in claim 1, wherein the proximal portion of the primary sleeve extends through the lumen of the catheter toward a proximal end of the catheter to allow access to the proximal portion of the primary sleeve by a user.

3. The catheter assembly as set forth in claim 2, wherein the primary sleeve extends through a side opening formed in the catheter and into the lumen.

7. The catheter assembly as set forth in claim 1, wherein the expandable device is a self-expanding stent graft.

8. The catheter assembly as set forth in claim 7 including a secondary sleeve that maintains the expandable device at an intermediate outer peripheral dimension larger than the collapsed configuration and smaller than the expanded configuration after opening the primary sleeve.

9. The catheter assembly as set forth in claim 8, wherein the secondary sleeve comprises a second sheet of material having first and second major surfaces and a plurality of openings extending between the first major surface and the second major surface.

13. The catheter assembly as set forth in claim 1, wherein the primary sleeve is formed from ePTFE.

14. A method of, said method comprising:

providing the catheter assembly of claim 1;

endoluminally delivering the leading end of the catheter toward the treatment site;

allowing expansion of the expandable device by opening the primary sleeve by displacing the primary coupling member from the openings in the primary sleeve; and

removing the primary sleeve from the treatment site.

15. The method as set forth in claim 14 including displacing the primary sleeve through the lumen of the catheter.

16. The method as set forth in claim 15 including displacing the primary sleeve through a side opening in the catheter.

17. The method as set forth in claim 14 including providing a knob attached to the primary sleeve and slidably coupled to the catheter for movement between a first position, wherein at least a portion of the sleeve overlaps the expandable device, and a second position, wherein the sleeve is spaced apart from the expandable device.

18. The method as set forth in claim 17 including displacing the sleeve away from the expandable device by displacing the knob from the first position toward the second position.

19. The method as set forth in claim 14 including providing a secondary sleeve that maintains the expandable device at an intermediate outer peripheral dimension larger than the collapsed configuration and smaller than the expanded configuration after opening the primary sleeve.

20. The method as set forth in claim 19 including opening the secondary sleeve after removal of the primary sleeve from the treatment site.

21. The method as set forth in claim 20 including leaving the secondary sleeve with the expandable device at the treatment site and removing remaining portions of the catheter assembly from the treatment site.

4. The catheter assembly as set forth in 3 including a knob coupled to the proximal portion of the primary sleeve.

5. The catheter assembly as set forth in 4, wherein the knob is releasably coupled to the catheter.

6. The catheter assembly as set forth in 4, wherein the knob is slidably coupled to the catheter for movement between a first position, wherein at least a portion of the sleeve overlaps the expandable device, and a second position, wherein the sleeve is spaced apart from the expandable device.

10. The catheter assembly as set forth in 9 including a secondary coupling member engaged with the openings in the secondary sleeve for releasably coupling portions of the second sheet to one another to constrain the expandable device at the intermediate outer peripheral dimension.

11. The catheter assembly as set forth in 10, wherein the secondary sleeve is fixedly secured to the expandable device and remains at the treatment site with the expandable device after deployment of the expandable device.

12. The catheter assembly as set forth in 11, wherein the secondary sleeve comprises ePTFE.