Deployment of endoluminal devices

• US 9,468,549 B2
• Filed: 09/13/2013
• Issued: 10/18/2016
• Est. Priority Date: 11/11/2010
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Norris, Patrick M., Peterson, Anthony P., Walsh, Stephanie M.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SIMPSON, SARAH A
• Application Number:
  US14/026,162
• Publication Number:
  US 20140018900A1
• Time in Patent Office: 1,131 Days
• Field of Search: 606/108, 606/191, 606/194, 623/1.11, 623/1.12, 623/1.22
• US Class Current: 1/1
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49947 by applying separate fastener

Abstract

A catheter assembly includes a single sleeve that constrains an expandable device to a dimension suitable for endoluminal delivery of the device to a treatment site, and further allows expansion of the device toward an outer peripheral dimension that is smaller than a fully deployed outer peripheral dimension to allow positioning of the device at the treatment site prior to full deployment and expansion of the device at the treatment site.

Claims

1. A catheter assembly comprising:

a catheter having opposite proximal and distal ends, the catheter having a lumen extending between the proximal and distal ends of the catheter;

an expandable device disposed at the distal end of the catheter and expandable toward a fully deployed outer peripheral dimension, the expandable device having a first end and an opposite second end, the expandable device having an outer surface and an opposite inner surface defining a flow lumen extending between the first end and second end; and

a flexible sleeve extending around the outer surface of the expandable device, wherein the flexible sleeve has a first releasable seam that maintains the flexible sleeve at a first dimension suitable for endoluminal delivery of the expandable device to a treatment site, and a second releasable seam, disposed between the catheter and the first releasable seam and radially aligned therewith, that maintains the flexible sleeve at a second dimension larger than the first dimension and smaller than the fully deployed outer peripheral dimension to allow blood flow through the flow lumen during positioning of the expandable device after release of the first releasable seam and prior to release of the second releasable seam.

2. The catheter assembly as set forth in claim 1, wherein at least one of the first releasable seam and the second releasable seams is releasably held together by a coupling member.

3. The catheter assembly as set forth in claim 2, wherein the first releasable seam and the second releasable seams are releasably held together by a common coupling member.

4. The catheter assembly as set forth in claim 2, wherein a substantial portion of an inner surface of the flexible sleeve remains in contact with the expandable device before and after actuation of the coupling member.

5. The catheter assembly as set forth in claim 2, wherein the expandable device remains constrained by the flexible sleeve both before and after actuation of the coupling member.

6. The catheter assembly as set forth in claim 1, wherein the first releasable seam and the second releasable seam are generally radially aligned with respect to a longitudinal axis of the catheter.

7. The catheter assembly as set forth in claim 6, wherein the second releasable seam is disposed between the longitudinal axis of the catheter and the first releasable seam.

8. The catheter assembly as set forth in claim 7, wherein the flexible sleeve is formed from a flattened tube to form a double-walled lumen extending about the expandable device.

9. The catheter assembly as set forth in claim 8, wherein the flattened tube is formed from ePTFE.

10. The catheter assembly as set forth in claim 1, wherein the flexible sleeve maintains the expandable device at the second dimension between the first and second ends of the expandable device after release of the first releasable seam.

11. A catheter assembly comprising:

a catheter having opposite proximal and distal ends, the catheter having a lumen extending between the proximal and distal ends of the catheter;

an expandable device releasably coupled to the catheter and expandable toward a fully deployed outer peripheral dimension, the expandable device having a first end and an opposite second end, the expandable device having an outer surface and an opposite inner surface defining a flow lumen extending between the first end and second end;

a flexible sleeve extending around the outer surface of the expandable device, the flexible sleeve having a first releasable seam that maintains the flexible sleeve at a first outer peripheral dimension suitable for endoluminal delivery and deployment of the expandable device to a treatment site, and a second releasable seam, disposed between the catheter and the first releasable seam and radially aligned therewith, that limits expansion of the flexible sleeve to a second outer peripheral dimension between the first and second ends of the expandable device, the second outer peripheral dimension being larger than the first outer peripheral dimension and smaller than the fully deployed outer peripheral dimension after release of the first releasable seam to allow blood flow through the flow lumen during positioning of the expandable device after release of the first releasable seam and prior to release of the second releasable seam.

12. The catheter assembly as set forth in claim 11 including at least a portion of an elongated member extending through the catheter lumen and being movable relative to the catheter.

13. The catheter assembly as set forth in claim 12, wherein a portion of the elongated member exits the catheter lumen through a distal side wall opening so as to extend along an outside surface of the catheter, and enters the catheter lumen through a proximal side wall opening.

14. The catheter assembly as set forth in claim 13, wherein the portion of the elongated member engages the expandable device between the distal side wall opening and the proximal side wall openings thereby releasably coupling the expandable device and the catheter.

15. The catheter assembly as set forth in claim 14, wherein the expandable device includes a stent frame and the portion of the elongated member engages the stent frame thereby releasably coupling the expandable device and the catheter.

16. The catheter assembly as set forth in claim 15, wherein the portion of the elongated member extends between an apice of the stent frame and a graft wall thereby releasably coupling the expandable device and the catheter.