EXTERNAL STEERABLE FIBER FOR USE IN ENDOLUMINAL DEPLOYMENT OF EXPANDABLE DEVICES

• US 20130123896A1
• Filed: 10/23/2012
• Published: 05/16/2013
• Est. Priority Date: 11/14/2011
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Walsh, Stephanie M., Bloss, Roberta A., Burkart, Dustin C., Norris, Patrick M., Sondreaal, Matthew G.
• Granted Patent: US 9,782,282 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can 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 can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

Claims

1. A catheter assembly comprising:

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

an expandable device positioned at the leading end of the catheter, the expandable device having a proximal end and a distal end, a collapsed configuration for endoluminal delivery of the expandable device to a treatment site, and an expanded configuration having a diameter larger than the diameter of the collapsed configuration; and

a steering line extending through the main lumen of the catheter and disposed within at least a portion of the expandable device to allow selective bending of the expandable device.

2. The catheter assembly of claim 1, further comprising a primary sleeve wrapped circumferentially around the expandable device, wherein the primary sleeve comprises a sheet of material having a first major surface and a second major surface and a plurality of openings extending from the first major surface to the second major surface;

and

a primary coupling member cooperating with the plurality of openings for releasably coupling portions of the sheet to one another to constrain the expandable device in the collapsed configuration.

3. The catheter assembly of claim 2, further comprising a secondary sleeve and secondary coupling member, wherein the secondary sleeve limits the expansion of the expandable device to an intermediate configuration having a diameter larger than the diameter of the collapsed configuration and smaller than the diameter of the expanded configuration.

4. The catheter assembly of claim 1, wherein the expandable device comprises a stent graft.

5. The catheter assembly of claim 4, wherein the stent graft comprises at least one apex, and wherein the steering line is woven through the at least one apex of the stent graft.

6. The catheter assembly of claim 1, wherein the steering line is removable.

7. The catheter assembly of claim 1, further comprising a lock wire extending through the main lumen, wherein the lock wire releasably engages the steering line and couples the steering line to the catheter.

8. The catheter assembly of claim 3, wherein the steering line is disposed within the secondary sleeve such that when the catheter assembly is inserted into a vessel, the steering line does not directly contact tissue within the vessel.

9. The catheter assembly of claim 1, wherein the expandable device is bendable more than about 90 degrees relative to an axis of the catheter.

10. The catheter assembly of claim 1, wherein a degree of bending of the expandable device relative to an axis of the catheter is proportional to an amount of tension on the steering line.

11. The catheter assembly of claim 1, wherein the expandable device substantially maintains a desired degree of bending while the expandable device is deployed to the expanded configuration.

12. The catheter assembly of claim 1, wherein the steering line is connected at one of the proximal end and the distal end of the expandable device.

13. The catheter assembly of claim 1, wherein the expandable device further comprises a radiopaque marker.

14. The catheter assembly of claim 13, wherein the radiopaque marker comprises a band extending around a perimeter of one of the proximal end and the distal end of the expandable device, wherein the catheter assembly is viewed with a radiographic device located outside of a patient'"'"'s body, and wherein when the expandable device is properly positioned within the treatment site, a two dimensional profile of the radiopaque marker is substantially a line.

15. The catheter assembly of claim 1, wherein the steering line torsionally anchors the expandable device and the catheter allowing rotational positioning of device at the treatment site via rotation of the catheter.

16. The catheter assembly of claim 3, further comprising a first secondary coupling member and a second secondary coupling member, wherein the first secondary coupling member is threaded along approximately half of a length of the secondary sleeve and the second secondary coupling member is threaded along the other approximately half of the secondary sleeve.

17. The catheter assembly of claim 1, further comprising a secondary coupling member and a plurality of secondary openings, wherein the secondary coupling member cooperates with the plurality of secondary openings for releasably coupling portions of the sheet to one another to constrain the expandable device in an intermediate configuration, the intermediate configuration having a diameter larger than the collapsed configuration and smaller than the expanded configuration.

18. A catheter assembly comprising:

a catheter having a leading end and a trailing end and comprising a main lumen extending between the leading end and the trailing end and a side port;

an expandable device positioned at the leading end of the catheter, the expandable device having a proximal end and a distal end, a collapsed configuration for endoluminal delivery of the expandable device to a treatment site, and an expanded configuration having a diameter larger than the diameter of the collapsed configuration; and

a lock wire extending through the main lumen, wherein a portion of the lock wire passes through the side port of the main lumen of the catheter, engages a fiber, and reenters the side port of the main lumen of the catheter.

19. The catheter assembly of claim 18, wherein the fiber is a steering fiber engaged to the expandable device.

20. The catheter assembly of claim 18, wherein the expandable device comprises a stent graft.