EXTERNAL STEERABLE FIBER FOR USE IN ENDOLUMINAL DEPLOYMENT OF EXPANDABLE DEVICES

• US 20130245742A1
• Filed: 01/16/2013
• Published: 09/19/2013
• Est. Priority Date: 03/13/2012
• 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 9,375,308 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 2/9517 handle assemblies therefor
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 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 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;

a primary sleeve wrapped circumferentially around the expandable stent graft, wherein the primary 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 primary coupling member cooperating with the openings for releasably coupling portions of the sheet to one another to constrain the expandable stent graft toward the collapsed configuration; and

at least one steering line extending through the main lumen of the catheter and at least disposed between the expandable device and the primary sleeve to allow selective bending of the expandable device and non-concentric engagement of the expandable implant in relation to the catheter.

2. The catheter assembly of claim 1, wherein the at least one steering line begins at a distal end of the expandable device on an outer curve of the expandable device, wherein the at least one steering line terminates at a proximal end of the expandable device on the inner curve of the expandable device, and wherein the at least one steering line helically transitions between the distal end and the proximal end toward an inner curve of the expandable device.

3. The catheter assembly of claim 2, wherein the at least one steering line comprises a first steering line and a second steering line.

4. The catheter assembly of claim 3, wherein the first steering line mirrors the second steering line across a sagittal plane through an axis of the expandable device.

5. The catheter assembly of claim 1, wherein the at least one steering line begins on an exterior at a distal end of the expandable device on an outer curve of the expandable device, wherein the at least one steering line helically transitions between the distal end and the proximal end toward an inner curve of the expandable device, wherein the at least one steering line enters into an interior of the expandable device at a proximal end of the expandable device on the inner curve of the expandable device, wherein the at least one steering line returns from the proximal end of the expandable device toward the distal end of the expandable device, and wherein the at least one steering line is secured at the distal end of the expandable device with a distal pin.

6. 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.

7. The catheter assembly of claim 2, wherein the expandable device comprises a stent graft.

8. The catheter assembly of claim 7, wherein the stent graft comprises at least one apex, and wherein the at least one steering line is woven through the at least one apex of the stent graft.

9. The catheter assembly of claim 2, wherein the at least one steering line is removable.

10. The catheter assembly of claim 2, wherein the expandable device is releasably coupled to the catheter.

11. The catheter assembly of claim 10, further comprising a lock wire extending through the main lumen, wherein the lock wire releasably engages the at least one steering line.

12. The catheter assembly of claim 6, wherein the at least one steering line is disposed within the secondary sleeve such that when the catheter assembly is inserted into a vessel, the at least one steering line remains covered by the secondary sleeve.

13. The catheter assembly of claim 6, wherein the at least one steering line is disposed within the secondary sleeve such that when the catheter assembly is inserted into a vessel, the at least one steering line does not directly contact tissue within the vessel.

14. The catheter assembly of claim 2, wherein the expandable device is bendable more than about 90 degrees relative to an axis of the catheter.

15. The catheter assembly of claim 2, wherein the degree of bending of the expandable device relative to an axis of the catheter is proportional to the amount of tension on the at least one steering line.

16. The catheter assembly of claim 2, wherein the degree of bending of the expandable device relative to an axis of the catheter is proportional to the amount of displacement of the at least one steering line.

17. The catheter assembly of claim 2, wherein the expandable device substantially maintains a desired bending radius while the expandable device is deployed to an expanded configuration.

18. The catheter assembly of claim 2, wherein the at least one steering line is connected to the proximal end of the expandable device.

19. The catheter assembly of claim 2, further comprising a radiopaque marker located at a proximal end of the expandable device.

20. The catheter assembly of claim 19, wherein the radiopaque marker comprises a band extending around a perimeter of the expandable device.

21. The catheter assembly of claim 19, 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.

22. The catheter assembly of claim 2, wherein the at least one steering line torsionally anchors the expandable device and catheter allowing rotational positioning of device at treatment site via rotation of catheter.

23. The catheter assembly of claim 6, further comprising a first and second secondary constraining member, wherein the first secondary coupling member is threaded along approximately half of the length of the secondary sleeve and the second secondary coupling member is threaded along the other approximately half of the secondary sleeve.

24. The catheter assembly of claim 2, further comprising a secondary coupling member and a plurality of secondary openings, wherein the secondary coupling member cooperates with the 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.

25. 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 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;

a primary sleeve wrapped circumferentially around the expandable stent graft, wherein the primary 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 primary coupling member cooperating with the openings for releasably coupling portions of the sheet to one another to constrain the expandable stent graft toward the collapsed configuration; and

at least one steering line extending through the main lumen of the catheter and extending generally helically about the expandable device between the expandable device and the primary sleeve to allow bending of the expandable device in response to selective tensioning of the at least one steering line.