APPOSITION FIBER FOR USE IN ENDOLUMINAL DEPLOYMENT OF EXPANDABLE IMPLANTS

• US 20130158647A1
• Filed: 06/13/2012
• Published: 06/20/2013
• Est. Priority Date: 06/14/2011
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Norris, Patrick M., Viskocil, Joseph M.
• Granted Patent: US 10,117,765 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

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 an apposition line or lines which facilitate bending of the expandable implant to improve conformation of the expandable implant to the vasculature of the 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 and a side port;

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

wherein the side port is located along the main lumen of the catheter at a position between the proximal end and the distal end of the expandable implant;

a primary sleeve wrapped circumferentially around the expandable implant, 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 plurality of openings of the sheet for releasably coupling portions of the sheet to one another to constrain the expandable implant in the collapsed configuration;

a lockwire configured to couple at least one portion of the expandable implant and the catheter; and

at least one apposition line extending through the main lumen and passing through the side port of the catheter, wherein the at least one apposition line couples to at least a portion of the expandable implant.

2. The catheter assembly of claim 1, further comprising a secondary sleeve and secondary coupling member, wherein the secondary sleeve limits expansion of the expandable implant to an intermediate configuration having a diameter larger than the diameter of the collapsed configuration and smaller than the diameter of the expanded configuration.

3. The catheter assembly of claim 1, wherein the expandable implant comprises a stent graft.

4. 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 implant in an intermediate configuration, the intermediate configuration having a diameter larger than the collapsed configuration and smaller than the expanded configuration.

5. The catheter assembly of claim 1, further comprising a plurality of apposition lines.

6. The catheter assembly of claim 5, wherein each of the plurality of apposition lines further comprises an eyelet.

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

8. The catheter assembly of claim 1, wherein the expandable implant is releasably coupled to the catheter.

9. The catheter assembly of claim 8, wherein the catheter further comprises a pair of distal end ports and the lock wire exits the main lumen through one of the pair of distal end ports, engages the expandable implant, and enters the main lumen through the other of the pair of distal end ports to removably couple the catheter and the distal end of the expandable implant.

10. The catheter assembly of claim 1, wherein the expandable implant substantially maintains a desired curvature while the expandable implant is deployed to the expanded configuration.

11. The catheter assembly of claim 1, further comprising a radiopaque marker located at the proximal end of the expandable implant.

12. The catheter assembly of claim 11, wherein the radiopaque marker comprises a band extending around a perimeter of the expandable implant.

13. The catheter assembly of claim 1, further comprising an end-constraining element located at the proximal end of the expandable implant and configured to maintain the proximal end of the expandable implant in the collapsed configuration.

14. A method for deploying an expandable implant comprising:

providing 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 implant having a proximal end and a distal end and positioned at the leading end of the catheter, the expandable implant having a collapsed configuration for endoluminal delivery of the expandable implant to a treatment site and an expanded configuration having a diameter larger than the diameter of the collapsed configuration, wherein the side port is located along the main lumen of the catheter at a position between the proximal end and the distal end of the expandable implant, a primary sleeve wrapped circumferentially around the expandable implant, 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 plurality of openings of the sheet for releasably coupling portions of the sheet to one another to constrain the expandable implant in the collapsed configuration, and at least one apposition line extending through the main lumen and passing through the side port of the catheter, wherein the at least one apposition line couples to at least a portion of the expandable implant.

introducing the leading end of the catheter assembly into a body of a patient;

navigating the leading end of the catheter assembly to the proximity of a treatment area;

partially expanding the expandable implant;

reducing tension to the end-constraining element;

applying tension to the at least one apposition line to achieve a desired curvature in the expandable implant;

fully expanding the expandable implant;

disengaging the at least one apposition line from the expandable implant; and

disengaging the lock wire from the end-constraining element and the catheter.

15. The method of claim 14, wherein the catheter assembly further comprises 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 implant in an intermediate configuration, the intermediate configuration having a diameter larger than the collapsed configuration and smaller than the expanded configuration, and

wherein the step of partially expanding the end-constraining element comprises disengaging the secondary coupling member to expand the expandable implant to the intermediate configuration.

16. The method of claim 15, wherein the step of fully expanding the expandable implant comprises disengaging the primary coupling member to expand the expandable implant to the expanded configuration.

17. The method of claim 14, wherein the catheter assembly further comprises a secondary sleeve and secondary coupling member, wherein the secondary sleeve limits expansion of the expandable implant to an intermediate configuration having a diameter larger than the diameter of the collapsed configuration and smaller than the diameter of the expanded configuration, and wherein the step of partially expanding the end-constraining element comprises disengaging the secondary coupling member and removing the secondary sleeve to expand the expandable implant to the intermediate configuration.

18. The method of claim 14, wherein the catheter assembly further comprises a plurality of apposition lines.

19. The method of claim 14, wherein the catheter further comprises a pair of distal end ports and the lock wire exits the main lumen through one of the pair of distal end ports, engages the expandable implant, and enters the main lumen through the other of the pair of distal end ports to removably couple the catheter and the distal end of the expandable implant.

20. The method of claim 14, wherein the expandable implant is a self-expanding stent graft.

21. The method of claim 14, wherein the catheter assembly further comprises an end-constraining element located at the proximal end of the expandable implant and configured to maintain the proximal end of the expandable implant in the collapsed configuration.

22. The method of claim 14, wherein the catheter assembly further comprises a lockwire configured to couple a portion of the expandable implant and the catheter.

23. The method of claim 21, wherein the catheter assembly further comprises a lockwire configured to couple a portion of the end-constraining element and the catheter.