System and method for deploying an endoluminal prosthesis at a surgical site

• US 9,101,506 B2
• Filed: 03/12/2010
• Issued: 08/11/2015
• Est. Priority Date: 03/13/2009
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Christian, Fletcher, Manguno, Joseph A. Jr., Canning, John C.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US12/723,431
• Publication Number:
  US 20100234932A1
• Time in Patent Office: 1,978 Days
• Field of Search: 606/108, 623/1.11, 623/1.12
• US Class Current: 1/1
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A system for implanting a prosthesis includes a control lumen and a nose cone affixed at a distal end of the control lumen. At least one supporting wire is affixed at one end, is substantially parallel to a major axis of the control lumen and is free at an opposite end, wherein the free end of at least one of the supporting wires is arcuate. Alternatively, a system for implanting a prosthesis includes at least one suture extending from a nose cone affixed to a distal end of a control lumen. The suture extends from the nose cone to a proximal end to a stent graft extending about the control lumen and from the stent graft to a fixed location on the control lumen. The suture is releasable from the stent graft by remote activation, whereby the suture separates from the nose cone to thereby deploy the stent graft.

Claims

1. A system for implanting a prosthesis, comprising:

a) an arcuate control lumen, the arcuate control lumen having a superior side, an inferior side, and a distal end;

b) a nose cone fixed at the distal end of the arcuate control lumen; and

c) at least one supporting wire having a fixed proximal end and a free distal end opposite the fixed proximal end, wherein only the proximal end is fixed, and wherein the at least one supporting wire extends along the inferior side of the arcuate control lumen and splays away from the arcuate control lumen, wherein the free distal end of the at least one supporting wire is flexible and arcuate, and arcs toward the arcuate control lumen.

2. The system of claim 1, further including an outer control tube slideable along the arcuate control lumen, wherein the fixed proximal end of the at least one supporting wire is fixed at one end to the outer control tube.

3. The system of claim 2, wherein the fixed proximal end of the at least one supporting wire is fixed to the outer control tube proximal to the nose cone to thereby form a fixed end and the free distal end is distal to the fixed end and is proximate to the nose cone.

4. The system of claim 3, further including an apex clasp at an end of the outer control tube and slideable along the control lumen with movement of the outer control tube.

5. The system of claim 4, further including a stent graft extending about the outer control tube and the at least one supporting wire, the stent graft including a proximal end at the clasp and a distal end that is proximal to the clasp.

6. The system of claim 5, wherein the stent graft includes at least one clasp stent defining at least one exposed portion that is releasably secured to the clasp.

7. The system of claim 6, wherein the stent graft includes for each of the at least one supporting wire, a loop within the stent graft that releasably secures the free distal end of each respective at least one supporting wire.

8. The system of claim 7, wherein the stent graft includes a crown stent at the proximate end of the stent graft.

9. The system of claim 8, wherein the crown stent is secured to an interior portion of a graft portion of the stent graft.

10. The system of claim 9, wherein the crown stent is between the clasp stent and the proximal end of the stent graft.

11. The system of claim 5, wherein the stent graft further includes at least one radiopaque marker.

12. The system of claim 1, further including a pusher support tube distal or proximal to the fixed distal end of the at least one supporting wire and slideable along the arcuate control lumen.

13. The system of claim 12, further including an outer control tube slideable along the arcuate control lumen, wherein the fixed proximal end of the at least one supporting wire is fixed at one end to the outer control tube.

14. The system of claim 13, further including an apex clasp at an end of the outer control tube and slideable along the control lumen with movement of the outer control tube.

15. The system of claim 1, wherein the at least one supporting wire is formed of at least one member selected from the group consisting of a metal, an alloy and a polymer.

16. The system of claim 15, wherein the metal includes stainless steel.

17. The system of claim 15, wherein the alloy includes a shape memory alloy.

18. The system of claim 17, wherein the shape memory alloy includes a nickel titanium alloy.

19. The system of claim 1, wherein the system includes at least two supporting wires.

20. The system of claim 19, wherein the system includes two supporting wires.

21. The system of claim 1, wherein the fixed proximal end of the at least one supporting wire is fixed to the arcuate control lumen proximate to the nose cone, and wherein the free distal end of the at least one supporting wire is proximal to the fixed proximal end.

22. The system of claim 21, further including an inner sheath that is fixed to the nose cone and extends proximally from the nose cone about the at least one supporting wire.

23. The system of claim 22, further including a stent graft extending about the control lumen and the at least one supporting wire and within the inner sheath.

24. The system of claim 23, wherein the stent graft includes at least one loop within the stent graft that releasably secures the free distal end of each respective at least one supporting wire.

25. The system of claim 1, further including an inner sheath with a distal portion, and wherein the nose cone defines a proximal cavity into which the distal portion of the inner sheath fits, whereby relative motion of the nose cone and the inner sheath releases the distal end of the inner sheath from the proximal cavity.

26. The system of claim 25, wherein the nose cone is retractable within the inner sheath after release of the inner sheath.

27. The system of claim 26, further including a stent graft within the inner sheath, inner sheath and the nose cone are retractable relative to the stent graft.

28. The system of claim 27, wherein the stent graft includes a loop inside the stent graft that releasably secures a respective at least one supporting wire, whereby movement of the loop along the at least one supporting wire is restricted.

29. The system of claim 26, whereby the stent graft is deployed by joint retraction of the inner sheath and the nose cone.

30. The system of claim 1, wherein the fixed proximal end of the at least one supporting wire is fixed to the arcuate control lumen.

31. The system of claim 1, further including a buttress having a proximal end and a distal end, the proximal end of the buttress fixed to the distal end of the arcuate control lumen proximal to the nose cone and wherein the fixed proximal end of the at least one supporting wire is fixed to the distal end of the buttress.

32. A system for implanting a prosthesis, comprising:

a) an arcuate control lumen, the arcuate control lumen having a superior side, an inferior side and a distal end;

b) a nose cone fixed at the distal end of the arcuate control lumen;

c) an flexible inner sheath extending about the arcuate control lumen that defines a distal opening at a distal end of the inner sheath, wherein the nose cone is retractable within the inner sheath; and

d) at least one supporting wire having a fixed proximal end and a free distal end, wherein only the proximal end is fixed, and wherein the at least one supporting wire extends along the inferior side of the arcuate control lumen and splays away from the arcuate control lumen and the free distal end of at least one of the supporting wires is flexible and arcuate, and arcs towards the arcuate control lumen.

33. The system of claim 32, wherein the inner sheath is a flexible inner sheath and the nose cone defines a cavity within which the distal end of the flexible inner sheath can fit, and which will release the distal end of the flexible inner sheath upon retraction of the distal end of the flexible inner sheath from the cavity of the nose cone, the nose cone being retractable within the flexible inner sheath after release of the distal end of the flexible inner sheath from the cavity.

34. The system of claim 32, wherein the fixed proximal end of the at least one supporting wire is fixed to the arcuate control lumen.

35. The system of claim 32, further including a buttress having a proximal end and a distal end, the proximal end of the buttress fixed to the distal end of the arcuate control lumen proximal to the nose cone and wherein the fixed proximal end of the at least one supporting wire is fixed to the distal end of the buttress.