Stent graft and introducer assembly

• US 9,925,032 B2
• Filed: 12/30/2015
• Issued: 03/27/2018
• Est. Priority Date: 11/18/2009
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Jensen, Kim Moegelvang, Rasmussen, Erik Edelboe, Oehlenschlaeger, Bent
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US14/984,492
• Publication Number:
  US 20160106532A1
• Time in Patent Office: 818 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A stent graft (40) for treating Type-A dissections in the ascending aorta (22) is provided with a plurality of diameter reducing suture loops (56-60) operable to constrain the stent graft during deployment thereof in a patient'"'"'s aorta. The diameter reducing loops (56-60) allow the stent graft (40) to be partially deployed, in such a manner that its location can be precisely adjusted in the patient'"'"'s lumen. In this manner, the stent graft can be placed just by the coronary arteries (26, 28) with confidence that these will not be blocked. The stent graft (40) is also provided with proximal and distal bare stents (44,52) for anchoring purposes.

Claims

1. A stent graft comprising:

a tube of graft material having proximal end, a distal end, a lumen therebetween and a first diameter;

a plurality of stent rings attached to the graft tube, including at least a first stent ring adjacent the proximal end, a second stent ring adjacent the distal end, and at least one intermediate stent ring disposed between the first stent ring and the second stent ring, wherein the at least one intermediate stent ring has a plurality of proximal apices and a plurality of distal apices;

a first diameter reducing loop disposed about the circumference of the of the tube of graft material at the proximal apices and threaded through the graft material at a plurality of points about the circumference such that first lengths of the first diameter reducing loop are disposed on an exterior of the tube of graft material and second lengths of the first diameter reducing loop are disposed on an interior of the tube of graft material;

a second diameter reducing loop disposed about the circumference of the tube of graft material at the distal apices and threaded through the graft material at a plurality of points about the circumference such that first lengths of the second diameter reducing loop are disposed on an exterior of the tube of graft material and second lengths of the second diameter reducing loop are disposed on an interior of the tube of graft material;

wherein the second lengths of the first and second diameter reducing loops pull the at least one intermediate stent and the graft from inside the lumen toward a center point of the stent graft to reduce the diameter of the at least one intermediate stent and a portion of the tube of graft material between the first and second stent rings to a second diameter smaller than the first diameter.

2. The stent graft of claim 1, wherein the at least one intermediate stent ring is located substantially half-way along the tube of graft material.

3. The stent graft of claim 1, wherein the first and second diameter reducing loops are threaded through the graft material at each of the proximal and distal apices.

4. The stent graft of claim 1, wherein the second lengths of the first and second diameter reducing loops are equally spaced about an internal circumference of the tube of graft material.

5. The stent graft of claim 1, wherein the first stent has proximal and distal apices and a third diameter reducing loop is disposed about the circumference of the tube of graft material at the proximal apices of the first stent.

6. The stent graft of claim 5, wherein the third diameter reducing loop is threaded through the graft material at a plurality of points about the circumference such that first lengths of the third diameter reducing loop are disposed on an exterior of the tube of graft material and second lengths of the third diameter reducing loop are disposed on an interior of the tube of graft material.

7. The stent graft of claim 6, wherein the second lengths of the third diameter reducing loop pull the proximal end of the tube of graft material from inside the lumen toward a center point of the stent graft to reduce the diameter of the proximal end to a third diameter smaller than the first diameter.

8. The stent graft of claim 1, wherein the second lengths of the third diameter reducing loop are equally spaced about an internal circumference of the tube of graft material.

9. The stent graft of claim 1 further comprising a flareable bare stent extending from the distal end of the tube of graft material.

10. The stent graft of claim 9, wherein the flareable bare stent is formed of an undulating stent structure having proximal and distal apices, wherein the proximal apices are attached to the tube of material at a distal edge of the tube of graft material and the distal apices extend away from the distal edge, and where the distal apices of the flareable bare stent have a greater radius of curvature than the proximal apices.

11. A stent graft comprising:

a tube of graft material having proximal and distal ends and a lumen therebetween;

a plurality of stent rings attached to the graft tube, including at least a first stent ring adjacent the proximal end, a second stent ring adjacent the distal end, and at least one intermediate stent ring disposed between the first stent ring and the second stent ring, wherein the at least one intermediate stent ring has a plurality of proximal apices and a plurality of distal apices;

a first diameter reducing loop disposed about the circumference of the tube of graft material and the at least one intermediate stent and threaded through the graft material at a plurality of points about the circumference such that first lengths of the first diameter reducing loop are disposed on an exterior of the tube of graft material and second lengths of the first diameter reducing loop are disposed on an interior of the tube of graft material;

wherein the second lengths of the first reducing loop pull the single intermediate stent and the graft from inside the lumen toward a center point of the stent graft to reduce the diameter of the at least one intermediate stent and a portion of the tube of graft material between the first and second stent rings.

12. The stent graft of claim 11, wherein the at least one intermediate stent ring is located substantially half-way along the tube of graft material.

13. The stent graft of claim 12, wherein the second lengths of the first diameter reducing loop are equally spaced about an internal circumference of the tube of graft material.

14. The stent graft of claim 11, further comprising a flareable bare stent extending from the distal end of the tube of graft material.

15. The stent graft of claim 14, wherein the flareable bare stent is formed of an undulating stent structure having proximal and distal apices, wherein the proximal apices are attached to the tube of material at a distal edge of the tube of graft material and the distal apices extend away from the distal edge, and where the distal apices of the flareable bare stent have a greater radius of curvature than the proximal apices.

16. An introducer assembly for introducing a stent graft into a vessel, comprising:

a tube of graft material having proximal end, a distal end, a lumen therebetween and a first diameter;

a plurality of stent rings attached to the graft tube, including at least a first stent ring adjacent the proximal end, a second stent ring adjacent the distal end, and at least one intermediate stent ring disposed between the first stent ring and the second stent ring, wherein the at least one intermediate stent ring has a plurality of proximal apices and a plurality of distal apices;

a first diameter reducing loop disposed about the circumference of the of the tube of graft material at the proximal apices and threaded through the graft material at a plurality of points about the circumference such that first lengths of the first diameter reducing loop are disposed on an exterior of the tube of graft material and second lengths of the second diameter reducing loop are disposed on an interior of the tube of graft material;

a second diameter reducing loop disposed about the circumference of the tube of graft material at the distal apices and threaded through the graft material at a plurality of points about the circumference such that first lengths of the second diameter reducing loop are disposed on an exterior of the tube of graft material and second lengths of the first diameter reducing loop are disposed on an interior of the tube of graft material;

the introducer assembly including a carrier for carrying the stent graft, an outer sheath movable from a position covering the carrier to a withdrawn position exposing the carrier; and

one or more trigger wires engaging the second lengths of the first and second diameter reducing loops within the lumen of the stent graft;

wherein the second lengths of the first and second diameter reducing loops pull the at least one intermediate stent and the graft from inside the lumen toward a center point of the stent graft to engage the carrier and reduce the diameter of the at least one intermediate stent and a portion of the tube of graft material between the first and second stent rings to a second diameter smaller than the first diameter.

17. The introducer assembly of claim 16, wherein the one or more trigger wires are configured to restrain the proximal end of the stent graft.

18. The introducer assembly of claim 16, wherein the trigger wires are configured to restrain the distal end of the stent graft.

19. The introducer assembly of claim 16, wherein the one or more trigger wires includes a plurality of sets of trigger wires.

20. The stent graft of claim 16, wherein the second lengths of the first diameter reducing loop are equally spaced about an internal circumference of the tube of graft material.