Valve cuff support

• US 9,289,292 B2
• Filed: 02/28/2013
• Issued: 03/22/2016
• Est. Priority Date: 06/28/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Anderl, Steven Frederick, Braido, Peter Nicholas, Schraut, Julia Ann
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Nelson, Christine
• Application Number:
  US13/781,381
• Publication Number:
  US 20140005777A1
• Time in Patent Office: 1,118 Days
• Field of Search: 623/2.14, 623/2.15, 623/2.18, 623/2.19, 623/1.24, 623/1.26
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent has a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts. A valve assembly is secured to the stent and includes a cuff and a plurality of leaflets. The plurality of leaflets are attached to the cuff adjacent an underwire that extends about the perimeter of the cuff.

Claims

1. A prosthetic heart valve, comprising:

a stent having a collapsed condition and an expanded condition, the stent having a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts;

an underwire disposed around a perimeter of the stent; and

a valve assembly secured to the stent, the valve assembly including a cuff and a plurality of leaflets, each of the plurality of leaflets having a pair of attachment portions, a free edge extending between the pair of attachment portions, and a belly portion extending between the pair of attachment portions and disposed opposite the free edge, a portion of the underwire having a shape that conforms to belly portions of the plurality of leaflets, the cuff being coupled to the underwire and the plurality of leaflets, and the cuff being disposed between the underwire and portions of the plurality of leaflets;

wherein the stent includes a plurality of commissure features and the underwire is coupled to the cuff with a repeating pattern, the pattern including a descending portion extending toward the proximal end of the stent, an ascending portion extending toward a commissure feature, and an intermediate portion between the descending portion and the ascending portion, the pattern being disposed solely between the commissure features and the proximal end of the stent.

2. The prosthetic heart valve according to claim 1 , wherein the underwire is coupled to the plurality of commissure features.

3. The prosthetic heart valve according to claim 1, wherein an end of the descending portion is spaced between 0.5 mm and 2.0 mm proximally of a first commissure feature, and an end of the ascending portion is spaced between 0.5 mm and 2.0 mm proximally of a second commissure feature.

4. The prosthetic heart valve according to claim 1, wherein the underwire forms a repeating parabolic pattern.

5. The prosthetic heart valve according to claim 4, wherein at least a portion of the underwire lies on an abluminal surface of the stent.

6. The prosthetic heart valve according to claim 1, wherein the underwire comprises a suture.

7. The prosthetic heart valve according to claim 6, wherein the underwire comprises a braided suture of multiple materials.

8. The prosthetic heart valve according to claim 1, wherein the underwire comprises a metal.

9. The prosthetic heart valve according to claim 1, wherein the underwire comprises a shape-memory wire that has been pre-set to form a shape corresponding to a contour of the cuff.

10. The prosthetic heart valve according to claim 1, wherein at least a portion of the underwire is radiopaque.

11. The prosthetic heart valve according to claim 10, wherein at least a portion of the underwire includes tantalum.

12. The prosthetic heart valve according to claim 1, wherein a portion of the underwire is coupled to the belly portion of each of the plurality of leaflets.

13. A prosthetic heart valve comprising:

a stent having a collapsed condition and an expanded condition, the stent having a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts;

an underwire disposed around a perimeter of the stent; and

a valve assembly secured to the stent, the valve assembly including a cuff and a plurality of leaflets, each of the plurality of leaflets having a pair of attachment portions, a free edge extending between the pair of attachment portions, and a belly portion extending between the pair of attachment portions and disposed opposite the free edge, a portion of the underwire having a shape that conforms to belly portions of the plurality of leaflets, the cuff being coupled to the underwire and the plurality of leaflets, and the cuff being disposed between the underwire and portions of the plurality of leaflets;

wherein the underwire is coupled to the cuff with a plurality of stitches, the plurality of stitches also attaching the plurality of leaflets to the cuff.

14. A prosthetic heart valve comprising:

a stent having a collapsed condition and an expanded condition, the stent having a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts;

an underwire disposed around a perimeter of the stent; and

a valve assembly secured to the stent, the valve assembly including a cuff and a plurality of leaflets, each of the plurality of leaflets having a pair of attachment portions, a free edge extending between the pair of attachment portions, and a belly portion extending between the pair of attachment portions and disposed opposite the free edge, a portion of the underwire having a shape that conforms to belly portions of the plurality of leaflets, the cuff being coupled to the underwire and the plurality of leaflets, and the cuff being disposed between the underwire and portions of the plurality of leaflets;

wherein the plurality of leaflets are attached to the cuff and the underwire via at least one suture that pierces the cuff and at least one of the plurality of leaflets and wraps around the underwire before piercing the cuff a second time.

15. A prosthetic heart valve comprising:

a stent having a collapsed condition and an expanded condition, the stent having a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts;

an underwire disposed around a perimeter of the stent; and

a valve assembly secured to the stent, the valve assembly including a cuff and a plurality of leaflets, each of the plurality of leaflets having a pair of attachment portions, a free edge extending between the pair of attachment portions, and a belly portion extending between the pair of attachment portions and disposed opposite the free edge, a portion of the underwire having a shape that conforms to belly portions of the plurality of leaflets, the cuff being coupled to the underwire and the plurality of leaflets, and the cuff being disposed between the underwire and portions of the plurality of leaflets;

wherein each of the plurality of leaflets is folded at a proximal end to form a belly flap and an inner layer, the belly flap and the cuff being sandwiched between the underwire and the inner layer.