Leaflet suturing to commissure points for prosthetic heart valve

• US 9,717,593 B2
• Filed: 08/23/2011
• Issued: 08/01/2017
• Est. Priority Date: 02/01/2011
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Alkhatib, Yousef F., Braldo, Peter Nicholas
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/216,124
• Publication Number:
  US 20120197391A1
• Time in Patent Office: 2,170 Days
• Field of Search: 623 124, 623 126, 623 21, 623 211, 623 212, 623 213, 623 214, 623 215, 623 216, 623 217, 623 218, 623 219, 623 238, 623 239, 623 24, 623 241, 623900, 623910
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2002/9534 for repositioning of stents
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A collapsible prosthetic heart valve includes a collapsible and expandable stent and a collapsible and expandable valve assembly. The stent has a proximal end and a distal end. A plurality of commissure points is disposed on the stent. The valve assembly is disposed within the stent and includes a plurality of leaflets. Each leaflet has a free edge. An end portion of the free edge of each leaflet is folded and sutured to a corresponding one of the plurality of the commissure points.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end and a distal end and comprising a plurality of struts and a plurality of cells defined by the plurality of struts;

a plurality of commissure points disposed on the stent, each of the commissure points including a body having an inner surface, an outer surface, a first lateral side and a second lateral side, each of the commissure points interconnecting first and second adjacent cells in an annular row of the stent such that the first lateral side faces the first cell and the second lateral side faces the second cell; and

a collapsible and expandable valve assembly disposed within the stent, the valve assembly including a plurality of leaflets, each leaflet having an end portion;

wherein the end portion of a first one of the leaflets includes a first folded portion and a first remainder portion, the first remainder portion having a first segment coextensive with the first folded portion and a second segment extending from the first segment away from one of the commissure points, the first folded portion of the first leaflet being attached to the one commissure point in contact with the inner surface of the one commissure point,

wherein the end portion of a second one of the leaflets adjacent the first leaflet includes a second folded portion and a second remainder portion, the second remainder portion having a first segment coextensive with the second folded portion and a second segment extending from the first segment of the second remainder portion away from the one commissure point, the second folded portion of the second leaflet being attached to the one commissure point in contact with the inner surface of the one commissure point,

wherein the first folded portion of the first leaflet is attached directly to the first segment of the first remainder portion of the first leaflet so that a surface of the first folded portion contacts a surface of the first segment of the first remainder portion, and

wherein the second folded portion of the second leaflet is attached directly to the first segment of the second remainder portion of the second leaflet so that a surface of the second folded portion contacts a surface of the first segment of the second remainder portion.

2. The prosthetic heart valve according to claim 1, wherein the first folded portion and the first segment of the first remainder of the first leaflet are generally parallel to the second segment of the first remainder of the first leaflet.

3. The prosthetic heart valve according to claim 1, wherein the first folded portion and the first segment of the first remainder of the first leaflet are generally perpendicular to the second segment of the first remainder of the first leaflet.

4. The prosthetic heart valve according to claim 3, wherein a free edge of the end portion of the first leaflet extends beyond a suture away from the first remainder portion of the first leaflet.

5. The prosthetic heart valve according to claim 3, wherein the end portion of the first leaflet is folded so that the first folded portion of the first leaflet includes at least two layers of the end portion of the first leaflet.

6. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end and a distal end and comprising a plurality of struts and a plurality of cells defined by the plurality of struts;

a plurality of commissure points disposed on the stent, each of the commissure points including a body having an inner surface, an outer surface, a first lateral side and a second lateral side, each of the commissure points interconnecting first and second adjacent cells in an annular row of the stent such that the first lateral side faces the first cell and the second lateral side faces the second cell; and

a collapsible and expandable valve assembly disposed within the stent, the valve assembly including a plurality of leaflets, each leaflet having an end portion;

wherein the end portion of a first one of the leaflets includes a first folded portion and a first remainder portion, the first remainder portion having a first segment coextensive with the first folded portion and a second segment extending from the first segment away from one of the commissure points, the first folded portion of the first leaflet being attached to the one commissure point in contact with the inner surface of the one commissure point, the first folded portion having a configuration selected from the group consisting of a U-shaped pleat, an S-shaped pleat, and an L-shaped fold;

wherein the end portion of a second one of the leaflets adjacent to the first leaflet includes a second folded portion and a second remainder portion, the second remainder portion having a first segment coextensive with the second folded portion and a second segment extending from the first segment away from the one commissure point, the second folded portion of the second leaflet being attached to the one commissure point in contact with the inner surface of the one commissure point, the second folded portion having a configuration selected from the group consisting of a U-shaped pleat, an S-shaped pleat, and an L-shaped fold;

wherein the first folded portion of the first leaflet is attached directly to the first segment of the first remainder portion of the first leaflet so that a surface of the first folded portion contacts a surface of the first segment of the first remainder portion; and

wherein the second folded portion of the second leaflet is attached directly to the first segment of the second remainder portion of the second leaflet so that a surface of the second folded portion contacts a surface of the first segment of the second remainder portion.

7. A prosthetic heart valve comprising:

a collapsible and expandable stent having a proximal end and a distal end;

a plurality of commissure points disposed on the stent, each of the commissure points including a body having an inner surface, an outer surface, a first side surface extending between the inner surface and the outer surface on a first lateral side of the body and a second side surface extending between the inner surface and the outer surface on a second lateral side of the body, each of the commissure points interconnecting a first cell adjacent to the first lateral side of the body and a second cell adjacent to the second lateral side of the body such that the first side surface faces the first cell and the second side surface faces the second cell; and

a collapsible and expandable valve assembly disposed within the stent, the valve assembly including a plurality of leaflets, each leaflet having an end portion;

wherein a first end portion of a first one of the leaflets is at least partially wrapped about the first side surface of one of the commissure points and a second end portion of a second one of the leaflets is at least partially wrapped about the second side surface of the one commissure point, such that the first end portion and the second end portion form first and second U-shaped pleats, respectively, enveloping the first side surface and second side surface of the one commissure point, respectively; and

wherein the first end portion and the second end portion are attached to the one commissure point, free ends of the first end portion and second end portions being independent of one another and facing one another.

8. The prosthetic heart of claim 7 further comprising a web of material overlying the end portion of the first leaflet and the end portion of the second leaflet and enveloping the first side surface and second side surface of the one commissure point, the web of material being attached to the end portion of the first leaflet, the end portion of the second leaflets and to the outer surface of the one commissure point.

9. A prosthetic heart valve comprising:

a collapsible and expandable stent having a proximal end and a distal end and comprising a plurality of struts and a plurality of cells defined by the plurality of struts;

a plurality of commissure points disposed on the stent, each of the commissure points including a body having an inner surface, an outer surface, a first side surface extending between the inner surface and the outer surface on a first lateral side of the body and a second side surface extending between the inner surface and the outer surface on a second lateral side of the body, each of the commissure points interconnecting a first cell adjacent to the first lateral side of the body and a second cell adjacent to the second lateral side of the body such that the first side surface faces the first cell and the second side surface faces the second cell;

a collapsible and expandable valve assembly disposed within the stent, the valve assembly including a plurality of leaflets, each leaflet having an end portion;

wherein the end portion of a first one of the leaflets and the end portion of a second one of the leaflets overlie the inner surface of one of the commissure points in an L-shaped configuration so that the first and second leaflets are adjacent to one another and contact the inner surface of the one commissure point;

wherein the end portion of the first leaflet extends from the first leaflet in a first direction toward the first lateral side of the one commissure point and is attached to the one commissure point, a free end of the end portion of the first leaflet pointing in the first direction; and

wherein the end portion of the second leaflet extends from the second leaflet in a second direction generally opposite the first direction toward the second lateral side of the one commissure point and away from the end portion of the first leaflet and is attached to the one commissure point, a free end of the end portion of the second leaflet pointing in the second direction; and

a web wrapped around the one commissure point so as to overlie the end portion of the first leaflet, the end portion of the second leaflet, the first lateral side and the second lateral side and the outer surface of the one commissure point.