STENT AND IMPLANTABLE VALVE INCORPORATING SAME

• US 20140012371A1
• Filed: 03/12/2013
• Published: 01/09/2014
• Est. Priority Date: 07/03/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Li, XueMei
• Granted Patent: US 10,004,597 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded

Abstract

A collapsible stent for an implantable prosthetic valve incorporates leaflet-supporting members having relatively large surface area in comparison to other members defining the remainder of the stent. The leaflet-supporting members may have openings extending through them. The valve leaflets may be attached to the stent so that an attached edge of each leaflet extends along the leaflet-supporting members and is attached to the members by polymer integral with the leaflet overlying the leaflet supporting members and extending into the openings of the leaflet supporting members. The secure attachment resists stress on the leaflets.

Claims

1. A stent for an implantable valve comprising:

(a) a proximal section extending circumferentially around an axis, the proximal section including a plurality of elongated proximal members connected with one another, each of the proximal members having a mean width; and

(b) a leaflet support section extending circumferentially around the axis, the leaflet support section being offset from the proximal section in a distal direction along the axis, the leaflet support section including a plurality of elongated leaflet support members defining a plurality of cusps projecting in the distal direction at locations spaced circumferentially around the axis and a plurality of valleys between the cusps such that two of the leaflet support members bound each valley, the leaflets support members bounding the valleys having mean perimeters greater than the mean perimeters of the proximal members,

the stent being radially collapsible and expandable.

2. A stent as claimed in claim 1 wherein the leaflet support members have openings extending through the members.

3. A stent as claimed in claim 2 wherein the leaflet support members have oppositely directed major surfaces and at least some of the openings extend through the leaflet support members from one major surface to another major surface.

4. A stent as claimed in claim 1 wherein the leaflet support members have a mean width greater than a mean width of the proximal members.

5. A stent as claimed in claim 1 wherein, when the stent is in an expanded condition, the leaflet support members bounding each valley define sections of a continuous curve concave in the distal direction.

6. A stent as claimed in claim 1 wherein the proximal members define a plurality of cells in the proximal section, and wherein the proximal members and leaflet support members cooperatively define a plurality of additional cells, each such cell being bounded by two proximal members and at least two leaflet support members.

7. A stent as claimed in claim 1 wherein the leaflet support members bounding each valley have proximal ends spaced apart from one another in the circumferential direction and connected to one another by a pair of proximal members, the proximal members of each such pair joining one another at a juncture proximal to the proximal ends of the leaflet support members.

8. A stent as claimed in claim 1 further comprising a plurality of anchor members defining an anchor section distal to the leaflet support section.

9. An implantable valve comprising a stent as claimed in claim 1 and a plurality of leaflets mounted to the stent, each such leaflet spanning one said valley and having an attached edge secured to and extending along the leaflet support members bounding that valley, each such leaflet having a free edge extending between the cusps disposed on opposite sides of that valley so that the free edges of the leaflets meet one another at commissures adjacent the cusps.

10. An implantable valve as claimed in claim 9 wherein the leaflets are formed from a polymeric material.

11. An implantable valve as claimed in claim 10 wherein the leaflets adhere to the leaflet support members.

12. An implantable valve as claimed in claim 10 wherein the leaflet support members have openings within them and wherein polymeric material integral with the leaflets extends into the openings to secure the leaflets to the leaflet support members.

13. An implantable valve as claimed in claim 12 wherein the openings extend through the leaflet support members and the polymeric material extends through the openings.

14. An implantable valve as claimed in claim 10, further comprising a cuff covering at least a part of the proximal section, the cuff being formed integrally with the leaflets.

15. An implantable valve as claimed in claim 9 wherein the leaflet support members bounding each valley have proximal ends spaced apart from one another in the circumferential direction so as to define a gap therebetween the attached edge of each leaflet extending across one said gap.

16. An implantable valve comprising a collapsible and expansible stent having a plurality of elongated members, at least some of the members having openings extending therein, and a flexible element formed from a polymeric material, the polymeric material of the flexible element extending into the openings in the members to secure the flexible element to the members.

17. An implantable valve as claimed in claim 16 wherein the openings extend through the member and the polymeric material extends through the openings.

18. A method of making an implantable valve comprising the steps of:

(a) placing a mandrel having leaflet-forming surfaces into a stent having spaced-apart elongated leaflet support members with openings therein so that the leaflet support members of the stent extend along edges of the leaflet-forming surfaces of the mandrel;

(b) depositing a flowable composition on the mandrel and stent so that the composition forms layers on the surfaces spanning between members of the stent, contacts the members of the stent and penetrates into the openings of the members;

(c) curing the composition to a flexible solid so as to form leaflets extending between the leaflet support members, the leaflets being secured to the members at least in part by cured composition in the openings; and

(d) removing the stent and the leaflets from the mandrel.

19. A method as claimed in claim 18 wherein the flowable composition covers a proximal section of the stent offset in a proximal direction from the leaflet support members and the cured flowable composition forms a cuff integral with the leaflets covering at least a part of the proximal section.