Valve replacement devices, delivery device for a valve replacement device and method of production of a valve replacement device

• US 9,333,075 B2
• Filed: 09/12/2011
• Issued: 05/10/2016
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Biadillah, Youssef, Delaloye, Stephane, Lombardi, Fabien, Hefti, Jean-Luc
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): BISSING, DANIEL J
• Application Number:
  US13/821,476
• Publication Number:
  US 20140018915A1
• Time in Patent Office: 1,702 Days
• Field of Search: 623/1.23, 623/1.24, 623/1.26, 623 211- 215, 623 217- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• 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 device for heart valve replacement comprises a valve component having at least two valve leaflets preferably made of pericardium tissue. Each valve leaflet includes at least two tabs. The device further includes a stent component configured to be radially compressible into a compressed state and expandable into a functional state. The stent component comprises a first end, a second end and at least one intermediate section arranged between said first and said second end. The intermediate section has at least two commissural posts generally aligned parallel to an axis spanning from the first end to the second end. The commissural posts are formed in the shape of a wishbone.

Claims

1. A valve replacement device for transcatheter implantation, comprising:

a stent component having an inflow extremity and an outflow extremity, the stent component being radially compressible to a compressed state for delivery to a site of implantation and radially expandable to a functional state, wherein the stent component further comprises an intermediate section between the inflow extremity and the outflow extremity, the intermediate section comprising at least two commissural posts;

valve leaflets mounted at least partly within the stent component;

an inner skirt attached to the valve leaflets, the inner skirt extending at least partly within the stent component towards the inflow extremity; and

an outer skirt extending at least partly outside the stent component, the outer skirt extending further than the inner skirt towards the inflow extremity;

wherein the leaflets are attached to the inner skirt, the inner skirt having commissural portions spaced by scallop-shaped clearances, each clearance spanned by a leaflet, and wherein each commissural portion of the inner skirt comprises at least one flap that is folded at least partly around a respective commissural post.

2. The device of claim 1, wherein the inner skirt and the outer skirt partly overlap in an axial direction.

3. The device of claim 1, wherein the inner skirt extends further than the outer skirt towards the outlet extremity of the stent component.

4. The device of claim 2, wherein the inner skirt extends further than the outer skirt towards the outlet extremity of the stent component.

5. The device of claim 1, wherein a mouth of the stent component has a zig-zag shape defined by a lattice structure of at least one row of cells, the zig-zag shape being defined by an alternating sequence of free apexes at the inflow extremity and connected apexes connecting to adjacent cells, the inner skirt extending only to a level corresponding to at least some of the connected apexes, and the outer skirt extending to a level corresponding to at least some of the free apexes.

6. The device of claim 1, wherein a row of cells at a mouth of the stent component includes at least first and second cells having an exposed free apex that extends beyond free apexes of adjacent cells in the row and is not covered by the outer skirt, the exposed free apexes providing attachment elements for engaging a stent-holder of a delivery device for delivering the valve replacement device to a site of implantation.

7. The valve replacement device of claim 1, wherein

the stent component comprises at least one attachment element for cooperating with a stent-holder of a delivery catheter, wherein the attachment element comprises a U-shape portion joining two stent struts, and wherein, in the compressed state of the stent component, the struts lie adjacent each other at the attachment element, such that an arc of the U-shape portion extends around a first angle more than 180 degrees to define a closed or near closed eyelet having an aperture larger than a spacing of the struts, and wherein, in the functional state of the stent component, the struts displace apart, and the arc of the U-shape portion extends around a second angle that is less than the first angle, to at least partly open the eyelet.

8. The device of claim 7, wherein in the compressed state, the U-shape of the attachment element is a horseshoe U-shape.

9. The device of claim 7, wherein in the functional state, the U-shape of the attachment element is not a horseshoe U-shape.

10. A valve replacement device for transcatheter implantation, comprising:

a stent component comprising a first end, a second end and at least one intermediate section arranged between the first end and the second end, the stent component being radially compressible to a compressed state for delivery to a site of implantation and radially expandable to a functional state, the intermediate section comprising at least two commissural posts each in a shape of a wishbone including a stem communicating with adjacent stent structure and two legs communicating with adjacent stent structure, and

at least two valve leaflets supported by the stent component, each valve leaflet including at least two tabs directly attached to the commissural posts, wherein the at least two valve leaflets are attached to an inner skirt, the inner skirt extending at least partly within the stent component;

wherein the leaflets are attached to the inner skirt, the inner skirt having commissural portions spaced by scallop-shaped clearances, each clearance spanned by a leaflet, and wherein each commissural portion of the inner skirt comprises at least one flap that is folded at least partly around a respective commissural post.

11. The device of claim 10, wherein the stent component comprises a lattice structure having at least one row of cells arranged between the intermediate section and the second end, the wishbone shape of each commissural post spanning a respective sequence of at least three adjacent cells such that the wishbone extends from outer cells of the sequence without attachment to at least one intermediate cell of the sequence.

12. The device of claim 10, wherein the tabs of the leaflets are attached to the stem of the wishbone shaped commissural posts.

13. The device of claim 10, wherein the legs of the wishbone shaped commissural posts are shaped such as to match lateral edges of the leaflets.

14. The device of claim 10, wherein the at least two commissural posts are connected together by at least two stabilization arches arranged between the first end and the intermediate section.

15. A valve replacement device for transcatheter implantation, comprising:

a stent component comprising a first end, a second end and at least one intermediate section arranged between the first end, and the second end, the stent component being radially compressible to a compressed state for delivery to a site of implantation and expandable to a functional state, the intermediate section comprising at least two commissural posts;

an inner skirt extending at least partly within an interior of the stent component; and

at least two valve leaflets each including at least two tabs, the tabs projecting through slits in the inner skirt and attached directly to the commissural posts;

wherein the leaflets are attached to the inner skirt, the inner skirt having commissural portions spaced by scallop-shaped clearances, each clearance spanned by a leaflet, and wherein each commissural portion of the inner skirt comprises at least one flap that is folded at least partly around a respective commissural post.

16. The device of claim 15, wherein tabs of two adjacent leaflets meet and project through the same slit in the inner skirt, and are attached directly to the same commissural post.

17. The device of claim 15, wherein each tab is attached directly to the commissural post by passing through a slot in the commissural post and/or being sutured to the commissural post.

18. The device of claim 15, wherein each commissural portion of the inner skirt comprises two flaps that are folded at least partly around a respective commissural post.

19. The device of claim 15 wherein the at least one flap covers a portion of the tab that is attached to the commissural post.

20. The device of claim 15, wherein the at least one flap extends axially beyond an edge of the tab that is attached to the commissural post.