Collapsible-expandable prosthetic heart valves with structures for clamping native tissue

• US 9,532,868 B2
• Filed: 09/28/2007
• Issued: 01/03/2017
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Braido, Peter Nicholas
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US11/906,133
• Publication Number:
  US 20140155997A1
• Time in Patent Office: 3,385 Days
• Field of Search: 623/900, 623/2.4, 623/2.13, 623/2.1, 623/2.11, 623/2.12, 623/2.14, 623/2.17, 623/1.24, 623/1.26, 623/1.36, 623/2.18, 623 236- 237, 623/1.3, 606/1
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient'"'"'s native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Claims

1. A prosthetic heart valve comprising:

an annular structure having an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient'"'"'s native aortic valve annulus and also in the patient'"'"'s aorta, the annular structure including an annularly continuous annulus portion adapted for implanting adjacent the patient'"'"'s native aortic valve annulus upstream from the ostia of the patient'"'"'s coronary arteries, and an annularly continuous aortic portion adapted for implanting in the patient'"'"'s aorta, the annulus portion and the aortic portion being connected to one another only by a plurality of linking structures, the annulus portion and the aortic portion each including an annular array of diamond-shaped cells, each cell having an upstream apex portion directly connected to a downstream apex portion at connection points, the upstream apex portion having an upstream apex aligned with a downstream apex of the downstream apex portion in a longitudinal direction of the annular structure, each of the linking structures having a first end connected directly to the upstream apex of one of the cells in the aortic portion, the first ends being spaced from one another in an annular direction of the aortic portion, and each of the linking structures having a second end connected to the cells in the annulus portion, the second ends being spaced from one another in an annular direction of the annulus portion;

a cuff extending annularly around the annulus portion and having a first annular edge positioned downstream of the upstream apices and a second annular edge positioned upstream of the downstream apices; and

a flexible leaflet structure attached to the annular structure, wherein

the upstream apex portion of each cell in a group of the cells in the annulus portion is resiliently biased to deflect radially outwardly from the connection points, and the downstream apex portion of each cell in the group of the cells is resiliently biased to deflect radially outwardly from the connection points,

whereby each cell in the group of the cells, in use, clamps tissue of the patient adjacent to the patient'"'"'s native valve annulus between the upstream apex portion of the cell and the downstream apex portion of the cell, with the upstream apex portion of the cell engaging tissue upstream from the native valve annulus and the downstream apex portion of the cell engaging tissue downstream from the native valve annulus.

2. The valve defined in claim 1 wherein the annular perimeter is elastically changeable in length between the first relatively small length and the second relatively large length.

3. The valve defined in claim 1, wherein

the resiliently biased, radially outward deflection of each of the upstream apex portions includes a downstream component of motion by the upstream apex portion, and

the resiliently biased, radially outward deflection of each of the downstream apex portions includes and upstream component of motion by the downstream apex portion.

4. The valve defined in claim 1 further comprising a plurality of commissure post members that are cantilevered from the annulus portion.

5. The valve defined in claim 4 wherein the commissure post members are spaced circumferentially around the annulus portion so that they can be aligned with respective commissures of the patient'"'"'s native aortic valve.

6. The valve defined in claim 4 wherein the linking structures consist essentially of a respective pair of struts associated with each of the commissure post members, the struts in each pair extending along respective opposite sides of the associated commissure post members to the aortic portion, each pair of struts including a first strut having an end connected to a first cell in the aortic portion and a second strut having an end connected to a second cell in the aortic portion different from the first cell.

7. The valve defined in claim 1 wherein the diamond-shaped cells of the aortic portion each defines an area larger than an area of each diamond-shaped cell of the annulus portion.

8. The valve defined in claim 1, wherein each of the upstream apices includes a barb.

9. The valve defined in claim 8, wherein each of the downstream apices includes a barb.

10. The valve defined in claim 1, wherein the annulus portion includes at least one annular row of cells, and the group of cells includes less than all of the cells in the annular row.

11. A prosthetic heart valve comprising:

an annularly compressible and expandable annular structure including (1) an annularly continuous annulus inflow portion adapted for implanting adjacent a patient'"'"'s native aortic valve annulus, (2) an annularly continuous aortic outflow portion adapted for implanting in the patient'"'"'s aorta, and (3) a plurality of linking structures connecting the annulus inflow portion to the aortic outflow portion, each of the linking structures having a first end connected directly to the aortic outflow portion, the first ends being spaced from one another in an annular direction around the annular structure, the annulus inflow portion defining a plurality of commissure tips that are spaced from one another in the annular direction, each of the commissure tips having a free end and an associated pair of the linking structures disposed on opposite sides of the commissure tip in the annular direction, the associated pair of linking structures including a first linking structure and a second linking structure, the first linking structure and the second linking structure being spaced apart from one another by a distance in the annular direction that is less than the distance in the annular direction between the first linking structure and a next adjacent linking structure not in the pair such that the second linking structure is not between the first linking structure and the next adjacent linking structure, the annulus portion including an annular array of diamond-shaped cells, each cell having an upstream apex portion directly connected to a downstream apex portion at connection points, the upstream apex portion having an upstream apex aligned with a downstream apex of the downstream apex portion in a longitudinal direction of the annular structure; and

a flexible leaflet structure attached to the annular structure, wherein

the upstream apex portion of each cell in a group of the cells is resiliently biased to deflect radially outwardly from the connection points, and the downstream apex portion of each cell in the group of the cells is resiliently biased to deflect radially outwardly from the connection points,

whereby each cell in the group of the cells, in use, clamps tissue of the patient adjacent to the patient'"'"'s native valve annulus between the upstream apex portion of the cell and the downstream apex portion of the cell.

12. The prosthetic heart valve defined in claim 11, wherein an edge of the annulus inflow portion that is most remote from the aortic outflow portion includes a recessed edge portion aligned in the longitudinal direction of the annular structure with at least one of the commissure tips, the recessed edge portion being closer to the aortic outflow portion than other portions of the edge of the annulus inflow portion.

13. A prosthetic heart valve comprising:

an annular structure having an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient'"'"'s native aortic valve annulus and also in the patient'"'"'s aorta, the annular structure including an annularly continuous annulus portion adapted for implanting adjacent the patient'"'"'s native aortic valve annulus upstream from the ostia of the patient'"'"'s coronary arteries, an annularly continuous aortic portion adapted for implanting in the patient'"'"'s aorta, and a plurality of commissure post members cantilevered from the annulus portion, the annulus portion and the aortic portion being connected to one another only by a plurality of linking structures, the annulus portion and the aortic portion each including an annular array of diamond-shaped cells, each cell having an upstream apex portion directly connected to a downstream apex portion at connection points, the upstream apex portion having an upstream apex aligned with a downstream apex of the downstream apex portion in a longitudinal direction of the annular structure, each of the linking structures having a first end connected directly to the upstream apex of one of the cells in the aortic portion, the first ends being spaced from one another in an annular direction of the aortic portion, and each of the linking structures having a second end connected directly to one of the commissure post members, the second ends being spaced from one another in an annular direction of the annulus portion;

a cuff extending annularly around the annulus portion and having a first annular edge positioned downstream of the upstream apices and a second annular edge positioned upstream of the downstream apices; and

a flexible leaflet structure attached to the annular structure, wherein

the upstream apex portion of each cell in a group of the cells in the annulus portion is resiliently biased to deflect radially outwardly from the connection points, and the downstream apex portion of each cell in the group of the cells is resiliently biased to deflect radially outwardly from the connection points,

whereby each cell in the group of the cells, in use, clamps tissue of the patient adjacent to the patient'"'"'s native valve annulus between the upstream apex portion of the cell and the downstream apex portion of the cell, with the upstream apex portion of the cell engaging tissue upstream from the native valve annulus and the downstream apex portion of the cell engaging tissue downstream from the native valve annulus.

14. The valve defined in claim 13, wherein the first end of each of the linking structures connects to the aortic portion at a point that is axially aligned with the commissure post member from which that linking structure extends.

15. The valve defined in claim 13, wherein the linking structures include a respective pair of struts associated with each of the commissure post members, the struts in each pair extending along respective opposite sides of the associated commissure post member to the aortic portion, each pair of struts including a first strut having an end connected to a first cell in the aortic portion and a second strut having an end connected to a second cell in the aortic portion different from the first cell.