Prosthetic heart valves with flexible leaflets and leaflet edge clamping

• US 7,803,186 B1
• Filed: 09/28/2007
• Issued: 09/28/2010
• Est. Priority Date: 09/28/2007
• Status: Expired due to Fees

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Woo, Yi-Ren, Li, XueMei
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Sharma; Yashita
• Application Number:
  US11/906,181
• Time in Patent Office: 1,096 Days
• Field of Search: 623 212- 215, 623 217- 219
• US Class Current: 623/2.19
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthetic heart valve includes an annular stent structure having a plurality of annularly spaced stent post regions, a plurality of leaflets that extend radially inward from the stent structure and that include radially outer portions that lie against a radially outer surface of the stent structure, and a clamping structure that is radially outside the other components and that clamps the radially outer portions of the leaflets against the radially outer surface of the stent structures to secure the leaflets to the stent structure. The above-described structural arrangement applies to the stent post regions as well as to other portions of the stent structure.

Claims

1. A prosthetic heart valve comprising:

a stent structure that extends annularly around the valve and that includes a plurality of stent post structures that are spaced from one another around the valve;

a plurality of leaflets that extend radially inward from the stent structure, each of the leaflets being preformed with a pocket that receives at least a portion of the stent structure therein, the pocket having a radially outer portion that lies against a radially outer surface of the stent structure including the stent post structures; and

a clamping structure that fits over the radially outer portions of the leaflets and that clamps the radially outer portions of the leaflets to the stent structure including the stent post structures substantially along the entire radially outer surface of the stent structure including the stent post structures.

2. The valve defined in claim 1 wherein the radially outer portion of each of the leaflets reaches the radially outer surface of the stent structure by passing around an inflow edge of the stent structure.

3. The valve defined in claim 1 wherein each of the stent post structures comprises two elongated members that extend from a remainder of the stent structure toward a stent post tip that is associated with that stent post structure, the two members of each stent post structure being spaced from one another in a direction that is annular of the valve.

4. The valve defined in claim 3 wherein spacing between the two members of each stent post structure allows parts of the radially outer portions of adjacent ones of the leaflets to pass through that spacing to reach the radially outer surface of those members.

5. The valve defined in claim 1 wherein the stent structure, including the stent post structures, includes a plurality of first apertures that pass radially through the stent structure and that are spaced from one another annularly around the valve, and wherein the clamping structure includes a plurality of second apertures, each of which is radially aligned with a respective one of the first apertures, including those in the stent post structures.

6. The valve defined in claim 5 further comprising:

securement structure that passes through radially aligned ones of the first and second apertures for securing the clamping structure to the stent structure, including the stent post structures.

7. The valve defined in claim 6 wherein the securement structure also passes through the radially outer portions of the leaflets between the clamping structure and the stent structure, including the stent post structures.

8. The valve defined in claim 6 wherein the securement structure comprises suture material.

9. The valve defined in claim 1 wherein the clamping structure comprises:

a sewing cuff structure that extends annularly around the valve without covering the stent post structures; and

a plurality of post covers that are separate from the sewing cuff structure, each of the post covers covering a respective one of the stent post structures.

16. The valve defined in claim 1 wherein the clamping structure is stitched to the stent structure including the stent post structures substantially along the entire radially outer surface.

10. A prosthetic heart valve comprising:

a stent member that extends annularly around the valve and that includes a plurality of stent post regions substantially parallel to a longitudinal axis that passes through the valve and about which the valve is annular, the stent post regions being spaced from one another in a direction that is annular to the valve;

a plurality of leaflets that extend radially inward from the stent member, each of the leaflets being preformed with a pocket that receives at least a portion of the stent member therein, the pocket having a radially outer portion that lies against the radially outer surface of the stent member including the stent post regions; and

a clamping structure that is disposed radially outside of a radially outer surface of the radially outer portions of the leaflets and that clamps the radially outer portions of the leaflets radially inwardly against substantially the entire radially outer surface of the stent member including the stent post regions.

11. The valve defined in claim 10 wherein the radially outer portion of each of the leaflets reaches the radially outer surface of the stent member by passing around an edge of the stent member that is toward a blood-inflow side of the valve when the valve is in use in a patient.

12. The valve defined in claim 10 wherein the clamping structure comprises:

a sewing cuff structure that extends annularly around the valve without covering the stent post regions; and

a plurality of post covers that are separate from the sewing cuff structure, each of the post covers covering a respective one of the stent post regions.

13. The valve defined in claim 10 further comprising:

stitching for securing the clamping structure to the stent member including the stent post regions.

14. The valve defined in claim 13 wherein the stitching passes through preformed and aligned holes in the clamping structure and the stent member including the stent post regions.

15. The valve defined in claim 13 wherein the stitching comprises suture material.

17. The valve defined in claim 10 wherein the clamping structure is stitched to the stent member including the stent post regions substantially along the entire radially outer surface.

18. The valve defined in claim 10 wherein the stent member undulates substantially parallel to the longitudinal axis, the undulations of the stent member causing the stent member to form the plurality of stent post regions, the stent post regions extending from a remainder of the stent member in a blood-outflow direction when the valve is in use in a patient.