Method of leaflet attachment for prosthetic heart valves

• US 4,501,030 A
• Filed: 08/17/1981
• Issued: 02/26/1985
• Est. Priority Date: 08/17/1981
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: American Hospital Supply Corp. (Baxter International Inc.)
• Inventors: Lane, Ernest
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US06/293,667
• Time in Patent Office: 1,289 Days
• Field of Search: 3/1.5, 3/1, 128/334 R, 128/334 C, 137/525.1, 137/525
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 including a frame having a plurality of commissure supports, a plurality of resilient supports, and a plurality of valve leaflets. The valve leaflets are attached to the resilient supports, and the resilient supports lie radially outwardly of the commissure supports, respectively. When in use, the valve is subjected to forces which are used to clamp the valve leaflets between the resilient supports and the commissure supports to augment whatever other leaflet attachment techniques may be used.

Claims

1. A prosthetic heart valve subject to a force when in use comprising:

means defining a plurality of valve leaflets;

means for mounting said valve leaflets for opening and closing movement and in a configuration suitable for a prosthetic heart valve; and

said mounting means including first means for attaching at least one of the valve leaflets to said mounting means and second means including first and second members responsive to the force on the valve when the valve is in use for clamping a region of said one valve leaflet between said first and second members to augment the attachment provided by said first means and reduce the stress on said first means.

2. A valve as defined in claim 1 wherein at least one of said first and second members is resilient.

3. A valve as defined in claim 1 wherein said mounting means includes a frame which includes first and second frame sections and an opening between said frame sections, said first member includes siad first frame section and said second member includes a resilient support adjacent said opening, said one valve leaflet is on said resilient support and extends through said opening and between said resilient support and said first frame section whereby said region of said one valve leaflet can be clamped between said resilient support and said first frame section.

4. A prosthetic heart valve subject to a force when in use comprising:

means for defining a plurality of valve leaflets;

means for mounting said valve leaflets for opening and closing movement in a configuration suitable for a prosthetic heart valve; and

said mounting means including first means responsive to the force on the prosthetic heart valve when the valve is in use for clamping at least one of said valve leaflets with a clamping force to assist in retaining said one valve leaflet on the mounting means, said first means including first and second resilient members for clamping said one valve leaflet.

5. A valve as defined in claim 4 wherein said first means is responsive to the force on said one valve leaflet for increasing said clamping force said one valve leaflet and is responsive to said force diminishing for reducing the clamping force on said one valve leaflet.

6. A prosthetic heart valve comprising:

a generally annular frame having a plurality of commissure supports, at least one of said commissure supports including a first frame section;

a resilient support;

means for attaching said resilient support to said frame with said support being adjacent said first frame section;

valve leaflet sheet material mounted on said frame to define a plurality of valve leaflets which are movable between open and closed positions, a first of said valve leaflets being drivingly coupled to the resilient support so that a radial inward force on said first valve leaflet deflects said resilient support radially inwardly;

a region of the first valve leaflet extending between the resilient support and the first frame section; and

said resilient support and said first frame section being located so that, the resilient support can deflect and press said region of the first valve leaflet against said first frame section in response to a force which deflects the resilient support radially inwardly.

7. A valve as defined in claim 6 including suture means for attaching the first valve leaflet to said resilient support.

8. A valve as defined in claim 6 wherein said frame is resilient whereby the first frame section can deflect when said region of the first valve leaflet is pressed against it by the support.

9. A valve as defined in claim 6 wherein said frame includes a second frame section circumferentially spaced from said first frame section to define an opening, said attaching means attaches the resilient support to the frame with said support being adjacent said opening, a second of said valve leaflets is drivingly coupled to the resilient support so that a radial inward force on the second valve leaflet deflects said resilient support radially inwardly, a region of the second valve leaflet extends between the resilient support and the second frame section, means for attaching said first and second valve leaflets together at a location intermediate said regions and adjacent said support, said first and second valve leaflets extend through said opening, and said resilient support and said second frame section being located so that the resilient support can deflect and press said region of the second valve leaflet against said second frame section in response to a force which deflects the resilient support radially inwardly.

10. A valve as defined in claim 6 wherein the commissure supports are resilient and covered with fabric, said resilient support being covered with fabric.

11. A valve as defined in claim 9 wherein the attachment of the first and second valve leaflets forms a composite valve leaflet, said resilient support has a surface facing radially outwardly, said composite valve leaflet extends along said resilient surface of said resilient support and said attaching means for said first and second valve leaflets includes suture means.

12. A valve as defined in claim 6 wherein said frame includes a wire formed into an annular configuration and defining a plurality of circumferentially spaced apical sections joined by curved sections, each of said commissure supports includes one of said apical sections, each of said curved sections is substantially elliptical in side elevation and forms a portion of an ellipse.

13. A valve as defined in claim 6 wherein said frame includes a wire formed into an annular configuration and having a plurality of circumferentially spaced apical sections joined by curved sections, each of said commissure supports includes one of said apical sections, each of said apical sections includes a reverse bend and first and second tangents joining the opposite ends of such reverse bend of such apical sections to the adjacent curved sections, respectively, said wire having ends at one of said tangents, and said valve including means for joining said ends together at said one tangent.

30. A valve as defined in claim 6 wherein said resilient support lies radially outwardly of the first frame section and said first valve leaflet has a portion which is wrapped at least part way around the resilient support and lies radially outwardly of the resilient support.

14. A method of making a frame for a prosthetic heart valve comprising:

forming a wire into a generally flat pattern with the wire having a plurality of part substantially elliptical sections joined by apical sections and with each of the apical sections including a reverse bend, said apical sections extending in the same general direction and said wire having opposite ends, said substantailly elliptical sections being substantially elliptical in a direction perpendicular to the flat pattern;

forming the flat pattern into an annular configuration; and

joining said opposite ends to retain the wire in said annular configuration whereby the overall axial dimension of the frame is reduced without introducing sharp bends into the wire.

15. A method as defined in claim 14 wherein a first of said apical sections has a straight segment which is tangent to the associated reverse bend and the associated elliptical section, said wire terminates in said segment, and said step of joining includes joining said ends at said segment.

16. A method as defined in claim 14 wherein each of said apical sections has first and second straight segments joining the opposite ends of the reverse bend of such apical section to the adjacent elliptical sections, respectively, when the wire is in said annular configuration and said step of joining includes splicing said opposite ends of said wire at one of said segments.

17. A method as defined in claim 16 wherein said step of forming the flat pattern includes forming the wire into a frustum of a cone whereby said apical sections extend toward each other as they extend away from the associated elliptical sections, said step of forming the wire forms said segments of each of the apical sections so that the segments of each such apical section extend away from each other as they extend from the associated reverse bend toward the associated elliptical sections, and there are three of said apical sections.

18. A frame for a prosthetic heart valve comprising:

a wire formed into an annular configuration and having a plurality of circumferentially spaced apical sections joined by curved sections, each of the apical sections including a reverse bend, said apical sections extending in the same direction; and

each of said curved sections being substantially elliptical as viewed from the side of the annular configuration and forming only a portion of an ellipse whereby the overall axial dimension of the frame is reduced without introducing sharp bends into the wire.

19. A frame as defined in claim 18 wherein a first of said apical sections has a tangent which is tangent to the associated reverse bend and the associated curved section, said wire has opposite ends at said segment, and said frame includes means for joining said opposite ends at said segments.

20. A frame as defined in claim 18 wherein said apical sections are resilient and are inclined inwardly as they extend away from the elliptical sections.

21. A frame for a prosthetic heart valve comprising:

a wire formed into an annular configuration and having a plurality of circumferentially spaced apical sections joined by curved sections, each of said apical sections including a reverse bend and first and second straight segments joining the opposite ends of the reverse bend of such apical section to the adjacent curved sections, respectively;

said wire having opposite ends at one of said segments; and

means for splicing said opposite ends of said wire together at said one of said segments.

22. A prosthetic heart valve comprising:

a frame of generally annular configuration having a plurality of commissure supports, each of said commissure supports extending in the same general direction;

each of said commissure supports including segments spaced circumferentially to define an opening;

a plurality of valve leaflet supports for the commissure supports, respectively;

means for attaching the valve leaflet supports to the frame with each of the valve leaflet supports being positioned generally radially outwardly of the associated commissure supports;

valve leaflet sheet material; and

means for attaching the valve leaflet sheet material to the valve leaflet supports and to the frame to define a plurality of valve leaflets which are movable between open and closed positions with said valve leaflet sheet material extending from each of the supports to which it is joined through the opening of the associated commissure support.

23. A valve as defined in claim 22 including a fabric cover on said frame, each of said commissure supports and the associated fabric cover forming a recess opening in a direction which is opposite to the direction in which the commissure supports extend, and said valve leaflet supports being received within said recesses, respectively.

24. A valve as defined in claim 22 wherein said valve leaflet sheet material includes a plurality of sections of sheet material defining said valve leaflets, respectively, means for attaching adjacent valve leaflets together adjacent the valve leaflet supports, respectively, each of said valve leaflet supports having a surface facing radially outwardly, and said valve leaflet sheet material including portions lying radially outwardly of each of said valve leaflet supports.

25. A valve as defined in claim 24 wherein each of said valve leaflet supports is resilient and can deflect toward the associated commissure support to press regions of the valve leaflets against the commissure supports.

26. A valve as defined in claim 25 wherein the frame includes wire having part elliptical curved sections joining the commissure supports, at least one of the commissure supports has a reverse bend and a segment joining the reverse bend to the adjacent curved section, said wire having opposite ends at said segment and means for splicing said opposite ends of said wire together at said segment.

27. A method of making a prosthetic heart valve comprising:

providing a first subassembly including an annular wire frame having a cloth cover with the frame having a plurality of circumferentially spaced commissure supports joined by curved sections and with each of the commissure supports including a reverse bend and circumferentially spaced wire segments joining such reverse bend to the adjacent curved sections, respectively, to form a recess at each commissure support which opens away from the associated reverse bend;

attaching valve leaflet sheet material to a plurality of valve leaflet supports with the number of the valve leaflet supports corresponding to the number of the commissure supports to form a second subassembly;

inserting the second subassembly into said recesses to a location adjacent said reverse bends with the valve leaflet supports lying radially outwardly of the associated commissure supports and with the valve leaflet sheet material extending from the associated valve leaflet supports radially outwardly through the adjacent recesses; and

attaching the subassemblies.

28. A method as defined in claim 27 wherein there are three of said commissure supports, three of said valve leaflet supports, and said valve leaflet sheet material includes three sections of valve leaflet sheet material and including attaching adjacent sections of the valve leaflet sheet material to each other adjacent each of said supports prior to said step of inserting.

29. A method as defined in claim 27 including attaching a suturing ring to said cover.