DEGENERATIVE VALVULAR DISEASE SPECIFIC ANNULOPLASTY RING SETS

• US 20120215304A1
• Filed: 03/16/2012
• Published: 08/23/2012
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Carpentier, Alain F., Adams, David H., Adzich, Vaso
• Granted Patent: US 8,764,821 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes.

Claims

1. A set of annuloplasty rings for correcting a heart valve annulus from which one can be selected for implant, the set of annuloplasty rings comprising:

a set of rings, each ring having a ring body able to resist deformation when subjected to a stress imparted thereon by a valve annulus and arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the valve annulus when the annuloplasty ring is implanted, each ring having an identified orifice size in 2 mm increments; and

wherein proportional shapes of the ring bodies for orifice sizes up to 32 mm remains relatively constant but changes for orifice sizes above 32 mm.

2. The set of annuloplasty rings of claim 1, wherein the annuloplasty rings are configured for implant at a mitral annulus and smaller rings in the set generally define a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and as the orifice sizes of the rings become larger above 32 mm the D-shape diminishes and becomes generally more circular.

3. The set of annuloplasty rings of claim 2, wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

4. The set of annuloplasty rings of claim 1, wherein the ring bodies are three-dimensional with opposite sides of the ring curving upward above a datum plane, and wherein the change in proportional shapes of the ring bodies is a change in the ratio of the heights of the opposite sides.

5. The set of annuloplasty rings of claim 1, wherein the annuloplasty rings are configured for implant at a mitral annulus and have an anterior segment opposite a posterior segment, and wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

6. The set of annuloplasty rings of claim 5, wherein the ratio C/D is about 3:

1.

7. The set of annuloplasty rings of claim 5, wherein the height C of the anterior segment rises up to at least 6 mm above the common datum plane.

8. The set of annuloplasty rings of claim 1, wherein the proportional shapes of the ring bodies change to comply with predicted shapes of a particular valvular disease for orifice sizes above 32 mm.

9. The set of annuloplasty rings of claim 8, wherein the annuloplasty rings are configured for implant at a mitral annulus and have an anterior segment opposite a posterior segment, and the valvular disease is Barlow'"'"'s valve.

10. The set of annuloplasty rings of claim 8, wherein the predicted shapes of the particular valvular disease have been calculated from echocardiographic and intraoperative measurements.

11. The set of annuloplasty rings of claim 10, wherein the annuloplasty rings are configured for implant at a mitral annulus and have an anterior segment opposite a posterior segment, and wherein the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus.

12. The set of annuloplasty rings of claim 1, wherein the annuloplasty rings are configured for implant in the tricuspid position.

13. A set of mitral annuloplasty rings for correcting a mitral heart valve annulus from which one can be selected for implant, the set of mitral annuloplasty rings comprising:

a set of rings, each ring having a ring body able to resist deformation when subjected to a stress imparted thereon by a mitral valve annulus and arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted, each ring body in plan view defining a major axis A and a minor axis B extending across from an anterior segment to a posterior segment, and each ring having an identified orifice size; and

wherein proportional shapes of the ring bodies change to comply with predicted shapes of degenerative valvular disease for different annulus orifice sizes and wherein,

each ring further includes a suture-permeable covering over the ring body, and the covering has a smooth relatively flat inflow side and a stepped outflow side.

14. The mitral set of annuloplasty rings of claim 13, wherein the plan view shape of the ring bodies is a more pronounced D-shape for smaller ring orifice sizes and becomes gradually more circular as the orifice size increases.

15. The mitral set of annuloplasty rings of claim 13, wherein the ratio B/A for each ring body changes with increasing ring orifice size.

16. The mitral set of annuloplasty rings of claim 13, wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, and wherein the ratio C/D changes with increasing ring orifice size.

17. The mitral set of annuloplasty rings of claim 13, wherein the ring bodies have varying flexibility around their peripheries, and wherein the relative flexibility between the anterior segment and the posterior segment changes with increasing ring orifice size.

18. The mitral set of annuloplasty rings of claim 13, wherein the stepped outflow side of each suture-permeable covering defines an outward bulge and includes a circular green suture line delineating the underside of the bulge.

19. A set of mitral annuloplasty rings for correcting a mitral heart valve annulus from which one can be selected for implant, the set of mitral annuloplasty rings comprising:

a set of rings, each ring having a ring body able to resist deformation when subjected to a stress imparted thereon by a mitral valve annulus and arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted, each ring body in plan view defining a major axis A and a minor axis B extending across from an anterior segment to a posterior segment, and each ring having an identified orifice size;

wherein a ratio B/A for each ring body changes with increasing ring orifice size; and

,

wherein the ring bodies are three-dimensional with the center of the anterior segment curving upward to a height C and the center of the posterior segment curving upward to a height D above a common datum plane, and wherein the ratio C/D for each ring body changes with increasing ring orifice size.

20. The mitral set of annuloplasty rings of claim 19, wherein the ring bodies are generally D-shaped in plan view with a relatively straight anterior segment opposite a curved posterior segment, and wherein the shape of the ring bodies is a more pronounced D-shape for smaller rings and becomes gradually more circular with increasing ring orifice size.

21. The mitral set of annuloplasty rings of claim 19, wherein the ratio C/D for each ring body increases with increasing ring orifice size and the height C of the anterior segment rises up to at least 6 mm above the common datum plane in at least one of the rings.

22. The mitral set of annuloplasty rings of claim 19, wherein each ring further includes a suture-permeable covering over the ring body, and the covering has a smooth relatively flat inflow side and a stepped outflow side.

23. The mitral set of annuloplasty rings of claim 19, wherein the ring bodies each define a continuous periphery.