MITRAL ANNULOPLASTY RINGS WITH SEWING CUFF

• US 20110238171A1
• Filed: 04/27/2011
• Published: 09/29/2011
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Adzich, Vaso, Carpentier, Alain F., Adams, David H.
• Granted Patent: US 9,011,529 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, such as fibroelastic deficiency (FED), Marfan'"'"'s or Barlow'"'"'s. 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. A bulge on the sewing cuff forms a step on the outflow side for ease of suturing, which may be indicated by a suture line.

Claims

1. A mitral annuloplasty ring that facilitates implant for correcting a patient'"'"'s mitral valve annulus, comprising:

an inner ring body formed of a metallic remodeling material that will resist deformation when subjected to the stress imparted thereon by the mitral valve annulus, the inner ring body defining a periphery as seen in plan view with a convex posterior segment adapted to be attached to a posterior aspect of the mitral annulus opposite a relatively straight anterior segment adapted to be attached to an anterior aspect of the mitral annulus, the inner ring body periphery being oriented about a central flow axis that defines an upper or inflow side facing toward the left atrium when implanted and a lower or outflow side facing toward the left ventricle when implanted; and

an outer covering of suture-permeable material enclosing the inner ring body, the outer covering including a molded elastomeric tube within a fabric sheath, wherein the elastomeric tube completely surrounds the inner ring body in a main portion and bulges outwards from the main portion on an inflow edge thereof to form a sewing cuff, wherein the inflow side of the outer covering is convex while the outflow side has an inward step from the sewing cuff to the main portion, and wherein as seen in radial cross-section, the sewing cuff has a height h of about 50% of the total annuloplasty ring height H, while the width of the sewing cuff is about 30% of the total annuloplasty ring width W.

2. The mitral annuloplasty ring of claim 1, wherein the inner ring body is 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.

3. The mitral annuloplasty ring of claim 2, wherein the ratio C/D is about 3:

1.

4. The mitral annuloplasty ring of claim 1, wherein the inner ring body has varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

5. The mitral annuloplasty ring of claim 4, wherein the inner ring body is defined by a plurality of concentric axially-oriented metallic bands with silicone interposed between the bands.

6. The mitral annuloplasty ring of claim 5, wherein the bands are formed from a biocompatible, anti-magnetic metal.

7. The mitral annuloplasty ring of claim 1, wherein the inner ring body is more flexible across the antero-posterior dimension (a minor axis) than in a cross plane transverse to the antero-posterior dimension (a major axis).

8. The mitral annuloplasty ring of claim 7, wherein the ratio of the stiffness of the inner ring body in the major axis over the stiffness in the minor axis is from about 1.15 to about 2.77.

9. A mitral annuloplasty ring for correcting a patient'"'"'s mitral valve annulus that minimizes platelet deposits, fibrous proliferation, and thrombus formation, comprising:

an inner ring body formed of a metallic remodeling material that will resist deformation when subjected to the stress imparted thereon by the mitral valve annulus, the inner ring body defining a periphery as seen in plan view with a convex posterior segment adapted to be attached to a posterior aspect of the mitral annulus opposite a relatively straight anterior segment adapted to be attached to an anterior aspect of the mitral annulus, the inner ring body periphery being oriented about a central flow axis that defines an upper or inflow side facing toward the left atrium when implanted and a lower or outflow side facing toward the left ventricle when implanted; and

an outer covering of suture-permeable material enclosing the inner ring body, the outer covering including a molded elastomeric tube within a fabric sheath, wherein the elastomeric tube completely surrounds the inner ring body in a main portion and bulges outwards from the main portion on an inflow edge thereof to form a sewing cuff, wherein the inflow side of the outer covering is convexly curved, smooth and streamlined to minimize platelet deposits, fibrous proliferation, and thrombus formation, while the outflow side has an inward step from the sewing cuff to the main portion.

10. The mitral annuloplasty ring of claim 9, wherein the inner ring body is 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.

11. The mitral annuloplasty ring of claim 10, wherein the ratio C/D is about 3:

1.

12. The mitral annuloplasty ring of claim 9, wherein the inner ring body has varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

13. The mitral annuloplasty ring of claim 9, wherein as seen in radial cross-section, the sewing cuff has a height h of about 50% of the total annuloplasty ring height H, while the width of the sewing cuff is about 30% of the total annuloplasty ring width W.

14. The mitral annuloplasty ring of claim 9, wherein the inner ring body is more flexible across the antero-posterior dimension (a minor axis) than in a cross plane transverse to the antero-posterior dimension (a major axis).

15. The mitral annuloplasty ring of claim 14, wherein the ratio of the stiffness of the inner ring body in the major axis over the stiffness in the minor axis is from about 1.15 to about 2.77.

16. The mitral annuloplasty ring of claim 9, further including a circular colored suture line sewn into the fabric sheath delineating the underside of the sewing cuff that maintains tension in the fabric sheath eliminating wrinkles to maximize smooth flow thereover and minimize platelet deposits, fibrous proliferation, and thrombus formation.

17. A mitral annuloplasty ring that facilitates implant for correcting a patient'"'"'s mitral valve annulus, comprising:

an inner ring body formed of a plurality of concentric axially-oriented metallic bands that will resist deformation when subjected to the stress imparted thereon by the mitral valve annulus, the inner ring body defining a periphery as seen in plan view with a convex posterior segment adapted to be attached to a posterior aspect of the mitral annulus opposite a relatively straight anterior segment adapted to be attached to an anterior aspect of the mitral annulus, the inner ring body periphery being oriented about a central flow axis that defines an upper or inflow side facing toward the left atrium when implanted and a lower or outflow side facing toward the left ventricle when implanted;

an outer covering of suture-permeable material enclosing the inner ring body, the outer covering including a molded elastomeric tube within a fabric sheath, wherein the elastomeric tube completely surrounds the inner ring body in a main portion and bulges outwards from the main portion on an inflow edge thereof to form a sewing cuff, wherein the inflow side of the outer covering is convex while the outflow side has an inward step from the sewing cuff to the main portion; and

a circular colored suture line sewn into the fabric sheath under and delineating the radially inner extent of the sewing cuff and facilitate implant of the ring by demarking for the surgeon a boundary on the ring within which sutures should not be passed to avoid contact with the bands of the inner ring body.

18. The mitral annuloplasty ring of claim 17, wherein the bands are formed from a biocompatible, anti-magnetic metal.

19. The mitral annuloplasty ring of claim 18, wherein metallic bands are Elgiloy.

20. The mitral annuloplasty ring of claim 17, wherein the inner ring body is defined by the metallic bands with silicone interposed therebetween.

21. The mitral annuloplasty ring of claim 17, wherein the maximum cross-section of the inner ring body is about 1.5 mm width and 2.5 mm height

22. The mitral annuloplasty ring of claim 17, wherein the inner ring body is 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.

23. The mitral annuloplasty ring of claim 22, wherein the ratio C/D is about 3:

1.

24. The mitral annuloplasty ring of claim 17, wherein the inner ring body has varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

25. The mitral annuloplasty ring of claim 17, wherein the inner ring body is more flexible across the antero-posterior dimension (a minor axis) than in a cross plane transverse to the antero-posterior dimension (a major axis).

26. The mitral annuloplasty ring of claim 25, wherein the ratio of the stiffness of the inner ring body in the major axis over the stiffness in the minor axis is from about 1.15 to about 2.77.