Annuloplasty Device for Tricuspid Valve Repair

• US 20110022169A1
• Filed: 07/30/2010
• Published: 01/27/2011
• Est. Priority Date: 01/26/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kuehn, Stephen, Redmond, Jerald L., Grossi, Eugene, Quill, Jason L., Ryan, Timothy R., Lange, Rudiger, Galloway, Aubrey, Vanermen, Hugo, Hill, Alexander J.
• Granted Patent: US 9,381,084 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

Annuloplasty device for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the device comprising: a ring body comprising: an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively; and first and second end portions that are more flexible than a remainder of the ring body to provide a gradual transition from the remainder of the ring body to tissue of the tricuspid valve annulus; wherein the ring body is curvilinear, with substantially no flat portions, and forming a shape. Related devices, kits and sizer devices.

Claims

1. An annuloplasty device for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the device comprising:

a ring body comprising;

an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively; and

first and second end portions that are more flexible than a remainder of the ring body to provide a gradual transition from the remainder of the ring body to tissue of the tricuspid valve annulus;

wherein the ring body is curvilinear, with substantially no flat portions, and forming a shape.

2. The annuloplasty device of claim 1 wherein the ring body is configured such that when the device is implanted, the first end portion will be located near a junction of the septal and anterior aspects of the annulus and the second end portion will be located near the septal aspect of the annulus.

3. The annuloplasty device of claim 1, wherein the ring body further comprises:

a sheath; and

, a stiffening element disposed within the sheath.

4. The annuloplasty device of claim 1, wherein first and second end portions of the ring body comprise a flexible material.

5. The annuloplasty device of claim 3, wherein the stiffening element comprises a diameter that is reduced towards first and second ends of the stiffening element such that the stiffening element is more flexible towards the first and second ends.

6. The annuloplasty device of claim 1, wherein the anterior portion comprises a curve extending in a superior direction, the posterior portion comprises a curve extending in the superior direction, the anterior portion curve extends farther in the superior direction than the posterior portion curve.

7. The annuloplasty device of claim 1, wherein the ring body mimics the shape of a native tricuspid valve annulus.

8. The annuloplasty device of claim 1, wherein the curvilinear shape includes varying slope between four slope minima.

9. The annuloplasty device of claim 1, wherein the ring body follows a path from first end portion to second end portion that contains at least two maximum and two minimum positions along the path.

10. The annuloplasty device of claim 1, wherein upon implantation, the end portions of the ring body avoid the AV node of the heart.

11. The annuloplasty device of claim 1, wherein upon implantation, the end portions of the ring body avoid the Triangle of Koch of the heart.

12. An annuloplasty device for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the device comprising:

a ring body comprising;

an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively; and

first and second end portions;

wherein the ring body is curvilinear, with substantially no flat portions, forming a shape, and the ends are configured such that when the device is implanted, the first end will be located near a junction of the septal and anterior aspects of the annulus and the second end will be located near the septal aspect of the annulus, and the anterior portion comprises a curve extending in a superior direction that includes a peak and the peak will be located within about 20 degrees from the junction of the septal aspect and the anterior aspect of the annulus and located adjacent the anterior aspect of the annulus when implanted.

13. The annuloplasty device of claim 12, wherein the peak of the anterior portion will be located about 10 to about 20 degrees from the junction of the septal and the anterior aspects of the annulus and located adjacent the anterior aspect of the annulus when implanted.

14. The annuloplasty device of claim 12, wherein the peak of the anterior portion will be located adjacent the junction of the septal aspect and the anterior aspect of the annulus when implanted.

15. The annuloplasty device of claim 12, wherein the posterior portion comprises a curve extending in the superior direction, the anterior portion curve extending farther in the superior direction than the posterior portion curve.

16. The annuloplasty device of claim 13, wherein the posterior portion comprises a curve extending in the superior direction, the anterior portion curve extending farther in the superior direction than the posterior portion curve.

17. A kit comprising a plurality of annuloplasty devices for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the plurality of annuloplasty devices each comprising an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively, wherein the plurality of annuloplasty devices are of a given size that correlates to a size of annulus and each comprise a different amount of reduction of the septal portion and the septal aspect of the annulus.

18. The kit of claim 17, wherein the amount of reduction of the septal aspect can be greater than about 28% and up to about 33%.

19. The kit of claim 17, wherein the plurality of annuloplasty devices includes devices of additional sizes and different amounts of reduction of the septal portion and septal aspect.

20. A sizer device for sizing a tricuspid valve annulus, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the sizer device comprising:

a sizing plate;

wherein the sizing plate includes markings that correspond to a junction of the anterior and septal aspects and a junction of the posterior and septal aspects.

21. The sizer device of claim 20, wherein the shape of the sizing device mimics the shape of a native tricuspid valve.

22. The sizer device of claim 20, wherein the sizing plate comprises an anterior portion, a posterior portion and a septal portion shaped to conform to, and for placement adjacent, the anterior, posterior and septal aspects of the annulus, respectively, in order to size the annulus, and wherein the anterior portion of the sizing plate includes a curve extending in a superior direction that includes a peak and the peak will be located near the junction of the septal aspect and the anterior aspect of the annulus when placed adjacent the annulus.

23. The sizer device of claim 20, wherein the sizing plate comprises an anterior portion, a posterior portion and a septal portion shaped to conform to, and for placement adjacent, the anterior, posterior and septal aspects of the annulus, respectively, in order to size the annulus, and wherein the anterior portion of the sizing plate includes a curve extending in a superior direction that includes a peak and the peak will be located about 10 to about 20 degrees from the junction of the septal and the anterior aspects when the sizing plate is placed adjacent the annulus.