Annuloplasty band and method

• US 7,371,259 B2
• Filed: 09/20/2005
• Issued: 05/13/2008
• Est. Priority Date: 03/15/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R., Morrow, Joseph C.
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US11/230,871
• Publication Number:
  US 20060025856A1
• Time in Patent Office: 966 Days
• Field of Search: 623 236- 241, 623/904
• US Class Current: 623/2.36
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Claims

1. A method of implanting an annuloplasty band for repairing an atrio-ventricular valve defining a valve annulus, the method comprising:

providing an annuloplasty band including a sheath and a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end and defining a compound curve shape between the first and second ends so as to mimic at least a portion of a natural valve annulus, each end forming an eyelet adapted to receive a suture;

positioning the annuloplasty band along at least a portion of the valve annulus; and

suturing the respective eyelets to tissue of the valve annulus and further suturing the annuloplasty band between the first and second ends thereof to tissue of the valve annulus for shaping the valve annulus based upon the shape of the stiffening element.

2. The method of claim 1, wherein the atrio-ventricular valve is a mitral valve defining an antero-lateral trigone and a postero-medial trigone, and further wherein suturing the eyelets includes suturing the eyelet of the first end to the antero-lateral trigone and suturing the eyelet of the second end to the postero-medial trigone.

3. The method of claim 1, wherein the atrio-ventricular valve is a tricuspid valve defining an anterior leaflet and a septal leaflet, each of the leaflets forming a base relative to the valve annulus, and further wherein suturing the eyelets includes suturing the eyelet of the first end to the base of the anterior leaflet adjacent the valve annulus and suturing the eyelet of the second end to the base of the septal leaflet adjacent the valve annulus.

4. The method of claim 1, wherein providing an annuloplasty band includes forming markings on the sheath indicative of locations of the eyelets, and further wherein suturing the eyelets include passing sutures through the respective markings.

5. A method of implanting an annuloplasty ring for repairing a mitral valve defining a valve annulus having a posterior annulus portion and an anterior annulus portion, the method comprising:

providing an annuloplasty ring comprising a polyester sheath, a generally arcuate, non-planar stiffening element disposed within the polyester sheath, the stiffening element comprising titanium and having a compound curve shape along at least a posterior portion thereof that is adapted to extend along the posterior annulus portion of the mitral valve annulus, wherein the non-planar stiffening element comprises a saddle shape to mimic a natural mitral valve annulus;

positioning the annuloplasty ring along the valve annulus; and

suturing the ring to tissue of the valve annulus for shaping the valve annulus based upon the saddle shape of the stiffening element.

6. A method according to claim 5 wherein the annuloplasty ring comprises first and second eyelets, the mitral valve defines an antero-lateral trigone and a postero-medial trigone, and further wherein suturing the ring includes suturing the first eyelet to the antero-lateral trigone and suturing the second eyelet to the postero-medial trigone.

7. The method of claim 6, wherein providing an annuloplasty ring includes forming markings on the sheath indicative of locations of the eyelets, and further wherein suturing the eyelets includes passing sutures through the respective markings.

8. A method of implanting an annuloplasty ring for repairing a mitral valve defining a valve annulus having a posterior annulus portion and an anterior annulus portion, the method comprising:

providing an annuloplasty ring comprising a polyester sheath, a generally arcuate, non-planar stiffening element disposed within the polyester sheath, the stiffening element comprising titanium and having a compound curve shape along at least a posterior portion thereof that is adapted to extend along the posterior annulus portion of the mitral valve annulus, wherein the ring comprises a continuous saddle shape;

associating a holder with the annuloplasty ring;

positioning the annuloplasty ring and associated holder along the valve annulus; and

suturing the ring to tissue of the valve annulus for shaping the valve annulus based upon the saddle shape of the stiffening element; and

disassociating the holder from the ring.

9. A method according claim 8, wherein the annuloplasty ring comprises first and second eyelets, the mitral valve defines an antero-lateral trigone and a postero-medial trigone, and further wherein suturing the ring includes suturing the first eyelet to the antero-lateral trigone and suturing the second eyelet to the postero-medial trigone.

10. The method of claim 9, wherein providing an annuloplasty ring includes forming markings on the sheath indicative of locations of the eyelets, and further wherein suturing the eyelets includes passing sutures through the respective markings.

11. The method of claim 8, wherein associating a holder with the annuloplasty ring comprises suturing the ring to the holder.

12. The method of claim 11 wherein disassociating the holder from the ring comprises cutting the suture that sutures the ring to the holder.

13. The method of claim 8 wherein providing a ring comprises providing a metal stiffening element that has a first radius of curvature in an X-Y plane and a second radius of curvature in the X-Y plane, the internal metal stiffening element having a saddle shape in a Z plane.