Flexible annuloplasty prosthesis

• US 9,011,528 B2
• Filed: 04/26/2006
• Issued: 04/21/2015
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R., Tabor, Charles P.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US11/411,274
• Publication Number:
  US 20070191939A1
• Time in Patent Office: 3,282 Days
• Field of Search: 623 236- 241, 623/23.72
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A flexible annuloplasty prosthesis for repairing a heart valve having a valve annulus. The annuloplasty prosthesis comprises a flexible body defining an exterior of the prosthesis formed of a biocompatible material and configured to rest against and support the heart valve annulus upon implantation. The flexible annuloplasty prosthesis has a height of not more than 2.5 mm. This low profile characteristic enhances a surgeon'"'"'s ability to implant the prosthesis. In one preferred embodiment, the flexible body is a fabric material folded onto itself along a length thereof, with the annuloplasty prosthesis being characterized by an elevated longitudinal stiffness.

Claims

1. A flexible annuloplasty prosthesis for repairing a heart valve having a valve annulus, the annuloplasty prosthesis comprising:

a flexible body defining an exterior of the prosthesis, the flexible body formed of a biocompatible fabric material folded onto itself and configured to rest against and support a heart valve annulus upon implantation, the folded fabric material forming opposing first and second major exterior surfaces and opposing first and second exterior sides, and including, in transverse cross-section;

a first layer defining the first major exterior surface,

a second layer defining the second major exterior surface,

a third layer positioned between, and oriented substantially parallel to, the first and second layers,

a fourth layer positioned between, and oriented substantially parallel to, the second and third layers,

a fifth layer positioned between, and oriented substantially parallel to, the second and fourth layers, wherein the folded fabric material forms a first fold segment interconnecting the first and second layers defines one of the opposing first and second exterior sides, the folded fabric material forms a second fold segment interconnecting the first and third layers, the folded fabric material forms a third fold segment interconnecting the second and fourth layers, the second and third fold segments combining to define another of the opposing first and second exterior sides, and the folded fabric material forms a fourth fold segment interconnecting the fourth and fifth layers, further wherein the first and second layers are transversely spaced apart to define a region therebetween, and wherein the region is further defined between the first and fourth fold segments; and

stitching along a length of the flexible body and through a height of the flexible body to compressively secure the layers to one another, the stitching including a first continuous stitch and a second continuous stitch, the first and second continuous stitches being laterally spaced from one another along the length of the flexible body, the first continuous stitch extending through each of the first major exterior surface, the first layer, the second layer, the third layer, the region, and the second major exterior surface, the second continuous stitch extending through each of the first major exterior surface, the first layer, the second layer, the third layer, the fourth layer, the fifth layer, and the second major exterior surface.

2. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis is configured such that the first major exterior surface intimately contacts annular tissue upon implantation, and further wherein the height is defined as a dimension from the first major exterior surface to the second major exterior surface.

3. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis is configured such that the first major exterior surface intimately contacts annular tissue upon implantation, the height being defined as a dimension between the opposing first and second major exterior surfaces and the width being defined as a dimension between the opposing first and second exterior sides.

4. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis has a height of not more than 2.3 mm.

5. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis is characterized by the absence of a metal stiffening member extending within the flexible body.

6. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis exhibits a Force-Displacement Slope Average Value of not less than 10.0 lbs/in over a first 1 mm of compression.

7. The annuloplasty prosthesis of claim 6, wherein the annuloplasty prosthesis exhibits a Force-Displacement Slope Average Value of not less than 10.5 lbs/in over a first 1 mm of compression.

8. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis has a width of not more than 5.0 mm.

9. The annuloplasty prosthesis of claim 8, wherein the annuloplasty prosthesis is configured such that the first major exterior surface intimately contacts annular tissue upon implantation, the height being defined as a dimension between the opposing first and second major exterior surfaces and the width being defined as a dimension between the opposing first and second exterior sides.

10. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis is substantially rectangular in transverse cross-section.

11. The annuloplasty prosthesis of claim 1, further comprising:

a radiopaque marker contained within the region of the folded fabric material.

12. The annuloplasty prosthesis of claim 11, wherein the first continuous stitch extends through the radiopaque marker to secure the radiopaque marker relative to the flexible body.

13. The annuloplasty prosthesis claim 1, wherein the biocompatible fabric material is a double velour material.

14. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis is a band.

15. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis is a ring.

16. The annuloplasty prosthesis of claim 1, wherein the flexible body has sutures to secure the flexible body to the heart valve annulus upon implantation, the sutures being separate from the first stitch and the second stitch.

17. The annuloplasty prosthesis of claim 1, further comprising a third stitch to connect the second and third fold segments.

18. The annuloplasty prosthesis of claim 1, wherein the first continuous stitch is adjacent the first fold segment and the second continuous stitch is adjacent the second and third fold segments.

19. The annuloplasty prosthesis of claim 1, wherein the stitching directly restrains the annuloplasty prosthesis to a maximum nominal height of not more than 2.5 mm.