Flexible annuloplasty prosthesis

• US 20070191939A1
• Filed: 04/26/2006
• Published: 08/16/2007
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tabor, Charles, Ryan, Tim
• Granted Patent: US 9,011,528 B2
• Time in Patent Office: Days
• 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 formed of a biocompatible material and configured to rest against and support a heart valve annulus upon implantation;

wherein the annuloplasty prosthesis has a height of not more than 2.5 mm.

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

3. The annuloplasty prosthesis of claim 1, wherein the annuloplasty prosthesis defines a length, a width, and the height, and further wherein the length is greater than the width and the width is greater than the height.

4. The annuloplasty prosthesis of claim 2, wherein the annuloplasty prosthesis defines opposing first and second major surfaces and opposing first and second sides extending between the major surfaces, and further wherein the annuloplasty prosthesis is configured such that the first major surface intimately contacts annular tissue upon implantation, the height being defined as a dimension between the opposing major surfaces and the width being defined as a dimension between the opposing sides.

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

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

7. 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 the first 1 mm of compression.

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

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

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

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

12. The annuloplasty prosthesis of claim 1, wherein the flexible body is a fabric material folded onto itself along a length thereof.

13. The annuloplasty prosthesis of claim 12, wherein the flexible body is folded to define a plurality of layers arranged in a substantially parallel fashion in transverse cross-section.

14. The annuloplasty prosthesis of claim 12, wherein the annuloplasty prosthesis is defined by opposing first and second major surfaces and opposing first and second sides, and further wherein in transverse cross-section, the folded fabric material forms a first layer defining the first major surface, a second layer defining the second major surface, and a third layer positioned between, and oriented substantially parallel to, the first and second layers.

15. The annuloplasty prosthesis of claim 14, wherein in transverse cross-section, the folded fabric further forms a fourth layer positioned between, and oriented substantially parallel to, the second and third layers.

16. The annuloplasty prosthesis of claim 15, wherein in transverse cross-section, the folded fabric further forms a first fold segment interconnecting the first and second layers and defining one of the opposing sides.

17. The annuloplasty prosthesis of claim 16, wherein in transverse cross-section, the folded fabric further forms a second fold segment interconnecting the first and third layers, and a third fold segment interconnecting the second and fourth layers, the second and third fold segments combining to define an other of the opposing sides.

18. The annuloplasty prosthesis of claim 17, wherein in transverse cross-section, the folded fabric further forms a fifth layer positioned between, and oriented substantially parallel to, the second and fourth layers.

19. The annuloplasty prosthesis of claim 12, further comprising:

a radiopaque marker contained within the folded fabric.

20. The annuloplasty prosthesis of claim 12, further comprising:

at least one row of stitching extending along a length of the flexible body and through a thickness thereof to secure the folded layers to one another.

22. The annuloplasty prosthesis of claim 12, further comprising:

a flexible support insert contained within the folded fabric.

23. The annuloplasty prosthesis of claim 22, wherein the flexible support insert comprises a woven material.

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

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

21. The annuloplasty prosthesis 12, wherein the fabric is a double velour material.

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

a flexible fabric material body folded onto itself along a length thereof to define an exterior surface of the annuloplasty prosthesis;

wherein;

the annuloplasty prosthesis has a height of not more than 2.5 mm,

the annuloplasty prosthesis has a width of not more than 5.0 mm,

the annuloplasty prosthesis is substantially rectangular in transverse cross-section,

the annuloplasty prosthesis exhibits a Force-Displacement Slope Average Value of not less than 10.0 lbs/in.

27. The annuloplasty prosthesis of claim 26, wherein the fabric material is a double velour material.

28. The annuloplasty prosthesis of claim 26, wherein the annuloplasty prosthesis is a band.

29. The annuloplasty prosthesis of claim 26, wherein the annuloplasty prosthesis is a ring.