TRICUSPID RING

• US 20110184511A1
• Filed: 01/20/2011
• Published: 07/28/2011
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Brunnett, William C., Curtis, Alison S.
• Granted Patent: US 8,449,608 B2
• Time in Patent Office: Days
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: B32B 1/00 Layered products having a non-planar shape
• CPC Class Codes: B32B 15/04 comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material next to a bituminous or tarry layer B32B11/08; next to a water-setting substance layer B32B13/06; next to a glass layer B32B17/061; next to a cellulosic plastic layer B32B23/042
• CPC Class Codes: B32B 15/08 of synthetic resin
• CPC Class Codes: B32B 15/09 comprising polyesters
• CPC Class Codes: B32B 15/18 comprising iron or steel B32B15/011, B32B15/012 and B32B15/013 take precedence
• CPC Class Codes: B32B 2250/44 Number of layers variable across the laminate
• CPC Class Codes: B32B 2262/02 Synthetic macromolecular fibres
• CPC Class Codes: B32B 2262/0276 Polyester fibres
• CPC Class Codes: B32B 2307/546 Flexural strength; Flexion stiffness
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 27/12 next to a fibrous or filamentary layer
• CPC Class Codes: B32B 27/283 comprising polysiloxanes
• CPC Class Codes: B32B 27/286 comprising polysulphones; polysulfides
• CPC Class Codes: B32B 27/288 comprising polyketones
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: B32B 27/36 : comprising polyesters
• CPC Class Codes: B32B 27/365 : comprising polycarbonates
• CPC Class Codes: B32B 3/04 : characterised by at least one layer folded at the edge, e.g. over another layer ; characterised by at least one layer enveloping or enclosing a material
• CPC Class Codes: B32B 3/18 : characterised by an internal layer formed of separate pieces of material which are juxtaposed side-by-side B32B5/02 takes precedence
• CPC Class Codes: B32B 5/024 : Woven fabric

Abstract

A prosthetic tricuspid remodeling annuloplasty ring having two free ends can be configured to be stiff in the XY plane and relatively flexible along the Z axis. A tricuspid ring can be provided with a substantially elliptical shape in the XY plane, and a saddle shape in the Z direction. Disclosed tricuspid rings can include an inner core, an elastomeric interface, and an outer fabric covering. In some embodiments, the inner core can include a plurality of stacked layers of different materials. In some embodiments, the inner core can be formed of a single material and sized specifically to create a tricuspid ring that has a greater stiffness in the XY plane than along the Z axis.

Claims

1. A tricuspid ring for use in an annuloplasty procedure, comprising:

an inner core comprising a plurality of layers stacked along the Z axis;

an elastomeric interface at least partially covering the inner core; and

a biocompatible flexible layer at least partially covering the elastomeric interface.

2. The tricuspid ring according to claim 1, wherein the tricuspid ring is configured to be rigid in the XY plane and flexible along the Z axis.

3. The tricuspid ring according to claim 1, wherein the plurality of layers comprises at least one structural layer and at least one interface layer.

4. The tricuspid ring according to claim 3, wherein the structural layers comprise at least one material selected from the group consisting of Elgiloy, Nitinol, titanium, stainless steel, cobalt chromium, and alloys thereof.

5. The tricuspid ring according to claim 3, wherein the interface layers comprise at least one material selected from the group consisting of polyester, PET, PEEK, PTFE, polycarbonate, polysulfone, and polyphenylsulfone.

6. The tricuspid ring according to claim 3, wherein the structural layers and the interface layers are arranged in an alternating stack along the Z axis.

7. The tricuspid ring according to claim 3, wherein the plurality of layers comprises four structural layers and three interface layers, with each of the interface layers being arranged between two structural layers.

8. The tricuspid ring according to claim 3, wherein each of the plurality of layers is substantially the same size.

9. The tricuspid ring according to claim 1, wherein each of the layers comprises a structural portion and a shim portion.

10. The tricuspid ring according to claim 9, wherein the structural portions comprise at least one material selected from the group consisting of Elgiloy, Nitinol, titanium, stainless steel, cobalt chromium, and alloys thereof.

11. The tricuspid ring according to claim 9, wherein the shim portions comprise at least one material selected from the group consisting of polyester, PET, PEEK, PTFE, polycarbonate, polysulfone, and polyphenylsulfone.

12. The tricuspid ring according to claim 9, wherein the structural portions of adjacent layers are arranged to at least partially overlap.

13. The tricuspid ring according to claim 9, wherein the plurality of layers comprises a plurality of pairs of layers, each pair of layers comprising a first layer and a second layer.

14. The tricuspid ring according to claim 13, wherein the structural portion of any layer is bigger than the shim portion of any adjacent layer.

15. The tricuspid ring according to claim 14, wherein the structural portion of any layer is arranged to overlap a portion of the structural portion of any adjacent layer.

16. The tricuspid ring according to claim 15, wherein the shim portion of any layer and the shim portion of any adjacent layer do not overlap.

17. The tricuspid ring according to claim 1, wherein the elastomeric interface comprises silicone overmolding and/or silicone tubing.

18. The tricuspid ring according to claim 1, wherein the biocompatible flexible layer comprises fabric or cloth.

19. The tricuspid ring according to claim 18, wherein the biocompatible flexible layer comprises a polyester.

20. The tricuspid ring according to claim 1, further comprising a sewing cuff.

21. The tricuspid ring according to claim 1, wherein the tricuspid ring is configured such that a gap exists between a first free end and a second free end, the tricuspid ring having a saddle shape having at least one high point and at least one low point.

22. The tricuspid ring according to claim 1, wherein the inner core is contained within the elastomeric interface without any weld points.

23. The tricuspid ring according to claim 1, wherein at least one weld point couples the layers of the inner core together.

24. A tricuspid ring for use in an annuloplasty procedure, comprising:

an inner core having a substantially rectangular cross section defined by a thickness and a width;

an elastomeric interface at least partially covering the inner core; and

a biocompatible flexible layer at least partially covering the elastomeric interface, wherein the inner core is configured such that its width and thickness result in a stiffness in the XY plane that is approximately 25 times the stiffness along the Z axis or greater.

25. The tricuspid ring according to claim 24, wherein the tricuspid ring is configured to be rigid in the XY plane and flexible along the Z axis.

26. The tricuspid ring according to claim 24, wherein the tricuspid ring further comprises a sewing cuff.

27. A tricuspid ring for use in an annuloplasty procedure, comprising at least two metallic layers stacked along the Z axis.