Tricuspid ring

• US 8,449,608 B2
• Filed: 01/20/2011
• Issued: 05/28/2013
• 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.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/010,079
• Publication Number:
  US 20110184511A1
• Time in Patent Office: 859 Days
• Field of Search: 623 236- 237
• 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, catheter medical patches B32B2556/00
• 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 parallel and separate layers stacked along and defining a periphery around a Z axis, each of the layers comprising a coplanar structural portion and a lubricious shim portion, and wherein the structural portion of each layer is a separate and distinct element from the structural portions of the other layers, wherein at least one weld point couples the layers of the inner core together;

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 significantly more rigid in bending in the XY plane than it is in bending in any Z axis plane.

3. The tricuspid ring according to claim 1, wherein each of the plurality of layers is substantially the same size.

4. The tricuspid ring according to claim 1, 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.

5. The tricuspid ring according to claim 1, wherein the shim portions 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 1, wherein the structural portions of adjacent layers are arranged to at least partially overlap.

7. The tricuspid ring according to claim 1, wherein the plurality of layers comprises a plurality of repeating pairs of layers, each pair of layers comprising a first layer and a second layer, wherein the first layers are identical and the second layers are identical.

8. The tricuspid ring according to claim 1, wherein the structural portion of any layer is bigger than the shim portion of any adjacent layer.

9. The tricuspid ring according to claim 8, wherein the structural portion of any layer is arranged to overlap a portion of the structural portion of any adjacent layer.

10. The tricuspid ring according to claim 9, wherein the shim portion of any layer and the shim portion of any adjacent layer do not overlap.

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

12. 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.

13. An annuloplasty ring, comprising:

an inner core comprising a plurality of parallel and separate layers stacked along and defining a periphery around a Z axis, each of the layers having a structural portion that extends around the periphery a different distance than the structural portion in any adjacent layer such that the structural portion in adjacent layers partially overlap, and each layer having a coplanar shim portion that extends between adjacent structural portions where they do not overlap.

14. The annuloplasty ring of claim 13, wherein the structural portions in adjacent layers are adhered together where they partially overlap.

15. The annuloplasty ring of claim 13, wherein the structural portions in adjacent layers are welded together where they partially overlap.

16. The annuloplasty ring of claim 13, wherein the shim portions comprise at least one material selected from the group consisting of polyester, PET, PEEK, PTFE, polycarbonate, polysulfone, and polyphenylsulfone.

17. The annuloplasty ring of claim 13, wherein the ring is configured such that a gap exists between a first free end and a second free end, and in any one layer the structural portion extends from one of the first or second free end while the shim portion extends from the other of the first or second free end, and the end from which the structural portion extends alternates in sequential layers.

18. The annuloplasty ring of claim 13, wherein the plurality of layers comprises a plurality of repeating pairs of layers, each pair of layers comprising a first layer and a second layer, wherein the first layers are identical and the second layers are identical.

19. An annuloplasty ring, comprising:

an inner core comprising a plurality of parallel and separate layers stacked along and defining a periphery around a Z axis, each of the layers having a relatively rigid structural portion that extends around the periphery a first distance and a coplanar shim portion that extends around the periphery a second distance different than the first distance, wherein the ring is configured such that a gap exists between a first free end and a second free end, and in any one layer the structural portion extends from one of the first or second free end while the shim portion extends from the other of the first or second free end, and the end from which the structural portion extends alternates in sequential layers.

20. The annuloplasty ring of claim 19, wherein the structural portion in each of the layers extends around the periphery a different distance than the structural portion in any adjacent layer such that the structural portion in adjacent layers partially overlap, and the shim portion in each layer extends between adjacent structural portions where they do not overlap.

21. The annuloplasty ring of claim 20, wherein the structural portions in adjacent layers are adhered together where they partially overlap.

22. The annuloplasty ring of claim 20, wherein the structural portions in adjacent layers are welded together where they partially overlap.

23. The annuloplasty ring of claim 19, wherein the shim portions comprise at least one material selected from the group consisting of polyester, PET, PEEK, PTFE, polycarbonate, polysulfone, and polyphenylsulfone.

24. The annuloplasty ring of claim 19, wherein the plurality of layers comprises a plurality of repeating pairs of layers, each pair of layers comprising a first layer and a second layer, wherein the first layers are identical and the second layers are identical.