DOCKING DEVICE MADE WITH 3D WOVEN FABRIC

• US 20180168804A1
• Filed: 12/13/2017
• Published: 06/21/2018
• Est. Priority Date: 12/20/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Son V., Rupp, Kevin D., Chadha, Ajay, Lindstrom, Jeff
• Granted Patent: US 10,813,749 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0071 thermoplastic
• 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 2230/0043 L-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/004 Using a positive or negative model, e.g. moulds
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: D03D 15/283 synthetic polymer-based, e.g. polyamide or polyester fibres cellulose-based artificial fibres D03D15/225
• CPC Class Codes: D03D 25/005 Three-dimensional woven fabrics
• CPC Class Codes: D03D 3/02 Tubular fabrics
• CPC Class Codes: D10B 2509/00 Medical; Hygiene

Abstract

A docking device for a bioprosthesis is disclosed that can change shape and recover after a deforming stress is removed, that adjusts to surrounding conditions to accommodate different complex anatomic geometries, and that mitigates leakage around the bioprosthesis. The docking device can include a 3D woven fabric forming an internal surface, an outer surface, and a thickness therebetween. A filler can be coupled to the outer surface. A method for making a docking device is also provided. The method includes weaving a 3D woven fabric by interlacing a shape memory material, a low-melt thermoplastic polymer or resin having a melting point, and a high-tenacity biocompatible material; and pressing and heating the 3D woven fabric over a shape-setting mold at temperatures greater than the melting point of the low-melt thermoplastic polymer or resin.

Claims

1. A docking device for a prosthesis, the docking device comprising:

a three-dimensional (3D) woven fabric forming a shaped element having an internal surface, an outer surface, and a thickness there between; and

a filler structure coupled to the outer surface of the shaped element.

2. The docking device of claim 1, wherein the prosthesis is a heart valve.

3. The docking device of claim 1, wherein the 3D woven fabric comprises first, second, and third different types of fibers or yarns.

4. The docking device of claim 3, wherein:

the first type of fiber or yarn comprises a shape memory material;

the second type of fiber or yarn comprises a low-melt thermoplastic polymer or resin; and

the third type of fiber or yarn comprises a high-tenacity biocompatible material.

5. The docking device of claim 4, wherein the shape memory material comprises Nitinol.

6. The docking device of claim 4 wherein the low-melt thermoplastic polymer or resin has a melting point between 85 degrees Celsius and 200 degrees Celsius.

7. The docking device of claim 6, wherein the low-melt thermoplastic polymer or resin comprises Nylon.

8. The docking device of claim 4 wherein the high-tenacity biocompatible material comprises polyethylene terephthalate (PET).

9. The docking device of claim 1, wherein the filler structure is covered with a material having low porosity and reduced permeability.

10. The docking device of claim 1, wherein the filler structure comprises polymer foam.

11. The docking device of claim 10, wherein the polymer foam is at least partially covered with a tubular woven fabric.

12. The docking device of claim 11, wherein the tubular woven fabric comprises PET.

13. A three-dimensional (3D) woven fabric for a bioprosthesis docking device, the 3D woven fabric comprising:

a shape memory material;

a low-melt thermoplastic polymer or resin; and

a high-tenacity biocompatible material.

14. The 3D woven fabric of claim 13, wherein the shape memory material comprises Nitinol.

15. The 3D woven fabric of claim 13, wherein the low-melt thermoplastic polymer or resin has a melting point of 85 degrees Celsius to 200 degrees Celsius.

16. The 3D woven fabric of claim 15, wherein the low-melt thermoplastic polymer or resin comprises Nylon.

17. The 3D woven fabric of claim 13, wherein the high-tenacity biocompatible material comprises PET.

18. A method for making a docking device for a prosthesis, the method comprising:

weaving a 3D woven fabric by interlacing a shape memory material, a low-melt thermoplastic polymer or resin, and a high-tenacity biocompatible material; and

pressing and heating the 3D woven fabric over a shape-setting mold at temperatures greater than a melting point of the low-melt thermoplastic polymer or resin.

20. The method of claims 18, further comprising attaching a filler structure to a surface of the three-dimensional (3D) woven fabric.

21. The method of claim 20, wherein said attaching the filler structure comprises sewing the filler structure to the surface of the 3D woven fabric.

22. The method of claim 20, further comprising covering the filler structure with a tubular woven fabric comprising PET, wherein the filler comprises polymer foam.

19. The method of 18, wherein:

the shape memory material comprises Nitinol;

the low-melt thermoplastic polymer or resin comprises Nylon having a melting point of 85 degrees Celsius to 200 degrees Celsius; and

the high-tenacity biocompatible material comprises polyethylene terephthalate (PET).

23-26. -26. (canceled)