REINFORCED VALVE

• US 20140257461A1
• Filed: 03/04/2014
• Published: 09/11/2014
• Est. Priority Date: 03/05/2013
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Robinson, Thomas, Brotherton, Richard A., Chatterton, Michelle
• Granted Patent: US 9,474,638 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

The embodiments disclosed herein relate to a valve that is configured to be coupled to a stent. The valve may include a body, a rim, and an opening. The opening may include three or more leaflets that are configured to open and close. The valve may further include a reinforcement member that may be coupled to the rim. The reinforcement member may be formed of a mesh or mesh-like material or may be made of a polymeric film. The reinforcement member may aid in preventing a stitching element from tearing through the rim of the valve and may be coupled to the inner diameter or the outer diameter of the rim. The reinforcement member may also be molded within the rim.

Claims

1. A valve for placement in a body lumen, comprising:

a body;

a substantially cylindrical-shaped rim disposed at a first end of the valve, the substantially cylindrical-shaped rim having a proximal end and a distal end;

an opening disposed at a second end of the valve, wherein the opening comprises one or more leaflets, the opening having a closed configuration in which the leaflets are closed, an antegrade open configuration in which the leaflets are opened in response to an antegrade force, and a retrograde open configuration in which the leaflets are opened in response to a retrograde force; and

a reinforcement member coupled to the substantially cylindrical-shaped rim, the reinforcement member being constrained to the substantially cylindrical-shaped rim.

2. The valve of claim 1, wherein the opening comprises at least three leaflets.

3. The valve of claim 1, wherein the reinforcement member is disposed between the proximal and distal ends of the substantially cylindrical-shaped rim.

4. The valve of claim 1, wherein the reinforcement member is coupled to an inner diameter of the substantially cylindrical-shaped rim.

5. The valve of claim 1, wherein the reinforcement member is coupled to an outer diameter of the substantially cylindrical-shaped rim.

6. The valve of claim 1, wherein the reinforcement member is molded within the substantially cylindrical-shaped rim.

7. The valve of claim 1, wherein the reinforcement member is integral with the substantially cylindrical-shaped rim.

8. The valve of claim 1, wherein the reinforcement member comprises a mesh material.

9. The valve of claim 1, wherein the tear strength of the reinforcement member is greater than the tear strength of the material used to form the substantially cylindrical-shaped rim.

10. The valve of claim 1, wherein the body comprises an inner surface and an outer surface, wherein, in the closed configuration, the inner surface is substantially concave and the outer surface is substantially convex.

11. The valve of claim 1, wherein the body comprises an inner surface and an outer surface, wherein, in the antegrade open configuration, the inner surface is substantially concave and the outer surface is substantially convex.

12. The valve of claim 1, wherein the body comprises an inner surface and an outer surface, wherein, in the retrograde open configuration, the inner surface is substantially convex and the outer surface is substantially concave.

13. The valve of claim 1, wherein the body of the valve is inverted in the retrograde open configuration.

14. An implantable device to be disposed within a body lumen, the implantable device comprising:

a substantially cylindrical-shaped stent having an inner lumen extending therethrough; and

a valve comprising a body, a substantially cylindrical-shaped rim, an opening, and a reinforcement member, the reinforcement member being coupled to the substantially cylindrical-shaped rim;

wherein the valve is coupled to the inner lumen of the substantially cylindrical-shaped stent by a stitching element disposed through the reinforcement member of the valve.

15. The implantable device of claim 14, wherein the stitching element passes through a wall of the substantially cylindrical-shaped stent, the substantially cylindrical-shaped rim of the valve, and the reinforcement member.

16. The implantable device of claim 14, wherein the reinforcement member comprises a mesh material.

17. The implantable device of claim 14, wherein the reinforcement member comprises a polymeric film.

18. The implantable device of claim 14, wherein the reinforcement member is coupled to an inner diameter of the substantially cylindrical-shaped rim.

19. The implantable device of claim 14, wherein the reinforcement member is coupled to an outer diameter of the substantially cylindrical-shaped rim.

20. The implantable device of claim 14, wherein the reinforcement member is molded within the substantially cylindrical-shaped rim.

21. The implantable device of claim 14, wherein the tear strength of the reinforcement member is greater than the tear strength of the material used to form the substantially cylindrical-shaped rim.

22. A method of making an implantable device to be disposed within a body lumen, the method comprising:

obtaining a substantially cylindrical-shaped metal stent, the substantially cylindrical-shaped stent having an inner lumen extending therethrough;

obtaining a valve, wherein the valve comprises a body, a substantially cylindrical-shaped rim, an opening, and a reinforcement member; and

coupling the valve to the inner lumen of the substantially cylindrical-shaped stent via a stitching element disposed through the reinforcement member of the valve.

23. The method of claim 22, further comprising;

coupling the reinforcement member to the substantially cylindrical-shaped rim prior to coupling the valve to the inner lumen of the substantially cylindrical-shaped stent.