Reinforced valve

• US 9,474,638 B2
• Filed: 03/04/2014
• Issued: 10/25/2016
• 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
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US14/196,012
• Publication Number:
  US 20140257461A1
• Time in Patent Office: 966 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.14, 623/2.18, 623/23.64, 623/23.65, 623/23.68
• US Class Current: 1/1
• 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 molded within the substantially cylindrical-shaped rim, the reinforcement member being constrained to the substantially cylindrical-shaped rim such that the reinforcement member is disposed between the proximal end and the distal end of the substantially cylindrical-shaped rim, the reinforcement member comprising a mesh material having a plurality of openings configured to receive a stitching element, wherein the reinforcement member is configured to prevent the stitching element from tearing through the substantially cylindrical-shaped rim in response to the antegrade force and the retrograde force, and wherein the reinforcement member is formed from a different material than 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 adjacent an inner diameter of the substantially cylindrical-shaped rim.

4. The valve of claim 1, wherein the reinforcement member is disposed adjacent an outer diameter of the substantially cylindrical-shaped rim.

5. 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.

6. 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.

7. 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.

8. 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.

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

10. The valve of claim 1, wherein the mesh material has a density of between about 135 ends per inch and about 425 ends per inch.

11. 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 two-way valve configured to allow passage of flow in both an antegrade direction and a retrograde direction, the two-way valve comprising a body, a substantially cylindrical-shaped rim, an opening, and a reinforcement member comprising a mesh material formed from a plurality of threads, the reinforcement member being molded within the substantially cylindrical-shaped rim, 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;

wherein the two-way valve is coupled to the inner lumen of the substantially cylindrical-shaped stent by a stitching element, the stitching element passing through each of a wall of the substantially cylindrical-shaped stent, the substantially cylindrical-shaped rim of the valve, and between a portion of the plurality of threads forming the mesh material of the reinforcement member such that the stitching element is prevented from tearing through the substantially cylindrical-shaped rim upon passage of flow through the two-way valve in the antegrade direction and the retrograde direction.

12. The implantable device of claim 11, wherein the reinforcement member is disposed adjacent an inner diameter of the substantially cylindrical-shaped rim.

13. The implantable device of claim 11, wherein the reinforcement member is disposed adjacent an outer diameter of the substantially cylindrical-shaped rim.

14. The implantable device of claim 11, wherein the substantially cylindrical-shaped rim has a proximal end and a distal end, and 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.

15. The implantable device of claim 11, wherein the mesh material has a density of between about 135 ends per inch and about 425 ends per inch.

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

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

obtaining a two-way valve configured to allow passage of flow in both an antegrade direction and a retrograde direction, wherein the two-way valve comprises a body, a substantially cylindrical-shaped rim, an opening, and a reinforcement member comprising a mesh material formed from a plurality of threads having a density of between about 135 ends per inch and about 425 ends per inch, the reinforcement member being molded within the substantially cylindrical-shaped rim, the reinforcement member being constrained to the substantially cylindrical-shaped rim such that the reinforcement member is disposed between a proximal end and a distal end of the substantially cylindrical-shaped rim, wherein the reinforcement member is formed from a different material than the substantially cylindrical-shaped rim; and

coupling the two-way valve to the inner lumen of the substantially cylindrical-shaped stent via a stitching element disposed through the substantially cylindrical-shaped stent, the substantially cylindrical-shaped rim of the valve, and a portion of the plurality of threads forming the mesh material of the reinforcement member of the two-way valve such that the stitching element is prevented from tearing through the substantially cylindrical-shaped rim upon passage of flow through the two-way valve in the antegrade direction and the retrograde direction.

17. The method of claim 16, further comprising:

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

18. A stent to be disposed within a body lumen, the stent comprising:

a scaffolding structure formed into a tube having a substantially cylindrical shape, the scaffolding structure having an inner lumen extending therethrough; and

a valve comprising;

a body;

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

an opening disposed at a second end of the body, 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 comprising a mesh material having a density of between about 135 ends per inch and about 425 ends per inch, the reinforcement member molded within the substantially cylindrical-shaped rim, the reinforcement member being constrained to the substantially cylindrical-shaped rim such that the reinforcement member is disposed between the proximal end and the distal end of the substantially cylindrical-shaped rim, wherein the reinforcement member is formed from a different material than the substantially cylindrical-shaped rim, and 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;

wherein the valve is coupled to the inner lumen of the scaffolding structure by a stitching element disposed through a plurality of openings of the mesh material of the reinforcement member, the mesh material configured to prevent the stitching element from tearing through the substantially cylindrical-shaped rim in response to the antegrade force and the retrograde force.