Esophageal valve device for placing in the cardia

• US 8,500,821 B2
• Filed: 06/19/2009
• Issued: 08/06/2013
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: Sobrino-Serrano, Gabriel, Behan, Niall, O'Halloran, Anthony
• Primary Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US12/488,037
• Publication Number:
  US 20100121462A1
• Time in Patent Office: 1,509 Days
• Field of Search: 600 29- 31, 604 8- 9, 623/1.24, 623/9, 623 2364- 237
• US Class Current: 623/23.68
• 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 2/2412 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: C08L 83/10 Block- or graft-copolymers containing polysiloxane sequences obtained by polymerising a compound having a carbon-to-carbon double bond on to a polysiloxane C08L51/08, C08L53/00

Abstract

A luminal valve for placing in a body lumen comprises at least four valve leaflets. The valve has a normally closed configuration in which the leaflets are engaged and an open configuration in which the leaflets are open. The valve may be mounted to an esophageal support.

Claims

1. An esophageal valve device for placing in a cardia, the valve device comprising:

a valve;

a support structure comprising a luminal prosthesis to which the valve is mounted; and

anchors for mounting the prosthesis in situ,

wherein the prosthesis comprises a self expanding plastics mesh,

and wherein the valve comprises a valve body of viscoelastic polymeric foam material,

the valve body comprising an outer support region which is mounted to the prosthesis and a main body region extending between the support region and valve leaflets, the valve comprising at least four valve leaflets,

the valve having a normally closed configuration in which the leaflets are engaged,

the valve having an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve, and a retrograde open configuration in response to a retrograde force which is larger than the antegrade force,

the valve leaflets and at least a portion of the main body region of the valve configured to invert to allow flow in the retrograde direction and, on reduction in retrograde forces, the main body region and the valve leaflets configured to automatically revert to the normally closed configuration under an inherent biasing of the viscoelastic foam material.

2. A valve device as claimed in claim 1 wherein the valve comprises at least five valve leaflets.

3. A valve device as claimed in claim 1 wherein the valve comprises six valve leaflets.

4. A valve device as claimed in claim 1 wherein the distance between a proximal end of the support region of the valve body and a distal end of the valve leaflets is less than 50 mm, or less than 40 mm, or less than 30 mm, or less than 25 mm.

5. A valve device as claimed in claim 1 wherein the length of the valve from a proximal end of the support region to a distal end of the valve leaflets is the same as the outer diameter of the support region of the valve.

6. A valve device as claimed in claim 1 wherein the distance between a proximal end of the support region of the valve body and a distal end of the valve leaflets is 23 mm.

7. A valve device as claimed in claim 1 wherein the support region is sutured to the prosthesis.

8. A valve device as claimed in claim 1 wherein the support region is bonded to the prosthesis.

9. A valve device as claimed in claim 1 wherein the prosthesis extends proximally of the valve.

10. A valve device as claimed in claim 1 wherein the prosthesis applies a radial force of less than 1.9 kPa.

11. A valve device as claimed in claim 1 wherein the anchors are adapted to extend through the mesh of the prosthesis.