Esophageal valve device for placing in the cardia

• US 8,673,020 B2
• Filed: 07/20/2012
• Issued: 03/18/2014
• 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:
  US13/554,666
• Publication Number:
  US 20120283842A1
• Time in Patent Office: 606 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. A medical device for placement in a gastrointestinal tract, the medical device comprising:

a valve member comprising a biomimetic viscoelastic polymeric foam material, the valve member having a proximal outer support region with a rim;

at least four valve leaflets;

a main body region extending between the rim and the valve leaflets, the main body region having a generally concave outer face and a generally convex inner face, the valve member having a normally closed configuration in which the leaflets are engaged at a region of co-aption of the valve leaflets and an antegrade open configuration;

the valve having a retrograde open configuration in response to a retrograde 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 polymeric foam material;

the main body region of the valve member having a first thickness, the valve leaflets at the region of co-aption having a second thickness which is greater than the first thickness to define a reinforced region which extends in a longitudinal direction; and

a support member which is configured to engage with a wall of the gastrointestinal tract, the rim of the valve being mounted to the support member.

2. The medical device as claimed in claim 1 wherein the valve is an esophageal valve.

3. The medical device as claimed in claim 1 wherein the valve has the antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve, wherein the retrograde force is larger than the antegrade force.

4. The medical device as claimed in claim 1 wherein the rim of the valve body is reinforced.

5. The medical device as claimed in claim 1 wherein a pressure of 0.7 mm Hg in an antegrade direction is sufficient to allow a flowrate through the valve of 140ml/min.

6. The medical device as claimed in claim 1 wherein the retrograde force required to open the valve is a pressure of greater than 15 mm Hg and less than 40 mm Hg.

7. The medical device as claimed in claim 1 wherein the viscoelastic foam is stable to gastric fluid for at least 3 months, for at least 4 months, for at least 5 months, for at least 6 months, for at least 7 months, for at least 8 months, for at least 9 months, for at least 10 months, for at least 11 months, or for at least one year.

8. The medical device as claimed in claim 1 wherein the viscoelastic foam takes up less than 5%, less than 10%, less than 15%, less than 20%, less than 25%, or less than 30% by weight of water at equilibrium.

9. The medical device as claimed in claim 1 wherein the viscoelastic foam has a % elongation of from 50% to 3000%, or 200 % to 1200%.

10. The medical device as claimed in claim 1 wherein the viscoelastic foam has a tensile strength of from 0.01 to 5 MPa, or 0.1 to 1.0 MPa, or 0.25 to 0.5 MPa.

11. The medical device as claimed in claim 1 wherein the viscoelastic foam has a Young'"'"'s Modulus of 0.1 to 0.6 MPa, or 0.1 to 0.5 MPa.

12. The medical device as claimed in claim 1 wherein the viscoelastic foam has a density of from 0.1 g/cm³, or 0.3 to 1.2 g/cm³, or 0.8 to 0.9 g/cm³, or 0.5 to 0.6 g/cm³.

13. The medical device as claimed in claim 1 wherein the region of co-aption of the valve leaflets has an axial extent of from 1 mm to 5 mm.

14. The medical device as claimed in claim 1 wherein the second thickness is from 0.1 mm to 10 mm.