VALVE

• US 20100121462A1
• Filed: 06/19/2009
• Published: 05/13/2010
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: O'HALLORAN, Anthony, BEHAN, Niall, SOBRINO-SERRANO, Gabriel
• Granted Patent: US 8,500,821 B2
• Time in Patent Office: Days
• US Class Current: 623/23.680
• 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 luminal valve for placing in a body lumen comprising at least four valve leaflets, the valve having a normally closed configuration in which the leaflets are engaged and an open configuration in which the leaflets are open.

2. The luminal valve as claimed in claim 1 comprising

(a) at least five valve leaflets, or

(b) six valve leaflets.

4. The luminal valve as claimed claim 1 wherein the valve is an esophageal valve.

5. The valve as claimed in claim 1 wherein the valve has 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 substantially larger than the antegrade force.

6. The valve as claimed claim 1 wherein the valve comprises a valve body of polymeric material.

7. The valve as claimed in claim 1 wherein

(a) the valve comprises an outer support region

the valve comprises an outer support region and further comprises a main body region extending between the support region and the valve leaflets;

or

(c) the valve comprises an outer support region, a main body region extending between the support region and the valve leaflets and the main body region is generally concave between the outer support region and a region of co-aption of the valve leaflets.

10. The valve as claimed in claim 7 wherein the valve leaflets and at least portion of the main body region inverts to allow flow in the retrograde direction.

11. The valve as claimed in claim 10 wherein, on reduction in retrograde forces the main valve region and the valve leaflets revert to the normally closed configuration.

12. The valve as claimed in claim 1 wherein

(a) the valve leaflets have a region of co-aption,

(b) the valve leaflets have a region of co-aption and the valve body is reinforced at the region of co-aption, or

(c) the valve leaflets have a region of co-aption and the valve body is thickened at the region of co-aption.

15. The valve as claimed in claim 12 wherein

(a) the region of co-aption extends for an axial length of at least 1 mm,

(b) the region of co-aption extends for an axial length of from 1 mm to 5 mm, or

(c) the support region of the valve is thickened.

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

20. The valve as claimed 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.

21. The valve as claimed claim 6 wherein

(a) the polymeric material of the valve body is of an elastic material,

(b) the polymeric material of the valve body is of a viscoelastic material,

(c) the polymeric material of the valve body comprises a foam,

(d) the polymeric material of the valve body comprises an open cell foam, or

(e) the polymeric material of the valve body comprises a polyurethane foam.

26. The valve according to claim 6 wherein

(a) the polymeric material is stable to gastric fluid for at least about 3 months, for at least about 4 months, for at least about months, for at least about 6 months, for at least about 7 months, for at least about 8 months, for at least about 9 months, for at least about 10 months, for at least about 11 months, or for at least about one year,

(b) the polymeric material takes up less than about 5%, less than about 10%, less than about 15%, less than about 20%, less than about 25%, or less than about 30% by weight of water at equilibrium,

(c) the polymeric material of the valve body has a percent elongation of from about 50% to about 3000%, or about 200 to about 1200%,

(d) the polymeric material of the valve body has a tensile strength of from about 0.01 to about 5 MPa, or about 0.1 to about 1.0 MPa, or about 0.25 to about 0.5 MPa

(e) the polymeric material has a Young'"'"'s Modulus of about 0.01 to about 0.6 MPa or about 0.1 to about 0.5 MPa

(f) the polymeric material of the valve body has a density of from about 0.1 g/cm³ to about 1.5 g/cm³, or from about 0.3 to about 1.2 g/cm³, or from about 0.8 to about 0.9 g/cm³, or from about 0.5 to about 0.6 g/cm³, or

(g) the distance between the proximal end of the support region of the valve body and the distal end of the valve leaflets is less than about 50 mm, or less than about 40 mm, or less than about 30 mm, or less than about 25 mm.

33. The valve as claimed in claim 6 comprising a support structure for the valve wherein

(a) the valve is mounted to the support structure,

(b) wherein the valve support region is sutured to the support structure,

(c) wherein the valve support region is bonded to the support structure, or

(d) wherein the support structure is overmoulded to the valve support region.

38. The valve as claimed in claim 33 wherein

(a) the support structure comprises a luminal prosthesis,

(b) the support structure comprises a luminal prosthesis and the luminal prosthesis extends proximally of the valve, or

(c) the support structure comprises a luminal prosthesis and the prosthesis comprises a self expanding plastics mesh,

(d) wherein anchors are adapted to extend through the mesh of the prosthesis, or

(e) wherein the prosthesis is adapted to be anchored to the cardia.

42. The valve as claimed in claim 38 comprising anchors for mounting the prosthesis in situ, wherein the anchors are optionally adapted to extend through the mesh of the prosthesis.

45. The valve as claimed in claim 7 wherein

(a) the length of the valve from the proximal end of the support region to the distal end of the valve leaflets is less than about 50 mm, less than about 40 mm, less than about 30 mm,

(b) the length of the valve is approximately 23 mm, or

(c) the length of the valve is approximately the same as the outer diameter of the support region of the valve.

48. A method for treating gastroesophageal reflux disease comprising placing a valve as claimed in claim 1 at a desired location,

wherein the desired location is optionally across the lower esophageal sphincter.

51. The method as claimed in claim 48 wherein the valve is provided with a support structure and the method comprises mounting the support structure at the desired location,

optionally comprising anchoring the support structure to the body wall at the desired location, or

comprising anchoring the support structure to the cardia.

3. (canceled)

8-9. -9. (canceled)

13-14. -14. (canceled)

16-18. -18. (canceled)

22-25. -25. (canceled)

27-32. -32. (canceled)

34-37. -37. (canceled)

39-41. -41. (canceled)

43-44. -44. (canceled)

46-47. -47. (canceled)

49-50. -50. (canceled)

52-53. -53. (canceled)