Esophageal valve

• US 8,029,557 B2
• Filed: 06/19/2009
• Issued: 10/04/2011
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: O'Halloran, Anthony, Sobrino-Serrano, Gabriel, Behan, Niall
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/488,016
• Publication Number:
  US 20100137998A1
• Time in Patent Office: 837 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219
• US Class Current: 623/1.24
• 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

An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets. The valve has a normally closed configuration in which the valve is closed, 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.

Claims

1. An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets, the valve having:

a normally closed configuration in which the valve is closed;

an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve;

a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force;

wherein the valve leaflets have a region of co-aption,

wherein;

(a) the valve body is reinforced at the region of co-aption;

or

(b) wherein the valve body is thickened at the region of co-aption; and

wherein

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

2. The esophageal valve as claimed in claim 1 wherein the main body region is generally concave between the outer support region and a region of co-aption of the valve leaflets.

3. The esophageal valve as claimed in claim 1 wherein the valve leaflets and at least portion of the main body region inverts to allow flow in the retrograde direction.

4. The esophageal valve as claimed in claim 3 wherein, on reduction in retrograde forces the main valve region and the valve leaflets revert to the normally closed configuration.

5. The esophageal valve as claimed in claim 1 wherein

(a) the valve comprises three valve leaflets, or

(b) the valve comprises six valve leaflets.

6. The esophageal 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.

7. The esophageal valve 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.

8. The esophageal valve as claimed in claim 1 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.

9. The esophageal valve as claimed in to claim 1 wherein

(a) the polymeric material 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,

(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 % 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, or less than about 20 mm, or less than about 15 mM.

10. The esophageal valve as claimed in claim 1 comprising a support structure for the valve, wherein

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

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

(c) the valve support region is bonded to the support structure.

11. The esophageal valve as claimed in claim 10 wherein the support structure comprises a luminal prosthesis, wherein

(a) the luminal prosthesis extends proximally of the valve,

(b) the luminal prosthesis extends distally of the valve, or

(c) the luminal prosthesis extends proximally and distally of the valve.

12. The esophageal valve as claimed in claim 11 wherein

(a) the luminal prosthesis has a coating and/or a sleeve thereon,

(b) the luminal prosthesis coating or sleeve is on the outside of the luminal prosthesis, or

(c) the luminal prosthesis coating or sleeve is on the inside of the luminal prosthesis.

13. The valve as claimed in claim 1 which is adapted to be mounted to a pre-deployed esophageal luminal prosthesis, wherein

(a) the luminal prosthesis comprises an esophageal stent,

(b) the valve further comprises a mounting means for mounting the valve to a the luminal prosthesis wherein the mounting means is provided on the valve,

(c) the valve further comprises a mounting means for mounting the valve to a the luminal prosthesis wherein the mounting means comprises engagement means for engagement with a pre-deployed stent, or

(d) the valve further comprises a mounting means for mounting the valve to a the luminal prosthesis wherein the mounting means comprises a surgical adhesive.

14. The valve as claimed in claim 1 wherein the valve comprises a support structure, wherein

(a) the support structure tapers outwardly or inwardly,

(b) the support structure is of generally uniform diameter along the length thereof,

(c) the support structure comprises a scaffold,

(d) the support structure comprises a stent-like structure, or

(e) a mounting means is provided by the support structure.

15. The valve as claimed in claim 14 wherein the mounting means comprises protrusions extending from the support structure wherein

(a) the protrusions are adapted to engage with a pre-deployed host esophageal luminal prosthesis,

(b) the protrusion comprises a loop,

(c) the apical tip of the protrusion is rounded, or

(d) the protrusions are releasably engagable with a pre-deployed host esophageal luminal prosthesis.

16. The valve as claimed in claim 14 comprising release means for releasing the valve from engagement with a pre-deployed host esophageal luminal prosthesis wherein

(a) the release means comprises means for reducing the diameter of at least portion of the valve support structure,

(b) the release means comprises a drawstring extending around the valve support structure,

(c) the release means comprises a drawstring extending around a proximal end of the support structure, or

(d) the release means comprises a first drawstring extending around the valve support structure and a second drawstring extends around a distal end of the support structure.

17. The valve as claimed in claim 14 wherein

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

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

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

(d) the valve is adhesively bonded to the support structure.

18. The esophageal valve as claimed in claim 1 wherein the region of co-aption extends for an axial length of from 1 mm to 5 mm.

19. An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets, the valve having:

a normally closed configuration in which the valve is closed;

an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve;

a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force; and

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 esophageal valve as claimed in claim 19 wherein the region of co-aption extends for an axial length of from 1 mm to 5 mm.

21. The esophageal valve as claimed in claim 19 wherein the main body region is generally concave between the outer support region and a region of co-aption of the valve leaflets.

22. The esophageal valve as claimed in claim 19 wherein the valve leaflets and at least portion of the main body region inverts to allow flow in the retrograde direction.

23. The esophageal valve as claimed in claim 22 wherein, on reduction in retrograde forces the main valve region and the valve leaflets revert to the normally closed configuration.

24. The esophageal valve as claimed in claim 19 wherein

(a) the valve comprises three valve leaflets, or

(b) the valve comprises six valve leaflets.

25. The esophageal valve as claimed in claim 19 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 esophageal valve as claimed in claim 19 wherein

(a) the polymeric material 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,

(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 % 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, or less than about 20 mm, or less than about 15 mm.

27. An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets, the valve having:

a normally closed configuration in which the valve is closed;

an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve;

a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force; and

wherein the retrograde force required to open the valve is a pressure of greater than 15 mm Hg and less than 40 mm Hg.

28. The esophageal valve as claimed in claim 27 wherein the region of co-aption extends for an axial length of from 1 mm to 5 mm.

29. The esophageal valve as claimed in claim 27 wherein the main body region is generally concave between the outer support region and a region of co-aption of the valve leaflets.

30. The esophageal valve as claimed in claim 27 wherein the valve leaflets and at least portion of the main body region inverts to allow flow in the retrograde direction.

31. The esophageal valve as claimed in claim 30 wherein, on reduction in retrograde forces the main valve region and the valve leaflets revert to the normally closed configuration.

32. The esophageal valve as claimed in claim 27 wherein

(a) the valve comprises three valve leaflets, or

(b) the valve comprises six valve leaflets.

33. The esophageal valve as claimed in claim 27 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.

34. The esophageal valve as claimed in claim 27 wherein

(a) the polymeric material 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,

(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 % 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, or less than about 20 mm, or less than about 15 mm.

35. An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets, the valve having:

a normally closed configuration in which the valve is closed;

an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve;

a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force, wherein

(a) the polymeric material 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,

(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 % 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, or less than about 20 mm, or less than about 15 mm.

36. An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets, the valve having:

a normally closed configuration in which the valve is closed;

an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve;

a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force;

wherein the valve further comprises a support structure, wherein

(a) the support structure tapers outwardly or inwardly,

(b) the support structure is of generally uniform diameter along the length thereof,

(c) the support structure comprises a scaffold,

(d) the support structure comprises a stent-like structure, or

(e) a mounting means is provided by the support structure; and

wherein the mounting means comprises protrusions extending from the support structure;

wherein

(f) the protrusions are adapted to engage with a pre-deployed host esophageal luminal prosthesis,

(g) the protrusion comprises a loop,

(h) the apical tip of the protrusion is rounded, or

(i) the protrusions are releasably engagable with a pre-deployed host esophageal luminal prosthesis.

37. An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets, the valve having:

a normally closed configuration in which the valve is closed;

an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve;

a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force;

wherein the valve further comprises a support structure, wherein

(a) the support structure tapers outwardly or inwardly,

(b) the support structure is of generally uniform diameter along the length thereof,

(c) the support structure comprises a scaffold,

(d) the support structure comprises a stent-like structure, or

(e) a mounting means is provided by the support structure; and

wherein the valve further comprises a release means for releasing the valve from engagement with a pre-deployed host esophageal luminal prosthesis wherein

(f) the release means comprises means for reducing the diameter of at least portion of the valve support structure,

(g) the release means comprises a drawstring extending around the valve support structure,

(h) the release means comprises a drawstring extending around a proximal end of the support structure, or

(i) the release means comprises a first drawstring extending around the valve support structure and a second drawstring extends around a distal end of the support structure.