ESOPHAGEAL VALVE DEVICE FOR PLACING IN THE CARDIA

• US 20120283842A1
• Filed: 07/20/2012
• Published: 11/08/2012
• 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
• Granted Patent: US 8,673,020 B2
• Time in Patent Office: Days
• 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

1-53. -53. (canceled)

54. 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.

55. A luminal valve as claimed in claim 54 wherein the valve is an esophageal valve.

56. A valve as claimed in claim 54 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.

57. A valve as claimed in claim 54 wherein the valve comprises an outer support region.

58. A valve as claimed in claim 57 comprising a main body region extending between the support region and the valve leaflets.

59. A valve as claimed in claim 58 wherein the main body region is generally concave between the outer support region and a region of co-aption of the valve leaflets.

60. A valve as claimed in claim 58 wherein the valve leaflets and at least portion of the main body region inverts to allow flow in the retrograde direction.

61. A valve as claimed in claim 60 wherein, on reduction in retrograde forces the main valve region and the valve leaflets evert to the normally closed configuration.

62. A valve as claimed in claim 54 wherein the valve leaflets have a region of co-aption.

63. A valve as claimed in claim 57 wherein support region of the valve body is reinforced.

64. A valve as claimed in claim 54 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.

65. A valve as claimed in claim 54 wherein the retrograde force required to open the valve is a pressure of greater than 15 mm Hg and less than 40 mm Hg.

66. A valve as claimed in claim 54 wherein the valve body is of a viscoelastic foam.

67. A valve as claimed in claim 66 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.

68. A valve as claimed in claim 66 wherein the viscoelastic foam 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.

69. A valve as claimed in claim 66 wherein the viscoelastic foam has a % elongation of from 50% to 3000%, or about 200 to 1200%.

70. A valve as claimed in claim 66 wherein the viscoelastic foam has a tensile strength of from 0.01 to 5 MPa, or about 0.1 to about 1.0 MPa, or about 0.25 to 0.5 MPa.

71. A valve as claimed in claim 66 wherein the viscoelastic foam has a Young'"'"'s Modulus of about 0.1 to 0.6 MPa, or about 0.1 to about 0.5 MPa.

72. A valve as claimed in claim 66 wherein the viscoelastic foam has a density of from 0.1 g/cm³ to 1.5 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.

73. A valve as claimed in claim 54 comprising a support structure for the valve.