PROSTHETIC VALVES FORMED WITH ISOTROPIC FILTER SCREEN LEAFLETS

• US 20120172978A1
• Filed: 12/23/2011
• Published: 07/05/2012
• Est. Priority Date: 01/05/2011
• Status: Abandoned Application

• Current Assignee: Curia Incorporated
• Original Assignee: Curia Incorporated
• Inventors: DuMontelle, Jeff Paul
• Application Number:
  US13/337,041
• Publication Number:
  US 20120172978A1
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

“In one embodiment of the invention, a prosthetic check valve is disclosed with leaflets cut from filtration screen material with uniform pore size having openings with a dimension inclusively between fifteen and sixty microns. The screen material is made from biocompatible material, such as polyester or polypropylene. One or more outer edges of the leaflet are fused or sealed to prevent fraying of the material and to form a more non-thrombogenic surface. Prosthetic check valves assembled with the leaflets can be collapsed to a diameter of less than or equal to twenty-nine french (29f), sterilized, and stored in a collapsed state. The collapsed valve can be implanted without prior rinsing to remove sterilant.

Claims

1. An apparatus comprising:

an isotropic filter screen formed of monofilament strands of biocompatible material that is porous to a body fluid;

the isotropic filter screen is flexible to flex back and forth between a concave and a convex condition; and

the isotropic filter screen is cut into a shape of one or more prosthetic valve leaflets each having at least one sealed edge.

2. The apparatus of claim 1, wherein

the biocompatible material is one of monofilament polyester, monofilament polypropylene, monofilament acetyl-polymer, silk, or spider web.

3. The apparatus of claim 1, wherein

a thickness of the isotropic filter screen and the one or more prosthetic valve leaflets is between one-hundredth and one-tenth of a millimeter.

4. The apparatus of claim 1, wherein

the monofilament strands of biocompatible material are woven or knitted together to form the isotropic filter screen with a uniform pore size.

5. The apparatus of claim 1, wherein

the isotropic filter screen is porous to blood, and

a pore size of openings in the isotropic filter screen and the one or more prosthetic valve leaflets is inclusively between fifteen and sixty microns.

6. The apparatus of claim 1, wherein

the isotropic filter screen is cut with a non-contact cutting device to form the one or more prosthetic valve leaflets with at least one sealed edge without extended strands to prevent unraveling.

7. The apparatus of claim 6, wherein

the non-contact cutting device is a laser.

8. The apparatus of claim 1, wherein

the isotropic filter screen is cut with a heated contact cutting device to form the one or more prosthetic valve leaflets with at least one sealed edge without extended strands to prevent unraveling.

9. The apparatus of claim 8, wherein

the heated contact cutting device is a radio-frequency or ultrasonic cutting device.

10. The apparatus of claim 1, wherein

the one or more prosthetic valve leaflets are sterilized by gamma radiation, e-beam, ethylene oxide (EtO), heat, or chemical sterilization.

11. The apparatus of claim 1, wherein

the one or more prosthetic valve leaflets are collapsed to a diameter of less than or equal to twenty-nine french (f).

12. The apparatus of claim 11, wherein

the one or more collapsed prosthetic valve leaflets are sterilized by gamma radiation, e-beam, ethylene oxide (EtO), heat, or chemical sterilization.

13. The apparatus of claim 1, wherein

the isotropic filter screen is cut into the shape of the one or more prosthetic valve leaflets such that each of the one or more prosthetic valve leaflets includes

an out-flow edge,

an in-flow edge, and

a pair of side edges.

14. The apparatus of claim 13, wherein

each of the one or more prosthetic valve leaflets further includes

a pair of tab portions respectively extending outwardly beyond the pair of side edges and adjacent the out-flow edge, the pair of tab portions adapted to couple to a supporting structure to support the prosthetic valve leaflet.

15-64. -64. (canceled)

65. An apparatus for checking back flow of a fluid in a tubular-like shaped vessel, the apparatus comprising:

a prosthetic valve leaflet formed from an isotropic screen material, the isotropic screen material having

pores with a pore size inclusively between fifteen microns and sixty microns, and

a thickness inclusively between one-hundredth of a millimeter and one-tenth of a millimeter.

66. The apparatus of claim 65, wherein

the prosthetic valve leaflet is formed with one or more sealed edges so that it can be handled without coming apart.

67. The apparatus of claim 65, wherein

the isotropic screen material is a monofilament polyester or polypropylene to form an isotropic structure with uniform pore size.

68. The apparatus of claim 66, wherein

the shape of the prosthetic valve leaflet is cut from the isotropic screen material using a laser or other non-contact method to form the one or more sealed edges.

69. The apparatus of claim 65, further comprising:

a support structure coupled to the prosthetic valve leaflet to support the leaflet between a first commissure portion and a second commissure portion of the support structure to form a prosthetic valve.

70. The apparatus of claim 65, wherein

two or more prosthetic valve leaflets are coupled together to form a prosthetic valve.

71. The apparatus of claim 70, further comprising:

a support structure coupled to the two or more prosthetic valve leaflets, the support structure to support the two or more prosthetic valve leaflets between a first commissure portion and a second commissure portion.

72. The apparatus of claim 71, wherein

a contact length at outflow edges between the two or more prosthetic valve leaflets (a depth of coaptation) is inclusively between three millimeters and nine millimeters.

73. The apparatus of claim 65, wherein

the isotropic screen material is formed by weaving or knitting a mono-filament polyester or mono-filament polypropylene.

74. The apparatus of claim 69, wherein

the prosthetic valve is collapsed to a diameter less than or equal to twenty-nine French (nine and seven-tenths millimeter) to form a collapsed prosthetic valve.

75. The apparatus of claim 69, wherein

the prosthetic valve is sterilized by gamma radiation, e-beam, ethylene oxide (EtO), heat (e.g., autoclave), or chemical sterilization.

76. The apparatus of claim 74, wherein

the collapsed prosthetic valve is sterilized by gamma radiation, e-beam, ethylene oxide (EtO), heat (e.g., autoclave), or chemical sterilization.

77. The apparatus of claim 74, wherein

the collapsed prosthetic valve is sterilized and stored in a storage container in a dry state such that it can be implanted into a mammal without rinsing.

78. The apparatus of claim 65, wherein

the isotropic screen material is formed out of an acetylpolymer.

79. The apparatus of claim 65, wherein

the isotropic screen material is formed out of silk.

80. The apparatus of claim 65, wherein

the isotropic screen material is formed out of a spider web.

81-105. -105. (canceled)