PROSTHETIC VALVES FORMED WITH SUPPORTING STRUCTURE AND ISOTROPIC FILTER SCREEN LEAFLETS

• US 20120172981A1
• 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, Jeffrey P.
• Application Number:
  US13/337,043
• Publication Number:
  US 20120172981A1
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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. The prosthetic check valve includes a supporting structure to which the leaflets may couple. Prosthetic check valves assembled with the leaflets can be collapsed to a diameter of less than or equal to twenty-nine french (29 f), sterilized, and stored in a collapsed state. The collapsed valve can be implanted without prior rinsing to remove sterilant.

Claims

1-14. -14. (canceled)

15. An apparatus comprising:

a supporting structure; and

one or more prosthetic valve leaflets coupled to the supporting structure,

each of the one or more prosthetic valve leaflets are cut from an isotropic filter screen formed of monofilament strands of biocompatible material that is porous to a body fluid; and

each of the one or more prosthetic valve leaflets has at least one sealed edge.

16. The apparatus of claim 15, 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.

17. The apparatus of claim 16, 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.

18. The apparatus of claim 15, further comprising

a sewing ring coupled to the one or more prosthetic valve leaflets, wherein the sewing ring is further cut from the isotropic filter screen.

19. The apparatus of claim 18, wherein

the supporting structure, one to four prosthetic valve leaflets, and the sewing ring are collapsed to a diameter of less than or equal to twenty-nine french (f).

20. The apparatus of claim 19, wherein

the collapsed supporting structure, the one to four collapsed prosthetic valve leaflets, and the collapsed sewing ring are sterilized by gamma radiation, e-beam, ethylene oxide (EtO), heat, or chemical sterilization prior to insertion into any vessel of a mammal.

21. The apparatus of claim 20, further comprising:

a storage device adapted to store the collapsed supporting structure, the one to four collapsed prosthetic valve leaflets, and the collapsed sewing ring prior to insertion into any vessel of a mammal.

22. The apparatus of claim 18, wherein

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

23. The apparatus of claim 15, further comprising

collagen infiltrated into pores of the one or more prosthetic valve leaflets to reduce leakage and become less regurgitant.

24. The apparatus of claim 19, wherein

the supporting structure is a self-expanding supporting structure formed of a shape-memory material such that it can be collapsed without strain damage and retain its collapsed shape and expand from its collapsed shape when heated above ambient temperature to a second phase.

25. The apparatus of claim 24, wherein

the shape-memory material out of which the supporting structure is formed is NiTiNOL material.

26. The apparatus of claim 19, wherein

the supporting structure is a non-self-expanding supporting structure that requires internal pressure from an expansion device to re-expand it.

27. The apparatus of claim 18, further comprising:

a storage device adapted to store the supporting structure, the one or more prosthetic valve leaflets, and the sewing ring, without collapsing, prior to insertion into any vessel of a mammal.

28. An apparatus comprising:

a supporting structure; and

two or more prosthetic valve leaflets coupled to the supporting structure,

each of the two or more prosthetic valve leaflets cut from an isotropic filter screen, formed of monofilament strands of biocompatible material, that is porous to a body fluid;

each of the one or more valve leaflets has at least one sealed edge and a pair of side edges; and

wherein side edges of adjacent valve leaflets are engaged together to form a valve structure with an in-flow end opposite an out-flow end.

29. The apparatus of claim 28, wherein

each of the two or more prosthetic valve leaflets further includes

an out-flow edge, and

an in-flow edge opposing the out-flow edge.

30. The apparatus of claim 29, 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.

31. The apparatus of claim 28, further comprising

a sewing ring coupled to the two or more prosthetic valve leaflets, wherein the sewing ring is further cut from the isotropic filter screen.

32. The apparatus of claim 31, wherein

the supporting structure, two to four prosthetic valve leaflets, and the sewing ring are collapsed to a diameter of less than or equal to twenty-nine french (f).

33. The apparatus of claim 31, wherein

the two or more prosthetic valve leaflets are movable between a closed position and an open position,

in the closed position, each prosthetic valve leaflet engages each other near the out-flow edges to deter blood flow, and

in the open position, the out-flow edges of each prosthetic valve leaflet are separated from each other to allow blood flow.

34. The apparatus of claim 33, wherein

the two or more prosthetic valve leaflets in the closed position are adapted to engage near the out-flow edges over a depth of coaptation between three and nine millimeters.

35-105. -105. (canceled)