POLYMERIC HEART VALVE

• US 20170245989A1
• Filed: 04/20/2017
• Published: 08/31/2017
• Est. Priority Date: 10/13/2011
• Status: Active Grant

• Current Assignee: The Research Foundation for The State University of New York (State University of New York), Arizona Board of Regents (University of Arizona)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York), Arizona Board of Regents (University of Arizona)
• Inventors: Bluestein, Danny, Claiborne, Thomas E., Slepian, Marvin J.
• Granted Patent: US 10,772,722 B2
• Time in Patent Office: Days
• 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 2250/0036 differing in thickness

Abstract

A polymeric valve which may include a heart valve, and also may include a trileaflet heart valve includes a stent having a base and a plurality of outwardly extending posts from the base and equidistant from each other. A plurality of leaflets each connected to a corresponding one of the posts at one end, and each of the leaflets connected to the base. Each of the leaflets having an operative end opposite the end connected to the post, and the operative ends of the leaflets being biased in a closed position such that the operative ends abut each other. The operative ends are configured to rhythmically open and close in relation to each other, and the leaflets include multiple cross sectional thicknesses at different portions of the leaflets.

Claims

1-24. -24. (canceled)

25. A polymeric valve, comprising:

a stent; and

a plurality of leaflets, each of the leaflets having an operative end, the operative ends of the leaflets being biased in a closed position such that the operative ends abut each other, the operative ends being configured to open and close in relation to each other, and the leaflets including multiple cross sectional thicknesses at different portions of the leaflets,

wherein the leaflets comprise a middle portion between the first end and the operative end,

wherein a first portion between the first end and the middle portion is thinner than the first end,

wherein the middle portion is about the same thickness as the first end,

wherein a second portion between the middle portion and the operative end is about the same thickness as the first portion,

wherein the operative end is about the same thickness as the first end, and

wherein the first end, the first portion, the middle portion, the second portion and the operative end are aligned from the first end to the operative end.

26. The valve of claim 25, wherein the valve is a heart valve.

27. The valve of claim 25, wherein the valve is a trileaflet heart valve.

28. The valve of claim 25, wherein the valve comprises xSIBS material.

29. The valve of claim 25, wherein the base of the stent includes a hemispherical ridge extending around a perimeter of the base.

30. The valve of claim 25, wherein the multiple thicknesses of the leaflets include thicknesses in the range of about 0.25 mm to about 0.18 mm.

31. The valve of claim 25, wherein the multiple thicknesses along an edge of the operative end of the leaflets include thicknesses in the range of about 0.25 mm to about 0.18 mm.

32. The valve of claim 25, wherein a upper and lower portion including the operative end of the leaflets has a thickness of about 0.25 mm.

33. The valve of claim 25, wherein a middle portion including the operative end of the leaflets has a thickness of about 0.25 mm.

34. The valve of claim 25, wherein an upper and lower portion including the operative end of the leaflet has a thickness of about 0.25 mm, a middle portion including the operative end of the leaflets has a thickness of about 0.25 mm., and incrementally space portions between the upper and lower portions and the middle portion have thicknesses of about 0.18 mm and 0.20 mm including the operative end of the leaflets.

35. The valve of claim 25, wherein the plurality of leaflets consist of an elastomer material.

36. The valve of claim 25, wherein the leaflets consist of a single layer of material.

37. The valve of claim 25, wherein the leaflets comprise a polymer material of multiple cross sectional thicknesses.

38. A method for manufacturing a heart valve using injection molding, comprising:

configuring a stent having a base;

configuring a plurality of leaflets each connected to the base;

molding each of the leaflets having an operative end, and the operative ends of the leaflets are biased in a closed position such that the operative ends abut each other;

configuring the operative ends to open and close in relation to each other;

molding the leaflets including multiple thicknesses of cross sectional areas at different portions of the leaflets; and

heating a resulting mold derived from the steps above.

39. The method of claim 38, wherein the mold includes three leaflets to configure a trileaflet heart valve.

40. A polymeric valve, comprising:

a stent having a base; and

a plurality of leaflets each connected to the base, each of the leaflets having an operative end, the operative ends of the leaflets being biased in a closed position such that the operative ends abut each other, and the leaflets including multiple cross sectional thicknesses at different portions of the leaflets,

wherein the leaflets are connected to the base at a first end, and comprise a middle portion between the first end and the operative end,

wherein a first portion is between the first end and the middle portion,

wherein a second portion is between the middle portion and the operative end, and

wherein the first end, the first portion, the middle portion, the second portion and the operative end are aligned from the first end to the operative end.

41. The valve of claim 40, wherein the multiple thicknesses of the leaflets include thicknesses in the range of about 0.25 mm to about 0.18 mm.

42. The valve of claim 40, wherein the multiple thicknesses along an edge of the operative end of the leaflets include thicknesses in the range of about 0.25 mm to about 0.18 mm.

43. The valve of claim 40, wherein an upper and lower portion including the operative end of the leaflets has a thickness of about 0.25 mm.

44. The valve of claim 40, wherein a middle portion including the operative end of the leaflets has a thickness of about 0.25 mm.

45. The valve of claim 40, wherein an upper and lower portion including the operative end of the leaflet has a thickness of about 0.25 mm, a middle portion including the operative end of the leaflets has a thickness of about 0.25 mm., and incrementally space portions between the upper and lower portions and the middle portion have thicknesses of about 0.18 mm and 0.20 mm including the operative end of the leaflets.