Valve with sinus

• US 8,672,997 B2
• Filed: 04/24/2012
• Issued: 03/18/2014
• Est. Priority Date: 09/21/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Drasler, William J., Hill, Jason P., Sogard, David J., Haverkost, Patrick A., Shoemaker, Susan M., Jensen, Mark L.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/454,778
• Publication Number:
  US 20120209378A1
• Time in Patent Office: 693 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219, 623/2.42, 623/1.3
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

A valve with a structural member and valve leaflets that provide a sinus.

Claims

1. A valve with ends and a longitudinal length measured from the ends, the valve comprising:

a frame comprising;

a first structural member forming an elongate base portion, the first structural member forming two curves at each end of the valve, each end of the valve having only two curves, the elongate base portion including an inlet region that defines an inlet cross sectional area, and an outlet region that defines an outlet cross sectional area, the first structural member defining two valve leaflet connections

a second structural member extending radially and longitudinally from the first structural member to form a bulbous portion positioned between the ends of the valve, the bulbous portion having a middle cross sectional area,

the inlet cross sectional area being different than the middle cross sectional area, wherein the bulbous portion has an expansion force that is greater than the inlet region and the outlet region;

a first valve leaflet and a second valve leaflet, each leaflet engaged to the first structural member,

each valve leaflet comprising a free edge a first inflow surface, and a first outflow surface opposite the first inflow surface, the free edges extending between the two valve leaflet connections of the first structural member, the free edges of each valve leaflet being configured to shift between an open position and a closed position;

the free edges of the first and second valve leaflets defining a free edge cross sectional area in the open position; and

a sinus region defined by a volume between the second structural member at the middle cross sectional area and the first outflow surfaces of the first and second valve leaflets in the open position.

2. The valve of claim 1, where the inlet cross sectional area is approximately equal to the outlet cross sectional area, is greater than the free edge cross sectional area, and is less than the middle cross sectional area.

3. The valve of claim 1, where the middle cross sectional area is greater than the inlet cross sectional and the inlet cross sectional area is greater than the free edge cross sectional area.

4. The valve of claim 1, where the inlet cross sectional area is approximately equal to both the free edge cross sectional area and the outlet cross sectional area, and the inlet cross sectional area is less than the middle cross sectional area.

5. The valve of claim 1, where the inlet cross sectional area is approximately equal to the outlet cross sectional area, the inlet cross sectional area is greater than the middle cross sectional area, and the middle cross sectional area is greater than the free edge cross sectional area.

6. The valve of claim 1, where the frame provides for a longitudinal center axis extending from the inlet region to the outlet region, wherein the free edge of the first and second valve leaflet are at a distance at least twenty-five (25) percent from the inlet region along the longitudinal center axis.

7. The valve of claim 6, where the free edge of the first and second valve leaflet ranges from a distance fifty (50) percent from the inlet region to eighty (80) percent from the inlet region along the longitudinal center axis.

8. The valve of claim 1, where the frame provides for a longitudinal center axis, where the free edge of the first or second valve leaflet in the open position and the bulbous portion of the frame define a gap having a maximum distance ranging from 0.5 to four (4) millimeters (mm) measured perpendicular to the longitudinal center axis.

9. The valve of claim 8, where the gap has a maximum distance ranging from one (1) to three (3) mm.

10. The valve of claim 9, where the maximum distance ranges from 1.5 to 2.5 mm.

11. The valve of claim 1, where the first and second valve leaflets have a valve leaflet length (L) along the inflow surface measured at a greatest length distance between the free edge and an attachment location of the first structural member perpendicular to the free edge, where the inlet cross sectional area has an inlet radius (r_i), and where the valve leaflet length (L) is a function of the inlet radius (r_i) and is at least approximately equal to the inlet radius (r_i).

12. The valve of claim 11, where the valve leaflet length (L) is a function of the inlet radius (r_i) that ranges from L=1.2r_i to L=8r_i.

13. The valve of claim 12, where the function ranges from L=1.5r_i to L=5r_i.

14. The valve of claim 1, where the frame provides for a longitudinal center axis, where the first and second valve leaflets have a valve leaflet width (W) measured at a greatest width distance between locations of the free edge engaged to valve leaflet connections of the first structural member existing on a plane extending perpendicularly from the longitudinal center axis, and where the first and second valve leaflets have a valve leaflet length (L) along the inflow surface measured at a greatest length distance between the free edge and an attachment location of the first structural member perpendicular to the free edge, and the ratio of valve leaflet length (L) to the valve leaflet width (W) ranges from 0.75:

1 to 1.5;

1.

15. The valve of claim 14, where the ratio of valve leaflet length (L) to valve leaflet width (W) is between 0.75:

1 and 1.5;

1.

16. The valve of claim 1, where the first valve leaflet is formed of a material selected from the group comprising urinary bladder matrix (UBM), expanded polytetrafluoroethylene (ePTFE), polyurethane, silicone, polystyrene, and a cellurized tissue from a human, an animal, or a plant source.

17. The valve of claim 16, where the first valve leaflet further comprises a metal mesh.

18. The valve of claim 1, the frame maintaining a static configuration when implanted thereby maintaining the relationship between the frame and the first and second leaflets, wherein the first and second leaflets are formed of a non-elastic material.

19. The valve of claim 1, wherein:

the first structural member comprises circumferentially adjacent longitudinal segments, each longitudinal segment extending between a curve at one end of the valve and a curve at the other end of the valve; and

the second structural member comprises bulbous portion members, each bulbous portion member having a first end and a second end, wherein one bulbous portion member engages circumferentially adjacent longitudinal segments of the first structural member, the first end of the bulbous portion member being engaged to one longitudinal segment of the first structural member and the second end of the bulbous portion member being engaged to a circumferentially adjacent longitudinal segment of the first structural member.

20. The valve of claim 1, wherein:

the first structural member forms a first zig-zag ring and a second zig-zag ring interconnected to one another by connecting segments;

the second structural member comprises bulbous portion members engaged to, and extending outward from, the first zig-zag ring to form the bulbous portion;

the first and second leaflets engaged to and extending between the first and second zig-zag rings, with the free edges engaged to the first zig-zag ring.