Venous Valve With Sinus

• US 20120209378A1
• Filed: 04/24/2012
• Published: 08/16/2012
• Est. Priority Date: 09/21/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Drasler, William J., Jenson, Mark L., Hill, Jason P., Sogard, David J., Haverkost, Patrick A., Shoemaker, Susan M.
• Granted Patent: US 8,672,997 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 venous valve-with a structural member and valve leaflets that provide a sinus.

Claims

1. A valve comprising:

a frame comprising a plurality of structural members, the frame forming an inlet region that defines an inlet cross sectional area, a middle region that defines a middle cross sectional area, and an outlet region that defines an outlet cross sectional area, the inlet cross sectional area being different than the middle cross sectional area, wherein the middle region 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 valve leaflet comprising a first attachment location connected to the frame, a first inflow surface and a first outflow surface opposite the first inflow surface, the first inflow surface and the first outflow surface each extending from the first attachment region to a free edge and between two sides, the free edges comprising second attachment locations connected to the frame, 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 frame 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, the free edge of the first and second valve leaflet extending from the first attachment location on the frame, where 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 middle region 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 the first attachment location to the frame 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 the second attachment locations to the 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 the first attachment location to the frame 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 material forming the first valve leaflet is reinforced with a metal mesh.

18. The valve of claim 1, the frame maintaining a relatively static configuration when implanted thereby maintaining the relationship between the frame and the first and second leaflets.

19. The valve of claim 18, wherein the first and second leaflets are formed of a non-elastic material.