Venous valve, system, and method with sinus pocket

• US 10,548,734 B2
• Filed: 10/05/2016
• Issued: 02/04/2020
• 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: Haverkost, Patrick A., Hill, Jason P., Shoemaker, Susan M.
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/286,025
• Publication Number:
  US 20170020672A1
• Time in Patent Office: 1,217 Days
• 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 frame and valve leaflets that provide a sinus pocket. The valve provides for unidirectional flow of a liquid through the valve.

Claims

1. A valve for implantation within a body lumen, comprising:

an elongate valve frame having a longitudinal axis, the elongate valve frame being configured to shift between a collapsed configuration and an expanded configuration, wherein the elongate valve frame is configured to exert a radially outward force against a wall of the body lumen in the expanded configuration; and

a first valve leaflet and a second valve leaflet attached to the elongate valve frame and defining a lumen through the valve, the first and second valve leaflets having an open configuration configured to permit flow of a bodily fluid therethrough and a closed configuration configured to restrict flow of the bodily fluid therethrough;

wherein at a first longitudinal position along the longitudinal axis, an outer surface of the elongate valve frame defines a circular cross-sectional area and a first perimeter value of the valve in the expanded configuration;

wherein at a second longitudinal position along the longitudinal axis, the outer surface of the elongate valve frame defines a non-circular cross-sectional area when the elongate valve frame expands from the collapsed configuration to the expanded configuration and defines a second perimeter value of the valve in the expanded configuration;

wherein the first longitudinal position is proximate an inflow end of the valve;

wherein the second longitudinal position is proximate an outflow end of the valve;

wherein in the expanded configuration, the second perimeter value is greater than the first perimeter value.

2. The valve of claim 1, wherein the first valve leaflet and the second valve leaflet each have a free edge, wherein the free edges are disposed at a third longitudinal position axially closer to the second longitudinal position than the first longitudinal position.

3. The valve of claim 1, wherein the radially outward force prevents retrograde flow of the bodily fluid around the outer surface of the elongate valve frame when the first valve leaflet and the second valve leaflet are in the closed configuration.

4. The valve of claim 1, wherein the non-circular cross-sectional area is defined by a first dimension and a second dimension each measured perpendicular to the longitudinal axis, wherein the first dimension is greater than the second dimension.

5. The valve of claim 4, wherein the non-circular cross-sectional area is elliptical.

6. The valve of claim 1, wherein the valve is configured to resiliently radially collapse and expand for percutaneous delivery within a delivery catheter.

7. The valve of claim 1, wherein the elongate valve frame is configured for repeatable travel between the collapsed configuration and the expanded configuration.

8. The valve of claim 1, wherein the first valve leaflet and the second valve leaflet define a commissure that reversibly opens and closes for unidirectional flow of the bodily fluid therethrough.

9. The valve of claim 1, wherein the first valve leaflet and the second valve leaflet each have a free edge, the free edges defining a circumference in the open configuration that is less than a circumference of the elongate valve frame in the expanded configuration.

10. The valve of claim 9, wherein the circumference defined by the free edges in the open configuration is less than the circumference of the elongate valve frame at the first longitudinal position in the expanded configuration.

11. The valve of claim 9, wherein the circumference defined by the free edges in the open configuration is less than the circumference of the elongate valve frame at the second longitudinal position in the expanded configuration.

12. The valve of claim 1, wherein the valve is configured to replace an existing valve structure within the body lumen.

13. The valve of claim 1, wherein the valve is configured to augment an existing valve structure within the body lumen.

14. The valve of claim 1, wherein the outer surface of the elongate valve frame in the expanded configuration defines a cylindrical portion of the elongate valve frame proximate the first longitudinal position and extending in at least one axial direction therefrom.

15. The valve of claim 1, wherein the outer surface of the elongate valve frame in the expanded configuration defines a non-cylindrical portion of the elongate valve frame proximate the second longitudinal position and extending in at least one axial direction therefrom.