Venous valve, system, and method with sinus pocket

• US 7,951,189 B2
• Filed: 07/27/2009
• Issued: 05/31/2011
• 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: Shoemaker, Susan M., Hill, Jason P., Haverkost, Patrick A.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US12/509,604
• Publication Number:
  US 20100005658A1
• Time in Patent Office: 673 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.3, 623/2.14, 623/2.17, 623/2.18
• 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 venous valve with a frame and valve leaflets that provide a sinus pocket. The venous valve provides for unidirectional flow of a liquid through the valve.

Claims

1. A method, comprising:

forming a venous valve frame having a structural member that defines an elongate base portion and a bulbous portion;

the elongate base portion having a first end, a second end, and an outer surface concentrically arranged relative a longitudinal axis, where the outer surface provides at least two points of a perimeter of a first elliptical plane orthogonal to and passing through the longitudinal axis, and where the structural member at each of the first end and the second end includes a first curve and a second curve opposite the first curve with the first curve and the second curve of the first end positioned radially orthogonal to the first curve and the second curve of the second end of the base portion, and

the bulbous portion extending between the first end and the second end of the elongate base portion to define a bulbous portion of the venous valve frame, where the outer surface of the elongate base portion and a second structural member provide at least four points of a perimeter of a plane orthogonal to the longitudinal axis, where the plane has an area that is greater than the area of the first elliptical plane;

positioning a free edge of the valve leaflets adjacent the bulbous portion to form a sinus pocket between the bulbous portion in the venous valve frame and the valve leaflets; and

coupling valve leaflets to the venous valve frame.

2. The method of claim 1, where forming the venous valve frame includes shaping the bulbous portion of the venous valve frame into an elliptical shape.

3. The method of claim 2, where the structural member defines a first axis of the elliptical shape and a second axis of the elliptical shape that is twenty percent (20%) to fifty percent (50%) greater than the first axis.

4. The method of claim 2, where the structural member defines a first axis of the elliptical shape and a second axis of the elliptical shape that is one (1) to four (4) millimeters greater than the length of the first axis.

5. The method of claim 1, where forming the venous valve frame includes shaping the bulbous portion of the venous valve frame into a round shape.

6. The method of claim 1, where forming the venous valve frame includes configuring the first elliptical plane as a circular plane.

7. The method of claim 1, including configuring an opening defined by the valve leaflets to create a Bernoulli effect across the valve leaflets when fluid flows over the valve leaflets.

8. The method of claim 1, where coupling valve leaflets to the venous valve frame includes providing a gap of at least a predetermined distance between a free edge of the valve leaflet and the bulbous portion in the venous valve frame.

9. The method of claim 8, where coupling valve leaflets to the venous valve frame includes maintaining at least the gap between the free edge of the valve leaflets and the bulbous portion in the venous valve frame as the valve leaflets cycles between open and close.

10. The method of claim 8, where providing the gap includes providing one-half (0.5) to two (2) millimeters between the free edge of the valve leaflet and the bulbous portion in the venous valve frame.

11. The method of claim 1, where forming the venous valve frame includes flaring the first curve and the second curve away from a center longitudinal axis.

12. The method of claim 1, where forming the venous valve frame includes forming a first opening and a second opening in the structural member for the valve leaflet connection location, where the first and second openings are adjacent a region of the bulbous portion of the valve frame and positioned opposite each other along a common axis.

13. A method, comprising:

forming a venous valve frame having a structural member that defines an elongate base portion and a bulbous portion;

the elongate base portion having a first end, a second end, and an outer surface concentrically arranged relative a longitudinal axis, where the outer surface provides at least two points of a perimeter of a first elliptical plane orthogonal to and passing through the longitudinal axis, and where the structural member at each of the first end and the second end includes a first curve and a second curve opposite the first curve with the first curve and the second curve of the first end positioned radially orthogonal to the first curve and the second curve of the second end of the base portion, and

the bulbous portion extending between the first end and the second end of the elongate base portion to define a bulbous portion of the venous valve frame, where the outer surface of the elongate base portion and a second structural member provide at least four points of a perimeter of a plane orthogonal to the longitudinal axis, where the plane has an area that is greater than the area of the first elliptical plane;

configuring an opening defined by the valve leaflets to create a Bernoulli effect across the valve leaflets when fluid flow over the valve leaflets; and

coupling valve leaflets to the venous valve frame.

14. A method, comprising:

forming a venous valve frame having a structural member that defines an elongate base portion and a bulbous portion;

the elongate base portion having a first end, a second end, and an outer surface concentrically arranged relative a longitudinal axis, where the outer surface provides at least two points of a perimeter of a first elliptical plane orthogonal to and passing through the longitudinal axis, and where the structural member at each of the first end and the second end includes a first curve and a second curve opposite the first curve with the first curve and the second curve of the first end positioned radially orthogonal to the first curve and the second curve of the second end of the base portion, and

the bulbous portion extending between the first end and the second end of the elongate base portion to define a bulbous portion of the venous valve frame, where the outer surface of the elongate base portion and a second structural member provide at least four points of a perimeter of a plane orthogonal to the longitudinal axis, where the plane has an area that is greater than the area of the first elliptical plane; and

coupling valve leaflets to the venous valve frame, where coupling the valve leaflets to the venous valve includes providing a gap of at least a predetermined distance between a free edge of the valve leaflet and the bulbous portion in the venous valve frame.