Venous valve, system, and method

• US 8,012,198 B2
• Filed: 06/10/2005
• Issued: 09/06/2011
• Est. Priority Date: 06/10/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Shoemaker, Susan M., Hill, Jason P., Kokate, Jaydeep Y.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/150,331
• Publication Number:
  US 20060282157A1
• Time in Patent Office: 2,279 Days
• Field of Search: 623 211- 219, 623/1.3, 623/1.31, 623 124- 126
• US Class Current: 623/1.24
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2475 Venous valves
• 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 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• 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

Abstract

A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Claims

1. A venous valve, comprising:

a frame having a first leaflet connection region and a second leaflet connection region, where the frame includes an outer surface and an inner surface opposite the outer surface, and a radial support member that couples the first leaflet connection region and the second leaflet connection region; and

a tubular cover over at least one of the outer surface and the inner surface of the frame, the tubular cover connected to at least the first leaflet connection region and the second leaflet connection region to provide a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve, where a lip of the reversibly sealing opening is coupled to the first leaflet connection region and the second leaflet connection region, where in an open position the tubular cover has a first circular circumference at a first end of the frame and a second circular circumference smaller than the first circular circumference at the lip of the reversibly sealing opening and the lip maintains essentially the same relative position around the circumference of the valve leaflets, where the first and second circular circumferences are perpendicular to a longitudinal axis of the frame and the unidirectional flow of the liquid passes through the first and second circular circumferences, where in an open position the lip is between the first end of the frame and the radial support member and where the second circular circumference is smaller than an inner circumference of the radial support member.

2. The venous valve of claim 1, wherein the radial support member includes a tubular ring, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

3. The venous valve of claim 2, wherein the tubular ring includes a zigzag configuration.

4. The venous valve of claim 1, wherein the radial support member has a radial flare that provides an increase in a peripheral frame dimension.

5. The venous valve of claim 1, wherein the first leaflet connection region and the second leaflet connection region are positioned opposite each other along a common axis.

6. A venous valve, comprising:

a frame including an outer surface and an inner surface opposite the outer surface and defining a lumen, wherein the frame further includes a radial support member, a first leaflet connection region including an opening that provides a first passage from the outer surface to the inner surface passing through the frame, and a second leaflet connection region including an opening that provides a second passage from the outer surface to the inner surface passing through the frame; and

a tubular cover over at least the inner surface of the frame, wherein the tubular cover is coupled adjacent the radial support member to at least the first and second leaflet connection regions using the openings through the frame to form a first valve leaflet and a second valve leaflet, the first valve leaflet and the second valve leaflet having surfaces, which are allowed to pivot relative the first and second leaflet connection regions between an open and closed configuration defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen and where a lip of the reversibly sealing opening is coupled to the first leaflet connection region and the second leaflet connection region, where in an open position the tubular cover has a first circular circumference at a first end of the frame and a second circular circumference smaller than the first circular circumference at the lip of the reversibly sealable opening and the lip maintains essentially the same relative position around the circumference of the valve leaflets, where the first and second circular circumferences are perpendicular to a longitudinal axis of the frame and the unidirectional flow of the liquid passes through the first circumference and the second circumference, where in an open position the lip is between the first end of the frame and the radial support member and where the second circular circumference is smaller than an inner circumference of the radial support member.

7. The venous valve of claim 6, wherein the radial support member includes a tubular ring, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

8. The venous valve of claim 7, wherein the tubular ring includes a zigzag configuration.

9. A venous valve, comprising:

a frame having a first vertex and a second vertex relative a first end of the frame, the frame having an outer surface and an inner surface opposite the outer surface, the outer surface defining a first frame dimension at the first end of the frame and a second frame dimension between the first vertex and the second vertex of the frame, where the second frame dimension is larger than the first frame dimension, wherein the outer surface of the frame radially arcs from the first frame dimension to the second frame dimension so as to provide a radial support member of the frame; and

a tubular cover over at least the inner surface of the frame, the tubular cover connected to the first vertex and the second vertex to provide a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve and a lip of the reversibly sealing opening is coupled to the first vertex and the second vertex, where in an open position the tubular cover has a first circular circumference at the first end of the frame and a second circular circumference smaller than the first circular circumference at the lip of the reversibly sealable opening between the first and second vertex of the frame and the lip maintains essentially the same relative position around the circumference of the valve leaflets, where the first and second circular circumferences are perpendicular to a longitudinal axis of the frame and such that the unidirectional flow of the liquid passes through the first circumference and the second circumference.

10. The venous valve of claim 9, wherein the first vertex and the second vertex are positioned opposite each other along a common axis.

11. The venous valve of claim 9, wherein the tubular cover is over the outer surface of the frame.

12. The venous valve of claim 11, wherein the tubular cover extends to at least the first vertex and the second vertex on the frame to form the first valve leaflet and the second valve leaflet.

13. The venous valve of claim 9, wherein the frame moves between a collapsed state and an expanded state.

14. A system, comprising:

a venous valve, wherein the venous valve includes;

a frame having a first leaflet connection region and a second leaflet connection region, an outer surface and an inner surface opposite the outer surface;

a tubular cover over at least the inner surface of the frame, the tubular cover connected to at least the first leaflet connection region and the second leaflet connection region to provide a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve and where a lip of the reversibly sealing opening is coupled to the first leaflet connection region and the second leaflet connection region, where in an open position the tubular cover has a first circular circumference at a first end of the frame and a second circular circumference smaller than the first circular circumference at the lip of the reversibly sealable opening adjacent to the first and second connection regions and the lip maintains essentially the same relative position around the circumference of the valve leaflets, where the first and second circular circumferences are perpendicular to a longitudinal axis of the frame and the unidirectional flow of the liquid passes through the first circumference and the second circumference; and

a catheter including a proximal end and a distal end, the venous valve located between the proximal end and distal end of the catheter.

15. The system of claim 14, wherein the frame includes a radial support member having a tubular ring, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

16. The system of claim 15, wherein the tubular ring includes a zigzag configuration.

17. The system of claim 14, wherein the first leaflet connection region and the second leaflet connection region provide a first vertex and a second vertex, respectively, relative the first end of the frame.

18. The system of claim 17, wherein the outer surface defining a peripheral frame dimension at the first end of the frame and a peripheral frame dimension at the second end of the frame between the first vertex and the second vertex of the frame, where the peripheral frame dimension at the second end of the frame is larger than the peripheral frame dimension at the first end of the frame.

19. The system of claim 14, wherein the frame includes a radial support member adjacent the first and second leaflet connection regions having a radial flare that provides an increase in a peripheral frame dimension at a second end of the frame relative to a peripheral frame dimension at the first end of the frame.

20. The system of claim 14, wherein the first leaflet connection region and the second leaflet connection region are positioned opposite each other along a common axis.

21. The system of claim 14, wherein the catheter includes an elongate body having a lumen longitudinally extending to the distal end, a deployment shaft positioned within the lumen, and a sheath positioned adjacent the distal end, the venous valve positioned at least partially within the sheath and adjacent the deployment shaft, wherein the deployment shaft moves within the lumen to deploy the venous valve.

22. The system of claim 14, wherein the catheter includes an elongate body and a retractable sheath over at least a portion of the elongate body, the venous valve positioned at least partially within the retractable sheath, wherein the retractable sheath moves along the elongate body to deploy the venous valve.

23. The system of claim 14, wherein the catheter includes an inflatable balloon positioned adjacent the distal end and a lumen longitudinally extending in an elongate body of the catheter from the inflatable balloon to the distal end, the inflatable balloon at least partially positioned within a lumen of the venous valve, where the inflatable balloon inflates to deploy the venous valve.