Venous valve apparatus, system, and method

• US 8,128,681 B2
• Filed: 12/19/2003
• Issued: 03/06/2012
• Est. Priority Date: 12/19/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Shoemaker, Susan M., Richardson, Leonard B., Chouinard, Paul F., Hill, Jason P.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US10/741,992
• Publication Number:
  US 20050137681A1
• Time in Patent Office: 3,000 Days
• Field of Search: 623/2.1, 623 124- 126, 623 216- 218
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0058 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: Y10T 137/0491 Valve or valve element assembling, disassembling, or replacing

Abstract

A venous valve with a tubular frame that includes an outer surface and an inner surface opposite the outer surface and defining a lumen, and a cover over at least the outer surface of the tubular frame, where the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen. A system with the venous valve 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. A method including forming the venous valve and reversibly joining the venous valve and a catheter. A method including positioning at least part of the catheter including the venous valve at a predetermined location and deploying the venous valve from the catheter at the predetermined location.

Claims

1. A venous valve, comprising:

a radially collapsible and expandable tubular frame with an open frame configuration, wherein the tubular frame includes an outer surface and an inner surface opposite the outer surface and defining a lumen, only one band of wishbone-shaped frame members, the band of wishbone-shaped frame members formed about a first end of the frame, and a first vertex and a second vertex relative the first end of the tubular frame, a first valley and a second valley extending from the first vertex and the second vertex to the first end of the tubular frame,

wherein the first vertex and the second vertex are positioned opposite one another along a common axis, and

wherein the first valley and the second valley are positioned opposite one another and are perpendicular to the common axis, and

wherein, a first strut of the tubular frame passes immediately from the first vertex to the first valley and a second strut of the tubular frame passes immediately from the first valley to the second vertex to form a tapering point, and

wherein each of the first strut and the second strut comprise a half-wishbone shape; and

a radially collapsible and expandable tubular cover positioned around the entire outer surface of the tubular frame, wherein the tubular cover is connected to the first vertex and to the second vertex to form a first valve leaflet across the first valley and a second valve leaflet across the second valley between the first vertex and the second vertex to oppose flow of a liquid through the lumen from the second end to the first end.

2. The venous valve of claim 1, wherein the first valve leaflet and the second valve leaflet include arcuate edges at one end of the tubular cover to define a reversibly sealable opening extending between the first vertex and the second vertex.

3. The venous valve of claim 1, further including the cover over the inner surface of the tubular frame, wherein the cover over the inner surface extends to at least a first connection point and a second connection point on the tubular frame to form a first valve leaflet and a second valve leaflet.

4. The venous valve of claim 3, wherein the first valve leaflet and the second valve leaflet form the reversibly sealable opening extending between the first connection point and the second connection point.

5. A venous valve, comprising:

a radially collapsible and expandable tubular frame with an open frame configuration including only one band of wishbone-shaped frame members, the band of wishbone-shaped frame members formed about a first end of the frame, a first vertex and a second vertex relative the first end of the tubular frame,

wherein the first vertex and the second vertex are positioned opposite each other along a common axis, a first valley and a second valley extending from the first vertex and the second vertex to the first end of the tubular frame, and

wherein the first valley and the second valley are positioned opposite each other and are perpendicular to the common axis, and

wherein the tubular frame includes an outer surface and an inner surface opposite the outer surface and defining a lumen, and a first strut of the tubular frame passes immediately from the first vertex to the first valley and a second strut of the tubular frame passes immediately from the first valley to the second vertex to form a tapering point, and

wherein each of the first strut and the second strut comprise a half-wishbone shape; and

a radially collapsible and expandable tubular cover extending over the entire outer surface of the tubular frame and connected to the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet therebetween,

wherein the first valve leaflet and the second valve leaflet reversibly transition between an open position and a closed position opposing flow of a liquid in one direction through the lumen.

6. The venous valve of claim 5, wherein the first valve leaflet and the second valve leaflet form a reversibly sealable opening extending between the first vertex and the second vertex.

7. The venous valve of claim 5, wherein the tubular frame and the tubular cover move between a collapsed state and an expanded state.

8. The venous valve of claim 5, wherein the first valve leaflet and the second valve leaflet include arcuate edges between the first vertex and the second vertex.

9. A system, comprising:

a venous valve, wherein the venous valve includes;

a radially collapsible and expandable tubular frame with an open frame configuration, wherein the tubular frame includes an outer surface and an inner surface opposite the outer surface and defining a lumen, only one band of wishbone-shaped frame members, the band of wishbone-shaped frame members formed about a first end of the frame, the frame having a first vertex and a second vertex relative the first end of the tubular frame,

wherein the first vertex and the second vertex are positioned opposite each other along a common axis, and having a first valley and a second valley extending from the first vertex and the second vertex to the first end of the tubular frame,

wherein the first valley and the second valley are positioned opposite each other and are perpendicular to the common axis and a first strut of the tubular frame passes immediately from the first vertex to the first valley and a second strut of the tubular frame passes immediately from the first valley to the second vertex to form a tapering point, and

wherein each of the first strut and the second strut comprise a half-wishbone shape;

a radially collapsible and expandable tubular cover that extends over at least the entire outer surface of the tubular frame and is connected to the first vertex and the second vertex on the tubular frame to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, where the first valve leaflet and the second valve leaflet reversibly transition between an open position and a closed position opposing flow of a liquid from the first end through the lumen; 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.

10. The system of claim 9, 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.

11. The system of claim 9, 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.

12. The system of claim 9, wherein the catheter includes an inflatable balloon positioned adjacent the distal end and a catheter 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 the lumen of the venous valve, where the inflatable balloon inflates to deploy the venous valve.

13. The system of claim 9, wherein the tubular cover extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet includes a surface defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen.

14. The system of claim 9, wherein the cover extends over at least a portion of the inner surface of the tubular frame, wherein the cover over the at least the portion of the inner surface extends to at least a first connection point and a second connection point on the tubular frame to form a first valve leaflet and a second valve leaflet, wherein the first valve leaflet and the second valve leaflet includes a surface defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen.