Venous valve apparatus, system, and method

• US 8,721,717 B2
• Filed: 01/27/2012
• Issued: 05/13/2014
• Est. Priority Date: 12/19/2003
• Status: Expired due to Term

• 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:
  US13/360,132
• Publication Number:
  US 20120130471A1
• Time in Patent Office: 837 Days
• Field of Search: 623/1.11, 623/1.24, 623/2.11, 623/2.14, 623/2.17, 623/2.19, 623/2.1, 623/2.16
• US Class Current: 623/2.17
• 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 valve, comprising:

a tubular frame for the valve, wherein the tubular frame includes a first end, a second end, an outer surface, and an inner surface opposite the outer surface and defining a lumen; and

a continuous piece of material forming a tubular cover, the cover folded around the first end of the frame so that the cover has an outer portion directly attached to the outer surface of the frame and a tapered inner portion extending over the inner surface of the frame, a first end of the cover forming an end of the outer portion and a second end of the cover forming an end of the inner portion, wherein the second end of the cover is attached directly to the tubular frame only at a first connection point and a second connection point to form first and second valve leaflets extending between the first and second connection points, the first valve leaflet and the second valve leaflet include surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen.

2. The valve of claim 1, wherein the tubular frame moves between a collapsed state and an expanded state.

3. The valve of claim 1, wherein the first valve leaflet and the second valve leaflet include support ribs having a predefined shape.

4. The valve of claim 1, the continuous piece of material being a synthetic biocompatible material.

5. The valve of claim 4, wherein the synthetic biocompatible material is selected from the group consisting of expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segments poly(carbonate-urethane), polyethylene (PE), polyethylene terephthalate (PET), silk, urethane, rayon, and silicone.

6. The valve of claim 1, wherein a pocket is between the frame and each of the first and second leaflets.

7. A method, comprising:

forming a valve that includes;

a tubular frame, wherein the tubular frame includes an outer surface and an inner surface opposite the outer surface and defining a lumen; and

a continuous piece of material forming a tubular cover, the cover folded around a first end of the frame so that the cover has an outer portion directly attached to the outer surface of the frame and a tapered inner portion extending over the inner surface of the frame, a first end of the cover forming an end of the outer portion and a second end of the cover forming an end of the inner portion, wherein the second end of the cover is attached directly to the tubular frame only at a first connection point and a second connection point to form first and second leaflets extending between the first and second connection points the first and second leaflets include surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen.

8. The method of claim 7, further comprising reversibly joining the valve and a catheter, wherein reversibly joining the valve and the catheter includes positioning the valve at least partially within a sheath of the catheter.

9. The method of claim 8, wherein positioning the valve at least partially within a sheath of the catheter include positioning the valve adjacent a deployment shaft of the catheter.

10. The method of claim 8, wherein the sheath includes a retractable sheath of the catheter.

11. The method of claim 7, further comprising reversibly joining the valve and a catheter, wherein the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within the lumen of the valve;

and

inflating the balloon to deploy the vascular valve.

12. The method of claim 7, wherein the tubular frame includes a first vertex and a second vertex relative a first end of the tubular frame, wherein the first vertex and the second vertex are positioned opposite each other along a common axis, the first connection point is located at the first vertex, and the second connection point is located at the second vertex.

13. A valve having a first valve end and a second valve end, the valve comprising an outer layer, a middle layer, and an inner layer attached to one another, the outer and inner layers formed by a single continuous piece of material, the middle layer formed by a tubular self-expanding frame, wherein:

at the first valve end, the outer, middle, and inner layers are directly attached to one another; and

at the second valve end the outer and middle layers are directly attached one another and the inner layer is directly attached to the middle layer only at two connection points wherein unattached regions of the inner layer extending between the two connection points form leaflets moveable between an open configuration and a closed configuration.

14. The valve of claim 13, the valve having an inner surface formed by an inner surface of the inner layer, the inner surface of the inner layer defining a lumen of the valve.

15. The valve of claim 13, each leaflet comprising a major face formed by an outer surface of the inner layer, wherein a pocket is between the major face and an inner surface of the middle layer.