VENOUS VALVE PROSTHESIS

• US 20170056175A1
• Filed: 08/25/2016
• Published: 03/02/2017
• Est. Priority Date: 08/25/2015
• Status: Active Grant

• Current Assignee: Innovein, Inc.
• Original Assignee: Innovein, Inc.
• Inventors: Walker, Austin, Chin, Albert K., Kramer, Thomas A.
• Granted Patent: US 10,231,838 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/009 magnetic
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A venous valve prosthetic implant for treatment of venous disease may include an expandable anchoring frame, a valve seat attached to the anchoring frame, a ball retention member attached to the anchoring frame, and a ball disposed within the lumen of the anchoring frame, between the valve seat and the ball retention member. The anchoring frame may include a first end, a second end, and a middle valve portion, where the middle valve portion expands to a smaller diameter than a diameter of either the first end or the second end. The ball may move back and forth within the middle valve portion, between a fully open position and a fully closed position.

Claims

1. A venous valve prosthetic implant for implantation in a vein for treatment of venous disease, the implant comprising:

an expandable anchoring frame comprising a lumen, a first end, a second end, and a middle valve portion between the first and second ends, wherein the middle valve portion expands to a smaller diameter than a diameter of either the first end or the second end;

a valve seat attached to the anchoring frame nearer to the first end than to the second end;

a ball retention member attached to the anchoring frame nearer to the second end that to the first end; and

a ball disposed within the lumen of the anchoring frame, between the valve seat and the ball retention member, such that it moves back and forth within the middle valve portion, between a fully open position, in which the ball contacts the ball retention member to allow forward flow of blood in a downstream direction through the implant, and a fully closed position, in which the ball contacts the valve seat to prevent backflow of blood in an upstream direction through the implant.

2. An implant as in claim 1, wherein the anchoring frame comprises a tubular, stent-like lattice structure, and wherein the implant further comprises a coating disposed over at least a portion of the anchoring frame.

3. An implant as in claim 2, wherein the coating is made of at least one substance selected from the group consisting of polymers, hyaluronic acid, heparin and anticoagulant agents.

4. An implant as in claim 2, wherein at least one of the first end or the second end of the anchoring frame comprises a wider expandable portion that expands to a wider diameter than an immediately adjacent portion of the anchoring frame, and wherein the wider expandable portion forms multiple anti-migration tips when the anchoring frame is expanded.

5. An implant as in claim 4, wherein the coating covers an entire surface area of the anchoring frame, other than the anti-migration tips.

6. An implant as in claim 1, further comprising multiple anti-migration barbs on the anchoring frame, to prevent downstream movement of the implant within the vein.

7. An implant as in claim 1, wherein the anchoring frame is self-expandable from a collapsed configuration, for delivery through a delivery catheter, to an expanded configuration upon release from the delivery catheter.

8. An implant as in claim 1, wherein portions of the anchoring frame near the first and second ends are sized to dilate the vein when the implant is implanted in the vein.

9. An implant as in claim 8, wherein the middle valve portion of the anchoring frame is also sized to dilate the vein when the implant is implanted in the vein.

10. An implant as in claim 1, wherein the middle valve portion has a substantially straight tubular shape.

11. An implant as in claim 1, wherein the middle valve portion has an hourglass shape.

12. An implant as in claim 1, wherein the valve seat comprises an expandable and collapsible ring attached to at least one of an outer surface of the anchoring frame or an inner surface of the anchoring frame.

13. An implant as in claim 1, wherein the ball retention member comprises at least one suture member extending across the lumen of the anchoring frame.

14. An implant as in claim 1, wherein the ball retention member comprises at least one U-shaped member attached to at least one of an outer surface of the anchoring frame, an inner surface of the anchoring frame, or the valve seat, and wherein the at least one U-shaped member extends across the lumen of the anchoring frame.

15. An implant as in claim 1, wherein the ball comprises a shell and a core.

16. An implant as in claim 15, wherein the shell comprises a first material and the core comprises a second material.

17. An implant as in claim 15, wherein the core comprises a magnetic material.

18. An implant as in claim 1, wherein the ball has a ball diameter, and wherein a distance between the valve seat and the ball retention member is between two times and four times greater than the ball diameter.

19. An implant as in claim 1, wherein the ball diameter is sized such that the ball contacts an inner surface of the middle valve portion as the ball travels back and forth between the valve seat and the ball retention member, and wherein contact between the ball and the middle valve portion is configured to dislodge a substance attached to at least one of the inner surface of the middle valve portion, the valve seat, the ball, or the ball retention member.

20. An implant as in claim 1, wherein the ball has a density of between 1.06 grams per cubic centimeter and 2.5 grams per cubic centimeter.

21. An implant as in claim 1, wherein the ball comprises at least one surface feature configured to facilitate flow of blood around the ball, and wherein the surface feature is selected from the group consisting of dimples, slits and grooves.

22. An implant as in claim 1, wherein the valve seat and the middle valve portion of the anchoring frame are compressible from outside of the implant to facilitate dislodging a substance attached to the implant.

23. A method for treating a vein, the method comprising:

advancing an implant delivery catheter into the vein;

advancing a venous valve prosthesis implant out of a distal end of the delivery device and into the vein, thus causing the implant to expand and anchor itself to an inner wall of the vein, wherein the implant comprises;

an expandable anchoring frame comprising a lumen, a first end, a second end, and a middle valve portion between the first and second ends, wherein middle valve portion expands to a smaller diameter than a diameter of either the first end or the second end;

a valve seat attached to the anchoring frame nearer to the first end than to the second end;

a ball retention member attached to the anchoring frame nearer to the second end that to the first end; and

a ball disposed within the lumen of the anchoring frame, between the valve seat and the ball retention member, such that it moves back and forth within the middle valve portion, between a fully open position, in which the ball contacts the ball retention member to allow forward flow of blood in a downstream direction through the implant, and a fully closed position, in which the ball contacts the valve seat to prevent backflow of blood in an upstream direction through the implant; and

removing the delivery catheter from the vein, leaving the implant in place within the vein to help facilitate blood flow through the vein.

24. A method as in claim 23, further comprising dilating the vein with at least a first portion of the anchoring frame adjacent the first end and a second portion of the anchoring frame adjacent the second end.

25. A method as in claim 23, further comprising dilating the vein with the middle valve portion of the anchoring frame.

26. A method as in claim 23, further comprising dislodging a substance attached to at least one of an inner surface of the middle valve portion, the valve seat, the ball, or the ball retention member of the anchoring frame, and thus self-cleaning the anchoring member, by providing the ball with a diameter configured so that the ball contacts the inner surface of the middle valve portion as it moves back and forth between the valve seat and the ball retention member.

27. A method as in claim 23, further comprising applying external compression to the implant to expel an obstruction out of the implant.

28. A method as in claim 23, wherein the ball comprises a magnetic material, and wherein the method further comprises moving a magnet outside of the implant to cause the ball to move back and forth within the middle valve portion to expel an obstruction out of the implant.

29. A method as in claim 23, further comprising removing the ball from the implant, while leaving the implant in the vein.

30. A method as in claim 23, further comprising removing the valve seat from the implant, while leaving the implant in the vein.