Percutaneously delivered temporary valve assembly

• US 6,989,027 B2
• Filed: 04/29/2004
• Issued: 01/24/2006
• Est. Priority Date: 04/30/2003
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Coppin, Chris M., Allen, Jeffrey W., Brin, David S.
• Primary Examiner(s): Gherbi, Suzette J-J
• Application Number:
  US10/835,153
• Publication Number:
  US 20040225354A1
• Time in Patent Office: 635 Days
• Field of Search: 606/200, 623/1.12, 623/904, 623/2.18
• US Class Current: 623/2.18
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

The percutaneously delivered temporary valve assembly of the present invention, and method of using the same, provides an elongate element and a temporary valve disposed on the elongate element. The temporary valve can comprise struts and a membrane attached to the struts. The elongate element can include at least one lumen. The percutaneously delivered temporary valve assembly can be used to replace an aortic valve by locating a temporary valve in a patient'"'"'s ascending aorta; deploying the temporary valve; removing the native aortic valve past the temporary valve; implanting the prosthetic aortic valve past the temporary valve; collapsing the temporary valve; and removing the temporary valve from the patient. The temporary valve can be sized to the patient and can be left in place while the prosthetic aortic valve heals in.

Claims

1. A temporary valve system comprising:

an elongate element; and

a temporary valve disposed on the elongate element, the temporary valve comprising struts and a membrane attached to the struts; and

the struts further comprising centering struts and flow struts.

2. The temporary valve system of claim 1 wherein the elongate element includes at least one lumen.

3. The temporary valve system of claim 1, the temporary valve further comprising a seating edge and a skirt attached to the seating edge.

4. The temporary valve system of claim 1 wherein the membrane is coated with an anti-thrombotic material.

5. The temporary valve system of claim 1 wherein the struts are attached to a strut collar, the strut collar being disposed about the elongate element.

6. The temporary valve system of claim 5 wherein the strut collar and struts are a single piece.

7. The temporary valve system of claim 1 wherein strut shape is selected from the group consisting of straight, concave, convex, S-shaped, sigmoidal, and combinations thereof.

8. The temporary valve system of claim 1 wherein the elongate element has a long axis and a distal tip, and the distal tip is angled with respect to the long axis.

9. The temporary valve system of claim 1 wherein the elongate element has a distal tip, and the distal tip is steerable.

10. The temporary valve system of claim 1 wherein the elongate element has a distal tip, and the temporary valve is a distance from the distal tip that locates the temporary valve in an ascending aorta during use.

11. The temporary valve system of claim 1 wherein the elongate element has a distal tip, and the temporary valve is between about 1 and 8 centimeters from the distal tip.

12. The temporary valve system of claim 11 wherein the temporary valve is about 5 centimeters from the distal tip.

13. The temporary valve system of claim 1 further comprising means for deploying the temporary valve.

14. The temporary valve system of claim 1 further comprising a sheath, the heath being slidably mounted along the elongate body, the sheath having a first position and a second position, wherein the sheath at least partially covers the temporary valve in the first position and the sheath deploys the temporary valve in the second position.

15. The temporary valve system of claim 1 wherein the centering struts alternate with the flow struts.

16. The temporary valve system of claim 1 wherein the temporary valve comprises at least a first region and a second region, and the centering struts in the first region have a first stiffness and the centering struts in the second region have a second stiffness.

17. The temporary valve system of claim 1 further comprising means for centering the elongate member in a body lumen.

18. The temporary valve system of claim 1 further comprising a centering balloon, the centering balloon being disposed on the elongate member.

19. The temporary valve system of claim 18 wherein the temporary valve has a seating edge, the seating edge being aligned to contact the centering balloon.

20. The temporary valve system of claim 18 wherein the centering balloon includes an opening, the opening being covered with filter material.

21. The temporary valve system of claim 1 wherein the temporary valve is eccentric.

22. The temporary valve system of claim 1 further comprising a bypass catheter, the bypass catheter being locatable between the struts.

23. The temporary valve system comprising:

a elongate element, the elongate element including at least one lumen; and

an umbrella-like temporary valve having centering struts and flow struts, the umbrella-like temporary valve disposed on the elongate element.

24. The temporary valve system of claim 23, the temporary valve further comprising a seating edge and a skirt attached to the seating edge.

25. The temporary valve system of claim 23 wherein the temporary valve is coated with an anti-thrombotic material.

26. The temporary valve system of claim 23 wherein the elongate element has a long axis and a distal tip, and the distal tip is angles with respect to the long axis.

27. The temporary valve system of claim 23 wherein the elongate element has a distal tip, and the distal tip is steerable.

28. The temporary valve system of claim 23 wherein the elongate element has a distal tip, and the temporary valve is a distance from the distal tip that locates the temporary valve in an ascending aorta during use.

29. The temporary valve system of claim 23 further comprising means for deploying the temporary valve.

30. The temporary valve system of claim 23 further comprising a sheath, the sheath being slidably mounted along the elongate body, the sheath having a first position and a second position, wherein the sheath at least partially covers the temporary valve in the first position and the sheath deploys the temporary valve in the second position.

31. The temporary valve system of claim 23 further comprising means for centering the elongate member in a body lumen.

32. The temporary valve system of claim 23 further comprising a centering balloon, the centering balloon being disposed on the elongate member.

33. The temporary valve system of claim 32 wherein the temporary valve has a seating edge, the seating edge being aligned to contact the centering balloon.

34. The temporary valve system of claim 32 wherein the centering balloon includes an opening, the opening being covered with filter material.

35. The temporary valve system of claim 23 wherein the temporary valve is eccentric.

36. A method for replacing a native aortic valve with a prosthetic aortic valve in a patient comprising:

providing a temporary valve assembly having an elongate element having a temporary valve disposed on the elongate element, the temporary valve comprising struts and a membrane attached to the struts; and

the struts further comprising centering struts and flow struts;

sizing the temporary valve to the patient;

locating the temporary valve in an ascending aorta of the patient;

deploying the temporary valve;

removing the native aortic valve past the temporary valve;

implanting the prosthetic aortic valve past the temporary valve;

collapsing the temporary valve; and

removing the temporary valve from the patient.

37. The method of claim 36 wherein sizing the temporary valve to the patient comprises trial fitting the temporary valve.

38. The method of claim 36 wherein sizing the temporary valve to the patient comprises pre-measuring the patient.