Percutaneously-deliverable mechanical valve

• US 8,628,571 B1
• Filed: 11/13/2012
• Issued: 01/14/2014
• Est. Priority Date: 11/13/2012
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Zipory, Yuval, Reich, Tal, Miller, Eran, Hacohen, Gili, Gross, Amir
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/675,119
• Time in Patent Office: 427 Days
• Field of Search: 623/1.24, 623/1.26
• US Class Current: 623/2.2
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

Apparatus for regulating blood flow of a subject is provided, the apparatus comprising a prosthetic valve that comprises a tubular element, shaped to define a lumen therethrough; and a valve member, configured to be coupled to the tubular element and to be disposed within the lumen. The prosthetic valve has (1) a compressed configuration in which the lumen has a compressed width, the valve member is generally cylindrical, and the prosthetic valve is configured to be percutaneously delivered into the subject, and (2) an expanded configuration in which the lumen has an expanded width that is greater than the compressed width, and the valve member is generally disc-shaped, is coupled to the tubular element, and is disposed within the lumen. Other embodiments are also described.

Claims

1. Apparatus for regulating blood flow of a subject, the apparatus comprising a prosthetic valve, the prosthetic valve:

comprising;

a tubular element, shaped to define a lumen therethrough, and

a valve member, configured to be coupled to the tubular element and to be disposed within the lumen, and

having;

a compressed configuration in which the lumen has a compressed width, the valve member is generally cylindrical, and the prosthetic valve is configured to be percutaneously delivered into the subject, and

an expanded configuration in which;

the lumen has an expanded width that is greater than the compressed width, and

the valve member is generally disc-shaped, is coupled to the tubular element, and is disposed within the lumen.

2. The apparatus according to claim 1, wherein, in the compressed configuration, the valve member is coupled to the tubular element.

3. The apparatus according to claim 1, wherein, in the compressed configuration, the valve member is disposed within the lumen.

4. The apparatus according to claim 1, wherein:

the lumen has a first end and a second end, and

the valve member, when the valve is in the expanded configuration thereof;

has an open state, in which the first and second ends of the lumen are in fluid communication with each other,

has a closed state, in which the first and second ends of the lumen are generally not in fluid communication with each other, and

is movable between the open and closed states.

5. The apparatus according to claim 4, wherein, in the expanded configuration, the valve member is configured to move between the open and closed states in response to changes in relative pressure between the first and second ends of the lumen.

6. The apparatus according to claim 4, wherein the valve member has a compressed diameter in the compressed configuration of the prosthetic valve, and an expanded diameter in the in the expanded configuration of the prosthetic valve, and wherein the expanded diameter is at least twice as great as the compressed diameter.

7. The apparatus according to claim 4, wherein, in the expanded configuration, the prosthetic valve is configured to act as a check valve.

8. The apparatus according to claim 7, wherein, in the expanded configuration, the valve member is configured to move toward the open state when pressure at the first end of the lumen is greater than pressure at the second end of the lumen, and to move toward the closed state when pressure at the second end of the lumen is greater than pressure at the first end of the lumen.

9. The apparatus according to claim 4, wherein the valve member is configured to move between the open and closed states by collapsing and expanding.

10. The apparatus according to claim 4, wherein the valve member is configured to move between the open and closed states thereof without changing a shape thereof.

11. The apparatus according to claim 4, wherein the prosthetic valve is configured such that, when the valve member moves toward the open state, at least part of the valve member moves toward the first end of the lumen and at least part of the valve member moves toward the second end of the lumen.

12. The apparatus according to claim 4, wherein the valve member is configured to move between the open and closed states thereof by changing a shape thereof.

13. The apparatus according to claim 4, wherein the valve member is configured to be biased toward being in the closed state thereof.

14. The apparatus according to claim 4, wherein the valve member is coupled to the tubular element at at least two coupling points, the coupling points defining an axis therebetween.

15. The apparatus according to claim 14, wherein the valve member is configured to move between the open and closed states thereof, by rotating around the axis between the coupling points.

16. The apparatus according to claim 14, wherein the valve member is configured to move between the open and closed states thereof, by deflecting around the axis between the coupling points.

17. The apparatus according to claim 14, further comprising a coupling rod, coupled to the coupling points, and coupled to the valve member along the axis between the coupling points, wherein the valve member is configured to move between the open and closed states thereof, by bending around the coupling rod.

18. The apparatus according to claim 1, wherein, in the compressed configuration, the prosthetic valve has a greatest transverse diameter of less than 12 mm.

19. The apparatus according to claim 1, wherein the prosthetic valve is intracorporeally expandable from the compressed configuration to the expanded configuration.

20. The apparatus according to claim 19, wherein the prosthetic valve is configured to be percutaneously delivered in the constrained configuration thereof, by being restrained in the compressed configuration during the percutaneous delivery, and wherein the prosthetic valve is configured to automatically expand toward the expanded configuration thereof when no longer restrained.