Percutaneously-deliverable mechanical valve

• US 9,498,332 B2
• Filed: 11/13/2013
• Issued: 11/22/2016
• Est. Priority Date: 11/13/2012
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Hacohen, Gili, Reich, Tal, Zipory, Yuval, Miller, Eran, Gross, Amir
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/442,541
• Publication Number:
  US 20160213473A1
• Time in Patent Office: 1,105 Days
• US Class Current: 1/1
• 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 (20) that comprises a tubular element (22), shaped to define a lumen (23) therethrough, and a valve member (24), configured to be coupled to the tubular element (22) and to be disposed within the lumen (23). The prosthetic valve (20) has (1) a compressed configuration in which the lumen (23) has a compressed width, the valve member (24) is generally cylindrical, and the prosthetic valve (20) is configured to be percutaneously delivered into the subject, and (2) an expanded configuration in which the lumen (23) has an expanded width that is greater than the compressed width, and the valve member (24) is generally disc-shaped, is coupled to the tubular element (22), and is disposed within the lumen (23). 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 first frame;

defining an arrangement of cells that shape the first frame as a tubular element having a first end and a second end;

having a compressed state in which the first frame is generally cylindrical, has a compressed width, and is transluminally deliverable into the subject, and

having an expanded state in which the first frame is generally cylindrical, has an expanded width that is greater than the compressed width, and defines a lumen between the first end and the second end; and

a second frame;

coupled to the first frame,

defining an arrangement of cells,

having a compressed state in which the valve member is transluminally deliverable into the subject, and

having an expanded state in which the second frame;

is disposed within the lumen, and

defines a valve member that provides directional fluid flow through the lumen by the second frame moving with respect to the first frame in response to changes in relative fluid pressure between the first end and the second end.

2. The apparatus according to claim 1, wherein the valve member provides directional fluid flow through the lumen without changing shape in response to changes in relative fluid pressure between the first end and the second end.

3. The apparatus according to claim 1, wherein:

the valve member provides directional fluid flow through the lumen by moving, in response to changes in relative fluid pressure between the first end and the second end, between (i) an open state in which the first and second ends of the lumen are in fluid communication with each other, and (ii) a closed state in which the first and second ends of the lumen are generally not in fluid communication with each other, and

the valve member is biased toward assuming the closed state.

4. The apparatus according to claim 1, wherein:

the valve member provides directional fluid flow through the lumen by moving, in response to changes in relative fluid pressure between the first end and the second end, between (i) an open state in which the first and second ends of the lumen are in fluid communication with each other, and (ii) a closed state in which the first and second ends of the lumen are generally not in fluid communication with each other, and

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.

5. The apparatus according to claim 1, wherein the prosthetic valve further comprises a valve seat that protrudes into the lumen and facilitates sealing between the tubular element and the valve member.

6. The apparatus according to claim 5, wherein the valve seat is annular.

7. The apparatus according to claim 5, wherein the valve seat is a first arc-shaped valve seat, and wherein the prosthetic valve further comprises a second arc-shaped valve seat.

8. The apparatus according to claim 1, wherein the second frame is coupled to the first frame at two coupling points.

9. The apparatus according to claim 8, wherein the coupling points lie on a central transverse axis of the tubular element.

10. The apparatus according to claim 8, wherein the coupling points lie on a non-central transverse axis of the tubular element.

11. The apparatus according to claim 8, wherein the valve member provides directional fluid flow by the second frame deflecting around an axis between the two coupling points in response to changes in relative fluid pressure between the first end and the second end.

12. The apparatus according to claim 11, further comprising a coupling rod that extends between the two coupling points, and the valve member provides directional fluid flow by the second frame bending around the coupling rod in response to changes in relative fluid pressure between the first end and the second end.

13. The apparatus according to claim 1, wherein the valve member provides directional fluid flow by the second frame rotating around an axis between the two coupling points in response to changes in relative fluid pressure between the first end and the second end.

14. The apparatus according to claim 1, wherein the second frame is coupled to the first frame such that when the first frame is in its compressed state and the second frame is in its compressed state, the second frame is disposed within the lumen.

15. The apparatus according to claim 1, wherein the valve member provides directional fluid flow by the second frame bending in response to changes in relative fluid pressure between the first end and the second end.

16. The apparatus according to claim 1, wherein the valve member provides directional fluid flow by the second frame changing shape in response to changes in relative fluid pressure between the first end and the second end.

17. The apparatus according to claim 1, wherein the valve member is unevenly rigid.