Percutaneously-deliverable dual-frame valve

• US 10,500,040 B2
• Filed: 08/10/2018
• Issued: 12/10/2019
• Est. Priority Date: 11/13/2012
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hacohen, Gil, Zipory, Yuval, Reich, Tal, Miller, Eran, Gross, Amir
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/100,718
• Publication Number:
  US 20180344455A1
• Time in Patent Office: 487 Days
• 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

A prosthetic valve comprises a first frame, defining an arrangement of cells; a second frame, a first protrusion, and a second protrusion. In an expanded state of the valve, the first frame is generally cylindrical and has an expanded width, and the valve defines a lumen having a first end and a second end. In a compressed state of the valve, the first and second frames are both generally cylindrical, and the first frame has a compressed width that is smaller than the expanded width. In the expanded state, the valve provides directional fluid flow through the lumen. The valve defines first and second coupling points, and an axis therebetween, the axis lying on a transverse cross-section of the first frame. The first and second coupling points couple the second frame to the first frame by protruding into respective first and second slots defined by the first frame.

Claims

1. Apparatus for use at a native valve of a heart of a subject, the apparatus comprising a prosthetic valve, the prosthetic valve comprising:

a first frame, defining an arrangement of cells;

a second frame;

a first protrusion; and

a second protrusion,

wherein;

the prosthetic valve has a compressed state in which the prosthetic valve is transluminally deliverable to the heart, and an expanded state into which the prosthetic valve is expandable within the heart,

in the expanded state, the first frame is generally cylindrical and has an expanded width, and the prosthetic valve defines a lumen having a first end and a second end,

in the compressed state, the first frame and the second frame are both generally cylindrical, and the first frame has a compressed width that is smaller than the expanded width,

in the expanded state, the prosthetic valve provides directional fluid flow through the lumen by opening and closing in response to changes in relative fluid pressure between the first end and the second end,

the prosthetic valve defines a first coupling point, a second coupling point, and an axis therebetween, the axis lying on a transverse cross-section of the first frame, and

in both the compressed state and the expanded state;

at the first coupling point, the first protrusion couples the second frame to the first frame by protruding into a first slot defined by the first frame, and

at the second coupling point, the second protrusion couples the second frame to the first frame by protruding into a second slot defined by the first frame.

2. The apparatus according to claim 1, wherein, in the expanded state, the prosthetic valve provides directional fluid flow through the lumen by the second frame rotating around the axis in response to changes in relative fluid pressure between the first end and the second end.

3. The apparatus according to claim 1, wherein, in the expanded state, the prosthetic valve provides directional fluid flow through the lumen by the second frame rotating deflecting around the axis in response to changes in relative fluid pressure between the first end and the second end.

4. The apparatus according to claim 1, wherein the axis is a non-diameter chord of the transverse cross-section of the first frame.

5. The apparatus according to claim 1, wherein the first frame defines a flared end that facilitates coupling of the prosthetic valve to the native valve.

6. The apparatus according to claim 1, wherein in both the compressed state and the expanded state, the first frame circumscribes the second frame.

7. The apparatus according to claim 1, wherein, in the expanded state, the prosthetic valve provides directional fluid flow through the lumen by opening and closing, without the second frame changing shape, in response to changes in relative fluid pressure between the first end and the second end.

8. The apparatus according to claim 1, wherein both the first frame and the second frame comprise nitinol.

9. The apparatus according to claim 1, wherein, in the expanded state, difference between (i) a transverse cross-sectional diameter of the first frame, and (ii) a transverse cross-sectional diameter of the second frame, is no more than 5 percent.

10. The apparatus according to claim 1, wherein the second frame 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.

11. The apparatus according to claim 1, wherein the prosthetic valve is configured such that, while the second frame remains coupled to the first frame at the first coupling point and at the second coupling point, the second frame is movable with respect to the first frame such that at least part of the second frame moves toward the first end and at least part of the second frame moves toward the second end.

12. The apparatus according to claim 1, wherein the prosthetic valve is configured:

to be transluminally delivered in the compressed configuration by being restrained in the compressed configuration during the transluminal delivery, and

to automatically expand toward the expanded configuration thereof when no longer restrained.

13. The apparatus according to claim 1, further comprising a first covering that at least partly covers the first frame, and a second covering that at least partly covers the second frame.

14. The apparatus according to claim 13, wherein the first covering and the second covering are polymeric coverings.