# US 10,869,759 B2 · Mechanically expandable heart valve

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- Number: US 10,869,759 B2
- Document ID: US10869759B2
- Status: Granted
- Kind: B2
- Application number: 15/995,528
- Filed: 2018-06-01
- Published: 2018-12-06
- Granted: 2020-12-22
- Earliest claimed: 2017-06-05
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Alexander Barash; Yair A. Neumann; Tomer Saar; Ziv Yohanan; Noam Nir
- Web page: https://patentgrep.com/patent/US10869759B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/844: folded prior to deployment
- A61F 2/9517: {handle assemblies therefor}
- A61F 2002/9511: {the retaining means being filaments or wires}
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2230/0015: Kidney-shaped, e.g. bean-shaped
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges are provided to interconnect the struts. In still another embodiment, separate flanged rivets are provided to connect the struts.

## Claims

### Claim 1

An implantable medical device comprising
a first set of a plurality of first struts extending in a first direction; and
a second set of a plurality of second struts extending in a second direction;
wherein the first struts are interwoven with the second struts to form an annular frame that is radially compressible and expandable;
wherein each first strut:
is pivotally connected to at least one second strut, and
passes radially outside of at least one second strut and radially inside of at least one second strut.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein each first strut comprises a plurality of projections spaced apart from each along a length of the first strut and each second strut comprises a plurality of apertures extending along a length of the second strut, and wherein the projections of the first struts extend into respective apertures of the second struts.

### Claim 3 (depends on 2)

The medical device of claim 2, wherein each first strut has at least one projection that extends radially inwardly and into an aperture of an adjacent second strut and at least one projection extends radially outwardly and into an aperture of an adjacent second strut.

### Claim 4 (depends on 1)

The medical device of claim 1, wherein the projections are integrally formed on the first struts.

### Claim 5 (depends on 1)

The medical device of claim 1, wherein each first strut passes radially outside of at least two second struts and radially inside of at least two second struts.

### Claim 6 (depends on 1)

The medical device of claim 1, further comprising a valve member comprising a plurality of leaflets mounted inside the annular frame.

### Claim 7

An implantable medical device comprising:
a radially expandable and compressible annular frame comprising a plurality of interconnected struts, the plurality of struts comprising a first set of a plurality of first struts and a second set of a plurality of second struts, wherein the first struts overlap adjacent second struts at junctions and expansion or compression of the annular frame causes the first struts to pivot relative to the second struts at the junctions;
wherein the frame comprises a plurality of hinges at the junctions extending from the first struts through corresponding non-circular apertures of the second struts at the junctions; and
wherein each hinge comprises a cylindrical pivot portion that can rotate in a corresponding aperture of a second strut and a locking member extending from the pivot portion, wherein the locking member is sized and shaped relative to the corresponding aperture of the second strut so as to prevent radial separation of the first and second struts whenever the locking member is rotationally offset from the corresponding aperture upon radial expansion and compression of the frame.

### Claim 8 (depends on 7)

The medical device of claim 7, wherein the second struts are formed with recessed portions surrounding the non-circular apertures and the locking members of the hinges are disposed within the recessed portions.

### Claim 9 (depends on 7)

The medical device of claim 7, further comprising one or more actuators mounted on the frame and configured to radially expand and compress the frame between a radially compressed state defining a compressed diameter and a radially expanded state defining an expanded diameter, wherein the locking members are rotationally offset from corresponding non-circular apertures in the second struts at the compressed diameter, the expanded diameter, and all diameters in between the compressed and expanded diameters.

### Claim 10 (depends on 7)

The medical device of claim 7, wherein the hinges are integrally formed on the first struts.

### Claim 11 (depends on 7)

The medical device of claim 7, wherein:
the hinges are separate components from the first and second struts;
each of the first struts comprises a plurality of non-circular apertures; and
each hinge extends through an aperture in a first strut and an adjacent aperture in a second strut at a junction.

### Claim 12 (depends on 11)

The medical device of claim 11, wherein each of the hinges further comprises a retaining member configured to be retained within the non-circular apertures on the first struts.

### Claim 13 (depends on 11)

The medical device of claim 11, wherein each of the hinges further comprises a circular base member configured to be retained within a circular recess surrounding one of the non-circular apertures on the first struts.

### Claim 14 (depends on 7)

The medical device of claim 7, wherein the locking members comprise a non-circular shape.

### Claim 15 (depends on 7)

The medical device of claim 7, wherein the locking members comprise a non-circular central protrusion with at least two ears extending outward therefrom in a plane parallel to the strut.