# US 10,869,755 B2 · Replacement cardiac valves and methods of use and manufacture

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- Number: US 10,869,755 B2
- Document ID: US10869755B2
- Status: Granted
- Kind: B2
- Application number: 14/677,320
- Filed: 2015-04-02
- Published: 2016-06-09
- Granted: 2020-12-22
- Earliest claimed: 2014-12-09
- Assignees: Cephea Valve Technologies, Inc.
- Applicants: Cephea Valve Technologies, Inc.
- Inventors: Juan F. Granada; Gary Erzberger; Michael P. Corcoran; Dan Wallace; Matteo Montorfano; Alaide Chieffo; Thierry Thaure; Aaron Grogan; Peter Gregg
- Web page: https://patentgrep.com/patent/US10869755B2

## CPC

- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/243: {Deployment by mechanical expansion}
- A61B 2017/00243: {cardiac}
- A61F 2210/0019: operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2230/0006: circular
- A61F 2230/0069: cylindrical
- A61F 2240/001: Designing or manufacturing processes
- A61F 2240/002: Designing or making customized prostheses
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0036: differing in thickness
- A61F 2250/0063: Nested prosthetic parts
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Prosthetic mitral valves and their methods of manufacture and use.

## Claims

### Claim 1

A replacement mitral valve having a proximal and a distal end, comprising:
a self-expandable anchor comprising a ventricular anchor, a central portion, and an atrial anchor having a first frame with a plurality of first arches and a second frame with a plurality of second arches at least a portion of which overlap the plurality of first arches at the proximal end of the replacement mitral valve, the self-expandable anchor having a self-expanded configuration in which the ventricular anchor and the atrial anchor are flared radially outward relative to the central portion and relative to a longitudinal axis of the device such that the replacement mitral valve is configured to be secured within a mitral valve orifice, the ventricular anchor having a ventricular stiffness at radial outer portion of the ventricular anchor in a direction parallel to the longitudinal axis when the expandable anchor is in the self-expanded configuration and the atrial anchor having an atrial stiffness at radial outer portion of the atrial anchor in a direction parallel to the longitudinal axis when the expandable anchor is in the self-expanded configuration, the ventricular stiffness greater than the atrial stiffness; and
a plurality of replacement leaflets secured to the expandable anchor.

### Claim 2 (depends on 1)

The replacement mitral valve of claim 1 wherein the ventricular anchor has a plurality of ventricular arches with a first thickness, either one of the plurality of first arches and plurality of second arches has a second thickness less than the first thickness, and wherein the thickness dimensions is measured radially when the expandable anchor is in a collapsed configuration.

### Claim 3 (depends on 2)

The replacement mitral valve of claim 2, wherein the second thickness being the thickness of the plurality of first arches, the plurality of second arches having a third thickness less than the first thickness.

### Claim 4 (depends on 3)

The replacement mitral valve of claim 3 wherein the second thickness is the same as the third thickness.

### Claim 5 (depends on 1)

The replacement mitral valve of claim 1, the ventricular anchor having a plurality of ventricular arches with ventricular peaks and valleys, the first frame with the a plurality of first arches includes atrial peaks and valleys, the linear distance between ventricular valleys being less than the linear distance between atrial valleys, when the expandable anchor is in the expanded configuration.

### Claim 6 (depends on 5)

The replacement mitral valve of claim 5 wherein the second frame with the plurality of second arches includes peaks and valleys, the linear distance between ventricular valleys also being less than the linear distance between valleys of the second frame.

### Claim 7 (depends on 1)

The replacement mitral valve of claim 1, the ventricular anchor having a plurality of ventricular arches with ventricular peaks and the atrial anchor having a plurality of atrial arches defining atrial peaks, wherein midpoints of the ventricular peaks have greater stiffness in the axial direction than midpoints of the atrial peaks.

### Claim 8 (depends on 1)

The replacement mitral valve of claim 1 wherein the plurality of ventricular arches are stiffer than each of the first arches and the second arches in the axial direction.

### Claim 9 (depends on 1)

The replacement mitral valve of claim 1 having a ventricular end and an atrial end, the two ends being the radially outermost points of either side of a midline of the expandable anchor when the anchor is in the expanded configuration.

### Claim 10 (depends on 1)

The replacement mitral valve of claim 1 wherein the ventricular anchor comprises, when the expandable anchor is in a collapsed configuration, a plurality of triangular arches pointing towards a ventricular end of the replacement mitral valve, and the central portion comprises a plurality of triangular central arches pointing towards an atrial end of the replacement mitral valve.

### Claim 11 (depends on 1)

The replacement mitral valve of claim 1 wherein at least a portion of the plurality of first arches and at least a portion of the plurality of second arches each comprise a protuberance at a midpoint of the arch.

### Claim 12 (depends on 1)

The replacement mitral valve of claim 1 wherein the ventricular anchor comprises a plurality of arches having triangular configurations.

### Claim 13 (depends on 12)

The replacement mitral valve of claim 12 wherein the plurality of arches define a plurality of peaks and a plurality of valleys, the height of the peaks being greater than the linear distance between adjacent valleys, the height being measured orthogonal to the linear distance between adjacent valleys.

### Claim 14 (depends on 13)

The replacement mitral valve of claim 13 wherein the ventricular anchor comprises a plurality of arches each having the same triangular configuration with a rounded end.

### Claim 15 (depends on 1)

The replacement valve of claim 1 further comprising a plurality of struts secured to the self-expandable anchor and the replacement leaflets.

### Claim 16 (depends on 15)

The replacement valve of claim 15 further comprising a cylindrical strut frame secured to the self-expandable anchor, the strut frame comprising the plurality of struts.

### Claim 17 (depends on 16)

The replacement valve of claim 16 wherein the strut frame is secured to the central portion of the expandable anchor.

### Claim 18 (depends on 17)

The replacement valve of claim 17 wherein the strut frame includes a plurality of apertures and the central portion comprises a plurality of apertures, each of the plurality of apertures on the strut frame is aligned with an aperture on the central portion, the central portion secured to the strut frame at the location of the aligned apertures.

### Claim 19

A replacement mitral valve, comprising:
a self-expandable anchor comprising a ventricular anchor, a central portion, and an atrial anchor, the self-expandable anchor having a self-expanded configuration in which the ventricular anchor and the atrial anchor are flared radially outward relative to the central portion such that the replacement mitral valve is configured to be secured within a mitral valve orifice, wherein the ventricular anchor has a plurality of ventricular arches defining ventricular peaks and valleys and the atrial anchor has a plurality of atrial arches defining atrial peaks and valleys, a ventricular linear distance between ventricular valleys being less than an atrial linear distance between atrial valleys and a ventricular height from ventricular valleys to ventricular peaks being less than an atrial height between atrial peaks and atrial valleys when the expandable anchor is in the expanded configuration such that the ventricular arches are stiffer than the atrial arches;
a cylindrical strut frame disposed radially within and secured to a radially inner portion of the self-expandable anchor;
a plurality of attachment elements connecting the cylindrical strut frame to the expandable anchor; and
a plurality of replacement leaflets secured to the self-expandable anchor.

### Claim 20 (depends on 19)

The replacement mitral valve of claim 19 wherein the atrial anchor is secured to the central portion but not integral with the central portion and the ventricular anchor is integral with the central portion.

### Claim 21 (depends on 20)

The replacement mitral valve of claim 20 wherein the atrial anchor is secured to the central portion at a plurality of couplings.

### Claim 22 (depends on 21)

The replacement mitral valve of claim 21 wherein the atrial anchor comprises an annular frame, and wherein the annular frame is secured to the central portion at a plurality of couplings.

### Claim 23 (depends on 22)

The replacement mitral valve of claim 22 wherein the atrial anchor comprises a second annular frame, wherein the second frame is secured to the central portion at a second plurality of couplings.

### Claim 24 (depends on 23)

The replacement mitral valve of claim 23 wherein the first and second plurality of coupling are movable couplings between the central portion and the first and second frames at the location of the first and second plurality of couplings.

### Claim 25 (depends on 24)

The replacement mitral valve of claim 24 wherein the first and second couplings alternate around a longitudinal axis of the central portion.

### Claim 26 (depends on 19)

The replacement mitral valve of claim 19, wherein struts of each of the ventricular arches have a first thickness and struts of each of the atrial arches have a second thickness less than the first thickness, wherein the thickness dimension is measured radially when the expandable anchor is in a collapsed configuration.

### Claim 27 (depends on 19)

The replacement mitral valve of claim 19 wherein the atrial arches are part of a first frame, the atrial anchor further including a second frame with a plurality of second arches defining peaks and valleys, at least one of the atrial arches overlaps with one of the plurality of second arches, the linear distance between ventricular valleys also being less than the linear distance between valleys of the second frame.

### Claim 28 (depends on 19)

The replacement mitral valve of claim 19, wherein midpoints of the ventricular peaks have greater stiffness in the axial direction than midpoints of the atrial peaks.

### Claim 29 (depends on 19)

The replacement mitral valve of claim 19 wherein the ventricular anchor comprises, when the expandable frame is in a collapsed configuration, a plurality of triangular arches pointing towards a ventricular end of the replacement mitral valve, and the central portion comprises a plurality of triangular central arches pointing towards an atrial end of the replacement mitral valve.

### Claim 30 (depends on 19)

The replacement mitral valve of claim 19 wherein the atrial anchor includes a first frame with a plurality of first arches and a second frame with a plurality of second arches, at least a portion of the plurality of first arches overlapping with a portion of the plurality of second arches.

### Claim 31 (depends on 30)

The replacement mitral valve of claim 30 wherein at least a portion of the plurality of first arches and at least a portion of the plurality of second arches each comprise a protuberance at a midpoint of the arch.

### Claim 32 (depends on 19)

The replacement mitral valve of claim 19, wherein the ventricular height is greater than the ventricular linear distance when the expandable anchor is in the expandable configuration.