# US 10,368,990 B2 · Replacement mitral valves

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- Number: US 10,368,990 B2
- Document ID: US10368990B2
- Status: Granted
- Kind: B2
- Application number: 16/012,666
- Filed: 2018-06-19
- Published: 2018-10-18
- Granted: 2019-08-06
- Earliest claimed: 2017-01-23
- Assignees: Cephea Valve Technologies, Inc.
- Applicants: Cephea Valve Technologies, Inc.
- Inventors: Spencer Noe; Dan Wallace; Jonathan Oakden
- Web page: https://patentgrep.com/patent/US10368990B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2002/825: {having longitudinal struts}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0006: circular
- A61F 2230/001: Figure-8-shaped, e.g. hourglass-shaped
- A61F 2230/0054: V-shaped
- A61F 2230/0065: toroidal, e.g. ring-shaped, doughnut-shaped
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0039: differing in diameter
- A61F 2250/006: modular
- A61F 2250/0063: Nested prosthetic parts
- A61F 2250/0069: Sealing means
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

## Claims

### Claim 1

A prosthetic mitral valve comprising:
a valve support assembly comprising a ventricular anchor, a central portion, and an atrial anchor, wherein the valve support assembly comprises a plurality of diamond-shaped cells, the valve support assembly configured to self-expand from a collapsed configuration to an expanded configuration;
a plurality of leaflets secured to the valve support assembly; and
a plurality of retention hooks attached to the ventricular anchor, each of the retention hooks extending from an apex of an interior diamond-shaped cell, wherein each of the retention hooks curves radially outwards to point in an atrial direction when the valve support assembly is in the expanded configuration, each retention hook having a ratio of radius of curvature to thickness of 4:1 or greater.

### Claim 2 (depends on 1)

The prosthetic mitral valve of claim 1, wherein the ratio is between 4:1 and 8:1.

### Claim 3 (depends on 1)

The prosthetic mitral valve of claim 1, wherein each of the plurality of retention hooks is configured to point at an angle of 10-40 degrees relative to a central longitudinal axis of the prosthetic mitral valve.

### Claim 4 (depends on 3)

The prosthetic mitral valve of claim 3, wherein the angle is approximately 28°.

### Claim 5 (depends on 1)

The prosthetic mitral valve of claim 1, wherein a radius of curvature of each of the plurality of retention hooks is less than 4 mm.

### Claim 6 (depends on 1)

The prosthetic mitral valve of claim 1, wherein a radius of curvature of each of the plurality of retention hooks is between 2 mm-4 mm.

### Claim 7 (depends on 1)

The prosthetic mitral valve of claim 1, wherein a thickness of each of the plurality of retention hooks is less than 1.6 mm.

### Claim 8 (depends on 1)

The prosthetic mitral valve of claim 1, wherein a thickness of each retention hooks is between 0.25 mm and 1 mm.

### Claim 9 (depends on 1)

The prosthetic mitral valve of claim 1, wherein a ratio of width to thickness of each retention hook is between 0.3:1 and 1:1.

### Claim 10 (depends on 1)

The prosthetic mitral valve of claim 1, wherein each hook is configured to engage approximately 3-10 mm of mitral valve tissue when the valve support assembly is in the expanded configuration.

### Claim 11 (depends on 1)

The prosthetic mitral valve of claim 1, wherein the plurality of retention hooks are integral with the valve support assembly.

### Claim 12 (depends on 1)

The prosthetic mitral valve of claim 1, wherein the valve support assembly includes an anchor assembly comprising the ventricular and atrial anchors and the central portion and an annular strut frame positioned radially within the anchor assembly.

### Claim 13 (depends on 12)

The prosthetic mitral valve of claim 12, wherein the plurality of retention hooks are attached to the anchor assembly.

### Claim 14 (depends on 1)

The prosthetic mitral valve of claim 1, wherein the central portion is configured to align with a native valve orifice, and wherein the ventricular anchor and the atrial anchors are configured to compress native cardiac tissue therebetween.

### Claim 15 (depends on 1)

The prosthetic mitral valve of claim 1, wherein a retention hook extends from each apex in a circumferential line around the prosthetic mitral valve except a position closest to a leaflet attachment point.

### Claim 16

A prosthetic mitral valve comprising:
a valve support assembly comprising a ventricular anchor, a central portion, and an atrial anchor, the valve support assembly configured to self-expand from a collapsed configuration to an expanded configuration;
a plurality of leaflets secured to the valve support assembly; and
a plurality of retention hooks attached to the ventricular anchor, wherein each of the retention hooks curves radially outwards to point in an atrial direction when the valve support assembly is in the expanded configuration, each retention hook having a ratio of radius of curvature to thickness of greater than 4:1 and points at an angle of approximately 28° relative to a central longitudinal axis of the prosthetic mitral valve.

### Claim 17 (depends on 16)

The prosthetic mitral valve of claim 16, wherein a ratio of width to thickness of each retention hook is between 0.3:1 and 1:1.

### Claim 18 (depends on 16)

The prosthetic mitral valve of claim 16, wherein each hook is configured to engage approximately 3-10 mm of mitral valve tissue when the valve support assembly is in the expanded configuration.

### Claim 19 (depends on 16)

The prosthetic mitral valve of claim 16, wherein a radius of curvature of each of the plurality of retention hooks is less than 4 mm.
