# US 10,478,288 B2 · Trileaflet mechanical prosthetic heart valve

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- Number: US 10,478,288 B2
- Document ID: US10478288B2
- Status: Granted
- Kind: B2
- Application number: 14/870,049
- Filed: 2015-09-30
- Published: 2017-03-30
- Granted: 2019-11-19
- Earliest claimed: 2015-09-30
- Assignees: Clover Life Sciences Inc.
- Applicants: Clover Life Sciences Inc.
- Inventors: Osvaldo N. Amerio; Carlos Enrique Schvezov
- Web page: https://patentgrep.com/patent/US10478288B2

## CPC

- A61F 2/2403: {with pivoting rigid closure members (check valves with hinged closure members in general F16K15/03)}
- 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 2230/0071: spherical
- 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

A mechanical prosthetic heart valve having a ring, multiple hinges, and multiple leaflets. The hinges are attached to the ring and are evenly spaced from one another along the inner circumference of the ring. Each leaflet is rotably attached to a hinge by an opening located in the center of the lower portion of the leaflets. The ring can include multiple protrusions located along the inner circumference of the ring. The protrusions of the ring limit the opening angle of the leaflets. By limiting the opening angle of the leaflets, wear and tear of the hinges and leaflets, as well as the probability of malfunction of the mechanical prosthetic heart valve are reduced. In addition, limiting the opening angle of the leaflets may increase the opening and closing speed of the leaflets, thus improving performance of the mechanical prosthetic heart valve when the patient is experiencing an elevated cardiac frequency.

## Claims

### Claim 1

A trileaflet mechanical prosthetic heart valve comprising:
a ring including three or more protrusions located along an inner circumference of the ring;
three or more hinges attached to the ring, the three or more hinges evenly spaced from one another along the inner circumference of the ring; and
three or more leaflets, each leaflet attached to one of the three or more hinges, each leaflet attached to a hinge by an opening located in a center of a lower portion of the leaflet, each leaflet including:
a front surface having a concave shape in a transverse axis and a flat shape in a longitudinal axis,
a rear surface having a convex shape in the transverse axis and a flat shape in the longitudinal axis, the rear surface of the leaflets configured to be in contact with the protrusions of the ring when the leaflets are in an open position such that there is an arc shaped gap formed between the rear surface of the leaflets and the inner circumference of the ring when the leaflets are in the open position, wherein the the rear surface of the leaflets substantially tracks the inner circumference of the ring when the leaflets are in the open position; and
flat regions on left and right sides of the front surface of the leaflets, the flat regions for improved fluid dynamics.

### Claim 2 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, further comprising a bio-hemo-compatible layer of titanium oxide covering the ring, the three or more hinges, and the three or more leaflets.

### Claim 3 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the ring, the three or more hinges, and the three or more leaflets are composed of titanium.

### Claim 4 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the leaflets have a concave-convex cross section along a transversal plane of the leaflets.

### Claim 5 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the leaflets each have a generally triangular shape.

### Claim 6 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the lower portion of the leaflets together form a circular shape along the inner circumference of the ring.

### Claim 7 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the protrusions of the ring are configured to prevent the leaflets from forming an angle greater than 90° with respect to a transversal plane of the ring.

### Claim 8 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the protrusions are evenly spaced relative to each other along the inner circumference of the ring.

### Claim 9 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the hinges are coupled to the ring at a lower portion of the protrusions.

### Claim 10 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the protrusions of the ring have a semi-circular cross section.

### Claim 11 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the hinges are configured such that each leaflet opens and closes by sliding along the hinge at the opening in the center of the lower portion of the leaflet.

### Claim 12 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein the leaflets are configured to be positioned at 35° with respect to a transversal plane of the ring when closed and at 90° with respect to the transversal plane of the ring when open.

### Claim 13 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein each hinge attaches to the ring at each end of the hinge, the hinge including an open area in a middle of the hinge, and wherein each leaflet is positioned on each hinge such that the hinge sits within the opening of the leaflet.

### Claim 14 (depends on 13)

The trileaflet mechanical prosthetic heart valve of claim 13, wherein each leaflet includes protuberances on either side of the opening, the protuberances protruding into the opening.

### Claim 15 (depends on 14)

The trileaflet mechanical prosthetic heart valve of claim 14, wherein the protuberances of each leaflet form a first portion of the opening above the protuberance, the first portion being wider than a second portion of the opening between the protuberances, the leaflet being slidable along the hinge with the hinge positioned within the first portion of the opening.

### Claim 16 (depends on 15)

The trileaflet mechanical prosthetic heart valve of claim 15, wherein the second portion of the opening of each leaflet is narrowed by the protuberances, the leaflet being slidable along the hinge with the protuberances protruding into the open area of the hinge during opening and closing of the leaflets.

### Claim 17 (depends on 15)

The trileaflet mechanical prosthetic heart valve of claim 15, wherein the opening of each leaflet includes a third portion below the protuberances that is wider than the second portion, the third portion being open to a base of the hinge, the third portion configured to engage and slide over the hinge during opening of the leaflet.

### Claim 18 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, each leaflet further comprising:
a bottom surface having a convex shape,
wherein:
the concave shape of the front surface has a first radius of curvature,
the convex shape of the rear surface has a second radius of curvature larger than the first radius of curvature, and
the convex shape of the bottom surface has a third radius of curvature, the third radius of curvature substantially equal to the second radius of curvature.

### Claim 19 (depends on 1)

The trileaflet mechanical prosthetic heart valve of claim 1, wherein a distance from the inner circumference of the ring to the rear surface of a leaflet of the three or more leaflets is less than 1 mm at any point around the inner circumference of the ring when the leaflets are in the open position.

### Claim 20

A trileaflet mechanical prosthetic heart valve comprising:
a ring having an inner circumference and three or more protrusions located along the inner circumference of the ring;
three or more hinges attached to the ring, the three or more hinges evenly spaced from one another along the inner circumference of the ring; and
three or more leaflets, each leaflet cut from a cylindrical piece, each leaflet attached to one of the three or more hinges, each leaflet including flat regions on left and right sides, the flat regions for improved fluid dynamics, each leaflet attached to a hinge by an opening located in a center of a lower portion of the leaflet, each leaflet including protuberances on either side of the opening that protrude into the hinge allowing rotation of the leaflet along the hinge, wherein the leaflets are configured to be in contact with the protrusions of the ring when the leaflets are in an open position, and wherein the leaflets are configured not to be in contact with the protrusions of the ring when the leaflets are in a closed position.

### Claim 21 (depends on 20)

The trileaflet mechanical prosthetic heart valve of claim 20, further comprising three or more protrusions located along an inner circumference of the ring, the protrusions of the ring configured to prevent the leaflets from forming an angle greater than 90° with respect to a transversal plane of the ring.

### Claim 22 (depends on 20)

The trileaflet mechanical prosthetic heart valve of claim 20, wherein each hinge includes an open area in a middle of the hinge, and wherein each leaflet is positioned on each hinge such that the protuberances protrude into the open area of the hinge to allow the leaflet to be slidable along the hinge for opening and closing of the leaflets.
