# US 11,026,787 B2 · Heart valve holder

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- Number: US 11,026,787 B2
- Document ID: US11026787B2
- Status: Granted
- Kind: B2
- Application number: 16/397,376
- Filed: 2019-04-29
- Published: 2019-10-31
- Granted: 2021-06-08
- Earliest claimed: 2018-04-30
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Richard Kaleta
- Web page: https://patentgrep.com/patent/US11026787B2

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- 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 holder for a prosthetic heart valve may include a hub having an outer surface extending about a longitudinal axis, a commissure support extending downward from the hub, and a plurality of legs extending outward from the hub in radial directions, each leg having a foot extending in a longitudinal direction. Each foot may have two channels on its outer surface, each channel extending from a closed end at a spaced distance from the bottom of the foot to an open end at the bottom of the foot, and two suture holes each spaced apart from the bottom of the foot and extending between the inner surface and the outer surface of the foot.

## Claims

### Claim 1

A holder for a prosthetic heart valve, the holder comprising:
a hub having an outer surface extending about a longitudinal axis;
a commissure support extending downward from the hub; and
a plurality of legs extending outward from the hub in first radial directions, each leg having a foot extending in a longitudinal direction generally parallel to the longitudinal axis, each foot having:
an inner surface, an outer surface, and a bottom; and
a structure defining two channels on the outer surface of the foot, each channel extending from a closed end at a spaced distance from the bottom of the foot to an open end at the bottom of the foot, each channel defining a concave inner surface, the structure further defining two suture holes each spaced apart from the bottom of the foot and extending between the inner surface and the outer surface of the foot.

### Claim 2 (depends on 1)

The holder of claim 1, wherein each channel defines a chamfer with an angled transition surface extending between an inner surface of a respective one of the suture holes and the concave inner surface of the channel.

### Claim 3 (depends on 1)

The holder of claim 1, wherein the concave inner surface of each channel extends substantially parallel to the longitudinal axis.

### Claim 4 (depends on 1)

The holder of claim 1, wherein the concave inner surface of each channel extends in a medially angled direction, such that a longitudinal centerline of the concave inner surface at the open end of the channel is closer to the inner surface of the foot than the longitudinal centerline of the concave inner surface at the closed end of the channel.

### Claim 5 (depends on 1)

The holder of claim 1, wherein each foot has first and second lateral surfaces that each intersect the bottom of the foot at a corner, and an inner surface of each of the suture holes is located a first distance from a closest one of the corners and a second distance from the bottom of the foot, the first distance being greater than the second distance.

### Claim 6 (depends on 1)

The holder of claim 1, wherein the first radial directions are evenly spaced about the longitudinal axis.

### Claim 7 (depends on 1)

The holder of claim 1, wherein the commissure support has a trunk extending generally along the longitudinal axis and a plurality of arms extending outward from the trunk in second radial directions, each arm having a support surface extending in a plane substantially parallel to the longitudinal axis and substantially perpendicular to a respective one of the second radial directions.

### Claim 8 (depends on 1)

The holder of claim 1, wherein the second radial directions alternate with the first radial directions such that each of the second radial directions is offset from two adjacent ones of the first radial directions by about 60°.

### Claim 9 (depends on 1)

The holder of claim 1, wherein the hub has an opening defined in a top surface thereof, the opening being configured to receive a handle.

### Claim 10

A prosthetic heart valve assembly, comprising:
a prosthetic heart valve having a frame extending circumferentially about a longitudinal axis and surrounding a central opening, a plurality of valve leaflets disposed in the central opening and affixed to the frame, adjacent lateral ends of the leaflets each defining a commissure, and a cuff affixed to the frame and extending circumferentially about an exterior of the frame; and
a holder having a hub, a commissure support extending downward from the hub and having a plurality of support surfaces each in contact with a respective one of the commissures, and a plurality of legs extending outward from the hub in first radial directions, each leg having a foot in contact with an upward-facing surface of the cuff, each foot having:
an inner surface, an outer surface, and a bottom; and
a structure defining two channels on the outer surface of the foot, each channel extending from a closed end at a spaced distance from the bottom of the foot to an open end at the bottom of the foot, each channel defining a concave inner surface, the structure further defining two suture holes each spaced apart from the bottom of the foot and extending between the inner surface and the outer surface of the foot,
wherein the prosthetic heart valve is sutured to the holder by at least one suture extending through the suture holes and the cuff at locations adjacent the legs of the holder.

### Claim 11 (depends on 10)

The assembly of claim 10, wherein the cuff is made from a fabric material and encapsulates a flexible ring extending circumferentially through the cuff.

### Claim 12 (depends on 11)

The assembly of claim 11, wherein the assembly defines a clearance between the inner edge of the cuff and the inner surface of each foot, and a cuff bite between the outer edge of the cuff and the outer surface of each foot, the cuff bite being at least half of the first width of the cuff.

### Claim 13 (depends on 10)

The assembly of claim 10, wherein the cuff has a first width between an inner edge and an outer edge thereof, and each foot has a second width between its inner surface and its outer surface, the first width being at least two times the second width.

### Claim 14 (depends on 10)

The assembly of claim 10, wherein the prosthetic heart valve is sutured to the holder by one or more sutures, each of the sutures extending around at least a part of a circumference of the cuff, the sutures together extending through each of the suture holes in each of the feet, through each of the channels in each of the feet, and through portions of the cuff at the locations adjacent the legs of the holder.

### Claim 15 (depends on 14)

The assembly of claim 14, wherein each of the legs defines two suture openings that extend transversely through the leg, and the sutures together extend through each of the suture openings defined in each of the legs.

### Claim 16 (depends on 10)

The assembly of claim 10, wherein each channel defines a chamfer with an angled transition surface extending between an inner surface of a respective one of the suture holes and the concave inner surface of the channel.

### Claim 17 (depends on 10)

The assembly of claim 10, wherein the concave inner surface of each channel extends substantially parallel to the longitudinal axis.

### Claim 18 (depends on 10)

The assembly of claim 10, wherein the concave inner surface of each channel extends in a medially angled direction, such that a longitudinal centerline of the concave inner surface at the open end of the channel is closer to the inner surface of the foot than the longitudinal centerline of the concave inner surface at the closed end of the channel.

### Claim 19 (depends on 10)

The assembly of claim 10, wherein each foot has first and second lateral surfaces that each intersect the bottom of the foot at a corner, and an inner surface of each of the suture holes is located a first distance from a closest one of the corners and a second distance from the bottom of the foot, the first distance being greater than the second distance.

### Claim 20 (depends on 10)

The assembly of claim 10, wherein the commissure support has a trunk extending generally along the longitudinal axis and a plurality of arms extending outward from the trunk in second radial directions, each arm having a respective one of the support surfaces extending in a plane substantially parallel to the longitudinal axis and substantially perpendicular to a respective one of the second radial directions.
