# US 11,026,786 B2 · Prosthetic heart valve having identifiers for aiding in radiographic positioning

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- Number: US 11,026,786 B2
- Document ID: US11026786B2
- Status: Granted
- Kind: B2
- Application number: 17/029,234
- Filed: 2020-09-23
- Published: 2021-01-07
- Granted: 2021-06-08
- Earliest claimed: 2008-09-15
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Yossi Tuval; Raphael Benary
- Web page: https://patentgrep.com/patent/US11026786B2

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2230/008: paraboloidal
- A61F 2250/0097: Visible markings, e.g. indicia
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- 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

A prosthetic heart valve having identifiers for aiding in radiographic positioning is described.

## Claims

### Claim 1

A method comprising the steps of:
providing a valve prosthesis that includes a prosthetic heart valve and at least one commissural post formed of a material, the prosthetic heart valve being coupled to the at least one commissural post, the at least one commissural post being provided with a radiographic identifier that is shaped to be reflection-asymmetric about an axis of the at least one commissural post that is generally parallel with the central longitudinal axis of the valve prosthesis wherein the at least one commissural post is shaped to define an opening through a thickness of the material of the at least one commissural post such that the opening does not include the material of the at least one commissural post, the opening defining an entirety of the radiographic identifier such that the radiographic identifier is bounded by the material of the at least one commissural post and is void of the material of the at least one commissural post, the opening having a reflection-asymmetric shape about the axis of the at least one commissural post, and even further wherein a radiopacity of the valve prosthesis at the radiographic identifier is less than a radiopacity of the material of the at least one commissural post;
while the valve prosthesis is in the collapsed position, placing, via a blood vessel of the subject, the valve prosthesis at least partially in a heart of a subject in a vicinity of a native heart valve having native commissures;
generating a fluoroscopic image of the native commissures and valve prosthesis; and
rotationally aligning the radiographic identifier visible in the image with at least one of the native commissures;
wherein rotationally aligning comprises:
rotating the valve prosthesis;
observing whether the radiographic identifier appears to move in the image in the same direction that the valve prosthesis is rotated, or in an opposite direction; and
if the radiographic identifier appears to move in the image in the opposite direction, rotating the valve prosthesis to correct a rotational alignment of the valve prosthesis.

### Claim 2 (depends on 1)

The method of claim 1, wherein if the radiographic identifier appears to move in the image in the opposite direction, the valve prosthesis is rotated approximately 60 degrees to correct a rotational alignment of the valve prosthesis.

### Claim 3 (depends on 1)

The method of claim 1, wherein the valve prosthesis is configured to have threefold rotational symmetry.

### Claim 4 (depends on 1)

The method of claim 1, wherein the radiographic identifier has a shape of a reflection-asymmetric character.

### Claim 5 (depends on 1)

The method of claim 1, wherein the at least one commissural post is shaped so as to define both reflection asymmetrical radiographic identifier and a reflection-symmetric shape.

### Claim 6 (depends on 1)

The method of claim 1, wherein the radiographic identifier is shaped like a letter of the alphabet.

### Claim 7 (depends on 1)

The method of claim 1, wherein the radiographic identifier is shaped like a number.

### Claim 8 (depends on 1)

The method of claim 1, wherein the radiographic identifier is a slit.

### Claim 9 (depends on 1)

The method of claim 1, wherein the at least one commissural post includes three commissural posts.