# US 2019/0167422 A1 · Methods of identifying and replacing implanted heart valves

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- Number: US 2019/0167422 A1
- Document ID: US20190167422A1
- Status: Published application
- Kind: A1
- Application number: 16/270,849
- Filed: 2019-02-08
- Published: 2019-06-06
- Earliest claimed: 2014-06-20
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Jessica Guttenberg; Da-Yu Chang; Derrick Johnson; Brian S. Conklin; Qinggang Zeng; Myron Howanec, JR.; Grace Myong Kim
- Web page: https://patentgrep.com/patent/US20190167422A1

## CPC

- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2472: {Devices for testing}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2250/0085: Identification means; Administration of patients
- A61F 2250/0089: coded with symbols, e.g. dots, numbers, letters, words
- 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)

## Abstract

A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

## Claims

### Claim 1

A method of deploying a second prosthetic heart valve within a first prosthetic heart valve previously implanted in a patient's body, comprising:
using an external imager, viewing a valve-type indicator of a first prosthetic heart valve implanted in the patient, the valve-type indicator signifying the capability of the first prosthetic heart valve for post-implant expansion;
deploying a second prosthetic heart valve within the first prosthetic heart valve; and
expanding the second prosthetic heart valve within the first prosthetic heart valve to cause a diameter of the first prosthetic heart valve to expand.

### Claim 2 (depends on 1)

The method of claim 1, wherein the valve-type indicator further indicates one of the group selected from: valve size, valve make, or valve model.

### Claim 3 (depends on 1)

The method of claim 1, wherein the first prosthetic heart valve has a labeled valve size, and the valve-type indicator further indicates the labeled valve size.

### Claim 4 (depends on 3)

The method of claim 3, wherein the valve-type indicator comprises a numerical value that equals the labeled valve size in millimeters.

### Claim 5 (depends on 1)

The method of claim 1, wherein the external imager is selected from one of the group consisting of: X-ray imaging, fluoroscopy, magnetic resonance imaging, medical ultrasonography or ultrasound, and positron emission tomography.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first prosthetic heart valve has an internal support frame defining a flow orifice therethrough, wherein the internal support frame is adapted for post-implant expansion, and the first prosthetic heart valve has a plurality of flexible leaflets attached to the support frame and extending across the flow orifice and coming together within the orifice to define one-way flow therethrough.

### Claim 7 (depends on 6)

The method of claim 6, wherein the internal support frame comprises a structural component that shows up as a positive image on the external imager, and the valve-type indicator is formed by one or more voids integrated into the structural component which show up as negative images on the external imager.

### Claim 8 (depends on 7)

The method of claim 7, wherein the structural component of the internal support frame comprises a generally tubular band with a diameter that is expandable post-implant.

### Claim 9 (depends on 6)

The method of claim 6, wherein the first prosthetic heart valve further includes an expandable tubular frame attached to an inflow end of the internal support frame on which the valve-type indicator is located.

### Claim 10 (depends on 1)

The method of claim 1, wherein the first prosthetic heart valve has a soft sealing ring surrounding an inflow end, and the valve-type indicator is mounted to the sealing ring.

### Claim 11

A method of deploying a second prosthetic heart valve within a first prosthetic heart valve previously implanted in a patient's body, comprising:
using an external imager, viewing a valve-type indicator of a first prosthetic heart valve implanted in the patient, the first prosthetic heart valve having a first functional diameter as implanted, the valve-type indicator signifying the capability of the first prosthetic heart valve for post-implant expansion;
mechanically expanding the first prosthetic heart valve to a larger second non-functional diameter; and
deploying a second prosthetic heart valve within the first prosthetic heart valve.

### Claim 12 (depends on 11)

The method of claim 11, wherein the valve-type indicator further indicates one of the group selected from: valve size, valve make, or valve model.

### Claim 13 (depends on 11)

The method of claim 11, wherein the first prosthetic heart valve has a labeled valve size, and the valve-type indicator further indicates the labeled valve size.

### Claim 14 (depends on 13)

The method of claim 13, wherein the valve-type indicator comprises a numerical value that equals the labeled valve size in millimeters.

### Claim 15 (depends on 11)

The method of claim 11, wherein the external imager is selected from one of the group consisting of: X-ray imaging, fluoroscopy, magnetic resonance imaging, medical ultrasonography or ultrasound, and positron emission tomography.

### Claim 16 (depends on 11)

The method of claim 11, wherein the first prosthetic heart valve has an internal support frame defining a flow orifice therethrough, wherein the internal support frame is adapted for post-implant expansion, and the first prosthetic heart valve has a plurality of flexible leaflets attached to the support frame and extending across the flow orifice and coming together within the orifice to define one-way flow therethrough.

### Claim 17 (depends on 16)

The method of claim 16, wherein the internal support frame comprises a structural component that shows up as a positive image on the external imager, and the valve-type indicator is formed by one or more voids integrated into the structural component which show up as negative images on the external imager.

### Claim 18 (depends on 17)

The method of claim 17, wherein the structural component of the internal support frame comprises a generally tubular band with a diameter that is expandable post-implant.

### Claim 19 (depends on 16)

The method of claim 16, wherein the first prosthetic heart valve further includes an expandable tubular frame attached to an inflow end of the internal support frame on which the valve-type indicator is located.

### Claim 20 (depends on 11)

The method of claim 11, wherein the first prosthetic heart valve has a soft sealing ring surrounding an inflow end, and the valve-type indicator is mounted to the sealing ring.

### Claim 21 (depends on 11)

The method of claim 11, wherein the second prosthetic heart valve is expanded post-deployment to improve engagement between the first prosthetic heart valve and the second prosthetic heart valve.

### Claim 22 (depends on 11)

The method of claim 11, wherein the deployment of the second prosthetic heart valve itself expands the diameter of the first prosthetic heart valve.
