# US 2023/0057553 A1 · Replacement heart valve implant

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- Number: US 2023/0057553 A1
- Document ID: US20230057553A1
- Status: Published application
- Kind: A1
- Application number: 17/889,774
- Filed: 2022-08-17
- Published: 2023-02-23
- Earliest claimed: 2021-08-18
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Michael G. Hayes; Andrea Goldbey; Tara Hogan
- Web page: https://patentgrep.com/patent/US20230057553A1

## CPC

- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- 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)

## Abstract

Example heart valves are disclosed. An example heart valve may comprise an expandable framework configured to shift from a closed configuration to an expanded configuration, the expandable framework having an inflow end, an outflow end and a lumen extending therein. The heart valve may also include a plurality of valve leaflets coupled to the expandable framework, each of the plurality of valve leaflets including a root edge and a free edge. Further, the heart valve may also include an outer skirt coupled to the plurality of valve leaflets, the outer skirt including a proximal edge, wherein the root edge of each of the plurality of valve leaflets is attached to the proximal edge of the outer skirt.

## Claims

### Claim 1

A heart valve, comprising:
an expandable framework configured to shift from a closed configuration to an expanded configuration, the expandable framework having an inflow end, an outflow end and a lumen extending therein;
a plurality of valve leaflets coupled to the expandable framework, each of the plurality of valve leaflets including a root edge and a free edge; and
an outer skirt coupled to the plurality of valve leaflets, the outer skirt including a proximal edge;
wherein the root edge of each of the plurality of valve leaflets is attached to the proximal edge of the outer skirt.

### Claim 2 (depends on 1)

The heart valve implant of claim 1, wherein the outer skirt is positioned along an outer surface of the expandable framework.

### Claim 3 (depends on 2)

The heart valve implant of claim 2, wherein the plurality of valve leaflets is positioned within the lumen of the expandable framework.

### Claim 4 (depends on 3)

The heart valve implant of claim 3, wherein the root edge of each of the plurality of valve leaflets is sutured to the proximal edge of the outer skirt.

### Claim 5 (depends on 4)

The heart valve implant of claim 4, wherein root edge of each of the plurality of valve leaflets and the proximal edge of the outer skirt are sutured around the expandable framework such that the root edge of the plurality of valve leaflets and the proximal edge of the outer skirt may move relative to the expandable framework.

### Claim 6 (depends on 1)

The heart valve implant of claim 1, wherein the outer skirt further includes a distal edge, and wherein the distal edge of the outer skirt is attached to one or more of the plurality of valve leaflets at one or more attachment points.

### Claim 7 (depends on 1)

The heart valve implant of claim 1, wherein the outer skirt extends radially outward from the expandable framework to capture fluid flow around an exterior of the expandable framework within the outer skirt.

### Claim 8 (depends on 1)

The heart valve implant of claim 1, wherein the outer skirt is substantially impervious to fluid.

### Claim 9 (depends on 1)

The heart valve implant of claim 1, wherein the proximal edge of the outer skirt is disposed upstream of the inflow end of the expandable framework.

### Claim 10 (depends on 9)

The heart valve implant of claim 9, wherein the expandable framework further includes an upper crown, wherein the distal edge of the outer skirt is disposed proximal of the upper crown.

### Claim 11

A heart valve, comprising:
an expandable framework having an inflow end, an outflow end, and a medial region positioned between the inflow end and the outflow end;
a plurality of valve leaflets attached to the medial region of the expandable framework, each of the plurality of valve leaflets including a root edge; and
an outer skirt disposed along an outer surface of the expandable framework, the outer skirt including a proximal edge and a distal edge;
wherein the outer skirt is configured to shift between an unexpanded configuration and an expanded configuration;
wherein the root edge of each of the plurality of valve leaflets is attached to the proximal edge of the outer skirt.

### Claim 12 (depends on 11)

The heart valve implant of claim 11, wherein the plurality of valve leaflets is positioned within a lumen of the expandable framework.

### Claim 13 (depends on 11)

The heart valve implant of claim 11, wherein the root edge of each of the plurality of valve leaflets is sutured to the proximal edge of the outer skirt.

### Claim 14 (depends on 13)

The heart valve implant of claim 13, wherein root edge of each of the plurality of valve leaflets and the proximal edge of the outer skirt are sutured around the expandable framework such that the root edge of the plurality of valve leaflets and the proximal edge of the outer skirt may move relative to the expandable framework.

### Claim 15 (depends on 11)

The heart valve implant of claim 11, wherein the distal edge of the outer skirt is attached to one or more of the plurality of valve leaflets at one or more attachment points.

### Claim 16 (depends on 11)

The heart valve implant of claim 11, wherein the outer skirt is configured to capture fluid flow around an exterior of the expandable framework within the outer skirt.

### Claim 17 (depends on 11)

The heart valve implant of claim 11, wherein the outer skirt is substantially impervious to fluid.

### Claim 18 (depends on 11)

The heart valve implant of claim 11, wherein the proximal edge of the outer skirt is disposed upstream of the inflow end of the expandable framework.

### Claim 19 (depends on 11)

The heart valve implant of claim 11, wherein the expandable framework further includes an upper crown, wherein the distal edge of the outer skirt is disposed proximal of the upper crown.

### Claim 20

A method for delivering a heart valve implant at a target site, the method comprising:
advancing a heart valve implant to a target site adjacent the heart, the heart valve implant including:
an expandable framework configured to shift from a closed configuration to an expanded configuration, the expandable framework having an inflow end, an outflow end and a lumen extending therein;
a plurality of valve leaflets coupled to the expandable framework, each of the plurality of valve leaflets including a root edge and a free edge; and
an outer skirt coupled to the plurality of valve leaflets, the outer skirt including a proximal edge;
wherein the root edge of each of the plurality of valve leaflets is attached to the proximal edge of the outer skirt; and
deploying the implantable heart valve at the target site.
