# US 11,439,504 B2 · Replacement heart valve with improved cusp washout and reduced loading

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- Number: US 11,439,504 B2
- Document ID: US11439504B2
- Status: Granted
- Kind: B2
- Application number: 16/870,266
- Filed: 2020-05-08
- Published: 2020-11-12
- Granted: 2022-09-13
- Earliest claimed: 2019-05-10
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Michael G. Hayes; Tara Hogan
- Web page: https://patentgrep.com/patent/US11439504B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2415: {Manufacturing methods}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/0023: differing in porosity
- A61F 2250/0024: made from both porous and non-porous parts, e.g. adjacent parts
- 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

A medical implant may include an expandable anchor member having a lumen extending through the expandable anchor member from an inflow end to an outflow end; a plurality of valve leaflets disposed within the lumen extending through the expandable anchor member; a seal member disposed adjacent an exterior of the expandable anchor member; and a porous material extending from the seal member to the plurality of valve leaflets.

## Claims

### Claim 1

A medical implant, comprising:
an expandable anchor member having a lumen extending through the expandable anchor member from an inflow end to an outflow end;
a plurality of valve leaflets disposed within the lumen extending through the expandable anchor member, the plurality of valve leaflets configured to move between an open configuration and a closed configuration;
a seal member disposed adjacent an exterior of the expandable anchor member; and
a porous material extending from the seal member to the plurality of valve leaflets, the porous material configured to allow fluid flow therethrough while the plurality of valve leaflets are in the closed configuration.

### Claim 2 (depends on 1)

The medical implant of claim 1, wherein the seal member is disposed outside of the lumen extending through the expandable anchor member.

### Claim 3 (depends on 1)

The medical implant of claim 1, wherein at least a portion of the porous material is disposed within the lumen extending through the expandable anchor member.

### Claim 4 (depends on 1)

The medical implant of claim 1, wherein the seal member includes a reinforcing band disposed proximate the inflow end of the expandable anchor member.

### Claim 5 (depends on 4)

The medical implant of claim 4, wherein the porous material extends from the reinforcing band to the plurality of valve leaflets.

### Claim 6 (depends on 4)

The medical implant of claim 4, wherein the reinforcing band does not pass through interstices in the expandable anchor member.

### Claim 7 (depends on 4)

The medical implant of claim 4, wherein the porous material does not pass through interstices in the expandable anchor member.

### Claim 8 (depends on 1)

The medical implant of claim 1, wherein the porous material includes a polymeric coating.

### Claim 9

A medical implant, comprising:
an expandable anchor member having a lumen extending through the expandable anchor member from an inflow end to an outflow end;
a plurality of valve leaflets disposed within the lumen extending through the expandable anchor member, the plurality of valve leaflets configured to move between an open configuration and a closed configuration;
a seal member disposed adjacent an exterior of the expandable anchor member; and
a fabric material extending from the seal member to the plurality of valve leaflets, the fabric material having a plurality of holes therethrough permitting fluid to flow between an inflow side of the plurality of valve leaflets and an outflow side of the plurality of valve leaflets without passing through the plurality of valve leaflets, while the plurality of valve leaflets are in the closed configuration.

### Claim 10 (depends on 9)

The medical implant of claim 9, wherein at least one seal stitch secures the seal member to the fabric material.

### Claim 11 (depends on 10)

The medical implant of claim 10, wherein the at least one seal stitch includes at least one whip stitch.

### Claim 12 (depends on 9)

The medical implant of claim 9, wherein at least one leaflet stitch secures the fabric material to the plurality of valve leaflets.

### Claim 13 (depends on 12)

The medical implant of claim 12, wherein the at least one leaflet stitch includes a running stitch.

### Claim 14 (depends on 12)

The medical implant of claim 12, wherein the at least one leaflet stitch includes a double running stitch.

### Claim 15 (depends on 12)

The medical implant of claim 12, wherein the at least one leaflet stitch includes at least one whip stitch.

### Claim 16

A medical implant, comprising:
an expandable anchor member having a lumen extending through the expandable anchor member from an inflow end to an outflow end;
a plurality of valve leaflets disposed within the lumen extending through the expandable anchor member; and
a seal member disposed adjacent an exterior of the expandable anchor member and attached to the plurality of valve leaflets at the inflow end of the expandable anchor member;
wherein the plurality of valve leaflets each include a thinned region disposed proximate the inflow end of the expandable anchor member.

### Claim 17 (depends on 16)

The medical implant of claim 16, wherein the thinned region includes a plurality of holes extending through the thinned region permitting fluid to flow between an inflow side of the plurality of valve leaflets and an outflow side of the plurality of valve leaflets without passing through a lumen defined by free edges of the plurality of leaflets.

### Claim 18 (depends on 17)

The medical implant of claim 17, wherein the plurality of holes has a variable size.

### Claim 19 (depends on 17)

The medical implant of claim 17, wherein the plurality of holes decreases in size in a direction from the inflow end of the expandable anchor member toward the outflow end of the expandable anchor member.

### Claim 20 (depends on 16)

The medical implant of claim 16, wherein the thinned region does not pass through interstices in the expandable anchor member.
