# US 11,278,403 B2 · Balloon-expandable heart valve system and method of implantation

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- Number: US 11,278,403 B2
- Document ID: US11278403B2
- Status: Granted
- Kind: B2
- Application number: 16/871,005
- Filed: 2020-05-10
- Published: 2021-11-11
- Granted: 2022-03-22
- Earliest claimed: 2020-05-10
- Assignees: Vitae LLC
- Applicants: Vitae LLC
- Inventors: Bin Tian
- Web page: https://patentgrep.com/patent/US11278403B2

## CPC

- A61F 2/2433: {using balloon catheter}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2002/9583: {Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve}
- A61F 2250/0029: differing in bending or flexure capacity
- A61F 2250/0039: differing in diameter
- 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 system has a heart valve assembly that includes a stent-frame having an anchoring section and an outflow section, with the anchoring section having a distal annulus section and a support section that is positioned between the distal annulus section and the outflow section. The distal annulus section has a concave inflection. A leaflet assembly is stitched to the anchoring section. The system also includes a balloon on which the heart valve assembly is crimped, the balloon having a central valve contact portion that has an outflow portion, a neck portion, and a central portion between the outflow portion, and the neck portion. The outflow portion of the balloon receives the outflow section of the stent-frame, the central portion of the contact portion of the balloon receives the support section of the stent-frame, and the neck portion receives the annulus section of the stent-frame.

## Claims

### Claim 1

A system, comprising:
a heart valve assembly, comprising:
a stent-frame comprising an anchoring section and an outflow section, the anchoring section having a distal annulus section and a support section that is positioned between the distal annulus section and the outflow section,
wherein the distal annulus section is defined by a single distal row of cells that has a distal-most annular ring of alternating peaks and valleys, with the distal row of cells having a concave inflection,
wherein the outflow section is defined by a single proximal row of cells, with each cell in the proximal row of cells having a generally hexagonal shape, and having a proximal-most annular ring of alternating peaks and valleys, and
a leaflet assembly stitched to the anchoring section; and
a balloon on which the heart valve assembly is crimped, the balloon comprising:
a proximal section and a distal section; and
a central valve contact portion positioned between the proximal and distal sections, the contact portion having an outflow portion, a neck portion, and a central portion between the outflow portion and the neck portion, wherein the neck portion has an inflection zone that corresponds in size and shape with the concave inflection of the distal annulus section; and
wherein the outflow portion of the balloon receives the outflow section of the stent-frame, the central portion of the contact portion of the balloon receives the support section of the stent-frame, and the neck portion receives the annulus section of the stent-frame.

### Claim 2 (depends on 1)

The system of claim 1, wherein the entire support section is defined by a generally annular body having a plurality of four-sided cells.

### Claim 3 (depends on 2)

The system of claim 2, wherein each cell in the single distal row of cells is four-sided.

### Claim 4 (depends on 1)

The system of claim 1, wherein the alternating peaks and valleys of the proximal-most annular ring are connected to each other by angled struts, and each valley has a straight strut extending therefrom to connect to the support section.

### Claim 5 (depends on 1)

The system of claim 1, wherein the distal-most annular ring of alternating peaks and valleys defines a ring of distal peaks that has a distal peak diameter and a ring of distal valleys that has a distal valley diameter, with the distal peak diameter having the greatest diameter for the entire stent-frame, and the distal valley diameter having the smallest diameter for the entire stent-frame.

### Claim 6 (depends on 1)

The system of claim 1, wherein the distal annulus section is more flexible than the support section.

### Claim 7 (depends on 1)

The system of claim 1, wherein the outflow section is more flexible than the support section.

### Claim 8 (depends on 1)

The system of claim 1, wherein the outflow section is more flexible than the distal annulus section.

### Claim 9 (depends on 1)

The system of claim 1, wherein the support section has a tapered configuration.

### Claim 10 (depends on 1)

The system of claim 1, wherein the balloon has a varying diameter which is smallest at the inflection zone.

### Claim 11 (depends on 1)

The system of claim 1, wherein the contact portion of the balloon has a tapered configuration.