# US 11,076,954 B2 · Gradually-expandable stent apparatus and method

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- Number: US 11,076,954 B2
- Document ID: US11076954B2
- Status: Granted
- Kind: B2
- Application number: 16/136,694
- Filed: 2018-09-20
- Published: 2019-03-21
- Granted: 2021-08-03
- Earliest claimed: 2017-09-21
- Assignees: The Cleveland Clinic Foundation
- Applicants: The Cleveland Clinic Foundation
- Inventors: Hani Najm; Kelly B. Emerton; Alex Lewis; Justin Metcalf
- Web page: https://patentgrep.com/patent/US11076954B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2210/0004: bioabsorbable
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2250/001: for adjusting a diameter
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- A61F 2250/0063: Nested prosthetic parts
- A61F 2250/0065: telescopic
- A61F 2250/0071: breakable or frangible
- A61F 2250/0082: specially designed for children, e.g. having means for adjusting to their growth
- 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 gradually-expandable stent includes a base ring completely encircling a central valve-accepting area. A plurality of uprights is provided. Each upright includes two longitudinally extending upright struts. Each upright strut has a strut base directly connected to the base ring and a strut tip directly attached to the other strut tip of the upright strut at a rounded upright apex. The upright apex is longitudinally spaced from the base ring. At least one expansion feature is associated with the base ring and gradually expands to enlarge the central valve-accepting area toward a maximum valve-accepting area responsive to growth of the patient over an extended dwell time.

## Claims

### Claim 1

A gradually-expandable stent, comprising:
a base ring, completely encircling a central valve-accepting area;
a plurality of uprights, each upright including two longitudinally extending upright struts, each upright strut having a strut base integrally formed with a portion of the base ring and a strut tip directly attached to the other strut tip of the upright strut at a rounded upright apex, the upright apex being longitudinally spaced from the base ring, each upright also including at least one crossbrace extending radially between adjacent upright struts of a chosen upright; and
at least one expansion feature associated with the base ring, the expansion feature including a beam integrally formed with a selected upright for selectively sliding radially with respect to a cuff integrally formed with an other upright, the expansion feature gradually expanding to enlarge the central valve-accepting area toward a maximum valve-accepting area responsive to growth of the patient over an extended dwell time.

### Claim 2 (depends on 1)

The stent of claim 1, being at least partially formed from a biodegradable material, the biodegradable material being strategically placed to facilitate gradual expansion of the stent over time as the biodegradable material degrades.

### Claim 3 (depends on 1)

The stent of claim 1, wherein the dwell time is a plurality of years.

### Claim 4 (depends on 1)

The stent of claim 1, wherein the plurality of uprights are each spaced equidistantly from one another around the base ring.

### Claim 5 (depends on 1)

The stent of claim 1, including a plurality of expansion features and wherein each expansion feature is interposed circumferentially between two adjacent uprights.

### Claim 6 (depends on 1)

The stent of claim 1, wherein the at least one expansion feature forms an integral part of the base ring.

### Claim 7 (depends on 1)

The stent of claim 1, wherein at least one expansion feature includes a beam for selectively sliding radially with respect to a cuff, at least one cuff being associated with each upright.

### Claim 8

A gradually-expandable stent, comprising:
a base ring, completely encircling a central valve-accepting area;
a plurality of uprights, each upright including two longitudinally extending upright struts, each upright strut having a strut base directly connected to the base ring and a strut tip directly attached to the other strut tip of the upright strut at a rounded upright apex, the upright apex being longitudinally spaced from the base ring;
at least one external ring feature, extending coaxially with the base ring and spaced laterally outside at least one upright; and
at least one expansion feature associated with at least one of the external ring feature and the base ring, each expansion feature gradually expanding to enlarge the central valve-accepting area toward a maximum valve-accepting area responsive to growth of the patient over an extended dwell time;
wherein each upright strut has a strut base integrally formed with a portion of the base ring, and the expansion feature includes a beam integrally formed with a selected upright for selectively sliding radially with respect to a cuff integrally formed with an other upright.

### Claim 9 (depends on 8)

The stent of claim 8, being at least partially formed from a biodegradable material, the biodegradable material being strategically placed to facilitate gradual expansion of the stent over time as the biodegradable material degrades.

### Claim 10 (depends on 8)

The stent of claim 8, wherein the dwell time is a plurality of years.

### Claim 11 (depends on 1)

The stent of claim 1, wherein the beam of at least one expansion feature is a smaller height than a portion of the base ring including the cuff.

### Claim 12 (depends on 1)

The stent of claim 1, wherein each upright is formed integrally with a base ring segment and an expansion feature including a beam and a cuff to create an upright/base unit, the stent being comprised of a plurality of daisy-chained upright/base units mutually connected by the beam and cuff of adjacent ones thereof.

### Claim 13 (depends on 12)

The stent of claim 12, wherein each upright/base unit is planar before being assembled into mutual connection with at least one other upright/base unit.

### Claim 14 (depends on 1)

The stent of claim 1, wherein the beam has a height which is larger than a thickness of the beam.

### Claim 15 (depends on 8)

The stent of claim 8, wherein the beam of at least one expansion feature is a smaller height than a portion of the base ring including the cuff.

### Claim 16 (depends on 8)

The stent of claim 8, including at least one crossbrace extending radially between adjacent upright struts of a chosen upright.

### Claim 17 (depends on 8)

The stent of claim 8, wherein each upright is formed integrally with a base ring segment and an expansion feature including a beam and a cuff to create an upright/base unit, the stent being comprised of a plurality of daisy-chained upright/base units mutually connected by the beam and cuff of adjacent ones thereof.

### Claim 18 (depends on 17)

The stent of claim 17, wherein each upright/base unit is planar before being assembled into mutual connection with at least one other upright/base unit.

### Claim 19 (depends on 8)

The stent of claim 8, wherein the beam has a height which is larger than a thickness of the beam.
