# US 10,500,076 B2 · Shape memory bioresorbable polymer peripheral scaffolds

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- Number: US 10,500,076 B2
- Document ID: US10500076B2
- Status: Granted
- Kind: B2
- Application number: 15/588,514
- Filed: 2017-05-05
- Published: 2017-10-12
- Granted: 2019-12-10
- Earliest claimed: 2012-07-23
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: John J. Stankus; Hugh Zhao; Mikael Trollsas; Syed Faiyaz Ahmed Hossainy; Michael H. Ngo; Yunbing Wang; Benjamyn Serna
- Web page: https://patentgrep.com/patent/US10500076B2

## CPC

- A61F 2/86: Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61L 31/041: {Mixtures of macromolecular compounds}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61F 2002/91508: {the meander having a difference in amplitude along the band}
- A61F 2002/91541: {Adjacent bands are arranged out of phase}
- A61F 2002/91558: {connected peak to peak}
- A61F 2210/0019: operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
- A61F 2230/0054: V-shaped
- A61F 2230/0056: W-shaped, e.g. M-shaped, sigma-shaped
- A61F 2230/006: Y-shaped
- A61F 2250/001: for adjusting a diameter
- A61L 2400/16: Materials with shape-memory or superelastic properties
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Bioabsorbable scaffolds having high crush recoverability, high fracture resistance, and reduced or no recoil due to self expanding properties at physiological conditions are disclosed. The scaffolds are made from a random copolymer of PLLA and a rubbery polymer such as polycaprolactone.

## Claims

### Claim 1

A stent, comprising:
a scaffold formed from a polymer tube and configured for being crimped to a balloon,
the scaffold having a pattern of interconnected struts and
the scaffold having an expanded diameter when expanded from a crimped state by the balloon,
wherein the scaffold comprises a random copolymer of poly(L-lactide) (PLLA) and polycaprolactone (PCL) and the PCL is 3 to 10 wt % or mol % of the copolymer,
wherein the glass transition temperature of the random copolymer is between 30° C. and 50° C.,
wherein the scaffold pattern includes a plurality of undulating rings having crowns and longitudinally extending links connecting one ring to another adjacent ring, wherein the crowns include W-crowns, Y-crowns, and free crowns,
wherein a first link connects a first ring to an adjacent ring, the first link forms with the first ring a W-crown, and the first link forms with the adjacent ring a Y-crown;
wherein the first ring, the adjacent ring, and the first link forms repeating W-V closed cells, and
wherein the W-V cells have three free crowns between the W-crown and a Y-crown.

### Claim 2 (depends on 1)

The stent of claim 1, wherein the scaffold attains greater than about 80% of the expanded diameter after being crushed to at least 50% of the expanded diameter.

### Claim 3 (depends on 1)

The stent of claim 1, wherein the scaffold comprises a blend of the copolymer and another polymer.

### Claim 4 (depends on 1)

The stent of claim 1, wherein a glass transition temperature (Tg) of the copolymer changes by less than 15% from a dry to a wet state.

### Claim 5 (depends on 1)

The stent of claim 1, wherein a weight average molecular weight of the copolymer is between 60 and 150 kDa.

### Claim 6 (depends on 1)

The stent of claim 1, wherein any of the crowns have a maximum crown angle of between about 90 degrees and 115 degrees when the scaffold has the expanded diameter.

### Claim 7 (depends on 1)

The stent of claim 1, wherein the crystallinity of the scaffold is 20% to 30%.

### Claim 8 (depends on 1)

The stent of claim 1, wherein the crystallinity of the scaffold is 10% to 40%.

### Claim 9

A stent, comprising:
a scaffold formed from a polymer tube and configured for being crimped to a balloon,
the scaffold having a pattern of interconnected struts and the scaffold having an expanded diameter when expanded from a crimped state by the balloon,
wherein the scaffold comprises a random copolymer of poly(L-lactide) (PLLA) and polycaprolactone (PCL) and the PCL is 1 to 75 wt % or mol % of the copolymer,
wherein the crystallinity of the scaffold is 20% to 30%,
wherein the scaffold pattern includes a plurality of undulating rings having crowns and longitudinally extending links connecting one ring to another adjacent ring, wherein the crowns include W-crowns, Y-crowns, and free crowns not connected to a link, wherein the scaffold pattern forms closed cells,
wherein a first link connects a first ring to an adjacent ring, the first link forms with the first ring a W-crown, and the first link forms with the adjacent ring a Y-crown;
wherein the first ring, the adjacent ring, and the first link form repeating W-V closed cells,
wherein the W-V cells have three free crowns between a W-crown and a Y-crown.

### Claim 10 (depends on 9)

The stent of claim 9, wherein the glass transition temperature of the random copolymer is between 30° C. and 50° C.

### Claim 11 (depends on 9)

The stent of claim 9, wherein when the scaffold self-expands in a lumen, it exerts an outward residual force on the lumen wall.

### Claim 12 (depends on 9)

The stent of claim 9, wherein the PCL is 15 to 50 wt % or mol % of the copolymer.

### Claim 13 (depends on 9)

The stent of claim 9, wherein the PCL is 15 to 30 wt % or mol % of the copolymer.

### Claim 14 (depends on 9)

The stent of claim 9, wherein the PCL is 50 to 75 wt % or mol % of the copolymer.

### Claim 15 (depends on 9)

The stent of claim 9, wherein the PCL is 1 to 5 wt % or mol % of the copolymer.

### Claim 16 (depends on 9)

The stent of claim 9, wherein the PCL is less than 15 wt % or mol % of the copolymer.

### Claim 17 (depends on 9)

The stent of claim 9, wherein the scaffold attains greater than about 80% of the expanded diameter after being crushed to at least 50% of the expanded diameter.

### Claim 18 (depends on 9)

The stent of claim 9, wherein the PCL is 3 to 10 wt % or mol % of the copolymer.