# US 9,517,150 B2 · Time-dependent polymer scaffolds

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- Number: US 9,517,150 B2
- Document ID: US9517150B2
- Status: Granted
- Kind: B2
- Application number: 13/842,432
- Filed: 2013-03-15
- Published: 2014-04-24
- Granted: 2016-12-13
- Earliest claimed: 2012-10-23
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Syed Hossainy; Mikael Trollsas; Michael Huy Ngo; Erik David Eli
- Web page: https://patentgrep.com/patent/US9517150B2

## CPC

- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- B29C 55/26: biaxial
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2002/91575: {connected peak to trough}
- A61F 2210/0004: bioabsorbable
- A61F 2230/0054: V-shaped
- A61F 2240/00: Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F 2240/008: Means for testing implantable prostheses
- A61F 2250/0071: breakable or frangible
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- B29C 55/24: radial
- B29C 69/001: {a shaping technique combined with cutting, e.g. in parts or slices combined with rearranging and joining the cut parts (for reinforced material B29C70/545; B29C49/4278, B29C51/268 take precedence)}
- B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)}
- Y10T 29/49: Method of mechanical manufacture
- Y10T 29/49927: Hollow body is axially joined cup or tube
- 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)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- 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)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings.

## Claims

### Claim 1

A medical device, comprising:
a balloon;
a scaffold that was cut from a tube comprising PLLA, wherein the tube has a ratio of diameter to wall thickness of between 20-40;
wherein the scaffold forms a network of rings interconnected by links, including
at least 8 crests and 8 troughs per ring,
a first ring,
a second ring adjacent the first ring, and
at most 2 links connecting the first ring to the second ring;
wherein the scaffold is crimped to the balloon by plastic deformation of the scaffold such that the scaffold has a crimped state;
wherein the scaffold has a post-dilation diameter when plastically deformed from the crimped state by inflation of the balloon and the scaffold attains over 80% of the post-dilation diameter after being crushed by an amount equal to over 50% of the post-dilation diameter; and
wherein the scaffold rings comprise struts and at least 90% of the struts are intact after a six-month simulated walking test.

### Claim 2 (depends on 1)

The device of claim 1, wherein the balloon has a nominal inflation diameter of between 5 to 8 mm and the tube is a biaxially-expanded tube having at least a 6 mm outer diameter.

### Claim 3 (depends on 1)

The device of claim 1, wherein the scaffold is made from a polymer composition comprising PLLA.

### Claim 4 (depends on 1)

The device of claim 1, wherein polymer chains of the crimped scaffold are aligned substantially in a radial direction resulting from a radial expansion of between about 400% and 450% and axial expansion of between 150% and 200%.

### Claim 5 (depends on 1)

The device of claim 1, wherein the scaffold attains about 80% of the post-dilation diameter after being crushed by an amount equal to over 60% of the post-dilation diameter.

### Claim 6 (depends on 1)

The device of claim 1, wherein the scaffold has 8, 9 or 12 crowns per ring.

### Claim 7

A medical device, comprising:
a scaffold formed from a radially expanded polymer tube and configured for being crimped to a balloon by plastic deformation of the scaffold wherein the plastically deformed scaffold has a crimped state;
the scaffold having a pre-crimp diameter and a wall thickness, wherein a ratio of the pre-crimp diameter to the wall thickness is between 20-40, and wherein the scaffold forms a network of rings interconnected by links, including
at least 8 crests and 8 troughs per ring,
a first ring,
a second ring adjacent the first ring, and
at most 2 links connecting the first ring to the second ring;
wherein the scaffold has a post-dilation diameter when plastically deformed from the crimped state by inflation of the balloon and the scaffold attains over 80% of the post-dilation diameter after being crushed by an amount equal to over 50% of the post-dilation diameter.

### Claim 8 (depends on 7)

The medical device of claim 7, wherein
the scaffold has 8 crests and 8 troughs per ring, or 12 crests and 12 troughs per ring,
each ring having a plurality of U crowns, Y crowns and W crowns,
the rings further including a third ring adjacent the second ring, and a fourth ring adjacent the third ring,
the first ring is connected to the second ring by two links, each of which being connected to the first ring at a W crown and the second ring at a Y crown and such that there are an equal number of U crowns on each side of the W crown of the first ring and each side of the Y crown of the second ring,
the second ring is connected to the third ring by two links, each of which being connected to the second ring at a W crown and the third ring at a Y crown and such that there are an equal number of U crowns on each side of the W crown of the second ring and each side of the Y crown of the third ring,
the third ring is connected to the fourth ring by two links, each of which being connected to the third ring at a W crown and the fourth ring at a Y crown and such that there are an equal number of U crowns on each side of the W crown of the third first ring and each side of the Y crown of the fourth ring.

### Claim 9 (depends on 8)

The medical device of claim 8, wherein each of the links has a longitudinal axis and extends parallel to a longitudinal axis of the scaffold, and wherein each of the links connecting the first ring to the second ring is co-linear with a respective one of the links connecting the third ring to the fourth ring.