Time-dependent polymer scaffolds

Patent metadata

Field	Value
Publication number	US-9517150-B2
Application number	US-201313842432-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Oct 23, 2012
Publication date	Dec 13, 2016
Grant date	Dec 13, 2016

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.

First claim

What is claimed is:

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.

2. 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.

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

4. 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%.

5. 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.

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

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.

8. 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.

9. 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.

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Hossainy Syed
• Trollsas Mikael
• Ngo Michael Huy
• Eli Erik David

Classifications

• A61F2240/00

  Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof · CPC title

• B29L2031/753

  Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008) · CPC title

• A61F2/915 Primary

  with bands having a meander structure, adjacent bands being connected to each other · CPC title

• A61F2/958

  Inflatable balloons for placing stents or stent-grafts · CPC title

• A61F2230/0054

  V-shaped · CPC title