Crush recoverable polymer scaffolds

Patent metadata

Field	Value
Publication number	US-9770351-B2
Application number	US-201314042512-A
Country	US
Kind code	B2
Filing date	Sep 30, 2013
Priority date	Jan 30, 2010
Publication date	Sep 26, 2017
Grant date	Sep 26, 2017

Abstract

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold, after being deployed by the balloon, provides a crush recovery of about 90% after the diameter of the scaffold has been pinched or crushed by 50%. The scaffold has a pattern including an asymmetric closed cell connecting links connecting the closed cells.

First claim

What is claimed is:

1. An implantable medical scaffold, comprising:
a set of rings including a proximal end ring, a distal end ring opposing the proximal end ring, and middle rings positioned between the end rings, wherein each ring is associated with its direct neighboring ring by links, and wherein at least one pair of neighboring middle rings can be delineated, via corresponding links there between, into closed cells comprising a W- or a general W-shaped zone included within the closed cell;
at least one of the links being a marker link, the marker link having a first cylindrical or part-cylindrical protrusion off a first side wall of the marker link for holding a first marker and a second cylindrical or part-cylindrical protrusion off a second, opposite side wall of the marker link for holding a second marker, wherein a distance of the first marker from an end point of the marker link is equal to the distance of the second marker from the same end point of the marker link such that the first and second protrusions are symmetrically aligned off of the marker link and are not longitudinally off-set from one another off of the marker link; and
wherein the set of rings includes a minimum crimped diameter such that in the minimum crimped diameter, a pair of rings, between which the marker link resides, do not make contact with a bulging perimeter of the first and second protrusions,
wherein the rings include crowns and struts, each link adjoining a pair of the neighboring rings at a crown of each ring, and
wherein minimum crimped diameter (MCD) is less than a value derived from equation 1 or equation 2:
MCD<(Σ Swi+ΣCrj+ΣLwk )*(π) −1 +2*WT  (equation 1)

MCD<(Σ Swi+ΣCrj+ΣLwk )*(π) −1   (equation 2)

such that
Σ Swi (i=1 . . . n) is the sum of n ring struts having width Swi;
Σ Crj (j=1 . . . m) is the sum of m crown inner radii having radii Crj (times 2);
Σ Lwk (k=1 . . . p) is the sum of p links having width Lwk; and
WT is a ring wall thickness.

2. The implantable medical scaffold of claim 1 , wherein at least some of the struts have an aspect ratio (AR) of 0.8 to 1.4, AR being defined as ratio of width to thickness.

3. The implantable medical scaffold of claim 2 , wherein at least some of the links have an AR of 0.4 to 0.9.

4. The implantable medical scaffold of claim 1 , wherein the marker link is longer than the links which do not have a marker.

5. The implantable medical scaffold of claim 1 , wherein the crowns have a crown angle of less than 115 degrees.

6. The implantable medical scaffold of claim 1 , wherein a pre-crimped crown angle is greater than a deployment crown angle.

7. The implantable medical scaffold of claim 1 , wherein the first protrusion and the second protrusion including the first and second markers are circumferentially off-set from the marker link and spaced from the pair of rings associated with the marker link.

8. The implantable medical scaffold of claim 1 , wherein each pair of neighboring middle rings forms only 4 closed cells.

9. The implantable medical scaffold of claim 1 , wherein the middle rings comprise a network of circumferentially positioned closed cells and longitudinally positioned closed cells, the circumferentially positioned closed cells can be numbered 1 to n, and the longitudinally positioned closed cells can be numbered 1 to m, such that the odd numbered longitudinally positioned closed cells are in phase with each other, the even numbered longitudinally positioned closed cells are in phase with each other, and the odd numbered cells and even numbered cells longitudinally positioned closed cells are out of phase with each other.

10. The implantable medical scaffold of claim 9 , wherein n is 4.

11. The implantable medical scaffold of claim 1 ,
wherein at least one pair of the neighboring middle rings is adjoined by middle links, each middle link is associated with one crown of one ring and another crown of the neighboring ring, such that each middle link and its corresponding crown for the one ring form a generally “Y” shaped structure and each middle link and its corresponding crown for the neighboring ring form a generally “W” shaped structure.

12. The implantable medical scaffold of claim 1 , wherein the marker link and two strut segments of a ring associated with the marker link form a “Y” shaped segment.

13. The implantable medical scaffold of claim 1 , wherein the rings are approximately zig-zag like in pattern.

14. The implantable medical scaffold of claim 1 , wherein the rings are curved like in pattern.

15. The implantable medical scaffold of claim 1 , wherein all of the links are parallel to a longitudinal axis of a tubular device made from the rings and links.

16. The implantable medical scaffold of claim 1 ,
wherein the marker link runs parallel to a longitudinal axis of a tubular device made from the rings and links,
wherein the first marker is oriented at a distance and circumferentially from the second marker, and
wherein the first marker at least partially overhangs from the first side wall and the second marker at least partially overhangs from the second side wall.

17. The implantable medical scaffold of claim 1 , wherein the rings comprise a first ring, a second ring, and a third ring, the second ring being positioned between the first and third rings, wherein the links residing between the first ring and the second ring are circumferentially off-set from the links residing between the second ring and the third ring.

18. The implantable medical scaffold of claim 17 ,
wherein the first and second rings, including the links there between, define a first set of closed cells each having a W- or general W-shaped configuration,
wherein the second and third rings, including the links there between, define a second set of closed cells each having a W- or general W-shaped configuration, and
wherein the W- or general W-shaped configurations of the first set of closed cells are circumferentially off-set from the W- or general W-shaped configurations of the second set of closed cells.

19. The implantable medical scaffold of claim 18 , wherein the first set consists of 4 closed cells and the second set consists of 4 closed cells, and further wherein each cell consists of 4 crowns that are not connected to any links.

20. The implantable medical scaffold of claim 1 ,
wherein the links between a first pair of rings are out of phase or circumferentially off-set from the links between a second pair of rings, the first pair of rings and the second pair of rings sharing a common middle ring; and
wherein the links between the first pair of rings are in phase or not circumferentially off-set from the links between a third pair of rings, the second pair of rings and the third pair of rings sharing a common middle ring.

21. The implantable medical scaffold of claim 1 , wherein the rings comprise a first ring, a second ring next to the first ring, a third ring next to the second ring, the second ring being in between the first and third rings, and a fourth ring next to the third ring, the third ring being in between the second and fourth rings, wherein the links between the first ring and the second ring are circumferentially offset from the links between the second ring and third ring, wherein the links between the second ring and the third ring are circumferentially offset from the links between the third ring and the fourth ring, and wherein the links between the first ring and the second ring are aligned with and not circum

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Trollsas Mikael
• Ngo Michael H
• Anukhin Boris
• Nikanorov Alexander
• Hossainy Syed
• Papp John E
• Jayasinghe Dudley
• Solter Zella

Classifications

• A61L31/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2230/0006

  circular · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• Y10T29/49908

  Joining by deforming · CPC title