Polymer scaffolds having a low crossing profile

• US 9,827,119 B2
• Filed: 07/03/2014
• Issued: 11/28/2017
• Est. Priority Date: 01/30/2010
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Anukhin, Boris, Ngo, Michael H., Trollsas, Mikael, Hossainy, Syed, Papp, John
• Primary Examiner(s): Besler, Christopher
• Application Number:
  US14/323,992
• Publication Number:
  US 20140330363A1
• Time in Patent Office: 1,244 Days
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: B23P 11/005 by expanding or crimping
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29C 69/00 Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore B29C48/001 takes precedence
• CPC Class Codes: Y10T 29/49908 Joining by deforming

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 also has a reduced crimped profile and a modification of the scaffold'"'"'s ring structure at the crowns that contributes to the reduced crimped profile.

Claims

1. A method, comprising:

using a balloon having an inflated diameter (Di);

using a bioabsorbable scaffold having a pre-crimp diameter (Dpc), the scaffold formed from a tube comprising a bioabsorbable polymer; and

crimping the scaffold to the balloon;

wherein the scaffold and balloon satisfy the following equation;

1.1×

(Di)×

(1.2)<sup>−

1</sup>≦

Dpc≦

1.7×

(Di)×

(1.2)<sup>−

1</sup>,

and

wherein the scaffold comprises

a set of longitudinally spaced rings formed by struts and crowns, the struts configured to fold towards and unfold away from each other at the crowns, and

the set of longitudinally spaced rings including a proximal end ring, a distal end ring opposing the proximal end ring, and interior rings positioned between the end rings, wherein each ring is associated with its direct neighboring ring by links.

2. The method of claim 1, wherein the crowns have a pre-crimped crown angle of less than 115 degrees.

3. The method of claim 1, wherein each strut has an aspect ratio (AR) of 0.8 to 1.4, AR being defined as a ratio of width to thickness and wherein each link has an aspect ratio of (AR) 0.4 to 0.9.

4. The method of claim 1,

wherein at least one pair of neighboring interior 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.

5. The method of claim 1, wherein at least some of the interior rings have sinusoidal segments and a repeating pattern of “

Y”

shaped and “

W”

shaped crowns where the sinusoidal segments meet the links, and wherein the pattern further includes a crown that is link-free between each “

Y” and

“

W”

shaped crown.

6. The method 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 interior 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 interior ring.

7. The method claim 1, comprising 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 circumferentially offset from the links between the third ring and fourth ring, all links running along a longitudinal, central axis of the scaffold made from the rings and links.

8. The method of claim 1, wherein a space bounded by portions of at least one pair of longitudinally spaced neighboring interior rings and circumferentially spaced links connecting the pair of interior rings form a W-shaped closed cell.

9. The method of claim 8, wherein the at least one pair of the longitudinally spaced neighboring interior rings forms only 4 W-shaped closed cells.

10. The method of claim 9, wherein each of the closed cells consists of 4 link-free crowns.

11. The method of claim 1, wherein the scaffold comprises a first ring, a second ring, and a third ring, the second ring being positioned between the first and third rings, and

wherein the first and second rings, including the links there between, define a first set of W-shaped closed cells,

wherein the second and third rings, including the links there between, define a second set of W-shaped closed cells, and

wherein the W-shaped closed cells of the first set are circumferentially off-set from the W-shaped closed cells of the second set.

12. The method of claim 11, 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.

13. The method of claim 1, wherein

at least one of the links of the scaffold comprises a marker structure for holding a pair of markers,

the marker structure includes a pair of depots in which the markers are placed, the depots being placed in a planar view along a vertical axis (B-B) perpendicular to a longitudinal axis (A-A);

and

wherein the set of rings includes a minimum crimped diameter (MCD) such that in the minimum crimped diameter, a pair of rings, between which the marker structure resides, do not make contact with the marker structure.

14. The method of claim 13, wherein the minimum crimped diameter (MCD) is an inner diameter of the scaffold when the following step is performed:

bending the struts of the rings towards each other, wherein the struts bend at the crowns, such that after bending, at least one of a pair of struts adjoined by a crown is separated by a distance of about zero or the at least one pair of struts are touching each other.

15. The method of claim 13,

wherein each link adjoins a pair of the neighboring rings at a crown of each ring, and

wherein the minimum crimped diameter (MCD) is equal to a value derived from equation 1 for struts having an essentially square cross-section or from equation 2 for struts having a trapezoidal cross-section:

(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

)<sup>−

1</sup>+2*WT 

 

(equation

     1)

(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

<sup>−

1</sup> 

 

(equation

     2)

wherein

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.

16. The method of claim 13,

wherein each link adjoins a pair of the neighboring rings at a crown of each ring, and

wherein the minimum crimped diameter (MCD) is less than a value derived from equation 1 for struts having an essentially square cross-section or from equation 2 for struts having a trapezoidal cross-section:

(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

)<sup>−

1</sup>+2*WT 

 

(equation

     1)

(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

<sup>−

1</sup> 

 

(equation

     2)

wherein

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.

17. The method of claim 1, wherein a space bounded by portions of at least one pair of longitudinally spaced neighboring interior rings and circumferentially spaced links connecting the pair of interior rings form a W-V shaped closed cell.

18. The method of claim 17, wherein the at least one pair of the longitudinally spaced neighboring interior rings forms only 3 W-V shaped closed cells.

19. The method of claim 1, comprising a first ring, a second ring, and a third ring, the second ring being positioned between the first and third rings, and

wherein the first and second rings, including the links there between, define a first set of W-V shaped closed cells,

wherein the second and third rings, including the links there between, define a second set of W-V shaped closed cells, and

wherein the W-V shaped closed cells of the first set are circumferentially off-set from the W-V shaped closed cells of the second set.

20. The method of claim 19, wherein each of the closed cells consists of 8 link-free crowns.

21. The method of claim 1, wherein at least some of the interior rings have a repeating pattern of “

Y”

shaped and “

W”

shaped crowns where the rings meet the links, and

wherein the pattern further includes a pattern of one and three link-free crowns between the “

Y” and

“

W”

shaped crowns.

22. The method 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 interior ring;

and

wherein the links between the first pair of rings are out of phase or 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 interior ring.

23. The method of claim 1, comprising 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 second ring are circumferentially offset from the links between the third ring and fourth ring.

24. The method of claim 1, wherein the scaffold further includes four or three links connecting a first ring to a second ring, wherein each link is straight and extends parallel to a longitudinal axis.