Crush recoverable polymer scaffolds

• US 9,198,785 B2
• Filed: 12/04/2013
• Issued: 12/01/2015
• Est. Priority Date: 01/30/2010
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Trollsas, Mikael, Ngo, Michael H., Anukhin, Boris, Nikanorov, Alexander, Hossainy, Syed, Papp, John E., Jayasinghe, Dudley, Solter, Zella
• Primary Examiner(s): Hong, John C
• Application Number:
  US14/097,172
• Publication Number:
  US 20140090231A1
• Time in Patent Office: 727 Days
• Field of Search: 295/16, 295/05, 294/28, 294/50, 623/1.15, 623/1.18
• US Class Current: 1/1
• 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 2/844 folded prior to deployment
• CPC Class Codes: 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
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: 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
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/00 : Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61L 31/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: B21D 39/046 : Connecting tubes to tube-like fittings
• CPC Class Codes: B29C 2035/0838 : using laser
• CPC Class Codes: B29C 35/08 : by wave energy or particle radiation B29C64/00, B29C71/04 take precedence
• CPC Class Codes: B29K 2067/046 : PLA, i.e. polylactic acid or polylactide
• CPC Class Codes: B29L 2023/00 : Tubular articles B29L2024/00 takes precedence ; catheters B29L2031/7542
• CPC Class Codes: B29L 2031/7543 : Balloon catheters
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 71/02 : Polyalkylene oxides
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 29/4987 : Elastic joining of parts
• CPC Class Codes: Y10T 29/49908 : Joining by deforming
• CPC Class Codes: Y10T 29/49925 : Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/49927 : Hollow body is axially joined cup or tube

Abstract

A method of manufacturing a stent is disclosed. The stent includes a minimum crimped diameter such that in the minimum crimped diameter, a pair of stent rings, between which marker support structures reside, do not make contact with the marker support structures. The crimped profile of the stent of the present invention can be as small as the crimped profile of a same stent but without the marker support structures.

Claims

1. A method making a medical device, comprising:

(a) providing a polymeric tube;

(b) changing at least one of the mechanical properties of the tube;

(c) cutting a pattern into the tube by a laser process, wherein the pattern includes;

(i) 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 cells;

(ii) at least one of the links being a marker link, the marker link having a first part-cylindrical protrusion off a first side wall of the marker link for holding a first marker and a second part-cylindrical protrusion off a second, opposite side wall of the marker link for holding a second marker, wherein 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

(iii) wherein the polymeric tube is cut by the laser such that the set of rings and links are shaped to have 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; and

(d) placing the first and second markers in the protrusions and forming a stent;

(e) crimping the stent to a crimped diameter on a section of a catheter delivery assembly, wherein the crimping includes heating the polymeric stent to a target temperature, such that the pair of rings, between which the marker link resides, do not make contact with the bulging perimeter of the first and second protrusions in the crimped diameter, whereby a medical device comprising the stent and catheter is produced.

2. The method of claim 1, wherein the laser process includes a pico-second green light laser and the method further comprises using helium gas as a coolant during the cutting step.

3. The method of claim 2, wherein the laser process includes parameters having the following ranges:

4. The method of claim 1, wherein the laser process includes a pico-second green light laser.

5. The method of claim 1, wherein the diameter of the tube is greater than an expanded diameter of the stent when implanted in a lumen.

6. The method of claim 1, wherein the tube comprises PLLA and the target temperature is less than a glass transition temperature of the PLLA.

7. The method of claim 6, wherein the target temperature is 5 to 10 degrees below a glass transition temperature of the PLLA.

8. The method of claim 1, wherein the minimum crimped diameter is less than the crimped diameter.

9. The method of claim 1, wherein the stent is crimped on a balloon of the catheter assembly.

10. The method of claim 1,

wherein the rings include crowns and struts, each link adjoining a pair of the neighboring rings at a crown of each ring, and

wherein the minimum crimped diameter (MCD) is equal to the value derived from equation 1 or equation 2:

MCD=(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

)<sup>−

1</sup>+2*WT 

 

(equation

     1)

MCD=(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

)<sup>−

1</sup> 

 

(equation

     2)

such that

Swi (i=1 . . . n) is the sum of n ring struts having width Swi;

Crj (j=1 . . . m) is the sum of m crown inner radii having radii Crj (times

     2);

Lwk (k=1 . . . p) is the sum of p links having width Lwk; and

WT is a ring wall thickness.

11. The method of claim 10, wherein each ring has an aspect ratio (AR) of 0.8 to 1.4, AR being defined as ratio of width to thickness.

12. The method of claim 11, wherein each link has an AR of 0.4 to 0.9.

13. The method of claim 1,

wherein the rings include crowns and struts, each link adjoining a pair of the neighboring rings at a crown of each ring, and

wherein the minimum crimped diameter (MCD) is less than the value derived from equation 1 or equation 2:

MCD<

(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

)<sup>−

1</sup>+2*WT 

 

(equation

     1)

MCD<

(Σ

Swi+Σ

Crj+Σ

Lwk)*(π

)<sup>−

1</sup> 

 

(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.

14. The method of claim 13, wherein each ring has an aspect ratio (AR) of 0.8 to 1.4, AR being defined as ratio of width to thickness.

15. The method of claim 14, wherein each link has an AR of 0.4 to 0.9.

16. The method of claim 1, wherein the marker link is longer than the links which do not have a marker.

17. The method of claim 1, wherein the rings have crowns and the crowns have a crown angle of less than 115 degrees.

18. The method of claim 1, wherein the rings have crowns such that a pre-crimped crown angle is greater than a deployment crown angle.

19. The method 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.

20. The method of claim 1, wherein each pair of neighboring middle rings forms only 4 closed cell, the cells being W- or general W-shaped, and wherein at least some of the closed cells are immediately abutted against 6 neighboring closed cells.

21. The method 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 are out of phase with each other.

22. The method of claim 21, wherein n is 4.

23. The method 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 forms a generally “

Y”

shaped structure and each middle link and its corresponding crown for the neighboring ring forms a generally “

W”

shaped structure.

24. The method of claim 1, wherein each of the middle rings has undulated segments and a repeating pattern of “

Y”

shaped and “

W”

shaped constructions where the undulated segments meet the links, and wherein the pattern further includes an undulated segment that is link-free between each “

Y” and

“

W”

shaped construction.

25. The method of claim 1, wherein the minimum crimped diameter is an inner diameter of the stent when the following step is performed:

bending struts of the rings towards each other, wherein the struts bend at 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 is touching each other.

26. The method of claim 1, wherein the marker link and two strut segments of a ring associated with the marker link form a “

Y”

shaped segment.

27. The method of claim 1, wherein the rings are approximately zig-zag like in pattern.

28. The method of claim 1, wherein the rings are wave-like in pattern.

29. The method of claim 1, wherein all of the links are parallel to the longitudinal axis of the stent.

30. The method of claim 1,

wherein the marker link runs parallel to the longitudinal axis of the stent,

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.

31. 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, 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.

32. The method of claim 31,

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

wherein the W- or general W-shaped configuration of the first set of closed cells is circumferentially off-set from the W- or general W-shaped configuration of the second set of closed cells.

33. The method of claim 32, wherein the first set consist of 4 closed cells and the second set consist of 4 closed cells, and further wherein each cell consist of 4 crowns that are not connected to any links.

34. 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 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.

35. 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 the second ring are aligned with and not circumferentially offset from the links between the third ring and fourth ring, all links running parallel to a longitudinal, central axis of the stent.

36. The method of claim 1, wherein each of the closed cells consists of 4 link-free crowns.

37. The method of claim 1, wherein each ring is composed of strut segments such that a strut segment has an aspect ratio (AR) of 0.8 to 1.4, AR being defined as ratio of width to thickness.

38. The method of claim 1, wherein each of the links has an aspect ratio of (AR) 0.4 to 0.9, AR being defined as ratio of width to thickness.

39. The method of claim 1, wherein each ring as a pattern of undulations such that every other undulation is associated with a link.

40. The method of claim 1, wherein changing at least one of the mechanical properties of the tube comprises altering a fracture toughness of the tube.

41. The method of claim 1, wherein changing at least one of the mechanical properties of the tube comprises strengthening the tube.

42. The method of claim 1, wherein the closed cells form a W-V shaped closed cell.

43. The method of claim 42, wherein each of the closed cells consists of 8 link-free crowns.

44. The method of claim 1, wherein the at least one pair of neighboring middle rings forms only 3 W-V shaped closed cells.

45. 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.

46. The method of claim 1, wherein at least some of the middle 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.

47. 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.

48. 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.

49. A method of making a medical device, comprising:

(a) providing a polymeric tube;

(b) changing at least one of the mechanical properties of the tube;

(c) cutting a pattern into the tube by a laser process, wherein the pattern includes;

(i) a set of rings forming an open tubular body, the rings including struts that fold towards and unfold away from each other at crowns,

(ii) a plurality of links, wherein each ring is associated with a neighboring ring by links, and (iii) at least one of the links positioned between a first ring and a second ring being designated as a marker link, the marker link running parallel to a longitudinal axis of the tubular body, the marker link having a first quasi-cylindrical overhang off of a first side of the marker link for holding a first marker and a second quasi-cylindrical overhang off of a second, opposite side of the marker link for holding a second marker,

(d) placing the first marker in the first overhang and the second marker in the second overhang and forming a stent, wherein the first marker and second marker are positioned at a distance in a circumferential arrangement with respect to each other such that the first marker at least partially extends out from the first side of the marker link and the second marker at least partially extends out from the second side of the marker link,

wherein the position of the first overhang from the first side of the maker link mirrors the position of the second overhang from the second opposite side of the marker link such that the overhangs are not longitudinally offset from each other,

and

(e) crimping the stent on a balloon of a catheter at an elevated temperature, such that in a crimped configuration the pair of first and second rings adjoining the marker link do not make contact with the first and second marker overhangs, and

wherein the first overhang and second overhang including the first and second markers are arranged circumferentially off of the marker link and spaced from the first and second rings such that a crimped profile of the stent is the same as the crimped profile of a same stent but without the first and second overhangs.

50. The method of claim 49, wherein first ring includes an alternating pattern of peaks and troughs and the second ring includes an alternating pattern of peaks and troughs, such that there is at least one peak or trough for the first ring that is free from any links between the links that connect the first ring to the second ring, and such that there is at least one peak or trough for the second ring that is free from any links between the links that connect the first ring to the second ring.

51. The method of claim 49, wherein each ring is composed of a set of struts having an aspect ratio (AR) of 0.8 to 1.4.

52. The method of claim 49, wherein the laser process includes a pico-second green light laser and the method further comprises using helium gas as a coolant during the cutting step.

53. The method of claim 52, wherein the laser process includes parameters having the following ranges:

54. The method of claim 49, wherein the laser process includes a pico-second green light laser.

55. The method of claim 49, wherein the diameter of the tube is greater than an expanded diameter of the stent when implanted in a lumen.

56. The method of claim 49, wherein the tube comprises PLLA and the elevated temperature is less than a glass transition temperature of the PLLA.

57. The method of claim 56, wherein the elevated temperature is 5 to 10 degrees below the glass transition temperature of the PLLA.