Method of making a stent
First Claim
Patent Images
1. A method for making a medical device, comprising:
- (a) providing a polymeric tube;
(b) cutting a pattern into the tube by a laser, 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-V shaped zone;
(ii) the rings include struts and crowns, the struts fold towards and unfold away from each other at the crowns;
(iii) at least one of the links being a marker link, the marker link having a first structure off a first side wall of the marker link for holding a first marker and a second structure off a second, opposite side wall of the marker link for holding a second marker, wherein the first and second structures are not longitudinally off-set from one another off of the marker link; and
(iv) 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 the first and second structures;
and(c) placing the first and second markers in the structures and forming a stent; and
(d) crimping the stent to a crimped diameter on a section of a catheter delivery assembly, such that the pair of rings, between which the marker link resides, do not make contact with the first and second structures in the crimped diameter, whereby a medical device comprising the stent and catheter is produced.
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Accused Products
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.
585 Citations
31 Claims
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1. A method for making a medical device, comprising:
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(a) providing a polymeric tube; (b) cutting a pattern into the tube by a laser, 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-V shaped zone; (ii) the rings include struts and crowns, the struts fold towards and unfold away from each other at the crowns; (iii) at least one of the links being a marker link, the marker link having a first structure off a first side wall of the marker link for holding a first marker and a second structure off a second, opposite side wall of the marker link for holding a second marker, wherein the first and second structures are not longitudinally off-set from one another off of the marker link; and (iv) 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 the first and second structures; and (c) placing the first and second markers in the structures and forming a stent; and (d) crimping the stent to a crimped diameter on a section of a catheter delivery assembly, such that the pair of rings, between which the marker link resides, do not make contact with the first and second structures in the crimped diameter, whereby a medical device comprising the stent and catheter is produced. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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; andWT is a ring wall thickness.
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7. The method of claim 6, wherein each strut has an aspect ratio (AR) of 0.8 to 1.4, AR being defined as ratio of width to thickness, and wherein each link has an AR of 0.4 to 0.9.
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8. The method of claim 1,
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 the value derived from equation 1 or equation 2: -
MCD=(Σ
Swi+Σ
Crj+Σ
Lwk)*(π
)−
1+2*WT
(equation
1)
MCD=(Σ
Swi+Σ
Crj+Σ
Lwk)*(π
)−
1
(equation
2)such that Σ
Swi (1=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; andWT is a ring wall thickness.
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9. The method of claim 8, wherein each strut has an aspect ratio (AR) of 0.8 to 1.4, AR being defined as ratio of width to thickness, and wherein each link has an AR of 0.4 to 0.9.
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10. The method of claim 1, wherein the marker link is longer than the links which do not have a marker.
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11. The method of claim 1, wherein a pre-crimped crown angle is greater than a deployment crown angle.
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12. The method of claim 1, wherein the first structure and the second structure 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.
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13. 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.
- Y”
-
14. The method of claim 1, wherein at least one 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.
- Y”
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15. The method of claim 1, wherein the minimum crimped diameter is an inner diameter of the stent 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 is touching each other.
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16. 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.
- Y”
-
17. The method of claim 1, wherein the set of rings comprises 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.
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18. The method of claim 1, wherein at least one of the struts has an aspect ratio (AR) of 0.8 to 1.4, and wherein at least one of the links has an aspect ratio of (AR) 0.4 to 0.9, AR being defined as ratio of width to thickness.
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19. The method of claim 1, wherein each of the closed cells consists of 8 link-free crowns.
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20. The method of claim 1, wherein the at least one pair of neighboring middle rings forms only 3 W-V shaped closed cells.
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21. The method of claim 1, wherein the set of rings 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-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. -
22. 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, andwherein the pattern further includes a pattern of one and three link-free crowns between the “
Y” and
“
W”
shaped crowns.
- Y”
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23. 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.
- and
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24. The method of claim 1, wherein the set of rings comprises 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 the 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 circumferentially offset from the links between the third ring and the fourth ring.
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25. A method of making a medical device, comprising:
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(a) cutting a pattern into a tube by a laser, 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 pair of rings is designated as a marker link, the marker link having a first element off of a first side of the marker link for holding a first marker and a second element off of a second, opposite side of the marker link for holding a second marker, (d) placing the first marker in the first element and the second marker in the second element 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 first and second elements are not longitudinally offset from each other, and (e) crimping the stent on a balloon of a catheter, such that in a crimped configuration the pair of rings adjoined by the marker link do not make contact with the first and second elements, and wherein the first element and second element including the first and second markers are arranged circumferentially off of the marker link and spaced from the pair of 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 elements. - View Dependent Claims (26, 27, 28, 29, 30, 31)
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Specification