Stent with radiopaque markers
First Claim
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1. A method of crimping a stent on a balloon, comprising:
- (a) providing a biodegradable polymeric stent, wherein the material from which structural elements of the stent are made consists of a lactide or lactic acid polymer (“
lactide-based polymer”
);
(b) attaching markers to the lactide-based polymeric stent to provide capability of obtaining images of the lactide-based polymeric stent with an imaging device during and after implantation of the stent in a vessel,wherein the stent consists of two pairs of markers, a first and second markers being attached in an adjacent configuration about a proximal end of the stent, and a third and fourth markers being attached in an adjacent configuration about a distal end of the stent, such that the stent has no other markers but for the four markers to allow for imaging of the lactide-based polymeric stent and such that an entire length of the stent between the first pair and second pair of markers is devoid of any markers,wherein the first marker is positioned at a circumferential distance from its adjacent second marker,wherein the third marker is positioned at a circumferential distance from its adjacent fourth marker, andwherein the pair of markers about the proximal end of the polymeric stent are circumferentially off-set from the pair of markers about the distal end of the polymeric stent; and
(c) crimping the stent on a balloon of a catheter assembly by application of a crimping pressure to the stent positioned over the balloon,wherein when the crimping pressure is applied to the stent, the stent has regions of low strain and regions of high strain, such that lactide-based elements to which each pair of marker is attached do not compromise the mechanical integrity of the stent,wherein the four markers have a shape selected from a group consisting of pellet, bead, slug or spherical, andwherein the four markers are deposited in depots, the depots extend partially or completely through the lactide-based elements to which each pair of marker is attached.
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Abstract
Various embodiments of stents with radiopaque markers arranged in patterns are described herein.
480 Citations
9 Claims
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1. A method of crimping a stent on a balloon, comprising:
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(a) providing a biodegradable polymeric stent, wherein the material from which structural elements of the stent are made consists of a lactide or lactic acid polymer (“
lactide-based polymer”
);(b) attaching markers to the lactide-based polymeric stent to provide capability of obtaining images of the lactide-based polymeric stent with an imaging device during and after implantation of the stent in a vessel, wherein the stent consists of two pairs of markers, a first and second markers being attached in an adjacent configuration about a proximal end of the stent, and a third and fourth markers being attached in an adjacent configuration about a distal end of the stent, such that the stent has no other markers but for the four markers to allow for imaging of the lactide-based polymeric stent and such that an entire length of the stent between the first pair and second pair of markers is devoid of any markers, wherein the first marker is positioned at a circumferential distance from its adjacent second marker, wherein the third marker is positioned at a circumferential distance from its adjacent fourth marker, and wherein the pair of markers about the proximal end of the polymeric stent are circumferentially off-set from the pair of markers about the distal end of the polymeric stent; and (c) crimping the stent on a balloon of a catheter assembly by application of a crimping pressure to the stent positioned over the balloon, wherein when the crimping pressure is applied to the stent, the stent has regions of low strain and regions of high strain, such that lactide-based elements to which each pair of marker is attached do not compromise the mechanical integrity of the stent, wherein the four markers have a shape selected from a group consisting of pellet, bead, slug or spherical, and wherein the four markers are deposited in depots, the depots extend partially or completely through the lactide-based elements to which each pair of marker is attached. - View Dependent Claims (2, 3)
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4. A method of crimping a stent on a balloon, comprising:
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(a) providing a biodegradable polymeric stent, wherein the material from which structural elements of the stent are made consists of a lactide or lactic acid polymer (“
lactide-based polymer”
);(b) attaching markers to the lactide-based polymeric stent to provide capability of obtaining images of the lactide-based polymeric stent with an imaging device during and after implantation of the stent in a vessel, wherein the stent consists of two pairs of markers, first and second markers being attached in an adjacent configuration about a proximal end of the stent, and third and fourth markers being attached in an adjacent configuration about a distal end of the stent, such that the stent has no other markers but for the four markers to allow for imaging of the lactide-based polymeric stent and such that an entire length of the stent between the first pair and second pair of markers is devoid of any markers, wherein the first marker is positioned at a circumferential distance from its adjacent second marker, wherein the third marker is positioned at a circumferential distance from its adjacent fourth marker, and wherein the pair of markers about the proximal end of the polymeric stent are circumferentially off-set from the pair of markers about the distal end of the polymeric stent; and (c) crimping the stent on a balloon of a catheter assembly by application of a crimping pressure to the stent positioned over the balloon, wherein when the crimping pressure is applied to the stent, the stent has regions of low strain and regions of high strain, such that the markers are coupled off of sidewall faces of structural elements in regions of low strain, wherein the four markers have a shape selected from a group consisting of pellet, bead, slug or spherical, and wherein the four markers are deposited in depots, the depots extend partially or completely through lactide-based elements to which each pair of marker is attached. - View Dependent Claims (5, 6)
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7. A method of crimping a stent on a balloon, comprising:
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(a) providing a biodegradable polymeric stent, wherein structural elements of the stent are made from a poly(L-lactide-co-caprolactone) polymer; (b) attaching markers to the polymeric stent to provide capability of obtaining images of the polymeric stent with an imaging device during and after implantation of the stent in a vessel, wherein the stent consists of two pairs of markers, first and second markers being attached in an adjacent configuration about a proximal end of the stent, and third and fourth markers being attached in an adjacent configuration about a distal end of the stent, such that the stent has no other markers but for the four markers to allow for imaging of the polymeric stent and such that an entire length of the stent between the first pair and second pair of markers is devoid of any markers, wherein the first marker is positioned at a circumferential distance from its adjacent second marker, wherein the third marker is positioned at a circumferential distance from its adjacent fourth marker, and wherein the pair of markers about the proximal end of the polymeric stent are circumferentially off-set from the pair of markers about the distal end of the polymeric stent; and (c) crimping the stent on a balloon of a catheter assembly by application of a crimping pressure to the stent positioned over the balloon, wherein when the crimping pressure is applied to the stent, the stent has regions of low strain and regions of high strain, such that the markers are coupled off of sidewall faces of structural elements in regions of low strain, and wherein the four markers are deposited in cylindrical depots. - View Dependent Claims (8, 9)
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Specification