# US 9,038,260 B2 · Stent with radiopaque markers

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- Number: US 9,038,260 B2
- Document ID: US9038260B2
- Status: Granted
- Kind: B2
- Application number: 14/273,127
- Filed: 2014-05-08
- Published: 2014-08-28
- Granted: 2015-05-26
- Earliest claimed: 2006-05-26
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Patrick P. Wu
- Web page: https://patentgrep.com/patent/US9038260B2

## CPC

- A61L 31/18: Materials at least partially X-ray or laser opaque
- A61F 2/06: Blood vessels
- 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)
- A61F 2/844: folded prior to deployment
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61L 29/00: Materials for catheters, {medical tubing, cannulae, or endoscopes} or for coating catheters (shape or structure of catheters A61M25/00)
- A61L 31/04: Macromolecular materials
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/148: {Materials at least partially resorbable by the body}
- B29C 65/48: using adhesives {, i.e. using supplementary joining material; solvent bonding}
- B29D 23/00: Producing tubular articles (B29D24/00 takes precedence)
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2002/91516: {the meander having a change in frequency along the band}
- A61F 2002/91566: {connected trough to trough}
- A61F 2002/91583: {by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band}
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2230/0054: V-shaped
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- B29L 2031/7543: {Balloon catheters}
- Y10T 29/49885: with coating before or during assembling
- Y10T 29/49913: by constricting outer annulus
- Y10T 29/49927: Hollow body is axially joined cup or tube
- Y10T 29/49929: Joined to rod
- Y10T 29/49993: Filling of opening
- Y10T 156/1034: Overedge bending of lamina about edges of sheetlike base
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29D: PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE (making granules B29B9/00; making preforms B29B11/00)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Various embodiments of stents with radiopaque markers arranged in patterns are described herein.

## Claims

### Claim 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, 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.

### Claim 2 (depends on 1)

The method of claim 1, wherein the markers are a mixture or alloy of two types of metals.

### Claim 3 (depends on 1)

The method of claim 1, wherein the markers are coupled off of sidewall faces of structural elements in regions of low strain.

### Claim 4

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, 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.

### Claim 5 (depends on 4)

The method of claim 4, wherein the markers are a mixture or alloy of two types of metals.

### Claim 6 (depends on 4)

The method of claim 4, wherein the lactide-based polymer is poly(L-lactide-co-caprolactone).

### Claim 7

A method of crimping a stent on a balloon, comprising:
(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.

### Claim 8 (depends on 7)

The method of claim 7, wherein the markers are a mixture or alloy of two types of metals.

### Claim 9 (depends on 8)

The method of claims 8, wherein the markers are deposited in the cylindrical depots and attached by gluing.
