Method of making stents with radiopaque markers

• US 8,752,267 B2
• Filed: 08/09/2013
• Issued: 06/17/2014
• Est. Priority Date: 05/26/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Wu, Patrick P.
• Primary Examiner(s): COZART, JERMIE E
• Application Number:
  US13/964,006
• Publication Number:
  US 20130319603A1
• Time in Patent Office: 312 Days
• Field of Search: 623/1.34, 294/58, 295/08, 295/16, 295/17
• US Class Current: 29/458
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: 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
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 29/00 Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters shape or structure of catheters A61M25/00
• CPC Class Codes: A61L 31/04 Macromolecular materials
• 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 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: B29C 65/48 : using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29D 23/00 : Producing tubular articles B29D24/00 takes precedence
• 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: Y10T 156/1034 : Overedge bending of lamina about edges of sheetlike base
• CPC Class Codes: Y10T 29/49885 : with coating before or during assembling
• CPC Class Codes: Y10T 29/49913 : by constricting outer annulus
• CPC Class Codes: Y10T 29/49927 : Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/49929 : Joined to rod
• CPC Class Codes: Y10T 29/49993 : Filling of opening

Abstract

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

Claims

1. A method of manufacturing a medical device, comprising:

(a) providing a tube made from a material consist of poly(l-lactide) (PLLA) and one other polymer (“

PLLA-based polymer”

);

followed by

(b) patterning the PLLA-based polymer tube;

followed by

(c) attaching markers to the patterned PLLA-based polymer tube to provide capability of obtaining images of the PLLA-based polymer tube with an imaging device during and after implantation of the medical device,

wherein the patterned PLLA-based polymer tube consists of a first and second marker positioned in a circumferentially adjacent configuration about a proximal end of the patterned PLLA-based polymer tube, and consists of a third and fourth marker positioned in a circumferentially adjacent configuration about a distal end of the patterned PLLA-based polymer tube, with the proviso that the patterned PLLA-based polymer tube has no other markers but for the four markers to allow for imaging of the PLLA-based polymer tube and further with the proviso that an entire length of the patterned PLLA-based polymer tube between the first/second markers and the third/fourth markers is devoid of any markers,

wherein a center point of the first marker is positioned at a circumferential distance from a center point of its adjacent second marker,

wherein a center point of the third marker is positioned at a circumferential distance from a center point of its adjacent fourth marker,

wherein each of the markers is circumferentially off-set from the other markers,

wherein a shortest distance from the center point of the first marker to a proximal most edge of the patterned PLLA-based polymer tube is the same as a shortest distance from the center point of the second marker to the proximal most edge of the patterned PLLA-based polymer tube,

wherein a shortest distance from the center point of the third marker to a distal most edge of the patterned PLLA-based polymer tube is the same as a shortest distance from the center point of the fourth marker to the distal most edge of the patterned PLLA-based polymer tube, and

wherein a circumferential distance of the first marker to the second marker is less than 45 degrees and the circumferential distance of the third marker to the fourth marker is less than 45 degrees, followed by

(c) crimping the patterned PLLA-based polymer tube on a balloon of a catheter assembly by application of a crimping pressure to the patterned PLLA-based polymer tube positioned over the balloon,

wherein when the crimping pressure is applied to the patterned PLLA-based polymer tube, the patterned PLLA-based polymer tube has regions of low strain and regions of high strain, such that PLLA-based elements on which each pair of marker is positioned are regions of low strain.

2. The method of claim 1, wherein the PLLA-based elements do not reduce the mechanical integrity of the patterned PLLA-based polymer tube.

3. A method of manufacturing a medical device, comprising:

(a) providing a tube made from a material consist of poly (D, L-lactic acid) or poly(D, L-lactide) (PDLLA);

followed by

(b) patterning the PDLLA tube;

followed by

(c) attaching markers to the patterned PDLLA tube to provide capability of obtaining images of the PDLLA tube with an imaging device during and after implantation of the medical device,

wherein the patterned PDLLA tube consists of a first and second marker positioned in a circumferentially adjacent configuration about a proximal end of the patterned PDLLA tube, and consists of a third and fourth marker positioned in a circumferentially adjacent configuration about a distal end of the patterned PDLLA tube, with the proviso that the patterned PDLLA tube has no other markers but for the four markers to allow for imaging of the PDLLA tube and further with the proviso that an entire length of the patterned PDLLA tube between the first/second markers and the third/fourth markers is devoid of any markers,

wherein a center point of the first marker is positioned at a circumferential distance from a center point of its adjacent second marker,

wherein a center point of the third marker is positioned at a circumferential distance from a center point of its adjacent fourth marker,

wherein each of the markers is circumferentially off-set from the other markers,

wherein a shortest distance from the center point of the first marker to a proximal most edge of the patterned PDLLA tube is the same as a shortest distance from the center point of the second marker to the proximal most edge of the patterned PDLLA tube,

wherein a shortest distance from the center point of the third marker to a distal most edge of the patterned PDLLA tube is the same as a shortest distance from the center point of the fourth marker to the distal most edge of the patterned PDLLA tube, and

wherein a circumferential distance of the first marker to the second marker is less than 45 degrees and the circumferential distance of the third marker to the fourth marker is less than 45 degrees, followed by

(c) crimping the patterned PDLLA tube on a balloon of a catheter assembly by application of a crimping pressure to the patterned PDLLA tube positioned over the balloon,

wherein when the crimping pressure is applied to the patterned PDLLA tube, the patterned PDLLA tube has regions of low strain and regions of high strain, such that PDLLA-based elements on which each pair of marker is positioned are regions of low strain.

4. The method of claim 3, wherein the PDLLA-based elements do not reduce the mechanical integrity of the patterned PDLLA tube.

5. A method of manufacturing a medical device, comprising:

(a) providing a tube consisting of a lactide or lactic acid polymer (“

lactide-based polymer tube”

);

followed by

(b) patterning the lactide-based polymer tube;

followed by

(c) attaching markers to the patterned lactide-based polymer tube to provide capability of obtaining images of the lactide-based polymer tube with an imaging device during and after implantation of the medical device,

wherein the patterned lactide-based polymer tube consists of a first and second marker positioned in a circumferentially adjacent configuration about a proximal end of the patterned lactide-based polymer tube, and consists of a third and fourth marker positioned in a circumferentially adjacent configuration about a distal end of the patterned lactide-based polymer tube, with the proviso that the patterned lactide-based polymer tube has no other markers but for the four markers to allow for imaging of the lactide-based polymer tube and further with the proviso that an entire length of the patterned lactide-based polymer tube between the first/second markers and the third/fourth markers is devoid of any markers,

wherein a center point of the first marker is positioned at a circumferential distance from a center point of its adjacent second marker,

wherein a center point of the third marker is positioned at a circumferential distance from a center point of its adjacent fourth marker,

wherein each of the markers is circumferentially off-set from the other markers,

wherein a shortest distance from the center point of the first marker to a proximal most edge of the patterned lactide-based polymer tube is the same as a shortest distance from the center point of the second marker to the proximal most edge of the patterned lactide-based polymer tube,

wherein a shortest distance from the center point of the third marker to a distal most edge of the patterned lactide-based polymer tube is the same as a shortest distance from the center point of the fourth marker to the distal most edge of the patterned lactide-based polymer tube, and

wherein a circumferential distance of the first marker to the second marker is less than 45 degrees and the circumferential distance of the third marker to the fourth marker is less than 45 degrees, followed by

(c) crimping the patterned lactide-based polymer tube on a balloon of a catheter assembly by application of a crimping pressure to the patterned lactide-based polymer tube positioned over the balloon,

wherein when the crimping pressure is applied to the patterned lactide-based polymer tube, the patterned lactide-based polymer tube has regions of low strain and regions of high strain, such that lactide-based elements on which each pair of marker is positioned are regions of low strain.

6. The method of claim 5, wherein the lactide-based elements do not reduce the mechanical integrity of the patterned lactide-based polymer tube.