US20080015684A1 - Method And Apparatus For Attaching Radiopaque Markers To A Stent - Google Patents
Method And Apparatus For Attaching Radiopaque Markers To A Stent Download PDFInfo
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- US20080015684A1 US20080015684A1 US11/771,974 US77197407A US2008015684A1 US 20080015684 A1 US20080015684 A1 US 20080015684A1 US 77197407 A US77197407 A US 77197407A US 2008015684 A1 US2008015684 A1 US 2008015684A1
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- Prior art keywords
- stent
- rollers
- mandrel
- markers
- gap
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91566—Adjacent bands being connected to each other connected trough to trough
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10T29/49826—Assembling or joining
- Y10T29/49908—Joining by deforming
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49908—Joining by deforming
- Y10T29/49909—Securing cup or tube between axially extending concentric annuli
- Y10T29/49913—Securing cup or tube between axially extending concentric annuli by constricting outer annulus
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10T29/49826—Assembling or joining
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- Y10T29/49925—Inward deformation of aperture or hollow body wall
- Y10T29/49927—Hollow body is axially joined cup or tube
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10T29/49826—Assembling or joining
- Y10T29/49945—Assembling or joining by driven force fit
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10T29/00—Metal working
- Y10T29/53—Means to assemble or disassemble
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10T29/00—Metal working
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- Y10T29/53539—Means to assemble or disassemble including work conveyor
- Y10T29/53543—Means to assemble or disassemble including work conveyor including transporting track
- Y10T29/53548—Means to assemble or disassemble including work conveyor including transporting track and work carrying vehicle
Abstract
A mandrel for supporting a stent and rollers for pressing a radiopaque marker into a stent are disclosed. The mandrel can have a forward portion for carrying the stent and a rear portion for urging the stent forward portion into a gap between the rollers. The mandrel may be pushed or pulled into the gap, which is sized to allow the rollers to press the marker into engagement with the stent. Prior to moving the mandrel into the gap, the marker may be placed on a surface of the stent or partially inside a recess in the stent. Several markers can be efficiently and uniformly pressed onto the stent by moving the mandrel into the gap in one continuous movement in an axial or lateral direction. Markers can also be pressed onto the stent by placing the stent in the gap and rotating the stent about its central axis.
Description
- This application claims the benefit of U.S. Provisional Application No. 60/830,201, filed Jul. 11, 2006, the entire contents of which are incorporated herein by reference.
- 1. Field of the Invention
- This invention relates generally to implantable medical devices, such as stents, and, more particularly, to attaching radiopaque markers to polymeric stents. Description of the State of the Art Expandable endoprostheses are adapted to be implanted in a bodily lumen. An “endoprosthesis” corresponds to an artificial device that is placed inside the body. A “lumen” refers to a cavity of a tubular organ such as a blood vessel. A stent is an example of such an endoprosthesis. Stents are generally cylindrically shaped devices, which function to hold open and sometimes expand a segment of a blood vessel or other anatomical lumen such as urinary tracts and bile ducts. Stents are often used in the treatment of atherosclerotic stenosis in blood vessels. “Stenosis” refers to a narrowing or constriction of the diameter of a bodily passage or orifice. In such treatments, stents reinforce blood vessels and prevent restenosis following angioplasty in the vascular system. “Restenosis” refers to the reoccurrence of stenosis in a blood vessel or heart valve after it has been treated (as by balloon angioplasty, stenting, or valvuloplasty) with apparent success.
- The structure of stents is typically composed of scaffolding that includes a pattern or network of interconnecting structural elements or struts. The scaffolding can be formed from wires, tubes, or sheets of material rolled into a cylindrical shape. In addition, a medicated stent may be fabricated by coating the surface of either a metallic or polymeric scaffolding with a polymeric carrier. The polymeric scaffolding may also serve as a carrier of an active agent or drug.
- The first step in treatment of a diseased site with a stent is locating a region that may require treatment such as a suspected lesion in a vessel, typically by obtaining an x-ray image of the vessel. To obtain an image, a contrast agent, which contains a radiopaque substance such as iodine is injected into a vessel. “Radiopaque” refers to the ability of a substance to absorb x-rays. The x-ray image depicts the lumen of the vessel from which a physician can identify a potential treatment region. The treatment then involves both delivery and deployment of the stent. “Delivery” refers to introducing and transporting the stent through a bodily lumen to a region in a vessel that requires treatment. “Deployment” corresponds to the expanding of the stent within the lumen at the treatment region. Delivery and deployment of a stent are accomplished by positioning the stent about one end of a catheter, inserting the end of the catheter through the skin into a bodily lumen, advancing the catheter in the bodily lumen to a desired treatment location, expanding the stent at the treatment location, and removing the catheter from the lumen. In the case of a balloon expandable stent, the stent is mounted about a balloon disposed on the catheter. Mounting the stent typically involves compressing or crimping the stent onto the balloon. The stent is then expanded by inflating the balloon. The balloon may then be deflated and the catheter withdrawn. In the case of a self-expanding stent, the stent may be secured to the catheter via a retractable sheath or a sock. When the stent is in a desired bodily location, the sheath may be withdrawn allowing the stent to self-expand.
- The stent must be able to simultaneously satisfy a number of mechanical requirements. First, the stent must be capable of withstanding the structural loads, namely radial compressive forces, imposed on the stent as it supports the walls of a vessel lumen. In addition to having adequate radial strength or more accurately, hoop strength, the stent should be longitudinally flexible to allow it to be maneuvered through a tortuous vascular path and to enable it to conform to a deployment site that may not be linear or may be subject to flexure. The material from which the stent is constructed must allow the stent to undergo expansion, which typically requires substantial deformation of localized portions of the stent structure. Once expanded, the stent must maintain its size and shape throughout its service life despite the various forces that may come to bear thereon, including the cyclic loading induced by the beating heart. Finally, the stent must be biocompatible so as not to trigger any adverse vascular responses.
- In addition to meeting the mechanical requirements described above, it is desirable for a stent to be radiopaque, or fluoroscopically visible under x-rays. Accurate stent placement is facilitated by real time visualization of the delivery of a stent. A cardiologist or interventional radiologist can track the delivery catheter through the patient's vasculature and precisely place the stent at the site of a lesion. This is typically accomplished by fluoroscopy or similar x-ray visualization procedures. For a stent to be fluoroscopically visible it must be more absorptive of x-rays than the surrounding tissue. Radiopaque materials in a stent may allow for its direct visualization.
- In many treatment applications, the presence of a stent in a body may be necessary for a limited period of time until its intended function of, for example, maintaining vascular patency and/or drug delivery is accomplished. Therefore, stents fabricated from biodegradable, bioabsorbable, and/or bioerodable materials may be configured to meet this additional clinical requirement since they may be designed to completely erode after the clinical need for them has ended. Stents fabricated from biodegradable polymers are particularly promising, in part because they may be designed to completely erode within a desired time frame.
- However, a significant shortcoming of biodegradable polymers (and polymers generally composed of carbon, hydrogen, oxygen, and nitrogen) is that they are radiolucent with no radiopacity. Biodegradable polymers tend to have x-ray absorption similar to body tissue.
- One way of addressing this problem is to attach radiopaque markers to structural elements of the stent. A radiopaque marker can be disposed within a structural element in such a way that the marker is secured to the structural element. However, the use of stent markers on polymeric stents entails a number of challenges. One challenge relates to the difficulty of insertion of markers.
- Another challenge pertains to the fact that some regions of polymeric struts tend to undergo significant deformation or strain during crimping and expansion. In particular, such changes are due to plastic deformation of polymers. Thus, during stent deployment, the portion of a stent containing an element may crack or stretch as stress is being applied to the expanding stent. As a result, the marker may become dislodged.
- Attachment of radiopaque markers to stents usually requires a significant amount of time to perform with reliability and uniformity. The amount of time required is increased when several markers must be attached at different locations on the stent. Also, conventionally-placed markers may project inward from the luminal surface of the stent to such a degree that blood flow is disrupted, or project outward from the abluminal surface of the stent to such a degree that the walls of the blood vessel are traumatized.
- Accordingly there is a need to for an apparatus and method of easily attaching radiopaque markers on stents. There is also a need for an apparatus and method of attaching radiopaque markers on stents such that the marker is retained in the stent during deformation of the stents during subsequent stent crimping and expansion. There is a further need for an apparatus and method of attaching a plurality of radiopaque markers to a stent with greater efficiency and uniformity. Also, there is a need to attach radiopaque markers such that the radiopaque markers do not overly protrude from the stent. The present invention satisfies these and other needs.
- Briefly and in general terms, the present invention is directed to a method and apparatus of attaching a radiopaque marker onto a stent. Such a method can comprise conveying a stent positioned between two rollers, wherein a radiopaque marker disposed at a surface of the stent is pressed into a recess in the stent by one of the rollers
- In detailed aspects of the present invention, conveying the stent includes translating the stent along its central axis into a gap between the rollers. In other detailed aspects, conveying the stent includes translating the stent into a gap between the rollers, wherein the stent is translated along a direction perpendicular to a central axis of the stent.
- In further aspects of the invention, the method comprises placing the radiopaque marker on a surface of the stent prior to conveying the stent between the two rollers. In yet other aspects, the method comprises placing the radiopaque marker partially in the recess in the stent prior to conveying the stent between the two rollers.
- In other detailed aspects, each of the rollers can rotate about an axis that is substantially perpendicular to the central axis of the stent. Each of the rollers, in other detailed aspects, can rotate about an axis that is substantially parallel to the central axis of the stent.
- A method of attaching a radiopaque marker onto a stent can comprise translating a stent mounted on a mandrel relative to a roller, the stent including a radiopaque marker positioned at a surface of the stent, and allowing the roller to press the radiopaque marker in a manner that couples the radiopaque marker to the stent.
- In detailed aspects of the invention, translating the stent relative to the roller includes translating the stent relative to the roller in a direction parallel to a central axis of the stent. In other detailed aspects, translating the stent relative to the roller includes linearly translating the stent relative to the roller in a direction perpendicular to a central axis of the stent. Translating the stent relative to the roller, in yet other detailed aspects, includes rotationally translating the stent relative to the roller about a central axis of the stent.
- An apparatus for attaching a radiopaque marker onto a stent comprises a cylindrical mandrel including a forward portion and a rear portion, an outer diameter of the forward portion being less than an outer diameter of the rear portion, the forward portion for supporting a stent, and rollers spaced apart by a gap that is greater than or equal to the outer diameter of the rear portion of the mandrel, wherein the mandrel and rollers are movable in relation to each other so that the mandrel passes through the gap.
- In other aspects, the rollers are oriented to allow each of the rollers to rotate about a rotational axis that is perpendicular to a longitudinal axis of the mandrel. In yet other aspects, the rollers are oriented to allow each of the rollers to rotate about a rotational axis that is parallel to a longitudinal axis of the mandrel.
- The features and advantages of the invention will be more readily understood from the following detailed description which should be read in conjunction with the accompanying drawings.
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FIG. 1 is a perspective view showing a cylindrically-shaped stent. -
FIG. 2 is a plan view showing a flattened stent pattern with depots for receiving radiopaque markers. -
FIG. 3 is a perspective view of a portion of a stent, showing a depot for receiving a radiopaque marker. -
FIG. 4 is a perspective view of the stent ofFIG. 3 , showing a spherical radiopaque marker disposed over the depot. -
FIG. 5 is a side view showing a stent with two radiopaque markers disposed over openings in the stent. -
FIG. 6 is an end view showing the stent and one of the markers ofFIG. 5 . -
FIG. 7 is a side view showing a mandrel for carrying a stent, the mandrel having a forward portion and a rear portion. -
FIG. 8 is a side view of an apparatus for attaching radiopaque markers onto a stent, showing the mandrel ofFIG. 7 carrying the stent ofFIG. 5 , and showing rollers having a rotational axis substantially perpendicular to the central axis of the stent, and the forward portion of the mandrel placed in a gap between the rollers. -
FIG. 9 is a side view of the apparatus ofFIG. 8 showing the mandrel and stent having been moved axially through the gap between the rollers and showing the markers pressed into engagement with the stent. -
FIG. 10 is a perspective view of a portion of the stent ofFIG. 5 , showing one of the radiopaque markers pressed into engagement with the stent after having passed through the gap between the rollers. -
FIG. 11 is a side view of a marker attachment apparatus, showing a stent mounted on a mandrel and rollers adjacent the stent and mandrel, the rollers having a rotational axis substantially parallel to the central axis of the stent such that a marker and the stent are pressed into engagement with each other when the stent is moved laterally through a gap between the rollers. -
FIG. 12 is a side view of a marker attachment apparatus, showing a stent mounted on a mandrel and rollers adjacent the stent and mandrel, the rollers having a rotational axis substantially parallel to the central axis of the stent such that a marker and the stent are pressed into engagement with each other when the stent is placed between a gap between the rollers and rotated about its central axis. - The present invention may be applied to stents and, more generally, implantable medical devices such as, but is not limited to, self-expandable stents, balloon-expandable stents, stent-grafts, vascular grafts, cerebrospinal fluid shunts, pacemaker leads, closure devices for patent foramen ovale, and synthetic heart valves.
- A stent can have virtually any structural pattern that is compatible with a bodily lumen in which it is implanted. Typically, a stent is composed of a pattern or network of circumferential and longitudinally extending interconnecting structural elements or struts. In general, the struts are arranged in patterns, which are designed to contact the lumen walls of a vessel and to maintain vascular patency. A myriad of strut patterns are known in the art for achieving particular design goals. A few of the more important design characteristics of stents are radial or hoop strength, expansion ratio or coverage area, and longitudinal flexibility. The present invention is applicable to virtually any stent design and is, therefore, not limited to any particular stent design or pattern. One embodiment of a stent pattern may include cylindrical rings composed of struts. The cylindrical rings may be connected by connecting struts.
- A stent may be formed from a tube by laser cutting the pattern of struts in the tube. The stent may also be formed by laser cutting a polymeric sheet, rolling the pattern into the shape of the cylindrical stent, and providing a longitudinal weld to form the stent. Other methods of forming stents are well known and include chemically etching a polymeric sheet and rolling and then welding it to form the stent. A polymeric wire may also be coiled to form the stent. The stent may be formed by injection molding of a thermoplastic or reaction injection molding of a thermoset polymeric material. Filaments of the compounded polymer may be extruded or melt spun. These filaments can then be cut, formed into ring elements, welded closed, corrugated to form crowns, and then the crowns welded together by heat or solvent to form the stent. Lastly, hoops or rings may be cut from tubing stock, the tube elements stamped to form crowns, and the crowns connected by welding or laser fusion to form the stent.
- Referring now in more detail to the exemplary drawings for purposes of illustrating embodiments of the invention, wherein like reference numerals designate corresponding or like elements among the several views, there is shown in
FIG. 1 a cylindrically-shapedstent 10 withstruts 4 that form cylindrical rings 12 which are connected by linkingstruts 8. The cross-section of the struts instent 10 is rectangular-shaped. The struts have abluminal faces 20, luminal faces 22, and sidewall faces 26. The cross-section of struts is not limited to what has been illustrated, and therefore, other cross-sectional shapes are applicable with embodiments of the present invention. The pattern should not be limited to what has been illustrated as other stent patterns are easily applicable with embodiments of the present invention. - A stent can be made of a biostable and/or biodegradable polymer. As indicated above, a stent made from a biodegradable polymer is intended to remain in the body for a duration of time until its intended function of, for example, maintaining vascular patency and/or drug delivery is accomplished. After the process of degradation, erosion, absorption, and/or resorption has been completed, no portion of the biodegradable stent, or a biodegradable portion of the stent will remain.
- It is generally desirable to minimize the interference of a stent or marker with the structure of a lumen and/or with flow of bodily fluid through the lumen. Sharp edges, protrusions, etc. in the path of blood flow can result in formation of turbulent and stagnant zones which can act as a nidus for thrombosis. A smaller and/or smoother profile of a body portion may be more hemocompatible. Additionally, a smaller and smoother profile presented by a marker has much less likelihood of catching on other parts of the delivery system such as the guidewire or guiding catheter. The embodiments discussed herein involve markers, which after having been pressed into engagement onto a stent, do not contribute significantly to the form factor, or profile, of the stent in such a way that interferes with the structure of a lumen and/or with flow of bodily fluid through the lumen.
- As indicated above, it is desirable to have the capability of obtaining images of polymeric stents with x-ray fluoroscopy during and after implantation. Various embodiments of the present invention involve stents with markers disposed within depots or holes in a stent. A depot may be formed in a structural element by laser machining. The depot may extend partially or completely through the portion of the stent. For example, an opening of a depot may be on an abluminal or luminal surface and extend partially through the stent or completely through to an opposing surface. The markers may be sufficiently radiopaque for imaging the stent.
-
FIG. 2 shows astent pattern 40 withdepots 44 for receiving a marker. InFIG. 2 , thestent pattern 40 is shown in a flattened condition showing an abluminal or luminal surface so that the pattern can be clearly viewed. When the flattened portion of thestent pattern 40 is in a cylindrical condition, it forms a radially expandable stent. Thestent pattern 40 includes cylindrically alignedstructural elements 46 and linkingstructural elements 48. -
FIG. 3 shows a portion of astent 60 with adepot 62 for retaining a radiopaque marker. Thestent 60 includes cylindrically alignedstructural elements 64 and linkingstructural elements 66. Thedepot 62 is located in aportion 68 which is a region of intersection of four structural elements. As depicted inFIG. 3 , thedepot 62 has a cylindrical shape and extends completely through the radial thickness of thestructural elements 64. - Certain embodiments of the present invention involve a deformed radiopaque marker disposed in a depot in a portion of the stent. The marker may be coupled to the portion at least partially by an interference or press fit between an expanded section of the marker and an internal surface of the portion of the stent within the depot. In some embodiments, a marker in an undeformed state may be disposed in a depot and compressed to couple the marker within the depot. Compressing the marker may expand a portion of the marker within the depot to create the interference fit. Alternatively, the stent material may deform to achieve the interference fit with little or no deformation of the marker.
-
FIG. 4 shows amarker 70 disposed over thedepot 62 extending through anabluminal surface 72 of thestent 60. In practice, themarker 70 may be positioned using a syringe so that the marker rests on top of theabluminal surface 72, partially inside thedepot 62, or both. Themarker 70 may be held at the end of the syringe by a vacuum or surface tension of a viscous fluid. - The present invention encompasses markers fabricated by methods including, but not limited to, molding, machining, assembly, or a combination thereof. All or part of a metallic or polymeric marker may be fabricated in a mold or machined by a method such as laser machining. Markers can have any shape or size. Preferably, though not necessarily, the markers are spherical in shape. Compared to markers of a cylindrical or other shape having a longitudinal axis, spherical markers are easier to align for placement on top of or into an opening formed in the stent.
- Markers may be biodegradable. It may be desirable for the markers to degrade at the same or substantially the same rate as the stent. For instance, the markers may be configured to completely or almost completely erode at the same time or approximately the same time as the stent. Alternatively, the markers may degrade at a faster rate than the stent. In this case, the markers may completely or almost completely erode before the body of the stent is completely eroded.
- Also, a biocompatible biodegradable metal may be used for the markers. A biocompatible biodegradable metal forms erosion products that do not negatively impact bodily functions. The markers may be composed of a pure or substantially pure biodegradable metal. Representative examples of biodegradable metals for use in a marker may include, but are not limited to, magnesium, zinc, and iron. Representative mixtures or alloys may include magnesium/zinc, magnesium/iron, zinc/iron, and magnesium/zinc/iron. Radiopaque compounds such as iodine salts, bismuth salts, or barium salts may be compounded into the metallic biodegradable marker to further enhance the radiopacity. Other representative examples of biostable metals include platinum and gold.
- Further, the markers may be a mixture of a biodegradable polymer and a radiopaque material. The radiopaque material may be biodegradable and/or bioabsorbable. Representative radiopaque materials may include, but are not limited to, biodegradable metallic particles and particles of biodegradable metallic compounds such as biodegradable metallic oxides, biocompatible metallic salts, gadolinium salts, and iodinated contrast agents.
- Certain embodiments of the present invention include disposing, coupling, or pressing radiopaque markers within a recess or depot in a stent structure. Such embodiments are described below in connection with
FIGS. 7-12 . -
FIGS. 5 and 6 show astent 100 withmarkers 102 protruding radially from thestent 100. Themarkers 100 have been placed partially inside recesses formed in the stent. The recesses are not shown for clarity and ease of illustration. The recesses can be depots that extend completely through a stent structure, from anabluminal surface 104 to aluminal surface 106. Alternatively, the recesses can be cavities that extend partially into the stent structure. The terms “recess” and “opening” are used interchangeably herein. The stent has acentral axis 108 extending along the entire length of thestent 100. -
FIG. 7 shows astep mandrel 110 having a forward portion 1 12 and arear portion 114. Theforward portion 112 has adiameter 116 that is less than thediameter 118 of therear portion 114. The forward portion is adapted to carry thestent 100. Themandrel 110 has alongitudinal axis 119 extending along the entire length of the mandrel. Themandrel 110 can be made of a relatively rigid material, in comparison to a stent, selected to provide firm support for the stent. Examples of suitable materials includes plastics, such as Delrin, PVC, nylon, and others; metals such as steel, stainless steel, aluminum, titanium, and others; and glass. Themandrel 110 can also include a relatively resilient and compliant material that is selected to provide sufficient support to the stent and to cushion the stent from excessive pressure from rollers described below. - In
FIG. 8 , thestent 100 has been mounted onto theforward portion 112 of the mandrel 1 10, which has been moved between tworollers 120 that may rotate about a retainingpin 122 in the direction ofrotational arrows 124. Theforward portion 112 supports thestent 100 at its luminal surface when themarkers 102 are later pressed onto the stent. Therollers 120 have a circular cross-section. The retainingpin 122 is substantially perpendicular to the central axis of the stent, which allows eachroller 120 to rotate about an axis that is substantially perpendicular to thelongitudinal axis 119 of thestent 100. Further movement of themandrel 110 and thestent 100 in the direction ofaxial arrow 126 will cause themarkers 102 to be pressed into the surface of thestent 100 without damagingstent 100. - The
rollers 120 can be made of a relatively rigid material, in comparison to thestent 100 andmarkers 102, to facilitate pressing the markers into engagement with stent. Examples of suitable materials includes plastics, such as Delrin, PVC, nylon, and others; metals such as steel, stainless steel, aluminum, titanium, and others; and glass. Therollers 120 can also include a relatively resilient and compliant material that is selected to avoid damaging thestent 100 ormarkers 102 yet provide sufficient pressure to press the markers into engagement with the stent. - In some embodiments, the
rollers 120 are positioned over themandrel 110 such that thetop roller 120 does not contactstent 100 and contacts only themarkers 102. In this way, stress on thestent 100 is minimized. Thebottom roller 120 contacts the stent to support the stent when thetop roller 120 presses themarkers 120. Themarkers 102 are compacted tightly against the opening ofstent 100 and themarkers 102 are retained in the stent during stent crimping, delivery, and deployment in a bodily lumen. -
FIG. 9 shows thestent 100 andmandrel 110 after having been moved axially in the direction ofaxial arrow 126 from their positions inFIG. 8 . As a result, themarkers 102 have been pressed into the openings ofstent 100 to fabricate a stent with markers that partially protrude from thestent 100. In one embodiment, therollers 120 cause themarkers 102 to deform to reduce or eliminate protrusion of themarkers 102 from thestent 100. Thus, the invention provides a method and apparatus for pressing markers into the stent such that the marker is tightly fit into the stent, thereby improving marker retention onto the stent as well as reducing or eliminating protrusion of the marker from the stent. - Both
markers 102 have been pressed into engagement with thestent 100 with one continuous axial movement of themandrel 110 carrying thestent 100.FIG. 10 shows one of themarkers 102 after having been pressed into one of theopenings 127 of thestent 100. Although only twomarkers 102 are illustrated inFIGS. 8 and 9 , it will be appreciated that any number of markers may be positioned on the stent and pressed into engagement with efficiency by one continuous axial movement of themandrel 110. Use of the same set ofrollers 120 on all the markers allows for uniformity in pressing the markers into engagement with thestent 100. - In other embodiments, the
stent 100 may be passed through thegap 128 between therollers 120 in a plurality of discrete movements. In yet other embodiments, thestent 100 may be passed through thegap 128 more than one time in order to press markers located at other portions of the stent. Also, thestent 100 may be passed through thegap 128 more than one time to press the markers into engagement with thestent 100 in a progressive fashion. For example, thegap 128 may be decreased after each time thestent 100 passes through the gap. - Referring again to
FIG. 8 , thegap 128 between the two rollers may be equal to or slightly larger than theouter diameter 130 ofstent 100, thereby avoiding damage to the stent. Theouter diameter 118 of therear portion 114 of themandrel 110 may be made equal to or substantially equal to the stentouter diameter 130. Theouter diameter 118 may be greater than or equal to the stentouter diameter 130. Also, theouter diameter 116 of the mandrelforward portion 112 may be equal to or smaller than the inner diameter of thestent 100. In this way, thestent 100 can have a slip or interference fit with the mandrelforward portion 112. - The
markers 102 are deformed by pushing thestent 100 through therollers 120. When thestent 100, having luminal surfaces supported by theforward portion 112 of themandrel 110, is pushed through therollers 120, themarkers 102 are pressed inward and against the stent by therollers 120. - In practice, the
free end 140 of the mandrelforward portion 112 may be pulled axially in the direction ofaxial arrow 126 until themarkers 102 are pressed by therollers 120. In this manner, the mandrelrear portion 114 engages arear end 142 of thestent 100 so as to push thestent 100 into thegap 128 between the rollers. - In some embodiments, the
free end 144 of the mandrelrear portion 114 may be pushed axially in the direction ofaxial arrow 126 until themarkers 102 are pressed by therollers 120. -
FIGS. 8 and 9 show how thestent 100 can be linearly translated relative to therollers 120. Linear translation of thestent 100 relative to therollers 120 can be achieved in other ways. For example, in other embodiments, thestent 100 and themandrel 110 are held fixed in position while therollers 120 are moved axially over the stent and mandrel until themarkers 102 are pressed into engagement with the stent. In yet other embodiments, themandrel 110 androllers 120 are both moved relative to each other to facilitate pressing themarkers 102 onto thestent 100. - It will be appreciated that any number of rollers may be used. For example, the
mandrel 110 may be supported at one or both its ends such that thebottom roller 102 inFIGS. 8 and 9 can be eliminated, and only thetop roller 120 inFIGS. 8 and 9 is needed to press themarkers 102 into engagement with thestent 100. More than two rollers, on the same or different sides of thestent 100, may be used to provide greater support of thestent 100 or to guide themandrel 110 into the gap between the rollers. Also, more than two rollers may be used to press markers in a progressive fashion. For example, a first set of rollers may be used to press the markers onto the stent, and a second set of rollers that are spaced closer together may be used to press the markers further onto the stent. Progressive sets of rollers can have gaps between them that become smaller with each succeeding set of rollers. -
FIG. 11 shows an apparatus and method in accordance with another embodiment of the present invention. Astent 150 is mounted over amandrel 152. Aradiopaque marker 154 has been placed on thestent 150. Tworollers 156, adjacent thestent 150, are vertically aligned and are oriented such that a retainingpin 158 at the center of each roller is substantially parallel to the central axis of thestent 150. In this way, each of therollers 156 may rotate along the direction ofrotational arrows 160 about a rotational axis that is substantially parallel to the central axis of the stent. - Instead of being moved axially as in
FIG. 9 , thestent 150 and themandrel 152 ofFIG. 11 are moved laterally along the direction oflateral arrow 162 into agap 164 between therollers 156. Thestent 150 is oriented such that themarker 154 is pressed into engagement against the stent as the stent passes through thegap 164. The lateral direction of movement of thestent 150 is substantially perpendicular to the central axis of thestent 150. In other embodiments, the lateral direction is at an angle between zero and ninety degrees from the central axis of thestent 150. - Preferably, the
stent 150 is prevented from rotating about itscentral axis 168 while the stent passes through thegap 164. For example, thestent 150 may be held on themandrel 152 with a slight interference fit, and the ends of themandrel 152 may be secured against rotation. Also, thetop roller 156 preferably rotates along the direction ofarrow 160 while themarker 154 passes beneath it to ensure that the marker is pressed downward onto thestent 150 and to avoid pushing the marker sideways. - Referring again to
FIG. 11 , thegap 164 is carefully selected to allow thestent 150 to pass through thegap 164 without being damaged. Preferably, the vertical size of thegap 164 is greater than or equal to theouter diameter 166 of thestent 150. The vertical size of thegap 164 is selected such that the rollers provide sufficient pressure to deform themarker 154 into engagement with an opening in thestent 154 and to reduce the amount with which themarker 154 protrudes radially from thestent 154. -
FIG. 12 shows an apparatus and method in accordance with yet another embodiment of the present invention. Astent 170 is mounted over amandrel 172. Threeradiopaque makers 174 have been placed on thestent 170. Tworollers 176, adjacent thestent 170, are each held by a retainingpin 178. Therollers 176 are vertically aligned and are oriented such that theirrotational axes 177 are substantially parallel to thecentral axis 179 of thestent 170. In this way, therollers 176 may rotate along the direction ofrotational arrows 180. Thestent 170 is placed between in the gap between the tworollers 176. Thestent 170 is oriented such that themarkers 174 avoid contact with the rollers when first placed in the gap. Then, thestent 170 is rotated about its central axis alongrotational arrow 182, thereby bringing themarkers 174 into contact with the rollers. As thestent 170 continues to rotate, therollers 176 press themarkers 174 into engagement with the stent. -
FIG. 12 shows how thestent 170 can be rotationally translated relative to therollers 176. Rotational translation of thestent 170 relative to therollers 176 can be achieved in other ways. For example, in other embodiments, therollers 176 may rotate about thecentral axis 179 of thestent 170. After thestent 170 is placed between in the gap between the tworollers 176, therollers 176 are rotated about thecentral axis 179 of thestent 170 while thestent 170 is prevented from rotating about itscentral axis 179, thereby bringing therollers 176 into contact with themarkers 174. As therollers 176 continue to rotate, therollers 176 press themarkers 174 into engagement with thestent 170. Further, in other embodiments, both thestent 170 and therollers 176 are rotated about thecentral axis 179 of thestent 170. - Although three
markers 174 are illustrated inFIG. 12 , it will be appreciated that any number of markers may be positioned on the stent and pressed into engagement with efficiency by one continuous rotational movement of thestent 170. It will also be appreciated that additional rollers may be used. Additional rollers may be used to provide greater support to thestent 170 or help keep the stent aligned within the gap between the rollers. - In
FIGS. 8-12 , the retaining pins at the center of the rollers are fixed in position relative to each other. In other embodiments, retaining pins are movable relative to each other. For example, movable retaining pins may be held by a spring or device the biases the rollers to achieve a nominal gap between the rollers. The nominal gap may be less than, equal to, or greater than the outer diameter of the stent. When the stent is passed through the gap, the spring or other biasing device allows the rollers to move apart so as to maintain a selected level of pressure on the stent and marker. In this manner, the risk of damage to the stent and marker is reduced. - While several particular forms of the invention have been illustrated and described, it will also be apparent that various modifications can be made without departing from the scope of the invention. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
Claims (21)
1. A method of attaching a radiopaque marker onto a stent, the method comprising:
conveying a stent positioned between two rollers, wherein a radiopaque marker disposed at a surface of the stent is pressed into a recess in the stent by one of the rollers.
2. The method of claim 1 , wherein conveying the stent includes translating the stent along its central axis into a gap between the rollers.
3. The method of claim 1 , wherein conveying the stent includes translating the stent into a gap between the rollers, wherein the stent is translated along a direction perpendicular to a central axis of the stent.
4. The method of claim 1 , further comprising placing the radiopaque marker on a surface of the stent prior to conveying the stent.
5. The method of claim 1 , further comprising placing the radiopaque marker partially in the recess in the stent prior to conveying the stent.
6. The method of claim 1 , wherein the radiopaque marker is deformed when it is pressed into the recess to reduce or eliminate protrusion of the marker from the stent surface.
7. The method of claim 1 , wherein the stent is supported on a mandrel and conveying the stent includes translating the mandrel.
8. The method of claim 7 , wherein the mandrel comprises a forward portion for carrying the stent, the forward portion having a diameter less than or equal to an inner diameter of the stent.
9. The method of claim 7 , wherein the mandrel comprises a rear portion having a diameter greater than or equal to an outer diameter of the stent.
10. The method of claim 7 , wherein the mandrel comprises a rear portion having a diameter less than or equal to a gap between the rollers.
11. The method of claim 1 , wherein each of the rollers can rotate about an axis that is substantially perpendicular to the central axis of the stent.
12. The method of claim 1 , wherein each of the rollers can rotate about an axis that is substantially parallel to the central axis of the stent.
13. A method of attaching a radiopaque marker onto a stent, the method comprising:
translating a stent mounted on a mandrel relative to a roller, the stent including a radiopaque marker positioned at a surface of the stent; and
allowing the roller to press the radiopaque marker in a manner that couples the radiopaque marker to the stent.
14. The method of claim 13 , wherein translating the stent relative to the roller includes linearly translating the stent relative to the roller in a direction parallel to a central axis of the stent.
15. The method of claim 13 , wherein translating the stent relative to the roller includes linearly translating the stent relative to the roller in a direction perpendicular to a central axis of the stent.
16. The method of claim 13 , wherein translating the stent relative to the roller includes rotationally translating the stent relative to the roller about a central axis of the stent.
17. The method of claim 13 , wherein the stent is supported by the mandrel while the radiopaque marker is pressed with the roller.
18. An apparatus for attaching a radiopaque marker onto a stent, comprising:
a cylindrical mandrel including a forward portion and a rear portion, an outer diameter of the forward portion being less than an outer diameter of the rear portion, the forward portion for supporting a stent; and
rollers spaced apart by a gap that is greater than or equal to the outer diameter of the rear portion of the mandrel;
wherein the mandrel and rollers are movable in relation to each other so that the mandrel passes through the gap.
19. The apparatus of claim 18 , wherein a stent is mounted over the forward portion of the mandrel.
20. The apparatus of claim 18 , wherein the rollers are oriented to allow each of the rollers to rotate about a rotational axis that is perpendicular to a longitudinal axis of the mandrel.
21. The apparatus of claim 18 , wherein the rollers are oriented to allow each of the rollers to rotate about a rotational axis that is parallel to a longitudinal axis of the mandrel.
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Also Published As
Publication number | Publication date |
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US8745842B2 (en) | 2014-06-10 |
US8127422B2 (en) | 2012-03-06 |
US9452067B2 (en) | 2016-09-27 |
US8966736B2 (en) | 2015-03-03 |
US20110000070A1 (en) | 2011-01-06 |
US20120144663A1 (en) | 2012-06-14 |
US20150107085A1 (en) | 2015-04-23 |
US20120151744A1 (en) | 2012-06-21 |
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