WO2012119037A1 - Stent with reduced profile - Google Patents

Stent with reduced profile Download PDF

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Publication number
WO2012119037A1
WO2012119037A1 PCT/US2012/027401 US2012027401W WO2012119037A1 WO 2012119037 A1 WO2012119037 A1 WO 2012119037A1 US 2012027401 W US2012027401 W US 2012027401W WO 2012119037 A1 WO2012119037 A1 WO 2012119037A1
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WO
WIPO (PCT)
Prior art keywords
stent
peaks
distance
balloon
width
Prior art date
Application number
PCT/US2012/027401
Other languages
French (fr)
Inventor
Timothy J. Mickley
Original Assignee
Boston Scientific Scimed, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Scimed, Inc. filed Critical Boston Scientific Scimed, Inc.
Publication of WO2012119037A1 publication Critical patent/WO2012119037A1/en

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Classifications

    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded

Definitions

  • the disclosure relates to endoprosthesis devices for implantation within a body vessel and delivery systems for delivering such devices.
  • a stent is a medical device introduced to a body lumen and is well known in the art.
  • a stent is implanted in a blood vessel at the site of a stenosis or aneurysm endoluminally, i.e., by so-called “minimally invasive techniques” in which the stent in a radially reduced configuration, optionally restrained in a radially compressed configuration by a sheath and/or catheter, is delivered by a stent delivery system or "introducer" to the site where it is required.
  • the introducer may enter the body from an access location outside the body, such as through the patient's skin, or by a "cut down" technique in which the entry blood vessel is exposed by minor surgical means.
  • Stents, grafts, stent-grafts, vena cava filters, expandable frameworks, and similar implantable medical devices are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneous ly.
  • Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, fallopian tubes, coronary vessels, secondary vessels, etc. They may be self-expanding, expanded by an internal radial force, such as when mounted on a balloon, or a combination of self-expanding and balloon expandable (hybrid expandable).
  • this disclosure describes medical devices, systems, and techniques that allow portions of a stent to be folded within a balloon of a stent delivery system.
  • the various medical devices, systems, and techniques described throughout this disclosure allow one or more peaks and/or troughs of a stent to be folded into a balloon fold Docket No.: S63.2C-15078-WO01 of a pleated delivery balloon. In this manner, a profile of the stent can be reduced when the stent is crimped onto the balloon.
  • the disclosure is directed to a stent delivery system comprising a catheter comprising an expandable balloon, the balloon having a pleated state and an unpleated state, the balloon having at least two pleats in the pleated state, adjacent pleats of a balloon being separated by a fold in the pleated state, and a stent having a reduced state and an expanded state.
  • the stent comprises a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands comprising a plurality of peaks and a plurality of troughs, wherein in the reduced state and positioned on the balloon, at least one of the plurality of peaks of at least one of the plurality of rings extends into a fold of the balloon in the pleated state, the at least one peak being positioned a first distance from the longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance, and wherein in the expanded state, the plurality of peaks of the stent being positioned at substantially the same distance from the longitudinal axis.
  • the disclosure is directed to a stent having a reduced state and an expanded state, the stent comprising a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands comprising a plurality of peaks and a plurality of troughs, wherein in the reduced state, at least one of the plurality of peaks of at least one of the plurality of rings is positioned a first distance from the reduced state.
  • FIG. 1 is a side view of a stent delivery system that may be used in accordance with various techniques of this disclosure. Docket No.: S63.2C-15078-WO01
  • FIG. 2A is an isometric view of one example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 2B is a side view of the example annular ring depicted in FIG. 2 A.
  • FIG. 2C is an end view of the example annular ring depicted in FIG. 2A.
  • FIG. 3A is an isometric view of the example annular ring depicted in FIG. 2A in an expanded state.
  • FIG. 3B is a side view of the example annular ring depicted in FIG. 3A.
  • FIG. 3C is an end view of the example annular ring depicted in FIG. 3A.
  • FIGS. 4A-4B are perspective views of a balloon in an unpleated state and a pleated state, respectively, that may be used in conjunction with the stent delivery system shown in
  • FIG. 5 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 5B is a side view of the example annular ring depicted in FIG. 4A.
  • FIG. 5C is an end view of the example annular ring depicted in FIG. 4A.
  • FIG. 6A is a perspective view of one example of a portion of an annular ring.
  • FIG. 6B is a perspective view of another example of a portion of an annular ring.
  • FIG. 7 A is a perspective view of an example stent for use with a pleated balloon, in accordance with this disclosure.
  • FIG. 7B is a cross-sectional view of the example stent and balloon depicted in FIG. 6A.
  • FIG. 8A is a perspective view of another example stent for use with a pleated balloon, in accordance with this disclosure.
  • FIG. 8B is a cross-sectional view of the example stent and balloon depicted in FIG. 7A.
  • FIG. 9 is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 10A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 10B is a side view of the example annular ring depicted in FIG. 10A.
  • FIG. IOC is an end view of the example annular ring depicted in FIG. 10A. Docket No.: S63.2C-15078-WO01
  • FIG. 11 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 1 IB is a side view of the example annular ring depicted in FIG. 11 A.
  • FIG. 11C is an end view of the example annular ring depicted in FIG. 11 A.
  • This disclosure describes medical devices, systems, and techniques that allow portions of a stent to be folded into a balloon fold of a delivery balloon.
  • a portion of the stent can be embedded within a fold of the delivery balloon during the folding process.
  • Embedding a portion of the stent within a fold of the balloon provides one or more advantages over designs that do not utilize such techniques. For example, embedding a portion of the stent within a fold of the balloon reduces the profile of the stent in a crimped state. In addition, embedding a portion of the stent within a fold of the balloon helps secure the stent to the balloon.
  • FIG. 1 is a side view of a stent delivery system that may be used in accordance with various techniques of this disclosure.
  • stent delivery system 10 includes a catheter 12 having distal end 14 upon which a delivery balloon and stent may be secured in order to deliver the stent to a site within a patient's body.
  • Stent delivery systems such as stent delivery system 10 are well known and, for purposes of conciseness, will not be described in detail in this disclosure.
  • FIG. 2A is an isometric view of one example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • the example annular ring of FIG. 2A shown generally at 20, includes a plurality of peaks 22A-22G (collectively referred to in this disclosure as "peaks 22") and a plurality of troughs 24A-24G (collectively referred to in this disclosure as "troughs 24") created by interconnected struts 25.
  • annular band 20 is arranged about longitudinal axis 26 and defines a cylindrical volume, represented by dashed lines 28A and 28B in FIG. 2B (collectively referred to in this disclosure as "lines 28").
  • the cylindrical volume is defined by the unbent peaks 22 and troughs 24 of annular ring 20. Additionally, line 28A defines a proximal end of annular band 20 and line 28B defines a distal end of annular band 20. Docket No.: S63.2C-15078-WO01
  • At least one of the peaks and/or troughs of an annular ring of a stent is configured to bend inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon, i.e., the space between adjacent pleats of a pleated balloon.
  • peak 22H of ring 20 bends inward into the cylindrical volume defined by the ring.
  • peak 22H bends into a balloon fold when placed onto a pleated delivery balloon.
  • a first proximal end of at least one of the plurality of peaks or troughs of the stent extends into a fold of the balloon in the pleated state, the at least one peak being positioned a first distance from the longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance.
  • Each of the plurality of rings 20 has a respective proximal end 27 and a respective distal end 31.
  • one or more of the plurality of peaks of the stent e.g., bent peak 22H
  • bent peak 22H is positioned such that bent peak 22H is a first distance from longitudinal axis 26, e.g., distance D ls and another one of the plurality of peaks, e.g., unbent peak 22E, is positioned a second distance from
  • one or more of the plurality of peaks of the stent extends into a fold of a balloon in a pleated state. That is, when the example configuration depicted in FIG. 2A is positioned on a pleated balloon, bent peak 22H extends into a fold of the balloon (e.g., fold 46 of balloon 30 in FIG. 4B).
  • both a peak and a trough can be bent to extend into a fold of a pleated balloon.
  • a trough of ring 20 can similarly be bent inward.
  • trough 24E when a stent is in a reduced state, trough 24E can be bent inward such that it is positioned at a third distance from longitudinal axis 26 while unbent troughs, e.g., trough 24B, are positioned at a fourth distance from longitudinal axis 26, where the third distance is less than the fourth distance.
  • a ring can include at least one bent peak and at least one bent trough.
  • configuring at least one peak and/or trough of a ring of a stent to bend inward into a balloon fold reduces the profile of the stent after crimping by minimizing the number of peaks (or troughs) that can interfere with another peak (or trough) during the crimping process.
  • a stent can only be crimped to the point that its peaks or troughs begin to touch one another, thereby limiting the extent to which the stent's size can be reduced by crimping.
  • the peaks and/or troughs are essentially eliminated from the circumference of the stent. In this manner, the stent can be crimped to a smaller size than would otherwise be achievable, thereby reducing the profile of the stent.
  • a peak or trough of a ring can be configured to bend inward and extend into a balloon fold of a balloon using various techniques in accordance with this disclosure.
  • peaks or troughs of a ring e.g., peak 22H of ring 20
  • peaks or troughs of a ring are bent inward by folding the peak(s) or trough(s) at particular portions of struts 25.
  • fold lines are depicted in FIG. 2 A at 29 A and 29B
  • fold lines 29 (referred to generally in this disclosure as "fold lines 29"). Although only two fold lines 29A and 29B are depicted in FIG. 2A, annular ring 20 can have more fold lines 29 or only a single fold line 29. As seen in FIG. 2 A, peak 22H of ring 20 is bent inward into the cylindrical volume defined by ring 20 by folding at fold lines 29 A, 29B, as indicated by the fact that the struts adjacent trough 24G are closer to each other than struts adjacent other troughs of ring 20, e.g., trough 24F.
  • Peaks or troughs of a ring can be folded at fold lines 29 using various techniques in accordance with this disclosure.
  • the material at one or more portions of one or more struts of a ring can be reduced in order to create portion(s) that are thinner than the remainder of the strut.
  • material near fold line 29A and/or fold line 29B can be reduced such that a width of strut 25 is thinner near the fold line than elsewhere along on the strut.
  • material near fold line 29A and/or fold line 29B can be reduced such that a thickness of strut 25 is thinner near the fold line than elsewhere along on the strut.
  • the strut can be formed by laser cutting, chemical etching, electroforming or stamping of a tube.
  • the geometry of the stent can be Docket No.: S63.2C-15078-WO01 configured to allow peaks and/or troughs to be folded.
  • crimping techniques are employed instead.
  • crimping techniques are used that bend one or more peaks and/or troughs inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon.
  • a mold is employed, e.g., a clamshell mold, that includes pins that push certain portions of a stent below other portions as the mold is closed in order to bent certain peaks into folds of the balloon.
  • Any suitable stent material may be used in the manufacture of the rings and stents described in this disclosure.
  • suitable stent material include metals such as stainless steel, tantalum, elgiloy and shape memory metals such as nitinol and shape memory polymers.
  • the rings and stents may also be made of suitable polymeric materials.
  • FIG. 2B is a side view of the example annular ring 20 depicted in FIG. 2A.
  • FIG. 2B depicts ring 20 arranged about longitudinal axis 26 and having a peak, namely peak 22H, bending inward into the cylindrical volume defined by the ring, represented by dashed lines 28.
  • FIG. 2C is an end view of the example annular ring 20 depicted in FIG. 2A.
  • FIG. 2C depicts ring 20 arranged about longitudinal axis 26 and having a peak, namely peak 22H, bending inward into the cylindrical volume defined by the ring (not shown in FIG. 2B).
  • FIG. 3 A is an isometric view of the example annular ring depicted in FIG. 2A in an expanded state.
  • peak 22H (which was previously bent in FIG. 2A) has expanded outwardly away from longitudinal axis 26 such that peak 22h is positioned at substantially the same distance from longitudinal axis 26 as previously unbent peaks, e.g., peak 22E.
  • Di and D 2 are approximately equal.
  • FIGS 3B and 3C are side and end views, respectively, of the example annular ring depicted in FIG. 3A.
  • FIGS. 4A-4B are perspective views of a delivery balloon in an unpleated state and a pleated state, respectively, that can be used in conjunction with the stent delivery system shown in FIG. 1.
  • delivery balloon 30 with balloon body 32 shown in an Docket No.: S63.2C-15078-WO01 unpleated, or expanded state, can be secured to distal end 14 of catheter 12 (FIG. 1), e.g., by adhesive attachment of proximal end 34 of balloon 30 to an outer shaft of catheter 12 and distal end 36 of balloon 30 to an inner shaft of catheter 12.
  • FIG. 4B depicts delivery balloon 30 with balloon body 32 in a pleated state, prior to folding of the balloon.
  • balloon body 32 includes three pleats, namely pleats 40, 42, and 44. In other configurations, balloon body 32 includes fewer or more pleats.
  • the balloon body, or balloon has at least two pleats in the pleated state.
  • At least one of the peaks of an annular ring of a stent is configured to bend inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon.
  • a balloon fold is the area or space between adjacent pleats on a balloon.
  • FIG. 4B depicts balloon 30 having balloon fold 46 located between adjacent pleats 40, 44.
  • balloon 30 has two other balloon folds (not shown) located between adjacent pleats 40, 42 and adjacent pleats 42, 44.
  • FIG. 5 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 5A depicts annular ring 50 arranged about longitudinal axis 26 and configured to have four peaks that bend inward into a cylindrical volume defined by ring 50 and into a balloon fold of a balloon.
  • peaks 22B, 22D, 22F, and 22H of ring 20 bend inwards into the cylindrical volume defined by the ring.
  • peaks 22B, 22D, 22F, and 22H bend into a balloon fold when placed onto a pleated delivery balloon.
  • FIGS. 5B and 5C depict a side view and an end view, respectively, of the example annular ring depicted in FIG. 5A.
  • FIG. 6A is a perspective view of one example of a portion of an annular ring.
  • FIG. 6A depicts fold lines 29 in a portion of an annular ring, e.g., annular rings 20 or 50.
  • fold lines 29 are formed by reducing a portion of the thickness of strut 25, e.g., a notch in strut 25, in the bend area.
  • peaks 22 A and 22G can be compressed toward Docket No.: S63.2C-15078-WO01 each other, thereby allowing peak 22H to be bent so that it extends into a fold of a pleated balloon.
  • FIG. 6B is a perspective view of another example of a portion of an annular ring.
  • FIG. 6B depicts fold lines 29 in a portion of an annular ring, e.g., annular rings 20 or 50.
  • fold lines 29 are formed by reducing a portion of the width of strut 25, e.g., a notch in strut 25, in the bend area.
  • peak 22H can be compressed and bent so that it extends into a fold of a pleated balloon.
  • strut(s) 25 can be formed into a bent shape.
  • the bent shape reduces or eliminates the need for a notch or other reduction in a portion of strut 25.
  • FIG. 7A is a perspective view of an example stent for use with a pleated balloon, in accordance with this disclosure.
  • FIG. 7A depicts a stent delivery system, shown generally at 60, that comprises a stent, shown generally at 62, having a plurality of interconnected annular rings 20A-20F, e.g., annular rings 20 of FIGS. 2A-2C, positioned on expandable balloon 64 and arranged about a longitudinal axis, shown generally at 70.
  • Balloon 64 is depicted in a pleated state and includes adjacent pleats 65 and 66. Adjacent pleats 65, 66 are separated by fold 68.
  • Stent 62 depicted in a reduced in FIG. 7A, includes at least one peak, namely peak 22H, extending into fold 68 of pleated balloon 64.
  • Peak 22H of ring 20A for example, extends into fold 68 by being bent inward along fold line 29.
  • at least one of annular bands 20 of stent 62 includes a peak, e.g., peak 22H, positioned a first distance from longitudinal axis 70 and another peak, e.g., peak 22G, positioned a second distance from longitudinal axis 70, the first distance being less than the second distance.
  • FIG. 7B is a cross-sectional view of the example stent and balloon depicted in FIG. 7A, taken along line A-A.
  • a portion of stent 62 is embedded within a fold of the balloon, thereby reducing the profile of stent 62 in a reduced or crimped state.
  • embedding a portion of the stent within a fold of the balloon helps secure the stent to the balloon.
  • stent 62 is depicted as having six rings 20A-20F, stent 62 is not limited to such a configuration. Rather, stent 62 can have more or fewer rings 20. Additionally, although pleated balloon 64 is depicted as having two adjacent pleats and a fold in between, balloon 64 can have more pleats, and thus more folds, thereby allowing more peaks in a ring to be extend into folds. Further, it should be noted that although each of rings 20A-20F includes a peak that extends into fold 68 of balloon 64, the disclosure is not so limited.
  • only one ring, e.g., ring 20A, of stent 62 includes a bent peak that extends into a fold.
  • multiple rings 20 of stent 62, but less than all rings 20, include a bent peak that extends into a fold.
  • FIG. 8A is a perspective view of another example stent for use with a pleated balloon, in accordance with this disclosure.
  • FIG. 8A depicts a stent delivery system, shown generally at 80, that comprises a stent, shown generally at 82, having a plurality of interconnected annular rings 20A-20F, e.g., annular rings 20 of FIGS. 2A-2C, positioned on expandable balloon 64 and arranged about a longitudinal axis, shown generally at 70.
  • Balloon 64 is depicted in a pleated state and includes pleats 84, 86, and 88. Adjacent pleats 84, 86 are separated by fold 88 and adjacent pleats 86, 88 are separated by fold 90.
  • Stent 82 depicted in a reduced in FIG. 8A, includes at least one peak, namely peak 22H, extending into fold 88 of pleated balloon 64. Peak 22H of ring 20A, for example, extends into fold 88 by being bent inward along fold line 29C.
  • at least one of annular bands 20 of stent 82 includes a peak, e.g., peak 22H, positioned a first distance from longitudinal axis 70 and another peak, e.g., peak 22G, positioned a second distance from longitudinal axis 70, the first distance being less than the second distance.
  • the plurality of peaks 22 of stent 82 are positioned at substantially the same distance from longitudinal axis 70, as shown and described above with respect to FIGS. 3A-3C.
  • At least one of annular bands 20 of stent 82 includes a trough, e.g., trough 24F, that extends into a fold, e.g., fold 88, of pleated balloon 64.
  • Trough 24F is positioned a third distance from longitudinal axis 70 and another trough, e.g., trough 24G, is positioned a fourth distance from longitudinal axis 70, the third distance being less than the fourth distance.
  • FIG. 8B is a cross-sectional view of the example stent and balloon depicted in FIG. 8A, taken along line B-B.
  • FIG. 9 is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • bent peak 22H of ring 100 is configured to expand before the unbent peaks, e.g., peaks 22A-22G, when a stent comprising ring 100 transitions from a reduced state to an expanded state.
  • Ring 100 forms part of a stent in a reduced state.
  • FIGS. 3A-3C depict a ring in an expanded state.
  • bent peak 22H of ring 100 of FIG. 9 is configured to expand before the unbent peaks, e.g., peaks 22A-22G. That is, by constructing struts of the bent peak to be thinner than struts of the unbent peaks, the bent peaks can open prior to the unbent peaks as the stent expands from a reduced state.
  • unbent peaks e.g., unbent peak 22G
  • bent peak 22H is formed by struts 25B having a width W 2 , where width Wi is greater than width W 2 .
  • Such a configuration allows a bent peak, e.g., peak 22H, that extends into the fold of a balloon, e.g., fold 68 of balloon 64, to expand outwardly prior to the remaining unbent peaks, e.g., 22A-22G, during an expansion from the reduced state to the expanded state.
  • a bent peak e.g., peak 22H
  • the remaining unbent peaks e.g., 22A-22G
  • each bent peak can comprise struts that are thinner than the struts of unbent peaks.
  • FIG. 10A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 10A depicts annular ring 110 arranged about longitudinal axis 26 and configured to have two peaks that bend inward into a cylindrical volume defined by ring 110 and into a balloon fold of a balloon.
  • peaks 22D and 22H of ring 110 bend inwards into the cylindrical volume defined by the ring.
  • FIGS. 10B and IOC depict a side view and an end view, respectively, of the example annular ring depicted in FIG. 10A. Docket No.: S63.2C-15078-WO01
  • FIG. 11 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
  • FIG. 11 A depicts annular ring 110 arranged about longitudinal axis 26 and configured to have four peaks that bend inward into a cylindrical volume defined by ring 110 and into a balloon fold of a balloon.
  • peaks 22B, 22D, 22F, and 22H of ring 110 bend inwards into the cylindrical volume defined by the ring.
  • Ring 110 is similar to ring 50 of FIGS. 5A-5C, except that bent peaks 22B, 22D, 22F, and 22H of ring 110 are deformed even more than the bent peaks of 50.
  • Peaks 22B, 22D, 22F, and 22H of ring 110 can be deformed in the manner shown by adding additional fold lines 29, such as fold lines 29A-29C as seen best in FIG. l lC.
  • FIGS. 1 IB and 11C depict a side view and an end view, respectively, of the example annular ring depicted in FIG. 11 A.
  • the stent, the delivery system or other portion of the assembly may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc.
  • imaging modalities such as X-Ray, MRI, ultrasound, etc.
  • at least a portion of the stent and/or adjacent assembly is at least partially radiopaque.
  • the stent is configured to include one or more mechanisms for the delivery of a therapeutic agent.
  • the agent will be in the form of a coating or other layer (or layers) of material placed on a surface region of the stent, which is adapted to be released at the site of the stent's implantation or areas adjacent thereto.
  • a therapeutic agent may be a drug or other pharmaceutical product such as non- genetic agents, genetic agents, cellular material, etc.
  • suitable non-genetic therapeutic agents include but are not limited to: anti-thrombogenic agents such as heparin, heparin derivatives, vascular cell growth promoters, growth factor inhibitors, Paclitaxel, etc.
  • an agent includes a genetic therapeutic agent, such a genetic agent may include but is not limited to: DNA, RNA and their respective derivatives and/or components; hedgehog proteins, etc.
  • the cellular material may include but is not limited to: cells of human origin and/or non-human origin as well as their respective components and/or derivatives thereof.
  • the polymer agent may be a polystyrene-polyisobutylene -polystyrene triblock copolymer (SIBS), polyethylene oxide, silicone rubber and/or any other suitable substrate.
  • SIBS polystyrene-polyisobutylene -polystyrene triblock copolymer

Abstract

Medical devices, systems, and techniques are described for reducing the profile of a stent. In one example, a stent having a reduced state and an expanded state includes a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands (20) comprising a plurality of peaks (22A-22G) and a plurality of troughs (24A-24G), wherein in the reduced state, at least one of the plurality of peaks of at least one of the plurality of rings is positioned a first distance (Dl) from the longitudinal axis (26), another one of the plurality of peaks being positioned a second distance (D2) from the longitudinal axis, the first distance being less than the second distance, and wherein in the expanded state, the plurality of peaks of the stent being positioned at substantially the same distance from the longitudinal axis.

Description

Docket No.: S63.2C-15078-WO01
STENT WITH REDUCED PROFILE
TECHNICAL FIELD
[0001] The disclosure relates to endoprosthesis devices for implantation within a body vessel and delivery systems for delivering such devices.
BACKGROUND
[0002] A stent is a medical device introduced to a body lumen and is well known in the art. Typically, a stent is implanted in a blood vessel at the site of a stenosis or aneurysm endoluminally, i.e., by so-called "minimally invasive techniques" in which the stent in a radially reduced configuration, optionally restrained in a radially compressed configuration by a sheath and/or catheter, is delivered by a stent delivery system or "introducer" to the site where it is required. The introducer may enter the body from an access location outside the body, such as through the patient's skin, or by a "cut down" technique in which the entry blood vessel is exposed by minor surgical means.
[0003] Stents, grafts, stent-grafts, vena cava filters, expandable frameworks, and similar implantable medical devices are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneous ly. Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, fallopian tubes, coronary vessels, secondary vessels, etc. They may be self-expanding, expanded by an internal radial force, such as when mounted on a balloon, or a combination of self-expanding and balloon expandable (hybrid expandable).
SUMMARY
[0004] In general, this disclosure describes medical devices, systems, and techniques that allow portions of a stent to be folded within a balloon of a stent delivery system. In particular, the various medical devices, systems, and techniques described throughout this disclosure allow one or more peaks and/or troughs of a stent to be folded into a balloon fold Docket No.: S63.2C-15078-WO01 of a pleated delivery balloon. In this manner, a profile of the stent can be reduced when the stent is crimped onto the balloon.
[0005] In one example, the disclosure is directed to a stent delivery system comprising a catheter comprising an expandable balloon, the balloon having a pleated state and an unpleated state, the balloon having at least two pleats in the pleated state, adjacent pleats of a balloon being separated by a fold in the pleated state, and a stent having a reduced state and an expanded state. The stent comprises a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands comprising a plurality of peaks and a plurality of troughs, wherein in the reduced state and positioned on the balloon, at least one of the plurality of peaks of at least one of the plurality of rings extends into a fold of the balloon in the pleated state, the at least one peak being positioned a first distance from the longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance, and wherein in the expanded state, the plurality of peaks of the stent being positioned at substantially the same distance from the longitudinal axis.
[0006] In another example, the disclosure is directed to a stent having a reduced state and an expanded state, the stent comprising a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands comprising a plurality of peaks and a plurality of troughs, wherein in the reduced state, at least one of the plurality of peaks of at least one of the plurality of rings is positioned a first distance from the
longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance, and wherein in the expanded state, the plurality of peaks of the stent being positioned at substantially the same distance from the longitudinal axis.
[0007] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
BRIEF DESCRIPTION OF DRAWINGS
[0008] FIG. 1 is a side view of a stent delivery system that may be used in accordance with various techniques of this disclosure. Docket No.: S63.2C-15078-WO01
[0009] FIG. 2A is an isometric view of one example annular ring of a stent that can be used to implement various techniques of this disclosure.
[0010] FIG. 2B is a side view of the example annular ring depicted in FIG. 2 A.
[0011] FIG. 2C is an end view of the example annular ring depicted in FIG. 2A.
[0012] FIG. 3A is an isometric view of the example annular ring depicted in FIG. 2A in an expanded state.
[0013] FIG. 3B is a side view of the example annular ring depicted in FIG. 3A.
[0014] FIG. 3C is an end view of the example annular ring depicted in FIG. 3A.
[0015] FIGS. 4A-4B are perspective views of a balloon in an unpleated state and a pleated state, respectively, that may be used in conjunction with the stent delivery system shown in
FIG. 1.
[0016] FIG. 5 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
[0017] FIG. 5B is a side view of the example annular ring depicted in FIG. 4A.
[0018] FIG. 5C is an end view of the example annular ring depicted in FIG. 4A.
[0019] FIG. 6A is a perspective view of one example of a portion of an annular ring.
[0020] FIG. 6B is a perspective view of another example of a portion of an annular ring.
[0021] FIG. 7 A is a perspective view of an example stent for use with a pleated balloon, in accordance with this disclosure.
[0022] FIG. 7B is a cross-sectional view of the example stent and balloon depicted in FIG. 6A.
[0023] FIG. 8A is a perspective view of another example stent for use with a pleated balloon, in accordance with this disclosure.
[0024] FIG. 8B is a cross-sectional view of the example stent and balloon depicted in FIG. 7A.
[0025] FIG. 9 is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
[0026] FIG. 10A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
[0027] FIG. 10B is a side view of the example annular ring depicted in FIG. 10A.
[0028] FIG. IOC is an end view of the example annular ring depicted in FIG. 10A. Docket No.: S63.2C-15078-WO01
[0029] FIG. 11 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure.
[0030] FIG. 1 IB is a side view of the example annular ring depicted in FIG. 11 A.
[0031] FIG. 11C is an end view of the example annular ring depicted in FIG. 11 A.
DETAILED DESCRIPTION
[0032] This disclosure describes medical devices, systems, and techniques that allow portions of a stent to be folded into a balloon fold of a delivery balloon. As such, using certain techniques of this disclosure, a portion of the stent can be embedded within a fold of the delivery balloon during the folding process. Embedding a portion of the stent within a fold of the balloon provides one or more advantages over designs that do not utilize such techniques. For example, embedding a portion of the stent within a fold of the balloon reduces the profile of the stent in a crimped state. In addition, embedding a portion of the stent within a fold of the balloon helps secure the stent to the balloon.
[0033] FIG. 1 is a side view of a stent delivery system that may be used in accordance with various techniques of this disclosure. As seen in FIG. 1, stent delivery system 10 includes a catheter 12 having distal end 14 upon which a delivery balloon and stent may be secured in order to deliver the stent to a site within a patient's body. Stent delivery systems such as stent delivery system 10 are well known and, for purposes of conciseness, will not be described in detail in this disclosure.
[0034] FIG. 2A is an isometric view of one example annular ring of a stent that can be used to implement various techniques of this disclosure. In particular, the example annular ring of FIG. 2A, shown generally at 20, includes a plurality of peaks 22A-22G (collectively referred to in this disclosure as "peaks 22") and a plurality of troughs 24A-24G (collectively referred to in this disclosure as "troughs 24") created by interconnected struts 25. As seen in FIG. 2A, annular band 20 is arranged about longitudinal axis 26 and defines a cylindrical volume, represented by dashed lines 28A and 28B in FIG. 2B (collectively referred to in this disclosure as "lines 28"). The cylindrical volume is defined by the unbent peaks 22 and troughs 24 of annular ring 20. Additionally, line 28A defines a proximal end of annular band 20 and line 28B defines a distal end of annular band 20. Docket No.: S63.2C-15078-WO01
[0035] In accordance with this disclosure, at least one of the peaks and/or troughs of an annular ring of a stent is configured to bend inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon, i.e., the space between adjacent pleats of a pleated balloon. In FIG. 2A, peak 22H of ring 20 bends inward into the cylindrical volume defined by the ring. Although not depicted in FIG. 2A, peak 22H bends into a balloon fold when placed onto a pleated delivery balloon. In this manner, when in a reduced state and positioned on the balloon, a first proximal end of at least one of the plurality of peaks or troughs of the stent extends into a fold of the balloon in the pleated state, the at least one peak being positioned a first distance from the longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance.
[0036] Each of the plurality of rings 20 has a respective proximal end 27 and a respective distal end 31. In accordance with certain techniques of this disclosure, when a stent is in a reduced state, and thus when ring 20 is in a reduced state, as shown in FIGS. 2A-2C, one or more of the plurality of peaks of the stent, e.g., bent peak 22H, is positioned such that bent peak 22H is a first distance from longitudinal axis 26, e.g., distance Dls and another one of the plurality of peaks, e.g., unbent peak 22E, is positioned a second distance from
longitudinal axis 26, e.g., distance D2, where the first distance, e.g., distance Dls is less than the second distance, e.g., distance D2. In this manner, one or more of the plurality of peaks of the stent extends into a fold of a balloon in a pleated state. That is, when the example configuration depicted in FIG. 2A is positioned on a pleated balloon, bent peak 22H extends into a fold of the balloon (e.g., fold 46 of balloon 30 in FIG. 4B).
[0037] In some example configurations, both a peak and a trough can be bent to extend into a fold of a pleated balloon. For example, in addition to peak 22H of FIG. 2A being bent and thus positioned at a distance from longitudinal axis 26 that is greater than the distance of unbent peaks, e.g., unbent peak 22E, from longitudinal axis 26, a trough of ring 20 can similarly be bent inward. For example, when a stent is in a reduced state, trough 24E can be bent inward such that it is positioned at a third distance from longitudinal axis 26 while unbent troughs, e.g., trough 24B, are positioned at a fourth distance from longitudinal axis 26, where the third distance is less than the fourth distance. In this manner, a ring can include at least one bent peak and at least one bent trough. Docket No.: S63.2C-15078-WO01
[0038] As shown and described in more detail below, configuring at least one peak and/or trough of a ring of a stent to bend inward into a balloon fold reduces the profile of the stent after crimping by minimizing the number of peaks (or troughs) that can interfere with another peak (or trough) during the crimping process. A stent can only be crimped to the point that its peaks or troughs begin to touch one another, thereby limiting the extent to which the stent's size can be reduced by crimping. In accordance with this disclosure, by bending one or more peaks and/or troughs of one or more annular rings of a stent into a balloon fold prior to crimping, the peaks and/or troughs are essentially eliminated from the circumference of the stent. In this manner, the stent can be crimped to a smaller size than would otherwise be achievable, thereby reducing the profile of the stent.
[0039] A peak or trough of a ring, e.g., peak 22H of ring 20, can be configured to bend inward and extend into a balloon fold of a balloon using various techniques in accordance with this disclosure. In one example, peaks or troughs of a ring, e.g., peak 22H of ring 20, are bent inward by folding the peak(s) or trough(s) at particular portions of struts 25. These portions of struts 25, referred to as fold lines, are depicted in FIG. 2 A at 29 A and 29B
(referred to generally in this disclosure as "fold lines 29"). Although only two fold lines 29A and 29B are depicted in FIG. 2A, annular ring 20 can have more fold lines 29 or only a single fold line 29. As seen in FIG. 2 A, peak 22H of ring 20 is bent inward into the cylindrical volume defined by ring 20 by folding at fold lines 29 A, 29B, as indicated by the fact that the struts adjacent trough 24G are closer to each other than struts adjacent other troughs of ring 20, e.g., trough 24F.
[0040] Peaks or troughs of a ring can be folded at fold lines 29 using various techniques in accordance with this disclosure. In one example, the material at one or more portions of one or more struts of a ring can be reduced in order to create portion(s) that are thinner than the remainder of the strut. For example, in FIG. 2A, material near fold line 29A and/or fold line 29B can be reduced such that a width of strut 25 is thinner near the fold line than elsewhere along on the strut. As another example, in FIG. 2A, material near fold line 29A and/or fold line 29B can be reduced such that a thickness of strut 25 is thinner near the fold line than elsewhere along on the strut. The strut can be formed by laser cutting, chemical etching, electroforming or stamping of a tube. In this manner, the geometry of the stent can be Docket No.: S63.2C-15078-WO01 configured to allow peaks and/or troughs to be folded. These techniques are shown and described in more detail below with respect to FIGS. 6 A and 6B.
[0041] In another example folding technique, rather than configuring the geometry of the stent to allow peaks and/or troughs to be folded in the manner described throughout this disclosure, crimping techniques are employed instead. In accordance with this disclosure, crimping techniques are used that bend one or more peaks and/or troughs inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon. In one example crimping process, a mold is employed, e.g., a clamshell mold, that includes pins that push certain portions of a stent below other portions as the mold is closed in order to bent certain peaks into folds of the balloon.
[0042] Any suitable stent material may be used in the manufacture of the rings and stents described in this disclosure. Examples of such materials include metals such as stainless steel, tantalum, elgiloy and shape memory metals such as nitinol and shape memory polymers. The rings and stents may also be made of suitable polymeric materials.
[0043] FIG. 2B is a side view of the example annular ring 20 depicted in FIG. 2A.
Specifically, FIG. 2B depicts ring 20 arranged about longitudinal axis 26 and having a peak, namely peak 22H, bending inward into the cylindrical volume defined by the ring, represented by dashed lines 28.
[0044] FIG. 2C is an end view of the example annular ring 20 depicted in FIG. 2A. In particular, FIG. 2C depicts ring 20 arranged about longitudinal axis 26 and having a peak, namely peak 22H, bending inward into the cylindrical volume defined by the ring (not shown in FIG. 2B).
[0045] FIG. 3 A is an isometric view of the example annular ring depicted in FIG. 2A in an expanded state. In the expanded state, peak 22H (which was previously bent in FIG. 2A) has expanded outwardly away from longitudinal axis 26 such that peak 22h is positioned at substantially the same distance from longitudinal axis 26 as previously unbent peaks, e.g., peak 22E. In other words, in FIG. 3A, Di and D2 are approximately equal. FIGS 3B and 3C are side and end views, respectively, of the example annular ring depicted in FIG. 3A.
[0046] FIGS. 4A-4B are perspective views of a delivery balloon in an unpleated state and a pleated state, respectively, that can be used in conjunction with the stent delivery system shown in FIG. 1. In FIG. 4A, delivery balloon 30 with balloon body 32, shown in an Docket No.: S63.2C-15078-WO01 unpleated, or expanded state, can be secured to distal end 14 of catheter 12 (FIG. 1), e.g., by adhesive attachment of proximal end 34 of balloon 30 to an outer shaft of catheter 12 and distal end 36 of balloon 30 to an inner shaft of catheter 12.
[0047] FIG. 4B depicts delivery balloon 30 with balloon body 32 in a pleated state, prior to folding of the balloon. As depicted in FIG. 4B, balloon body 32 includes three pleats, namely pleats 40, 42, and 44. In other configurations, balloon body 32 includes fewer or more pleats. The balloon body, or balloon, has at least two pleats in the pleated state.
[0048] As mentioned above, using certain techniques of this disclosure, at least one of the peaks of an annular ring of a stent is configured to bend inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon. In one example, a balloon fold is the area or space between adjacent pleats on a balloon. By way of specific example, FIG. 4B depicts balloon 30 having balloon fold 46 located between adjacent pleats 40, 44. Similarly, balloon 30 has two other balloon folds (not shown) located between adjacent pleats 40, 42 and adjacent pleats 42, 44. By configuring at least one peak of annular rings of a stent, e.g., peak 22H of annular ring 30 of FIGS. 2A-2C, to bend inward into the cylindrical volume defined by the ring and into a balloon fold of a balloon, e.g., balloon fold 46 of balloon 30 of FIG. 4B, the profile of the stent is reduced in a crimped state. The combination of a stent and balloon is shown and described in detail below with respect to FIGS. 7 A and 8 A.
[0049] FIG. 5 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure. In particular, FIG. 5A depicts annular ring 50 arranged about longitudinal axis 26 and configured to have four peaks that bend inward into a cylindrical volume defined by ring 50 and into a balloon fold of a balloon. In FIG. 5A, peaks 22B, 22D, 22F, and 22H of ring 20 bend inwards into the cylindrical volume defined by the ring. As shown below in FIG. 6, peaks 22B, 22D, 22F, and 22H bend into a balloon fold when placed onto a pleated delivery balloon. FIGS. 5B and 5C depict a side view and an end view, respectively, of the example annular ring depicted in FIG. 5A.
[0050] FIG. 6A is a perspective view of one example of a portion of an annular ring. In particular, FIG. 6A depicts fold lines 29 in a portion of an annular ring, e.g., annular rings 20 or 50. In the example configuration depicted in FIG. 6A, fold lines 29 are formed by reducing a portion of the thickness of strut 25, e.g., a notch in strut 25, in the bend area. By reducing a portion of the thickness of strut 25, peaks 22 A and 22G can be compressed toward Docket No.: S63.2C-15078-WO01 each other, thereby allowing peak 22H to be bent so that it extends into a fold of a pleated balloon.
[0051] FIG. 6B is a perspective view of another example of a portion of an annular ring. In particular, FIG. 6B depicts fold lines 29 in a portion of an annular ring, e.g., annular rings 20 or 50. In the example configuration depicted in FIG. 6B, fold lines 29 are formed by reducing a portion of the width of strut 25, e.g., a notch in strut 25, in the bend area. By reducing a portion of the width of strut 25, peak 22H can be compressed and bent so that it extends into a fold of a pleated balloon.
[0052] In other example configurations, strut(s) 25 can be formed into a bent shape. In such an example configuration, the bent shape reduces or eliminates the need for a notch or other reduction in a portion of strut 25.
[0053] FIG. 7A is a perspective view of an example stent for use with a pleated balloon, in accordance with this disclosure. In particular, FIG. 7A depicts a stent delivery system, shown generally at 60, that comprises a stent, shown generally at 62, having a plurality of interconnected annular rings 20A-20F, e.g., annular rings 20 of FIGS. 2A-2C, positioned on expandable balloon 64 and arranged about a longitudinal axis, shown generally at 70.
Balloon 64 is depicted in a pleated state and includes adjacent pleats 65 and 66. Adjacent pleats 65, 66 are separated by fold 68.
[0054] Stent 62, depicted in a reduced in FIG. 7A, includes at least one peak, namely peak 22H, extending into fold 68 of pleated balloon 64. Peak 22H of ring 20A, for example, extends into fold 68 by being bent inward along fold line 29. As shown and described above in detail with respect to FIGS. 2A-2C, at least one of annular bands 20 of stent 62 includes a peak, e.g., peak 22H, positioned a first distance from longitudinal axis 70 and another peak, e.g., peak 22G, positioned a second distance from longitudinal axis 70, the first distance being less than the second distance. When stent 62 is in an expanded state, the plurality of peaks 22 of stent 62 are positioned at substantially the same distance from longitudinal axis 70, as shown and described above with respect to FIGS. 3A-3C. FIG. 7B is a cross-sectional view of the example stent and balloon depicted in FIG. 7A, taken along line A-A.
[0055] In this manner, a portion of stent 62 is embedded within a fold of the balloon, thereby reducing the profile of stent 62 in a reduced or crimped state. In addition, embedding a portion of the stent within a fold of the balloon helps secure the stent to the balloon. Docket No.: S63.2C-15078-WO01
[0056] Although stent 62 is depicted as having six rings 20A-20F, stent 62 is not limited to such a configuration. Rather, stent 62 can have more or fewer rings 20. Additionally, although pleated balloon 64 is depicted as having two adjacent pleats and a fold in between, balloon 64 can have more pleats, and thus more folds, thereby allowing more peaks in a ring to be extend into folds. Further, it should be noted that although each of rings 20A-20F includes a peak that extends into fold 68 of balloon 64, the disclosure is not so limited.
Rather, in some examples, only one ring, e.g., ring 20A, of stent 62 includes a bent peak that extends into a fold. In other example configurations, multiple rings 20 of stent 62, but less than all rings 20, include a bent peak that extends into a fold.
[0057] FIG. 8A is a perspective view of another example stent for use with a pleated balloon, in accordance with this disclosure. In particular, FIG. 8A depicts a stent delivery system, shown generally at 80, that comprises a stent, shown generally at 82, having a plurality of interconnected annular rings 20A-20F, e.g., annular rings 20 of FIGS. 2A-2C, positioned on expandable balloon 64 and arranged about a longitudinal axis, shown generally at 70.
Balloon 64 is depicted in a pleated state and includes pleats 84, 86, and 88. Adjacent pleats 84, 86 are separated by fold 88 and adjacent pleats 86, 88 are separated by fold 90.
[0058] Stent 82, depicted in a reduced in FIG. 8A, includes at least one peak, namely peak 22H, extending into fold 88 of pleated balloon 64. Peak 22H of ring 20A, for example, extends into fold 88 by being bent inward along fold line 29C. As shown and described above in detail with respect to FIGS. 2A-2C, at least one of annular bands 20 of stent 82 includes a peak, e.g., peak 22H, positioned a first distance from longitudinal axis 70 and another peak, e.g., peak 22G, positioned a second distance from longitudinal axis 70, the first distance being less than the second distance. When stent 62 is in an expanded state, the plurality of peaks 22 of stent 82 are positioned at substantially the same distance from longitudinal axis 70, as shown and described above with respect to FIGS. 3A-3C.
[0059] In addition, in the example shown in FIG. 8A, at least one of annular bands 20 of stent 82 includes a trough, e.g., trough 24F, that extends into a fold, e.g., fold 88, of pleated balloon 64. Trough 24F is positioned a third distance from longitudinal axis 70 and another trough, e.g., trough 24G, is positioned a fourth distance from longitudinal axis 70, the third distance being less than the fourth distance. When stent 82 is in an expanded state, the plurality of troughs 24 of stent 82 are positioned at substantially the same distance from Docket No.: S63.2C-15078-WO01 longitudinal axis 70, as shown and described above with respect to FIGS. 3A-3C. FIG. 8B is a cross-sectional view of the example stent and balloon depicted in FIG. 8A, taken along line B-B.
[0060] FIG. 9 is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure. In FIG. 9, in accordance with this disclosure, bent peak 22H of ring 100 is configured to expand before the unbent peaks, e.g., peaks 22A-22G, when a stent comprising ring 100 transitions from a reduced state to an expanded state. Ring 100 forms part of a stent in a reduced state. FIGS. 3A-3C, described in detail above, depict a ring in an expanded state.
[0061] In accordance with certain techniques of this disclosure, bent peak 22H of ring 100 of FIG. 9 is configured to expand before the unbent peaks, e.g., peaks 22A-22G. That is, by constructing struts of the bent peak to be thinner than struts of the unbent peaks, the bent peaks can open prior to the unbent peaks as the stent expands from a reduced state. In FIG. 9, unbent peaks, e.g., unbent peak 22G, is formed by struts 25A having a width Wi and bent peak 22H is formed by struts 25B having a width W2, where width Wi is greater than width W2. Such a configuration allows a bent peak, e.g., peak 22H, that extends into the fold of a balloon, e.g., fold 68 of balloon 64, to expand outwardly prior to the remaining unbent peaks, e.g., 22A-22G, during an expansion from the reduced state to the expanded state. Additional detail regarding stents that include struts with varying widths can be found in U.S. Patent Application No. 61/448,843, entitled "Low Strain High Strength Stent" and filed on March 3, 2011, incorporated herein by reference in its entirety.
[0062] It should be noted that although one peak, namely peak 22H, is depicted in FIG. 9 as being bent, two or more peaks can be bent inward, as described in detail above. As such, each bent peak can comprise struts that are thinner than the struts of unbent peaks.
[0063] FIG. 10A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure. In particular, FIG. 10A depicts annular ring 110 arranged about longitudinal axis 26 and configured to have two peaks that bend inward into a cylindrical volume defined by ring 110 and into a balloon fold of a balloon. In FIG. 10A, peaks 22D and 22H of ring 110 bend inwards into the cylindrical volume defined by the ring. FIGS. 10B and IOC depict a side view and an end view, respectively, of the example annular ring depicted in FIG. 10A. Docket No.: S63.2C-15078-WO01
[0064] FIG. 11 A is an isometric view of another example annular ring of a stent that can be used to implement various techniques of this disclosure. In particular, FIG. 11 A depicts annular ring 110 arranged about longitudinal axis 26 and configured to have four peaks that bend inward into a cylindrical volume defined by ring 110 and into a balloon fold of a balloon. In FIG. 11 A, peaks 22B, 22D, 22F, and 22H of ring 110 bend inwards into the cylindrical volume defined by the ring. Ring 110 is similar to ring 50 of FIGS. 5A-5C, except that bent peaks 22B, 22D, 22F, and 22H of ring 110 are deformed even more than the bent peaks of 50. Peaks 22B, 22D, 22F, and 22H of ring 110 can be deformed in the manner shown by adding additional fold lines 29, such as fold lines 29A-29C as seen best in FIG. l lC. FIGS. 1 IB and 11C depict a side view and an end view, respectively, of the example annular ring depicted in FIG. 11 A.
[0065] In some examples, the stent, the delivery system or other portion of the assembly may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc. In other examples, at least a portion of the stent and/or adjacent assembly is at least partially radiopaque.
[0066] In some examples, at least a portion of the stent is configured to include one or more mechanisms for the delivery of a therapeutic agent. Often the agent will be in the form of a coating or other layer (or layers) of material placed on a surface region of the stent, which is adapted to be released at the site of the stent's implantation or areas adjacent thereto.
[0067] A therapeutic agent may be a drug or other pharmaceutical product such as non- genetic agents, genetic agents, cellular material, etc. Some examples of suitable non-genetic therapeutic agents include but are not limited to: anti-thrombogenic agents such as heparin, heparin derivatives, vascular cell growth promoters, growth factor inhibitors, Paclitaxel, etc. Where an agent includes a genetic therapeutic agent, such a genetic agent may include but is not limited to: DNA, RNA and their respective derivatives and/or components; hedgehog proteins, etc. Where a therapeutic agent includes cellular material, the cellular material may include but is not limited to: cells of human origin and/or non-human origin as well as their respective components and/or derivatives thereof. Where the therapeutic agent includes a polymer agent, the polymer agent may be a polystyrene-polyisobutylene -polystyrene triblock copolymer (SIBS), polyethylene oxide, silicone rubber and/or any other suitable substrate. Docket No.: S63.2C-15078-WO01
[0068] The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. The various elements shown in the individual figures and described above may be combined or modified for combination as desired. Various examples of the disclosure have been described. These and other examples are within the scope of the following claims.

Claims

Docket No.: S63.2C-15078-WO01 CLAIMS:
1. A stent delivery system comprising:
a catheter comprising an expandable balloon, the balloon having a pleated state and an unpleated state, the balloon having at least two pleats in the pleated state, adjacent pleats of a balloon being separated by a fold in the pleated state; and
a stent having a reduced state and an expanded state, the stent comprising a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands comprising a plurality of peaks and a plurality of troughs,
wherein in the reduced state and positioned on the balloon, at least one of the plurality of peaks of at least one of the plurality of rings extends into a fold of the balloon in the pleated state, the at least one peak being positioned a first distance from the longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance, and
wherein in the expanded state, the plurality of peaks of the stent being positioned at substantially the same distance from the longitudinal axis.
2. The stent delivery system of claim 1,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak that extends into the fold comprises at least one first strut having a first thickness,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second thickness, and
wherein the first thickness is less than the second thickness.
3. The stent delivery system of claim 1,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak that extends into the fold comprises at least one first strut having a first width,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second width, and Docket No.: S63.2C-15078-WO01 wherein the first width is less than the second width.
4. The stent delivery system of claim 1,
wherein the fold is a first fold of the balloon, and
wherein at least one of the plurality of troughs of at least one of the plurality of rings extends into a second fold of the balloon in the pleated state, the at least one trough being positioned a third distance from the longitudinal axis, another one of the plurality of peaks being positioned a fourth distance from the longitudinal axis, the third distance being less than the fourth distance.
5. The stent delivery system of claim 4,
wherein the plurality of troughs are defined by a plurality of struts,
wherein the at least one trough that extends into the fold comprises at least one first strut having a first thickness,
wherein each of the remaining troughs of the annular band comprise at least one second strut having a second thickness, and
wherein the first thickness is less than the second thickness.
6. The stent delivery system of claim 1,
wherein in the reduced state and positioned on the balloon, at least one of the plurality of peaks of each of the plurality of rings extends into a fold of the balloon in the pleated state.
7. The stent delivery system of claim 1,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak that extends into the fold comprises at least one first strut having a first thickness,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second thickness, and
wherein the first thickness is less than the second thickness. Docket No.: S63.2C-15078-WO01
8. The stent delivery system of claim 1,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak that extends into the fold comprises at least one first strut having a first width,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second width, and
wherein the first width is less than the second width.
9. The stent delivery system of claim 1,
wherein during an expansion from the reduced state to the expanded state, the at least one peak that extends into the fold is configured to expand outwardly prior to the remaining peaks.
10. The stent delivery system of claim 9,
wherein the at least one peak configured to expand outwardly prior to the remaining peaks comprises at least one strut having a first width,
wherein the remaining peaks comprise a plurality of struts that each have a second width, and
wherein the first width is less than the second width.
11. A stent having a reduced state and an expanded state, the stent comprising:
a plurality of interconnected annular rings arranged about a longitudinal axis, each of the plurality of annular bands comprising a plurality of peaks and a plurality of troughs, wherein in the reduced state, at least one of the plurality of peaks of at least one of the plurality of rings is positioned a first distance from the longitudinal axis, another one of the plurality of peaks being positioned a second distance from the longitudinal axis, the first distance being less than the second distance, and
wherein in the expanded state, the plurality of peaks of the stent being positioned at substantially the same distance from the longitudinal axis. Docket No.: S63.2C-15078-WO01
12. The stent of claim 11 ,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak positioned a first distance from the longitudinal axis comprises at least one first strut having a first thickness,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second thickness, and
wherein the first thickness is less than the second thickness.
13. The stent of claim 11 ,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak positioned a first distance from the longitudinal axis comprises at least one first strut having a first width,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second width, and
wherein the first width is less than the second width.
14. The stent of claim 11 ,
wherein at least one of the plurality of troughs of at least one of the plurality of rings is positioned a third distance from the longitudinal axis, another one of the plurality of peaks being positioned a fourth distance from the longitudinal axis, the third distance being less than the fourth distance.
15. The stent of claim 14,
wherein the plurality of troughs are defined by a plurality of struts,
wherein the at least one troughs that extends into the fold comprises at least one first strut having a first thickness,
wherein each of the remaining troughs of the annular band comprise at least one second strut having a second thickness, and
wherein the first thickness is less than the second thickness. Docket No.: S63.2C-15078-WO01
16. The stent of claim 14,
wherein the plurality of troughs are defined by a plurality of struts,
wherein the at least one trough positioned a third distance from the longitudinal axis comprises at least one first strut having a first width,
wherein each of the remaining troughs of the annular band comprise at least one second strut having a second width, and
wherein the first width is less than the second width.
17. The stent of claim 11 ,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak positioned a first distance from the longitudinal axis comprises at least one first strut having a first thickness,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second thickness, and
wherein the first thickness is less than the second thickness.
18. The stent of claim 11 ,
wherein the plurality of peaks are defined by a plurality of struts,
wherein the at least one peak positioned a first distance from the longitudinal axis comprises at least one first strut having a first width,
wherein each of the remaining peaks of the annular band comprise at least one second strut having a second width, and
wherein the first width is less than the second width.
19. The stent of claim 11 ,
wherein during an expansion from the reduced state to the expanded state, the at least one peak that extends into the fold is configured to expand outwardly prior to the remaining peaks. Docket No.: S63.2C-15078-WO01
20. The stent of claim 19,
wherein the at least one peak configured to expand outwardly prior to the remaining peaks comprises at least one strut having a first width,
wherein the remaining peaks comprise a plurality of struts that each have a second width, and
wherein the first width is less than the second width.
PCT/US2012/027401 2011-03-03 2012-03-02 Stent with reduced profile WO2012119037A1 (en)

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