US20050209673A1 - Bifurcation stent delivery devices - Google Patents

Bifurcation stent delivery devices Download PDF

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Publication number
US20050209673A1
US20050209673A1 US10/899,034 US89903404A US2005209673A1 US 20050209673 A1 US20050209673 A1 US 20050209673A1 US 89903404 A US89903404 A US 89903404A US 2005209673 A1 US2005209673 A1 US 2005209673A1
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US
United States
Prior art keywords
stent
balloon
catheter
stent delivery
distal
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
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US10/899,034
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English (en)
Inventor
Yoav Shaked
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Y Med Inc
Original Assignee
Y Med Inc
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Filing date
Publication date
Priority to US10/899,034 priority Critical patent/US20050209673A1/en
Application filed by Y Med Inc filed Critical Y Med Inc
Assigned to Y MED INC. reassignment Y MED INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SHAKED, YOAV
Priority to CN2010102667581A priority patent/CN101912322B/zh
Priority to US11/070,294 priority patent/US7438720B2/en
Priority to EP11193219.0A priority patent/EP2431069B1/en
Priority to JP2007501448A priority patent/JP5137568B2/ja
Priority to EP05709151A priority patent/EP1732636A4/en
Priority to CN2005800111427A priority patent/CN1972728B/zh
Priority to PCT/IL2005/000258 priority patent/WO2005084130A2/en
Publication of US20050209673A1 publication Critical patent/US20050209673A1/en
Priority to US11/240,631 priority patent/US7766951B2/en
Priority to US11/431,918 priority patent/US7780715B2/en
Priority to US11/868,568 priority patent/US7753951B2/en
Priority to US12/787,067 priority patent/US11744723B2/en
Priority to US12/791,787 priority patent/US20100241212A1/en
Priority to US12/838,286 priority patent/US9504473B2/en
Priority to US13/035,670 priority patent/US9050437B2/en
Priority to US14/727,770 priority patent/US10022524B2/en
Priority to US15/297,065 priority patent/US10028748B2/en
Priority to US16/032,281 priority patent/US20180317931A1/en
Abandoned legal-status Critical Current

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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
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • 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
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0186—Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1045—Balloon catheters with special features or adapted for special applications for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1056—Balloon catheters with special features or adapted for special applications having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
    • 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
    • A61M25/1011—Multiple balloon catheters

Definitions

  • the present invention relates to stent delivery devices and methods and, more particularly, to stent delivery devices for positioning at a bifurcation, the devices having low profiles and predictable positioning capabilities, both rotationally and translationally.
  • U.S. Pat. No. 6,048,361 to Von Oepen An example of a prior art bifurcation stent delivery system is disclosed in U.S. Pat. No. 6,048,361 to Von Oepen.
  • the system includes a stent with an increased radial opening and a balloon catheter on which the stent is mounted, the balloon catheter having a hollow chamber for passage of a guiding wire so that it exits in a center of the increased opening.
  • the system disclosed therein includes two passageways for guidewires, necessitating a relatively large outer diameter. Furthermore, the presence of two wires can lead to problems of wire entanglement.
  • Gumm discloses a catheter assembly having a rotatably mounted balloon, and further including a side branch hollow member attached to the catheter balloon.
  • a noted feature of the device is the use of rotating members sealed to opposite ends of the balloon.
  • the side branch hollow member, the balloon and the rotating members act as a unit which rotates freely relative to the main hypotube.
  • This particular feature is considered an integral part of the design, providing improved orientation of the stent relative to the side branch at the bifurcation.
  • this feature also results in an increased overall diameter of the system. Furthermore, it does not provide a way to accurately position the stent in the translational plane.
  • a stent delivery system includes a main elongated element having a proximal end, a distal end and a body connecting the proximal and distal ends, the main elongated element being for advancement within a main vessel, an auxiliary elongated element having a proximal and distal end, the auxiliary elongated element being for advancement within an auxiliary vessel.
  • the auxiliary elongated element is at least partially attached to the main elongated element.
  • the system also includes a crotch point, wherein at the crotch point, the body of the main elongated element is attached to the auxiliary elongated element, and wherein a location of the crotch point is configured to stop advancement of the system upon reaching a bifurcation.
  • a stent delivery device including a catheter having a distal end and a proximal end, a balloon positioned on the catheter, the balloon having a distal end and a proximal end, wherein the balloon is immovable with respect to the catheter, a wire attached to the distal end of the balloon, and a side element having a distal end and a proximal end, the side element at least partially attached to the balloon.
  • a stent delivery system including a catheter having a distal end and a proximal end, a balloon positioned on the catheter, the balloon having a distal end and a proximal end, a wire attached to the distal end of the balloon, a side element having a distal end and a proximal end, the side element at least partially attached to the balloon, and a crotch point, wherein at the crotch point, the side element and the balloon are attached, and wherein a location of the crotch point is configured to stop advancement of the system upon reaching a bifurcation.
  • a stent delivery system including a catheter having a distal end and a proximal end, a balloon positioned on the distal end of the catheter, the balloon having a distal end and a proximal end, and wherein the balloon is immovable with respect to the catheter, a stent positioned on the balloon, the stent having a side opening, wherein the side opening has a proximal end and a distal end, and a side branch lumen having a distal end and a proximal end, wherein the proximal end is attached to a proximal end of the balloon, and wherein the distal end is configured to exit through the side opening of the stent.
  • a stent delivery system including a catheter having a distal end and a proximal end, a stent positioned on the catheter, the stent having a distal end and a proximal end, an auxiliary elongated element having a distal end and a proximal end, the auxiliary elongated element positioned outside of the stent, and a crotch point located at the proximal end of the stent whereby the auxiliary elongated element is attached to the catheter at the crotch point.
  • a stent delivery system including a catheter having a distal end and a proximal end, a distal balloon positioned on the distal end of the catheter, the distal balloon having a distal end and a proximal end, a proximal balloon positioned on the catheter proximal to the distal balloon, a stent positioned on the proximal balloon, the stent having a distal end and a proximal end, an auxiliary elongated element having a distal end and a proximal end, the auxiliary elongated element positioned inside of the stent and exiting at the distal end of the stent, and a crotch point located at the distal end of the stent wherein the auxiliary elongated element is attached to the balloon at the crotch point.
  • a catheter system including a catheter having a distal end, a proximal end and a body connecting the distal and proximal ends, a side branch lumen having a distal end, a proximal end and a body connecting the distal and proximal ends, wherein a first portion of the side branch lumen is positioned inside the body of said catheter, and a second portion of the side branch lumen is positioned outside the body of the catheter, and an exit point located on the body of said catheter wherein the first portion is proximal to the exit point and the second portion is distal to the exit point.
  • a method for treating a bifurcation including introducing a side branch guidewire into a side branch vessel, providing a stent delivery system including a main elongated element, a side branch element, and a crotch point, wherein at the crotch point, the main and side branch elements are attached, and wherein a location of the crotch point is configured to stop advancement of the system when it reaches a bifurcation, and a stent positioned on the main elongated element, inserting a proximal end of the side branch guidewire into the distal end of the side branch lumen, advancing the stent delivery system over the side branch guidewire until a location at which the advancing automatically stops due to the crotch point reaching said bifurcation, and deploying the stent.
  • a method for treating a bifurcation including providing a stent delivery system, wherein the system includes a catheter having a balloon at a distal end thereof, a fixed wire at a distal end of the balloon, and a side branch lumen at least partially attached to the catheter, wherein a point of attachment defines a stopping point, and advancing the stent delivery system through a main vessel until a location at which the advancing automatically stops due to the crotch point reaching the bifurcation.
  • the main elongated element is a catheter and the auxiliary elongated element is a side branch lumen.
  • the catheter includes a balloon.
  • the catheter may be a fixed wire balloon catheter, an over-the-wire catheter or a rapid exchange catheter.
  • the main elongated element is a catheter and the auxiliary elongated element is a positioning system.
  • the positioning system includes at least one stopper, which may be a spring wire, for example, and an attachment mechanism, wherein in one embodiment, the attachment mechanism is a polymer jacket, and wherein the polymer jacket is configured to hold a proximal portion of the spring wire in place, and wherein a distal end of the polymer jacket defines a crotch point.
  • the attachment mechanism is a polymer jacket, and wherein the polymer jacket is configured to hold a proximal portion of the spring wire in place, and wherein a distal end of the polymer jacket defines a crotch point.
  • the system includes a stent with a side opening positioned on the main elongated element, and the crotch point is located at a distal portion of the side opening of the stent.
  • the system includes a stent having a proximal end and a distal end, the stent positioned on the main elongated element, and wherein the crotch point is located at the proximal end of said stent.
  • the system includes a proximal stent having a proximal end and a distal end and a distal stent having a proximal end and a distal end, the proximal stent positioned on the main elongated element and the distal stent positioned distal to the proximal stent on the main elongated element.
  • the crotch point may be located at the distal end of the proximal stent, and the two stents may be deployed separately.
  • proximal to the crotch point the bodies of the main and auxiliary elongated elements are attached.
  • an outer diameter of the system is less than 1 mm. In an exemplary preferred embodiment, the outer diameter of the system is approximately 0.5 mm.
  • the stent delivery device includes a feature wherein the proximal end of the side branch lumen is positioned within the catheter, and wherein the distal end of the side branch lumen which is detached from the balloon is positioned outside of the catheter.
  • the stent delivery system includes a distal connecting element at the distal end of the balloon.
  • the distal connecting element lies on a same side of the catheter as the side branch lumen, and is configured for receiving a side branch guidewire which is positionable through both the side branch lumen and the distal connecting element.
  • the distal connecting element lies on an opposite side of the catheter as the side branch lumen, and is configured for receiving a main guidewire which is positionable through the distal connecting element and outside of the stent.
  • the present invention successfully addresses the shortcomings of the presently known configurations by providing a stent delivery system with a low profile and substantially predictable translational and rotational positioning.
  • FIG. 1 is an illustration of a first type of vessel bifurcation with plaque buildup
  • FIG. 2 is an illustration of a prior art bifurcation stent delivery system
  • FIG. 3 is an illustration of a bifurcation stent delivery system in accordance with a preferred embodiment of the present invention
  • FIGS. 4 a - d are illustrations of the system of FIG. 3 shown without a stent
  • FIG. 5 is an illustration of the system of FIG. 3 in position at a bifurcation
  • FIG. 6 is an illustration of a the system of FIG. 3 , shown without a stent, and further including a distal connecting element;
  • FIG. 7 is an illustration of a bifurcation stent delivery system, shown without a stent, in accordance with another embodiment of the present invention.
  • FIG. 8 is an illustration of a bifurcation stent delivery system, shown without a stent, in accordance with yet another embodiment of the present invention.
  • FIGS. 9 a and 9 b are illustrations of a bifurcation stent delivery system in accordance with another embodiment of the present invention.
  • FIG. 10 is an illustration of a second type of vessel bifurcation with plaque buildup
  • FIG. 11 a - c are illustrations of a system for treating a bifurcation such as the one depicted in FIG. 10 ;
  • FIG. 12 is an illustration of the system of FIG. 11 a in position at a bifurcation
  • FIG. 13 is an illustration of a third type of vessel bifurcation with plaque buildup
  • FIGS. 14 a and b are illustrations of a system for treating a bifurcation such as the one depicted in FIG. 13 ;
  • FIGS. 15 a and b are illustrations of the system of FIG. 14 , further including a holder;
  • FIGS. 16 a and b are illustrations of the system of FIG. 14 , further including a holder, in an alternative embodiment
  • FIG. 17 is an illustration of the system of FIG. 14 being introduced into a guiding catheter
  • FIGS. 18 a - c are illustrations of the system of FIG. 14 during positioning and deployment;
  • FIG. 19 is an illustration of a fourth type of vessel bifurcation with plaque buildup
  • FIG. 20 is an illustration of a system, shown without a stent, for treating a bifurcation such as the one depicted in FIG. 19 ;
  • FIG. 21 is an illustration of the system depicted in FIG. 20 , further including stents thereon;
  • FIGS. 22 a - d are illustrations of a method of deploying the system of FIG. 20 ;
  • FIG. 23 is an illustration of a tapered balloon system with a side branch lumen, in accordance with another embodiment of the present invention.
  • the present invention is of a stent delivery system and method for delivery of a stent to a bifurcation area.
  • the present invention can be used to position a stent at a bifurcation with rotational and translational alignment.
  • the devices and systems of the present invention have small outer diameters as compared with prior art bifurcation stent delivery systems, and reduce the possibility of wire entanglement.
  • FIG. 1 is an illustration of vessel bifurcation with plaque buildup.
  • a main vessel 1 and a branch vessel 2 are connected at a bifurcation point 3 .
  • a buildup of plaque 4 may be found anywhere within the vessels, but if there is plaque buildup located at or close to bifurcation point 3 , as shown in FIG. 1 , the location presents a specific challenge with regard to accurate stent placement.
  • Stents placed at bifurcations are typically deployed either slightly proximal or slightly distal to the bifurcation point, which can lead to stent jailing and/or insufficient coverage.
  • FIG. 2 is an illustration of a prior art bifurcation stent delivery system 5 .
  • System 5 includes a catheter 6 having a stent 7 with a dedicated side hole 8 .
  • a main guidewire 9 is positioned in main vessel 1 and passed through a main guidewire lumen in catheter 6 .
  • a side branch guidewire 11 is positioned within a second guidewire lumen, through side hole 8 , and into branch vessel 2 .
  • FIG. 1 there is a tendency for system 5 to overshoot bifurcation point 3 during placement.
  • prior art bifurcation stent systems are generally large in diameter due to the presence of two guidewire lumens—one for main guidewire 9 and one for branch guidewire 11 .
  • the two wires often become entangled with one another, causing a failure in delivery and/or removal of the system.
  • the present invention seeks to address the limitations of prior art systems, by providing substantially predictable positioning and alignment, both translationally and rotationally within the vessel, while retaining a small profile and eliminating wire crossing so as to provide ease of delivery.
  • Several different embodiments of the invention provide solutions for different types of bifurcations, as will be described in further detail hereinbelow.
  • a stent delivery system 10 is designed to be delivered at a bifurcation, such as the one illustrated in FIG. 1 , having a main vessel 1 and a branch vessel 2 , wherein the plaque 4 is located within the main vessel in the vicinity of bifurcation point 3 .
  • FIG. 3 and FIGS. 4 a - d are illustrations of a bifurcation stent delivery system 10 , shown with and without a stent respectively.
  • System 10 includes a main elongated element 16 , and an auxiliary elongated element 34 aligned with main elongated element 16 .
  • auxiliary elongated element 34 is positioned within main elongated element 16 proximal to an exit point 37 and alongside main elongated element 16 distal to exit point 37 , as depicted in FIG. 3 .
  • auxiliary elongated element 34 is positioned alongside main elongated element 16 , as will be described hereinbelow with reference to FIG. 8 .
  • main elongated element 16 is a catheter 18 having a distal end 20 and a proximal end 22 .
  • a balloon 24 is positioned on distal end 20 of catheter 18 .
  • Catheter 18 includes a hypotube 25 running along the length of the catheter, and an inflation lumen within hypotube 25 in communication with balloon 24 .
  • the inflation lumen is designed for introducing a fluid, preferably a liquid, into balloon 24 for inflation of balloon 24 at the appropriate location.
  • a port for inflation is positioned at proximal end 22 , in a configuration which is well known in the art.
  • Catheter 18 shown in FIGS. 3 and 4 a - d may be any commercially available balloon catheter.
  • a torquer device may be introduced to proximal end 22 for improving torquability. Such torquer devices are well known in the art.
  • balloon 24 is a fixed wire balloon and as such, includes a fixed wire 26 attached to a distal end of balloon 24 at a bonding area 28 .
  • a fixed wire skeleton 30 runs along the interior of balloon 24 to provide rigidity.
  • Fixed wire balloons are known in the art, and may be obtained from, for example, Boston Scientific Scimed [ACE balloon, catalog number 02071-04].
  • System 10 includes a stent 12 positioned on main elongated element 16 , the stent 12 having a side opening 14 .
  • side opening 14 is a dedicated side opening, and in another embodiment, side opening 14 is any opening within the structure of stent 12 .
  • auxiliary elongated element 34 is a side branch lumen 36 for placement of a side branch guidewire therethrough.
  • Side branch lumen 36 has a distal end 40 and a proximal end 42 and is attached to catheter 18 at proximal end 42 and unattached to catheter 18 at distal end 40 .
  • crotch point 44 The point at which the detachment between main and auxiliary elongated elements (catheter 18 and side branch lumen 36 in the present embodiment) occurs is defined as a crotch point 44 .
  • side branch lumen 36 is unattached to catheter 18 both proximal and distal to crotch point 44 , and is attached to catheter 18 only at crotch point 44 .
  • Balloon 24 further includes fluorescent markers 32 which can be visualized during a procedure under fluorescence.
  • markers 32 are located at both ends of stent 12 and at a location which is aligned with crotch point 44 .
  • any configuration on markers which would enable viewing of key locations of system 10 can be used.
  • Crotch point 44 is preferably located close to distal end 40 of side branch lumen 36 . It should be noted that the depiction of crotch points in the figures is for indication purposes only, and that crotch points may not include an actual connecting element as shown.
  • the length of the unattached portion is preferably less than 1 mm. In an exemplary preferred embodiment, the length of the unattached portion is approximately 0 mm, i.e. the distal end 40 of side branch lumen 36 is at crotch point 44 . It should be noted that in this embodiment, a guidewire within side branch lumen 36 is configured to enter a side branch vessel, as will be described hereinbelow with reference to FIG. 5 .
  • the length of the unattached portion is approximately 1-5 mm, or more preferably approximately 2 mm.
  • Side branch lumen 36 may be as long or as short as necessary, both proximally and distally.
  • the portion of side branch lumen 36 which is proximal to crotch point 44 is approximately 10-30 mm, and in an exemplary preferred embodiment is approximately 25 mm.
  • the portion of side branch lumen 36 which is proximal to crotch point 44 is approximately 5-15 mm.
  • FIGS. 4 b , 4 c and 4 d A cross-sectional view along lines A-A, B-B and C-C are depicted in FIGS. 4 b , 4 c and 4 d , respectively.
  • side branch lumen 36 is located within catheter 18 .
  • Fixed wire skeleton 30 is in the center, and side branch lumen 36 is between fixed wire skeleton 30 and the edge of catheter 18 .
  • side branch lumen 36 is bonded to catheter 18 .
  • side branch lumen 36 is outside and adjacent to balloon 24 , as shown in FIG. 4 d.
  • FIG. 5 is an illustration of system 10 positioned at a bifurcation.
  • Crotch point 44 is a key element in positioning of stent 12 within the vessel.
  • catheter 18 in main vessel 1 and a side branch guidewire 38 within side branch lumen 36 positioned in branch vessel 2 system 10 cannot be advanced beyond the point at which crotch point 44 reaches bifurcation point 3 .
  • system 10 is substantially predictably aligned, and overshooting is prevented.
  • a method for introducing system 10 is as follows. First, a side branch guidewire 38 is positioned within branch vessel 2 . A proximal end of side branch guidewire 38 is introduced into distal end 40 of side branch lumen 36 . With side branch guidewire 38 positioned within side branch lumen 36 , system 10 is advanced through main vessel 1 . Fixed wire 26 provides guidance as advancement occurs. In an alternative embodiment, side branch guidewire 38 is not introduced initially, and system 10 is advanced using only fixed wire 26 as a guide. In either case, system 10 is free to rotate without risk of entanglement. When crotch point 44 reaches bifurcation point 3 , advancement of system 10 automatically stops.
  • system 10 is in place, with side branch guidewire 38 in branch vessel 2 , and stent 12 in a correct position both translationally and rotationally. Balloon 24 is then inflated, thus deploying stent 12 within the vessel. Thus, the exact location of crotch point 44 predetermines accuracy of positioning. After deployment, system 10 is removed from branch vessel 2 .
  • a particular feature of the invention as described is the ability to provide rapid exchange of catheters via branch guidewire 38 , if necessary.
  • the specific features of the present invention allow for accurate positioning in both the rotational and the translational direction, while providing a small outer diameter overall.
  • the overall outer diameter is 0.5-1.5 mm.
  • side branch lumen 36 acts as a guide in the translational plane.
  • the use of a fixed wire provides torquability and ease of rotation, particularly since there is only one guidewire present (i.e. the branch guidewire).
  • side branch lumen 36 wherein a distal end 40 thereof is unattached to main elongated element 16 , or wherein a guidewire placed therethrough is unattached to main elongated element 16 allows for initial entry of side branch lumen 36 into branch vessel 2 .
  • system 10 further includes a distal connecting element 46 , attached to a distal end of balloon 24 .
  • distal connecting element 46 is attached at bonding area 28 of balloon 24 .
  • distal connecting element 46 is attached at any other location on balloon 24 which is distal to side branch lumen 36 .
  • Distal connecting element 46 is configured to hold side branch guidewire 38 in place until system 10 is in the vicinity of bifurcation 3 . This prevents side branch guidewire 38 from moving around within the vessel during delivery of system 10 , possibly causing damage.
  • side branch guidewire 38 is pulled proximally and released from distal connecting element 46 , after which it is advanced into branch vessel 2 .
  • System 10 is then advanced until crotch point 44 prevents further advancement, balloon 24 is inflated, and stent 12 is deployed.
  • FIG. 7 is an illustration of system 10 in accordance with yet another embodiment of the present invention.
  • side branch lumen 36 is located internally within balloon 24 , and includes an exit point 37 at a location along balloon 24 .
  • the location of exit point 37 with respect to stent 12 defines a crotch point, which coincides with the location of crotch point 44 described in the earlier embodiments, and is functionally equivalent thereto.
  • side branch lumen 36 ends at crotch point 44 .
  • side branch lumen 36 extends distally beyond crotch point 44 .
  • FIG. 8 is an illustration of system 10 in accordance with yet another embodiment of the present invention.
  • Side branch lumen 36 is located external and adjacent to main elongated element 16 .
  • Crotch point 44 is located distal at an attachment point between side branch lumen 36 and balloon 24 .
  • the portion of side branch lumen 36 which lies between exit point 37 and crotch point 44 may be attached or unattached to balloon 24 .
  • FIGS. 9 a and 9 b are illustrations of system 10 in accordance with yet another embodiment of the present invention, shown with a stent thereon.
  • side hole 14 is not a dedicated side hole, but rather is any opening within the body of stent 12 . It should be noted that this type of side hole may be found on any of the embodiments described herein.
  • System 10 includes a main guidewire 39 rather than a fixed wire at the distal end of balloon 24 .
  • a main guidewire lumen 50 is located at bonding area 28 of balloon 24 .
  • main guidewire lumen 50 is relatively short, i.e. 1-5 mm.
  • main guidewire lumen 50 extends proximally along a side of balloon 24 .
  • main guidewire 39 is positioned outside of stent 12 so as to avoid wire crossing between main guidewire 39 and side branch guidewire 38 , as shown in FIG. 9 a .
  • main guidewire 39 is positioned within stent 12 , as shown in FIG. 9 b .
  • main guidewire lumen 50 is positioned on an opposite side from side branch lumen 36 , as depicted.
  • system 10 includes a main guidewire lumen in place of a fixed wire, and further includes a crotch point 44 in accordance with the different embodiments described above.
  • a stent delivery system 110 is designed to be delivered at a bifurcation as illustrated in FIG. 10 , having a main vessel 1 and a branch vessel 2 at an angle with respect to main vessel 1 , and wherein plaque 4 is located in main vessel 1 at an area of a bifurcation 3 .
  • a location is the coronary artery, where blockage of, for example, the left anterior descending (LAD) artery is to be avoided while providing coverage to the plaque within the coronary artery.
  • LAD left anterior descending
  • Other examples include renal arteries, the left main coronary artery, vein grafts, and others.
  • FIGS. 11 a - c are illustrations of different embodiments of a system 110 for delivery of a stent at a bifurcation such as the one depicted in FIG. 10 .
  • System 110 may be designed with a fixed wire, as shown in FIG. 11 a , as on over-the-wire system, as shown in FIG. 11 b , or as a rapid exchange system, as shown in FIG. 11 c.
  • System 110 includes a main elongated element 116 and an auxiliary elongated element 134 .
  • main elongated element 116 is a catheter 118 .
  • catheter 118 includes a balloon 124 with a fixed wire 126 at a distal end thereof.
  • a stent 112 is positioned on balloon 124 .
  • auxiliary elongated element 134 is a side branch lumen 136 , and is attached to catheter 118 at a crotch point 144 .
  • Side branch lumen 136 has a proximal end 142 and a distal end 140 .
  • side branch lumen 136 is positioned within catheter 118 proximally, exits at an exit point 137 , and is attached to main elongated element 116 at crotch point 144 .
  • the portion of side branch lumen 136 between exit point 137 and crotch point 144 may be attached or unattached.
  • a distal end of side branch lumen 136 is at crotch point 144 , and a guidewire placed therethrough extends distally to provide a stopping point.
  • the distal end of side branch lumen is located 1-5 mm distal to crotch point 144 , and is unattached to the catheter 118 in this location.
  • side branch lumen 136 is located external to and positioned alongside catheter 118 proximal to crotch point 144 , and is unattached to elongated element 116 distal to crotch point 144 .
  • side branch lumen 136 is unattached to catheter 118 both proximal to and distal to crotch point 144 .
  • Crotch point 144 is located at or near a proximal end of stent 112 . In a preferred embodiment, crotch point 144 is just proximal to the proximal end of stent 112 .
  • FIG. 11 b is an illustration of system 110 ′ designed as an over-the-wire, double rail system.
  • System 110 ′ is similar to system 110 shown in FIG. 11 a , except that in place of a fixed wire on the distal end of balloon 124 ′, a main guidewire lumen 125 is present and runs the length of catheter 118 ′.
  • a main guidewire is positioned through main guidewire lumen 125 for entry into main vessel 1 .
  • System 110 ′ may be introduced to the site via a main guidewire located in main guidewire lumen 125 or via a branch guidewire located in side branch lumen 136 ′.
  • FIG. 11 c is an illustration of system 110 ′′, designed as a rapid exchange dual wire system.
  • System 110 ′′ is similar to both systems 110 and 110 ′ depicted in FIGS. 11 a and 11 c , except that in place of a fixed wire or a main guidewire lumen running the length of catheter 118 ′′, a short main guidewire lumen 127 is present and runs proximally until an exit point 129 .
  • These types of systems are well known in the art, and are known to provide ease of catheter exchange.
  • the location of crotch point 144 allows for more accurate placement within the vessel.
  • FIG. 12 is a depiction of system 110 positioned at bifurcation 3 .
  • a side branch guidewire 138 is introduced into branch vessel 2 .
  • System 110 is guided over side branch guidewire 138 and either fixed wire 126 or a main guidewire 139 , depending on the type of system, until crotch point 144 of side branch lumen 136 is at bifurcation point 3 .
  • distal end 140 is at crotch point 144 , and only guidewire 138 enters branch vessel 2 .
  • side branch lumen 136 extends and into side branch vessel 2 .
  • System 1110 is slowly advanced until crotch point 144 reaches bifurcation point 3 , after which system 110 automatically stops advancing.
  • Balloon 124 is then inflated, deploying stent 112 . After deployment, balloon 124 is deflated, and system 110 is removed.
  • a stent delivery system 210 is designed to be delivered at a bifurcation such as the one illustrated in FIG. 13 , having a main vessel 1 and a branch vessel 2 at an angle with respect to main vessel 1 , and wherein plaque 4 is located in branch vessel 2 at an area of a bifurcation 3 .
  • main vessel 1 is an aorta.
  • System 210 includes a main elongated element 216 and an auxiliary elongated element 234 .
  • main elongated element 216 is a catheter 218 having a proximal end 222 and a distal end 220 .
  • Catheter 218 has a balloon 224 at distal end 220 , with a stent 212 positioned thereon.
  • balloon 224 includes a main guidewire lumen 227 .
  • balloon 224 is a fixed wire balloon, such as described with reference to the first and second embodiments, and shown at least in FIGS.
  • main guidewire lumen 227 extends only partially in the proximal direction along catheter 218 and includes an exit point 229 for rapid exchange.
  • system 210 is an over-the-wire system and main guidewire lumen 227 extends proximally to the proximal end of catheter 218 .
  • auxiliary elongated element 234 is a positioning system 236 , which will be described in further detail hereinbelow.
  • positioning system 236 includes a stopper element 250 and an attachment mechanism 252 .
  • stopper element 250 is separate from attachment mechanism 252 and comprises, for example, spring wires, flexible polymers, or any other material which can be extended in a first configuration and which can be folded, sprung or otherwise positioned to act as a stopper in a second configuration.
  • stopper element 250 is part of attachment mechanism 252 , but can also be extended in a first configuration and positioned to act as a stopper in a second configuration.
  • stopper element 250 is comprised of a shape memory metal such as, for example, Nitinol.
  • attachment mechanism 252 attaches the spring wires to main elongated element 216 to form crotch points 244 .
  • attachment mechanism 252 is a jacket having a proximal end 256 and a distal end 254 .
  • Attachment mechanism 252 at least partially encloses stopper element 250 (shown as spring wires), such that a proximal portion of stopper element 250 enclosed by attachment mechanism 252 is relatively straight, and a distal portion of stopper element 250 is unenclosed and able to move freely.
  • Attachment mechanism 252 can comprise any biocompatible material, and is preferably comprised of a polymer.
  • crotch points 244 are located at a proximal end of balloon 224 .
  • FIG. 14 b is a cross-sectional view of system 210 along the lines A-A, in accordance with one embodiment.
  • Catheter 218 has main guidewire lumen 227 for introduction of a main guidewire 239 .
  • stopper element 250 Surrounding catheter 218 is stopper element 250 , which is held in place by attachment mechanism 252 .
  • FIGS. 15 a - b are illustrations of system 210 partially enclosed within a holder 254 .
  • the purpose of holder 254 is to temporarily hold stopper element 250 in a substantially straight configuration until the area of bifurcation point 3 is reached.
  • holder 254 is a peel-away device.
  • stopper element 250 is enclosed and lies approximately along the plane of main elongated element 216 .
  • stopper elements 250 are straightened in the distal direction, such that they run alongside stent 212 .
  • the area proximal to crotch points 244 is shown in cross section in FIG. 15 b , and includes a main guidewire lumen 227 within catheter 218 , stopper elements 250 enclosed within attachment mechanism 252 , and holder 254 surrounding attachment mechanism 252 .
  • FIGS. 16 a - b are illustrations of system 210 partially enclosed within holder 254 , in accordance with another embodiment of the present invention.
  • stopper elements 250 are bent in a proximal direction, with holder 254 surrounding stopper elements 250 and holding them in place. That is, stopper elements 250 are folded over attachment mechanism 252 .
  • the area proximal to crotch points 244 is shown in cross section in FIG. 16 b , and includes a main guidewire lumen 227 within catheter 218 , stopper elements 250 enclosed both within and outside of attachment mechanism 252 , and holder 254 surrounding attachment mechanism 252 and stopper elements 250 .
  • FIG. 17 is a depiction of system 210 within a guiding catheter 260 .
  • Guiding catheter 260 includes a proximal end 262 , through which system 210 is introduced, and a distal end 264 , which is open to a vessel.
  • holder 254 is removed, since stopper element 250 will remain in place within guiding catheter 260 .
  • holder 254 is a peel-away system, wherein the outer walls may be peeled away and removed from the system while system 210 is being introduced into guiding catheter 260 . This introduction is performed outside of the body.
  • holder 254 is a sheath, which can be pulled back as system 210 is being introduced into guiding catheter 260 .
  • Holder 254 can be any device for holding stopper element 250 in place until system 210 is within guiding catheter 260 .
  • FIGS. 18 a and 18 b are depictions of a method for introducing system 210 to a bifurcation in accordance with an embodiment of the present invention.
  • Guiding catheter 260 with system 210 positioned therein is introduced through main vessel 1 until bifurcation point 3 .
  • Distal end 264 of guiding catheter 260 is visualized using methods currently known in the art, such as, for example, fluorescent markers.
  • system 210 is advanced through distal end 264 of guiding catheter 260 , as shown in FIG. 18 a .
  • stopper elements 250 are no longer held in place by guiding catheter 260 , and will spring or coil into their second configuration, acting as stoppers, as shown in FIG. 18 b .
  • System 210 is then advanced until stopper elements 250 prevent system 210 from further advancement, as shown in FIG. 18 c . At this point, system 210 is properly positioned, and stent 212 is deployed.
  • a stent delivery system 310 is designed to be delivered at a bifurcation 3 as illustrated in FIG. 19 , having a Y-configuration.
  • Main vessel 1 branches into two branch vessels: a first branch vessel 2 and a second branch vessel 2 ′, and plaque 4 is located in main and or branch vessels at the area of bifurcation point 3 .
  • System 310 includes a main elongated element 316 and an auxiliary elongated element 334 .
  • main elongated element 316 is a catheter 318 .
  • Catheter 318 has a proximal end 322 and a distend nd 320 .
  • Proximal end 322 includes a hub 321 having a Y-valve for dual inflation.
  • Distal end 320 has two balloons: a proximal balloon 324 and a distal balloon 325 .
  • proximal and distal balloons 324 and 325 is in fluid communication with its own inflation channel.
  • An outer inflation channel 335 communicates with proximal balloon 324 and an inner inflation channel 327 communicates with distal balloon 325 .
  • Outer inflation channel 335 is coaxial with inner inflation channel 327 .
  • outer inflation channel 335 and inner inflation channel 327 are positioned side by side. In either case, balloons 324 and 325 may be inflated separately.
  • outer inflation channel communicates with distal balloon 325 and inner inflation channel 327 communicates with proximal balloon 324 .
  • distal balloon 325 has a fixed wire 326 at a distal end thereof.
  • system 310 includes a main guidewire lumen or a short external guidewire lumen such as distal connecting element 50 shown in FIG. 6 .
  • auxiliary elongated element 334 is a side branch lumen 336 having a proximal end 342 and a distal end 340 .
  • side branch lumen 336 is located internally within catheter 318 , and exits therefrom at an exit point 337 . Distal to exit point 337 , side branch lumen 336 is adjacent to proximal balloon 324 and attached thereto at a crotch point 344 . In an alternative embodiment, side branch lumen 336 lies alongside proximal balloon 324 .
  • FIG. 21 is an illustration of system 310 with stents.
  • two stents are included, as shown.
  • a proximal stent 312 is positioned on proximal balloon 324
  • a distal stent 313 is positioned on distal balloon 325 .
  • Each stent may be separately deployed by inflating its corresponding balloon.
  • Proximal stent 312 is positioned such that distal end of side branch lumen 336 is approximately aligned with a distal end of proximal stent 312 .
  • the distal edges of side branch lumen 336 and stent 312 form a crotch point 344 .
  • side branch lumen 336 extends distally past crotch point 344 . All of the embodiments described earlier in the present application may further be applied here.
  • system 310 includes one, two or no stents, depending on the application.
  • system 310 may be used for predilatation, with a stent only on proximal balloon 324 .
  • a tapered vessel may require two different stent sizes, wherein one stent of a particular size is positioned on distal balloon 325 , while another stent of a different size is positioned on proximal balloon 324 .
  • FIGS. 22 a - d are illustrations of a method of deploying system 310 within a Y-bifurcation.
  • a side branch guidewire 338 is introduced into a first branch vessel 2 .
  • a proximal end of side branch guidewire 338 is then placed through a distal end of side branch lumen 336 .
  • System 310 is advanced over side branch guidewire 38 through main vessel 1 and into second branch vessel 2 ′.
  • crotch point 344 reaches bifurcation 3
  • system 310 will not be advanceable, and system 310 will be in place, as shown in FIG. 22 a .
  • FIG. 22 a As shown in FIG.
  • distal balloon 325 is inflated via inner inflation channel 327 , deploying distal stent 313 in a branch vessel, just distal to bifurcation point 3 .
  • proximal balloon 324 is inflated via outer inflation channel 335 , deploying proximal stent 312 .
  • FIG. 22 c An alternate method is depicted in FIG. 22 c , wherein proximal stent 312 is deployed first, and then distal stent 313 is deployed. In an alternative embodiment, both stents are deployed simultaneously. The final result with both stents deployed and in position is shown in FIG. 22 d.
  • tapered balloon system 410 includes a main elongated portion and an auxiliary elongated element 434 .
  • auxiliary elongated element 434 is a side branch lumen.
  • a balloon has a proximal outer diameter and a distal outer diameter which is different from the proximal outer diameter.
  • the distal outer diameter is smaller than the proximal outer diameter, although the reverse may be provided as well. This type of balloon system may be useful for introduction of a tapered stent into a vessel, so as to avoid over-expansion of a stent within a distal portion of the vessel.

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US10/899,034 2004-03-04 2004-07-27 Bifurcation stent delivery devices Abandoned US20050209673A1 (en)

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US10/899,034 US20050209673A1 (en) 2004-03-04 2004-07-27 Bifurcation stent delivery devices
CN2010102667581A CN101912322B (zh) 2004-03-04 2005-03-03 支架输送系统
US11/070,294 US7438720B2 (en) 2004-03-04 2005-03-03 Stent delivery devices
EP11193219.0A EP2431069B1 (en) 2004-03-04 2005-03-03 Stent delivery devices
JP2007501448A JP5137568B2 (ja) 2004-03-04 2005-03-03 ステント送達装置
EP05709151A EP1732636A4 (en) 2004-03-04 2005-03-03 EXTENSION ROUTING DEVICES
CN2005800111427A CN1972728B (zh) 2004-03-04 2005-03-03 支架输送装置
PCT/IL2005/000258 WO2005084130A2 (en) 2004-03-04 2005-03-03 Stent delivery devices
US11/240,631 US7766951B2 (en) 2004-03-04 2005-10-03 Vessel treatment devices
US11/431,918 US7780715B2 (en) 2004-03-04 2006-05-11 Vessel treatment devices
US11/868,568 US7753951B2 (en) 2004-03-04 2007-10-08 Vessel treatment devices
US12/787,067 US11744723B2 (en) 2004-03-04 2010-05-25 Vessel treatment devices
US12/791,787 US20100241212A1 (en) 2004-03-04 2010-06-01 Vessel treatment devices
US12/838,286 US9504473B2 (en) 2004-03-04 2010-07-16 Vessel treatment devices
US13/035,670 US9050437B2 (en) 2004-03-04 2011-02-25 Positioning device for ostial lesions
US14/727,770 US10022524B2 (en) 2004-03-04 2015-06-01 Positioning device for ostial lesions
US15/297,065 US10028748B2 (en) 2004-03-04 2016-10-18 Vessel treatment devices
US16/032,281 US20180317931A1 (en) 2004-03-04 2018-07-11 Vessel Treatment Devices

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EP2431069B1 (en) 2019-10-16
EP1732636A4 (en) 2009-08-12
CN1972728B (zh) 2010-09-15
WO2005084130A3 (en) 2006-03-02
JP5137568B2 (ja) 2013-02-06
CN101912322A (zh) 2010-12-15
EP2431069A1 (en) 2012-03-21
JP2007526073A (ja) 2007-09-13
WO2005084130A2 (en) 2005-09-15
EP1732636A2 (en) 2006-12-20
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CN1972728A (zh) 2007-05-30
US20050209677A1 (en) 2005-09-22

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