US20100241212A1 - Vessel treatment devices - Google Patents
Vessel treatment devices Download PDFInfo
- Publication number
- US20100241212A1 US20100241212A1 US12/791,787 US79178710A US2010241212A1 US 20100241212 A1 US20100241212 A1 US 20100241212A1 US 79178710 A US79178710 A US 79178710A US 2010241212 A1 US2010241212 A1 US 2010241212A1
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- Prior art keywords
- balloon
- stent
- catheter
- guidewire
- distal end
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
- A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
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Abstract
A catheter system for treating lesions is provided. The system is suitable for treatment of bifurcation lesions, has a low profile and provides substantially predictable translational and rotational positioning. In one embodiment, the system includes a fixed wire balloon catheter and a partially attached guidewire lumen, wherein the guidewire lumen is attached to the catheter at a crotch point. The location of the crotch point is predetermined so as to provide substantially predictable positioning. Several embodiments of the system are described for various types of lesions and vessel configurations.
Description
- This application is a continuation of U.S. patent application Ser. No. 11/868,568, filed Oct. 8, 2007, which is a continuation-in-part of U.S. patent application Ser. No. 11/240,631, filed Oct. 3, 2005, which is a continuation-in-part of U.S. patent application Ser. No. 11/070,294, filed Mar. 3, 2005, which is a continuation-in-part of U.S. patent application Ser. No. 10/899,034, filed Jul. 27, 2004, which claims the benefit of U.S. Provisional Application No. 60/549,554, filed Mar. 4, 2004, all of which are incorporated herein by reference in their entireties.
- The present invention relates to vessel treatment devices and methods and, more particularly, to catheter systems having low profiles and predictable positioning capabilities, both rotationally and translationally.
- Several problems are associated with known prior art stent delivery devices, particularly ones which are suitable for treating bifurcation lesions. First, they generally have large outer diameters, particularly since the known designs usually include two guidewire lumens—one for a main guidewire and one for a side branch guidewire. The relatively large profiles of currently known systems cause difficulties in maneuverability and access to the site. Furthermore, the presence of two guidewires often results in wire entanglement, making the procedure difficult to perform without multiple insertions and retractions. Another problem which persists in these devices is inaccurate positioning within the vessel. This problem has been addressed with the use of radiopaque markers placed in strategic locations. However, visualization is done in the two-dimensional plane, while the actual procedure takes place within the three-dimensional realm. As such, inaccurate deployment is commonplace, often resulting in either stent jailing or insufficient coverage.
- 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.
- Other examples of prior art bifurcation stent delivery systems and methods are disclosed in U.S. Pat. No. 6,692,483 to Vardi et al. and U.S. Publication Number 2001/0049548 to Vardi et al. These include a balloon catheter having a main guidewire lumen and a flexible side sheath having a side branch lumen. The method disclosed aims to reduce wire entanglement by first inserting one of the guidewires, then advancing the system, and finally advancing the second guidewire. Alternatively, one of the guidewires is housed within the system and only released once the system is in place. However, problems of wire entanglement may also occur upon removal of the system. Furthermore, the system disclosed therein is prone to overshooting of the bifurcation, resulting in sub-optimal placement. Finally, the dual lumen configuration results in a relatively large profile for the overall system.
- Other similar examples of prior art bifurcation stent delivery systems are disclosed in U.S. Pat. No. 5,749,825 to Fischell et al. and U.S. Pat. No. 6,682,556 to Ischinger. The systems disclosed therein include balloon catheters with side branch tubes, and require two guidewires: one for the main vessel and one for the branch vessel. Similar to the aforementioned prior art, large profile, wire entanglement, and inaccurate positioning are potential problems.
- A prior art device which aims to provide improved rotational orientation while avoiding wire entanglement is disclosed in U.S. Publication Number 2003/0055483 to Gumm. 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. Thus, 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. However, 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.
- Attempts have been made to reduce the profile of a single stent delivery device by using a fixed wire balloon catheter, such as is disclosed in U.S. Publication Number 2002/0147491 to Khan et al. The device disclosed therein includes either a short section of guidewire fixedly attached to the distal end of a balloon, or a core wire that extends within the system. This design reduces the profile of the system as compared to prior art devices by eliminating the inner guidewire lumen. However, the system disclosed therein does not teach or suggest the possibility of bifurcation stenting, nor does it provide rapid exchange capabilities.
- There is thus a widely recognized need for, and it would be highly advantageous to have, a stent delivery system devoid of the above limitations.
- According to the present invention, there is provided a system for positioning of a stent at a bifurcation. The system includes a catheter having a main body with a main body proximal end and a main body distal end, a balloon positioned at the main body distal end, the balloon having a balloon proximal end and a balloon distal end, the balloon having an inflated configuration and a pre-inflated configuration, a wire positioned at the balloon distal end, wherein the wire is immovable with respect to the balloon while the balloon is in its pre-inflated configuration. The system further includes a core wire positioned through the balloon, an auxiliary elongated element having an auxiliary elongated element proximal end, an auxiliary elongated element distal end, and a balloon contacting portion positioned alongside at least a portion of the balloon, wherein the auxiliary elongated element distal end is attached to the catheter, a stent positioned on the balloon, the stent having stent edges, and at least three radiopaque markers, including at least one radiopaque marker longitudinally aligned with each of the stent edges, and wherein at least two of the radiopaque markers are positioned on the core wire and at least one of the radiopaque markers is positioned on the balloon contacting portion of the auxiliary elongated element.
- According to further embodiments of the present invention, there is provided a method for treating a vessel at a bifurcation. The method includes providing a catheter with a main body, a balloon positioned at a distal end of the main body, the balloon having an inflated configuration and an pre-inflated configuration, a wire positioned at a distal end of the balloon, the wire immovable with respect to the balloon while the balloon is in its pre-inflated configuration, a core wire positioned through the balloon, an auxiliary elongated element positioned alongside at least a portion of the balloon and having a distal end attached to the catheter so as to form a crotch point, a stent positioned on the balloon, the stent having stent edges, at least three radiopaque markers, including at least one radiopaque marker longitudinally aligned with each of the stent edges, and wherein at least two of the radiopaque markers are positioned on the core wire and at least one of the radiopaque markers is positioned on the auxiliary elongated element. The method further includes introducing the catheter into a main vessel into a vicinity of the bifurcation, positioning a guidewire within a branch vessel, rotating the catheter until the radiopaque marker positioned on the auxiliary elongated element is at a vertical distance from the radiopaque markers positioned on the core wire and is adjacent a branch vessel, advancing the catheter until the crotch point prevents further advancement of the catheter and until at least one of the radiopaque markers is aligned with an opening of the branch vessel, and deploying the stent by inflating the balloon.
- Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
- The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
- In the drawings:
-
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 ofFIG. 3 shown without a stent; -
FIG. 5 is an illustration of the system ofFIG. 3 in position at a bifurcation; -
FIG. 6 is an illustration of a the system ofFIG. 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; -
FIGS. 11 a-c are illustrations of a system for treating a bifurcation such as the one depicted inFIG. 10 ; -
FIG. 12 is an illustration of the system ofFIG. 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 inFIG. 13 ; -
FIGS. 15 a and b are illustrations of the system ofFIG. 14 , further including a holder; -
FIGS. 16 a and b are illustrations of the system ofFIG. 14 , further including a holder, in an alternative embodiment; -
FIG. 17 is an illustration of the system ofFIG. 14 being introduced into a guiding catheter; -
FIGS. 18 a-c are illustrations of the system ofFIG. 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 inFIG. 19 ; -
FIG. 21 is an illustration of the system depicted inFIG. 20 , further including stents thereon; -
FIGS. 22 a-d are illustrations of a method of deploying the system ofFIG. 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; -
FIGS. 24 a-c are illustrations of different embodiments of a system for delivery of a stent at aType 3 bifurcation lesion or at a non-bifurcated lesion; -
FIG. 25 is an illustration of the system ofFIG. 24 a in place at a bifurcation; -
FIG. 26 is an illustration of the system ofFIG. 24 a in place at a non-bifurcated lesion; -
FIGS. 27 a-d are illustrations of a configuration of markers; -
FIG. 28 is an illustration of a specific shape configuration of markers; -
FIGS. 29 a-f are illustrations of different types of bifurcation lesions; -
FIGS. 30A-30E are illustrations of steps of a method of treating an intracranial aneurysm, in accordance with embodiments of the present invention; -
FIGS. 31A and 31B are cross-sectional illustrations of a balloon in its deflated state and having a guidewire positioned within a temporary lumen, in accordance with embodiments of the present invention; -
FIG. 32 is an illustration of a system without a stent, in accordance with embodiments of the present invention; -
FIG. 33A is an illustration of a system without a stent, in accordance with another embodiment of the present invention; -
FIG. 33B is an illustration of the system ofFIG. 33A , with a balloon in an expanded state; -
FIG. 33C is a cross-sectional illustration of a portion of the system ofFIG. 33A ; -
FIGS. 33D and 33E are cross-sectional illustrations of another portion of the system ofFIG. 33A , showing the balloon in a deflated state; -
FIG. 33F is a cross-sectional illustration of the portion of the system shown inFIGS. 33D and 33E , with the balloon in an inflated state; -
FIG. 33G is a cross-sectional illustration of the portion of the system shown inFIG. 33D-33F , with the balloon in an inflated state, according to another embodiment of the present invention; -
FIG. 34A is an illustration of the system ofFIGS. 33A-33F , adapted for over-the wire delivery; -
FIGS. 34B and 34C are cross-sectional illustrations of the system ofFIG. 34A ; -
FIG. 35 is a schematic illustration of a catheter in accordance with embodiments of the present invention, showing a relationship between radiopaque markers, a stent, an auxiliary elongated element and a crotch point, in accordance with one embodiment of the present invention; -
FIG. 36 is a schematic illustration of a catheter in accordance with embodiments of the present invention, showing a relationship between radiopaque markers, a stent, an auxiliary elongated element and a crotch point, in accordance with another embodiment of the present invention; -
FIG. 37 is a schematic illustration of a catheter in accordance with embodiments of the present invention, showing a relationship between radiopaque markers, a stent, an auxiliary elongated element and a crotch point, in accordance with yet another embodiment of the present invention; and -
FIGS. 38A-38E are schematic illustrations showing a method of positioning a stent at a bifurcation, in accordance with embodiments of the present invention. - The present invention is of a catheter systems and methods. Specifically, the present invention can be positioned in a vessel with rotational and translational alignment. In addition to providing substantially predictable alignment, the devices and systems of the present invention have small outer diameters as compared with prior art systems, particularly ones which are suitable for treating a bifurcation, and reduce the possibility of wire entanglement.
- The principles and operation of systems and methods according to the present invention may be better understood with reference to the drawings and accompanying descriptions.
- Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
- Reference is now made to
FIG. 1 , which is an illustration of a vessel bifurcation with plaque buildup. Amain vessel 1 and abranch vessel 2 meet at abifurcation point 3. A buildup ofplaque 4 may be found anywhere within the vessels, but if there is plaque buildup located at or close tobifurcation point 3, as shown inFIG. 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. - Reference is now made to
FIG. 2 , which is an illustration of a prior art bifurcation stent delivery system 5. System 5 includes a catheter 6 having astent 7 with adedicated side hole 8. A main guidewire 9 is positioned inmain vessel 1 and passed through a main guidewire lumen in catheter 6. A side branch guidewire 11 is positioned within a second guidewire lumen, throughside hole 8, and intobranch vessel 2. As shown inFIG. 1 , there is a tendency for system 5 to overshootbifurcation point 3 during placement. Additionally, 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. Furthermore, 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 lesions, as will be described in further detail hereinbelow.
-
Lesion Type 1,Type 2 and Type 4: - In a first embodiment, a
stent delivery system 10 is designed to be delivered at aType 1,Type 2 orType 4 bifurcation lesion, as illustrated inFIGS. 29 a, 29 b and 29 d, respectively. In these types of bifurcation lesions, theplaque 4 is at least partially located within the main vessel in the vicinity ofbifurcation point 3, and may also be located withinbranch vessel 2. - Reference is now made to
FIG. 3 andFIGS. 4 a-d, which are illustrations of a bifurcationstent delivery system 10, shown with and without a stent respectively.System 10 includes a mainelongated element 16, and an auxiliaryelongated element 34 aligned with mainelongated element 16. In a preferred embodiment, auxiliaryelongated element 34 is positioned within mainelongated element 16 proximal to anexit point 37 and alongside mainelongated element 16 distal to exitpoint 37, as depicted inFIG. 3 . In an alternative embodiment, auxiliaryelongated element 34 is positioned alongside mainelongated element 16, as will be described hereinbelow with reference toFIG. 8 . - In a preferred embodiment, main
elongated element 16 is acatheter 18 having adistal end 20 and aproximal end 22. Aballoon 24 is positioned ondistal end 20 ofcatheter 18.Catheter 18 includes ahypotube 25 running along a proximal portion of the catheter, and an inflation lumen withinhypotube 25 in communication withballoon 24.Hyoptube 25 is comprised of stainless steel, or any other suitable material which provides rigidity. At a distal portion ofcatheter 18, a polymer jacket replaceshypotube 25, providing flexibility for navigation through the vessel. The inflation lumen continues to run through the polymer jacket portion ofcatheter 18 and intoballoon 24. The inflation lumen is designed for introducing a fluid, preferably a liquid, intoballoon 24 for inflation ofballoon 24 at the appropriate location. A port for inflation is positioned atproximal end 22, in a configuration which is well known in the art.Catheter 18 shown inFIGS. 3 and 4 a-d may be any commercially available balloon catheter. Optionally, a torquer device may be introduced toproximal end 22 for improving torqueability. Such torquer devices are well known in the art, and may be purchased, for example from Qosina Corp. (Edgewood, N.Y., USA, catalog part number 97333). - In an exemplary preferred embodiment,
balloon 24 is a fixed wire balloon and as such, includes a fixedwire 26 attached to a distal end ofballoon 24 at abonding area 28. A core wire 30 (or skeleton) runs along the interior ofballoon 24 to provide rigidity to the flexible portion ofcatheter 18. In a preferred embodiment,core wire 30 is a continuation of fixedwire 26. It is a particular feature of the present invention thatcore wire 30 is connected at a proximal end thereof to hypotube 25, at a distal end thereof to the distal end ofballoon 24, and in at least one other location in between. Referring again toFIGS. 4 a and 4 c,core wire 30 is bonded tocatheter 18 at an area of cross section B-B, whereside branch lumen 36exits catheter 18. Furthermore,core wire 30 is relatively thick as compared to a filament which is present within commercially available fixed wire balloons. Such filaments are typically within a range of 0.005 to 0.009 inches (most commonly around 0.007 inches), while thecore wire 30 of the present invention is in a range of 0.009-0.012 inches (most preferably around 0.01 inches). This thickness, along with additional bonding ofcore wire 30 tocatheter 18, provides rigidity along an entire length ofcatheter 18. This rigidity allows transmission of torque forces fromproximal end 22 todistal end 20 ofcatheter 18, and minimal loss of such forces due to bending or twisting of the polymer jacket, thus providing enhanced torqueability of the system. Furthermore, the rigidity provided bycore wire 30 and the features described above provide enhanced pushing capability of the system of the present invention, by preventing absorption of pushing forces by the polymer jacket or by other relatively compliant portions ofsystem 10. -
System 10 includes astent 12 positioned on mainelongated element 16, thestent 12 having a side opening 14. In one embodiment, side opening 14 is a dedicated side opening, and in another embodiment, side opening 14 is any opening within the structure ofstent 12. For example, a stent having a diamond configuration of struts might not require a dedicated side opening, as any cell may be used to access the branch vessel. In a preferred embodiment, auxiliaryelongated element 34 is aside branch lumen 36 for placement of a side branch guidewire therethrough.Side branch lumen 36 has adistal end 40 and aproximal end 42 and is attached tocatheter 18 atproximal end 42 and unattached tocatheter 18 atdistal end 40. The point at which the detachment between main and auxiliary elongated elements (catheter 18 andside branch lumen 36 in the present embodiment) occurs is defined as acrotch point 44. In an alternative embodiment,side branch lumen 36 is unattached tocatheter 18 both proximal and distal tocrotch point 44, and is attached tocatheter 18 only atcrotch point 44.Core wire 30 further includesfluorescent markers 32 which can be visualized during a procedure under fluorescence. In a preferred embodiment,markers 32 are aligned with each end ofstent 12 and withcrotch point 44, forming a row of markers. In an exemplary preferred embodiment, an additional marker is included atdistal end 40 ofside branch lumen 36. This configuration provides a view of the rotational alignment ofsystem 10 within the vessel. A discussion of marker configuration and alignment is discussed in more detail hereinbelow with respect toFIGS. 27 a-d and 28. In alternative embodiments, any configuration of markers which would enable viewing of key locations ofsystem 10 can be used. -
Crotch point 44 is preferably located close todistal end 40 ofside 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. thedistal end 40 ofside branch lumen 36 is atcrotch point 44. It should be noted that in this embodiment, a guidewire withinside branch lumen 36 is configured to enter a side branch vessel, as will be described hereinbelow with reference toFIG. 5 . This guidewire positioned withinside branch lumen 36, and mainelongated element 16form crotch point 44. In an alternative embodiment, 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. In a preferred embodiment, the portion ofside branch lumen 36 which is proximal tocrotch point 44 is approximately 10-30 mm, and in an exemplary preferred embodiment is approximately 25 mm. By extendingside branch lumen 36 proximally along at least a portion ofhypotube 25, the rigidity ofsystem 10 is increased, thus providing ease of rotation within the vessel. In an alternative embodiment, the portion ofside branch lumen 36 which is proximal tocrotch point 44 is approximately 5-15 mm. - Cross-sectional views along lines A-A, B-B and C-C are depicted in
FIGS. 4 b, 4 c and 4 d, respectively. As shown inFIG. 4 b, at a proximal location,side branch lumen 36 is located withincatheter 18.Core wire 30 is in the center, andside branch lumen 36 is betweencore wire 30 and the edge ofcatheter 18. As shown inFIG. 4 c, atexit point 37,side branch lumen 36 is bonded tocatheter 18. Distal to exitpoint 37,side branch lumen 36 is outside and adjacent to balloon 24, as shown inFIG. 4 d. - Reference is now made to
FIG. 5 , which is an illustration ofsystem 10 positioned at a bifurcation.Crotch point 44 is a key element in positioning ofstent 12 within the vessel. Withcatheter 18 inmain vessel 1 and a side branch guidewire 38 withinside branch lumen 36 positioned inbranch vessel 2,system 10 cannot be advanced beyond the point at whichcrotch point 44 reaches bifurcationpoint 3. Thus,system 10 is substantially predictably aligned, and overshooting is prevented. Side branch guidewire 38 is chosen to have optimal stiffness. In a preferred embodiment, guidewire 38 has an intermediate stiffness, such that it is stiff enough to guidesystem 10 and to preventsystem 10 from advancing beyondcrotch point 44, but not too stiff so as to risk puncturing the vessel. - In an exemplary preferred embodiment, a method for introducing
system 10 is as follows. First, a side branch guidewire 38 is positioned withinbranch vessel 2. A proximal end of side branch guidewire 38 is introduced intodistal end 40 ofside branch lumen 36. With side branch guidewire 38 positioned withinside branch lumen 36,system 10 is advanced throughmain vessel 1.Fixed wire 26 provides guidance as advancement occurs. In an alternative embodiment, side branch guidewire 38 is not introduced initially, andsystem 10 is advanced using only fixedwire 26 as a guide. In this embodiment, side branch guidewire 38 is initially backloaded intoside branch lumen 36 and remains withinside branch lumen 36 assystem 10 is advanced throughmain vessel 1. In either case,system 10 is free to rotate without risk of entanglement. Whencrotch point 44 reaches bifurcationpoint 3, advancement ofsystem 10 automatically stops. At this point,system 10 is in place, with side branch guidewire 38 inbranch vessel 2, andstent 12 in a correct position both translationally and rotationally.Balloon 24 is then inflated, thus deployingstent 12 within the vessel. Thus, the exact location ofcrotch point 44 predetermines accuracy of positioning. After deployment,system 10 is removed frombranch 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. - It should be apparent that 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. In a preferred embodiment, the overall outer diameter is 0.5-1.5 mm. Specifically, by attaching
side branch lumen 36 directly toballoon 24, for example, and predetermining the location ofcrotch point 44,side branch lumen 36 acts as a guide in the translational plane. The use of a fixed wire provides torqueability and ease of rotation, particularly since there is only one guidewire present (i.e. the branch guidewire). The presence of a bonded, relativelythick core wire 30 provides rigidity and ease of transmission of torque and pushing forces. The configuration ofside branch lumen 36 wherein adistal end 40 thereof is unattached to mainelongated element 16, or wherein a guidewire placed therethrough is unattached to mainelongated element 16 allows for initial entry ofside branch lumen 36 intobranch vessel 2. These aspects allow for substantially predictable rotation of the system and substantially predictable rotational positioning, without wire entanglement. - In one embodiment, the
system 10 illustrated inFIGS. 3 , 4 a-d and 5 is configured for use in treating an intracranial aneurysm. Current methods for treating such aneurysms include the use of self-expanding stents such as, for example, the Neuroform™ stents manufactured by Boston Scientific Corp. (MA, USA). Specifically, such stents are presented to the site of the aneurysm and deployed, after which a standard microcatheter is introducible through openings of the deployed stent. An embolic coil is introduced into the aneurysm through the microcatheter to plug the site of the aneurysm. Self expanding stents are generally used due to their low profile and maneuverability, features which are crucial for small vessels associated with intracranial aneurysms. However, they are prone to positioning problems and are difficult to anchor in place during deployment. A system such as the one described in preferred embodiments of the present invention can be used in place of self expanding stents for treatment of aneurysms, and provide both the benefits of small profile and maneuverability as well as better positioning and anchoring. - Reference is now made to
FIGS. 30A-30E , which are illustrations of steps of a method for treating an intracranial aneurysm in accordance with one embodiment of the present invention. As shown inFIG. 30A ,system 10 is introduced into avessel 200 with ananeurysm 202, and positioned such that side opening 14 ofstent 12 is situated at the site of the aneurysm, as shown inFIG. 30B . Alternatively, a stent without a side opening may be used. Positioning may be done by using markers and/or by the introduction ofguidewire 38 throughside branch lumen 36. Once the system is in place,stent 12 is deployed, as shown inFIG. 30C .Catheter 18 is removed, leavingstent 12 and guidewire 38 in place at the site of the aneurysm, as shown inFIG. 30D . As shown inFIG. 30E , astandard microcatheter 204 is then introduced overguidewire 38 through side opening 14 and into the area of the aneurysm, through which anembolic coil 206 may be delivered to the site. - Reference is now made to
FIG. 6 , which is an illustration ofsystem 10 in accordance with an alternative embodiment of the present invention. As shown inFIG. 6 ,system 10 further includes a distal connecting element 46, attached to a distal end ofballoon 24. In a preferred embodiment, distal connecting element 46 is attached atbonding area 28 ofballoon 24. In an alternative embodiment, distal connecting element 46 is attached at any other location onballoon 24 which is distal toside branch lumen 36. Distal connecting element 46 is configured to hold side branch guidewire 38 in place untilsystem 10 is in the vicinity ofbifurcation 3. This prevents side branch guidewire 38 from moving around within the vessel during delivery ofsystem 10, possibly causing damage. Oncesystem 10 is within the general vicinity ofbifurcation 3, side branch guidewire 38 is pulled proximally and released from distal connecting element 46, after which it is advanced intobranch vessel 2.System 10 is then advanced untilcrotch point 44 prevents further advancement,balloon 24 is inflated, andstent 12 is deployed. - Reference is now made to
FIG. 7 , which is an illustration ofsystem 10 in accordance with yet another embodiment of the present invention. As shown inFIG. 7 ,side branch lumen 36 is located internally withinballoon 24, and includes anexit point 37 at a location alongballoon 24. The location ofexit point 37 with respect tostent 12 defines a crotch point, which coincides with the location ofcrotch point 44 described in the earlier embodiments, and is functionally equivalent thereto. In one embodiment,side branch lumen 36 ends atcrotch point 44. In an alternative embodiment,side branch lumen 36 extends distally beyondcrotch point 44. - Reference is now made to
FIG. 8 , which is an illustration ofsystem 10 in accordance with yet another embodiment of the present invention.Side branch lumen 36 is located external and adjacent to mainelongated element 16.Crotch point 44 is located distal to an attachment point betweenside branch lumen 36 andballoon 24. The portion ofside branch lumen 36 which lies between the attachment point andcrotch point 44 may be attached or unattached to balloon 24. - Reference is now made to
FIGS. 9 a and 9 b, which are illustrations ofsystem 10 in accordance with yet another embodiment of the present invention, shown with a stent thereon. In this depiction, side hole 14 is not a dedicated side hole, but rather is any opening within the body ofstent 12. It should be noted that this type of stent may be included on any of the embodiments described herein.System 10 includes amain guidewire 39 rather than a fixed wire at the distal end ofballoon 24. Amain guidewire lumen 50 is located atbonding area 28 ofballoon 24. In a preferred embodiment,main guidewire lumen 50 is relatively short, i.e. 1-5 mm. In alternative embodiments,main guidewire lumen 50 extends proximally along a side ofballoon 24. In a preferred embodiment,main guidewire 39 is positioned outside ofstent 12 so as to avoid wire crossing betweenmain guidewire 39 and side branch guidewire 38, as shown inFIG. 9 a. In an alternative embodiment,main guidewire 39 is positioned withinstent 12, as shown inFIG. 9 b. In a preferred embodiment,main guidewire lumen 50 is positioned on an opposite side fromside branch lumen 36, as depicted. - In an alternative embodiment (not shown) of the present invention,
system 10 includes a main guidewire lumen in place of a fixed wire, and further includes acrotch point 44 in accordance with the different embodiments described above. - The embodiment shown in
FIG. 9 b allows formain guidewire 39 to be fixed during insertion and movable after inflation ofballoon 24. In one embodiment,main guidewire 39 is fixed during insertion by crimping of a stent thereon. In another embodiment,balloon 24 is formed to holdguidewire 39 therein prior to inflation and to releaseguidewire 39 following inflation. The configuration ofballoon 24 forms a “temporary lumen”, defined as a lumen which is present onballoon 24 only in a deflated state. That is, inflation ofballoon 24 causesballoon 24 to unfold, resulting in a disappearance of the temporary lumen and release ofguidewire 39. Reference is now made toFIGS. 31 a and 31 b, which are cross-sectional illustrations ofsystem 10 showingballoon 24 in a deflated state withmain guidewire 39 positioned within a temporary lumen 27, in accordance with embodiments of the present invention. As shown inFIG. 31A ,balloon 24 is folded in an “S” shape having a containment area 80 in one of the curved portions of the “S” shape. Main guidewire 39 is positioned in containment area 80, while auxiliaryelongated element 34 is positioned outside ofballoon 24.Stent 12 is positioned aroundballoon 24,main guidewire 39 and auxiliaryside branch lumen 36. In another embodiment, shown inFIG. 31B ,balloon 24 is folded in a hooked “Y” shape, wherein the bottom portion of the “Y” shape is curved to form a containment area 82. The portion of the “Y” shape determined by the two arms of the “Y” acts as asecondary containment area 84 for holdingside branch lumen 36 therein. Containment area 80 or 82 acts as a temporary lumen 27, at least partially containingmain guidewire 39 therein until inflation ofballoon 24.Stent 12 is positioned aroundballoon 24,main guidewire 39 andside branch lumen 36. - In this embodiment,
side branch lumen 36 is a guidewire enclosure for placing of a guidewire therethrough. In a preferred embodiment the guidewire enclosure is at least partially attached to the catheter at the crotch point. In a preferred embodiment, the guidewire enclosure is at least partially positioned within the catheter body so as to minimize the outer profile of the catheter. The distal end of the guidewire enclosure can be located at or distal to the attachment point. - In a preferred embodiment, a
guidewire lumen 50 is attached to the balloon distal end, and has a length of less than 15 mm. The containment area 80 or 82 forming temporary lumen 27 is preferably longitudinally aligned with the guidewire lumen, such that a distal end of the guidewire is positionable through the guidewire lumen and a portion of the guidewire which is proximal to the distal end of the guidewire is positionable in the temporary lumen 27. In a preferred embodiment, the temporary lumen 27 and the guidewire lumen are on an opposite side from the guidewire enclosure. According to additional features, the guidewire enclosure is at least partially positioned within said catheter body and is attached to the catheter body at a location on the balloon. The location is approximately in a center of the balloon. - During a procedure, the catheter system with
guidewire 39 positioned throughguidewire lumen 50 and in temporary lumen 27 is introduced into the vessel. Upon inflation of the balloon, guidewire 39 is released from temporary lumen 27, and becomes movable with respect to the catheter. In a preferred embodiment, a housing positioned proximal to a proximal end of temporary lumen 27 holds a portion ofguidewire 39 in place. Furthermore, a torquer may be placed at a proximal end of the catheter. The method provides the benefits of a fixed wire, with the additional benefit of a second guidewire positioned in the vessel during the procedure. - Lesion Types 4A and 4B:
- In a second embodiment, a
stent delivery system 110 is designed to be delivered at aType FIGS. 29 e and 29 f. In aType 4A lesion,plaque 4 is located inbranch vessel 2, at or nearbifurcation 3. In aType 4B lesion,plaque 4 is located inmain vessel 1 distal to the point ofbifurcation 3. One example of such 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. Other examples include renal arteries, the left main coronary artery, vein grafts, and others. - Reference is now made to
FIGS. 11 a-c, which are illustrations of different embodiments of asystem 110 for delivery of a stent at aType 4A orType 4B bifurcation lesion.System 110 may be designed with a fixed wire, as shown in FIG. 11 a, as on over-the-wire system, as shown inFIG. 11 b, or as a rapid exchange system, as shown inFIG. 11 c. - Reference is now made to
FIG. 11 a, which is an illustration ofsystem 110 designed as a single wire system.System 110 includes a mainelongated element 116 and an auxiliaryelongated element 134. In a preferred embodiment, mainelongated element 116 is acatheter 118. In a preferred embodiment,catheter 118 includes aballoon 124 with a fixed wire 126 at a distal end thereof. Astent 112 is positioned onballoon 124. In a preferred embodiment, auxiliaryelongated element 134 is aside branch lumen 136, and is attached tocatheter 118 at acrotch point 144.Side branch lumen 136 has aproximal end 142 and adistal end 140. In a preferred embodiment,side branch lumen 136 is positioned withincatheter 118 proximally, exits at anexit point 137, and is attached to mainelongated element 116 atcrotch point 144. The portion ofside branch lumen 136 betweenexit point 137 andcrotch point 144 may be attached or unattached. In a preferred embodiment, a distal end ofside branch lumen 136 is atcrotch point 144, and a guidewire placed therethrough extends distally to provide a stopping point. In an alternative embodiment, the distal end of side branch lumen is located 1-5 mm distal tocrotch point 144, and is unattached to thecatheter 118 in this location. - In an alternative embodiment,
side branch lumen 136 is located external to and positioned alongsidecatheter 118 proximal tocrotch point 144, and is unattached toelongated element 116 distal tocrotch point 144. In an alternative embodiment,side branch lumen 136 is unattached tocatheter 118 both proximal to and distal tocrotch point 144.Crotch point 144 is located at or near a proximal end ofstent 112. In a preferred embodiment,crotch point 144 is just proximal to the proximal end ofstent 112. - Reference is now made to
FIG. 11 b, which is an illustration ofsystem 110′ designed as an over-the-wire, double rail system.System 110′ is similar tosystem 110 shown inFIG. 11 a, except that in place of a fixed wire on the distal end ofballoon 124′, a main guidewire lumen 125 is present and runs the length ofcatheter 118′. A main guidewire is positioned through main guidewire lumen 125 for entry intomain 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 inside branch lumen 136′. - Reference is now made to
FIG. 11 c, which is an illustration ofsystem 110″, designed as a rapid exchange dual wire system.System 110″ is similar to bothsystems FIGS. 11 a and 11 c, except that in place of a fixed wire or a main guidewire lumen running the length ofcatheter 118″, a shortmain guidewire lumen 127 is present and runs proximally until anexit point 129. These types of systems are well known in the art, and are known to provide ease of catheter exchange. In the present invention, the location ofcrotch point 144 allows for more accurate placement within the vessel. - Reference is now made to
FIG. 12 , which is a depiction ofsystem 110 positioned atbifurcation 3 for aType 4B lesion. A side branch guidewire 138 is introduced intobranch 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, untilcrotch point 144 ofside branch lumen 136 is atbifurcation point 3. In a preferred embodiment,distal end 140 is atcrotch point 144, and only guidewire 138 entersbranch vessel 2. In an alternative embodiment,side branch lumen 136 extends and intoside branch vessel 2.System 110 is slowly advanced untilcrotch point 144 reaches bifurcationpoint 3, after whichsystem 110 automatically stops advancing.Balloon 124 is then inflated, deployingstent 112. After deployment,balloon 124 is deflated, andsystem 110 is removed. For aType 4A lesion, a similar method would be used, but side branch guidewire 138 would be introduced intomain vessel 3, andsystem 110 would be guided intobranch vessel 2. - In an alternative embodiment,
system 110 is a catheter system and does not include a stent, as shown inFIG. 32 .Crotch point 144 is an attachment point which is located at or near a proximal end ofballoon 124, rather than at or near a proximal end ofstent 112. More specifically,balloon 124 includes a workinglength portion 146, a proximal narrowedportion 148, and a distal narrowedportion 149. Workinglength portion 146 is defined as the portion ofballoon 124 with the largest outer diameter, while proximal and distal narrowedportions balloon 124 which have a smaller diameter than workinglength portion 146. In one embodiment,crotch point 144 is proximal to workinglength portion 146, and in some embodiments is located at a junction where workinglength portion 146 meets up with proximal narrowedportion 148. Auxiliaryelongated element 134 is a guidewire enclosure for placing of a guidewire therethrough. In a preferred embodiment the guidewire enclosure is at least partially attached to the catheter at the crotch point. In a preferred embodiment, the guidewire enclosure is at least partially positioned within the catheter body so as to minimize the outer profile of the catheter. The distal end of the guidewire enclosure can be located at or distal to the attachment point. It should be readily apparent that a core wire 130 may be positioned throughballoon 124 to attach the fixed wire 126 to a hypotube of the catheter, providing rigidity throughoutsystem 110. - Reference is now made to
FIGS. 33A-33G , which are schematic illustrations of asystem 710 without a stent, in accordance with another embodiment of the present invention.System 710 includes a mainelongated element 716, which in embodiments of the present invention is a catheter shaft, and acore wire 730 attached to mainelongated element 716 and positioned therethrough. At a corewire exit point 743, located at some point along mainelongated element 716,core wire 730 exits the catheter shaft so that it is positioned outside of mainelongated element 716, and is termed anexternal core wire 731. In one embodiment, corewire exit point 743 is at a distal end of mainelongated element 716. In other embodiments, corewire exit point 743 is at other locations along mainelongated element 716. Aballoon 724 is positioned at the distal end of mainelongated element 716, and is in fluid communication with an internal portion of mainelongated element 716, either via a designated inflation lumen or in a configuration wherein the internal portion of mainelongated element 716 acts as an inflation lumen.Balloon 724 can be made of a variety of diameters, ranging from 1.25-10.0 mm, for example. A fixedwire 726 is positioned on the distal end ofballoon 724. In one embodiment,balloon 724 is a fixed wire balloon as is commonly known in the art. An example of such a balloon is the type used for the Ace™ Balloon Catheter of Boston Scientific Corporation (Natick, Mass., USA). In another embodiment,balloon 724 is any balloon with a fixed wire attached thereto.External core wire 731 runs alongsideballoon 724, and is connected to fixedwire 726 at a distal portion ofballoon 724. In one embodiment,core wire 730,external core wire 731 and fixedwire 726 are all comprised of the same wire. In another embodiment, some or all ofcore wire 730,external core wire 731 and fixedwire 726 are separate pieces of wire which are connected at particular locations. In either case, several attachment or bonding locations provide transmission of forces through the length of the catheter, and thus enhance overall torquability and rotatability. In particular, bonding can be done at any or all of the following locations: at a distal tip ofballoon 724, at corewire exit point 743, and at aninternal attachment point 745, which is a location within mainelongated element 716 at whichcore wire 730 is attached to mainelongated element 716. In embodiments of the present invention, main elongated element is comprised of a hypotube, andcore wire 730 is attached to the hypotube. Additional attachment points may be included as well.External core wire 731 further includesmarkers 732 for visualization. - In the embodiment shown in
FIG. 33A , auxiliaryelongated element 734 has anexit point 729 for rapid exchange. At least a portion of auxiliaryelongated element 734 is positioned inside mainelongated element 716, and also has adistal exit point 737 for aguidewire 739 placed therethrough. In one embodiment, guidewire 739 positioned throughdistal exit point 737 forms acrotch point 744 at or near a proximal end ofballoon 724. The presence of a crotch point may be useful, for example, for anchoringsystem 710 within a side branch to avoid slippage within the vessel to be treated. InFIG. 33B ,balloon 724 is shown in its expanded state. As shown,external core wire 731 is positioned alongsideballoon 724, and provides an area of focused force for cracking or breaking up hard or difficult lesions. In one embodiment, anadditional guidewire 739 positioned through auxiliaryelongated element 734 can be used to provide an additional area of focused force. In some embodiments,additional guidewire 739 is positioned at a rotational distance fromexternal core wire 731 so as to provide multiple areas of focused force aroundsystem 710. For example, auxiliaryelongated element 734 may be positioned approximately 180 degrees fromexternal core wire 731, although it should be readily apparent that many different rotational distances are possible. - Reference is now made to
FIG. 33C , which is a cross-sectional illustration of a portion ofsystem 710 which is proximal to corewire exit point 743. As shown inFIG. 33C , mainelongated element 716 includes an inflation area or a designatedinflation lumen 720, which is in fluid communication withballoon 724 and provides fluid thereto for inflation ofballoon 724. Fluid is introducible through aninflation port 752, located at the proximal end of mainelongated element 716. Auxiliaryelongated element 734 is positioned within mainelongated element 716.Core wire 730 can be positioned anywhere within mainelongated element 716, and more specifically may be positioned withininflation lumen 720. - Reference is now made to
FIGS. 33D-33F , which are cross-sectional illustrations of a portion ofsystem 710 throughballoon 724, withballoon 724 shown in an unexpanded state according to two embodiments inFIGS. 33D and 33E , and in an expanded state inFIG. 33F . As shown,balloon 724 is folded in its unexpanded configuration.External core wire 731 is positioned within folds ofballoon 724. If aguidewire 739 is present, guidewire 739 can be seen alongsideballoon 724. As shown inFIG. 33F , whenballoon 724 is expanded,external core wire 731 is positioned alongsideballoon 724.Guidewire 739 is also positioned alongsideballoon 724, in a different location around the circumference of the balloon. It should be readily apparent that the use ofguidewire 739 is optional. In addition, theentire system 710 may be fabricated without an auxiliary elongated element, whereinexternal core wire 731 is relied on to provide the focused force. - Reference is now made to
FIG. 33G , which is a cross-sectional illustration of the portion ofsystem 710 includingballoon 724, in accordance with another embodiment. In this embodiment, severalexternal core wires core wire 730 is split into multiple wires at corewire exit point 743, and the multiple core wires are bundled together atfixed wire 726. - Reference is now made to
FIGS. 34A-34C , which are illustrations ofsystem 710 with an over-the-wire configuration. In this embodiment, there is noexit point 729 for rapid exchange. Rather, aguidewire port 750 is positioned at a proximal end of mainelongated element 716 and auxiliaryelongated element 734 runs internally along the entire length of mainelongated element 716.Guidewire port 750 andinflation port 752 may be configured, for example, in a Y-configuration, as shown. As shown inFIGS. 34B and 34C , which are two embodiments showing a cross-section along the shaft ofsystem 710, auxiliaryelongated element 734 andinflation lumen 720 run alongside one another, withcore wire 730 positioned alongside both auxiliaryelongated element 734 andinflation lumen 720. It should be readily apparent that the relative positioning of auxiliaryelongated element 734,inflation lumen 720 andcore wire 730 is variable, for example as shown in two variations inFIG. 34B andFIG. 34C , respectively. - A catheter system having a fixed wire balloon and auxiliary
elongated element 734 such as described above may be beneficial in treating both regular lesions and bifurcated lesions. For a non-bifurcated lesion, a guidewire is introduced into the vessel and through the lesion. The catheter is then advanced over the guidewire by introducing a proximal end of the guidewire into auxiliaryelongated element 734. The catheter is advanced until it reaches the lesion, and is thus in a position such that the guidewire lies alongside the balloon. Upon inflation of the balloon, the guidewire is compressed into the lesion site, and provides a focused force to enable the user to crack hard lesions at low pressure before the balloon is fully inflated. Doing so allows vessel stretching to occur at a lower strain rate, thus minimizing the trauma associated with balloon dilatation. The use of anexternal core wire 731 provides an additional focused force. Alternatively, instead of introducing a guidewire, fixedwire 726 is used to cross the lesion. In this embodiment, auxiliaryelongated element 734 may optionally not be included.Balloon 724 is then expanded, andexternal core wire 731 provides the focused force. If auxiliaryelongated element 734 is present, aguidewire 739 may additionally be introduced through auxiliaryelongated element 734 to provide additional focused force. These forces may be useful in treating a variety of lesions, including those found at renal or peripheral vessels, and may be useful for procedures requiring high forces such as valvioplasty. -
System 710 further provides a low profile carrier for appliances which need to be introduced distal to a lesion.Fixed wire 726 orguidewire 739 is used to cross the lesion.Balloon 724 is then expanded, with the focused force provided byexternal core wire 731, or by several external core wires or byguidewire 739 or any combination thereof. Once the lesion is cracked,system 710 can be positioned distal to the lesion area. Auxiliaryelongated element 734 is then available as a conduit for any additional items or appliances which are needed such as a guidewire, contrast media, or any other item which might have clinical utility. Such items may be readily placed through auxiliaryelongated element 734, and into the vessel at a point distal to the lesion. - The presence of a guidewire enclosure further provides an opportunity to treat lesions located at a bifurcation without reintroduction of the system. After treatment of a lesion in the first vessel, the guidewire is pulled back proximally and introduced into a second vessel which is connected to the first vessel at a bifurcation. The balloon is deflated, the catheter is retracted along the guidewire, and introduced into the second vessel. The balloon is then inflated so as to compress the lesion in the second vessel.
- In an alternative method, the guidewire is introduced into the second vessel, the catheter is advanced over the guidewire past the bifurcation and into the first vessel. The first lesion is then treated by inflating the balloon and compressing the lesion. The balloon is deflated, the catheter is retracted, and introduced into the second vessel such that the guidewire is positioned alongside the balloon. Upon inflation of the balloon, the guidewire is compressed into the lesion site, and provides a focused force to enable the user to crack hard lesions at low pressure before the balloon is fully inflated.
- In an alternative embodiment, a
stent delivery system 210 is designed to be delivered at a bifurcation lesion such as the one illustrated inFIG. 13 , having amain vessel 1 and abranch vessel 2 at an angle with respect tomain vessel 1, and whereinplaque 4 is located inbranch vessel 2 at an area of abifurcation 3. In an exemplary preferred embodiment,main vessel 1 is an aorta. - Reference is now made to
FIGS. 14 a and 14 b, which are views of asystem 210 in accordance with an embodiment of the present invention.System 210 includes a main elongated element 216 and an auxiliary elongated element 234. In a preferred embodiment, main elongated element 216 is acatheter 218 having aproximal end 222 and adistal end 220.Catheter 218 has aballoon 224 atdistal end 220, with astent 212 positioned thereon. In one embodiment,balloon 224 includes amain guidewire lumen 227. In an alternative embodiment,balloon 224 is a fixed wire balloon, such as described with reference to the first and second embodiments, and shown at least inFIGS. 4 a and 11 a. In a preferred embodiment,main guidewire lumen 227 extends only partially in the proximal direction alongcatheter 218 and includes anexit point 229 for rapid exchange. In an alternative embodiment,system 210 is an over-the-wire system andmain guidewire lumen 227 extends proximally to the proximal end ofcatheter 218. In a preferred embodiment, auxiliary elongated element 234 is a positioning system 236, which will be described in further detail hereinbelow. - In a preferred embodiment, positioning system 236 includes a
stopper element 250 and anattachment mechanism 252. In a preferred embodiment,stopper element 250 is separate fromattachment 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. In an alternative embodiment,stopper element 250 is part ofattachment mechanism 252, but can also be extended in a first configuration and positioned to act as a stopper in a second configuration. In one preferred embodiment,stopper element 250 is comprised of a shape memory metal such as, for example, Nitinol. In the embodiment described herein, spring wires are used asstopper element 250, which are designed to lay substantially horizontal tocatheter 218 in their unextended positions and to coil or spring into a stopper upon release.Attachment mechanism 252 attaches the spring wires to main elongated element 216 to form crotch points 244. In a preferred embodiment,attachment mechanism 252 is a jacket having aproximal end 256 and adistal end 254.Attachment mechanism 252 at least partially encloses stopper element 250 (shown as spring wires), such that a proximal portion ofstopper element 250 enclosed byattachment mechanism 252 is relatively straight, and a distal portion ofstopper element 250 is unenclosed and able to move freely.Attachment mechanism 252 can comprise any biocompatible material, and is preferably comprised of a polymer. In a preferred embodiment, crotch points 244 are located at a proximal end ofballoon 224. - Reference is now made to
FIG. 14 b, which is a cross-sectional view ofsystem 210 along the lines A-A, in accordance with one embodiment.Catheter 218 hasmain guidewire lumen 227 for introduction of a main guidewire 239. Surroundingcatheter 218 isstopper element 250, which is held in place byattachment mechanism 252. - Reference is now made to
FIGS. 15 a-b, which are illustrations ofsystem 210 partially enclosed within aholder 254. The purpose ofholder 254 is to temporarily holdstopper element 250 in a substantially straight configuration until the area ofbifurcation point 3 is reached. In a preferred embodiment,holder 254 is a peel-away device. Whenholder 254 is in place,stopper element 250 is enclosed and lies approximately along the plane of main elongated element 216. In the embodiment shown inFIGS. 15 a and b,stopper elements 250 are straightened in the distal direction, such that they run alongsidestent 212. The area proximal to crotch points 244 is shown in cross section inFIG. 15 b, and includes amain guidewire lumen 227 withincatheter 218,stopper elements 250 enclosed withinattachment mechanism 252, andholder 254 surroundingattachment mechanism 252. - Reference is now made to
FIGS. 16 a-b, which are illustrations ofsystem 210 partially enclosed withinholder 254, in accordance with another embodiment of the present invention. In the illustration shown inFIGS. 16 a and b,stopper elements 250 are bent in a proximal direction, withholder 254 surroundingstopper elements 250 and holding them in place. That is,stopper elements 250 are folded overattachment mechanism 252. The area proximal to crotch points 244 is shown in cross section inFIG. 16 b, and includes amain guidewire lumen 227 withincatheter 218,stopper elements 250 enclosed both within and outside ofattachment mechanism 252, andholder 254 surroundingattachment mechanism 252 andstopper elements 250. - Reference is now made to
FIG. 17 , which is a depiction ofsystem 210 within a guiding catheter 260. Guiding catheter 260 includes a proximal end 262, through whichsystem 210 is introduced, and adistal end 264, which is open to a vessel. Assystem 210 is guided into proximal end 262 of guiding catheter 260,holder 254 is removed, sincestopper element 250 will remain in place within guiding catheter 260. In a preferred embodiment,holder 254 is a peel-away system, wherein the outer walls may be peeled away and removed from the system whilesystem 210 is being introduced into guiding catheter 260. This introduction is performed outside of the body. In an alternative embodiment,holder 254 is a sheath, which can be pulled back assystem 210 is being introduced into guiding catheter 260.Holder 254 can be any device for holdingstopper element 250 in place untilsystem 210 is within guiding catheter 260. - Reference is now made to
FIGS. 18 a and 18 b, which are depictions of a method for introducingsystem 210 to a bifurcation in accordance with an embodiment of the present invention. Guiding catheter 260 withsystem 210 positioned therein is introduced throughmain vessel 1 untilbifurcation point 3.Distal end 264 of guiding catheter 260 is visualized using methods currently known in the art, such as, for example, fluorescent markers. Oncedistal end 264 of guiding catheter 260 is at the entrance to branchvessel 2,system 210 is advanced throughdistal end 264 of guiding catheter 260, as shown inFIG. 18 a. Assystem 210 is advanced,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 inFIG. 18 b.System 210 is then advanced untilstopper elements 250 preventsystem 210 from further advancement, as shown inFIG. 18 c. At this point,system 210 is properly positioned, andstent 212 is deployed. - Y-Bifurcation:
- In another embodiment, a stent delivery system 310 is designed to be delivered at a
bifurcation 3 as illustrated inFIG. 19 , having a Y-configuration.Main vessel 1 branches into two branch vessels: afirst branch vessel 2 and asecond branch vessel 2′, andplaque 4 is located in main and/or branch vessels at the area ofbifurcation point 3. - Reference is now made to
FIG. 20 , which is an illustration of a stent delivery system 310, in accordance with one embodiment of the present invention. System 310 includes a main elongated element 316 and an auxiliary elongated element 334. In a preferred embodiment, main elongated element 316 is a catheter 318. Catheter 318 has a proximal end 322 and a distal end 320. Proximal end 322 includes a hub 321 having a Y-valve for dual inflation. Distal end 320 has two balloons: aproximal balloon 324 and adistal balloon 325. Each of proximal anddistal balloons proximal balloon 324 and an inner inflation channel 327 communicates withdistal balloon 325. Outer inflation channel 335 is coaxial with inner inflation channel 327. Alternatively, 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. In an alternative embodiment, outer inflation channel communicates withdistal balloon 325 and inner inflation channel 327 communicates withproximal balloon 324. In a preferred embodiment,distal balloon 325 has a fixed wire 326 at a distal end thereof. In alternative embodiments, system 310 includes a main guidewire lumen or a short external guidewire lumen such as distal connectingelement 50 shown inFIG. 6 . - In a preferred embodiment, auxiliary elongated element 334 is a
side branch lumen 336 having a proximal end 342 and a distal end 340. In a preferred embodiment,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 toproximal balloon 324 and attached thereto at acrotch point 344. In an alternative embodiment,side branch lumen 336 lies alongsideproximal balloon 324. - Reference is now made to
FIG. 21 , which is an illustration of system 310 with stents. In a preferred embodiment, two stents are included, as shown. Aproximal stent 312 is positioned onproximal balloon 324, and adistal stent 313 is positioned ondistal balloon 325. Each stent may be separately deployed by inflating its corresponding balloon.Proximal stent 312 is positioned such that distal end ofside branch lumen 336 is approximately aligned with a distal end ofproximal stent 312. The distal edges ofside branch lumen 336 andstent 312 form acrotch point 344. In an alternative embodiment,side branch lumen 336 extends distallypast crotch point 344. All of the embodiments described earlier in the present application may further be applied here. - In alternative embodiments, system 310 includes one, two or no stents, depending on the application. For example, system 310 may be used for predilatation, with a stent only on
proximal balloon 324. Alternatively, a tapered vessel may require two different stent sizes, wherein one stent of a particular size is positioned ondistal balloon 325, while another stent of a different size is positioned onproximal balloon 324. - Reference is now made to
FIGS. 22 a-d, which are illustrations of a method of deploying system 310 within a Y-bifurcation. First, a side branch guidewire 338 is introduced into afirst branch vessel 2. A proximal end of side branch guidewire 338 is then placed through a distal end ofside branch lumen 336. System 310 is advanced over side branch guidewire 38 throughmain vessel 1 and intosecond branch vessel 2′. Whencrotch point 344 reachesbifurcation 3, system 310 will not be advanceable, and system 310 will be in place, as shown inFIG. 22 a. As shown inFIG. 22 b,distal balloon 325 is inflated via inner inflation channel 327, deployingdistal stent 313 in a branch vessel, just distal to bifurcationpoint 3. After deployment ofdistal stent 313,proximal balloon 324 is inflated via outer inflation channel 335, deployingproximal stent 312. An alternate method is depicted inFIG. 22 c, whereinproximal stent 312 is deployed first, and thendistal 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 inFIG. 22 d. - Reference is now made to
FIG. 23 , which is an illustration of atapered balloon system 410, in accordance with an alternative embodiment of the present invention. Similar to the earlier embodiments,tapered balloon system 410 includes a main elongated portion and an auxiliaryelongated element 434. In a preferred embodiment, auxiliaryelongated 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. In a preferred embodiment, 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. - Lesion Type 3:
- In another embodiment, a
stent delivery system 510 is designed to be delivered at aType 3 bifurcation lesion as illustrated inFIG. 29 c. In aType 3 lesion,plaque 4 is located inmain vessel 1, proximal to the point ofbifurcation 3.Stent delivery system 510 is also suitable to be delivered at a lesion in a non-bifurcated vessel, as will be described more fully hereinbelow. - Reference is now made to
FIGS. 24 a-c, which are illustrations of different embodiments of asystem 510 for delivery of a stent at aType 3 bifurcation lesion.System 510 may be designed with a fixed wire, as shown inFIG. 24 a, as on over-the-wire system, as shown inFIG. 24 b, or as a rapid exchange system, as shown inFIG. 24 c. - Reference is now made to
FIG. 24 a, which is an illustration ofsystem 510 designed as a single wire system.System 510 includes a mainelongated element 516 and an auxiliaryelongated element 534. In a preferred embodiment, mainelongated element 516 is acatheter 518. In a preferred embodiment,catheter 518 includes aballoon 524 with a fixedwire 526 at a distal end thereof. Astent 512 is positioned onballoon 524. In a preferred embodiment, auxiliaryelongated element 534 is aguidewire lumen 536, and is attached tocatheter 518 at acrotch point 544.Guidewire lumen 536 has aproximal end 542 and adistal end 540.Crotch point 544 is located atdistal end 540. In a preferred embodiment,guidewire lumen 536 is positioned withincatheter 518 proximally, exits at anexit point 537, and is attached to mainelongated element 516 atcrotch point 544. The portion ofguidewire lumen 536 betweenexit point 537 andcrotch point 544 may be attached or unattached. In a preferred embodiment, a distal end ofguidewire lumen 536 is atcrotch point 544, and a guidewire placed therethrough extends distally to provide a stopping point. In an alternative embodiment, the distal end of guidewire lumen is located 1-5 mm distal tocrotch point 544, and is unattached to thecatheter 518 in this location. - In one embodiment,
guidewire lumen 536 is located external to and positioned alongsidecatheter 518 proximal tocrotch point 544, and is unattached toelongated element 516 distal tocrotch point 544. In an alternative embodiment,guidewire lumen 536 is unattached tocatheter 518 both proximal to and distal tocrotch point 544.Crotch point 544 is located at or near a distal end ofstent 512. In a preferred embodiment,crotch point 544 is approximately 2-3 mm distal to the distal end ofstent 512. - Referring to
FIG. 27 a, in an exemplary preferred embodiment,balloon 524 is a fixed wire balloon and as such, includes a fixedwire 526 attached to a distal end ofballoon 524 at abonding area 528. A core wire 530 (or skeleton) runs along the interior ofballoon 524 to provide rigidity to the flexible portion ofcatheter 518.Core wire 530 is a continuation of fixedwire 526. It is a particular feature of the present invention thatcore wire 530 is connected at a proximal end thereof to hypotube 525, at a distal end thereof to the distal end ofballoon 524, and in at least one other location in between. Specifically,core wire 530 is bonded tocatheter 518 at an area whereguidewire lumen 536 exitscatheter 518. Furthermore,core wire 530 is relatively thick as compared to a filament which is present within commercially available fixed wire balloons. Such filaments are typically within a range of 0.005 to 0.009 inches (most commonly around 0.007 inches), while thecore wire 530 of the present invention is in a range of 0.009-0.012 inches (most preferably around 0.01 inches). This thickness, along with additional bonding ofcore wire 530 tocatheter 518, provides rigidity along an entire length ofcatheter 518. This rigidity allows transmission of torque forces from proximal end 522 todistal end 520 ofcatheter 518, thus providing enhanced torqueability of the system. Furthermore, the rigidity provided bycore wire 530 and the features described above provide enhanced pushing capability of the system of the present invention, by preventing absorption of pushing forces by the polymer jacket or by other relatively compliant portions ofsystem 510. - Reference is now made to
FIG. 24 b, which is an illustration ofsystem 510′ designed as an over-the-wire, double rail system.System 510′ is similar tosystem 510 shown inFIG. 25 a, except that in place of a fixed wire on the distal end ofballoon 524′, amain guidewire lumen 525 is present and runs the length ofcatheter 518′. A main guidewire is positioned throughmain guidewire lumen 525 for entry intomain vessel 1.System 510′ may be introduced to the site via a main guidewire located inmain guidewire lumen 525 or via a branch guidewire located inguidewire lumen 536′. - Reference is now made to
FIG. 24 c, which is an illustration ofsystem 510″, designed as a rapid exchange dual wire system.System 510″ is similar to bothsystems FIGS. 24 a and 24 c, except that in place of a fixed wire or a main guidewire lumen running the length ofcatheter 518″, a shortmain guidewire lumen 527 is present and runs proximally until anexit point 529. In the present invention, the location ofcrotch point 544 allows for more accurate placement within the vessel. - Reference is now made to
FIG. 25 , which is a depiction ofsystem 510 positioned atbifurcation 3 for aType 3 lesion. A side branch guidewire 538 is introduced intobranch vessel 2.System 510 is guided over side branch guidewire 538 and either fixedwire 526 or a main guidewire 539, depending on the type of system, untilcrotch point 544 ofguidewire lumen 536 is atbifurcation point 3. In a preferred embodiment,distal end 540 is atcrotch point 544, and only guidewire 538 entersbranch vessel 2. In an alternative embodiment,guidewire lumen 536 extends intoside branch vessel 2.System 510 is slowly advanced untilcrotch point 544 reaches bifurcationpoint 3, after whichsystem 510 automatically stops advancing.Balloon 524 is then inflated, deployingstent 512. After deployment,balloon 524 is deflated, andsystem 510 is removed. - Reference is now made to
FIG. 26 , which is a depiction ofsystem 510 positioned at a non-bifurcated lesion within avessel 600. In one embodiment, aguidewire 610 is introduced intovessel 600 and through the lesion.System 510 is guided overguidewire 610 and fixedwire 526 untilcatheter 518 reaches the lesion site. Location is determined by markers 532, as will be described more fully hereinbelow with respect toFIGS. 27 a-d and 28.Balloon 524 is then inflated, deployingstent 512. After deployment,balloon 524 is deflated, andsystem 510 is removed. By providing a guidewire in the vessel which is held in a guidewire lumen having an exit port distal to the proximal end ofcatheter 518, a rapid exchange of catheters is possible if necessary. Furthermore, the system can be used in a direct stenting procedure, without the need for predilatation, reducing the invasiveness of the procedure. In an alternative embodiment, guidewire 610 is backloaded and housed inguidewire lumen 536, andsystem 510 is introduced into the vessel guided by fixedwire 526.System 510 is suitable for crossing the lesion on its own due to the rigidity provided bycore wire 530. Oncesystem 510 is in place, guidewire 610 is advanced so that a backup wire is present at and distal to the lesion (for rapid exchange capabilities, for example).Balloon 524 is then inflated, deployingstent 512. There are several advantages in usingsystem 510 as a regular non-bifurcation stent delivery system, over the typical delivery systems currently available. It is widely recognized that rapid exchange has certain advantages, including ease of delivery and ease of interchanging catheters if necessary. However, the presence of a bonded, relatively thick core wire allows for greater ease of rotation and transmission of torque forces without increasing overall diameter, which is advantageous during delivery of the system. Furthermore, in a direct stenting procedure, eitherguidewire 610 or fixedwire 526 is suitable for crossing the lesion. With fixedwire 526 crossing the lesion,stent 512 is automatically in place. - Reference is now made to
FIGS. 27 a-d, which are illustrations of a marker configuration, in accordance with a preferred embodiment. As shown inFIG. 27 a, afirst marker 630, asecond marker 632 and athird marker 634 are included oncore wire 30, and are aligned with proximal and distal ends ofstent 12 and withcrotch point 44, respectively. Afourth marker 636 is positioned atcrotch point 44, thus forming a triangle with first andsecond markers FIG. 27 b, whensystem 10 is in position, the relative locations of the three markers are consistent with the original configuration. That is, first, second andthird markers fourth marker 636 is off to one side. As shown inFIG. 27 c, whensystem 10 is rotated 90 degrees, all four markers are relatively in the same line. As shown inFIG. 27 d, whensystem 10 is rotated 180 degrees,fourth marker 636 is on the other side of first, second andthird markers system 10 on a two-dimensional viewing screen. In addition,markers 634 and/or 636 may be configured in a triangle or pointing shape, as depicted inFIG. 28 , pointing toward the branch access. This also provides additional confirmation of correct positioning. Thus, proper alignment at a bifurcation is ascertained when all the markers are correctly positioned with respect to one another, and when the pointing shaped marker points toward the branch. - Reference is now made to
FIG. 35 , which is a schematic illustration ofcatheter 18 in accordance with embodiments of the present invention, showing a relationship betweenradiopaque markers stent 12, auxiliaryelongated element 34 andcrotch point 44.Stent 12 includes stent edges, including stentdistal end 802, stentproximal end 804, stent side openingdistal end 806, and stent side openingproximal end 808. Side opening 14 may be a dedicated side opening or may be any opening within the structure ofstent 12 through which a side branch guidewire may be introduced. Auxiliaryelongated element 34 has aballoon contacting portion 838, whereinballoon contacting portion 838 includes the portion of auxiliaryelongated element 34 which is in contact with any portion ofballoon 24.Balloon contacting portion 838 generally is positioned at least at a proximal end ofballoon 24, and may also extend further distally, depending on the type of stent used and the type of lesion to be treated. Thus,balloon contacting portion 838 may lie alongsideballoon 24 from a proximal end ofballoon 24 to a mid-portion ofballoon 24, as shown inFIG. 35 . Alternatively,balloon contacting portion 838 may lie alongsideballoon 24 from a proximal end ofballoon 24 until a distal end ofballoon 24, as shown inFIG. 36 . Alternatively,balloon contacting portion 838 may lie alongsideballoon 24 only at a proximal end ofballoon 24, as shown inFIG. 37 . Awire 826 is positioned at a distal end ofballoon 24, whereinwire 826 is immovable with respect to balloon 24 whileballoon 24 is in an uninflated state. In one embodiment,wire 826 is a fixed wire which is attached to a distal end ofballoon 24. In another embodiment,wire 826 is positioned within a short main guidewire lumen at a distal end ofballoon 24 and is temporarily immobilized with respect to balloon 24 whileballoon 24 is in an uninflated state by being positioned within folds ofballoon 24 and/or crimped underneathstent 12, as described more fully with respect toFIGS. 9 b and 31 a and 31 b. It should be readily apparent that all of the embodiments described herein inFIGS. 35-37 may be designed with a fixed wire or a temporarily immobilized wire, as long aswire 826 is immovable with respect to balloon 24 at least during insertion and positioning ofcatheter 18 inmain vessel 1. - A
longitudinal axis 900 defines translational positions ofradiopaque markers branch vessel 2, radiopaque markers are positioned in longitudinal alignment with each of stent edges 800. Thus, although not all ofradiopaque markers radiopaque markers longitudinal axis 900 is to be taken as an x-axis) which corresponds to the longitudinal position (x-coordinate) of each of stent edges 800. In particular, firstradiopaque marker 630 is longitudinally aligned with stentproximal end 804, secondradiopaque marker 632 is longitudinally aligned with stent side openingdistal end 806, thirdradiopaque marker 634 is longitudinally aligned with stentdistal end 802, and fourthradiopaque marker 636 is longitudinally aligned with stent side openingproximal end 808. This provides visualization of translational alignment ofstent 12 and stent side opening 14 with an ostium ofbranch vessel 2. A distance between secondradiopaque marker 632 and a fourthradiopaque marker 636 approximates an average diameter of a side branch. This distance in some embodiments is 2-3 mm or 2-2.5 mm, for example. - In addition, at least one of
radiopaque markers radiopaque markers core wire 30, and at least one of the radiopaque markers is positioned onballoon contacting portion 838 of auxiliaryelongated element 34, as previously described with reference toFIGS. 27 a-27 d. This configuration provides visualization of rotational alignment, and ensures thatcatheter 18 is rotated such that stent side opening 14 is facing the ostium ofbranch vessel 2. In one embodiment,markers core wire 30 andmarker 636 is positioned on auxiliaryelongated element 34. In another embodiment,markers core wire 30 andmarkers elongated element 34. In yet another embodiment,markers core wire 30 andmarker 630 is positioned on auxiliaryelongated element 34. It should be noted that all radiopaque markers are immovable with respect tocatheter 18 and are configured to remain withinmain vessel 1 at the desired locations (ie, none of the radiopaque markers are configured to enter branch vessel 2). This configuration provides a constant distance between markers, clearly marking relationships between the markers in both the longitudinal direction and rotationally. - In one embodiment, as shown in
FIG. 35 , auxiliaryelongated element 34 has adistal tip 840 which is distal to stent side openingproximal end 808. Thus,distal end 40 of auxiliaryelongated element 34 exits mainelongated element 16 atexit point 37, distal to whichballoon contacting portion 838 is in contact withballoon 24. In the embodiment shown inFIG. 35 ,balloon contacting portion 838 is positioned at least partially understent 12, and extends distally past stent side openingproximal end 808.Distal tip 840 is positioned onballoon 24 and attached thereto, and is within stent side opening 14. The attachment ofdistal tip 840 to balloon 34 forms acrotch point 44. In some embodiments,crotch point 44 is located slightly proximal to stent side openingdistal end 806. A distance betweencrotch point 44 and stent side openingdistal end 806 may vary depending on the size ofstent 12, but is generally within a range of 0.25-1.5 mm and in some embodiments is approximately 0.5 mm. This distance allows forguidewire 39 to enterbranch vessel 2 at an angle of less than 90 degrees whencatheter 18 is aligned properly. - It is a particular feature of the present invention that the combination of
crotch point 44, and translationally and rotationally positioned markers allows for accurate positioning ofcatheter 18 with side opening 14 positioned at the ostium ofbranch vessel 2. - Reference is now made to
FIG. 36 , which is a schematic illustration ofcatheter 18 in accordance with additional embodiments of the present invention, whereincrotch point 44 is in a distal position. The schematic illustration ofFIG. 36 depicts a relationship betweenradiopaque markers stent 12, auxiliaryelongated element 34 andcrotch point 44.Stent 12 includes stent edges, including stentdistal end 802 and stentproximal end 804. Auxiliaryelongated element 34 has aballoon contacting portion 838, whereinballoon contacting portion 838 includes the portion of auxiliaryelongated element 34 which is in contact with any portion ofballoon 24. In the embodiment shown inFIG. 36 ,balloon contacting portion 838 lies alongsideballoon 24 from a proximal end ofballoon 24 until a distal end ofballoon 24. - A
longitudinal axis 900 defines translational positions ofradiopaque markers stent 12 proximal to an ostium ofbranch vessel 2, radiopaque markers are positioned in longitudinal alignment with each of stent edges 802 and 804. Moreover, at least one radiopaque marker is positioned on a different longitudinal axis than the other radiopaque markers. Thus, at least two radiopaque markers are in a longitudinal position (x coordinate, iflongitudinal axis 900 is to be taken as an x-axis) which corresponds to the longitudinal position (x-coordinate) of each of stent edges 804 and 802. In particular, firstradiopaque marker 640 is longitudinally aligned with stentproximal end 804, and secondradiopaque marker 642 is longitudinally aligned with stentdistal end 802. This provides visualization of translational alignment ofstent 12 withinmain vessel 1, wherein secondradiopaque marker 642 is proximal to an ostium ofbranch vessel 2. Athird radioapaque marker 644 is positioned distal to secondradiopaque marker 642 to provide visualization of the ostium ofbranch vessel 2. A distance between secondradiopaque marker 642 and thirdradiopaque marker 644 may approximate an average diameter of a side branch. This distance in some embodiments is 2-3 mm or 2-2.5 mm, for example. - At least one of
radiopaque markers radiopaque markers core wire 30, and at least one of the radiopaque markers is positioned onballoon contacting portion 838 of auxiliaryelongated element 34. This configuration provides visualization of rotational alignment, and ensures thatcatheter 18 is rotated such thatguidewire 39, placed through auxiliaryelongated element 34, is facing the ostium ofbranch vessel 2. In one embodiment,markers core wire 30 andmarker 644 is positioned on auxiliaryelongated element 34. In another embodiment,markers core wire 30 andmarker 642 is positioned on auxiliaryelongated element 34. It should be noted that all radiopaque markers are immovable with respect tocatheter 18 and are configured to remain withinmain vessel 1 at the desired locations (ie, none of the radiopaque markers are configured to enter branch vessel 2). This configuration provides a constant distance between markers, clearly marking relationships between the markers in both the longitudinal direction and rotationally. - In the embodiment shown in
FIG. 36 , auxiliaryelongated element 34 has adistal tip 840 which is distal to stentdistal end 802. Thus,distal end 40 of auxiliaryelongated element 34 exits mainelongated element 16 atexit point 37, distal to whichballoon contacting portion 838 is in contact withballoon 24. In the embodiment shown inFIG. 36 ,balloon contacting portion 838 is positioned understent 12, and extends distally past stentdistal end 802.Distal tip 840 is positioned on a distal portion ofballoon 24 and attached thereto, forming acrotch point 44. A distance betweencrotch point 44 and stentdistal end 802 may vary depending on the size ofstent 12, but is generally within a range of 0.25-1.5 mm and in some embodiments is approximately 0.5 mm. This distance allows forguidewire 39 to enterbranch vessel 2 at an angle of less than 90 degrees withoutstent 12 blocking the ostium ofbranch vessel 2. - It is a particular feature of the present invention that the combination of
crotch point 44, and translationally and rotationally positioned markers allows for accurate positioning ofcatheter 18 proximal to the ostium ofbranch vessel 2. - Reference is now made to
FIG. 37 , which is a schematic illustration ofcatheter 18 in accordance with additional embodiments of the present invention, whereincrotch point 44 is in a proximal position. The schematic illustration ofFIG. 37 depicts a relationship betweenradiopaque markers stent 12, auxiliaryelongated element 34 andcrotch point 44.Stent 12 includes stent edges, including stentdistal end 802 and stentproximal end 804. Auxiliaryelongated element 34 has aballoon contacting portion 838, whereinballoon contacting portion 838 includes the portion of auxiliaryelongated element 34 which is in contact with any portion ofballoon 24. In the embodiment shown inFIG. 36 ,balloon contacting portion 838 lies alongsideballoon 24 at a proximal end ofballoon 24. - A
longitudinal axis 900 defines translational positions ofradiopaque markers stent 12 proximal to an ostium ofbranch vessel 2, radiopaque markers are positioned in longitudinal alignment with each of stent edges 802 and 804. Moreover, at least one radiopaque marker is positioned on a different longitudinal axis than the other radiopaque markers. Thus, at least two radiopaque markers are in a longitudinal position (x coordinate, iflongitudinal axis 900 is to be taken as an x-axis) which corresponds to the longitudinal position (x-coordinate) of each of stent edges 804 and 802. In particular, firstradiopaque marker 650 is longitudinally aligned with stentproximal end 804, and secondradiopaque marker 652 is longitudinally aligned with stentdistal end 802. This provides visualization of translational alignment ofstent 12 withinmain vessel 1, wherein firstradiopaque marker 650 is distal to an ostium ofbranch vessel 2. Athird radioapaque marker 654 is positioned proximal to firstradiopaque marker 650 to provide visualization of the ostium ofbranch vessel 2. A distance between firstradiopaque marker 650 and thirdradiopaque marker 654 may approximate an average diameter of a side branch. This distance in some embodiments is 2-3 mm or 2-2.5 mm, for example. - At least one of
radiopaque markers radiopaque markers core wire 30, and at least one of the radiopaque markers is positioned onballoon contacting portion 838 of auxiliaryelongated element 34. This configuration provides visualization of rotational alignment, and ensures thatcatheter 18 is rotated such thatguidewire 39, placed through auxiliaryelongated element 34, is facing the ostium ofbranch vessel 2. In one embodiment,markers core wire 30 andmarker 654 is positioned on auxiliaryelongated element 34. It should be noted that all radiopaque markers are immovable with respect tocatheter 18 and are configured to remain withinmain vessel 1 at the desired locations (ie, none of the radiopaque markers are configured to enter branch vessel 2). This configuration provides a constant distance between markers, clearly marking relationships between the markers in both the longitudinal direction and rotationally. - In the embodiment shown in
FIG. 37 , auxiliaryelongated element 34 has adistal tip 840 which is proximal to stentproximal end 804. Thus,distal end 40 of auxiliaryelongated element 34 exits mainelongated element 16 atexit point 37, distal to whichballoon contacting portion 838 is in contact withballoon 24. In the embodiment shown inFIG. 37 ,balloon contacting portion 838 is positioned proximal tostent 12.Distal tip 840 is positioned on a proximal portion ofballoon 24 and attached thereto, forming acrotch point 44. A distance betweencrotch point 44 and stentproximal end 804 may vary depending on the size ofstent 12, but is generally within a range of 0.25-1.5 mm and in some embodiments is approximately 0.5 mm. This distance allows forguidewire 39 to enterbranch vessel 2 at an angle of less than 90 degrees withoutstent 12 blocking the ostium ofbranch vessel 2. - It is a particular feature of the present invention that the combination of
crotch point 44, and translationally and rotationally positioned markers allows for accurate positioning ofcatheter 18 distal to the ostium ofbranch vessel 2. - Reference is now made to
FIGS. 38A-38E , which are schematic illustrations of a method of positioning a stent at a bifurcation, in accordance with embodiments of the present invention.Catheter 18 is introduced intomain vessel 1 and positioned in an area ofbranch vessel 2.Markers catheter 18 is oriented correctly with respect tobranch vessel 2. In one embodiment,catheter 18 is introduced overguidewire 39, which has been pre-positioned withinbranch vessel 2. In another embodiment, guidewire 39 is introduced together withcatheter 18, andcatheter 18 is advanced viawire 826, which may be a fixed wire attached to balloon 24 or which may be temporarily immobilized prior to inflation ofballoon 24.Guidewire 39 may then be advanced intobranch vessel 2. As shown inFIG. 38A , ifmarkers 630 632, 634, 636 indicate thatcatheter 18 is not oriented correctly with respect tobranch vessel 2, either rotationally or translationally or both,catheter 18 is then rotated, as indicated byarrow 904 inFIG. 38B or advanced as indicated byarrow 902 inFIG. 38B , as necessary. As shown inFIG. 38B , whencatheter 18 is properly oriented rotationally,marker 636 will be on a side ofcatheter 18 which is adjacent to branchvessel 2. As shown inFIG. 38C ,catheter 18 is further oriented by pushingcatheter 18 until resistance is felt atcrotch point 44. Thus, by combining the use of markers andcrotch point 44, and by using markers which are designed to indicate both translational and rotational orientation, it is possible to positioncatheter 18 in the proper location. As shown inFIG. 38D ,balloon 24 may then be expanded, deployingstent 12. In the embodiment shown inFIGS. 38D and 38E ,wire 826 is a temporarily immobilized wire, which is released upon expansion ofballoon 24. In this way, whencatheter 18 is removed frommain vessel 1, as depicted inFIG. 38E ,wire 826 can remain in main vessel 1 (and guidewire 39 may remain in branch vessel 2), for further treatment if necessary. In an alternative embodiment,wire 826 is a fixed wire attached to balloon 24 and is removed along withcatheter 18. - Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. For example, a self-expandable stent may be used in place of a balloon expandable stent, in which case the catheter would not necessarily be a balloon catheter. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
Claims (16)
1. A system for positioning a stent at a bifurcation, the system comprising:
a catheter having a main body including a main body proximal end and a main body distal end;
a balloon positioned at the main body distal end, the balloon including a balloon proximal end and a balloon distal end, the balloon having an inflated configuration and a pre-inflated configuration;
a wire positioned at the balloon distal end, the wire immovable with respect to the balloon in the pre-inflated configuration;
a core wire positioned through the balloon;
an auxiliary elongated element attached to the catheter to form a crotch point, the auxiliary elongated element including an auxiliary elongated element proximal end and an auxiliary elongated element distal end;
a stent positioned on the balloon, the stent having a plurality of stent edges; and
first, second, and third radiopaque markers immovable with respect to the catheter main body, two of the first, second, and third radiopaque markers are positioned on a first longitudinal axis and longitudinally aligned, respectively, with a first and second of the stent edges, one of the first, second, and third radiopaque markers positioned on a second longitudinal axis different from the first longitudinal axis.
2. The system according to claim 1 , wherein the stent includes a stent proximal end and a stent distal end, and wherein the first and second radiopaque markers are longitudinally aligned, respectively, with the stent proximal end and the stent distal end.
3. The system according to claim 1 , wherein two of the first, second, and third radiopaque markers are positioned on the core wire.
4. The system according to claim 1 , wherein one of the first, second, and third radiopaque markers is positioned at the crotch point.
5. The system according to claim 1 , wherein one of the first, second, and third radiopaque markers comprises a different shape.
6. The system according to claim 1 , wherein one of the first, second, and third radiopaque markers includes an apex pointing away from the longitudinal axis of the catheter.
7. The system according to claim 1 , wherein the stent includes a stent opening, and wherein the plurality of stent edges comprise a stent distal end, a stent proximal end, a stent opening distal end, and a stent opening proximal end.
8. The system according to claim 7 , further comprising a fourth radiopaque marker, wherein each of the first, second, third, and fourth radiopaque marker is aligned with one of the stent proximal end, the stent distal end, the stent opening distal end, and the stent opening proximal end.
9. The system according to claim 1 , wherein two of the first, second, and third radiopaque markers are longitudinally distanced from each other to approximate an average diameter of a vessel side branch.
10. The system according to claim 9 , wherein the distance is approximately 2 to 3 mm.
11. The system according to claim 9 , wherein the distance is approximately 2 to 2.5 mm.
12. The system according to claim 1 , wherein the crotch point is positioned so that a guidewire positioned within the auxiliary elongated element forms an angle with a longitudinal axis of the catheter less than 90 degrees.
13. The system according to claim 1 , wherein said wire is a fixed wire attached to the balloon distal end.
14. The system according to claim 1 , wherein said wire is a movable wire when the balloon is in the inflated configuration, and wherein when the balloon is in the pre-inflated configuration, said wire is trapped inside the balloon and stent so that said wire is immovable with respect to the balloon.
15. A method for treating a vessel at a bifurcation, the method comprising:
providing a catheter having a main body, a balloon positioned at a distal end of the main body, the balloon having an inflated configuration and a pre-inflated configuration, a wire positioned at a distal end of the balloon, the wire immovable with respect to the balloon in the pre-inflated configuration, a core wire positioned through the balloon, an auxiliary elongated element positioned alongside at least a portion of the balloon and having a distal end attached to the catheter to form a crotch point, a stent positioned on the balloon, the stent having a plurality of stent edges, first, second, and third radiopaque markers immovable with respect to the catheter main body, two of the first, second, and third radiopaque markers are positioned on a first longitudinal axis and longitudinally aligned, respectively, with a first and second of the stent edges, one of the first, second, and third radiopaque markers positioned on a second longitudinal axis different from the first longitudinal axis;
positioning a guidewire within a branch vessel;
introducing the catheter over the guidewire and into a main vessel in a vicinity of the bifurcation between the main vessel and the branch vessel;
rotating the catheter until the third radiopaque marker is at a vertical distance from at least one of the first and second radiopaque markers;
advancing the catheter until the crotch point prevents further advancement and until at least one of the first, second, and third radiopaque markers is aligned with an opening of the branch vessel; and
deploying the stent by inflating the balloon.
16. The method according to claim 15 , further comprising:
releasing said wire upon inflation of the balloon such that said wire is movable with respect to the balloon;
deflating the balloon; and
removing the catheter from the main vessel, leaving the guidewire in the branch vessel and said wire in the main vessel.
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CN112423824B (en) | 2018-05-17 | 2023-02-21 | 92号医疗公司 | Aspiration catheter system and method of use |
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