JP2007510491A - Treatment method of blood vessel bifurcation - Google Patents

Abstract

  A device for the treatment of a vascular bifurcation where a first blood vessel (24) intersects a second blood vessel (26). The device has a balloon (40, 90) for placement at the vessel bifurcation. The balloon has a first inflation characteristic, a first portion (42, 94) adapted to be placed in the first blood vessel, and a second inflation characteristic different from the first inflation characteristic; A second portion (44, 92) adapted to be disposed in the second blood vessel;

Description

  This application claims the benefit of US Provisional Patent Application No. 60 / 517,213 filed on November 3, 2003 and US Provisional Patent Application No. 60 / 607,064 filed on September 2, 2004. To do. The disclosures of these related applications are incorporated into the present invention by reference.

  The present invention relates generally to vascular catheterization, and in particular to intravascular balloons and stents.

  Intravascular stents are used for a variety of purposes, including opening closed blood vessels. Generally, stents are provided in a narrow, narrow, deflated form and have a deflated balloon inside the stent. The stent and balloon are held at the distal end of the catheter. The physician inserts a guide wire into the blood vessel, and then slides the catheter over the wire to position the catheter in place. The balloon is then inflated through the catheter passage to expand the stent to secure it in place and hold the blood vessel open. Once the stent is expanded, the balloon is deflated and deflated from the blood vessel with the catheter.

  It is sometimes necessary to insert a stent at the bifurcation where two blood vessels meet. In such cases, the stent must be inserted into the vessel to be expanded so that other vessels at the bifurcation are not obstructed by the stent or damaged by the procedure. The physician performing the procedure must be careful not to remove platelets from one blood vessel at the bifurcation during the procedure.

  The complexity of the vessel bifurcation is recognized in the prior art, and various solutions have been proposed. For example, US Pat. No. 6,361,544, whose disclosure is incorporated herein by reference, describes a stent and catheter for treatment at a bifurcation. The stent described in that invention includes a stent for a secondary branch vessel with a sloped portion corresponding to the slope formed by the intersection of the side branch vessel and the main vessel. The main vascular stent is a Y-shaped stent having an opening that is aligned with the opening to the side branch vessel. The side branch and main vascular catheter assembly carry the stent, place it in approximately the correct position, and are advanced over a pair of guide wires for implantation. A double balloon Y-shaped catheter is also described.

  Branched balloons for use in catheterization procedures are described, for example, in US Pat. No. 6,017,324, US Pat. No. 6,210,380, US Pat. No. 6,123,718, and US Pat. Also described in 2003/0069561. The disclosures of these patents and patent applications are hereby incorporated by reference into the present invention.

  Embodiments of the present invention provide a novel balloon for the treatment of vascular bifurcations as well as methods for implanting stents in the bifurcation region using such balloons. (As used herein, the term “branch” refers to a region where two blood vessels intersect and have a ostium) These methods allow the physician to position the stent more accurately and more easily To. Balloons also help reduce the likelihood that platelets will be released into the bloodstream during treatment.

  In some embodiments of the invention, the intravascular balloon has two portions with different inflation characteristics. In other words, the two parts of the balloon are configured to respond differently to a defined inflation pressure. In general, when a balloon is inflated at a vessel bifurcation, one of the two portions of the balloon is placed in one blood vessel, while the other portion is placed in another blood vessel.

  In some of these embodiments, the bifurcated balloon has a major longitudinal portion that has a radial protrusion at a predetermined location and slopes along the major region. A stent is typically crimped onto a balloon. The stent can have side openings such that when expanded, the radial protrusions of the balloon protrude through the side openings of the stent. In one embodiment, the side openings are covered by radial struts that open under pressure by radial protrusions. The physician uses the protrusion to align the side opening of the stent with the side vessel at the bifurcation. Once the stent is properly aligned in this manner, the balloon is fully inflated so that the stent is expanded and thus optimally aligned with the side vessels and secured in place. . The balloon is then deflated and deflated.

  Alternatively, the balloon can be used independently of the stent, for example, in angioplasty to open an occluded vessel near a bifurcation of the vessel. In this case, the radial protrusion of the balloon in the side vessel also helps to align the balloon, so that platelets are released at or near the branch when one of the vessels is dilated. Help prevent. This additional benefit of preventing platelets from being released may be provided when a bifurcated balloon is used for the expanding stent, as described above.

  In other embodiments, the balloon has a narrow inner portion for insertion into a side vessel at a bifurcation point and a collar surrounding one end of the balloon's narrow inner portion. The collar is configured to expand to a larger diameter than the inner portion. During treatment, the narrow portion of the balloon is inserted into the side vessel and the collar is positioned in the stoma where the side vessel joins the main vessel. The inflation of the balloon causes the inner portion to expand in the side vessel, while the collar whose inflated diameter is larger than the side vessel is still in the main vessel. In one embodiment, the inflated collar serves as a stop for the stoma and assists the operating surgeon in properly positioning the stent in the stoma. In another embodiment, the balloon is used in implanting a new stent in a side vessel, with one end of the stent protruding from the side vessel into the main vessel, and one end of the stent engaging the stoma In order to do so, it is expanded by a collar to a larger diameter than the rest of the stent.

  Therefore, in accordance with an embodiment of the present invention, an apparatus is provided for treating a vessel bifurcation where a first blood vessel meets a second blood vessel, the device having a balloon for placement at the blood vessel bifurcation,

  The balloon has a first inflation characteristic, a first portion adapted to be disposed in the first blood vessel, a second inflation characteristic different from the first inflation characteristic, and a second Having a second portion adapted to be disposed in the blood vessel.

  In certain embodiments, the second portion is adapted to project radially from the first portion when the balloon is inflated. In general, the second portion is adapted to be a partially inflated balloon to expand within the second blood vessel in order to easily align the balloon with the vessel bifurcation.

  In one embodiment, the second portion is prevented from folding upon inflation of the balloon and the second portion has a fan-fold extending into the second blood vessel. In other embodiments, the balloon is deflated, but at least a portion of the second portion is contained within the first portion and the second portion is outward from the first portion upon inflation of the balloon. It is designed to stretch. In yet another embodiment, the device has a deflation mechanism coupled to the second portion such that when the balloon is deflated, the second portion is deflated radially toward the first portion.

  In one aspect of the invention, the device has a radiopaque marker in at least a portion of the second portion, the marker being visually imaged of the balloon relative to the bifurcation under angiographic imaging. Configured to enable accurate positioning. In one embodiment, the radiopaque marker has a ring that surrounds the position of the second portion.

  In other embodiments, the device comprises a stent mounted over the first portion of the balloon and adapted to be placed in the first blood vessel by inflation of the balloon, wherein the stent is A radial opening to allow access between the second blood vessel and the second blood vessel so that the second portion of the balloon projects radially through the radial opening of the stent. Has been. The stent may be adapted to elute the therapeutic agent.

  In one embodiment of the invention, the inflation characteristics are such that the first and second portions of the balloon have different, constant compliances. In one embodiment, the second portion of the balloon has a sleeve that is secured to a portion of the first portion of the balloon to inhibit compliance of the portion of the first portion.

  In some embodiments, the first blood vessel and the second blood vessel have characteristic first and second diameters, the first diameter being greater than the second diameter, and the balloon The first portion is assumed to have an expanded diameter greater than the second diameter during inflation of the balloon while the second portion is positioned in the second blood vessel. In the disclosed embodiment, the first portion of the balloon is configured as a collar around the second portion of the balloon when the balloon is inflated. Generally, the first portion of the balloon has a conic curve rotation surface that surrounds a portion of the second portion of the balloon.

  In some of these embodiments, the first portion of the balloon is adapted to engage the ostium on the balloon opening. In one embodiment, the device has a stent attached to the second portion of the balloon and adapted to be placed in the second blood vessel by inflation of the balloon. The stent has a proximal end that is adapted to be expanded to a size greater than the second diameter, and the first portion of the balloon is adapted to secure the proximal end to the ostium. It is intended to expand the proximal end of the stent. The proximal end of the stent can have a plurality of struts configured to expand to a size greater than the second diameter. In other embodiments, the first portion of the balloon may serve to serve as a stop for the ostium to help align the stent with the second blood vessel when expanded. .

  In general, at least one of the first and second portions of the balloon has a lumen that passes therethrough to provide a guidewire used for balloon placement. In certain embodiments, only one of the first and second portions of the balloon has a lumen therethrough. The first and second portions of the balloon may share a common inflation port or may have separate respective inflation ports.

There is also provided a method of treating a vascular bifurcation where a first blood vessel meets a second blood vessel, according to an embodiment of the invention, the method comprising:
Providing a balloon having a first part having a first inflation characteristic and a second part having a second part having a second inflation characteristic different from the first inflation characteristic;
Placing the balloon in the vessel bifurcation so that the first part is placed in the first blood vessel and the second part is placed in the second blood vessel;
Inflating the first and second portions of the balloon of the first blood vessel and the second blood vessel, respectively.

In accordance with an embodiment of the present invention, there is additionally provided a device for treatment of a vessel bifurcation where a first blood vessel meets a second blood vessel, the device comprising
A balloon for placement in a blood vessel bifurcation, a first portion having a first inflation characteristic and adapted to be placed in a first blood vessel, and a second different from the first inflation characteristic A second portion having an inflation characteristic and adapted to be disposed in a second blood vessel;
A balloon connected and having a catheter having a distal end adapted to pass through the first blood vessel so as to place the balloon at the vessel bifurcation.

  There is further provided a method of manufacturing an intravascular balloon according to an embodiment of the present invention, wherein the method processes a first portion of the balloon to have a first inflation characteristic, and the first inflation characteristic. Having a second portion of the balloon coupled to the first portion to have a second inflation characteristic different from the first portion.

  In one embodiment, making the first and second portions of the balloon includes making at least one of the first and second portions by injection molding using a bifurcated mold. .

  In other embodiments, processing the first and second portions of the balloon includes processing at least one of the first and second portions by blow molding using a bifurcated mold. including. The bifurcated mold may be a stretchable mold. Alternatively, processing at least one of the first portion and the second portion includes using at least one of a suction and an inclined pin to direct the raw material to the bifurcated mold.

  In another embodiment, processing the first portion and the second portion of the balloon includes processing the first portion and the second portion by immersing the bifurcated mold in a liquid polymer. including.

  Additionally or alternatively, processing the first portion and the second portion of the balloon includes processing the first portion of the balloon, and then the first portion to form the second portion. Applying a local treatment to the region of the part.

Further provided is a vascular stunt according to an embodiment of the present invention, wherein the vascular stunt is adapted to be placed in a predetermined diameter vessel proximate to the foramen and to be expanded. When,
A proximal end adapted to be expanded relative to the forehead to a size greater than a predetermined diameter in order to securely fix the proximal end to the forehead.

  In one embodiment, the end of the stent has a first number of struts along the periphery of the stent, and the proximal portion of the stent has a second number of struts greater than the first number. In other embodiments, the proximate portion has a plurality of struts configured to bend outward to engage the fore edge. At least one of the terminal and proximal portions can be adapted to elute the therapeutic agent.

There is further provided a device for treatment of a vascular bifurcation where a first blood vessel meets a second blood vessel according to an embodiment of the invention, the device comprising a balloon for placement at the vascular bifurcation. And the balloon is
A first portion adapted to be placed in the first blood vessel;
A second portion adapted to project radially from the first portion to facilitate alignment of the balloon with the vessel bifurcation when the balloon is inflated.

  In certain embodiments, the device has a stent attached to the first portion of the balloon and adapted to be placed in the first blood vessel by inflation of the balloon, the stent being connected to the first blood vessel. With a radial opening to allow access between the second blood vessels, the second portion of the balloon is adapted to project radially through the radial opening of the stent. In one embodiment, the stent has a strut covering the radial opening, and the second portion of the balloon is adapted to open the strut outward when the balloon is inflated.

An apparatus for treatment of a vessel bifurcation where a first blood vessel meets a second blood vessel according to an embodiment of the present invention is also provided, wherein the first blood vessel and the second blood vessel are characteristic firsts. And the first diameter is greater than the second diameter, and the device has a balloon for placement at the vessel bifurcation,
While the inner portion adapted to be placed in the second blood vessel and the second portion are placed in the second blood vessel, the balloon has an expanded diameter larger than the second diameter when inflated. It has a collar around the inner part that is supposed to be presupposed.

  In some embodiments, the collar is adapted to engage the ostium when the balloon is inflated. In one embodiment, the device includes a stent attached to the inner portion of the balloon and adapted to be placed in the second blood vessel by inflation of the balloon, the stent having a proximal end, The collar is adapted to expand the proximal end of the stent in order to secure the proximal end to the foramen. In other embodiments, the collar is adapted to serve as a stop for the ostium to help align the stent with the second blood vessel when expanded.

Further provided is a method for the treatment of a vascular bifurcation where a first blood vessel meets a second blood vessel according to the present invention, the method comprising:
Providing a balloon having a first portion having a first inflation characteristic and a second portion adapted to project radially from the first portion when the balloon is inflated;
Placing a balloon proximate to the vessel bifurcation so that the first portion is located in the first blood vessel;
Partially inflating the balloon near the vessel bifurcation so that the second portion projects radially away from the first portion;
Aligning the partially inflated balloon of the second part with the second blood vessel;
Fully inflating the balloon after aligning the second portion.

There is further provided a method for the treatment of a vascular bifurcation where a first blood vessel meets a second blood vessel, according to an embodiment of the invention, wherein the first blood vessel and the second blood vessel are characterized by a first feature. The first diameter is greater than the second diameter, and the method includes:
Providing a balloon having an inner portion and a collar around the inner portion;
A balloon is disposed at the vessel bifurcation so that the inner portion is disposed in the first blood vessel and the collar is disposed in the second blood vessel;
Having the collar expand to an expanded diameter that is longer than the second diameter and inflating the balloon to engage the ostium.

  The invention will be more fully understood from the following detailed description of embodiments of the invention taken together with the drawings.

  FIG. 1 is a schematic side view of a stent 20 inserted into a blood vessel 24 at a blood vessel bifurcation in accordance with an embodiment of the present invention. The branch portion in this example is a position where the blood vessel 24 and the blood vessel 26 intersect. The blood vessel 24 is hereinafter referred to as the “main blood vessel” because the stent is inserted through the blood vessel into the bifurcation. In general, the main blood vessels have larger blood vessels and carry a relatively large amount of blood than the amount of blood that the side vessels 26 carry. In general, however, the principles of the present invention can be used to treat both “main vessels” and “side vessels” regardless of the relative size of the vessels. In other words, “main vessel” and “side vessel” are used in this patent application document and in the claims only for convenience of explanation and clarity of explanation, to enhance the applicability of embodiments of the present invention. Should not be construed as limited to one type of blood vessel or other type of blood vessel.

  The stent 20 is typically rolled over a balloon 32 that is inserted into a blood vessel 24 over a guide wire to treat platelets 30 that block the blood vessels in the bifurcation region. Initially, during insertion of the stent through blood vessel 24, balloon 32 remains deflated and the stent has a narrow diameter as shown in FIG. The stent has a side opening 28 that must be aligned with the side vessel 26 at the bifurcation to allow access to the side vessel. The stent allows blood flow to the side vessels after the stent has been expanded, and also allows further treatment in the side vessels (the side opening of the stent is initially shown in the figure 4 may be closed by a suitable structure, such as a radial strut), and has a side opening 28. Stents are generally constructed of a biocompatible material or a rigid expandable material and are configured to elute the therapeutic agent after implantation using known methods and procedures.

  Reference is made to the schematic side view of the stent 20 in the blood vessel 24 at the successive stages of implanting the stent according to an embodiment of the present invention. At the stage shown in FIG. 2, the balloon 32 inside the stent 20 is partially inflated to project the balloon radial protrusion 34 through the side opening of the stent. This radial protrusion can be made inherently more elastic than the main body of the balloon 32 by appropriate treatment of the balloon during manufacture. (The manufacturing method used for this purpose will be described later) Alternatively, the radial protrusion is positioned inside the opening 28 and is therefore not restrained by the stent, so it is simply more elastic. Can be. In general, the stage shown in FIG. 2 is inflated to a low pressure of, for example, about 1/4 atm through the passage of a catheter (not shown) used for stent insertion. The low pressure is sufficient to expand the radial protrusion through the side opening, but not enough to allow the balloon body (inside the stent) to expand the stent itself.

  In order to align the side opening 28 of the stent 20 with the side vessel 26, the surgeon performs the following two steps. Rotation of the stent about its longitudinal axis and longitudinal movement of the stent along that axis. Typically, doctors use X-ray images or other radiographs of blood vessels and stents to assist the stent during these stages. Additionally or alternatively, the balloon protrusion 34 may provide tactile feedback to the physician informing when the protrusion is inserted into the side vessel opening. In some embodiments, the balloon is partially inflated prior to the rotation phase, as shown in FIG. In other embodiments, the balloon is partially inflated only after the stent is oriented in the proper direction, and the balloon protrusions therefore longitudinally align the side openings of the stent with the side vessels. Used to first.

  In certain embodiments, the balloon 32 is inflated in a radiopaque region such as a saline solution mixed with a suitable contrast agent. The operating doctor can therefore see the balloon under the X-ray image, in particular the position of the radial protrusion 34 of the balloon. The side opening 28 of the stent is appropriately positioned proximate to the entrance of the side vessel 26 at the bifurcation, and the radial projection of the balloon is at least by the wall of the main vessel 24 or the platelet 30 of the vessel. Partially compressed. When the side opening of the stent is properly adjusted, however, the physician will see the radial protrusion of the balloon expanded outside the side vessel, as shown in FIG.

  After the stent 20 is correctly positioned using the partially inflated balloon 32, the balloon is inflated at full pressure as shown in FIG. For example, the balloon pressure may be increased at this location at about 1.5-2 atmospheres, which is generally sufficient to expand the stent. The balloon radial protrusion 34 expands further under increased pressure, pressing the platelets in the region of the bifurcation. Expansion of the balloon protrusion has two desirable effects: (1) During stent expansion, the protrusion holds the side opening 28 of the stent exactly in line with the side vessel 26 and (2) the balloon helps prevent the collapse of the side vessel 26 wall. Helps prevent platelets 30 from being released from the vessel wall while the stent is expanded. These latter, anti-embolism effects on a branched balloon are also beneficial when only the balloon is used to dilate a branched vessel in the absence of a stent.

  Once the stent is fully expanded, the balloon 32 is deflated and then withdrawn from the vessel, leaving the stent 20 in place. The radial protrusion 34 of the balloon (of course the guidewire 22 is also deflated) is sufficiently small when deflated and pulled back through the side opening 28 of the stent without the risk of clogging in situ. As noted above, the protrusions generally have different inflation characteristics than the rest of the balloon 32 to facilitate the different inflation processes described above. For example, the protrusion 34 can be made of a flexible but relatively non-resilient material to prevent overexpansion when high pressure is applied to expand the stent.

  FIG. 4 is a schematic perspective view of a stent 35 according to another embodiment of the present invention. Stent 35 has side openings 36 that are initially closed by radial struts 37. Once the stent 35 is properly positioned at the vessel bifurcation, the expansion of the balloon radial protrusion (not shown in this view) causes the struts 37 to open outside the side vessels and hence the ostium. Support. The balloon is then deflated and deflated.

  5 and 6 are schematic side views illustrating the insertion and alignment of the balloon 40 at the bifurcation of the blood vessel 24 and blood vessel 26 according to the present invention. The balloon 40 can be used with a stent as in the previous embodiment, or it can be used by itself as shown in FIGS. The balloon has a radial protrusion 44 surrounded by a main body 42 and a radiopaque marker 46. In this case, the balloon is also designed to be inserted into the bifurcation region by a catheter 48 covering the guide wire 22 without the aid of the guide wire in the side vessel 26. Alternatively, the guide wire can be inserted into the side vessel 26 in addition to or instead of the guide wire 22 of the blood vessel 24, or the balloon can be bifurcated without the use of a guide wire. Can be inserted.

  In one embodiment, the marker 46 has a wire coil that surrounds the protrusion 44. For example, the coil can have a super-elastic shape memory alloy such as Nitinol that is normally shaped when there is no external force, and the coil has the compressed shape shown in FIGS. Have. Generally, the coil is embedded in the balloon material. Alternatively, the coil can be positioned either inside or outside the protrusion 44. The protrusions 44 can have a sector fold shape with multiple accordion-like folds. In order to align the protrusion 44 with the side vessel 26, the operating physician uses an appropriate imaging system, such as an angiography system or other type of fluoroscope, to locate the bifurcation region. Observe. The imaging system is adjusted so that the imaging plane is parallel to the plane that includes both the blood vessel 24 and the blood vessel 26 at the bifurcation, ie, the planes of the pages of FIGS. In FIG. 5, the protrusion 44 has not yet been aligned with the side 26 and the marker 46 therefore appears as an ellipse in the angiographic image. The physician rotates the catheter 48 until the protuberance 44 is aligned with the opening of the blood vessel 26, where the marker 46 appears as a straight line as shown in FIG.

  FIG. 7 is a schematic side view showing inflation of the balloon 40 inside the bifurcation. The balloon is inflated by infusion of the appropriate fluid through the catheter 48, as in other embodiments described herein. The inflation pressure causes the protrusion 44 to widen and therefore expand into the side vessel 26. As a result, the marker 46 expands and the wound coils are separated from each other. When the procedure is complete, the balloon is deflated and the coil is deflated back to its original shape, pulling the protrusion 44 toward the main body 42 of the balloon 40, thus facilitating removal from the body. .

  Alternatively, other means can be used to mark the protrusions 34 or 44 for the purpose of aligning the bifurcation 26. For example, instead of a wire coil, the marker 46 may have one or more wire rings. Additionally or alternatively, a radiopaque paint or dye may be embedded in the balloon wall in the region of the protrusion. In one embodiment, the marker 46 has a ring of radiopaque paint around the base of the protrusion 46 that has a similar appearance under angiography to the wire coil described above.

  FIG. 8 is a schematic perspective view of a balloon 50 according to another embodiment of the present invention. The balloon 50 has a main body 54 and a protruding portion 52 in the radial direction as in the above-described embodiment. In this case, however, the radial protrusion 52 is inverted until the balloon 50 is inflated inside the bifurcation and is therefore restrained inside the main body 54. In this configuration, the radial protrusions are inverted and appear as depressions rather than protrusions. The end of the radial protrusion 52 has an opening 64 that allows the inner tube (not shown in this figure) containing the guide wire to penetrate the radial protrusion into the side vessel 26. Have. The main body 54 of the balloon 50 may include additional lumens (not shown) for mating with other guide wires in the main vessel. As previously mentioned, it may be used to treat a vessel bifurcation with or without a stent.

  FIG. 9 is a schematic side view of the bifurcation of blood vessels 24 and 26 showing the placement of the bifurcated balloon 50, in accordance with an embodiment of the present invention. A catheter 56 is used to place the balloon 50 having an inner tube 58 that passes through the opening 64 at the end of the protrusion 50. In the embodiment shown in FIG. 9, the main body 54 of the balloon 50 is attached to the closed end at the end of the catheter. Or even if the front-end | tip of the main body 54 is open so that it may fit a guide wire like the above-mentioned embodiment. In order to insert the balloon 50 at the bifurcation, a guide wire 62 is first inserted through the blood vessel 24 and into the blood vessel 26 as shown in the figure. The catheter 56 (as shown in FIG. 8) with the balloon 50 in its deflated state is then advanced over the guide wire 62 into the bifurcation region, while the inner tube 58 passes through the side vessel 26 while The end 60 is still in the main blood vessel 24. Inflation of the balloon 50 then reverses the protrusion 52 from its initial position inside the main body 54 shown in FIG. 8 to the outside, in the expanded shape shown in FIG.

  Alternatively, for example, a balloon with a non-inverted protrusion as shown in FIGS. 5 and 6 may be inserted and inflated over the guide wire in the manner shown in FIG.

  10 and 11 are schematic perspective views showing a mechanism 70 that can be used to assist in contracting the radial protrusion 52 after use, in accordance with an embodiment of the present invention. FIG. 10 shows the protrusion 52 and mechanism 70 in the retracted position, while FIG. 11 shows the protrusion mechanism in the expanded position. The mechanism 70 is shown here coupled to the balloon 50, and a similar mechanism may be used with other types of radial protrusions described herein.

  The mechanism 70 has an indirect arm 72, and the arm 72 is attached at its distal end to the tip of the projecting portion 52, and its proximal end is held by a spring. Initially, as shown in FIG. 10, during insertion of the balloon 50 into the bifurcation region, the spring 74 is extended and the arm 72 is thus contracted, causing the protrusion 52 to be inverted within the main body 54. (Ie, in the configuration shown in FIG. 8). Expansion of the balloon 50 causes the protrusion 52 to extend outside the main body 54. Expansion of the protrusion 52 compresses the spring 74 by pulling the arm 72 outward along with the protrusion at its distal end as shown in FIG. (The spring 74 is designed so that the tension it exerts is sufficiently small to be overwhelmed by the inflation pressure of the protrusion 52.) When the balloon 50 is finally compressed at the end of the procedure, the spring 74 is Pulling the arm 72 back in its proximal direction, thus pulling the protrusion 52 back to its initial position inside the main body 54, as shown in FIG. In this position, the operating physician can retrieve the balloon 50 from the patient's body without obstruction by the protrusion 52.

  FIG. 12 is a schematic perspective view of a stent 80 for implanting into a side vessel at a bifurcation, according to an embodiment of the present invention. Stent 80 is designed to engage the foramen as described below. As in other embodiments, the stent 80 has a suitable biocompatible material that can elute the therapeutic agent after implantation. Stent 80 has a distal region 82 of conventional construction and a proximal end from which struts 84 are made. The struts 84 can be deformed outward to fit the shape of the fore edge, as shown below in FIG. In general, the strut can be bent approximately 90 ° outward. However, while carrying the stent through the vasculature, the entire stent, including the struts 84, is maintained in a contracted shape with a substantially constant diameter over the entire length of the stent.

  FIG. 13 is a schematic perspective view of a balloon 90 for use in endovascular treatment of a bifurcation region according to an embodiment of the present invention. The balloon is designed to engage the fork of the bifurcation. The balloon 90 can be used with, for example, an implant stent 80 as described below. Alternatively, the balloon 90 may be used by itself for the treatment of vascular bifurcations without a stent. The balloon is shown in its fully inflated shape in the figure. During delivery of the balloon through the vasculature, the balloon is generally deflated.

  The balloon 90 has two parts with different inflation characteristics. The inner portion 92 is made of a semi-elastic material, and the collar 94 surrounding the proximal end of the inner portion 92 is made of a completely elastic material. In this embodiment, the inner portion 92 and the collar 94 can be fabricated as separate balloons using a collar having the general form of a conic rotation surface mounted around the inner portion. The inner portion and the collar may share a common inflation port, or they may alternatively have separate inflation ports that allow the two portions to be inflated at different pressures. Although the inner portion 92 and the collar 94 are shown in FIG. 13 to share a common axis in another embodiment, the axis of the collar 94 may be tilted with respect to the axis of the inner portion 92. This slanted configuration is useful, for example, for treatment with a Y-shaped branch.

  14 and 15 are schematic side views of the region of the vessel bifurcation showing the stage of implanting the stent 80 into the side vessel 26 using a balloon 90, in accordance with an embodiment of the present invention. Reference is made. This implant procedure can be used with virtually any bifurcation and is particularly useful for treatment at the ostium of the bifurcation from the aorta, such as the bifurcation of the annular aorta from the ascending aorta. As shown in FIG. 14, the deflated stent 80 is rolled over and attached over the deflated balloon 90, and the proximal end of the stent is connected to the inner portion 92 of the balloon and the distal end of the collar 94. It extends over. The stent is carried by a catheter 96 of a guide catheter 97 that covers a threaded guide wire 98 from the main vessel 24 to the side vessel 26. In this embodiment, the balloon 90 has a central lumen with a distal opening to fit the guide wire. The central lumen also allows blood flow through the lumen to the side vessel 26 even when the balloon is fully inflated.

  Once the stent 80 is placed in the side vessel 26, the highly elastic collar 94 of the balloon 90 expands the collar to a diameter that is larger than the diameter of the side vessel 26. The surgeon operating at this stage can push the catheter 96 forward in the distal direction, and the collar 94 engages the ostium. This engagement ensures that the stent 80 is properly positioned for expansion. Alternatively, the balloon 90 may be designed and operated so that the collar 94 is inflated only after the inner portion 92 and the stent 80 have been placed and inflated in the inner blood vessel 26.

  Finally, as shown in FIG. 15, the balloon 90 is fully inflated, causing the balloon to have the shape shown in FIG. Inner portion 92 pushes distal region 82 of stent 80 outward until blood vessel 26 is expanded. Collar 94, on the other hand, spreads strut 84 relative to the inlet to support the inlet and secure the stent in place. Balloon 90 is then deflated and withdrawn from the body via vessel 24 using catheter 96.

  FIG. 16 is a schematic side view illustrating the deflation of the balloon 100 according to another embodiment of the present invention. The balloon 100 has a semi-elastic end 102 and a complete elastic proximity 104. A sleeve-type end 102 is mounted over the proximate portion 104 and secured in place, for example, by glue or fusion with thermal or ultrasonic energy. With the inflation of the balloon 100, the proximal end of the proximal portion 104 (upper right in FIG. As a result, the balloon 100 is brought into the shape shown in FIG. In other words, the distal portion 102 forms the inner portion of the balloon, while the proximal portion 104 forms a collar. The balloon 100 can therefore be used in place of the balloon 90 in the procedure described above and below. Other balloons designed with different criteria are similarly used for this purpose and are considered to be within the scope of the present invention.

  FIG. 17 is a schematic perspective view of a stent 110 according to another embodiment of the present invention. The stent 110 can be used in place of the stent 80 in the procedure described above. As in other embodiments, the stent 110 has a suitable biocompatible material that can elute the therapeutic agent after implantation.

  Stent 110 has a distal region 112 and a proximal end 114. The proximal end has more struts along its periphery than the distal region. As a result, proximal end 114 can be expanded to a larger diameter than region 112, as illustrated in FIG. 17 (showing a partially expanded configuration of the stent). As in the previous embodiment, the stent 110 has a substantially constant diameter over the entire length of the stent and is maintained in a contracted shape during delivery of the stent through the vasculature and then completely at the bifurcation. Expanded. The stent designs illustrated in FIGS. 12 and 17 are shown by way of example only, and other stent designs that allow greater expansion of the proximal end of the stent at the entrance region will become apparent in the prior art. The proximal portion may be manufactured as a single part of the stent in a single process, or the proximal portion may alternatively be manufactured separately and welded to the distal portion or attached in any other suitable manner. Good.

  18 and 19 are schematic side views of the vessel bifurcation region showing the stage of implanting the stent 120 into the side vessel 26 using the balloon 122, in accordance with an embodiment of the present invention. Balloon 122 is shown above and is similar in design to balloon 90 as described above. In this case, however, as shown in FIG. 18, the stent 120 in its deflated state is rolled up over the deflated balloon 122 and the stent is as in the previous embodiment. Without extending over the collar 126 of the balloon, it extends only over the inner portion 124 of the balloon. The stent 120 is carried to the side vessel 26 by a catheter 96 that covers a guide wire 98 in the guide catheter 97 as shown in FIG.

  Using prior art methods, proper alignment of the stent to the bifurcation entrance region is a difficult task and generally causes the operating physician to visualize the position of the stent. Requires the use of impermeable markers. The balloon 122, however, allows the physician to accurately align the stent 120 to the entry region without the need for such markers. For this purpose, the physician inflates the collar 126 as shown in FIG. The physician then pushes the catheter 96 distally to advance the inner portion 124 (with the stent 120 rounded over it). The inflated collar serves as a mechanical stop, stopping the advancement of the distal end of the stent, just at its desired location in the side vessel 26. The physician then completes the expansion of the portion 124 to expand the stent 120 in place in the side vessel.

  Like balloon 90, balloon 122 has a central lumen with a distal opening to fit guidewire 98. The central lumen can also allow blood flow through the lumen to the side vessel 26 even when the balloon is fully inflated.

Various methods can be used to produce the balloons described above.
a) Injection using a bifurcation mold with an open or closed protruding end (whether the end of the balloon has an opening is generally by matching a guide wire as described above) Molding. Liquid, powder, or other types of balloon ingredients are preheated and injected into the mold. After the material is stabilized inside the mold, it is cooled to an appropriate final shape.
b) Blow molding using a branch mold. Tubular balloon material is placed inside the mold. This tube (either heated or room temperature) is then expanded using air, water or other material to apply internal pressure, forming the tube into the shape of the mold.
c) Blow molding using a branch mold and a vacuum nozzle. This method is the same as in the previous paragraph, except that it adds the intake through a vacuum nozzle to push the tube material into the required protrusion shape, as formed by the blow molded shape. Similar to the method described.
d) of the bifurcation with a movable inner tilt pin (in addition to or instead of adding air intake) to guide the mold tube material to form the required protrusions Blow molding using a mold.
e) Injection molding using an extendable mold at the branch. The part of the mold used to form the radial projection of the balloon can be stretched or deflated, for example, to form a projection of the type shown in FIG.
f) Immerse the branched balloon model using liquid polymer. For example, to form the balloon shown in FIG. 8, one branch of the model (used to form a radial protrusion) can be retracted into the model and the model Becomes cylindrical. The balloon model with the retractable branches expanded is immersed in a container containing a liquid polymer that adheres to the surface. The surface coated model is then removed from the container and allowed to dry. After the polymer is consolidated and stabilized, the retractable branch is retracted into the model to allow removal of the balloon.
g) Blow molding to create the main chamber of the balloon is followed by local treatment at the desired location under appropriate pressure conditions to create the side protrusions. The topical treatment can have, for example, heat, ultrasound irradiation, or chemotherapy.

  Although the figures of this patent application illustrate certain special configurations of vessel bifurcations, stents and balloons, these configurations are shown merely as examples. Other configurations based on the principles of the invention will be apparent to those skilled in the art. For example, in some embodiments shown in the figures, the vessel bifurcation (and hence the balloon) has a “T” shape, while in other embodiments the bifurcation and balloon are “Y”. Shape. Each of these embodiments can be made to be used at both “T” and “Y” type branches as well as other more complex shapes according to the problematic vessel configuration. . Some balloons shown in the figures are configured to be inserted over a guidewire. Balloons (and catheters used to insert them) can alternatively be configured for work without guide wires, or where appropriate, more than one guide wire for insertion Used for. The radial protrusions or proximate portions of the balloon can also be machined as a chamber separate from the main portion, as described above, and thus different pressures through different passages from the main portion of the balloon. Can be inflated.

  It will be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to the invention particularly shown and described above. On the contrary, the scope of the present invention includes both the combinations and subcombinations of the various features described above, as well as improvements and modifications noticed by those skilled in the art reading the foregoing description and improvements and modifications not disclosed in the prior art.

FIG. 1 is a schematic side view of a stent and balloon used to implant a stent at a bifurcation of a blood vessel at successive stages of the implant process, according to an embodiment of the present invention. FIG. 2 is another schematic side view of a stent and balloon used to implant a stent at a bifurcation of a blood vessel at successive stages of the implant process, according to an embodiment of the present invention. FIG. 3 is another schematic side view of a stent and balloon used to implant a stent at a bifurcation of a blood vessel at successive stages of the implant process according to an embodiment of the present invention. FIG. 4 shows a perspective view of a stent for an implant at a bifurcation according to another embodiment of the present invention. FIG. 5 is a schematic perspective view of an inflated balloon aligned with a bifurcation of a blood vessel at successive stages of the alignment and inflation process, according to another embodiment of the present invention. FIG. 6 is another schematic perspective view of an inflated balloon aligned with a bifurcation of a blood vessel in successive stages of the alignment and inflation process, according to another embodiment of the present invention. FIG. 7 is a schematic perspective view of an inflated balloon aligned with a bifurcation of a blood vessel at successive stages of the alignment and inflation process, according to another embodiment of the present invention. FIG. 8 is a schematic cross-sectional view of a balloon with radial protrusions according to an embodiment of the present invention. FIG. 9 is a schematic perspective view showing insertion of a balloon into a bifurcation of a blood vessel according to an embodiment of the present invention. FIG. 10 illustrates a mechanism for retracting a balloon with a radial protrusion and a radial protrusion in a continuous stage of the process of inserting the balloon into a bifurcation of a blood vessel, according to an embodiment of the present invention. FIG. FIG. 11 shows a mechanism for retracting a balloon with a radial protrusion and a radial protrusion in a continuous stage of the process of inserting the balloon into the bifurcation of the blood vessel, according to an embodiment of the present invention. FIG. 4 is another schematic perspective view shown. FIG. 12 is a schematic perspective view of a stent according to an embodiment of the present invention. FIG. 13 is a schematic perspective view of a balloon in a blood vessel according to an embodiment of the present invention. FIG. 14 is a schematic perspective view showing successive stages in the process of implanting a stent into a side vessel at a bifurcation, in accordance with an embodiment of the present invention. FIG. 15 is another schematic perspective view showing successive stages in the process of implanting a stent into a side vessel at a bifurcation, in accordance with an embodiment of the present invention. FIG. 16 is a schematic exploded view showing a portion of a balloon in a blood vessel according to another embodiment of the present invention. FIG. 17 is a schematic perspective view of a stent according to another embodiment of the present invention. FIG. 18 is a schematic perspective view showing successive stages in the process of implanting a stent into a side vessel at a bifurcation, according to another embodiment of the present invention. FIG. 19 is another schematic perspective view showing successive steps in the process of implanting a stent into a side vessel at a bifurcation, according to another embodiment of the present invention.

Claims (82)

A device for the treatment of a vascular bifurcation where a first blood vessel meets a second blood vessel,
The device has a balloon for placement at the blood vessel bifurcation,
The balloon is
A first portion having a first inflation characteristic and adapted to be disposed in the first blood vessel;
A second portion having a second inflation characteristic different from the first inflation characteristic and adapted to be disposed in the second blood vessel.   The apparatus of claim 1, wherein the second portion is adapted to project radially from the first portion when the balloon is inflated.   The second portion of claim 2, wherein the second portion is adapted to extend into a second blood vessel to facilitate alignment of the balloon with the vessel bifurcation upon partial inflation of the balloon. apparatus.   3. The device of claim 2, wherein the second portion has a fan-shaped curvature that is adapted to open upon inflation of the balloon such that the second portion extends into the second blood vessel. . When the balloon is deflated, at least a portion of the second portion is contained inside the first portion;
The apparatus of claim 2, wherein the second portion is adapted to extend outward from the first portion upon inflation of the balloon.   The apparatus according to claim 2, further comprising a retracting device coupled to the second part to retract the second part radially with respect to the first part when the balloon is deflated.   At least a portion of the second portion has a radiopaque marker that allows visualization of the alignment of the balloon relative to the bifurcation under an angiographic image The apparatus of claim 2, wherein the apparatus is configured.   The apparatus of claim 7, wherein the radiopaque marker comprises a ring surrounding the second portion. A stent mounted over the first portion of the balloon and adapted to be placed in the first blood vessel by inflation of the balloon;
The stent has a radial opening to allow access between the first and second vessels;
The device of claim 2, wherein the second portion of the balloon is adapted to project radially through the radial opening of the stent.   The apparatus of claim 9, wherein the stent is adapted to elute a therapeutic agent.   The apparatus of claim 1, wherein the inflation characteristic has a constant compliance such that the first and second portions of the balloon have different respective constant compliances.   12. The second portion of the balloon is secured over a portion of the first portion of the balloon so as to suppress compliance with a portion of the first portion. apparatus.   The first blood vessel and the second blood vessel have characteristic first and second diameters, the first diameter being larger than the second diameter, The one portion is adapted to have an expanded diameter greater than the second diameter while the second portion is disposed in the second blood vessel upon inflation of the balloon. The apparatus according to 1.   14. The apparatus of claim 13, wherein the first portion of the balloon is configured as a collar around the second portion of the balloon when the balloon is inflated.   15. The apparatus of claim 14, wherein the first portion of the balloon has a conic curve rotation surface that surrounds a portion of the second portion of the balloon.   14. The apparatus of claim 13, wherein the first portion of the balloon is adapted to engage a fore edge when the balloon is inflated. Having a stent attached over the second portion of the balloon and adapted to be placed in the second blood vessel by inflation of the balloon;
The stent has a proximal end adapted to expand to a size larger than the second diameter;
The apparatus of claim 16, wherein the first portion of the balloon is adapted to expand the proximal end of the stent to secure the proximal end to the ostium.   The apparatus of claim 17, wherein the proximal end of the stent has a plurality of struts configured to expand to a size larger than the second diameter.   The apparatus of claim 17, wherein the stent is adapted to elute a therapeutic agent.   A stent mounted over the second portion of the balloon and adapted to be placed in the second blood vessel by inflation of the second portion of the balloon; 17. The portion of claim 16, wherein a portion is adapted to serve as a stop for the ostium to assist in aligning the stent with the second blood vessel when expanded. apparatus.   21. The device of claim 20, wherein the stent is adapted to elute a therapeutic agent.   22. At least one of the first and second portions of the balloon has a lumen therethrough to conform to a guide wire used for placement of the balloon. A device according to claim 1.   23. The device of claim 22, wherein only one of the first and second portions of the balloon has the lumen therethrough.   22. A device according to any one of the preceding claims, wherein the first and second portions of the balloon share a common inflation port.   22. A device according to any one of the preceding claims, wherein the first part and the second part of the balloon have separate respective inflation ports. A method for the treatment of a vascular bifurcation where a first blood vessel and a second blood vessel meet, the method comprising:
Providing a first part having a first expansion characteristic and a second part having a second expansion characteristic different from the first expansion characteristic;
Disposing the balloon at the vessel bifurcation such that the first portion is disposed in the first blood vessel and the second portion is disposed in the second blood vessel;
Inflating the first portion of the balloon in the first blood vessel and the second portion in the second blood vessel, respectively.   27. The method of claim 26, wherein the second portion is adapted to project radially from the first portion when the balloon is inflated. Placing the balloon
Partially inflating such that the second portion projects radially away from the first portion;
28. The method of claim 27, comprising: using the second portion to align the partially inflated balloon before fully inflating the balloon.   The second portion has a fan-shaped curvature and expands the first portion and the second portion having a fan-shaped curvature that extends so that the second portion extends in the second blood vessel. 28. The method of claim 27.   While the balloon is deflated, at least a portion of the second portion is contained inside the first portion, and inflation of the first portion and the second portion is caused by the second portion. 28. The method of claim 27, wherein the method extends outwardly from the first portion.   28. The method of claim 27, wherein upon deflation of the balloon, the second portion retracts radially toward the first portion. A radiopaque marker is positioned on at least a portion of the second portion;
28. The method of claim 27, wherein positioning the balloon comprises using the marker under an angiographic image to visualize the alignment of the balloon relative to the bifurcation.   33. The method of claim 32, wherein the radiopaque marker has a ring that surrounds the second portion.   Attaching a stent over the first portion of the balloon, the stent having a radial opening to allow access between the first blood vessel and the second blood vessel. And inflating the first portion and the second portion of the balloon comprises placing the stent in the first blood vessel by inflation of the balloon, and the second portion of the balloon 28. The method of claim 27, wherein a portion is projected radially into the second blood vessel through the radial opening of the stent.   35. The method of claim 34, wherein the stent is adapted to elute a therapeutic agent.   27. The method of claim 26, wherein the inflation characteristic has a constant compliance such that the first and second portions of the balloon have different, constant compliances.   37. The second portion of the balloon has a sleeve secured over a portion of the first portion of the balloon so as to inhibit compliance of a portion of the first portion. The method described in 1.   The first blood vessel and the second blood vessel have a unique first diameter and a second diameter, the first diameter being greater than the second diameter, and the first of the balloon 27. The method of claim 26, wherein expanding the portion and the second portion comprises expanding the first portion to an expanded diameter that is greater than the second diameter.   40. The method of claim 38, wherein the first portion of the balloon is configured as a collar around the second portion of the balloon when the first portion of the balloon is inflated.   40. The method of claim 39, wherein the first portion of the balloon has a conic rotation surface that surrounds a portion of the second portion of the balloon.   40. The method of claim 38, wherein positioning the balloon comprises positioning the balloon such that when the balloon is inflated, the first portion of the balloon engages a fore edge.   Having a stent attached over the second portion of the balloon and inflating the first portion and the second portion of the balloon secures the proximal end relative to the ostium To expand the proximal end of the stent to a size larger than the second diameter by expansion of the first portion of the balloon, the expansion of the second portion of the balloon 42. The method of claim 41, comprising placing the stent in a second blood vessel.   43. The method of claim 42, wherein the proximal end of the stent has a plurality of struts, and expanding the proximal end comprises expanding the strut.   43. The method of claim 42, wherein the stent is adapted to elute a therapeutic agent. Attaching a stent covering the second portion of the balloon;
The positioning of the balloon is
Like the first portion of the balloon that serves as a stop for the ostium, after inflating the first portion of the balloon to the expanded diameter, inside the second blood vessel Aligning the stent of the second portion of the balloon;
42. after aligning the second portion of the balloon, expanding the second portion of the balloon to place the stent into the second blood vessel. The method described in 1.   46. The method of claim 45, wherein the stent is adapted to elute a therapeutic agent.   Placing the balloon includes passing a guide wire through at least one lumen of the first portion and the second portion of the balloon, and placing the balloon at the blood vessel bifurcation on the guide wire. 47. The method of any one of claims 24-46, comprising:   48. The method of claim 47, wherein only one of the first and second portions of the balloon has the lumen therethrough.   47. Inflating the first and second portions of the balloon comprises inflating both portions of the balloon via a common inflation port. The method described in 1.   Inflating the first part and the second part of the balloon comprises inflating the first part and the second part of the balloon via separate respective inflation ports. 47. A method according to any one of claims 24-46. An apparatus for treating a blood vessel branch where a first blood vessel intersects a second blood vessel, comprising a balloon for placement at the blood vessel branch, the balloon having a first inflation characteristic A first portion adapted to be disposed in the first blood vessel and a second portion adapted to be disposed in the second blood vessel having a second expansion characteristic different from the first expansion characteristic And a portion of
The apparatus comprises a catheter having a distal end to which the balloon is coupled and adapted to penetrate the first blood vessel to place the balloon at the bifurcation.   A method for manufacturing a balloon in a blood vessel, comprising: processing a first portion of the balloon to have a first inflation characteristic; and a second inflation different from the first inflation characteristic. Processing a second portion of the balloon coupled to the first portion to have properties.   53. The method of claim 52, wherein processing the second portion of the balloon comprises processing the second portion as a branch from the first portion.   53. The method of claim 52, wherein the second portion of the balloon is processed such that when the balloon is inflated, the first portion forms a collar around the second portion.   53. The method of claim 52, wherein the first expansion characteristic and the second expansion characteristic have different constant first compliance and second compliance, respectively.   Processing the second portion of the balloon comprises fixing a sleeve over a portion of the first portion of the balloon to suppress compliance of the portion of the first portion. 56. The method of claim 55, comprising:   53. The method of claim 52, comprising attaching a stent over at least one of the first portion and the second portion of the balloon.   Processing the first portion and the second portion of the balloon is processing at least one of the first portion and the second portion by injection molding using a branched mold. 53. The method of claim 52, comprising:   Processing the first portion and the second portion of the balloon is processing at least one of the first portion and the second portion by injection molding using a branched mold. 53. The method of claim 52, comprising:   60. The method of claim 59, wherein the branched mold comprises a telescopic mold.   The processing of at least one of the first portion and the second portion comprises using at least one of a suction and a tilt pin to direct material to the branched mold. 59. The method according to 59.   The processing of the first portion and the second portion of the balloon comprises processing the first portion and the second portion by immersing a mold branched into a liquid polymer. 52. The method according to 52.   Processing the first portion and the second portion of the balloon includes processing the first portion of the balloon and then forming the second portion to form the second portion. 54. The method of claim 52, comprising applying a local treatment to a region of the portion. A vascular stent is disposed in a blood vessel of a predetermined diameter, proximate to the ostium, and is adapted to expand.
A proximate region adapted to be expanded with respect to the foramen to a size larger than the predetermined diameter so as to fix the proximate region with respect to the foramen.   The distal region of the stent has a first number of struts along the circumference of the stent, and the proximal region of the stent has a second number of struts greater than the first number. 65. The stent of claim 64, comprising:   65. The stent of claim 64, wherein the proximate region comprises a plurality of struts configured to bend outward to engage the foramen.   67. A stent according to any one of claims 64-66, wherein at least one of the end region and the proximal region is adapted to elute a therapeutic agent. A device for treatment of a blood vessel branch where a first blood vessel intersects a second blood vessel, the device comprising a balloon for placement in the blood vessel branch;
The balloon includes a first portion adapted to be disposed in the first blood vessel;
A second portion adapted to project radially from the first portion for easily aligning the balloon with the vessel bifurcation when the balloon is inflated. Having a stent mounted over the first portion of the balloon and adapted to be placed in the first blood vessel by inflation of the balloon;
The stent has a radial opening to allow access between the first blood vessel and the second blood vessel, and the second portion of the balloon is in the radial direction in the stent. 69. The device of claim 68, adapted to project radially through the aperture of the device.   70. The stent of claim 69, wherein the stent has a strut covering the radial opening, and the second portion of the balloon is adapted to open the strut outward when the balloon is inflated. The device described.   At least a portion of the second part has a radiopaque marker that allows visualization of the balloon alignment relative to the bifurcation under an angiographic image 71. Apparatus according to any one of claims 68 to 70, configured to:   An apparatus for treating a vascular bifurcation where a first blood vessel intersects a second blood vessel, wherein the first blood vessel and the second blood vessel have a unique first diameter and second diameter. The first diameter is greater than the second diameter, and the device has a balloon for placement at the vessel bifurcation, the balloon being placed in the second blood vessel. And an expanded diameter larger than the second diameter while the second portion is placed in the second blood vessel when the balloon is inflated. And a collar surrounding the inner portion.   73. The apparatus of claim 72, wherein the collar has a conical curve rotation surface that surrounds a portion of the inner portion of the balloon.   74. The apparatus of claim 72 or 73, wherein the collar is adapted to engage a fore edge when the balloon is inflated.   A stent mounted over the inner portion of the balloon and adapted to be placed in the second blood vessel by inflation of the balloon, the stent being larger than the second diameter Having a proximal end adapted to expand in size, wherein the collar is adapted to expand the proximal end of the stent so as to secure the proximal end relative to the ostium, 75. The apparatus of claim 74.   A stent mounted over the inner portion of the balloon and adapted to be placed in the second blood vessel by inflation of the second portion of the balloon; and the collar is expanded 75. The apparatus of claim 74, sometimes adapted to serve as a stop for the ostium to assist in aligning the stent with the second blood vessel. A method for the treatment of a vascular bifurcation where a first blood vessel intersects a second blood vessel,
Providing a balloon having a first portion having a first inflation characteristic and a second portion adapted to project radially from the first portion when the balloon is inflated. When,
Placing the balloon in the vicinity of the vessel bifurcation so that the first portion is located in the first blood vessel;
Partially inflating the balloon in the vicinity of the vessel bifurcation so that the second portion protrudes radially away from the first portion;
Aligning the second portion of the partially inflated balloon with the second blood vessel;
Fully inflating the balloon after aligning the second portion.   A stent is attached over the first portion of the balloon, the stent having a radial opening to allow access between the first blood vessel and the second blood vessel. And fully inflating the balloon by inflating the balloon, causing the second portion of the balloon to project radially into the second blood vessel through a radial opening in the stent. 78. The method of claim 77, comprising placing the stent in the first blood vessel.   The stent has struts covering the radial openings, and fully inflating the balloon opens the radial struts outwardly with respect to the ostium in the second portion of the balloon. 79. The method of claim 78. A method for treating a vessel bifurcation where a first blood vessel intersects a second blood vessel, wherein the first blood vessel and the second blood vessel have a unique first diameter and second diameter. The first diameter is greater than the second diameter, and the method includes:
Providing the balloon having an inner portion and a collar around the inner portion;
Placing the balloon at the vessel bifurcation such that the inner portion is disposed in the first blood vessel and the collar is disposed in the second blood vessel;
Inflating the balloon so that the collar expands to an expanded diameter greater than the second diameter and engages a foramen.   Attaching a stent over the inner portion of the balloon, placing the balloon comprises placing the stent in the second blood vessel, and inflating the balloon comprises 81. The method of claim 80, wherein a collar is allowed to expand the proximal end of the stent to a size larger than the second diameter to secure the proximal end with respect to the eyelet. Attaching a stent over the inner portion of the balloon, and placing the balloon comprises
After inflating the collar to the expanded diameter so that the collar serves as a stop for the ostium, align the stent in the inner portion of the balloon with the second vessel. To do
81. After aligning the inner portion of the balloon, expanding the second portion of the balloon to place the stent in the second blood vessel. .

Images