Controlled and precise stent placement at mouth of coronary artery in percutaneous coronary interventional therapy

Abstract

A stent delivery system (100) comprises a balloon inflatable stent (10) having a guide wire (31) for guiding the stent (10) into a target blood vessel (V1) to treat a stenosis (4) in the target blood vessel (V1), the stent (10) to be delivered at a predetermined stent location (Xs). An anchoring wire (32) is provided through an anchoring port (52) to anchor the stent (10) by entering a lumen branching from the target blood vessel (V1) or a second blood vessel (V2) at a branching location (Xb). The anchor port (42) is freely adjustable along the length ([Delta] X) of the guide wire (31) to adjust the anchor position (Xa) relative to the bracket position (Xs), or vice versa. The anchor positioning device (41) is connected to the anchor port (42) and is configured to control the freely adjustable anchor position (Xa) relative to the stent position (Xs), for example by pushing and pulling on a hypotube.

Description

[0001] Technical Field and Background Art

[0002] The present invention relates to a system for delivering a stent to a stenosis of a target vessel near a branching location in the target vessel that branches from a lumen or a second vessel (neck or bifurcation). The present invention also relates to a kit of components for constructing such a system, and an anchor port assembly for use in a stent delivery system or kit of components.

[0003] Coronary artery stenosis is a ubiquitous disease. Since the introduction of percutaneous coronary intervention (PCI) by Andreas Grüntzig in 1977, the number of PCIs as well as the development of techniques and devices have increased exponentially. Currently, almost all technical aspects of coronary artery disease have been addressed, including the long-awaited successful treatment of chronic total occlusions. PCI of coronary artery lesions located in or near the coronary periosteum is part of mainstream clinical practice, but the procedure is technically challenging.

[0004] Accurate positioning of (the proximal edge of) the coronary stent on the coronary periosteum is extremely important, if pursued at all. Although more difficult than with conventional lesions, operators are limited to the same PCI techniques, including the limitations of 2D angiography and patient-induced motion. This can result in excessive radiation, contrast agent use, and uncontrolled / undesirable coronary stent positioning.

[0005] The problem of stent placement can be solved by the so-called "tail wire" or "Szabo" technique. The tail wire technique uses the most proximal stent strut as an anchor through which a second or "anchor" wire is passed. The anchor wire is positioned in a space where the stent should not protrude, usually the aorta, or in the case of a bifurcation, a branch vessel. The anchor stops the stent from advancing into the coronary artery, positioning its proximal portion precisely at the carina. Although this technique provides more control during stent positioning, which is of great value in stenting at the coronary ostium, it also requires manipulation of the stent, introducing follow-up problems.

[0006] In a previous patent disclosure WO2019 / 156560A1, the inventors alleviated the problems of traditional "tail wire" technology by separating the anchoring possibility from the stent. Specifically, the patent disclosure describes a system for delivering a stent to a predetermined stent position in a target vessel. The stent is wrapped around an expandable balloon having a guide channel. The guide wire for entering the target vessel passes through the guide channel to guide the stent into the target vessel. A portion of the expandable balloon is wrapped by an elastic sleeve. The sleeve also provides an anchoring port separated from the stent strut for guiding the anchoring wire into, for example, a branch vessel. In addition, the sleeve is configured to at least partially prevent or delay the expansion of the expandable balloon at the wrapped portion compared to another portion of the expandable balloon opposite to the stent. The anchoring port can be connected to an anchoring port line, which is configured to remotely control the departure direction of the anchoring port.

[0007] Although the anchoring port in the known system of WO2019 / 156560A1 has the advantage of preventing the stent from being damaged by not being directly connected to the stent strut, the inventor has now recognized the shortcomings of the known system. First of all, it should be recognized that the anchoring port is still fixed to the expandable balloon also inside the stent via an elastic sleeve. Therefore, basically, the elastic sleeve wrapped around the balloon forming the anchoring port and the stent wrapped around the same balloon can only be delivered to the patient as a single unit. In practice, the surgeon will usually first insert the main guide wire and the anchoring wire into the corresponding branch, and then pass the stent with the anchoring port along these two wires. Unfortunately, these wires may accidentally become rotated around each other during delivery. When the stent with the anchor advances as a single unit along the rotating wire (passing through the stent balloon and the anchoring port, respectively), this may become a problem because the fixed position of the anchoring port may not allow the guide wire to be easily untied. Therefore, the entanglement may be further concentrated by being pushed along the wire until they may be stuck. Furthermore, it should be appreciated that while the anchoring ports of known systems allow adjustment of the angle of the anchoring wire exiting the anchoring port, the position of the anchoring port relative to the position of the stent is fixed. This may limit the possibility of controlling the position of the stent relative to the anchoring wire.

[0008] There remain further improvements that can alleviate one or more problems with known stent delivery systems while maintaining at least some of their advantages. Specifically, the inventors have recognized the problem of tangling of wires in known systems and the need to more freely determine the precise location of stent placement relative to branch vessel structures while maintaining the necessary precision and control over stent deployment. Summary of the invention

[0009] Aspects of the present invention relate to a kit of systems or components for delivering a stent. Specifically, the system is configured to deliver a stent to a predetermined stent location in a target vessel that is adjacent to a branching location where the target vessel branches from a lumen or a second vessel. Typically, a stent delivery system typically includes a balloon expandable stent that is advanced over a guide wire to enter the target vessel. A secondary guide wire may be introduced that enters the branch vessel or any other adjacent vascular structure, such as the aorta. The secondary guide wire is used in conjunction with the present invention to provide an anchor or tail wire so that the position of the stent can be moved relative to the branching location. Specifically, the anchoring guide wire can be passed through an anchoring port to fix the position accordingly.

[0010] In contrast to previous solutions, as described herein, the position of the anchoring port is separated from the stent delivery catheter. In addition, the anchoring port can be used not only as an anchoring point for anchoring the guide wire, but also as a lumen through which the stent delivery catheter and the accompanying guide wire are advanced. As a result of the balloon inflator connection hub as part of the standard stent delivery catheter, the guide wire, the anchoring port assembly as described herein, and the stent delivery catheter generally need to be subsequently introduced into the patient in a corresponding order. Advantageously, the anchoring port can be freely adjusted along the length of the guide wire relative to the stent position. Similarly, the stent delivery catheter and the anchoring wire can all be freely moved around each other in an axial manner, preventing the guide wire from being clamped or entangled with the struts of the curled stent. In addition, the stent position can also be adjusted relative to the anchoring position (determined by the anchoring wire relative to the branch position). As will be understood, this construction can provide improved control of the precise stent position while maintaining the accuracy provided by the anchoring relative to the branch position. For example, this can be compared with other solutions, in which the anchoring port is formed by a stent strut (as in the conventional Szabo technique), or is fixed relative to a stent such as disclosed in the above-mentioned previous patent publication of the inventor by being connected to a sleeve, which is immovable by being wrapped around the balloon and is therefore not freely adjustable. In addition, as described herein, an anchoring positioning device preferably including a hypotube or a rigid control wire is directly or indirectly connected to the anchoring port for controlling the freely adjustable position, for example, by pushing and pulling on the hypotube. This is different from the above-mentioned previous patent disclosure of the inventor, in which the anchoring port is optionally connected to the anchoring port line, but is only used to adjust its orientation, and is not suitable for changing the relative position relative to the balloon, at least not by pushing the guide wire to change the relative position relative to the balloon. In addition, since the anchoring port disclosed in the previous patent is basically fixed to the stent via an elastic sleeve and a balloon, it has been found that the guide wire and the anchoring wire may become tangled. This problem is alleviated because the guide wire can now rotate freely around each other in a separate and freely adjustable anchoring port. In summary, the distinguishing features of the anchoring port assembly of the present invention alleviate entanglement of the guide wire when pushing the stent and allow greater freedom to adjust the exact position relative to the balloon / stent, where the main guide wire and the anchoring wire are split into the corresponding blood vessels. Additional synergistic aspects include providing the anchoring port with a radiopaque material that allows the device to be accurately placed. Additional aspects may also include the ability to form the anchoring port as a widened tubular member that can slide over the proximal portion of the balloon and prevent or delay its expansion.

[0011] Other or further aspects relate to an anchoring assembly for supplementing a balloon expandable stent delivery system. The assembly can be used, for example, as a visual and mechanical aid to accurately position and / or anchor a coronary stent at the ostium of a coronary artery, for example, defined by a so-called "carina". Other types of stents may also benefit from the assembly. For example, while the accuracy of precise positioning in coronary vessels is the most challenging, similar techniques can also be applied to other (larger) vessels, such as bifurcations at renal vessels (arteries and veins), leg vessels, cerebral vessels, etc. As described herein, the device is preferably composed of an anchoring positioning device connected to a ring or tubular extension that may contain radiopaque material to define the precise location of the ostium, so that the operator can accurately aim at the desired stent position, particularly by using two separate guide wires in combination, one positioned in the target vessel and the other positioned in an adjacent structure (e.g., a branch vessel). For example, after positioning the two guide wires, the ostium can be marked by carefully pushing the tubular extension until resistance is encountered, thereby mechanically and then visually identifying the carina.

[0012] By providing an opening with a minimum inner diameter for the anchoring port, which is larger than the outer diameter of the crimped stent before balloon expansion, after the anchoring port has been guided to the anchoring position along the guide wire and the anchoring wire, the crimped stent can be allowed to pass through the opening of the anchoring port to reach the stent position. For example, the anchoring port assembly can be used in combination with relatively small stents (e.g., coronary stents). For the typical sizes of these and other stents, the assembly can include an anchoring port formed by an annular or tubular shape, which preferably has a minimum inner diameter between one millimeter and two millimeters. Other diameters can also be used depending on the size of the crimped stent that can be assembled through the anchoring port.

[0013] By forming the anchoring positioning device with a main cord terminating in a set of branch cords, interconnecting the main cords with the anchoring ports at different locations around the perimeter of the opening, the inventors have found that the assembly can be more easily retracted, such as into a guide catheter, thereby alleviating the potential problem of the anchoring port becoming stuck, which is more likely to occur if the tube or ring is connected at only one location on the perimeter. By forming the branch cords of an elastic material or structure that is configured to recover its shape after deformation, it is relatively easy to pass the crimped stent between the branch cords, after which they can recover for easier retraction. Similarly, by forming the anchoring port from the same or different elastic material or any structure that is configured to recover its shape after deformation, it is relatively easy to pass the crimped stent through the anchoring port, while the shape is subsequently recovered to perform the function of anchoring and / or delaying balloon expansion.

[0014] By forming a main rope formed by a hypotube or a rigid control wire, the anchoring position can be controlled and / or maintained more accurately. The individual branch ropes can be relatively flexible compared to the main rope, and in combination, they can provide sufficient rigidity to control and / or maintain the anchoring position. For example, the main rope formed by a hypotube or a (rigid) control wire generally has an outer diameter smaller than the anchoring port, such as less than two millimeters, preferably less than one millimeter, such as between 0.2-0.5 millimeters. In order to provide sufficient extension inside the body, the main rope generally has a length of at least half a meter, preferably at least one meter. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] These and other features, aspects and advantages of the apparatus, systems and methods of the present invention will become better understood from the following description, appended claims and accompanying drawings, in which:

[0016] Figure 1A and 1B Delivery and deployment of a stent to treat a stenosis in a target vessel near a bifurcation with a second vessel is shown; and

[0017] Figures 2A-2D The use of a stent delivery system is shown, including a preferred sequence of steps for delivery;

[0018] Figure 3A Details of an anchor assembly for use in a stent delivery system are shown; and

[0019] Figure 3B-3D Different anchoring assemblies are shown;

[0020] Figures 4A-4D Other aspects of the anchor assembly are shown. DETAILED DESCRIPTION

[0021] The terms used to describe specific embodiments are not intended to be limitations of the present invention. As used herein, the singular forms "one", "an" and "the" are also intended to include plural forms, unless otherwise clearly stated in the text. The term "and / or" includes any and all combinations of one or more associated listed items. It will be understood that the terms "include" and / or "include" illustrate the presence of the stated features, but do not exclude the presence or addition of one or more other features. It will be further understood that when a specific step of a method is referred to as a follow-up to another step, it can directly follow the other step, or one or more intermediate steps can be performed before performing the specific step, unless otherwise stated. Similarly, it will be understood that when describing a connection between multiple structures or multiple components, this connection can be established directly or through an intermediate structure or component, unless otherwise stated.

[0022] The present invention will be described more fully below with reference to the accompanying drawings, in which embodiments of the invention are shown. In the accompanying drawings, the absolute and relative sizes of systems, components, layers and regions may be exaggerated for clarity. Reference may be made to schematic and / or sectional views of possible ideal embodiments and intermediate structures of the present invention. In the description and drawings, the same reference numerals always represent the same elements. Relative terms and their derivatives should be understood as referring to the orientation described at the time or the orientation shown in the figure in question. Unless otherwise stated, these relative terms are only for convenience of description and do not require that the system be constructed or operated in a specific direction.

[0023] Figure 1A and 1B The delivery and deployment (expansion) of a balloon expandable stent 10 is shown to treat a stenosis 4 in a target vessel V1 near a bifurcation with a second vessel V2. Figures 2A to 2D The use of the stent delivery system 100 is shown, including a preferred sequence of steps for delivery. Other uses and / or sequences of steps are also contemplated.

[0024] In some embodiments, the system includes an expandable balloon 20. In one embodiment, the stent 10 includes an extendable frame 11 wrapped around the expandable balloon 20. In another or additional embodiment, the system includes a guide wire 31 for entering the target vessel V1. For example, the guide wire 31 can pass through a guide channel 21 inside the stent or balloon to guide the expandable balloon 20 with the stent 10 (when crimped) together with the guide wire 31 or together with the guide wire 31 into the target vessel V1.

[0025] In some embodiments, the system includes an anchor wire 32 for determining an anchor position Xa relative to a branch position Xb at which the target vessel V1 branches from the lumen or the second vessel V2. In one embodiment, the system includes an anchor port 42 in use, the anchor port 42 having an anchor wire 32 passing through the anchor port 42 and determining the anchor position Xa relative to the stent position Xs. Typically, the guide wire 31 and the anchor wire 32 can first be positioned in the corresponding vessels V1, V2, for example, Figure 2A and 2B After this, the anchor port 42 is guided from the outside into the patient over the two wires and then advanced to the carina, such as Figure 2CAs shown. Therefore, it should be understood that the anchoring port 42 is preferably not attached, i.e., not fixed to either the expandable balloon 20 or the balloon expandable stent 10. Therefore, the anchoring position Xa of the anchoring port 42 can be freely adjusted along the length ΔX of the guide wire 31 relative to the stent position Xs of the stent 10. In a preferred embodiment, an anchoring positioning device 41 is provided, which has a distal end connected to the anchoring port 42. The proximal end of the anchoring positioning device 41 is configured to control the freely adjustable anchoring position Xa relative to the stent position Xs by pushing and pulling the proximal end. Most preferably, the anchoring positioning device 41 includes a hypotube, which is directly or indirectly connected to the anchoring port 42, for controlling the freely adjustable anchoring position Xa relative to the stent position Xs, for example, by pushing and pulling the hypotube 41.

[0026] For example, US2017 / 0274179 A1 describes a hypotube construction. As explained in this prior art, a hypotube is typically a long metal tube with microengineering features along its length. A hypotube can be used as a component of a minimally invasive catheter, opening a blocked artery together with a balloon and a stent. Typically, the balloon portion of the catheter can be attached to the head of the hypotube. The hypotube can have a reinforcement that can give its pad more support and integrity when the catheter navigates the vascular system to the treatment location. In some cases, a polymer sheath is distributed over the outer diameter of the hypotube to provide a seal and also minimize any surface roughness imparted by the laser cutting of the hypotube while still providing flexibility. Other types of hypotubes can also be used.

[0027] As described herein, by connecting the anchor port 42 to a hypotube, the freely adjustable anchor position Xa relative to the stent position Xs can be more accurately controlled, for example, by pushing and pulling on the hypotube. In addition, the controllable position can be more accurately maintained, especially when the balloon is inflated. Alternatively or in addition to the hypotube, other or further relatively rigid and / or incompressible structures can also be used, such as a rigid wire, such as a metal wire, which is not necessarily a tube, for example, does not have to be hollow.

[0028] In some embodiments, the anchoring port 42 is formed by an annular and / or tubular member connected to the hypotube 41. In one embodiment, the guide wire 31 passes through the anchoring port 42. For example, the proximal portion of the guide wire 31 can be located inside the second hypotube connected to the balloon expandable stent. In another or additional embodiment, each of the guide wire 31 and the anchoring wire 32 passes through the same opening of the anchoring port 42, such as through the ring or tube forming the anchoring port. For example, this provides a simple construction with a single opening to guide two wires (and stent). Alternatively, there may be a separate opening for the respective wires.

[0029] In some embodiments, the anchoring port 42 is configured to fit at least a portion of the expandable balloon 20 inside. For example, a portion of the expandable balloon 20 (before deployment) can fit within the anchoring port 42, for example, up to the extendable frame 11, or further. By fitting a portion of the balloon 20 inside the anchoring port 42 when the balloon is expanded, the anchoring port 42 can at least partially prevent and / or delay expansion of the portion of the balloon. Depending on the nature of the narrowing or stenosis, this may be advantageous in further controlling the expansion period, such as preventing the stent frame from shifting during expansion, which is a common phenomenon during percutaneous interventions and is disadvantageous in the treatment of open lesions.

[0030] In some embodiments, the crimped stent 10 (ie, the undeployed stent framework 11 surrounding the deflated balloon) fits completely within the anchoring port 42 and / or can be guided through the anchoring port 42, e.g. Figure 2C and 2D This may be advantageous, for example, if the stent 10 is delivered along the guide wire 31 after the location of the anchoring port 42 is established. For example, Figure 1B The deployed stent is shown with the proximal side 20p of the inflated balloon partially expanded within the tubular extension forming the anchoring port 42. By preventing or delaying expansion, for example, the stent framework may be prevented from moving away from a desired position during expansion.

[0031] Figure 3A Details of an anchor assembly 40 for use, for example, in a stent delivery system 100 as described herein are shown. For example, the anchor assembly 40 can be a stand-alone device used to supplement an existing stent delivery system.

[0032] In some embodiments, the anchor port 42 (eg, a tubular member or other tube or ring as shown) has a (minimum) inner diameter D 最小 Or Dp, which is greater than the cumulative outer diameter of the guide wire 31 and the anchor wire 32, for example, greater than at least 1.1 times, 1.5 times, 2 times or more times. For example, the minimum inner diameter Dp is greater than twice the outer diameter of each of the guide wire 31 and the anchor wire 32. This allows each of the guide wire 31 and the anchor wire 32 to slide freely through the anchor port 42 and / or allows the anchor port 42 to be freely adjusted along the wire. Typically, the diameter of the anchor port 42 is at least greater than the hypotube 41 used to control its position. In one embodiment, the outer diameter of the anchor port 42 is greater than the outer diameter of the hypotube 41, for example, greater than at least 2 times, 4 times, 6 times, 8 times, 10 times or more times.

[0033] In some embodiments, the anchoring port 42 is formed by a tubular member shaped to slide over the proximal region of the expandable balloon 20 for at least partially preventing and / or delaying expansion at the proximal region. In one embodiment, the anchoring port 42 has an inner diameter Dd greater than the outer diameter Db (before expansion) of the expandable balloon 20 at least at the distal side facing the proximal side of the expandable balloon 20. As described above, this allows at least a portion of the expandable balloon 20 to fit inside the anchoring port 42.

[0034] In some embodiments, the anchor port 42 has a minimum inner diameter D 最小 , which is larger than the outer diameter Ds of the (crimped) stent 10 before the balloon 20 is expanded. This allows the crimped stent 10 to be installed inside and passed through the anchoring port 42. In other or additional embodiments, the anchoring port 42 has a minimum inner diameter D 最小 , the minimum inner diameter is (slightly) larger than the cumulative outer diameter of the anchoring wire 32 and the (crimped) stent 10 before inflation of the balloon 20, for example by a factor between 1.01 and 1.5, preferably between 1.05 (5% larger) and 1.3 (30% larger). This allows the crimped stent 10 to be fitted inside and passed through the anchoring port 42 also when the anchoring wire 32 has already passed through the anchoring port 42, for example Figure 2C and 2D shown.

[0035] In a typical balloon expandable stent for coronary applications, the outer diameter Ds of the (crimped) stent prior to deployment is typically between one tenth of a millimeter and four millimeters, more typically between 0.3 millimeters and 2 mm. The minimum inner diameter D of the anchoring port 42 is 最小 Preferably slightly larger than the outer diameter Ds of the curled stent, for example, at least one tenth of a millimeter (0.1 mm) larger. For example, the thickness of the guide wire 31 and / or the anchor wire 32 is typically less than one millimeter, more typically less than half a millimeter, for example 0.3 mm. Therefore, in one embodiment, depending on the stent, the minimum inner diameter Dmin of the anchor port 42 is typically less than half a centimeter, preferably between 0.4 and 2.5 mm, more preferably between 1 and 2 mm, most preferably between 1.2 and 1.5 mm, or larger. When unfolded, the diameter can, for example, increase by 1.5 to 2.5 times or more, for example between 2 mm and 5 mm or more. The typical length of the stent (frame) can vary, for example, between 8 mm and 40 mm, more typically between 10 mm and 30 mm, or between 12 mm and 20 mm.

[0036] In some embodiments, the system 100 comprises a (coronary) guide catheter 1 having an inner diameter Dc configured to fit inside the maximum outer diameter of the anchoring port 42 for guiding the anchoring port 42 through the guide catheter 1. For example, the maximum outer diameter of the anchoring port 42 is slightly larger than its maximum inner diameter Dd (depending on the thickness of the tube wall or annulus). In other or additional embodiments, the hypotube 41 is configured to push the anchoring port 42 through the guide catheter 1 and along the guide wire 31 and / or the anchoring wire 32 beyond the distal end of the guide catheter 1.

[0037] In some embodiments, the anchoring port 42 is formed as a tubular member having a length Lt greater than its (minimum and / or maximum) inner diameter Dp, Dd. In a typical balloon expandable stent, the expandable balloon or at least the portion with the expanded diameter extends beyond the edge of the stent frame, for example at least one hundredth of a millimeter, more typically at least one tenth of a millimeter, for example between 0.1 mm and 5 mm, or greater. In one embodiment, the length Lt of the anchoring port 42 is the same or similar to the length of the (expandable) portion of the balloon extending beyond the stent frame, for example within 1.2 times, or 1.5 times, up to 2 times or more. Therefore, in one embodiment, the length Lt of the anchoring port 42 is between 1 and 20 mm, more typically between 4 and 15 mm, or between 6 and 10 mm, or any other suitable length depending on the stent. Preferably, there is no continuous closed lumen between the guide catheter and the anchoring port to prevent high pressure accumulation of fluid (e.g., contrast agent) at the distal end of the anchoring port. Alternatively, for example, as Figure 3D As shown, the tubular component can also be embodied as a relatively short tube, for example a ring.

[0038] In some embodiments, for example, Figure 3A and Figure 3B As shown, the anchor port 42 is formed by an extended tubular member having a proximal end and a distal end, where the proximal end is where the anchor port 42 is connected to the anchor positioning device 41 and the distal end is opposite to the proximal end, wherein the extended tubular member has an (inner) proximal diameter Dp at the proximal end (e.g., determining the minimum diameter D 最小 ), wherein the diameter increases at the distal end toward the (inner) distal diameter Dd. For example, the increased diameter can allow a relatively large opening angle between the guide wire 31 and the anchor wire 32 exiting the distal end of the tubular member, while still substantially preventing or delaying the expansion of a portion of the balloon 20. For example, the tubular member has a truncated conical hollow shape. Other diverging shapes can also be used. In other or additional embodiments, for example, Figure 3CAs shown, the anchoring port 42 is formed by an extended tubular member having an (inner) diameter Dd that increases toward both the distal and proximal ends. For example, the tubular member has a relatively low waist diameter Dw at the distal and / or proximal ends relative to the diameters Dd, Dp, such as at least 10%, 20%, up to 50% or more lower. In other or additional embodiments (not shown), the tubular member can be a straight tube, for example, with a relatively large diameter to allow a large opening angle.

[0039] In some embodiments, for example, compared with the material of balloon 20, anchoring port 42 comprises a rigid material. For example, the balloon is made of rubber or nylon. For example, the material of anchoring port 42 has a Young's modulus greater than 0.1GPa, usually greater than 1GPa. In one embodiment, anchoring port 42 comprises a tubular member having a (relatively rigid) middle section and at least one end section with higher flexibility than the middle section. For example, by providing one or two end sections with greater flexibility, this can promote a greater angle between the guide wire 31 and the anchoring wire 32 guided therethrough, while keeping preventing or delaying the expansion of the balloon. In other or additional embodiments, anchoring port 42 comprises and / or is shaped as a groove and / or has any other discontinuity in its circular form. For example, this can prevent the potential harmful pressure accumulation of fluids such as contrast agents at the distal end of anchoring port 42.

[0040] In some embodiments, the anchor port 42 includes a radiopaque material 42r. Those skilled in the art will appreciate that the radiopaque material has a relatively high absorbance to X-rays, at least to the extent that it is generally visible and distinguishable (e.g., from a biological tissue background) in a radiological image of the body. In contrast, a radiolucent or radiopaque material is substantially transparent to X-rays, such that it is generally invisible or barely visible in a radiological image, e.g., having X-ray properties similar to a tissue background. Therefore, by providing the anchor port 42 with a radiopaque material 42r, an operator of the system can easily discern the location of the anchor port 42 inside the body using radiological / X-ray imaging. Typically, at least a portion of the stent, such as the outer edge, is also provided with a radiopaque material. This allows the location of the stent to be determined in a radiographic image. For example, the radiopaque material 42r of the anchor port 42 can be the same or similar to the radiopaque material provided on the stent. Providing both the anchor port 42 and the stent 10 with corresponding radiopaque materials allows the location of the anchor port 42 relative to the stent to be determined in a radiographic image, which can help further control its deployment.

[0041] In some embodiments, the anchor port 42 has a tubular shape and includes a radiopaque material 42r, which is (at least or only) arranged at the distal edge of the tubular shape (opposite to the anchor positioning device 41), for example forming a radiopaque ring at the distal edge. In this way, the exact location of the distal end can be distinguished more accurately, which is most relevant because it forms the exit for different guide wires and determines the location where balloon inflation can be prevented. For example, the rest of the tubular shape, such as the proximal area, is formed of a radiolucent or radiolucent material, for example at least more transparent to X-rays than the radiopaque material 42r.

[0042] As described herein, the anchoring positioning device 41 is preferably configured to allow various forms of control over the positioning of the anchoring port 42, for example, allowing the anchoring port 42 to be pushed toward the stent / balloon. Preferably, the anchoring positioning device includes a hypotube 41 attached directly or indirectly to the proximal edge of the anchoring port 42. The hypotube is typically manufactured to have a diameter between 0.2-5 mm. In some embodiments, the system includes a plurality of hypotubes. In one embodiment, the anchoring port 42 is connected to a first hypotube 41, and the balloon-expandable stent 42 is connected to a separate second hypotube. In principle, the second hypotube can be the same or similar to the first hypotube. Typically, the second hypotube connected to the stent can be different, for example having a larger diameter to accommodate an internal balloon expansion channel. The guide wire 31 can also be accommodated inside the second hypotube leading to the balloon-expandable stent.

[0043] For the purposes of the present invention, the anchoring positioning device 41, such as a hypotube (or other rigid control guide wire), which is directly or indirectly connected to the anchoring port 42, preferably has a relatively low (inner and / or outer) diameter, such as less than 2 mm, less than 1 mm, less than 0.5 mm or even less than 0.3 mm. Typically, the hypotube 41 is hollow, but the tube can also be filled if it is only used to manipulate the anchoring port 42. The hypotube has the specific advantage of control at a minimum thickness, although in principle it can also replace tubular and / or filamentary structures, such as nitinol, which allow similar operations, such as pushing and pulling on the anchoring port 42. In one embodiment, the hollow hypotube 41 is additionally used as a guide, for example for guiding the anchoring wire 32 inside. For example, the proximal end of the hollow hypotube 41 can terminate in the anchoring port 42 or be closed before the anchoring port 42 (proximal end), so that the anchoring wire 32 can exit through the anchoring port 42.

[0044] In some embodiments, the hypotube 41 is formed of a long tube, such as a metal or other material, typically having microengineering features along its length. For example, the microengineering features may include one or more of a continuous or discontinuous spiral cutting pattern, a radial cutting pattern, a cutting hole, etc. In order to facilitate deployment and / or prevent damage, the hypotube 41 may be coated, for example, with Teflon. Typically, the hypotube 41 has a length similar to that of the wires 31, 32 and / or the passage leading to the inflatable balloon. For example, the length Lh of the hypotube 41 is at least half a meter, more typically at least one meter, for example between 1.2 meters and 2.5 meters, or greater. Each of the hypotube 41 and the anchoring port 42 is typically made of medical grade material.

[0045] Figures 4A to 4D 4 shows other aspects of the anchor assembly 40. In some embodiments, the anchor positioning device 41 includes a main rope 41m terminating in a set of branch ropes that interconnect the main rope 41m with the anchor port 42. In one embodiment, for example, Figure 4A and 4C As shown, the anchoring positioning device 41 includes two branch ropes 41a, 41b. In another or additional embodiment, for example, Figure 4B and 4D As shown, the anchoring and positioning device 41 includes three branch ropes 41a, 41b.

[0046] In some embodiments, the anchoring port 42 includes a proximal edge 42p that forms a portion of the opening through which the anchoring wire 32 can pass. In one embodiment, the branch ropes 41a, 41b, 41c are connected to different positions around the periphery of the opening, such as the proximal edge 42p. This can allow one or more (preferably each) of the guide wire 31, the anchoring wire 32, and the curling stent to pass between the branch ropes 41a, 41b, 41c and through the opening of the anchoring port 42. In principle, more than three branch ropes, such as four, can also be used, but this may begin to hinder the ability of other parts of the system passing therebetween. Therefore, preferably, the number of branch ropes is limited to two or three. Most preferably, two, three or more branch ropes 41a, 41b, 41c are equidistantly distributed around the periphery of the proximal edge 42p. On the one hand, this configuration can allow easier passage through other parts of the system and form a structure that can be more easily retracted, for example, retracted into a guide catheter or otherwise.

[0047] In some embodiments, the anchoring positioning device 41 includes a hypotube or a (rigid) control wire, which is configured to control a freely adjustable anchoring position, for example relative to the stent position, by pushing and pulling the hypotube. In other or further embodiments, the main rope 41m is formed by a hypotube or a rigid control wire. In one embodiment, the branch ropes 41a, 41b, 41c are formed by an elastic material or structure configured to restore its shape after deformation. In another or further embodiment, the anchoring port 42 is formed by an elastic material or structure configured to restore its shape after deformation. Preferably, one or more of the branch ropes and / or anchoring ports include nitinol or are substantially formed by nitinol. Nitinol (nickel-titanium) is a shape memory alloy that exhibits various properties that make it particularly suitable for the present application, including its shape memory effect, superelasticity, high corrosion resistance, biocompatibility, high fatigue resistance, low friction coefficient, high strength-to-weight ratio, etc. Of course, other suitable elastic materials can also be used. Alternatively or in addition to using an elastic material, the anchor port 42 may include a spring structure (not shown) that forms part of the ring.

[0048] In some embodiments, for example, Figure 4A and Figure 4B As shown, the anchor port 42 is formed by an annular member. Figure 4C and Figure 4D As shown, the anchor port 42 is formed by a tubular member. Of course, the anchor port 42 (connected to the main rope 41m via a set of branch ropes 41a, 41b, 41c) can also be used as previously referenced. Figures 3A to 3D Any shape described in any one of the above, thereby providing similar advantages. In a preferred embodiment, for example, Figure 4C and 4D As shown, the anchor port 42 includes a radiopaque material 42r. For example, the tubular shape includes a radiopaque material ring 42r at the distal end of the tube. Similarly, for a tubular shape in which the anchor port 42 is composed of an annular shape (e.g., Figure 4A , 4B ) or a relatively short tube (e.g., as shown in Figure 3D In an embodiment formed as shown), the entire ring or short tube may include or be substantially formed of non-radiopaque material 42r.

[0049] In interpreting the appended claims, it should be understood that the word "comprising" does not exclude the presence of other elements or actions than those listed in a given claim; the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements; any figure marks in the claims do not limit the scope; several "means" may be represented by the same or different (one or more) things or structures implemented or functions implemented; unless otherwise specifically stated, any disclosed means or parts thereof may be combined together or separated into further parts. When one claim refers to another claim, this may mean that synergistic advantages are achieved by combining their corresponding features. However, the fact that certain measures are recited in mutually different claims does not mean that a combination of these measures cannot be used to produce good results.

Claims

1. A stent delivery system (100), comprising: A balloon expandable stent (10), the stent (10) comprising a stent frame (11) wrapped around an expandable balloon (20) and having a guide wire (31) for guiding the stent (10) into a target vessel (V1) to treat a stenosis (4) in the target vessel (V1), wherein the stent (10) is to be delivered at a predetermined stent position (Xs); An anchoring wire (32) for anchoring the stent (10) by entering the lumen of a second blood vessel (V2) branched from the target blood vessel (V1) at a branching position (Xb); an anchoring port (42) configured to be guided along the guide wire (31) and the anchoring wire (32), both of which pass through the anchoring port (42), and to determine an anchoring position (Xa) relative to the stent position (Xs), wherein The anchoring position (Xa) of the anchoring port (42) is freely adjustable along the length (ΔX) of the guide wire (31) for adjusting the anchoring position (Xa) relative to the stent position (Xs), or vice versa; as well as An anchoring positioning device (41) has a distal end connected to the anchoring port (42) and has a proximal end, and the proximal end is configured to control the freely adjustable anchoring position (Xa) relative to the support position (Xs) by pushing and pulling the proximal end.

2. The system according to claim 1, characterized in that The anchor port (42) has a minimum inner diameter (D 最小 ), the minimum inner diameter being larger than the outer diameter of the curled stent (10) before the balloon (20) is inflated, thereby allowing the curled stent to pass through the opening of the anchoring port (42) to the stent position (Xs) after the anchoring port has been guided to the anchoring position (Xa) along the guide wire (31) and the anchoring wire (32).

3. The system according to claim 2, characterized in that The anchoring positioning device (41) includes a main rope (41m), which terminates in a set of branch ropes (41a, 41b, 41c), and the branch ropes interconnect the main rope (41m) with the anchoring port (42), wherein the anchoring port (42) includes a proximal edge (42p) forming a portion of an opening through which the guide wire (31), the anchoring wire (32) and the curled stent can pass, wherein the branch ropes (41a, 41b, 41c) are connected to different positions around the circumference of the proximal edge (42p), thereby allowing each of the guide wire (31), the anchoring wire (32) and the curled stent to pass between the branch ropes (41a, 41b, 41c) and through the opening of the anchoring port (42).

4. A system according to any one of the preceding claims, characterised in that The anchoring positioning device (41) comprises a hypotube and a rigid control wire, wherein the rigid control wire is configured to control the freely adjustable anchoring position (Xa) relative to the support position (Xs) by pushing and pulling on the hypotube or the rigid control wire.

5. The system according to claims 3 and 4, characterized in that The main rope (41m) is formed by the hypotube or the rigid control wire.

6. The system according to claim 3 or its dependent claims, characterized in that The branch ropes (41a, 41b, 41c) are formed of an elastic material or structure configured to restore its shape after deformation.

7. System according to any one of the preceding claims, characterized in that The anchor port (42) is formed of a resilient material or structure configured to recover its shape after being deformed.

8. System according to any one of the preceding claims, characterized in that The anchoring port (42) is formed by a ring or a tubular shaped member.

9. The system according to claims 7 and 8, characterized in that The anchor port (42) includes a spring structure forming part of the ring.

10. System according to any one of the preceding claims, characterized in that The anchoring port (42) is not fixed to either the expandable balloon (20) or the balloon expandable stent (10).

11. System according to any one of the preceding claims, characterized in that The anchoring port (42) comprises a material that is more rigid than the material forming the balloon (20).

12. System according to any one of the preceding claims, characterized in that The anchoring port (42) has a tubular shape and includes a radiopaque material (42r) disposed exclusively at a distal edge of the tubular shape to form a radiopaque ring at the distal edge.

13. A kit of parts for assembling a stent delivery system (100) according to any one of the preceding claims.

14. An anchoring port assembly (40) for use in a stent delivery system (100) or a kit of parts according to any one of the preceding claims, the assembly (40) comprising a stent having a minimum inner diameter (D 最小 ) an anchoring port (42) formed in a ring or tubular shape; and The anchoring positioning device (41) comprises a main rope (41m) having an outer diameter of less than two millimeters, preferably less than one millimeter, and having a length of at least one meter, wherein: The distal end of the main rope (41m) terminates in a set of branch ropes (41a, 41b, 41c), which interconnect the main rope (41m) with the anchor port (42), wherein the branch ropes (41a, 41b, 41c) are connected to different positions around the circumference of the anchor port (42).

15. The anchor port assembly (40) according to claim 14, characterized in that: The anchor port (42) is formed of a resilient material or structure configured to recover its shape after deformation; The set of branch ropes consists of two or three branch ropes, the two or three branch ropes being formed of an elastic material or structure configured to recover its shape after deformation; as well as The main rope (41m) is formed of a hypotube or a rigid control wire having a stiffness and / or thickness greater than that of one of the branch ropes (41a, 41b, 41c).

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