Method and apparatus for stent delivery

Abstract

To provide a method, apparatus, and kit for assisting in the expansion of a self-expanding stent, especially within highly curved or tortuous blood vessels.SOLUTION: An elongated pusher 112 having an expandable distal mesh portion can be positioned within a self-expanding stent, expanding during delivery to provide extra expansion force to the stent to ensure the stent properly expands.SELECTED DRAWING: Figure 3

Description

【Technical Field】 【0001】 [Related Applications] This application claims priority to U.S. Provisional Patent Application No. 62 / 404,102, filed on October 4, 2016, entitled "Methods for Stent Delivery and Stent Use", the entire contents of which are incorporated herein by reference. 【Background Art】 【0002】 Stents are generally tubular devices that are delivered to a patient's vasculature by a catheter or similar delivery device. Stents can be used to treat a variety of conditions, including stenosis and aneurysms. When used to treat stenosis (the narrowing of a blood vessel), the stent is used to push thrombi through the vessel and allow normal blood flow. When used to treat an aneurysm, a low porosity stent can be used to restrict blood flow to the vessel (so-called shunt stents) to promote aneurysm thrombosis and reduce the risk of aneurysm rupture. Alternatively, the stent can be used as a scaffold to hold other embolization materials (such as embolization coils) within the aneurysm. 【0003】 Stent delivery is usually easy when the stent is positioned in a substantially straight portion of the blood vessel. For example, the distal end of the delivery catheter can be advanced to near the desired delivery location, the outer sheath can be withdrawn, and the stent can be expanded within the blood vessel. Even in these straight blood vessels, stent delivery can still be difficult due to variable factors such as the size of the stent, the size of the delivery catheter, and the size of the blood vessel. Self-expanding stents can be difficult to properly position when they need to be positioned in or near a bent or greatly curved portion of the blood vessel. For example, Figure 1 shows a self-expanding stent 12 (e.g., as described in Patent Document 1, which is entirely incorporated herein by reference) positioned in a greatly curved portion of blood vessel 10. Even when the catheter 14 releases the stent 12, the stent forms a flat or folded portion 12A against the outer curved surface of blood vessel 10. Figure 2 shows a second flat or folded portion 12A formed against the outer surface of a second curve of blood vessel 10 when the stent 12 is further expanded. When folded portion 12A occurs, the only alternative for the physician is to try rotating the catheter 14 and / or partially retracting and repositioning the stent 12. [Prior art documents] [Patent Documents] 【0004】 [Patent Document 1] U.S. Patent No. 9,439,791 [Overview of the Initiative] 【0005】 The present invention relates to methods, apparatus, and kits for assisting the expansion of self-expanding stents, particularly in highly curved or bent blood vessels. 【0006】 One embodiment relates to a stent delivery device including an elongated pusher having a self-expanding mesh portion at its distal end. The mesh portion preferably includes one or more mesh valve portions connected to each other by a diameter-reducing region. Optionally, various regions of the mesh portion, such as intermediate regions of the valve portions, may have denser braided portions with a higher pic per inch. 【0007】 In one embodiment, the mesh portion is positioned on a core wire extending from the distal end of the pusher. The mesh portion is longitudinally slidable on the core wire, and its proximal end can be fixed to the core wire or the pusher, or its distal end can be fixed to the core wire. 【0008】 The mesh portion may contain one valve portion, or it may contain multiple valve portions (for example, 2 to 10, or more). Furthermore, the valve portions may have a variety of shapes, such as spherical, ellipsoidal, elongated cylindrical, conical, or diamond-shaped. 【0009】 In one embodiment, the core wire can be terminated at the distal end of the pusher or midway within the first valve portion. The support device is more flexible and can tolerate a greater degree of vascular curvature because it does not extend to the end of the mesh portion. 【0010】 In one embodiment, structural wire members extend between valve portions and above the reduced diameter region. These structural wire members are used to capture any lumps or other fragments removed during the stent delivery procedure. 【0011】 In one embodiment, the distal protection device is included in the distal end of the device. The distal protection device may include a relatively large expandable mesh valve section containing a filter or similar structure to capture any material removed during stent placement. The distal protection device may be braided integrally with the mesh section, or it may be another structure connected near the distal end of the core wire. 【0012】 The present invention also covers a method for positioning a stent, which includes the steps of: exposing the distal portion of the stent within a curved region of a vascular structure; expanding the mesh portion of a stent support device within the stent to apply a radial expansion force to the inside of the stent; positioning the stent appropriately; and withdrawing the stent support device. 【0013】 Furthermore, the present invention also covers a kit including a catheter, a pusher inside the catheter, a self-expanding mesh portion attached to the distal end of the pusher, and a stent placed on the mesh portion. 【0014】 These acceptable embodiments, features, and advantages of the present invention, as well as other embodiments, features, and advantages, will become clearer and more apparent from the following description of embodiments of the present invention with reference to the accompanying drawings. [Brief explanation of the drawing] 【0015】 [Figure 1] Figure 1 shows a stent placed in a curved section of a blood vessel. [Figure 2] Figure 2 shows the stent from Figure 1, which is further positioned at a bend in the blood vessel. [Figure 3] Figure 3 shows one embodiment of an extended stent support device according to the present invention. [Figure 4] Figure 4 shows the distal end of the stent support device shown in Figure 3 within a stent, according to the present invention. [Figure 5] Figure 5 shows the stent support device shown in Figure 3 within a stent according to the present invention. [Figure 6] Figure 6 shows the stent support device from Figure 3, which assists in the placement of stents within curved vascular structures. [Figure 7] Figure 7 shows the stent support device from Figure 3, which assists in the further placement of the stent from Figure 6. [Figure 8] Figure 8 shows another embodiment of the stent support device according to the present invention. [Figure 9] FIG. 9 shows another embodiment of a stent support device having a plurality of mesh valve portions according to the present invention. [Figure 10] FIG. 10 shows a plurality of various possible shapes for the mesh valve portion of the present invention. [Figure 11] FIG. 11 shows another embodiment of a stent support device having a core wire that terminates within the proximal position of the mesh portion according to the present invention. [Figure 12] FIG. 12 shows the stent support device of FIG. 11 within a stent according to the present invention. [Figure 13] FIG. 13 shows the proximal valve portion of the stent support device of FIG. 11 according to the present invention. [Figure 14] FIG. 14 shows the distal tip portion of the stent support device of FIG. 11 according to the present invention. [Figure 15] FIG. 15 shows a stent support device having a wire frame member between valve portions according to the present invention. [Figure 16] FIG. 16 shows a stent support device having a distal protection device attached to the mesh portion according to the present invention. [Figure 17] FIG. 17 shows a stent support device having a distal protection device separated from the mesh portion according to the present invention. 【Mode for Carrying Out the Invention】 【0016】 Here, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, the present invention can be represented in various configurations and should not be construed as being limited to the embodiments shown in this specification. Rather, these embodiments are provided so that this disclosure is accurate and complete and so as to fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the drawings, like numbers indicate like components. 【0017】 The present invention generally relates to a device that can expand within the internal passage of a self-expanding stent 12 during placement in order to provide an additional expansion force to assist in the radial expansion of the self-expanding stent 12 and to maintain that radially expanded state. This additional expansion force may be particularly useful in highly curved blood vessels 10, as shown and described with reference to Figures 1 and 2, where a folded portion 12A is more likely to form in the stent 12. 【0018】 In Figure 3 and subsequent figures, unless otherwise specified, all elements on the right side of the diagram are considered distal (direction towards the patient and the patient's vascular structure), and all elements on the left side of the diagram are considered proximal (away from the patient and the patient's vascular structure, or outward from them). 【0019】 Figure 3 shows an expandable stent support device 100 according to one embodiment of the present invention. The stent support device 100 can be conceived as the distal portion of a broad delivery system or pusher used to mechanically push or deliver a stent 12. The stent support device 100 includes an elongated cylindrical pusher body 112 terminated with a radiopaque (e.g., tantalum) marker band 109, and a stationary or fixed core wire 104 exposed distal to the pusher body 112. 【0020】 In one embodiment, the core wire extends through the lumen of the pusher body 112, with only the distal portion of the core wire 104 exposed. In another embodiment, the core wire 104 is attached to the distal end of the pusher body 112. The core wire 104 includes a fixed radiopaque marker band 107. In one embodiment, the stent 12 may include a number of proximal flared ends or loops having an expanding marker coil region, one or more of which are positioned within marker bands 109 and 107 at position 104A to hold the stent in place during delivery. The expanding marker coil region maintains the stent's flared loops, which are held in place between marker bands 107 and 109. The marker bands 107 and 109 may have a diameter of approximately 0.0135 inches, and the core wire 104 has a diameter of approximately 0.003 inches. When the stent is placed within the delivery catheter 14, it takes on a first folded configuration, which is clearly shown in Figures 4 and 5. When the pusher body 112 is pushed beyond the distal end of the catheter 14, or when the catheter 14 retracts, the stent expands to its heat-set expanded shape. Similar stents and delivery systems and configurations in which the retained stent loop flare expands and is not held in position 104A when the stent is sufficiently pushed away from the catheter 14 can be found in the aforementioned cited Patent Document 1. 【0021】 The stent support device 100 further includes a mesh portion 102 positioned along the core wire 104. The purpose of this mesh portion is to apply an additional radially outward force to the stent 12 to assist in the expansion of the stent 12 during the procedure and to maintain its expanded shape. The mesh portion 102 is formed from multiple wires and is heat-set to an expanded shape so that the mesh portion self-expands when released from the overlapping delivery catheter 14. 【0022】 Preferably, the mesh portion 102 is braided and heat-set to form one or more valve portions 102A (for example, two valve portions as shown in Figure 3, or more valve portions), and each valve portion is connected by a reduced diameter portion 102B. The mesh portion includes a number of crimp points (proximal crimp point 108, distal crimp point 106). The crimp points 106, 108 can be made by crimping the wire themselves, welding, bonding, or using metal bands (e.g., radiopaque marker bands). In various embodiments, the crimp points 106-108 can float and slide on the core wire 104 or be fixed to the core wire 104 in the manner described below. 【0023】 The mesh section 102 can be woven into a variety of configurations. For example, 12, 16, 24, 36, or 48 wires can be woven together into a 1x1, 1x2, or other wire configuration. 【0024】 The porosity or opening size of the mesh portion 102 in the extended configuration may vary with the length of the mesh portion 102. In the embodiment shown in Figure 3, the radially central portion 102C of the valve portion 102A has a lower porosity (i.e., a larger number of wires or a higher pic per inch). This creates a stronger and more reinforced region of the mesh portion 102 that can apply a larger radially outward force and make it less likely for the stent 12's wires to become entangled when the stent 12 comes into contact with the mesh portion 102. 【0025】 In other embodiments, the mesh portion 102 may have other parts reinforced in this manner, such as the end of the valve portion 102A or the reduced diameter region 102B. In one embodiment, the wires of the mesh portion 102 contain nitinol and have a diameter in the range of about 0.001 inches to 0.0015 inches. Radiopaque (e.g., tantalum) wires may also be included in the mesh to increase visibility and provide areas of increased robustness in the braided portion, thereby further improving the contact force with the overlapping stent 12. Dawn-filled tubing having a nitinol jacket and a tantalum core, or vice versa, can also be used. 【0026】 The mesh portion 102 can be manufactured in various ways. For example, a mandrel having a valve region with a shape similar to the valve portion 102A and a reduced-diameter region with a shape similar to region 102B may be used to manufacture the mesh portion shape. After weaving the wire on the mandrel, it can be heat-set to give it shape, or a pre-woven mesh tube can be placed on the mandrel and heat-set. 【0027】 Alternatively, the mesh portion can be woven onto a mandrel having a uniform diameter. Then, the mesh portion 102 is removed from the mandrel, and strings or marker bands are selectively added to predetermined positions to create the reduced diameter region 102B. Finally, heat treatment is performed to give it the shape shown in Figure 3, for example. 【0028】 In one embodiment, the core wire 104 maintains a fixed position relative to the other components of the pusher body 112. The crimp point 108 is fixed to the core wire 104, while the crimp point 106 slides or floats longitudinally on the core wire 104. The braided mesh structure tends to decrease in length when expanded radially, and the longitudinally slidable crimp point 106 allows the distal end of the mesh portion 102 to move proximal as the mesh portion 102 is exposed from the catheter 14 and begins to expand radially. 【0029】 If the stent 12 is extremely large compared to the blood vessel, a large radial force against the vessel wall may be present, immobilizing the stent 12. This may also immobilize the mesh portion 102, as it is also excessively large relative to the blood vessel and therefore immobile within the vessel or relative to the stent wire. To avoid a situation where the mesh portion 102 becomes immobile in the expanded shape, the core wire may include a fixing marker band 110 between the two crimp points 106 and 108, which acts as a backstop to ensure that the crimp point 106 cannot be shortened extremely proximal. 【0030】 Other embodiments are also possible, including configurations in which either one of the crimp points 106 or 108 is fixed or slidable, or in which both crimp points 106 and 108 are fixed or both are slidable. To achieve a slidable crimp point, the inner diameter of the crimp point must be at least slightly larger than the core wire diameter. In one embodiment, the core wire may have a diameter of about 0.003 inches, while any sliding crimp point may have an inner diameter of about 0.005 to 0.006 inches. To create a fixed crimp point, in one embodiment, the crimp point can be mechanically attached to the core wire 104 using a crimping tool, adhesive, or welding. 【0031】 The core wire 104 may contain nitinol. As best shown in Figure 4, the distal end of the core wire 104 includes a relatively flexible distal tip 114, which may consist of a tantalum or platinum wire coiled around the underlying nitinol wire, for example. The coiled tantalum or platinum wire aids visualization, allowing the user to know where the distal end of the wire 104 is positioned, while the coil increases flexibility, preventing the portion 114 from becoming immobile against the vessel wall when it comes into contact with it. The flexible distal tip 114 may have a pre-adjusted J-shape as shown in Figure 4, or it may be fused so that the user can give this J-shape on a given mandrel. An angled J-shape is particularly useful when guiding the system through vascular bifurcations. This distal tip may eliminate the need for another guidewire to track the catheter and stent to the target treatment area. 【0032】 Figures 4 and 5 generally show how the stent 12 takes its expanded configuration upon delivery and how the mesh portion can support and assist in opening the stent. In Figure 4, the stent 12 is released from the catheter 14, and the distal portion of the stent 12 is in its expanded shape. In Figure 5, the mesh portion 102A expands relative to the proximal portion of the stent 12, providing scaffolding force to the proximal portion of the stent 12 and assisting in opening the stent. In Figure 5, the mesh portion uses only one valve portion 102A, or the stent 12 is only partially positioned so that a limited amount of the stent 12 corresponding to only the distal portion of the mesh portion 102 is exposed. 【0033】 During the procedure, as can be seen in Figures 6 and 7, the distal end of the catheter 14 is advanced to or near the area where the physician intends to place the stent 12. Then, the catheter 14 is retracted from the stent 12, or the stent 12 is pushed outward from the internal passage of the catheter. Once the stent 12 is positioned around a curved portion of the patient's blood vessel 10, the mesh portion 102 and especially the bead portion 102A expand radially and push outward from inside the stent 12, supporting and opening the stent as shown in Figure 7. 【0034】 Since catheters often include a radiopaque marker band positioned 3 centimeters from their distal tip, the user can determine the position of the proximal end of the stent by aligning the marker band positioned along either of the delivery pushers. In this regard, the physician can determine when the stent is fully or nearly fully positioned based on the longitudinal position of the pusher. In Figure 3 and above, a marker band 109 connected to the pusher body 112 and a marker band 107 along the core wire 104 are shown. Any of these markers can be aligned with the 3-centimeter marker on the catheter to determine when the stent is fully or nearly fully positioned. Once the stent 12 is fully positioned, the pusher body 112 is retracted proximal to return the mesh portion 102 into the passage of the catheter 14. 【0035】 In some embodiments, the core wire 104 is freely movable relative to the body of the pusher body 112. This movable core wire 104 allows the physician to manually control the expansion and / or contraction of the mesh portion 102 in accordance with the configuration of the crimp points 106 and 108. 【0036】 As an example, Figure 8 shows such an embodiment of a stent support device 120 in which a core wire 104 is movable independently of the pusher body 112 in order to selectively increase the diameter of the mesh valve portion 102A to increase the radial pressing force against the overlapping stent 112. In this embodiment, the pusher body 112 includes a lumen that extends along its length and opens at its proximal and distal ends. The core wire 104 can be pushed and pulled independently of the pusher body 112 through this lumen, and the proximal end of the core wire 104 is operable independently of the pusher body 112 by the user / physician. 【0037】 The proximal crimp point 108 is fixed to either the pusher body 112 or the core wire 104. When the proximal crimp point 108 is fixed to the core wire 104 (rather than to the pusher body 112), it is positioned relatively close to the pusher body 112 so that when the core wire is retracted, the crimp point immediately contacts the pusher body 112, preventing further proximal movement of the mesh portion 102. The distal crimp point 106 is longitudinally movable on the core wire 104. The core wire 104 includes another fixed distal marker band 122, which is distal to the mesh crimp point 106 and fixed to the core wire. When the user / physician retracts the core wire 104, the distal marker band 122 contacts the crimp point 106, and because the crimp point 106 is slidable, it moves proximal inward, increasing the radial profile of the mesh portion 102A. This is due to the longitudinal contraction of the mesh portion 102A caused by the pressing force applied by the distal marker 122. In this way, the user can selectively increase the radial expansion force applied to the stent by making the diameter of the mesh valve portion 102A independently controllable. The marker band 110 provides a backstop surface that limits how much the distal crimp point 106 can float, as shown in the embodiment of Figure 3. 【0038】 Other embodiments are similar to device 120 in Figure 8. However, in this embodiment, the lumen of the pusher body 112 is larger than the crimp points 106, 108 so that all or part of the mesh portion 102A can be retracted into the pusher body 112 by pulling the core wire 104 proximal. The proximal crimp point 108 is slidable on the core wire 104, while the distal crimp point 106 is fixed to the core wire 104. By retracting the core wire 104, the proximal crimp point 108 enters the delivery pusher body 112. By retracting the core wire 104 further, the mesh portion 102 can also enter the pusher body 112 (whether this is possible depends on how much the inner diameter of the pusher body 112 is excessively large compared to the mesh portion 102). However, by allowing the proximal portion of the mesh portion 102 to be housed within the pusher body 112, the user can customize how much of the mesh portion 102 contacts the overlapping stent. 【0039】 In one embodiment, the core wire takes a first retracted configuration in which all or part of the mesh portion 102 is housed within the pusher body 112. When the user delivers the stent 12 and there is a tracking problem where the stent 12 becomes immobile at a bend where part of the stent does not open, the user can push the core wire distally, exposing the mesh portion 102 and causing the mesh valve portion 102A to contact and push against the stent 12, allowing it to open. This is mainly achieved by the fact that the proximal crimp point 108 can slide in this embodiment, which allows the mesh portion 102 to expand longitudinally and contract radially. 【0040】 Alternatively, this function is also possible when the proximal crimp point 108 is fixed to the core wire 104, but the distal crimp point 106 is slidable relative to the core wire 104. In this configuration, when the core wire 104 is retracted into the pusher body 112, the proximal crimp point 108 enters the pusher body 112, and as further mesh portions 102 retract into the pusher body 112, the mesh portions 102 expand longitudinally, pushing the slidable distal crimp point 106 distally, which allows for continuous radial contraction and longitudinal expansion of the mesh portion 102. On the other hand, if both crimp points 106 and 108 are fixed, the mesh portion 102 has a relatively constant shape, and it becomes difficult to obtain a shape that is radially compressed and longitudinally expanded to fit into the pusher body 112. 【0041】 Figure 9 shows a stent support device 130 having six valve sections 102A instead of the two valve sections 102A generally shown in the embodiments of the stent support device in the previous drawings. It is conceivable that many valve sections 102A may be included as part of the mesh section (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 or more valve sections). The number, length, and diameter of these valve sections 102A can be selected to correspond to the length and expansion diameter of a particular stent 12 used together. 【0042】 In addition to various numbers of valve portions 102A, the valve portions 102A can have diverse shapes (for example, all valve portions may have the same shape, or various shapes may exist). Figure 10 shows example valve shapes, including a spherical shape 132, a spheroid 133, an elongated cylindrical shape 134, a conical shape that increases proximally 135, a conical shape that decreases proximally 136, or a diamond-like shape 137 having tapered conical portions that decrease proximally and distally. These shapes can be given to the mesh portion 102 by braiding the mesh portion 102 on a mandrel having the desired shape (for example, a mandrel having the same shape as the mesh shape in Figure 10), and then heat-setting it to give it the shape when expanded. Alternatively, these shapes can be produced by braiding the mesh 102 on a mandrel having a uniform and consistent shape (e.g., cylindrical), heat-setting the shape on the mandrel, removing the mesh portion 102, and then tying the shaped portion or selectively placing marker bands around the shaped portion to obtain the shape shown in Figure 10. 【0043】 In the previous embodiment, a core wire 104 was described that extends over the entire mesh portion 102, with the mesh portion 102 directly positioned on the core wire 104. In other embodiments, a core wire 104 can be used that terminates proximal to the distal end of the mesh portion 102. This earlier termination point provides the mesh portion with some degree of independence, allowing it to conform to the curvature of the vascular structure and further assist in fully expanding the stent. 【0044】 As an example, Figures 11, 12, 13, and 14 show other embodiments of the stent support device 140 in which the core wire 104 terminates within or near the mesh portion 102. In Figure 11, the core wire tip portion 142 of the core wire 104 is located within the first nearest valve portion 102A. In one embodiment, the core wire tip portion 142 may be a nitinol wire or a platinum or tantalum wire coiled around the distal end of the core wire 104. In another embodiment, the core wire 104 terminates within the body of the pusher body 112, exposing only the core wire tip portion 142 (e.g., a coiled platinum or tantalum wire around a nitinol wire) within the first nearest valve portion 102A. This tip portion 142 can be seen in the enlarged view of Figure 13. The proximal end of the mesh portion 102 is fixed either directly to the main body of the pusher body 112, or immediately adjacent to the main body of the pusher body 112 via the proximal crimp point 108. 【0045】 Optionally, the distal end of the mesh portion 102 may include a distal tip 114 connected to the distal end of the mesh portion 102, similar to the embodiments described above, to provide a guide surface and a soft vascular contact surface beneath the stent 12 to assist in the placement of the stent 12 without causing vascular trauma. As best shown in Figure 14, the distal tip 114 includes an underlying nitinol wire having a proximal laser-welded ball 114A within the most distal mesh valve portion 102A. A coil 114B of tantalum or platinum wire is wound around the nitinol wire and the most distal portion of the mesh portion 102. Additionally, a coil 114C of platinum or tantalum wire is wound around the nitinol wire and intertwined with a portion of the tantalum-platinum coil 114B, extending along the remaining distal length of the nitinol wire. Optionally, adhesive or welding may be used on the distal end of the tip 114. Furthermore, the portion of the underlying nitinol wire may be flattened or shaped. 【0046】 Once a stent is placed in a patient, thrombi may be removed and move downstream, potentially leading to further complications in the vascular structure. The following description pertains to embodiments used for collecting or capturing thrombi removed during stent placement procedures. 【0047】 Figure 15 shows an embodiment of a stent support device 150 in which a wire frame member 152 uses a mesh portion 102 extending between expansion valve portions 102A. These wire frame members 152 allow for further structural support to the valve portions 102A and can be used to collect and capture any blood clots that may form during the procedure. These wire frame members 152 are preferably composed of wires of the same diameter as or larger than those constituting the mesh portion 102 and are attached to the wires of the mesh portion 102, the underlying core wire 104, or a combination thereof, so that the wire frame member 152 expands and contracts together with the mesh portion 102. 【0048】 In one embodiment (as shown in Figure 15), four equidistant wireframe members 152 are used, each forming an outward arc shape with a diameter similar to that of the valve portion 102A when expanded. However, the wireframe members 152 may also have a helical shape around the mesh portion 102, a linear shape between the valves 102A, or a similar geometric shape. 【0049】 Figures 16-17 show embodiments of a stent support device having a distal mesh element for capturing removed thrombi. In Figure 16, the stent support device 160 uses a mesh portion 102 having a relatively large mesh valve portion 162 including a concave filter 164 that functions as a distal protective portion during the procedure, capturing blood clots, thrombi, or other fragments that may be removed during the placement of the stent 12. The concave filter 164 can be made of a fine mesh, fabric, polymer film, or similar known filter material. Furthermore, other filter shapes 164, such as a circular plane, are also possible. A larger mesh valve portion 162 can be woven from the wires of the mesh portion 102 to form an interconnected mesh structure. During the procedure, the mesh valve portion 162 can advance distally beyond the stent 12 (or be positioned in front of the stent 12) so as to expand ahead of the stent 12 and contact the blood vessel. 【0050】 Alternatively, as seen in device 166 in Figure 17, the mesh valve portion 162 can be fixed separately from the mesh portion 102 near the distal end of the core wire 104. This position allows the physician to more easily position the valve portion 162 and filter 164 before or at the start of stent placement 12. The separated mesh valve portion 162 can be configured to slide longitudinally along the core wire 104, or to be locked in place for sliding. 【0051】 Embodiments disclosed herein utilize a common delivery pusher body 112 for delivering the stent 12 and the mesh portion 102. In other embodiments, the stent 12 can be connected to a first elongated delivery pusher having a passage. A second pusher body 112 of the stent support device is positioned within the first pusher, allowing the user to move the stent and the stent support device separately and independently. 【0052】 It should be understood that the present invention also covers a kit comprising a guide tube, a pusher body 112 positioned within the guide tube, any of the stent support embodiments described herein attached to the pusher body 112, and a stent positioned near the distal end of the guide tube and on the mesh portion 102 of the pusher body 112. During use, the physician can connect the guide tube to the proximal hub of the catheter 14 and advance the pusher (including the mesh portion 102) and stent 12 into the catheter 14. 【0053】 Although the present invention describes other components such as the pusher body 112, core wire 104, and mesh portion 102, it is important to understand that one or more of these components may also be considered as a pusher, stent support system, or stent support device. 【0054】 While the present invention describes specific embodiments and uses, those skilled in the art can implement further embodiments and modifications from this teaching without deviating from the intent or scope of the invention. Accordingly, it should be understood that the drawings and description herein are provided as examples to facilitate understanding of the invention and should not be construed as limiting its scope.

Claims

[Claim 1] core wire and A stent delivery device comprising a plurality of mesh valve sections arranged on the core wire, wherein each of the plurality of mesh valve sections has a compression configuration and a radial expansion configuration. A stent delivery device in which, in the radial expansion configuration, at least one of the plurality of mesh valve portions expands inward into the stent so as to support and open the stent around the curved portion of the patient's blood vessel. [Claim 2] The stent delivery device according to claim 1, wherein the plurality of mesh valve portions include a first mesh valve portion and a second mesh valve portion, and the second mesh valve portion has a larger diameter than the first mesh valve portion. [Claim 3] The stent delivery device according to claim 2, wherein the second mesh valve portion is disposed distal to the first mesh valve portion. [Claim 4] The stent delivery device according to claim 3, wherein the second mesh valve portion includes a filter. [Claim 5] The stent delivery device according to claim 3, wherein the second mesh valve portion is spaced distally from the first mesh valve portion. [Claim 6] The stent delivery device according to claim 1, wherein the core wire extends distally from the pusher body. [Claim 7] The stent delivery device according to claim 1, wherein at least two of the plurality of mesh valve sections are interconnected by a mesh portion. [Claim 8] The stent delivery device according to claim 1, wherein at least two of the plurality of mesh valve portions are spaced apart by the core wire. [Claim 9] The stent delivery device according to claim 1, wherein the distal portion of the core wire extends distally from the furthest mesh valve portion of the plurality of mesh valve portions. [Claim 10] The stent delivery device according to claim 1, further comprising one or more wire frame members installed between the first mesh valve portion and the second mesh valve portion of the plurality of mesh valve portions. [Claim 11] The stent delivery device according to claim 1, wherein each of the plurality of mesh valve portions includes a proximal crimp point and a distal crimp point, and the distal crimp point of each of the plurality of mesh valve portions is movable longitudinally on the core wire. [Claim 12] The stent delivery device according to claim 11, wherein, in the valve adjustment configuration, the diameter of at least one of the plurality of mesh valve portions is reduced by advancing the core wire distally, and the diameter of at least one of the plurality of mesh valve portions is increased by retracting the core wire proximal. [Claim 13] The stent delivery device according to claim 11, further comprising a marker band fixed to the core wire distal to at least one of the distal crimp points of the plurality of mesh valve portions. [Claim 14] The stent delivery device according to claim 13, wherein in a valve expansion configuration, the core wire is retracted and the marker band contacts at least one of the distal crimp points of the plurality of mesh valve portions, causing the distal crimp point to move proximal, thereby expanding the diameter of at least one of the plurality of mesh valve portions. [Claim 15] The stent delivery device according to claim 14, wherein in a valve compression configuration, the core wire is advanced and the marker band moves distally away from the distal crimp point along the core wire, thereby reducing the diameter of at least one of the plurality of mesh valve portions.

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