Delivery System for a Stent Having a Protruding Feature

Abstract

[0003] A delivery system for expandable elements, such as stents or scaffolds, having spikes, flails, or other protruding features for delivering agents within a patient's body and / or penetrating target tissue, and related methods for using such systems. The delivery systems can be configured to deliver and position an expandable structure within a body lumen (e.g., a vessel). These delivery systems can also be configured to unfold and expand the expandable structure within the body lumen. The delivery systems can further be configured to engage the expanded structure and collapse the structure for removal from the body lumen. The delivery systems can be configured to deliver another expandable structure or the same expandable structure to another body lumen or the same body lumen, either in a single procedure or over multiple procedures.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 482,600, entitled "Delivery System for a Stent Having a Protruding Drug Delivery Feature, and Related Devices and Methods," filed on April 6, 2017, the entire disclosure of which is incorporated herein by reference.

[0002] Broadly speaking, this description relates to a delivery system (delivery system) for expandable elements such as stents or scaffolds having spikes, flares, or other protruding features for delivering drugs and / or penetrating into target tissues within a patient's body.

Background Art

[0003] Various devices can be used to deliver a drug to a desired treatment location within the body of a human patient. For example, a drug-eluting stent (DES) can be placed at the location of stenosis (arterial stenosis) resulting from arteriosclerosis. A DES generally includes a drug-containing polymer that coats a metal stent or scaffold, or a bioabsorbable stent or scaffold made of a drug-containing polymer. After being delivered to a treatment location within a body cavity (e.g., a blood vessel), the DES is expanded against the wall of the body cavity (e.g., the blood vessel wall), and the drug is released through direct contact with the wall. The direct delivery of the drug to the blood vessel wall enables a dose that is significantly less than the required dose by other delivery means (e.g., pills or injections). However, depending on the underlying design of the stent or scaffold, more than 85% of the area of the blood vessel wall where the stent is implanted may not be in contact with the struts of the stent. Thus, a significant diseased portion of the blood vessel wall may not receive the desired dose, or the drug may not be delivered uniformly across the entire treatment site. Additionally, some portions of the DES may be in contact with other fluids or substances within the blood vessel lumen that are not the intended delivery sites for the blood, arterial plaque, and / or the drug. These problems can result in the drug tissue concentration being lower than the desired value or being more non-uniform than the desired value.

[0004] Drug-eluting balloons (DEBs) and non-drug-eluting balloons provide an alternative to DESs and can address some of the limitations discussed above. For example, DEBs can also be delivered to a desired treatment location and inflated against the vessel wall to release a drug. However, a DEB can have a drug coating over the entire surface area of the balloon that inflates to contact the vessel wall uniformly. Thus, a DEB can deliver a more uniform dose to adjacent vascular tissue. Further, when used in combination with angioplasty, a drug can be delivered at any location and time of vascular injury that occurs during the procedure. Still, DEBs also have some limitations. For example, during drug delivery (i.e., when the balloon is inflated), blood flow in the associated vessel stops or is severely occluded, and other treatment devices cannot pass through the vessel. Further, neither DEBs nor existing DESs can deliver drugs at all locations along the adjacent vessel wall. Specifically, non-uniform vessel walls, occlusions, outer diameters, or other geometries can prevent the balloon surface or stent struts from reaching portions of the vessel wall. Further, existing DESs and DEBs cannot deliver drugs into the vessel wall (i.e., penetration of the vessel wall for drug delivery into the tissue itself).

[0005] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale relative to each other. Instead, emphasis has been placed on clearly showing the principles of the present technology. For ease of reference, throughout this disclosure, the same reference numbers are used to identify the same or at least generally similar components or features (constituent parts).

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0007] In one or more embodiments, not all of the components shown in each figure may be required, and one or more embodiments may have additional components not shown in the figures. Without departing from the scope of the present disclosure, the structure and type of the components can be changed. Additional components, different components, or fewer components can be utilized within the scope of the present disclosure.

[0008] The detailed description set forth below is intended as a description of various embodiments and is not intended to represent the only embodiments in which the present technology can be practiced. As will be understood by those skilled in the art, the described embodiments can be modified in various different ways without departing from the scope of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

[0009] The following disclosure describes various embodiments of a delivery system for an expandable structure, such as a stent or scaffold, having spikes, frills, or other protruding features for delivering a drug and / or penetrating a target tissue within a patient's body, as well as related devices and methods. The delivery system can be configured to deliver and dispose of the expandable structure within a body cavity (e.g., a blood vessel). Further, such a delivery system can also be configured to deploy and expand the expandable structure within the body cavity. The delivery system can further be configured to engage the expanded structure and collapse (fold) the structure for removal from the body cavity. In one embodiment, the delivery system can be configured to deliver another expandable structure or the same expandable structure to another body cavity or the same body cavity, either in a single procedure or during multiple procedures. Such a delivery system is expected to simplify and facilitate transcatheter procedures and more effectively deliver and dispose of the expandable structure within the target tissue. Further, if the delivery system is configured to re-capture the deployed expandable structure, it can be used in multiple procedures, such as deployment of the expandable structure. Still other embodiments of the delivery system configured in accordance with the present technology can include various features and / or procedures for using such a system.

[0010] To provide a complete understanding of the various embodiments of this disclosure, specific details are set forth in the following description and FIGS. 1-16. To avoid unnecessarily obscuring the description of the various embodiments of the disclosure, other details regarding well-known structures and systems that are often associated with expandable structures, drug delivery features, and components or devices related to the manufacture of such structures are not shown below. Further, many of the details and features shown in the figures are merely illustrative of specific embodiments of this disclosure. Accordingly, other embodiments can have other details and features without departing from the spirit and scope of this disclosure. Thus, those skilled in the relevant art will understand that this technology, including related devices, systems, and procedures, can include other embodiments having additional elements or steps and / or can include other embodiments lacking some of the features or steps shown and described below with reference to FIGS. 1-16. Additionally, the various embodiments of the disclosure can include structures other than those shown in the figures and are not explicitly limited to the structures shown in the figures.

[0011] I. A delivery system for a stent comprising a drug delivery feature and other structures, as well as related devices and methods FIG. 1 is a partial schematic side view of a delivery system 100 (the "system 100") having a drug delivery feature in a delivery state (e.g., a thin or collapsed configuration). In the embodiment shown in FIG. 1, the system 100 includes an elongate inner shaft 110 (e.g., a guidewire tube or guidewire) disposed within the lumen of an elongate outer shaft 120 (e.g., a catheter). The system 100 also includes a proximal connector, such as a luer connector 175, coupled to the proximal portion 110a of the elongate inner shaft 110. The luer connector 175 can have a single component configuration, or a multi-component configuration having two or more components configured to be combined with each other. When composed of two or more components, the luer connector 175 can be further adapted to facilitate insertion of the elongate inner shaft 110 into the elongate outer shaft 120. Further, when composed of two or more components, the luer connector 175 can be adapted to facilitate flushing of the system 100, such as delivery of one or more fluids to at least a portion of the system 100. The inner shaft 110 can be formed as a tubular structure (with or without slits), such as a coiled tube, braided tube, reinforced tube, or a combination thereof, and can be composed of a polymeric material such as polyimide. However, in other embodiments, the inner shaft 110 has a guidewire, and in such embodiments, the system 100 can optionally include a second guidewire (not shown) disposed laterally within the lumen of the elongate outer shaft 120 or along a portion of the outer wall of the outer shaft 120. In certain embodiments, the outer shaft 120 can also have one or more layers. In such embodiments, for example, the layers of the outer shaft 120 can include an inner layer, an outer layer, a liner, or a combination thereof. Each layer can be formed from a material including a polymer, high-density polyethylene (HDPE), polytetrafluoroethylene, silicone, Pebex® (polyether block amide), or a combination thereof. In certain embodiments, each layer of the outer shaft 120 is formed from the same material. However, in other embodiments, one or more layers can be formed from different materials.

[0012] In an exploded view of the distal portion 100b of the system, the tip 115 (e.g., a non-invasive tip) is disposed at the distal end (not shown) of the elongate inner shaft. As shown, the tip 115 is adjacent to the distal end of the elongate outer shaft 120. The tip 115 may have the same cross-sectional dimensions (e.g., 5 French (1.7 mm in diameter)) as the elongate outer shaft, or the tip 115 may have different cross-sectional dimensions. In one embodiment, the distal end 115b of the tip 115 tapers such that it has a smaller cross-sectional dimension compared to the proximal end 115a of the tip. The distal edge and / or proximal edge of the tip 115 may be curved / rounded to prevent the tip 115 from catching (e.g., sticking) on other parts of the system 100 during delivery, placement, deployment, etc. The tip 115 may be formed of the same material as the elongate outer shaft 120. However, in other embodiments, the tip 115 may be formed of a material different from the outer shaft 120.

[0013] The elongated inner shaft 110 and the elongated outer shaft 120 can be sized and shaped to enter a target site (e.g., a treatment site) within a patient's blood vessel. In one embodiment, for example, the elongated outer shaft 110 has a length of from about 150 cm to about 180 cm and suitable cross-sectional dimensions for placement within the vasculature of a subject. The length of the elongated inner shaft 110 can be an operating length such as a length that can be placed within the vasculature of a subject. In one embodiment, the operating length is, for example, from about 70 cm to about 300 cm, from about 150 cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm. In other embodiments, the elongated outer shaft 120 has a length of from about 130 centimeters (cm) to about 140 cm and a cross-sectional dimension of 4 French, 5 French, or 6 French. The length of the elongated outer shaft 120 can be an operating length such as a length that can be placed within the vasculature of a subject. In one embodiment, the operating length is from about 50 cm to about 200 cm, from about 100 cm to about 150 cm, or about 50 cm, about 60 cm, about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 125 cm, about 130 cm, about 135 cm, about 140 cm, about 145 cm, about 150 cm, about 155 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, or about 200 cm.

[0014] In the exploded view of the proximal portion 100a of the system 100 of FIG. 1, the proximal end 120c of the elongated outer shaft is connected to the outer shaft hub 140. In the illustrated embodiment, the outer shaft hub 140 is fixedly (e.g., by bonding) connected to the outer shaft 120. The outer shaft hub 140 can be formed of polycarbonate using various techniques known to those skilled in the art, such as molding. The system 100 can optionally include a force element 130, such as a strain relief element, directly and fixedly connected to the distal end of the outer shaft hub 140. In one embodiment, the force element 130 can at least partially cover a portion of the proximal portion 120a of the outer shaft. The force element 130 is configured to maintain the guide wire 160, the inner shaft 110, and the outer shaft 120 in a substantially linear configuration, for example, by preventing the formation of any twists, breaks, bends, crushed portions, and / or combinations thereof when the system 100 is in the delivery or expanded state. The force element 130 can be formed of a tube, such as a shrink tube, molded from one or more flexible materials including polyurethane and Pebex® (e.g., Pebex® 35D). However, in other embodiments, the proximal end 120c of the outer shaft is directly connected to the outer shaft hub 140.

[0015] The outer shaft hub 140 is further fixedly coupled to a connector 150 (e.g., a y-connector) having a lumen (not shown) extending therethrough. In particular, the distal end portion 150b of the connector 150 can be coupled to the outer shaft hub 140 via coupling features and receiving features (not shown). The coupling features and receiving features can be coupled to the proximal portion of the outer shaft 120 or the distal end portion 150b of the connector 150. The proximal end portion 150a of the connector 150 can comprise a touhy bourst seal configured to securely hold it in place at the location of one or more shafts within the system 100. The connector 150 further comprises an outlet port 152 extending radially and / or longitudinally therefrom. The system 100 can optionally comprise a hemostatic connector 170 coupled to the proximal end portion 150a of the y-connector 150.

[0016] System 100 is configured to carry a drug-eluting stent (not shown) in a delivered / crushed state within the distal portion of an elongate outer shaft 120. As will be described in more detail below, a system configured in accordance with the present technique may further be configured to carry a non-drug-eluting stent. In one embodiment, the stent can be at least partially covered by the elongate outer shaft 120. The stent can be fixedly or removably coupled to an actuating mechanism (e.g., stabilizing wire 160) by any suitable process. In one embodiment, the actuating mechanism is integrally formed within a portion of the stent, such as the proximal portion. In other embodiments, the distal portion of the actuating mechanism is welded or attached to the proximal portion of the stent using a clamp. As will be illustrated and described in more detail with reference to FIG. 3, a visual marker can be disposed at the proximal portion of the stent, such as the location where the actuating mechanism is coupled to the stent. Although system 100 is illustrated as a stent delivery system, it will be understood that embodiments of the present technique may also include catheter tips that are circumferentially expandable with or without a lumen in a cage, mesh, balloon, membrane, tubular structure, cylinder, expandable element, expandable membrane, expandable structure, expandable tubular structure, and guide wire. As will be described in more detail with respect to FIGS. 6A-6D, a system configured in accordance with the present technique can be configured to be delivered intraluminally through a patient's body cavity (e.g., a blood vessel) and to place a stent (not shown) at a desired treatment location within the body cavity.

[0017] As described above, in the embodiment shown in FIG. 1, the stabilization wire 160 is connected to the stent. The stabilization wire 160 is slidably disposed within the elongate outer shaft 120 and extends distally from the proximal end of the outer shaft and proximally from the proximal end of the exit port. The stabilization wire 160 can be formed of a high durometer plastic such as nylon, polyether ether ketone (PEEK), metal, a metal alloy such as nitinol, and / or combinations thereof. The stabilization wire 160 is configured to at least generally maintain the location of the stent (not shown) while the elongate outer shaft 120 is withdrawn, as will be described in more detail below with reference to FIG. 16, when the stent is placed at a desired treatment location (e.g., see vasculature 720 in FIG. 7).

[0018] The stabilization wire 160 can be sized and shaped to extend proximally from the proximal end of the exit port when the stent is positioned at the target site. For example, the stabilization wire 160 can have a length of from about 150 cm to about 180 cm and suitable cross-sectional dimensions for placement within a patient's body cavity. The stabilization wire 160 can have an operative length (i.e., a length that can be placed within the target body cavity) of from about 70 cm to about 300 cm, from about 150 cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm.

[0019] Figures 2A - 2F are cross - sectional views of various configurations of the region of the drug delivery system 100 of FIG. 1 taken along line 2 - 2. As shown in FIG. 2A, the elongated inner shaft 110 (e.g., a guide wire tube and / or a guide wire) and the stabilization wire 160 are at least partially disposed within the lumen of the elongated outer shaft 120. In certain embodiments, the outer shaft 120, the inner shaft 110, and the stabilization wire 160 each have a circular cross - sectional shape. However, in other embodiments, the outer shaft 120, the inner shaft 110, and the stabilization wire 160 can have other cross - sectional shapes, such as oval, “C” - shaped, rectangular, triangular, etc.

[0020] The stabilization wire 160 and the inner shaft 110 can be disposed within the lumen of the outer shaft 120 in any configuration, such as forward and backward or inner and outer as shown. Further, the stabilization wire 160 and the inner shaft 110 can be positioned relative to each other within the lumen of the outer shaft 120 as shown, or the stabilization wire 160 and the inner shaft 110 can be arranged in a reverse configuration where the stabilization wire 160 is in the position where the inner shaft 110 is shown, and vice versa. In further embodiments, the drug delivery system of FIG. 4 can have either the configuration and / or structure shown in FIG. 2A or any of the configurations and / or structures described herein with reference thereto.

[0021] As shown in FIGS. 2B-2F, a system configured in accordance with an embodiment of the present technique can optionally include a pusher shaft 280 instead of the stabilization wire 160. When the system is configured in accordance with these embodiments, the pusher shaft 280 is at least partially disposed within the lumen of the outer shaft 120. In these embodiments, the pusher shaft 280 includes a first pusher shaft lumen 282 and optionally a second pusher shaft lumen 284, each having a circular cross-sectional shape and being covered by the pusher shaft 280 (FIGS. 2B-2D). In other embodiments, the first pusher shaft lumen 282 and the second pusher shaft lumen 284 have a cross-sectional "C" shape, where the pusher shaft lumens 282 and 284 are partially covered by the pusher shaft 280 (FIGS. 2B-2D). The "C"-shaped pusher shaft lumens 282 and 284 are configured to allow for the rapid removal of the shaft carried therein by advancing at least a portion of any shaft passing through the "C"-shaped opening, such as the inner shaft 110 and / or a stent tensioning wire shaft (not shown). Further, in one configuration, instead of having an inner shaft lumen 284, the pusher shaft 280 may have a semi-circular cross-sectional shape (FIGS. 2E and 2F). In these configurations, the stent tensioning wire 118 is carried by the outer shaft 220. The location of the stent tensioning wire 228 is at least partially maintained within the outer shaft lumen 266 due to the shape of the pusher shaft 280. In other embodiments, the first and second pusher shaft lumens 282 and 284 can have any number of other suitable shapes known to those skilled in the art. In a further embodiment, the system 100 shown in FIG. 1 and the system 400 shown in FIG. 4 and discussed below with reference to FIG. 4 can have any of the configurations shown in or described with reference to FIGS. 2B-2F.

[0022] Figure 3 is a partial schematic side view of the distal portion 100b of the drug delivery system of FIG. 1 in a deployed state. In the illustrated embodiment, the stent 190 is fixedly coupled to the stabilization wire 160 and removed from the distal portion 120b of the elongated outer shaft. The proximal visualization marker 192 is disposed near the proximal portion of the stent 190 on the stabilization wire 160, and the distal visualization marker 197 is disposed on the distal end 190c of the stent. In some embodiments, the proximal visualization marker 192 and / or the distal visualization marker 197 may be disposed on the stabilization wire 160. The visualization markers 192 / 197 can be formed of any material that can be visualized while the stent 190 is disposed within a blood vessel (e.g., within a target blood vessel). In one embodiment, the visualization markers 192 / 197 are, for example, X-ray contrast markers. The tip 115 is disposed at the end 110c of the elongated inner shaft (e.g., a guide wire) and can cover the end 110c that extends proximally along the distal portion 110b and / or distally from the end 110c. The inner shaft 110 (FIG. 1) extends distally from the distal end of the outer shaft through the lumen of the stent 190 and, optionally, distally from the distal end of the stent. In the deployed configuration, the drug delivery feature 194 extends radially from the longitudinal axis of the stent 190.

[0023] FIG. 4 is a partial schematic side view of a delivery system 400 (the "system 400") of a stent in a delivery configuration (e.g., a thin (low profile) or collapsed configuration) constructed in accordance with an embodiment of the present technique. In the embodiment shown in FIG. 4, the system 400 includes, for example, an elongate inner shaft 410 (e.g., a guide wire tube) disposed within the lumen of an elongate outer shaft 420 (e.g., a catheter). The inner shaft 410 and the outer shaft 420 each have a proximal portion 410a and 420a, respectively, and a distal portion 410b and 420b, respectively. The inner shaft 410 can be formed as a tube (with or without slits) and can be constructed of a polymeric material such as polyimide. In other embodiments, the inner shaft 410 is a guide wire, and in such embodiments, the system 400 can optionally include a second guide wire. The outer shaft 420 is formed with the characteristics of the outer shaft 120 described previously with reference to FIG. 1 and can have the characteristics of the outer shaft 120.

[0024] As shown in FIG. 4, the proximal end of the elongated outer shaft 420 is connected to the outer shaft hub 440. The outer shaft hub 440 can be fixedly connected to the outer shaft 420 (e.g., by bonding). The outer shaft hub 440 can be formed of polycarbonate using any number of techniques known to those skilled in the art, such as molding. The system 400 can optionally include a force element 430, such as a strain relief element, directly and fixedly connected to the distal end of the outer shaft hub 440. The force element 430 can be formed of a tube, such as a shrink tube, molded from one or more flexible materials including polyurethane and Pebex® (e.g., Pebex® 35D). The outer shaft hub 440 is also fixedly connected to a connector 450 (e.g., a Y-connector). In particular, the distal end 450b of the connector 450 can be connected to the outer shaft hub 440 via coupling features and receiving features (not shown). The coupling features and receiving features can be connected to the proximal portion of the outer shaft 420 or the distal end 450b of the connector 450. The proximal end 450a of the connector 450 can include a tube yoke seal configured to securely hold it in place at one or more shaft locations within the system 400. In one embodiment, the connector 450 can also include an outlet port 452 extending radially and / or longitudinally therefrom.

[0025] System 400 can further include a pusher shaft 280 disposed within the lumen of the connector and extending distally into the lumen of the outer shaft and proximally from the proximal end 450a of the connector 450. The pusher shaft 280 can be formed of a plastic such as a high durometer plastic including nylon, polyetheretherketone (PEEK), and / or combinations thereof. A twee-bolt seal at the proximal portion 450a of the connector 450 can be configured to fixedly position (e.g., securely hold) the pusher shaft 280 at a desired location (e.g., the vessel wall, see 520 in FIG. 5). In this embodiment, the pusher shaft 280 is fixedly coupled to a pusher shaft hub 480 at the proximal portion of the pusher shaft. However, in other embodiments, the pusher shaft hub 480 can be removably coupled to the pusher shaft 280. As discussed in more detail above with respect to FIG. 2, the pusher shaft 280 can have two or more pusher shaft lumens, grooves, or combinations thereof extending through the pusher shaft, such as a first pusher shaft lumen (e.g., inner shaft 410) configured to carry a guide wire or guide wire tube, and a second pusher shaft lumen (not shown) configured to carry a wire such as a stent retraction wire.

[0026] In one embodiment, system 400 can further include a stent retraction wire hub 470 coupled to the proximal portion of the stent retraction wire. The stent retraction wire hub 470 and the pusher shaft hub 480 can each include mating features and receiving features (both not shown) configured to engage each other and removably couple the stent retraction wire hub 470 to the pusher shaft hub 480 when coupled to the system 400. Both the stent retraction wire hub 470 and the pusher shaft hub 480 can be formed or machined from any suitable material.

[0027] System 400 is configured to carry a stent (not shown) in a delivered / crushed state within the distal portion 420b of the elongated outer shaft 420 and is coupled to an actuating mechanism (e.g., a stent tensioning wire). Although system 400 is illustrated as a stent delivery system, it will be understood that embodiments of the present technology can also include a catheter tip that is circumferentially expandable with or without a lumen in a cage, mesh, balloon, membrane, tubular structure, cylinder, expandable element, expandable membrane, expandable structure, expandable tubular structure, and guide wire. As will be described in more detail with respect to FIGS. 4A-4D, system 400 is configured to be delivered intravascularly through a patient's body cavity (e.g., a vasculature lumen) and to place a stent (not shown) at a desired treatment location.

[0028] FIG. 5 is an isometric side view of a region of system 400 of FIG. 4 taken along line 5-5. In the embodiment shown in FIG. 5, pusher shaft 280 has a first pusher shaft groove 284 and a second pusher shaft groove 282. As shown, a portion of inner shaft 410 is disposed within the first pusher shaft groove 284 (e.g., an inner shaft groove). In this embodiment, inner shaft 410 has a guide wire groove 516 configured to carry a guide wire (not shown). The second pusher shaft groove 282 (e.g., the lumen of a stent tensioning groove) is configured to carry a stent tensioning wire (not shown). The first pusher shaft groove 284 and the second pusher shaft groove 282 can each have any number of arrangements and orientations within pusher shaft 280 (FIGS. 2B-2F). Such arrangements and orientations are configured to facilitate the release of shafts carried therein, such as inner shaft 410 and / or a stent tensioning wire (not shown), and engagement with different shafts (e.g., catheter exchange).

[0029] Figures 6A-6D are partial schematic side views of system 400 at various stages of the delivery procedure according to an embodiment of the present technology. As shown in FIG. 6A, system 400 is initially configured in a low-profile delivery state. In this initial configuration, the distal region of system 400, which includes the distal portion 410b of inner shaft 410 and the distal portion 420b of outer shaft 420, is configured to advance distally through a body cavity (e.g., a vascular lumen such as the femoral artery) along a guidewire to a desired position. In one embodiment, at least a portion of system 400 may be delivered within a guide sheath of a suitable size (e.g., 5 French or 6 French).

[0030] Referring next to FIG. 6B, when the distal region of system 400 is positioned at the desired location, outer shaft 420 is configured to be at least partially retracted proximally by retracting outer shaft hub 440. When outer shaft 420 is partially retracted, a portion of stent 490 is removed from the sheath and drug delivery feature 494 is configured to expand radially outward from system 400. Pusher shaft 280 carried by outer shaft 420 is engaged with the proximal end 490a of the stent and is configured to advance and release stent 490 distally. As previously described with reference to FIGS. 2B-2F, pusher shaft 280 is configured to carry inner shaft 410 and stent tension wire 182. In this embodiment, pusher shaft 280 is configured to advance distally before, during, or after outer shaft 420 is at least partially retracted proximally.

[0031] As shown in FIG. 6C, outer shaft 420 is retracted and stent 490 is removed from the sheath. In this configuration, stent 490 is configured to advance distally by pusher shaft 280 and, after advancement, pusher shaft 280 is configured to be fixed, for example, by being held or immobilized to maintain the position of stent 490 using pusher shaft hub 480.

[0032] Next, referring to FIG. 6D, the pusher shaft 280 is further configured to be removed by advancing the pusher shaft hub 480 in the proximal direction when the stent 490 is in the proper position. In the embodiment shown in FIG. 6D, after the pusher shaft 280 is removed, the system 400 is configured to insert a balloon (not shown, see balloon 840 in FIG. 8A) into the proximal portion 420a of the outer shaft 420 and advance the balloon in the distal direction to the distal portion 420b of the outer shaft 420.

[0033] As further described below, the expandable stent 490 includes a plurality of drug delivery features 494 provided by the stent 490. In one embodiment, the plurality of drug delivery features 494 are configured to expand radially after the stent 490 is removed from the outer shaft 420. Further, some embodiments can be designed to apply a drug onto the stent or onto a drug delivery feature configured to receive and release the drug when the stent is expanded at a desired location (e.g., a target site, a treatment site). In one embodiment, the outer shaft 420 can have an inner layer configured to prevent residue released from the drug delivery feature 494 of the stent 490 from entering the lumen of the outer shaft.

[0034] Using the system 400, various configurations of the system 400, and other systems described herein, not only the procedures and methods described herein but also procedures and methods known to those of ordinary skill in the art, stents 190, other stents, or other suitable elements can be delivered, positioned, deployed, and / or recaptured. For example, FIG. 7 is a partial schematic side view of the distal portion of the system 400 in a delivery state according to an embodiment of the present technology. As shown in FIG. 7, the system 400 is in a delivery state within a patient's body cavity 710 (e.g., a blood vessel). In this embodiment, the system 400 is configured to be delivered intraluminally (e.g., intravascularly) through a patient's blood vessel (e.g., the femoral artery). To enter the femoral artery, a sheath (e.g., 5F or 6F) and a guidewire are introduced into the lumen of the femoral artery. The system 400 is delivered into the body cavity by tracking the distal portion 410b of the inner sheath that covers the guidewire and advancing the system 400 distally to a desired position 720 within the vasculature. In many embodiments, an angioplasty procedure is performed at the desired position 720 before the system 400 advances to the desired position 720. In such embodiments, the guidewire may be the same guidewire used for angioplasty.

[0035] When the system 400 is positioned at the desired position 720, the distal portion 420b of the outer sheath is retracted proximally, and the sheath of the stent 490 is removed. In the illustrated embodiment, the body of the stent 490 is at least partially expanded when the sheath is removed and the drug delivery feature 494 is collapsed. However, the drug delivery feature 494 can be configured to expand when the distal portion 420b of the outer sheath is retracted. In other embodiments, a stabilizing wire (not shown) can be fixed, such as advancing distally, being held, or being immobilized, before, during, and / or after the outer sheath is retracted proximally to deploy the stent. That is, it can be fixed at the desired position for positioning the stent. As shown, the distal tip 419 of the system 400 is disposed distally of the distal end of the stent, and the inner shaft 410 remains disposed within at least a portion of the lumen of the stent 190.

[0036] In the deployed state, the drug delivery feature 494 of the stent 490 is configured to expand radially and, further, when the deployed stent 490 expands and contacts the vessel wall, is configured to pierce the lumen wall at a desired location (see FIGS. 8A and 8B). As will be described in more detail below, stents and other expandable structures can be configured to self-expand, such that when the stent and other expandable structures are at least partially removed from the outer shaft, they expand at least partially from a collapsed / delivery state to a deployed and / or expanded state, expanding outwardly, for example. In certain embodiments, stents and other expandable structures are configured to expand when operably coupled to an inflatable element or mechanism, such as a balloon. In further embodiments, self-expanding stents and other structures are configured to expand further when coupled to an inflatable mechanism. Whether or not stents and other expandable structures self-expand or expand when coupled to an inflatable element, the stents and other expandable structures can be configured to expand radially (symmetrically or asymmetrically). In certain embodiments, at least partially expanded stents and other expandable structures can be configured to position at least some of the drug delivery features perpendicular to the vessel wall.

[0037] In the embodiments shown in FIGS. 8A and 8B, the system 400 is configured to insert a balloon 840 connected to an elongated shaft, such as a wire, into the lumen of a stent (see the elongated shaft 820 in FIGS. 8A and 8B). The balloon 840 is further disposed within the lumen of the stent and configured to expand therein to further expand the stent 490 from a delivery state to an expanded and deployed state. In certain embodiments, the balloon 840 can be coated with a drug delivery coating and drug, such as the coatings and drugs described herein. As further discussed elsewhere herein, the stent 490 can be operably coupled to an actuation mechanism, such as a mechanical actuation mechanism (e.g., stabilization wires, stent tensioning wires, pusher shafts, or combinations thereof) configured to position, expand, retract, reposition, and / or remove the stent 490 within a body cavity.

[0038] FIG. 8A is a cross-sectional view of a region of the system 400 in an expanded state within a body cavity according to an embodiment of the present technology. In the embodiment shown in FIG. 8A, the stent 490 is expanded within the blood vessel 720 by the balloon 840. To expand the deployed stent 490, the balloon 840 is connected to an elongated shaft 820 and advanced distally through the lumen of the stent 490 to be deployed until the distal tip 830 of the elongated shaft 820 is disposed near the distal end 490b of the stent 490 to be deployed. As shown, the distal end 490b of the stent 490 includes an X-ray contrast marker 810. However, in other embodiments, the X-ray contrast marker 810 may be disposed at other locations on the system 400 or omitted from the system 400.

[0039] FIG. 8B is a partial cross-sectional view of the system 400 in an expanded state, and the stent 490 includes a drug delivery feature 494 that expands within a portion of the vessel wall and penetrates a portion of the vessel wall. As shown in FIG. 8B, the balloon 840 engages the stent 490 and is deployed to further expand the stent 490 into contact with the luminal vasculature and expand radially. When the stent 490 is expanded, the drug delivery feature 494 penetrates further into the wall.

[0040] FIG. 9 is a cross-sectional view of the system 400 in a treatment state according to an embodiment of the present technology. In the treatment state, the balloon 840 (FIG. 8A) is deflated, retracted proximally along the inner shaft 410, and removed from the body cavity. As shown, the distal portion 410b of the inner shaft 410 remains within the body cavity. After removing the balloon 840, the stent 490 remains expanded and in contact with the lumen wall, and the drug delivery feature 494 remains penetrating the wall. Any drug carried by the drug delivery feature 494 is released at least partially into the body cavity wall in the treatment state. In other embodiments, the stent 490 can be fixed to the balloon 840, for example, by crimping the stent 490 to at least partially surround the balloon 840, and the stent 490 can be expanded by inflating the balloon 840 and collapsed by deflating it.

[0041] In one embodiment, after the stent 490 is expanded, some elements of the system 400 are further removed from the body cavity. For example, FIG. 10 is a partial schematic side view of a region of the system 400 in a removed state according to an embodiment of the present technology. As shown in FIG. 10, the stent 490 remains expanded in contact with the wall of the vasculature 720 as the distal portions of the inner shaft 410 and the outer shaft 420 are retracted proximally. The retrieval system, as well as related devices and methods, are further discussed below with reference to FIGS. 11, 12, and 16.

[0042] FIG. 11 is a partial schematic side view of a retrieval system (“System 1100”) configured in accordance with an embodiment of the present technique. In the embodiment shown in FIG. 11, System 1100 includes an elongate outer shaft 1120 having a tip portion 1115 at a distal portion 1120b of the outer shaft (see exploded view of distal portion 1100b). In one embodiment, the tip portion 1115 tapers such that the distal end has a smaller cross-sectional dimension than the proximal end. Further, at least a portion of the tip portion 1115 can have the same cross-sectional dimension (e.g., 5 French) as the elongate outer shaft 1120. The tip portion 1115 is configured to engage a proximal portion of a stent (not shown). The distal end and / or proximal end of the tip portion 1115 can be rounded to prevent the tip portion 1115 from snagging (e.g., sticking) on other parts of System 1100 during retrieval of the stent or any other use for which System 1100 may be configured.

[0043] In the embodiment shown in FIG. 11, the tip portion 1115 is continuous with the outer shaft 1120. However, in other embodiments, the tip portion 1115 can be a separate element coupled to the distal end of the outer shaft. The tip portion 1115 can be formed of the same material as the elongate outer shaft 1120. In other embodiments, the tip portion 1115 can be formed of a material different from the outer shaft 1120.

[0044] The distal end portion 1115 has an opening 1118 at the distal end of the distal end portion and a groove (not shown) fluidly coupled to an outer shaft lumen (not shown). The groove is configured to carry at least a portion of the inner shaft 110, guide wire, and / or stabilization wire 160 discussed previously with reference to FIG. 1. The distal end of the distal end portion is configured to engage at least a portion of the expanded stent 190, and upon engagement, as the outer shaft 1120 advances to again cover at least a portion of the collapsed stent 190, the distal end portion 1115 is configured to collapse the expanded stent 190. As will be described in more detail below, the outer shaft 1120 is configured to at least partially surround a portion of the stabilization wire 160 (and optionally the guide wire), while the stent 190 is held in place at the target location, collapsed, and at least partially covered with a sheath. The drug delivery feature 194 can be configured to collapse towards the frame 193 of the stent. Alternatively, the drug delivery feature can be adapted to remain at least partially penetrating a portion of the lumen wall for a period of time (short periods such as 1, 2, 5, 10, 15, 20 minutes, long periods such as 1, 2, 3, 6, 12, 24, 48 hours).

[0045] As shown in the exploded view of the proximal portion 1110a, the system 1100 further includes the force element 130 and the outer shaft hub 140 described previously with reference to FIG. 1, coupled to the proximal portion 1120a of the elongated outer shaft 1120. Similar to the outer shaft 120 of FIG. 1, the outer shaft 1120 can also have one or more layers. In such embodiments, for example, the layers of the outer shaft 1120 can include an inner layer, an outer layer, a liner, or combinations thereof. Each layer can be formed from a material including, for example, a polymer, high density polyethylene (HDPE), polytetrafluoroethylene, silicone, Pebex® (polyether block amide), or combinations thereof. In one embodiment, each layer of the outer shaft 1120 is formed from the same material. However, in other embodiments, one or more layers can be formed from different materials.

[0046] The elongated outer shaft 1120 can be sized and shaped to enter a target site within a blood vessel in a patient's body. For example, the elongated outer shaft 1120 can have a length of from about 130 cm to about 140 cm and a cross-sectional dimension of 4 French, 5 French, or 6 French. The length of the elongated outer shaft 1120 can be the working length (i.e., the length that can be disposed within the vasculature of a subject). In certain embodiments, the working length can be, for example, from about 50 cm to about 200 cm, from about 100 cm to about 150 cm, or about 50 cm, about 60 cm, about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 125 cm, about 130 cm, about 135 cm, about 140 cm, about 145 cm, about 150 cm, about 155 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, or about 200 cm.

[0047] In other embodiments, a stent, such as stent 490, can be used in a detachable configuration with the delivery system shown in FIG. 4 and collapsed after a drug delivery procedure to be removed from the body cavity. For example, FIGS. 12A - 12C are partial schematic side views of the delivery system in a retrieval configuration showing various stages in a partially retracted state, according to an embodiment of the present technique. As shown in FIG. 12A, the stent 490 and the drug delivery feature 494 are collapsed towards the distal portion 420b of the outer shaft 420 and engage the distal tip of the pusher shaft 280. FIG. 12B shows the distal portion 420b of the outer shaft 420 that partially re-covers the collapsed stent 490. The outer shaft hub 440 can be advanced distally towards the collapsed stent 490 and / or the stent tension wire hub 470 can be retracted proximally as shown in FIG. 12C to re-cover the stent 490 entirely or partially with a sheath again. During re-covering with the sheath, the drug delivery feature 494 can remain impaled on the wall of the body cavity or can be radially retracted / collapsed towards the frame 493 for removal.

[0048] Furthermore, some embodiments of the present technology can achieve the separation of stents or other structures having drug delivery features within a body cavity. For example, in some embodiments, a wire or attachment member can release the stent by mechanical means, thermal means, electrical means, or other means. In one embodiment, the stent can be operably coupled to a circular or non-circular longitudinal member configured to release and / or recapture the stent within the system described herein. This member can be directly or indirectly coupled to the frame of the stent. In some of these embodiments, the stent or other structure can be designed to be permanently placed within the patient's body.

[0049] II. Stents and Other Structures, Drug Delivery Features, and Related Systems and Methods FIG. 13 is a partial schematic side view of a drug eluting expandable structure (e.g., a stent) 1300 having a drug delivery feature in a deployed state within a body cavity and configured according to an embodiment of the present technology. The stent 1300 includes a plurality of struts 1310 that form a radially expandable cylindrical frame 1330, and members that engage the struts 1310 and extend between two or more rows of struts 1310. The drug delivery feature 1350 is an integral part of the struts 1310, is disposed over at least a portion of the outer dimension of the stent 1300, and extends radially outwardly away from the stent 1300 toward a target portion of the body cavity. As shown, the struts 1310 of the expanded stent 1300 are juxtaposed against the wall of the body cavity 520. In one embodiment, the stent 1300 is a self-expanding structure or a partially self-expanding structure. In other embodiments, the stent 1300 can be coupled to a balloon 840 (see FIGS. 7-9), or other suitable techniques and / or structures known to those skilled in the art can be used to deform the stent 1300 from a thin delivery state to the deployed and / or expanded state shown in FIGS. 7-9.

[0050] The frame 1330, strut 1313, and / or drug delivery feature 1350 can be constructed or formed from a variety of materials including, for example, any of nitinol, cobalt-chromium, stainless steel, various other metals or metal alloys, or combinations thereof. The frame 1330, strut 1313, and / or drug delivery feature 1350 can also be constructed or formed from bioabsorbable, biodegradable, nanoporous or non-bioabsorbable, non-biodegradable, non-nanoporous materials including, for example, one or more polymers, nitinol, plastic materials, etc., or combinations thereof. In certain embodiments, the frame 1330 and strut 1392 can be formed from a bioabsorbable material and the drug delivery feature 1350 can be formed from a non-bioabsorbable material such as nitinol. In such embodiments, the drug delivery feature 1350 can remain engaged with or penetrate a portion of the body cavity after the expanded frame 1330 and strut 1313 have been bioabsorbed. After the expanded frame 1330 and strut 1313 have been bioabsorbed, the body cavity in which the stent 1300 was expanded is no longer partially occluded by the frame 1330 and strut 1313 and a larger volume of fluid, such as an aqueous pharmaceutical composition, can pass through the body cavity and contact the lumen wall. The drug delivery feature 1350 can also be formed from a bioabsorbable material and when the stent 1300 is bioabsorbed, the space within the body cavity wall emptied by the drug delivery feature 1350 can contact the fluid passing through the body cavity. In this way, the stent 1300 can increase the surface area of the body cavity wall that contacts the fluid.

[0051] As shown in FIG. 13, the stent 1300 includes a drug delivery feature 1350 equipped by struts 1310. The drug delivery feature 1350 may be equipped by two or more struts 1310, the frame 1330, or a combination thereof. The drug delivery feature 1350 may be integrally formed with the struts 1310, for example, by bending or twisting a part of one or more struts and / or the frame 1330 away from the longitudinal axis of the stent 1300. Alternatively, the drug delivery feature 1350 may be a separate individual component attached at a desired position along the struts 1310 and / or the frame 1330.

[0052] FIGS. 14A and 14B are isometric views of a portion of a drug-eluting expandable structure (e.g., a stent) having a drug delivery feature configured according to a further embodiment of the present technology. For example, in the embodiment shown in FIG. 14A, the drug delivery feature 1460 has a radially elongated curved needle-like structure. A portion of the stent 1400 includes a frame 1430 and a plurality of struts 1410 and is configured to engage and / or penetrate into a body cavity such as a blood vessel. The protruding feature 1460 is an integrally formed part of the strut 1410 and extends radially outward away from the stent 1400 toward the target portion of the body cavity. In certain embodiments, the drug delivery feature 1460 can penetrate through a body cavity wall (e.g., a blood vessel wall) to directly deliver a drug into the target tissue beyond the blood vessel wall. In other embodiments, the drug delivery feature 1460 can be separated from the frame 1430 and configured to remain at least partially penetrating within the blood vessel wall. In such embodiments, the separated drug delivery feature 1460 can be configured to deliver a drug to a target tissue within the blood vessel wall in the short or long term. Blood vessels and target tissues are described elsewhere in this specification.

[0053] In the embodiment shown in FIG. 14B, for example, the stent 1470 comprises struts 1410 with a drug delivery feature 1482 having one or more reservoirs 1480, and a drug carried by the reservoir. The reservoir 1480 can at least partially contain the drug and protect against premature release of the drug (e.g., due to abrasion when delivering an associated stent through a catheter). In various embodiments, the reservoir 1480 and / or the drug delivery feature 1482 may be configured to separate from the strut 1410 and remain within the vessel wall, or to engage the wall to deliver the drug and remain fixedly connected to the strut 1410. Further, the drug delivery feature 1482 can have a variety of different shapes, sizes, and configurations. The drug delivery features disclosed herein enhance engagement with and / or penetration into the lumen wall, enhance drug delivery, and enable better treatment at the desired location. In some embodiments, such as a non-drug eluting stent, the drug delivery feature 1482 can be a protruding feature.

[0054] The materials for forming the frames, struts, and / or drug delivery features described herein can be selected based on mechanical and / or thermal properties such as strength, ductility, hardness, elasticity, flexibility, flexural modulus, flexural strength, plasticity, rigidity, emissivity, thermal conductivity, specific heat, thermal diffusivity, thermal expansivity, any other various properties, or combinations thereof. When formed of a material having thermal properties, the material can be activated to provide thermal therapy to the desired treatment site. Regardless of the material, the frames, struts, and / or drug delivery features can be formed from a wire such as a tube or a stiff wire by laser cutting or other suitable techniques. When formed from a wire, a portion of the wire can be removed by chemical etching or another suitable method to create the inner dimension of the stent.

[0055] According to the present technology, a stent (e.g., a frame and struts) can be sized and shaped for placement within various body cavities, including blood vessels, without rupturing the vasculature. For example, some stents and other structures configured in accordance with the present technology can have a radial strength such that the anatomy of the body cavity (e.g., the vessel wall) can accept a drug without an incision or injury to the body cavity. The blood vessels in which the stents described herein can be sized and shaped for placement can include arteries such as the coronary arteries, peripheral arteries, carotid arteries, circle of Willis, anterior cerebral arteries, middle cerebral arteries, posterior cerebral arteries, any lenticulostriate arteries, renal arteries, femoral arteries, veins such as the cerebral veins, cavernous veins, arteriovenous fistulas, or any other blood vessels that may include the treatment site. The stents can have various shapes, including cubes, rectangular prisms, cylinders, cones, pyramids, or variants thereof.

[0056] Stents and other structures having drug delivery features configured in accordance with the present technology can have various dimensions (in both a thin delivery state and an expanded and deployed state). Such embodiments can provide expandability that allows for use covering a wide range of dimensions in various situations, for treating and / or for preventing incisions. The stent, regardless of its shape, can have a length of about 0.25 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, or about 100 mm. Further, a stent shaped as a cube, rectangular prism, or pyramid can have a width of about 0.25 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 25 mm, or about 30 mm. Further, a stent shaped as a cylinder or cone can have a diameter of about 0.25 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 50 mm. The width or diameter of the stent can decrease and become shorter in accordance with the length of the stent. Further, the stent can be sized and shaped to prepare the body cavity for a particular procedure such as a stent placement procedure.

[0057] The stent 1300, other stents, and other expandable structures configured in accordance with the present technology in an expanded state can have cross-sectional dimensions from about 2 mm to about 10 mm, including an expanded drug delivery feature. For example, a frame (such as frame 1330) configured in accordance with the present technology can have cross-sectional dimensions from about 1 mm to about 9 mm, and each drug delivery feature can have a length from about 0.1 mm to about 1.5 mm. In one embodiment, the stent has an overall cross-sectional dimension of about 4 mm, the frame 1330 has a cross-sectional dimension of about 2 mm, and each drug delivery feature has a length of about 1 mm. In one embodiment, the stent has an overall cross-sectional dimension of about 6 mm, the frame 1330 has a cross-sectional dimension of about 4 mm, and each drug delivery feature has a length of about 1 mm. In a further embodiment, the drug delivery features can have multiple lengths such that the lengths of the drug delivery features of the stent or other expandable structure are different. For example, the stent can have drug delivery features having lengths of about 0.2 mm, about 0.5 mm, and about 1 mm.

[0058] The outer shape of the stent or other structure can be sized such that the stent or other structure is compatible with a wide range of catheter sizes. Embodiments according to the present technology can include stents or other structures designed to receive a guide wire, such as a guide wire having a diameter of 0.25 mm (0.010 inches), 0.36 mm (0.014 inches), 0.46 mm (0.018 inches), 0.89 mm (0.035 inches), or 0.97 mm (0.038 inches). In some embodiments, the stent or scaffold structure can be sized and designed to be delivered through a micro-catheter through which it is pushed. In one embodiment, a stent or structure configured in accordance with the present technology can be incorporated into a delivery system, including a modular or single-unit delivery system.

[0059] The stents and other structures described herein can include one or more radiopaque markers (see radiopaque marker 810 in FIGS. 8A, 8B, and 9) or other markers for visualizing the stent within the body cavity. The radiopaque markers can be formed of Clearfil Photo Core PLT (registered trademark), tantalum, titanium, tungsten, barium sulfate, and zirconium oxide, or another suitable radiopaque label. The markers can be formed by the proximal portion, distal portion, intermediate portion, or combinations thereof of the stent. The markers can be bands, coils, clips, plated on one or more portions of the stent, filled within one or more portions of a tube within the stent, or combinations thereof. Regardless of the type of marker, the marker can be cast, swaged, wound, or wrapped along or on any portion of the stent.

[0060] Stents and other structures constructed in accordance with the present technology can have sufficient flexibility to track various anatomical forms, including those having curvature. The flexible properties of the stents and other structures can be provided by the materials from which they are formed. Additionally, the flexible properties can be provided by breaking one or more members that engage the struts and extend between two or more rows of struts. Further, the stent or other structure can be easily deployed and expanded and then retracted and collapsed. The stent or other structure can also be easily repositioned within a vessel or other body cavity.

[0061] In some embodiments, the drug-eluting compound is coated on at least a portion of the drug delivery feature, frame, strut, and / or balloon. The coating can be any suitable coating known to those skilled in the art that is suitable for delivering the drug to the wall. For example, suitable coatings include, but are not limited to, a snow coating or a crystalline coating having edges configured to remain within the wall. The drug-eluting compound can be a synthetic or biological polymer coated in various different patterns and thicknesses suitable for delivering the drug contained therein. In other embodiments, the drug delivery feature itself may be composed of a drug-eluting material. The drug carried by the drug-eluting compound and / or drug delivery feature according to the present technology can be any drug suitable for treating the treatment site where the stent will be placed, and may or may not contain excipients. The drug can be, for example, an anti-proliferative agent, an anti-tumor agent, a migration inhibitor, an enhanced healing factor, an immunosuppressant, an anti-thrombotic agent, a blood thinner, or a radioactive compound. Examples of anti-tumor agents include, but are not limited to, sirolimus, tacrolimus, everolimus, leflunomide, M-prednisolone, dexamethasone, cyclosporine, mycophenolic acid, mizoribine, interferon, and tranilast. Examples of anti-proliferative agents include, but are not limited to, taxol / paclitaxel, actinomycin, methotrexate, angiopep, vincristine, mitomycin, statin, c-myc antisense, Abbot ABT-578, RestinASE, 2-chloro-deoxyadenosine, and PCNA ribozyme. Examples of migration inhibitors include, but are not limited to, batimastat, prolyl hydroxylase, halofuginone, c-protease inhibitor, and probucol. Examples of enhanced healing factors include, but are not limited to, BCP671, VEGF, estradiol, NO donor compound, and EPC antibody.Examples of radioactive compounds include, but are not limited to, strontium chloride 89 (Metastron®), samarium-153 (Quadramet®), radium chloride 223 (Xofigo®), yttrium-90, and iodine-131. In certain embodiments, the drug eluting compound and / or drug delivery feature can carry multiple types of drugs.

[0062] In certain embodiments, the drug delivery feature can have a textured surface (e.g., ridged) that is expected to provide a larger surface area for drug delivery. Additionally, any drug delivery feature can have a textured surface, such as a ridged surface (perpendicular, horizontal, radial, or circular to the longitudinal plane of the drug delivery feature), a cross-hatched surface, an isotropic surface, or other types of surfaces suitable for providing a larger surface area for drug delivery.

[0063] The drug delivery feature can be sized and shaped to engage and / or penetrate the occlusion, neointima, intima, internal elastic lamina (IEL), media, external elastic lamina (EEL), adventitia, or combinations thereof. The drug delivery feature can also be sized and shaped to engage and / or penetrate tissue and / or structures adjacent to the body cavity in which the stent is to be placed without rupturing the body cavity. For example, the stent can have square drug delivery features sized and configured to penetrate the intima and / or media of the body cavity, or pointed drug delivery features sized and configured to penetrate and extend into the media and / or IEL. Additionally, the drug delivery feature can be configured to bend in one or more directions relative to the longitudinal axis of the stent to engage and / or penetrate a portion of the body cavity described herein. In some embodiments, the drug delivery feature can penetrate deeper into the wall of a diseased body cavity, such as a blood vessel, compared to a stent without the drug delivery feature. Further, the stent can be in an expanded position and allow blood to flow even while drug elution is ongoing.

[0064] The various drug delivery features described herein can deliver drugs deeper into the vessel wall than is possible with angioplasty balloons or other existing devices. In addition to carrying one or more drugs for treatment of a site, the drug delivery features can carry suitable molecules that degrade occlusions, neointima, and / or portions of the intima, enabling the drug delivery features to penetrate deeper into the vessel wall than they would without those molecules. For example, molecules suitable for degradation can be enzymes such as elastase, collagenase, or proteases such as metalloproteinase, serine protease, cysteine protease, extracellular sulfatase, hyaluronidase, lysyl oxidase, lysyl hydroxylase, or combinations thereof.

[0065] Furthermore, it will be understood that stents constructed in accordance with the present technology can be equipped with one or more drug delivery features on a portion or portions of the stent. For example, the stent can be equipped with about 5 drug delivery features, about 10 drug delivery features, about 15 drug delivery features, about 20 drug delivery features, about 30 drug delivery features, about 40 drug delivery features, about 50 drug delivery features, about 60 drug delivery features, about 70 drug delivery features, about 80 drug delivery features, about 90 drug delivery features, or about 100 drug delivery features. The drug delivery features can be equipped by a frame, struts, or combinations thereof. The number of drug delivery features can vary, for example, depending on the target treatment site, the type of drug being delivered, the size of the stent, and the like. Furthermore, the drug delivery features equipped by the stent can be of the various types of drug delivery features disclosed herein.

[0066] In one embodiment, when the tissue and / or fluid is disposed in contact with the body cavity wall (e.g., the vessel wall), it can interact with the drug delivery feature to dissolve the drug and selectively release the drug from the reservoir. In other embodiments, the drug delivery feature can be configured to deliver the drug by various means when the stent is expanded. Accordingly, the drug delivery feature is expected to provide an effective means for selectively delivering the drug to the desired location while reducing inadvertent loss or release of the drug. In other embodiments, the stent can have a plurality of drug delivery features, or one drug delivery feature with a plurality of reservoirs. In some embodiments, a stent having a drug delivery feature configured in accordance with the present technology can have a drug delivery feature that hides (e.g., retracts) the coating or reservoir until the stent is placed at the treatment site. When placed at the target site, the drug delivery feature can be exposed (e.g., expanded / protruded) during and / or after expansion of the stent. This is expected to reduce any loss of the drug carried by the drug delivery feature during delivery to the treatment site.

[0067] It should be understood that the embodiments shown in FIGS. 13 and 14A - 14B do not have protruding features such as drug delivery features having various shapes, but other embodiments can have drug delivery features. For example, the drug delivery feature can include a protruding feature that is sized and shaped for placement within various body cavities including the vessels described herein. The size and shape can be selected to achieve a desired engagement or penetration with the particular anatomy of the body cavity (e.g., target tissue) in which the stent is to be placed. The protruding feature can have several shapes including, but not limited to, a cube, square, rectangular prism, cylinder, circle, cone, pyramid, curved spike, or other pointed shapes. Any of these shapes can have flat, blunt, pointed, and / or sharp distal portions.

[0068] In one embodiment, the stent may further have a material (such as polyamides, silicones such as PTFE, dacron, nylon and / or polyurethane-based materials) disposed thereover that covers the stent, the scaffold, or other structures having a drug delivery feature covering at least a portion of the outer surface area. In one embodiment, the material covers the entire outer surface area. The material can be a mesh or braid. In one embodiment, the material may be configured to increase the surface area of the stent, which is useful for providing additional surface area on the stent for coating with a drug. In other embodiments, the material may further be configured to allow blood flow to pass through the inner diameter of the stent and / or to restrict blood flow to the outer diameter of the stent. In a further embodiment, the material can create a barrier between the fluid flow (e.g., blood flow) and the drug delivery location. Further, the material may be configured to prevent debris from the body cavity wall from entering the blood stream. In such embodiments, the associated systems and devices can be used to track or fill in temporary detachment portions of areas that may have been perforated during the procedure.

[0069] FIG. 15 is a partial schematic side view of a stent 1500 constructed in accordance with an embodiment of the present technology, comprising a drug delivery feature 1590 deployed within chamber 1540 and body cavity 510. In the illustrated embodiment, stent 1500 is covered by an outer layer 1520 (e.g., a cover) and an inner layer 1530 (e.g., a liner). Outer layer 1520 and inner layer 1530 can each be formed from a material including a polymer, high density polyethylene (HDPE), polytetrafluoroethylene, silicone, Pebex® (polyether block amide), or combinations thereof. In one embodiment, each layer is formed from the same material. In other embodiments, each layer is formed from different materials.

[0070] In the illustrated embodiment, the outer layer 1520 is adjacent to the inner layer 1530 and at least partially defines a chamber 1540 configured to carry one or more agents for delivery within the vessel wall. In other embodiments, the stent 1500 can comprise additional chambers formed by the outer layer 1520 and the inner layer 1530, or the stent 1500 can comprise additional layers configured to form one or more chambers. As illustrated, the chamber 1540 comprises an inlet port 1550 in the proximal region 1500a of the stent 1500. In other embodiments, the stent 1500 can comprise additional ports, such as inlet ports and / or outlet ports, disposed in other regions of the stent 1500 (e.g., the distal region 1500b and / or the proximal region 1500a).

[0071] The chamber 1540 further comprises a conduit 1560 fluidly coupled to the chamber and covering a plurality of drug delivery features 1590. As illustrated, each of the conduits 1560 comprises an outlet port 1580 at its end. In other embodiments, the outlet port 1580 can be disposed at other locations on the conduit 1560. In further embodiments, the chamber 1540 and the conduit 1560 can be fluidly coupled to a connector 150 of the system 100. The connector 150 can be configured to inject a fluid containing an agent into the chamber 1540 via a port 152 (e.g., an infusion port) and to discharge fluid from the chamber 1540.

[0072] The conduit 1560 is configured to release the drug from the chamber 1540 through the outlet port 1580 into the wall after the drug delivery feature 1590 pierces the lumen wall. One or more conduits 1560 can at least partially contain the drug and protect against premature release of the drug into the lumen wall (e.g., by abrasion when delivering an associated stent through a catheter). When in contact with or piercing the body cavity wall (e.g., blood vessel wall), tissue and / or fluid can interact with the drug delivery feature 1590, one or more conduits 1560, and / or one or more openings 1580 to selectively release the drug from the chamber 1540. In other embodiments, the drug delivery feature 1590 can be configured to deliver the drug by various means when the stent 1500 is expanded. Thus, the drug delivery feature 1590 is expected to provide an effective means for selectively delivering the drug to a desired location while reducing unintentional loss or release of the drug.

[0073] In some embodiments, a stent 1500 comprising a drug delivery feature 1590 configured in accordance with the present technique can include a drug delivery feature 1590, a chamber 1540, a conduit 1560, and / or an opening 1580 of the conduit that is hidden (e.g., retracted) until the stent 1500 is placed at a desired location (e.g., target site or treatment site). When placed at the treatment site, the drug delivery feature 1590, the chamber 1540, the conduit 1560, and / or the opening 1580 of the conduit can be revealed (e.g., expanded / protruded, etc.) during and / or after expansion of the stent 1500. This is expected to reduce any loss of the drug carried by the drug delivery feature 1590 during delivery to the treatment site.

[0074] III. Methods of Delivering and Retrieving Stents and Other Structures, and Related Systems and Methods FIG. 16 is a configuration diagram showing a method ( "method 1600") for delivering and retrieving an expandable structure according to an embodiment of the present technology. The expandable structure is a stent such as a stent having one or more drug delivery features. Method 1600 can include, at block 1610, advancing the expandable structure distally to a target site within a patient's body using a stabilization wire attached to the expandable structure. As described in more detail previously, the stabilization wire can have a length suitable for maintaining the location of the expandable structure at the target site while the outer shaft and / or guide wire advances distally and / or is retracted proximally. In one embodiment, for example, the location of the stabilization wire is maintained by actuating a portion of the stabilization wire disposed outside the body. In one embodiment, method 1600 further includes delivering a guide wire, such as a 0.36 mm (0.014 inch) guide wire, to the target site. For example, the guide wire can be inserted into an inner shaft, such as a delivery catheter, and then into an outer shaft, such as a guide catheter, introducer sheath.

[0075] Method 1600 includes, at block 1620, placing the expandable structure at the target site within the blood vessel using the attached stabilization wire and guide wire. The step of placing the stent further includes advancing the outer shaft to the treatment site, which may have previously undergone a different procedure (e.g., percutaneous transluminal angioplasty) in some cases. In one embodiment, the stent is placed using fluoroscopic guidance and can include markers that allow the clinician to align it with the target site.

[0076] Method 1600 includes, at block 1630, deforming an expandable structure from a thin delivery state to an expanded and deployed state at a target site while engaging attached stabilizing wires. For example, using a suitable visualization technique, the outer shaft can be retracted proximally until one or more X-ray contrast markers at the distal end of the stent are detected. After the distal end becomes visible, a fixation mechanism coupled to the stabilizing wire can be used to fix the stabilizing wire in place. In one embodiment, the fixation mechanism is adjusted to maintain the location of the stabilizing wire and the stent attached to the stabilizing wire, while the outer shaft (and optionally the inner shaft) can be retracted proximally (and optionally advanced distally) and removed from the body cavity.

[0077] After the stent has been delivered and expanded to the target site, a balloon can be delivered into at least a portion of the lumen of the expanded stent by inserting the balloon onto a guide wire using any number of standard techniques until the distal portion of the balloon is aligned with the distal portion of the stent. For example, the balloon can comprise a distal X-ray contrast marker that can be visualized using fluoroscopic guidance. In one embodiment, the balloon can be a percutaneous transluminal angioplasty balloon (e.g., approximately 4 mm x approximately 60 mm on a 0.36 mm (0.014 inch) guide wire). As discussed with respect to block 1630, the stabilizing wires can be fixed in a position that maintains the location of the expanded stent while the balloon is being delivered, expanded (e.g., inflated), deflated (e.g., collapsed), and withdrawn.

[0078] Method 1600 includes, at block 1640, delivering a retrieval catheter to a target site along a stabilization wire and a guide wire attached to an expandable structure. For example, the retrieval catheter can be delivered such that when the retrieval catheter is delivered into the body cavity, a groove fluidly connected to an opening at a distal portion, such as an opening at the tip, carries the stabilization wire and the guide wire. In certain embodiments, fluoroscopy can be used to visualize the position of the distal portion of the retrieval catheter to deliver the retrieval catheter to the target site.

[0079] Method 1600 also includes, at block 1650, advancing the retrieval catheter distally over the expandable structure to crush the expandable structure and at least partially cover it again. In certain embodiments, the distal end of the tip of the retrieval catheter can engage the proximal portion of a stent expanded at the target site and can at least partially crush the stent. The retrieval catheter can be advanced distally, for example, until the crushed stent is again covered within the distal portion of the retrieval catheter. For example, one or more radiopaque markers disposed on the proximal and distal portions of the stent can be visualized to determine, such as the visualized proximal end of one or more radiopaque markers connected to the distal portion of the retrieval catheter, when the stent is again covered within the distal portion of the retrieval catheter.

[0080] Method 1600 further includes, at block 1660, advancing the crushed expandable structure within the retrieval catheter from the target site by retracting the stabilization wire and the guide wire. Method 1600 can also include, after block 1660, withdrawing the retrieval catheter from the body cavity to remove the crushed stent covered within the retrieval catheter. Optionally, method 1600 can continue with steps such as delivering a second stent and / or a second balloon to the target site by using any number of intraluminal techniques.

[0081] IV. Further Embodiments of Stents and Other Structures, and Related Systems and Methods The embodiments described herein provide a delivery system for one or more structures having means for delivering a drug to a specific region within a body cavity, such as a vasculature, while allowing fluid (e.g., blood) to still flow through a treatment area disposed within the body cavity adjacent to the structure and / or other devices or treatment means. In certain embodiments, fluid flow through the treatment area is temporarily impeded while one or more regions of a system (e.g., system 100) configured in accordance with the techniques herein are being delivered, deployed, positioned, and / or removed from the body cavity. Additionally, the delivery system can be configured to prepare the body cavity for treatment, proximal or distal to the treatment site, by tilting, pulling, rotating, or combinations thereof, a stent. In other embodiments, the delivery system can be configured to rotate a stent when a mechanical force is applied.

[0082] The systems disclosed herein enable adjustment, re-engagement, and / or redeployment of an associated stent or other structure and / or deployment of a different stent or other structure, allowing the operator to more effectively and precisely treat a desired region with greater care. In some embodiments, a stent or other delivery structure can be deployed for a temporary period (e.g., less than 24 hours), then retracted and removed. In such embodiments, the drug delivery features engage and / or penetrate the luminal wall and can remain in the luminal wall after the stent or other delivery structure is removed or can be retracted and removed with the stent or other delivery structure. The stent can be configured to self-expand or partially self-expand when deployed from the delivery system. The stent can also be configured to further expand within the body cavity when a balloon is inflated within the stent. The stent can be configured to expand later when removed from the body cavity. In other embodiments, a stent or other delivery structure can be deployed for a temporary extended period (e.g., less than 2 weeks, less than 1 month, less than 6 months, less than 1 year), then retracted and removed. In one embodiment, another stent or delivery structure can be deployed after the first stent or delivery structure is retracted and removed. The deployment period and the period after removal prior to deploying another stent or delivery structure can vary from minutes to hours, days, weeks, months, or years. In such embodiments, the removal of the first stent or delivery structure and the deployment of another stent or delivery structure can be performed 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times. Additionally, the embodiments described herein can enable a system that is thinner than currently available balloons.

[0083] In the embodiments described herein and other embodiments configured in accordance with the present technology, stents and other expandable structures can have non-drug delivery features such as deployable and / or expandable features that are not configured to deliver a drug to a target location. For example, stents and other expandable structures configured in accordance with the present technology can comprise one or more drug delivery features, one or more non-drug delivery features, or a combination thereof.

[0084] Many embodiments of the stents and / or structures described herein include stents, while further embodiments of expandable elements such as stents and / or structures can include non-drug eluting stents and / or non-drug eluting structures. In such embodiments, a non-drug eluting stent can comprise one or more protruding members such as spikes. The spikes can be configured to engage and / or penetrate a portion of a body cavity or vasculature. For example, the spikes can penetrate the vessel wall, thereby reducing and / or eliminating the elasticity of the vessel wall. In such embodiments, the protruding members can be configured to prevent the vessel wall from moving inwardly towards the body cavity and restricting and / or limiting the flow within the vessel wall. The protruding members can be formed integrally with the struts or disposed on the surface of the struts and extend radially outwardly from the struts towards the target tissue.

[0085] V. Further Examples The following examples are some exemplary embodiments of the present technology. 1. a connector having a connector lumen; an elongate outer shaft fixedly connected to the distal end of the connector and the outer shaft hub and having an outer shaft lumen; an elongate pusher shaft slidably disposed within the outer shaft lumen and the connector lumen, fixedly connected to the pusher shaft hub, and having a first pusher shaft lumen and a second pusher shaft lumen; An elongated inner shaft having a lumen and slidably disposed within a first pusher shaft lumen; A stent shaft slidably disposed within a second pusher shaft lumen and fixedly coupled to the proximal end of a stent to be delivered by the system to a target location within a patient's body; A stent system having the same. The system of Example 1, further comprising a balloon slidably disposed within the inner shaft lumen. The systems of Examples 1 and 2, further comprising a force element fixedly coupled to the outer shaft. The systems of Examples 1 to 3, wherein the element is disposed distally on the outer shaft from the outer shaft hub. The systems of Examples 1 to 4, wherein the connector further comprises a port coupled to the connector lumen. The systems of Examples 1 to 5, wherein the outer shaft hub is disposed distally on the outer shaft from the connector. The systems of Examples 1 to 6, wherein the pusher shaft hub is disposed proximally on the outer shaft from the connector. The systems of Examples 1 to 7, further comprising a stent shaft hub fixedly or slidably coupled to the stent shaft. The systems of Examples 1 to 8, wherein the stent shaft hub is disposed proximally on the stent shaft from the connector. The systems of Examples 1 to 9, wherein the pusher shaft hub is disposed distally on the pusher shaft from the stent shaft hub. The systems of Examples 1 to 10, wherein the pusher shaft hub further comprises a first coupling feature and the stent shaft hub further comprises a second coupling feature, and the first coupling feature is sized and shaped to engage the second coupling feature. The systems of Examples 1 to 11, wherein the first coupling feature is engaged with the second coupling feature. 13. The inner shaft lumen is a system from Example 1 to 12 that is partially covered by the inner shaft. 14. The second pusher - shaft lumen is a system from Example 1 to 13 that is partially covered by a part of the pusher - shaft. 15. The system from Example 1 to 14 further having a guide wire slidably disposed within the inner shaft lumen. 16. The inner shaft is a guide - wire tube in the system from Example 1 to 15. 17. The element is a strain - relieving shrink - tube in the system from Example 1 to 16. 18. The stent is a radially expandable cylindrical frame or braided mesh comprising a plurality of struts or wires, and a plurality of protruding features equipped by one or more struts in the system from Example 1 to 17. 19. The system from Example 1 to 18, wherein the plurality of protruding features has a first set of protruding features equipped by a first strut and a second set of protruding features equipped by a second different strut. 20. The system from Example 1 to 19, wherein the plurality of protruding features are separate individual components attached to the struts. 21. The system from Example 1 to 20, wherein the plurality of protruding features have a liquid reservoir integrally formed therein. 22. The system from Example 1 to 21, wherein the plurality of protruding features, the stent, or a combination thereof is coated with a substrate. 23. The stent further has an X - ray contrast marker in the system from Example 1 to 22. 24. The stent, a part of the stent, the plurality of protruding features, a part of the plurality of features, each part of the plurality of features, or a combination thereof is biodegradable in the system from Example 1 to 23. 25. A system for delivering, deploying, and recapturing a stent within a patient's body cavity, An elongate outer shaft configured to cover at least one region of the stent, an outer shaft hub configured to retract the outer shaft in a proximal direction and / or advance it in a distal direction, and an elongate pusher shaft configured to advance the stent in a distal direction, a pusher shaft hub configured to retract the pusher shaft in a proximal direction and / or advance it in a distal direction and having, wherein the stent is configured to deform between a thin delivery state and an expanded and deployed state, and in the deployed state, a plurality of protruding features equipped with one or more struts extend radially outward away from the struts and are configured to engage a first portion of the body cavity, a system. 26. The system of example 25, further comprising an elongate inner shaft configured to dispose a guide wire within the body cavity, having a partially sealed inner shaft lumen, and being partially configured to release the guide wire. 27. The system of examples 25 and 26, wherein the guide wire is configured to release to remove a first catheter from the system and insert a second catheter into the system. 28. The system of examples 25 to 27, wherein the stent self-expands. 29. The system of examples 25 to 28, wherein the stent is configured to be mechanically actuated to deform the stent between a delivery state and a deployed state. 30. The system of examples 25 to 29, further comprising a balloon configured to expand when disposed within the lumen of the stent. 31. The system of examples 25 to 30, wherein when the balloon expands, the stent deforms from a delivery state to a deployed state. 32. The system of examples 25 to 31, wherein the first of the outer shafts further comprises a strain relief element configured to prevent the first portion of the outer shaft from collapsing on the second portion of the outer shaft. 33. The pusher shaft, from Example 25 to 32, is configured to prevent the stent from advancing in the proximal direction while the stent deforms from the delivery state to the deployed state. 34. The system from Example 25 to 33 further includes a stent shaft and a stent shaft hub fixedly coupled to the stent shaft and configured to maintain the location of the stent. 35. The stent is further configured to deform from the deployed state to a thin, removable state, in which the plurality of protruding features retract inwardly toward the struts and the outer shaft is configured to again cover the stent, from Example 25 to 34. 36. When the stent transitions from the deployed state to the removable state, the stent shaft hub maintains the location of the stent during the transition, from Example 25 to 35. 37. A method for delivering and deploying a stent within a patient's body cavity, delivering an elongated shaft covering the stent intravascularly to a target treatment site within the patient's body cavity; retracting the elongated shaft in a proximal direction to at least partially remove the stent; advancing a balloon in a thin delivery state distally into the lumen of the stent; expanding the stent radially to an expanded state by deforming the balloon from the thin delivery state to an inflated state; piercing a portion of the wall of the patient's lumen with one or more protruding features; and having, the stent a radially expandable cylindrical frame comprising a plurality of struts; a plurality of protruding features equipped with one or more struts and configured to deliver a drug to a treatment site within the patient's body cavity; Method. 38. The method of Example 37, further comprising the step of deploying the stent at a target treatment site by advancing a pusher shaft, which is connected to the proximal end of the stent, through the lumen of the elongate shaft in the distal direction. 39. The method of Examples 37 and 38, further comprising the step of removing the pusher shaft from the lumen of the elongate shaft. 40. The methods of Examples 37 to 39, further comprising the step of radially compressing the stent from an expanded state to a thinner state. 41. The methods of Examples 37 to 40, further comprising the steps of disposing the pusher shaft within the lumen of the elongate shaft, engaging the distal end of the pusher shaft with the proximal end of the stent, and removing the stent from the lumen. 42. The methods of Examples 37 to 41, further comprising the steps of advancing the elongate shaft distally to cover the compressed stent and retracting the elongate shaft proximally. 43. The methods of Examples 37 to 42, wherein one or more of the plurality of projecting features separate from the frame after piercing a portion of the wall of the patient's body cavity. 44. The methods of Examples 37 to 43, wherein the plurality of projecting features have fluid reservoirs integrally formed therein and / or the plurality of projecting features, the stent, or combinations thereof are coated with a substrate configured to deliver a medicament carried therein to the patient to prevent clotting, prevent occlusion of the stent, or a combination thereof. 45. The methods of Examples 37 to 44, wherein the frame is connected to the stent and has a chamber extending along the length of the stent. 46. The methods of Examples 37 to 45, wherein one or more of the plurality of projecting features comprise conduits fluidly connected to the fluid reservoir, the chamber, or a combination thereof. 47. The methods of Examples 37 to 46, wherein when the frame is in an expanded state within the body cavity, the stent is configured to allow one or more substances to flow from the fluid reservoir, the chamber, or a combination thereof, through at least one of the conduits of the drug delivery feature and through the wall. 48. An expandable element delivery system comprising: a connector having a connector lumen; an outer shaft hub; an elongate outer shaft fixedly connected to the distal end of the connector and the outer shaft hub and having an outer shaft lumen; an expandable element carried by the distal portion of the elongate outer shaft and configured to be delivered to a target location within a patient's body; an elongate positioning shaft slidably disposed within the lumen of the outer shaft, extending through an opening in the connector, and having its distal portion fixedly connected to the expandable element; an elongate inner shaft slidably disposed within the lumen of the outer shaft; and a delivery system having the same. 49. The delivery system of example 48, wherein the inner shaft has a guidewire lumen. 50. The delivery system of example 49, further comprising a guidewire slidably disposed within the lumen of the guidewire. 51. The expandable element comprises: a radially expandable cylindrical frame or braided mesh comprising a plurality of struts or wires; a plurality of protruding features equipped with one or more struts; and a delivery system according to any of examples 48 to 50 having the same. 52. The delivery system of example 51, wherein the plurality of protruding features comprises a first set of protruding features equipped with a first strut and a second set of protruding features equipped with a second different strut. 53. The delivery system of example 51, wherein the plurality of protruding features are separate individual components attached to the struts. 54. The delivery system of example 51, wherein the plurality of protruding features have liquid reservoirs integrally formed therein. 55. The delivery system of example 51, wherein the plurality of protruding features, stents, or combinations thereof are at least partially coated with a material. 56. The expandable element is the delivery system of Examples 48 to 55, further having an X-ray contrast marker. 57. The X-ray contrast marker is disposed on the proximal portion of the elongated positioning shaft, the distal portion of the elongated positioning shaft, or a combination thereof, of the delivery system of Example 56. 58. The positioning shaft is a stabilizing shaft, of the delivery system of Examples 48 to 57. 59. The expandable element, a part of the expandable element, a plurality of protruding features, a part of the plurality of features, a part of each of the plurality of features, or a combination thereof is biodegradable, of the delivery system of Examples 48 to 58. 60. The elongated positioning shaft is configured to maintain the location of the expandable element at a target location within the patient's body during treatment, of the delivery system of Examples 48 to 59. 61. The elongated positioning shaft is configured to maintain the location of the expandable element while the elongated outer shaft, the elongated inner shaft, another shaft, or a combination thereof is disposed intravascularly within the patient's body, of the delivery system of Examples 48 to 60.

[0086] References to elements in the singular are not intended to mean "only one" unless specifically stated otherwise, but rather are intended to mean "one or more." For example, a "module" may refer to multiple modules. Elements beginning with "a," "an," "the," or "said" do not, in the absence of other constraints, preclude the presence of additional same elements.

[0087] Headings and subheadings, if any, are used for convenience only and do not limit the invention. The use of the word "exemplary" means serving as an example or illustration. To the extent that terms such as "comprising", "having", etc. are used, such terms are intended to be inclusive in the same manner as the term "having" is construed when used as a transitional term in a claim. The use of relative terms such as "first" and "second" can distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between the entities or actions.

[0088] Phrases such as "aspect", "the aspect", "another aspect", "some aspects", "one or more aspects", "embodiment", "the embodiment", "another embodiment", "some embodiments", "one or more embodiments", "example", "the example", "another example", "some examples", "one or more examples", "configuration", "the configuration", "another configuration", "some configurations", "one or more configurations", "the present technology", "disclosure", "the present disclosure", and other variations thereof are for convenience only and do not imply that the disclosure related to such phrases is essential to the present technology or that such disclosure applies to all configurations of the present technology. The disclosure related to such phrases may apply to all configurations or to one or more configurations. The disclosure related to such phrases may provide one or more examples. Phrases such as "aspect" or "some aspects" can refer to one or more "aspects", and vice versa, and this applies equally to the other aforementioned phrases.

[0089] The phrase "at least one" preceding a series of items modifies the entire list rather than each element of the list, accompanied by the term "and" or "or" that separates any of the items. The phrase "at least one" does not necessarily require the selection of at least one item, but rather can mean including at least one of any one of the items, at least one of any combination of the items, and / or at least one of each of the items. As an example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refers to only A, only B, or only C, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0090] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes are examples of exemplary approaches. Unless otherwise specified, it should be understood that the specific order or hierarchy of steps, operations, or processes can be performed in a different order. Some steps, operations, or processes can be performed simultaneously. The appended method claims, if any, present the various steps, operations, or elements of the process in an order of examples and are not meant to be limited to the specific order or hierarchy presented. These can be performed sequentially, continuously, in parallel, or in a different order. It should be understood that the instructions, operations, and systems described can generally be integrated into a single software / hardware product or packaged into multiple software / hardware products.

[0091] In one aspect, terms such as "connected" can refer to being directly connected. In another aspect, terms such as "connected" can refer to being indirectly connected.

[0092] Terms such as "upper", "lower", "front", "rear", "side", "horizontal", "vertical", etc. refer to any reference configuration rather than the reference configuration by normal gravity. Thus, such terms can extend in an upward, downward, diagonal, or horizontal direction within the reference configuration by gravity.

[0093] The disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some cases, well-known structures and components are shown in block diagram form in order not to obscure the concepts of the present technology. The disclosure provides various examples of the present technology, and the present technology is not limited to such examples. Various modifications to such aspects will be readily apparent to those skilled in the art. And the principles described herein may be applied to other aspects.

[0094] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Further, nothing disclosed herein is intended to be dedicated to the public whether or not the disclosure is expressly recited in the claims. Claim elements should not be construed under 35 U.S.C. § 112, ¶ 6 unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "steps of".

[0095] The title, background, brief description of the drawings, summary, and drawings are incorporated herein by reference and provided as illustrative examples of the present disclosure, not as limiting descriptions. It is understood and submitted that these will not be used to limit the scope or meaning of the claims. Further, in the detailed description, the description provides illustrative examples and it can be seen that various features are grouped together in various embodiments to rationalize the disclosure. The method of the disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as reflected in the claims, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation. The claims are incorporated herein by reference into the detailed description, and each claim stands on its own as a separately claimed subject matter.

[0096] The claims are not intended to be limited to the aspects described in this specification, but rather the full scope consistent with the language of the claims should be allowed, and all legal equivalents should be encompassed. Nevertheless, none of the claims are intended to cover, nor should they be construed to cover, subject matter that fails to meet the requirements of the applicable patent law.

Claims

1. A stent system, comprising an elongate outer shaft (120, 220, 420) having an outer shaft lumen (266), an elongate pusher shaft (280) slidably disposed within the outer shaft lumen, the elongate pusher shaft (280) having a first pusher shaft lumen (282) and a second pusher shaft lumen (284), an elongate inner shaft (110, 410) having a lumen (516) slidably disposed within the first pusher shaft lumen, a stent tensioning wire (118, 182, 228) slidably disposed within the second pusher shaft lumen, a stent (190) having a plurality of spines, the stent being disposed distally of the distal end of the elongate pusher shaft, the elongate inner shaft extending through the lumen of the stent, the stent tensioning wire being fixedly connected at its distal end to the proximal end of the stent, such that the stent tensioning wire and the stent remain integrally connected when the stent tensioning wire slides relative to the elongate outer shaft, and the stent being movable beyond the distal end of the elongate outer shaft from within the outer shaft lumen by being pushed distally by the elongate pusher shaft or by pulling the elongate outer shaft proximally, the stent self-expanding to a deployed state such that when delivered to a target position within a patient, the spines extend radially outwardly and penetrate a portion of the body cavity for a temporary period, a stent (190) having a stent system.

2. Further comprising a balloon connected to an elongate shaft extending through the elongate outer shaft, the balloon being configured to be disposed within the lumen of the stent, the system of claim 1.

3. A stent pulling wire hub connected to the stent pulling wire, A pusher shaft hub connected to the pusher shaft and further comprising The pusher shaft hub further comprises a first coupling feature, the stent pulling wire hub further comprises a second coupling feature, and the first coupling feature is sized and shaped to engage the second coupling feature. The system according to claim 1. **Claim 4** The inner shaft lumen of the inner shaft is only partially covered by the "C"-shaped cross-section of the inner shaft, thereby enabling rapid removal of the shaft carried therein. The system according to claim 1. **Claim 5** The second pusher shaft lumen is only partially covered by the "C"-shaped cross-section of a part of the pusher shaft, thereby enabling rapid removal of the stent pulling wire. The system according to claim 1. **Claim 6** The stent has a radially expandable cylindrical frame having a plurality of struts, and the spines carried by the struts The system according to claim 1. **Claim 7** A system for delivering a stent (190) into a patient's body cavity, the stent having a stent lumen, an elongated outer shaft (120, 220, 420) configured to cover at least one region of the stent, an elongated pusher shaft (280) within the elongated outer shaft, the elongated pusher shaft having a first pusher shaft lumen (282) and a second pusher shaft lumen (284), and the stent being disposed distal to the distal end of the elongated pusher shaft. The elongated pusher shaft (280), A stent tension wire (118) slidably disposed within the lumen of the second pusher shaft, the stent being fixedly coupled to the stent tension wire, the stent tension wire (118); An elongated inner shaft (110, 410) slidably disposed within the lumen of the first pusher shaft and extending through the lumen of the stent; having; The stent can be moved from within the lumen of the outer shaft beyond the distal end of the elongated outer shaft by being pushed distally by the elongated pusher shaft or by pulling the elongated outer shaft proximally; The stent self-expands to deform between a thin delivery state and a temporarily expanded deployed state, and In the deployed state, a plurality of protruding features carried by one or more struts of the stent extend radially outward away from the struts and are configured to engage a first portion of the body cavity; System. **Claim 8** The system according to claim 7, further comprising a balloon extending through the elongated outer shaft, the balloon being configured to expand when disposed within the lumen of the stent. **Claim 9** The system according to claim 7, further comprising a stent tension wire hub, the tension wire hub being coupled to the stent tension wire. **Claim 10** The system according to claim 7, wherein the stent is further configured to deform from the deployed state to a thin removable state, and in the removable state, the outer shaft is configured to again cover the stent. **Claim 11** A delivery system for a stent, An elongated outer shaft (120, 220, 420); The stent (190) carried within the distal portion of the elongated outer shaft, the stent being configured for delivery to a target location within a patient's body for a temporary period and having a radially self-expandable cylindrical frame having a plurality of struts and spines carried by the struts, the spines being circumferentially spaced from each other along the perimeter formed by the struts and extending radially in the deployed state of the stent for penetrating a portion of a body cavity, the stent (190); An elongated pusher shaft (280) within the elongated outer shaft, the elongated pusher shaft being configured to advance the stent distally, the stent being coupled to the elongated pusher shaft, the pusher shaft having a first pusher shaft lumen (282) and a second pusher shaft lumen (284), the elongated pusher shaft (280); A stent tensioning wire (118, 182, 228) slidably disposed within the second pusher shaft lumen, the distal portion of which is fixedly coupled to the stent by welding, the stent tensioning wire (118, 182, 228); An elongated inner shaft (110, 410) slidably disposed within the first pusher shaft lumen and extending through the stent, the stent tensioning wire and the stent being slidable integrally with respect to the elongated outer shaft, the elongated inner shaft (110, 410); A delivery system having.

12. The delivery system according to claim 11, wherein the stent, a part of the stent, the spine, a part of the spine, each part of the spine, or a combination thereof is biodegradable.

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